More pilot trials could plan to use qualitative data: a meta-epidemiological study.

Area of Science:

• Clinical Trials Methodology
• Qualitative Research in Health

Background:

• Pilot trials commonly use quantitative data (e.g., recruitment, retention rates) to assess feasibility for larger trials.
• Qualitative data, capturing perceptions of patients and providers, can offer valuable insights often overlooked.

Purpose of the Study:

• To determine the frequency of qualitative data collection plans in pilot trial protocols.
• To identify factors associated with the inclusion of qualitative data in pilot studies.

Main Methods:

• A systematic search of pilot randomized trial protocols was conducted in PubMed (2013-2017).
• Protocols were analyzed to identify plans for collecting qualitative data and associated study characteristics.

Main Results:

• Only 40.5% of 227 pilot trial protocols planned to collect qualitative data.
• Larger pilot studies (≥ 60 participants) and those from Europe were more likely to include qualitative data.
• Pilot trials of pharmacological interventions were less likely to plan for qualitative data collection.

Conclusions:

• Qualitative data collection is underutilized in pilot trial design.
• Factors influencing qualitative data inclusion include study size, geographic location (Europe), and intervention type (non-pharmacological).
• Increased use of qualitative data in pilot trials can enhance the design and feasibility of subsequent larger trials.