efficiency and safety of care pathways for knee and hip ... · sr systematic review tha total hip...

Protocol ID: CP K&HA

Version 1.5: April 2016

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PROTOCOL

Efficiency and safety of care pathways for knee and hip arthroplasty:

a systematic review with planned meta-analysis



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PROTOCOL TITLE :

Efficiency and safety of care pathways for knee and hip arthroplasty: a systematic

review with planned meta-analysis

Protocol ID CP K&HA

Short title : Care pathways for knee and hip arthroplasty

Version 1.5

Date April 2016

Coordinating investigator/project M.J.L.F. Heymans, medical information specialist, department Zuyderland Academy

[email protected]

Drs M.G.M. Schotanus, research manager, department of orthopaedic surgery

[email protected]

Zuyderland Medical Centre, PO Box 5500, 6130 MB Sittard-Geleen, the Netherlands

Drs B.A.M. Snoeker, department of Clinical Epidemiology, Biostatistics and Bioinformatics

b.a. [email protected]

Academic Medical Centre AMC, University of Amsterdam, PO Box 22660, 1100 DD Amsterdam, the Netherlands

Principal investigator(s) (in

Dutch: hoofdonderzoeker

/uitvoerder)

Dr N.P. Kort, orthopaedic surgeon

[email protected]

Zuyderland Medical Centre, PO Box 5500, 6130 MB Sittard-Geleen, the Netherlands

mailto:[email protected]


mailto:b.a.%[email protected]




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PROTOCOL SIGNATURE SHEET

Name Signature Date

Principal Investigator:

Dr N.P. Kort, orthopaedic

surgeon, Zuyderland Medical

Centre, Sittard-Geleen

Coordinating investigator M.J.L.F. Heymans,

Zuyderland Medical Centre

Sittard-Geleen

Co-reader Drs M.G.M. Schotanus,

Zuyderland Medical Centre,

Sittard-Geleen

Co-reader/ mentor Drs B.A.M. Snoeker,

Academic Medical Centre

University of Amsterdam,

Amsterdam



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TABLE OF CONTENTS

1. INTRODUCTION AND RATIONALE .............................................................................. 7

2. OBJECTIVES ................................................................................................................. 9

3. METHODS ....................................................................................................................10

3.1 Eligibility criteria .....................................................................................................10

3.2 Information sources ................................................................................................10

3.3 Search strategy ......................................................................................................11

3.4 Study records .........................................................................................................12

3.4.1 Datamanagement

3.4.2 Selection process

3.4.3 Data collection process

3.5 Data items ..............................................................................................................12

3.6 Outcomes and prioritization ....................................................................................13

3.7 Risk of bias in individual studies .............................................................................13

3.8 Data synthesis ........................................................................................................14

4. ETHICAL CONSIDERATIONS ......................................................................................15

5. ADMINISTRATIVE ASPECTS AND PUBLICATION ......................................................15

6. REFERENCES ..............................................................................................................16



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LIST OF ABBREVIATIONS

ADL Activities Daily Living

AE Adverse Event

CP Clinical Pathways / Care Pathways

ERP Enhanced Recovery Pathways

JC Joint Care

LOS Length of Stay

MA Meta-analysis

METC Medical research ethics committee (MREC); in Dutch: Medisch

ethische toetsing commissie (METC)

OA Osteoarthritis

OS Outpatient Surgery

PROMS Patient Reported Outcome Measurement

RCT Randomized Controlled Trial

RR Rapid Recovery

(S)AE (Serious) Adverse Events

SR Systematic Review

THA Total Hip Arthroplasty

TKA Total Knee Arthroplasty

WHO World Health Organization

WMO Medical Research Involving Human Subjects Act (in Dutch: Wet

Medisch-wetenschappelijk Onderzoek met Mensen



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SUMMARY

Rationale: Numbers of hip and knee arthroplasties are increasing worldwide. The

optimization of the treatment and the scientifically supported procedures are implemented in

clinical pathways (CPs). CPs have developed during the past decades and this systematic

review (SR) with planned meta-analysis (MA) evaluates the efficiency and safety of various

care pathways for knee and hip arthroplasty.

