STrategies for developing REseArch Methods guidance (STREAM): protocol

Background Health researchers rely on clear, trustworthy methods guidance (MG) to support the planning, conduct, analysis, and interpretation of their studies (eg, guidance on study design, data collection, statistical methods, qualitative analysis). MG should not only be practically useful but also help ensure that the resulting evidence is valid and meaningful to patients, research participants, and other interest-holders. However, how to develop such methods guidance and which processes and approaches are useful is currently unclear. Important uncertainties include how to integrate methodological evidence and the views of health researchers, the intended users. This lack of clarity in the development process may undermine the validity, trustworthiness, and usefulness of MG, ultimately limiting its contribution to the production of high-quality, patient-important evidence. Objectives To describe STrategies for developing REseArch Methods guidance (STREAM). Methods We will work with a steering committee consisting of MG developers, health researchers, and an experienced patient partner who will help us establish a deliberative and meaningful patient contribution. To systematically develop STREAM, we will conduct a series of interlinked studies: (1) Review of existing standards: A scoping review to identify any existing standards or suggestions for developing MG. (2) Study of current practice: We will analyse a sample of recently published MG articles and catalogue the methods used for developing MG. (3) Interviews with MG users: We will conduct interviews with recent users of selected MG articles to elicit their views on strengths, weaknesses, and opportunities for improvement. (4) Development of STREAM: A panel of guidance developers and users from academia and industry will draft an initial version of STREAM and apply consensus methods. The panel will consider the findings from studies 1-3 and processes for developing other types of guidance, such as reporting guidelines and clinical practice guidelines. (5) Testing and refining STREAM: Guidance developers will apply the draft STREAM to ongoing MG development projects and provide feedback that will inform the final version. Results STREAM will be a comprehensive, evidence-informed, user-centred, and practice-tested instrument for creating MG. It will provide practical recommendations for MG developers on involving relevant interest-holders, selecting and using methodological evidence, translating evidence into recommendations, and presenting guidance in a clear and implementable format. Plain Language Summary Health researchers need clear and trustworthy guidance to help them plan, conduct, analyse, and interpret their studies. The guidance should ensure that the research is valid and genuinely beneficial to patients. However, there is currently uncertainty about the ways for creating this guidance. As a result, experts often develop guidance in an unstructured way or are uncertain how to integrate existing evidence or the views of health researchers who are the intended users of the guidance. This may undermine trust in the guidance, making it less helpful than it could be. Our goal is to address this. We aim to provide a process, STREAM, for creating trustworthy and user-friendly guidance that leads to meaningful and valid health research. Here is our plan: (1) Review existing suggestions for creating guidance: We will analyze existing publications that make suggestions on how to create guidance. (2) Review existing guidance: We will analyse a sample of recent guidance to see how experts currently create guidance: for example, how they collected information, involved users, reached a consensus, and tested the guidance. (3) Engage with guidance users: We will interview health researchers who recently used guidance. We want to understand what makes guidance trustworthy and meaningful to them. (4) Develop STREAM: We will assemble a diverse group including experts and health researchers. Together, we will develop the new process, STREAM. (5) Test STREAM: We will collaborate with experts currently creating guidance and ask them to test the new process. We will collect feedback to refine and finalize STREAM. To ensure that our research makes sense, we will consider possibilities for engaging health researchers, patients, and members of the public throughout the projects. In summary, our aim is to provide practical advice for experts who create guidance for conducting health research. We will call the new process STREAM and it will be evidence-based, user-centred, and practice-tested. STREAM will make it easier to create guidance that is clearer for health researchers and will lead to evidence that is more actionable and relevant to patients.