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Primary care evaluation : a study of a community clinic Robertson, Ann 1984

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PRIMARY CARE EVALUATION: A STUDY OF A COMMUNITY CLINIC By ANN ROBERTSON B.Sc, Honours, McMaster Uni v e r s i t y , 1968 A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE i n THE FACULTY OF GRADUATE STUDIES (Department of Health Care and Epidemiology) We accept this thesis as conforming to the required standard THE UNIVERSITY OF BRITISH COLUMBIA A p r i l 1984 fj?S Ann Robertson, 1984 In presenting t h i s thesis i n p a r t i a l f u l f i l m e n t of the requirements fo r an advanced degree at the University of B r i t i s h Columbia, I agree that the Library s h a l l make i t f r e e l y a v a i l a b l e for reference and study. I further agree that permission for extensive copying of t h i s thesis f o r s c h o l a r l y purposes may be granted by the head of my department or by h i s or her representatives. I t i s understood that copying or p u b l i c a t i o n of t h i s t h e s i s f o r f i n a n c i a l gain s h a l l not be allowed without my written permission. Department of H&htXM CAicte c Effit.fr t ^ ' O L.0 6j The University of B r i t i s h Columbia 1956 Main Mall Vancouver, Canada V6T 1Y3 ABSTRACT This thesis presents a discussion of Primary Care Evaluation using a s p e c i f i c q u a l i t y of care evaluation as a case study. The nature of Primary Care i s discussed and a b r i e f review of q u a l i t y assessment methodology i s presented. The issue of process versus outcome evaluation as i t i s presented i n the l i t e r a t u r e i s discussed. The study i t s e l f i s a q u a l i t y of care assessment undertaken i n an urban, m u l t i - d i s c i p l i n a r y community family practice c l i n i c . Using an i n d i c a t o r condition approach, and e x p l i c i t process c r i t e r i a for chart auditing developed for the Burlington Randomized Control T r a i l (BRCT), we reviewed randomly selected charts demonstrating episodes of care given i n seven s p e c i f i c i n d i c a t o r conditions: o t i t i s media; hypertension; urinary t r a c t i n f e c t i o n ; care of the newborn (up to 12 months of age); prenatal care; depression; and childhood immunization. The study period was s p e c i f i e d as J u l y 1, 1981 to June 30, 1982. Of the 583 t o t a l charts a v a i l a b l e for study ( i . e . charts "a c t i v e " during the study period), 103 (17.7%) f i t the c r i t e r i a for the i n d i c a t o r conditions chosen. The f i n a l study sample represented 8.6% of the 1200 charts randomly selected from the t o t a l of 6,923 charts a v a i l a b l e i n the record-room. The work of a l l seven (5 doctors and 2 nurses) p r a c t i t i o n e r s active during the study period was surveyed. The 103 charts contained 124 episodes of care i n the seven i n d i c a t o r conditions. Interrater r e l i a b i l i t y was determined and o v e r a l l agreement between two observers (one physician, one non-physician) was 85%, with agreement beyond chance (KAPPA) of .66. - i i -O v e r a l l , 83 (66.9%) of the 124 e p i s o d e s o f c a r e s t u d i e d were r a t e d adequate or s u p e r i o r , and 33.1% r a t e d i n a d e q u a t e , u s i n g the c r i t e r i a as g i v e n . R e i n t e r p r e t a t i o n o f the p r e n a t a l component, to a d j u s t f o r e p i s o d e s which had f e a t u r e s o f s u p e r i o r and inadequate c a r e i n c r e a s e d the p r o p o r t i o n o f e p i s o d e s judged adequate or s u p e r i o r t o 70.2%. A c r o s s the seven i n d i c a t o r c o n d i t i o n s the p r o p o r t i o n of e p i s o d e s judged adequate o r s u p e r i o r ranged from a low o f 33.3% f o r h y p e r t e n s i o n to 80.9% f o r c a r e o f the newborn. Comparison w i t h the r e s u l t s o b t a i n e d w i t h t h ese seven i n d i c a t o r c o n d i t i o n s ( u s i n g the same c r i t e r i a ) i n the two c l i n i c groups s t u d i e s i n the BRCT r e v e a l e d t h a t the study c l i n i c had a h i g h e r p r o p o r t i o n o f e p i s o d e s r a t e d adequate o r s u p e r i o r than e i t h e r BRCT c l i n i c group f o r o t i t i s media and u r i n a r y t r a c t i n f e c t i o n ; had a p r o p o r t i o n o f e p i s o d e s r a t e d adequate or s u p e r i o r , which was i n t e r m e d i a t e between the two BRCT groups, f o r h y p e r t e n s i o n , d e p r e s s i o n , c a r e o f newborn, and immunization; and had fewer e p i s o d e s r a t e d as adequate or s u p e r i o r than e i t h e r o f the two BRCT c l i n i c s f o r p r e n a t a l c a r e . In terms o f o v e r a l l p r o p o r t i o n s o f e p i s o d e s r a t e d adequate or s u p e r i o r , a t e s t o f p r o p o r t i o n s found th a t the study c l n i c was not s i g n i f i c a n t l y d i f f e r e n t from e i t h e r o f the BRCT study groups. The r e a s o n s f o r inadequacy and the i m p l i c a t i o n s o f these f i n d i n g s f o r q u a l i t y a s s u r a n c e a c t i v i t i e s at the stu d y c l i n i c are d i s c u s s e d . F i n a l l y , the g e n e r a l r e l e v a n c e o f p r o c e s s e v a l u a t i o n s , such as the one a p p l i e d at the stu d y c l i n i c , as a p o l i c y t o o l i s d i s c u s s e d . TABLE OF CONTENTS Page A b s t r a c t i i L i s t o f T a b l e s v i i L i s t o f F i g u r e s v i i i Acknowledgement i x I n t r o d u c t i o n 1 CHAPTER 1 - P r i m a r y Care 1.1 What i s P r i m a r y Care 5 1.2 Why e v a l u a t e P r i m a r y Care 11 1.3 T h r u s t f o r P r i m a r y Care E v a l u a t i o n 12 1.4 How to e v a l u a t e P r i m a r y Care 14 Notes 16 CHAPTER 2 - L i t e r a t u r e Review - Q u a l i t y Assessment 2.1 E a r l y S t u d i e s 19 2.2 Development o f the Methodology 20 2.3 What i s q u a l i t y i n m e d i c a l c a r e 29 2.4 P r o c e s s v s Outcome E v a l u a t i o n 32 2.5 P a t i e n t C h a r a c t e r i s t i c s 34 2.6 Summary 35 Notes 36 - i v -Page CHAPTER 3 - Study C l i n i c : The Methodology 3 . 1 Study S e t t i n g 4 1 3 . 2 I n i t i a t i o n o f the Study 4 2 3 . 3 S e l e c t i o n o f an Approach f o r the Study 4 2 3 . 4 Study P e r i o d 4 4 3 . 5 C h a r t S e l e c t i o n 4 5 3 . 6 A b s t r a c t i o n o f Data 4 6 o 3 . 7 V a l i d i t y and R e l i a b i l i t y 4 6 Notes 4 8 CHAPTER 4 - Study C l i n i c : R e s u l t s 4 . 1 R e s u l t s o f Ch a r t S e l e c t i o n 4 9 4 . 2 Reach C l i n i c 4 9 4 . 3 Comparison o f Reach C l i n i c w i t h BRCT 5 0 4 . 4 Reasons f o r Inadequacy at Reach C l i n i c 5 1 Notes 6 0 CHAPTER 5 - Study C l i n i c : D i s c u s s i o n 5 . 1 G e n e r a l 6 1 5 . 2 The Methodology 6 1 5 . 3 The R e s u l t s 6 5 5 . 4 C o n c l u s i o n 6 6 Notes 6 8 - v -Page CHAPTER 6 - P o l i c y Considerations and Implications 6.1 Preamble 69 6.2 F e a s i b i l i t y of Process Evaluation 70 6.3 Relevance of Process Evaluation 70 6.4 Summary 74 Notes 76 BIBLIOGRAPHY APPENDIX I Lett e r of Agreement APPENDIX II C r i t e r i a and Abstract Sheets APPENDIX III R e l i a b i l i t y Check - v i -LIST OF TABLES Page TABLE I D i s t r i b u t i o n o f Time and C o n d i t i o n E l i g i b l e E p i s o d e s 54 TABLE I I Number o f E p i s o d e s o f Care A s s e s s e d and Judgment o f Adequacy by I n d i c a t o r C o n d i t i o n 55 TABLE I I I Comparison o f Number o f E p i s o d e s o f I n d i c a t o r C o n d i t i o n s and P e r c e n t a g e Scored Adequate o r S u p e r i o r Between Reach M e d i c a l C l i n i c and the B u r l i n g t o n Randomized C o n t r o l l e d T r i a l Randomized Nurse P r a c t i t i o n e r (RNP) Group and Community C o n t r o l (CC) Group. 56 TABLE IV Comparison o f O v e r a l l Judgment o f Adequacy Between BRCT Groups and Reach C l i n i c U s i n g S t a n d a r d i z e d + and U n d e r s t a n d a r d i z e d E p i s o d e F r e q u e n c i e s 57 TABLE V Reasons f o r Inadequacy 58 TABLE VI D i s t r i b u t i o n o f Reasons f o r Inadequacy by I n d i c a t o r C o n d i t i o n and Component o f Care C a t e g o r y 59 - v i i -LIST OF FIGURES Page F i g u r e 1 - Monthly P r e v a l e n c e E s t i m a t e s o f I l l n e s s i n the Community and the R o l e s o f P h y s i c i a n s , H o s p i t a l s and U n i v e r s i t y M e d i c a l C e n t e r s i n the P r o v i s i o n o f M e d i c a l Care ( A d u l t s S i x t e e n Y e a r s and Over) F i g u r e 2 - P a t i e n t Model o f H e a l t h Care 10 F i g u r e 3 - Dynamics o f H e a l t h Outcome 22 F i g u r e 4 - D e t a i l s o f Ch a r t S e l e c t i o n 53 - v i i i -ACKNOWLEDGEMENTS I would l i k e to thank Reach C l i n i c f o r the opportunity to conduct t h i s study; Dr. Sam Sheps for his guidance; and Ms. Irene Korosec for her s k i l l and patience i n producing t h i s manuscript. I would l i k e to acknowledge my parents, May and Tom Robertson who nurtured i n me the desire to know, and the self-confidence to take r i s k s . And f i n a l l y I would l i k e to express appreciation to my husband Alan Wood, whose love and support sustained me throughout t h i s project. - i x -INTRODUCTION The purpose of th i s thesis i s to present the res u l t s of a q u a l i t y of care evaluation of a p a r t i c u l a r care setting - an urban community c l i n i c - i n the context of evaluation methodology i n general and Primary Care evaluation i n p a r t i c u l a r . Questions had been raised about the q u a l i t y of care delivered by the study c l i n i c and, because i t i s d i r e c t l y funded by the B.C. Mi n i s t r y of Health, i t was e s s e n t i a l for the c l i n i c to conduct an external objective q u a l i t y of care evaluation. This i s not a d i s s i m i l a r s i t u a t i o n from that facing many organizations who inc r e a s i n g l y are required to j u s t i f y not only what they do, but often t h e i r very existence. With the increasing public concern about the current economic s i t u a t i o n , more ac c o u n t a b i l i t y i s being demanded of service providers at a l l l e v e l s from p r a c t i t i o n e r s to p o l i c y makers and p o l i t i c i a n s . Popular "buzz words" these days are "cost containment", "retrenchment", " f i s c a l r e s p o n s i b i l i t y " , " f i n a n c i a l a c c o u n t a b i l i t y " . Regardless of the v a l i d i t y of the perception that human service costs are " s p i r a l l i n g " and "out of c o n t r o l " , nevertheless that i s the perception (or at l e a s t , the assertion) of many from p o l i c y makers, p o l i t i c i a n s and p r a c t i t i o n e r s to members of the general p u b l i c . Hence, many s o c i a l services and programs, which for years have enjoyed a c e r t a i n immunity from public scrutiny, are now being examined i n terms of t h e i r e f f i c i e n c y and effectiveness and are being subjected to cost/benefit analyses. As governments at a l l l e v e l s attempt to cope with the task of a l l o c a t i n g resources i n some r a t i o n a l , j u s t , way, many of t h e i r major programs - such as health care services - are obvious targets for evaluation. - 1 -E v a l u a t i o n has been d e f i n e d as "a s o c i a l p r o c e s s o f making judgments o f worth..."'''. While t h i s may appear to be a r a t h e r vague, g e n e r a l d e f i n i t i o n o f e v a l u a t i o n , i t i s i n f a c t e x t r e m e l y u s e f u l f o r i t c a p t u r e s the sense t h a t e v a l u a t i o n has more to do w i t h v a l u e s e t t i n g - which i s a s o c i a l / p o l i t i c a l p r o c e s s - than w i t h making d e c i s i o n s about what i s a " w o r t h w h i l e " s e r v i c e or program based on h a r d s c i e n t i f i c a n a l y s e s of d a t a , c o s t s , b e n e f i t s , e t c . T h i s l a t t e r p r o c e s s i s more i n the domain of e v a l u a t i v e r e s e a r c h which has been c h a r a c t e r i z e d as r e f e r r i n g " t o those p r o c e d u r e s f o r c o l l e c t i n g and a n a l y z i n g d a t a which i n c r e a s e the p o s s i b i l i t y o f p r o v i n g r a t h e r than a s s e r t i n g the worth of some a c t i v i t y " ^ . The d i s t i n c t i o n between e v a l u a t i o n and e v a l u a t i v e r e s e a r c h i s s i g n i f i c a n t because i t may be t h a t some s e r v i c e or program w i l l have i t s worth a s s e r t e d f o r some p o l i t i c a l o r s o c i a l - v a l u e r e a s o n , even i f t h e r e i s no c o n c l u s i v e p r o o f t h a t i t i s i n f a c t w orthwhile - i . e . has an impact. A major p a r t o f the e v a l u a t i o n o f h e a l t h c a r e s e r v i c e s has been d i r e c t e d a t measuring the q u a l i t y o f c a r e d e l i v e r e d , on the assumption t h a t b e t t e r q u a l i t y of c a r e l e a d s to b e t t e r h e a l t h i n the i n d i v i d u a l and t h u s , i n the p o p u l a t i o n as a whole. Q u a l i t y of c a r e assessments have l o n g been conducted i n h o s p i t a l s as p a r t o f q u a l i t y a s s u r a n c e programs, i n o r d e r to meet a c c r e d i t a t i o n r e q u i r e m e n t s . Q u a l i t y assessment - measuring the q u a l i t y o f c a r e d e l i v e r e d - has o n l y r e c e n t l y been f o c u s s e d on P r i m a r y Care. T h i s t h e s i s a d d r e s s e s these i s s u e s u s i n g a q u a l i t y of c a r e e v a l u a t i o n o f a s p e c i f i c P r i m a r y Care s e t t i n g . The format i s as f o l l o w s : C hapter 1 examines the scope o f P r i m a r y Care and l o o k s b r i e f l y at the impetus f o r the e v a l u a t i o n o f P r i m a r y C a r e . - 2 -Chapter 2 focuses on the advancement of evaluation methodology by looking h i s t o r i c a l l y at the major conceptual developments and how those concepts were operationalized and applied. Chapter 3 describes the study setting and the s p e c i f i c method used to conduct the q u a l i t y of care evaluation. The r e s u l t s of the study c l i n i c evaluation are presented i n Chapter 4; Chapter 5 i s a discussion of the study c l i n i c r e s u l t s and the methodology as applied to the study c l i n i c . F i n a l l y , i n Chapter 6, the more general p o l i c y issues of q u a l i t y of care evaluations, t h e i r f e a s i b i l i t y and relevance w i l l be discussed. - 3 -INTRODUCTION - NOTES 1. Suchman, E., Evaluative Research: p r i n c i p l e s and pr a c t i c e In public services and s o c i a l action programs. (New York: R u s s e l l Sage Foundation, 1967). - 4 -CHAPTER 1 Primary Care 1.1 What i s Primary Care? Primary Care as a recognized d i s c i p l i n e of medicine i s a r e l a t i v e l y recent development. I t was not u n t i l 1974 that Index Medicus gave the term the rank of a major subject heading^". Attempts have been made to define what the pr a c t i c e of Primary Care consists of. For example the World Health Organization describes Primary Care i n very general terms of almost i n f i n i t e scope: Primary health care consists of the advice given to a person or a group of persons for preventative or therapeutic purposes by one or more members of the health or re l a t e d professions, acting alone or as a team^. On the other hand the B r i t i s h Medical Association attempts to narrow the focus and specif y the c h a r a c t e r i s t i c s of Primary Health Care that distinguishes i t from other types of health care: ...primary care deals with the work of the doctor whom the patient f i r s t approaches when he wants advice or medical treatment. The d i s c i p l i n e of primary medicine i s based on a p a r t i c u l a r synthesis of knowledge drawn from c l i n i c a l and s o c i a l ( i n c l u d i n g preventive) medicine, psychology and sociology. The c l i n i c a l s k i l l s of the primary physician should enable him, not so much to attach a diagnostic l a b e l as to unravel the un d i f f e r e n t i a t e d , c l i n i c a l problem, which i s often a complex of physi c a l , emotional and s o c i a l f a c t o r s , and to take immediate and appropriate action^.(emphasis added) Others have attempted to define Primary Care i n d i r e c t l y by describing the a c t i v i t i e s of Primary Care providers, f o r example, - 5 -He must be capable of e s t a b l i s h i n g a p r o f i l e of the t o t a l needs of the patient and h i s family. This evaluation should include s o c i a l , economics and psycho-l o g i c a l d e t a i l s as well as the more s t r i c t l y 'medical' aspects. He should then define a plan of care, deciding which parts are to be c a r r i e d out by himself and which by others. The plan should have a long-range dimension. I t should be understandable to the patient and his family and i t should include a follow-up on whether they have been e f f e c t i v e ^ , (emphasis added) A textbook on general practice i s even more exhaustive on the r o l e of the Primary Care physician: The general p r a c t i t i o n e r provides personal, primary and continuing medical care to i n d i v i d u a l s , f a m i l i e s and a p r a c t i c e population, i r r e s p e c t i v e of age, sex and i l l n e s s . He w i l l attend his patients i n his consulting room and i n t h e i r homes, and sometimes i n a c l i n i c or h o s p i t a l . His aim i s to make early diagnoses. He w i l l include and integrate p h y s i c a l , psychological and s o c i a l factors i n his considerations about health and i l l n e s s . He w i l l make an i n i t i a l d e cision about every problem which i s presented to him. He w i l l undertake the continuing management of h i s patients with chronic, recurrent or terminal i l l n e s s . He w i l l p ractice i n cooperation with other colleagues, medical and non-medical. He w i l l know how and when to intervene through treatment, prevention and education to promote the health of his patients and t h e i r f a m i l i e s . He w i l l recognize that he also has a professional r e s p o n s i b i l i t y to the community-*. (emphasis added) What emerges from the above quotations derived from varied sources are the operative words which have been underlined. I t i s these words which convey the sense of what Primary Care i s about. The word "primary" has the sense of f i r s t or basic. As such, according to Stephen^ i t must be accessible and r e a d i l y a v a i l a b l e . Access relates to p o t e n t i a l b a r r i e r s to health care. Penchansky and Thomas^ have discussed the concept of access i n terms of f i v e dimensions: ( i ) A v a i l a b i l i t y , the r e l a t i o n s h i p of the volume and type of e x i s t i n g services (and resources) to the c l i e n t s ' volume - 6 -and types of needs. It refers to the adequacy of the supply of physicians, dentists and other providers; of f a c i l i t i e s such as c l i n i c s and h o s p i t a l s ; and of s p e c i a l i z e d programs and services such as mental health and emergency care, ( i i ) A c c e s s i b i l i t y , the r e l a t i o n s h i p between the l o c a t i o n of supply and the l o c a t i o n of c l i e n t s , taking account of c l i e n t transportation resources and t r a v e l time, distance and cost, ( i i i ) Accommodation, the r e l a t i o n s h i p between the manner i n which the supply resources are organized to accept c l i e n t s (including appointment systems, hours of operation, walk-in f a c i l i t i e s , telephones, services) and the c l i e n t s ' a b i l i t y to accommodate to these factors and the c l i e n t s ' perception of t h e i r appropriateness. ( i v ) A f f o r d a b i l i t y , the r e l a t i o n s h i p of prices of services and providers' insurance or deposit requirements to the c l i e n t s ' income, a b i l i t y to pay, and e x i s t i n g health insurance. C l i e n t perception of worth r e l a t i v e to t o t a l cost i s a concern here, as i s c l i e n t s ' knowledge of p r i c e s , t o t a l cost and possible c r e d i t arrangements, (v) A c c e p t a b i l i t y , the r e l a t i o n s h i p of c l i e n t s ' a t t i t u d e s about personal and practice c h a r a c t e r i s t i c s of providers to the actual c h a r a c t e r i s t i c s of e x i s t i n g providers, as well as to provider attitudes about acceptable personal c h a r a c t e r i s t i c s of c l i e n t s . In the l i t e r a t u r e , the term appears to be used most often to r e f e r to s p e c i f i c consumer reaction to such provider a t t r i b u t e s as age, sex, e t h n i c i t y , type of f a c i l i t y , neighborhood of f a c i l i t y , or r e l i g i o u s a f f i l i a t i o n of f a c i l i t y or provider. In turn, providers have att i t u d e s about the preferred a t t r i b u t e s of c l i e n t s or t h e i r financing mechanisms. Providers either may be unwilling to serve c e r t a i n types of c l i e n t s (e.g., welfare patients) or, through accommodation, make themselves more or less a v a i l a b l e . In Canada, while the concept of access has been expanded to include the elimination of f i n a n c i a l obstacles to obtaining medical care through two federal g acts - the Hospital and Diagnostic Services Act of 1957 and the Medical 9 Care Act of 1966 - which provide for u n i v e r s a l comprehensive health insurance for a l l Canadians, the other dimensions of a c c e s s i b i l i t y s t i l l need to be addressed. Geographical d i s t r i b u t i o n of health care resources and physician s p e c i a l t y d i s t r i b u t i o n are two obvious examples. In that Primary Care represents the f i r s t and most basic medical care given, i t functions as the point-of-entry into the e n t i r e health care system; - 7 -r e f e r r a l s t o s p e c i a l i s t and h o s p i t a l c a r e a r e g e n e r a t e d at the P r i m a r y Care l e v e l . I n a c l a s s i c paper e n t i t l e d "The E c o l o g y o f M e d i c a l C a r e " , K e r r White and c o l l e a g u e s ^ demonstrated t h a t from a base p o p u l a t i o n o f 1000, 250 p e r s o n s (33% o f the 750 " s i c k " ) w i l l c o n s u l t a g e n e r a l p r a c t i t i o n e r one or more times a month, w h i l e o n l y 9 per month (1.2% o f the " s i c k " ) w i l l be admitted to h o s p i t a l and 5 p e r month (0.7% o f the " s i c k " ) w i l l be r e f e r r e d to another p h y s i c i a n (see F i g u r e 1 ) . C l e a r l y the b u l k of m e d i c a l c a r e i s d e l i v e r e d by the c a r e g i v e r o f f i r s t c o n t a c t . The c u r r e n t terms o f " p r i m a r y " , " s e c o n d a r y " and " t e r t i a r y " c a r e are e a s i l y a p p l i e d to White's model. The movement of the p a t i e n t to more i n t e n s e l e v e l s o f c a r e - secondary and t e r t i a r y - i s g e n e r a l l y at the d i s c r e t i o n of the P r i m a r y Care p r o v i d e r ( e x c l u d i n g o c c u r r e n c e s l i k e h o s p i t a l a d m i s s i o n s through emergency wards). F o r t h i s r e a s o n the P r i m a r y Care p r o v i d e r - i . e . the g e n e r a l o r f a m i l y p r a c t i t i o n e r - has c o n s i d e r a b l e i n f l u e n c e on the e x t e n t t o which the e n t i r e h e a l t h c a r e system i s u t i l i z e d , and t h e r e f o r e , how i t e v o l v e s . T h i s i s p a r t i c u l a r l y t r u e i n Canada where c o n v e n t i o n a l m e d i c a l p r a c t i c e r e q u i r e s t h a t c o n s u l t a t i o n w i t h a s p e c i a l i s t i s through r e f e r r a l by a f a m i l y p h y s i c i a n . The P r i m a r y Care p r o v i d e r a c t s not o n l y as the g a t e k e e p e r to the e n t i r e h e a l t h c a r e system, c o n t r o l l i n g the f l o w of p a t i e n t s to o t h e r p a r t s o f the system - h o s p i t a l s , s p e c i a l i s t s , d i a g n o s t i c s e r v i c e s and l a b o r a t o r i e s , but a l s o as a g u i d e f o r the p a t i e n t through the l a b y r i n t h of a v a i l a b l e c a r e . T o n k i n * i l l u s t r a t e s how c o n f u s i n g the h e a l t h c a r e system can be to the p a t i e n t / c l i e n t ( F i g u r e 2 ) . F o r t h i s r e a s o n T i t m u s s says p a t i e n t s need a f a m i l y d o c t o r to p r o t e c t them from the e xcesses o f s p e c i a l i z e d t e c h n o c r a c y : to defend them a g a i n s t narrow-mindedness; and to h e l p them humanely to f i n d t h e i r way among the complex maze o f s c i e n t i f i c m e d i c i n e . - 8 -FIGURE 1 - MONTHLY PREVALENCE ESTIMATES OF ILLNESS IN THE COMMUNITY  AND THE ROLES OF PHYSICIANS, HOSPITALS AND UNIVERSITY  MEDICAL CENTERS IN THE PROVISION OF MEDICAL CARE ( ADULTS  SIXTEEN YEARS AND OVER ) 1000 - Adult population at r i s k 750 - Adults reporting one or more i l l n e s s e s or i n j u r i e s — 250 - Adults consulting a physician one or more times — 97 - Adults admitted to h o s p i t a l ' 5 - Adults r e f e r r e d to another physician 1 - Adults r e f e r r e d to a U n i v e r s i t y Medical Center ADAPTED FROM: White, K. et a l , The Ecology of Medical Care, NEJM, 1961;265 (18):885 - 9 -PATIENT MODEL OF HEALTH CARE The word "care" has come to include the sense of continuity and compre-hensiveness. Stephen states that with the present predominance of chronic degenerative and psycho-social i l l n e s s over acute i n f e c t i o u s disease (at le a s t i n the developed world) there should be a change i n emphasis i n medical care from "curing" to "caring". This brings up the concept of a personal doctor who has been described as someone who ...