1 25
PHYSICIAN EXTENDERS, PROTOCOLS, AND QUALITY MEDICAL CARE* ROBERT J. SULLIVAN, JR., M.D. Vice-Chairman and Assistant Professor, Department of Community Health Sciences Assistant Professor, Department of Medicine Duke University Medical Center Durham, N.C.
A SSESSING the quality of medical care requires that something be measured by some method, and that the results which are obtained be compared to a standard of excellence. Table I lists components of each of these. Dr. Avedis Donabedian has suggested that medical care can be assessed in terms of three elements: i) the outcome of care in terms of recovery, restoration of function, or survival; 2) the process of care, including correctly obtaining a clinical history, physical examination, and diagnostic tests, justification of diagnosis and therapy, etc.; and 3) the structure in which care is given, including facilities and equipment, qualifications of medical staff, and the like.' Studies by R. H. Brook have explored the application of standards of excellence which include i) implicit judgments relying on the subjective opinion of the individual judge and 2) explicit judgments relying on predetermined criteria set by group agreement.2'3 Prospeciive and retrospective methods of study are possible in each case. In the past few years, the quality of medical care has been defined largely through explicit structural standards. When variations in the process or outcome of care have been assessed, implicit standards often have been employed in retrospective studies,2 exemplified by the traditional review of charts by teams of physicians. This reflects the reality that, in medical care, details of an adequate process or outcome remain largely undefined. *Presented in a panel, Educating the Health Professions for High-Quality Care, as part of the 1975 Annual Health Conference of the New York Academy of Medicine, The Professional Responsibility for the Quality of Health Care, held April 24 and 25, 1975. Based upon research done in the Department of Community Health Sciences, Duke University Medical Center, Durham, N. C., by Drs. Richard H. Grimm, Jr., Kitty Shimoni, William R. Harlan, Jr., Eugene S. Schneller, M. Julian Duttera, and E. Harvey Estes, Jr., and supported in part by grants from the Henry J. Kaiser Family Foundation and the Robert Wood Johnson Foundation.
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TABLE I. APPROACHES TO QUALITY ASSESSMENT IN MEDICAL CARE
What to assess Outcome Process Structure
Standard of excellence applied
Method utilized
Implicit
Prospective
Explicit
Retrospective
Hospital quality-assurance programs and professional standards review organizations are now requiring that standards be stated explicitly, but the focus still remains largely on retrospective studies which use the medical record. In an earlier paper, Dr. Donabedian underscored the importance of performing prospective research analyses to achieve desired goals effectively and efficiently.5 He contends that the tools exist to do the job if we have the will to use them. Studies done in laboratories traditionally call for prospective study to test a hypothesis. Results then are used to modify the hypothesis, and further testing ensues. The same rigorous prospective design is now being applied in ambulatory clinics. An unusual event led to the feasibility of this research: the arrival of a new health professional. Dr. Magraw told us of the expanding "medical collective" which originally consisted of physician, nurse, and hospital." Today a variety of new health professionals are found on the medical scene. Most of them, such as laboratory and x-ray technicians, have specific jobs and have had training which qualifies them for their work. They personify the impact of technology on the practice of medicine, and their roles are defined by that technology. Another group of health professionals, the physician extenders, are not bound by the same limits. Physician extenders include those who assist the physician in providing medical care (see Table II), such as graduates of the Medex, Primex, physician's assistant, physician's associate, and nurse-practitioner programs, and similar programs. Many individuals trained on the job in physician's offices fit this description, although they may not have academic credentials. Let us trace briefly how their arrival has affected the assessment of quality. By according academic credentials to individuals destined to replace physicians in the performance of selected medical functions, Bull. N. Y. Acad. Med.
PHYSICIAN EXTENI)ERS, PROTOCOLS, A ND QUALITY CARE
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TABLE II. PHYSICIAN EXTENDERS
Phvsicimin's aide Physician's assistant Physician's associate Medex Primex
Nurse Nurse practitioner Nurse clinician Health assistant Allied health professional
recently established training programs for physician extenders have broadened the concept of who may render medical care. Although the general role of the physician extender is to collect, analyze, and present data about patients to the physician, the precise role of physician extenders remains largely undefined. Three patterns in the utilization of physician extenders have been observed in a study of I4 primary care practices undertaken by Duttera and Harlan.7 i) The extender may see all patients initially, collect data, and then present those data to a physician. 2) Both the physician and the physician extender may see patients together, with no preselection. 3) Patients with specific problems may be assigned to the physician extender. Using both implicit and explicit criteria, Harlan and Duttera concluded that, if properly managed, each of these patterns can yield competent medical care. The development of an interdependent relation between the physician and the physician extender and the proper organization of the practice were identified as key problem areas.7 Schneller's analysis of the literature on the physician's assistant reveals a continued state of growth; assistants are assuming more tasks that the medical profession no longer believes require some esoteric knowledge acquired through the long process of medical education.8 Schneller calls this a process of "negotiated autonomy."9 Since the role of physician extender is undefined, training programs have varied widely in depth and breadth.10 Credentials consequently represent a wide variety of areas of academic achievement." To clarify the specific role to be played by physician extenders and, simultaneously, to define the training Vol. 52, No. 1, January 1976
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Fig. 1. Portion of the protocol for urinary tract infections (UTI) and vaginitis leading to the diagnosis of a UTI. Reproduced by permission from Sherman, H. and Komaroff, A.L.: Ambulatory Care Project Progress Report 1A, 1969-1974. Boston, Lincoln Laboratory, Mass. Inst. Technology, 1974, p. 28.
Fig. 2. Portion of the protocol for urinary tract infections (UTI) and vaginitis leading to the diagnosis of vaginitis. TRICH=Trichomonas. Reproduced by permission from Sherman, H. and Komaroff, A.L.: Ambulatory Care Project Progress Report 1A, 1969-1974. Boston, Lincoln Laboratory, Mass. Inst. Technology, 1974, p. 28.
