Examining Pilot and Feasibility Trials
Author Information
Author(s): Shanyinde Milensu, Ruth M Pickering, Mark Weatherall
Primary Institution: University of Southampton
Hypothesis
What are the characteristics and outcomes of pilot and feasibility randomized controlled trials?
Conclusion
Most published pilot and feasibility trials do not adequately address methodological issues necessary for planning subsequent studies.
Supporting Evidence
- 56% of trials discussed methodological issues in depth.
- Only 12% of authors were conducting future trials.
- Drug trials addressed safety while non-drug trials focused more on methodology.
Takeaway
This study looked at 50 trials called pilot studies and found that many didn't really help plan bigger studies, especially those about drugs.
Methodology
A random sample of 50 papers from EMBASE and MEDLINE was reviewed, focusing on their objectives, results, and conclusions.
Potential Biases
Potential bias in the designation of studies as pilot or feasibility based on perceived rigor.
Limitations
The study only included papers published in English and indexed as RCTs, which may limit the generalizability of the findings.
Statistical Information
P-Value
p<0.05
Confidence Interval
95% CI 41% to 70%
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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