(looks) a f t e r people as people and not as problems... His function i s to meet what i s r e a l l y the primary medical need. A person i n d i f f i c u l t i e s wants i n the f i r s t place the help of another person on whom he can r e l y as a f r i e n d - someone with knowledge of what i s f e a s i b l e but also with good judgement on what i s desirable i n the p a r t i c u l a r circumstances, and an understanding of what the circumstances are. The more complex medicine becomes, the stronger are the reasons why everyone should have a personal doctor who w i l l take continuous r e s p o n s i b i l i t y f o r him and, knowing how he l i v e s , w i l l keep things i n proportion - protecting him i f need be, from the zealous s p e c i a l i s t ^ . 13 However, Cartwright makes the point i n r e f e r r i n g to the above statement that c o n t i n u i t y of care means more than just having the same doctor 14 for several years, r e f e r r i n g f o r example to McKeown's concept of a "medical f r i e n d " . I t i s i n t e r e s t i n g to note that i n her study of General Practice i n the U.K., Cartwright notes that 87% of the general p r a c t i t i o n e r s interviewed saw t h e i r role as "medical f r i e n d " encompassing problems other than s t r i c t l y medical. In summary, the scope of Primary Care^""* emerges as the f i r s t point of contact with the health care system encompassing basic, continuous and comprehensive care. 1.2 Why evaluate Primary Care? The evaluation of Primary Care would appear to be important from several perspectives. F i r s t l y , since most people's f i r s t (and i n most cases only) - 11 -e n c o u n t e r ( s ) w i t h the h e a l t h c a r e system i s w i t h a P r i m a r y Care p r o v i d e r , from the p o i n t o f v iew o f the i n d i v i d u a l p a t i e n t / c l i e n t i t i s e s s e n t i a l that t h i s l e v e l o f c a r e be of the h i g h e s t q u a l i t y . Subsequent e n c o u n t e r s w i t h the h e a l t h c a r e system are g e n e r a l l y v i a the P r i m a r y Care l e v e l , the n a t u r e and q u a l i t y o f which are, as noted above, to a s i g n i f i c a n t degree determined by the P r i m a r y Care p r o v i d e r ^ . From the p o i n t o f view of enhancing the " p r o f e s s i o n a l " image, o f P r i m a r y Care p r o v i d e r s ^ , e v a l u a t i o n f e e d i n g i n t o C o n t i n u i n g M e d i c a l E d u c a t i o n i s of s i g n i f i c a n t and i n c r e a s i n g importance. T h i r d l y , s i n c e the b u l k o f m e d i c a l c a r e o c c u r s at the P r i m a r y Care l e v e l ^ " 0 o r i s g e n e r a t e d at t h i s l e v e l , the s t r u c t u r e and f u n c t i o n i n g o f the e n t i r e h e a l t h c a r e d e l i v e r y system i s a f f e c t e d by what o c c u r s at t h i s l e v e l . An u n d e r s t a n d i n g of any h e a l t h c a r e d e l i v e r y system must b e g i n w i t h an e v a l u a t i o n and a n a l y s i s o f the a c t i v i t i e s t h a t comprise P r i m a r y H e a l t h Care. F i n a l l y , i f the b u l k o f m e d i c a l c a r e i s e i t h e r d e l i v e r e d o r generated a t the P r i m a r y Care l e v e l , then the m a j o r i t y o f h e a l t h c a r e c o s t s are a r e s u l t o f what happens at t h i s l e v e l o f h e a l t h c a r e . I n the c o n t e x t o f a p u b l i c a l l y funded h e a l t h c a r e system, i t i s important from a c o s t / b e n e f i t a n a l y s i s p o i n t of view to know more p r e c i s e l y what o c c u r s at the P r i m a r y Care l e v e l . 1.3 T h r u s t f o r P r i m a r y Care E v a l u a t i o n The t h r u s t f o r the e v a l u a t i o n o f P r i m a r y Care has come from s e v e r a l a r e a s . E v a l u a t i o n s o f h o s p i t a l i n - p a t i e n t c a r e have been i n e x i s t e n c e i n the U.S. f o r many y e a r s under The H o s p i t a l S t a n d a r d i z a t i o n Program and s i n c e 1952 under the - 12 -J o i n t Commission on A c c r e d i t a t i o n of H o s p i t a l s (JCAH) . As a r e s u l t o f the r e q u i r e m e n t f o r h o s p i t a l s to conduct e v a l u a t i o n s o f i n p a t i e n t c a r e , emergency rooms e v e n t u a l l y came under s c r u t i n y . S e v e r a l s t u d i e s of emergency room use of l a r g e i n n e r - c i t y h o s p i t a l s i n d i c a t e d t h a t t h e se f a c i l i t i e s were more f r e q u e n t l y b e i n g used by the poor and working c l a s s e s f o r the m a j o r i t y o f t h e i r P r i m a r y 19 19—23 Care . E v a l u a t i o n s t u d i e s o f t h e se emergency f a c i l i t i e s i n d i c a t e d , g e n e r a l l y , g r e a t d i s c r e p a n c i e s i n d i a g n o s t i c and t h e r a p e u t i c p r o c e s s e s and f o l l o w u p , r e s u l t i n g i n o v e r a l l low q u a l i t y o f c a r e , and t h e r e b y emphasizing the need to e v a l u a t e f u r t h e r the q u a l i t y o f c a r e r e c e i v e d by people s e e k i n g t h i s k i n d o f m e d i c a l h e l p . As a r e s u l t of t h e s e and o t h e r e v a l u a t i o n s t u d i e s i n d i c a t i n g low q u a l i t y o f c a r e at the P r i m a r y Care l e v e l , the f o c u s o f the q u a l i t y i s s u e s h i f t e d , i n the U.S., to the H e a l t h Maintenance O r g a n i z a t i o n s (HMO's) which had emerged i n the 1960's as a l t e r n a t i v e p r o v i d e r s o f P r i m a r y Care. The r e g u l a t o r y requirement f o r the e v a l u a t i o n o f P r i m a r y Care o r i g i n a t e d i n the U.S. w i t h the H e a l t h 24 Maintenance O r g a n i z a t i o n (HMO) Act of 1973 . T h i s A c t r e q u i r e s an ongoing q u a l i t y a s s u r a n c e o f ambulatory c a r e on the p a r t o f each p a r t i c i p a t i n g HMO. P r o f e s s i o n a l S t a n d a r d s Review O r g a n i z a t i o n s (PSRO) were e s t a b l i s h e d i n the U.S. i n 1972 i n o r d e r to c o v e r the gap l e f t by the JCAH - p r i v a t e o f f i c e p r a c t i c e . Of the PSRO's, Jonas says f o r the f i r s t time a law - w i t h some f a i r l y sharp t e e t h i n i t -r e q u i r e d peer r e v i e w o f i n d i v i d u a l i n s t a n c e s of p h y s i c i a n d e l i v e r y of m e d i c a l c a r e ^ . I n i t i a t i v e s have a l s o come from a s s o c i a t i o n s , both i n s t i t u t i o n a l and p r o f e s s i o n a l . The A c c r e d i t a t i o n A s s o c i a t i o n f o r Ambulatory H e a l t h Care and the F e d e r a l Bureau of Community H e a l t h S e r v i c e s r e q u i r e s i t s v o l u n t a r y a f f i l i a t e s - 13 -to conduct i n t e r n a l q u a l i t y assurance programs . The medical profession i t s e l f has undertaken a peer review process for the purposes of Continuing Education. Indeed the American Academy of Family Practice requires a c e r t a i n . 25 number of hours of continuing medical education for continued membership More recently the American Society of Internal Medicine has proposed that formal review of physician performance i n ambulatory care be the basis for renewal of h o s p i t a l p r i v i l e g e s , relicensure, renewal of professional association membership . . . . . 2 4 and r e c e r t i f i c a t i o n for s p e c i a l t y p r a c t i c e 1.4 How to evaluate Primary Care? The j u s t i f i c a t i o n of and regulatory requirement for the evaluation of Primary Care having been established, researchers were faced with the problem of how to accomplish i t . The d i f f i c u l t y i s compounded by the fact that Primary Care appears to be the area of medical care least well grounded i n s c i e n t i f i c r a t i o n a l e . For many of the decisions a provider must make, there may exi s t no hard evidence to guide the decision-making process. The Primary Care provider operates i n a context of high d i v e r s i t y and low s p e c i f i c i t y . S/he i s often faced with a wide array of symptomology which must be f i l t e r e d i n order to converge towards some diagnostic outcome. By the time patients reach ei t h e r a s p e c i a l i s t or h o s p i t a l much of the diagnostic focussing has already been done. Another d i f f i c u l t y with evaluating Primary Care i s that the kinds of problems seen i n Primary Care are quite d i f f e r e n t from those of h o s p i t a l in-patients; patients with acute l i f e - t h r e a t e n i n g diseases are rare and care - 14 -t y p i c a l l y i n v o l v e s a c u t e , s e l f - l i m i t e d d i s e a s e , c h r o n i c d i s e a s e , p s y c h o - s o c i a l 24 problems and p r e v e n t i v e c a r e . W i t h i n the c o n t e x t o f e x t r e m e l y h i g h volumes, the P r i m a r y Care p r o v i d e r must d i s c r i m i n a t e between s u b s t a n t i v e and s e l f - l i m i t e d d i s e a s e , o f t e n i n the f a c e o f u n c e r t a i n t y and inadequate d a t a . 13 C a r t w r i g h t makes a v e r y i n t e r e s t i n g statement on t h a t p o i n t : Methods o f e v a l u a t i n g s t a n d a r d s o f c a r e need to be developed which count as good c a r e the n o n - i n v e s t i g a t i o n o f symptoms which c l e a r up q u i c k l y and s p o n t a n e o u s l y as w e l l as the adequate i n v e s t i g a t i o n o f c o n d i t i o n s which need i t . 24 . . . Palmer and Nesson have i d e n t i f i e d f o u r major components o f Pr i m a r y Care: i ) s o l u t i o n o f problems p a t i e n t s c o m p l a i n about ( e . g . sore t h r o a t , e a r a c h e ) , i i ) case f i n d i n g f o r asymptomatic d i s e a s e (e.g. h y p e r t e n s i o n ) . i i i ) a p p l i c a t i o n o f p r e v e n t i v e measures ( e . g . pap t e s t s , w e l l baby c a r e , i m m u n i z a t i o n ) , i v ) management o f diagnosed c h r o n i c d i s e a s e (e.g. d i a b e t e s m e l l i t u s , a r t h r i t i s ) . However, as noted i n the opening d i s c u s s i o n , P r i m a r y Care r e q u i r e s more than competent m e d i c a l c a r e . I t r e q u i r e s , as w e l l , i n t e r p e r s o n a l s k i l l s o f c l e a r communication, l i s t e n i n g , r a p p o r t and s u p p o r t . A l l o f t h i s makes the e v a l u a t i o n o f P r i m a r y Care an enormous t a s k , much o f which has y e t to be undert a k e n . What f o l l o w s i s a r e v i e w o f the d e v e l o p i n g methodology f o r the e v a l u a t i o n o f P r i m a r y Care. - 15 -CHAPTER 1 - NOTES 1. T o n k i n , R.S., " P r i m a r y H e a l t h Care". Canadian J o u r n a l of P u b l i c H e a l t h , 1976; 67:289. 2. World H e a l t h O r g a n i z a t i o n . The R o l e o f the P r i m a r y P h y s i c i a n i n H e a l t h  S e r v i c e s . (Geneva: World H e a l t h O r g a n i z a t i o n , 1970), c i t e d by Stephen, W.J., An A n a l y s i s of P r i m a r y H e a l t h Care - An I n t e r n a t i o n a l Study (London: Cambridge U n i v e r s i t y P r e s s , 1979), p.6. 3. B r i t i s h M e d i c a l A s s o c i a t i o n , P r i m a r y M e d i c a l Care: P l a n n i n g U n i t Report  No.4 ( B r i t i s h M e d i c a l A s s o c i a t i o n , 1970), c i t e d by Stephen, i b i d . , p.67 4. J o n a s , S., Some Thoughts on p r i m a r y c a r e : problems o f i m p l e m e n t a t i o n . I n t e r n a t i o n a l J o u r n a l of H e a l t h S e r v i c e s , 1973; 2:178, c i t e d by Stephen, i b i d , p.6. 5. F r y , J . ( e d . ) , Trends i n G e n e r a l P r a c t i c e 1977. London: B r i t i s h M e d i c a l J o u r n a l , 1977, c i t e d by Stephen, i b i d , p.6. 6. Stephen, i b i d . , p.7. 7. Penchansky, R. and Thomas, W.J., The Concept o f A c c e s s : D e f i n i t i o n and R e l a t i o n s h i p to Consumer S a t i s f a c t i o n . Med. Care, 1981; XIX:127. 8. H o s p i t a l I n s u r a n c e and D i a g n o s t i c S e r v i c e s A c t , A p r i l 12, 1957, and R e g u l a t i o n s , 5-6 E l i z a b e t h I I (Ottawa: Queen's P r i n t e r , 1957) 9. B i l l C-227, M e d i c a l Care A c t , 1966, 14-15 E l i z a b e t h I I (Ottawa: Queen's P r i n t e r , 1966) 10. White, K.L., e t a l , The E c o l o g y of M e d i c a l Care, NEJM, 1961; 265: 885. 11. T i t m u s s , R.M., R o l e o f the F a m i l y D o c t o r Today i n the Context o f B r i t a i n ' s S o c i a l S e r v i c e s . L a n c e t , 1965; i : l , c i t e d by C a r t w r i g h t , A. P a t i e n t s and t h e i r D o c t o r s : A Study of G e n e r a l P r a c t i c e (London: R o u t l e d g e & Kegan P a u l , 1967), p . l . - 16 -12. Fox, T.F., The P e r s o n a l D o c t o r and h i s R e l a t i o n to the H o s p i t a l . L a n c e t , 1960; i:743, c i t e d by C a r t w r i g h t , i b i d . , p.100. 13. C a r t w r i g h t , i b i d . , p.102. 14. McKeown, T., M e d i c i n e i n Modern S o c i e t y (London: George A l l e n and Unwin, 1965) c i t e d by C a r t w r i g h t , i b i d . , p.102. 15. The term "ambulatory c a r e " appears c o n s i s t e n t l y i n the l i t e r a t u r e . One d e f i n i t i o n g i v e n f o r t h i s term i s : " I t i s p e r s o n a l or combined h e a l t h care s e r v i c e g i v e n t o a p e r s o n who i s not a bed p a t i e n t i n a h e a l t h c a r e i n s t i t u t i o n " [ Jonas, S., Ambulatory Care. I n Jonas, S. and c o n t r i b u t o r s , H e a l t h Care D e l i v e r y i n the U n i t e d S t a t e s (New York: S p r i n g e r P u b l i s h i n g Company, 1977), p.120.] While the term "ambulatory c a r e " may encompass a g r e a t e r scope o f m e d i c a l c a r e than connoted by the term " p r i m a r y c a r e " , f o r the purposes o f t h i s d i s c u s s i o n t h e s e terms w i l l be c o n s i d e r e d synonomous. 16. Donabedian, A., "A Frame of R e f e r e n c e " . In A Guide to M e d i c a l Care  A d m i n i s t r a t i o n , Volume I I : M e d i c a l Care A p p r a i s a l - Q u a l i t y and  U t i l i z a t i o n (New York: American J o u r n a l o f P u b l i c H e a l t h , 1969), p.6. 17. Jonas, S., "Measurement and C o n t r o l o f the Q u a l i t y o f H e a l t h Care" I n J o n a s , S. and c o n t r i b u t o r s , o p . c i t . 18. Sanazaro, P.J., Q u a l i t y Assessment and Q u a l i t y A s s u r a n c e i n M e d i c a l Care. Ann. Review Pub. H e a l t h , 1980; 1: 37-68. 19. Brook, R.H. and Stevenson, R.L., E f f e c t i v e n e s s o f P a t i e n t Care i n an Emergency Room. NEJM, 1970; 283: 904. 20. Brook, R.H., e t a l . E f f e c t i v e n e s s o f Non-emergency Care v i a an Emergency Room: A Study o f 166 P a t i e n t s w i t h G a s t r o i n t e s t i n a l symptoms. Ann. I n t .  Med., 1973; 78: 333. 21. Brook, R.H., and A p p e l , F.A., Q u a l i t y o f Care Assessment: Choosing a Method f o r Peer Review. NEJM, 1973; 288: 1323. 22. W i l l i a m s o n , J.W., E v a l u a t i n g Q u a l i t y o f P a t i e n t Care: A S t r a t e g y R e l a t i n g Outcome and P r o c e s s Assessment. JAMA, 1971; 218(4): 555. - 17 -23. Gonnella, J.S., Evaluating Patient Care, JAMA, 1970; 214: 2040. 24. Palmer, R.H., and Nesson, H.R., A Review of Methods for Ambulatory Medical Care Evaluations. Med. Care, 1982; XX (8): 758. 25. Escovitz, G.H., "The Continuing Education of Physicians: Its Relationship to Quality of Care Evaluation." In Symposium on Changing Concepts of Disease, Med. C l i n i c s of N.A., 1973; 57: 1135. 26. Jonas, S., o p . c i t . , note 17, p.396. 27. Cartwright, A., o p . c i t . , p.221. - 18 -CHAPTER 2 L i t e r a t u r e Review - Q u a l i t y Assessment 2.1 E a r l y S t u d i e s E v a l u a t i o n o f the q u a l i t y o f m e d i c a l c a r e i n t h i s c e n t u r y goes back t o the work o f Codman^ who i n 1912 examined the s u c c e s s of s u r g e r y one ye a r a f t e r o p e r a t i o n on the b a s i s o f p h y s i o l o g i c a l and f u n c t i o n a l s t a t u s and m o r t a l i t y . Indeed, much o f the e a r l y work e v a l u a t i n g the q u a l i t y o f m e d i c a l c a r e f o c u s e d on 2 3 the outcomes o f v a r i o u s s u r g i c a l p r o c e d u r e s performed i n h o s p i t a l s ' . I t was not u n t i l the mid 1950's, however, t h a t e v a l u a t i o n s t u d i e s of Pri m a r y Care began to emerge. The H e a l t h I n s u r a n c e P l a n o f G r e a t e r New York 4 . . . commissioned an e v a l u a t i o n i n terms o f p r e m a t u r i t y and p e r i n a t a l m o r t a l i t y r a t e s o f p r e n a t a l and o b s t e t r i c c a r e g i v e n i n d i f f e r e n t p r a c t i c e s e t t i n g s -group p r a c t i c e v e r s u s p r i v a t e f e e - f o r s e r v i c e . Peterson"* conducted the f i r s t , and to date the o n l y , l a r g e s c a l e o b s e r v a t i o n a l study i n the e a r l y 1950's of p h y s i c i a n c a r e i n p r i v a t e p r a c t i c e o f f i c e s e t t i n g s i n North C a r o l i n a r e l a t i n g the q u a l i t y of c a r e r e n d e r e d t o v a r i o u s p h y s i c i a n f a c t o r s such as e d u c a t i o n , methods o f p r a c t i c e , p r a c t i c e s e t t i n g , e t c . H i s r e s u l t s i n d i c a t e d c o n s i d e r a b l e d e f i c i e n c i e s i n b a s i c s k i l l s . A Canadian study** was conducted i n the e a r l y 1960's u s i n g the method develo p e d by P e t e r s o n , comparing a p r a c t i c e s e t t i n g i n Nova S c o t i a w i t h one i n O n t a r i o . I t a r r i v e d a t the same c o n c l u s i o n s as the P e t e r s o n study. I n t e r e s t i n P r i m a r y Care e v a l u a t i o n s i n c r e a s e d i n the l a t e 1960's, p a r t i c u l a r l y a f t e r the e s t a b l i s h m e n t o f neighbourhood h e a l t h c e n t r e s i n s e v e r a l 7 8 l a r g e N o r t h American c i t i e s ' , when f i n a n c i a l a c c o u n t a b i l i t y was r e q u i r e d - 19 -of agencies spending large amounts of money on the urban poor. In the early 1970's, Hulka et a l ^ ' * ^ and Romm et a l * * conducted an extensive multifaceted review of private o f f i c e p r a c t i c e . Their r e s u l t s showed that the best i n d i c a t o r of f i n a l health status was i n i t i a l disease status, i n d i c a t i n g a n e g l i g i b l e impact of medical care on the health of patients. These r e s u l t s also highlighted one of the d i f f i c u l t i e s i n conducting q u a l i t y of care evaluations, that i s , the s e l e c t i o n of components of medical care that can be shown to have a p o s i t i v e e f f e c t on the health of the patient. Despite the improvement i n evaluation methodology i n recent years, t h i s continues to be one of the major l i m i t a t i o n s of process evaluations. A f t e r the passage of The Health Maintenance Organization Act i n 1973, es t a b l i s h i n g the regulatory requirement f o r the evaluation of ambulatory care delivered by HMO's, i t became imperative to advance the methodology for Primary Care Evaluation. Several conceptual developments were instrumental i n defining and c l a r i f y i n g t h i s methodology. 2.2 Development of the Methodology The e a r l i e s t e f f o r t s to place the evaluation of the q u a l i t y of medical 12 care within a conceptual framework i s represented by the work of Sheps who outlined three categories of the care system i n hos p i t a l s that are amenable to evaluation: assumed prerequisites f o r q u a l i t y care ( f a c i l i t i e s organization, s t a f f , standards); elements of the performance of the care provider(s) c o l l e c t i v e l y termed " e f f o r t " ; and outcome of care or " e f f e c t " . 