Sandra Zelman Lewis, PhD November 30, 2017

1. GUIDELINE COLLABORATIONClinical Practice Guidelines, Development and Implementation in Mexico: International Forum Sandra Zelman Lewis, PhD November 30, 2017

2. Disclosures Chief Guidelines Officer, Doctor Evidence SaaS company offering technologies and services in support of high quality, methodologically rigorous, and transparent systematic reviews GROWTH (Guideline & Research Organizations Worldwide for Transparency & Harmonization) clients are mostly guideline developers President, EBQ Consulting Guideline development, trustworthy consensus-based statements, implementation, and quality improvement

3. Outline Historical review of collaboration Common challenges in guideline collaboration: • Minimal standards for guideline development • Multi-stakeholder involvement • Minimal standards for conflict of interest approval and management • Minimal standards for common peer review • Longitudinal issues related to sharing revenues and updating guidelines • Solutions to the challenges • Resources

4. Levels of Collaboration • Collaboration can take place at various levels: • Equal partnerships with titles including all collaborators • Representative panelist(s) • Reviewer(s) • Endorsement

5. Changing environment for guideline development Historically, little cooperation on guideline development, especially user groups. • Lead to proliferation of multiple guidelines covering the same medical conditions, often conflicting recs Now reassessment of this need to collaborate: • Stringent standards for guidelines and systematic reviews • Calls for multi-stakeholder engagement • Examination of panel member COIs • Escalating costs Further, this need was recognized by the IOM and recommended by other standard-setting organizations.

6. Changing environment for guideline development The benefits to collaborative approaches are significant: • Intensify globally harmonized recommendations, thereby reducing the chance of competing and incompatible guidance; • Increase the credibility and acceptance by clinicians, promoting wider adoption; • Enhanced prestige • Promote wider adoption and increase acceptance by clinicians in multiple specialties through co-marketing power by the various specialty societies and disciplines, broadening dissemination and implementation; • Share the financial and staff resources so that the burden on any single organization is more acceptable; There are also challenges.

7. Minimal standards for guideline development • Collaborating organizations must agree to specific methodological and policy standards. • Major goal: conduct high-quality systematic reviews leading to methodologically-rigorous analyses • Agreement on a common method for assessing the quality of the evidence and the strength of recommendations • Agree on key clinical (PICO) questions • Addressing multiple comorbidities, when possible, even employing indirect evidence, if necessary • Multi-stakeholder representation on panels • Agreement on conflict of interest (COI) review and management policies • Inclusion of patient preferences

8. Multi-stakeholder involvement • There are many examples of medical professional societies collaborating to bring variety of disciplines together, even across borders • Important to include nurses, allied health providers, support services and other team members • Becoming more common to include patient and consumer perspectives • But it remains rare to include representation of • Healthcare systems – the key implementers • Quality improvement administrators • Payers • Purchasers

9. Minimal standards for COI approval & management • Lack of attention to COI policies can result in loss of trust by readers • Funding should not include industry sources • Neither directly nor indirectly • Full transparency of all resources should be required • COI disclosure, review, and management • Assign to organization with the most rigorous processes or agree upon policies • Disclosures – how to obtain and update? • Reviews – by whom and according to which rules? • Management – how will experts with non-disqualifying conflicts be managed? • Permitted to draft or vote on recommendations? Author or discuss relevant sections?

10. Minimal standards for common peer review • Timely peer review is important but challenging • Shared reviews across organizations – unlikely because each wants to ensure it meets their standards • Avoid sequential reviews and multiple layers • Establish firm timelines and properly manage process • Agree whether public comments will be permitted • Who and how to collate and respond to comments • Do not permit any anonymous comments • No reviewers can single-handedly change recommendations because they were the result of a deliberate evidence-based process • All reviewers must declare any relevant COIs, and be disqualified when appropriate • Include expertise in guideline methodology and the content area

11. Longitudinal issues related to sharing revenues and updating guidelines • Decide on which organization(s) will develop derivative products (eg, clinical pathways, staging tools, shared decision-making tools, patient education materials, performance measures) • How will sales revenue be shared? • Agree upon plan for keeping guidelines updated and living over time • Establish criteria that could trigger an update of the guidelines • Monitoring of the literature – who and how? • How will the collaborative reconvene and function to update the guidelines

12. Solutions to the challenges • The most important solution is a well-written MOU (Memorandum or Understanding) • Based on extensive communication among all parties covering all topics • Complete transparency and establishment of trust • Share resources but also share in final deliverables • Include termination agreements and opt-outs with dissolution of assets • But also how to include additional collaborating partners in the future • Share in benefits: who will publish the full guidelines, the systematic review, the executive summary? Rotate this for future editions and updates. • Remember, these collaborations and the solutions to these challenges can be opportunities!

13. Important Resources for Guideline Standards • Institute of Medicine (IOM) standards for trustworthy CPGs • Committee on Standards for Developing Trustworthy Clinical Practice Guidelines (2011). Clinical Practice Guidelines We Can Trust. Washington DC, Institute of Medicine. • IOM standards for systematic reviews • Committee on Standards for Systematic Reviews of Comparative Effectiveness Research (2011). Finding What Works in Health Care:  Standards for Systematic Reviews. Washington DC, Institute of Medicine. • G-I-N standards for guideline development • Qaseem, A., et al. (2012). "Guidelines International Network: Toward International Standards for Clinical Practice Guidelines." Ann Intern Med156: 525-531. • G-I-N conflict of interest principles • Schünemann HJ, et al. (2015). "Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines." Ann Intern Med163: 548-553.

14. Sandra Zelman Lewis, PhD EBQconsulting@gmail.com