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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.”
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Wu, Y., Zhang, W., Li, X., Zhang, X., Zheng, X., & Chang, H. (2026) · Geriatric Nursing · doi:10.1016/j.gerinurse.2026.104126
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“…non-participation by ensuring that enrollees are eligible and understand their responsibilities [25]; identify adaptations necessary for the intervention to maximize participation and fidelity; and plan how to maintain contact with recruits and incentivize their continued participation [44, 45].”
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Choi, E., Roth, M. E., Hacker, E. D., Li, Y., & Lü, Q. (2026) · JMIR Research Protocols · doi:10.2196/93460 · Cited by 1
“%) completion rate would have a half-width of approximately 15.5% (or 17.9% in the worst-case scenario), which is acceptable for estimating feasibility [45,46].”
InfluentialChen, K., Gou, C., Wu, Z., & Guo, L. (2026) · Supportive Care in Cancer · doi:10.1007/s00520-026-10887-5
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Parthasarathy, S., Sauer, C., Horowitz, B., & Victorson, D. E. (2026) · Global Advances in Integrative Medicine and Health · doi:10.1177/27536130261459352
“45 We also calculated Cohen’s d effect size coefficients ( M 1 -”
Keramati, M., Abadi, M. R. H., & Kontulainen, S. A. (2026) · PLoS ONE · doi:10.1371/journal.pone.0349290
“Likewise, our mean adherence rate of 90% was comparable to the 78–80% range reported by Weber et al. [61] and exceeded the minimum acceptable adherence threshold of 70% recommended by the National Center for Complementary and Integrative Health [58].”
Autistic Adult Online Interoception Feasibility Pilot Program
Graziosi, S. G. S., Oliver, E., Arline, V., Mahler, K., Ratcliff, K., Pryor, L., & Hilton, C. L. (2026) · Occupational Therapy International · doi:10.1155/oti/4437761
“…to examine whether it is feasible to conduct an online program to address interoception in autistic adults while determining the appropriateness of the evaluation tools used and testing the intervention on a small number of participants before conducting a larger study using the intervention [53].”
Grew, J., Gøtzsche, N., Broberg, L., & Schiøtz, M. L. (2026) · BMC Pediatrics · doi:10.1186/s12887-026-07172-z
“The selection of feasibility domains, outcomes, instruments, and progression criteria was informed by published guidance on feasibility and pilot studies in public health interventions [13, 22, 23, 28].”
Dong, K., & Abdullah, B. (2026) · Life · doi:10.3390/life16061036
“Other studies in the field of exercise training have also noted that the sample size for pilot studies typically ranges from 6 to 15 participants [24].”
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“The sample size of 23 patients is consistent with published guidance on pilot study methodology, which supports the use of smaller samples when the primary aim is to assess feasibility and generate preliminary data rather than to test hypotheses definitively [31–33].”
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“A recommended first step is to investigate the feasibility of a planned intervention, in accordance with accepted criteria for study design [23,24].”
Poudel, R. R., Thapa, D., Singh, J., Maharjan, B., & Dhungel, B. (2026) · Charak Journal of Health Research · doi:10.5005/cjhr-11037-0024
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“Feasibility outcomes and progression criteria were drafted following several rounds of discussions and informed by the existing literature (45, 60, 61) and trialists ’ experience.”
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The value of pilot and feasibility studies in nursing education research: a worked example
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“This pattern is consistent with broader digital health research, where early-stage pilot studies frequently prioritize feasibility and user experience over clinical or population-level impact [86].”
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“Furthermore, we consider that participant retention through the screening process (even after failing to achieve a sufficient score) is indicative of the HCAT’s feasibility and applicability [43].”
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“The planned sample size is 50 participants, with 1:1 allocation to probiotic or placebo groups (26, 29).”
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“24”
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“This sample size was consistent with prior feasibility and qualitative studies in similar populations (34–41), with the goal of reaching information saturation for qualitative outcomes.”
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“(Leon et al., 2011; Proctor et al., 2011; Teresi et al., 2022).”
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Belogianni, K., Gil-Salmerón, A., Schiffler, T., Gawronska, J., Gómez-Trenado, R., Tabaki, I., Μουδάτσου, Μ., Smith, L., Alhambra‐Borrás, T., Blanes-Selva, V., et al. (2026) · European Journal of Public Health · doi:10.1093/eurpub/ckag119
“These considerations are particularly important for populations facing health disparities and complex needs, as they help identify necessary adaptations for this specific population [27].”