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required, parts of the process of medical care have been committed to writing in the form of protocols.'2-'6 Using protocols in the care of patients is not new. Nevertheless, they have undergone substantial refinement coincident with the growth of interest in physician extenders. A variety of meanings can be attached to the word protocol. As defined by a group in Boston and as used at Duke University Medical Center, a protocol is an instrument that describes steps to be taken in the management of a disease or complaint.'3 These written outlines define explicitly the process of medical care to be rendered in specified situations. Protocols are distinguished from general medical histories in that protocols contain only data related to particular presenting symptoms or diagnoses. Standing orders or general guidelines deal more with the process of collecting and analyzing data, and are generally less precise and focused than protocols, which specify the data to be collected for each condition, direct the analysis of the data, and establish a plan of therapy. Guidelines may not lead to a specific plan of treatment, while protocols are explicit and leave no doubt about the data to be collected or the actions to be taken. To illustrate how specific a protocol can be, let us examine the decision tree for the urinary tract infection and vaginitis protocol developed by the group in Boston. This can be considered a hypothesis to be tested and a distillation of the best care recorded in the medical literature, which is designed to serve as an explicit standard of quality. First (Figure i), dysuria or urinary frequency lead to a urinalysis; bacteria and pyuria are sought. If these are present, a diagnosis of urinary tract infection is made. Treatment for this condition is detailed elsewhere in the protocol. This relatively simple process becomes more complex when one includes questions about vaginitis, a complex of symptoms which are commonly associated with infections of the urinary tract (Figure 2). The outline illustrated in Figure I can be found in the lower half of the decision tree in Figure 2. The full complexity and specificity of decisions related to the protocol on the infection of the urinary tract are shown in Figure 3. The material Fig. 3. Entire protocol for diagnosing urinary tract infections (UTI) and vaginitis illustrating the complexity of the decision process which is used. (See Figures 1 and 2 for example of details.) Reproduced by permission from Sherman, H. and Komaroff, A.L.: Ambulatory Care Project Progress Report 11A, 1969-1974. Boston, Lincoln Laboratory, Mass. Inst. of Technology, 1974, p. 28.
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Fig. 4. Checklist used for the protocol on sore throats (top) and for the protocol on urinary tract infections (UTI) at Duke University Medical Center. R=right, L=left, PE=physical examination, TEMP=temperature, ANT'ranterior, POST' posterior,
PT=patient, INFO=inforniation, PROT. NOT FLLW'D=protocol not followed, HT=heart, INF. MONO=i)nfectious mononucleosis, ANTIB=antibiotic, PREV. UROLOG. EVAL.=previous uirological evaluation, B.C.=birth control, WBC=white blood count, RBC=red blood count. Reproduced by permission from the Department of Community Health Sciences, Duke University Medical Center, Durham, N.C.
shown in Figure 2 is located in the right center of Figure 3. This decision tree represents a consensus of methods for the treatment of infection of the urinary tract. Surprisingly, it is not difficult to use this outline. It represents procedures which are commonly followed today. Duke University Medical Center, for example, developed a virtually identical protocol independently. We never drew it out so elegantly; ours remained mostly in written format. To facilitate the collection of data, a simple checklist is used at Bull. N. Y. Acad. Med.
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Duke University Medical Center to document the critical information needed for each protocol. The checklists used for our protocols on sore throat and urinary infection are illustrated in Figure 4. We chose these two topics for investigation because of their frequency in our clinic and the need to define the constituents of quality care for these conditions. The checklists are kept in the physician's office and are filled out and placed in a medical record when a patient presents with applicable symptoms. By a series of checkmarks, data are collected rapidly. The pattern of response leads to specific therapy as found in the decision tree which is kept for referral in the physician's desk drawer. This technology was developed primarily because of physician extenders. Structural assessment of their qualifications (credentials) was difficult in light of the varied training already mentioned. Accordingly, in some programs, process assessment of their ability to follow specific protocols has been substituted.13' 13, 17, 18, 19 To assure that providers of health care who have no or minimal credentials adhere to the guidelines, audits have been instituted to i) assure compliance with the mandates of the protocol; 2) to assist in the education of those who use the protocols by feeding back information on errors; and 3) to facilitate research on primary care.20 Accumulated data show that the medical care rendered in this way is good.12' 21, 22, 23 Duke University established its physician's associate program in I965. It provides a two-year series of college-level courses taught within the medical school, leading to a degree of baccalaureate level. We employ several physician's associates in our University Health Services Clinic and rely on them to deliver a large amount of medical care under the close supervision of our staff. We began to use protocols last year for two reasons: i) to improve the definition of the role to be played by physician's associates and 2) to improve the quality of medical care provided in our clinic. Because graduates of our physician's-associate program have completed a rigorous course of training, they do not require protocols to deliver adequate medical care under the supervision of physicians. However, since their roles in medical care are ultimately defined by their relations with the physicians for whom they work, and since we have nine physicians in our clinic, there has been much variation in expectation. XWe therefore introduced protocols to clarify the medical tasks that could be delegated to our Vol. 52, No. 1, January 1976
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extenders without further intervention by physicians. The protocols represent a consensus of the best quality of care available for certain conditions. We felt that if physician's associates were required to adhere to them, the physician should be bound by similar guidelines. The result of implementing our protocols has been published recently.24 Both physician's associates and physicians were willing to use the guidelines, and we documented a substantial change in the care rendered in our clinic. Simultaneously, the role of the physician's associate was defined more clearly. We have audited the use of our protocols for sore-throats for a year, and the use of our protocol for urinary tract infection for seven months. First, we asked whether the checklist actually was used when the patient's symptoms indicated that it was applicable. In virtually ioo% of the cases the physician's associates used the checklist when it was indicated. Physicians, by contrast, completed a checklist between 8o% and 90% of the time. Use of the protocol remained remarkably constant until the influenza epidemic in January I975, when people said that they were "too busy to use the sore throat checklist." Our checklist for urinary tract infections, by contrast, has not enjoyed the same popularity and has had only 70% and 900o utilization. This probably reflects its complexity and indicates that we have more work to do in clarifying the components of an adequate process for the diagnosis and treatment of urinary tract infection before this checklist becomes as widely used as our sore-throat checklist. When we analyze compliance with specific recommendations of the protocols, we find that physicians do better than the physician extenders. In part this is attributable to the fact that our protocols call for a physician extender to consult with a physician if any complicating conditions exist. Thus, physician extenders are eligible for substantially more instances of noncompliance than are physicians. Over-all, compliance with the guidelines in the decision tree has exceeded 85%. Documented deviations have been considered in later modifications of the protocols. The impact of protocols on the operation of our clinic has been great, as shown in Table III. The collection of historical data has improved and the use of antibiotics has decreased. Laboratory tests have been influenced selectively. The net cost to the patient has been decreased as a result.24 Bull. N. Y. Acad. Med.