13 Donabedian , i n a paper that remains a c l a s s i c , refined these categories proposed by Sheps to include three s p e c i f i c areas - structure, process and outcome. The r a t i o n a l e behind these categories i s that i n general, one can assess or evaluate three broad components of the care system: i t s - 20 -s t r u c t u r e , i . e . s t a f f i n g p a t t e r n s , numbers o f p r o f e s s i o n a l s , a c c e s s i b i l i t y , e t c . ; i t s p r o c e s s , i . e . procedures done, c h a r t i n g , l a b o r a t o r y t e s t s u t i l i z a t i o n ; and outcome, i . e . improvement i n i n d i v i d u a l h e a l t h , p r e v e n t i o n o f s e q u e l a e , a c t i v i t i e s o f d a i l y l i v i n g , e t c . Donabedian i s v e r y c a r e f u l to p o i n t out t h a t t h ese c a t e g o r i e s a r e not m u t u a l l y e x c l u s i v e . Indeed, they are i n t e r r e l a t e d i n v e r y complex ways. I n a 14 l a t e r paper S t a r f i e l d i l l u s t r a t e d t h i s concept o f s t r u c t u r e -process-outcome ( F i g u r e 3). In o r d e r to conduct e v a l u a t i o n s w i t h any k i n d of g e n e r a l i z a b i l i t y and c o m p a r a b i l i t y , s t a n d a r d s o f c a r e had to be e s t a b l i s h e d . Donabedian saw s t a n d a r d s as a r i s i n g i n two ways: ( i ) E m p i r i c a l Standards - t h a t i s s t a n d a r d s which d e r i v e from a c t u a l p r a c t i c e and which g e n e r a l l y conform to a t t a i n a b l e l e v e l s o f c a r e . (Presumably t h e s e s t a n d a r d s are shaped by f a c t o r s i n a d d i t i o n to academic t r a i n i n g , such as p r a c t i c e s e t t i n g , s t a f f i n g p a t t e r n s , p h y s i c i a n p e r s o n a l c h a r a c t e r i s t i c s , e t c . ) ( i i ) Normative Standards - which Donabedian says d e r i v e , i n p r i n c i p l e , from the sources t h a t l e g i t i m a t e l y s e t the s t a n d a r d s of knowledge and p r a c t i c e i n the dominant m e d i c a l c a r e system. I n p r a c t i c e , they are s e t by s t a n d a r d t e x t b o o k s or p u b l i c a t i o n s , p a n e l s o f p h y s i c i a n s , h i g h l y q u a l i f i e d p r a c t i t i o n e r s who s e r v e as judges or a r e s e a r c h s t a f f i n c o n s u l t a t i o n w i t h q u a l i f i e d p r a c t i t i o n e r s . Normative s t a n d a r d s can be put v e r y h i g h and r e p r e s e n t the " b e s t " m e d i c a l c a r e t h a t can be p r o v i d e d , or they can be s e t at a more modest l e v e l s i g n i f y i n g " a c c e p t a b l e " o r "adequate" c a r e ^ . - 21 -FIGURE 3 - D Y N A M I C S OF H E A L T H O U T C O M E STRUCTURE PERSONNEL FACILITIES EQUIPMENT ORGANIZATION INFORMATION SYSTEMS FINANCING PROVISION PROBLEM RECOGNITION OF CARE DIAGNOSIS MANAGEMENT REASSESSMENT PROCESS PATIENTS RECEIPT OF CARE UTILIZATION ACCEPTANCE UNDERSTANDING COMPLIANCE SOCIAL AND PHYSICAL ENVIRONMENT OUTCOME LONGEVITY ACTIVITY COMFORT SATISFACTION DISEASE POTENTIAL RESILIENCE - 22 Source: B. Starfleld, N.E.J.H., 289(3) July 19, 1973, p.134 He distinguishes normative standards from empirical standards saying, t h e i r [normative standards] d i s t i n c t i v e c h a r a c t e r i s t i c i s that they stem from a body of legitimate knowledge and values rather than from s p e c i f i c examples of actual p r a c t i c e . As such, they depend for t h e i r v a l i d i t y on the extent of agreement concerning f a c t s and values within the profession or, at l e a s t , among i t s leadership. Where equally legitimate sources d i f f e r i n t h e i r views, judgments concerning q u a l i t y become correspondingly ambiguous^. The development of normative standards was an important contribution to the advancement of q u a l i t y of care evaluation methodology. Indeed, the concept of 2 standards of care was not a new one. By the mid-1950's Lembcke had already established the concept of v a l i d care c r i t e r i a for h o s p i t a l care. They were to embody the p r i n c i p l e s of o b j e c t i v i t y , v e r i f l a b i l i t y , uniformity, s p e c i f i c i t y , pertinence and a c c e p t a b i l i t y . Payne^ l a t e r expanded Lembcke's concept to optimal care c r i t e r i a . Working with panels of s p e c i a l i s t s he eventually established optimal care c r i t e r i a f o r 51 d i f f e r e n t conditions 16 covering 135 ICDA diagnoses encompassing ambulatory as well as h o s p i t a l care. The r a t i o n a l e behind the concept of optimal care c r i t e r i a i s to select a few, v a l i d , s p e c i f i c dimensions of care within s p e c i f i e d diagnostic categories rather than to conduct general evaluations of unspecified dimensions of care, which i s not only imprecise but also marginally i n s t r u c t i v e i n terms of c o r r e c t i v e a c t i o n . This concept i s the foundation of the medical audit which Lembcke defines as the evaluation of medical care i n retrospect through analysis of c l i n i c a l records^. - 23 -I t was the concept of normative standards that established the medical audit as an acceptable evaluation t o o l . In a more recent paper Sanazaro*^ characterizes the medical audit as having two basic features: (a) s e l e c t i n g an important element of performance (b) comparing the observed l e v e l of performance with predetermined c r i t e r i a or standards. However, Sanazaro outlines several c r i t i c i s m s of the medical audit: f i r s t , there i s an assumption that there i s some r e l a t i o n s h i p between the information recorded i n the patient chart and actual q u a l i t y of care received; second, there i s no way of knowing which of the recorded diagnostic or therapeutic procedures i s e s s e n t i a l ; and f i n a l l y , many studies have shown e i t h e r weak or no c o r r e l a t i o n s between recorded processes and patient outcomes. These continue to be weaknesses i n the medical or chart audit method. While structure-process-outcome i s a u s e f u l conceptual model, considerable work was required to operationalize t h i s concept and to provide p r a c t i c a l methods of measuring the m u l t i p l i c i t y of variables which influence each of these components of care. Recent evaluative studies have greatly enhanced the c l a r i t y with which q u a l i t y of care assessments have been conceived by comparing methodologies. 18 In p a r t i c u l a r , Brook and Appel delineated and compared f i v e d i f f e r e n t peer-review methods of assessing the q u a l i t y of medical care: i m p l i c i t process (which resembles Donabedian's empirical standards); i m p l i c i t outcome; i m p l i c i t process/outcome combined; e x p l i c i t process (which corresponds to Payne's optimal care c r i t e r i a and Donabedian's normative standards); and e x p l i c i t outcome. The major di f f e r e n c e between the i m p l i c i t and e x p l i c i t methods was that, for the former, p r o f e s s i o n a l judgments were made as to whether - 24 -or not the process of care and/or patient outcomes were acceptable; f o r the l a t t e r actual process items and patient outcomes were compared with preset process c r i t e r i a and predetermined estimates of acceptable outcomes. Their r e s u l t s showed that f o r the same patient sample judgments of the q u a l i t y of care rendered ranged from 63.2% acceptable when i m p l i c i t outcome judgments were used to 1.4% when e x p l i c i t process was used. Since e x p l i c i t process i s the method inherent i n the external medical audit (although not always used), i t i s clear that the most widely used evaluation methodology produces the "severest judgments" of q u a l i t y of care. Several researchers have conducted evaluation studies i n outpatient c l i n i c s of large urban h o s p i t a l s , focussing on the a p p l i c a t i o n of preset e x p l i c i t c r i t e r i a f o r diagnostic and therapeutic processes and outcomes^ Others have done s i m i l a r studies i n various Primary Care settings such as neighbourhood c l i n i c s ^ ' ^ , and private o f f i c e p r a c t i c e s ^ Several general conclusions can be drawn from these studies: a very low l e v e l of care i s being provided at considerable cost; because of the lack of adequate patient follow-up, i n e f f e c t i v e and/or inappropriate behaviour of physicians ( e s p e c i a l l y young physicians) may be reinforced; diagnostic process i s as important as therapeutic process; and f i n a l l y - perhaps most importantly f o r the development of evaluation methodology - better l i n k s must be established between items of the medical care process and patient outcomes - i . e . e x p l i c i t process items must be l i m i t e d to those which have been conclusively demonstrated to have an e f f e c t on patient outcome. This l a s t point continues to be the bete noire of q u a l i t y of care evaluation. The most notable recent Canadian Primary Care evaluation using e x p l i c i t process c r i t e r i a was the Burlington Randomized Controlled T r i a l conducted by - 25 -26—28 i n v e s t i g a t o r s at McMaster U n i v e r s i t y i n H a m i l t o n . While t h i s study was p r i m a r i l y a comparison o f the q u a l i t y o f c a r e d e l i v e r e d by nurse p r a c t i t i o n e r / p h y s i c i a n teams and by c o n v e n t i a l p h y s i c i a n s , i t i s an e x c e l l e n t example o f an a p p l i e d methodology - i . e . an e x p l i c i t - p r o c e s s - c r i t e r i a c h a r t a u d i t . The study had the a d d i t i o n a l m e r i t i n t h a t the r e s e a r c h e r s a l s o attempted to l i n k p a t i e n t outcomes to the e x p l i c i t p r o c e s s c a r e items. Methods f o r d e v e l o p i n g e x p l i c i t c r i t e r i a l i s t s have been e x p l o r e d u s i n g ( i ) t e xtbooks and e x p e r t panels*^'^"* 28 29 ( i i ) s m a l l groups o f p r a c t i c i n g p h y s i c i a n s ' 30 ( i i i ) q u e s t i o n n a i r e s m a i l e d to l a r g e r groups ( i v ) a D e l p h i t e c h n i q u e which g e n e r a t e s consensus through a feedback e 31 or group r e s p o n s e s S e v e r a l o t h e r p r a c t i c a l d i f f i c u l t i e s o f c o n d u c t i n g P r i m a r y Care e v a l u a t i o n s s t i l l needed to be a d d r e s s e d . F o r i n s t a n c e , i t became c r i t i c a l t o d e v e l o p a u n i t o f measurement of c a r e s i n c e s i n g l e v i s i t s o r p r o c e d u r e s are not e n t i r e l y c o n s i s t e n t w i t h the concept of P r i m a r y C a r e . The c o n c e p t u a l i z a t i o n of " e p i s o d e s 32 33 of c a r e " by S o l o n e t a l ' encompassing d i a g n o s i s , treatment and f o l l o w - u p f o r a s i n g l e p r e s e n t i n g c o m p l a i n t p r o v i d e d f o r a p r a c t i c a l u n i t o f measurement. E p i s o d e s o f c a r e w i l l encompass d i f f e r e n t time frames f o r d i f f e r e n t c o n d i t i o n s : f o r example an e p i s o d e of c a r e f o r o t i t i s media may cover 2-4 weeks from the i n i t i a l d i a g n o s i s through to the d i s a p p e a r a n c e o f a l l symptoms; f o r p r e n a t a l c a r e the e p i s o d e of c a r e i n c l u d e s the e n t i r e p r e n a t a l p e r i o d . E p i s o d e s of c a r e , however, are more d i f f i c u l t t o d e f i n e f o r c a r e o f c h r o n i c c o n d i t i o n s , such as h y p e r t e n s i o n and d i a b e t e s m e l l i t u s . - 26 -I t also became important to develop a method for i d e n t i f y i n g appropriate samples of care without having to assess the care given i n every conceivable 34 medical condition. Kessner provided the framework f o r t h i s by r e f i n i n g and describing the concept of "t r a c e r s " or i n d i c a t o r conditions. This was not a new idea; the concept of tracers had been i m p l i c i t i n the work of 19 18 23 24 Williamson and Brook ' ' who studied the q u a l i t y of care delivered i n h o s p i t a l emergency rooms to patients presenting with s p e c i f i c conditions, e.g. g a s t r o i n t e s t i n a l complaints, hypertension and urinary t r a c t i n f e c t i o n . Indeed hypertension as a "tracer" condition was used i n some of the e a r l i e s t evaluations of Primary Care done i n h o s p i t a l outpatient 35 7 8 c l i n i c s and neighbourhood c l i n i c s ' . However, i t was not u n t i l 1969 that the I n s t i t u t e of Medicine of the National Academy of Sciences focused on the use of tracers A tracer i n the context of health care i s a d i s c r e t e , i d e n t i f i a b l e health problem which can be used to analyze the health d e l i v e r y system. The r a t i o n a l e underlying the tracer method i s that how a physician manages c e r t a i n ailments common to a l l Primary Care settings w i l l be an i n d i c a t o r of the general q u a l i t y of care delivered o v e r a l l . Although c o n t r o v e r s i a l , i n that questions have been raised about g e n e r a l i z a b i l i t y to o v e r a l l q u a l i t y of care when only a few 36 "tracer" conditions are evaluated , the c l i n i c a l breadth of the conditions chosen and t h e i r representativeness i n s p e c i f i c c l i n i c settings can be determined, and the number and kind of "tracer" conditions adjusted accordingly f o r each care s e t t i n g . For example, i f prenatal care comprises a large bulk of the care given i n a s p e c i f i c care s e t t i n g , an evaluation of that c l i n i c would most appropriately assess more prenatal care than (say) care of - 27 -h y p e r t e n s i o n . The i d e a l would be to e v a l u a t e the c a r e g i v e n i n s e l e c t e d i n d i c a t o r c o n d i t i o n s i n the p r o p o r t i o n s i n which they make up the c a r e l o a d . T r a c e r s are an important a d d i t i o n to the c h a r t a u d i t method which i s p r i m a r i l y a measurement o f the a c t i v i t i e s o f h e a l t h p r o f e s s i o n a l s . T h e r e f o r e , a t r a c e r c o n d i t i o n s h o u l d most i m p o r t a n t l y be one f o r which the management o f c a r e has an impact on h e a l t h outcome. F o r t h a t r e a s o n c o n d i t i o n s u n l i k e l y t o be t r e a t e d and those t h a t cause n e g l i g i b l e f u n c t i o n a l impact a r e not u s e f u l . T r a c e r c o n d i t i o n s s h o u l d a l s o be e a s i l y d e f i n e d , be r e a s o n a b l y p r e v a l e n t , and be those f o r which t h e r e are w e l l e s t a b l i s h e d minimal s t a n d a r d s o f c a r e . K e s s n e r g i v e s g u i d e l i n e s f o r the development o f c r i t e r i a f o r t r e a t i n g t r a c e r c o n d i t i o n s We b e l i e v e c r i t e r i a f o r t r e a t i n g the t r a c e r c o n d i t i o n s c o u l d a v o i d r i g i d i t y i f they were f o r m u l a t e d on t h r e e p r e m i s e s : they s h o u l d o u t l i n e m i n i m a l , o r b a s e - l i n e , c a r e ; they s h o u l d be p r a g m a t i c , t a k i n g i n t o account u n a v a i l a b i l i t y of s o p h i s t i c a t e d d i a g n o s t i c equipment; and they s h o u l d be p e r i o d i c a l l y r e v i s e d In summary, the co n c e p t s o f s t r u c t u r e - p r o c e s s - o u t c o m e , i m p l i c i t / e x p l i c i t process/outcome, e p i s o d e s o f c a r e and t r a c e r c o n d i t i o n s r e p r e s e n t the major c o n c e p t u a l s t e p p i n g stones i n the d e v e l o p i n g methodology f o r the e v a l u a t i o n o f P r i m a r y C a r e . Much o f the r e c e n t work has been concerned w i t h the a p p l i c a t i o n o f these c o n c e p t s i n f i e l d s t u d i e s 7,11,20,23-26,31 S e v e r a l important i s s u e s have a r i s e n out o f th e s e f i e l d s t u d i e s i n c l u d i n g : - 28 -( i ) what is_ q u a l i t y i n medical care? ( i i ) process versus outcome evaluations. ( i i i ) the emergence of patient characteristics-compliance, s a t i s f a c t i o n , health b e l i e f , health status as important components for evaluation., A b r i e f discussion of these issues follows. 2.3 What i s q u a l i t y i n medical care? Any evaluation of the q u a l i t y of medical care i s necessarily based on a conceptualized and operationalized - however i m p l i c i t - d e f i n i t i o n o f ' q u a l i t y " . One of the e a r l i e s t d e f i n i t i o n s of q u a l i t y care was written by Lee and Jones : Good medical care i s the kind of medicine practiced and taught by the recognized leaders of the medical profession at a given time or period of s o c i a l , c u l t u r a l , and professional development i n a community or population group. They base t h e i r concept of q u a l i t y on what they c a l l c e r t a i n " a r t i c l e s of f a i t h " : 1. Good medical care i s l i m i t e d to the prac t i c e of r a t i o n a l medicine based on the medical sciences. 2. Good medical care emphasizes prevention. 3. Good medical care requires i n t e l l i g e n t cooperation between the lay public and the p r a c t i t i o n e r s of s c i e n t i f i c medicine. 4. Good medical care tre a t s the i n d i v i d u a l as a whole. 5. Good medical care maintains a close and continuing personal r e l a t i o n between physician and patient. 6. Good medical care i s coordinated with s o c i a l welfare work. 7. Good medical care coordinates a l l types of medical services. 8. Good medical care implies the a p p l i c a t i o n of a l l the necessary services of modern s c i e n t i f i c medicine to the needs of a l l the people. Given that t h i s was written i n 1933, these statements are remarkably enlightened i n t h e i r presentation of a " h o l i s t i c " approach to medical care. Rather than being p o s i t i v i s t statements as to what q u a l i t y medical care is_ these - 29 -" a r t i c l e s o f f a i t h " are r e a l l y n o r m a tive statements as to what i t s h o u l d be. Donabedian p o i n t s out they are n o t h i n g more than v a l u e judgments t h a t are a p p l i e d to s e v e r a l a s p e c t s , p r o p e r t i e s , i n g r e d i e n t s o r dimensions of a p r o c e s s c a l l e d m e d i c a l c a r e . As such, the d e f i n i t i o n o f q u a l i t y may be almost a n y t h i n g anyone wishes i t to be, a l t h o u g h i t i s , o r d i n a r i l y , a r e f l e c t i o n o f v a l u e s and g o a l s c u r r e n t i n the m e d i c a l c a r e system and i n the l a r g e r s o c i e t y o f which i t i s a part-^8. D e f i n i t i o n s o f q u a l i t y have, by and l a r g e , been l e f t up to the p r o v i d e r s , i . e . p h y s i c i a n s ; have, f o r the most p a r t , been equated w i t h t e c h n i c a l s t a n d a r d s of c a r e ( i m p l i c i t i n the s e a r c h f o r e x p l i c i t p r o c e s s c r i t e r i a i s the s e a r c h f o r q u a l i t y c a r e ) ; and have been employed p r i m a r i l y through peer review. The major problem w i t h d e f i n i n g " q u a l i t y " i n h e a l t h c a r e i s t h a t the d e f i n i t i o n depends almost e n t i r e l y on who i s d o i n g the d e f i n i n g and at what 39 . . . . . . . " l e v e l o f c o n c e r n " t h e i r d e f i n i t i o n comes from. At the i n d i v i d u a l p a t i e n t - p r o v i d e r l e v e l , " q u a l i t y " may indeed be d e f i n e d most a p p r o p r i a t e l y i n terms o f t e c h n i c a l m e d i c a l s t a n d a r d s o f c a r e , w i t h the a d d i t i o n o f p s y c h o s o c i a l s k i l l s such as r a p p o r t , c o u n s e l l i n g , l i s t e n i n g , e t c . A t the l e v e l o f the h e a l t h c a r e d e l i v e r y system, the concept o f q u a l i t y expands to i n c l u d e c o n t i n u i t y , comprehensiveness and a c c e s s . F i n a l l y , at the l e v e l o f s o c i e t y as a whole, " q u a l i t y " most c e r t a i n l y i s a s s o c i a t e d w i t h i s s u e s o f not o n l y a c c e s s , but a l s o more i m p o r t a n t l y the e q u i t a b l e a l l o c a t i o n of h e a l t h c a r e r e s o u r c e s - human, p h y s i c a l , t e c h n o l o g i c a l and f i n a n c i a l - which, o f c o u r s e , d i r e c t l y a f f e c t s 39,40 access 41 . . . . . H a v i g h u r s t and B l u m s t e i n take the d i s c u s s i o n o f q u a l i t y i n m e d i c a l c a r e a s t e p f u r t h e r , w i t h t h e i r argument t h a t whoever c o n t r o l s the d e f i n i t i o n of - 30 -need (as opposed to demand) for health services also controls the d e f i n i t i o n of q u a l i t y . They say that i t i s the health care providers who have c o n t r o l l e d the d e f i n i t i o n of need and that c o n f l i c t a r ises with those responsible for a l l o c a t i n g resources because ....need i s defined i n terms of what i s t e c h n i c a l l y f e a s i b l e , without s p e c i f i c regard to d o l l a r cost, a resource-allocation problem i s sharply presented. In f a c t , need appears to be the standard by which " q u a l i t y of care" i s evaluated: any f a i l u r e to meet p r o f e s s i o n a l l y defined needs i s ipso facto inadequate q u a l i t y ^ 1 . Cle a r l y , following from t h i s argument, as non-medical professionals have and do become more i n f l u e n t i a l i n the health care f i e l d - planners, policy-makers, administrators, health economists, and p r a c t i t i o n e r s other than physicians - the d e f i n i t i o n of need and hence, q u a l i t y has expanded and become more complex and w i l l continue to do so. Donabedian very s u c c i n c t l y pointed out that the major d i f f i c u l t y with what he c a l l s the " m u l t i p a r t i t e nature of q u a l i t y " i s that of determining the degree to which there are i n t e r n a l c o n f l i c t s or i n c o m p a t i b i l i t i e s among the various components. This implies that the achievement of q u a l i t y i n one component of care may be associated with a tendency to d e t e r i o r a t i o n i n another. Is i t possible, for example, that technical excellence may tend to be associated with fragmentation and impersonality of care? I f t h i s were true, s p e c i a l attention might need to be directed, i n the process of a p p r a i s a l , to those dimensions of q u a l i t y that appear to be i n c o n f l i c t . Such p o s s i b i l i t i e s also have important implications for the organization of service. Services ought to be organized so as to minimize such c o n f l i c t s . In some si t u a t i o n s i t may be d i f f i c u l t to achieve comparable le v e l s of excellence i n a l l components of care. P r i o r i t i e s may need to be set up and d i f f i c u l t choices may have to be made^ . - 31 -2.4 Process vs Outcome Evaluation X5 36 f^3~*Ai7 Much debate has gone on in the l i t e r a t u r e ' ' in the l a s t ten years around the question of whether process or outcome evaluations of the 48 q u a l i t y of medical care are more v a l i d , r e l i a b l e and f e a s i b l e It i s generally accepted that the underlying goal of any health care system is the maintenance/improvement of the health status/health outcome of the individual/population. But health outcome i s an extremely d i f f i c u l t e n t i t y to 49 36 define l e t alone measure . As Brook points out measurement of outcome necessitates measurement of "health" i t s e l f , or some aspect of i t . He goes on to delineate the problems of assessing health outcome even when outcome measures are developed: ( i ) The outcomes most frequently used, such as death or incidence of major complications, may be so uncommon that detection of s i g n i f i c a n t differences i n these outcomes between patient groups requires a sample so large that the f e a s i b i l i t y of the study i s l i m i t e d , ( i i ) "Ultimate" outcomes or end r e s u l t s such as death or r e s t o r a t i o n of normal function often occur so late i n the course of treatment that timely evaluation i s impossible. ( i i i ) Such commonly used measures as m o r t a l i t y or return to function are heavily influenced by intervening factors such as genetic makeup and the physical and s o c i a l environment that are beyond the control of the medical care system. (i v ) Information about many outcomes i s not r e a d i l y available or contained i n the patient's medical record, requiring the use of follow-up interviews. These are expensive to conduct and may be d i f f i c u l t to complete for the e n t i r e patient population, (v) Information on the breadth of the outcome c r i t e r i a that should be used i n assessing q u a l i t y of care i s absent. Should outcome assessment be limited to physical and physiologic measures, or should i t include psychological measures such as sexual function following a r a d i c a l mastectomy for breast cancer? - 32 -And f i n a l l y he summarizes: In summary, there exists a paradoxical s i t u a t i o n i n which p o l i c y demands that operational q u a l i t y assurance systems use the outcome method to assess q u a l i t y of care, while there i s a dearth of v a l i d and r e l i a b l e outcome c r i t e r i a and standards and no method of proven f e a s i b i l i t y by which they can be applied. In contrast, process c r i t e r i a are well developed, although Brook says t h e i r 36 v a l i d i t y has not been adequately tested . The underlying assumption, of course, i n conducting process evaluations i s that outcome i s linked to process -i.e. good process w i l l r e s u l t i n a good outcome. The immediately obvious weakness i n t h i s assumption, as noted above, i s that outcome may be affected by a myriad of other factors - genetics, health b e l i e f , compliance, health status, the s o c i a l / political/economic climate - so that "good" process may i n fact lead to "poor" outcome, or a "good" outcome may r e s u l t from a "poor" process. Many studies have been done s p e c i f i c a l l y on the linkage between the process of care _ . 