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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
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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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
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“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
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Acute motor–cognitive responses to a bouldering fatigue protocol in indoor recreational climbers
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“…adopted informed by the systematic review of Parker et al. [37] looking at health interventions in schools, guidelines developed by Teresi et al. [38] for designing feasibility and pilot studies, and the BRIGHT trial that worked with similar aged adolescent participants delivering an oral health…”
UM APLICATIVO DIGITAL PARA REGISTRO E MONITORAMENTO DA DOR EM CRIANÇAS: ESTUDO PILOTO DO APDOR
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“30 With a targeted recruitment rate of 40%, a sample size of 12 participants per group will be feasible.”
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“Feasibility (Q1-3) and acceptability (Q4) were firstly assessed against minimum success criteria (i.e., lowest threshold indicative of success [27]), then explained qualitatively for each key question.”
Laulan, P., & Fernandez, M. L. G. (2026) · Research Square · doi:10.21203/rs.3.rs-9097265/v1
Kleinlooh, S. T., Samaritter, R., Koes, B. W., Hoekstra, R., & Stubbe, J. (2026) · Pilot and Feasibility Studies · doi:10.1186/s40814-026-01816-8
“As a result, early-phase evaluation of feasibility and acceptability is strongly recommended during the initial stages of study and intervention development to identify methodological challenges and ensure that proposed designs are implementable in real-world clinical settings [5, 6, 8, 13, 34, 37].”
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Shi, Y., Stanmore, E., McGarrigle, L., Wang, X. H., Gu, C., Ye, Y., & Todd, C. J. (2026) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2026.105467
Mutumba, M., Brathwaite, R., Nannono, S., Kabarambi, A., & Ssewamala, F. M. (2026) · AIDS Care · doi:10.1080/09540121.2026.2655052
“Following noted experts and NIH guidance, we acknowledge that pilot RCT studies are too small to allow for sufficiently powered statistical tests or reliable effect size estimates to be determined and formal tests of clinical outcomes (Kraemer et al., 2006; Leon et al., 2011; Teresi et al., 2022).”
Exploring Cancer Survivors’ Preferences for a Physical Activity Maintenance Program
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Mohamed, N., Ramana, K., Digala, P., Prathap, S., Alagesan, J., & Manasa, T. (2026) · AIP conference proceedings · doi:10.1063/5.0312450
Window Opening Behaviours in Irish Primary Schools: Insights from a Pilot Teacher Survey
Honan, D., Littlewood, J. R., Garvey, J., & Gallagher, J. (2026) · Smart innovation, systems and technologies · doi:10.1007/978-3-032-14677-9_8
Zheng, X., Yang, Z., Wu, H., Zhao, M., Que, C., Xiong, X., Mu, Y., Zhang, G., Kang, L., Gao, Y., et al. (2026) · Frontiers in Medicine · doi:10.3389/fmed.2026.1754648
Callegari, A., Moscatelli, S., Heying, R., & McMahon, C. J. (2026) · International Journal of Cardiology Congenital Heart Disease · doi:10.1016/j.ijcchd.2026.100677
“…adaptive trial designs, Bayesian statistical approaches, and platform trials now support rigorous inference even with limited sample sizes [10,12,13] Bayesian adaptive designs can minimize the number of participants exposed to inferior treatments by stopping trials early if strong effects…”
Han, W. (2026) · Journal of dementia and Alzheimer's disease · doi:10.3390/jdad3020021
“Research is now at a point where feasibility findings should be treated as a floor rather than an endpoint [66].”
Sree, S., Palanisamy, B., Luke, L. H., Subramanian, P. A., & Sivakumar, S. P. (2026) · Discover Public Health · doi:10.1186/s12982-026-01789-2
Scoville, C. W., Mirembe, B. G., Voldal, E. C., Maena, J., Etima, J., Harris-Wisecarver, J., Rukundo, I., Ssemere, H., Kemigisha, D., Nakyanzi, T., et al. (2026) · JMIR Research Protocols · doi:10.2196/87612
“…the primary driver, to inform client recruitment targets, we also assessed the number of participants per shop needed to detect meaningful differences in HIV testing between study arms, defined as a difference between arms of 20% in the proportion of participants self-initiating HIV testing [63].”