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TABLE III. COMPARISON OF CLINICAL BEHAVIOR BEFORE AND AFTER INTRODUCTION OF THE PROTOCOL FOR SORE THROATS (livical behavior
Historv of rheumatic fever History of drug allergies Throat culture performed rest for mononucleosis ordered Blood count ordered Antibiotics given
Before protocol
After protocol
5 7 83
98 97 90 10 12 16
13
19 45
As yet undocumented, but equally important, have been the multiple insights that protocols have brought regarding the operation of our clinic. The processing and accuracy of charts has been improved, laboratory delays have been corrected, and routines for the recall of patients have been perfected. We found our medical care support systems to be suboptimal; using our protocols as tracers, we have been able to undertake a multitude of improvements. As Dr. Mildred A. Morehead suggested, the existence of an audit in any form is bound to have an impact on the entire system.25 In our physician's-associate training program we expose students to protocols during their rotation through the University Health Services Clinic. We have yet to institute a formal presentation regarding protocols in the curriculum, since we have yet to resolve the ultimate contribution of protocols to the assessment of the quality of medical care. To the degree that protocols are a team effort and represent a consensus of opinions among all physicians within an organization, they are a strong influence for defining acceptable processes of medical care and for defining what a physician extender may and may not do. It is the audit of performance which brings problems, since this is not part of the definition of the physician extender's role. Our experience has shown that when protocols are audited, attention must be given first and foremost to the potential educational and research value of the audit. Great effort must be made to avoid any punitive aspects of the exercise. As Dr. Donabedian cautioned, we must refine our criteria and not just police existing criteria.5 Vol. 52, No. 1, January 1976
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There is a continued risk that protocols will impose a bureaucracy on the previously informal relations between patients and physicians or between physicians and physician extenders. According to industrial experience, as long as a bureaucracy is participatory it serves the ends of all involved; once it becomes punitive it loses support.26' 27 If we expect protocols to accomplish more than a simple definition of roles -to improve the quality of medical care-some form of audit is essential to guarantee that documented deviations will be used to educate those who provide care or to alter the protocol, thus leading to improved delivery of medical care.20' 21,28,29,30 The degree to which protocols will find application in private practice remains to be seen. The definition of roles is less of a problem in situations where the physician extender works directly with one or two physicians. In such situations clear lines of authority soon emerge spontaneously. Large group practices, however, may find protocols to be essential in cases in which a satisfactory definition of roles cannot be accomplished by other means. Protocols can offer explicit definitions of the process of medical care to be followed. Acceptance of protocols by patients is being investigated in our clinic by means of a mailed questionnaire. Our data are incomplete, but studies done elsewhere suggest that the use of protocols does not adversely influence the relation between patient and physician.12', 17,18 22 This is important, especially in the light of Dr. Mack Lipkin's remarks, in which he cautioned against excessive emphasis on rigorous scientific analysis to explain all clinical benefit. There is a whole realm of medical care that is impossible to quantitate by today's methods. Dr. Inglefinger has raised similar issues in questioning the application of algorithms.31 Protocols should be an adjunct to clinical investigation and to the systematic recording of data. They should supplement, but never replace or interfere with, the traditional interaction between doctor and patient.
SUMMIARY At Duke University Medical Center we are educating physician extenders in methods of assessing the process and outcome of medical care by means of explicit criteria stated in the form of protocols. We have found that both physicians and physician extenders will accept this approach. A substantial effect on the quality of medical care has Bull. N. Y. Acad. Med.
