Introduction Evidence-to-decision (EtD) frameworks intend to ensure that all criteria of relevance to a health decision are systematically considered. This paper, part of a series commissioned by the WHO, reports on the development of an EtD framework that is rooted in WHO norms and values, reflective of the changing global health landscape, and suitable for a range of interventions and complexity features. We also sought to assess the value of this framework to decision-makers at global and national levels, and to facilitate uptake through suggestions on how to prioritise criteria and methods to collect evidence.
Methods In an iterative, principles-based approach, we developed the framework structure from WHO norms and values. Preliminary criteria were derived from key documents and supplemented with comprehensive subcriteria obtained through an overview of systematic reviews of criteria employed in health decision-making. We assessed to what extent the framework can accommodate features of complexity, and conducted key informant interviews among WHO guideline developers. Suggestions on methods were drawn from the literature and expert consultation.
Results The new WHO-INTEGRATE (INTEGRATe Evidence) framework comprises six substantive criteria—balance of health benefits and harms, human rights and sociocultural acceptability, health equity, equality and non-discrimination, societal implications, financial and economic considerations, and feasibility and health system considerations—and the meta-criterion quality of evidence. It is intended to facilitate a structured process of reflection and discussion in a problem-specific and context-specific manner from the start of a guideline development or other health decision-making process. For each criterion, the framework offers a definition, subcriteria and example questions; it also suggests relevant primary research and evidence synthesis methods and approaches to assessing quality of evidence.
Conclusion The framework is deliberately labelled version 1.0. We expect further modifications based on focus group discussions in four countries, example applications and input across concerned disciplines.
- public health
- health systems
- health policy
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EAR and JMS contributed equally.
Handling editor Seye Abimbola
Contributors EAR conceived the overall research project with substantial input from JMS. RB, IBS, AP and SLN all provided important contributions to the overall direction of the project and to the draft manuscript. JMS undertook most of the work in step 1, with EAR and RB duplicating relevant elements in the process and all three analysing the findings. EAR implemented step 2a. JMS designed step 2b with input from EAR, collected the data and jointly analysed them with IBS. EAR, with input from AP, undertook the work in step 3. All authors discussed different versions of the framework, making revisions to criteria, definitions, subcriteria and example questions in an iterative manner. EAR wrote the manuscript, with JMS drafting selected sections; all authors critically reviewed the different versions of the manuscript, suggested revisions and approved the version to be published.
Funding Funding provided by the World Health Organization Department of Maternal, Newborn, Child and Adolescent Health through grants received from the United States Agency for International Development and the Norwegian Agency for Development Cooperation. The development of this framework would not have been possible without the financial and, even more so, intellectual and procedural, support from the WHO, in particular from AP and SLN. We also gratefully acknowledge that JMS’s position was funded by the Bavarian Health and Food Safety Authority, and that IBS’s input was funded by the Norwegian Agency for Development Cooperation (NORAD).
Disclaimer The USAID, the Bavarian Health and Food Safety Authority, and NORAD had no influence on the research process or content of this manuscript. SLN and AP are staff members of the WHO. The authors alone are responsible for the views expressed in this publication, which do not necessarily represent the decisions or policies of the WHO.
Competing interests SLN helps oversee the quality of WHO guidelines and reports being a member of the RIGHT Working Group and the GRADE Working Group. EAR is a member of the GRADE Working Group.
Patient consent Not required.
Ethics approval Ethical approval was obtained from both the WHO Ethics Review Committee and the Ethics Committee of the Ludwig-Maximilians-Universität (LMU Munich), Germany.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
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