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Randomized controlled trials (RCTs) are essential for evaluating the efficacy of clinical interventions, where the causal chain between the agent and the outcome is relatively short and simple and where results may be safely extrapolated to other settings. However, causal chains in public health interventions are complex, making RCT results subject to effect modification in different populations. Both the internal and external validity of RCT findings can be greatly enhanced by observational studies using adequacy or plausibility designs. For evaluating large-scale interventions, studies with plausibility designs are often the only feasible option and may provide valid evidence of impact. There is an urgent need to develop evaluation standards and protocols for use in circumstances where RCTs are not appropriate.

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Background The Lives Saved Tool (LiST) uses estimates of the effects of interventions on cause-specific child mortality as a basis for generating projections of child lives that could be saved by increasing coverage of effective interventions. Estimates of intervention effects are an essential element of LiST, and need to reflect the best available scientific evidence. This article describes the guidelines developed by the Child Health Epidemiology Reference Group (CHERG) that are applied by scientists conducting reviews of intervention effects for use in LiST.Methods The guidelines build on and extend those developed by the Cochrane Collaboration and the Working Group for Grading of Recommendations Assessment, Development and Evaluation (GRADE). They reflect the experience gained by the CHERG intervention review groups in conducting the reviews published in this volume, and will continue to be refined through future reviews.Presentation of the guidelines Expected products and guidelines are described for six steps in the CHERG intervention review process: (i) defining the scope of the review; (ii) conducting the literature search; (iii) extracting information from individual studies; (iv) assessing and summarizing the evidence; (v) translating the evidence into estimates of intervention effects and (vi) presenting the results.Conclusions The CHERG intervention reviews represent an ambitious effort to summarize existing evidence and use it as the basis for supporting sound public health decision making through LiST. These efforts will continue, and a similar process is now under way to assess intervention effects for reducing maternal mortality.

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