Naslund, J. A., Tyagi, V., Tugnawat, D. K., Bhan, A., & Khan, A. (2026) · SSM - Mental Health · doi:10.1016/j.ssmmh.2026.100635
“This sample size was feasible to recruit in the project timeframe, while allowing emphasis on collection of both qualitative and quantitative data on program acceptability, and is consistent with the design of prior mixed methods pilot studies (Aschbrenner et al., 2022; Teresi et al., 2022).”
Prima, G. D., Mauceri, M. L., Coppini, M., Mantia, C. L., Mauceri, R., Campisi, G., & De, V. (2026) · Drug Delivery and Translational Research · doi:10.1007/s13346-026-02122-9
Holch, P., Bagnall, A., Hughes, S., & McSorley, L. K. (2026) · Pilot and Feasibility Studies · doi:10.1186/s40814-026-01801-1
“…to recruit 43 students per arm (total n = 86) as guided by the literature which is sufficient to estimate recruitment as wide confidence intervals are expected [22, 23], and given we are not estimating effect sizes [24] and reflecting a similar sample size of a previous university-based study [13].”
Bosnar, L., Tisma, D. S., Ciko, T., Hrabač, P., Brinar, I. V., & Lang, V. B. (2026) · Journal of Clinical Medicine · doi:10.3390/jcm15083169
“Only participants with available baseline and follow-up measurements who attended at least 70% of exercise sessions were included in the analysis [38].”
Messner, K., Sutter, V., Allemann, S. S., & Arnet, I. (2026) · Exploratory Research in Clinical and Social Pharmacy · doi:10.1016/j.rcsop.2026.100790
“27 Therefore, we assessed recruitment rate of the study (defined as number of individuals who participated in the study compared to number of invited eligible patients), completion rate (defined as number of participants who completed the study compared to number of included participants), as well…”
Kulangara, S., S, S. K., Mohanan, D., Viswaroopan, D., Reshma, N. S., & Salethoor, S. N. (2026) · Frontiers in Medicine · doi:10.3389/fmed.2026.1796572 · Cited by 1
Tripathi, T., Watson, J., Holmes, N. E., McCoy, J., Stump, H., & Hui, L. (2026) · Research Square · doi:10.21203/rs.3.rs-7669354/v2
Protocol for a feasibility study of a peer support program for trauma survivors
Wasilewski, M. B., Reis, L., Ahmed, Y. H. E., Alitawi, R., Hitzig, S. L., Mayo, A. L., Vogt, K., McFarlan, A., Haas, B., Kuluski, K., et al. (2026) · Pilot and Feasibility Studies · doi:10.1186/s40814-026-01820-y
“For the qualitative phase, sampling will occur until data saturation is reached (i.e., data redundancy is observed) [82].”
Smith, L. L., Olson, L., & Gearing, R. E. (2026) · Research on Social Work Practice · doi:10.1177/10497315261441539
“Procedural feasibility, which is often the main reason for conducting pilot studies, is a piece of the larger question of scienti fi c feasibility (Teresi et al., 2022).”
van Rijssen, I. M., Wouda, N. C., Gorter, J. W., Visser‐Meily, J. M. A., & Verschuren, O. W. (2026) · Disability and Rehabilitation · doi:10.1080/09638288.2026.2661471
Ding, L., Lv, S., Wang, W., Ji, Z., Gong, X., Jia, Q., Yang, X., Zang, Y., Huang, S., Tan, Z., et al. (2026) · Stroke and Vascular Neurology · doi:10.1136/svn-2025-004778
Svensson, I., & Egerhag, H. (2026) · Journal of Multilingual and Multicultural Development · doi:10.1080/01434632.2026.2664518
Hussain, R., Anjum, S., Abraham, Y. S., Rambo-Hernandez, K. E., Akanmu, A., & Nnaji, C. A. (2026) · Computer Applications in Engineering Education · doi:10.1002/cae.70198 · Cited by 1
“The sample size for the laboratory and informal deployments aligns with recommendations for exploratory usability and educational technology studies, where formative evaluation and iterative refinement are prioritized over population‐level generalization [55].”
