Cited by 734Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsHealth Policy Implementation Science

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Guidelines for Designing and Evaluating Feasibility Pilot Studies

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Teresi, Jeanne A., Yu, Xiaoying, Stewart, Anita L., Hays, Ron D.·2022·Medical Care

DOI 10.1097/mlr.0000000000001664PMC PMC8849521

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Abstract

BACKGROUND: Pilot studies test the feasibility of methods and procedures to be used in larger-scale studies. Although numerous articles describe guidelines for the conduct of pilot studies, few have included specific feasibility indicators or strategies for evaluating multiple aspects of feasibility. In addition, using pilot studies to estimate effect sizes to plan sample sizes for subsequent randomized controlled trials has been challenged; however, there has been little consensus on alternative strategies. METHODS: In Section 1, specific indicators (recruitment, retention, intervention fidelity, acceptability, adherence, and engagement) are presented for feasibility assessment of data collection methods and intervention implementation. Section 1 also highlights the importance of examining feasibility when adapting an intervention tested in mainstream populations to a new more diverse group. In Section 2, statistical and design issues are presented, including sample sizes for pilot studies, estimates of minimally important differences, design effects, confidence intervals (CI) and nonparametric statistics. An in-depth treatment of the limits of effect size estimation as well as process variables is presented. Tables showing CI around parameters are provided. With small samples, effect size, completion and adherence rate estimates will have large CI. CONCLUSION: This commentary offers examples of indicators for evaluating feasibility, and of the limits of effect size estimation in pilot studies. As demonstrated, most pilot studies should not be used to estimate effect sizes, provide power calculations for statistical tests or perform exploratory analyses of efficacy. It is hoped that these guidelines will be useful to those planning pilot/feasibility studies before a larger-scale study.

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How we design feasibility studies
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Background
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Method
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Background
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Background
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Background
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“According to the guidance for pilot intervention studies [110], it is suggested a minimum sample of 30 per group for the feasibility evaluation.”
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“25,26 A participatory research approach guided the process and the implementation plan was adapted with participants.”
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“Guidelines for conducting feasibility studies recommend to include variables such as acceptance, adoption or dropout rates as key markers for successful implementation [32–34].”
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CEDART study: protocol for a non-randomized feasibility study
Kwak, J., Jafari, A., Salter, A., Perry, A., Shepherd, A. D. M., Jayasundera, M., Stayer, S., Brode, M., Patel, S. G., & Kvale, E. A. (2026) · Pilot and Feasibility Studies · doi:10.1186/s40814-026-01909-4

Authors: Teresi, J. A., Yu, X., Stewart, A. L., & Hays, R. D.
Affiliations: Hebrew Home (US)
The University of Texas Medical Branch at Galveston (US)
University of California, San Francisco (US)
University of California, Los Angeles (US)
Corresponding author: Teresi, Jeanne A.
ORCID: Hays, Ron D.
Venue: Medical Care
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2021-11-23
Volume: 60
Issue: 1
Pages: 95-103
ISSN: 0025-7079 (ISSN-L)
DOI: 10.1097/mlr.0000000000001664
PMC: PMC8849521
OpenAlex: W3215891836
Cited by: 734
References: 46
Citations by year: 2026: 280 · 2025: 279 · 2024: 141 · 2023: 26 · 2022: 7
FWCI: 32.16
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Medical Care (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
Funders: National Institutes of Health (2p30ag028741-16)
University of California, San Francisco
National Institute on Aging (P30‐AG028741, P30AG059303, P30AG059301, P30AG021684, P30AG015272, P30AG022845)
National Institute of Allergy and Infectious Diseases
Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12HD052023)
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 › Health Professions › General Health Professions › Health Policy Implementation Science
Keywords: effect size estimation, sample size determination, randomized controlled trials, recruitment and retention, intervention fidelity, treatment acceptability, adherence, participant engagement, intervention adaptation, minimally important difference, confidence intervals, nonparametric statistics, design effect
MeSH terms: Feasibility Studies, Humans, Pilot Projects, Research Design, Guidelines as Topic

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Guidelines for Designing and Evaluating Feasibility Pilot Studies

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