University of Alberta

Awareness, Measurement, Treatment and Control of Hypertension

by

Donna Lee McLean

A thesis submitted to the Faculty of Graduate Studies and Research

in partial fulfillment of the requirements for the degree of

Doctor of Philosophy

Faculty of Nursing

Donna Lee McLean

Fall 2012

Edmonton, Alberta

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Dedication

Although there is only one name on this thesis, work of this undertaking is a much

supported effort, and this is monumentally true of this one. Without the continued

support of my parents, Emilie and Andrew Horboway and my children, Carson, Cierra

and Savannah, this endeavor would never have been accomplished. Thank you for

staying the course with me.

I would also like to dedicate this work to my grandparents who are now deceased, but

live in my memory, Lena and Zek Zaderey, Mary and Steve Horboway, who came to

Canada from the Ukraine, so our families would have a better life. They always

believed in having an education and supported me dearly, knowing it would open new

doors to opportunity.

Carson, Cierra and Savannah, I only wish that your future will hold similar

opportunities to pursue your educational dreams so you too can help others. There are

no short cuts to any place worth going.

Abstract

Hypertension is a complex, chronic condition that is often referred to as the

"silent killer". Most cases of hypertension either are not diagnosed or go untreated.

The condition is a key contributor to the development of cardiovascular and

cerebrovascular disease, with nearly two-thirds of all cases of stroke and one-half of all

cases of ischemic heart disease being directly attributable to hypertension.1

The purpose of this paper-based thesis was to explore and design a community-

based approach to improve blood pressure control. Given the great burden of illness of

cardiovascular disease in patients with high blood pressure, investment in novel

community-based strategies to improve the management of hypertension were and are

still greatly needed. As such, a multicentre randomized trial utilizing advanced nurse

practitioners and community pharmacists identified patients with diabetes and elevated

blood pressure using recommended screening methods, and acted as a liaison between

the patient and their primary care physician, and assisted in follow-up of these patients

to achieve the recommended target blood pressure.

This final dissertation consists of 5 papers related to blood pressure

measurement and hypertension management, whereby, four papers have already been

published. The final fifth paper (unpublished) uses historical method to review

selected nursing literature on blood pressure measurement between 1945 and 2000.

1 Lawes, C., Vander Hoorn, S. & Law, H. Blood pressure and the global burden of disease 2000. Part II: Estimates of attributable burden. Journal of Hypertension, 24, 423-430.

The purpose of this historical research project was to undertake a beginning study of

the history of blood pressure measurement in nursing.

Treatment and control of blood pressure is a major public health problem.

Given the magnitude of this problem it is clear that traditional methods of patient

screening and management, primarily through family physicians have been inadequate

we need innovative community-based solutions whereby nurses and nurses

practitioners play a role. Improvements to the delivery of primary care must go

beyond the confines of the family physician's office and consider the important role

that other community-based healthcare professionals can play.

Word Count: 338

Acknowledgements

I wish to acknowledge the guidance and expertise of by both my thesis supervisors,

Dr. Pauline Paul and Dr. Rene Day. Your belief in the process and your gentle

sound research advice made this project evolve into an exceptional learning

experience. I am grateful for your support and encouragement. I wish to extend a

special thank you and gratitude to my supportive committee members:

Dr. Florence Myrick, Faculty of Nursing, University of Alberta

Dr. Brenda Cameron, Faculty of Nursing, University of Alberta

Dr. Caroline Ross, Faculty of Nursing, University of Alberta

Dr. Elizabeth Taylor, Faculty of Rehabilitation Medicine, University of Alberta

Dr. Sean Clarke, Faculty of Nursing, McGill University (External Member)

I wish to extend a special thank you to the research participants who took time from

their busy schedules to participate in my research. I would also like to gratefully

acknowledge the financial assistance I received from the Alberta Registered Nurses

Educational Trust, Canadian Diabetes Association, the Heart and Stroke

Foundation of Canada, the Canadian Council of Cardiovascular Nurses, Merck

Frosst Canada Ltd, Covenant Health, Alberta Health Services and my CIHR

TORCH traineeship (Tomorrow's Research Cardiovascular Health

Professionals) and the World Heart Federation.

Finally I want to thank all my colleagues, friends far and near, and family members

who have supported, encouraged and inspired me to pursue my studies.

TABLE OF CONTENTS

Page Number

CHAPTER 1: INTRODUCTION AND BACKGROUND 1

My Motivation 12

Outline of the Dissertation 14

References 18

CHAPTER 2: TREATMENT AND BLOOD PRESSURE CONTROL IN 47,964 PEOPLE WITH DIABETES AND HYPERTENSION: A SYSTEMATIC

REVIEW OF OBSERVATIONAL STUDIES

Introduction 23

Methods 24

Literature Search 24

Analyses 32

Results 25

Discussion 26

Appendix 1: Search Strategy for Identification of Studies 29

References 30

Table 1: Hypertension Treatment and Achievement of Targets 41

Figure 1: Flow Diagram of Study Inclusion and Exclusion 43

Figure 2: Overall Treatment and Blood Pressure Control in Subjects with 44

Diabetes and Hypertension

CHAPTER 3: COMMUNITY PHARMACIST PRACTICES IN HYPERTENSION MANAGEMENT

Introduction 45

Methods 46

Stage 1 46

Stage 2 47

Training of the Standardized Patients 48

Results 49

Discussion 50

Conclusions 51

Appendix A: Determining Practice Standards for Community Pharmacists 58

Appendix B: Standardized Patient Scenario 59

References 61

CHAPTER 4: IMPROVING BLOOD PRESSURE MANAGEMENT IN PATIENTS WITH DIABETES: THE DESIGN OF THE SCRTP-HTN STUDY

Background and Rationale 63

Methods 63

Discussion 66

Figure 1: Protocol Summary 68

Figure 2: Opinion Leader Statement 69

References 70

CHAPTER 5: A RANDOMIZED TRIAL OF THE EFFECT OF COMMUNITY PHARMACIST AND NURSE CARE ON IMPROVING BLOOD PRESSURE MANAGEMENT IN PATIENTS WITH DIABETES MELLITUS: STUDY OF CARDIOVASCULAR RISK INTERVENTION (SCRJP-HTN)

Introduction 71

Methods 73

Results 76

Discussion 79

Conclusion 83

References 87

Figure 1: Trial Profile 90

Figure 2: Trial Flow Diagram 91

Figure 3: Primary Endpoint 92

Figure 4: Achieving Goal Blood Pressure

Appendix A: Primary Articles Central Topic Description by Decade and Journal 252

CHAPTER 7: Conclusion

How the Papers are Connected Together 268

Main Conclusions 269

Future Nursing Implications 274

Nursing Practice Recommendations 276

Nursing Research Recommendations 279

Recommendations for Continuing Education 281

Limitations 285

In Conclusion 285

References 287

CHAPTER 1:

INTRODUCTION AND BACKGROUND

Cardiovascular disease is the major cause of death and disability in Canada.