Objective:

This SR studies the effectiveness and safety of clinical pathways for knee and hip

arthroplasty, together with the financial consequences.

Study design: This is a SR based on therapeutic studies. The SR consists of Randomized

Controlled Trials (RCTs) as well as non-RCTs (observational studies).

Study population: The study population consists of patients undergoing hip or knee

arthroplasty.

Intervention: The different clinical pathways, e.g. fast track, rapid recovery.

Main study outcomes:

- Length of hospital stay (LOS)

- readmission rate

- (serious) adverse events ((S)AEs)

- functional recovery

- patient reported outcome measures (PROMS)

- financial benefits and cost.



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1. INTRODUCTION AND RATIONALE

Osteoarthritis (OA) is a clinical syndrome of joint pain with varying degrees of functional

limitations and reduced quality of life.1 Of all joint diseases, it is the most common and one of

the leading causes of pain and disability worldwide.1,2,8 OA is mainly located in knees and

hip.1 The treatment may include pain relief, lifestyle advice, exercise therapy, prosthesis

placement or a combination thereof.1,8 Over the last two to three decades the number of total

hip arthroplasty (THA) and total knee arthroplasty (TKA) as a result of OA has increased.2,5,8

With an aging population and the higher prevalence of risk factors such as obesity and lack

of exercise, TKA and THA will increase even further.7,10 The rates vary by country, which

may be due to differences in socioeconomic status, health care systems, patient

preferences and prevalence of OA which is the most common underlying cause for THA and

TKA.2 In the United States, 402.100 TKAs were performed in 2003 and the estimation is that

by 2030 the annual demand will have grown with 673% to 3.48 million arthroplasties.4,9

For these specific orthopedic surgeries, the concept of clinical pathways (CP) has varied

over the last decades. The aim of CPs is the optimization of protocols and multidisciplinary

procedures to improve the quality of the treatment, to hasten recovery, to minimize variation

in care and to reduce costs.3

While the number of these surgeries worldwide is increasing, CPs have been developed to

improve efficiency and decrease hospital stay3,6,14 The LOS depends apart from the clinical

outcome and patients’ comorbidity, on social and marital status and cultural aspects. Even

the health insurances may have influence.3 The LOS has reduced significantly by the use of

CPs.13 Nowadays, an outpatient surgery (OS) pathway with possible discharge on the day of

surgery has been developed reducing the LOS to one day.7,14 With the OS the patient stays

in the hospital for one day only; it is a day care surgery with a day procedure, a patients-

specific approach, an optimized process in which the proactive patient is essential.

Admission and discharge are on the day of surgery, without an overnight hospital stay.11 This

reduction of LOS might satisfy the patient 7,14 as he is able to return home on the same day.

Therefore, the effects of CPs and the decreasing LOS in terms of (serious) adverse events

((S)AE), readmission, functional recovery and PROMS have to be investigated. It should also

take into account the long waiting lists and the increasing economic burden on the public

health system.4,8,10



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This systematic research is complementary to previous reviews10,12,13 because it includes the

most recent OS pathway.

Therefore, it is important to conduct this review to identify and to evaluate the efficiency and

safety of the several CPs for knee and hip arthroplasty and to approach the most optimized

pathway to address the increasing need for knee and hip arthroplasty.



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2. OBJECTIVES

The general objective is to perform a systematic review and to summarize the available

literature regarding the efficiency and safety of clinical pathways for patients undergoing

knee or hip arthroplasty.

Primary Objective: To identify the most efficient and safe clinical pathways for knee and hip

arthroplasty

P patients with hip or knee arthroplasty

I clinical pathways:

joint care (JC)

rapid recovery (RR)

enhanced recovery pathway (ERP)

fast tract surgery

day care surgery, outpatient surgery (OS)

C standard care

O efficiency and safety

M Therapeutic study -> SR, MA

Secondary Objective(s): Do CPs for hip and knee arthroplasty provide financial benefit?