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been documented. When audit is instituted continued vigilance is required in order to give assurance that the method continues to be oriented toward education and research. It remains to be seen whether protocols will find general acceptance in the practice of medicine. ACKNOWLEDGEMENTS I am indebted to Drs. E. Harvey Estes, Jr., Eugene S. Schneller, Kitty Shimoni, Michael Hamilton, and Reginald Carter for assistance in preparing this manuscript and to Nancy Topham, protocol auditor, for assistance in compiling the data. REFERENCES 8. Schneller, E. S.: A content analysis of the literature on the P. A.: A method for studying occupations and professions. A mer. Sociological Ass., San Francisco, 1975. Unpublished. 9. Schneller, E. S.: Perceptions of autonomy of prospective physician's associates. Second Ann. Conf. New Health Practitioners, New Orleans, April 1974. Unpublished. 10. The National Physic-an Assistant Program Profile. Washington, D. C., Ass. Phys. Assistant Programs, 1974. 11. Dobmeyer, T. W., Sonderegger, L. L., and Lowin, A.: A report of a 1972 survey of plhysician's assistant training programs. Med. Care 13:291, 1975. 12. Greenfield, S., Bragg, F. E., McCraith, D. L., and Blackburn, J.: Upper respiratory tract complaint protocol for physician-extenders. Arch. Intern. Med. _133:204, 1974. 13. Komaroff, A. L., Reiffen, B., and Sherman, H.: Problem-Oriented Protocols for Physician Extenders. In: Applying the Problem Oriented System, Walker, H. K., Hurst, J. W., and Woody, M. F., editors. New York, Medcom, 1973. 14. Tompkins, R. K., Kniffin, W. D., Sox, H. C., Sox, C. H., and Kaplan, A. D.: Use of a Clinical Algorithm System in a Physicians Assistant Program. In:
1. Donabedian, A.: Evaluating the quality of medical care. MilbeiAk Mem. Funzd Quart. ;4:166, 1966. 2. Brook, R. H.: Quality of care assessment: A comparison of five methods of peer review. National Center for Health Services Research and Development, Publication No. HRA-74-3100, Departmnent of Health Education and Welfare, Health Services and Mental Health Administration. Rockville, Md., 1973. 3. Brook, R. H. and Appel, F. A.: Quality of care assessment: Choosing a method for peer review. New Evy. J. Med. 288:1323, 1973. 4. Goldstein, R. L., Roberts, J. S., Stanton, B., Maglott, D. B., and Aoran, M. F.: Data for peer review: Acquisition and use-results in the experimental medical care review organization program. Ain. Interii. Med. 82:262, 1975. 5. Donabedian, A.: Measuring and evaluating hospital and medical care. Bu11. N. Y. Acad. Med. .52:51-59, 1976. 6. Magraw, R. M.: Formal quality assessment and utilization review programs: Their effects on the basic transactions of medical education. Bull. N. Y. Acad. Med. 5.2:105-18, 1976. 7. Duttera, M. J. and Harlan, AV. R.: Evaluation of physician extenders in the rural southeast: Patterns of practice and patient care. Amer. College of Physicians, San Francisco, April 1975.
Unpublished.
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15. Hodges, B.: The Role and Training of Allied Health Professionals at PROMIS Clinic, Haampden Highlands, Maine. In: Applying the Problem Oriented System, Walker, H. K., Hurst, J. W., and Woody, M. F., editors. New York, Medcom, 1973. 16. Taylor, J. E.: The Evolution of the Nurse's Role at PROMIS Clinic (The Management of Long-Terin Health Problems in the Problem-Oriented Svs-
tem). In: Applying the Problem Ori-
17.
18.
19.
20.
21.
ented System, Walker, H. K., Hurst, J. W., and Woody, M. F., editors. New York, Medcom, 1973. Charles, G., Stimson, D. H., Maurier, M. D., and Good, J. C.: Physician's assistants and clinical algorithms in health care delivery-A case study. Ann. Intern. Med. 81:733, 1974. Greenfleld S., Anderson, H., Winickoff, R. N., Morgan, A., and Komaroff, A. L.: Nurse-protocol management of lowback pain: Outcomes, patient satisfaction, and efficiency of primary care. Amer. Federation of Clinical Research National Meeting. Atlantic City, N. J., May 1974. Submitted for publication. Sherman, H. and Komaroff, A. L.: Ambulatory Care Project Progress Report 114. 1969-1974. Boston, Lincoln Laboratory, Massachusetts Inst. Technology, 1974, p. 28. Kaplan, A. D., Kniffin, W. D., Tomnpkins, R. K., Strauss, B., and Sox, H. C.: Audit of Clinical Performance as the Basis for the Education of Physician's Assistants. In: Applying the Problem Oriented System, Walker, H. K., Hunt, J. W., and Woody, M. J., editors. New York Medcom, 1973. Komaroff, A. L., Reiffen, B., and Sherman, H.: Protocols for Paramedics: A Quality Assurance Tool. In: Quality Assurance of Medical Care. Pub. No. (HSM) 73-7021, Health Services and Mental Health Administration, Dept.
HEW. Rockville, Md., 1973, p. 161. 22. Komaroff, A. L., Black, W. L., Flatley, M., Knopp, R. H., Reiffen, B., and Sherman, H.: Protocols for physicians assistants-ianagemient of diabetes and hypertension. New Eng. J. Med. 290: 307, 1974. 23. Greenfield, S., Friedland, G., Scifers, S., Rhodes, A., Black, W. L., and Komaroff, A. L.: Protocol management of dysuria, urinary frequency, and vaginal discharge. Ann. Intern. Med. 81: 4.52, 1974. 24. Grim, R. H., Shimoni, K., Harlan, W. R., and Estes, E. H.: Evaluation of patient-care protocol use by various providers. New Eng. J. Med. 292:507, 1975. 25. Morehead, M. A.: Ambulatory care review: A neglected priority. Bull. N. Y. Arad. Med. 52:60-69, 1976. 26. Smigel, E. O.: The Wall Street Lawyer: Professiotial Organization Man? New York, Indiana University Press, 1969, p. 280. 27. Gouldner, A. WV.: Patterns of Industrial Bureaucracy. New York, Free Press, 1954, p. 15. 28. Thompnins, R. K.: The Role of Medical Audit in the Definition of the Qualitv of Patient Care Rendered by Physicians Assistants. In: Quality Assurance of Medical Care. Pub. No. (HSM) 73-7021, Health Administration, Dept. HEW. Rockville, Md., 1973. 29. Sox, H. C., Sox, C. H., and Tompkins, R. K.: The training of physicians assistants: The use of a clinical algorithm system for patient care, audit of performance and education. New Eng. J. Med. '88:818, 1973. 30. Weed, L. L.: Quality Control. In: The Problem Oriented System, Walker, H. K., Hurst, J. WV. and WXoody, M. J., editors. New York, Medcomn, 1973. 31. Inglefinger, F.: Algorithms anyone? New Eng. J. Med. 288:847, 1973.
Bull. N. Y. Acad. Med.
