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 ResearchRobert M. Plovnick, M.D., M.S., Director, Dept of Quality

ImprovementRobert Kunkle, M.A., Director, Practice Guidelines Project

Joel Yager, M.D., ChairJames 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., ConsultantMolly T. Finnerty, M.D. Kristen Ochoa, M.D., FellowFrancis G. Lu, M.D. Jeremy Wilkinson, M.D., FellowPaul Summergrad, M.D. Sheila Hafter Gray, M.D., LiaisonMichael J. Vergare, M.D.