1. GUIDELINE COLLABORATION Clinical 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 Med 156:
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 Med 163:

14. Sandra Zelman Lewis, PhD