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Download date: 12 Nov 2020

BRICKS ANDBRIDGESIN HEALTHCARE

By

Alexandru Mihai Rotar

A series of international comparative studies on how rationalization strategies are applied across different levels of health care systems.

Bricks & Bridges in Healthcare

A series of international comparative studies on how rationalization strategies are applied across different

levels of health care systems

by Alexandru Mihai Rotar

Bricks & Bridges in HealthcareA series of international comparative studies on how rationalization strategies are applied across different levels of health care systems

Alexandru Mihai Rotar

ISBN: 978-90-823122-6-3

Cover design: Bogdan Tănase-MarinescuLayout: Ana FranciscPrinting: Aimee C&A

© Alexandru Mihai RotarAll right reserved. No part of this publication may be reported, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the author or the copyright-owning journals for published chapters.

Bricks & Bridges in HealthcareA series of international comparative studies on how rationalization strategies are applied across different levels of health care systems

ACADEMISCH PROEFSCHRIFT

ter verkrijging van de graad van doctoraan de Universiteit van Amsterdamop gezag van de Rector Magnificus

prof. dr. ir. K.I.J. Maex

ten overstaan van een door het College voor Promoties ingestelde commissie, in het openbaar te verdedigen in de Agnietenkapel

op vrijdag 7 februari 2020, te 14.00 uurdoor Alexandru Mihai Rotar

geboren te Iasi

Promotiecommissie:

Promotor: Prof. dr. N.S. Klazinga AMC - UvA

Copromotor: Dr. M.J. van den Berg AMC - UvA

Overige leden: Prof. dr. K. Stronks AMC - UvA Prof. dr. N.F de Keizer AMC - UvA

Prof. dr. D.M.J. Delnoij Erasmus Universiteit Rotterdam Prof. dr. J. Mainz Aalborg University Prof. dr. M.J.M.H. Lombarts AMC - UvA

Faculteit der Geneeskunde

CONTENT

INTRODUCTION page 7

CHAPTER 1 Shared decision making between patient and GP about referrals from primary care: Does gatekeeping make a difference

page 23

CHAPTER 2 Mapping health care system strategies to support rational drug prescribing in primary care across 13 European countries

page 41

CHAPTER 3 The involvement of medical doctors in hospital governance and implications for quality management: a quick scan in 19 and an in depth study in 7 OECD countries

page 55

CHAPTER 4

CHAPTER 4.1 Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria

page 77

CHAPTER 4.2 The role of managed entry agreements in Central and Eastern European countries

page 103

CHAPTER 5 Reporting and use of the OECD Health Care Quality Indicators at national and regional level in 15 countries

page 125

DISCUSSION page 157

SUMMARY/ SAMENVATTING

page 175

BIOGRAPHY & PhD PORTFOLIO

page 183

ACKNOWLEDGEMENTS page 189

INTRODUCTION

9

BACKGROUNDThe World Bank reports that in 2017 the global life expectancy at birth is 72 years [1], with many developed countries exceeding it [2][3]. Several countries experienced a fast increase in life expectancy, some adding over the past 50 years more than 25 years to the average life expectancy [4][5]. However, this leap forward also poses major societal challenges. This constant increase in life expectancy is associated with 1) rising expectations about health care, 2) ageing populations, 3) changes in epidemiology - more specifically, a rising prevalence of chronic conditions and multi morbidity, and 4) fast technological development. All these, lead to an increased use and related costs of health care services. Getting a grip on health spending has become an economic and political challenge for many governments, especially in the aftermath of the economic crisis in 2008. Providing good health care becomes more challenging since funding is also needed for other public interests (e.g. education, housing, environment) [6]. Consequently, rationalization can be a useful approach to optimize the use of the existing resources. Questions on how to do this in practice, however, are still multiple, and are the focus of many scientific endeavours. This thesis aims to contribute to answering part of these questions, by looking at rationalization from the perspective of Quality of Care (QoC) and related approaches of Evidence Based Medicine (EBM) and Health Technology Assessment (HTA) that are applied in the decision-making processes across different levels of health care systems. The concept of rationalization was firstly introduced by Max Weber in 1905 through his work “The Protestant Ethic and the Spirit of Capitalism” [7]. According to Weber, rationalization refers to the process by which the modern society has an increasing focus on 1) efficiency – achieving the maximum result with the minimum amount of effort, 2) predictability – the desire to predict what will happen in the future, 3) a concern with numerical data, i.e. statistics and scoring, and 4) dehumanization – employ technology as means to control human behaviour. Rationalization is a product of science and technological advances. Weber argues that rationalization has led to behaviours based on reason and practicality instead of customs and traditions. Consequently, rationalization played a critical role in the societal transformations and the development of capitalism. According to the Merriam-Webster dictionary, rationalization means “to apply the principles of scientific management to something, (such as an industry or its operations) for a desired result (such as increased efficiency)” [8]. Building’s on Weber’s work, during the industrialization period, Frederick Taylor in “The Principles of Scientific Management” [9] uses rationalization to improve operationalization strategies with the final goal to increase productivity through scientific management of workers. The scientific management methods intended to optimize work outcomes and simplify jobs, so that workers could be trained to obtain maximum from their tasks, i.e. maximize efficiency. In this respect, he proposed in 1911 four principles of scientific management:

1) replace “rule-of-thumb” methods with work paths based on scientific evidence,

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2) formal selection, training, and development of each worker,3) assure that the scientific established methods are followed and 4) ensure that the managers apply the scientific management principles

for work planning and that workers actually perform the tasks.

The implementation of these principles became popular in the following years, especially among large organizations (e.g. Henry Ford), with often-associated increased productivity. The special thing about the rationalization of the health care production industry is that the knowledge on which it is based is science too, and in its optimization we see two waves – 1) the rationalization of the complexity of the delivery system by Donabedian through operationalizing Quality of Care in late 70’s – early 80’s, and 2) successive two approaches of the late 20th century for optimizing the synthesis of the evidence itself – Evidence Based Medicine and Health Technology Assessment.

Quality of Care (QoC) The principles of scientific management that strongly influenced the work on quality management of Joseph Juran, the leading pioneer of quality [10][11], were later applied to the growing complexity of health care services and delivery. Within the health care delivery process, rationalization and the principles of scientific management are meant to organize and optimize the production processes and clinical practice [12][13][14]. This was already reflected in Florence Nightingale’s attempt to evaluate and organize care during the Crimean War by using easy to understand visualizations of outcome statistics and Ernest Codman’s implementation of outcomes measurement in health care in 1910. A few decades later, after health service rationalization was seen as a major public policy emerging in Western Europe, Donabedian used, in late 70’s – early 80’s, the theories of scientific management to use science as a basis in medicine to measure quality of care along three categories – structure, process and outcomes [13][14]. He saw health care as a production process that needs to be managed, not just by having a trained workforce, but also by standardizing it through guidelines, indicators and continuous feed-back for learning.

The work of Donabedian brought the already applied Weber’s and Taylor’s concepts by other sectors (e.g. car manufacturing) to health care, which diffused to all its related areas, starting from use of medicines, hospitalizations and broader health system policy-making. Among many, it offered additional grounding, aside from Codman’s standardization of the production processes, for Evidence Based Medicine (EBM) [12] and Health Technology Assessment [16][17]. Both of them are pillars for summarizing scientific knowledge and techniques to systematically embed the scientific knowledge in the production processes – practice of medicine, delivery of health care services, the organization and performance of health care systems and decision-making support.

11

Measuring outcomes accordingly, would become a guiding principle and an indispensable tool for health care reforms and continuous monitoring and learning.

Evidence Based Medicine (EBM) EBM is an approach intended to optimize the decision-making process in medical practice by using scientific evidence and is conceptually related to rationalization [18][19]. It was first introduced in 1996 by the McMaster University group as a new “paradigm for medical practice” [18], criticizing the existing clinical decision-making grounded on individual experience. As a consequence, extensive work has been done on the relation between EBM and rationalization, with many voices arguing that EBM should be part of the further rationalization of health services, with the final aim at improving health outcomes as measured by quality indicators [20][21]. This created a reply from social sciences [21] that led to the idea that not only medical practice, but also health care policy-making should be grounded on evidence. Evidence based policy-making (EBP) has been conceptualized as a set of regulations and institutional arrangements aiming at transparency and justifiable decisions [22]. The importance of EBP started to grow, especially in the UK, following the Cochrane Collaboration establishment in 1993 and its aim to provide grounding research in human health and health policy, by bringing together the existing evidence into reviews and meta-analysis, and used for the policy agenda later on by the Blair administration [23][24][25]. The purpose of including EBP in the decision-making process agenda was to replace the ideological driven policies with more rational decisions [23].

Health Technology Assessment (HTA)HTA at its core is a tool for evidence development aimed at informing policy-making for creating rational decisions on the adoption and use of technology. It was first conceptualized in 1976 in the United States of America [26]. In the same time period, a group of Swedish researchers started to perform evaluations for a selected group of technologies for rationalization reasons. It wasn’t until a few decades later that the concept was picked up by Western Europe countries in the 90’s [27]. The main drivers behind the growing popularity of HTA, and to create room for it to influence policy in Western Europe, were the same as for the Swedish researchers – questions about costs, value for money, benefits and risks [16]. With different needs and health care systems, varied political priorities and distinctive human resource capabilities, there is little wonder why HTA develop differently across countries. At a European Union level, most countries have some form of HTA in place, with the Eastern European block being the last group of countries to adopt it. Estonia, Hungary and Poland during the 2000’s

12

were the first countries in Eastern Europe to include HTA in the decision-making processes during the pre-accession period to the EU. The spread of HTA continued further, catalysed also by the 2008 economic crisis. More recently, HTA’s growing importance has been shown by the implication of the European Commission and its attempt to provide a level of harmonization across Member States.

Levels in the health care system where rationalization strategies are appliedHealth care systems have many interconnected layers and stakeholders, with various forms of interaction among them (e.g. patients and professionals in the consulting room), all embedded in larger services and organizations (primary care practice, hospitals). All these are, in turn, part of larger systems of governance and financing (health care systems). Rationalization thinking and scientific management principles can be applied on all these levels, in alternative ways, involving various stakeholders. This thesis contains a series of studies on the application of rationalization strategies on different levels of health care systems, on a variety of related topics, across different countries. The theoretical reasons to study the rationalization phenomenon across different layers and countries, lies in the choice to keep a broad perspective and focus on the interaction between services and system components, rather than on specific aspects at one level, service or country. Hence, as is reflected in the title of this thesis, emphasis is not only on isolated bricks of rationality, but also how they are interconnected across different levels in the health care system – bridges. The assumption is that this multi-layered international comparative approach may generate valuable insights with a potential of transferability and learning across countries. For practical reasons, this thesis is also grounded in several international research and policy initiatives that serve as the basis for data-collection (i.e. QUALICOPC, DUCQuE, OECD Health Care Quality Indicators Programme) [28][29][30]. By taking this multi-layered, multi-country approach, an attempt is made to get a better understanding of the application of rationalization strategies in the practice of health care services and systems.Rationalization can be applied at any level in health care. Decision-making processes exist at all levels and lay the foundation on their functioning with a direct impact on the outcomes. For this purpose, we have conceptualized a health care system consisting of 5 levels of activities related to each other as halo’s (see Figure 1): 1) professional-patient level, 2) professional practice level, 3) health services/organizational level, 4) system level, and 5) international level. On all these levels, different forms of decision-making exist across countries, and it is important to understand how those decision-making processes can be made more rational.

13

FIGURE 1 – Rationalization levels in health care

Level 1 – professional-patient – of the conceptualized structure addresses the interaction between patients and professionals, which can be considered the core production process of health care. The production of health care includes a variety of decision-making processes (e.g. communication, referrals, follow-up). At this level, this thesis examines 1) the doctor–patient relationship in primary care by looking at the shared decision-making (SDM) of the referrals as perceived by GPs, and 2) whether the perceived SDM is related to the existing referral structure in the health care system (i.e. gate-keeping). Primary care has been chosen for two reasons. Firstly, in many rationalization policies, it is seen as a place to which many health care services should be substituted to increase the performance of the system as a whole [31][32][33][34][35][36][37][38][39]. And secondly, the gatekeeping function of many primary care systems is a rationalization strategy, which in the light referrals needs to balance its rationalizing role with patients’ expectations. The importance of strengthening primary care is a key

14

government priority of the health care systems, given the increasing prevalence of chronic diseases, while being seen as a cost reduction mechanism for hospital expenditures. Thus, countries are looking to find ways to measure and improve quality of care in their primary care systems [40]. An underlying assumption is that the provided care applies to the principles of EBM and SDM, to be able to assure individual value. This part of the thesis focuses on the interaction between the primary care doctor and patient in the consulting room, where most of the contacts take place, health care is provided and rationalization may be firstly applied. The research at this level looks at GPs’ perceived SDM, as a rational approach that brings together the demands and needs of the patient with what the provider can offer.

At level 2 – professional practice level – the decision-making is related to the medical practice itself on whether rationalization of individual professionals incurs by conforming to guidelines and EBM. This can take the forms of prescribing patterns, diagnosis procedures and many others. The issue studied in this thesis is the medication prescribing in primary care, since this is the place where the patients get their first medication. This is a shift from the decision-making process between doctors and patients from the practice levels, to the decisions that are ideally fully in the domain of the doctor, in this case prescribing. The assumption is that prescribing is a decision of the doctors based on knowledge & science. At this level the thesis looks at the extent of existence of strategies to rationalize prescribing on the practice level of primary care and on the system level. The coexistence of these various rationalization strategies at different system levels is explored.

In level 3 – health services/organizational – the decision-making can be linked to the management of the clinical and organizational pathways in broader health care settings (e.g. hospitals, polyclinics, nursing homes), depending on patient profiles (e.g. myocardial infarction, stroke, hip replacement), and how the clinical decisions are embedded in the logistical processes. This thesis studies the hospital sector since it plays an important role in the health care industry. It accounts for 21% to 40% of the total health expenditure in OECD countries [3]. They are the centre of complex medical practice and are considered to be the place where medicine happens. Therefore, it is not surprising why the hospital sector is constantly in the centre of reform. As part of this process, doctors are drawn in the hospital governance mechanisms across the world [41][42]. Hospital performance can be increased if led by people who are key producers of clinical care [43] and organize their practices based on medical professionalization against management science or bureaucracy [44]. This assures that evidence based clinical pathways are at the basis of the management of the care delivery. Consequently, this level studies 1) the doctors’ involvement in management decisions, 2) whether that leads to quality improvements in hospitals, and 3) explores how this differs between European countries. At this level the research focuses on the relation between doctors and their level of involvement in management while complying with evidence-based practices.

15

Level 4 – system – is the level affected by many crucial decision-making processes. At this level, we find some of the most important decisions in a health care system – how to pay for health care (e.g. taxes), what to pay for (e.g. reimbursement), who should benefit from what (e.g. basic package), etc.. This thesis studies the decision-making processes based on rational decisions about deciding what is worth paying for – introducing and reimbursing new technologies takes place frequently at a system level. Building on David Banta’s work, with HTA being a rationalization strategy part of scientific management in health care, especially on pharmaceuticals, this part of the thesis studies the introduction and reimbursement conditions of medication on a system level. The pharmaceutical expenditures represent a significant share of health care spendings [3] and the importance of HTA grows on the governance agenda, moved forward by different bodies (e.g. EUNetHTA, European Commission). Consequently, at this level this thesis assesses the drug policies at a system level on HTA and Managed Entry Agreements – MEAs (as an associated mechanism for rationalization of drug reimbursement from public funds) – in a set of countries that have not been studied extensively, more specifically Central and Eastern European (CEE) countries.

At level 5 – international – rational decisions are often on how to steer the governance of health care systems based on performance outcomes comparison between countries, sharing good practices and developing international cooperation on global issues. The purpose of this work is to assess the use of performance and outcomes data for the improvement of the system. The research is rooted in the scientific management and quality outcomes discussion. Up to this day, there seems to be an established international consensus by policy-makers that the provision of high-quality care is an essential value of health care systems [45][46]. Through the years, OECD member states have developed a list of quality indicators enabling health care system comparisons [30][47][48]. The research at this level offers an international outlook of quality of care, by reporting how practice is monitored in a cyclic way in an attempt to learn and improve. Hence, it provides an outlook on whether a rational approach towards international comparisons of performance is actually embedded in national policy reporting and strategies.

Aims and outline of the thesisThe aim of this thesis is to contribute to the international knowledge on how rational decision-making strategies are implemented in health care, by offering an overview and examining how different rationalization strategies have developed at the 5 levels conceptualized within the health care systems’ complexity, across a series of countries. For this purpose, this thesis includes 5 chapters (1-5), that address several research questions and sub-questions corresponding to each of the 5 levels conceptualized, as represented in Figure 2.

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FIGURE 2 – Research questions for the rationalization levels in health care

Level 1Professional –

patient

Chapter 1Shared decision-making between patient and GP about referrals from primary care: Does gatekeeping make a difference?

• Do countries vary in how GPs perceive shared decision-making (SDM), in deciding upon patients’ referral?

• To what extent does shared-decision making in GPs’ referrals differ between gatekeeping and non-gatekeeping systems?

• What factors do GPs consider when referring to a medical specialist and how does this differ between gatekeeping and non-gate keeping systems?

Level 2 Professional

practice

Chapter 2 Strategies to enhance rational prescribing in primary care

• To what extent have European countries embedded strategies to support rational prescribing (targeted and system-oriented) and what are the types implemented?

Level 3Health services/organizational

Chapter 3 The involvement of medical doctors in hospital governance and implications for quality management: a quick scan in 19 and an in depth study in 7 OECD coutries

• What is the current situation with regards to doctor managers in the hospital systems of 19 OECD countries?

• What is the association between the level of doctors’ involvement in hospital management and the level of implementation of Quality Management Systems in 7 OECD countries (drawing upon the DUQuE project – “Deepening our understanding of quality improvement in Europe”)?

Level 4 National

Chapter 44.1 Health Technology Assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria

4.2 Rationalizing the introduction and use of pharmaceutical products: The role of managed entry agreements in Central and Eastern European contries

• What are the HTA policies in the series of CEE countries to date?• What are the similarities and differences between the individual

CEE countries?• How HTA was formalized, institutionalized, standardized its

methodology, is used in practice and what is the degree of professionalization of HTA in the region?

• What is the role of MEAs in CEE countries and the extend of their use?

• Which drugs are subject to MEAs in CEE and is there a match or not with the ones in Western Europe?

Level 5International

Chapter 5 Reporting and use of the OECD Heath Care Quality Indicators at national and regional level in 15 countries

• What is the extent of quality performance reports: what kind of indicators are described, what is their focus and function?

• How are the specific sets of the OECD quality indicators reported and used in these reports?

For answering the research questions, this work includes a series of international comparative studies on specific rationalization strategies and decision-making processes existing at each level. International comparative studies are used to understand the extent at which rationalization takes place. The studies included in this thesis have 3 main characteristics.

Firstly, all studies are explorative (chapter 1 & 3) and descriptive (chapters 2, 4 & 5). These health service research methodologies were chosen against others (e.g. experimental, quasi-experimental) given 1) the nature of the research questions, and 2) the need to standardize the existing phenomena and definitions of the same concepts across different health care systems.

Secondly, all studies are of international comparative nature. This provides challenges and limitations in standardization. Nevertheless, the purpose of this approach is to understand and offer insights on policies and decision processes at a broader level vs. in-depth health care system specificities.

Thirdly, although different clinical topics are chosen in several studies, the works main focus is medication. This is because medication is the most common type of treatment people receive, while the prescribing (e.g. in primary care as per the study part of this thesis) and the reimbursement (e.g. HTA and MEAs) decision-making processes are constantly under scrutiny across countries, as illustrated in Figure 2.

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Chapter 1 looks at rational decisions from the perspective of SDM in primary care between the primary care doctor and patient. Primary care was chosen since its strengthening is a priority for many countries. In this context, SDM is critical since it builds the values of the patient in the decisions taken, and thus enhances rationalization of the decisions. This chapter provides an international overview of the GPs perception on their rationalization of the specialists’ referrals. The study is based on data from the cross-sectional QUALICOPC study (Quality and Costs of Primary Care in Europe) collected from 34 countries through physician surveys between October 2011 and December 2013. The aim for each country was to draw a nationally representative sample of GPs with one GP per practice [49]. The GP questionnaire was completed by 7,183 GPs. Details about the study protocol, questionnaire development and data collection, have been published elsewhere [28][49][50]. This chapter also intends to clarify whether the typology of the primary care system – gatekeeping vs. non-gatekeeping (according to QUALICOPC taxonomy) – plays a role in this process.

Chapter 2 studies the decision-making process of individual doctors. In this case rational decisions are meant to be taken based on guidelines and also other mechanisms that influence rational decision-making for prescription practice. This topic was considered given that prescribing is an act entirely in the hands of the doctors, being a classical decision based primarily on knowledge. This section provides an international overview on the implementation of strategies to enhance rational prescribing in primary care. This study includes 13 countries, from which the data was collected through a standardized questionnaire filled in by country experts, between August 2018 and April 2019. After assessment, we performed the revalidation of the received information with the expert group through interviews and email communication. The last step was taken in June 2019 when the findings were presented to the OECD Health Care Quality and Outcomes working party for final feed-back.

Chapter 3 targets broader health care organizations, in the case of this thesis, hospitals. A key element of the hospitals function processes are the organizational clinical care pathways. Therefore, it is important to understand whether behind their conceptualization there is clinical rationale and whether the body that develops the organizational clinical pathways involves doctors, as they have professional knowledge on managing those pathways and enhancing better decisions. This chapter aims at understanding how the presumably evidence-based doctors’ approaches lead to quality improvements and whether they are integrated in the decision-making process at a hospital level in a series of countries. The study uses combined data from 1) a quick scan drawing upon a short structured questionnaire collected in November 2013 amongst 19 country experts (highly placed national public servants representing their national Ministries of Health) in the OECD’s Health Care Quality Indicator program, and 2) from a cross-sectional multilevel study (DUQuE – a multi-method, cross-sectional study design to collect quality-related information between May 2011 and February 2012 in hospitals in 7 OECD countries – Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey) on doctors’ involvement in hospital management and the implementation of quality management systems.

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Chapter 4 has two parts reporting on system policies on decision-making processes that create rational decisions. The first part (4.1) offers an overview on how CEE countries formalized and implemented HTA to support rational decision-making for providing access to pharmaceuticals. Materials for this paper were collected during 2013 through document analysis and pooling of country expertise. Experts from all studied countries were involved in the systematic discussion of the situation in their country, based on a common set of questions. Country descriptions were further validated and refined through consultation with other CEE HTA experts and policy-makers, as well as through discussions based on draft texts amongst the authors. The second part (4.2) explores the status of MEAs as a tool to aid rational decisions for affordable and value-based reimbursement of pharmaceuticals in 6 CEE countries. The research questions were explored by developing a framework, built on the taxonomy proposed by Ferrario et al. [51], to conceptualize the kind of objectives countries are trying to achieve through MEAs, based on the types implemented (financial or performance based schemes) – limiting budget impact, address uncertainty on clinical effectiveness and/or cost-effectiveness, manage appropriate utilization. Subsequently, the conceptual framework was turned into a standardized questionnaire and was sent to selected experts from the participating countries on November 17, 2014 and collected by February 2015, followed by interviews until April 2015. The questionnaire collected information on 1) expert’s perception on country rationalization policy strategies, the legal embedding of MEAs in the drugs’ reimbursement system and their actual implementation, 2) expert perceived importance of the policies MEAs aim for, and 3) existing number and typology of MEAs implemented. It also included a specific list of drugs founded to be most frequent subject to MEAs in Western Europe [51]complemented by a selected list of drugs (n=32), with the possibility of including additional ones.

Chapter 5 provides an overview on the reported quality indicators by a series of OECD countries. The OECD quality indicators have been constantly developed since 2002, when the OECD created the Health Care Quality Indicators (HCQI) project. The objective was to develop a set of performance measures to compare health care outcomes across countries. This chapter aims to show the extent at which the OECD developed measures have been picked up and used in national and regional reporting mechanisms. The data for this research was collected from June until mid-December 2014 through a survey amongst HCQI-members representing 30 different countries. During the data collection period, we identified which indicators are used by which countries and in which types of reports. To standardize the reports a three-tier framework was developed to create a taxonomy (level – national/regional; focus – general/disease/type of care/thematic; function – general reporting/comparative of quality monitoring/target setting/reimbursement).

The discussion section concludes the thesis and will summarize the main results, reflect on the overall use of rationalization strategies at the 5 different levels of health care services and systems and provide recommendations for research and practice.

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[29]. Secanell M, Groene O, Arah O, Lopez M, Kutryba B, Pfaff H et al. Deepening our understanding of quality improvement in Europe (DUQuE): overview of a study of hospital quality management in seven countries. International Journal for Quality in Health Care. 2014;26(suppl 1):5-15.

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[45]. Expert Panel on effective ways of investing in Health (EXPH). Final report on Future EU Agenda on quality of health care with a special emphasis on patient safety. Brussels: European Commission, 2014.

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[50]. Schäfer, W., Boerma, W., Kringos, D., De Ryck, E., Greß, S., Murante, A., Rotar-Pavlic, D., Schellevis, F., Seghieri, C., Van den Berg, M., Willems, S. and Groenewegen, P. (2013). Measures of quality, costs and equity inprimary health care: instruments developed to analyse and compare primary health carein 35 countries. Quality in Primary Care, [online] (21), pp.67–79. Available at: http://postprint.nivel.nl/PPpp4696.pdf [Accessed 22 Aug. 2017].

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CHAPTER 1Shared decision making between patient and GP about referrals from primary care: Does gatekeeping make a difference?

This chapter was published as:Rotar A, Van Den Berg M, Schäfer W, Kringos D, Klazinga N. Shared decision making between patient and GP about referrals from primary care: Does gatekeeping make a difference? PLOS ONE. 2018;13(6):e0198729

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ABSTRACTPrimary care faces challenging times in many countries, mainly caused by an ageing population. The GPs’ role to match patients’ demand with medical need becomes increasingly complex with the growing multiple conditions population. Shared decision-making (SDM) is recognized as ideal to the treatment decision making process. Understanding GPs’ perception on SDM about patient referrals and whether patients’ preferences are considered, becomes increasingly important for improving health outcomes and patient satisfaction. This study aims to 1) understand whether countries vary in how GPs perceive SDM, in patients’ referral, 2) describe to what extent SDM in GPs’ referrals differ between gatekeeping and non-gatekeeping systems, and 3) identify what factors GPs consider when referring to specialists and describing how this differs between gatekeeping and non-gatekeeping systems. Data were collected between October 2011 and December 2013 in 32 countries through the QUALICOPC study (Quality and Costs of Primary Care in Europe). The first question was answered by assessing GPs’ perception on who takes the referral decision. For the second question, a multilevel logistic model was applied. For the third question we analysed the GPs’ responses on what patient logistics and need arguments they consider in the referral process. We found: 1) variation in GPs reported SDM – 90% to 35%, 2) a negative correlation between gatekeeper systems and SDM – however, some countries strongly deviate and 3) GPs in gatekeeper systems more often consider patient interests, whereas in non-gatekeeping countries the GP’s value more own experience with specialists and benchmarking information. Our findings imply that GPs in gatekeeper systems seem to be less inclined to SDM than GPs in a non-gatekeeping system. The relation between gatekeeping/non-gatekeeping and SDM is not straightforward. A more contextualized approach is needed to understand the relation between gatekeeping as a system design feature and its relation with and/or impact on SDM.

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INTRODUCTIONPrimary care is facing challenging times in many countries, mainly caused by an ageing population and increase in the burden of disease. The delivery of care requires a new approach built around the fundamentals of primary care, particularly continuity and care coordination.[1] The need to move to more efficient and patient centric primary care, pressures decision-makers for reform. In western countries, primary care is often the first contact point between the public and the health care system. Strong primary care is often associated with the gatekeeping position of GPs.[2] Strengthening primary care increases incentives for the gatekeeping role of GPs. Most often, GPs are better informed on options for treatments by medical specialists than patients.[3] By performing the gatekeeping role, GPs mitigate supplier-induced demand by handling the asymmetry of information between patients and specialists, limiting the possibility of the specialists to create their own market.Economic theory places GPs’ gatekeeping role as a restriction on the demand side. In healthcare, patient demand is matched with the medical needs as perceived by the health care professional. Therefore, the GPs’ role is to match the demand of the patients with their medical need, which becomes increasingly complex with the growing number of persons with multiple conditions. By many, the gatekeeping function is considered to promote coordination of care, and is perceived to work well when the GP-patient relationship is based on trust. It is also perceived as a tool for rationing, by limiting access to specialists through regulating referrals. [2][3][4]For decades, countries like the U.K. and the Netherlands have had a primary care system with a gatekeeping role.[5][6] In the U.K., its introduction was intended to be a response to specialists’ shortage by slowing down the rate of referral to help regulate waiting times for secondary care, while it was seen also as a tool to control costs.[7] However, it is unclear if the intended effects on decreased costs occurred. There is evidence on both sides, showing associations with increases and decreases in healthcare utilization and costs.[8][9] Gatekeeping has also showed a positive relationship with a reduction in the adverse effects of overtreatment.[10] However, gatekeeping may have “unexpected, serious side effects”, as associations were found with lower survival rates in oncology, potentially caused by delayed diagnosis.[11] There are stakeholders who have been lobbying actively for abolition of gatekeeping believing it limits patient choice. More recently, it has been suggested, “gatekeeping negates the person-centered model, patient choice, and shared decision making”.[12][13] Despite its critiques and confounding evidence, strong primary care systems, with a gatekeeping role in place, have shown associations with improved population health outcomes, reduced socio-economic inequalities, fewer avoidable hospitalizations, and more continuity as perceived by patients.[14][15] Since the early 1990’s, Central Eastern European countries reformed their health care systems by introducing new concepts, such as gatekeeping. However, gatekeeping

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came along with a reputation as a bureaucratic hurdle to specialized medical services and having generalist doctors with less medical knowledge making key decisions.[10] Irrespective of the GPs’ gatekeeping role intensity in different countries, patients’ involvement in healthcare has been widely recognized by the medical community [16] and needs to be aligned with strategies aimed at promoting efficiency. In the past decades, SDM has been recognized as an ideal for the treatment decision making process.[17] SDM seems to be of benefit for disadvantage groups, improve cognitive outcomes and quality of life.[18][19][20] Still, general outcomes are yet undetermined. Nevertheless, understanding the GPs’ perception on shared decision making about patient referrals, and whether patients’ preferences are considered, becomes increasingly important. It is also unknown to what extent logistical factors and need influence GPs’ professional behavior with regard to referrals. Additionally, there is no evidence for any association between shared decision-making, the referral practice and the typology of the primary care system, gatekeeping system vs. non-gatekeeping system. Our aim is to investigate these elements. More specifically, our study addresses three research questions, by analyzing 32 countries with different historical background on their healthcare systems typology:Do countries vary in how GPs perceive shared decision-making (SDM), in deciding upon patients’ referral? To what extent does shared-decision making in GPs’ referrals differ between gatekeeping and non-gatekeeping systems?What factors do GPs consider when referring to a medical specialist and how does this differ between gatekeeping and non-gate keeping systems?

Materials and methodsTo address the research questions, we used the GPs survey data from the cross-sectional QUALICOPC study (Quality and Costs of Primary Care in Europe), which included 31 European countries and Australia, Canada and New Zealand. Data collection took place between October 2011 and December 2013. The aim for each country was to draw a nationally representative sample of GPs with one GP per practice.[21] The GP questionnaire was completed by 7,183 GPs. Details about the study protocol, questionnaire development and data collection, have been published elsewhere.[21][22][23] The study is written within the aims of the QUALICOPC study and its ethical approval. Ethical review was conducted in accordance with the legal requirements in each country. See the S1 Table for an overview of names of ethics committees by country.Greece and Finland were excluded from our analysis after validating the primary findings with the country coordinators. In Greece, there was a translation error in the question to be analyzed, and in Finland, at the time of the survey, there were

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some developments in the health care system that impacted the reliability of the physicians’ answers to the questions related to this topic.To answer the first research question, we used the GP’s reported perception on who makes the decision in case of referrals. The participating GPs were asked through the survey to respond 1) if they make the decision, 2) if the patient does or 3) if it is a shared decision.For the second question, a multilevel logistic model was applied. The response to the question on who decides in case of a referral was dichotomized into 1 (it is a shared decision) and 0 (either the patient of the doctor). We call this variable ‘shared decision making’ (SDM). The model has two levels, with GPs (level 1) clustered into countries (level 2). In step-1, the variable ‘gatekeeping’ (0 for no, 1 for yes) was added to the model. In step 2, controlling variables were added to the model: age and sex of the GP and the practice location - big (inner)city, suburbs, (small) town, mixed urban-rural and rural.For the third research question we analysed the GPs responses on what patient logistics and need arguments they consider in the referral process, including: 1) the patient’s preference where to go, 2) the travel distance for the patient, 3) the physician’s previous experiences with the medical specialist, 4) comparative performance information on medical specialists, 5) waiting time for the patient and 6) costs for the patient. Each of the 6 items had three answer options: always, sometimes and never. Our analysis focused on the “always” since if considering “always” and “sometimes” as a positive answer, there were almost no differences between countries and between the aspects they take into consideration (see annex 1). We compiled the data based on the responses and benchmarked countries 1) against each other, 2) against the total weighted average, 3) the gatekeeping systems against the total weighted average of the gatekeeping systems and 4) the non-gatekeeping systems against the total weighted average of the non-gatekeeping. To classify whether primary care systems have a gatekeeping system in place or not, the QUALICOPC, OECD and PHAMEU data bases were examined.[24][25] For reasons of consistency the taxonomy of QUALICOPC data was used.

