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The Role of Qualitative Research in Progression Decision-Making in Mixed-Methods Pilot and Feasibility Randomized
Matilda Björklund1, Nicola Cornwall1, Melanie Ann Holden1
1Primary Care Centre Versus Arthritis School of Medicine, Keele University, Keele, UK.
Qualitative Health Research
|April 18, 2026
Summary
Qualitative research in pilot and feasibility randomized controlled trials (RCTs) offers valuable insights. However, its use in guiding progression to full-scale trials is limited but promising, requiring clearer guidance for consistent application.
Area of Science:
- Health Services Research
- Qualitative Research Methods
- Clinical Trial Design
Background:
- Pilot and feasibility randomized controlled trials (RCTs) are crucial for informing full-scale trial decisions.
- Qualitative research can provide insights into intervention feasibility, acceptability, and implementation beyond quantitative data.
- The influence of qualitative findings on progression decisions in pilot/feasibility RCTs remains unclear.
Purpose of the Study:
- To conduct a scoping review on the use of qualitative research in informing progression decisions for pilot and feasibility RCTs.
- To identify how qualitative findings have influenced decisions to proceed to full-scale trials.
- To explore approaches for integrating qualitative research into progression decision-making.
Main Methods:
- Scoping review guided by Joanna Briggs Institute methodology.
- Searched MEDLINE for pilot/feasibility RCTs of health interventions (2017-2022) in four target journals.
- Included studies using qualitative research to inform progression decisions, screened titles/abstracts, and extracted data on trial characteristics and decision processes.
Main Results:
- 69 trials (94 publications) met inclusion criteria from 932 records.
- Two main approaches identified: prespecified progression criteria and mixed-methods integration.
- Limited but promising examples of meaningful integration were found, with few trials using qualitative progression criteria or mixed-methods integration.
Conclusions:
- Qualitative research offers valuable insights for pilot and feasibility RCTs, but its integration into progression decision-making is not consistently applied.
- There are promising, albeit limited, examples of using qualitative data to inform decisions about proceeding to full-scale trials.
- Clearer guidance is needed to support the consistent and transparent use of qualitative research in pilot and feasibility RCT progression decisions.
Keywords:
feasibility studiespilot projectsprogression criteriaqualitative researchrandomized controlled trialsMore Related Videos
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