More pilot trials could plan to use qualitative data: a meta-epidemiological study
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METHODOLOGY
Open Access
More pilot trials could plan to use qualitative data: a meta-epidemiological study Tejan Baldeh1* , Tonya MacDonald1,2, Sarah Daisy Kosa1,3, Daeria O. Lawson1, Rosa Stalteri1, Oluwatobi R. Olaiya4, Ahlam Alotaibi5, Lehana Thabane1,6,7,8,9 and Lawrence Mbuagbaw1,6,10
Abstract Background: Pilot trials often use quantitative data such as recruitment rate and retention rate to inform the design and feasibility of a larger trial. However, qualitative data such as patient, healthcare provider, and research staff perceptions of an intervention may also provide insights for a larger trial. Methods: As part of a larger study investigating the reporting of progression criteria in pilot studies, we sought to determine how often pilot studies planned to use qualitative data to inform the design and feasibility of a larger trial and the factors associated with plans to use qualitative data. We searched for protocols of pilot studies of randomized trials in PubMed between 2013 and 2017. Results: We included 227 articles. Only 92 (40.5%; 95% confidence interval [CI] 34.1–47.2) reported plans to collect qualitative data. The factors associated with collecting qualitative data were large studies (defined as sample size ≥ 60; adjusted odds ratio [aOR] 2.77; 95% CI 1.47–5.23; p = 0.002) and studies from Europe (aOR 3.86; 95% CI 1.68– 8.88; p = 0.001) compared to North America and the rest of the world. Pilot trials with pharmacological interventions were less likely to plan to collect qualitative data (aOR 0.20; 95% CI 0.07–0.58; p = 0.003). Conclusions: Qualitative data is not used enough in pilot trials. Large pilot trials, pilot trials from Europe, and pilot trials of non-pharmacological interventions are more likely to plan for qualitative data. Keywords: Pilot, Feasibility, Trials, Qualitative data, Protocols
Background Feasibility studies are a category of study which aim to determine if a study should be done, can be done, and, if so, how it might be done [1]. Pilot studies are a type of feasibility study that maintains an element of study design (e.g. randomization), albeit on a smaller scale than what is intended for the full trial [1–3]. Data from pilot studies is of great value to researchers for identifying * Correspondence: [email protected] 1 Department of Health Research Methods, Evidence and Impact, McMaster University Health Sciences Centre, McMaster University, 1280 Main Street West, Hamilton, ON L8N 4K1, Canada Full list of author information is available at the end of the article
and correcting problems which might otherwise compromise acceptability and delivery of interventions in the full study. By correcting these issues before carrying out a larger study, researchers may reduce misuse of resources and inappropriate evaluation techniques in the larger trial [4–6]. Since pilot studies are based on the methods intended for a full-scale investigation, quantitative and qualitative methods can be used. Both methods have the potential to yield useful data in the context of a pilot study
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