ResultsFig. 1 shows the reported levels of referral practice across 32 countries. “SDM” is reported to be most common (levels higher than 50%) in 28 countries. The values range from 92.3% (the Netherlands) to 52.5% (FYR Macedonia). GP-based decision is most common in 4 countries: - Denmark (50.7%), Slovakia (52.6%), Spain (59.9%) and Turkey (63.2%). Patients being the main decision-taker is reported far less frequently. In 25 countries the values range low, from 0.5% (the Czech Republic and Denmark) to 8.7% (Bulgaria) and 19.9% (Poland), while in the remaining 7 countries, the patient never makes the decision.

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FIGURE 1 – Answer to the question: In case of referral, who usually decides about where the patient is referred?

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The results of our logistic regression analysis are shown in Table 1. The first model (column 2) shows a negative odds ratio for gate keeping, suggesting that GPs in gatekeeping systems are less likely to make shared decisions. This negative relation remains after controlling for a number of variables, such as female doctors and practice location (model 2). Female doctors and those in rural areas are more likely to report that they make shared decisions.

TABLE 1 – Results logistic regression multilevel analyses association between the shared decision making (SDM) levels and gate keeping system

Ni=32; Nj=6572 Odds ratio SE Odds ratio SE

Intercept 2.387 0.035 1.520 0.158

Gatekeeping (baseline NO) 0.865 0.053 0.859 0.055

Age 1.002 0.002

Gender - male/female (baseline - MALE) 1.208 0.055

Practice location

Suburbs (baseline - Big city) 1.3420.085

Small town (baseline - Big city) 1.3350.089

Mixed urban-rural (baseline - Big city) 1.589

0.072

Rural (baseline - Big city) 1.839 0.083

Table 2 shows the amounts to which different considerations are taken into account when referring a patient. Patient preference (48.5%) and previous experience with specialists (59.1%) are reported to be the most important factors affecting GPs decision on referrals. There is, however, a high variation between countries on the importance of patients’ preference, ranging from 15% to 81%. Only a few countries stand out for using benchmark information (Czech Republic, Bulgaria and Romania) while this is virtually not-used in some others (Iceland and Norway). In some cases very practical reasons play a role. For instance, travel time which is mainly an issue in large geographically spread countries such as Australia and Canada.

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TABLE 2 - Answer to the question: In case of referral, to what extent do you take into account the following considerations?

gatekeeping system (GK) QUALICOPC

Austria 177 85 48.00% 97 54.80% 137 77.40% 37 20.90% 20 11.30% 68 38.40% NO

Belgium 384 283 73.70% 103 26.80% 301 78.40% 100 26.00% 60 15.60% 64 16.70% NO

Cyprus 70 26 37.10% 17 24.30% 21 30.00% 15 21.40% 14 20.00% 22 31.40% NO

Czech Republic 207 67 32.40% 38 18.40% 169 81.60% 145 70.00% 29 14.00% 18 8.70% NO

Denmark 206 89 43.20% 49 23.80% 135 65.50% 92 44.70% 51 24.80% 52 25.20% NO

Germany 234 103 44.00% 131 56.00% 172 73.50% 33 14.10% 31 13.20% 31 13.20% NO

Iceland 74 32 43.20% 18 24.30% 44 59.50% 3 4.10% 6 8.10% 12 16.20% NO

Luxembourg 73 54 74.00% 16 21.90% 59 80.80% 27 37.00% 10 13.70% 5 6.80% NO

Malta 65 41 63.10% 11 16.90% 32 49.20% 20 30.80% 28 43.10% 34 52.30% NO

Poland 192 104 54.20% 87 45.30% 92 47.90% 60 31.30% 102 53.10% 91 47.40% NO

Slovakia 185 28 15.10% 36 19.50% 86 46.50% 41 22.20% 35 18.90% 32 17.30% NO

Switzerland 189 103 54.50% 81 42.90% 167 88.40% 34 18.00% 30 15.90% 27 14.30% NO

Turkey 297 64 21.50% 99 33.30% 107 36.00% 40 13.50% 73 24.60% 132 44.40% NO

FYR Macedonia 122 30 24.60% 33 27.00% 66 54.10% 24 19.70% 45 36.90% 58 47.50% NO

Bulgaria 199 104 52.30% 61 30.70% 136 68.30% 112 56.30% 48 24.10% 81 40.70% YES

Estonia 129 71 55.00% 36 27.90% 75 58.10% 11 8.50% 38 29.50% 35 27.10% YES

Hungary 205 81 39.50% 89 43.40% 118 57.60% 48 23.40% 81 39.50% 98 47.80% YES

Ireland 162 106 65.40% 71 43.80% 108 66.70% 31 19.10% 70 43.20% 81 50.00% YES

Italy 201 72 35.80% 39 19.40% 129 64.20% 63 31.30% 61 30.30% 77 38.30% YES

Latvia 206 114 55.30% 76 36.90% 139 67.50% 70 34.00% 98 47.60% 83 40.30% YES

Lithuania 216 79 36.60% 19 8.80% 68 31.50% 36 16.70% 40 18.50% 19 8.80% YES

Netherlands 226 195 86.30% 103 45.60% 114 50.40% 18 8.00% 43 19.00% 26 11.50% YES

Norway 195 67 34.40% 48 24.60% 84 43.10% 13 6.70% 58 29.70% 56 28.70% YES

Portugal 205 80 39.00% 77 37.60% 72 35.10% 55 26.80% 81 39.50% 103 50.20% YES

Romania 214 84 39.30% 60 28.00% 115 53.70% 113 52.80% 66 30.80% 107 50.00% YES

Slovenia 203 41 20.20% 36 17.70% 80 39.40% 37 18.20% 65 32.00% 32 15.80% YES

Spain 409 84 20.50% 96 23.50% 246 60.10% 153 37.40% 96 23.50% 74 18.10% YES

Sweden 95 39 41.10% 23 24.20% 49 51.60% 14 14.70% 33 34.70% 22 23.20% YES

United Kingdom 167 126 75.40% 88 52.70% 62 37.10% 22 13.20% 60 35.90% 32 19.20% YES

Australia 149 121 81.20% 97 65.10% 123 82.60% 41 27.50% 57 38.30% 82 55.00% YES

Canada 754 501 66.40% 425 56.40% 484 64.20% 112 14.90% 350 46.40% 302 40.10% YES

New Zealand 162 116 71.60% 65 40.10% 92 56.80% 22 13.60% 62 38.30% 108 66.70% YES

total 6572 3190 48.50% 2325 35.40% 3882 59.10% 1642 25.00% 1941 29.50% 2064 31.40%

total GK 4097 2081 50.80% 1509 36.80% 2294 56.00% 971 23.70% 1407 34.30% 1418 34.60%

total non GK 2475 1109 44.80% 816 33.00% 1588 64.20% 671 27.10% 534 21.60% 646 26.10%

Diff 6.00% 3.90% -8.20% -3.40% 12.80% 8.50%

p <0.005<0.005 <0.005 <0.005 <0.005 <0.005

CountryTotal no. of GPs

Always takes into account

patient's preference where to go

travel distance for the patient

own previous experience with

the specialist

comparative performance

information on specialists

waiting time for the patient

costs for the patient

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White denotes 0-25%, red denotes >25-50%, yellow denotes >50-75%, green denotes >75-100%.GPs in countries with gatekeeping systems in place are more likely to always take into account patients’ preference, travel distance, waiting time and costs, while the GPs from countries with no gatekeeping in place are more likely to consider their previous experience with a specialist and comparative performance information. The “p” value is <0.005 for all items.

DISCUSSIONThe first question of this study was whether countries vary to the extent GPs report shared decision-making (SDM), in deciding upon patients’ referral. Although GPs reported that SDM is the most common practice in 20 of the 32 countries, the results showed a strong variation between countries, ranging from over 90% to 35%. When decisions on referrals are not a shared decision, in most cases it is the GP who decides. Patients being the main decision-taker was reported rarely. Only one country, Poland, stands out for a particularly high percentage of decisions made by patients. This finding was explained by the Polish country coordinator based on the patients’ legal right of a “free choice”, i.e. GPs are not allowed to have the name of a specific specialist on the referral letter (personal communication with Prof. Dr. Adam Windak on June 8th, 2017). To what extent does SDM in GPs referrals differ between gatekeeping and non-gate keeping systems? The paradoxical results of our analysis revealed that the answer to this question is not straightforward. On the one hand, we found a negative correlation between gatekeeper systems and SDM. Implying that GPs in gatekeeper systems in general, seem to be less likely to make shared decisions than GPs in a non-gatekeeping system. On the other hand, when looking in more detail at individual countries, it turns out that some countries deviate strongly from this general finding. The Netherlands, for instance, shows the highest score on SDM whereas this country has been one of the typical strong gatekeeper countries for a very long time. The same goes for the UK, a strong gatekeeper system, which shows over 80% of SDM. Other gatekeeper systems such as Spain and Denmark ended up on the other side of the distribution. This finding could potentially be related to variation between countries in for instance the level of patient trust in their GP, patient level characteristics such as education level and health literacy, and beliefs about healthcare use. We also investigated what factors GPs consider when referring to a medical specialist and how this differs between gatekeeping and non-gate keeping systems. Also, here our findings seem to nuance the negative relation between SDM and gatekeeping: it became apparent that GPs in gatekeeper systems more often take into account all kinds of patient interests, such as their preference, waiting time, costs, etc. compared to non-gatekeeping countries. In non-gatekeeping countries, the GPs’ own experiences with specialists and benchmarking information is

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more important. In general, it turns out that GPs apparently rely on their own experience, rather than e.g. benchmarking information.The strength of our study lies in the large number of countries included and the statistically significant GP sample in each country and the data source similarity. Our study has also some limitations: 1) our findings are based only on GPs self-reported perception about how they do the referral, 2) no theoretical information on SDM was given to the GPs (question framed with 3 answer options: i) if they make the decision, ii) if the patient does or iii) if it is a shared decision), therefore, the results do not cover different understandings and culture around SDM, 3) we used the QUALICOPC classification of primary care systems: gatekeeping vs. non gatekeeping while other classifications (OECD) show there is also another cluster “in the middle” and a more nuanced approach to what constitutes gatekeeping can be taken and 4) the cultural bias between countries and languages and its effects on scoring “sometimes”.Our study is one of the very few that can enrich the existing discussion (such as in BMJ) with empirical information. To our knowledge, this study is unique in the sense of providing a large international image, through the large number of countries included.These results will aid clinicians having an overall view of the international practice. These mixed results may urge policymakers for 1) reconsidering the existing primary care mechanisms, 2) rethinking the use of ‘gatekeeper’ as a metaphor for something which is probably more a guide. The term gatekeeper seems to suggest that such GPs are mainly interested in protecting what is behind the gate and in preventing unwanted visitors from entering, rather than that they care about the preferences of people. This clearly is in sharp contrast with what this study showed. Likewise, our results will offer a debating ground for research articles for reflections like this. It seems a more nuanced and contextualized approach is needed to understand the relation between gatekeeping as a system design feature and its relation with and/or impact on shared decision making. There is a need for further research. Our study is based on GPs’ perception, but it is also important to know how patients perceive the referral decision-making practice. Also, it is important to know what the main aspects are that GPs need to take into consideration when referring patients. International comparative research can help to understand the underlying phenomena but should be accompanied by contextualized knowledge on national situations to provide evidence for policy makers to redesign their health care system to optimize patient centeredness, efficiency and effectiveness alike.

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ACKNOWLEDGEMENTSThe authors thank their partners in the QUALICOPC project for their role throughout the study and their coordination of the data collection: NIVEL, the Netherlands Institute for Health Services Research, The Netherlands (W Boerma, P Groenewegen); StANNA, Sant’Anna School of Advanced Studies, Italy (S Nuti, A M Murante, C Seghieri, M Vanieri); Department of Family Medicine and Primary Health Care, Ghent University, Belgium (J De Maeseneer, J Detollenaere, L Hanssens, S Willems); University of Ljubljana, Slovenia (D Rotar Pavlič, I Švab); Hochschule Fulda, University of Applied Sciences, Germany (S Greß, S Heinemann); RIVM, National Institute for Public Health and the Environment (T van Loenen). Authors would also like to thank the coordinators of the data collection in each country.

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[15] Schäfer W, Boerma W, Murate A, Sixma H, Schellevis F, Groenewegen P. Assessing the potential for improvement of primary care in 34 countries: a cross sectional survey. Bulletin of the World Health Organization. 2015;93(3):161-168.

[16] Britten, N. (2000). Misunderstandings in prescribing decisions in general practice: qualitative study. BMJ, 320(7233), pp.484-488.

[17] Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: What does it mean? (or it takes at least two to tango). Social Science & Medicine. 1997;44(5):681-692.

[18] Durand M, Carpenter L, Dolan H, Bravo P, Mann M, Bunn F et al. Do Interventions Designed to Support Shared Decision-Making Reduce Health Inequalities? A Systematic Review and Meta-Analysis. PLoS ONE. 2014;9(4):e94670.

[19] Shay L, Lafata J. Where Is the Evidence? A Systematic Review of Shared Decision Making and Patient Outcomes. Medical Decision Making. 2014;35(1):114-131.

[20] Kew K, Malik P, Aniruddhan K, Normansell R. Shared decision-making for people with asthma. Cochrane Database of Systematic Reviews. 2017.

[21] Groenewegen, P., Greß, S. and Schäfer, W. (2016). General Practitioners’ Participation in a Large, Multicountry Combined General Practitioner-Patient Survey: Recruitment Procedures and Participation Rate. International Journal of Family Medicine, 2016, pp.1-9.

[22] Schäfer, W., Boerma, W., Kringos, D., De Maeseneer, J., Greß, S., Heinemann, S., Rotar-Pavlic, D., Seghieri, C., Švab, I., Van den Berg, M., Vainieri, M., Westert, G., Willems, S. and Groenewegen, P. (2011). QUALICOPC, a multi-country study evaluating quality, costs and equity in primary care. BMC Family Practice, 12(1).

[23] Schäfer, W., Boerma, W., Kringos, D., De Ryck, E., Greß, S., Murante, A., Rotar-Pavlic, D., Schellevis, F., Seghieri, C., Van den Berg, M., Willems, S. and Groenewegen, P. (2013). Measures of quality, costs and equity inprimary health care: instruments developed to analyse and compare primary health carein 35 countries. Quality in Primary Care, [online] (21), pp.67–79. Available at: http://postprint.nivel.nl/PPpp4696.pdf [Accessed 22 Aug. 2017].

[24] Health at a Glance: Europe 2016. Health at a Glance: Europe 2016. 2016;.[25] Kringos D, Boerma W, Bourgueil Y, Cartier T, Hasvold T, Hutchinson A et

al. The european primary care monitor: structure, process and outcome indicators. BMC Family Practice. 2010;11(1):81-89.

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SUPPORTING INFORMATIONS1 Table: Overview of the ethics committees in each countryOverview of the ethics committees in each country

Country Ethics committee

Australia The Australian National University (ANU) Human Research Ethics Committee.University of Western Sydney Human Research Ethics Committee.The Royal Australian College of General Practitioners (RACGP) National Research and Evaluation Ethics Committee.

Austria Ethics committee of the Medical University of Vienna.

Belgium University Hospital Ghent - Commission for Medical Ethics.

Bulgaria The coordinator sent an official letter to the Ministry of Health which gave consent and support for the survey. The coordinator confirmed that there is no statutory requirement for ethical approval for this study.

Canada 10 different ethics boards*.

Cyprus National Bioethical Committee of Cyprus.

Czech Republic General University Hospital linked to the First Faculty of Medicine, Charles University in Prague.

Denmark The coordinator confirmed that there is no statutory requirement for ethical approval for this study.

Estonia The national coordinator consulted with the Ethics Review Committee on Human Research of the University of Tartu. It was confirmed that there is no statutory requirement for ethical approval for this study.

Germany Ethics Commision of the „Landesärtzenkammer Hessen”.

Hungary National Ethical Committee.

Iceland The Icelandic Bioethics Committee. A national committee under the Ministry of Welfare.

Ireland Irish College of General Practitioners Research Ethics Committee – National Committee.

Italy At Local Health Authorities level. Approval was requested from LHA Ethical Committees.

Latvia Latvian Physicians Association Board of Certification.

Lithuania Kauno Regionus Biomedicininu Tyrimu Etikos Komitetas.

Luxembourg National committee of Research Ethic (CNER) in Luxembourg.

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Country Ethics committee

FYR Macedonia Medical Faculty Skopje, R.Macedonia.

Malta University of Malta Research Ethics Committee.

Netherlands The ethics committee of VU Medisch Centrum confirmed via an official letter that the research is outside the scope of the WMO (Medical Research Involving Human Subjects Act).

New Zealand Northern regional committee (Northern Y) for the nationally coordinated Health and Disability Ethics Committees (HDEC).

Norway The coordinator confirmed that there is no statutory requirement for ethical approval for this study.

Poland Bioethics approval of Jagiellonian University

Portugal Ethical committee of Lisbon and Oporto regions; the National Commission for Health Data Safety.

Romania Scientific Committee of CPSS.

Spain Research Units of Primary Care of the Autonomous Community in the Basque Country. In all other Autonomous Communities, the study was approved at the Healthcare Area level.

Slovakia The national coordinator consulted the Council of the Slovak Society of General Practice. It was confirmed that there is no statutory requirement for ethical approval for this study.

Slovenia National medical ethics committee.

Sweden Regional Research Ethics Committte.

Switzerland Ethical Committee of the University of Lausanne.

Turkey Ethical committee of Kartal Research and Education Hospital in Istanbul.

United Kingdom University of Lincoln School of Health and Social Care Ethics Committee; National Research Ethics Service.

* See: Wong ST, Chau LW, Hogg W et al. An international cross-sectional survey on the Quality and Costs of Primary Care (QUALICO-PC): recruitment and data collection of places delivering primary care across Canada. BMC Family Practice (2015) 16:20.

CHAPTER 2Mapping health care system strategies to support rational drug prescribing in primary care across 13 European countries

This chapter was submitted for publication under the authorship of:Rotar A, Van Den Berg M, Klazinga N

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ABSTRACTBackground

Irrational prescribing has received increasing attention among policy-makers to improve safety and effectiveness while avoiding economic waste. The policies intended to rationalize prescribing have been grouped by The World Health Organization under a taxonomy, classifying them in two types of strategies: 1) targeted approaches (micro-level) and 2) system-oriented approaches (macro-level). The extent to which countries implement strategies and the existing types is currently unknown. This paper answers the following research question: to what extent have European countries embedded strategies to support rational prescribing (targeted and system-oriented) and what are the types implemented?

Methods

We assessed the available information on policies intended to promote rational prescribing. We used the WHO taxonomy to explore our research question as the basis for a standardized questionnaire. The data were collected between August 2018 and April 2019. The questionnaire consisted of questions that solicited the opinion of experts on the implementation of prescribing control mechanisms in primary care in their respective countries. The questionnaire was sent to 17 country experts from different countries, 15 responded and 13 were used in our analysis. Answers were validated through follow-up correspondence, interviews and presentation at an OECD meeting.

Results

Expert reported data shows that all the countries included in our study have several mechanisms in place for enhancing rational prescribing in primary care. All approaches were implemented in at least two countries. We identified two groups of countries: 1) a small group of countries (n=3) with fewer mechanisms in place, and 2) a larger group of countries (n=10) with a large number of strategies with accompanying instruments at micro and macro level.

Conclusions

The data reported by the experts shows that all countries included in our study have several mechanisms in place for enhancing rational prescribing in primary care, on both micro and macro level. We have also identified in our sample two groups of countries.

Keywords: primary care, prescription, rational drug use

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BACKGROUNDRational use of medicines is a long-standing topic on the heath care agenda in most countries. In 1985, the World Health Organization (WHO) defined rational use of medicines as a process in which “patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community” [1]. Later on, the World Bank proposed a new definition by adding the concepts of 1) drug use based on scientific data and 2) societal financial ability [2]. The irrational use of medicines is also acknowledged as a problem faced by many health systems across the world [3]. WHO estimates that 50% of all medicines across the world are inappropriately prescribed, dispensed or used [4]. This has fuelled global recognition of both underuse and overuse of medicines, leading to poor health outcomes [5][6]. Over-prescription (overuse) often results from the system’s undesired effects of financial incentives towards prescribers. Underuse is generally caused by poor access, health system delivery problems, (e.g. logistics, financial constraints, physicians’ awareness and skill level) or by patients not accessing, postponing or declining treatment [6]. The supply side (prescribers) is the main source of overuse, while patients (demand side) can drive both underuse and overuse [7]. The unintended effects have consequences on the population’s well-being, by causing disabilities and loss of life years, but also on the financial resources use of patients and governments [5][6].In this context, rational use of medicines plays an important role in today’s international policy debate. The global threat of antimicrobial therapies (AMTs) overuse resulting in resistance to antibiotics is one major policy challenge [8][9][10]. Furthermore, the debate on overuse has been expanded more recently towards benzodiazepines and opioids [11][12][13]. Consequently, irrational prescribing has been brought to the attention of policy-makers to improve safety and effectiveness while avoiding economic waste [14][15][16]. Reported medical goods spending in European Union (EU) countries vary between 10% and 44% of the total national spending on health care [4][17][18][19].

In the EU, the history of governance mechanisms for medicines begun with safety and efficacy. This resulted in decisions for all pharmaceuticals on granting market authorization, starting from 1995, by the European Medicines Agency (EMA). In an attempt to limit prescribing and tackle financial waste, different initiatives were taken. At hospital level, cost-oriented governance models were implemented, while for making decisions on the added value of pharmaceuticals, health technology assessment (HTA) seemed to be the cure [20][21]. However, the concerns related to safety, effectiveness and economic waste are strongly

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influenced by irrational use. This, as the AMT overuse, is caused by loosely regulated prescription requirements in primary care (e.g. drug policies, logistics) associated with less rational behavioral patterns and levels of knowledge on appropriate use (e.g. professional training and culture, personal experience, knowledge about availabilities and patients’ health literacy) [7][18]. In the efforts to rationalize prescribing, as a large portion of total prescribing occurs in the community, outside of hospitals, primary care plays an important role [14][22]. In the UK only, despite a decreasing trend in the both share and value, NHS data show that in 2017 primary care accounts for more than 50% of the total proportion of estimated costs at list price [23].

Saini et al. distinguished three main drivers of under- and overuse: 1) money and finance, 2) knowledge bias and uncertainty, and 3) power and human relationships, all acting at a global, national, regional, and local/individual level [24]. To limit inappropriate prescribing and enhance rational use of medicines, countries have put in place several policy interventions. In attempts to improve prescribing, the WHO classified these policies in their publication Managing Access to Medicines and other Health Technologies [25]. The conceptual framework from WHO classifies policy measures as two types of strategies: 1) targeted approaches (micro level) and 2) system-oriented approaches (macro level). Targeted approaches are strategies with a clinical focus (continuous medical education – CME and continuous profession development – CPD) and at the health service level (managerial interventions such as limited procurement lists, cost information, therapy packaging). The clinical profile approaches seek to inform prescribers, while the health service-oriented approaches aim at regulating practice. At a system level, rational prescribing is enhanced by economic and regulatory interventions. From an economic perspective, the goal is to stimulate positive financial incentives while removing the waste creating mechanisms. Regulatory wise, the legal and regulatory framework focuses on prescribing restrictions and pre-requisites [25].

Knowing which strategies countries take in tackling inappropriate use of medicines can help to identify opportunities for international learning. Currently, there is no overview of to what extent countries implement strategies and the types they have in place in this domain. Consequently, this paper aims at answering the following research question:

• To what extent have European countries embedded strategies to support rational prescribing (targeted and system-oriented) and what are the types implemented?

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METHODSWe have made an assessment of the available information on policies that intend to promote rational prescribing. For our research, we adapted the WHO taxonomy to explore the research question by applying it as the basis for a standardized questionnaire (see Appendix 1) [25]. Subsequently, the questionnaire was sent to experts from a series of countries (15/17 response rate). The experts were recruited from the Drug Utilization Review network1 and participants of a WHO Observatory Summer School on Quality of Care2. We used our personal research and policy network to identify experts in some of the other countries. The data collection process started in August 2018 and was completed in April 2019. The questionnaire consisted of questions that solicited the experts’ opinion on the implementation of prescribing control mechanisms in primary care in their respective countries. The key experts identified were selected based on their experience and their affiliation to organizations that are important and knowledgeable players in this field (e.g. academic institutions, ministries of health, practitioner organizations, etc.). During the data collection process, some of the contacted experts have also engaged other experts from their country to assist in providing the required information. For validation purposes, once a questionnaire was received, we verified the answers and had active interaction with the responders via email and follow-up interviews, especially where the experts were unsure about the answers. Out of the 15 responders, we excluded 2, since these experts did not consider themselves knowledgeable enough to provide sufficient answers and alternative experts could not be identified or were non-responsive. Finally, the data were presented to the OECD Health Care Quality and Outcomes expert group in June 2019, Paris to provide feedback on the findings3.

RESULTSTable 1 summarizes the data reported by experts. It shows that 1) all countries included in our study have several mechanisms in place for enhancing rational prescribing in primary care and 2) all approaches are implemented in at least two countries in our group. Table 1 also shows the extent to which countries report to have embedded targeted and system-oriented strategies. Two groups can be identified: a small group of countries with fewer mechanisms in place and a large group of countries that have in place a large number of strategies with accompanying instruments at micro and macro level.

1. This is a network of researchers working on prescribing.2. The European Observatory on Health Systems and Policies organizes every year a Venice Summer School for

policy-makers from different countries. In 2018, the Observatory Venice Summer School had as its main topic quality of care.

3. The OECD has a working party on Health Care Quality and Outcomes that was discussing several papers on prescribing in June 2018 in Paris, France.

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The small group of countries consists of Bosnia and Herzegovina (BH), Greece and Romania, out of which Romania appears to have in place the highest number of mechanisms, mainly at a macro level (system approaches). The only common element among these three countries is that they have in place standard diagnosis and treatment guidelines (targeted approach). The macro level approaches reported to exist in BH are also reported to be in place by Greece (generic substitution) and Romania (pharmaceutical registration and limited medicines lists), except for the mechanism of tenders. The most common elements shared among Greece and Romania are: international reference pricing (IRP), prescription fill limits, caps of no. of pills/month, Rx/month, prescribing restricted to specialists and dispensing timeframes.

The larger group of countries consists of the remaining 10: Austria, France, Germany, Italy, the Netherlands, Norway, Scotland, Slovenia, Spain and Sweden. Within this second group, we distinguish three sub-groups:

1) Norway and Scotland appear to have almost all studied strategies on the micro level in place (targeted approaches), with fewer complementing macro level strategies;

2) Austria, France, Germany, Spain and Sweden, have a wide range of both micro and macro level strategies; and,

3) Italy, Netherlands and Slovenia for which the country experts reported the existence of almost all types of strategies.

At the micro level, all 10 countries have implemented seminars, workshops, clinical literature and newsletters, treatment guidelines and medicine formularies, illustrated materials and educational outreach, while at a macro level none of the studied mechanisms are implemented in all countries. All the approaches are implemented in at least half of the countries in this group (5). One exception is supervisory visits implemented in France, Norway, Slovenia and Spain. The second exemption, which is an economic disincentive for rational prescribing, medicines sales by prescribers, is reported to be implemented in Austria and the Netherlands in remote or rural areas where there are no pharmacies.

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TABLE 1 – Overview of strategies to enhance rational prescribing in primary care in 13 countries

Source: based on country expert opinion.

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DISCUSSIONThis study aimed at mapping to what extent European countries have implemented targeted and system-oriented rational prescribing strategies in their primary care systems and what types of strategies have been implemented. According to the country experts who responded to the survey, our study shows two main findings. Firstly, all countries have several mechanisms in place to enhance rational prescribing in primary care. Secondly, all the identified approaches are implemented in at least one of the studied countries.

For this study, we performed a literature and general policy documents search. We identified a taxonomy in a WHO publication, on which we built the questionnaire for our study. Although there is a fair amount of literature on the effectiveness of individual strategies, scientific evidence on the impact of applying a series of strategies on micro and macro level simultaneously was not identified. The results of this study are based on expert opinion, which means the results are subject to the level of knowledge of the responding experts and may not reflect a fully accurate picture of their country.

To our knowledge, this study is unique by way of offering a first attempt at mapping the use of existing prescribing strategies in primary care across countries and offers an overview allowing for further cross-country comparison. This study also sets the basis for more in-depth quantitative and qualitative research in this area and may help policy-makers to understand the large differences between countries in prescribing rates as reported by international studies and organizations [18][26]. For countries that want to improve their strategies for rationalizing prescribing in primary care, this study can be a reference for implementing rational prescribing mechanisms further.

There is a need for further research. Our study is based on expert opinion, which is important to be validated further. Also, the sample of countries included in this study presents opportunities for expanding to a broader international group. Our international comparative research can help understand some of the existing gaps in rational prescribing strategies in primary care settings across countries and help filling them, but it also should be accompanied by quantifications of the effects of the implemented approaches. The continuous monitoring of the further development and implementation of strategies at micro and macro level is needed to complement the existing (international) data on prescribing volumes, such as the OECD Health at a Glance publication [27].

CONCLUSIONSThe data reported by the experts shows that all countries included in our study have several mechanisms in place, on both levels – micro (targeted approaches) and macro (system approaches), for enhancing rational prescribing in primary care and that all approaches are implemented in at least two countries in our group.

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We have also identified in our sample two groups of countries: 1) a small group of countries with fewer mechanisms in place, and 2) a large group of countries that have in place a large number of strategies (at both micro & macro level). Our study shows that strategies for enhancing rational prescribing do not exist in isolation at one level of the system. To address the differences in prescribing rates between countries it is necessary to learn more about the relative effectiveness of the mix of strategies to rationalize prescribing that countries have been implementing. Macro level policies should be considered in combination with the operational tools at clinical and practice level as done in this study.

DECLARATIONS

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data and materials

All data generated or analysed during this study are included in this published article.

Competing interests

AR is currently an employee of Takeda Pharmaceuticals Romania.

Funding

Not applicable.

Authors’ contributions

AR & NK developed the questionnaire and drafted the manuscript. MvdB substantially contributed to the analyses and writing of the article. All authors read and approved the final manuscript.

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ACKNOWLEDGEMENTSThe authors thank the expert group who participated in the project for their role throughout the study and information collection process: Josef Probst, Main Association of Austrian Social Security Institutions, Vienna, Austria; Pichetti Sylvain, Institute for Research and Information in Health Economics (IRDES), Paris, France; Gisbert W. Selke, WIdO (AOK Research Institute), Berlin, Germany; Athina Tatsioni, University of Ioannina, Ioannina, Greece; Maria Pia Fantini, University of Bologna, Comune di Bologna, Italy; Petra Denig, University of Groningen, Groningen, the Netherlands; Hege Salvesen Blix, Norwegian Institute of Public health, Oslo, Norway; Raluca Zoitanu, Patronatul Medicilor de Familie Bucuresti-Ilfov, Bucharest, Romania; Marius Ungureanu, Department of Public Health, Babes-Bolyai University, Cluj-Napoca, Romania; Sean MacBride-Stewart, NHS Greater Glasgow and Clyde (GGC), Glasgow, UK; Mircha Poldrugovac, Academic Medical Centre, Amsterdam, the Netherlands; Jurij Fürst, Health Insurance Institute of Slovenia, Ljubljana, Slovenia; Mikael Hoffmann, The NEPI Foundation, Linköping University Hospital, Linköping, Sweden; Erica Barbazza Department of Public Health, Academic Medical Center, University of Amsterdam, the Netherlands

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[6]. Glasziou P, Straus S, Brownlee S, Trevena L, Dans L, Guyatt G et al. Evidence for underuse of effective medical services around the world. The Lancet. 2017;390(10090):169-177.

[7]. Seiter, A. A Practical Approach to Pharmaceutical Policy; The World Bank: Washington, DC, USA, 2010.

