Abstract
The American Academy of Dermatology is modernizing its clinical practice guidelines to be more timely and easily interpretable, while decreasing the influence of conflicts of interest in guideline generation. The main changes include the transition from SORT to GRADE methodology and the requirement that nonconflicted members of the guideline work groups remain nonconflicted throughout the entire guidelines process. (J Am Acad Dermatol https://doi.org/10.1016/j.jaad.2019.12.075.)
Keywords: conflicts of interest, dermatology, evidence-based medicine, GRADE, practice guidelines, quality assurance
For many dermatologists, clinical practice guidelines are the easiest way to access evidence-based medicine.1 This statement outlines 3 major changes to how guidelines will now be developed by the American Academy of Dermatology (AAD): (1) guidelines will use Grading of Recommendations Assessment, Development, and Evaluation (GRADE) instead of Strength of Recommendation Taxonomy (SORT) to rate evidence, (2) guideline generation will be streamlined, and (3) guideline committees will have new conflicts of interest requirements.
THE TRANSITION FROM SORT TO GRADE
There are numerous systems for the development of clinical practice guidelines, creating substantial confusion in interpreting recommendations. Since the mid-2000s, the AAD has been using SORT.2 The benefit of SORT is that it has a simple scale that emphasizes patient-oriented evidence (Table I).3 However, GRADE has since become the most widely used approach for guideline development, adopted by more than 100 organizations, including the World Health Organization and the Centers for Disease Control and Prevention. GRADE determines strength of recommendation based on the certainty of evidence and the balance of benefits and harms (Supplemental Material; available via Mendeley at https://doi.org/10.17632/fhh65zhpkr.1).4 We believe the transition from SORT to GRADE will ease the synthesis of guideline generation across organizations and allow recommendations to be more easily understood.
Table I.
Guideline generation criteria | SORT | GRADE |
---|---|---|
| ||
Certainty of evidence | Level 1, level 2, or level 3 | High, moderate, low, or very low |
Certainty of evidence determined by | Level 1: Good-quality patient-oriented evidence Level 2: Limited-quality patient-oriented evidence, based on risk of bias, inconsistency, or inadequate statistical power Level 3: Other evidence |
Generally, randomized controlled trials are most highly rated, followed by observational studies and then case series. Quality of evidence is downgraded for • Risk of bias • Imprecision • Inconsistency • Indirectness • Publication bias Quality of evidence is upgraded for • Large effect • Dose response • Opposing confounding |
Strength of recommendation | A, B, or C | Strong or conditional |
Strength of recommendation determined by | A: Recommendation is based on consistent and good-quality patient-oriented evidence. B: Recommendation is based on inconsistent or limited-quality patient-oriented evidence. C: Recommendation is based on consensus, usual practice, opinion, disease-oriented evidence, and case series OR is not based on patient-oriented evidence. |
• Balance between benefits and harms • Patient values and preferences • Cost |
GRADE, Grading of Recommendations Assessment, Development, and Evaluation; SORT, Strength of Recommendation Taxonomy.
STREAMLINING THE GUIDELINE DEVELOPMENT PROCESS
To make the guideline generation process more efficient, the AAD will (1) create living guidelines, which will allow for continuous updates based on changing evidence; (2) shorten the time for the development and review of guidelines by reducing work group size and expediting the approvals process; and (3) build innovative strategies for moving guidelines into practices, including derivative products and machine-readable files, assessing the need for and value of new clinical guidance formats, and building processes for their production.
CHANGES TO THE CONFLICTS OF INTEREST POLICY
Widespread conflicts of interest among the authors of clinical practice guidelines are a threat to their integrity.5 To combat this issue, moving forward, at least 51% of AAD clinical guidelines work group members must not have a relevant financial conflict of interest. A nonconflicted member acquiring new relevant conflicts during the course of guideline development will be removed and replaced by a nonconflicted member. The appointee removed for this reason will forfeit the authorship role, even if this member contributed significantly in developing the guideline. Additionally, the chair of the work group is prohibited from having any relevant financial conflict of interest, unless the expertise and leadership is deemed necessary by the Clinical Guidelines Committee. In this instance, a cochair with no relevant financial conflict of interest will be appointed. The chair or co-chair must also remain free of relevant conflicts of interest for at least 1 year after guideline publication.
CONCLUSION
The AAD is implementing a number of changes to modernize its clinical practice guidelines. The next steps for modernizing the AAD’s guidelines include converting the guidelines into a user-friendly electronic format that is constantly updated, as well as integrating the guidelines into the electronic medical record system to aid in patient decision making.
Supplementary Material
Acknowledgments
Funding sources: Dr Freeman is supported in part by a National Institutes of Health Career Development Award (grant K23 AI136579).
Abbreviations used:
- AAD
American Academy of Dermatology
- GRADE
Grading of Recommendations Assessment, Development, and Evaluation
- SORT
Strength of Recommendation Taxonomy
Footnotes
IRB approval status: Not applicable.
Boston, Massachusetts; Rosemont, Illinois; St Louis, Missouri; Hagerstown, Maryland; Miami, Florida; and Cleveland, Ohio
Conflicts of interest: None disclosed.
REFERENCES
- 1.Eddy DM. Evidence-based medicine: a unified approach. Health Aff (Millwood). 2005;24(1):9–17. [DOI] [PubMed] [Google Scholar]
- 2.Maymone MBC, Gan SD, Bigby M. Evaluating the strength of clinical recommendations in the medical literature: GRADE, SORT, and AGREE. J Invest Dermatol. 2014;134(10):1–5. [DOI] [PubMed] [Google Scholar]
- 3.Ebell MH, Siwek J, Weiss BD, et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician. 2004; 69(3):548–556. [PubMed] [Google Scholar]
- 4.Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ. What is “quality of evidence” and why is it important to clinicians? BMJ. 2008;336(7651):995–998. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Balshem H, Helfand M, Schünemann HJ, et al. GRADE guide-lines: 3. rating the quality of evidence. J Clin Epidemiol. 2011; 64(4):401–406. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.