Carpenter, K., Hunter‐Mullis, K., Berlin, H., Uluturk, C., Salmon, E. E., Jain, N., & Davis, J. M. (2026) · doi:10.2196/preprints.109599
Khaliliyan, H., Vaziri, A. S., Bahramizadeh, M., Zare, A., Ansari, M., Mehrpour, S. R., Nabian, M. H., Tahmasebi, M., Jouibari, M. F., Karimpour, M., et al. (2026) · Bioengineering · doi:10.3390/bioengineering13080925
“…in the VAS score following a TENS intervention [38], and considering a statistical power of 0.60, representing the minimum acceptable level for pilot studies, and a significance level of α = 0.10 to account for constraints in participant availability [39], the required sample size was determined.”
InfluentialDeterminants of Sustainable Water Supply Among Urban Households in Kakamega Municipality, Kenya
Makisiki, M. F., Rutto, R., & Mungai, A. (2026) · Journal of Business and Social Review in Emerging Economies · doi:10.26710/jbsee.v12i2.3901
Acupressure and hypnosis in arterial hypertension: a series of N-of-1 trials
Ortiz, M., Schreiner, M. M., Volz, N., Tissen‐Diabaté, T., Jansen, E., Siewert, J., Teut, M., & Brinkhaus, B. (2026) · Frontiers in Medicine · doi:10.3389/fmed.2026.1871793
“Feasibility was considered in relation to the patients` recruitment, treatment - specific adherence and retention, adherence to the randomized sequence and treatment-specific fidelity rates (22, 23).”
Schwartz, S., Libman, A. E., Lee, D., Naimi, A., & Ogunsakin, O. A. (2026) · Research Square · doi:10.21203/rs.3.rs-10720111/v1
El-Gabalawy, R. M., Sabourin, B. C., Tkachuk, G. A., Logan, G. S., Penner, K. E., Shay, B. L., Bilevicius, E., Graff, L. A., Skrabek, R. Q., Senn, J., et al. (2026) · Canadian Journal of Pain · doi:10.1080/24740527.2026.2696248
“44,45 The sample size was determined pragmatically based on recruitment capacity, available resources, and timelines rather than being powered to detect efficacy outcomes.”
Safety and feasibility of telesurgical robot assisted radical prostatectomy: prospective pilot study
Naeyer, G. D., Beatrici, E., Barretta, A., Frego, N., Peñaranda, N. R., Pepillo, F., Guidotti, A., de ANGELIS, M., Cei, F., Brancelli, C., et al. (2026) · British Journal of Urology · doi:10.1111/bju.70430
“Given the exploratory pilot design and limited sample size, analyses were primarily descriptive, and the clinically matched on-site cohort was included to provide clinical context for the interpretation of perioperative outcomes rather than to establish comparative effectiveness [15].”
Culturally Relevant Heart Health Program for Older African American Women of Rural Areas
Andrabi, M. S., Key, B. A., Ovabor, K., Lin, C., Mumba, M. N., Shah, A., & Ball, K. (2026) · Journal of Transcultural Nursing · doi:10.1177/10436596261478074
Zeb, A., Neven, A., Burtin, C., Janssens, L., Peters, B., Schyvens, A.-M., Oost, N. C. V., Meus, T., Timmermans, A. A. A., & Verbrugghe, J. (2026) · Applied Sciences · doi:10.3390/app16178353
Guede-Rojas, F., Bello-Díaz, J., Flores-Leal, K., Oporto-Ruiz, Y., Riquelme-Briones, M., Vera-Angulo, R., Ulloa-Díaz, D., Jerez‐Mayorga, D., & Carvajal-Parodi, C. (2026) · International Journal of Human-Computer Interaction · doi:10.1080/10447318.2026.2719185
Papadakis, Z., & Stamatis, A. (2026) · Frontiers in Sports and Active Living · doi:10.3389/fspor.2026.1902953
“This pilot serves primarily as an empirical benchmark for the sample sizes and effect magnitudes future replications should plan around (13, 18, 84, 99, 138, 158, 159).”