PHYSICIAN EXTENDERS, PROTOCOLS, AND QUALITY MEDICAL CARE* ROBERT J. SULLIVAN, JR., M.D. Vice-Chairman and Assistant Professor, Department of Community Health Sciences Assistant Professor, Department of Medicine Duke University Medical Center Durham, N.C.
A SSESSING the quality of medical care requires that something be measured by some method, and that the results which are obtained be compared to a standard of excellence. Table I lists components of each of these. Dr. Avedis Donabedian has suggested that medical care can be assessed in terms of three elements: i) the outcome of care in terms of recovery, restoration of function, or survival; 2) the process of care, including correctly obtaining a clinical history, physical examination, and diagnostic tests, justification of diagnosis and therapy, etc.; and 3) the structure in which care is given, including facilities and equipment, qualifications of medical staff, and the like.' Studies by R. H. Brook have explored the application of standards of excellence which include i) implicit judgments relying on the subjective opinion of the individual judge and 2) explicit judgments relying on predetermined criteria set by group agreement.2'3 Prospeciive and retrospective methods of study are possible in each case. In the past few years, the quality of medical care has been defined largely through explicit structural standards. When variations in the process or outcome of care have been assessed, implicit standards often have been employed in retrospective studies,2 exemplified by the traditional review of charts by teams of physicians. This reflects the reality that, in medical care, details of an adequate process or outcome remain largely undefined. *Presented in a panel, Educating the Health Professions for High-Quality Care, as part of the 1975 Annual Health Conference of the New York Academy of Medicine, The Professional Responsibility for the Quality of Health Care, held April 24 and 25, 1975. Based upon research done in the Department of Community Health Sciences, Duke University Medical Center, Durham, N. C., by Drs. Richard H. Grimm, Jr., Kitty Shimoni, William R. Harlan, Jr., Eugene S. Schneller, M. Julian Duttera, and E. Harvey Estes, Jr., and supported in part by grants from the Henry J. Kaiser Family Foundation and the Robert Wood Johnson Foundation.
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TABLE I. APPROACHES TO QUALITY ASSESSMENT IN MEDICAL CARE
What to assess Outcome Process Structure
Standard of excellence applied
Method utilized
Implicit
Prospective
Explicit
Retrospective
Hospital quality-assurance programs and professional standards review organizations are now requiring that standards be stated explicitly, but the focus still remains largely on retrospective studies which use the medical record. In an earlier paper, Dr. Donabedian underscored the importance of performing prospective research analyses to achieve desired goals effectively and efficiently.5 He contends that the tools exist to do the job if we have the will to use them. Studies done in laboratories traditionally call for prospective study to test a hypothesis. Results then are used to modify the hypothesis, and further testing ensues. The same rigorous prospective design is now being applied in ambulatory clinics. An unusual event led to the feasibility of this research: the arrival of a new health professional. Dr. Magraw told us of the expanding "medical collective" which originally consisted of physician, nurse, and hospital." Today a variety of new health professionals are found on the medical scene. Most of them, such as laboratory and x-ray technicians, have specific jobs and have had training which qualifies them for their work. They personify the impact of technology on the practice of medicine, and their roles are defined by that technology. Another group of health professionals, the physician extenders, are not bound by the same limits. Physician extenders include those who assist the physician in providing medical care (see Table II), such as graduates of the Medex, Primex, physician's assistant, physician's associate, and nurse-practitioner programs, and similar programs. Many individuals trained on the job in physician's offices fit this description, although they may not have academic credentials. Let us trace briefly how their arrival has affected the assessment of quality. By according academic credentials to individuals destined to replace physicians in the performance of selected medical functions, Bull. N. Y. Acad. Med.
PHYSICIAN EXTENI)ERS, PROTOCOLS, A ND QUALITY CARE
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TABLE II. PHYSICIAN EXTENDERS
Phvsicimin's aide Physician's assistant Physician's associate Medex Primex
Nurse Nurse practitioner Nurse clinician Health assistant Allied health professional
recently established training programs for physician extenders have broadened the concept of who may render medical care. Although the general role of the physician extender is to collect, analyze, and present data about patients to the physician, the precise role of physician extenders remains largely undefined. Three patterns in the utilization of physician extenders have been observed in a study of I4 primary care practices undertaken by Duttera and Harlan.7 i) The extender may see all patients initially, collect data, and then present those data to a physician. 2) Both the physician and the physician extender may see patients together, with no preselection. 3) Patients with specific problems may be assigned to the physician extender. Using both implicit and explicit criteria, Harlan and Duttera concluded that, if properly managed, each of these patterns can yield competent medical care. The development of an interdependent relation between the physician and the physician extender and the proper organization of the practice were identified as key problem areas.7 Schneller's analysis of the literature on the physician's assistant reveals a continued state of growth; assistants are assuming more tasks that the medical profession no longer believes require some esoteric knowledge acquired through the long process of medical education.8 Schneller calls this a process of "negotiated autonomy."9 Since the role of physician extender is undefined, training programs have varied widely in depth and breadth.10 Credentials consequently represent a wide variety of areas of academic achievement." To clarify the specific role to be played by physician extenders and, simultaneously, to define the training Vol. 52, No. 1, January 1976
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Fig. 1. Portion of the protocol for urinary tract infections (UTI) and vaginitis leading to the diagnosis of a UTI. Reproduced by permission from Sherman, H. and Komaroff, A.L.: Ambulatory Care Project Progress Report 1A, 1969-1974. Boston, Lincoln Laboratory, Mass. Inst. Technology, 1974, p. 28.
Fig. 2. Portion of the protocol for urinary tract infections (UTI) and vaginitis leading to the diagnosis of vaginitis. TRICH=Trichomonas. Reproduced by permission from Sherman, H. and Komaroff, A.L.: Ambulatory Care Project Progress Report 1A, 1969-1974. Boston, Lincoln Laboratory, Mass. Inst. Technology, 1974, p. 28.