[8]. Cecchini M, Langer J, Slawomirski L. Antimicrobial Resistance In G7 Countries And Beyond: Economic Issues, Policies and Options for Action [Internet]. 2015 [cited 6 July 2018]. Available from: https://www.oecd.org/els/health-systems/Antimicrobial-Resistance-in-G7-Countries-and-Beyond.pdf

[9]. World Bank, 2016, ‘Drug-Resistant Infections: A Threat to Our Economic Future’, Washington, DC

[10]. G20 Health Ministers’ Meeting: Fighting Antimicrobial Resistance - OECD [Internet]. Oecd.org. 2018 [cited 6 July 2018]. Available from: http://www.oecd.org/about/secretary-general/g20-health-ministers-meeting-fighting-antimicrobial-resistance.htm

[11]. Benzodiazepines and Opioids [Internet]. Drugabuse.gov. 2019 [cited 3 July 2019]. Available from: https://www.drugabuse.gov/drugs-abuse/opioids/benzodiazepines-opioids

[12]. Opioids - OECD [Internet]. Oecd.org. 2019 [cited 3 July 2019]. Available from: https://www.oecd.org/health/health-systems/opioids.htm

[13]. Verhamme K, Bohnen A. Are we facing an opioid crisis in Europe?. The Lancet Public Health. 2019;4(10):e483-e484.

[14]. Realising the Full Potential of Primary Health Care [Internet]. 2019 [cited 8 October 2019]. Available from: http://www.oecd.org/health/health-systems/OECD-Policy-Brief-Primary-Health-Care-May-2019.pdf

[15]. Global Action Plan on Antimicrobial Resistance [Internet]. 2015 [cited 8 October 2019]. Available from: https://apps.who.int/iris/

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bitstream/handle/10665/326454/WHO-HIS-SDS-2018.56-eng.pdf?sequence=1&isAllowed=y

[16]. Antimicrobial resistance and primary health care [Internet]. 2019 [cited 8 October 2019]. Available from: https://apps.who.int/iris/bitstream/handle/10665/326454/WHO-HIS-SDS-2018.56-eng.pdf?sequence=1&isAllowed=y

[17]. Richard Ofori-Asenso, Akosua Adom Agyeman - Irrational Use of Medicines—A Summary of Key Concepts. Pharmacy 2016, 4(4) 35; https://doi.org/10.3390/pharmacy4040035

[18]. OECD/EU (2018), Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris. https://doi.org/10.1787/health_glance_eur-2018-en

[19]. OECD (2017), Tackling Wasteful Spending on Health, OECD Publishing, Paris. http://dx.doi.org/10.1787/9789264266414-en

[20]. A. M. Rotar, D. Botje, N. S. Klazinga, K. M. Lombarts, O. Groene, R. Sunol and T. Plochg – The involvement of medical doctors in hospital governance and implications for quality management: a quick scan in 19 and an in depth study in 7 OECD countries, BMC Health Services ResearchBMC series – open, inclusive and trusted201616(Suppl 2):160 DOI: 10.1186/s12913-016-1396-4© Rotar et al.

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[26]. Addressing Problematic Opioid Use in OECD Countries. Paris: OECD Publishing; 2019.

[27]. OECD/EU (2018), Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris. https://doi.org/10.1787/health_glance_eur-2018-en

CHAPTER 3The involvement of medical doctors in hospital governance and implications for quality management: a quick scan in 19 and an in depth study in 7 OECD countries.

This chapter was published as:Rotar A, Botje D, Klazinga N, Lombarts K, Groene O, Sunol R et al. The involvement of medical doctors in hospital governance and implications for quality management: a quick scan in 19 and an in depth study in 7 OECD countries. BMC Health Services Research. 2016;16(S2).

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ABSTRACTBackground: Hospital governance is broadening its orientation from cost and production controls towards ‘improving performance on clinical outcomes’. Given this new focus one might assume that doctors are drawn into hospital management across OECD countries. Hospital performance in terms of patient health, quality of care and efficiency outcomes is supposed to benefit from their involvement. However, international comparative evidence supporting this idea is limited. Just a few studies indicate that there may be a positive relationship between medical doctors being part of hospital boards, and overall hospital performance. More importantly, the assumed relationship between these so-called doctor managers and hospital performance has remained a ‘black-box’ thus far. However, there is an increasing literature on the implementation of quality management systems in hospitals and their relation with improved performance. It seems therefore fair to assume that the relation between the involvement of doctors in hospital management and improved hospital performance is partly mediated via quality management systems. The threefold aim of this paper is to 1) perform a quick scan of the current situation with regard to doctor managers in hospital management in 19 OECD countries, 2) explore the phenomenon of doctor managers in depth in 7 OECD countries, and 3) investigate whether doctor involvement in hospital management is associated with more advanced implementation of quality management systems.

Methods: This study draws both on a quick scan amongst country coordinators in OECD’s Health Care Quality Indicator program, and on the DUQuE project which focused on the implementation of quality management systems in European hospitals.

Results: This paper reports two main findings. First, medical doctors fulfil a broad scope of managerial roles at departmental and hospital level but only partly accompanied by formal decision-making responsibilities. Second, doctor managers having more formal decision-making responsibilities in strategic hospital management areas is positively associated with the level of implementation of quality management systems.

Conclusions: Our findings suggest that doctors are increasingly involved in hospital management in OECD countries, and that this may lead to better implemented quality management systems, when doctors take up managerial roles and are involved in strategic management decision making.

Keywords: Doctors in management, Quality management, Hospital governance, European comparison, Professionalism

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BACKGROUND Hospitals are under increasing scrutiny to improve their performance. This does not only include the performance in terms of efficiency, but also, and increasingly, the performance in terms of quality and patient outcomes [1][2]. Consequently, hospital governance is broadening its orientation from ‘control’ of costs and production towards ‘performance’ in terms of clinical outcomes. Hospital governance can be understood as a broad and ambiguous term. It essentially refers to the complex patterns of hospital-related decision-making at different levels shaping the actual “governance structure” for hospitals. It should be distinguished from hospital management which is narrower focusing on the day-to-day operational management of staff and services inside the hospital organization [2].Against the backdrop of the so-called outcome-based hospital governance, doctors are drawn into hospital governance around the world [3][4]. The argument is twofold. First, hospitals would improve their performance successfully, if led by people who are the key producers of clinical care. This seems common sense, as one needs a deeper understanding of the primary processes of patient care, i.e., professional expertise, for being able to improve the quality of care and patient outcomes for the better. The implementation of Quality Management Systems is considered one of the main mechanisms to realize performance improvement [5].Second, hospital governance is notoriously strained due to its dual organizational structure - that is the co-existence of both managerial and professional decision-making structures, as initially recognized and depicted in the concept of the ‘professional bureaucracy’ [6]. Later the US sociologist Eliot Freidson (2001) theorized that clinicians, being professionals, predominantly organize their practices following the logic of professionalization, while hospital managers follow the logic of management science or bureaucracy [7]. As both logics are often at odds with each other, tensional relationships between clinicians and hospital managers are common. Drawing doctors into hospital management would therefore ease the tensional relationship, and ultimately enhance the performance of the hospital [8][9][10]. More recent conceptualizations go beyond this dualism by emphasizing the intermingling of managerial and professional roles that currently seems to take place, especially when it is related to quality management [11][12].Studying the phenomenon of so called doctor managers fits in with the broader research on hospital governance. Research shows that there seems to be a convergent trend towards more independent governance models for hospitals in many countries as the traditional command-and-control model will no longer be viable [2][13]. Hospitals will need to be governed as part of a network of outpatient and inpatient care providers that are concerned with patient responsiveness and better attention to the role of professionals. However, the comparative research on the impact of these newly emerging models is scattered and inconclusive. There are still many aspects that are not well understood.

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Amongst others, few studies have investigated the relationship between hospital governance and quality performance. There are some studies reporting associations between quality performance and a range of initiatives including the establishing of strategic goals setting for quality improvement, putting quality performance on the agenda of board meetings, monitoring quality dashboards, and appointing a quality committee [14][15][16][17]. Furthermore, the engagement of CEOs in quality management was associated with the success of quality improvement projects [18]. However, most studies on hospital governance have been carried out in the US, and the underlying mechanisms remain unclear.Even more scarce is the research about the role of doctor managers and their impact on hospital performance. Just one study found on the basis of a secondary analysis of publicly available data of hospital trusts in the UK that those hospitals headed up by a doctor perform better than those led by lay managers [19]. Another cross-sectional study reported strong associations between the top-100 US hospitals media-generated ranking of quality and the medical background of the chief executive officer [20]. In conclusion, the processes through which doctor managers may mediate better hospital performance in terms of patient, quality and financial outcomes remains a ‘black-box’ thus far. Research on the relationship between doctor managers and quality of care is scarce, and international comparative research in this area is lacking. Therefore, it was timely and relevant to provide a quick scan of the current situation with regard to doctor managers in the hospital systems of 19 OECD countries. In addition, we explored in depth this phenomenon as related to the implementation of Quality Management Systems in 7 OECD countries drawing upon the DUQuE project (“Deepening our understanding of quality improvement in Europe”) [21][22]. Within this in-depth study we explored the hospital governance and organisational context, the formal managerial roles doctor managers have taken up in their respective hospitals and we tested the association between the level of their involvement in hospital management and the level of implementation of Quality Management Systems.

METHODSTo address the research objectives, we combined empirical data from: 1) a quick scan drawing upon a short-structured questionnaire amongst 19 country experts in the OECD’s Health Care Quality Indicator program, and 2) from a cross-sectional multilevel study, both on doctors’ involvement in hospital management and on the implementation of quality management systems, in the 7 OECD countries included in the DUQuE study.

The impact of doctor managers in 7 OECD countriesFor developing a quick overview of doctors’ involvement in hospital governance decisions in 19 OECD countries, we developed a short-structured questionnaire.

61

It was designed in four parts covering the (i) medical doctors’ involvement in governance decisions, (ii) the involvement of the governing board in clinical quality, (iii) use of quality indicators and (iv) suggestions for further country information sources.The questionnaire was used to collect data through face-to-face interviews with OECD country experts attending the OECD Health Care Quality Indicators meeting in Paris, November 2013. These country experts were highly placed national public servants representing their national Ministries of Health. Out of all participating country experts, 19 of them agreed to participate. Respondents were conveniently selected on their availability, but also purposefully selected to get all country experts from the seven countries included in DUQuE study (i.e., Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey [21][22]). All approached experts agreed to participate. The data from the interviews were complemented with the literature to map the hospital governance and organisational context of doctor managers in the 7 OECD countries included in the DUQuE study in more detail. This was done against the comparative framework developed by Kirkpatrick et al. [23]. The framework distinguishes four key areas: strategic (governance), middle management, the nature of authority structures and development of nonclinical management roles [23].

Cross-sectional data from the Duque projectThe DUQuE project encompassed a multi-method, cross-sectional study design to collect quality-related information from European hospitals between May 2011 and February 2012. Included countries represented a geographical reach of the EU and various approaches to organizing health care. Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey agreed to participate. These heath care systems provided a variation in the ratio between public and private hospitals, the number of teaching hospitals and hospital size. From each country, a random sample of 30 hospitals was recruited. The inclusion criteria were size (>130 beds) and treatment typology (acute myocardial infarction (AMI), hip fracture, stroke and deliveries) [22]. To address the main objective of studying the effectiveness of quality improvement systems in European hospitals, the DUQuE project team conceptualized, adapted and operationalized several constructs that were considered to be relevant to the quality of hospital care, including the doctors’ involvement in hospital management. This was done to capture a factor that could influence the uptake and implementation of quality improvement activities in hospitals.

62

Study populationIn each participating hospital we sent questionnaires to 10 leading medical doctors. We defined a leading medical doctor as one who has a formal or informal leading role within the hospital. The identified leading medical doctors could indicate to what extent they had a formal management role and were involved in hospital management decision-making. In addition, the quality manager of each hospital was asked to fill in a questionnaire describing the level of implementation of their quality management system.

Measures usedThe formal management role was measured by asking the respondents whether they held a formal management role and at what level (departmental or hospital). Answering categories to three items were 1 = Yes; 2 = No. In addition, we used a validated measure for professional involvement within hospitals [24]. This measure focused on the self-reported participation in hospital management decision-making by leading doctors and nurses. The professional involvement was measured in various areas of hospital management as perceived by leading medical doctors. Answering categories were: 1 = No involvement; 2 = Giving an opinion; 3 = Shared decision-making; 4 = Final decision-making responsibility. For the purpose of this study, we only used the self-reported formal management role and the perceived participation of leading medical doctors in hospital decision-making. The questionnaire is available on request.The extent to which a quality management system is implemented, was measured by the Quality Management System Index (QMSI). This measurement tool was developed based on previous research by the DUQUE team and following a systematic review of the literature on conceptual models and measurement instruments [25]. QMSI measures the implementation of nine dimensions trough 46 items: quality policy documents, quality monitoring by the board, training of professionals, formal protocols for infection control, formal protocols for medication and patient handling, analysing performance of care processes, analysing performance of care professionals, analysing feedback patient experiences and evaluate results. Quality managers were asked to answer questions related to these dimensions. The implementation of the management system is expressed as an index (0–27), based on the extent of implementation of QI activities. Thus, the maturity index tells us something about how mature/well implemented the activity is within the hospital. In other words, a high score would mean that i) a wide scope of QI dimensions is addressed in the QM system, and ii) these dimensions are not only addressed at the level of strategic planning, but are actually implemented and their implementation is assessed (items are phrased based on the PDCA cycle).

Statistical analysesDescriptive statistics were calculated to describe hospital characteristics (teaching status, ownership, and size) and demographic characteristics of participating leading medical doctors (gender, age, and number of years in job). Descriptive

63

statistics are also reported for the outcome QMSI and main predictor (professional involvement in hospital management) in the analysis. We analysed the relationship between professional involvement with the implementation of quality management as measured by QMSI. A multivariable linear regression model with random intercept by country was used to analyse the relationship between professional involvement (predictor) and the implementation of quality management systems as measured by QMSI (outcome). A linear regression model was applied to estimate the relationship between scalar predictor and outcome variables. We used a multivariable model to be able to adjust for hospital confounders. Hospital teaching status, ownership type and number of beds were treated as confounder in the model. Since we also expected that country differences can influence the abovementioned relationship, we included a random intercept for country in order to account for clustering of hospitals within countries. To determine statistical differences, the level of significance was set at 5%. All statistical analyses were carried out in STATA.

RESULTS

Doctors’ involvement in hospital management in 19 OECD countriesTable 1 provides the overview of the involvement of doctors in hospital governance within the 19 OECD countries. According to the OECD country experts, in 18 out of 19 countries medical doctors are part of the hospital top structure, and in some countries together with a ‘manager from another background, i.e., economics, health care administration, nursing, law or epidemiology.Fourteen country experts reported that the hospitals in their countries have adopted a formalized structure based on mutual responsibilities, working guidelines and policies that regulates the relationship and interaction between the medical doctors and governing board. These formalized interactions are reported to exist since the late 80s’ and countries have adopted them gradually over time. The experts reported that medical doctors are involved in hospital governance in 18 countries (all except Germany). The types of tasks in which medical doctors are involved create a mixed picture. In 9 of the countries the involvement is clinically related limited to medical activities while in another 8 countries the role is broader including all other managerial activities (e.g. budget holder, human resources etc.). Amongst the clinically related activities, the main reported focus is related to guideline development and quality indicators (e.g. Denmark, Israel, Spain). The medical doctors involved have the role to oversee the delivery and volume of services, waiting times (Slovenia) and to take decisions on hi-tech acquisitions (South Korea). The role of the medical doctors in hospital governance decisions is formalized through a set of working guidelines in all countries except England. It was reported that in 8 countries the role is consultative, in 7 countries decisional and in the remaining, the role is both consultative and decisional.

64

TABLE 1 The phenomenon of doctor managers in 19 OECD countries

Country

MDs in Top Management

Team

Formalized interaction

between MDs and TM

Formalization into force

since

MDs involvement in TM tasks

Type of tasksMDs role in

TM decisions

Belgium Medical doctorsEconomistsManagersNursesJurist

YES 1987 YES Mostly advisory consultative

Czech Republic

Medical doctorsManagers

YES 2012 YES all - most managers are MD

Decisional

Denmark Medical doctorsEconomistsManagersNurses

YES 1990 YES support the development of clinical indicators & practice guidelines; education; human resources;

Decisional

England EconomistsFinance

NO N/A YES depending on internal processes and regulation; nothing standardized

NO

France Medical doctorsManagers

YES - YES e.g. infection management

Decisional (in practice)Consultative (in theory)

Germany Medical doctorsEconomistsManagersAcademia – where the case

YES NO N/A Consultative

Israel Medical doctorsEconomists

YES 2009 YES National Programme of Quality Indicators

Consultative

Italy Medical doctorsManagers

NO N/A YES only at a medical unit level

Consultative

Luxembourg Medical doctorsEconomistsNurses

YES 1998 YES coordination of medical interdepartmental activities

Consultative

Poland Medical doctorsManagers

YES 1998 YES advisory and decisional DecisionalConsultative

Portugal Medical doctorsEconomistsManagersNursesLegal

YES many years ago

YES e.g. infection control DecisionalConsultative

Slovenia Medical doctorsEconomists

NO N/A YES e.g. delivery of services, volume of services, waiting times;

Consultative

Spain Medical doctorsManagers

YES - depends on the region

2006 YES local guidelines Decisional

Sweden Medical doctorsManagers

NO - in most regions

N/A YES e.g. setting Quality Indicators and guidelines

Consultative

Turkey Medical doctorsEconomists

NO N/A YES all hospital management task

Decisional

Japan Medical doctors YES 2000 YES CEO DecisionalSingapore Medical doctors

ManagersYES 2009 YES almost all hospital

management taskDecisional

South Korea Medical doctorsManagers - rarely

YES - only in large hospitals

2000 YES e.g. most decisions on hi-tech acquisitions and quality assessment

Decisional

Canada Medical doctorsEconomistsManagersEpidemiologists

YES 2003-2008 YES almost all hospital management task

Consultative

65

Doctor managers in 7 OECD countries Sample characteristicsThere were 188 hospitals participating in the Duque study (Table 2). Most hospitals were public (n = 156, 82.9%), and medium sized with 200 to 500 beds (N = 79, 42.0%). Almost half of the hospitals had a teaching profile (N = 81, 43.0%). In 188 hospitals there were 1,670 leading medical doctors who completed the questionnaire, yielding an overall response rate of 88%. Questionnaire completeness was high; 1,505 respondents (90%) responded to all questions in the survey.Most of the respondents were male (N = 1,151, 68.9). Their average age was 49.3 (SD 8.3) years. All respondents were experienced, as reflected in the 21.9 (SD 9.7) years on average since they completed their professional training. Most of the respondents were member of a professional society (N = 1,464, 87.6%).

TABLE 2 Characteristics of the DUQUE study sampleCharacteristics of the hospitals N %All Hospitals 188 (100)

Teaching Hospitals 81 (43.0)

Public Hospitals 156 (82.9)

Approximate number of beds in hospital N %

<200 18 (9.5)

200-500 79 (42.0)

501-1000 62 (32.9)

>1000 29 (15.4)

Characteristics of the leading doctorsa

Gender N %Male 1151 (68.9)

Female 510 (30.5)

Gender missing 9 (0.5)

Age (years), Mean (SD) 49.3 (8.3)

Number of years since completion of professional training, Mean (SD) 21.6 (9.9)

0-5 years, N (%) 106 (6.3)

6-10 years, N (%) 139 (8.3)

11-20 years, N (%) 483 (28.9)

21+ years, N (%) 914 (54.7)

Missing, N (%) 28 (1.6)

Member of professional society, N (%) 1464 (87.6)

aIncludes attending physicians and residents-in-training

66

Hospital governanceTable 3 provides a more detailed description of the hospital governance and organisation within the 7 OECD countries included in the DUQuE study. The data fits in with the bigger picture that hospital governance practices move away from governing hospitals through parallel hierarchies, with doctors represented by a senior medical committee, sometimes with powers to veto management decisions. All 7 countries are changing or have changed the hospital governance. The focus is now on strong medical management roles on departmental level and all doctors reporting through a single, unitary chain of command to a clinical director who in turn is accountable to the chief executive or general manager of a hospital. Notwithstanding the convergent trend, the hospital governance and organisation arrangements differ amongst the 7 OECD countries.

Formal management rolesA small proportion of our respondent sample (9.8%) held no formal management role (Table 4). More than half of the respondents (51.7%) held a formal management role at the department level. The rest held formal management roles at the hospital level only (5.3%) or both at the hospital and department levels (17.5%). When it comes to the professional involvement in hospital management decision-making, the majority of the respondents only gives their opinion. This did not differ much across the four decision-making areas. Only when it comes to the managing of medical practice, the respondents share decision-making responsibility (mean 2.8; SD 0.7).

67

TABLE 3 – Hospital governance and organization in 7 OECD countries

Coun

try

Hosp

ital g

over

nanc

eM

iddl

e tie

rM

anag

emen

t aut

horit

yDe

velo

pmen

t of

non

-clin

ical

m

anag

emen

tCz

ech

Repu

blic

[27]

Hos

pita

l gov

erna

nce

varie

s de

pend

ing

on

the

type

of h

ospi

tal.

Stat

e ho

spita

ls us

ually

ha

ve s

impl

e or

gani

satio

nal s

truc

ture

s he

aded

by

a di

rect

or c

ontr

olle

d by

a g

iven

st

ate

depa

rtm

ent.

Mun

icip

al h

ospi

tals

are

gove

rned

by

boar

ds o

f dire

ctor

s co

nsisti

ng

of b

etw

een

six a

nd te

n em

ploy

ees

(mai

nly

med

ical

doc

tors

). Pr

ivat

ely

owne

d ho

spita

ls ha

ve to

p-do

wn

trad

ition

al p

yram

id

owne

rshi

p st

ruct

ures

, whe

re a

boa

rd o

f di

rect

ors

cons

ists

of c

ompa

ny m

anag

ers

and

a su

perv

isory

boa

rd re

pres

ents

ow

ners

an

d op

erat

e un

der s

tand

ard

profi

t orie

nted

bu

sines

s pr

inci

ples

.

At d

epar

tmen

t lev

el, c

hief

s of

war

d/cl

inic

are

the

impo

rtan

t med

ical

m

anag

emen

t rol

es.

Inte

rest

s of

boa

rd m

embe

rs a

re

usua

lly q

uite

disti

nct f

rom

eac

h ot

her a

nd th

eref

ore

corp

orat

e pe

rfor

man

ce is

not

alw

ays

rega

rded

as

the

mos

t im

port

ant o

bjec

tive.

Ac

cord

ingl

y, di

sput

es a

mon

g th

e di

ffere

nt in

-gro

ups

resu

lt in

hig

her

auto

nom

y of

man

agem

ent a

t the

ex

pens

e of

ow

ners

.

Appr

oxim

atel

y ha

lf of

the

hosp

itals

have

no

w a

sen

ior m

anag

er

with

a n

on- m

edic

al

qual

ifica

tion.

Fran

ce [2

8]Th

e go

vern

ance

of h

ospi

tals

is ch

arac

teris

ed

by a

trip

artit

e st

ruct

ure

com

prisi

ng

1) a

n ex

ecuti

ve c

ounc

il (in

clud

ing

the

Gen

eral

Dire

ctor

and

Pre

siden

t of t

he

Med

ical

Cou

ncil)

; 2) a

n ad

min

istra

tive

(or

supe

rviso

ry) c

ounc

il re

pres

entin

g ex

tern

al

stak

ehol

ders

, and

3) a

med

ical

cou

ncil

(or

com

miss

ion)

repr

esen

ting

med

ical

doc

tors

.

After

200

7 ho

spita

ls ar

e or

gani

sed

into

clin

ical

and

non

-clin

ical

acti

vity

po

les

run

by a

triu

mvi

rate

of d

irect

or,

adm

inist

rativ

e m

anag

er a

nd n

urse

m

anag

er. A

ll po

les

also

hav

e a

coun

cil

with

stro

ng re

pres

enta

tion

from

m

edic

al h

eads

of c

linic

s. In

theo

ry

activ

ity p

oles

ope

rate

as

sem

i-in

depe

nden

t bus

ines

ses

cont

ract

ed b

y th

e ho

spita

l.

Desp

ite e

ffort

s to

stre

amlin

e m

anag

emen

t, au

thor

ity a

t hos

pita

l an

d ac

tivity

pol

e le

vel r

emai

ns

frag

men

ted,

cha

ract

erise

d by

in

tern

al c

heck

s an

d ba

lanc

es.

Publ

ic h

ospi

tals

empl

oy n

on-c

linic

al

man

ager

s bo

th

cent

rally

and

, in

crea

singl

y, w

ithin

at

activ

ity p

ole

cent

res.

A

larg

e pr

opor

tion

of th

ese

‘man

ager

s’

are

also

civ

il se

rvan

ts

(with

lega

l or p

oliti

cal

scie

nce

back

grou

nds)

w

ith st

atut

ory

role

s.G

erm

any

[29]

Hos

pita

ls ha

ve a

n ex

ecuti

ve c

omm

ittee

an

d so

meti

mes

an

advi

sory

com

mitt

ee

com

pose

d of

sen

ior m

edic

al d

octo

rs.

Trad

ition

ally

the

exec

utive

com

mitt

ee is

co

mpo

sed

of a

‘tro

ika’

con

sistin

g of

as

a m

edic

al d

irect

or, t

he to

p re

pres

enta

tive

of n

urse

s, a

nd th

e he

ad o

f the

hos

pita

l’s

adm

inist

ratio

n.

At th

e le

vel o

f dep

artm

ents

doc

tors

m

ay d

esig

n cl

inic

al m

anag

emen

t filli

ng

in a

regu

lato

ry g

ap th

at re

sults

from

th

e ab

senc

e of

a c

ompr

ehen

sive

troi

ka

stru

ctur

e. N

ew m

odes

of p

erfo

rman

ce

man

agem

ent a

re e

stab

lishe

d, b

ut

acco

unta

bilit

y st

ruct

ures

are

not

ad

equa

tely

ada

pted

. Thi

s cr

eate

s sp

ace

for s

trat

egic

acti

on o

f med

ical

do

ctor

s as

the

mos

t pow

erfu

l gro

up in

ho

spita

l gov

erna

nce.

Hos

pita

l aut

horit

y re

mai

ns v

arie

d,

with

a lo

t of d

iscre

tion

give

n to

ow

ners

and

boa

rds.

Tod

ay’s

hosp

itals

may

eith

er o

rgan

ize th

eir m

edic

al

depa

rtm

ents

as

self-

depe

nden

t ho

spita

ls “s

ub-e

nter

prise

s,” w

ith

a he

ad d

octo

r (cl

inic

al d

irect

or)

hold

ing

a m

ore

enco

mpa

ssin

g bu

dget

resp

onsib

ility

, or m

aint

ain

head

phy

sicia

ns a

s m

ere

med

ical

ex

pert

s an

d di

rect

ors

of a

mor

e ce

ntra

lly c

ontr

olle

d m

edic

al

depa

rtm

ent.

In th

e ho

spita

ls CE

O

positi

ons

abov

e th

e tr

oika

are

est

ablis

hed

and

often

fulfi

lled

by a

no

n-cl

inic

al m

anag

er.

68

Pola

nd [3

0]M

ost h

ospi

tals

are

publ

ic o

wne

d by

loca

l go

vern

men

ts a

nd u

nive

rsiti

es. A

roun

d 30

pe

r cen

t of t

hem

hav

e be

en tr

ansf

orm

ed

into

“no

n-pu

blic

” en

tities

, ope

ratin

g un

der

the

sam

e le

gal f

ram

ewor

k as

com

mer

cial

co

mpa

nies

. Hos

pita

ls ha

ve a

n ex

ecuti

ve

boar

d co

mpo

sed

of a

CEO

and

a m

edic

al

dire

ctor

.

At d

epar

tmen

t lev

el, c

hief

s of

war

d/cl

inic

are

the

impo

rtan

t med

ical

m

anag

emen

t rol

es. T

he p

ost i

s he

ld b

y a

seni

or d

octo

r, re

porti

ng to

a m

edic

al

dire

ctor

, who

is re

spon

sible

for a

ll w

ard

oper

ation

s. S

ome,

but

not

all,

ch

iefs

also

hav

e re

spon

sibili

ty fo

r the

fin

anci

al st

andi

ng o

f the

uni

t.

At d

epar

tmen

tal l

evel

the

stru

ctur

e la

cks

cohe

renc

e. C

entr

alise

d m

anag

eria

l con

trol

s in

crea

singl

y in

terv

ene

in m

edic

al b

udge

ts,

thus

, red

ucin

g m

edic

al p

ower

, whi

le

orga

nisa

tiona

l con

trol

s ar

e w

eake

r an

d fle

xibi

lity

of d

octo

rs h

ighe

r in

the

area

of q

ualit

y an

d sa

fety

m

anag

emen

t.

The

CEO

role

is

incr

easin

gly

held

by

non

-med

ical

pr

ofes

siona

ls.

Port

ugal

[31]

[32]

Troi

ka st

ruct

ure

at to

p le

vel w

ith s

ome

flexi

bilit

y. M

anag

ers

are

in th

e le

ad o

f the

bo

ard

of d

irect

ors.

The

adm

inist

ratio

n bo

ard

cons

ists

of m

edic

al d

octo

rs a

nd n

urse

s.

The

Boar

d ap

poin

ts a

dire

ctor

for e

ach

med

ical

are

a (s

ervi

ce o

r de

part

men

t) fr

om a

mon

g th

e m

ost

qual

ified

doc

tors

in th

e pr

ofes

siona

l ca

reer

.

In a

situ

ation

of p

oorly

est

ablis

hed

acco

unta

bilit

y st

ruct

ures

, the

abi

lity

of d

octo

rs to

use

man

agem

ent

stra

tegi

cally

is in

crea

sing

on th

e le

vel

of d

epar

tmen

tsan

d in

the

area

of q

ualit

y m

anag

emen

t.

Non

-med

ical

m

anag

ers,

who

are

no

w in

cont

rol o

f the

hos

pita

l bo

ard

of d

irect

ors,

ar

e ex

pect

ed to

pla

y a

cruc

ial r

ole

in h

ospi

tal

gove

rnan

ce.

Spai

nTr

oika

stru

ctur

e re

leva

nt a

t all

leve

ls; b

ut

doub

le st

ruct

ure

of g

ener

al &

‘doc

tors

onl

y’

boar

ds a

ssur

es fl

exib

ility

& m

edic

al p

ower

.

Med

icin

e is

expa

ndin

g in

to

man

agem

ent a

nd th

is is

driv

en b

y bo

th d

epar

tmen

talis

ation

and

the

esta

blish

men

tof

clin

ical

man

agem

ent w

ith d

octo

rs

utilis

ing

cont

rol b

ottom

-up.

Top-

dow

n w

ith s

ome

bott

om-u

p co

ntro

ls; tr

oika

stru

ctur

e ex

pand

ing,

bu

t qua

lity

mai

nly

man

aged

by

med

ical

doc

tors

; wea

k co

ordi

natio

n &

flex

ibili

ty.

Ther

e ar

e no

n-m

edic

al

man

ager

s in

the

syst

em.

Turk

ey [3

3][3

3]Th

e m

anag

emen

t of p

ublic

hos

pita

ls is

unde

r go

vern

men

t con

trol

. Th

e ch

ief m

edic

al d

octo

r is

the

man

ager

of

the

hosp

ital a

nd is

ass

isted

by

hosp

ital

man

ager

s re

spon

sible

for a

dmin

istra

tive,

fin

anci

al a

nd te

chni

cal i

ssue

s an

d by

chi

ef

nurs

es re

spon

sible

for n

ursin

g se

rvic

es.

Und

er th

e ‘p

ilot h

ospi

tal a

uton

omy

law

’ (20

07) t

he tr

aditi

onal

cen

tral

ised

gove

rnan

ce st

ruct

ure

is re

plac

ed b

y a

‘pub

lic-e

nter

prise

’ mod

el w

here

by h

ospi

tals

join

ing

the

pilo

t pro

ject

wou

ld b

e m

anag

ed

by b

oard

s, w

hile

rem

aini

ng a

ffilia

ted

to th

e M

inist

ry o

f Hea

lth.

At th

e de

part

men

tal l

evel

med

ical

do

ctor

s ha

ve to

wor

k as

man

ager

s in

a

stro

ng to

p do

wn

hier

arch

y.

Stro

ng h

iera

rchy

with

inte

grati

on o

f m

edic

al p

ower

.Th

ere

are

few

qu

alifi

ed h

ealth

m

anag

ers

who

took

pa

rt in

a m

anag

emen

t co

urse

.

