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Holger Schünemann Professor and Chair, Dept. of Clinical Epidemiology & Biostatistics

Holger Schünemann Professor and Chair, Dept. of Clinical Epidemiology & Biostatistics Professor of Medicine Michael Gent Chair in Healthcare Research McMaster University, Hamilton, Canada.

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Holger Schünemann Professor and Chair, Dept. of Clinical Epidemiology & Biostatistics

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  1. Holger Schünemann Professor and Chair, Dept. of Clinical Epidemiology & Biostatistics Professor of Medicine Michael Gent Chair in Healthcare Research McMaster University, Hamilton, Canada New York, December 11, 2012Theme IV Breakout Session 3: How to overcome barriers to and maximize opportunities for collaboration between guideline developersGuideline collaboration: what made us happy…

  2. Disclosure • Co-chair GRADE Working Group • World Health Organization: Advisory Committee for Health Research, Expert Advisory Panel on Clinical Practice Guidelines and Clinical Research Methods and Ethics & Chair of various guideline panels; funding for guideline development/SR • Work with various other guideline groups using GRADE • American College of Physicians (ACP) Clinical Practice Guidelines Committee • American College of Chest Physicians (ACCP) • No direct/personal payments from drug or device industry

  3. Allergic rhinitis in asthma (ARIA) • Example for a successful collaboration for guideline development and implementation • Evidence assessment • Moving from evidence to recommendations • World Allergy Organization (WAO) • Another example ontent C

  4. ARIA • Published in 2010, JACI • 48 general recommendations • subgroup recommendations • Followed best methods of guideline development • Adhered largely to new Institutes of Medicine standards • COI • Patient representation • Methodologists did background work and provided draft recommendations

  5. Aim: to develop a common, transparent and sensible system for grading the quality of evidence and the strength of recommendations • International group (>300 contributors) – since 2000 • Over 70 organizations adopted GRADE Grades of Recommendation Assessment, Development and Evaluation CMAJ 2003, BMJ 2004, BMC 2004, BMC 2005, AJRCCM 2006, Chest 2006, BMJ 2008, JCE 2011-2012

  6. Create evidence profile with GRADEpro Summary of findings & estimate of effect for each outcome Guideline development Gradeoverall quality of evidence across outcomes based on lowest quality of critical outcomes Rate quality of evidence for each outcome Outcomes across studies Randomization increases initial quality Formulate question Rate importance Select outcomes Risk of bias Inconsistency Indirectness Imprecision Publication bias P I C O Outcome Critical High  Outcome Critical Moderate O Grade down Low OO Outcome Important Very low OOO Outcome Not Large effect Dose response Opposing bias & Confounders important Grade up Input? Panel • Grade recommendations • For or against (direction)  • Strong or conditional/weak (strength) • By considering balance of: • Quality of evidence • Balance benefits/harms • Values and preferences • Revise if necessary by considering: • Resource use (cost) Systematic review Guideline • Formulate Recommendations ( | …) • “The panel recommends that ….should...” ( | …) • “The panel suggests that ….should...” (? | …) • “The panel suggests to not ...” (? | …) • “The panel recommends to not...” ( | …)

  7. ARIA recommendations

  8. Understanding recommendations and the underlying evidence

  9. Rec with V & P

  10. WAO Cows milk allergy guidelines • Question formulation with panel • Determination of all relevant outcomes • Systematic Reviews for questions that underwent GRADE approach • Independent lead by non-subject experts with input subject experts • Production of Evidence Profiles using GRADEpro • Presentation to panel in face-to-face meeting • Agreement on recommendations

  11. 17 fold improvement in tolerance (common)  16 fold increase in anaphylaxis (common) Recommendations require valuing the importance of outcomes

  12. Immunotherapy In patients with IgE-mediated CMA, we recommend that clinicians do not administer oral immunotherapy with cow’s milk, unless this is done in the context of formal clinical research (strong recommendation | very low quality evidence). Underlying Values and Preferences This recommendation places a relatively high value on avoiding serious adverse effects of oral immunotherapy, and a relatively low value on the increased probability of desensitization to milk. Rec 18

  13. WHO and other international guidelines

  14. Collaboration is possible • Key aspects of what is required identified • Of use: • Joint ownership and engagement • Buy-in to and adherence to methodological standards • Leadership • Funding • Roof organization • WAO • ARIA (WHO) • Happiness to be involved S ummary

  15. Conclusions • International collaboration is possible • Key aspects of what is required identified • Requires: common ownership • Preparatory work for demonstration project is completed • Challenge is funding rather than collaboration! • Next phase: demonstration project

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