Advancing the WHO-INTEGRATE Framework as a Tool for Evidence-Informed, Deliberative Decision-Making Processes: Exploring the Views of Developers and Users of WHO Guidelines

Background: Decision-making on matters of public health and health policy is a deeply value-laden process. The World Health Organization (WHO)-INTEGRATE framework was proposed as a new evidence-to-decision (EtD) framework to support guideline development from a complexity perspective, notably in relation to public health and health system interventions, and with a foundation in WHO norms and values. This study was conducted as part of the development of the framework to assess its comprehensiveness and usefulness for public health and health policy decision-making. Methods: We conducted a qualitative study comprising nine key informant interviews (KIIs) with experts involved in WHO guideline development and four focus group discussions (FGDs) with a total of forty health decision-makers from Brazil, Germany, Nepal and Uganda. Transcripts were analyzed using MAXQDA12 and qualitative content analysis. Results: Most key informants and participants in the FGDs appreciated the framework for its relevance to real-world decision-making on four widely differing health topics. They praised its broad perspective and comprehensiveness with respect to new or expanded criteria, notably regarding societal implications, equity considerations, and acceptability. Some guideline developers questioned the value of the framework beyond current practice and were concerned with the complexity of applying such a broad range of criteria in guideline development processes. Participants made concrete suggestions for improving the wording and definitions of criteria as well as their grouping, for covering missing aspects, and for addressing overlap between criteria. Conclusion: The framework was well-received by health decision-makers as well as the developers of WHO guidelines and appears to capture all relevant considerations discussed in four distinct real-world decision processes that took place on four different continents. Guidance is needed on how to apply the framework in guideline processes that are both transparent and participatory. A set of suggestions for improvement provides a valuable starting point for advancing the framework towards version 2.0.

More harm than good? Building a framework to identify adverse effects of public health interventions

Background While the importance of adverse events of medical interventions is widely recognized, adverse effects of public health interventions remain a neglected topic. This project aims to develop a framework to guide researchers and decision-makers to systematically reflect on and identify potential adverse effects of public health interventions. Methods We conducted a mixed-method systematic review of theoretical and conceptual publications on adverse events of public health interventions to develop a preliminary framework employing best-fit framework synthesis. We used the WHO-INTEGRATE framework as a starting point for the synthesis, a multidimensional evidence-to-decision framework developed for complex interventions in complex systems. Results The framework includes two interlinked parts: The first maps domains in which potential adverse events might arise. Drawing on the WHO-INTEGRATE framework, these domains include aspects related to health, but also domains related to societal, economic, and environmental implications. The second part maps general mechanisms through which public health interventions can lead to adverse effects (e.g. reactive behaviour change, increase of labelling and stigmatization, and exposure to environmental risk-factors). Conclusions The framework will be advanced in the second phase of the project through empirical studies of harmful effects in public health interventions, which we will identify through an overview of systematic reviews. Adverse effects of public health interventions are currently not sufficiently considered in research and practice. Taking them into account is essential for informed decision-making and establishing appropriate countermeasures. Our framework could be a valuable asset for researchers and policy makers in developing, implementing and evaluating public health interventions. Key messages Awareness of the adverse effects of public health interventions is essential for informed decision-making and establishing countermeasures. This framework supports researchers and decision-makers in systematically reflecting on and identifying adverse events when developing, piloting, implementing or evaluating public health interventions.