69

TABLE 4. Doctors’ involvement in hospital management in 7 European countries Having a formal management role N %No formal management role 165 (9.8)

Formal management role at the department level only 864 (51.7)

Formal management role at the hospital level only 90 (5.3)

Formal management role at both the department and hospital level 293 (17.5)

Formal management role missing/unknown 258 (15.4)

Professional involvement in management Mean SD“How would you describe your participation within the following decision-making areas?” 1=No involvement, 2= Giving an opinion, 3=Shared decision making, 4=Final decision-making responsibility Administration and budgeting 2.1 0.7

Managing medical practice 2.8 0.7

Strategic management 1.7 0.6

Managing nursing practice 1.8 0.6

Professional involvement and quality management systemsAssociational analysis between the professional involvement measure and the quality management system index (QMSI) showed a significant positive association between the professional involvement in strategic management and the QMSI. This means that those hospitals where leading medical doctors share decision-making or have final decision-making responsibility in strategic issues have a higher score on QMSI (Table 5).

TABLE 5. Regression coefficients for the association between professional involvement in management (4 subscales) and hospital quality management indices QMSI

QMSIa (mi)b (SE)

Strategic management 3.86 (1.61)*

Administration and budgeting 1.37 (0.96)

Managing medical practice 2.57 (1.52)

Managing nursing practice 0.35 (1.12)

Professional involvement scale (total) 0.68 (0.34)a For each of the 4 scales of professional involvement in management, we estimated its association with QMSI using a multivariable linear regression model with random intercept by country, adjusted for confounders at hospital level (number of beds, ownership, teaching status)*significance p < 0.05

70

DISCUSSIONWe were able to conduct an international study on the involvement of leading medical doctors in hospital governance in OECD countries, and more in depth in 7 European countries. The large sample of 1,670 respondents in 188 hospitals yielding a response rate of 88% provides novel evidence in this research area that is still in its infancy.Hospitals are broadening their focus from steering on efficiency, productivity and cost control towards steering on improvement of outcomes in terms of quality and patient outcomes [1][2]. Furthermore, indicative evidence shows that involving doctors in hospital governance is positively associated with the performance of hospitals [19][20]. The findings of this study confirm that involving of medical doctors in hospital management is common practice in almost all of the 19 OECD countries on both departmental (middle management) and hospital level. This finding is quantitatively substantiated by our in-depth study in 7 OECD countries showing that almost all leading medical doctors have taken up formal management roles, mostly at the departmental level, but also on hospital level or both. Still, 1 out of 10 leading medical doctors in our study reported not to hold any formal management role. Thus, being a leading medical doctors does not automatically go along with a formal managerial position. Moreover, the formalisation of managerial roles is not automatically accompanied by final decision-making responsibility. On average, most medical doctors are consulted and asked to give their opinion. Thus, it seems that doctors execute management tasks, but without the mandate to really take the managerial decisions. This is in line with the contextual data on the hospital governance and organisation within these 7 countries sketching an ambiguous role of leading medical doctors in hospital management, which is also highlighted in the literature [11][12]. Furthermore, our findings indicate that leading medical doctors actually having decision-making responsibility in strategic management issues matters. It is associated with higher levels of implemented quality management systems. This finding supports the hypothesis that involving medical doctors in hospital management leads to better performing hospitals mediated through the implementation of quality systems. Moreover, it sheds light on why drawing medical doctors in management is associated with better hospital performance [19]. In the larger Duque study, a clear relation was found between the implementation of departmental quality strategies and clinical practice [26] . Hence a relation with the medical management roles on departmental level is a fair assumption. Our finding also suggests that the actual decision-making responsibility in strategic management areas is critical for the assumed relationship with hospital performance. Thus, a critical factor may not be the uptake of managerial tasks by doctors in itself, but giving them also the actual decision-making responsibility in strategic management areas.

71

STRENGTHS AND LIMITATIONS OF THE STUDYThis study has a number of limitations that need to be highlighted. First, we cannot draw conclusions on causality due to the cross-sectional nature of both the quick scan and the Duque study. Second, international research on the involvement of medical doctors in hospital governance needs to account for contextual differences across countries. Hospital governance systems differ significantly amongst OECD countries [2]. This also influences how medical doctors take up managerial roles and how quality systems are implemented. For this reason, we complemented the DUQuE study with a quick scan yielding contextual data on doctor managers in 19 OECD countries. Within the DUQuE study, we tackled this issue by specifically developing and validating an instrument that fitted our research objective [24]. Above all, we were able to adjust for different country and hospitals characteristics in ways that allowed us to address competing explanations and plausible (non)causal associations, while minimizing sources of bias [22]. A third limitation is related to the sampling strategies employed. The convenient sampling of country experts for the quick scan may have led to some bias. Even so, the random sampling of the countries, hospitals and medical doctors for the Duque study may have led to selection bias (e.g., self-selection by the hospitals and medical doctors accepting to participate). Therefore, generalization to participating countries and hospitals was limited.

CONCLUSIONS Our findings suggest that in OECD countries medical doctors are increasingly involved in hospital governance on both departmental (middle management) and strategic hospital level. Most importantly, doctors’ involvement is associated with better implemented quality management systems, especially when doctors are involved in strategic management decision making. Hence increased focus on hospital performance seems to go along with strong medical involvement in hospital governance.

72

The DUQuE Project Consortium comprises: Klazinga N, Kringos DS, MJMH Lombarts and Plochg T (Academic Medical Centre-AMC, University of Amsterdam, THE NETHERLANDS); Lopez MA, Secanell M, Sunol R and Vallejo P (Avedis Donabedian University Institute-Universitat Autónoma de Barcelona FAD. Red de investigación en servicios de salud en enfermedades crónicas REDISSEC, SPAIN); Bartels P and Kristensen S (Central Denmark Region & Center for Healthcare Improvements, Aalborg University, DENMARK); Michel P and Saillour-Glenisson F (Comité de la Coordination de l’Evaluation Clinique et de la Qualité en Aquitaine, FRANCE) ; Vlcek F (Czech Accreditation Committee, CZECH REPUBLIC); Car M, Jones S and Klaus E (Dr Foster Intelligence-DFI, UK); Bottaro S and Garel P (European Hospital and Healthcare Federation-HOPE, BELGIUM); Saluvan M (Hacettepe University, TURKEY); Bruneau C and Depaigne-Loth A (Haute Autorité de la Santé-HAS, FRANCE); Shaw C (University of New South Wales, Australia); Hammer A, Ommen O and Pfaff H (Institute for Medical Sociology, Health Services Research and Rehabilitation Science, University of Cologne-IMVR, GERMANY); Groene O (London School of Hygiene and Tropical Medicine, UK); Botje D and Wagner C (The Netherlands Institute for Health Services Research-NIVEL, the NETHERLANDS); Kutaj-Wasikowska H and Kutryba B (Polish Society for Quality Promotion in Health Care-TPJ, POLAND); Escoval A and Lívio A (Portuguese Association for Hospital Development-APDH, PORTUGAL) and Eiras M, Franca M and Leite I (Portuguese Society for Quality in Health Care-SPQS, PORTUGAL); Almeman F, Kus H and Ozturk K (Turkish Society for Quality Improvement in Healthcare-SKID, TURKEY); Mannion R (University of Birmingham, UK); Arah OA, DerSarkissian M, Thompson CA and Wang A (University of California, Los Angeles-UCLA, USA); Thompson A (University of Edinburgh, UK).

Ethics approval and consent to participateNot applicable

Consent for publicationNot applicable

Competing interestsThe authors declare that they have no competing interests.

Funding The study, “Deepening our Understanding of Quality Improvement in Europe (DUQuE)” has received funding from the European Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 241822.

Authors’ contributionsConception and design: NK, TP. Acquisition of data: AR, DB. Interpretation of data: AR, DB, NK, TP. Drafting of the manuscript: AR, DB, TP. Critical revision: AR, DB, NK, OG, RS, LB, TP. Overall approval of the paper: AR, DB, NK, OG, RS, LB, TP.All authors read versions of the manuscript and approved the final version.

73

ACKNOWLEDGEMENTS The authors would like to the DUQuE Project Consortium, comprising: Klazinga N, Kringos DS, MJMH Lombarts and Plochg T (Academic Medical Centre—AMC, University of Amsterdam, THE NETHERLANDS); Lopez MA, Secanell M, Sunol R and Vallejo P (Avedis Donabedian University Institute-Universitat Autónoma de Barcelona FAD. Red de investigación en servicios de salud en enfermedades crónicas REDISSEC, SPAIN); Bartels P (Central Denmark Region & The Department of Clinical Medicine, Aalborg University, Denmark), Kristensen S (Central Denmark Region & Center for Healthcare Improvements, Aalborg University, DENMARK); Michel P and Saillour-Glenisson F (Comité de la Coordination de l’Evaluation Clinique et de la Qualité en Aquitaine, FRANCE); Vlcek F (Czech Accreditation Committee, CZECH REPUBLIC); Car M, Jones S and Klaus E (Dr Foster Intelligence-DFI, UK); Bottaro S and Garel P (European Hospital and Healthcare Federation-HOPE, BELGIUM); Saluvan M (Hacettepe University, TURKEY); Bruneau C and Depaigne-Loth A (Haute Autorité de la Santé-HAS, FRANCE); Shaw C (University of New SouthWales, AUSTRALIA); Hammer A, Ommen O and Pfaff H (Institute for Medical Sociology, Health Services Research and Rehabilitation Science, University of Cologne-IMVR, GERMANY); Groene O (London School of Hygiene and Tropical Medicine, UK); Botje D andWagner C (The Netherlands Institute for Health Services Research—NIVEL, The NETHERLANDS); Kutaj-Wasikowska H and Kutryba B (Polish Society for Quality Promotion in Health Care-TPJ, POLAND); Escoval A and Lívio A (Portuguese Association for Hospital Development-APDH, PORTUGAL) and Eiras M, Franca M and Leite I (Portuguese Society for Quality in Health Care-SPQS, PORTUGAL); Almeman F, Kus H and Ozturk K (Turkish Society for Quality Improvement in Healthcare-SKID, TURKEY); Mannion R (University of Birmingham, UK); Arah OA, DerSarkissian M, Thompson CA andWang A (University of California, Los Angeles—UCLA, USA); Thompson A (University of Edinburgh, UK).

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[8]. Edwards N. Doctors and managers - A constructive dialogue has to replace mutual suspicion. BMJ. 2003; 326:116–7

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[10]. Plochg T, Klazinga NS. Talking towards excellence: a theoretical underpinning of the dialogue between doctors and managers. Clinical Governance. 2005; 10(1):41-48.

[11]. Noordegraaf M. Risky Business: How Professionals and Professional Fields (Must) Deal with Organizational Issues. Organization Studies. 2011; 32:1349.

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[18]. Jha AK, Epstein AM. Hospital governance and the quality of care. Health Affairs (Millwood) 2010;29(1):182–7.

[19]. Veronesi G, Kirkpatrick I. Clinicians on the board: What difference does it make? Social Science & Medicine 2013; 77:147-155.

[20]. Goodall AH. Physician-leaders and hospital performance: is there an association? Social Science & Medicine 2011; 73(4):535-9.

[21]. Groene O, Klazinga NS, Wagner C, Arah, OA, Thompson A, Bruneau C, Suñol R. Investigating organizational quality improvement systems, patient empowerment, organizational culture, professional involvement and the quality of care in European hospitals: the “Deepening our Understanding of Quality Improvement in Europe (DUQuE)” project. BMC HSR 2010;10:281.

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[24]. Plochg T, Arah OA, Botje D, Thompson CA, Klazinga NS, Wagner C, Mannion R, Lombarts K. Measuring clinical management by physicians and nurses in European hospitals: development and validation of two scales. Int J Qual Health Care 2014; 26(suppl. 1):56-65.

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CHAPTER 4.1Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria

This chapter was published as:Gulácsi L, Rotar A, Niewada M, Löblová O, Rencz F, Petrova G et al. Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria. The European Journal of Health Economics. 2014;15(S1):13-25.

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ABSTRACT This paper describes and discusses the development and use of health technology assessment (HTA) in five Central and Eastern European countries (CEE): Poland, the Czech Republic, Hungary, Romania and Bulgaria. It provides a general snapshot of HTA policies in the selected CEE countries to date by focusing on country case-studies based on document analysis and expert opinion. It offers an overview of similarities and differences between the individual CEE countries and discusses in detail the role of HTA by assessing its formalization and institutionalization, standardization of methodology, the use of HTA in practice and the degree of professionalization of HTA in the region. It finds that HTA has been to some extent implemented in all five countries studied, with methodologies in accordance with international standards, but that challenges remain when it comes to the role of HTA in health care decision-making as well as to human resource capacities of the countries. This paper suggests that coming years will show whether CEE countries develop adequate national analytical capacity to assess and appraise technologies in the context of local need and affordability, instead of using HTA as a mere administrative procedure to fulfil (inter)national requirements. Finally, suggestions are provided to strengthen HTA in CEE countries through cooperation, mutual learning, a common accreditation of HTA bodies and increased network building among CEE HTA experts.

KEYWORDSHealth technology assessment, Bulgaria, Czech Republic, Hungary, Poland, Romania

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INTRODUCTION: health technology assessment in Central and Eastern EuropeCountries of Central and Eastern Europe (CEE) share a common past but have, since 1989, taken different routes in the organization and financing of their health care systems. All have undertaken various reforms in order to improve their health systems’ performance. Health technology assessment (HTA) as a tool for informing decision-making on value for money of publicly reimbursed health technologies and their conscious introduction and use has been one possible avenue to increase efficiency of health systems, one that many CEE countries have considered and to some extent implemented. Compared to a decade ago, there has been a significant increase of activity related to HTA for decision-making purposes in Central and Eastern Europe. In this paper we evaluate the developments in the field of HTA to date in five CEE countries (Poland, the Czech Republic, Hungary, Romania and Bulgaria), with a focus on its institutionalization, standardization of methodology, use of HTA in practice and capacity-building. Materials for this paper were collected through document analysis and pooling of country expertise. Experts from all countries under study were involved in the systematic discussion of the situation in their country, based on a common set of questions. Country descriptions were further validated and refined through consultation with other CEE HTA experts and policy-makers as well as through discussions based on draft texts amongst the authors.This article starts by describing the context of health care spending in the selected countries. Next, the HTA situation in the five countries is described, comparing the institutionalization, standardization and professionalization of HTA, as well as its use by decision-makers. Finally, an assessment of current issues with HTA in CEE is presented and suggestions are put forward for further progress of HTA in the region.

HTA in context: expenditure on health care in CEE countriesEconomic situations, as well as spending on health care, vary among individual CEE countries (see Table 1).

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TABLE 1 GDP and expenditure on health care in CEE countries, 2011

CountryGDP per

capita (current US$)

Total health expenditure per capita

(current US$)

Total health expenditure (% of GDP)

Public health

expenditure (% of GDP)

Private Health

expenditure (% of GDP)

Bulgaria 7,287 522 7.3 4 3.2Czech Republic 20,580 1,507 7.4 6.2 1.2

Hungary 13,909 1,085 7.7 5 2.7Poland 13,382 899 6.7 4.8 1.9Romania 8,539 500 5.8 4.7 1.2

Source The World Bank DataBank, available: 16/11/2013http://databank.worldbank.org/data/home.aspx

Similarly, pharmaceutical expenditure per capita and its growth rate (2003–2011) for these countries differ significantly (Fig. 1). There are countries such as Hungary with high per capita pharmaceutical expenditure and very high, sometimes double digit, yearly growth rates. Yearly growth rate was very high, for instance, in Romania (19.2 % from 2007 to 2008), although the starting level of per capita pharmaceutical expenditure was very low. Both per capita expenditure and its growth rate were stable in the Czech Republic in this period. The yearly growth rate was between 1.9 and 8.2 % in Poland, although Poland started from a low spending level and in 2011 its drug budget was still much lower compared to other CEE countries except Romania. Bulgaria is difficult to analyze due to lack of data.

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FIGURE 1 – Changes in pharmaceutical expenditures in US$ PPP per capita in CEE countries between 2003 and 2011 (or nearest year). Miscellaneous: pharmaceutical expenditures cannot be separated and include medical non-durables. Sources: OECD Statistics Database, Eurostat Statistics Database, available: 10/11/2013. http://epp.eurostat.ec.europa.eu/portal/page/portal/health/public_health/data_public_health/database. http://stats.oecd.org/Index.aspx

Without suggesting any straightforward relationship between health care expenditure in CEE countries and the use of HTA in pricing and reimbursement decision-making, it is important to keep the diverse context in mind as we turn to a qualitative overview of the role of HTA in Poland, the Czech Republic, Hungary, Romania and Bulgaria.

PolandThe Agency for Polish Health Technology Assessment (AHTAPol) was established in 2005 and published its first HTA guidelines in 2007. The current version of HTA guidelines was published in 2010 [1]. Additionally, the Minister of Health issued in April 2012 an official statement on the minimum requirements for HTA reports supporting reimbursement applications, setting of the official sales price or increasing the official sales price of a drug, a special purpose dietary supplement

84

or a medical device [2]. Both the statement and HTA guidelines specify how to prepare the HTA report that is submitted to the Ministry of Health (MoH) and then transferred to AHTAPol, where the processes of assessment and appraisal take place and a statement by the expert Transparency Council (until 2011 known as the Consultative Council) is issued, followed by a final recommendation from the President of AHTAPol. There is a standardized format for recommendations that currently covers: statement on public financing, justification, objective, health problem, description of technology, alternative technology, efficacy, safety, relation of cost to health effects, impact on payer budget, recommendation from HTA institutions from other countries, course of preparing the recommendation. Since 2009 AHTAPol has been an independent legal entity with its own budget, operating at the national level under supervision of the MoH. Manufacturers are obliged to pay a fee (€25,000) after every submitted reimbursement application. The AHTAPol team consists of around 60 qualified employees and the annual budget is about €650 000. AHTAPol assesses and appraises all medical technologies, drugs, devices, and other services (i.e. screenings or other health orientated programs funded through local authorities’ budgets) that are claiming public funding. The role of AHTAPol covers the assessment and appraisal of HTA reports including scoping (definition of the decision problem), systematic review of clinical findings, economic evaluation, and budget impact analysis. An important issue is the cost-effectiveness threshold of 3 x GDP per capita/QALY (quality-adjusted life-year) that has been published in the Reimbursement Act and affects all medical technologies claiming public funding [3].Statements of the Transparency Council, the President’s recommendations and meeting proceedings are available on the AHTAPol website (http://www.aotm.gov.pl). The majority of reports are submitted by the pharmaceutical industry and prepared by consulting companies.Between 1 January 2007 and 31 January 2014, 543 reimbursement recommendations were made: 516 on drugs and 27 on non-drug medical technologies.There have been three reviews and evaluations of AHTAPol recommendations for drug therapies published so far [4][5][6]. Kolasa et al. evaluated the recommendations for drug therapies issued between 2007 and 2009 and assessed the impact for policy-making [4]. Altogether 151 recommendations of drug therapies were evaluated: the number of positive and negative recommendations was 88 and 63, respectively. The reasons for negative recommendations were: insufficient clinical data (32 cases), poor efficacy or safety (19 cases), unacceptable cost-effectiveness/cost-utility ratio (9 cases), an unacceptable budget impact (2 cases) and risk of off label use (1). From the 88 positive recommendations, 33 were classified as for use with major restrictions, 40 with minor restrictions and

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15 without restrictions. A comparison of 67 recommendations issued in 2008 in Poland with the Scottish Medicinal Consortium’s decisions [[5]] showed that among clinical reasons, inappropriate comparators were the most frequent cause of negative recommendations and rejections in Scotland; however, in Poland safety concern was one of the most often cited reason for rejection. Another evaluation of the published AHTAPoL recommendations was performed and published by Niewada et al. [6]. All 344 recommendations completed before 7 October 2011 and available on the AHTAPoL website were analyzed: 218 positive (62.8%) and 126 negative (37.2%) recommendations. Clinical efficacy, impact of hard endpoints, safety, cost-effectiveness, and formal issues were explicitly discussed by the Consultative Council in 238 (69.2%), 169 (49.1%), 155 (45.1%), 140 (40.7%) and 47 (13.7%) recommendations, respectively. Altogether, 106 (30.8 %) recommendations included cost/QALY and 193 (56.1%) budget impact estimates. Negative recommendations (n = 126) were made due to unsatisfying and unfavorable results, most important arguments were: clinical efficacy (68 recommendations, 54%), impact on hard endpoints (48, 38.1%), safety (57, 45.2%), cost-effectiveness (56, 44.4%), budget impact (17, 13.5%) and other formal issues (61, 17.7%). No clear relationship was observed between cost-effectiveness and budget impact and positive or negative recommendations, while clinical aspects seem to be more important than economic ones. Clinical efficacy and safety profile were found to contribute most to the final recommendations. No empirical threshold value for cost-effectiveness and budget impact analyses that would separate positive and negative recommendations could be identified. Clinical efficacy and safety profile were found to contribute most to the final recommendations.

Czech RepublicThe Czech Republic does not have a formal HTA body in the sense of an independent agency (such as AHTAPol in Poland) or a unit with the MoH (such as TAHD in Hungary). The creation of an HTA agency was on the agenda of the Ministry of Health in 2013 [7] and several organizational setups were considered throughout 2012–2013 [8][9]. The new minister of health (in office since January 2014) has so far not mentioned HTA as a policy priority and the fate of a future HTA body is now uncertain. On the other hand, the State Institute for Drug Control [10][11], which has been responsible since 2008 for pricing and reimbursement (P&R) decisions in the Czech Republic, has recently developed a certain interest in HTA, although the institute does not claim to do HTA per se but focuses rather on further developing and formalizing the use of pharmacoeconomics. SUKL’s future initiatives in the field could be affected by the dismissal of the institute’s director in mid-February 2014—the new minister of health expressed dissatisfaction with the institute’s work on pricing and reimbursement and put forward that SUKL should be ‘‘more

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flexible and under greater control of the state’’ [12].P&R decisions are made by SUKL in a joint procedure. The application dossier, mandatory for all new pharmaceuticals in order to be covered by public health insurance, must include a pharmacoeconomic analysis of cost-effectiveness and budget impact analysis in addition to clinical information and other elements required by law. Organizational, social and other issues considered by multidisciplinary HTA analysis are not taken into account by the institute.Cost-effectiveness and budget impact analyses are typically carried out by the marketing authorization holder or consultancies; SUKL enters only at the appraisal stage— which is, as the institute is not an HTA body with advisory functions but a regulator for P&R, identical with the decision-making phase. There is no separation of the appraisal/decision stages within SUKL from an organizational point of view. SUKL’s decision-making style has been described as a ‘‘bureaucratic process’’ by some observers [13], with an emphasis on legal and formal transparency of procedures. SUKL’s P&R staff has mainly a legal or pharmacy and medical background, with little formal academic training in HTA, as there are no master’s or doctoral study programs in the Czech Republic specialized primarily in HTA, and only a few which cover health economics, mainly at post-master level. SUKL published, in October 2012, official guidelines for budget impact analysis and in February 2013 for pharmacoeconomic analysis, as well as checklists for both [10][11]. Cost-utility analysis with QALY (or LYG) is preferred by the institute; only permanently reimbursed products can be in principle considered comparators.The institute’s decisions are publicly available on the internet and contain an overview of the dossiers as well as related reasoning. Typically, a decision would provide a detailed overview of the procedural and legal aspects as well as brief summaries of evidence provided by the applicants and used by SUKL for appraisal. This evidence generally includes clinical and sometimes health economic publications in the Czech language or in English.Throughout the process, third parties (especially professional associations of specialists) can provide statements to inform the decision. Marketing authorization holders have the right to appeal to the Ministry of Health if they do not agree with a decision. Unlike in Poland, there is no legally binding official financing threshold of cost-effectiveness requirement; SUKL is merely required by Law 48/1997 Article 39b to take into account the drug’s cost-effectiveness and budget impact. However, the institute did, in 2013, repeatedly mention in its decisions a ‘‘generally accepted willingness-to-pay threshold’’, set at the WHO-recommended 3 times GDP/QALY [14]. It is at this point unclear how strict the institute will be in denying reimbursement to drugs that fail to pass under the threshold. Drugs applying for reimbursement under the special category of ‘‘highly innovative medicinal products’’ are in any case exempt from having to prove their cost-effectiveness.

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Article 40 of Ordinance 376/2011 defines highly innovative medicinal products (Vysoce inovativni lecivy pripravek, VILP) by their clinical characteristics in considerable detail. In short, VILPs are products for severe diseases which either reduce adverse effects compared to existing treatment, offer clinical benefits for diseases without known effective therapy, or for which there is a lack of cost-effectiveness or real-life clinical outcomes data if available data points to benefits of the product compared to existing treatment. Regarding the temporary nature of reimbursement of VILPs, see also the April 2012 Opinion of the Ministry of Health on reimbursement of highly innovative products, which opens the possibility of longer reimbursement than the 3 years’ maximum [15]. Drugs approved for reimbursement in the past have been known to surpass the threshold. This is especially true for orphan drugs [16]. The weight of economic considerations in SUKL’s decisions is unknown; to the best of our knowledge no study of its decisions has been done to this date. We observe in the Czech Republic a hybrid situation: on the one hand, we see a body which is highly active, formalized and transparent in appraising cost-effectiveness. Moreover, this body has regulatory capacity and its appraisals of cost-effectiveness analyses are immediately translated into decisions—which is quite rare also in countries with longer traditions in HTA [17]. On the other hand, the body does not show significant interest in other aspects of HTA. For the moment, cost-effectiveness and budget impact analysis seem sufficient for decision-making purposes.

HungaryThe Office of Health Technology Assessment (OHTA) was established in 2004. OHTA, as an assessment and appraisal unit of the MoH has the task of providing an organizational framework for HTA that serves as the basis for the subsidy approval decisions of the National Health Insurance Fund Administration (NHIFA). OHTA performs assessments of drugs (since 2004) and medical devices (since 2007). In 2012, OHTA was integrated into the National Institute for Quality and Organisational Development in Healthcare and Medicines, and was re-named as Technology Appraisal Head Department (TAHD). TAHD carries out assessment, a formal procedure including the evaluation of the submitted economic dossier which is a legally required part of each company submission. In 2002, the Ministry of Health released guidelines for conducting health economic analyses which determine the methodological issues of health economic evaluations. The current version of the guideline was issued in 2013 [18]. In this guideline, technologies claiming for public funding are declared as cost-effective under the threshold of 2 x GDP per capita/QALY, and proclaimed not cost-effective if the ICER is higher than 3 x GDP per capita/QALY.Between 2004 and 2010 altogether 997 company submissions were received by OHTA and evaluated by its staff and a further 250 were received and evaluated

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after 2011 until the end of 2013 [19]. Companies have to pay a contribution fee which is, for pharmaceuticals, under the normal procedure 1.5 million HUF (€5,068) per submission. Details on TAHD assessments, aspects of decision making and recommendations are not publicly available. The final reimbursement decisions made by NHIFA can be found on the NHIFA website. In 2004, 20% of the submissions contained a health economic analysis, while in 2010 this rate was more than 80% [19]. OHTA/TAHD published one systematic literature review (as partial HTA) about drug eluted stents [20]. Itemized funding refers to a case based reimbursement of new medical technology when not hospitals but NHIFA buys the medical devices or medications (e.g. biological drugs) and high-value medical interventions (e.g. PET, CT) from manufacturers, finances them item by item according to protocol, and distributes them to hospitals for the treatment of selected patients. A reimbursement priority score card was introduced by a ministerial decree in 2010 for the evaluation of new hospital medical technologies financed through the DRG scheme or itemized funding [21]. Between 2010 and September 2013, 14 company submissions were assessed and appraisal decisions were made. Technologies included drug pumps, test strips, joint prosthesis, monochromatic polarized light, laboratory assays or a valve replacement system [22]. Recommendations and results of these appraisals are not publicly available. In this priority scoring system, the maximum achievable score is 100 (Table 2). Scoring is done by NHIFA, technologies reaching 60 points become potential candidates to be financed through DRG. Technologies are to be financed if they receive at least 60 points and reach at least 40% of achievable points of all the six criteria.

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TABLE 2 Reimbursement priorities for hospital medical technologies in Hungary

Priorities Maximum number of points

I. Priorities of the health care system 20I.1. National public health programs 6I. 2. Health policy priorities 7I. 3. Total health gain 7II. Severity of the disease 15II.1. Acute l ife-threatening disease 13 – 15II.2. Chronic l ife-threatening disease 10 – 12II.3. Acute non-life-threatening disease 8 – 9II.2. Chronic non-life-threatening disease 6 – 7III. Equity 15III.1. Size of the target patient population 8III.2. Accessibil ity 7IV. Cost-effectiveness, quality of l ife 30IV.1. ICER 15IV.2. Health gain per patient 15V. Budget impact 10VI. Opinions from Hungary and abroad 10VI.1. Professionals College in Hungary 3VI.2. International experiences 3VI.3. Available level of evidence 4

Total 100

VI.1–2. The College of Professionals in Hungary; International experiences professional opinions and international experiencesmust be considered,

VI.3. Available level of evidence according to the hierarchy of evidence, the highest evidence gains 4 points and the levelsbeneath count 0.5 point less per level

I.2.7. Preventive care

I.3. Total health gain considering QALYs, DALYs or life-years gained, a procedure with high societal QALY or life years gained orlow DALY receives more points

II. Severity of the disease acute life-threatening diseases gain more points and chronic non-life-threatening diseases fewerpoints

III.1. Size of the target patient population the smaller patient population gains more points. III.2. Accessibil ity: procedures gainmore points which are available across the whole country

IV.1. ICER incremental cost-effectiveness ratio, IV.2. Health gain per patient: considering QALYs, DALYs or life-years gained perpatient, a procedure with high societal QALY or l ife years gained or low DALY receives more

V. Budget impact procedures gain more points that result in smaller outflows or larger savings in the National HealthInsurance Fund

I.2. Health policy priorities I.2.1. Procedures that improve efficiency of the health care system, I.2.2. Procedures that reduce or substitute the length of hospital stay,I.2.3. Telemedicine: use of telecommunication in health care service, I.2.4. Minimally invasive or non-invasive procedures,

I.2.5. Procedures that promote rehabilitation, I.2.6. Treatments that affect the etiology of the disease not symptomatictreatments,

Source 28/2010. (12/05/2010) Decree of the Ministry of Health in HungaryI.1. National public health programs procedures gain points which promote one of the following public health actions: I.1.1. National Action Plan for Child Health, I.1.2. National Action Against Cancer, I.1.3. Hungarian National Cardiovascular Program, I.1.4. National Mental Health Program

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Romania

Pharmaceutical expenditures were growing rapidly over the past decade in Romania, until the financial crisis of 2008 (Fig. 1). This persistent growth became one of the concerns of the external creditors of the Romanian government, the International Monetary Fund (IMF) and the World Bank (WB). Following their suggestions, the government expressed its engagement in initiating development of HTA by the end of 2011 as a cost containment mechanism [23]. As a result, the Romanian government, financed by the WB, contracted as consultants NICE International (UK) to provide recommendations on how to reform the health care system. Among others (e.g. the revision of the basic benefit package), the advice was to create a de facto HTA process in order to increase the transparency and efficiency of decision-making [24][25].

On 24 April 2012, the Romanian government made the first step in embedding HTA in health care governance.

The first phase was to create a legal framework, followed by the development of a methodology and a submission process only for new drugs. The legal framework for HTA was created through Government Decision 351/2012, which was an amendment of a previous Government Decision 144/2010, regarding the organization and function of the MoH [26]. As a result of this legislation, an HTA unit was set up within the MoH in late 2012. The mandate of the HTA unit, introduced by the legislation, is broad: HTA can be applied to all existing medical technologies such as pharmaceuticals, medical devices, health policies and public health. According to an HTA guideline, published in 2013 by the MoH [27], the assessment of innovative drugs is made using a 6-item scoring chart where the maximum number of points is 10, and for a positive reimbursement recommendation, the pharmaceutical product has to score at least 6 (Table 3).

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TABLE 3. Technology assessment criteria Romania

No. Criteria PointsA Results of HTA evaluation HAS, FranceA1 SMR I-II 1A2 SMR III-IV 0.5A3 Therapeutic value is insufficient 0B Results of HTA evaluation NICE, SMC, AWMSG, United KingdomB1 Approved reimbursement without restriction 1B2 Approved reimbursemenet with restriction 0.5B3 Not reimbursed 0C Reimbursement status in EUC1 Reimbursed in minimum 16 and maximum 24 EU countries 2C2 Reimbursed in minimum 11 and maximum 15 EU countries 1.5C3 Reimbursed in minimum 6 and maximum 10 EU countries 1C4 Reimbursed in minimum 1 and maximum 5 EU countries 0.5D Relative efficacyD1 Superior relative efficacy vs comparator / active comparator or placebo 2D2 Non-inferior relative efficacy vs comparator / active comparator or placebo 1D3 Lower relative efficacy vs comparator / active comparator or placebo 0E Relative safetyE1 Lower side effects vs comparator / active comparator or placebo 2E2 Similar / equal side effects vs comparator / active comparator or placebo 1E3 More side effects vs comparator / active comparator or placebo 0F Patient reported outcomesF1 Superior PRO vs comparator / active comparator or placebo 2F2 Similar / equal PRO vs comparator / active comparator or placebo 1F3 Lower PRO vs comparator / active comparator or placebo 0

TOTAL 10SMR (Service Medical Rendu – therapeutic value) index classifies the importance of an intervention such as major (I), important (II), moderate (III), weak (IV), and insufficient to justify a reimbursement (V). (http://www.ispor.org/htaroadmaps/france.asp)HAS – Haute Autorite´ de Sante´,NICE – National Institute of Clinical Excellence, SMC – Scottish Medicines Consortium,AWMSG – All Wales Medicines Strategy Group

Based on Table 3 we can conclude that the decision on reimbursement is reached by assessing two distinct types of evidence:• Reimbursement recommendations given by HAS, France, and 3 HTA bodies

in the UK (NICE/SMC/ AWMSG), and reimbursement status in other EU member states;

• Clinical profile of the intervention: relative efficacy, relative safety and patient reported outcome (PRO) [28].

