- Email: [email protected]
Cholesterol: Consensus and controversy
J Clin Epidemiol Vol. 43, No. 10, pp. 1021-1022, 1990
0895-4356/90 53.00 + 0.00 Copyright c 1990 Pergamon Press plc
Printed in Great Britain. All rights reserved
Editorial CHOLESTEROL: CONSENSUS AND CONTROVERSY L. LINTON
ADAM
Vice President Ontario Medical Association
It might be expected that critical evaluation and appropriate diffusion of new drugs, technologies, and programs would be readily achievable within a universal, publicly-funded health care system such as exists in each Canadian province. However, in Ontario, the largest province with a population of 9.4 million, the record is uneven. At the same time that concern has arisen about how to shape the adoption of new programs and techniques, utilization - measured as the volume and real cost of medical services consumed per citizen -has steadily increased. The provincial Ministry of Health and the Ontario Medical Association (OMA) have debated the causes of increasing utilization of the system, and in an attempt to find solutions, established a conjoint Task Force on the Use and Provision of Medical Services. The Task Force has equal representation from Government and the medical association. Its mandate is broad - the study of any factors which might affect the cost or quality of health care. In the earliest meetings of the Task Force, the investigation and treatment of asymptomatic hypercholesterolemia was identified as a topic worthy of study on both counts. The Task Force recognized that the recommendations of experts in the field of lipid disorders, as well as publicity from the drug industry, the food industry and the media, were all forces that would eventually lead to very widespread testing and treatment. The Task Force’s interest was particularly catalyzed by the 1988 Canadian Consensus Conference on Cholesterol, which endorsed a medical program of universal adult testing similar to the National Cholesterol Education Program of the American National Institutes of Health. Task Force members perceived that critical evaluation of the supporting scientific evidence was scanty.
The cost implications were considerable, but quality of care and the impact on patients were also major issues, given the problems of inaccurate testing, drug side-effects and “medicalization” of a substantial segment of the population. The Task Force requested the advice of a working group composed of researchers in clinical epidemiology, preventive medicine, biostatistics, family and community medicine, and program evaluation. Because the focus was on epidemiologic evidence and the implications for both the primary care sector and population at large, the group did not include a subspecialist in lipid disorders. This became one of the points of controversy about the process of policy formulation. The group conducted an analysis of the published data on asymptomatic hypercholesterolemia, and produced a draft document which was submitted to external review. For the review process, the working group submitted the names of twelve experts in the field to the Task Force, who chose eight to be commissioned to appraise the report. Six of the eight were able to comply. These included three members of the expert panel of the Canadian Consensus Conference on Cholesterol-a cardiologist with a longstanding interest in lipid disorders, a senior nutrition researcher, and an epidemiologist. Three other reviewers from the United States covered a broad base of expertise. One was an internist and economist, who had served as a consultant on cholesterolrelated issues for Blue Cross-Blue Shield and the Office of Technology Assessment. Another was an authority in preventive medicine, who had done consultative work in the cholesterol field for the American Task Force on Preventive Services. The third reviewer was a distinguished investigator in clinical nutrition and lipidology, and had been a member of expert panels for America’s National Cholesterol Education Program.
1021
Various of the reviewers disagreed with some of the conclusions and recommendations of the Working Group. However, while some of their opinions were incorporated into the final document, there was no clear consensus among the reviewers on the substantive issues. Indeed, the sharp disagreements among the expert referees supported the view that much of the quoted evidence was inconclusive and open to conflicting interpretations - in itself, a disturbing finding given the massive scale of some of the programs proposed for clinical detection and management of asymptomatic hypercholesterolemia. The Ontario Task Force reviewed the criticisms, proposed revisions, and final report, which it endorsed and released in March 1989 [ 11.The report was also endorsed by the sponsoring agencies -the Ministry of Health of Ontario and the Ontario Medical Association. Voluntary practitioner guidelines based on the Working Group’s conclusions and recommendations were drawn up by the Task Force, and subsequently circulated to all physicians in the province. The release of the Task Force report provoked protests from academic experts in various aspects of lipid disorders, including published communications which questioned the appropriateness of asking an epidemiologically-oriented working group to analyze scientific evidence and offer recommendations in the area of asymptomatic hypercholesterolemia [2,3]. The tenor of the debate was acrimonious [4,5]. The cholesterol controversy in Ontario raises generic issues of importance in the appraisal and rational diffusion of medical innovations. Even in a universal and publicly-funded system, we have few established structures or processes to deal with the scientific evaluation of new techniques and programs, be it with respect to effectiveness, impact analysis, or efficiency. Considerations of clinical and economic efficiency may raise the hackles of traditional clinicians. However, these measures must surely be considered when programs compete with each other for resources. In promoting consensus at the interface of clinical and public policy, some variant on the processes used by the Rand Corporation [6,7] and Canadian Consensus Conference on Aspects of Cesarean Birth [8,9] seems to hold out most hope. These processes presume the participation of respected practitioners from interested sections of the profession, and thereby help ensure that justice is seen to be done.
