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Addressing complex public health problems, such as smoking, obesity and mental health, requires complex, often multilevel, interventions. Given the costs associated with delivering such interventions and the possibility of unanticipated harm, they need to be evaluated using the most robust methods available. It is important, where possible, that public health interventions and their proposed evaluation designs are optimised prior to being subject to an expensive evaluation of their effectiveness, through rigorous assessment of their feasibility.1 Consequently, a growing number of exploratory studies (ie, studies intended to generate the evidence needed to decide whether and how to proceed with a full-scale evaluation, also (inconsistently) referred to as ‘pilot’ or ‘feasibility’ studies) are being conducted. These generally have one, or both, of the following objectives: to optimise or assess the (1) feasibility of the intervention or (2) design of the full-scale effectiveness evaluation. However, conflicting guidance exists regarding what exploratory studies should be called, what they should achieve, what they should entail, whether and how they should determine progression to future studies and how they should be reported.2 3 This presents a challenge for researchers in designing and conducting exploratory studies, and for peer reviewers and funders in judging the merits of research proposals and outputs. This paper briefly discusses these issues, before describing current work funded by the Medical Research Council (MRC)/National Institute of Health Research (NIHR) Methodology Research Programme to develop GUidance for Exploratory STudies of complex public health interventions (henceforth referred to as the GUEST study).
There is increasing recognition that pressure to identify effective interventions has led to premature commissioning of large-scale evaluation trials of poorly developed interventions, wasting finite resource.1 4 In the development of pharmaceuticals, over 80% fail to reach ‘Phase III’ effectiveness trials, even after considerable investment.5 Yet, with public health …
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