Cardiovascular disease (CVD) is the number one cause of death and disability

in Canada and hypertension is a major contributor, accounting for two-thirds of

strokes and half of coronary disease events.1 In 2003, 33% of all deaths in Canada

were due to CVD. 2 CVD imparts a profound burden on the health of Canadians

and the healthcare system. The high prevalence of the major risk factors for

CVD continues to contribute to the epidemic of heart disease and stroke in

Canada. Many of these risk factors are modifiable, and numerous studies have

conclusively demonstrated the efficacy of aggressive treatment of risk factors

such as hypertension, hyperglycemia, smoking cessation and dyslipidemia in

reducing death and disability from CVD.4

' Health Canada, Health Protection Branch-Laboratory Centre for Disease Control. Economic burden of illness in Canada. Catalogue No. 1993 H21-136/1993E. Ottawa, 1997; Public Health Agency of Canada. 2009 Tracking Heart Disease and Stroke in Canada. Retrieved from http://www.phac-aspc.gc.ca/pubIicat/2009/cvd-avc/index-eng.php

2 Statistics Canada. Mortality: Summary list of causes 2003. Catalogue number 84F0209XIE. Ottawa: Minister of Industry, 2006. Retrieved from http://www.statcan.ca

3 Wielgosz A, Arango M, et al, eds. The Changing Face of Heart Disease and Stroke in Canada 2000. Ottawa, Ontario: Heart and Stroke Foundation of Canada; 1999. Retrieved from: http://www.hc-sc.gc.ca: Tarride, J., Lim, M., DesMeules, M., Luo, W., Burke, N., O'Reilly, D., Brown, J., & Goeree, R. (2009). A review of the cost of cardiovascular disease. Canadian Journal of Cardiology, 25, el95-e202.

4 Statistics Canada. Mortality: Summary list of causes 2003; Canadian Heart and Stroke Surveillance System On-line, 1999; A joint editorial statement by the American Diabetes Association; the National Heart, Lung, and Blood Institute;

1

http://www.hc-sc.gc.ca

Hypertension is a strong and independent risk factor for cardiovascular disease

and despite being the most important avoidable cause of death worldwide,

hypertension remains sub-optimally managed.

Hypertension is a highly prevalent and strong, independent risk factor for the

development of coronary heart disease. Hypertension is a 'silent killer' as

individuals may have the disease for years without knowing it. In Canada in 2001,

it has been estimated that 4.1 million Canadians (21.1%) have high blood pressure

(BP >140/90 mm Hg). Amazingly, 43% of these individuals are unaware (not

diagnosed) of their condition.5 Even in those patients diagnosed with

hypertension, the Canadian Heart Health Surveys have demonstrated very poor

management of hypertension: > 43% of hypertensive patients are unaware (and

untreated) and 22% are neither treated nor controlled.6 Although hypertension is

the most important avoidable cause of death worldwide and treatment

dramatically improves patient outcomes, only 13% of individuals with

hypertension have been diagnosed, treated and controlled; having reached their

target values for blood pressure (

million Canadians (87% of those with hypertension) have poorly controlled blood

pressure. Clearly, the poor detection and treatment of hypertension represents a

significant evidence to practice care gap with important public health

implications. Poor adherence to prescribed antihypertensive medications and

clinical inertia are major barriers to achieving blood pressure (BP) control. In

order to reduce the burden of CVD, there must be a greater focus on identification

and control of hypertension.

Recent data have suggested Canada is likely the world's leading country in

the prevention and control of hypertension with a fivefold increase in treatment

and control of hypertension in Ontario between 1992 and 2006.8 The recently

completed Heart and Stroke Foundation survey of blood pressure awareness,

treatment and control from the province of Ontario found unprecedented levels of

blood pressure control with 2 out of 3 people with hypertension under control.

However, for people with diabetes, rates of control were only 1 in 3, with two-

thirds above the target of less than 130/80 mm Hg.9

7 Wielgosz A et al., The Changing Face of Heart Disease and Stroke in Canada 2000; Canadian Heart and Stroke Surveillance System On-line, 1999; A joint editorial statement by the American Diabetes Association Circulation; Joffres et al., American Journal of Hypertension; Haffner, S.M., Lehto, S., Ronnemaa, T., Pyorala, K., & Laakso, M. (1998). Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. New England Journal of Medicine, 339, 229-234.

11 Campbell, N.R., Brandt, R., & Johansen, H. (2009). Increases in antihypertensive prescriptions and reductions in cardiovascular events in Canada. Hypertension, 55, 128-134.

9 Leenen, F., Dumais, J., Mclnnis, N., Turton, P., Stratychuk, L., Nemeth, K., Lum-Kwong, M., & Fodor, G. (2008). Results of the Ontario survey on the

3

Diabetes is also a strong risk factor for cardiovascular disease.

Over two million Canadians have diabetes, and its prevalence increases with

age.10 The true prevalence of diabetes in Canada is substantially underestimated

because of high numbers of undiagnosed cases of diabetes, a situation similar to

that described for hypertension above. The incidence, prevalence and mortality

from all forms of CVD are markedly increased in patients with diabetes compared

to those without. The relative risk for CVD is 2-6 fold higher in patients with

diabetes than in nondiabetics ,n In fact, patients with diabetes have equal risk for

cardiovascular events as nondiabetics with a previous myocardial infarction.12

Moreover, when patients with diabetes develop clinical CVD, they have a much

1 ^ worse prognosis than patients without diabetes. Eighty percent of people with

prevalence and control of hypertension. Canadian Medical Association Journal, 178, 1441-1449.