However, to ensure an impartial review of the evidence upon which verdicts are rendered, these formal group processes also presuppose the preparation of background documents by experts in the evaluative sciences. It is the stance of the Task Force that this domain is one where we must acknowledge and apply the special skills of clinical and population epidemiologists, biostatisticians, and health economists. The Ontario Task Force on the Use and Provision of Medical Services is accordingly pleased to support the publication of the Toronto Working Group’s updated report as a special issue of the Journal of Clinical Epidemiology. We expect the current report will form a large part of the evidentiary background to facilitate a fresh round of discussion, consonant with our hope that a successful consensusbuilding process can be followed in any future guideline initiatives. In the interim, we look forward to commentary from the international epidemiological community.
REFERENCES 1.
2.
Toronto Working Group on Cholesterol Policy. Detection and Management of Asymptomatic Hypercholesterolemia (Toronto: Ontario Ministry of Health/Ontario Medical Association, 1989). Steiner G, Angel A, Wolfe B et al: Asymptomatic hypercholesterolemia: viewpoint of the lipid research groups in Ontario. Ontario Medical Review 1989; 56 (11):7-10. Horlick L. Managing hypercholesterolemia. Can Med Assoc J 1989; 141: 861-862. Hollenberg CH. Ontario cholesterol controversy. Can Med Assoc J 1990; 142: 520-521. Little JA. Cholesterol report lacks credibility:CCCC. Ontario Medical Review 1990,57(2):6. Brook RH, Chassin MB, Fink A, Solomon DH, Kosecoff I, Park RE. A method for the detailed assessment of the appropriateness of medical technologies. Int J Tech Assess Health Care 1986; 2~53-64. Park RE, Fink A, Brook RH et al. Physician ratings of appropriate indications for six medical and surgical procedures. Am J Public Health 1986; 76:766-772. Hannah Wet al (Panel), Lomas J et al (Planning Committee). Indications for cesarean section: final statement of the panel of the National Consensus Conference on Aspects of Cesarean Birth. Can Med Assoc J 1986: 134:1348-1352. Lomas J, Anderson G, Enkin M, Vayda E, Roberts R, Mackinnon B. The role of evidence in the consensus process: results from a Canadian consensus exercise. JAMA 1988; 259:300-3005.
0895-4356/90 53.00 + 0.00 Copyright c 1990 Pergamon Press plc
Printed in Great Britain. All rights reserved
Editorial CHOLESTEROL: CONSENSUS AND CONTROVERSY L. LINTON
ADAM
Vice President Ontario Medical Association
It might be expected that critical evaluation and appropriate diffusion of new drugs, technologies, and programs would be readily achievable within a universal, publicly-funded health care system such as exists in each Canadian province. However, in Ontario, the largest province with a population of 9.4 million, the record is uneven. At the same time that concern has arisen about how to shape the adoption of new programs and techniques, utilization - measured as the volume and real cost of medical services consumed per citizen -has steadily increased. The provincial Ministry of Health and the Ontario Medical Association (OMA) have debated the causes of increasing utilization of the system, and in an attempt to find solutions, established a conjoint Task Force on the Use and Provision of Medical Services. The Task Force has equal representation from Government and the medical association. Its mandate is broad - the study of any factors which might affect the cost or quality of health care. In the earliest meetings of the Task Force, the investigation and treatment of asymptomatic hypercholesterolemia was identified as a topic worthy of study on both counts. The Task Force recognized that the recommendations of experts in the field of lipid disorders, as well as publicity from the drug industry, the food industry and the media, were all forces that would eventually lead to very widespread testing and treatment. The Task Force’s interest was particularly catalyzed by the 1988 Canadian Consensus Conference on Cholesterol, which endorsed a medical program of universal adult testing similar to the National Cholesterol Education Program of the American National Institutes of Health. Task Force members perceived that critical evaluation of the supporting scientific evidence was scanty.
The cost implications were considerable, but quality of care and the impact on patients were also major issues, given the problems of inaccurate testing, drug side-effects and “medicalization” of a substantial segment of the population. The Task Force requested the advice of a working group composed of researchers in clinical epidemiology, preventive medicine, biostatistics, family and community medicine, and program evaluation. Because the focus was on epidemiologic evidence and the implications for both the primary care sector and population at large, the group did not include a subspecialist in lipid disorders. This became one of the points of controversy about the process of policy formulation. The group conducted an analysis of the published data on asymptomatic hypercholesterolemia, and produced a draft document which was submitted to external review. For the review process, the working group submitted the names of twelve experts in the field to the Task Force, who chose eight to be commissioned to appraise the report. Six of the eight were able to comply. These included three members of the expert panel of the Canadian Consensus Conference on Cholesterol-a cardiologist with a longstanding interest in lipid disorders, a senior nutrition researcher, and an epidemiologist. Three other reviewers from the United States covered a broad base of expertise. One was an internist and economist, who had served as a consultant on cholesterolrelated issues for Blue Cross-Blue Shield and the Office of Technology Assessment. Another was an authority in preventive medicine, who had done consultative work in the cholesterol field for the American Task Force on Preventive Services. The third reviewer was a distinguished investigator in clinical nutrition and lipidology, and had been a member of expert panels for America’s National Cholesterol Education Program.