9-11,20,25,26,50 . . . , and patient outcomes > with variable and not u n i v e r s a l l y accepted r e s u l t s . E s t a b l i s h i n g p o s i t i v e associations between process and outcome variables i s the next major step i n the developing methodology of q u a l i t y of care evaluations. Process v a r i a b l e s , which are easier to define and measure, i f c l e a r l y linked to patient outcomes could then be used as surrogate measures for outcome v a r i a b l e s . Aside from the problem of linkage between process and outcome, one of the major p r a c t i c a l problems with conducting process evaluations i s t h e i r reliance on the patient chart for data. Questions have been raised as to the v a l i d i t y and r e l i a b i l i t y of t h i s data source^'"**. Patient charts are not only often i l l e g i b l e and highly i d i o s y n c r a t i c but also there i s no way to v e r i f y that - 33 -what has been recorded as having been done has a c t u a l l y been done. There i s no evidence that computerized medical records eliminate t h i s basic l i m i t a t i o n of 52 the chart audit . T y p i c a l l y , however, process evaluations are easier and cheaper - therefore, perhaps more f e a s i b l e - to conduct. In that process evaluations are b a s i c a l l y a measure of the a c t i v i t i e s of health care providers, they ind i c a t e very l i t t l e about patient c h a r a c t e r i s t i c s . 2.5 Patient C h a r a c t e r i s t i c s In the l a s t ten years, with the emphasis on prevention and health promotion, there has been a growing i n t e r e s t i n studying patient c h a r a c t e r i s t i c s that may a f f e c t health outcome. Studies have been done on compliance with 53 . r , , 26,54 , 55 treatment , s a t i s f a c t i o n with treatment , health b e l i e f 56 and health behaviour and f i n a l l y on developing health p r o f i l e s on self-perceived health status"^. Cert a i n l y these studies are valuable i n completing the picture of Primary Care. However, they do not r e a l l y help i f the object i s to measure and assess 43 the a c t i v i t i e s of health care providers. Kessner i s very quick to point out the differ e n c e between health outcome and health status: Outcome r e f e r s to the e f f e c t of medical care on the patients health, whereas (health) status may be affected by genetic, s o c i a l , c u l t u r a l and economic f a c t o r s . If the question of i n t e r e s t i s about the a b i l i t y of the health care system to d e l i v e r services i n an e f f i c a c i o u s way, then process and outcome studies are relevant. I f , however, the question of i n t e r e s t i s the nature of health i t s e l f and how to quantify, measure and f a c i l i t a t e i t , then the studies on patient c h a r a c t e r i s t i c s above are most relevant and provocative. - 34 -2.6 Summary Two themes emerge from the preceeding discussion: 1. The major conceptual developments i n the evolving Primary Care Evaluation methodology -( i ) structure - process - outcome ( i i ) i m p l i c i t / e x p l i c i t process/outcome c r i t e r i a ( i i i ) episodes of care (i v ) " t r a c e r " or i n d i c a t o r conditions 2. The on-going d i f f i c u l t i e s of adequately evaluating Primary Care -( i ) the often spurious r e l a t i o n s h i p between c e r t a i n items of the medical care process and patient outcome ( i i ) the d i f f i c u l t y of defining " q u a l i t y " ( i i i ) the emergence of patient c h a r a c t e r i s t i c s as components of the care process The next three chapters describe and analyse a q u a l i t y of care evaluati conducted i n a s p e c i f i c Primary Care s e t t i n g - an urban community c l i n i c -within the context of these themes. - 35 -CHAPTER 2 - NOTES 1. Codman, E.A., A Study i n Hospital E f f i c i e n c y As Demonstrated by the Case  Report of the F i r s t Five Years of Private Hospital, Thomas Todd Co., (Boston), 1918. 2. Lembcke, P.A., Medical Auditing by s c i e n t i f i c methods: I l l u s t r a t e d by major female p e l v i c surgery. JAMA, 1956; 162: 646. 3. Doyle, J . C , Unnecessary hysterectomies: Study of 6,248 operations i n t h i r t y - f i v e h o s p i t a l s during 1948. JAMA, 1953; 151: 360. 4. Shapiro, S. et a l . , Comparison of prematurity and pe r i n a t a l m o r tality i n a general population and i n a population of a prepaid group practice medical care plan. Am. J . Pub. Health, 1958; 48: 170. 5. Peterson, O.L., et a l . , An A n a l y t i c a l Study of North Carolina General Practice 1953-1954. J . Med. Ed., 1956; 31: 1. 6. Clute, K.F., The General P r a c t i t i o n e r , Toronto: U n i v e r s i t y of Toronto Press, 1963. 7. Morehead, M.A., et a l . , "Evaluating Quality of Medical Care i n the Neighborhood Health Center Program of the O f f i c e of Economic Opportunity." Med. Care, 1970; 8: 118. 8. Morehead, M.A., et a l . , Comparisons between 0E0 neighborhood health centers and other health care providers of ratings of the q u a l i t y of health care. Am. J . Pub. Health, 1971; 61: 1294. 9. Hulka, B.S., and Cassel, J . C , The AAFP-UNC study of the organization, u t i l i z a t i o n , and assessment of primary medical care. Am. J . Pub. Health, 1973; 63: 494. 10. Hulka, B.S., Kupper, L.L., Cassel, J . C , "Physician Management i n Primary Care." Am. J . Pub. Health, 1976; 66: 1173. 11. Romm, F.J., Hulka, B.S., and Mayo, F., Correlates of outcomes i n patients with congestive heart f a i l u r e s . Med. Care, 1976; 14: 765. - 36 -12. Sheps, M.C., "Approaches to the Quality of Hospital Care." Public Health  Reports, 1953; 70: 877-886. 13. Donabedian, A., Evaluating Quality of Medical Care. Milbank Memorial  Fund Quarterly, 1966; XLIV. 14. S t a r f i e l d , B., "Health Services Research." NEJM, 1973; 289: 132. 15. Donabedian, A., o p . c i t . , p.177-178. 16. Payne, B.C., Continued evolution of a system of medical care appraisal. JAMA, 1967; 201: 536. 17. Sanazaro, P.J., Quality Assessment and Quality Assurance i n Medical Care. Ann. Review of Pub. Health, 1980; 1: 37-68. 18. Brook, R.H., and Appel, F.A., Quality of Care Assessment: Choosing a Method for Peer Review. NEJM, 1973; 288: 1323. 19. Williamson, J.W., Evaluating Quality of Patient Care: A Strategy Relating Outcome and Process Assessment. JAMA, 1971; 218(4): 555. 20. Schroeder, S.A., and Donaldson, M.S., The F e a s i b i l i t y of an Outcome Approach to Quality Assurance - A Report from One HMO. Med. Care, 1976; 14: 49. 21. Kessner, D.M., "Quality Assessment and Assurance: Early Signs of Cognitive Dissonance." NEJM, 1978; 298: 381. 22. Gonnella, J.S., "Evaluating Patient Care" JAMA, 1970; 214: 2040. 23. Brook, R.H., et a l . , Effectiveness of Patient Care i n an Emergency Room. NEJM, 1970; 283: 904. 24. Brook, R.H., et a l . , Effectiveness of Non-emergency Care v i a an Emergency Room: A Study of 166 Patients with G a s t r o i n t e s t i n a l symptoms. Ann. Int. Med., 1973; 78: 333. - 37 -25. Hulka, B.S., e t a l . , Peer Review i n Ambulatory Care: Use of E x p l i c i t C r i t e r i a and I m p l i c i t Judgements, 1979, Med. Care, 17(3): Suppl.1. 26. S p i t z e r , W.O., e t a l . , The B u r l i n g t o n Randomized T r i a l o f the Nurse P r a c t i t i o n e r , NEJM, 1974; 290: 251. 27. Sackett, D.L., et a l . , The Burlington Randomized T r a i l of the Nurse P r a c t i t i o n e r : Health Outcomes of Patients. Ann. Int. Med., 1974; 80: 137. 28. Sibley, J . C , et a l . , Quality-of-Care Appraisal i n Primary Care: A Quantitative Method. Ann. Intern. Med., 1975; 83: 46. 29. Payne, B.C., and Lyons, T.F., O f f i c e Care Study (Ann Arbor: University of Michigan, School of Medicine"! 1972), c i t e d by Romm, F.J. and Hulka, B.S., Developing C r i t e r i a for Quality of Care Assessment: E f f e c t of the Delphi Technique, Health Ser. Research, 1979; 14: 309. 30. Wagner, E.H., et a l . , A Method for s e l e c t i n g c r i t e r i a to evaluate medical care, Am. J . Pub. Health, 1978; 68: 464. 31. Romm, F . J . , and Hulka, B.S., o p . c i t . 32. S o l o n , J.A., e t a l . , D e l i n e a t i n g E p i s o d e s o f Care. Am. J . Pub. H e a l t h , 1967; 57: 401. 33. Solon, J.A., e t a l . , E p i s o d e s o f N u r s i n g Care: N u r s i n g S t u d e n t s Use o f M e d i c a l S e r v i c e s . Am. J . Pub. H e a l t h , 1969; 59: 936. 34. Kessner, D.M., et a l . , Assessing Health Quality - The Care for Tracers. NEJM, 1973; 288: 189. 35. Ciocco, A., et a l . , S t a t i s t i c s on c l i n i c a l services to new patients i n medical groups, Pub,. Health Rep. , 1950; 65: 99, c i t e d by Kessner, i b i d . 36. Brook, R.H., et a l . , Assessing the Quality of Medical Care Using Outcome Measures: An Overview of the Method. Med. Care Supplement, 1977; 15: 1. - 38 -37. Lee, R.J., and Jones, L.W., The Fundamentals o f Good M e d i c a l Care. (Chicago: U n i v e r s i t y o f C h i c a g o P r e s s , 1933), c i t e d by Donabedian, A. "A Frame o f R e f e r e n c e " i n A Guide to M e d i c a l Care A d m i n i s t r a t i o n , Volume I I : M e d i c a l Care A p p r a i s a l - Q u a l i t y and U t i l i z a t i o n (New York: American J o u r n a l of P u b l i c H e a l t h , 1969), p.8. 38. Donabedian, A., E v a l u a t i n g Q u a l i t y o f M e d i c a l Care. M i l b a n k Memorial  Fund Q u a r t e r l y , 1966; XLIV, p.167. 39. Donabedian, A., o p . c i t . , note 37, p.5. 40. Recent developments i n Canada w i t h r e s p e c t to the F e d e r a l Government's proposed p o l i c y on f u n d i n g to p r o v i n c e s who a l l o w p h y s i c i a n e x t r a - b i l l i n g and h o s p i t a l u s e r charges h i g h l i g h t s t h i s i s s u e . That the Honourable Monique B e g i n c o n s i d e r s the i s s u e o f " a c c e s s " as coming under h e r mandate i s i l l u s t r a t e d by the f o l l o w i n g quote from the Canada H e a l t h A c t White Paper - D r a f t - 2 Proposed d e f i n i t i o n [of a c c e s s ] A c c e s s i b i l i t y r e f e r s t o the p r o v i s i o n o f r e a s o n a b l e access to i n s u r e d s e r v i c e s f o r each r e s i d e n t o f Canada. Reasonable a c c e s s means t h a t i n s u r e d persons s h o u l d be assured o f adequate q u a n t i t y , q u a l i t y and d i s t r i b u t i o n o f i n s u r e d h e a l t h s e r v i c e s on a p r e p a i d b a s i s , unimpeded by f i n a n c i a l b a r r i e r s , (emphasis added) 41. H a v i g h u r s t , C.C., and B l u m s t e i n , J . F . , Coping w i t h Q u a l i t y / C o s t T r a d e - O f f s i n M e d i c a l Care: The Role o f PSROs. No r t h w e s t e r n Law Review, 1975; 70: 6. 42. Donabedian, A., o p . c i t . , note 37, p.10. 43. K e s s n e r , D.M., Q u a l i t y Assessment and A s s u r a n c e : E a r l y S i g n s o f C o g n i t i v e D i s s o n a n c e . NEJM, 1978; 298: 381. 44. M c A u l i f f e , W.E., Measuring the Q u a l i t y o f M e d i c a l Care: P r o c e s s v e r s u s Outcome. M i l b a n k Memorial Fund Q u a r t e r l y , 1979; 57 ( 1 ) : 118. 45. Brook, R.H., S t u d i e s o f Process-Outcome c o r r e l a t i o n s i n M e d i c a l Care E v a l u a t i o n s . Med. Care, 1979; 17: 868. - 39 -46. McAuliffe, W.E., Response to Dr. Brook. Med. Care, 1979; 17: 874. 47. Palmer, R.H., and Nesson, H.R., A Review of Methods f o r Ambulatory Medical Care Evaluations. Med. Care, 1982; 20: 758. 48. V a l i d i t y - ref e r s to the extent to which a measure a c t u a l l y measures what i t purports to measure. R e l i a b i l i t y - r e f e r s to the r e p e a t a b i l i t y of a measure. F e a s i b i l i t y - r e f e r s to the ease or p r a c t i c a l i t y of measurement. 49. For a concise depiction of some current outcome concepts see Brook, R.H., o p . c i t . , note 36, Chapter I I I , Table 5. 50. S t a r f i e l d , B., Scheff, D., Effectiveness of P e d i a t r i c Care: The Relationship between Processes and Outcome. P e d i a t r i c s , 1972; 49: 547. 51. Romm, F.J., and Putnam, S.M., The V a l i d i t y of the Medical Record. Med. Care, 1981; 19: 310. 52. Studney, D.R., personal communication, September, 1983. 53. Sackett, D.L., Hypertension V: Compliance with Antihypertensive Therapy. A Report from the Canadian Hypertension Task Force. In Can. J . Pub.  Health, 1980; 71: 153. 54. Rohgmann, K.J., et a l . , S a t i s f a c t i o n with Medical Care: I t s Measurement and Relation to U t i l i z a t i o n . Med. Care, 1979; 17: 461. 55. Becker, M.H. (ed.), The Health B e l i e f Model and Personal Health Behaviour (Thorofare, N.J.: Charles B. Slack Publishing, 1974). 56. Wiley, J .A., and Camacho, T.C., L i f e - S t y l e and Future Health: Evidence from the Alameda County Study. Prev. Med., 1980; 9: 1. 57. Parkerson, G.R., et a l . , The Duke-UNC Health P r o f i l e : An Adult Health Status Instrument f o r Primary Care. Med. Care, 1981; XIX: 806. - 40 -CHAPTER 3 Study C l i n i c : The Methodology 3.1 Study S e t t i n g : The Reach Community C l i n i c ( h e r e a f t e r r e f e r r e d t o as Reach) i s a n o n - p r o f i t s o c i e t y , funded by the B.C. M i n i s t r y of H e a l t h , and r e s p o n s i b l e to a Board o f D i r e c t o r s e l e c t e d by members o f the s o c i e t y . The C l i n i c began i n 1969 i n a c o n v e r t e d f r u i t and v e g e t a b l e shop as a j o i n t p r o j e c t o f r e s i d e n t s i n the Grandview-Woodlands a r e a ( m a i n l y through the A r e a C o u n c i l ) and the UBC Department o f P e d i a t r i c s under Dr. Sydney I s r a e l s * . Dr. Roger T o n k i n was the o r g a n i z e r and f i r s t E x e c u t i v e D i r e c t o r o f Reach. Reach i s s i t u a t e d on the E a s t s i d e o f Vancouver i n a m u l t i - c u l t u r a l , m u l t i - r a c i a l , r e s i d e n t i a l and l i g h t i n d u s t r i a l a r e a . S e r v i c e s p r o v i d e d i n c l u d e a m e d i c a l c l i n i c , a d e n t a l c l i n i c and v a r i o u s community programs such as Pregnant Teen Program and a m u l t i - c u l t u r a l p r e s c h o o l program. S t a f f o f the m e d i c a l c l i n i c i n c l u d e : 5 p a r t - t i m e s a l a r i e d p h y s i c i a n s (4 F u l l Time E q u i v a l e n t s ) , one o f whom i s the M e d i c a l C o o r d i n a t o r ; 2 nur s e p r a c t i t i o n e r s (B.Sc.N.); 2 c l i n i c a l c o o r d i n a t o r s (LPN); 1 p h a r m a c i s t ; 1 n u t r i t i o n i s t ; and 3 m e d i c a l r e c e p t i o n i s t s . P h y s i c a l f a c i l i t i e s i n c l u d e : 8 o f f i c e s , 1 l a b o r a t o r y ; 1 pharmacy; and a l a r g e r e c e p t i o n a r e a , which houses the r e c o r d s . The m e d i c a l c l i n i c averages a p p r o x i m a t e l y 1500 p a t i e n t c o n t a c t s a month. Reach r e p r e s e n t s a unique a l t e r n a t i v e f o r the p r o v i s i o n o f Pr i m a r y Care s e r v i c e s , the m a j o r i t y o f P r i m a r y Care i n B.C., inde e d i n Canada, b e i n g d e l i v e r e d i n p r i v a t e p r a c t i c e o f f i c e s e t t i n g s . Other community c l i n i c s s i m i l a r to Reach ( a l t h o u g h w i t h d i f f e r e n t o r i g i n s ) i n c l u d e the James Bay Community - 41 -C l i n i c i n V i c t o r i a , the Houston Community C l i n i c near T e r r a c e and the M a s s e t t Community C l i n i c i n the Queen C h a r l o t t e I s l a n d s . 3.2 I n i t i a t i o n o f the Study In September 1982, members o f the Reach C l i n i c s t a f f , r e p r e s e n t i n g the Board of D i r e c t o r s , approached Dr. Sam Sheps, o f the Department o f H e a l t h Care and E p i d e m i o l o g y , U.B.C, to d i s c u s s the p o s s i b i l i t y o f c o n d u c t i n g a q u a l i t y o f c a r e assessment at the Reach C l i n i c . F u r t h e r d i s c u s s i o n over the e n s u i n g weeks e s t a b l i s h e d t h a t such an assessment was f e a s i b l e , and i n October 1982, a l e t t e r of agreement was s i g n e d s t i p u l a t i n g the o v e r a l l r e s e a r c h approach, the r e s p o n s i b i l i t y o f the r e s e a r c h e r s and Reach C l i n i c s t a f f and Board, and the s c h e d u l e f o r c o m p l e t i n g the assessment. (Appendix I) The study d e s c r i b e d below was planned and c a r r i e d out over the f i v e month p e r i o d , November 1982 - March 1983. 3.3 S e l e c t i o n o f an Approach f o r the Reach Study: A f t e r r e v i e w i n g the l i t e r a t u r e , i t was f e l t t h a t the B u r l i n g t o n Randomized 2 C o n t r o l l e d T r i a l (BRCT) r e p r e s e n t e d a good model upon which to base the Reach C l i n i c Study. As mentioned i n Chapter 2 the BRCT was d e s i g n e d to compare the q u a l i t y o f c a r e d e l i v e r e d by nurse p r a c t i t i o n e r / p h y s i c i a n teams ( t h e Randomized Nurse P r a c t i t i o n e r [RNP] g r o u p ) , c a r e d e l i v e r e d by c o n v e n t i o n a l f a m i l y p r a c t i c e - a p h y s i c i a n w i t h an o f f i c e n u r s e ( t h e Randomized C o n t r o l [RC] g r o u p ) , and c a r e d e l i v e r e d by two c o n v e n t i o n a l f a m i l y p h y s i c i a n s p r a c t i s i n g i n c l o s e a s s o c i a t i o n w i t h each o t h e r ( t h e Community C o n t r o l [CC] g r o u p ) . A l l t h r e e study groups were i n P r i m a r y Care o f f i c e p r a c t i c e s e t t i n g s . The method used was the a p p l i c a t i o n o f p r e s e t e x p l i c i t - p r o c e s s c r i t e r i a to t e n (10) i n d i c a t o r c o n d i t i o n s , p r e s c r i p t i o n s o f t h i r t e e n (13) drugs and r e f e r r a l d e c i s i o n s . The - 42 -evaluation was accomplished through a prospective chart audit i n which information was abstracted from patient charts and judgments made as to the adequacy of care on the basis of the preset care c r i t e r i a . The BRCT also examined patient outcomes i n terms of ph y s i c a l , emotional and s o c i a l function one year a f t e r care was received. The BRCT model was chosen because i n the f i r s t place, the BRCT used a pr a c t i c e s e t t i n g very s i m i l a r to that found at Reach, p a r t i c u l a r l y with regard to the f a c t that both study settings employed nurse-practitioner/physician teams. Functionally, the operation of Reach resembles the RNP group, i n that much of the preventive care, such as b i r t h - c o n t r o l counselling, well-baby care, etc. i s managed by the nurse-practitioners. Secondly, the BRCT employed e x p l i c i t process c r i t e r i a covering a l l aspects of care ( i . e . diagnostic, therapeutic, and follow-up). T h i r d l y , a reasonable v a r i e t y of indicator conditions were chosen f o r assessment0, thus a number of general aspects of care could be evaluated. Fourth, the e x p l i c i t process c r i t e r i a developed for the BRCT were generated by family p r a c t i t i o n e r s , not academic physicians. F i f t h , the BRCT was undertaken i n a Canadian context, and thus many general medical care issues (e.g. financing) would be s i m i l a r to the Reach s i t u a t i o n . F i n a l l y , the r e s u l t s of the BRCT provided an external comparison, based on i d e n t i c a l case d e f i n i t i o n and c r i t e r i a for assessment, with the r e s u l t s obtained i n the Reach Study. The method used was a retrospective randomized chart audit, using e x p l i c i t 2 process c r i t e r i a developed by Sibley et a l for the BRCT. . The c l i n i c a l s t a f f at Reach were asked to submit a l i s t of the conditions judged to be the most frequently encountered. This l i s t was compared to the conditions included - 43 -i n the BRCT and the following seven i n d i c a t o r conditions were chosen: o t i t i s media, hypertension, prenatal care, care of newborn, immunization up to 24 months, depression, and urinary t r a c t i n f e c t i o n (UTI). Three i n d i c a t o r conditions used i n the Burlington Randomized T r i a l — knee in j u r y , p i t y r i a s i s , and anemia — were not included i n the present study because the Reach s t a f f i n d i c a t e d these were infrequently encountered. The seven i n d i c a t o r conditions chosen are also relevant i n that they f a l l i n t o four categories of care considered to be t y p i c a l of a l l Primary 3 Care: (1) Care of acute i n f e c t i o u s disease: o t i t i s media, UTI. (2) Preventive/wellness care: prenatal care, care of newborn, immunization up to 24 months. (3) Care of chronic diseases: hypertension, UTI (4) Care of psycho-social conditions: depression. A pre-study chart survey of 50 randomly selected charts indicated that approximately 16% of the Reach charts recorded at least one episode of one of the seven i n d i c a t o r conditions chosen. 3.4 Study Period The study period, July 1, 1981 to June 30, 1982 was chosen because i t represented recent care given during a period of consistency i n s t a f f i n g . P r i o r to and a f t e r the study period s t a f f i n g changes occurred and i t was f e l t a f t e r discussion with the Reach S t a f f that i t was important to undertake the evaluation during a period when s t a f f i n g was stable. Also t h i s study period represented care given at a time well before the i n i t i a l plans f o r the study - 44 -were discussed^ thus no bias i n e i t h e r p r a c t i c e or recording could have occurred. 3.5 Chart S e l e c t i o n The number of charts at Reach as of November 22, 1982 t o t a l l e d 6,923; charts are numbered i n a chronological order according to the date of the patient's f i r s t v i s i t to Reach (so that the newest patient w i l l have the highest chart number), and are cross-referenced to names of patients on a cumulative alphabetized patient l i s t . Each patient on t h i s l i s t was assigned a number from 1 to 6923 i n a l p h a b e t i c a l order. 1800 random numbers between 1 and 6923 were generated using a Random Number computer program and charts of those patients f o r whom a random number occurred were selected f o r study. Charts were reviewed for e l i g i b i l i t y i n groups of 200 proceeding through the cumulative patient l i s t i n alphabetical order. The o r i g i n a l i n t e n t i o n was to study 1800 charts but, because there was no way to i d e n t i f y which charts contained episodes of s p e c i f i c complaints or diagnoses, the chart s e l e c t i o n process took longer than expected and, therefore, time constraints necessitated reducing t h i s number to 1200. An analysis of each group of 200 charts indicated that there was no a l p h a b e t i c a l bias i n terms of the d i s t r i b u t i o n of diagnostic or chart categories. Thus the reduction i n the number of charts studied d i d not bias the s e l e c t i o n process. E l i g i b l e charts are those i n which at least one episode of care occurred within the study period. This d e f i n i t i o n , however, may include care given before or a f t e r the study period. For example, i f the l a s t ( f i r s t ) prenatal v i s i t occurred within the study period, the e n t i r e course of prenatal care was - 45 -evaluated, even though the bulk of care may have occurred p r i o r to ( a f t e r ) the study period. I n e l i g i b l e charts were defined as follows: 1) Transient - any v i s i t without any follow-up v i s i t i s considered by Reach to be a transient v i s i t ; 2) Inactive - a chart with the l a s t recorded v i s i t p r i o r to September 1980 was considered by Reach to be in a c t i v e ; 3) Time i n e l i g i b l e - these are active charts, but no recorded v i s i t occurred within the study period ( t h i s also includes charts i n which recorded v i s i t s started a f t e r J u l y 1, 1982); 4) Condition i n e l i g i b l e - charts i n which none of the recorded v i s i t s occurring within the study period were for one of the seven i n d i c a t o r conditions. 