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The Paradox of 'Low-Quality Evidence; Strong Recommendation': An Analysis of the Evidence and Ethics in the WHO 2010 Gui

This article analyzes the evidence and ethics underlying the WHO 2010 Guidelines on HIV and Infant Feeding, exploring the associations between the strength of evidence and recommendations. It highlights the tensions between evidence and ethics in making guidelines and proposes strategies for improving guideline communication.

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The Paradox of 'Low-Quality Evidence; Strong Recommendation': An Analysis of the Evidence and Ethics in the WHO 2010 Gui

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  1. The paradox of ‘low quality evidence; strong recommendation’: An analysis of the evidence and ethics underpinning the WHO 2010 Guidelines on HIV and Infant feeding Anne Matthews, Health & Society, School of Nursing and Human Sciences, DCU

  2. Evidence-based approaches to public health • Espousing an evidence-based approach to global health policy and practice implies a linear association between the level of quality of evidence and strength of the related recommendation. • The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to “grading quality of evidence and strength of recommendations” (http://www.gradeworkinggroup.org/) is used by the World Health Organisation and other in international and national clinical and healthcare guidelines. • Evidence is deemed to be of highest quality when derived from systematic reviews of Randomised Controlled Trials (RCTs), and then from single RCTs.

  3. GRADE criteria • GRADE criteria for assessing the quality of evidence • risk of bias/study limitations, directness, consistency of results, precision, publication bias, magnitude of the effect, dose-response gradient, influence of residual plausible confounding and bias “antagonistic bias”) • The overall quality of evidence should be assessed for each important outcome and expressed using four (e.g. high, moderate, low, very low) or, if justified, three (e.g. high, moderate, and very low and low combined into low) categories based on definitions for each category that are consistent with the definitions used by the GRADE Working Group. • GRADE criteria for assessing the strength of a recommendation • the balance of desirable and undesirable consequences, quality of evidence, values and preferences, and resource use • and a general approach should be reported (e.g. if and how costs were considered, whose values and preferences were assumed, etc.).

  4. An overview of the guidelines development process http://gdt.guidelinedevelopment.org/central_prod/_design/client/index.html

  5. Evidence Tables: building in GRADEPro

  6. Focus: WHO 2010 Guidelines on HIV and Infant feeding • Aim: to examine the evidence and ethics underpinning the WHO 2010 Guidelines on HIV and Infant feeding, in particular to examine the associations between the strength of evidence and of recommendations. • The 7 recommendations and supporting evidence within the WHO 2010 Guidelines on ‘HIV and Infant feeding’ were analysed. • “The Guideline Development Group agreed on guiding principles and revised recommendations on infant feeding and HIV following consideration of the evidence presented, including systematic reviews, GRADE evidence profiles, risk-benefit tables, and discussion on the potential impact of draft recommendations, human rights issues, and costs” (WHO 2010 p1).

  7. Recommendations 1 & 2: Evidence base

  8. Recommendations 3-5: Evidence base

  9. Recommendations 1 & 2: Evidence base

  10. Results • Of the 6 ‘strong’ recommendations, only one two are based on high quality evidence; strength of recommendation depends on other criteria. • The two recommendations with ‘very low quality of evidence’ highlight the tensions between evidence and ethics/other considerations in such guidelines: • one of which has a strong recommendation (what to feed when breastfeeding is stopped) and • one with a weak recommendation (regarding the use of heat-treated breast-milk). • At face value this seems paradoxical. However in both cases factors beyond systematic review and RCT-generated evidence are taken into account, all transparently reported.

  11. Grade profile with WHO Guidelines on HIV and infant feeding

  12. Conclusions • Decisions about strength of recommendations are explained, with transparent report of approach adopted. • Quality of evidence about critical outcomes is an important consideration, but not the only one. • Reporting only the ‘evidence quality’ level beside recommendation may undermine the recommendation to readers who do not access the annexes – summarise other criteria in main guideline too? • Challenges to communicating such guidelines in any case – changes to previous approach

  13. Thank you.

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