Costs are only included if they are listed properly and carefully. Also other postoperative

complications, relevant to the question, will be summarized.



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3. METHODS

3.1 Eligibility criteria

The CP K&HA is a systematic review of therapeutic studies. The systematic review consists

of randomized controlled trials (RCTs) and observational studies as well. Prospective studies

will be selected. Results should be published as a full report and there will be no restrictions

on date or language of the article.

The aim of the study is to investigate the efficiency and safety of clinical pathways to all adult

patients (aged 18 years or older) who have undergone an elective hip or knee arthroplasty.

Inclusion criteria

Studies including patients of 18 years or older undergoing implantation of a hip or knee

prosthesis;

Studies which compare the intervention with standard care.

Exclusion criteria

Studies including patients undergoing revision arthroplasty;

Strictly descriptive articles, e.g. historical articles.

3.2 Information sources

We will search the following databases for randomized controlled trial and prospective

observational studies:

Pubmed

EMBASE

The Cochrane Library

Web of Science

CINAHL

We will search clinical trials.gov and the World Health Organization (WHO) trial registry

portal (http://www.who.int/ictrp/en), clinicaltrails.gov (http://clinicaltrials.gov) and PROSPERO

(www.crd.york.ac.uk/PROSPERO) for ongoing unpublished trials. We will also search the

reference list of included trials to identify any studies missed by the search.

http://www.who.int/ictrp/en

http://clinicaltrials.gov/



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3.3 Search strategy

PubMed 11 February 2016

((critical path*[tiab] OR clinical path*[tiab] OR critical path*[ot] OR clinical path*[ot] OR Ambulatory Surg*[tiab] OR

Outpatient Surg*[tiab] OR Office Surg*[tiab] OR day surg*[tiab] OR Ambulatory Surg*[ot] OR Outpatient Surg*[ot]

OR Office Surg*[ot] OR day surg*[ot] OR Outpatient*[tiab] OR Out patient*[tiab] OR Outpatient*[ot] OR Out

patient*[ot] OR Ambulatory Care[tiab] OR Ambulatory Health Center*[tiab] OR Ambulatory Care[ot] OR

Ambulatory Health Center*[ot] OR Ambulant surg*[tiab] OR ambulant ther*[tiab] OR ambulant treatment[tiab] OR

outward patient[tiab] OR policlinic[tiab] OR polyclinic[tiab] OR Ambulant surg*[ot] OR ambulant ther*[ot] OR

ambulant treatment[ot] OR outward patient[ot] OR policlinic[ot] OR polyclinic[ot]) OR ("Day Care, Medical"[Mesh])

OR ("Outpatient Clinics, Hospital"[Mesh]) OR ("Outpatients"[Mesh]) OR ("Ambulatory Care

Facilities"[Mesh:noexp]) OR ("Ambulatory Care"[Mesh:noexp]) OR ("Ambulatory Surgical Procedures"[Mesh]) OR

("Critical Pathways"[Mesh])) AND ((("Arthroplasty, Replacement, Knee"[Mesh]) OR (Knee Replac*[tiab] OR Knee

Arthroplast*[tiab] OR knee prosthes*[tiab] OR Knee Replac*[ot] OR Knee Arthroplast*[ot] OR knee prosthes*[ot]))

OR (("Arthroplasty, Replacement, Hip"[Mesh]) OR (hip arthroplast*[tiab] OR hip replace*[tiab] OR hip

prosthes*[tiab] OR hip arthroplast*[ot] OR hip replace*[ot] OR hip prosthes*[ot])))