3.6 Abstraction of Data Information was abstracted from the study e l i g i b l e charts using abstract sheets developed by Sibley et a l f o r the BRCT. For each condition a clear d e f i n i t i o n of an episode of care was provided. Care of the newborn and immunization were assessed i n the same charts, although on separate occasions i n order to minimize b i a s . Judgments of the q u a l i t y of care rendered f o r each episode of care studied were made according to e x p l i c i t process c r i t e r i a and d e f i n i t i o n s of "superior", "adequate" and "inadequate" care developed f o r the BRCT. A complete set of abstract sheets, e x p l i c i t process c r i t e r i a and judgment category requirements for each i n d i c a t o r condition studied appear i n Appendix I I . 3 .7 V a l i d i t y and R e l i a b i l i t y : V a l i d i t y : The c r i t e r i a f o r the BRCT were developed by a "Peer Advisory Group" of three family practice physicians, representing a range of community and academic experience, s p e c i f i c a l l y to r e f l e c t community rather than - 46 -academic standards of care. Analysis i n terms of i n t e r n a l consistency, comparison with external mortality and morbidity data and patient 2 4 outcomes ' , suggest that the c r i t e r i a are v a l i d for the evaluation of primary care. While these c r i t e r i a may d i f f e r from those considered necessary or s u f f i c i e n t by other physicians, time did not permit either the development of s p e c i f i c c r i t e r i a or a reworking of the BRCT c r i t e r i a for the Reach study, or a review of the BRCT c r i t e r i a by the Reach c l i n i c a l s t a f f . However, process c r i t e r i a developed elsewhere do provide an objective external q u a l i t y of care measure (the BRCT r e s u l t s ) against which to compare the care delivered at Reach. R e l i a b i l i t y : A p i l o t study to assess the r e l i a b i l i t y of the abstraction process was undertaken on 32 charts at the Family P r a c t i c e Unit at the University of B r i t i s h Columbia. This produced an o v e r a l l agreement of 81% (KAPPA = 0.62) between the two investigators (one physician, one non-physician). KAPPA i s a mathematical method of determining the amount of agreement occurring beyond that expected by chance"*. Lardis and Koch*3 state that KAPPA values between 0.61 and 0.80 indicates substantial agreement beyond that expected by chance, with values over 0.80 i n d i c a t i n g e s s e n t i a l l y perfect agreement. A second r e l i a b i l i t y study was conducted on the Reach charts using a randomly chosen sample of 34 (27.4%) of the 124 episodes of care, r e s u l t i n g in an o v e r a l l agreement of 85% (KAPPA = 0.66) between the two i n v e s t i g a t o r s . This r e l i a b i l i t y study also revealed that the physician investigator tended to be the more severe judge: a l l of the f i v e episodes of care in which there was disagreement were rated by the physician as inadequate and most of these were for care of the newborn. (See Appendix I I I for the determination of KAPPA values) - 47 -CHAPTER 3 - NOTES 1. Reach Community C l i n i c , Eleven Years at Reach (Vancouver: Reach Community C l i n i c , 1970) for a more d e t a i l e d review of the h i s t o r y and development of Reach C l i n i c see: Tonkin, R.S., The Reach Centre - i t s h i s t o r y and work (1969-1976). I. H i s t o r i c a l Background and program d e s c r i p t i o n . Can. J . Pub. Health, 1979; 70: 199. - The Reach Centre: i t s h i s t o r y and work. I I . The Paediatric P r a c t i c e . Can. J . Pub. Health, 1979; 70: 333. - The Reach Centre: i t s h i s t o r y and work. I I I . A study of the q u a l i t y of paediatric care. Can. J . Pub. Health, 1979; 70: 405. 2. Sibley, J . C , et a l . , Quality-of-Care Appraisal i n Primary Care: A Quantitative Method. Ann. Int. Med., 1975; 83: 46. 3. Palmer, R.H., and Nesson, H.R., A Review of Methods for Ambulatory Medical Care Evaluations. Med. Care, 1982; XX: 758. 4. Sackett, D.L., et a l . , The Burlington Randomized T r i a l of the Nurse P r a c t i t i o n e r : Health Outcomes of Patients. Ann. Int. Med., 1974; 80: 137. 5. Spitzer, R.L., et a l . , Q u a n t i f i c a t i o n of Agreement i n P s y c h i a t r i c Diagnosis: A New Approach. Arch. Gen. Psych., 1967; 17: 83. 6. L a r d i s , J.R., and Koch, G.G., The Measurement o f O b s e r v e r Agreement f o r C a t e g o r i c a l D a t a . B i o m e t r i c s , 1977; 33: 159. - 48 -CHAPTER 4  Study C l i n i c : Results 4.1 Results of Chart Selection The r e s u l t s of the chart s e l e c t i o n process are shown i n Figure 4. Of the 1200 randomly selected charts, only 103 (8.6%) were e l i g i b l e for study. However, of a l l the charts considered to be time e l i g i b l e (583), because one or more v i s i t s were recorded within the study period, 103 (17.7%) were condition e l i g i b l e , i n that these v i s i t s were for one of the indicator conditions chosen. Table 1 shows the number of episodes of care i n each i n d i c a t o r condition and the d i s t r i b u t i o n of these episodes i n terms of the t o t a l number of time e l i g i b l e and study e l i g i b l e charts. Column 2 indicates that o v e r a l l , 21% of the care delivered at Reach was sampled and that of a l l conditions seen at Reach about 5% are o t i t i s media, about 4% are prenatal, etc. As indicated i n Column 3, of the 124 episodes of care evaluated, 25% were for o t i t i s media, 7.3% were for hypertension, etc. 4.2 Reach C l i n i c Table 2 shows the d i s t r i b u t i o n of the q u a l i t y of care judgements at Reach for the i n d i c a t o r conditions i n d i v i d u a l l y and o v e r a l l . The r e s u l t s for prenatal care require further explanation. Some of the charts which,were judged as inadequate on the basis of the s t r i c t c r i t e r i a , also showed features of superior care. Where only one feature of the s t r i c t c r i t e r i a was not met (e.g. missed one u r i n a l y s i s ) i t was f e l t that a modification of the judgement from inadequate to adequate was j u s t i f i e d i f the rest of the chart was judged superior. These adjusted scores are shown i n parentheses. - 49 -I t i s clear from the t o t a l s i n Table 2, that there was an almost equal d i s t r i b u t i o n among the three judgement categories when o v e r a l l q u a l i t y of care i s considered: 1/3 of the care was judged superior; 1/3 adequate; and 1/3 inadequate. However, Column 3 of Table 3 indicates that the range of adequate or superior care was from 33.3% f o r hypertension to 80.9% f o r care of newborn. 4.3 Comparison of Reach C l i n i c with BRCT Table 3 also shows the comparison between Reach and the two groups studied i n the BRCT, a "randomized nurse-practitioner (RNP) group" comprised of nurse-practitioner/physician teams, and a "community control (CC) group", comprised of a conventional family p r a c t i c e * . As can be seen, f o r some ind i c a t o r conditions Reach achieved a higher proportion of adequate or superior care than e i t h e r of the BRCT groups — i . e . o t i t i s media, and UTI; for some the Reach score was lower — prenatal; and for the rest the Reach score was between the RNP and CC groups — hypertension, depression, care of newborn, and Immunization. O v e r a l l , the Reach score f o r adequate or superior care was between that of the RNP and CC groups: 66.9% (adjusted - 70.2%) as compared to 70.5% and 59.8% re s p e c t i v e l y . The standard error of the mean for th i s sample of episodes of care (66.9%) i s + .038. Thus i f d i f f e r e n t samples of 124 episodes of care were taken for the ind i c a t o r conditions studied the o v e r a l l proportion judged adequate or superior would be l i k e l y to l i e between 59.3% and 74.5%. A te s t of proportions (Table 4) showed that while the difference between the RNP and CC scores was s i g n i f i c a n t , (z = 2.052, p = 0.04), we f a i l e d to f i n d a s i g n i f i c a n t difference between the Reach score and either the RNP score (z = 0.140, p = 0.52), or the CC score (z = 1.276, p = 0.20). This was true for both - 50 -u n s t a n d a r d i z e d and s t a n d a r d i z e d d a t a . 4.4 Reasons f o r Inadequacy at Reach C l i n i c T a b l e 5 l i s t s r easons f o r an e p i s o d e o f c a r e r e c e i v i n g a judgement of inadequacy. Note t h a t t h e r e are a t o t a l o f 48 r e a s o n s f o r j u d g i n g e p i s o d e s of c a r e as inadequate, thus some e p i s o d e s had more than one r e a s o n . I n o r d e r to e x p l o r e the d a t a f o r p a t t e r n s of inadequacy, the p r i m a r y c a r e c a t e g o r i e s , as noted above have been adapted (combining the f o u r c a t e g o r i e s 2 d i s c u s s e d by Palmer and Nesson i n t o t h r e e c a t e g o r i e s ) , and s p e c i f i c c l i n i c a l - f u n c t i o n a l areas ( h i s t o r y - t a k i n g ; p h y s i c a l exam; l a b o r a t o r y d a t a ; and management) which d e s c r i b e s p e c i f i c components o f c a r e have been d e l i n e a t e d . The d i s t r i b u t i o n o f reasons f o r inadequacy a l o n g these two dimensions i s p r e s e n t e d i n T a b l e 6. As can be seen, o m i s s i o n s of p a t i e n t management accounted f o r n e a r l y 50% o f a l l o f the reasons f o r inadequacy, b e i n g almost e q u a l l y d i v i d e d between acu t e i n f e c t i o u s d i s e a s e c a r e and p r e v e n t i v e c a r e . L a b o r a t o r y o m i s s i o n s , a l t h o u g h a c c o u n t i n g f o r o n l y 18.8% o f a l l o f the reasons f o r inadequacy, r e p r e s e n t e d 31% (9/29) o f the o m i s s i o n s i n p r e v e n t i v e c a r e , a l l o f these o c c u r r i n g i n p r e n a t a l c a r e . P h y s i c a l exam o m i s s i o n s were seen p r i m a r i l y i n p r e v e n t i v e c a r e , but a l s o i n c h r o n i c d i s e a s e c a r e , w h i l e o m i s s i o n s i n h i s t o r y - t a k i n g were s t r i k i n g l y c o n c e n t r a t e d i n c h r o n i c d i s e a s e c a r e (5/7 = 71%). Examining c a t e g o r i e s o f P r i m a r y Care, i t can be seen t h a t the r a t e o f o m i s s i o n s per 100 e p i s o d e s i s h i g h e s t f o r c h r o n i c d i s e a s e (50/100 e p i s o d e s ) , a l t h o u g h t h i s f i g u r e i s o n l y somewhat h i g h e r than seen f o r p r e v e n t i v e c a r e - 51 -(43.3/100 episodes). Care of acute i n f e c t i o u s diseases has the lowest rate of omissions (26.8/100 episodes). - 52 -Figure 4 Details of Chart Selection 6923 Total No. Charts 1200 Randomly Selected (17.3%) 1097 To t a l I n e l i g i b l e Charts (91.4) 75 Transient 300 Inactive 242 Time I n e l i g i b l e 480 Condition (6.3%) (25.0%) (20.2%) I n e l i g i b l e (40.0%) 103 E l i g i b l e (8.6%) Study e l i g i b l e charts Time e l i g i b l e charts 103 103 = 17.7% 103 + 480 583 *Transient - walk-in v i s i t only. Inactive - no v i s i t recorded a f t e r September 1980. Time I n e l i g i b l e - no v i s i t i n study period J u l y 1, 1981 to June 30, 1982. Condition I n e l i g i b l e - no episode of any of the seven indica t o r conditions. within study period. - 53 -TABLE I D i s t r i b u t i o n o f Time and C o n d i t i o n E l i g i b l e E p i s o d e s  Reach C l i n i c Study I n d i c a t o r C o n d i t i o n No. % Time E l i l g i b l e (583) % Study E l i g i b l e (124) O t i t i s Media H y p e r t e n s i o n P r e n a t a l Care o f Newborn Immunization D e p r e s s i o n UTI TOTAL 31 9 23 21 23 7 10 5.3 1.5 3.9 3.6 3.9 1.2 1.7 25.0 7.3 18.5 16.9 18.5 5.6 8.1 124* 21.1 99.9 * A l l 21 Care o f Newborn c h a r t s were a l s o e l i g i b l e f o r the Immunization c a t e g o r y r a i s i n g the t o t a l e p i s o d e s o f c a r e s t u d i e d from 103 to 124. - 54 -TABLE II Number of Episodes of Care Assessed and Judgement of Adequacy by Indicator Condition Reach C l i n i c Study INDICATOR TOTAL NO. SUPERIOR ADEQUATE INADEQUATE CONDITION CASES # % # % # % O t i t i s Media 31 17 54 .8 7 22.6 7 22.6 H y p e r t e n s i o n * 9 - 3 33.3 6 66.7 P r e n a t a l * * 23 11 47 .8 0(4) 0(17. 4) 12 52.2 (34.8) Care o f Newborn 21 13 61 .8 4 19.1 4 19.1 Immunization* 23 - 17 73.9 6 26.1 D e p r e s s i o n * 7 - 5 71.4 2 28.6 UTI 10 1 10 .0 5 50.0 4 40.0 TOTAL 124 42 33 .8 41 33.1 41 33.1 -(45) (36.3) (37) (29.8) * No s u p e r i o r c a t e g o r y f o r t h e s e i n d i c a t o r c o n d i t i o n . ** Numbers i n p a r e n t h e s e s r e p r e s e n t a d j u s t e d s c o r e s . See r e s u l t s s e c t i o n f o r e x p l a n a t i o n . - 55 -TABLE I I I - Comparison o f Number of E p i s o d e s o f I n d i c a t o r C o n d i t i o n s and P e r c e n t a g e Scored Adequate o r S u p e r i o r Between Reach M e d i c a l C l i n i c and the B u r l i n g t o n Randomized C o n t r o l l e d T r i a l Randomized Nurse P r a c t i t i o n e r (RNP) Group and Community C o n t r o l (CC) Group. INDICATOR CONDITION BURLINGTON RANDOMIZED CONTROL REACH TRIAL+ RNP CC # % # % # % O t i t i s Media 39 74 36 67 31 77.4 H y p e r t e n s i o n 9 56 13 31 9 33.3 P r e n a t a l Care 13 77 23 70 23 47.8(65 .2 ) * Care of Newborn 17 71 33 82 21 80.9 Immunization 10 90 19 11 23 73.9 D e p r e s s i o n 37 81 34 71 7 71.4 UTI 24 42 36 53 10 60.0 TOTALS 149 70.5 194 59.8 124 66.9(70 . 2 ) * + These r e s u l t s are taken from T a b l e 1 o f the BRCT. 1 2 * A d j u s t e d Score - see r e s u l t s s e c t i o n f o r e x p l a n a t i o n . Table IV Comparison of Overall Judgment of Adequacy Between BRCT Groups and Reach C l i n i c  Using Standardized * and Unstandardized Episode Frequencies BRCT RNP CC % Episodes Judged Adequate or Superior* Test of Proportions Z Score P Reach C l i n i c (N=124) Test of Proportions Reach/RNP Reach/CC Z P Z P Unstandardized 70.5 59.8 Data 2.05 0.04 66.9 0.14 0.52 1.28 0.2 Standardized 73.2 56.1 3.26 0.001 66.9 1.13 0.25 -1.92 0.054 for Frequency of episodes + Frequencies for episodes found i n the Reach Sample was used as the standard and BRCT frequencies adjusted accordingly. * Proportions of charts rated adequate or superior as found i n the BRCT were applied to adjusted episode frequencies. TABLE V Reasons for Inadequacy  Reach C l i n i c Study Indicator Condition Total No. Episodes Inadequate No. Episodes Reason O t i t i s Media Hypertension 31 6 - no return v i s i t *1 - previous drug s e n s i t i v i t y 4 - no family or personal his t o r y 2 - no repeat B.P. within 3 months Prenatal 23 (using s t r i c t c r i t e r i a ) 12 Care of Newborn Immunization Depression UTI 21 23 10 **9 - missed one or more u r i n a l y s i s 4 - no pelvic assessment when indicated 4 - less than required no. of v i s i t s no DLMP no complete physical within one year missed one or more weights immunization not up to date no DPTP booster only 2 DPTP no notation re any immunizat ion no family h i s t o r y no complete physical within one year no return v i s i t for assessment and follow-up u r i n a l y s i s TOTALS 124 41 48 * A n t i b i o t i c prescribed where previous s e n s i t i v i t y to i t had been noted. ** Some charts had more than one reason for inadequacy. - 5 8 -TABLE VI D i s t r i b u t i o n o f Reasons f o r Inadequacy by I n d i c a t o r C o n d i t i o n and Component o f Care C a t e g o r y Reach C l i n i c Study C a t e g o r y * I n d i c a t o r C o n d i t i o n H i s t o r y P h y s i c a l Exam Lab Management T o t a l Acute I n f e c t i o u s D i s e a s e : O t i t i s Media UTI S u b t o t a l 6 4 10 7 4 11 P r e v e n t i v e C a r e : P r e n a t a l Care Care o f Newborn Immunization S u b t o t a l 5 3 4 1 6 11 19 4 6 29 C h r o n i c D i s e a s e : H y p e r t e n s i o n D e p r e s s i o n S u b t o t a l 4 1 5 6 2 8 TOTALS # % 7 (14.5) 11 (22.9) 9 (18.8) 21 (43.8) 48 (100) * We have adapted Palmer and Nesson's typology-'- 3 by combining C h r o n i c and P s y c h o / S o c i a l c o n d i t i o n s because: l ) f o r our study we c o n s i d e r e d D e p r e s s i o n as a form of c h r o n i c d i s e a s e and 2) by combining H y p e r t e n s i o n and D e p r e s s i o n we can examine at l e a s t two forms o f c h r o n i c d i s e a s e . CHAPTER 4 - NOTES 1. Sibley, J . C , et a l . , Quality-of-Care Appraisal i n Primary Care: A Quantitative Method. Ann. Int. Med., 1975; 83: 46. 2. Palmer, R.H., and Nesson, H.R., A Review of Methods for Ambulatory Medical Care Evaluations. Med. Care, 1982; XX: 758. - 60 -CHAPTER 5 Study C l i n i c : Discussion 5.1 General The previous two chapters have described the methodology and the r e s u l t s of a q u a l i t y of care evaluation of a p a r t i c u l a r Primary Care s e t t i n g . A s p e c i f i c evaluation methodology has been applied and care was taken that i t be a random, v a l i d and r e l i a b l e a p p l i c a t i o n . The study has generated c e r t a i n observations about and in s i g h t s into the process of medical care at the study c l i n i c and provided i n d i c a t i o n s for where improvements might be made. In add i t i o n , important features of the methodology i t s e l f have been highlighted. 5.2 The Methodology Several l i m i t a t i o n s of the in d i c a t o r condition, e x p l i c i t process, chart audit method need to be acknowledged and discussed. F i r s t , since t h i s i s a process evaluation, no attempt i s made to examine outcome; thus the r e s u l t s can, i n no way, be extended to conclusions about patient outcomes, i n d i v i d u a l or o v e r a l l . While the BRCT did include the assessment of outcome''" time did not permit t h i s i n the Reach Study. However, as discussed i n Chapter 2, there appears to be no way to control for a l l the variables that a f f e c t patient outcome, and i n f a c t , there are, as yet, few meaningful, q u a n t i f i a b l e , widely accepted outcome measures. Thus, process evaluation, such as the one described here, emerges as an e n t i r e l y v a l i d and fe a s i b l e option, rather than as a poor substitute for outcome evaluation. In terms of f e a s i b i l i t y , the study i t s e l f from s t a r t to f i n i s h took f i v e months with the chart selectioon process, the data abstraction and the data - 61 -a n a l y s i s b e i n g accomplished over a t h r e e and h a l f month p e r i o d u t i l i z i n g a s i n g l e r e s e a r c h e r on a two day a week b a s i s . Thus the e v a l u a t i o n i n s t r u m e n t i s f e a s i b l e f o r use i n s h o r t term s t u d i e s and i s r e l a t i v e l y i n e x p e n s i v e i n terms of r e s e a r c h time and money. Furthermore, i n u n d e r t a k i n g e v a l u a t i v e s t u d i e s o f m e d i c a l c a r e i t i s , o f c o u r s e , a g r e a t advantage, f o r r e a s o n s o f convenience as w e l l as f o r c o m p a r a b i l i t y o f d a t a a c r o s s study s e t t i n g s , to use e x i s t i n g i n s t r u m e n t s and m e t h o d o l o g i e s . The e x p e r i e n c e w i t h the Reach C l i n i c s t u d y demonstrated t h a t the BRCT c r i t e r i a were easy to use. The d a t a c o l l e c t i n g s heets were c l e a r and c r i t e r i a f o r making judgments o f adequacy unambiguous. While Reach c l i n i c a l s t a f f may not concur w i t h a l l the p r o c e s s c r i t e r i a developed f o r the BRCT, the c r i t e r i a used had enough l a t i t u d e to a l l o w f o r c o n s i d e r a b l e i n d i v i d u a l p r a c t i t i o n e r v a r i a t i o n . F o r the study d e s c r i b e d here the method o f p r o c e s s e v a l u a t i o n chosen was a c h a r t a u d i t . T h i s i n i t s e l f has l i m i t a t i o n s . I n the f i r s t p l a c e , one o f the major d i f f i c u l t i e s i n c o n d u c t i n g a c h a r t a u d i t e v a l u a t i o n l i e s w i t h the d a t a source - the p a t i e n t c h a r t . They are o f t e n i l l e g i b l e and can be h i g h l y i d i o s y n c r a t i c i f s t a n d a r d i z e d c h a r t i n g methods are not used. A l s o , i f p a t i e n t d a t a are not cumulated i n any way, such as by d i a g n o s t i c c a t e g o r y , as was the case i n t h i s s t u d y , the s e a r c h f o r c h a r t s e l i g i b l e f o r study can be v e r y time consuming. Improvements i n p a t i e n t i n f o r m a t i o n systems would g r e a t l y enhance the f e a s i b i l i t y o f the c h a r t a u d i t . However, a more s e r i o u s l i m i t a t i o n o f the c h a r t a u d i t method as i d e n t i f i e d i n Chapter 2, i s t h a t i t r e l i e s e n t i r e l y on the documentation i n p a t i e n t c h a r t s . In o t h e r words, t h e r e i s no way to a s s e s s what may have been done, but not 2 . . . r e c o r d e d . Romm and Putnam found s i g n i f i c a n t d i s c r e p e n c i e s between - 62 -information contained i n patient charts of a h o s p i t a l general medicine c l i n i c , and t r a n s c r i p t s of audiotaped verbal i n t e r a c t i o n s between patient and provider. They make the important obse r v a t i o n that t h i s incomplete recording of information p a r t i a l l y explains low lev e l s of performance on recommended care items found i n q u a l i t y of care studies. Without attempting to comment on the r e l a t i v e c l i n i c a l s i g n i f i c a n c e of any of the reasons for inadequacy found i n this study (Table VI), i t would appear that many omissions may simply be a re s u l t of f a i l u r e s i n charting. Standardization of charting protocol may minimize t h i s problem. Thus, while limited i n some respects, a chart audit method may h i g h l i g h t important, but e a s i l y corrected problems i n recording. Improvement i n t h i s area may not only enhance the v a l i d i t y and u t i l i t y of the patient chart as a means of communication, but may also have an influence on patient outcomes, compliance and s a t i s f a c t i o n . C l e a r l y , future research should focus on these r e l a t i o n s h i p s . Using patient charts as a way to evaluate the process of care has other implications. Patient charts are not only the provider's record of care; they are also an e s s e n t i a l means for communication with colleagues, e s p e c i a l l y i n a se t t i n g such as Reach which emphasizes a team approach to care. This c r u c i a l feature of the medical record i s of course a raison d'etre of the chart audit method. Also, from a purely external, pragmatic point of view, patient charts are the only l e g a l record of care. Thus, from several perspectives i t i s both relevant and germane to examine the a c t i v i t i e s of care providers as they are recorded i n the patient chart. - 63 -The " t r a c e r " o r i n d i c a t o r c o n d i t i o n method r e q u i r e s some q u a l i f i c a t i o n . S i n c e i n e f f e c t one i s sampling c a r e g i v e n , g e n e r a l i z a b i l i t y may be a problem. While we must acknowledge t h i s problem and thus be c i r c u m s p e c t i n our c o n c l u s i o n s about the t o t a l c a r e p r o v i d e d a t Reach i t i s i n t e r e s t i n g t o note S i b l e y e t a l ' s o b s e r v a t i o n t h a t P r i m a r y Care p r a c t i t i o n e r s cannot be expected to be u n i f o r m l y "good" o r "bad". D i f f e r e n c e s i n s c o r e among i n d i c a t o r c o n d i t i o n s ...are n o r m a t i v e i n P r i m a r y C a r e ^ . (emphasis added) We might e x p e c t , f o r example, a p r a c t i t i o n e r to be more i n t e r e s t e d i n o P r e n a t a l Care than g e r i a t r i c c a r e ; t h i s d i f f e r e n c e i n p r e f e r e n c e might show up i n the q u a l i t y o f c a r e p r o v i d e d f o r these two a r e a s o f P r i m a r y Care. F i n a l l y , the methodology f o c u s e s p r i m a r i l y on the t e c h n i c a l a s p e c t s o f c a r e and thus p r o v i d e s l i t t l e scope f o r examining p s y c h o - s o c i a l i s s u e s which may be deemed important components o f c a r e i n some c l i n i c a l s e t t i n g s . I t i s 4 i n t e r e s t i n g to note Berg and K e l l y ' s f i n d i n g i n t h e i r study o f a u d i t p r o t o c o l s used i n an urban m u l t i h o s p i t a l c o n t e x t , t h a t o n l y 4% o f the c r i t e r i a items r e l a t e d to p a t i e n t e d u c a t i o n and 3% r e l a t e d to e i t h e r p s y c h o s o c i a l h i s t o r y , p s y c h o s o c i a l c o n s u l t a t i o n or the impact o f i l l n e s s on the p a t i e n t . While t h i s may be a p p r o p r i a t e f o r h o s p i t a l c a r e , i t may be t h a t c a r e p r o t o c o l s f o r P r i m a r y Care ought to i n c l u d e more non-medical c r i t e r i a i t e m s . I f P r i m a r y Care does encompass the " m e d i c a l f r i e n d " concept as suggested i n Chapter 1, then, c l e a r l y , t h i s i s an a r e a where f u t u r e work needs to be done. The i s s u e s d i s c u s s e d above are i n t e n d e d , p r i m a r i l y , to be c a v e a t s i n the i n t e r p r e t a t i o n and use o f the d a t a r a t h e r than major c r i t i c i s m s o f the methods employed. The l i m i t a t i o n s i n the methodology must a l s o be tempered w i t h Brook - 64 -and A p p e l ' s o b s e r v a t i o n t h a t e x p l i c i t p r o c e s s e v a l u a t i o n produces the " s e v e r e s t judgment" o f the q u a l i t y o f c a r e when compared to o t h e r methods of e v a l u a t i o n . 