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Table 1 Guidance for using qualitative research in feasibility studies for trials

From: Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

Aspects of the feasibility study Issues to consider
1. Research questions a. When designing the feasibility study, consider the wide range of questions. Then, consider those best addressed by qualitative research.
b. Prioritise the initial questions by identifying key uncertainties, whilst allowing for the possibility of emergent questions.
c. Consider the often overlooked questions, such as ‘what is considered to be usual care?’.
2. Design and data collection a. Consider the range of qualitative methods that might be used to address the key feasibility questions, including dynamic or iterative approaches which allow learning from early qualitative research findings to be implemented before further qualitative research is undertaken as part of the feasibility study.
b. Select from a range of appropriate qualitative methods to address the feasibility questions and provide a rationale for the choices made; non-participant observation may be an important consideration.
c. Pay attention to diversity when sampling participants, groups, sites and stage of intervention.
d. Appreciate the difference between qualitative research and public and patient involvement.
3. Analysis a. Consider timing of analysis which might be in stages in a dynamic approach.
b. Many different approaches to analysis can be used, including framework, thematic and grounded theory-informed analysis.
c. Data can cover a breadth of issues, but the analysis may focus on a few key issues.
4. Teamworking a. Have a qualitative researcher as part of the feasibility study design team.
b. Consider relationships between the qualitative researchers and the wider feasibility study team.
c. Consider who will make changes to the intervention or trial conduct.
5. Reporting a. Publish feasibility studies where possible because they help other researchers consider the feasibility of similar interventions or trials.
b. Describe the qualitative analysis and findings in detail.
c. Be explicit about the learning for a future trial or a similar body of interventions or generic learning for trials.