Clinical Practice Guideline for PTSD: An Overview of the Process and the Product Featuring APA Staff Psychologist Lynn Bufka, PhD

Transcription

1 APA Webinar Clinical Practice Guideline for PTSD: An Overview of the Process and the Product Featuring APA Staff Psychologist Lynn Bufka, PhD December 12, 2017 THE WEBINAR WILL BEGIN MOMENTARILY AMERICAN PSYCHOLOGICAL ASSOCIATION

2 Developing and Implementing an Evidence-Based Clinical Practice Guideline: PTSD INTRODUCTION TO THE APA CLINICAL PRACTICE GUIDELINE on PTSD Lynn F. Bufka, PhD

3 APA Clinical Practice Guideline for PTSD All content contained within this presentation is for informational purposes (Copyright The American Psychological Association) and may not be reproduced or altered in any form without express permission by the Association.

4 Disclaimers No proprietary or commercial interests We all bring perspectives.

5 APA Clinical Practice Guideline for PTSD HAVE A QUESTION? While you won t be able to talk during the webinar, please submit your questions for Dr. Bufka by using the Questions field located in the webinar control panel.

6 What is a clinical practice guideline? APA defines two main types of guidelines: 1. Professional practice guidelines- recommendations to professionals concerning their conduct and the issues to be considered in particular areas of clinical practice (APA, 2002). 2. Clinical practice guidelines- provide specific recommendations about treatments to be offered to patients and they tend to be condition or treatment specific (APA, 2002).

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10 How did APA develop the PTSD guideline? Issued call for nominations for panel members Multidisciplinary panel included Psychology (clinicians, researchers), Medicine (psychiatry, general), Social Work, and Patient/Consumer/Community Members APA follows the Institute of Medicine s 2011 standards for guideline development Independent systematic review Public comment period

11 PTSD Panel Members Christine Courtois, PhD (Chair) Private Practice (retired), Bethany Beach, DE Joan Cook, PhD Yale School of Medicine, West Haven, CT Matthew Friedman, MD, PhD National Center for PTSD, White River Junction, VT Russell Jones, PhD Virginia Tech, Blacksburg, VA Thomas Mellman, MD Howard University College of Medicine, Washington, DC Priscilla Schulz, LCSW-C The Peace Corps, Washington, DC Laura Brown, PhD Private Practice, Seattle, WA John A. Fairbank, PhD Duke Univ. Med. Center, Durham, NC Joseph Gone, PhD University of Michigan, Ann Arbor, MI Annette La Greca, PhD University of Miami, Miami, FL John Roberts Wounded Warriors Project, Houston, TX Jeffrey Sonis, MD, MPH (Vice-Chair) University of North Carolina, Chapel Hill, NC

12 What Makes a Quality Guideline (IOM, 2011) Transparency in development and funding Resolve conflicts of interest (disclose and divest) Panels multidisciplinary and balanced (adversarial collaboration) Based on systematic reviews of literature (plus grey) Rate quality of evidence and recommendation strength Frame recommendations as actionable statements Submit draft guideline for public review and comments Update guideline periodically as necessary

13 Clinical Practice Systematic Guideline Review for PTSD Process Select, Scope & Refine Topic Formulate Key Questions Specify review protocol P I C O T S Outcome 1 Outcome 2 Outcome 3 Systematic Review Team (SRT) CPG Development Process Guideline Development Panel (GDP) 1) Rate quality of evidence per critical outcomes (benefits & harms), for all relevant treatment decisions Evidence Quality Domains: Risk of bias Consistency Directness Precision Publication bias Effect size Dose-response 2) Rate strength of evidence (SOE) for each PICOTS question (all comparisons), aggregated across all critical outcomes: SOE graded as: High Moderate Low Very Low/Insufficient 3) For each recommendation, GDP determines the recommendation s: a) Direction (For or Against); b) Strength (e.g., Strong or Conditional); and, c) Wording (Standardized; Reflects a & b above): We recommend using We suggest using X for patients with Y. We recommend against using We suggest against using X for patients with Y. 1) GDP completes decision tables/grids for each relevant treatment option. 2) GDP formulates treatment recommendations, considering: Strength of evidence Balance of benefits/harms (Net Benefit) Patient values and preferences Applicability of evidence to real patients Adapted from: Falk-Ytter & Schünemann (2009); Schünneman & Berkman (2011); Owens et al. (2009)

14 Systematic Review for PTSD Guideline Topic nominated by APA Funded by Agency for Healthcare Research and Quality Psychologists had input into key questions Panel did not commission the review but opted to use recent existing review given relative strengths Conducted by independent evidence based practice center (RTI, Inc) Followed IOM best practices for conducting SR

15 Determinants of Quality Evidence - GRADE Methodological limitations Inconsistency of results Indirectness of evidence Imprecision of results Publication bias Risk of bias: Sources of indirectness: Allocation concealment Blinding Intention-to-treat Follow-up Stopped early Indirect comparisons Patients Interventions Comparators Outcomes