5.3 The R e s u l t s While o n l y 21% o f a l l the c a r e p r o v i d e d at Reach was sampled i n t h i s s t u d y , i t was f e l t t h a t the range o f c o n d i t i o n s s t u d i e d was broad enough to be an adequate i n d i c a t o r o f the o v e r a l l q u a l i t y o f c a r e . In examining the d i s t r i b u -t i o n o f the i n d i c a t o r c o n d i t i o n s i n terms of how f r e q u e n t l y they were encountered at Reach i t i s important to note t h a t t h i s does not n e c e s s a r i l y r e f l e c t the amount o f time spent on each c o n d i t i o n ; the c a r e o f an e p i s o d e of o t i t i s media, f o r example, may r e q u i r e o n l y two v i s i t s , w h i l e p r e n a t a l c a r e may r e q u i r e f i f t e e n o r more v i s i t s . The e s t i m a t e s i n Column 2 o f T a b l e 1, may appear low to the c l i n i c i a n who may be more aware of the o v e r a l l time spent on each i n d i c a t o r c o n d i t i o n . The v a r i a t i o n i n the number o f e p i s o d e s o f c a r e e v a l u a t e d i n each i n d i c a t o r c o n d i t i o n may have some bea r i n g ' on the i n t e r p r e -t a t i o n o f the r e s u l t s . However, g i v e n the r a n d o m i z a t i o n p r o c e s s , t h i s s h o u l d r e p r e s e n t an a c c u r a t e p r o f i l e o f the case l o a d at Reach. Tw o - t h i r d s o f the c a r e d e l i v e r e d by the study c l i n i c has been shown to be judged e i t h e r s u p e r i o r or adequate by the methodology as a p p l i e d . Furthermore, areas where c o r r e c t i v e a c t i o n c a n be taken - at l e a s t i n the c h a r t i n g o f the p r o c e s s of p a t i e n t c a r e - have been i n d i c a t e d . T a b l e V I shows t h a t , f o r each o f the d i f f e r i n g c a t e g o r i e s of P r i m a r y Care, a t t e n t i o n to d i f f e r e n t components o f the m e d i c a l c a r e p r o c e s s - a t l e a s t as they are r e c o r d e d - i s r e q u i r e d . Thus, f o r acute i n f e c t i o u s d i s e a s e s , the c l a r i f i c a t i o n and e x p l i c i t statement o f management p l a n s would seem to be important i n enhancing the q u a l i t y o f c a r e as - 65 -judged by t h i s methodology. For preventive care, attention appears to be required i n many areas - regular weighing (or charting of weight) of prenatal patients being the major omission. F i n a l l y , f o r chronic disease care, increased at t e n t i o n to the h i s t o r y and physical exam would seem to be warranted. In terms of the comparability of the q u a l i t y of care delivered by Reach with that delivered i n other Primary Care settings, t h i s study has shown that the present adequate or superior score for Reach appears to be s i m i l a r to that of the BRCT groups (Table I I I ) . However, the f a i l u r e to detect a differ e n c e between the Reach score and eit h e r of the BRCT scores (Table IV) may be a res u l t of the smaller o v e r a l l sample siz e achieved for Reach*' (reasons f o r the reduction of the sample siz e were outlined i n the previous chapter). An i n d i c a t i o n that a possible difference exists i s provided by Table IV, i n which comparison of the standardized scores of Reach and the CC group shows a differen c e which nearly achieves s t a t i s t i c a l s i g n i f i c a n c e . While t h i s study does not allow for i t to be said that Reach d e l i v e r s a better q u a l i t y of care than the CC group, neither i s i t l i k e l y that Reach d e l i v e r s a s i g n i f i c a n t l y worse q u a l i t y of care than the RNP group. Thus, i t i s probable that Reach d e l i v e r s a q u a l i t y of care at le a s t as adequate as the BRCT groups. Whether or not th i s l e v e l of adequacy i s acceptable i n any absolute terms i s another issue; what i s important here i s the comparability of the qu a l i t y of care i n d i f f e r e n t Primary Care s e t t i n g s . 5 . 4 Conclusion The r e s u l t s indicate that: 1) Reach Community C l i n i c d e l i v e r s a q u a l i t y of medical care as measured which i s most l i k e l y comparable to that demonstrated for a s i m i l a r practice s e t t i n g ; 2) s p e c i f i c areas of practice or recording can be i d e n t i f i e d as requiring attention by c l i n i c i a n s and other s t a f f , and thus can - 66 -be a focus of future evaluations of t h i s p r a c t i c e s e t t i n g ; and 3) the methodology developed for the BRCT i s e a s i l y adaptable and relevant to primary care settings other than reported i n the BRCT. - 67 -CHAPTER 5 - NOTES 1. Sackett, D.L., et a l . , The Burlington Randomized T r i a l of the Nurse P r a c t i t i o n e r : Health Outcomes of Patients. Ann. Int. Med., 1974; 80: 137. 2. Romm, F.J., and Putnam, S.M., The V a l i d i t y of the Mecical Record. Med. Care, 1981; 19: 310. 3. Sibley, J . C , et a l . , Quality-of-Care Appraisal i n Primary Care: A Quantitative Method. Ann. Int. Med., 1975; 83: 46. 4. Berg, J.K., and K e l l y , T.T., Evaluation of Psychological Health Care i n Quality Assurance A c t i v i t i e s . Med. Care, 1981; 19: 24. 5. Brook, R.H., and Appel, F.A., Quality of Care Assessment: Choosing a Method f or Peer Review. NEJM, 1973; 288: 1323. 6. For a discussion on the e f f e c t of sample siz e on the r e s u l t s of randomized con t r o l l e d t r i a l s see: Freiman, J.A. et a l , The Importance of Beta, The Type II Error and Sample Size i n the Design and Interpretation of the Randomized Control T r i a l . NEJM, 1978; 299: 690. - 68 -CHAPTER 6 Po l i c y Considerations and Implications 6.1 Preamble This thesis has presented the r e s u l t s of a q u a l i t y of care evaluation of a community c l i n i c i n the context of a s p e c i f i c Primary Care evaluation methodology: an e x p l i c i t - p r o c e s s - c r i t e r i a , i n d i c a t o r - c o n d i t i o n chart audit developed f o r the Burlington Randomized Controlled T r i a l . This study has allowed f o r the assessment of the u t i l i t y of the process c r i t e r i a developed for the BRCT. While the BRCT was primarily concerned with the comparison of nurse p r a c t i t i o n e r s and physicians, i t was f e l t that the process c r i t e r i a developed for that study might be useful i n more general evaluations of primary care. As far as can be ascertained from a thorough review of the l i t e r a t u r e no such wider a p p l i c a t i o n of these c r i t e r i a has been reported to date. This study, then, i l l u s t r a t e s the relevance and f e a s i b i l i t y of the BRCT methodology i n a community c l i n i c s e t t i n g . Questions about the i n t e r n a l v a l i d i t y and r e l i a b i l i t y of s p e c i f i c methodologies need to be addressed by evaluators and researchers developing evaluation t o o l s , and, indeed, i s the focus of much of the current evaluative research, as discussed i n Chapter 2. Techniques for e s t a b l i s h i n g v a l i d i t y and r e l i a b i l i t y also need to be tested e m p i r i c a l l y and w i l l not be dealt with here. What i s of i n t e r e s t here, to p o l i c y makers, who may be making s i g n i f i c a n t p o l i c y decisions on the basis of evaluations and to organizations, who are required to conduct evaluations, i s the f e a s i b i l i t y and relevance of process evaluations. - 69 -6.2 F e a s i b i l i t y o f P r o c e s s E v a l u a t i o n The f e a s i b i l i t y of the s p e c i f i c p r o c e s s e v a l u a t i o n methodology used i n the study p r e s e n t e d here has a l r e a d y been add r e s s e d i n Chapter 5. I n terms of the g e n e r a l f e a s i b i l i t y o f p r o c e s s e v a l u a t i o n s , the major d i f f i c u l t y i s i n the development of the m e d i c a l c a r e c r i t e r i a t h e m s e l v e s . As has been d i s c u s s e d i n Chapter 2, c r i t e r i a s h o u l d be i d e a l l y l i m i t e d to those items of the m e d i c a l c a r e p r o c e s s t h a t have been shown to be l i n k e d to p o s i t i v e p a t i e n t outcomes, i . e . the e f f i c a c y o f the c a r e items chosen must be demonstrable. T h i s i s , of c o u r s e , an i n h e r e n t d i f f i c u l t y i n p r o c e s s e v a l u a t i o n s and w i l l c o n t i n u e to be, as l o n g as m e d i c a l c a r e i s based on the p r e v a i l i n g n o r m a tive s t a n d a r d s of m e d i c a l p r a c t i c e . As m e d i c a l p r a c t i c e changes and e v o l v e s , q u a l i t y o f c a r e c r i t e r i a w i l l have t o be r e v i s e d and r e f i n e d . However, once d e v e l o p e d , c a r e c r i t e r i a can be a p p l i e d i n a f a i r l y s t r a i g h t f o r w a r d way as shown by t h i s s t u d y . What i s more important than knowing i f a q u a l i t y o f c a r e e v a l u a t i o n can be done e a s i l y and c h e a p l y , i s knowing i f , when i t i s done, i t t e l l s us a n y t h i n g v e r y r e l e v a n t about our h e a l t h c a r e system. 6.3 R e l e v a n c e of P r o c e s s E v a l u a t i o n The major assumption a t the b a s i s of any h e a l t h c a r e system i s t h a t the d e s i r e d end r e s u l t i s the improvement i n the h e a l t h of the p o p u l a t i o n . But, what i s h e a l t h and what can be c o n s i d e r e d improvement? H e a l t h can be d e f i n e d on a spectrum from "the absence of d i s e a s e " to the World H e a l t h O r g a n i z a t i o n d e f i n i t i o n , " H e a l t h i s a s t a t e of complete p h y s i c a l , m ental, s o c i a l and economic w e l l - b e i n g . . . " . While the l a t t e r d e f i n i t i o n may e n s h r i n e a n o b l e i d e a l , i t l e a v e s much o u t s i d e the r e a l m of the c u r r e n t h e a l t h - 70 -care d e l i v e r y system. On the other hand, the former d e f i n i t i o n of health i s obsolete, belonging to a time when the major i n f e c t i o u s diseases were the concern of the health care system; i t i s no longer an operational d e f i n i t i o n , at l e a s t i n the developed countries, where the major health problems are of a chronidegenerative sort - heart disease, hypertension, cancer - which have large psychosocial components. Not only do we not have an operational d e f i n i t i o n of health, we also do not have a clea r understanding of what the product of the health care system ought to be. "Improvement of health" seems an obvious one, but i t i s imprecise. I t can mean anything from reductions i n mortality/morbidity rates - the t r a d i t i o n a l way of assessing the e f f i c a c y of any intervention by the health care system, to the currently popular term "added quality-adjusted l i f e years". Again, while the former i s a crude measure, the l a t t e r opens up a Pandora's box of other issues - what jts_ q u a l i t y of l i f e , and more importantly, who w i l l define i t . These questions border on the e t h i c a l and the theological and for the most part have not been addressed by the current health d e l i v e r y system. We would do well, too, to remember Ressner's warning that health outcome i s not the same as health status*. Improvement i n health outcome has t r a d i t i o n a l l y been the province of the health care system - for example, the lowering of blood pressure through d i e t and pharmaceutical regimes, the prevention of polio through mass vaccination programs, the reduction of p e r i n a t a l r i s k s through broad-base maternal-infant services and programs. Health status, on the other hand, has existed l a r g e l y outside the health care system being dependent on myriad factors from genetics to l i f e s t y l e to health b e l i e f . - 71 -L i f e s t y l e has to do with aspects of our personal behaviour that a f f e c t our health - smoking, drinking, wearing seat b e l t s , exercise, n u t r i t i o n , etc. The 2 Lalonde Report, A New Perspective on the Health of Canadians , established the concept of l i f e s t y l e as an e s s e n t i a l component of the health care package. Health b e l i e f i s b a s i c a l l y the concept that our b e l i e f s about how healthy we are and about the e f f i c a c y of any treatment have a s i g n i f i c a n t impact on both actual health status and health outcome. The emergence of l i f e s t y l e and health b e l i e f as legitimate components of the health care sytem has i n i t i a t e d a whole range of new research areas as well as l e g i t i m i z i n g several new health professions - health educators, l i f e s t y l e counsellors, etc. Health and health care has become everybody's business, i n both senses of the word! However, there are those for whom these issues are red herrings, smacking of v i c t i m blaming and s h i f t i n g of the r e s p o n s i b i l i t y for health from a s o c i a l l e v e l to an i n d i v i d u a l l e v e l , thereby absolving government from r e s p o n s i b i l i t y . A l l of the above i s by way of a r e f l e c t i o n on the d i f f i c u l t i e s of defining the product of the health care system i n any e a s i l y q u a n t i f i a b l e and measurable way, e s p e c i a l l y as our concepts of health continue to change and expand. So, i f i t i s i n c r e a s i n g l y d i f f i c u l t to examine the outcome or product of the health care system we can at least look at what people do. Donabedian loaned some c r e d i b i l i t y to t h i s view when he said Conformity of practice to accepted standards has a kind of c o n d i t i o n a l or interim v a l i d i t y which may be more relevant to the purposes of assessment i n s p e c i f i c i n s t a n c e s . 3 4 Moreover, i n a recent a r t i c l e the authors provide several compelling reasons why process evaluations may be even more useful to c l i n i c i a n s and p o l i c y makers, s t a t i n g - 72 -...quality of care studies that focus only on structure or outcomes are u n l i k e l y to provide v a l i d information about the re a l q u a l i t y of care being delivered... Indeed, much of the q u a l i t y assurance a c t i v i t i e s undertaken by ho s p i t a l s , i n order to meet a c c r e d i t a t i o n standards, i s i n terms of structure and administrative process. However, much evaluation of c l i n i c a l process, both i n and out of h o s p i t a l s , remains i m p l i c i t i n the form of peer review, making i t almost inaccessible to objective evaluation. A very good case for the relevance of process evaluations i s raised i n a recent paper by Catherine Hewes of the I n s t i t u t e of P o l i c y Sciences at Duke University"*. In looking at the use of outcome measures f or the evaluation of long term care - which can perhaps be regarded as a s p e c i a l case of Primary Care - she looks at the whole concept of care as a process. Health care, apart from the preventative aspects, i s primarily a service industry, providing various types of highly personalized service. This means that the product i s mainly consumed at i t s point of production and the act of giving care takes place at the same time and i n the same place as the act of receiving i t . In other words, process cannot be separated from outcome as i n most produc-t i o n systems. Of course, there i s an assumption that there i s a ration a l e underlying the a c t i v i t i e s of health care providers, i . e . what they do has some kind of p o s i t i v e e f f e c t . Weak as th i s l i n k may sometimes appear, there i s s t i l l relevance i n looking e x p l i c i t l y at the a c t i v i t i e s of health professionals. This i s e s p e c i a l l y true i n the context of a p u b l i c a l l y funded health care system. One of the major problems currently facing those who pay for health care i s the a l l o c a t i o n of scarce resources. As Stoddart says the question i s : Is t h i s health procedure, service or program worth doing  compared with other things we could do with these same  resources? Are we s a t i s f i e d that the health resources (required to make the procedure, service or program ava i l a b l e to those who could benefit from i t ) should be spent i n t h i s rather than some other way?^ - 73 -I t could be shown for example, that two d i f f e r e n t Primary Care service d e l i v e r y packages - a community c l i n i c and a private group practice - d e l i v e r comparable q u a l i t y of care as determined by an e x p l i c i t process evaluation. Given the s o c i a l , p o l i t i c a l and economic context, p o l i c y makers may opt for the l e a s t c o s t l y d e l i v e r y mode. This l a s t statement, of course, raises issues beyond the scope of t h i s t h e s i s . What i s important i s that c l e a r l y defined medical care process evaluation can be a useful p o l i c y t o o l . 6.4 Summary This thesis has demonstrated the u t i l i t y of a p a r t i c u l a r evaluation methodology, and provided a context for the discussion of the function and s i g n i f i c a n c e of process evaluation. In a d d i t i o n the major areas where future work i s required i n the development of evaluation methodology have been high-l i g h t e d . Improved c l i n i c a l data management needs to be developed, that i s both acceptable to c l i n i c a l and other s t a f f and that can enhance the f e a s i b i l i t y of q u a l i t y of care evaluations. Current work on patient information systems at both the c l i n i c a l and M i n i s t r y of Health l e v e l i n B.C. i s increasing the p o s s i b i l i t y of meeting t h i s requirement. Future developments i n Primary Care evaluation methodology are needed i n the a p p l i c a t i o n of the methodology used i n t h i s study to a greater d i v e r s i t y of p r a c t i c e settings to confirm i t s u t i l i t y , the linkage of recorded a c t i v i t i e s and other factors such as patient s a t i s f a c t i o n , compliance, etc., and continued development of process c r i t e r i a correlated with p o s i t i v e outcomes. - 74 -In addition, there i s an indicated need f o r further empirical demonstration of the u t i l i t y of process evaluation as a medical care assessment methodology since i t s r e l a t i v e l y low cost and ease of a p p l i c a t i o n make such an approach a t t r a c t i v e when health care costs are of increasing concern. And f i n a l l y , i n order for governments to know whether or not they are getting value for t h e i r money, they f i r s t need to answer some apparently simple questions - who i s doing what to whom, where, when, how and why? As cost-effectiveness analyses become incr e a s i n g l y a t t r a c t i v e to governments who bear the cost of health s e r v i c e s , c l e a r e r d e f i n i t i o n s of outcome or the product of the health care system w i l l need to be developed. U n t i l widely accepted outcome measures are a v a i l a b l e , examining the a c t i v i t i e s of the health care system, or i n Donabedian's terms the process of medical care, i s a relevant endeavour and can provide useful data on some aspects of the effectiveness side of cost-effectiveness and related studies. The study presented here i l l u s t r a t e s one of the ways that t h i s can be accomplished. - 75 -CHAPTER 6 - NOTES 1. Kessner, D.M., Quality Assessment and Assurance: Early Signs of Cognitive Dissonance. NEJM, 1978; 298: 381. 2. Department of National Health and Welfare A New Perspective on the Health of Canadians Ottawa: Information Canada, 1973. 3. Donabedian, A., Evaluating Quality of Medical Care. Milbank Memorial  Fund Quarterly, 1966; XLIV. 4. Department of C l i n i c a l Epidemiology and B i o s t a t i s t i c s , McMaster Uni v e r s i t y Health Sciences Centre, How to read c l i n i c a l journals: VI. To learn about the q u a l i t y of c l i n i c a l care. CMAJ, 1984; 130: 377. 5. Hewes, C , Outcome Measures and Long-Term Care: Defining and Assuring Quality. Paper prepared f o r presentation at the F i f t h Annual Research Conference. 