The DOI matches its Crossref record; 13 of the 13 references it cites were found in a registry or an index.
The Distinction Between Randomized Clinical Trials (RCTs) and Preliminary Feasibility and Pilot Studies: What They Are and Are Not
Abstract
Feasibility and pilot studies play an important role in the preliminary planning of a proposed full-size randomized clinical trial (RCT). In essence, feasibility studies are used to help develop trial interventions or outcome measures, whereas pilot studies replicate, in miniature, a planned full-size RCT. However, the terms used for these preliminary studies are sometimes considered synonymous, and in practice may overlap considerably or be combined. The important issue is not the distinction between these: the important distinction is between such preliminary studies and a proper RCT. J Orthop Sports Phys Ther 2014;44(8):555–558. doi:10.2519/jospt.2014.0110
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“Based on guidance in the literature,47 the research team estimated that a sample size of 40 (20 in each treatment arm) would be sufficient to adequately evaluate the feasibility of undertaking a full clinical trial.31”
In the citing paper
“These are feasibility problems that would have been revealed in a preliminary feasibility study.47”
In the citing paper
“Conducting a feasibility study is an important step before conducting a full clinical trial,47 especially in a setting where a high-quality clinical trial has never been conducted, which lacks recommendations from previous experiences for such a study.”
Citations
Cites
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A tutorial on pilot studies: the what, why and how
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Design and analysis of pilot studies: recommendations for good practice
Lancaster, G. A., Dodd, S., & Williamson, P. R. (2004) · Journal of Evaluation in Clinical Practice · doi:10.1111/j..2002.384.doc.x · Cited by 2,572
What is a pilot or feasibility study? A review of current practice and editorial policy
Arain, M., Campbell, M. J., Cooper, C. L., & Lancaster, G. A. (2010) · BMC Medical Research Methodology · doi:10.1186/1471-2288-10-67 · Cited by 1,483
Sample size calculations: basic principles and common pitfalls
Noordzij, M., Tripepi, G. L., Dekker, F. W., Zoccali, C., Tanck, M. W. T., & Jager, K. J. (2010) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfp732 · Cited by 440
Sample size calculations for pilot randomized trials: a confidence interval approach
Cocks, K., & Torgerson, D. J. (2013) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2012.09.002 · Cited by 431
Coombes, B. K., Bisset, L., Brooks, P., Khan, A., & Vicenzino, B. (2013) · JAMA · doi:10.1001/jama.2013.129 · Cited by 360
Questions asked and answered in pilot and feasibility randomized controlled trials
Shanyinde, M., Pickering, R. M., & Weatherall, M. (2011) · BMC Medical Research Methodology · doi:10.1186/1471-2288-11-117 · Cited by 229
Hale, L. A., Waters, D. L., & Herbison, P. (2011) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2011.08.004 · Cited by 129
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Research works printed but not linked: 1
- Ribeiro DC, J Orthop Sports Phys Ther.
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Boyne, P., Dunning, K. K., Carl, D., Gerson, M. C., Khoury, J. C., Rockwell, B., Keeton, G., Westover, J., Williams, A., McCarthy, M. J., et al. (2016) · Physical Therapy · doi:10.2522/ptj.20150277 · Cited by 144
Should treatment effects be estimated in pilot and feasibility studies?
Sim, J. (2019) · Pilot and Feasibility Studies · doi:10.1186/s40814-019-0493-7 · Cited by 123
Conducting a pilot study: case study of a novice researcher
Doody, O., & Doody, C. M. (2015) · British Journal of Nursing · doi:10.12968/bjon.2015.24.21.1074 · Cited by 214
Creaser, A. V., Clemes, S. A., Costa, S., Hall, J., Ridgers, N. D., Barber, S., & Bingham, D. D. (2021) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph18126211 · Cited by 104
Jamison, R. N., Jurcik, D. C., Edwards, R. R., Huang, C.-C., & Ross, E. L. (2017) · The Clinical Journal of Pain · doi:10.1097/ajp.0000000000000455 · Cited by 83
Metadata
- Authors
- Abbott, J. H.
- Corresponding author
- Abbott, J. Haxby
- ORCID
- Abbott, J. Haxby
- Venue
- Journal of Orthopaedic & Sports Physical Therapy
- Published
- 2014-08
- Volume
- 44
- Issue
- 8
- Pages
- 555-558
- ISSN
- 0190-6011 (ISSN-L)
- 1938-1344
- OpenAlex
- W2064386551
- Cited by
- 204
- References
- 13
- Citations by year
- 2026: 14 · 2025: 23 · 2024: 20 · 2023: 22 · 2022: 29 · 2021: 28 · 2020: 18 · 2019: 17 · 2018: 6 · 2017: 12 · 2016: 7 · 2015: 6
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Orthopaedic and Sports Physical Therapy (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Nursing › Research and Theory › Methodologies in Health Research and Practice
- Keywords
- randomized controlled trials, feasibility study, pilot study, trial design, intervention development, outcome measures
- MeSH terms
- Feasibility Studies, Humans, Terminology as Topic, Pilot Projects, Randomized Controlled Trials as Topic
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