Search Add to builder

Query Items found

#28 Add Search #27 AND #10 675

#27 Add Search #26 OR #25 OR #23 OR #21 OR #19 OR #17 OR #14 OR #12 214721

#26 Add Search critical path*[tiab] OR clinical path*[tiab] OR critical path*[ot] OR clinical path*[ot] OR Ambulatory Surg*[tiab] OR Outpatient Surg*[tiab] OR Office Surg*[tiab] OR day surg*[tiab] OR Ambulatory Surg*[ot] OR Outpatient Surg*[ot] OR Office Surg*[ot] OR day surg*[ot] OR Outpatient*[tiab] OR Out patient*[tiab] OR Outpatient*[ot] OR Out patient*[ot] OR Ambulatory Care[tiab] OR Ambulatory Health Center*[tiab] OR Ambulatory Care[ot] OR Ambulatory Health Center*[ot] OR Ambulant surg*[tiab] OR ambulant ther*[tiab] OR ambulant treatment[tiab] OR outward patient[tiab] OR policlinic[tiab] OR polyclinic[tiab] OR Ambulant surg*[ot] OR ambulant ther*[ot] OR ambulant treatment[ot] OR outward patient[ot] OR policlinic[ot] OR polyclinic[ot]

163751

#25 Add Search "Day Care, Medical"[Mesh] 4831

#23 Add Search "Outpatient Clinics, Hospital"[Mesh] 15894

#21 Add Search "Outpatients"[Mesh] 11259

#19 Add Search "Ambulatory Care Facilities"[Mesh:NoExp] 15172

#17 Add Search "Ambulatory Care"[Mesh:NoExp] 37425

#14 Add Search "Ambulatory Surgical Procedures"[Mesh] 10485

#12 Add Search "Critical Pathways"[Mesh] 5132

#10 Add Search #8 OR #9 52095

#9 Add Search #6 OR #7 32376

#8 Add Search #3 OR #4 23940

#7 Add Search hip arthroplast*[tiab] OR hip replace*[tiab] OR hip prosthes*[tiab] OR hip arthroplast*[ot] OR hip replace*[ot] OR hip prosthes*[ot]

26238

#6 Add Search "Arthroplasty, Replacement, Hip"[Mesh] 18810

#4 Add Search Knee Replac*[tiab] OR Knee Arthroplast*[tiab] OR knee prosthes*[tiab] OR Knee Replac*[ot] OR Knee Arthroplast*[ot] OR knee prosthes*[ot]

21138

#3 Add Search "Arthroplasty, Replacement, Knee"[Mesh] 15086

http://www.ncbi.nlm.nih.gov/pubmed


http://www.ncbi.nlm.nih.gov/pubmed/?cmd=HistorySearch&querykey=28



















































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3.4 Study records

3.4.1 Data management

The results of the literature searches will be collated in the reference management

program RefWorks and will be deduplicated.

3.4.2 Selection process

All articles will be screened objectively and independently by the reviewers (MH and MS)

who first examine titles and abstract. We will exclude publications that clearly do not meet

the inclusion criteria. Then we will retrieve and examine the full text of all potentially

relevant articles independently, review each study and indicate if the study should be

included, excluded or to be decided. We will resolve disagreements regarding study

inclusion by consensus between the two reviewers and, if necessary, by the involvement

of a third review author (BS).

3.4.3 Data collection process

The two reviewers will independently and objectively extract data from each of the

included studies with the tool ReviewManager (RevMan 5).15 RevMan is used to assess

studies for risk of bias, analysis of results, presentation of results, interpretation of results

and to draw conclusions.

3.5 Data items

We will calculate descriptive statistics in table 1: Study characteristics of included studies

study ID (author, year)

number patients (n)

age in years (mean)

male (%)

female (%)

country

study design (RCT, observational study)

level of evidence (I, II, III, IV)

type arthroplasty (TKA, THA, UKA)

Length of stay (days)

readmission (yes/no)



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preoperative care

intraoperative care

postoperative care, including first mobilization (hours)

functional recovery

patient reported outcome measurements (PROMS)

(serious) adverse effects ((S)AE):

o medical complications: cardio, pulmonary, renal, cerebral morbidity, falls

o surgical complications: fractures, infections, wound disorder

o prosthesis related: loosening, dislocation

costs

3.6 Outcomes and prioritization

We will investigate CP safety and efficiency with respect to the following parameters:

Length of hospital stay, from admission to discharge (days)

Patient’s (S)AE

Readmission

Functional recovery

PROMS

Costs

3.7 Risk of bias in individual studies

The independent reviewers assess the risk of bias of each of the included studies with the

Cochrane Risk of Bias Tool,15 to determine whether biases may affect the results. The

standardized checklists are available on the Dutch Cochrane Centre website

(http://netherlands.cochrane.org/). Non randomized studies will be accessed with the

ACROBAT-NRSI checklist.15 Each study will be evaluated for:

selection bias: comparison of the groups, participants characteristics, random sequence

performance bias: blinding of participants and personnel

detection bias: blinding of outcome assessment

attrition bias: incomplete outcome data, differences in follow up

reporting bias: selective outcome reporting

confounding

Items to be considered are randomization and allocation concealment.

http://netherlands.cochrane.org/



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3.8 Data synthesis

Each outcome will be summarized using RevMan 5.15 Continuous data are expressed as

mean difference (MD) and 95% CI or standardized mean difference (SMD). Dichotomous

data are expressed as relative risk (RR), absolute risk (AR) or odds ratio (OR). An estimation

of the effect, variance of the standard error (SE) and homogeneity in terms of patients,

interventions and outcomes will be described.

The outcomes will be reported in the summary of findings table. This table will provide key

information concerning the evidence. Grade software16 will be used to provide an overall

grading of the quality of the evidence per outcome.

To quantify the statistical heterogeneity in the studies, the Q test (null hypothesis) will be

used and I2 value, that is the proportion of the total variance explained by heterogeneity. In

observational studies more heterogeneity is expected than in RCTs. In case of considerable

heterogeneity (>75%) data are not pooled. Only if studies are sufficiently clinical (patient

characteristics, interventions), methodological (design) and statistical homogenous, the data

will be pooled in a meta-analysis. The association between CPs and the endpoints will be

analysed using univariable and multivariable models.



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4. ETHICAL CONSIDERATIONS

This review is a non Medical Research Involving Human Subjects Act (in dutch: non WMO)

study.

5. ADMINISTRATIVE ASPECTS AND PUBLICATION

This study will not be submitted to the Medical Research Ethics Committee (in dutch: METC).



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6. REFERENCES

1. National Clinical Guideline Centre (2014). Osteoarthritis: The care and management of

osteoarthritis in adults. National Institute for Health and Care Excellence NICE Clinical

guideline CG177

2. Singh, J. A. (2011). Epidemiology of Knee and Hip Arthroplasty: A Systematic Review.

The Open Orthopaedics Journal, 5, 80–85

3. den Hertog, A., Gliesche, K., Timm, J., Mühlbauer, B., & Zebrowski, S. (2012). Pathway-

controlled fast-track rehabilitation after total knee arthroplasty: a randomized prospective

clinical study evaluating the recovery pattern, drug consumption, and length of stay. Archives

of orthopaedic and trauma surgery, 132(8), 1153-1163.

4. Kurtz, S. M., Ong, K. L., Schmier, J., Mowat, F., Saleh, K., Dybvik, E., ... & Malchau, H.

(2007). Future clinical and economic impact of revision total hip and knee arthroplasty. The

Journal of Bone & Joint Surgery, 89(suppl 3), 144-151.

5. Jansen E, Brienza S, Gierasimowicz-Fontana A, Matos C, Reynders-Frederix-Dobre C,

HateM SM.(2015) [Rehabilitation after total knee arthroplasty of hip and knee].

Revue Medical de Bruxelles, 36(4),313-20.

6. Matziolis, G., & Röhner, E. (2015). [Total knee arthroplasty in 2014: Results, expectations,

and complications]. Der Orthopade, 44(4), 255-260.

