miércoles, 31 de marzo de 2010

Applying the GRADE Approach: Perspective from the Canadian Agency for Drugs and Technologies in Health


Expert Commentary
Perspective

Applying the GRADE Approach: Perspective from the Canadian Agency for Drugs and Technologies in Health

By: Denis Bélanger, B.Sc.Phm., ACPR


Dr. Ned Calonge raises some very good points in his Expert Commentary on the GRADE approach. In addition to the groups he identified that use GRADE, the Canadian Agency for Drugs and Technologies in Health (CADTH) also applies GRADE for generating recommendations. To date, recommendations on insulin analogues and self-monitoring of blood glucose (SMBG) have been developed by our expert review committee, known as COMPUS Expert Review Committee (CERC). CERC develops recommendations and advice with the aim of promoting optimal drug therapy and fostering a sustainable health care system for Canadians. CERC considers the practical needs of policy makers, health care providers, and consumers who will be implementing and using the recommendations.

While applying GRADE, CADTH researchers and CERC members have encountered both advantages and challenges that we would like to share.

From our perspective, the early engagement of the expert committee in identifying critical outcomes for generating a recommendation is a significant advantage. As CERC is responsible for making a recommendation, it is useful for members to be involved in determining what evidence will be required for the committee to fulfill its mandate, and the list of outcomes helps CADTH researchers compile all relevant information from available evidence. With this step in place, the research team avoids guessing about which outcomes should be reported or excluded from the analyses.

Traditional means of assessing quality of evidence focus on individual studies. In contrast, the GRADE process appraises the overall quality of evidence available for each outcome of interest. Quality of evidence can vary across outcomes reported in the same study, since some outcomes may be more prone to bias than others. For example, ascertainment bias due to lack of blinding is more likely for a subjective outcome, such as quality of life, than for an objective outcome, such as plasma glucose concentration. The GRADE approach provides a clear picture of the confidence that the expert committee has in the results for each outcome.

For CADTH, the clarification of how evidence is presented to CERC and how CERC arrives at a specific recommendation is an additional benefit of the GRADE process. The fact that CERC must discuss and visibly disclose the values and preferences around its recommendation helps our audiences better understand the recommendation. This explanation also helps the reader compare his or her values against those of the committee. A reader who places more importance on a value that is aligned with CERC is more likely to adopt the recommendation. For example, a recommendation encouraging the use of a specific agent because of improved safety profile (e.g., significantly less weight gain than the comparators) would be more appealing to consumers who place more value on avoiding the specific side effect. Likewise, a reader with values and preferences that differ from CERC can better judge whether he or she wishes to adopt the recommendation.

While the process for developing GRADE evidence profiles is very well documented by the GRADE Working Group, the process a committee uses to move from evidence to recommendations is not as well defined. The challenge faced by groups and organizations who want to adopt GRADE is how to operationalize GRADE at the Panel/Committee level. To address this challenge, CADTH describes the process that CERC used to generate recommendations in our published optimal therapy recommendation reports on insulin analogues (1) and self-monitoring of blood glucose (2). With each project, we identify opportunities for improved transparency and efficiencies for developing and presenting the evidence, as well as developing, documenting and presenting recommendations.

In our experience, the GRADE process has provided CADTH with a sound and consistent way of approaching the development of recommendations. Regular contact between GRADE Working Group members, CERC members, and CADTH researchers so that they may exchange ideas and share challenges, opportunities, and lessons learned proves invaluable to the successful implementation of GRADE in our work.

Author

Denis Bélanger, B.Sc.Phm., ACPR
Canadian Agency for Drugs and Technologies in Health (CADTH)

Disclaimer

The views and opinions expressed are those of the author and do not necessarily state or reflect those of the National Guideline Clearinghouse™ (NGC), the Agency for Healthcare Research and Quality (AHRQ), or its contractor ECRI Institute.

Potential Conflicts of Interest

Denis Bélanger is the Director, Topics and Research for the Canadian Agency for Drugs and Technologies in Health (CADTH). In addition, he lists the Canadian Association for Population Therapeutics as a professional affiliation. He states no financial or personal conflicts of interest.

References

Canadian Agency for Drugs and Technologies in Health. Optimal therapy recommendations for the prescribing and use of insulin analogues. Optimal Therapy Report - COMPUS 2009;2(7). Available: http://www.cadth.ca/media/pdf/compus_IA_OT_rec_report.pdf (accessed 2010 Mar 12).
Canadian Agency for Drugs and Technologies in Health. Optimal therapy recommendations for the prescribing and use of blood glucose test strips. Optimal Therapy Report - COMPUS 2009;3(6). Available: http://www.cadth.ca/media/pdf/compus_BGTS_OT_Rec_e.pdf (accessed 2010 Mar 12).
http://www.guideline.gov/expert/commentary.aspx?file=GRADE_CADTH.inc

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