In the scoring scheme, all items have equal weights and none of them represent a knock-out criterion. Apart from the documents referring to the 6 scoring criteria, budget impact data is required in the reimbursement dossier. However, this has the role only of informing the decision-maker on the potential total expenses of a given technology and does not influence the final scoring. Supporting documentation has to be submitted according to a required structure which is critically assessed by means of a checklist. Both the structure and the checklist are adapted from the tools developed by the Canadian think-tank EVIDEM [29]. The supporting documentation has to be submitted to MoH and received by the HTA unit and the Specialty Committees. The HTA unit reviews all the

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documentation, French (HAS) and UK (NICE/SMC/AWMSG) HTA reports, the reimbursement status of the given drugs in EU countries, the clinical efficacy, safety, PRO data and analyses the budget impact. Specialty Committees review only clinical efficacy, safety and PRO. The final scoring consists of an average of the grading given both by the HTA unit and the Specialty Committees.Biosimilars are assessed slightly differently. For a positive recommendation they need to be accepted already for reimbursement in a certain number of EU countries, out of the number of countries where the product is marketed. The maximum price for which they can apply is set by law to a maximum 80 % of the original INN (International Nonproprietary Name) price.By August 2013 the MoH published a list of 167 dossiers received [30]. According to law, all these applications were supposed to be assessed and followed by a final recommendation in a maximum of 55–60 days after the day of application. In reality, this timeline was more than doubled. On 15 November 2013, the MoH started to publish its appraisals with the commitment for the rest to come in the following weeks [31]. By late December, the reviews of the HTA unit and the Specialty Committees for all 167 dossiers received by August were published. This was followed shortly by a report of the National Committee, summarizing the appraisals, which also included the decision of the final reimbursement recommendation and the need for prescription guidelines and restrictions [32]. Additionally, a new element was included in this document: “conditional reimbursement” for 12 months. In this timeframe, the manufacturer should collect and submit data from health economics analysis and budget impact. However, there are no guidelines or specific requirements as to how to satisfy this requirement.

BulgariaThe pricing and reimbursement processes are controlled by the National Pricing and Reimbursement Council (NPRC) which is responsible for the inclusion and exclusion of pharmaceutical products on the Positive Drugs List (PDL), as well as its amendments. The NPRC, responsible for HTA assessment and appraisal, was established in April 2013 by the Council of Ministers and has its own budget, as well as nearly 40 employees. NPRC decisions are based on legislative requirements of the Law for Medicine [33], the Health Insurance Act [34] and related regulations [35]. Overall inclusion in PDL takes at least 60 days. Adapted or locally prepared pharmacoeconomic analysis as well as budget impact analysis must be part of the company submission. No HTA guidelines have been published yet. Company submissions received by NPRC are assessed by external experts in pharmacoeconomics, appointed by the minister of health. Current requirements for gaining reimbursement are: (a) a registered price in Bulgaria, (b) a positive reimbursement decision in at least in 5 EU countries (c) favourable results from pharmacoeconomic analysis submitted with the application.Only medicinal products included in the PDL can be reimbursed by public funds. Once a product has a marketing authorization it must have its price registered, for

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OTC products, or regulated, for prescription medicines. Pharmaceutical products for retail sale are subject to maximum prices registration. The maximum price of a prescription product (referred to as “approved ceiling price”) is subject to regulation and approval by the NPRC. To obtain approval, the manufacturer or holder of the marketing authorization must submit to the NPRC an application detailing the elements included in the ceiling price. The application form is available on the site of the NPRC. The level of payment for medicinal products with the same INN and the same formulation reimbursed by NHIF is determined by the abovementioned HTA criteria. Clinical efficacy, safety data and results from health economics analysis are taken into account. Submissions are evaluated by the Pricing and Reimbursement Committee: the decision is based on experts’ opinion. Since its establishment, the NPRC has assessed 271 medicines included in the PDL; detailed reports are not publicly available.

DiscussionIn all five CEE countries studied, HTA activities have been developed and have become internalized in the decision-making processes on technologies over the past decade. However, there are important similarities and differences. Table 4 summarizes the main characteristics. It groups the characteristics by level of formalization and institutionalization (legislation, official institutes with HTA tasks and their embedding in the health care system), by nature of the standardization (HTA guidelines, standard methodology, national criteria for decision-making), by execution (number and types of decisions made) and by professionalization (capacity building).

Formalization and institutionalizationHTA has been embedded in the law of four countries, in Hungary and Poland in 2005 and in Romania and Bulgaria in 2013. The Czech Republic has no legal embedding of HTA but CEA and BIA are mandatory requirements. Each of the countries studied has an HTA body: one (AHTAPol) is a legally independent organization with its own budget and a staff of 60 professionals, another (SUKL) has no separate HTA capacity, while the other three are relatively small units with 2–4 HTA professionals within the health care ministry or national insurance institute. Only the Polish and Hungarian HTA bodies are members of INAHTA, although representatives from all five countries participate in the current EUnetHTA Joint Action 2 as well as in the European HTA Network established in 2013 by Directive 2011/24/EU on cross-border health care. In all five countries HTA bodies play a role in the decision-making process, although their importance and competences vary. Stages of assessment and appraisal (in the sense of evaluation and recommendation, respectively, as understood in the UK context by NICE) [36] are more or less intertwined, with most bodies producing recommendations (appraisals) based on a review of company submissions rather than in-depth assessments; the procedure seems to have more of a technical administrative nature. Only reports provided by the Polish AHTAPol and the

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Hungarian TAHD contain de novo analyses. Final decisions are typically made by the ministry of health, with the exception of the Czech Republic where SUKL’s decision is binding unless appealed against. Pharmaceuticals and medical devices are the most frequently assessed technologies. In most of the countries all medical services claiming public funds are subject to HTA, in some countries management and policy tools are included as well. The status of vaccines is somewhat different: they are considered as any other drug and the normal rules of HTA assessment and appraisal apply in Bulgaria and Poland, while in Hungary and Romania HTA assessment and appraisal is not required.

StandardizationHTA guidelines are provided to industry as a guide to create company submissions and are comparable in the CEE countries. Guidelines are also very similar to the ones in other EU countries, methodology is standardized and there is no important difference between old EU member states and CEE countries. Guidelines require information about clinical efficacy and safety of the new medical technologies, systematic reviews, meta-analysis (mainly drugs), epidemiology of the given disease, disease burden, results from health economics analysis and patient reported outcomes. Local data are required to be used in industry economic dossiers for submissions. However, there is limited experience in most of the countries in analyzing published RCTs or other results (patient level study data from trials is not required in CEE countries). There is a shortage of input data to local health economics analysis (costs, unit costs, heath status, QoL). Only a limited number of registries that can be used as a local data-sources are maintained; in several cases insurance databases are used as quasi-registries. Results from health economics and HTA from other countries, especially England (NICE) are used, however, HTA guidelines do not provide methodological support on how to adapt and transfer these results to CEE jurisdictions. Transferability of HTA results between countries implies the question as to what kind of data on effectiveness and costs can be transferred from one country to another. Up to now, data from clinical trials have been widely used in many countries without national/local participation in the trial. Hence findings on efficacy in trials might in practice have different levels of effectiveness in different countries depending on the functioning of the health care system. Epidemiological data like incidence or mortality might also be different among countries; however, their transfer is accepted in many cases. Cost data seem to be the most country specific issue, which means that applicants must use country specific cost data in the submission. However, due to the large number of submissions this is not a realistic requirement either. Available data have to be used; if the data is from a similar country in terms of economic development and overall funding levels in health care, as for instance from Poland to Hungary, this might be easier; if data comes from NICE or another Western European agency, a sophisticated methodology is needed to transfer data in a valid way to the local context.

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These transferability issues are all the more pressing where there is no link between public health priorities and reimbursement decision-making. Although four out of the five countries state that their country has specific public health priorities, it is far from clear how this influences the decision-making process for reimbursement of technologies.There are differences in the criteria for positive recommendations in CEE countries related to safety issues, implementation of financing thresholds and the importance of reimbursement status in other countries. Safety issues are important and have a greater influence on reimbursement decisions in Poland than perhaps in other countries in Europe [5]. The quality of clinical trial evidence, used by the Food and Drug Administration (FDA) varied widely across indications, the effectiveness and safety of newly approved therapeutic agents might not be well understood [36]. A similar review has not been published yet about the clinical trial evidence used by the EMA; however, the findings might be generalizable regarding EMA. Due to the shortage of registries, the capacity to control safety problems in the CEE might be weaker than in developed countries. As with effectiveness and costs, it is unclear whether safety findings from other countries can be safely transferred to the situation in CEE countries. The financing threshold is also an important issue: a 3 x GDP/capita threshold was implemented officially in Poland and in Hungary, and tends to be used in the Czech Republic, Romania and Bulgaria. Providing all drugs under the threshold and none above might be an attractive decision-making approach due to its simplicity. However, despite the existing academic consensus, thresholds alone are not sufficient for assessing the interventions’ value for money and a series of other important factors have to be taken into consideration [37][38][39]. It is unclear how flexible or rigid the approach of CEE decision-makers will be with regards to thresholds.Reimbursement decisions from other countries, mainly from NICE, are taken into consideration in all CEE countries studied. Officially, Romania declared in its HTA guidelines that reimbursement decisions are based on decisions from four HTA agencies (UK and France) and reimbursement practice in other EU member states. On the one hand this might be a good strategy if the main aim is to avoid major mistakes in reimbursement decisions; on the other hand, if the drug is cost-effective and reimbursed (for whatever reason) in France and in the UK it does not imply that this drug is cost-effective in Romania and, what is even more important, if the given drug is cost-effective in Romania it does not mean that this drug is really needed given the national public health priorities or, if needed, is necessarily fundable from public sources. In countries like England or France the final coverage decisions are the results of lengthy negotiations with industry and are not necessarily applicable in other countries with different economic and health care contexts.If the aim is to maximize value in health care in CEE countries there is another topic that needs attention: drugs already under the reimbursement scheme, the ‘‘old drugs’’. Copies of products which were patented before 1988–2000 are still available on CEE markets and represent an important share in the turnover of domestic manufacturers. Some products have been deleted from the list of available drugs, usually at the request of the manufacturers. A number of these drugs were never evaluated and their effectiveness and cost-effectiveness are

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unknown. According to some studies from Hungary, even the clinical efficacies of some of these drugs are clearly lacking or questionable, yet these drugs are still reimbursed with significant budget impact [40]. The economic evaluation of old drugs presents a major challenge for HTA bodies in CEE countries. Many of these drugs were never internationally marketed or are no longer marketed in other EU countries. As a consequence, no good quality clinical evidence is available on the efficacy of these drugs, or the available evidence is 20–40 years old. It is also unlikely that clinical trials will ever be conducted for these drugs by either pharmaceutical manufacturers or governments [41].In summary, standardization of HTA in the countries studied seems very much in line with the international methodological approaches towards HTA. However, the tendency to build HTA on effectiveness, safety and cost data and even norms that stem from more advanced HTA agencies in Europe has its limitations, and transferability should be assessed carefully. Furthermore, linkage to national public health needs and assessment of “old drugs” needs more attention.

ExecutionIn all five countries a large number of company submissions are regularly assessed and many appraisal decisions are made. This large number refers to various administrative procedures: one drug can be assessed for more than one indication and also already reimbursed drugs can apply for reimbursement for new indications. An evaluation of the functioning of this process in practice has only be performed and published in Poland. Poland also seems the most transparent in the publication of the details of appraisal reports in the public domain.In the Czech Republic, SUKL does not carry out assessments, only appraisal decision-making. The process is relatively transparent (decisions are available online and include reasoning) and there are official guidelines. In the other countries processes focus on the assessment and appraisal of dossiers submitted by industry and although the methodology has been standardized, transparency on the actual execution of the assessment and appraisal can still be improved.In all countries the focus in the execution seems to be on the administrative procedures of assessment and appraisal and only limited resources seem to be available to assess transferability of effectiveness, safety and cost data from elsewhere and/or de novo analyses with local data. Hence the danger lurks that HTA in CEE countries remains reduced to a merely technical administrative process based on a rationale that has not been fine-tuned for the national context.

ProfessionalizationAlthough all five countries have academics and civil servants who are knowledgeable and have been trained in the field of HTA, the overall capacity is still limited. Three of the five countries (Poland, Czech Republic and Hungary) have started training schemes to increase the number of HTA professionals. Whether the human resource capacity in a given country is sufficient or not is difficult to judge. Professionals with some knowledge in HTA are employed by MoHs, consultancy agencies, pharmaceutical companies, and academic institutions. Professionals are hired from other countries as well. From a comparative perspective, though, Poland is clearly best equipped in terms of human resources

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whose number seems to be proportional to fulfil the mission of AHTAPoL. However, more important than training and headcounts of professionals as such is the question of whether HTA in CEE countries will develop in scope and depth in the direction of the performance of national analytical studies based on local data and the national context that reflect a reliable and valid approach towards value creation. This will depend on whether HTA is merely an administrative procedure, checking submissions from industry against a set of criteria, or includes de novo execution of analyses grounded in local context. In addition, the future of HTA will depend on how seriously policy-makers take HTA conclusions and how evidence-based policy processes in health care overall take place. A negative scenario is an HTA practice fuelled by industry with little counterbalancing power by health care administrators and policymakers, resulting in a bureaucratic decision-making process copying results from elsewhere that have not been validated for the local context. A positive scenario is further professionalization of both government HTA staff and awareness of policy-makers, resulting in transparent decision- making processes through which evidence from industry is weighed systematically against societal values and priorities furnished by national studies based on local data.

CONCLUSIONHealth technology assessment has, over the past decade, been developed and implemented in Poland, Hungary, Romania, Bulgaria, and to some extent also in the Czech Republic. These five CEE countries have formal requirements for HTA and HTA institutes, although organizational embedding, size and importance for decision-making differ. Standards for HTA are largely modelled after international examples. However, after the first phase of formalization, institutionalization and standardization, HTA in CEE countries now seems to be at crossroads. It can remain a technical administrative exercise to assess and appraise technologies using effectiveness, safety and cost data which comes from elsewhere and whose transferability can be questioned. It can also develop further to a more robust form of HTA where local data serve increasingly as input for analysis and where decisions are grounded in national priorities and values. To achieve the latter, the following actions can be considered. First, local data on effectiveness, safety and costs could be shared amongst CEE countries. It can be expected that these data will increasingly become available and, given the similarities between CEE countries in economic development and health care systems, sharing of the data would enhance transferability compared with the present situation. Second, a common training of HTA staff might ensure that stress is put on insights and methodologies which are presently needed in order to bring HTA in the region to the next phase. Third, a mutual assessment and recognition of HTA bodies through certification or accreditation might be considered. Of course, this depends on whether countries agree on developing their HTA to a more mature level, but an international form of assessment and recognition, as exists in other areas such as the accreditation of accreditation organizations for hospitals as run through the International Society for Quality in Health Care, is worth considering. Lastly, it is important that HTA experts in CEE countries form their own community and exchange their knowledge and

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experience, which has accumulated over the past years by active participation in international HTA initiatives, including notably the EUnetHTA and EUROREGIO II initiatives: out of the 40 partners of the current EUnetHTA Joint Action 2 (2012–2015), 11 are from CEE countries. These are health ministries, national schools of public health, quality and accreditation institutes, and an HTA agency (AHTAPol). Strengthening of the network of HTA experts in CEE countries should facilitate knowledge sharing and promote a more rigorous and robust approach to HTA in the region.

ACKNOWLEDGMENTS The authors would like to thank Prof. Tomasz Pasierski, Head of the Cardiology and Cardiovascular Diseases Unit at the Specialist Hospital in Miedzylesie, Department of Bioethics in the Medical University of Warsaw and Head of the Transparency Board of AHTAPol for his invaluable comments on drug safety perception in reimbursement decision-making in Poland and to Dr. Jozsef Gajdacsi, Deputy Director General, Dr. Peter Varga, Head of Analysis, Medical Expertise and Controlling, National Health Insurance Fund Administration, Hungary and Gabriella Jona, Head of TAHD, Hungary for their helpful comments and contribution.Proofreading of the manuscript was supported by the TAMOP 4.2.2./B-10/1-2010-0023 project.

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CHAPTER 4.2The role of managed entry agreements in Central and Eastern European countries

This chapter was published as:Rotar A, Preda A, Löblová O, Benkovic V, Zawodnik S, Gulacsi L et al. Rationalizing the introduction and use of pharmaceutical products: The role of managed entry agreements in Central and Eastern European countries. Health Policy. 2018;122(3):230-236.

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ABSTRACTThis paper aims to provide an overview of the rationalization strategies for the introduction and use of pharmaceuticals, focusing on the role of managed entry agreements (MEA) in Central and Eastern European (CEE) countries, namely Bulgaria, the Czech Republic, Croatia, Hungary, Poland and Romania. We developed a conceptual framework on MEAs that was used as the basis for a standardized assessment questionnaire sent to country experts to capture their perceptions on their countries’ rationalization strategies and MEAs. Our study shows that the main role of MEAs and other related policies embedded in the health care system is to limit the budget impact of drugs in all examined 6 countries. Uncertainty about outcomes and appropriate utilization seem to be of lower priority. Finance-based MEAs are used by all countries. Performance-based MEAs are scarce and used to a limited extent by Hungary and Poland. The overall transparency of the existence and details of MEAs is limited. Expansion of the use and increased transparency of MEAs is recommended. Still, the informational infrastructure and competencies in implementing MEA’s need to be developed further.

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INTRODUCTIONSafety, efficacy and quality of manufacturing are mandatory for all new drugs [1][2][3]. The reimbursement from public finances is linked to discussions on cost-effectiveness, financial risk-sharing and solidarity [4][5]. Likewise, the quality of usage of medicines is an important prerequisite for effectiveness [6][7] and the public payer-purchasing price should contribute to fiscal sustainability [6][8]. Consequently, we believe these four focal points of regulation and governance are inter-related and overlap as is illustrated in the Venn-diagram we developed for this study, to help positioning our topic: managed entry agreements (MEAs) (see Figure 1).

FIGURE 1 – Positioning of managed entry agreements (MEAs) amongst four focal points of governmental regulation and governance.

Decisions on pharmaceuticals reimbursement from public finances (via social health insurance or a national health service) are the competence of individual European Union Member States. To support decision making, in many European countries, health technology assessment (HTA) was introduced to assess the value of (new) drugs. Over the past two decades, HTA has become strongly institutionalized and fine-tuned as a way of informing decision making on pharmaceuticals reimbursement from public funds. The topic of outcomes observed in routine practice of the reimbursed drugs, has been addressed increasingly over the past decade. It is not uncommon for the clinical efficacy shown in clinical trials not to be confirmed in less controlled real-life situations. There can be a difference between the outcomes promised in clinical trials (efficacy) and what is happening in daily clinical practice (effectiveness) producing less value than predicted as part of the decision making on re-

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imbursement and hence a potential waste of resources [9]. This led to stricter HTA appraisals and the search for real-world evidence to reveal the true health outcomes in daily clinical practice. Therefore, governments began to implement new mechanisms (e.g. patient registries) for assessing effectiveness and hence assuring value for money.Still, the HTA approaches put in place by European countries cannot guarantee financial sustainability. The public payer-purchasing price is under pressure to be decreased, especially in the aftermath of the 2008 economic crisis, when there was an overall decrease in spending on health care with a relative stronger decrease in spending on pharmaceuticals [10]. Existing HTA approaches showed their limitations in providing the desired financial sustainability and addressing the right set of evidence countries are looking for. One recent example is the debate in the United Kingdom around the reimbursement of the latest hepatitis C treatments. Despite NICE’s long-standing approach of cost per QALY, the reimbursement of the latest hepatitis C treatments is strongly questioned on budget impact grounds [11] and government financial sustainability. More recently, countries started to struggle to find regulatory and governance strategies for limiting public payer-purchasing price and linking it realized outcomes in routine practice. The natural step was to design new policy interventions for reducing the acquisition price deals (financial-based MEAs) and sharing the financial risk (outcome-based MEAs) amongst the producers of the drugs and the governments or purchasing bodies acting on their behalf [12] . Within this context, the managed entry agreements (MEAs) have been developed. A first definition of the concept was provided in 2011 by Klemp et al [13]. According to Ferrario et al [14], a MEA is a tool that aids governments to share the financial risk, implemented as formal arrangements between payers and manufacturers in different shapes (e.g. price-volume agreements, discounts, coverage with evidence development).Ferrario et al. stress that the main goal of MEAs is to manage uncertainty (or risk) for the payer of unexpected performance of a new medicine. A drug may under-perform and prove less effective than expected. In the context of existing governance initiatives taken by countries, MEAs can be seen as a government policy strategy enabled by a contractual relationship between a manufacturer and payer/provider that allows reimbursement/coverage from public funds of a drug subject to specified conditions. These arrangements can be shaped as different policy interventions to address uncertainty about the performance of pharmaceutical products or to manage the adoption of pharmaceutical products in order to maximize their effective use, or limit their budget impact. Contrary to Klemp, we consider a MEA to be a policy strategy rather than an arrangement. The foundation of a MEA should be a bilateral contractual agreement between the manufacturer and the payer. In terms of reimbursement, HTA as a formal part of reimbursement decision-making is still under development in Central and Eastern Europe (CEE) and does not seem to be extremely strong or to gain power [15]. Addressing the

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concern on the public payer-purchasing price and effectiveness is the next step in the adoption of new pharmaceuticals, by moving forward to regulatory and governance models for financial and outcome risk-sharing, i.e. managed entry agreements. In this light, our paper has two research questions. Firstly, we aim to find out what is the role of MEAs in CEE countries and the extent of their use. Secondly, we want to find out which drugs are subject to MEAs and to see whether there is a match or not with the ones in Western Europe.

We selected six CEE countries: Bulgaria (BG), Croatia (HR), the Czech Republic (CZ), Hungary (HU), Poland (PL) and Romania (RO). While these countries differ in many respects (e.g. GDP, health spending per capita, organization of health systems etc.) [16], traditionally many policy innovations have diffused to CEE later than in countries of Western Europe (see for instance the limited use of HTA in CEE). It is therefore valuable to see to what extent and how CEE countries adopt and adjust the very recent practice of MEAs.

MethodsThe research questions were explored by developing a framework to conceptualize the kind of objectives countries are trying to achieve through MEAs, based on the types implemented (see Figure 2). It is built on the taxonomy proposed by Ferrario et al. and maps the role of MEAs in six CEE countries, based on their typology. Subsequently, the conceptual framework was turned into a standardized questionnaire (see Appendix 1, Supplementary material) with general and specific questions, to assess the situation related to MEAs, and was sent to selected experts (10/10 response rate) from the participating countries on November 17, 2014. The general part consisted of questions that describe the expert’s perception on country rationalization policy strategies, the legal embedding of MEAs in the drugs’ reimbursement system and their actual implementation. We asked the country experts to rank the existing policies and number of MEAs from a scale of 1 to 5, 1 being “not important” and 5 being “highly important”. The existing number of MEAs was estimated based on the same 1 to 5 scale, with 1 being “non-existing” and 5 considered being “most frequent”.The specific part aimed at quantifying the number and types of MEAs implemented for a specific series of drugs. The drug sample was chosen based on the one found to be most frequent subject to MEAs in Western Europe [14]. The list was completed by including the drugs subject to MEAs according to NICE’s appraisals starting from January 2012 (end date of the data collection of the Ferrario et al research project) until January 2015. The total number of drugs included in the predefined list was 32 (see Appendix 1, Supplementary material). To avoid selection bias, country experts had the possibility of including additional drugs. We received all questionnaires by February 2015. For data validation purposes, we conducted extended phone call interviews with each of the 10 country experts until April 2015 after which the data set was analysed.

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FIGURE 2 – Conceptual framework of MEAs typology and the related objectives

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ResultsAll CEE countries under review are using MEAs as a policy tool for the rationalization of introduction and use of pharmaceutical products. Also, significant steps have been made in the past 5 years in embedding in the decision-making process specific guidelines and regulations. Nevertheless, there are significant differences among our sample of countries. Table 2 summarizes the main features.Table 1a highlights the reported policy goals targeted by the CEE countries when applying reimbursement decisions for pharmaceuticals. All 6 countries under review have as a primary focus to “limit budget impact” of the introduction and usage of pharmaceuticals. All country experts rated it with 5, highly important. Countries’ policy goal to “address uncertainty on clinical effectiveness AND/OR cost-effectiveness” is less important. On our 1 to 5 scale, Bulgaria, the Czech Republic and Croatia rated it 2 in terms of importance, while Hungary, Poland and Romania rated at 3. Two countries, the Czech Republic and Romania, rated “manage appropriate utilization” at 2 and Bulgaria, Hungary, Croatia and Poland rated it at 3.An overall image of the experts’ opinion on the existing MEAs in their respective countries is presented in Table 1b. “Price volume agreements” are reported as non-existent in Bulgaria, the Czech Republic, Croatia and Romania, but their presence in Hungary and Poland is rated at medium, with 3. In 5 countries, “discounts” are the most frequent MEAs. Only the Czech Republic rated it at 3. “Dose caps” do not exist in 4 countries and rated at a medium level in Hungary and Poland. “Budget caps” are not used by Bulgaria and Romania, used at a medium level by Croatia, Hungary and Poland, while in the Czech Republic they represent the most frequent type of MEAs. “Price match with comparator” is present only in Poland on an average level. None of the reviewed countries have in place a performance-based MEA, “coverage with evidence development”. “Outcome guarantees” are present only in Hungary and used at an average level. Hungary also uses at an average level the “decrease of the price/limit utilization to improve the ICER” type of MEAs, while Poland rates it higher, at 4, in terms of frequency. None of the other countries have this type of MEA in place. “Limiting prescribing and reimbursement to specific therapeutic indication and to those patients sub-groups who are most likely to benefit” is implemented only in Poland and is very frequent. It is rated at 4.Our interview-based research showed that the extent to which MEAs are used is rather limited and that CEE countries use different mechanisms embedded in the architecture of the health care system structure (e.g. prescription guidelines, patient co-payment coverage, disease budget caps, class budget cap). Apart from “limiting budget impact” for which the financial focused MEAs are in place, the remaining policy goals, “addressing uncertainty on clinical effectiveness AND/OR cost-effectiveness” and “managing appropriate utilization”, are achieved through MEAs only in Poland and to a lesser extent in Hungary. Still, these goals are partly achieved in all countries by strict reimbursement guidelines and budget caps for treatments of a given disease.

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TABLE 1 – Policy goals importance and frequency of MEAs used by typology

Table 1a - Policy goals importance1 2 3 4 5

Not important

Highly important

Finance Based

1 Limit budget impact BG, CZ, HR, HU, PL, RO

2 Address uncertainty on clinical effectiveness AND/OR cost-effectiveness

BG, CZ, HR

HU, PL, RO

3 Manage appropriate utilization

CZ, RO BG, HR, HU, PL

Table 1b - Frequency of MEAs used by typology

1 2 3 4 5Non-

existent Most

frequentFinance Based

1 Price volume agreements BG, CZ, HR, RO

HU, PL

2 Discounts CZ BG, HR, HU, PL, RO

3 Dose caps BG, CZ, HR, RO

HU, PL

4 Budget cap BG, RO HR, HU, PL

CZ

5 Price match with comparator BG, CZ, HR, HU, RO

PL

Performance-based

6 Coverage with evidence development

BG, CZ, HR, HU, PL, RO

7 Outcome guarantees BG, CZ, HR, PL, RO

HU

8 Decrease the price/limit utilization to improve the ICER

BG, CZ, HR, RO

HU PL

9 Limit prescribing and reimbursement to specific therapeutic indication and to those patients sub-groups who are most likely to benefit

BG, CZ, HR, HU, RO

PL

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Different formalization levelsA legal framework is in place in Bulgaria, Croatia, Hungary, Poland and Romania. Hungary was the first one to introduce legal provisions for MEAs and implement it in 2005. The last country to embed MEAs in the legal framework was Romania in 2014, but its actual implementation was missing. Poland is the only country to have the adoption of MEAs formalized as a policy tool, but without a formal procedure to enter in such a mechanism. Bulgaria, Croatia and Romania have implemented legal guidelines for entering MEAs. Still, all CEE countries under review have implemented in their decision-making process MEAs, even in the absence of specific regulations - the Czech Republic, Hungary and Romania (before developing a legal framework). The first policy intervention to establish MEAs was in 2005 in Hungary and expanded gradually: 2008 in Romania, 2011 in Bulgaria and Poland, and 2013 in the Czech Republic and Croatia.Parties involved in the process and implementationCountries developed different system pathways to implement MEAs. Some of them involve in the negotiation process more parties than others. In Bulgaria, the Czech Republic and Croatia, the procedure includes a rather limited variety of bodies: only the market authorization holder (MAH) and the public payer. Hungary, Poland and Romania appear as a more dynamic environment to negotiate the form and the implementation details of MEAs. There are more bodies involved, including MAHs, public payer, MoH (Economic Commission - responsible for price and MEAs negotiations in Poland), HTA body (Poland, Romania) and health service providers for implementation purposes (only Poland).The exact number of MEAs in the CEE countries is difficult to assess, except for Romania. The numbers and the types of agreements presented in Table 2 are based solely on experts’ opinion, centred on their knowledge and practice and may not reflect a precise reality. Romania is the only country where all the details are available, but this is soon to be changed to a similar approach as in the rest of the countries. The newly released legal framework will treat these agreements as confidential [17][18].Countries also show differences in the contract duration for the implemented MEAs. However, all of them, regardless of the disease or the time validity, have the option to be prolonged if a new agreement is reached. Hungary does not have a specific duration, but some diseases contracts are reported to be valid for only 6 months. Bulgaria and Romania have yearly-based agreements; the Czech Republic typically uses a 3-year time-horizon, while in Croatia and Poland these details are also a matter of confidentiality. However, for Poland it is safe to assume that the contractual duration of MEAs is identical as the reimbursement decision – 2 years’ time horizon.

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TABLE 2 – Comparison on MEAs in CEE countries

Bulgaria Croatia Czech Republic

Hungary Poland Romania

Formalization

National legislation in

place

Yes Yes No Yes Yes Yes

Introduction year 2010 2013 NA 2005 2011 2014

Implementation year

2011 2013 NA 2005 2012 Not applied

Formal procedure to

enter MEA

Yes Yes No No No Yes

First MEA introduction

2011 2013 2013 2005 Formally January 2012. However,

agreements were present before

this date.

2008

Process involved parties and implementation

Involved parties MAH and public payer

MAH and public payer

MAH and public payers (VZP and the Association of Health Insurance

Funds, SZP)

MAH, public payers and

MoH (only in the approval

phase)

MAH, HTA body, MoH (Economic

Commission - responsible for price and MEAs negotiations),

public payer and health services

provides in implementation

MAH, public payer, HTA body and

MoH

Total no. of MEAs currently

implemented

37 Approx. 50 (+/-5)

Approx. 10 Not possible to specify -

confidential

Not possible to specify -

confidential

2

Confidentiality of contractual

terms

Not publicly available

Not publicly available

Not publicly available

Not publicly available

Not publicly available

Currently, the details are publicly available; in the future it will be

confidential

Contract duration

Yearly Not publicly available

Typically 3 years (VZP)

or unlimited with notice period (SZP)

No specific duration, in some

therapeutic areas this is 6

moths.

There is no specified

timeline. It can be assumed that duration of most

MEAs is equal to the length of reimbursement

decision (2 years)

Yearly

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Individual drugs subject to MEAsThe results of our research, both from the expert interviews and their exploration for public available sources, do not allow us to offer a complete overview of the drugs that are subject to MEAs in CEE countries. As the country experts reported, the contracts are confidential and no public information is available on drugs subject to MEAs, while in Romania none of the drugs from our study sample is among them.

