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Clinical Practice Guidelines and People with Multimorbidity. Cynthia M. Boyd, MD MPH Johns Hopkins University David Kent, Katrin Uhlig, Tom Trikalinos, Bruce Leff, Jodi Segal, Carlos Weiss, Sydney Dy, Ravi Varadhan
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Clinical Practice Guidelines and People with Multimorbidity Cynthia M. Boyd, MD MPH Johns Hopkins University David Kent, Katrin Uhlig, Tom Trikalinos, Bruce Leff, Jodi Segal, Carlos Weiss, Sydney Dy, Ravi Varadhan Funders: AHRQ R21 “Improving Clinical Practice Guidelines for Complex Patients,” National Institute on Aging Beeson K23, Robert Wood Johnson Physician Faculty Scholars Program cyboyd@jhmi.edu
Clinical Practice Guidelines (CPGs) and People with Multimorbidity • Prevalence of co-occurring chronic conditions is high • CPGs developed for and emphasize single disease perspective “Treating an Illness Is One Thing. What About a Patient With Many?” New York Times, March 31, 2009 Image: Brendan Smialowski for the New York Times
It’s Not Easy Living with Multimorbidity Boyd, JAMA 2005;294:716-724
How Applicable are CPGs for People with Multimorbidity? • Reviewed 9 CPGs for chronic conditions • Most single disease CPGs fail to give adequate guidance for older patients with multimorbidity Boyd et al. JAMA 2005;294:716-724
What Do Clinicians Need? Maximize use of therapies likely to benefit patients with multimorbidity Minimize use of therapies unlikely to benefit or likely to harm patients with multimorbidity Incorporate patient preferences and values regarding burdens, risks, and benefits
AHRQ R21 Project: Development of a Preliminary Frameworkfor Guidelines That Are More Applicable to People with Multimorbidity Goals: 1) Describe issues that currently interfere with the consideration of multimorbidity in the development of CPGs 2) Develop an approach for addressing these issues in future research and guideline development initiatives. Boyd et al, in progress, 2009
Development of a Preliminary Frameworkfor Guidelines That Are More Applicable to People with Multimorbidity Three Domains: Framework Ultimate Goal: Prioritization within, and across, diseases for what is most likely to benefit an individual patient Study Design and Analysis Study Design and Analysis Systematic Review and Meta-Analysis Guideline Development Boyd et al, in progress, 2009
Development of a Preliminary Frameworkfor Guidelines That Are More Applicable to People with Multimorbidity • Eric Bass • Mary Barton • Caroline Blaum • Stephanie Bruce • Klara Brunnhuber • Carla Cassidy • Joe Francis • Lee Green • Sheldon Greenfield • Jeremy Grimshaw • Gordon Guyatt • Dana Safran • Ken Schmader • Holger Schünemann • Harold Sox • Vincenza Snow • Barbara Starfield • Andrew Vickers • Louise Walter • James Woodcock • Richard ZuWallack • Kevin High • Sherrie Kaplan • Richard Kravitz • Jerry Krishnan • Joseph Lau • Thomas Lee • Rosanne Leipzig • David Martin • Cynthia Mulrow • Gary Noronha • Peter Rothwell
Study Design and Analysis • Heterogeneity of treatment effect • Baseline risks • Competing risks • Treatment responsiveness • Treatment harms • Pragmatic Trials : Generalizable information? • Only if treatment effects really are generalizable across all patients enrolled • New analytic strategies • Appropriate use of observational data to address evidence gaps Kent, Kitsios Trials 2009 Boyd et al, in progress 2009
Systematic Reviews and Meta-analyses • By definition inherit all the limitations of their building blocks (primary studies) • Analytic framework and key questions • Choice of Studies for Systematic Reviews: • Trade off between internal validity and generalizability • Meta-regressions of aggregate data may draw erroneous conclusions • Need for novel methods for aggregate data meta-analysis and meta-regressions • Meta-analyses of individual participant data • Decision modeling Trikalinos et al, in progress 2009 Boyd et al, in progress 2009
Guideline Development 1. Choosing Topics (Priority Setting) • Broad • Scoping or Framing 2. Commissioning Work Group and Process 3. Refining Questions 4. Choosing Important Outcomes 5. Systematic Reviews 6. Grading quality of evidence • Each outcome • Overall 7. Summary of benefits and harms • Burdens • Values and preferences 8. Formulating recommendations 9. Implementation and Evaluation GRADE, NICE, USPSTF Boyd et al, in progress, 2009
Final Comments • Thank you