10 Canadian Diabetes Association. Canadian Diabetes Association 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. S1-S152; Canadian Diabetes Association. Canadian Diabetes Association 2008 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Retrieved from: http://www.diabetes.ca/files/cpg2008/cpg-2008.pdf

11 Ibid.

12 Haffner et al., New England Journal of Medicine.

13 A joint editorial statement by the American Diabetes Association, Circulation; Sowers, J.R., Epstein, M., & Frohlich, E.D. (2001). Diabetes, hypertension, and cardiovascular disease: An update. Hypertension, 37, 1053-1059.

4

diabetes die of some form of heart or blood vessel disease.14 Over 25% of the

healthcare costs for people with diabetes are related to CVD.15

Diabetes and hypertension are a lethal combination of risk factors.

Hypertension is frequently associated with diabetes.16 There are numerous

published population studies confirming that the prevalence of hypertension is

much higher in individuals with diabetes than in the general population.17 The

prevalence of hypertension in patients with diabetes is estimated at 40-50% in

Canada, about twice that of the nondiabetic population.18 In one US study, about

73% of adults with diabetes have blood pressure readings >130/80 mm Hg or use

prescription medications for hypertension.19 In the Framingham Heart Study 20

14 Sowers et al., Hypertension.

15 Simpson, S.H., Jacobs, P., Corabian, P., & Johnson, J.A. (2003). The cost of major co-morbidities in a cohort of Saskatchewan residents with diabetes. Canadian Medical Association Journal 168, 1661-1667.

16 Leenen et al., Canadian Medical Association Journal; United Kingdom Prospective Diabetes Study III. (1985). Prevalence of hypertension and hypotension therapy in patients with newly diagnosed diabetes. Hypertension, 7 (suppl II), 118-1113; Standi, E., Stiegler, H., Roth, R., Schultz, K., & Lehmacher, W.(1989). On the impact of hypertension on the prognosis of NICCM results of the Schwabing GP-Program. Diabetes Metabolism, 15, 352-358.

17 Krolewski, A.S., Warran, J.H., & Cupples, A. (1985). Hypertension, orthostatic hypotension and microvascular complications of diabetes. Journal of Chronic Disease, 38, 319-326.

18 Health Canada, Health Protection Branch-Laboratory Centre for Disease Control; Joffres et al., American Journal of Hypertension; Leenen et al., Canadian Medical Association Journal.

19 The National Center for Chronic Disease Prevention and Health Promotion. National estimates on diabetes. Retrieved from: http://www.cdc.gov/diabetes/pubs/estimates.htm

20 Kannel, W.B., Neaton, J.D., Wentworth, D., Thomas, H.E, Stamler, J., & Hulley S.B. (1986). Overall and coronary heart disease mortality rates in relation

5

the prevalence of hypertension in individuals with diabetes was 50%, but in the

San Antonio Heart Study 21 it was 85%. The clustering of risk factors in persons

with diabetes produce synergistic negative effects leading to a greater risk for

cardiovascular events.22 Gardner et al reports a synergistic relationship between a

history of diabetes and hypertension in risk of ischemic heart disease mortality.23

A number of prospective studies have shown the clinical benefits of treating

hypertension, specifically among individuals with diabetes. The United Kingdom

Prospective Diabetes Study (UKPDS) 3824 intervention study of type 2 diabetics

showed reduced mortality, macro vascular and microvascular complications. This

study closely monitored blood pressure in those with diabetes (144/82 compared

with 154/87 mm Hg, a difference of 10/5 mm Hg). In the UKPDS 38 intervention

study, the risk of diabetic complications was associated with elevated systolic

blood pressure of 110 to 170 mm Hg. For a 10 mm Hg difference in blood

pressure there was a risk reduction of 12% in all diabetic complications. The

to major risk factors in 325,348 men screened for MRFIT. American Heart Journal, 112, 825-836.

21 Mitchell, B.D., Stern, M.P, Haffner, S.M., Hazuda, H.P., & Patterson, J.K. (1990). Risk factors for cardiovascular mortality in Mexican Americans and non-Hispanic whites. San Antonio Heart Study. American Journal of Epidemiology, 131, 423-433.

22 Wingard, D.L., Barrett-Connor, E., Criqui, M.H. & Suarez, L. (1983). Clustering of heart disease risk factors in diabetic compared to nondiabetic adults. American Journal of Epidemiology, 117,19-26.

23 Gardner, L.I., Wagner, H.A., & Tyroler, C.H. (1980). Diabetes and hypertension synergism in the Evans County Study population. Preventive Medicine, 9,525-533.

24 UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. (1998). British Medical Journal, 317, 703-713.

6

Hypertension Optimal Treatment study (HOT) also showed that treatment aimed

at lowering diastolic pressure to 80 mm Hg or less, was associated with

significant reduction in cardiovascular events when compared with treatment

aimed at lowering diastolic pressure to a level of 90 mm Hg or less.25

Recognizing the increased risk imparted by diabetes, national organizations

advocate aggressive risk factor management in people with diabetes.26

Recommendations of the Canadian Hypertension Education Program (2005,

2009) 27and the Joint Committee on Prevention, Detection, Evaluation, and

25 Hansson, L., Zanchetti, A., Carruthers, S., Dahlof, B., Elmfeidt, D., Julius, S., et al. (1998). Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: Principal results of the Hypertension Optimal Treatment (HOT) randomised trial. Lancet, 351, 1755-1762.

26 American Diabetes Association. (2000). Management of dyslipidemia in adults with diabetes. Diabetes Care, 23(Suppl 1), S57-S60; Meltzer, S., Leiter, L., Daneman, D., Gerstein, H.C., Lau, D., & Ludwig, S. (1998). 1998 clinical practice guidelines for the management of diabetes in Canada. Canadian Diabetes Association. Canadian Medical Association Journal, 159, S1-29; Fodor, J.G., Frohlich, J.J., Genest, J.J.G., & McPherson, P.R., for the Working Group on Hypercholesterolemia and Other Dyslipidemias. (2000). Recommendations for the management and treatment of dyslipidemia. Canadian Medical Association Journal, 162, 1441-1447; Wood, D., de Backer, G., Faergeman, O., Graham, I., Mancia, G., & Pyorala, K. (1998). Prevention of coronary heart disease in clinical practice. European Heart Journal, 19, 1434-1503.