7. Kort, N. P., Bemelmans, Y. F., & Schotanus, M. G. (2015). Outpatient surgery for

unicompartmental knee arthroplasty is effective and safe. Knee Surgery, Sports

Traumatology, Arthroscopy, 1-9.

8. Xu, H., He, M. L., Xiao, Z. M., & Cao, Y. (2013). Hip resurfacing versus traditional total hip

arthroplasty for osteoarthritis and other non‐traumatic diseases of the hip. The Cochrane

Library.

9. Weissman BN, Shah N, Daffner RH, Bancroft L, Bennett DL, Blebea JS, Bruno MA, Fries

IB, Hayes CW, Kransdorf MJ, Luchs JS, Morrison WB, Palestro CJ, Roberts CC, Stoller DW,

Taljanovic MS, Tuite MJ, Ward RJ, Wise JN, Zoga AC, Expert Panel on Musculoskeletal

http://www.ncbi.nlm.nih.gov/pubmed/?term=Jansen%20E%5BAuthor%5D&cauthor=true&cauthor_uid=26591319

http://www.ncbi.nlm.nih.gov/pubmed/?term=Brienza%20S%5BAuthor%5D&cauthor=true&cauthor_uid=26591319

http://www.ncbi.nlm.nih.gov/pubmed/?term=Gierasimowicz-Fontana%20A%5BAuthor%5D&cauthor=true&cauthor_uid=26591319

http://www.ncbi.nlm.nih.gov/pubmed/?term=Matos%20C%5BAuthor%5D&cauthor=true&cauthor_uid=26591319

http://www.ncbi.nlm.nih.gov/pubmed/?term=Reynders-Frederix-Dobre%20C%5BAuthor%5D&cauthor=true&cauthor_uid=26591319

http://www.ncbi.nlm.nih.gov/pubmed/?term=HateM%20SM%5BAuthor%5D&cauthor=true&cauthor_uid=26591319

http://www.ncbi.nlm.nih.gov/pubmed/?term=jansen+rehabilitation+total+knee+hip



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Imaging. ACR Appropriateness Criteria® imaging after total knee arthroplasty. [online

publication]. Reston (VA): American College of Radiology (ACR); 2011. 13 p

10. Barbieri, A., Vanhaecht, K., Van Herck, P., Sermeus, W., Faggiano, F., Marchisio, S., &

Panella, M. (2009). Effects of clinical pathways in the joint replacement: a meta-analysis.

BMC medicine, 7(1), 32

11. Castoro, C., Bertinato, L., Baccaglini, U., Drace, C. A., & McKee, M. (2007). Day surgery:

making it happen. Policy Brief. Copenhagen: WHO-EURO and European Observatory on

Health Systems and Policies.

12. Kim, S., Losina, E., Solomon, D. H., Wright, J., & Katz, J. N. (2003). Effectiveness of

clinical pathways for total knee and total hip arthroplasty Literature review. The Journal of

arthroplasty, 18(1), 69-74.

13. Van Herck, P., Vanhaecht, K., Deneckere, S., Bellemans, J., Panella, M., Barbieri, A., &

Sermeus, W. (2010). Key interventions and outcomes in joint arthroplasty clinical pathways:

a systematic review. Journal of evaluation in clinical practice, 16(1), 39-49.

14. Hartog, Y. M. D., Mathijssen, N. M., & Vehmeijer, S. B. (2015). Total hip arthroplasty in

an outpatient setting in 27 selected patients. Acta orthopaedica, 86(6), 667-670.

15. Higgins, J. P. T., Altman, D. G., & Sterne, J. A. C. (2011) on behalf of the Cochrane

Statistical Methods Group and the Cochrane Bias Methods Group. Chapter 8: Assessing risk

of bias in included studies. Cochrane handbook for systematic reviews of interventions

version, 5(0).

16. Cochrane Collaboration. (2011). Chapter 12: Interpreting results and drawing

conclusions. Cochrane handbook for systematic reviews of interventions (Version 5.1. 0).

Oxford, UK: Cochrane Collaboration.

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