Guideline controversy

The recent exchange on the discord between influential recommendations is highly relevant for our health care systems [1-3]. Organizations such as the Canadian Diabetes Association (CDA) play many important roles in our health care systems. These roles may, however, not always sit together comfortably. Such is the case for CDA’s role in advocating for people with diabetes and it’s role in leading the development of national Clinical Practice Guidelines (CPG).

The CDA CPG, past[4] and present[5], are amongst the most rigorous and evidence-based guidelines in Canada [6]; yet, about 50% of the recommendations are based solely on consensus [7], with only the lowest level of evidence available in the grading scheme used [5]. It is well recognized that reaching consensus can difficult [8,9]. It should also be recognized that a consensus reached by one group, using one process, may be different than the consensus reached by another group, using a different process [10,11]. This underscores the role of individuals and influences in the achievement of consensus, particularly in the absence of stronger evidence.

What is important in the ongoing exchange is not just about differences in consensus, however, but differences in mandate. It is not surprising that recommendations from groups such as the Canadian Expert Drug Advisory Committee (CEDAC) differ from those of the CDA CPG Expert Committee; their mandates are clearly different. CDA should, however, recognize that its mandate “to advocate for and increase treatment options” is separate from its community service mandate in creating evidence-based CPG. Whereas CEDAC and the various provincial formulary advisory committees must consider evidence of effectiveness as well as cost-effectiveness [3], the CDA CPG Expert Committee has explicitly excluded cost and cost-effectiveness considerations from their deliberations [12]. What is surprising is that developers of clinical guidelines explicitly exclude considerations of cost and cost- effectiveness, and then advocate that bodies such as CEDAC, or the various provincial formulary advisory committees, should accept the CPG recommendations. This is also a common strategy used by pharmaceutical manufacturers in their argument for inclusion of their product on a formulary (e.g., “our product is listed in the CPGs, so therefore it should be available on formulary”). Ironically, by explicitly excluding cost and cost-effectiveness consideration from the guideline development process, developers have provided formulary advisors an effective defense against this strategy (i.e., “yes, but, those CPG didn’t consider cost or cost-effectiveness”).

One strategy for attenuating this discord is the inclusion of cost and cost-effectiveness considerations in the development of clinical practice guidelines [7,13,14]. This need not take the form of two different, competing recommendations, one based on clinical evidence, the other based solely on cost [12]. Indeed, the consideration of both cost and effectiveness together form the basis of cost-effectiveness analyses. If a new technology offers a clinical advantage (i.e., is safer or more effective), which should be the first consideration, is that incremental benefit worth the incremental cost? Surely, if Grade D Consensus can be the evidentiary basis for 50% of the recommendations in the current version of the CDA CPGs, there is room for consideration of cost and cost- effectiveness in that process.

Regardless, collaboration and communication between CPG creators and policy makers should be enhanced; the expertise of disease specialists might be coupled with economic and resource considerations in the creation of specific limitations for funded therapies (for example, as suggested by the CDA in its recommendations for insulin glargine). While the creation of “limited use” or “special authorization” criteria may seem unduly bureaucratic to practicing physicians, the subtleties of Grade D Consensus guidelines expressed as “therapy might be considered” are too frequently not perceived, and often abused by advocates and marketing forces.

Given the recent growth in health care expenditures as the largest portion of overall provincial spending, ignoring cost considerations seems to be a naive approach to advocacy. Consider, for example, an organization advocating for resource allocation for technologies and services that are recommended on the basis of Grade D Consensus. In the absence of stronger evidence, such products and services may be less effective, ineffective, or worse, potentially harmful. Advocates for such technologies and services would, in fact, be doing a disservice to their constituency, by potentially siphoning away resources from those proven effective interventions from which patients will gain the greatest benefit (i.e., the concept of opportunity cost).

As a community, we have embraced the concept of evidence-based medicine, and we hope that our work can be considered in evidence-based policy. Organizations such as the CDA, and similarly, developers of guidelines, who are likely to be most familiar with the products and services which should be the greatest priorities for their patients [2], should consider a strategy of evidence-based advocacy, judiciously encouraging health care systems to ensure access to those interventions or services which have the greatest evidence of benefit, as priorities, rather than simply advocating for all products and services that are currently available [15].

References

1. Clinical practice guidelines and conflict of interest [editorial] CMAJ 2005;173;1297-1299.

2. Howlett MC, Lillie D. The Canadian Diabetes Association guidelines: putting evidence first. CMAJ 2006;174:333-334.

3. Laupacis A. On bias and transparency in the development of influential recommendations. CMAJ 2006;174:335-336.

4. Canadian Diabetes Association.1998 clinical practice guidelines for the management of diabetes in Canada. CMAJ 1998;159 Suppl 8:S1-29.

5. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. 2003 clinical practice guidelines for the prevention and treatment of diabetes. Can J Diabetes 2003;27:Suppl 2.

6. Graham I, Beardall S, Carter AO, et al. What is the quality of drug therapy clinical practice guidelines in Canada? CMAJ 2001;165:157- 63.

7. Koshman S, Johnson JA. Consensus, cost-effectiveness and clinical practice guidelines. [Letter to Editor] Can J Diabetes 2005;29:374-376.

8. Campbell SM, Braspenning J, Hutchinson A, Marshall M. Research methods used in developing and applying quality indicators in primary care. Qual Saf Health Care 2002;11:358-364.

9. Majumdar SR, Johnson JA, Bowker SL, et al. A Canadian consensus for the standardized evaluation of quality improvement interventions in type 2 diabetes: Development of a Quality Indicator Set. Can J Diabetes 2005;29:220-229.

10. Coulter I, Adams A, Shekelle P. Impact of varying panel membership on ratings of appropriateness in consensus panels: a comparison of a multi- and single disciplinary panel. Health Serv Res. 1995;30:577- 591.

11. Leape LL, Park RE, Kahan JP, Brook RH. Group judgments of appropriateness: the effect of panel composition. Qual Assur Health Care 1992;4:151-159.

12. Harris SB, McFarlane P, Lank CN. Consensus, cost-effectiveness and clinical practice guidelines. [Response from Authors]. Can J Diabetes 2005;29:376-378.

13. Ramsey SD. Economic analyses and clinical practice guidelines. Why not a match made in heaven? J Gen Intern Med 2002;17:235-37.

14. Wallace JF, Weingarten SR, Chiun-Fang C, et al. The limited incorporation of economic analyses in clinical practice guidelines. J Gen Intern Med 2002;17:210-20.

15. Canadian Diabetes Association, Diabetes Report 2005. December 2005. Available at: http://www.diabetes.ca/section_advocacy/index.asp. Accessed February 15, 2006.

Conflict of Interest:

JAJ has received research grant funding from the CDA, supervised students who have received CDA Doctoral Research Awards, has served on the CDA Personnel Awards Committee (2003-2006) and CDA Applied Research Grants Committee (2002-2006). JAJ has received research grant funding from Eli Lilly, Sanofi-Aventis, Glaxo SmithKline, and Pfizer. JAJ is currently a member of the Expert Committee on Drug Evaluation and Therapeutics for Alberta Health and Wellness. ALE has acted as an investigator for a number of industry funded trials and prior to 2003 received speaker’s fees for educational presentations. JAJ and ALE are participating in the revisions to the CDA CPG for 2008. Acknowledgements: JAJ holds a Government of Canada Research Chair in Diabetes Health Outcomes and is a Health Scholar with the Alberta Heritage Foundation for Medical Research. The views expressed in this letter are those of the authors and do not necessarily represent the views of other members of Alberta’s Expert Committee on Drug Evaluation and Therapeutics.