27 The Canadian Hypertension Society. The 2005 Canadian recommendations for the management of hypertension. Retrieved from http://hvpertension.ca/chep/: Padwal, R.S., Hemmelgarn, B.R., Khan, N.A., Grover, S., McKay, D.W., Wilson, T., Penner, B., Burgess, E., McAlister, F.A., Bolli, P., Hill, M.D.,Mahon, J., Myers, M.J., Abbott, C., Schiffrin, E.L., Honos, G., Mann, K., Tremblay, G., Milot, A., Cloutier, L., Chockalingam, A., Rabkin, S.W., Dawes, M., Touyz, R., Bell, C., Burns, K.D., Ruzicka, M., Campbell, N.R.C., Vallee, M., Prasad, R., Lebel, M., & Tobe, S.W. for the Canadian Hypertension Education Program. The 2009 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 1 - blood pressure measurement, diagnosis and assessment of risk. (2009). Canadian Journal of Cardiology, 25, 279-286.

7

http://hvpertension.ca/chep/

Treatment of High Blood Pressure (JNC VII)(2003)28 both suggest that

individuals with diabetes should have lower blood pressure targets of

examine BP treatment and control rates in patients with diabetes mellitus.31 In

this analysis of 44 studies, (77,649 subjects with diabetes mellitus), we observed

that overall, less than 37% achieve treatment targets. In those studies using a BP

target of

The most commonly cited reasons why appropriate preventive care was not

provided were that patients do not present for such care and that there Eire no

reminder systems for physicians and patients for whom preventive care is

necessary. As such, improvements to the delivery of primary care must go

beyond the confines of the family physician's office and consider the important

role that other community-based healthcare professionals could play.

Registered nurses have knowledge and skills that address the client's

ongoing health situation within the context of the person's wholeness, including

biophysical, psychological, emotional, social, cultural and spiritual dimensions.

Registered nursing practice is individualized focused on identifying the client's

uniqueness and facilitating the achievement of specific health goals of a client.

Registered nurses have excellent patient assessment and communications skills

which are well-suited to community-based screening and management programs.

They work closely and collaboratively with members of the health-care team and

contribute to improving health and preventing illness with enhanced knowledge.

Community pharmacists are also well-placed to assist in the identification

of at-risk patients for preventive care. Indeed, pharmacists are often the first point

of contact for patients, are highly accessible, and often see their patients more

frequently than family physicians. In two recently published studies, SCRIP and

SCRIP -plus, the EPICORE research group has conclusively demonstrated proof

5-7

of the concept that pharmacists can play a major role in preventive health care.

33 Tsuyuki, R.T., Johnson, J.A., Teo, K.K., Simpson, S.H., Ackman, M.L., Biggs, R.S., Cave, A.J., Chang, W.C., Dzavik, V., Farris, K.B., Galvin, D., Semchuk,

10

The Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP) was a

675-patient, 54-centre randomized trial of community pharmacist intervention

versus usual care on cholesterol risk management in patients at high risk for CVD

events. Pharmacist intervention included identification of patients at high risk for

CVD events, point of care cholesterol measurement, patient education regarding

cardiovascular risk factors, referral of the patient to their primary care physician

for further assessment/management, and regular follow-up for four months.

Notably, this study was terminated early due to a large impact of pharmacist

intervention. Pharmacist intervention led to a 3-fold increase in the odds of

improvement in cholesterol management (measurement of full fasting lipid profile

by the family physician or institution/dosage increase of lipid-lowering therapy).

Therefore, given the great burden of illness of cardiovascular disease in

patients with diabetes, investment in novel community-based strategies to

improve the management of hypertension are greatly needed. Hence, there is

limited data and few rigorous studies describing the prevalence of elevated blood

pressure in individuals with diabetes with regards to the extent to which it is being

treated and meeting specific diabetic target blood pressure values. It appears that

W., & Taylor, J.G. (2002). A randomized trial of the effect of community pharmacist intervention on cholesterol risk: The Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP). Archives of Internal Medicine, 162, 1149-1155; Tsuyuki, R.T., Olson, K.L., Dubyk, A.M., Schindel, T., & Johnson, J.A. (2004). Effect of community pharmacist intervention on cholesterol levels in patients with high risk of cardiovascular events: The second Study of Cardiovascular Risk Intervention by Pharmacists (SCREP-p/ws). American Journal of Medicine, 116, 130-133.

11

achieving optimal blood pressure target values in individuals with diabetes is very

poor and broad-based efforts are needed to improve blood pressure control.

My Motivation

My motivation to conduct this series of studies (chapters #2-3) began

during the beginning courses of my Ph.D. I conducted a number of smaller

studies relating to the "prevalence" and "mechanisms" of undertreatment of

hypertension. These studies provided valuable insight to me into the development

of a randomized trial of a community-based, multidisciplinary approach to the

detection and treatment to target of hypertension (chapters #4-5). I was

responsible for the development of the study protocols, funding applications

(including budgeting), study implementation (working with our data management

team and research coordinators), data collection, day-to-day study conduct (as a

Project Officer), data analysis (under the direction of our biostatisticians and

faculty), abstract and manuscript preparation and presentation.

The first step in addressing the gap between the evidence of a condition

and its application in clinical practice, is to accurately describe the extent of the

problem. As such, we performed a systematic review to examine the

contemporary management of hypertension in patients with diabetes from 1990-

2000 (chapter #2), including a comparison of BP treatment and control rates

between health care settings and countries. We found that fewer than one in eight

people with diabetes and hypertension have adequately controlled BP, with

remarkable uniformity across studies conducted in a variety of settings. This

12

suggests that there is an urgent need for multidisciplinary, community-based

approaches to manage these high-risk patients.

In a broader context we demonstrated that BP control in individuals with

diabetes is infrequently achieved in all settings, meaning that improvements in BP

control will require novel approaches that extend beyond the four walls of the

primary care physician's office. Interdisciplinary, community-based programs

hold particular promise for chronic and common conditions such as diabetes.

Given the result data, the development of such programs as SCRIP-HTN (chapter

#4-5) for the management of cardiovascular risk factors in patients with diabetes

is a research and public health imperative.

On a personal level, in part because of the role I play as a nurse

practitioner, I was interested in the roles that nurses have played historically with

regards to blood pressure management (chapter #6). I was interested in

understanding if nursing practice and nursing roles had changed over time in the

last 50 years with regards to hypertension management.

My short-term goal is to make a significant contribution to knowledge and

to the cardiovascular health of Canadians as a cardiovascular nurse researcher

with the projects I have completed. I have recognized the need and benefit of

having a multidisciplinary approach as well as a patient-tailored approach.

