American Psychiatric Association Practice Guideline Development Challenges and Ideas for Standards

Laura J. Fochtmann, M.D. Professor, Departments of Psychiatry and Behavioral Science and Pharmacological Sciences, Stony Brook University, Stony Brook, New York Medical Editor, Practice Guidelines, American Psychiatric Association No disclosures

APA Practice Guidelines Acute Stress Disorder and PTSD (2004) Alzheimer’s Disease and Other Dementias (1997, 2007) Bipolar Disorder (1994, 2002, in development) Borderline Personality Disorder (2001) Delirium (1999) Eating Disorders (1993, 2000, 2006) HIV/AIDS (2000) Major Depressive Disorder (1993, 2000, in development) Obsessive-Compulsive Disorder (2007) Panic Disorder (1998, 2009) Psychiatric Evaluation (1995, 2006) Schizophrenia (1997, 2004) Substance Use Disorders (1995, 2006) Suicidal Behaviors (2003)

Print publications Education and Certification Online CME Examinations Self-Evaluation Tools Quality indicators National Guideline Clearinghouse Concise formats

APA Development Process Comprehensive literature search Evidence tables Expert work group Zero industry funding Conflict of interest policy for all participants Broad, iterative review of drafts Approval by the APA Assembly and Board of Trustees

General Development Challenges  Increasing demand for new guidelines  Need for constant updating of prior guidelines  Volume of new evidence  Time- and resource-intensive development process, especially for rigorous systematic literature reviews  Composition of volunteer work groups  Approval through APA governance

Funding Challenges  Need to maintain independence from industry funding  Desire for broad dissemination over publication profits  Limited funds available for staff and other support  Limited public grant opportunities to support development?

Challenges Related to Available Evidence Base RCTs may be unavailable for important clinical questions or for off-patent treatments. RCTs can be biased. Studies often have limited generalizability. Available data rarely lend themselves to medical decision analysis. Relatively small samples do not permit assessment of confounds or special factors that may alter treatment.

Challenges in Determining Strength of Recommendation Evidence is rarely straightforward to translate into practice recommendations. Best methods for achieving consensus recommendations have not been defined (e.g., methodology, consensus panel composition, strength ratings). Consensus of a small expert panel may not represent broader clinical opinion.

Challenges in Increasing Usability and Adherence Need for broadly stated recommendations to Reflect complexity of real world patients Give clinicians flexibility in individualizing care without creating medicolegal or utilization review difficulties Reflect ambiguous or limited evidence Need for simplification and clarity to Enhance use of guidelines at the point of care Make them applicable to specific clinical situations Translate them into quality measures and machine- readable algorithms

Ideas for Standards for Guideline Development Specify clear, distinct criteria for strength of evidence and ratings of recommendation strength Be explicit about evidence used in making a recommendation, method by which the recommendation was reached, and evidence gaps. Develop standardized approaches to considering (and making explicit or minimizing) effects of bias. Develop standardized methods for achieving consensus. Allow for flexibility in composition of guideline panels. Choose clinically meaningful EHR and quality measures. Recognize that guideline-related needs of clinicians and patients may vary across specialties and settings.

Ideas for Improving Guideline Concordance and Currency Standardize the reporting of clinical trial data. Create a publicly funded database of the clinical trial evidence tables (e.g., within MEDLINE). Create a mechanism for developers to share information about guidelines that are in process. Continue expansion of AHRQ funding of systematic reviews. Consider alternative models for funding of guideline development per se Avoid standards or accreditation that would place additional costs or burdens on guideline development by professional societies.

APA Steering Committee on Practice Guidelines Darrel A. Regier, M.D., Director, Division of Research Robert M. Plovnick, M.D., M.S., Director, Dept of Quality Improvement Robert Kunkle, M.A., Director, Practice Guidelines Project Joel Yager, M.D., Chair James E. Nininger, M.D., Vice-Chair APA Staff Daniel J. Anzia, M.D.Sherwyn M. Woods, M.D., Ph.D. Thomas J. Craig, M.D. John S. McIntyre, M.D., Consultant Molly T. Finnerty, M.D.Kristen Ochoa, M.D., Fellow Francis G. Lu, M.D.Jeremy Wilkinson, M.D., Fellow Paul Summergrad, M.D.Sheila Hafter Gray, M.D., Liaison Michael J. Vergare, M.D.