16 Managing Conflicts of Interest Identify real and perceived COI Disclose, disclose, disclose Adversarial collaboration Financial = divest Manage Disclose and discuss Recuse from debate Recuse from voting

17 Two Key Factors Critical and important outcomes Critical- essential and necessary to treatment decision making process PTSD symptom reduction and serious harms (adverse events) Important- significant but not critical for making a decision Public comment process 60 day public comment period 890 individuals submitted comments Responded to collective sample of comments Modified guideline accordingly

18 PTSD Guideline Recommendations Recommendations are strong or conditional based on strength of evidence, balance of benefits versus harms/ burdens, patient values and preferences, applicability Recommendations for psychological and pharmacological interventions Relatively limited evidence in the SR directly comparing treatments; especially psychological interventions and medications

19 Strong Recommendations for Psychological Interventions CBT Cognitive Processing Therapy Cognitive Therapy Prolonged Exposure

20 Strong Recommendations for Psychological Interventions x

21 Strong Recommendations for Psychological Interventions An example: Prolonged Exposure Description Link to case example Link to manual For Patients and Families References and Resources

22 Conditional Recommendations for Psychological Interventions Brief Eclectic Psychotherapy Eye Movement Desensitization and Reprocessing Therapy (EMDR) Narrative Exposure Therapy

23 Pharmacological Recommendations Conditional recommendation Fluoxetine Paroxetine Sertraline Venlafaxine No recommendation Risperidone Topiramate

24 Comparative Effectiveness Suggests PE over relaxation* Suggests CBT over relaxation Suggests either PE or Exposure plus cognitive restructuring Insufficient evidence to recommend for or against Seeking Safety versus active controls Suggests either venlafaxine ER or sertraline

25 What s Missing in the Guideline? Guideline focuses on efficacy data Not all interventions used have strong data evaluating efficacy Relatively little high quality comparative effectiveness has been conducted Do not infer any sort of ranking of interventions Diversity Inadequate data in systematic review to provide meaningful recommendations for children and adolescents; little information on older adults Little information on outcomes in specific populations- however, fair amount of diversity in study participants Use APA s professional practice guidelines Clinical decision making

26 Dissemination and Implementation PDF of guideline on Publish executive summary in American Psychologist Website of supportive content for all recommended interventions Description Case example More learning opportunities Additional resources Consumer section as well

27 Assessment Descriptions and links to interviews and self-report instruments Additional resources related to PTSD assessment for practitioners

28 Other Resources Resources for Clinicians Manuals Training and Continuing Education Online courses Case examples Books and Videos Treatment dose, timing and duration For Patients and Families

29 Placing Clinical Guidelines in Context Applicable to all CPGs Address concerns raised at Council Created by ASC and Dr. Chris Courtois CPGs are about efficacy, other factors important in determining plan of treatment; patient values and preferences + clinician expertise also important*; value of research beyond RCTs; value of nonspecific factors; value of recognizing individual differences; CPGs not meant to stifle innovation; issues specific to implementing CPG for PTSD Living document, not policy; more easily updated and changed

30 Professional Practice Guideline Council approved PTSD guideline and directed that a professional practice guideline be developed as expeditiously as possible Board of Professional Affairs bears responsibility for guidelines, Committee on Professional Practice and Standards to develop Not based on a systematic review but based on research literature Guidance on use of a CPG in practice Will likely not be solely a PTSD PPG Aim to have out for public comment by March 2018

31 Practice Implications CPGs have recommendations regarding efficacious interventions Applied in context of culture, patient preferences, professional relationship = fundamentals Guidelines are aspirational, not a requirement Guidelines are not intended to limit scope of practice or coverage determinations Facilitate systematic development of profession Guide best practice and facilitate decision making Important to discern quality guidelines

32 QUESTIONS

33 ines/ptsd.pdf

34 Conflicts of Interest Education regarding COI Education modules Opportunity for discussion Two primary domains of COI Intellectual Financial Policy and Declaration of COI Reviewed before being finalized as a member of committee or panel Staff review and review by chair of oversight committee Discussed at face to face meetings Updated annually

35 Critical and Important Outcomes Critical- essential and necessary to treatment decision making process PTSD symptom reduction and serious harms (adverse events) Important- significant but not critical for making a decision Remission (no symptoms), loss of diagnosis, quality of life, disability or functional impairment, prevention or reduction of comorbid medical or psychiatric conditions, adverse events leading to treatment discontinuation, other adverse events, burdens

36 Public Comment Process 60 day public comment period Call for comments disseminated through APA e-newsletters, listservs, identified experts, professional organizations 890 individuals submitted comments Members of panel read every single one Responded to collective sample of comments Modified guideline accordingly

37 THANK YOU For more webinars, visit psyciq.apa.org AMERICAN PSYCHOLOGICAL ASSOCIATION

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