My long-term goals are to contribute and increase the capacity of the

Canadian health research community by continuing to develop my knowledge

base, skill set and attitudes which are fundamental to embarking on a successful

13

career as a cardiovascular nurse researcher. I would like to be a future mentor to

other nurse research students and participate in developing a network of

cardiovascular nurse researchers.

Outline of the Dissertation

Chapter 1 is the introductory chapter to this topic surrounding

hypertension and the outline of the series of studies.

Chapter 2 is a systematic review of observational studies focusing on the

treatment and blood pressure control in 47,964 people with diabetes and

hypertension. Databases and hand searches of bibliographies of relevant studies

were conducted from 1990-2004. Data sources included: MEDLINE, EMBASE,

HealthSTAR, CINAHL, Web of Science, Clinical Evidence including

Government Health/Statistical Sites. A total of 44 studies found less than 1 in 8

people with diabetes and hypertension had adequately controlled blood pressure.

That meaning, blood pressure controlled to recommended levels

blood pressure target values; review of patient medical histories; accuracy and

confirmation of blood pressure readings; education and lifestyle measures, and

referrals. It was found that pharmacists took reasonable steps to determine the

accuracy of the blood pressure measurement, explained the diagnosis of

hypertension and did refer patients to a physician. Major deficiencies were noted

in medical history taking and assessment of target blood pressures. Pharmacists

in collaboration with other health professionals were identified as be able to play a

role in identifying, screening and managing individuals with hypertension.

Chapter 4 describes in detail the design of the randomized controlled trial

SCRIP-HTN. SCRIP-HTN is a multicentre randomized trial that evaluated a

unique program of nurse intervention and community pharmacists, within a

multidisciplinary team, to improve management of blood pressure in patients with

diabetes. The trial began in May 2005. This paper provided a brief summary of

the design of the trial including: methods, inclusion and exclusion criteria, patient

recruitment strategies, randomization, and outcome measures. Treatment and

control of hypertension is a major public health problem and a key goal of the

Canadian Hypertension Education Program (CHEP). Novel ways of identifying

and treating this population to current blood pressure guidelines are urgently

needed and suggested.

Chapter 5 reports the results of the trial SCRIP-HTN. The trial purpose

was to determine the efficacy of a community-based multidisciplinary screening

and intervention program on blood pressure control in patients with diabetes.

Recognizing that blood pressure control in individuals with diabetes is poor, with

15

few patients reaching the recommended target of

nursing education and the healthcare organization of the current time.

Historically, nurses have focused on preventing hypertension.

Chapter 7 serves as the overall conclusion to the series of studies

completed with a focus of the findings of the studies on the future implications for

nursing research, administration and education.

17

References

American Diabetes Association; the National Heart, Lung, and Blood Institute; the Juvenile Diabetes Foundation International; the National Institute of Diabetes and Digestive and Kidney Diseases; and the American Heart Association. (1999). Diabetes mellitus: a major risk factor for CVD. Circulation, 100, 1132-1133.

American Diabetes Association. (2000). Management of dyslipidemia in adults with diabetes. Diabetes Care, 23(Suppl 1), S57-S60.

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22

CHAPTER 2

Treatment and Blood Pressure Control in 47,964 People with Diabetes and Hypertension: A Systematic Review of Observational Studies1

INTRODUCTION

In 2000, there were 171 million people with diabetes worldwide; by 2030

this figure is expected to more than double (1-3). Diabetes is a strong risk factor

for atherosclerosis and approximately 50% to 75% of deaths in patients with

diabetes are cardiovascular (4-5).

More than half of North Americans with diabetes also have elevated blood

pressure (BP); reducing BP reduces the risks of both cardiovascular disease and

renal dysfunction in patients with diabetes (6). There is a direct relationship

between systolic or diastolic BP and cardiovascular risk in individuals with

diabetes, and antihypertensive therapy reduces the relative risk of cardiovascular

events by approximately 25% to 30% in those with blood pressures exceeding

130/80 mm Hg (6-10). Many clinicians feel that BP control actually confers

greater cardiovascular benefits in patients with diabetes than control of blood

glucose (6-13). However, we suspect that the management of diabetes in clinical

practice continues to be largely focused around achieving glycemic control. For

example, data from the Canadian Heart Health Study suggested that less than 9%

of individuals with diabetes had a BP < 140/90 mm Hg (compared to 13% in non-

diabetics) (11).

'A version of this chapter was publish as: McLean, D.L., Simpson, S.H., McAlister, F.A., & Tsuyuki, R.T. (2006). Treatment and blood pressure control in 47,964 people with diabetes and hypertension: A systematic review of observational studies. Canadian Journal of Cardiology, 22, 855-860.

23

The first step in addressing any gap between the evidence and its

application in clinical practice is to accurately describe the extent of the problem.

As such, we performed a systematic review to examine the contemporary

management of hypertension in patients with diabetes from 1990 to 2004

including a comparison of blood pressure treatment and control rates between

health care settings and countries.

METHODS

We included all studies published, in any language, between January 1,

1990 and June 30, 2004 that reported BP treatment and/or control rates in adult

patients with diabetes. As we were interested in BP control rates in clinical

practice, studies were excluded if they only reported data from clinical trials, only

included patients with gestational diabetes, or if they did not contain original data

(that is, we excluded editorials, review articles, or guidelines). As we were also

interested in exploring whether gaps were unique to particular health care settings

or providers, we sought all relevant articles, irrespective of setting.

Literature Search

A search of MEDLINE (1966-2004), EMBASE (1980-2004), CINAHL,

HealthSTAR, Web of Science, Clinical Evidence, and Government Health and

statistical sites was conducted using the key words: "diabetes", "hypertension"

and "epidemiology" (see Appendix 1 for full search strategy). The reference lists

of retrieved articles were hand-searched for other relevant studies and content

experts were consulted. All articles potentially meeting the inclusion criteria were

reviewed by 2 reviewers (D.M. and S.S.) independently; disagreements were

24

resolved by consensus. Both reviewers also independently extracted the data

from the included publications.

Analyses

We used the definitions of BP control specified in each study (160/90,

140/90, or 130/85). Weighted averages (by number of subjects with diabetes)

and observed ranges are reported. Studies were stratified by type of practice

(general or specialty) and region.