Discussion and conclusionMEAs have been gradually introduced in all six CEE countries studied in the past decade as a government policy intervention when reimbursing pharmaceuticals from public funds. The first MEAs were put in place in Hungary in 2005, followed by Romania in 2008. At that time, Romania had no legal framework for such agreements. Therefore, the implementation of MEAs is not conditional to a pre-set legal framework. Still, important steps have been made by CEE countries to embed MEAs in their health care system. Except for the Czech Republic and Hungary, all countries have implemented a legal framework. This is a clear sign of formalizing a new type of rationalization strategy and embedding it in the health care system architecture. Bulgaria, Croatia and Romania are even a further step ahead. They created a legal framework for procedural and institutional guidelines on how to enter MEAs. Of the six countries in our study, only Romania (between 2008 and 2014) made the content of a contract between a public payer and a manufacturer, a matter of public knowledge; this is no longer the case after the recent reforms [17][18].Finance based agreements are most frequently present while performance-based agreements are limited (only in Hungary and Poland) in all reviewed countries. The most frequent type are the discounts. It is safe to assume that both governments and pharmaceutical companies choose to implement finance based agreements, especially discounts, for their low transaction costs (limited bureaucratic and administrative burden and the ease of implementation due to the unsophisticated technological infrastructure) and their high financial sustainability and predictability. Still, for a greater control over spending, commonly, discounts come bundled together with a disease-specific budget cap. Financial based agreements (e.g. discounts, dose caps) have been frequently implemented in countries like the UK through NICE’s recommendations and increased NHS affordability and patient access. The Netherlands and Sweden frequently apply performance-based agreements, under the form of coverage with evidence development, and establish a price based on the achieved real-life outcomes [14]. CEE countries try to achieve the balance between safety, reimbursement, effectiveness and public payer purchasing price through a combination of policies embedded in the architecture of their health care systems, in addition to MEAs. Currently, the role of MEAs, as per our framework to assess their policy objective, is mainly to limit the budget impact. The attempt to achieve a balance is also sought through other policies aimed to address uncertainty on clinical effectiveness AND/OR cost-effectiveness and manage appropriate utilization (e.g. prescription guidelines, prescription limitations to a certain type of physicians). Based on the little experience countries have, MEAs can remain a strictly technical

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and administrative feature aimed just at controlling costs and potentially prolong access, or can develop further in more complex governmental tools to enhance payment based on value. Establishing complex MEAs, without having a mature HTA system in place, leaves room for error in controlling the budget and outcome measurement. Assessing which technology can have the highest impact at patient level and fit in a limited budget, may become more a political process, which combined with lack of transparency, can lead to accountability risks.There is a clear need for creating more transparency about MEAs. Coupled with HTA approaches that are still under development [15] and a lack of policy focus and information infrastructure to capture the actual appropriateness of utilization of drugs and effectiveness, creates an opaque situation. Our expert interviews have not provided indications that this will change in the near future, since payers loose negotiation power and MAHs want to limit spill-overs in other countries through external referencing pricing [12]. However, low levels of transparency do not ensure fair use of public finances, widen the gap between society and governmental institutions and leave potential room for fraud. In practice, some Western European countries, such as Italy or UK [19] , equally keep many elements of MEAs confidential, but at least mention their existence. Therefore, given today’s standards of transparent governance where public budgets are involved, the degree of confidentiality of MEAs in CEE countries is unusual. From this perspective, a low level of transparency is undesirable. As part of the democratic transition, public and political debates on increasing transparency and oversight of public finance are a continuous process in CEE countries. Low transparency increases the level of asymmetric information between payers and market players, leading to an imbalanced transaction power, potentially causing market disruptions. In contrast, the existing level of transparency for MEAs in several Western European countries contribute to creating a sharper image of the economic environment and is associated with wide contracting options [20]. MEAs in CEE have limited procedural legitimacy. Therefore, lack of transparency could also be an advantage of payers and decision-makers, whose room for negotiations with MAHs is increased as long as they are on the winning end of asymmetric information (e.g. prices paid to competitors). Eventually, opaque contractual agreements can be seen as acceptable if policy-makers and the informed public are convinced that they are the only way of providing access at affordable prices to new drugs. The lack of transparency was also a hindering element in our expert interview-based research and the quest for publicly available sources, when wanting to contribute to a European overview of the existence of MEAs. Moreover, 1) it implies that economic evaluations in the literature may be biased and should be used with caution for international benchmarking (their transferability in the absence of realistic cost information would lead to biased decisions) and 2) it affects external price referencing, a tool commonly used by policy makers in Europe to regulate prices of new drugs [21][22]. The fairness of public financing needs a strong HTA system and policy mechanisms to ensure quality of care, which requires good monitoring of the use of drugs and continuous feed-back and improvement. Hence, a good information infrastructure

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to capture effectiveness of drug use and competencies of all parties involved, are essential to turn a MEA in a functioning rationalization strategy. Countries need to develop the capacity of measuring and recording real-world outcomes, create a reliable IT infrastructure, train medical professionals and other human resources to work and culturally adhere to rigorous data registering and reporting. However, this takes a considerable amount of time and resources. Therefore, it is expected for the best practices for performance-based agreements to come from countries with a long-standing history with governance mechanisms for reimbursement decisions and measuring health outcomes (e.g. Netherlands, Denmark and Sweden).Nevertheless, there is the need of broadening the implementation of MEAs to their other function and use it at a wider purpose than limiting budget impact. The role should expand to address uncertainty on clinical effectiveness AND/OR cost-effectiveness and manage appropriate utilization in a complementary manner with the already embedded policies in the health care system (e.g. strict reimbursement guidelines, disease budget caps). This approach is critical when moving forward in trying to achieve a balance between effectiveness and the public payer-purchasing price, by combining the financial and outcome risk-sharing governance mechanisms. In our view, an implementation of MEAs needs to have a two-step approach. First, to take advantage at best of the variety of financial based agreements and not limit their use to a specific rigid framework, but to allow room for proposals and innovative payment plans. This can lead to a higher financial sustainability. Secondly, while implementing financial based agreements, a cross-institutional work-stream (parties involved in MEAs, software engineers, training institutions etc.) is needed to develop an appropriate setting for performance-based agreements through facilitating international cooperation, knowledge sharing and strengthening the network of HTA experts in CEE and beyond. We encourage the use and further applicability of MEAs given the challenges faced by governments, but not in an opaque way. Transparency should be increased and ideally linked with comparative assessment of the existing alternatives. Also, MEAs should not be used for any drug, but only where tensions on price and/or a high degree of uncertainty on the results in the clinical trials exist. In this respect, there should also be a clear way and guidelines to define the categories of pharmaceuticals to be selected for entering MEAs.The full contractual terms cannot be always fully available, especially in CEE, where public prices are known to be significant lower compared to Western Europe. Having public details on the negotiated price reduces the commercial incentives of manufacturers to launch, caused by the external reference price system that can affect larger markets in Western countries [12]. Still, basic facts about MEAs (at the very least information about their existence) should be public information. However, to assure a better control and to eliminate the potential causes of fraud, an independent, credible and reliable audit office needs be in place to examine the contract details and the results. Ultimately, any investments can be justified only if linked to results. The regulatory and governance objectives for pharmaceuticals should not only be about safety, but also about solidarity and ensuring effectiveness by measuring outcomes, i.e. doing good with public money and creating value on health system level.

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REFERENCES

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[3] European Observatory on Health Systems and Policies Series. Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality. 2004. Available at: http://www.euro.who.int/en/publications/abstracts/regulating-pharmaceuticals-in-europe-striving-for-efficiency,-equity-and-quality [accessed: 25.10.2016]

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[5] Paris V, Belloni A. (2013), “Value in Pharmaceutical Pricing”, OECD Health Working Papers, No. 63, OECD Publishing. http://dx.doi.org/10.1787/5k43jc9v6knx-en

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[7] Cramer JA. Consequences of intermittent treatment for hypertension: the case for medication compliance and persistence. American Journal of Managed Care. 1998. 4:1563-1568.

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[9] Vitry A, Roughead E. Managed entry agreements for pharmaceuticals in Australia. Health Policy. 2014 Sep;117(3):345-52. doi: 10.1016/j.healthpol.2014.05.005.

[10] OECD (2012), Health at a Glance: Europe 2012, OECD Publishing., http://dx.doi.org/10.1787/9789264183896-en

[11] Boseley S. Hepatitis C drug delayed by NHS due to high cost. 2015. The Guardian, Available at: http://www.theguardian.com/society/2015/jan/16/sofosbuvir-hepatitis-c-drug-nhs [accessed: 27.07.2015]

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[12] Steven G. Morgan, Sabine Vogler, Anita K. Wagner. Payers’ experiences with confidential pharmaceutical pricediscounts: A survey of public and statutory health systems in North America, Europe, and Australasia. Health Policy Volume 121, Issue 4, April 2017, Pages 354-362. https://doi.org/10.1016/j.healthpol.2017.02.002

[13] Klemp M, Frønsdal KB, Facey K. What principles should govern the use of managed entry agreements? Int J Technol Assess Health Care 2011 Jan;27(1):77-83. doi: 10.1017/S0266462310001297

[14] Ferrario A, Kanavos P. Managed entry agreements for pharmaceuticals: the European experience. 2013. EMiNet, Brussels, Belgium Available at: http://eprints.lse.ac.uk/50513/1/__Libfile_repository_Content_Ferrario%2C%20A_Ferrario_Managed_%20entry_%20agreements_2013_Ferrario_Managed_%20entry_%20agreements_2013.pdf [accessed: 10.07.2015]

[15] Gulácsi L, Rotar AM, Niewada M, Löblová O, Rencz F, Petrova G et al. Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria. Eur J Health Econ (2014) 15 (Suppl 1):S13–S25; DOI 10.1007/s10198-014-0590-8

[16] OECD, Health at a Glance: Europe 2014, OECD Publishing. 2014. http://dx.doi.org/10.1787/health_glance_eur-2014-en

[17] Government Ordinance No. 77/2011with subsequent changes. 2015. Available at: http://www.lexmed.ro/doc/OUG_77_2011.pdf [accessed 27.07.2015]

[18] Ministry of Health Order No. 3/2015 with subsequent changes. Available at: http://lege5.ro/Gratuit/gqzdgmjvgm/ordinul-nr-3-1-2015-privind-modelul-de-contract-metodologia-de-negociere-incheiere-si-monitorizare-a-modului-de-implementare-si-derulare-a-contractelor-de-tip-cost-volum-cost-volum-rezultat [accessed: 27.07.2015]

[19] Palozzo A. New drugs—how much are they worth? The Italian registries: a model to evaluate appropriateness and effectiveness. European Journal of Hospital Pharmacy 2012; 19:398–403. doi:10.1136/ejhpharm-2012-000071

[20] List of technologies with approved Patient Access Schemes. https://www.nice.org.uk/About/What-we-do/Patient-access-schemes-liaison-unit/List-of-technologies-with-approved-Patient-Access-Schemes

[21] Vogler S, Zimmermann N, Leopold C, Joncheere KD. Pharmaceutical policies in European countries in response to the global financial crisis. Southern Med Review (2011) 4;2:22-32. doi:10.5655/smr.v4i2.1004

[22] OECD Health Policy Studies. Pharmaceutical Pricing Policies in a Global Market. OECD Publishing, Paris, France (2008).

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APPENDIX 1

I. General questions1. How important are the following policy goals in your country? Please fill in the

box with “x” where appropriate.

1 2 3 4 5

Not important Highly

important

1 Limit budget impact

2Address uncertainty on clinical effectiveness AND/OR cost-effectiveness

3Manage appropriate utilization

2a. Is there any national legislation where MEAs are mentioned as a possibility to enable reimbursement/coverage from public funds?

2b. If yes, when was it formally introduced (year)?

2c. If yes, when was it formally implemented (year)?

3. Is there a formal procedure set by government for entering MEAs?

4. Which parties are involved in making MEAs?

5. When was the first MEAs established in your country?

6. What is the approximate number of MEAs in place?

7. To what extent is the content of MEAs in the public domain in your country? Please Describe

8. What is the contractual required duration for MEAs?

9. Which is the most frequent MEA used in your country (1-5). Please fill in the box with “x” where appropriate.

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1 2 3 4 5Non-existent Most frequent

Finance Based

1 Price volume agreements

2 Discounts

3 Dose caps

4 Budget cap

5 Price match with comparator

Outcome based

6 Coverage with evidence devel-opment

7 Outcome guarantees

8 Decrease the price/limit utili-zation to improve the ICER

9

Limit prescribing and reim-bursement to specific thera-peutic indication and to those patients sub-groups who are most likely to benefit

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I. Specific question

Br

and

INN

AT

C

Reimbursement status

Total duration of MEA (months)

Type

of M

EA

Price volume agreements

Please describe

Discounts

Please describe

Dose caps

Please describe

Budget cap

Please describe

Price match with comparator

Please describe

Coverage with evidence development

Please describe

Outcome guarantees

Please describe

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Please describe

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therapeutic indication and to those patients sub-groups who

are most likely to benefit

Please describe

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5

CHAPTER 5Reporting and use of the OECD Health Care Quality Indicators at national and regional level in 15 countries

This chapter was published as:Rotar A, van den Berg M, Kringos D, Klazinga N. Reporting and use of the OECD Health Care Quality Indicators at national and regional level in 15 countries. International Journal for Quality in Health Care. 2016;28(3):398-404

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ABSTRACTQuality problem or issue: OECD member states are involved since 2003 in a project coordinated by the OECD on Health Care Quality Indicators (HCQI). All OECD countries are biennially requested by the OECD to deliver national data on the quality indicators for international benchmarking purposes.

Initial assessment: Currently, there is no knowledge whether the OECD HCQI information is used by the countries themselves for healthcare system accountability and improvement purposes.

Choice of solution: The objective of the study is to explore the reporting and use of OECD HCQI in OECD member-states.

Implementation: Data were collected through a questionnaire sent to all OECD member-states containing factual questions on the reporting on all OECD HCQ-indicators. Responses were received between June and December 2014. In this timeframe, two reminders were sent to the participants. The work progress was presented during HCQI Meetings in November 2014 and May 2015.

Evaluation: Fifteen countries reported to have a total of 163 reports in which one or more HCQIs were reported. One hundred and sixteen were national and 47 were regional reports. Forty-nine reports had a general system focus, 80 were disease specific, 10 referred to a specific type of care setting, 22 were thematic and 2 were a combination of two (disease specific for a particular type of care and thematic for a specific type of care). Most reports were from Canada: 49. All 15 countries use one or more OECD indicators.

Lessons learned: The OECD quality indicators have acquired a clear place in national and regional monitoring activities. Some indicators are reported more often than others. These differences partly reflect differences between healthcare systems. Whereas some indicators have become very common, such as cancer care indicators, others, such as mental healthcare and patient experience indicators are relatively new and require some more time to be adopted more widely.

Key words: OECD, quality of health care, healthcare quality indicators, reporting, performance indicators, health policy

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INTRODUCTIONRegularly measuring and reporting (monitoring) healthcare quality is an essential prerequisite to target interventions to improve the effectiveness, safety, and patient-centeredness of the healthcare system [1-4]. Over the years there seems to have established an international consensus by policymakers that the provision of high quality care is an essential value of healthcare systems [5, 6].

The potential usability of quality information is both high and diverse when it is based on valid measurement techniques and reliable data [7-16]. For example, quality information allows policymakers to prioritise the policy agenda to improve health system outcomes; provides researchers input to increase our understanding of the mechanisms to achieve high quality of care and identify cost-effective quality improvement interventions; provides healthcare providers self-evaluation information to improve the quality of care provided; and supports patients in choosing healthcare providers. It is therefore important that quality of care is measured and monitored at different healthcare system levels, e.g. country and regional level, but also at the levels of institutions, individual providers, and health plans. The measurement and reporting of quality of care at country level is of relatively recent date, compared with the progress that has been made over the years at the level of institutional providers [10, 17, 18].

From 2003, OECD member states joined forces by launching the Health Care Quality Indicators (HCQI) project, coordinated by the OECD. The project aims to measure and compare the quality of health systems and service provision in OECD countries [25, 26]. The applied indicator set has been re-evaluated and improved recently by an international expert group [27].The initiative was building on previous activities of the Commonwealth Fund and the Nordic Council of Ministers and is executed in close collaboration with the World Health Organization and the EU [19, 20]. In the following years, the working stream was growing importance and taken up by other groups of researchers for specific categories (mental health-care, diabetes, breast cancer, primary care) [21-24].

Through the years, a list of quality indicators has been developed by an OECD Expert Group enabling healthcare system comparisons [25, 27, 28]. All OECD countries are biennially requested by the OECD to deliver national data on the quality indicators for international benchmarking purposes. The indicator set currently covers indicators for care for chronic conditions and acute exacerbation, prescribing, patient safety, mental disorders, cancer, and patient experiences with ambulatory care. This is a unique set of indicators, particularly because of the international consensus on the selection and the commitment by Ministries of Health to regularly report national quality data to the OECD. The OECD biennially reports about the healthcare performance of its member states (e.g. [29, 30]). It is currently however unknown whether this information is also used by the countries themselves for healthcare system accountability and improvement purposes.

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In this study, we therefore investigate how these indicators and the results of the international benchmarks are used in national and regional reporting on healthcare. More specifically, we aim to answer the following research questions:

- What is the extent of quality performance reports: what kind of indicators are described, what is their focus and function?

- How are the specific sets of the OECD quality indicators reported and used in these reports (general reporting, comparative benchmarking or quality monitoring, target setting and performance-based reimbursement schemes)?

We assume that the use of information in policy making usually starts with regular reporting. Therefore, we specifically focussed on recurrent reports.

MethodsThe data collection period ran from June until mid-December 2014. The starting point was the roll-out of a questionnaire among the HCQI-members representing 30 different countries. The questionnaire contained factual questions on all OECD HCQ-indicators. Respondents were asked whether these indicators are reported and used in their respective countries at national and regional level and if yes, to provide a reference or link to the document. All references were kept in a database. To increase the response rate, two reminders were sent to the country experts.

During the data collection period, we identified which indicators are used by which countries and in which types of reports. We developed a three-tier framework for characterizing the reports (Figure 1). To categorize the reports, we created a coding system for the reports based on their typology as indicated in Figure 1.

Figure 1 – number of times indicators were reported, broken down by level and focus

Country HCQI Report

National (1) Regional (2)

Focus of reporting and use

General / System (1) Disease focus (2)

Function of reporting and use

General reporting (0)

Comparative (sector-specific)

benchmarking of quality monitoring? (1)

(Performance-based) reimbursement schemes

(3)

Have targets been set with respect to this

indicator by relevant policy makers? (2)

Type of care (3) Thematic (4)

Level of reporting and use

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ResultsGeneral description

Eighteen countries responded, out of which two had no reports (Singapore and Switzerland) and one did not fill out the questionnaire. We received references of 163 reports. The following 15 countries were included in the study: Belgium (BE), Canada (CA), Czech Republic (CZ), France (FR), Germany (GE), Ireland (IE), Israel (IL), Latvia (LV) (Latvia currently is an OECD candidate country (has ‘observer status’)), Netherlands (NL), Norway (NO), New Zealand (NZ), Slovakia (SK), Sweden (SE), the UK, the USA. Figure 2 displays the number of reports per country, broken down by level of reporting. The highest number was received from Canada.

Figure 2 – Number of reported publications by country

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One hundred and sixteen reports were national, 47 regional; 49 reports were general reports, 80 were disease specific, 10 concerned a specific care setting, 22 were thematic, 3 were a combination of two (disease specific for a particular type of care and thematic for a specific type of care). The number of times indicators were found in a report varied between 3-31. The least reported indicators was “excess mortality from mental disorders”, cancer indicators were reported most often, with the highest number for breast cancer screening. There were no indicators that were not covered in any publication.

Level of reportingDifferences between countries often reflect differences in healthcare system organization. For instance, Canada, where healthcare is mainly organized at provincial level has many regional reports, while countries where most things are organized on national level (e.g. Norway) have fewer reports. A specific category are reports that cover the whole country, but in which data are presented per region (e.g. Belgium).

Focus of reportsThere was a wide variation in the focus of reports: some covering more or less the whole healthcare system while others concerned a specific health intervention or disease. Sixty-three reports concerned a specific disease (e.g. diabetes type 2) or diseases category (cancer); seven covered a specific healthcare setting or type of care (e.g. hospitals); thirty-two covered the healthcare system or a substantial part of it; fourteen reports had a more thematic approach (e.g. patient safety).

Function of reportsMost reports aimed at general reporting to inform policymakers, offering an overall impression of the performance of the healthcare system. Others were for target setting or to provide patients or payers comparative benchmarking information.A detailed table of distribution of all included reports broken down by all three categories is included in Supplementary material, File S1.

Use of quality indicatorsTable 1 shows the main results of the study.

Care for chronic conditions / avoidable hospital admissionsFifty-one reports from 15 countries contained at least one of the nine indicators for chronic conditions (table 1a). Two reports, from Israel, contained all indicators, 20 reports contained only one. These indicators were mostly found in national reports. All regional reports were from Canadian provinces. Generally, the reports had a general (system) focus (30). Thirteen reports were disease-specific (e.g. diabetes care, asthma). Few reports covered a specific care setting or topic. Asthma hospital admissions were reported most frequently. Least often, publications contained the indicators on diabetes “lower extremity

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amputations” and “annual retinal exam for diabetes”. The latter one was the only one used for performance based reimbursement. In Ontario (Canada) the so-called diabetes incentive code was introduced for primary care physicians in 2002. By maintaining a diabetes flow sheet that tracked retinal eye examination together with other relevant parameters (e.g. cholesterol, hemoglobin A1c), primary care physicians could get an extra fee. The target has been set on one retinal exam every two years [31-33].In three other countries (Israel, New Zealand, United States), explicit targets have been set for some indicators. Israel had targets for all of the nine indicators. The USA had targets for asthma mortality and for three indicators on hospital admissions. New Zealand had a target for annual retinal exams.

Acute care related to AMI. Stroke and Hip FractureFour indicators concern acute care for urgent conditions (Table 1b). Thirty reports from 12 countries included at least one of the indicators. Six reports were regional (5 from Canada, 1 from Germany), and 24 were national. Often, a combination of these indicators was reported (e.g. admissions both types of stroke). Three reports, from Norway, Israel and The Netherlands, contained all indicators. “Case-fatality rates for AMI” was reported most frequently.

Function of most reports was general monitoring or comparative benchmarking. For all three case fatality indicators, Canada reported specific targets. For waiting time for hip fracture surgery, Israel uses performance-based reimbursement: hospitals can get a fee per case treated within 48 hours. In the USA, performance based reimbursement was reported for all three case fatality indicators, as part of an annual document that guides the data submission process for the Centers for Medicare & Medicaid Services (CMS) Hospital Inpatient Quality Reporting (IQR) Program [34].

PrescribingThese indicators were reported by eight countries (Belgium, Canada, Germany, Israel, The Netherlands, Norway, Sweden, and United Kingdom) in 13 reports (Table 1c). Three reports contained only “overall volume of antibiotics prescribed”, and the remaining ten included both. Twelve national and one regional (Canada) report included the “overall volume of antibiotics prescribed”, while the level of “cephalosporins and quinolones as a proportion of all antibiotics prescribed” was included in 10 national reports. Only one report was targeting a specific type of care and from the remaining 12, half has a general (system) focus and the other have a well-defined theme.

Two reports, from Belgium and Sweden, were used for comparative benchmarking and included both indicators. Israel had one report including both indicators based on which targets are being set as part of the HMO governance policies.

Patient safetyPatient safety Indicators were published in 24 reports from 12 countries (Belgium, the Czech Republic, Canada, Germany, Israel, Latvia, The Netherlands, Norway,

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New Zealand, Sweden, the UK, and the USA) (Table 1d). Two reports from Israel and Germany, contained all indicators while six publications report only one indicator. Nineteen reports were national and five were regional. The regional reports came from New Zealand (2) and Canada (3).When clustering the reports by their focus, a balanced picture unveils: eight had a general system focus, four were disease specific, six targeted a care setting, and seven had a particular theme. One report was double counted, having both a care setting and a theme. It is the case of a Canadian publication referring to hospital care and a quality improvement plan.The most reported indicator was “obstetric trauma, vaginal delivery without instrument”. The second most reported were “obstetric trauma, vaginal delivery with instrument” and “accidental puncture or laceration”. These indicators were reported by eight (Canada, the Czech Republic, Germany, Israel, Latvia, The Netherlands, Norway and New Zealand), respectively seven countries (Canada, Germany, Israel, Latvia, New Zealand, the UK and the USA).Three indicators were being used for performance based reimbursement schemes. One of these three, “accidental puncture or laceration”, was published in a US report and had an additional function. The targeting and the performance based reimbursement schemes of this report relate to a complex scheme established by Medicare at a hospital level - Hospital Inpatient Value-Based Purchasing (“Hospital VBP”) Program. All of the indicators were used for benchmarking purposes, except for “postoperative sepsis”.

Care for mental disorders

Thirteen reports from eight countries (Belgium, Canada, Israel, Latvia, New Zealand, Sweden, Slovakia and the UK) included at least one indicator (Table 1e). No reports contained all four indicators. Only Belgium, Canada, Israel, Latvia, New Zealand, Sweden and Slovakia had one report where multiple indicators on the care for mental disorders were included. Seven countries did not report on any of the indicators. Eleven reports were national reports. Only Canada had two regional reports reporting on readmission indicators. Most reports had a general focus. Only Israel, Latvia and Slovakia had a disease-specific report. The first two countries also had a report with a thematic focus. No reports were specific to a particular care setting.Indicators on unplanned re-admissions for schizophrenia and bipolar disorder were reported most frequently: in eight and seven reports, respectively. “Mental disorders excess mortality“ is the less reported indicator. Only Canada has set targets on decreasing the share of 30 days unplanned readmissions for mental health conditions. The indicator “unplanned schizophrenia re-admissions” was used for benchmarking in Latvia and Sweden. Sweden also uses the indicator “unplanned bipolar disorder re-admissions” for benchmarking. None of the indicators were used for performance-based reimbursement.

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Cancer care

The cancer care indicators include three on cervical cancer, three breast cancer and two on colorectal cancer. (Table 1f). These indicators were reported by all countries at least once in 76 reports. Several countries had at least one report that mentioned six or more cancer care indicators. Fifty-four reports were national and 22 had a regional focus. Five countries (Canada, France, Germany, The Netherlands, the UK) had both national and regional reports with one or more cancer care indicators. Fifty-three reports were disease specific and 20 reports had general focus. Only Belgium, The Netherlands and Canada had a report on a specific care setting or theme.Most indicators were reported in disease specific reports, and to a less extent in reports with general focus. Only the indicators on mammography screening and cervical cancer screening and mortality were also mentioned in five reports with either/both a focus on care setting or a specific theme.Israel was the only country that applied all eight listed indicators for benchmarking. Other countries that used one or more cancer care indicators for benchmarking were Belgium (cervical and breast cancer screening), Sweden (cervical cancer mortality, breast and colorectal cancer survival rate and mortality) and Canada. The USA, Latvia and Ireland set targets for one (Ireland) to five (the USA) cancer care indicators. Both Latvia and the USA set targets for cervical cancer screening. Only the USA has set targets on cervical, breast and colorectal cancer mortality. Ireland and Latvia also set targets on breast cancer screening rates. Canada was the only country that applied the cervical and breast cancer screening rates for performance based reimbursement as part of a wider regional quality improvement plan [35]. No other cancer care indicators were used for this purpose.

Patient experiences with ambulatory care

Thirteen reports from 7 countries (Canada, Israel, The Netherlands, Norway, New Zealand, the UK, the USA) published one or more patient experience indicators. All of these, except Norway and the USA, have reports containing all four indicators (Table 1g).Nine reports were national. Canada has four regional reports, each including a different patient experience indicator; in addition, Canada has one national report covering all four indicators.All indicators were eight or nine times mentioned in publications; there was no difference between the different types. Only in Canada the reports had a thematic focus, and in Israel a disease specific focus; all other countries reported on patient experiences in general focus publications.The seven countries that reported on patient experiences with ambulatory care all published data in general reports; only Israel used the indicators for benchmarking purposes. No targets were set on this type of indicators nor are they used for performance-based reimbursement.

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TABLE 1: number of times indicators were reported, broken down by level and focus

General Disease specific

Care setting Thematic

Both on disease

and care setting

Both on care setting and a

specific theme

Total

a. Care for chronic conditions / avoidable hospital admissionsDiabetes lower extremity amputation rate 5 5 1 1 - - 12

Annual retinal exam for diabetics 7 3 1 1 1 - 13Asthma mortality rate 8 3 1 2 - - 14Diabetes: long-term complications admission rate 10 3 1 1 - - 15

CHF admission rate 14 5 1 2 - - 22Uncontrolled diabetes hospital admission rates 10 4 1 1 - - 15

Diabetes: short-term complications admission rate 10 4 1 1 - - 15

COPD hospital admission rates 18 4 1 - - - 23Asthma hospital admission rates 19 3 1 1 - 24

b. Acute care for AMI, Stroke and Hip Fracture30 days after admission for AMI 12 3 2 2 - - 1930 days after admission hemorrhagic stroke 12 5 - 1 - - 18

30 days after admission for ischemic stroke 12 5 - 1 - - 18

In-hospital waiting time for hip fracture surgery

7 2 - 2 - - 11

c. Prescribing

Overall volume of antibiotics prescribed 6 - 1 6 - - 13

Cephalosporins and quinolones as a proportion of all antibiotics prescribed

4 - 1 5 - - 10

d. Patient safety

Obstetric trauma, vaginal delivery with instrument 5 1 3 2 - - 11

Obstetric trauma, vaginal delivery without instrument 6 2 3 3 - - 14

Foreign body left in during procedure 3 2 2 1 - 1 9

Accidental puncture or laceration 1 2 4 3 - 1 11Postoperative pulmonary embolism or deep vein thrombosis 2 2 2 2 - - 8

Postoperative sepsis 4 1 2 - - - 7

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General Disease specific

Care setting Thematic

Both on disease

and care setting

Both on care setting and a

specific theme

Total

e. Care for mental disorders

Unplanned hospital re-admissions for mental disorders 3 1 - 1 - - 5

Unplanned schizophrenia re-admissions (same or other hospital) 4 2 - 2 - - 8

Unplanned Bipolar disorder re-admissions (same or other hospital) 4 1 - 2 - - 7

Excess mortality from mental disorders (schizophrenia / bipolar disorder)

2 1 - - - - 3

f. Cancer care

Cervical cancer screening, percentage of women aged 20-69 screened

9 12 1 - - 1 23

Cervical cancer five-year relative survival rate 6 17 - - - - 23

Cervical cancer mortality, females 9 19 - 1 - - 29Mammography screening, percentage of women aged 50-69 screened

12 14 1 - - 1 28

Breast cancer five-year relative survival rate 9 19 - - - - 28

Breast cancer mortality, females 11 20 - - - - 31Colorectal cancer, five-year relative survival rate 9 17 - - - - 26

Colorectal cancer mortality 11 17 - - - - 28g. Patient experiences with

ambulatory careRegular doctor spending enough time with patient in consultation 7 1 - 1 - - 9

Regular doctor providing easy-to-understand explanations 7 1 - 1 - - 9

Regular doctor giving opportunity to ask questions or raise concerns 6 1 - 1 - - 8

Regular doctor involving patient in decisions about care and treatment 6 1 - 1 - - 8

Regular doctor spending enough time with patient in consultation 7 1 - 1 - - 9

Regular doctor providing easy-to-understand explanations 7 1 - 1 - - 9

Regular doctor giving opportunity to ask questions or raise concerns 6 1 - 1 - - 8

Regular doctor involving patient in decisions about care and treatment 6 1 - 1 - - 8

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DISCUSSION Our study shows an overall high healthcare quality indicator reporting activity. In the 15 OECD countries we reviewed, there were 163 reports, out of which Canada had the highest number: 49.

Fifteen out of the 17 responding countries used one or more OECD indicators in their national or regional reports. The reporting level resembles their healthcare system structure. Countries with NHS systems predominantly use national reports, whereas more decentralized healthcare systems use sets of regional reports. Only in the UK and Germany both national and regional reports were applied.

We found that countries most often reported disease and healthcare system/sector specific indicators. Out of these, the main focus was on reporting indicators on cancer and chronic care. Patient safety indicators were reported at a medium level while the lowest levels of reporting are on prescribing. Mental healthcare and patient experience with ambulatory care indicators were reported least often.

The variation between indicators in the extent to which they are reported may be attributed to different factors. First, it requires some time before indicators are commonly known and accepted. The more ‘traditional’ indicators that have been used in international comparisons for a long time were found more often in national and regional reports. Examples are cancer mortality rates and admissions for asthma. Relatively new indicators (e.g. prescription indicators) that were reported in Health at a Glance 2013 for the first time were less often found. Second, some indicators are more complex to measure and in many cases not feasible for countries. Excess mortality for mental disorders, for instance, could only be delivered for Health at a Glance 2013 by seven countries. Third, some indicators may be more debatable than others. In our study the 2013 version was used, which was most recently published at the time of the survey. However, in 2014 a revision took place of the indicator set and some indicators were dropped because they were considered less relevant, less feasible, less actionable or a limited international comparability (22). “Re-admissions of patients with psychiatric disorders” for instance, was dropped in this revision.