Bull. N. Y. Acad. Med.
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required, parts of the process of medical care have been committed to writing in the form of protocols.'2-'6 Using protocols in the care of patients is not new. Nevertheless, they have undergone substantial refinement coincident with the growth of interest in physician extenders. A variety of meanings can be attached to the word protocol. As defined by a group in Boston and as used at Duke University Medical Center, a protocol is an instrument that describes steps to be taken in the management of a disease or complaint.'3 These written outlines define explicitly the process of medical care to be rendered in specified situations. Protocols are distinguished from general medical histories in that protocols contain only data related to particular presenting symptoms or diagnoses. Standing orders or general guidelines deal more with the process of collecting and analyzing data, and are generally less precise and focused than protocols, which specify the data to be collected for each condition, direct the analysis of the data, and establish a plan of therapy. Guidelines may not lead to a specific plan of treatment, while protocols are explicit and leave no doubt about the data to be collected or the actions to be taken. To illustrate how specific a protocol can be, let us examine the decision tree for the urinary tract infection and vaginitis protocol developed by the group in Boston. This can be considered a hypothesis to be tested and a distillation of the best care recorded in the medical literature, which is designed to serve as an explicit standard of quality. First (Figure i), dysuria or urinary frequency lead to a urinalysis; bacteria and pyuria are sought. If these are present, a diagnosis of urinary tract infection is made. Treatment for this condition is detailed elsewhere in the protocol. This relatively simple process becomes more complex when one includes questions about vaginitis, a complex of symptoms which are commonly associated with infections of the urinary tract (Figure 2). The outline illustrated in Figure I can be found in the lower half of the decision tree in Figure 2. The full complexity and specificity of decisions related to the protocol on the infection of the urinary tract are shown in Figure 3. The material Fig. 3. Entire protocol for diagnosing urinary tract infections (UTI) and vaginitis illustrating the complexity of the decision process which is used. (See Figures 1 and 2 for example of details.) Reproduced by permission from Sherman, H. and Komaroff, A.L.: Ambulatory Care Project Progress Report 11A, 1969-1974. Boston, Lincoln Laboratory, Mass. Inst. of Technology, 1974, p. 28.
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Fig. 4. Checklist used for the protocol on sore throats (top) and for the protocol on urinary tract infections (UTI) at Duke University Medical Center. R=right, L=left, PE=physical examination, TEMP=temperature, ANT'ranterior, POST' posterior,
PT=patient, INFO=inforniation, PROT. NOT FLLW'D=protocol not followed, HT=heart, INF. MONO=i)nfectious mononucleosis, ANTIB=antibiotic, PREV. UROLOG. EVAL.=previous uirological evaluation, B.C.=birth control, WBC=white blood count, RBC=red blood count. Reproduced by permission from the Department of Community Health Sciences, Duke University Medical Center, Durham, N.C.
shown in Figure 2 is located in the right center of Figure 3. This decision tree represents a consensus of methods for the treatment of infection of the urinary tract. Surprisingly, it is not difficult to use this outline. It represents procedures which are commonly followed today. Duke University Medical Center, for example, developed a virtually identical protocol independently. We never drew it out so elegantly; ours remained mostly in written format. To facilitate the collection of data, a simple checklist is used at Bull. N. Y. Acad. Med.
PHYSICIAN EXTENDERS, PROTOCOLS, ANI) QUALITY CARE
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Duke University Medical Center to document the critical information needed for each protocol. The checklists used for our protocols on sore throat and urinary infection are illustrated in Figure 4. We chose these two topics for investigation because of their frequency in our clinic and the need to define the constituents of quality care for these conditions. The checklists are kept in the physician's office and are filled out and placed in a medical record when a patient presents with applicable symptoms. By a series of checkmarks, data are collected rapidly. The pattern of response leads to specific therapy as found in the decision tree which is kept for referral in the physician's desk drawer. This technology was developed primarily because of physician extenders. Structural assessment of their qualifications (credentials) was difficult in light of the varied training already mentioned. Accordingly, in some programs, process assessment of their ability to follow specific protocols has been substituted.13' 13, 17, 18, 19 To assure that providers of health care who have no or minimal credentials adhere to the guidelines, audits have been instituted to i) assure compliance with the mandates of the protocol; 2) to assist in the education of those who use the protocols by feeding back information on errors; and 3) to facilitate research on primary care.20 Accumulated data show that the medical care rendered in this way is good.12' 21, 22, 23 Duke University established its physician's associate program in I965. It provides a two-year series of college-level courses taught within the medical school, leading to a degree of baccalaureate level. We employ several physician's associates in our University Health Services Clinic and rely on them to deliver a large amount of medical care under the close supervision of our staff. We began to use protocols last year for two reasons: i) to improve the definition of the role to be played by physician's associates and 2) to improve the quality of medical care provided in our clinic. Because graduates of our physician's-associate program have completed a rigorous course of training, they do not require protocols to deliver adequate medical care under the supervision of physicians. However, since their roles in medical care are ultimately defined by their relations with the physicians for whom they work, and since we have nine physicians in our clinic, there has been much variation in expectation. XWe therefore introduced protocols to clarify the medical tasks that could be delegated to our Vol. 52, No. 1, January 1976
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extenders without further intervention by physicians. The protocols represent a consensus of the best quality of care available for certain conditions. We felt that if physician's associates were required to adhere to them, the physician should be bound by similar guidelines. The result of implementing our protocols has been published recently.24 Both physician's associates and physicians were willing to use the guidelines, and we documented a substantial change in the care rendered in our clinic. Simultaneously, the role of the physician's associate was defined more clearly. We have audited the use of our protocols for sore-throats for a year, and the use of our protocol for urinary tract infection for seven months. First, we asked whether the checklist actually was used when the patient's symptoms indicated that it was applicable. In virtually ioo% of the cases the physician's associates used the checklist when it was indicated. Physicians, by contrast, completed a checklist between 8o% and 90% of the time. Use of the protocol remained remarkably constant until the influenza epidemic in January I975, when people said that they were "too busy to use the sore throat checklist." Our checklist for urinary tract infections, by contrast, has not enjoyed the same popularity and has had only 70% and 900o utilization. This probably reflects its complexity and indicates that we have more work to do in clarifying the components of an adequate process for the diagnosis and treatment of urinary tract infection before this checklist becomes as widely used as our sore-throat checklist. When we analyze compliance with specific recommendations of the protocols, we find that physicians do better than the physician extenders. In part this is attributable to the fact that our protocols call for a physician extender to consult with a physician if any complicating conditions exist. Thus, physician extenders are eligible for substantially more instances of noncompliance than are physicians. Over-all, compliance with the guidelines in the decision tree has exceeded 85%. Documented deviations have been considered in later modifications of the protocols. The impact of protocols on the operation of our clinic has been great, as shown in Table III. The collection of historical data has improved and the use of antibiotics has decreased. Laboratory tests have been influenced selectively. The net cost to the patient has been decreased as a result.24 Bull. N. Y. Acad. Med.