RESULTS

Of the 3803 publications initially identified, 44 met our inclusion criteria

(14-57) (Figure 1). These 44 studies were from 19 countries and included data

from 12 different health care settings- these studies enrolled 77,649 subjects with

diabetes, 47,964 (62%) of whom had hypertension. The characteristics of each

study are outlined in Table 1.

In the 5 studies (11,339 patients) which used < 160/90 mm Hg to define

control, 68% (range 53% to 97%) of patients received antihypertensive drug

therapy and 37% (range 31% to 60%) achieved target BP. In the 26 studies

(66,833 patients) which used

< 140/90 mm Hg to define control; 83% of patients (range 32% to 100%) received

antihypertensive drug therapy and 30% (range 5% to 59%) had achieved target

BP. In the 24 studies (49,420 patients) with the most stringent definition of BP

control (< 130/85 mm Hg), 87% (range 53% to 100%) of_patients were receiving

antihypertensive drug therapy and 12% (range 6% to 30%) had achieved target

BP (Figure 2). Blood pressure treatment rates and control rates did not differ

appreciably between countries or health care settings (Table 1).

25

DISCUSSION

Despite evidence that aggressive lowering of BP in people with diabetes

reduces cardiovascular morbidity and mortality, we found that BP control in

individuals with diabetes is sub-optimal, with less than one seventh of patients

having BP's controlled to the levels currently suggested by hypertension and

diabetes guidelines (1, 59). Further, our systematic review has revealed that this

sub-optimal treatment pattern is not restricted to certain locales or physician

specialties, at least in the 44 studies from 19 countries we identified.

The 2 best-known North American population studies of BP treatment and

control are the Third National Health and Nutrition Examination Survey

(NHANES in 1988-1994) and the Canadian Heart Health Survey (CHHS 1986-

1992). NHANES III enrolled 1440 patients with diabetes and reported that 71 %

were treated for hypertension (42). The Canadian Heart Health Survey suggested

that control was even poorer in individuals with diabetes and hypertension, with

9% having a BP < 140/90 mm Hg compared to 13% in nondiabetics (11). This

study could not be included in this analysis, because we could not extract numbers

for individuals with diabetes or the proportion of hypertensive subjects treated.

It is sobering to note that control in diabetes may even be worse than our

figures suggest, since in Canada only about two-thirds of those with diabetes are

diagnosed (60), and one can surmise that people with undiagnosed diabetes have

poorer BP control.

Poor achievement of BP control in people with diabetes could be due to a

number of factors, including the possibility that a strong emphasis on glucose

control in diabetes has resulted in an inadvertent under-emphasis of treatment for

26

associated risk factors (such as hypertension) in these patients. In addition,

inadequate access to follow-up care and prescription medications, inappropriate

and/or ineffective treatments, poor adherence to prescription medication and

lifestyle modifications, or a combination of these factors may be responsible (61-

62). Given that randomized trials have proven that most patients will require 2 or

3 agents to control their blood pressure (10, 63-64), physician concerns over the

potential for polypharmacy in patients who are already on medications for other

conditions may also be relevant (65). It is difficult to control blood pressure in

patients with diabetes. Several randomized control trials suggest that 3-4

antihypertensive medications are required to control blood pressure in diabetics

(13, 66). Some clinicians and patients may be weighing the risk of polypharmacy

with optimal blood pressure control.

While we employed Cochrane methodology, 2 independent reviewers, and

explicit case definitions to ensure the validity of our systematic review, we cannot

exclude the possibility of publication bias. However, we would anticipate that

unpublished studies may well have shown worse control rates than those studies

that did get published (although one could argue that there may be more of a bias

towards publishing those studies which document small area variations or the

underuse of proven efficacious therapies in health services research).

While we used the authors' definition of control as we did not have access

to individual patient data, we also recognize that BP goals are a "moving target"

with lower targets recently. Nevertheless, this further highlights the need for

strategies to help attain these new lower targets.

27

Having demonstrated that BP control in individuals with diabetes is

infrequently achieved in all settings, we believe that improvements in BP control

will require novel approaches which extend beyond the four walls of the primary

care physician's office. Interdisciplinary, community-based programs hold

particular promise for chronic and common conditions such as diabetes. For

example, patients at high risk for cardiovascular disease could be identified when

they present with marker medications to their community pharmacists and

enrolled into interdisciplinary risk reduction programs. This model has been used

very successfully in the past in the Study of Cardiovascular Risk Intervention by

Pharmacists (SCRIP), a 52 center randomized trial of cholesterol risk

management by community pharmacists for patients at high cardiovascular risk

(67). Given our data, the development of such programs for the management of

other cardiovascular risk factors in patients with diabetes is a research and public

health imperative.

Acknowledgements: The authors thank Jeanette Buckingham, Janice Varney, and

Liza Chan who provided assistance with the literature search.

28

Appendix 1: Search Strategy for Identification of Studies

1. DIABETES MELLITUS, TYPE W or DIABETES MELLITUS/ or DIABETES MELLITUS, TYPE 1/ 2. diabetes.ti,ab,hw. 3. 1 or 2 4. Hypertension/ 5. hypertens$ (ti,ab,hw) 6. blood pressure.ti,ab,hw. 7. 4 or 5 or 6 8. 3 and 7 9. limit 8 to (all adult or adult or middle age or middle aged or aging or "all aged " or "aged ") 10. exp Adult/ 11. 8 and 10 12. Epidemiology/ 13. exp Morbidity/ 14. (epidemiol$ or prevalen$ or inciden$).ti,ab,hw. 15. exp Population Surveillance/ 16. "Epidemiologic Methods"/ 17. epidemiologic studies/ or case-control studies/ or cohort studies/ or cross-sectional studies/ 18. (population studies or population study).mp. [mp=title, abstract, name of substance, mesh subject heading] 19. ep.fs. 20. 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 21. 11 and 20 22. 12 or 13 or 14 or 19 23. 22 and 11 24. 15 or 16 or 17 or 18 25. 23 and 24 26. (pc or th or dt or dh).fs. 27. (control$ or manag$ or detect$ or treat$ or aware$ or determin$).ti,ab,hw. 28. 26 or 27 29. 25 and 28 30. 29 not pregnan$.ti,ab,hw. 31. limit 30 to yr= 1990-2004

29

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49. Rotchford AP, Rotchford KM. Diabetes in rural South Africa-an assessment

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55. Toth EL, Majumdar SR, Guirguis LM, Lewanczuk RZ, Lee TK, Johnson

JA. Compliance with clinical practice guidelines for type 2 diabetes in rural

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Hamada T et al. The status of hypertension management in Japan in 2000.

