Are some feasibility studies more feasible than others? A review of the outcomes of feasibility studies on the ISRCTN registry
Open accessAbstract
Background: Feasibility studies are often conducted before committing to a randomised controlled trial (RCT), yet there is little published evidence to inform how useful feasibility studies are, especially in terms of adding or reducing waste in research. This study attempted to examine how many feasibility studies demonstrated that the full trial was feasible and whether some feasibility studies were inherently likely to be feasible or not feasible, based on the topic area and/or research setting. Methods: Keyword searches were conducted on the International Standard Randomised Controlled Trials Number (ISRCTN) registry to identify all completed feasibility studies which had been conducted in the UK. Results: A total of 625 records from the 1933 identified were reviewed before it became evident that it would be futile to continue. Of 329 feasibility studies identified, 160 had a known outcome (49%), 133 (83%) trials were deemed to be feasible and only 27 (17%) were reported to be non-feasible. There were therefore too few studies to allow the intended comparison of differences in non-feasible studies by topic and/or setting. Conclusions: There were too few studies reported as non-feasible to draw any useful conclusions on whether topic and/or setting had an effect. However, the high feasibility rate (83%) may suggest that non-feasible studies are subject to publication bias or that many feasible studies are redundant and may be adding waste to the research pathway.
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If progression criteria are not set a priori, there is a risk that pilot trials may be optimistic in reporting that a future RCT is feasible.
“If progression criteria are not set a priori, there is a risk that pilot trials may be optimistic in reporting that a future RCT is feasible [11] and progress to a definitive RCT without modification or acknowledgement of potential limitations [12].”
From Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting (2023) · cites this paper as [11]
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References 19 · Cited by 16
- Authors
- Morgan, B., Hejdenberg, J., Kuleszewicz, K., Armstrong, D., & Ziebland, S.
- Affiliations
- National Institute for Health and Care Research (GB)
- King's College London (GB)
- Corresponding author
- Morgan, Ben
- Venue
- Pilot and Feasibility Studies
- Published
- 2021-11-08
- Volume
- 7
- Issue
- 1
- Pages
- 195-195
- ISSN
- 2055-5784 (ISSN-L)
- PMC
- PMC8573999
- OpenAlex
- W3214317709
- Cited by
- 16
- References
- 19
- Citations by year
- 2025: 6 · 2024: 4 · 2023: 3 · 2022: 3
- FWCI
- 1.45
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Pilot and Feasibility Studies (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Research Portal (King's College London) (submittedVersion, other-oa)
- Funders
- National Institute for Health Research
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- feasibility study, trial feasibility, research waste, publication bias, randomized controlled trials, research funding allocation
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