1021
Various of the reviewers disagreed with some of the conclusions and recommendations of the Working Group. However, while some of their opinions were incorporated into the final document, there was no clear consensus among the reviewers on the substantive issues. Indeed, the sharp disagreements among the expert referees supported the view that much of the quoted evidence was inconclusive and open to conflicting interpretations - in itself, a disturbing finding given the massive scale of some of the programs proposed for clinical detection and management of asymptomatic hypercholesterolemia. The Ontario Task Force reviewed the criticisms, proposed revisions, and final report, which it endorsed and released in March 1989 [ 11.The report was also endorsed by the sponsoring agencies -the Ministry of Health of Ontario and the Ontario Medical Association. Voluntary practitioner guidelines based on the Working Group’s conclusions and recommendations were drawn up by the Task Force, and subsequently circulated to all physicians in the province. The release of the Task Force report provoked protests from academic experts in various aspects of lipid disorders, including published communications which questioned the appropriateness of asking an epidemiologically-oriented working group to analyze scientific evidence and offer recommendations in the area of asymptomatic hypercholesterolemia [2,3]. The tenor of the debate was acrimonious [4,5]. The cholesterol controversy in Ontario raises generic issues of importance in the appraisal and rational diffusion of medical innovations. Even in a universal and publicly-funded system, we have few established structures or processes to deal with the scientific evaluation of new techniques and programs, be it with respect to effectiveness, impact analysis, or efficiency. Considerations of clinical and economic efficiency may raise the hackles of traditional clinicians. However, these measures must surely be considered when programs compete with each other for resources. In promoting consensus at the interface of clinical and public policy, some variant on the processes used by the Rand Corporation [6,7] and Canadian Consensus Conference on Aspects of Cesarean Birth [8,9] seems to hold out most hope. These processes presume the participation of respected practitioners from interested sections of the profession, and thereby help ensure that justice is seen to be done.
However, to ensure an impartial review of the evidence upon which verdicts are rendered, these formal group processes also presuppose the preparation of background documents by experts in the evaluative sciences. It is the stance of the Task Force that this domain is one where we must acknowledge and apply the special skills of clinical and population epidemiologists, biostatisticians, and health economists. The Ontario Task Force on the Use and Provision of Medical Services is accordingly pleased to support the publication of the Toronto Working Group’s updated report as a special issue of the Journal of Clinical Epidemiology. We expect the current report will form a large part of the evidentiary background to facilitate a fresh round of discussion, consonant with our hope that a successful consensusbuilding process can be followed in any future guideline initiatives. In the interim, we look forward to commentary from the international epidemiological community.
REFERENCES 1.
2.
Toronto Working Group on Cholesterol Policy. Detection and Management of Asymptomatic Hypercholesterolemia (Toronto: Ontario Ministry of Health/Ontario Medical Association, 1989). Steiner G, Angel A, Wolfe B et al: Asymptomatic hypercholesterolemia: viewpoint of the lipid research groups in Ontario. Ontario Medical Review 1989; 56 (11):7-10. Horlick L. Managing hypercholesterolemia. Can Med Assoc J 1989; 141: 861-862. Hollenberg CH. Ontario cholesterol controversy. Can Med Assoc J 1990; 142: 520-521. Little JA. Cholesterol report lacks credibility:CCCC. Ontario Medical Review 1990,57(2):6. Brook RH, Chassin MB, Fink A, Solomon DH, Kosecoff I, Park RE. A method for the detailed assessment of the appropriateness of medical technologies. Int J Tech Assess Health Care 1986; 2~53-64. Park RE, Fink A, Brook RH et al. Physician ratings of appropriate indications for six medical and surgical procedures. Am J Public Health 1986; 76:766-772. Hannah Wet al (Panel), Lomas J et al (Planning Committee). Indications for cesarean section: final statement of the panel of the National Consensus Conference on Aspects of Cesarean Birth. Can Med Assoc J 1986: 134:1348-1352. Lomas J, Anderson G, Enkin M, Vayda E, Roberts R, Mackinnon B. The role of evidence in the consensus process: results from a Canadian consensus exercise. JAMA 1988; 259:300-3005.