The DOI matches its Crossref record; 47 of the 47 references it cites were found in a registry or an index.
Guidelines for Designing and Evaluating Feasibility Pilot Studies
Open accessAbstract
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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“However, the sample size of the present study falls within the range recommended for pilot studies (Lancaster et al., 2004; Teresi et al., 2022).”
From Evaluation of effectiveness and acceptability of a psychological treatment for smoking cessation combined with a smartphone App: A pilot study (2024) · cites this paper as Teresi et al., 2022
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“The study aimed to recruit 80 participants to allow a 25% attrition rate and a final sample of 40 participants, appropriate for pilot feasibility studies (Creswell & Creswell, 2022; Teresi et al., 2022).”
From Acceptance and Commitment Therapy Tele-Counselling Program With Care Partners of Persons Living With Dementia: A Pilot Feasibility RCT. (2026) · cites this paper as Teresi et al., 2022
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How we design feasibility studies
Bowen, D. J., Kreuter, M., Spring, B., Cofta-Woerpel, L., Linnan, L., Weiner, D., Bakken, S., Kaplan, C. P., Squiers, L., Fabrizio, C., et al. (2009) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2009.02.002 · Cited by 4,021
Cella, D., Yount, S., Rothrock, N., Gershon, R., Cook, K., Reeve, B., Ader, D., Fries, J. F., Bruce, B., & Rose, M. (2007) · Medical Care · doi:10.1097/01.mlr.0000258615.42478.55 · Cited by 3,118
Sample size of 12 per group rule of thumb for a pilot study
Julious, S. A. (2005) · Pharmaceutical Statistics · doi:10.1002/pst.185 · Cited by 3,068
CONSORT 2010 statement: extension to randomised pilot and feasibility trials
on behalf of the PAFS consensus group, Eldridge, S. M., Chan, C. L., Campbell, M. J., Bond, C. M., Hopewell, S., Thabane, L., & Lancaster, G. A. (2016) · Pilot and Feasibility Studies · doi:10.1186/s40814-016-0105-8 · Cited by 2,843 · cited 1×
“Feasibility indicators can include completion rates and times for speci fi c components, perceived burden, incon-venience, and reasons for noncompletion, 9 all of which may inform assessment protocol modi fi cation.”
BackgroundBellg, A. J., Treatment Fidelity Workgroup of the NIH Behavior Change Consortium, Borrelli, B., Resnick, B., Hecht, J., Minicucci, D. S., Ory, M., Ogedegbe, G., Orwig, D., Ernst, D., et al. (2004) · Health Psychology · doi:10.1037/0278-6133.23.5.443 · Cited by 2,620
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
Revicki, D. A., Hays, R. D., Cella, D. F., & Sloan, J. A. (2007) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2007.03.012 · Cited by 2,384
Whitehead, A. L., Julious, S. A., Cooper, C. L., & Campbell, M. J. (2016) · Statistical Methods in Medical Research · doi:10.1177/0962280215588241 · Cited by 1,936
The role and interpretation of pilot studies in clinical research
Leon, A. C., Davis, L. L., & Kraemer, H. C. (2011) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2010.10.008 · Cited by 1,917
Eldridge, S. M., Lancaster, G. A., Campbell, M. J., Thabane, L., Hopewell, S., Coleman, C. L., & Bond, C. M. (2016) · PLOS ONE · doi:10.1371/journal.pone.0150205 · Cited by 1,581
Research works printed but not linked: 1
- Jones, 2016, Differential item functioning in Patient-reported Outcomes Measurement Information System (PROMIS®) physical functioning short forms, Psychol Test Assess Model, 58, 371
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Sorted by citations
SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171
Consolidated guidance for behavioral intervention pilot and feasibility studies
Pfledderer, C. D., von Klinggraeff, L., Burkart, S. A., Bandeira, A. D. S., Lubans, D. R., Jago, R., Okely, A. D., van Sluijs, E. M. F., Ioannidis, J. P. A., Thrasher, J. F., et al. (2024) · Pilot and Feasibility Studies · doi:10.1186/s40814-024-01485-5 · Cited by 69
Challenges and standardisation strategies for sensor-based data collection for digital phenotyping
Alam, N. B., Surani, M., Das, C. K., Giacco, D., Singh, S. P., & Jilka, S. (2025) · Communications Medicine · doi:10.1038/s43856-025-01013-3 · Cited by 41
“Pilot projects and validation studies play a critical role in demonstrating the feasibilityandbene fi tsofstandardisationefforts 125 .”
Kim, M., Patrick, K., Nebeker, C., Godino, J., Stein, S., Klasnja, P., Perski, O., Viglione, C., Coleman, A., & Hekler, E. B. (2024) · Journal of Medical Internet Research · doi:10.2196/49208 · Cited by 44
“Emerging recommendations from scientific groups, such as the 2010 CONSORT recommendations and others more relevant to digital health [96,97], suggest that the term “feasibility” be used to describe the probability that a particular type of study, such as a phase III clinical trial, can be conducted…”
Chandran, A., van Harten, M., Singh, D., Vilaseca, J., Patašius, A., Tupikowski, K., Amorín, Á. G., Galvin, D., López, H. G., Salazar, J. P., et al. (2024) · European Urology Open Science · doi:10.1016/j.euros.2024.09.003 · Cited by 37
“The sample size needed in a pilot study, considering participant flow, budgetary constraints, and the number of participants needed to reasonably evaluate feasibility goals in quantitative studies, is estimated to be 30 patients [9].”
Metadata
- 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
- Published
- 2021-11-23
- Volume
- 60
- Issue
- 1
- Pages
- 95-103
- ISSN
- 0025-7079 (ISSN-L)
- 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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