The use of the OECD-indicators by member states is one of the important reasons to justify the effort that these countries have to invest in the reporting of data to OECD and will contribute to the political basis for this work. Our results indicate that indeed countries profit from this international collaboration.

Strength and limitations

This study provides an overall impression of the use of OECD HCQ indicators in different countries. There are however some limitations to be mentioned. First, we limited our study to recurrent reports. This means that many studies in which indicators were somehow used or reported were not found. Our most important source of information was the members of the OECD-HCQI expert committee,

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whom all have a good overview of the use of healthcare information in their own country. However, it cannot be guaranteed that all relevant studies were reported. We did not carry out a systematic review because many reports used by policymakers cannot be found in scientific databases and are in the language of the countries. Lastly, in some cases, it was not entirely clear whether a reported indicator could be regarded a ‘real’ OECD-indicator. Countries often use their data to do analyses that are specifically suited to the local situation. Often the same data were used as delivered to OECD, but slightly different in/exclusions or definitions were used. However, with this study we wanted to investigate whether the topics the OECD covers with their indicators corresponds with things that are considered relevant in countries rather than the more methodological question which exact algorithm should be used. In the questionnaire the following note was added: “In case definitions or algorithm used of the listed quality indicators are somewhat different in your country but do cover the same concept, we are also interested in their use”.

ConclusionBesides OECDs own publications, the OECD quality indicators can be found in many national and regional reports. There is an overall high healthcare quality reporting activity in member states and the OECD quality indicators have acquired a clear place in such monitoring activities. There is a wide variation in the objectives and character of these publications and some indicators are reported more than others. These differences partly reflect differences between healthcare systems. Whereas some indicators (e.g. cancer care) have become very common, others are relatively new (e.g. mental healthcare, patient experiences) and require more time to be widely adopted. Our findings will allow countries to benchmark one against each other in terms of HCQ reports, ultimately leading to a widespread use of quality indicators.

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ACKNOWLEDGEMENTThe authors would like to thank the country experts and members of the OECD Health Care Quality Indicators project for their valuable work in collecting the data and their inputs to the draft manuscript.

CONFLICT OF INTERESTNiek Klazinga is coordinator of the health care quality project of the OECD, Michael van den Berg represents the Netherlands in the HCQI project.

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SUPPLEMENTARY FILE 1

Reference list for the quality reports reported by countries

Belgium:

1. Vrijens F, Renard F, Jonckheer P, Van den Heede K, Desomer A, Van de Voorde C, Walckiers D, Dubois C, Camberlin C, Vlayen J, Van Oyen H, Léonard C, Meeus P. De performantie van het Belgische gezondheidssysteem Rapport 2012. Health Services Research (HSR). Brussel: Federaal Kenniscentrum voor de Gezondheidszorg (KCE). 2012. KCE Report 196A. D/2012/10.273/110. Available at: https://kce.fgov.be/sites/default/files/page_documents/KCE_ 196A_performantie_Belgisch_gezondheidssysteem_0.pdfLast Accessed: July 21, 2014

2. Available at: http://www.kankerregister.org/default.asp1?lang=NLLast accessed: July 21, 2014

3. Meeus P, Van Aubel 1. Performance of General Medicine in Belgium, a check-up. Health Services Research (HSR). Brussels: Belgian National Institute for Health and Disease Insurance (NIHDI). 2012. D/2012/0401/13. Available at: https://www.riziv.fgov.be/information/nl/studies/study59/inde1.htm. Last Accessed: July 21, 2014

Canada

1. http://www.cihi.ca/hirpt/?language=enLast Accessed: July 23, 2014

2. www.ourhealthsystem.ca Effective September 18, 20143. The 2012 Cancer System Performance Report, DECEMBER 2012

Available at: http://www.partnershipagainstcancer.ca/wp-content/uploads/The-2012-Cancer-System-Performance-Report.pdfLast Accessed: July 23, 2014

4. Canadian Cancer Society’s Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2014. Toronto, ON: Canadian Cancer Society; 2014. Available at:http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2014-EN.pdfLast Accessed: July 23, 2014

5. http://www.healthcouncilcanada.ca/rpt_det.php?id=148 Last Accessed: July 23, 2014

6. Tracking Heart Disease & Stroke in Canada. Available at: http://www.phac-aspc.gc.ca/publicat/2009/cvd-avc/pdf/cvd-avs-2009-eng.pdfLast Accessed: July 23, 2014

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7. National Diabetes Surveillance System: Diabetes in Canada, 2008. Available at: http://www.phac-aspc.gc.ca/publicat/2008/ndssdic-snsddac-08/inde1-eng.php Last Accessed: July 23, 2014

8. Diabetes in Canada Facts and figures from a public health perspective Available at: http://www.phac-aspc.gc.ca/cd-mc/publications/diabetes-diabete/facts-figures-faits-chiffres-2011/pdf/facts-figures-faits-chiffres-eng.pdfLast Accessed: July 23, 2014

9. Heart and Stroke Foundation’s 2014 Stroke Report. Available at: http://www.heartandstroke.com/atf/cf/%7B99452D8B-E7F1-4BD6-A57D-B136CE6C95BF%7D/HSF_SMReport2014E_Final.pdfLast Accessed: July 23, 2014

10. Canadian Stroke Network: The Quality of Stroke Care in Canada. Available at: http://www.canadianstrokenetwork.ca/wp-content/uploads/2011/06/QoSC-EN1.pdf Last Accessed: July 23, 2014

11. http://waittimes.cihi.ca/ Last Accessed: July 23, 2014

12. Cervical Cancer Screening in Canada Monitoring Program Performance 2006 –2008 Available at: http://www.partnershipagainstcancer.ca/wp-content/uploads/CPAC_Cervical_CS_Report_E_WEB_Final.pdf Last Accessed: July 23, 2014

13. Public Health Agency of Canada’s report: Organized Breast Cancer Screening Programs in Canada. Available at: http://www.phac-aspc.gc.ca/cd-mc/publications/cancer/obcsp-podcs05/inde1-eng.php Last Accessed: July 23, 2014

14. Bruce S, Prior H, Katz A, Taylor M, Latosinsky S, Martens P, De Coster C, Brownell M, Soodeen R, Steinbach C. Application of Patient Safety Indicators in Manitoba: A First Look. Winnipeg, MB: Manitoba Centre for Health Policy, 2006. Available at: http://mchp-appserv.cpe.umanitoba.ca/reference/patient.safety.pdf Last Accessed: July 23, 2014

15. Manitoba RHA Indicators Atlas 2009. Available at: http://mchp-appserv.cpe.umanitoba.ca/reference/RHA_Atlas_Report.pdf Last Accessed: July 23, 2014

16. The 2013 RHA Indicatos Atlas. Available at: http://mchp-appserv.cpe.umanitoba.ca/reference//RHA_2013_web_version.pdf Last Accessed: July 23, 2014

17. Nova Scotia Department of Health - Annual Statistical Report Fiscal 2007/08 Available at: http://novascotia.ca/dhw/publications/annual-statistical-reports/DOH_Annual_Statistical_Report_2007_08.pdf Last Accessed: July 23, 2014

18. AHS Annual Performance Report 2012/13. Available at: http://www.albertahealthservices.ca/Publications/ahs-pub-pr-dashboard.pdf Last Accessed: July 23, 2014

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19. 2012/13 - Annual Service Plan Report. Available at: http://www.bcbudget.gov.bc.ca/Annual_Reports/2012_2013/pdf/ministry/hlth.pdf Last Accessed: July 23, 2014

20. BC Cancer Agency Care & Research - Cervi1 Cancer. Available at: http://www.bccancer.bc.ca/NR/rdonlyres/AC6262BC-634F-4227-BF14-163182197EDF/67298/Cancer_Type_Cervi1.pdf Last Accessed: July 23, 2014

21. BC Cancer Agency Care & Research - Survival Statistics 2007 Available at: http://www.bccancer.bc.ca/NR/rdonlyres/D8291ED8-FAEE-4692-A256-5320928187F2/44155/Survival_Statistics.pdf Last Accessed: July 23, 2014

22. BC Cancer Agency Care & Research - Cancer Deaths. Available at: http://www.bccancer.bc.ca/NR/rdonlyres/96AB78E4-A961-452C-B2BB-96C5DFEA5C66/67143/Cancer_Mortality.pdf Last Accessed: July 23, 2014

23. Capital Health’s Strategic Indicators Report. Available at: http://www.cdha.nshealth.ca/system/files/sites/343/documents/sir-june-2014.pdf. Last Accessed: July 24, 2014

24. Department of Epidemiology and Cancer Registry, CancerCare Manitoba. “Cancer in Manitoba, 2011 Annual Statistical Report.” Available at: http://www.cancercare.mb.ca/home/cancer_research/epidemiology_and_cancer_registry/reports/ Last Accessed: July 24, 2014

25. BC Cancer Agency Care & Research - Cancer Type Breast. Available at: http://www.bccancer.bc.ca/NR/rdonlyres/AC6262BC-634F-4227-BF14-163182197EDF/67170/Cancer_Type_Breast.pdf Last Accessed: July 24, 2014

26. BC Cancer Agency Care & Research - Colorectal Cancer. Available at: http://www.bccancer.bc.ca/NR/rdonlyres/AC6262BC-634F-4227-BF14-163182197EDF/67300/Cancer_Type_Colorectal.pdf Last Accessed: July 24, 2014

27. Ministry of Health 2012 - 2013 Annual Report. Available at: http://www.finance.gov.sk.ca/PlanningAndReporting/2012-13/201213HealthAnnualReport.pdf Last Accessed: July 24, 2014

28. Available at: http://www.hqontario.ca/public-reporting/yearly-reports Last Accessed: July 24, 2014

29. Cancer Quality Council of Ontario. Cancer System Quality Index (CSQI) 2013. Available at: http://www.csqi.on.ca/ Last Accessed: July 24, 2014

30. Manitoba Health - Health Information Management. Available at: http://www.gov.mb.ca/health/annstats/as1213.pdf. Last Accessed: July 24, 2014

31. Churchill RHA 2009 Community Health Assessment. Available at: http://www.churchillrha.com/pdfs/comhel09.pdf

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Last Accessed: July 24, 201432. Yearly Report on Ontario’s Health System. Available at: http://www.

hqontario.ca/portals/0/Documents/pr/hqo-yearly-report-2013-en.pdf Last Accessed: July 24, 2014

33. 2012 Report on Ontario’s Health System. Available at: http://www.hqontario.ca/portals/0/Documents/pr/qmonitor-full-report-2012-en.pdf Last Accessed: July 24, 2014

34. Ontario Health Care System Scorecard. Available at: http://www.hsprn.ca/seminarFiles/13id1335542146.pdf Last Accessed: July 24, 2014

35. Yukon 2012 Health Status Report. Available at: http://www.hss.gov.yk.ca/pdf/health_status_report_2012.pdf Last Accessed: July 24, 2014

36. New Brunswick Health System Report Card 2013. Available at: http://www.nbhc.ca/sites/default/files/pdf/care_e1p_2013/Report%20Card%202013_FINAL.pdf Last Accessed: July 24, 2014

37. Available at: http://www.qualityinsight.ca/indicators/sk/pes-listened-doc/month Last Accessed: July 24, 2014

38. Available at: http://www.qualityinsight.ca/indicators/sk/pes-explained-doc/month Last Accessed: July 24, 2014

39. Available at: http://www.qualityinsight.ca/indicators/sk/pes-comm-doc/month Last Accessed: July 24, 2014

40. Available at: http://www.qualityinsight.ca/indicators/sk/pes-partner-care-staff/month Last Accessed: July 24, 2014

41. Available at: http://www.vch.ca/media/BalancedScorecardJune2012(1).pdf Last Accessed: July 24, 2014

42. Nunavut Report on Comparable Health Indicators . Available at: http://www.scribd.com/doc/72033482/Nunavut-Report-on-Comparable-Health-Indicators Last Accessed: July 24, 2014

43. The Fraser Institute Hospital Report Card British Columbia 2011. Available at: http://www.hospitalreportcards.ca/bc/docs/Complete-Publication.pdfLast Accessed: July 24, 2014

44. Ontario Cervical Screening Program 2012 Report Available at: https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=295748 Last Accessed: July 24, 2014

45. Available at: http://www.screeningbc.ca/NR/rdonlyres/4545C16F-3F34-496C-ABF4-CB4B9BA04076/69596/CCSPAnnualReport2012PrintVersion.pdf Last Accessed: July 24, 2014

46. http://www.saskcancer.ca/mwg-internal/de5fs23hu73ds/progress?id=MFqsnKG2u1&dl Last Accessed: July 24, 2014

47. Bonuses for CEO. Available at: http://www.albertahealthservices.ca/rls/ne-

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rls-2009-09-15-performance-chart.pdf Last Accessed: July 28, 2014

48. Diabetes incentive code for primary care physicians Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3329816/pdf/1038.pdf Last Accessed: July 28, 2014

49. Available at: http://www.hamiltonhealthsciences.ca/sitemaker/websitefiles/WestLinc4206009/workfiles/Quality/Quality_Improvement_Plan.pdf Last Accessed: July 28, 2014

Czech Republic

1. http://www.uzis.cz/en/publications/hospitalization-hospitals-cr-2012 Last Accessed: July 21, 2014

2. http://www.uzis.cz/en/system/files/demozem2012.pdf Last Accessed: July 21, 2014

3. http://www.uzis.cz/en/catalogue/cancer-incidence Last Accessed: July 21, 2014

4. http://www.uzis.cz/en/system/files/diab2012.pdf Last Accessed: July 21, 2014

5. http://www.mamo.cz/inde1.php?pg=mamograficky-screening--vysledky-a-hodnoceni Last Accessed: July 21,2014

6. http://www.uzis.cz/nshnu/vysledky-benchmarkingu Last Accessed: July 21,2014

France

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2. L’état de santé de la population en France Suivi des objectifs anne1és à la loi de santé publique Available at: http://www.drees.sante.gouv.fr/01-l-etat-de-sante-de-la-population-en-france-rapport-2011,9985.html Last Accessed; July 21, 2014

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Germany

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The Netherlands

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Norway

1. www.helsenorge.no Last Accessed: July 22, 2014

2. www.kunnskapssenteret.no Last Accessed: July 22, 2014

3. www.fhi.no Last Accessed: July 22, 2014

4. http://www.fhi.no/eway/default.asp1?pid=239&trg=Content_6510&Main_6157=6261:0:25,6747& MainContent_6261 = 6510:0:25,7158&Content_6510=6259:109771: 25,7158:0:6250:1:::0:0 Last Accessed: July 22, 2014

5. www.kreftregisteret.no Last Accessed: July 22, 2014

New Zealand

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6. http://www.health.govt.nz/our-work/primary-health-care/about-primary-health-organisations/how-my-pho-performing/how-my-pho-performing-2013-14/primary-care-health-targets-2013-14-quarter-three-results-summary#heart. Last Accessed: July 22, 2014

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9. http://www.health.govt.nz/new-zealand-health-system/health-targets/about-health-targets/health-targets-more-heart-and-diabetes-checks Last Accessed: July 22, 2014

Slovakia

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4. http://www.nczisk.sk/Registre/Narodne-zdravotne-registre/Pages/Prezentacie.asp1 Last Accessed: July 22, 2014

Sweden

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United Kingdom

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3. Profile of Cervical Cancer in England Incidence, Mortality and Survival Available at: http://www.cancerscreening.nhs.uk/cervical/profile-cervical-cancer-england-report-october2012.pdf Last Accessed: July 31, 2014

United States

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DISCUSSION

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The aim of this thesis is to contribute to the international knowledge on how rational decision-making strategies are implemented in health care. It offers an overview and examines how different rationalization strategies have developed across a series of countries, at 5 levels, as represented in Figure 1.

FIGURE 1 – International health systems levels and research questions

Level 1Professional –

patient

Chapter 1Shared decision-making between patient and GP about referrals from primary care: Does gatekeeping make a difference?

• Do countries vary in how GPs perceive shared decision-making (SDM), in deciding upon patients’ referral?

• To what extent does shared-decision making in GPs’ referrals differ between gatekeeping and non-gatekeeping systems?

• What factors do GPs consider when referring to a medical specialist and how does this differ between gatekeeping and non-gate keeping systems?

Level 2 Professional

practice

Chapter 2 Strategies to enhance rational prescribing in primary care

• To what extent have European countries embedded strategies to support rational prescribing (targeted and system-oriented) and what are the types implemented?

Level 3Health services/organizational

Chapter 3 The involvement of medical doctors in hospital governance and implications for quality management: a quick scan in 19 and an in depth study in 7 OECD coutries

• What is the current situation with regards to doctor managers in the hospital systems of 19 OECD countries?

• What is the association between the level of doctors’ involvement in hospital management and the level of implementation of Quality Management Systems in 7 OECD countries (drawing upon the DUQuE project – “Deepening our understanding of quality improvement in Europe”)?

Level 4 National

Chapter 44.1 Health Technology Assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria

4.2 Rationalizing the introduction and use of pharmaceutical products: The role of managed entry agreements in Central and Eastern European contries

• What are the HTA policies in the series of CEE countries to date?• What are the similarities and differences between the individual

CEE countries?• How HTA was formalized, institutionalized, standardized its

methodology, is used in practice and what is the degree of professionalization of HTA in the region?

• What is the role of MEAs in CEE countries and the extend of their use?

• Which drugs are subject to MEAs in CEE and is there a match or not with the ones in Western Europe?

Level 5International

Chapter 5 Reporting and use of the OECD Heath Care Quality Indicators at national and regional level in 15 countries

• What is the extent of quality performance reports: what kind of indicators are described, what is their focus and function?

• How are the specific sets of the OECD quality indicators reported and used in these reports?

The health care system levels conceptualized in this thesis are 1) the professional/patient interaction, 2) professional practice, 3) health care organizations, 4) national and 5) international health system level. These levels constitute health sub-systems on micro, meso and macro level, bound by governance mechanisms with involvement of many stakeholders (e.g. legislators, patients, providers). The health systems are aimed to achieve health goals, while at the same time, building on Taylor’s principles of scientific management, are applying rationalization strategies. This is aimed at optimizing their production processes and create value (“as the patient health outcomes achieved per dollar spent” [1]), while also addressing patients’ preferences. As described in the introduction, rationalization strategies relate to approaches like the assessment and improvement of quality of care (QoC), Evidence Based Medicine (EBM) and Health Technology Assessment (HTA). The measurement of QoC – structure, process, outcomes – uses science in its process and is based on the theories of scientific management

160

[2][3]. EBM is used to optimize decision-making in medical practice by closing the gap between scientific evidence and practice [4][5]. HTA at its core is a tool for evidence development aimed at informing policy-making for taking rational decisions on the adoption and use of technology [6] with a focus on concepts as cost-effectiveness and cost-benefit.

This thesis explores a variety of rationalization strategies at different levels of the health care system (as conceptualized in Figure 1) and is grounded in a series of international comparative studies, for creating international comparative knowledge on their implementation in health care systems.

The focus of the studies is on the decision-making 1) that takes place between doctors and patients in primary care, where shared decision-making (SDM) is assumed to contribute to optimal decisions and high value outcomes, 2) on the practice level in primary health care – with a attention on rational prescribing of medication, 3) at the level of health care organizations, such as hospitals, through research on how the rationale of clinical knowledge is embedded in the management decisions taken for the organization as a whole, 4) at the national level, focused on the decisions on rational use of pharmaceuticals, especially how Health Technology Assessment (HTA) is applied and how the decision-making of access/reimbursement of drugs is made, and finally, 5) on whether and how the performance of systems is benchmarked through OECD data. For this purpose, each of the chapters, corresponding to the 5 levels, addressed a series of research questions and sub-questions as illustrated in Figure 1.

Main findings

Chapter 1 addressed the following questions: 1) Do countries vary in how GPs perceive SDM, in deciding upon patients’ referral? 2) To what extent does SDM in GPs’ referrals differ between gatekeeping and non-gatekeeping systems? And 3) Which factors do GPs consider when referring to a medical specialist and how does this differ between gatekeeping and non-gate keeping systems? Firstly, the study revealed a significant variation in the perceived SDM across countries, varying from 92.3% (the Netherlands) to 52.5% (FYR Macedonia). A multivariate analysis revealed a negative correlation between gatekeeper systems and SDM. This implies that GPs in gatekeeper systems in general, seem to be less likely to make shared decisions than GPs in non-gatekeeping systems. However, a more thorough examination of the data revealed that the countries deviating from this finding, i.e. reporting having more SDM, are the ones having gatekeeping in place for a very long time. Hence, GP’s referral behaviour seems to be determined also by historical context. Thirdly, our study also revealed that GPs in countries with gatekeeping systems in place are more likely to always consider patients’ preferences, travel distance waiting time and costs, while GPs in non-gatekeeping countries are more likely to consider their previous experience with a specialist and comparative performance information.

161

The research question in chapter 2 was: “To what extent have European countries embedded strategies to support rational prescribing (targeted and system oriented) and what are the types implemented?” The study represents a mapping of targeted (micro level) and system (macro level) oriented rational prescribing mechanisms in primary care in 13 European countries. All approaches were implemented in at least two countries. Within the group of included countries, we identified a smaller group (Bosnia-Herzegovina, Greece & Romania) with a low number of reported strategies in place, and a larger group (Austria, France, Germany, Italy, the Netherlands, Norway, Scotland, Slovenia, Spain and Sweden) with a higher number of reported strategies. All strategies are implemented in at least half of the countries in the second group.

Chapter 3 focuses on medical practice in organizational settings, i.e. hospitals. The study has two research questions: 1) What is the current situation with regard to doctor managers in the hospital systems of 19 OECD countries? And 2) What is the association between the level of doctors’ involvement in hospital management and the level of implementation of Quality Management Systems in 7 OECD countries? Our findings show different practices across countries and support the existing evidence that involving medical doctors in hospital governance is positively associated with hospital performance [7][8]. Furthermore, our findings support the hypothesis that involving medical doctors in hospital management leads to better performing hospitals mediated through the implementation of quality systems. Chapter 4 includes two studies on reimbursement policies, more specifically HTA and managed entry agreements (MEAs), a policy strategy that is commonly complementing the HTA process, in a series of Central and Eastern European (CEE) countries. The research questions of the first study are: 1) What are the HTA policies in the series of CEE countries to date? 2) What are the similarities and differences between the individual CEE countries? and 3) How was HTA formalized, institutionalized, standardized its methodology, used in practice, and what is the degree of professionalization (capacity building) of HTA in the region? The findings show that in CEE countries, HTA has been formally introduced in the decision-making system. HTA bodies differ in size, importance in the decision-making process and transparency levels. In the second study we aimed at answering 1) What is the role of MEAs in CEE countries and the extent of their use? And 2) Which drugs are subject to MEAs in CEE and is there a match with the ones in Western Europe? Our results show that when MEAs exist, there is little public information available. MEAs are mostly used as a financial tool and rarely linked to how medicines actually perform, and to the value these medicines produce in real life settings.Chapter 5 investigated to what extent international performance indicators are being used in national policy in OECD countries. More specifically, the study had two research questions: 1) What is the extent of quality performance reports: what kind of indicators are described, what is their focus and function? And

162

2) How are the specific sets of the OECD quality indicators reported and used in these reports? Our study shows an overall high healthcare quality indicator reporting activity among the countries assessed. It also shows variations across countries in the type, level and function of information reported, with some countries being more advanced than others. We attributed the variation between indicators and the extent to which they are reported to different factors: 1) it requires some time before indicators are commonly known and accepted, 2) measurement complexity and country feasibility, and 3) some indicators may be more debatable than others. Additionally, we observed that the reporting level resembles countries’ healthcare system structure; countries with NHS systems predominantly use national reports, whereas more decentralized healthcare systems use sets of regional reports.

Methodological considerationsThe five chapters in this manuscript use both explorative (chapter 1&3) and descriptive (chapter 2, 4 & 5) research techniques, building on larger international studies (QUALICOPC and DUQuE), the work of the OECD and international expert groups. Consequently, this research has the inherent limitations of international comparative research [9][10].

These limitations are related to: 1) reliability and validity of constructs, 2) comparability of the data, 3) generalizability, 4) cultural and language bias, and 5) the level of detail.

The reliability and validity of constructs may be hampered by specific features of health care systems that cannot be captured by a high-level policy analysis and that would require a more in-depth approach. To tackle this issue, we used, 1) data collected previously through measures already validated (e.g. in the study focusing on the involvement of doctors in hospital management – measurement of professional involvement within hospitals & Quality Management System Index (QSMI)), and 2) constructs with clear definitions (e.g. in the HTA, MEAs and rational prescribing mechanisms studies) and the results were validated through follow-up in depth interviews where the reported answers needed clarification.

To strengthen the comparability of the data we used standardized definitions, able to capture country specific features (e.g. definition of primary care & GP). These definitions were also discussed during follow-up interviews for final validation of the results. Where possible, the findings were confirmed by a second expert. Likewise, where we acknowledged that potential minor differences between constructs could hamper the overarching objective of the study, our methodological approach was designed to include variations. For example, our conceptual aim was to understand whether the OECD quality indicators are reported by countries at national/regional level. Therefore, we left experts the flexibility to report them as present, despite minor variations vs. OECD definitions (e.g. in age groups).

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The results of this research cannot fully be generalised across countries due to historical, cultural, economic history and system context (e.g. Western European vs. Eastern European countries, NHS vs. Bismarck health care systems, gatekeeping vs. non-gatekeeping). However, part of the results could be generalizable to a larger degree, namely the results of the studies in the selected CEE countries. They could be partly translated to other countries that share a similar historical background in health care system design and similarities in economic and social development (e.g. Commonwealth of Independent States). Likewise, part of the findings from the studies that include a higher number of countries can be generalized across countries, depending on the levels of similarities among them (e.g. economic development, culture, health system typology etc.). It is common for decision-makers to look at similar/neighbouring countries and find answers to their policy concerns, rather than benchmarking countries with whom they have less in common. The different levels of understanding among experts of the concepts and English language knowledge/skills may have introduced some cultural and language bias. Therefore, contextual differences across countries may have influenced the results (e.g. transparency levels - the existing public information on MEAs). Thus, future research needs to sharpen the definitions of the constructs to better address the inclusion of countries specific nuances/elements. We addressed potential language barriers through follow-up communication and interviews with the experts, during which we provided thorough explanations of the constructs and provided clarifications where necessary. Likewise, the general knowledge of the main researcher about the countries studied was an important element in limiting the biases.

The depth of the detailing in international comparative research is often limited. Our aim was to create a high-level overview of the studied phenomena across countries. Consequently, the results do not include detailed features of the constructs. For example, the age groups of the OECD reported quality indicators were not considered and the rational prescribing strategies were studied as per their existence, without any additional detailing on specific content or level of implementation.

All studies included in this manuscript are cross-sectional and largely expert-based. Cross-sectional studies do not allow drawing causal conclusions and the expert-based research does not guarantee that all available information has been reported. However, this could also be influenced by the varying levels of transparency across countries. Throughout the study, the selection criteria of the participants (experts, GPs & medical doctors), hospitals and countries based on availability, may have led to some bias. The results of the study also depend on the level of knowledge, access to information and sampling, which in some cases could create limitations also for country generalization.

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The use of country experts as the main source in several studies, does not guarantee absolute completeness of information. Expert opinion is also known for not having control over confounding factors since it is given on personal judgement or belief [11]. Given the nature of the research questions, we used this methodology for reasons of practicality and because very few alternatives exist. Despite these limitations, the results of this thesis have a significant degree of generalizability and could set the ground for further research in the area, where scientific evidence is still scarce. A strength of this thesis is in the international picture it creates on how rationalization strategies are implemented in the decision-making processes at different levels, and the high-level of standardization of existing definitions and phenomena common to different health care systems.

Policy and management implicationsUltimately, rationalization strategies in health care are intended to optimize health outcomes. Rationalization can apply to many factors related to efficient use of resources (e.g. avoiding duplication, optimizing services & processes, reducing waste). A successful implementation of rationalization strategies depends on how well such strategies are embedded in the health care system’s complex web and to what extend they create connections. Hence, the rationalization strategies constitute bricks that need to be interconnected by bridges, in the health care system as a whole to create the ultimate desired results.This section addresses the implications of the findings of this thesis on the policy and management side of the health care systems, at all five levels conceptualized.Level 1. The findings provide arguments for taking a broader and more in-depth look at how rationalization is achieved in the patient/professional interaction in primary care systems. Embedding rationalization in the routine medical practice can be done in multiple ways. One way is to foster SDM, where the pros and cons of the diagnostics and treatment options are discussed with patients and decisions are better tailored to the patient’s needs. A way to facilitate SDM is incorporating the measurement of PROMs (patient-reported outcome measures) and PREMs (patient-reported experience measures). Patient-reported measures can foster a dialogue in the patient-doctor interaction, and increase the value of the healthcare production processes [12]. The use of PROMs and PREMs can help steer the dialogue between doctors and patients while leaving room for patients to make a more informed decision. These tools can offer the provider a better understanding of the patients’ needs, which should lead to a discussion from which the patients would clearly understand the options and express their preferences. SDM is seen as a basic goal for health system improvement [13] and our study complements the overall movement to enhance SDM [14] as a way to rationalize decisions. This implies a shift towards value-based health systems by involving patients in decisions [15]. Our results show that there is not a straight forward link between perceived SDM and structural features of

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the primary care systems, such as “gatekeeping”. Hence, the structural elements of the primary care systems, often presumed to be hindering SDM, don’t always function as a barrier. The findings of this chapter suggest that some common assumptions about how primary care functions (e.g. gatekeeping working against SDM [16]), are not fully in line with the real-life experience. The term “gatekeeper” suggests that GPs primarily focus on ‘holding unwanted visitors outside the gate’, rather than considering their preferences. Our results raise the questions how adequate this metaphor actually is. Our study shows that GPs in gatekeeper systems in general seem to be less likely to make shared decisions than GPs in non-gatekeeping systems. However, a few countries strongly deviate from this finding (e.g. Netherlands, UK, Spain, Denmark). Therefore, the results suggest that gatekeeping as such does not limit SDM, but it is part of the wider net of factors that contribute to low levels of SDM. This points to the idea that when redesigning the role of the GPs, it is needed to consider each country’s history and context for providing the right incentives to take into account patients preference. Brick 1. Strengthening SDM between patients and GP’s in all contexts.

Level 2. Irrational prescribing is a cause for both under- and overuse of medicines, which in turn is influenced by money/finance, knowledge and power asymmetry, and human relationships [17][18]. The study revealed that all countries have in place rationalization strategies at both macro (health service – policies) and micro (clinical – continuous medical education) level. In addition, in most countries it seems that these strategies complement each other. Successful system reforms should account for a balanced implementation of rationalization strategies, so the macro-level strategies are complemented by micro-level strategies. Both policy makers and medical societies should be involved in designing approaches to transform prescription practices in a more knowledge-based and effective mechanism. Brick 2. Rational prescribing asks for a combination of micro and macro level strategies.

Level 3. Alongside efficiency, the provision of hospital care is also about optimizing the care processes and clinical pathways. As many policies consider volumes and production of health care, we see now that when looking at value, we should consider the effectiveness and performance of health care services. Care production is a complex process, and for understanding performance in health care, a medical background can add value. Hence, the involvement of physicians in management decisions helps optimizing outcomes [18]. Overall, there is an increasing integration of the medical knowledge in the decision-making processes of the business administration, by involving physicians and nurses [19][19]. These trends have been well documented in the literature, and many professional organizations support them [20][20]. The findings of this study can feed the existing debates on hospital governance models and could help making a step forward in hospital governance policy and management practices.

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The results suggest that there is an increasing trend of involvement of medical doctors in hospital governance on both departmental (middle management) and strategic hospital level (top management). Our study reveals that doctors’ involvement in the governance structures of the hospitals is associated with better implemented quality management systems, especially when they are part of the strategic decision-making process. It also suggests that the actual decision-making responsibility in strategic management areas is critical for the assumed relationship with hospital performance. Thus, a critical factor may not just be the uptake of managerial tasks by doctors but giving them also the actual decision-making influence on strategic management areas.Brick 3. Hospital management should involve medical professionals for leveraging their medical knowledge to provide optimal patient outcomes.

Level 4. The financing of medication from public funds has been a long-standing issue over the years and has often been addressed by researchers, international organizations and policy makers [22] [23][24][25][26][27]. There are many health systems mechanisms aimed at rationalizing decision-making. This is often being caused by the increasing struggle to finance medicines, and represent a consistent part of the policy agenda. Hence, rationalization strategies are increasingly implemented across countries. Everywhere, the underlying business models on health care and medication are challenged and it has often been questioned whether they are still applicable for the 21st century [28][29]. At this level we studied two components of this debate in CEE countries: 1) how HTA is shaped, and 2) the extent to which MEAs are used. These cross-sectional studies offer solutions for further advancement of the rationalization strategies in the drug reimbursement systems. The rational decisions, in this case, could be optimized through an increase of the cross-country collaboration. This in turn, offers the opportunity to enhance generalizability and transferability of the existing evidence, assessments and payment mechanisms. The converging to rational decision-making for medicines relies heavily on transparency and the availability of public information. Taking advantage of the existing technological advances (e.g. e-Health) can 1) help increase the transparency levels, and 2) provide the necessary tools on how to use the implemented mechanisms to maximize their potential and further enhance rational decision-makings. Brick 4. HTA and MEA could help rational decision-making in different national contexts, but ask for transparency and political will to apply them.