6. Stoddart, G.L., On Determining The E f f i c i e n c y of Health Programs. Unpublished document, McMaster U n i v e r s i t y , 1980. BIBLIOGRAPHY Becker, M.H. (ed.), The Health Belief Model and Personal Health Behaviour (Thorofare, N.J.: Charles B. Slack Publishing, 1974). Berg, J.K., and Kelly, T.T., Evaluation of Psychological Health Care in Quality Assurance Activities. Medical Care, 1981; 19: 24. Brook, R.H., Studies of Process-Outcome correlations in Medical Care Evaluations. Medical Care, 1979; 17: 868. Brook, R.H., and Appel, F.A., Quality of Care Assessment: Choosing a Method for Peer Review. New England Journal of Medicine, 1973; 288: 1323. Brook, R.H. and Stevenson, R.L., Effectiveness of Patient Care in an Emergency Room. New England Journal of Medicine, 1970; 283: 904. Brook, R.H., et al., Effectiveness of Non-emergency Care via an Emergency Room: A Study of 166 Patients with Gastrointestinal symptoms. Annals of  Internal Medicine, 1973; 78: 333. Brook, R.H., et al., Assessing the Quality of Medical Care Using Outcome Measures: An Overview of the Method. Medical Care Supplement, 1977; 15: 1. Canada, Bill C-227, Medical Care Act, 1966, 14-15 Elizabeth II (Ottawa: Queen's Printer, 1966). Hospital Insurance and Diagnostic Services Act, April 12, 1957, and  Regulations, 5-6 Elizabeth II (Ottawa: Queen's Printer, 1957). (Department of National Health and Welfare) A New Perspective on the  Health of Canadians Ottawa: Information Canada, 1973. Cartwright, A. Patients and their Doctors: A Study of General Practice (London: Routledge & Kegan Paul, 1967). Clute, K.F., The General Practitioner, Toronto: University of Toronto Press, 1963. - 77 -Codman, E.A., A Study i n Hospital E f f i c i e n c y As Demonstrated by the Case Report of the F i r s t Five Years of Private Hospital, Thomas Todd Co., (Boston), 1918. Department of C l i n i c a l Epidemiology and B i o s t a t i s t i c s , McMaster U n i v e r s i t y Health Sciences Centre, How to read c l i n i c a l journals: VI. To learn about the q u a l i t y of c l i n i c a l care. Canadian Medical Association Journal, 1984; 130: 377 Donabedian, A., Evaluating Quality of Medical Care. Milbank Memorial Fund  Quarterly, 1966; XLIV. Donabedian, A., "A Frame of Reference". In A Guide to Medical Care Administration, Volume I I : Medical Care Appraisal ~ Quality and U t i l i z a t i o n (New York: American Journal of Public Health, 1969). Doyle, J . C , Unnecessary hysterectomies: Study of 6,248 operations i n t h i r t y - f i v e h o s p i t a l s during 1948. Journal of the American Medical  Association, 1953; 151: 360. Es c o v i t z , G.H., "The Continuing Education of Physicians: I t s Relationships to Quality of Care Evaluation." In Symposium on Changing Concepts of Disease, Medical C l i n i c s of North America, 1973; 57: 1135. Gonnella, J.S., Evaluating Patient Care, Journal of the American Medical  Association, 1970; 214: 2040. Havighurst, C C , and Blumstein, J.F., Coping with Quality/Cost Trade-Offs i n Medical Care: The Role of PSROs. Northwestern Law Review, 1975; 70: 6. Hewes, C , Outcome Measures and Long-Term Care: Defining and Assuring Quality. 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Lembcke, P.A., Medical Auditing by s c i e n t i f i c methods: I l l u s t r a t e d by major female p e l v i c surgery. Journal of the American Medical Association, 1956; 162: 646. McAuliffe, W.E., Measuring the Quality of Medical Care: Process versus Outcome. Milbank Memorial Fund Quarterly, 1979; 57 (1): 118. McAuliffe, W.E., Response to Dr. Brook. Medical Care, 1979; 17: 874. Morehead, M.A., et a l . , "Evaluating Quality of Medical Care i n the Neighborhood Health Center Program of the O f f i c e of Economic Opportunity. Medical Care, 1970; 8: 118. Morehead, M.A., et a l . , Comparisons between 0E0 neighborhood health centers and other health care providers of ratings of the q u a l i t y of health care. American Journal of Public Health, 1971; 61: 1294. Palmer, R.H., and Nesson, H.R., A Review of Methods for Ambulatory Medical Care Evaluations. Medical Care, 1982; XX (8): 758. 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I f , i n our opinion, we are unable to present the f i n a l report to the Board as of March 1, 1983, we may request an extension, not to exceed three weeks, f or the presentation of the f i n a l r e p o r t . (2) We w i l l undertake s a i d Chart Audit on the s t r i c t understanding that under no circumstances w i l l the charts or any other i d e n t i f i a b l e medical i n f o r m a t i o n leave the premises of the Reach C l i n i c and a l l charts w i l l be checked out of and returned to the Record Room of the Reach C l i n i c by a method to be devised by us and the Record Room s t a f f . (3) We w i l l undertake that no pa t i e n t names or other information c l e a r l y i d e n t i f y i n g any i n d i v i d u a l w i l l be used i n any report or other w r i t t e n document, i n c l u d i n g any p o t e n t i a l j o u r n a l a r t i c l e s , a r i s i n g from t h i s A u d i t . (4) We w i l l undertake that no information c l e a r l y i d e n t i f y i n g by name or i n any other way any p h y s i c i a n or other s t a f f member at the Reach C l i n i c w i l l appear i n any report or other w r i t t e n document, i n c l u d i n g p o t e n t i a l j o u r n a l a r t i c l e s a r i s i n g from the Audit. (5) We w i l l have the r i g h t to use the r e s u l t s of t h i s Audit f o r p u b l i c a t i o n i n an ad j u d i c a t e d j o u r n a l with the f o l l o w i n g s t i p u l a t i o n s : (a) I f , i n the opinion of the Reach C l i n i c and us, the data suggest that the Reach C l i n i c does not compare favourably with data of a s i m i l a r nature i n the l i t e r a t u r e any p u b l i c a t i o n of s a i d data w i l l not r e f e r by name to the Reach C l i n i c ; or (b) I f , i n the opinion of the Reach C l i n i c or us, the dhta suggest that the Reach C l i n i c does compare favourably or i s at l e a s t comparable with the performance of s i m i l a r medical f a c i l i t i e s as c i t e d i n the l i t e r a t u r e , the name Reach C l i n i c may be used i n any p u b l i c a t i o n . T f .../3 Mr. John Richards October 22, 1982 Pafce 3  (6) We w i l l undertake to commit the equivalent of two days (16 hours) per week to t h i s p r o j e c t . (7) We w i l l undertake to provide signed r e c e i p t s f o r a l l monies paid to B) We, Mr. John Richards, President of the Board of Reach C l i n i c , Ms. M a r i l y n F o r s t e r , Administrator of the Reach C l i n i c , and Dr. Ian Gummeson, Medical Coordinator of the Reach C l i n i c w i l l : (1) Provide access to a l l medical charts chosen f o r a u d i t i n g . (2) Support Dr. Sheps and Ann Robertson i n any dispute regarding the p r o j e c t with any Reach s t a f f unless the p r o v i s i o n s of t h i s l e t t e r of agreement are deemed to have been broken by Dr. Sheps and/or Ann Robertson and i n the event of a concern about a v i o l a t i o n of the terms of t h i s agreement we w i l l n o t i f y Dr. Sheps i n w r i t i n g regarding s a i d v i o l a t i o n and wc w i l l meet with Dr. Sheps and Ann Robertson regarding s a i d v i o l a t i o n . (3) We agree to pay Dr. Sheps a t o t a l of f i v e thousand d o l l a r s ($5000.00) i n the f o l l o w i n g manner: (a) A f i r s t i n s t a l l m e n t of twelve hundred and f i f t y d o l l a r s ($1250.00) to be p a i d at a project review meeting held during the week of December 6 - 10, 1982 at the conclusion of Phase I: I n i t i a t i o n of Phase II i s dependent upon payment of the f i r s t i n s t a l l m e n t and non-payment of the f i r s t i n s t a l l m e n t w i l l be considered a termina-t i o n of t h i s agreement; (b) A second i n s t a l l m e n t of twelve hundred and f i f t y d o l l a r s ($1250.00) to be paid at a project review meeting held during the week of January 31 - February 4, 1983, i . e . at the conclusion of Phase I I : I n i t i a t i o n of Phase III Is dependent upon payment of the second i n s t a l l m e n t and non-payment of the second i n s t a l l m e n t w i l l c o n s t i -tute an end to t h i s agreement; (c) A t h i r d i n s t a l l m e n t of twenty-five hundred d o l l a r s ($2500.00) to be p a i d upon r e c e i p t of one copy of the f i n a l report of t h i s p r o j e c t e i t h e r on March 1 or i f w r i t t e n permission Is given f o r an extension (not to exceed three weeks) on r e c e i p t of the report of t h i s p r o j e c t . (A) We agree to the r i g h t of p u b l i c a t i o n as s t i p u l a t e d above. .../A Appendix II C r i t e r i a and Abstract Sheets INDICATOR COriOlTIO'l #1 - OTITIS MEDIA DEFIHITIQU or AH EPISODE - OTITIS KEDIA O t i t i s Media episode b qlns when patient f i r s t consults physician or nurse about complaints related to the oar, or when diagnosis i s recorded in the chart within the study period. This wust be a new condition, or there must be reasonable evidence that a prior episode had been resolved s a t i s f a c t o r i l y . The episode ends on the last re-corded v i B i t concerning this problem or at the end of the study period, whichever occurs later. CATEGORIES OF INTCRVrUTION 1. follow-up v i s i t within one month of i n i t i a l episode 2. An appropriate antibiotic (Erythronycin. P e n i c i l l i n , Sulpha, Ampicillin. An Inappropriate, a n t i b i o t i c would be Tetracycline in a c h i l d under the age of 6, or Chlorasiphcnical. 3. Consultation 4. Statement that patient is cured or a clear statement of patient's status. 5. Continue antibiotics plus a further repeat v i s i t . 6. Kyringotomy plus further repeat v i s i t . 7. Third or subsequent v i s i t s with evidence or a stat«—ent that hearing has been checked. 8. Follow-up or late consultation with audlooetrlc e>>>aUnatlon. SCORING ADEQUATE  OPTION I 1. Follow-up v i s i t within one ronth of i n i t i a l episode. 2. An appropriate a n t i b i o t i c (Erythromycin, P e n i c i l l i n , Sulpha, A i r p i c l l l i n . An inappropriate an t i b i o t i c would be Tetracycline ln a c h i l d under the age of B, or Chlorarrtphenlcal. OPTION Z 3. Consultation THADEQUATE Less than adequate SUPER!OR OPTION I Adequat* - plus 4. Statement that patient is cured or • clear l U U M n t of patient** status. OPTICS 2 Adequate - plus - any one of the following* 5. Continue antibiotics plus a further repeat v i s i t . 6. Myringotomy plus further repeat v i s i t . 7. Third or subsequent v i s i t s with evidence or • statsnsnt that hearing has been checked. 6. Pollow-up or late consultation with audioswtric examination. OTITIS KEPIA Episode begins wh«a the patient flrat consult* physician mt nurse about cocplalnts related to the ear, or when th* diagnosis Is recorded within the study period. This must be a nev condition, with reasonable *rldance that a prior; episode has been resolved satisfactorily. The episode end* on the last recorded visit concerning, th* problea or at the end of the study period, whichever occurs later. 1 - YES 1.0. ' T " L .! L_ 2 - NO 1 2 3 4 5 8 - NOT APPLICABLE 9 - UNKNOWN I . I . '.•x«: [ ° I A L ° R ° J STUDT CODE 6 9 CATEGORIES or ivTrsvryTiOT - follow-up visit (within one month) - Antibiotics (Tetracycline for 8 years of age and under; Chloroaphanlcal - not to be used) - Continue Antibiotic* end repeat v i s i t - Myringotomy and repeat v i s i t - Three or more visits and hearing chacked Follow-up or late consultation and audlotaetrlc eraa Contul ts t lcm • 12 w i 14 15 5 Q Medical Statu* Q'j i1 INDICATOR CONDITION 9 2 - KYPCRTEMSIOH DEFINITION or AN EPISODE - HYPERTENSION Episode begins with f i r s t record of assessment or suutsoMent of hypertension ln situations where the c l a s s i f i c a t i o n c r i t e r i a of any of the three categories are met. The episode ends with the last v i s i t related to this indicator condition in the period under survei1lancv. Patients should tc c l a s s i f i e d according to the level of d i a s t o l i c blood pressure at the timo episode begins. DEFINITION OF CATEGORIES OF HYPERTENSION 1. 6lsiple Hypertension - a d i a s t o l i c blood pressure of 100 to 110, 55 years of age and utdor. 2. Intermediate Stage - UnCQ-npUcated - D i a s t o l i c pressure of 111 to 120, CO years of age and under. -3. Intcrmediarc Stage - Coreplicatcd a) D i a s t o l i c pressure of over 120, regardlass of age, OR b) Symptomatic hypotension with end organ damage, such as T.I.A., angina, shortness of breath, heart f a i l u r e , azotemia. Grade III retinopathy (haemorrhages or exudates) OR c) A strong fajnily history of one f i r s t degree relative having complications of hypertension. The patient under review would have a d i a s t o l i c pressure of 110 or over, OR d) Recurrence) of hypertension after special therapy, d i a s t o l i c pressure 110 cr over. CATEGO. ES OF INTERVENTION 1. Mood prticurc 2. Evidence of enquiry re symptoms ("No synptoms" or -a * y B i p t c m a t l c " acceptable) 3. Enquiry »c fanlly history ("Family history Nog." or "Positive" acceptable) 4. Enquiry rc previous illnesses ("Not s i g n i f i c a n t " or "Positive" acceptable) Physical Exawlnatlon 5. Cardiovascular examination ("C.V.Neg.", Comment on pulses, hesrt, acceptable as C.V.examination) 6 . Repeat v i s i t - either planned or taXen place - within three sooths 7. Laboratory investigation - urinal y s i s 8. Referral for Consultation T2-Special Attention • . Punduscoplc examination 10. Enquiry re cigarette smoking 11. Life stylet personal pressures end attitudes Phyclcal Examination 12. Blood pressure - both eras 13. At least two serial blood pressure readings on two separate visits 14. Blood I'ressure - standing, plus one other position Special Investigations 15. Serun electrolytes 16. I. V. P. 17. E. C. C. 18. Chest x-ray 19. Statement of renal function or a specific test, such as one of the foilowingi B.U.N.i Creatinine; rishbergi Specific Gravity of urinei Urinalysis - Klcroscopic. Treatment 20. a) Diet, exercise, drugs, or counselling with evidence that subsequent diastolic pressures are under 110, OR b) A specific statement why no treatment had been initiated. SCORING I - SIMPLE HYPERTENSION  ADEQUATE OPTIO.t I 1. Blood pressure 2. Evidence of enquiry re symptoms ("No symptoms" or "aaymptonetic" acceptable) 3. Enquiry re family history ("Family history Keg." or "Positive" acceptable) 4. Enquiry re previous illnesses ("Not significant" or "Positive" acceptable) 5. Evidence of cardiovascular examination 6. Repest visit - either planned or taken place - within three months 7. Laboratory Investigation - urinalysis i SCORING 7 - INTTRMTPIATT STAGE - UNCOMPLICATED  ADEQUATE " OVTIO'J I 1. Blood pressure 2. Evidence of enquiry re symptoms ("No symplona" or "asymptomatic" acceptable) 3. Enquiry re fanily history (Tanlly history licg." or "Positive" acceptable) 4. Enquiry re previous Illnesses ("Not significant" or "Positive" acceptable.) 5. Cardiovascular examination ("C.V. Heg.", Comment on pulses, heart, acceptable) 6. Repeat vi s i t - either planned or taken place - within three stonths 7. Laboratory Investigation - urinalysis 9. Fundus copic examination 20. a) Diet exorcise, drugs or counselling with evidence that subsequent diastolic pressures are under 110 OR b) A specific statement why no treatment had been initiated P L U S ANY FOUR OF TirE FOLLOWING 10. Enquiry re cigarette smoking 11. Life style, personal pressures and attitudes 12. Blood pr**surc - both arm 13. At least two serial blood pressure readings on two separate visits 14. Blood pressure - standing, plus one other position 15. Serin electrolytes 16. I. V. P. 17. E. C. G. IB. Chest x-ray 19. Statement of rena*. function or a specific test, such as one of the following! B.U.N.j Creatlnli.ei Fishbergj • Specific Gravity of urinej Urinalysis - Microscopic OPTION 2 6. Referral for Consultation INADEQUATE Absence of any criteria as in adequate 9<f turgMOK OPT10S I X. Blood pressure 2. Evidence of enquiry re symptoms ("No symptoms" or "asymptomatic" acceptable) 3. enquiry re family history (Tanlly history Ncq." or "Positive" acceptable) 4. Enquiry re previous illnesses ("Not significant" or "Positive" acceptable) 5. Cardiovascular examination (Cocmnt regarding pulses and heart acceptable as C. V. examination) 6. Repeat visit - either planned or taXen place - within three months ?. Laboratory investigation - urinalysis 9. Punduscoplc examination 20. a) Diet, exuiclse, drugs or counselling with evidence that subsequent diastolic pressures are under 110. OR b) A specific statement why no treatment had been initiated fJjS ATT SEVEN OP THE FOLLOWING 10. Eiqulry re cigarette socking 11. Life style, personal pressures and attitudes 12. Blood pressure - both arcs 13. At least two serial blood pressure readings on two separate visits 14. Blood pressure - standing, plus on* other position 15. Scrum electrolytes 16. 1. V. P. 17. E. C. G. 18. Chest x-ray 19. Statement of renal function or a specific test, such as on* of the followingi B.U.N.I Creatinine! Plshb-srgi Specific Gravity of urinei Urinalysis - Microscopic A 'IPX 2 THE FOLLOWING ARE MANDATORY PRIOR TO CONSULTATION 1. Blood presture 2. Evidence of enquiry re symptoms ("No symptoms" or "asymptomatic" acceptable) 3. Enquiry re family history ("Family history Nog." or "Positive" acceptable) 4. Enquiry re previous illnesses ("Not significant* or "Positive" acceptable) i. Cardiovascular examination (Cosncnt reqardlng pulses and heart acceptable as C.V. examination) t . Repeat visit - cither planned or take* plaos - withla three months 7. Laboratory Investigation - urinalysis 9. fundusc<-pic PLUS Referral for Consultation SCORING 3 - H1TTR>ED»ATE STACK - COMPLICATED  ADEQUATE OPT 103 I 6. Referral for Consultation 0P170.7 : 1. Blood pressure 2. Evldenco of enquiry re symptoms Clio synptons" or "asymptomatic" acceptable) 3. Enquiry re family history (TaMly history Ncg." or "Positive* acceptable) 4. Enquiry re previous illnesses ("Hot significant* or "Positive" acceptable) 5. Cardiovascular examination ("C.V. Ncg.", Ccxnracnt regarding pulses and heart acceptable as C.V. examination) 6. Repeat visit - either planned or taken place; - vlthlm three months 7. Laboratory investigation - urinalysis 9. fundu'scopic examination 10. Enquiry re cigarette snoklng 11. Life style, personal pressures an4 attitudes 15. Serum electrolytes 16. 1. V. P. 17. E. C. C. 18. Chest x-ray 19. Statement of renal function or a specific test, such *a one of the followingi B.U.N.i Creatinine* fishborgi Specific Cravity of urine; Urinalysis - Microscopic 20. a) Diet, exercise, drug-., or counselling with evidence that subsequent diastolic pressures are under 110, OR b) A specific statement why no treatment had been initiated) rut* kit rwo or T H E rotxowno 12. Blood pressure - tooth art* 13. At least two aerial blood pressure readings eet two separate visits 14. Blood pressure - standing, plus one ether position lKAOrpOATK Absence of any criteria aa in adequate SUPERIOR Not applicable in this category £ • HYPERTrXSTOX EPISODE - Begin* - with the first record A u m i M a t or nanagement of any of the three categoric*. Ends - with the l a s t - v i s i t of th* condition or th* end of th* study period. C A T f C o m r s o r HYPTRT R \ ^T o x 1. frlrsle hvp.-rtt-a.ilcn (0201) - Patient 55 years of age or less with a d i a s t o l i c blood pressure of 100 to 110. 2. Intcr=<-diJt«- Stare - 'Jr.corallcjt^d fft->rm - Patient 60 years of age or less with diastolic blood pressure of 111 to 120. 3. Intern cdt it.- St.ree - Co-m\\r»T*A (0203) - Diastolic pressure over 120, regardless of age OR - Synptotitic hypertension with end organ daaage I.e. T.I.A., angina, shortness of breath, heart failure, azotemia. Grade III retinopathy (haemorrhages or exudates) OR - Strong l ^ n l l y history of one f i r s t degree relative having cocpllc^tlons of hypertension. The patient under review. OK - Recurrence of hypertension after special therapy, d i a s t o l i c pressure 110 or over YES NO I.D. A.T. STUDY CODE I I I I I I 1 2 3 4 5 5 " J i Blood prcssur* Blood pr«ssurs - both at Blood Pressure - standing and one other position • 12 • 13 • 14 - 2 • • r i a l ft.P. readings on 2 **p*ret« visit* - Enquiry r« s yep tons - really history - History of previous Illness - Cardiovascular examination (Co=cnt on pulses, heart, accsptebl*) - Repeat visit - within 3 months - Urinalysis - Micro - Consultation - Funcuscoplc examination - Enquiry re cigar*tte smoking - Life style - Serua electrolytes - l.V.P. - E.C.C. - Chest a-ray - Statement of renal function HYPERTENSION (Cont'd) Creatinine Flshberg Specific Crevity (urine) Diet end (subsequent D.P. under 110) Exercise end (subsequent D.P. under 110) dedication and (subsequent D.P. under 110) Counselling and (subsequent D.P. under 110) Treatnent (If treatment not given an explanation is acceptable) INDICATOR CONDITIO*! IJ - PRENATAL CARE IN PHYSICIAN'S OFFICE DEFINITION Or AN EPISODE - PRTNATA1. CAKE Assessment of prenatal care w i l l be of a period not lea* than five months of the gestation period, provided the fivo-month episode f a l l s within particular definite dates that identify the Interval of interest in the study. A patient that was seen four months prior to beginning date of study could be included, and the last five months of the pregnancy assessed. A patient whose date of gestation f e l l four months past closing date of the study, could be assessed for the f i r s t five months. The period under study ln the Darlington practices w i l l bo June 28. 1971 to June 30, 1972. CATEGORIES OF INTERVENTION 1. Pelvic assessment - If no previous successful delivery 2. Past obstetrical history 3. Complete physical assessment - within two yoar period 4. At least one hactaoglobln during prenatal period 5. Urinalysis on each v i s i t 6. Frequency of subsequent v i s i t s Monthly or four weekly - 1st to 7th sonth • two weekly - 8th month weekly - 9th month to tens 7. Must be record of weight 8. Must be record of. blood pressure 9. Must be record of Rh and S.T.S. 10. Must be statement of gestation 11. Evidence of a psycho-social interview (expressed fear or anxiety) 12. A meeting of t.ie husband and wife together during the pregnancy 13. Pap sncar 14. A two-hour P.C. sugar i f there Is a strong family history OR If there is glucosurla found, OR If there i s a history of large babies. SCORING ADEQUATE 1. Pelvic assessment - i f no previous successful delivery 2. Past ob s t e t r i c a l history 3. Complete physical assessment - within two year period 4. At least one haemoglobin during prenatal period 5. Urinalysis on each v i s i t 6..Frequency of subsequent v i s i t s Monthly or four weekly - 1st to 7th month two weekly - 8th month weekly - 9th month to term loi ~ 7. Must b« r e c o r d o f weight l l 0. Must be r e c o r d o f b l o o d p r o * s u r e 9. Must bo r e c o r d o f Rh end S.T.8. 10. Must bo s tatement o f g o s t a t i o n INADEQUATE Absence o f any one o f the above " SUPERIOR Adequate - fLUS ONE OF THE rOLLOWTTIGi 11. ev idence o f a p s y c h o - s o c i a l i n t e r v i e w (expres sed f e a r o r anx ie t y ) 12. A meet ing o f tho husband and w i f e t o g e t h e r d u r i n g the pregnancy 13. Pap smear 14. A two hour P.C. sugar i f t h e r e l e a s t r o n g f a m i l y h i s t o r y OR I f there Is g l u c o s u r i a f o u n d , OR I f t he re i s a h i s t o r y o f l a r g e b a b i e s . INTERMEDIATE STATE SCORING ADEQUATE F o r the f c l l o w l n g s p e c i f i c c o n d i t i o n s , the s t a t e d i n t e r v e n t i o n mu*t have been c a r r i e d out i n a d d i t i o n t o the a p p r o p r i a t e i n t e r -v e n t i o n s i t r m l z e d above (1 - 10) INADEQUATE Absence o f any one o f the above 6UPE!UOR Adequate as d e f i n e d - PLUS ONE OF THE FOLLOWINGI 11. 12. 13, 14, l i s t e d above. CONDITION 1WTTRVEWTI0N A A l b u m i n u r i a 1. Hunt have f u r t h e r u r i n a r y i n v e s t i g a t i o n o r an adequate e x p l a n a t i o n . • H y p e r t e n s i o n - a d i a s t o l i c 2. A s ta tement o f c o n c u r r e n t u r i n a r y ove r 90 o r IS mn. ove r the f i n d i n g s , p r e v i o u s b a s e l i n e . C E x c o r i l v e we ight g a i n 3. P a t i e n t c a u t i o n e d and /o r d i e t a r y (ove i S l b s . p e r 4 weeks) en forcement and/or more f r e q u e n t v i s i t s and /o r d i u r e t i c * . \0l-CONDITION nfTTFVENTIOH 12 D 1. Hypertension and weight gain 4.1. D 2. Hypertension and albuminuria 4.2. D 3. Hypertension plus albuminuria 4.3. plus weight gain Rest fte-vlslt within 72 hours S«lt restriction and/or diuretics D 4. Weight gain plus albuminuria 4.4. Sedation (Phenobarb) - optional D S. Glucosuria Discharge and/or pruritls -persistent or distressing 4.S. Cither a blood sugar recorded or an adequate explanation for the glucosuria 5. Culture and smear of the discharge F Pyuria 6. C Diagnosis of diabetes, either 7. previously established or currently established II Possible German Measles contacts. I Established German Measles contact 9. J . Last trimester bleeding 10. Urine, culture and sensitivity Consultation during pregnancy Ft. H. I. A. Consultation Admission to hospital and consultation First trimester bleeding not in the scope of this evaluation Premature rupture of membranes Inadequacy of pelvis ln primipara Rising Rh Titre or anticipated Rh problem 11 Hospitalisation Immediately In labour within 12 hours, or Consultation 12. Subsequent notation re dis-proportion 13. Subsequent laboratory follow-up, or Consultation INADEQUATE The appropriate intervention for not carried out. the specific condition was 10 J The patient nuat be under observation et least the last five months of testation and the pregnancy oust be concluded before tha terminal date of the study. 