Intellectual Conflicts of Interest and Consumer Engagement

Transcription

1 Intellectual Conflicts of Interest and Consumer Engagement LORRAINE JOHNSON, JD, MBA Executive Director, LymeDisease.Org Co- Chair, CUE Patient Representative, PCORI

2 Controversy is most common in areas where definitive studies are lacking or inherently difficult. (Atkins, Slutsky 2005) 2 9/5/2014

3 What are Intellectual Conflicts of Interests? IOM : professional affiliations and practice specialization, reimbursement incentives, intellectual preconceptions and previously stated positions, and the desire for recognition and career advancement (IOM 2009) Gordon Guyatt: academic activities: receipt of grants, participation in research, and authorship related to the topic that create the potential for an attachment to a specific point of view (Guyatt 2010) 3 9/5/2014

4 Why do they matter? If the person is conflicted between loyalty to the stated position and providing unbiased work on the project, then the key questions generated, literature search strategy, inclusion and exclusion criteria, study selection, definition of outcomes, analysis strategies, or interpretation of results may contribute to the report being biased towards his/her preconceived notion (Viswanathan 2012) 4 9/5/2014

5 What constitutes good enough evidence for a policy decision? This a judgment about the degree of certainty needed to provide medical care. It... is inherently a judgment about the risks of acting too soon (promoting a policy that turns out to be ineffective or harmful) and acting too late (delaying a beneficial intervention to get better evidence). (Atkins, Slutsky 2005)

6 When choice is restricted or relegated to someone else, there is a high chance that individuals will be prevented from realizing their interests or their interest will be sacrificed to someone else's interest. Dr. Ezekiel Emanuel Evidence is never enough it is always evidence in the context of values and preferences that influence guidelines and clinical care. Gordon Guyatt 6 9/5/2014

7 IOM: Trustworthy Guidelines Panel should be multidisciplinary and balanced, comprising a variety of methodological; experts and clinicians, and populations expected to be affected by the CPG..... Patient and public involvement should be facilitated by including (at least at the time of clinical question formulation and draft CPG review) a current or former patient, and a patient advocate or patient/consumer organization representative in the GDG.... Strategies to increase effective participation of patient and consumer representatives, including training in appraisal of evidence, should be adopted by GDGs. 7 9/5/2014

8 Rules of Engagement: Guideline development in controversy. 1. Process integrity is critical. Panels should be balanced and represent scientists and physicians from both paradigms. 2. Robust patient representation (2 or more) matters and should not be token. Patients should represent those on affected by disease and be empowered and prepared patients. 3. Good panel citizenship is mandatory. No process derailments. 4. Consensus should not be obtained by excluding people who disagree. 5. Controversies and disagreement should be acknowledged. Minority viewpoints should be published with the guidelines. 6. Guidelines should undergo rigorous peer review from all interested parties and responses to comments should be made public. 7. Guidelines should be updated in a vigorous process every 5 years. (Guyatt 2010; IOM 2011; Viswanathan 2013; Sniderman and Furberg 2009; Lenzer 2013)

9 References Atkins D, Siegel J, Slutsky J. Making policy when the evidence is in dispute. Health Aff (Millwood) Jan-Feb;24(1): Guyatt G, Akl EA, Hirsh J, Kearon C, Crowther M, Gutterman D, et al. The vexing problem of guidelines and conflict of interest: a potential solution. Annals of internal medicine Jun 1;152(11): Guyatt, G. and Montori, V. EBM Debate. (March 21, 2011) available at Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; Lenzer Jeanne, Hoffman Jerome R, Furberg Curt D, Ioannidis John P A. Ensuring the integrity of clinical practice guidelines: a tool for protecting patients BMJ 2013; 347:f5535 Johnson L, Stricker RB. The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines. Philos Ethics Humanit Med. 2010;5:9. Sniderman AD, Furberg CD: Why Guideline-Making Requires Reform. JAMA 2009, 301: Viswanathan M, Carey TS, Belinson SE, Berliner E, Chang S, Graham E, et al. Identifying and Managing Nonfinancial Conflicts of Interest for Systematic 9 Reviews May 9/5/2014

10 Intellectual Conflicts of Interest: Solutions Gordon Guyatt: Let the strongly biased experts speak, but take away their votes and have epidemiologists head the panels. Sniderman-Furberg: Acknowledge controversy, don t put forth a false consensus when there is divergence, and publish the discourse. Meera Viswanathan: Triage for controversy, assess harms COI could cause and where necessary insure diverse perspectives on the panel IOM: Representational patient involvement, diverse panel 10 9/5/2014