Level 5. At international level, there is a growing attention and work on the performance of the health care systems. Several international organizations are doing extensive work and advancing the agenda on performance measurement [30][31][32]. The findings of our study show that there is a sustained movement among the OECD countries to embed a rational approach in their national policy reporting and strategy development. This confirms the high-level consensus of policy makers that providing high-quality care is essential for improving the value of health systems overall [33][34]. However, some countries are more advanced

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in this respect than others. These differences in the development of capturing and reporting performance outcomes are caused by many factors, such as existing IT systems, human resource power and governance models. Streamed also by political consensus on the value of monitoring performance and practice in a cyclic way, our study contributes to understanding on how quality outcomes can be reported and how that process, if embedding the evidence in national strategies, can enhance rational decision-making.Brick 5. International comparative performance indicators can support national rationalisation strategies if they are applied in national performance management.

Final reflectionsHealth care systems are in many ways as complex as the human body, in which different rationalization strategies function simultaneously. The human body is a mix of systems (e.g. muscular, respiratory, circulatory) that coexist, and each applies its own dynamics and rationalization strategies in its own way. However, all of them are interlinked and function in perfect synergy while applying a single rationalization strategy to maintain and create life. Once their interlinkages stop functioning, the body gets ill, life can be under threat or not created. Consequently, when thinking of systems as a whole, for optimal outcomes, synergy, in between all the sub-systems/levels, is essential.

This section of the thesis is aimed at clarifying the synergies between the health care levels and to emphasize the interconnectedness of all the rationalization components, regardless their positioning in the system. Bridges as well as bricks are needed for creating connections.The common element of the bricks studied, is that regardless the health care system level, the decision-making processes converge to desired goals. A main focal point relates to the embedding of scientific evidence in the decisions taken in the health care production process with the main goal to produce value (Quality of Care, Evidence Based Medicine, Health Technology Assessment). As mentioned in the introduction, rationalization means to apply the principles of scientific management to an industry or its operations to increase efficiency. In other words, for health care, rationalization means to link scientific evidence with contextual elements at any level of the health care system to create value. However, fully understanding rationalization in health care, by looking at isolated pieces of rationality in a sea of services and dynamics, is challenging. This is mainly caused by the highly sophisticated nature of the health systems and their many governance, policy and management mechanisms, at each of the conceptualized levels. Consequently, by looking merely at one rationalization strategy at each level, this thesis leaves room for further research. For understanding the level on how rationalization strategies are embedded in the decision-making processes in the health care systems, many other mechanisms need to be studied. Likewise,

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given the cross-sectional nature of the research, further research is needed to understand how the topics studied have evolved over time and what influenced their transformation. Furthermore, in international comparative research, it is always important to consider the context without increasing focus on small system elements, while paying attention to their coexistence with other strategies/mechanisms. This thesis can serve as future foundation for a research and development agenda on how rationalization strategies can be implemented and be part of the decision-making processes, in the historical context and level of economic and social development.

Optimizing the resources in the provision of care has been an important part of the international debate and policy agenda. This thesis proposes rationalization as a sustainable solution for improving the optimization process for aligning different levels of the health system, while looking at scientific evidence to produce value. It also shows that the grounding principles of rationalization (Weber) and scientific management (Taylor) have set the beginnings of a new way to look at heath care. Several elements in their theoretical approaches have been adopted by others, i.e. Joseph Juran, who in turn influenced the work of Donabedian on quality of care and the development of evidence-based medicine and health technology assessment.

When studying policies and decision-making processes, there is the need to consider their impact on the system as a whole. This thesis is a plea for system thinking. Its theme surrounds the question “how can we make our health care systems more rational?”. Consequently, international comparative research can be of help and its findings can be contextualized for learning rather than copy-pasting elements from one country to another. Globally, when thinking of health care, the overall aim is to improve systems’ performance as a whole. Strengthening performance means, enhancing value creation, where value is being equivalent with “economic efficiency” which ultimately requires a connection between outcomes (including patients’ preferences) and costs. For achieving this in health care, several elements play an important role.

For creating more value at health system level, there is the need to strengthen patient centeredness, effectiveness, safety, and to have optimal use of resources. If the goal is to improve health system performance and enhance value creation, then the outcomes need to be connected to the costs. The outcomes need to be patient centred, effective and safe, reflect practice, and rely on a good use of the existing resources. While looking at health care systems, we see that some of these main drivers are linked to rationalization strategies.

One of these drivers is to improve patient or people centeredness. At macro level, countries are converging to adopt policies for PROMs and PREMs, and at micro level, increased SDM is the desired way forward. However, the macro and micro elements will function and lead to improvement only if they are interconnected and complementary. Furthermore, if we study the use of medication, we see

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countries attempting to rationalize at a macro level via HTA and MEAs. However, HTA and MEAs need to be complemented by a rational decision-making process of the prescription practices so both doctors and patients make the right choices. Another driver is smart budget allocation at macro level. The OECD showed that in many countries, a substantial share of the health spending is ineffective or wasteful [35]. Improving effectiveness requires smart budget allocation at a macro level, within the health care budget, but also at a micro level, by strengthening the inclusion of the medical thinking in the organization of medical institutions. However, this does not ultimately mean that doctors and nurses will have unlimited decision power. This only gives them enough space in the organization so they would have decision-making autonomy, thus maximizing their knowledge. Ultimately, this could contribute to improved care coordination (clinical pathways) and medical resource allocation, i.e. treatment options and prescribing behaviours. Finally, the success of any policy, implemented at any level, depends on the ability to measure quality. Consequently, reducing systems’ sub-optimization requires infrastructure for quality measurement, which is ultimately another form of rationalization that produces value to the overall system.

Achieving better control on the health care spending, while addressing social developments (rising expectations, aging populations, changes in epidemiology and technological development) and creating more value in health care, is a complex process and is not straightforward. Questions related to value and how to enhance value creation are constantly part of the policy-makers and scholars’ agendas. However, next to the discussions on funding control/allocation, innovation, structural reforms, there are also other elements that help enhancing value creation in health care. This thesis proposed as part of the solution for creating more value in health care, a concept created by social sciences and dating from the early 20th century, namely rationalization, from the perspective of Quality of Care (QoC), Evidence Based Medicine (EBM) and Health Technology Assessment (HTA). It has also shown that rationalization in health care does not solely imply EBM. The international view on rationalization strategies in health care from this thesis serves as an example. This thesis includes a series of international comparative studies on how rationalization can be applied in health care across all levels and is itself health services research. This makes it closer to social sciences, while the EBM is bio-medical research. Therefore, rationalization in health care, adds to biomedical evidence, rational (scientific) management approaches in the decision-making processes, and can help enhancing value creation in health care. Using rationalization (via health services research) as a link between biomedical research and Taylor’s scientific management principles, creates a way for increasing results-based accountability, just as the Donabedian model of structure-process-outcomes. Ultimately, this means 1) the optimization of the decision-making processes, 2) continuity coupled with resilience to change, and 3) a good understanding of the cohesiveness of the inter-linkages within the levels and between the levels.

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In this thesis, the examples we used on how to apply rationalization in health care are related to QoC, EBM & HTA, but using solely these tools will not lead the health care systems to perfection. All of them have their own limitations when applied in real life when it comes to perspective, resources, context and implementation capabilities. Likewise, for systems like health care, with a significant government implication (as also shown by this thesis), advancing any reform requires also political willingness and the success is related to the political stability/common agreement across parties and limited political dependency of the processes. Nevertheless, this does not imply there should be any hesitation in using rationalization strategies and applying them optimally, against the overarching context. A part of their value lies in their capacity to bridge the gap between evidence, clinical practice and policy-making. The use of scientific evidence regardless the form, which is ultimately what QoC, EBM, & HTA are, is one of the driving forces behind the constant development of the health care systems and beyond. In the end, applying rationalization means to use scientific evidence for optimizing current practices and lead to progress.

This thesis does not offer clear-cut solutions or strong recommendations on what strategies countries should use. It intends to show how different countries use the scientific evidence for policy-making. The international comparative research performed in this thesis aims at making visible common challenges across countries and identify the wide varieties of countries’ approaches to address these challenges. It is meant to be a source of inspiration on how policies can be modelled according to context, by revealing how the same things are done by different countries, and to strengthen already existing mutual learning. Often, the knowledge on the rationalization policies are not shared across borders, and therefore increasing the visibility of what strategies are implemented and how, adds value in informing policy-making. In international comparative studies, additional contextual information is needed, coupled with more data on what we can measure (e.g. volumes) and strengthening the link between context and quantitative data. Economists can calculate the cost of strategies, but the real value lies in linking this information with the wider context and being able to see the whole picture. Moving away from getting the volumes right (e.g. having sufficient doctors, hospitals, services, medicines) to looking at outcomes and the value health systems create, means to cherish the bricks and use them to create bridges to see a broader picture of health care systems.

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SUMMARY/ SAMENVATTING

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SUMMARY

The aim of this thesis is to contribute to the international knowledge on how rational decision-making strategies are implemented in health care, by offering an overview and examining how different rationalization strategies have developed at 5 different levels in health care systems: 1) the professional/patient interaction, 2) professional practice, 3) health care organizations, 4) national and 5) international health system level. The thesis is grounded on a series of international comparative studies.The focus of the studies is on the decision-making 1) that takes place between doctors and patients in primary care where shared decision-making (SDM) is assumed to contribute to optimal decisions and high value outcomes, 2) on the practice level in primary health care on rational prescribing of medication, 3) at the level of health care organizations, such as hospitals, on how the rationale of clinical knowledge is embedded in the organization’s management decision, 4) at the national level, on the decisions on rational use of pharmaceuticals, and 5) on whether and how the performance of systems is benchmarked through OECD data.

Chapter 1 addressed the following questions: 1) do countries vary in how GPs perceive SDM, in deciding upon patients’ referral?, 2) to what extent does SDM in GPs’ referrals differ between gatekeeping and non-gatekeeping systems?, and 3) what factors do GPs consider when referring to a medical specialist and how does this differ between gatekeeping (GK) and non-GK systems?. The study is based on data collected as part of a large international comparative study on primary health care QUALICOPC. Firstly, the study revealed a significant variation in the perceived SDM across countries, varying from 92.3% (the Netherlands) to 52.5% (FYR Macedonia). A multivariate analysis revealed a negative correlation between gatekeeper systems and SDM, implying GPs in GK systems seem to be less likely to make shared decisions than GPs in a non-GK system. A more thorough examination of the data revealed that the countries deviating from this finding are the ones having GK in place for a very long time. Hence, GP’s referral behavior seems to be determined also by historical context. Thirdly, it became apparent that GPs in GK systems more often consider several patients’ interests, while GPs from non-GK countries are more likely to consider performance elements. The research question in chapter 2 was: “to what extent have European countries embedded strategies to support rational prescribing (targeted and system oriented) and what are the types implemented?”. The study, based on expert consultation, represents a mapping of targeted (micro level) and system (macro level) oriented rational prescribing mechanisms in primary care in 13 European countries. Our results reveal that all approaches were implemented in at least two countries. Out of the included countries we identified a smaller group (3 countries) with a low number of reported strategies in place, and a larger group

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(10 countries) with a higher number of reported strategies. All strategies are implemented in at least half of the countries in the second group.

Chapter 3 focuses on medical practice in organizational settings, i.e. hospitals. The study has two research questions: 1) what is the current situation with regards to doctor managers in the hospital systems of 19 OECD countries, and 2) what is the association between the level of doctors’ involvement in hospital management and the level of implementation of Quality Management Systems in 7 OECD countries? Findings are partly based on a large scale survey as part of the DuQUE study. Our findings 1) show different practices across countries and support the existing evidence that involving medical doctors in hospital governance is positively associated with the hospital performance and 2) support the hypothesis that involving medical doctors in hospital management leads to better performing hospitals mediated through the implementation of quality systems.

Chapter 4 includes two studies on reimbursement policies for pharmaceuticals, more specifically HTA and managed entry agreements (MEAs), a policy strategy that is commonly complementing the HTA process, in a series of Central and Eastern European (CEE) countries. The studies are based on a combination of survey research and interviews. The research questions of the first study are: 1) what are the HTA policies in the series of CEE countries to date?, 2) what are the similarities and differences between the individual CEE countries?, and 3) how HTA was formalized, institutionalized, standardized its methodology, used in practice, and what is the degree of professionalization (capacity building) of HTA in the region?. The findings reveal 1) that in CEE countries HTA has been formally introduced in the decision-making system, and 2) HTA bodies differ (size, importance in the decision-making process and transparency levels). In the second study we aimed at answering 1) what is the role of MEAs in CEE countries and the extent of their use, and 2) which drugs are subject to MEAs in CEE and is there a match or not with the ones in Western Europe? Our results show that when MEAs exist, there is few public information available. MEAs are mostly used as a financial tool and rarely linked to how medicines perform in real life settings.

Chapter 5 investigated to what extent international performance indicators are being used in national policy in OECD countries. The study had two research questions: 1) what is the extent of quality performance reports: what kind of indicators are described, what is their focus and function? and 2) how are the specific sets of the OECD quality indicators reported and used in these reports?. Our findings show an overall high healthcare quality indicator reporting activity among the countries assessed. It also shows variations across countries in the type, level and function of information reported, with some countries being more advanced than others. Additionally, we observed that the reporting level resembles their healthcare system structure (countries with NHS systems predominantly use national reports and decentralized healthcare systems use regional reports).

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This thesis does not offer clear-cut solutions or strong recommendations on what strategies countries should use. It intends to show how different countries use the scientific evidence for policy-making. The international comparative research of this thesis aims at making visible common challenges across countries and identify the wide varieties of approaches countries take for addressing several matters. It is meant to be a source of inspiration on how policies can be modelled according to context, by revealing how the same things are done by different countries, and to strengthen mutual learning. Frequently, the knowledge on the rationalization policies taken by countries is not visible across borders. Also, it is often unclear how a specific strategy fits in the broader system picture of increasing the performance across all levels of the health care system. Increasing the visibility of what strategies are implemented and how, adds value in informing policy-making. In international comparative studies, additional contextual information is needed, coupled with more robust international comparative quantitative data.

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SAMENVATTINGMet dit proefschrift wordt beoogd een bijdrage te leveren aan de internationale kennis over hoe strategieën voor rationele besluitvorming worden geïmplementeerd in de gezondheidszorg. Dit wordt gedaan door een overzicht te geven van en te onderzoeken hoe verschillende “rationaliseringsstrategieën” zijn ontwikkeld en worden toegepast op vijf verschillende niveaus in gezondheidszorgsystemen: 1) de interactie tussen zorgprofessional en patiënt, 2) de beroepspraktijk, 3) gezondheidszorgorganisaties, 4) het landelijke gezondheidszorgsysteem, 5) het internationale niveau. Het proefschrift is gebaseerd op een serie internationaal vergelijkende studies.

De focus van de studies is op de besluitvorming 1) zoals die plaatsvindt tussen dokters en patiënten in de eerstelijnszorg waar gezamenlijke besluitvorming (Shared Decision Making, SDM) wordt verondersteld een bijdrage te leveren aan optimale besluiten en waardevolle uitkomsten, 2) op het niveau van de beroepspraktijk in de eerste lijn over het rationeel voorschrijven van geneesmiddelen, 3) op het niveau van zorgorganisatie zoals ziekenhuizen, over hoe de rationale van klinische kennis is ingebed in managementbesluiten, 4) op het landelijk niveau met betrekking tot rationale besluitvorming over het gebruik van geneesmiddelen, en 5) over of en hoe internationaal vergelijkende prestatie-informatie over zorgsystemen van de OESO door landen actief wordt gebruikt voor onderlinge vergelijking (benchmarking).

Hoofstuk 1 beantwoordt de volgende vragen: 1) verschillen landen in hoe huisartsen aankijken tegen gezamenlijke besluitvorming met de patiënt met betrekking tot verwijzing ?, 2) bestaat er verschil in deze percepties tussen landen met en zonder een poortwachtersysteem ? en 3) welke factoren nemen huisartsen in overweging wanneer ze verwijzen naar een specialist en bestaat hier een verschil tussen landen met en zonder poortwachtersysteem. De studie is uitgevoerd op basis van data verzameld in het kader van een grote internationaal vergelijkende studie naar eerstelijnszorg, QUALICOPC. Allereerst liet de studie zien dat er een significante variatie is in hoe het belang van SDM wordt gepercipieerd tussen de landen variërend van 92,3% (Nederland) tot 52,5% (FYR Macedonië). Een multivariate analyse laat een negatieve correlatie zien tussen poortwachtersystemen en SDM. Dit lijkt te impliceren dat huisartsen in poortwachter-systemen minder geneigd zijn tot het maken van gezamenlijke beslissingen met de patiënt dan in niet-poortwachtersystemen. Een meer diepgaande analyse van de data laat zien dat de landen die afwijken van deze bevinding de landen zijn die al sinds lange tijd een poortwachter-systeem kennen. Het verwijsgedrag van de huisartsen lijkt daarmee ook bepaald door de historisch context. Daarnaast werd het duidelijk dat huisartsen in poortwachtersystemen vaker verschillende belangen van patiënten zeggen mee te wegen terwijl de huisartsen in landen zonder poortwachtersysteem meer geneigd zijn prestatie-informatie mee te wegen.

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De onderzoeksvraag van hoofdstuk 2 was: “in welke mate hebben Europese landen strategieën voor het bevorderen van het rationeel voorschrijven van geneesmiddelen (op praktijk- en landelijk niveau) ingevoerd en welke strategieën zijn dat?”. De studie is gebaseerd op een consultatie van deskundigen en bestaat uit een beschrijving van de toegepaste strategieën in de eerstelijnszorg in een 13-tal Europese landen. Onze bevindingen laten zien dat alle strategieën worden toegepast in tenminste twee landen. Een kleine groep (3 landen) heeft maar een beperkt aantal strategieën ingevoerd, maar in een grote groep landen (10) is sprake van een groot aantal strategieën zowel op het praktijkniveau als op landelijk niveau. Elk van de onderzochte strategieën wordt in tenminste de helft van de landen uit de grote groep toegepast.

Hoofdstuk 3 focust op de medische praktijk in een organisatorische setting, i.e. het ziekenhuis. De studie heeft twee onderzoeksvragen: 1) wat is de huidige situatie van artsen met managementtaken in 19 OESO-landen, en 2) wat is het verband tussen de mate waarin artsen betrokken zijn bij het ziekenhuismanagement en de mate van invoering van kwaliteitsmanagementsystemen in 7 OESO-landen? De bevindingen zijn deels gebaseerd op grootschalig vragenlijstonderzoek als onderdeel van de DuQUE studie. De resultaten laten zien dat 1) er verschillende praktijken bestaan tussen de landen en ondersteund bestaand bewijs dat de betrokkenheid van artsen in de aansturing van het ziekenhuis een positief verband heeft met de prestaties van het ziekenhuis 2) ondersteund de hypothese dat de betrokkenheid van artsen in het ziekenhuismanagement leidt tot betere ziekenhuisprestaties via de invoering van kwaliteitssystemen.

Hoofstuk 4 doet verslag van twee studies rond beleid ten aanzien van vergoedingen voor geneesmiddelen, meer in het bijzonder het gebruik van Health Technology Assessment (HTA) en “managed entry agreements “ (MEA) in een aantal landen in Centraal en Oost Europa. De studies zijn gebaseerd op een combinatie van vragenlijstonderzoek en interviews. De onderzoeksvragen in de eerste studie zijn: 1) welke zijn de HTA beleidsmaatregelen in een aantal Centraal- en Oost-Europese landen (CCE-landen) op dit moment?, 2) welke overeenkomsten en verschillen zijn er tussen de individuele landen? en 3) hoe is HTA geformaliseerd, geïnstitutionaliseerd, gebaseerd op een gestandaardiseerde methodologie, gebruikt in de praktijk, en wat is de mate van professionalisering (capaciteitsborging) van HTA in de CEE regio? De resultaten laten zien dat 1) in CEE landen HTA formeel is ingevoerd in de besluitvorming en 2) HTA organisaties verschillen (in omvang, belang in het besluitvormingsproces en mate van transparantie in de werkwijze). In de tweede studie worden de vragen beantwoord 1) welke rol MEA’s spelen in CEE landen en de mate waarin ze worden gebruikt, 2) welke geneesmiddelen onderdeel uitmaken van MEA’s en of deze vergelijkbaar zijn met de MEA’s rond geneesmiddelen in West-Europa. Onze resultaten laten zien dat wanneer er sprake is van MEA’s, er maar zeer weinig informatie publiek beschikbaar is. MEA’s worden vooral gebruikt als een hulpmiddel bij de financiering en zijn zelden gericht op de vraag hoe geneesmiddelen daadwerkelijk presteren in de praktijk.

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Hoofstuk 5 doet verslag van onderzoek naar de mate waarin internationaal beschikbare prestatie-indicatoren worden gebruikt in het landelijke beleid van OESO-landen. De twee onderzoeksvragen zijn: 1) in hoeverre zijn er landelijke rapporten met prestatie-indicatoren; welke indicatoren worden beschreven en wat is hun focus en functie? 2) hoe worden specifieke sets van OESO-kwaliteitsindicatoren gerapporteerd en gebruikt in deze rapporten? De studie liet zien dat over de hele linie van de bestudeerde landen sprake is van uitvoerige rapportage van kwaliteitsindicatoren. Er is wel sprake van variatie tussen landen naar aard, niveau en functie van gerapporteerde informatie, waarin sommige landen verder gevorderd zijn dan andere. Daarnaast viel op dat het niveau van rapporteren sterk samenhangt met de structuur van de zorgsystemen (landen met een NHS-systeem gebruiken voornamelijk landelijke rapporten terwijl gedecentraliseerde systemen vooral regionale rapporten gebruiken).

Dit proefschrift levert geen eenduidige oplossingen of sterke aanbevelingen op over welke strategieën landen dienen te gebruiken. Wel laat het zien hoe verschillende landen wetenschappelijke inzichten gebruiken bij hun beleid. Het internationaal vergelijkend onderzoek in dit proefschrift maakt vergelijkbare uitdagingen in landen zichtbaar en identificeert de uiteenlopende manieren waarmee landen hier mee omgaan. Daarmee dient het als een inspiratiebron door te laten zien hoe beleid context-specifiek kan worden vormgegeven, door te laten zien hoe verschillende landen zaken aanpakken en hoe wederzijds nog meer kan worden geleerd. Veelal is de kennis over hoe rationaliseringsstrategieën door landen worden ontwikkeld en uitgevoerd, niet inzichtelijk over de landsgrenzen. Eveneens is vaak niet zichtbaar hoe een enkelvoudige strategie past in het grotere geheel van het verbeteren van de prestaties over alle niveaus van het gezondheidszorgsysteem. Vergroten van het inzicht in welke strategieën in andere landen worden gekozen en hoe ze worden toegepast kan waarde toevoegen aan beleidsvorming. Dit vraagt om meer contextuele informatie in combinatie met meer robuuste internationaal vergelijkbare kwantitatieve data.

BIOGRAPHY & PhD PORTFOLIO

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BIOGRAPHY

Alexandru – Mihai Rotar was born in 1985 in Iasi, Romania and studied at the University of Medicine and Pharmacy, “Gr. T. Popa”, Faculty of Dentistry, Iasi, Romania, graduating in 2009. In the same year, he enrolled in a MSc. programme of the same university in Dental Public Health. In 2010, he moved to Rotterdam as a student of the MSc. Health Economics, Policy and Law, Institute of Health Policy and Management, Erasmus University Rotterdam, the Netherlands, graduating in 2012. Starting from 2011 until now, he held several positions in various pharmaceutical companies in Bucharest, Romania focused on patients access to medicines and health policies. His portfolio expanded in other countries in Central and Eastern European countries. In parallel, starting from 2014 he enrolled as an external PhD at the Academic Medical Centre/University of Amsterdam. Throughout the years he has worked with several groups of international researchers and experts from Academia (DUQuE, QUALICOPC), international organizations (OECD, WHO), government officials, public institutions, patient associations and consultancy groups. His wife to be, Monika, is Australian and they live in Bucharest, to be married in April 2020 in Bali, Indonesia. He enjoys travelling, experiencing other cultures and reading.

PhD PORTFOLIOCourses & Diplomas

2016: Diploma course in Pharmaceutical Economics and Policy, London School of Economics, London, U.K.

2016: Diploma Course - Health in Context: A Course in Multilevel Modelling in Public Health and Health Services Research, Netherlands Institute for Health Services Research, Utrecht, The Netherlands

2016: London School of Economics Summit – Rethinking Regulation and Value Assessment of Medical Technologies: Challenges and Opportunities

2014: London School of Economics Summit – Managed Entry Agreements Summit;

2011, 2012, 2013, 2017: ISPOR 14th, 15th, 16th & 20th Annual European Congress Courses;

Presentations

o Health and Economic Development, Measuring Health, Introduction to Health Technology Assessment - Concepts and System Embedding in Central and Eastern European Countries, Managed Entry Agreements in Europe - Where do we stand? West vs. East – Konrad Adenauer Stiftung Foundation, Social and Health Policies Programme, June 2015, Sibiu, Romania

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o Rationalizing the Introduction and Use of Pharmaceutical Products: The Role of Managed Entry Agreements in Central European Countries, April 2015, Budapest, Hungary;

o International Comparison of Health Care Systems – NIHES Course, November 2014, Utrecht, The Netherlands;

o Managed Entry Agreements in CEE: implementation challenges and policy implications, Corvinus University Health Policy and Health Economics Conference Series 2016, November 2016, Budapest, Hungary;

o Teaching Assistant: Methods of Health Services Research – Erasmus Summer Programme, August 2014, Rotterdam, The Netherlands;

Research

o PublicationsGulácsi L, Rotar A, Niewada M, Löblová O, Rencz F, Petrova G et

al. Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria. The European Journal of Health Economics. 2014;15(S1):13-25.

Rencz F, Gulácsi L, Drummond M, Golicki D, Prevolnik Rupel V, Simon J, Stolk EA, Brodszky V, Baji P, Závada J, Petrova G, Rotar A, Péntek M.EQ-5D in Central and Eastern Europe: 2000–2015. Quality of Life Research. 2016;25(11):2693-2710.

Rotar A, Botje D, Klazinga N, Lombarts K, Groene O, Sunol R et al. The involvement of medical doctors in hospital governance and implications for quality management: a quick scan in 19 and an in depth study in 7 OECD countries. BMC Health Services Research. 2016;16(S2).

Rotar A, van den Berg M, Kringos D, Klazinga N. Reporting and use of the OECD Health Care Quality Indicators at national and regional level in 15 countries. International Journal for Quality in Health Care. 2016;28(3):398-404.

Zrubka Z, Rencz F, Závada J, Golicki D, Rupel VP, Simon J, Brodszky V, Baji P, Petrova G, Rotar A, Gulácsi L, Péntek M. EQ-5D studies in musculoskeletal and connective tissue diseases in eight Central and Eastern European countries: a systematic literature review and meta-analysis. Rheumatology International. 2017;37(12):1957-1977.

Rotar A, Preda A, Löblová O, Benkovic V, Zawodnik S, Gulacsi L et al. Rationalizing the introduction and use of pharmaceutical products: The role of managed entry agreements in Central and Eastern European countries. Health Policy. 2018;122(3):230-236.

Batóg P, Rencz F, Péntek M, Gulácsi L, Filipiak KJ, Prevolnik Rupel V, Simon J, Brodszky V, Baji P, Závada J, Petrova G, Rotar A, Golicki

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D. EQ-5D studies in cardiovascular diseases in eight Central and Eastern European countries: a systematic review of the literature. Kardiologia Polska. 2018;:860-870.

Rotar A, Van Den Berg M, Schäfer W, Kringos D, Klazinga N. Shared decision making between patient and GP about referrals from primary care: Does gatekeeping make a difference?. PLOS ONE. 2018;13(6):e0198729.

Brodszky V, Beretzky Z, Baji P, Rencz F, Péntek M, Rotar A et al. Cost-of-illness studies in nine Central and Eastern European countries. The European Journal of Health Economics. 2019;20(S1):155-172.

Prevolnik Rupel V, Divjak M, Zrubka Z, Rencz F, Gulácsi L, Golicki D, Mirowska-Guzel D, Simon J, Brodszky V, Baji P, Závada J8, Petrova G, Rotar A, Péntek M3.. EQ-5D studies in nervous system diseases in eight Central and East European countries: a systematic literature review. The European Journal of Health Economics. 2019;20(S1):109-117.

Other activitiesAcademic observer of the OECD Health Care Quality Indicators

meetings since 2011;Founding member: ISPOR Chapter Romania;Academic reviewer for BMC Public Health, International Journal for

Quality in Healthcare, European Journal for Health Economics, Journal of Evaluation in Clinical Practice, Journal of Health Organization and Management, International Journal of Health Policy and Management

ACKNOWLEDGEMENTS

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It all started in 2009 when I graduated from the “Gr. T. Popa”, Medical University of Iasi, Romania. For those of you who do not know what Iasi is, it is my hometown. Did I ever think back then I would get to this day? Definitely not!

Completing this PhD thesis would have not been possible without the encouragement, guidance, work and persuasiveness, contribution and constant enthusiastic support of a few people.

Before anyone else, my deepest gratitude goes to Niek Klazinga, a constant driving force behind all my work and development. I have met Niek shortly after arriving in the Netherlands as an MSc. student at the iBMG, Erasmus University Rotterdam while attending his course of Methods of Health Services Research at Erasmus Summer Programme. I knew nothing back then about how the next 9 years would look like. At first Niek supervised my Master thesis at the iBMG, following to which it seemed only natural to continue with a PhD under his guidance. Niek, you never gave up on me, and with an extreme patience you provided me with amazing intellectual guidance and challenge. I would always be thankful to your warm generosity and kindness and grateful for the mentorship. It is truly and honour to have you as a friend. For me, you have been one of those people that leave a big mark. It has been an amazing ride so far!

I would like to give a big thanks and acknowledgment to Michael van den Berg, my co-supervisor, who provided me with both guidance and warm friendship throughout the years. We have completed some really good work together and spent nice moments in the Netherlands, France and Romania. Among everything else, thanks to you I don’t find statistics that scary anymore! And that has not been easy!

Would also like to give my acknowledgements to Dionne Kringos (AMC) and Laszlo Gulacsi (Corvinus University Budapest, Hungary). You both have been incredible work partners and the current work would have not been the same without you.

For completing this thesis, I had the chance of working with some incredible people I met along the way and have them as my co-authors. Among all, would just like to mention some of you, with whom I worked closely – Daan Botje (former AMC), Marta Pentek (Corvinus University Budapest), Thomas Plochg (AMC), Willemijn Schäfer (former NIVEL) and Jeremy Veillard (Word Bank).

Ileana Diratian, Sanja Miletic and Razvan Nanulescu are the people I met in the beginnings of my professional life. You have constantly pushed, challenged and patiently supported me to continue my ambition and help me grow. And thank you for your friendship. A special recognition goes to Ileana and Sanja. I could not thank you enough for all the time and energy you spent on me with coaching and mentoring.

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I could not leave out Ovidiu Saltas-Dabija, Luiza Trusca & Mugurel Radulescu. Ovidiu, Luiza, you have been the best at understanding the needs associated with my academic work and provided me with all the need support and flexibility. Mugurel, thank you for the support, mentorship and sincere friendship. This manuscript exists also thanks to you!

Lastly, but definitely not least, I want to mention Dominika Kovacs – manager, mentor and friend. My recognition to you goes beyond the support you have constantly showed in my final steps of my PhD. It is also for the leadership example, constant challenge, warm and honest friendship.

But a PhD is not all about work-related people, despite many of the aforementioned ones have become close friends throughout the years. My deep gratitude goes also to my family, who despite not understanding much about my work, have always been supportive in my walk down this road. My parents’, together with my grandparents’ – Bibi & Sandu – constant enthusiasm, and restless curiosity about my PhD progress, fueled me in completing this thesis. I could not leave out from here my long-life group of friends from Iasi (I am not going to mention any names in here; you know all who you are), who had become family over the years.

Finally, the one I’m grateful to everyday is Monika – the one I’ve met on a tiny island in Indonesia and moved worlds away just to be beside me. Her constant shyness, yet incredible strength and courage have always been a source of inspiration. I could never thank her enough for her everyday support, unconditional love, kindness and softness. Above all, I thank her for her enormous patience and putting up with me.

Sincerely yours,

BRICKS ANDBRIDGESIN HEALTHCARE

By

Alexandru Mihai Rotar

A series of international comparative studies on how rationalization strategies are applied across different levels of health care systems.