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type 2 diabetes mellitus and symptomatic atherosclerosis. CMAJ

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40

Table 1

Hypertension Treatment and Achievement of Target BP in Patients with Diabetes and Hypertension

NORTH AMERICAN

Type of Practice On Hypertension Treatment Achievement of Target BP (range, %)

(range, %) 160/90 140/90 130/80

General Practice(26,29,34,37,38,42,43,60) 62.4-98.1 27-58.6 10.3-53.5

Specialty Practice(47,57) 61.3 29.6-51.7 14.9-21.8

General Population(21,41,44,58) 57-69.4 30.6-45 12.0-24.2

Other(23) 96.5 60.1

EUROPEAN

Type of Practice On Hypertension Treatment Achievement of Target BP(range,%)

(range, %) 160/90 140/90 130/80

General Practice(31,35,39,49,52,59,61) 75.7-93 15.5-19.4 6-28

Specialty Practice(25,30,32,45) 53-94.7 12.3-75.4

General Population(33,48,51,56) 96-97.8 32-56.7 9-22.2

Other(28) 63.7 8.3

41

OTHER

Type of Practice On Hypertension Treatment Achievement of Target BP(range, %)

(range, %) 140/90 130/80

General Practice(22,27,50,54,55) 78.2-100 9.9-10.9 6.1-12.5

Specialty Practice(21,24,37,40,46,62) 51.3-93.8 18.3-59.4 11.4-24.2

General Population(36,53) 32.4-62.5 15.5 11.7

Other

42

Figure 1: Flow diagram of study inclusion and exclusion

1259 excluded -1259 duplicate citations

^ *

44 studies included in final analysis

2544 abstracts identified

46 studies provisionally included

64 studies obtained for more detailed evaluation

328 potential abstracts reviewed for specific inclusion criteria

3803 reports identified by librarian-assisted literature search

2 excluded -Correspondence attempted with 2 authors for number clarification,

2216 excluded -1988 controlled trials -228 editorials, review articles, guidelines

20 excluded -16 unable to extract # of treated patients with diabetes -4 abstracts not published in English

264 abstracts excluded -unable to extract required numbers (# of patients with diabetes, # of patients that hypertensive with diabetes) -excluded studies with gestational diabetes

43

Figure 2: Overall treatment and blood pressure control in subjects with

diabetes and hypertension

Overall treatment and BP control in subjects with diabetes and hypertension

Definition of "Controlled BP" Treated * Controlled *

CHAPTER 3

Community Pharmacist Practices in Hypertension Management1

INTRODUCTION

Hypertension is a highly prevalent, strong and independent risk factor for

cardiovascular disease, the leading cause of death in the Canadian population and

worldwide (1-3). Hypertension has been shown to be poorly managed and

controlled in Canadians. In the Canadian Heart Health Survey, Joffres et al (4),

found that while approximately 21% of Canadians have hypertension, 43% are

not aware of their condition. In the 56% of the hypertensive individuals that were

aware of their diagnosis of hypertension, it was found that 21% of these

individuals were treated but not controlled, with 22% being neither treated nor

controlled. There has been little indication that awareness or control of

hypertension has changed significantly over time (5).

Hypertension treatment and control needs to be improved. Community

pharmacists are in a unique position and accessible resource in the community to

actively identify and screen individuals with high blood pressure (6).

Contemporary pharmacy practice suggests that pharmacists take

responsibility for medication management and patient outcomes (6). Community

pharmacists are uniquely positioned in the health care system to assist with

improving blood pressure control by utilizing strategies to solve medication-

1 A version of this chapter was published as: McLean, D.L., Bungard, T.J., Hui, C., & Tsuyuki, R.T. (2006). Community Pharmacists Practices in Hypertension Management. Canadian Pharmacy Journal, 139, 38-44.

45

related problems. Studies within integrated health systems have demonstrated

that when pharmacists are included as members of health care teams, control rates

for hypertension increase. In one older study (7) and three more recent studies (8-

10) found that blood pressure control was improved when community pharmacists

assisted with patient education, blood pressure monitoring, drug therapy

management, and medication adherence assessment. In two of these studies, blood

pressure control, based on measurements in the physicians' offices, was improved

(7,10). In addition, two studies found that quality of life improved among patients

who were followed by a pharmacist for 4-6 months (9,10).

Based on the aforementioned studies, a pharmacist could help improve

blood pressure control, yet hypertension management remains suboptimal in the

population. While several studies have demonstrated the value of pharmacists in

improving blood pressure control, the extent to which pharmacists have changed

their practices to incorporate these findings are unknown. The purpose of this

study was to determine the current state of practice of pharmacists in hypertension

management.

Methods

Stage 1 of our study was necessary to determine practice standards for

pharmacists for hypertension management. Until very recently (6) there were no

formal practice guidelines pertaining to hypertension management (or any specific

disease conditions) for pharmacists. As such, we conducted a survey of

professional opinions pertaining to pharmacy practice expectations for the

management of hypertension in the Capital Health Region in Edmonton, Canada

46

from May 27, 2003 to June 25, 2003. We used a convenience sample of family

physicians, general internists with expertise in hypertension management,

Canadian Hypertension Education Program panellists, pharmacists from

professional/regulatory associations, clinical pharmacists and front-line

community pharmacists. The interviewees were selected based on their area of

practice. Each interviewee was presented with a hypothetical scenario, similar to

that which was portrayed in Stage 2 of this study. Two open-ended questions

based on the scenario were asked to elicit opinions on reasonable pharmacy

practice for the management of hypertension in community pharmacies

(Appendix A). Interviews were conducted until saturation of responses occurred

(15 interviews).

The primary outcome was to gain a consensus on what a reasonable

pharmacist should do for patients with hypertension. For the purposes of this

analysis, the range of responses from the interviews were compiled and

qualitatively examined for common themes in expected practices. These common

practices were then compiled to become the list of reasonable standards by which

pharmacists' actions were evaluated.

Stage 2 of the study was a cross-sectional, observational study of

community pharmacists' current practices using a standardized patient (SP)

posing as a patient at risk for hypertension.