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TABLE III. COMPARISON OF CLINICAL BEHAVIOR BEFORE AND AFTER INTRODUCTION OF THE PROTOCOL FOR SORE THROATS (livical behavior
Historv of rheumatic fever History of drug allergies Throat culture performed rest for mononucleosis ordered Blood count ordered Antibiotics given
Before protocol
After protocol
5 7 83
98 97 90 10 12 16
13
19 45
As yet undocumented, but equally important, have been the multiple insights that protocols have brought regarding the operation of our clinic. The processing and accuracy of charts has been improved, laboratory delays have been corrected, and routines for the recall of patients have been perfected. We found our medical care support systems to be suboptimal; using our protocols as tracers, we have been able to undertake a multitude of improvements. As Dr. Mildred A. Morehead suggested, the existence of an audit in any form is bound to have an impact on the entire system.25 In our physician's-associate training program we expose students to protocols during their rotation through the University Health Services Clinic. We have yet to institute a formal presentation regarding protocols in the curriculum, since we have yet to resolve the ultimate contribution of protocols to the assessment of the quality of medical care. To the degree that protocols are a team effort and represent a consensus of opinions among all physicians within an organization, they are a strong influence for defining acceptable processes of medical care and for defining what a physician extender may and may not do. It is the audit of performance which brings problems, since this is not part of the definition of the physician extender's role. Our experience has shown that when protocols are audited, attention must be given first and foremost to the potential educational and research value of the audit. Great effort must be made to avoid any punitive aspects of the exercise. As Dr. Donabedian cautioned, we must refine our criteria and not just police existing criteria.5 Vol. 52, No. 1, January 1976
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There is a continued risk that protocols will impose a bureaucracy on the previously informal relations between patients and physicians or between physicians and physician extenders. According to industrial experience, as long as a bureaucracy is participatory it serves the ends of all involved; once it becomes punitive it loses support.26' 27 If we expect protocols to accomplish more than a simple definition of roles -to improve the quality of medical care-some form of audit is essential to guarantee that documented deviations will be used to educate those who provide care or to alter the protocol, thus leading to improved delivery of medical care.20' 21,28,29,30 The degree to which protocols will find application in private practice remains to be seen. The definition of roles is less of a problem in situations where the physician extender works directly with one or two physicians. In such situations clear lines of authority soon emerge spontaneously. Large group practices, however, may find protocols to be essential in cases in which a satisfactory definition of roles cannot be accomplished by other means. Protocols can offer explicit definitions of the process of medical care to be followed. Acceptance of protocols by patients is being investigated in our clinic by means of a mailed questionnaire. Our data are incomplete, but studies done elsewhere suggest that the use of protocols does not adversely influence the relation between patient and physician.12', 17,18 22 This is important, especially in the light of Dr. Mack Lipkin's remarks, in which he cautioned against excessive emphasis on rigorous scientific analysis to explain all clinical benefit. There is a whole realm of medical care that is impossible to quantitate by today's methods. Dr. Inglefinger has raised similar issues in questioning the application of algorithms.31 Protocols should be an adjunct to clinical investigation and to the systematic recording of data. They should supplement, but never replace or interfere with, the traditional interaction between doctor and patient.
SUMMIARY At Duke University Medical Center we are educating physician extenders in methods of assessing the process and outcome of medical care by means of explicit criteria stated in the form of protocols. We have found that both physicians and physician extenders will accept this approach. A substantial effect on the quality of medical care has Bull. N. Y. Acad. Med.
