Developing methods guidance for health researchers: literature review of proposed and applied strategies

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INTRODUCTION: Health researchers benefit from methods guidance (MG) for planning, conducting, analyzing and interpreting research studies. How to develop MG that is trustworthy and researcher-friendly is unclear; existing strategies for developing MG are fragmented and lack a coherent framework. The STrategies for developing REseArch Methods guidance (STREAM) project aims to provide such a framework for developers of MG. As a first step, we reviewed the literature to identify proposed and applied strategies for developing MG and explored possible knowledge gaps. METHODS: We conducted two literature reviews. First, a scoping review of the methodological literature to identify proposed strategies for developing MG. Second, a review of a purposeful sample of recently published MG articles to examine strategies applied in practice. We applied a qualitative content analysis to both sets of publications using one shared codebook. In addition, to identify possible knowledge gaps, we contrasted the findings with the established development processes for clinical practice guidelines and reporting guidelines. RESULTS: The first review included 17 publications and the second review 102 MG articles. We identified possible development steps including assessing the need for MG, establishing a working group, considering the findings from methodological studies, gathering input from interest-holders, testing the new MG, and disseminating and implementing MG. In addition, we identified various approaches to perform the steps including systematic reviews of previous guidance, reviews of methodological practice, simulation studies, surveys or interviews of interest-holders, consensus methods, and public review. Mapping these findings with established development processes identified areas that have so far received limited attention within MG development, including considering evidence from methodological research, judging the certainty of this evidence, reporting of MG, and approaches to implementation. CONCLUSION: This study provides an overview of proposed and applied strategies for developing MG, highlights needs for conceptual development, and provides a structured starting point for guidance for developing MG. PLAIN LANGUAGE SUMMARY: Almost every method used in health research comes with its own guidance - sets of advice and suggestions on how to plan and carry out the research, as well as helping with the analysis and interpretation of the results. When this guidance is clear and can be trusted, it helps researchers produce evidence that is valid and useful. However, the process for developing such guidance is currently unclear. The aim of this project called STrategies for developing REseArch Methods guidance (STREAM)is to create a framework for developing trustworthy, and user-friendly methods guidance. In this manuscript, we report on two literature reviews that will inform the new strategies. In the first, we looked for existing publications that suggest strategies for developing methods guidance. Secondly, we examined recently published methods guidance articles to see how they were developed. We also compared our findings with established development processes for other kinds of guidance: clinical practice guidelines and reporting guidelines. As a result, we found many possible and complementary strategies for developing methods guidance: forming a working group, reviewing previous research; seeking input from interest-holders; testing the guidance; and actively supporting dissemination and use. We also identified important areas where further research is needed. For example, we found that it is currently unclear how previous research should inform methods guidance or how to optimally present it. In summary, our reviews identified various possible strategies for developing methods guidance but also important gaps that the framework for developing methods guidance should address.

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