The study involved one-on-one encounters between two SPs and

pharmacists. It took place at 101 randomly selected community pharmacies in the

metropolitan Edmonton and surrounding area. These pharmacies were selected

47

by randomized stratified sampling by pharmacy type. The pharmacy types (chain,

independent, etc.) were obtained from the 2003 Pharmacy Sourcebook (11).

Pharmacists who were registered under the Alberta College of Pharmacists,

working at any community pharmacy in Edmonton and surrounding area were

candidates for the study. Consent was not obtained from pharmacists. A general

bulletin in a quarterly newsletter was sent to all Alberta pharmacists informing

them of the study and its objectives.

Training of the standardized patients. Two middle-aged male SPs were

selected and trained for the scenario by the Standardized Patient Program, Health

Sciences Council, University of Alberta. They were trained to act as a walk-in

customer, who was curious and concerned about their blood pressure reading

from his friend's home blood pressure monitor. The SP was provided with a

script for the encounter. The researchers created a medical history and medication

profile that was memorized by the SPs (Appendix B). The SP was taught his

medical history and pertinent life history, in preparation for the pharmacist

inquiring about the patient's past. If asked physician and prescription history, the

patient would provide the explanation that he was new in town, and does not have

regular family physician in the Edmonton area, nor has he ever filled a

prescription at the pharmacy. The SP was taught to deal with situations expected

to occur during the encounter with the pharmacist. The SP was also trained to pay

attention to the pharmacist's actions according to the practices outlined in the

guidelines, and was trained using simulations to accurately recall the encounter

and document the pertinent details of the encounter on a recall form, based on the

48

checklist of hypertension management practice standards developed in Stage 1.

We also recorded general comments from the SPs about the pharmacists' general

demeanour.

The SP waited until the pharmacist was not busy before approaching. He

inquired about a blood pressure reading (150/100 mm Hg) taken last weekend on

his friend's blood pressure monitor, and asked "what it means". The SPs

approached each pharmacist with the identical, scripted scenario (Appendix B).

No information about the patient's medical history or medication history was

volunteered, but was available if the pharmacist asked. The pharmacists'

responses were documented by having the SP complete a recall form immediately

after the encounter.

The primary outcome of the study was to determine the proportion of

community pharmacists meeting practice standards as determined in Stage 1.

Results

From Stage 1 of the study, the suggested practice standards for

hypertension for pharmacists from the interviewed pharmacists' and physicians'

responses for reasonable pharmacist practices for hypertension management fell

into five categories. First, pharmacists should know current blood pressure

guidelines (and target values) and be able to interpret them for the patient.

Secondly, pharmacists should inquire about the patient's history (cardiovascular,

medications, previous elevated blood pressure or hypertension diagnosis).

Thirdly, pharmacists should confirm the accuracy of the blood pressure

measurement. Fourthly pharmacists should provide some form of brief patient

49

education on blood pressure and hypertension. Fifthly, pharmacists should refer

the patient to a physician if deemed necessary. There was a remarkable

consistency of responses by all interviewees, regardless of their practice or

specialty.

One hundred and one pharmacists were visited by the SPs between

January 15 and February 28, 2004. Pharmacy types included 27% independents,

23% supermarkets, 18% franchises, 13% chains, 11% department stores, 8%

banners, and 1% wholesalers. On average the SP waited to speak with a

pharmacist 4.1 minutes; with the total duration of the visit averaging 6.3 minutes.

Knowledge of current blood pressure target values: Of the 101

pharmacists who were visited by the SPs, 69% offered a general blood pressure

target value to the SP

(< 120/80 mm Hg). Seven percent of the pharmacists stated the correct target

blood pressure value for the scenario (< 140/90 mm Hg). Only 14% of

pharmacists requested enough patient history to properly determine the target

blood pressure for this scenario.

Review of medical history: Few of the pharmacists questioned the SPs on

their medical history. Twenty-two percent of the pharmacists queried the SPs

regarding a previous diagnosis of hypertension. Twenty percent asked about

previous elevated BP readings. Less than 20% of pharmacists inquired about a

family history of cardiovascular disease or a medication profile or medical

history.

50

Accuracy and confirmation of BP reading: Half of the pharmacists (53%),

inquired about the conditions under which the BP was taken, with 39% of the

pharmacists offering to retake the blood pressure at the pharmacy.

Education and lifestyle measures: Most of the pharmacists discussed how

hypertension was diagnosed (76%) and the impact of lifestyle measures on the

blood pressure (60%). Nearly half of the pharmacists explained what

hypertension was (46%) and how to take a BP properly (46%). Some (29%)

pharmacists gave supplemental educational material to the SPs.

Referral: Most pharmacists (83%) advised the SP to make an appointment

to see their physician.

General demeanour: The SPs were generally very impressed with their

interactions with pharmacists, describing them as approachable (88%), easy to

understand (78%), helpful (69%), attentive (66%), patient (62%), happy (58%)

and concerned (43%).

Discussion

Overall, pharmacists took reasonable steps to determine the accuracy of

the blood pressure measurement, explain the diagnosis of hypertension and refer

that patient to a physician for further evaluation. Unacceptable deficiencies were

identified in the pharmacists' assessment of medical and medication history,

identification of appropriate target blood pressures and accuracy/confirmation of

the blood pressure reading. As such, most pharmacists did not perform up to the

expected standard for contemporary hypertension management.

51

To our knowledge, this is the first study to use unannounced SPs to assess

community pharmacists' practices in cardiovascular disease. Similar

methodologies have been used to evaluate physician and nursing practices in other

disease entities (12-15), although usually with the consent of the participant,

potentially leading to a volunteer bias and a Hawthorne effect.

Standardized patients are simulated patients who have been carefully

coached to present their illness in a standardized way. Much is known about the

use of SPs in medical education (16,17). Research comparing the SP method with

other data collection methods is scarce. Usually, the SP technique is used for the

first contact with the patient only, as was done in this study. Gerritsma and Smal

(18), consider the SP method less appropriate to study the medical decision

making process. They believe that a series of patient encounters reveal more

about the way medical decisions are made. Similarly, Tamblyn et al. (19) has

studied this 'first visit bias' in a case of osteoarthritis combined with gastritis (an

acute problem) and in a case of osteoarthritis paired with chronic hip complaints

(none acute problem). The quality score for two successive consultations was

higher than the first-visit score. Although our study design is different, this may

suggest that the pharmacists, like physicians' performance, may have been

underestimated as the SPs only visited each pharmacist once and perhaps a series

of encounters may have resulted in better pharma