InfluentialHearne, S., Lavan, A. H., & Davies, A. (2026) · Research Square · doi:10.21203/rs.3.rs-10279708/v1
Brown, A., Verma, S., Varma, P., Gibson, R. H., & Jackson, M. L. (2026) · Geriatric Nursing · doi:10.1016/j.gerinurse.2026.104302
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“…feasibility studies, which suggest that samples of approximately 50-60 participants are common and adequate for evaluating key feasibility outcomes such as recruitment, retention, intervention adherence, and acceptability, particularly when multiple feasibility indicators are of interest [21,22].”
Meier, N. F., Møller, M. H., Kjær, M. N., Sjövall, F., Munch, M. W., Kaas‐Hansen, B. S., Thorsen‐Meyer, H., Rasmussen, B. S., Helleberg, M., Hertz, F. B., et al. (2026) · Acta Anaesthesiologica Scandinavica · doi:10.1111/aas.70324
“The sample size for the feasibility phase was determined based on practical considerations [15], sample sizes in other pilot/feasibility trials [16] and the expected precision of the feasibility outcome estimates [17].”
Blocker, A., Biyabani, A., Mwangama, J., Datay, M. I., & Malila, B. (2026) · JMIR Human Factors · doi:10.2196/84272
“Quantitative data from surveys are reported but not statistically analyzed due to the small sample size and nature of the study design [46].”
Shin, Y.-J., Park, S., Ha, I., Jang, J.-S., Yim, M. H., Ku, B. U., Lee, S., Suh, H. S., Lee, Y.-W., Heo, I., et al. (2026) · Healthcare · doi:10.3390/healthcare14172788
Laranjo, S. M., Cunha, P. S., Guede-Fernández, F., Oliosi, E., Contins, R. C., Dias, P., Silva, C., Félix, A. C., Oliveira, M. M., & Londral, A. R. M. (2026) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2026.1755777
“Both the directional hypothesis and the 5 70% threshold are consistent with adherence benchmarks for feasibility pilots (27) and with retention and engagement rates reported in a comparable cardiovascular RPM intervention (e.g., 71% – 94% sustained activity/survey completion over six months) (28).”
Coulibaly, L. P., Laberge, M., Guay, M., Séguin‐Tremblay, N., Langlois, P., Paradis, I., Nadeau, J. P., Jobidon, M., Chamard, R., & Latulippe, K. (2026) · JMIR Research Protocols · doi:10.2196/84680
“A nonprobability convenience sampling method will be used [18].”
Reinhard, A.-K., Hauck, S., Lehnert, K., Lehnert, B., Brakemeier, E., & Wurm, S. (2026) · BMJ Open · doi:10.1136/bmjopen-2026-120224
Day, M. R., Wood, C., Corker, E., Pearson, N., Scargill, K., & Freeth, M. (2026) · Autism · doi:10.1177/13623613261480736
“Following guidelines for designing and evaluating feasibility pilot studies (NCCIH, 2025; Teresi et al., 2022), we chose the target sample size of 20 to be feasible and within the budgetary constraints of the project.”
Cunningham‐Erves, J., Hull, P. C., Dempsey, A. F., Koyama, T., Sun, L., Chalise, M., Stewart, E. C., Jones, J. L., Landsittel, D. P., Smalls, M., et al. (2026) · JMIR Cancer · doi:10.2196/78910
“We followed guidelines of Teresi et al [47] to assess various aspects of feasibility in our pilot study.”
Elphinston, R. A., Formosa, J., Armfield, N. R., van der Vegt, A. H., Ashton-James, C. E., Brain, K., Buckley, L., Papic, C., Khan, A., Eather, C.-E., et al. (2026) · BMJ Open · doi:10.1136/bmjopen-2026-123039
Schütz, M., Henriksson, I., Ulfarsson, T., & Schalling, E. (2026) · Aphasiology · doi:10.1080/02687038.2026.2725582
Luk, Y., Fung, M. M., Lui, D. T. W., & Lang, B. H. (2026) · Surgery · doi:10.1016/j.surg.2026.110653
Duong, V. N., Thompson, C., McVeigh, J. A., & Quested, E. (2026) · Research Quarterly for Exercise and Sport · doi:10.1080/02701367.2026.2733279
Nasif, J., Chong, A. S. S., & Ahmad, M. (2026) · Behavioral Sciences · doi:10.3390/bs16091682
“The sample size was based on pilot-study feasibility rather than a formal power calculation (Teresi et al., 2022).”
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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