Cited by 204Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsMethodologies in Health Research and Practice

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The Distinction Between Randomized Clinical Trials (RCTs) and Preliminary Feasibility and Pilot Studies: What They Are and Are Not

Abbott, J. Haxby·2014·Journal of Orthopaedic & Sports Physical Therapy

DOI 10.2519/jospt.2014.0110

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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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Authors: Abbott, J. H.
Corresponding author: Abbott, J. Haxby
ORCID: Abbott, J. Haxby
Venue: Journal of Orthopaedic & Sports Physical Therapy
Publisher: Journal of Orthopaedic & Sports Physical Therapy (JOSPT)
Published: 2014-08
Volume: 44
Issue: 8
Pages: 555-558
ISSN: 0190-6011 (ISSN-L)
1938-1344
DOI: 10.2519/jospt.2014.0110
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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The Distinction Between Randomized Clinical Trials (RCTs) and Preliminary Feasibility and Pilot Studies: What They Are and Are Not

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