Dyck, J., Perera, E., Filbert, B., Paletta, A., Logsetty, S., Spiwak, R. P., Claßen, C., Joaquin, C., & Sareen, J. (2026) · BMJ Open · doi:10.1136/bmjopen-2025-115741
Duong, V., Bloul, N., Bowden, J. L., Bracken, K., Bryce, K. L., Deveza, L. A., Eyles, J. P., Farivar, A., Huang, R., Kobayashi, S., et al. (2026) · JMIR Human Factors · doi:10.2196/84857
“We aimed to recruit a total of 30 participants for this study, which is an acceptable size for a feasibility study [32].”
Devine, L. D., Elliott, P. S., Gibney, E. R., & O'Sullivan, A. M. (2026) · Appetite · doi:10.1016/j.appet.2026.108580
Silva, D. M., Rocha, L. C., Lahr, G. J. G., Correia, L. H. A., Freire, A. P., & Salgado, A. D. L. (2026) · Expert Systems · doi:10.1111/exsy.70275
Owora, A. H., Jiang, B., Shah, Y., Kloepfer, K. M., Krupp, N. L., & Tepper, R. S. (2026) · Pilot and Feasibility Studies · doi:10.1186/s40814-026-01837-3
“With a final sample size of 139 clinicians, we exceeded the commonly recommended minimum sample size ( n ≥ 70) for pilot studies [20, 21].”
Page, J. M., Wang, G., Robbins, R., Ziporyn, P. S., Ordway, M. R., & Owens, J. A. (2026) · Frontiers in Sleep · doi:10.3389/frsle.2026.1787776
Li, Y., & Li, M. (2026) · Journal for Multicultural Education · doi:10.1108/jme-07-2025-0143
Kvidaland, H. K., Iversen, M. M., Frisk, B., Richards, D. A., Lomborg, K., Borge, C. R., & Kolltveit, B. H. (2026) · Pilot and Feasibility Studies · doi:10.1186/s40814-026-01832-8
“…calculations for feasibility studies where the intention is not to undertake between-group inferential statistical analyses [33]; however, a sample size of approximately 60 participants, with 30 in each arm, is regarded as suitable for testing procedural uncertainties such as recruitment [34, 35].”
Ghezzi, M., & Garvis, S. (2026) · Early Childhood Education Journal · doi:10.1007/s10643-026-02222-8
Drivers to Sustainable Entrepreneurial Orientation (SEO) Among Start-Ups in Emerging Economies
Mashingaidze, M. (2026) · Sustainable development goals series · doi:10.1007/978-981-95-6533-7_5
Fischer, S., Reizner, J., Kalch, A., Bilandzić, H., Berghaus, T. M., Christine, M., & Kirchberger, I. (2026) · Frontiers in Public Health · doi:10.3389/fpubh.2026.1814447
“This number also aligns with recommendations for sample size in feasibility studies (21, 22).”
Duong, V., Bloul, N., Bowden, J. L., Bracken, K., Bryce, K. L., Deveza, L. A., Eyles, J. P., Farivar, A., Huang, R., Kobayashi, S., et al. (2025) · doi:10.2196/preprints.84857
Clair, C. A., Curriero, S. N., & Saylor, M. A. (2026) · Journal of Patient-Reported Outcomes · doi:10.1186/s41687-026-01082-5
“As a pilot study, sample size was determined for feasibility and acceptability; we aimed for enrollment of 36 caregivers and anticipated an attrition rate of 30% [33].”
Wang, S., Zhao, J., Wang, X., Cao, G., Shi, X., Wang, S., & 谭红略 (2026) · International Orthopaedics · doi:10.1007/s00264-026-06856-6
“Feasibility studies are not designed to prove treatment efficacy, and small uncontrolled series should mainly be used to generate hypotheses for future comparative studies [23].”
Bujang, M. A. (2026) · Indian Journal of Psychological Medicine · doi:10.1177/02537176261447652
“7,8 This is because research feasibility is a multidimensional construct; a practical, observable proxy is the frequency of process deviations or adverse events during the pilot phase.”
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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