PHYSICIAN EXTENDERS, PROTOCOLS, ANt) QUALITY CARE
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been documented. When audit is instituted continued vigilance is required in order to give assurance that the method continues to be oriented toward education and research. It remains to be seen whether protocols will find general acceptance in the practice of medicine. ACKNOWLEDGEMENTS I am indebted to Drs. E. Harvey Estes, Jr., Eugene S. Schneller, Kitty Shimoni, Michael Hamilton, and Reginald Carter for assistance in preparing this manuscript and to Nancy Topham, protocol auditor, for assistance in compiling the data. REFERENCES 8. Schneller, E. S.: A content analysis of the literature on the P. A.: A method for studying occupations and professions. A mer. Sociological Ass., San Francisco, 1975. Unpublished. 9. Schneller, E. S.: Perceptions of autonomy of prospective physician's associates. Second Ann. Conf. New Health Practitioners, New Orleans, April 1974. Unpublished. 10. The National Physic-an Assistant Program Profile. Washington, D. C., Ass. Phys. Assistant Programs, 1974. 11. Dobmeyer, T. W., Sonderegger, L. L., and Lowin, A.: A report of a 1972 survey of plhysician's assistant training programs. Med. Care 13:291, 1975. 12. Greenfield, S., Bragg, F. E., McCraith, D. L., and Blackburn, J.: Upper respiratory tract complaint protocol for physician-extenders. Arch. Intern. Med. _133:204, 1974. 13. Komaroff, A. L., Reiffen, B., and Sherman, H.: Problem-Oriented Protocols for Physician Extenders. In: Applying the Problem Oriented System, Walker, H. K., Hurst, J. W., and Woody, M. F., editors. New York, Medcom, 1973. 14. Tompkins, R. K., Kniffin, W. D., Sox, H. C., Sox, C. H., and Kaplan, A. D.: Use of a Clinical Algorithm System in a Physicians Assistant Program. In:
1. Donabedian, A.: Evaluating the quality of medical care. MilbeiAk Mem. Funzd Quart. ;4:166, 1966. 2. Brook, R. H.: Quality of care assessment: A comparison of five methods of peer review. National Center for Health Services Research and Development, Publication No. HRA-74-3100, Departmnent of Health Education and Welfare, Health Services and Mental Health Administration. Rockville, Md., 1973. 3. Brook, R. H. and Appel, F. A.: Quality of care assessment: Choosing a method for peer review. New Evy. J. Med. 288:1323, 1973. 4. Goldstein, R. L., Roberts, J. S., Stanton, B., Maglott, D. B., and Aoran, M. F.: Data for peer review: Acquisition and use-results in the experimental medical care review organization program. Ain. Interii. Med. 82:262, 1975. 5. Donabedian, A.: Measuring and evaluating hospital and medical care. Bu11. N. Y. Acad. Med. .52:51-59, 1976. 6. Magraw, R. M.: Formal quality assessment and utilization review programs: Their effects on the basic transactions of medical education. Bull. N. Y. Acad. Med. 5.2:105-18, 1976. 7. Duttera, M. J. and Harlan, AV. R.: Evaluation of physician extenders in the rural southeast: Patterns of practice and patient care. Amer. College of Physicians, San Francisco, April 1975.
Unpublished.
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15. Hodges, B.: The Role and Training of Allied Health Professionals at PROMIS Clinic, Haampden Highlands, Maine. In: Applying the Problem Oriented System, Walker, H. K., Hurst, J. W., and Woody, M. F., editors. New York, Medcom, 1973. 16. Taylor, J. E.: The Evolution of the Nurse's Role at PROMIS Clinic (The Management of Long-Terin Health Problems in the Problem-Oriented Svs-
tem). In: Applying the Problem Ori-
17.
18.
19.
20.
21.
ented System, Walker, H. K., Hurst, J. W., and Woody, M. F., editors. New York, Medcom, 1973. Charles, G., Stimson, D. H., Maurier, M. D., and Good, J. C.: Physician's assistants and clinical algorithms in health care delivery-A case study. Ann. Intern. Med. 81:733, 1974. Greenfleld S., Anderson, H., Winickoff, R. N., Morgan, A., and Komaroff, A. L.: Nurse-protocol management of lowback pain: Outcomes, patient satisfaction, and efficiency of primary care. Amer. Federation of Clinical Research National Meeting. Atlantic City, N. J., May 1974. Submitted for publication. Sherman, H. and Komaroff, A. L.: Ambulatory Care Project Progress Report 114. 1969-1974. Boston, Lincoln Laboratory, Massachusetts Inst. Technology, 1974, p. 28. Kaplan, A. D., Kniffin, W. D., Tomnpkins, R. K., Strauss, B., and Sox, H. C.: Audit of Clinical Performance as the Basis for the Education of Physician's Assistants. In: Applying the Problem Oriented System, Walker, H. K., Hunt, J. W., and Woody, M. J., editors. New York Medcom, 1973. Komaroff, A. L., Reiffen, B., and Sherman, H.: Protocols for Paramedics: A Quality Assurance Tool. In: Quality Assurance of Medical Care. Pub. No. (HSM) 73-7021, Health Services and Mental Health Administration, Dept.
HEW. Rockville, Md., 1973, p. 161. 22. Komaroff, A. L., Black, W. L., Flatley, M., Knopp, R. H., Reiffen, B., and Sherman, H.: Protocols for physicians assistants-ianagemient of diabetes and hypertension. New Eng. J. Med. 290: 307, 1974. 23. Greenfield, S., Friedland, G., Scifers, S., Rhodes, A., Black, W. L., and Komaroff, A. L.: Protocol management of dysuria, urinary frequency, and vaginal discharge. Ann. Intern. Med. 81: 4.52, 1974. 24. Grim, R. H., Shimoni, K., Harlan, W. R., and Estes, E. H.: Evaluation of patient-care protocol use by various providers. New Eng. J. Med. 292:507, 1975. 25. Morehead, M. A.: Ambulatory care review: A neglected priority. Bull. N. Y. Arad. Med. 52:60-69, 1976. 26. Smigel, E. O.: The Wall Street Lawyer: Professiotial Organization Man? New York, Indiana University Press, 1969, p. 280. 27. Gouldner, A. WV.: Patterns of Industrial Bureaucracy. New York, Free Press, 1954, p. 15. 28. Thompnins, R. K.: The Role of Medical Audit in the Definition of the Qualitv of Patient Care Rendered by Physicians Assistants. In: Quality Assurance of Medical Care. Pub. No. (HSM) 73-7021, Health Administration, Dept. HEW. Rockville, Md., 1973. 29. Sox, H. C., Sox, C. H., and Tompkins, R. K.: The training of physicians assistants: The use of a clinical algorithm system for patient care, audit of performance and education. New Eng. J. Med. '88:818, 1973. 30. Weed, L. L.: Quality Control. In: The Problem Oriented System, Walker, H. K., Hurst, J. WV. and WXoody, M. J., editors. New York, Medcomn, 1973. 31. Inglefinger, F.: Algorithms anyone? New Eng. J. Med. 288:847, 1973.
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