1 - YES 1 I.D. ^ I J j ^ J J 2 - NO CoTJl R.T. STUDY CODE 1 1 I | 1 - Pelvic Assessnent (or previous successful delivery) - Obstetrical History • fl • / J • Co=?lete Physical (within 2 years) j 1 - Hae=o*lobln |*"""| a' - Urinalysis at each v i s i t | | - V l . l t t l»t - 7th Donth - conthly or q4 weeks | | i) 8th oonth - q2 weeks i c 9;h ronth - tern - o, week { J - n Blood pressure Rh STS - D L M P • Zi • Q • mNATAL (Cont'd) , , - . I f Doctor's awareness of th« presence or j absence of faslly problems "2a g testing husband-wife together i i 2 hour pc (strong family history of diabetes, glucosuria, history of large ~~7£ babies) iosr PRFXATAI. ISTFRYXpUT^  STACK On* of the condition* or problem* associated with pregnancy. 1 - YES 2 - NO 8 - SOT APPLICABLE 9 - UNKNOWN CATTGQRUS OF IN*TERVTN"HON Albuminuria [ Further urinary Investigation or explanation r i .... j Hypertension - D.P. greater than 90 or greater than "JQ . 13 na over previous baseline I . i. Excessive vele.ru z r i n ' j £ Counselling (over 5 lbs per 4 V C O A S ) 31 P Diet Concurrent urinary findings Hor* frequent v i s i t s >, Diuretic Hypertension -r v«l(-ht gain Kent Hypertension f albuminuria 33 Rc-vlslt within 72 hours } Hypertension • ••• weight gain albuminuria 1 ' 34 Salt restriction and/or / Diuretics W«:^ht gain * albuminuria :— 1 j. Sedation (Phenobarb) 35" j; ii • 36 • 37 • 39 • 40 1.1 42 0 44 Xi' • 46 t oU r y y j - i - :Nrrwni:.7i STACE (r.cnt'c) Clucosurla _ j 47 Blood Sugar > or $r Eaplanatlon of glucosurla Discharge or p r v r l t l s ^ J *48 Sxear for culture i ST 5 Pyuria . i9 * Urine - culture 4 s e n s i t i v i t y ( J 60 Diabetes | Consultation [" J 50 j *1 Possible Cenaan .basics _ J Contact 5i J R.H.I.A. !~| Established Cer=on b a s i c s Contact Consultation 52 Lasr. tn=».»ter bleeding . "53^ J Hospitalization & Consultation Pr^c-iturv rupture o;' >Ceibr*ne< i 1 4 Hospitalized lzxwdlately and in labor within 12 hours OR Consul.aiion Inadequacy ot Pelvis ~55* Subsequent notation re disproportion i Xl»lng Rh Vitro cr anticipated Rh problcr r • Subnequent laboratory follow-up OR i Consultation K 1 63 "64* r *-L I 65 *66" \" 67 -6V I ; ~6T lol-INDICATOR CONDITION #4 - CAR£ OF THE HEWBORJt TO THE EttO Of THE FIRST YEAR OF LIFE ceriHiTiCN or ELIGIBILITY Any child six months of age or under who enters th* practios after June 28, 1971. DEFINITION OF ATI EPISODE Episode begins with fir s t v i s i t of well child care in the patient's f i r s t year of l l f o within the study period, and ends on the child's first birthday, or the end of the study period, whichever comes sooner. A ch i l d nust bo under surveillance for a Minimum of five months during the study period for the episode to be eligible. CATEGORIES OF INTERVENTION 1. Weight on every v i s i t 2. Height and head circumference recorded twice in the fi r s t year of l i f e or at least once every six months. 3. iEsnunlzation programme completed and recorded by seven months to Include D.P.T.P. (If not completed, should be adequate explanation or evidence of illness) 4. An obs t e t r i c a l history 5. Anaesthetic history at the tlno of delivery 6. Maternal medication during pregnancy 7. Any intercurrent diseases which occur during mother'a pregnancy 8. Evidence of a psycho-social approach to the family unit 9. Recording of the landmarks of growth and development 10. Evidence of health education in the mother regarding hazards re c h i l d 11. Evidence of more than one notation about change in diet during the f i r s t year 0 12. Haemoglobin recorded or commented on 13. Urinalysis recorded or commented on 14. Hearing - evidence of being tested - statement made or recorded 15. Vision - evidence of having been tasted - statement made con-cerning v i s i o n , or recorded SCORING ADEQUATE 1. Weight on every visit 2. Holght and head circumference recorded twice in the f i r s t year of l i f e or at least once every six months. 3. Immunization programme completed and recorded by seven months to include D.P.T.P. (If not complated, should be adequate explanation or evidence of illness. INADEQUATE Abaonce of any of the above SUPERIOR ANY THREE OP THE rOLLOWIKCi 4. An obstotrical history 5. Anaesthetic history at the time of delivery 6. Maternal medication during pregnancy 7. Any intercurrent diseases which occur during the mother's pregnancy 8. Evidence of a psycho-social approach to the family unit 9. Recording of the landmarks of growth and development 10. Evidence of health education in the mother regarding hatards re c h i l d 11. Evidence of more than one notation about change l n diet during the f i r s t year. 12- Haemoglobin recorded or commented on 13. Urinalysis recorded or commented on 14. Hearing - evidence of being tested - statement made or recorded 15. Vision - evidence of having been tested - statement made concerning vision, or recorded tf-CW OK THY SttftlOXS A r h l l d entering the practice during the f i r s t three months of 11fs and who rcrvaln- ln the practice up to snd Including the 12th nonth. ' i Is th* responsibility of th« family Practitioner to be sware of and record a l l care given though he vuy not administer i t himself, i.e. immunisation, well baby csre. Weight (every routine v i s i t ) Height L head circumference (c.6 months) - I=Bunlzatlon programme (completed by 7 months or explanation) - Obstetrical history - Anaesthetic at lime of delivery - Landmarks of growth & development 1 - YES l.D. , i 2 - NO *•/ 2 3 * R.T. • 0 4 STUDY CODE 0 4 0 0 $ f to II It, 13 - Maternal indication during mother'--. pregnancy ~Jf - Intercurrent disease during mother's pregnancy / f l _ Doctor's Awareness of the prsssnce or 1 absence of fanlly problems. — To - Health education re hazards (to mother) I I'D CARE OF THE NTVXQIC; (Cont'd) More then one notation of change In diet ' J ll y Hacnoglobln 'Jrlaaly&i* • J Hearing Vision ' *2S' / / / INDICATOR CONDITION #5 - IrWHIZATION PROGRAMME UP TO THE END OF 24 KOKTHS OF AGE  15 PEMN1TION Or ELIGIBILITY Any infant who i<t not less than 12 months and not over 18 son the as of June 28, 1971 DEriNITIOH OF AN EPISODE The episode ends at the second year of age or the end of the study period, whichever comes sooner. There must be evidence that immuni-zation has been completed according to schedule CATEGORIES Or INTERVENTION 1. Three D.P.T.P. with ono booster shot 2. Measles vaccination (after 12 months) elthor given or a s p e c i f i c explanation as to why It has not been given 3. _ Measles vaccination given prior to 12 months 4. .Smallpox vaccination given prior to 24 months unless there is evidence that International travel i s intended SCORING ADEQUATE 1. Three D.P.T.P. with one booster shot 2. Measles vaccination (after 12 months), either given or a s p e c i f i c explanation as to why i t has not been given INADEQUATE ABSENCE OP I 1. Three D.P.T.P. with one booster shot 2. Measles vaccination (afte. 12 months) either given or a s p e c i f i c explanation as to why i t haa not been given OR PRESENCE OPi 3. Measles vaccination given pri o r to 12 months OR 4. Smallpox vaccination given pri o r to 24 months unless there is evidence that international travel is Intended. SUPERIOR There is no superior c l a s s i f i c a t i o n here. $ - I ^ V N I E A T I Q N rwor.rjsvrz tT TO Ttir. ryp or ?* wrrws or A eg There must be evidence that th« child la a long term patient, sod not •ore than 24 month- old during the period of the study. He oust have had at least one vi s i t during the study and before reaching th* ag* of 24 months. 1 - TT5 2 - NO l.D. I.T. STUDY CODt L T T •ft j ¥ r 3 CATTOORlr.S Of I?rTTRVFNTIQ^ - D ? T r - O f I ? (booster) - Measles Vaccination (after 12 s>OQthS or esplanatlon why not given) - Smallpox Vaccination - Evidence of Internal loos1 travel y • v n 10/7 INDICATOR CONDITION 16 - DEPRESSION ELIGIBILITY - An adult patient 22 years of age and over presentlog with three or more of the following symptoms, or ststsd diagnosis of depression. 1. A feeling of depression 2. Fatigue 3. Sleep disturbance 4. Apathy or 'turned o f f 5. Stated nervousness 6. Constipation 7. Loss of li b i d o 8. Loss of appetite 9. I r r i t a b i l i t y 10. Muscular skeletal discomfort 11. Chronic recurring headache EPISODE - begins 1. the f i r s t indication of a diagnosis of depression or the combination of symptoms as l i s t e d above. OR 2. pre-existing and continuing depression at the start of the study. ends - at the conclusion of the study period or on the last recorded v i s i t for depression. CATEGORIES OF INTERVENTION 1. A genersl physical examination (done within 6 months) If negative - st least a statement should be made such as "O.E.Heg."1, "Phys. exam Neg.". If positive - positive findings to be recorded. 2. Medical history - family history, past i l l n e s s , present complaint. 3. Doctor's awareness of the presence or absence of problems. (Record Is not as important as the evidence that appropriate examination and enquiry has been done). 4. Evidence of enquiry concerning drugs, either prescribed or self-administered. 5. Consultation or referral to a psyc h i a t r i s t (immediate i f evidence of suicld.) 6. Evidence of psychological support. 7. At least one follow-up v i s i t In a month. 8. Treatment by family physician up to one month If there i s a) evidence of structured therapy b) no deterioration 17 Treatment by family physician up to three months I f there Is evidence of Improvement. Hospitalization (Immediate If evidence of suicide) Treatment by family physician LOS'Cr.K then one month If there 1* evidence of Improvement to Crade II l e v e l . CRAPE I - Depression without evidence of impaired function or complication 0/7/0.7 I ADEQUATE 1. A general physical examination (done within 6 months) If negative - at least a statement should be made such as "O.E.Xeg.". "Phys exam Neg.M If positive - positive physicsl findings to be recorded. 2. Medical history - family history, past i l l n e s s , present complaint. -3. Doctor's awareness of the presence or absence of problems. (Record Is not as Important as the evidence that appropriate cxenlnatloo and enquiry has been done.) 6. Evidence of psychological support. 7. At least one follow-up v i s i t i n a month. QUESTIONABLE - less than Adequate OPTTOn IT 3. Consultation, or ref e r r a l to a psychiatrist CRADE II - Depression with impairment of function ( s o c i a l , vocational or physical) which has been recognized by one of the following! a) the patient b) a concerned person or relative c) the physician PPTIO* I ADEQUATE 1. A general physical examination (done within 6 months) If negative - at least a statement should be made such sa "O.E.Reg." "Phys. exam Neg." If positive - positive physical findings to be) recorded. 2. Medical history - family history, past i l l n e s s , present complaint. /<tf 9. 10. 11. 3. Doctor's awareness of the presence or absence of problems. (Record i s not as important as the evidence that appropriate examination and enquiry has been done) 4. Evidence of enquiry concerning drugs, either prescribed or self-administered 8. Treatment by family physician up to one month If there i s a) evidence of structured therapy b) no deterioration OR 9. Treatment by family phyolclan up to three months i f there i s evidence of improvement. QUESTIONABLE - Less than Adequate OPTION II 5. Consultation or r e f e r r a l (recommended and/or carried out) CRAPE III - Patient i s s u i c i d a l , psychotic or non-functional as determined by one of the following: a) patient b) significant other c) the physician onion i APEQUATE 1. A general physical examination (done within 6 months) If negative - at least a statement should be made such as "O.E.Xeg". "Phys exam Neg." If positive - positive physical findings to be recorded. 2. Medical history - family history, past i l l n e s s , present comp IsInt. 3. Clear indication of psycho-social enquiry. (Record la not as Important as the evidence that appropriate examination and enquiry has been done.) 4. Evidence of enquiry concerning drugs, either prescribed or self-administered 8. Treatment by family physician up to one month If there i s a) evidence of structured therapy b) no deterioration OR 11. Treatment by family physician LONGER than one month i f there i s evidence of improvement to Crade II l e v e l . OPTIOH II 5. Consultation or r e f e r r a l to a psychiatrist (immediate If evidence of suici d e ) . OPTION III 10. Hospitalisation (immediate i f evidence of suicide) Be vised 4 / 7 3 «,- ?r»rr.s«.Tnv CIIClU'tTTT _ An adult patient 22 vears of age and ovar pr«»«ntlng with ihrre or pore of the following symptoms or stated diagnosis of depression - feeling of depression - fatigue - atleop disturbance - apathy - "turned o f f " - stated nervousness - constipation - lo>t; of l i b i d o - loj* of wppctite - I r r i t a b i l i t y - cuscular skeletal dlscocfort - chr^r.lc recurring headaches Include* patients with pre-existing and continuing depression. Qr»<}e 1 (0601) - depression without evidence of i e p t l r s c function or complication Crjrir II (0602) - depression with lepalnaant of function ( s o c i a l , vocational or physical) Cr.idf III (0603) - patient n u l c l d s l , psychotic or coo-fanetlonal. i?. 1 ' " - i - * with a diagnosis or the *?prcprl»;s combination of sy=.pto=j - w"n':-.ln the study period. £ I'T >Or»^ ' •:-.<'-•• at the conclusion of the stu^y period or the last recorded v i s i t tor expression. 2 .NO R.7. STUDY CODE 3 i it CATTCOx;rS o r ;\-7rr.y.-!r.N General physical examination (within 6 sontha) -ii' Doctor's awareness of the presence or absence of probleos Family history DEPRESSION (Con't) -Past history u lb • g a . Treatment by family physician Lender than ons month [_ J 2i -Present cooplalnt -Enquiry re drugs (prescribed or se l f *dala**t«ired) -Psychological support ( f a a l l y physlcan) .At lea«t ons Xollov.up v i s i t a month (f a a l l y physlean) -Treatment by f a a l l y physlclsn up to ons month -Treatment by f a m i l y p h y s i c i a n up to t h r c s months -Evidence of improvement - i l v l dence of s t r u c t u r e d therapy - D e t e r i o r a t i o n of c o n d i t i o n • lmprov.-r.i-nt to grade two l e v e l - C o n s u l t a t i o n ; p s y c h l a c r I * t ( I m r ^ c l a t s I f s v l d e n c s of s u i c i d e ) -Kw»;>ltul L - n t l c n ( immediate 1' evidence of suicide.) • 'if I 1 o When r e v i e w i n g c h a r t s . I f p r e s c r i p t i o n c.-dl cat Ions arc r e c o r d e d , a c c e p t t h l j s e v i d e n c e that t..>: p h y s i c i a n i« aware of B c d l c a t l o n t taken by the p a t i e n t 1JT t h e r e ' • NO »vtccncc l n the re c o r d s that p r o s c r i p t i o n m e d i c a t i o n s a r c recorded ..ten there c u t t be evidence t h a t the p h y s i c i a n l\as made e n q u i r i e s as to the* m e d i c a t i o n s taken by the p a t i e n t . INDICATOR CONDITION f7 - SYKPTOMAT1C URINARY TRACT IMFTCTIOrrS Itl FEMALES OVER 16  1» DEFINITION OP v: EPITOPE - URINARY TRACT INFECTION For persons meeting indicator condition criteria, the fi r s t v i s i t ln which this diagnosis is recorded or necessary symptoms recorded withla the period of study. It ends at the conclusion of the study period or the last visi t concerning this Indicator condition, whichever comos later. DEFINITION OF TERrr.'Ot.QGY 1. Acute - a urinary tract Infection with no preceding episode within the past year. 2. Recurrent - this is self-evidenti recurrent urinary tract infections within one yeari second episode within the yoar. 3. Minor - syn^tcca arc localized to the bladder or urethral area. There are no secondary syr.ptocu such as fever, ch i l l s , rigor, loin pain, general malaise, etc. 4. MJjor - oyr.pto.-^  extending beyond the bladder, such as pain in the upper a'Klor.jn or loin, c h i l l s , fever. Haematurla could be coneiJ. rod in th? minor group since this would be an episode- of acute hacrorrhaglc cystitis. H,B. Haenaturia with syriptoos of cystitis would be approached like any other cyj t i t i s . An asynptotoatlc haematuria would be an entirely different indicator condition. For purposes of study, those patients who may previously have had surgical nanagi-r.ont and investigation of urethral vesicle reflux problems arc excluded. Symptoms acceptable under the definition of symptomatic infections include i frequency, dysurla, hacma".urla, suprapubic pain, »lank or loin pain, chills, fever, general malaise. CLASSIFICATION FOR PURPOSES OF THIS STUDY 1. Acute Minor or equivalent - equivalents acceptable axe acuta cystitis, cystitis, lower CU. Infection, urethritis, bladder infection, trlgonltis. 2. Acute Major - equivalents are pyelitis, pyelonephritis, perl-renal abscess, ureteritis. 3. Recurrent Minor - equivalents acceptable are chronic cystitis, recurring cystitis, recurring bladder infection, recurrlnq lower C.U. infection, chronic or recurring urethritis, etc. 4. Recurrent Major - equivalents acceptable are chronic pyelitis, recurring pyelitis, chronic or recurring pyelonephritis, chronic or recurring ureteritis. Bymptons CATEGORIES CT INTERVENTION A Examination 1. Abdominal examination. Including an examination for coetovertabral angle tenderness. 2. Pelvic examination B Laboratory and Diagnostic Procedures 3. Office urinalysis, for albumin, glucose and microscopic 4. KSU for urinalysis, culture and s e n s i t i v i t y 5. Repeat HSU after cessation of a n t i b i o t i c therapy 6. Gc. Smear 7. I. V. P. 8. Examination for acid-fast tubercle C Therapy e 9. Appropriate an t i b i o t i c (Inappropriate a n t i b i o t i c would Include Streptomycin, l.incomycln, Furad&ntin. etc.) not leas than ONE week. 10. Appropriate an t i b i o t i c as above for duration of POUR weeks. 11. Selective antibiotic after culture and s e n s i t i v i t y have been reported - (NOT LESS THAN ONE WT.EK) 12. Selective antibiotics as above - duration - POUR weeks 13. Follow-up v i s i t with repeat urinal y s i s (office or lab) . D 14. Consultation SCORING Acute Minor " ADEQUATE OPTION I 3. Office urinalysis, for albumin, glucose and microscopic 9. Appropriate a n t i b i o t i c (inappropriate a n t i b i o t i c would include Streptomycin, Llncomycln, Puradantin, etc. )not less than ONE week. 13. Follow-up v i s i t with repeat urinal y s i s (office or lab.) omo.v 2 14. Consultation INADEQUATE Less than adequate I to Acute Minor SUPERIOR 3. Office urinalysis, for albumin, glucose and microscopic 9. Appropriate antibiotic (inappropriate antibiotic would include Streptomycin. Llncomycln, Furadantin. etc.) not leas than ONE week 13. Follow-up v i s i t with repeat urinalysis (office or lab.) ONE OF THE FOLLOWING 4. KSU for urinalysis, culture and sensitivity 5. Repeat MSU after cessation of antibiotic therapy PLUS ONE OF TNE FOLLOWING! 1. Abdominal examination, including an examination for costo-vertebral angle tenderness. 6. Cc. Smear 7. I. V. P. 12. Selective antibiotics as above - duration - FOTOX weeks. Acute Major  ADEQUATE OPT/0.7 i 1. Abdominal examination. Including an examination for costo-vertebral angle tenderness. 3. Office urinalysis, for albumin, glucose and microscopic. 4. MSU for urinalysis, culturo and sensitivity. 7. I. V. P. 12. Selective antibiotics as above - duration - FOUR weeks. 13. Follow-up visit with repeat urinalysis (office or lab.) 5. Repeat KSU after cessation of antibiotic therapy 0PT1CM 2 14. Consultation INADEQUATE Less than adequate I 1,1 Acuta Major SUPERIOR  OPTJO.l I 1. Abdominal examination, including an examination for ooet-vcrtcbral angle tenderness. 3. Office urinalysis for albumin, glucose, and microscopic. 4. KSU for urinalysis, culture and s e n s i t i v i t y . 5. Rcj>eat KSU alter cessation of a n t i b i o t i c therapy. 7. I. V. P. 12. Selective ant'biotlcs as above - duration - FOUR weeks. 13. Follow-up v i s i t with repeat urinal y s i s (office or lab.) QPTio:: 2 14. Consultation PLUS ANY ONE OF THE FOLLOWING 2. Pelvic examination 6. Gc. Smear 8. Examination for acid-fast tubercle Recurrent Minor  ADEQUATE OPTIO:: i 1. Abdominal examination. Including an examination for costo-vertebral angle tenderness. i Pelvic examination 3. Office urinalysis, for albumin, glucose and microscopic 4. MSU for urinalysis, culturo and s e n s i t i v i t y 7. I. V. P. 12. Selective antibiotics as above - duration - FOUR weeks. 13. Follow-up v i r i t with repeat urinalysis (office or lab.) 5. Repeat KSU after cessation of an t i b i o t i c therapy OPTIOU 2 14. Consultation INADEQUATE Less than adequate III-23 Recurrent Minor  SUPERIOR Adequate PLUS 6 . Cc. Sneer OR 8. Examination (or acid-fast tubercle Recurrent Major  ADEQUATE 1. Consultation (MANDATORY) INADEQUATE Less than adequate SUPERIOR Adequate PLUS 13. Follow-up visit vlth repeat urinalysis (offloe or lab.) performed by the family physician ln hospital or ln the office. 5. Repeat MSU after cessation of antibiotic therapy US r.Pli?3I - 3v»in» - with a diagnosis or symptoms recorded within t h * study period. (frequency, dysuria, haematurla, suprapubic pain, (!ur.» or loin pa'.n. c h i l l s , fever, general nalalae) £nds - at the conclusion of the study period or th* last v i s i t concerning the condition. t: r * t c?Uode within the year, j;.—?t.':> - localised to bladder or u r e t e r a l are*. (cy»:iti». lover C.V. infection, u r e t h r i t i s , bladder infection, trlgor.itls) Recurrv.-.t IT - -U-currlng vithir. the yk-ar. 0702 ^'ZuJS^.t " i o ^ a l i j e d to bladder or urcthersl area. (recurring or chronic c y s t i t i s , bladder Infection, lower C.L'. Infection, urethritis.) Failure to respond to i n i t i a l therapy; f i r s t episode within the y«.ar. SVJ-M_O-\-. - pjin in upper abdomen or l o i n , c h i l l s , favsr. ( p y e l i t i s , pyelonephritis, perl-renal abscess, u r e t h r i t i s ) Recurring within the year. S..--it;-. - pain in upper abdoaen or l o i n , c h i l l s , fever. (e'r.ronic p y e l i t i s ) i- V - haematurla with symptoms of c y s t i t i s . -:| • -r - - Asymptomatic haimjturia - pat;ent» wit- previous surgical management and ir.veatlsatlon or urefr.erul vesicle reflux - tr.rcnlc problem oi 1.7. (paraplegics, c,uaJrapleglcs, multiple sclerosis) 1 • *LS 2 - XO 0701 0703 Sf f . r f v a i Si'gr 070-i 1.3. 1 R. T. 2 STUDY CODE 3 i £ J s" cT 7 % "T" i Abdominal examination a costovertebral '. j angle tenderness / £ I ' Pelvic examination ; j t3 (If Urinalysis Microscopic M S I ' - culture & se n s i t i v i t y Repeat X S 'J - post antibiotic therapy • C C Szear i I.V.r. - Ac'd-fasc tubercle •j r - Appropriate antibiotic (not lets than one wssk) , (inappropriate - strep; Llnconycin; ' j » - Appropriate antibiotic - four weeks I u - Selective anti'jlotic - not less than pns week (alter culture U s e n t l t l v i t y ) £5 - Selective antibiotic - four weeks - VlithjlJ a.-.tlblctlcs vhet.no growth reported - loliov-u? v l . l t r repeal urinalysis - Consultation I "7 Appendix III - R e l i a b i l i t y Check non-physician (A.R.) inadequate adequate or superior TOTALS physician (S.S.) inadequate adequate or superior 8 21 13 21 TOTALS 26 34 Kappa = P observed - P chance 1 - P chance Po = 8 + 2 1 = 0.85 34 Pc = 13x8 + 21x26 34 34 = 3.1 + 16.1 = 0.56 34 34 K = 0.85 - 0.56 = 0.29 = 0.66 1 - 0.56 0.44 r 

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