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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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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].”
The Impact of Language Complexity on Consumer Comprehension and Retention
Al-Badawi, M. A. (2024) · Studies in systems, decision and control · doi:10.1007/978-3-031-73545-5_71 · Cited by 29
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“Formal tests of health outcomes and attempts to obtain valid estimates of effect sizes are not statistically justified for pilot studies [59 –64 ] due to smaller sample sizes and design adjustments necessary to maximize recruitment, retention, and other outcomes.”
Berry, E. C. J., Sculthorpe, N. F., Warner, A., Mather, J. D., Sanal‐Hayes, N. E. M., & Hayes, L. D. (2025) · Frontiers in Aging · doi:10.3389/fragi.2025.1516481 · Cited by 25
Park, S., Lee, S., Woo, S., Webster, K., Chen, W., Veliz, P. T., & Larson, J. L. (2024) · BMC Public Health · doi:10.1186/s12889-024-19449-y · Cited by 21
“…sample threshold of 75 to capture studies that potentially had more heterogeneous samples within occupational groups; this choice was based on Teresi et al.’s (2023) recommendation that sample sizes of 70 to 100 per group should be required for detection of group differences in pilot studies [24].”
BackgroundBailey, D. P., Harper, J. H., Kilbride, C., McGowan, L. J., Victor, C. R., Brierley, M. L., & Chater, A. (2024) · BMC Geriatrics · doi:10.1186/s12877-024-05310-9 · Cited by 21
“In line with pilot and feasibility study guidelines [30, 31], this was considered to be appropriate for generating a SD and determining the feasibility, acceptability and safety of the trial and intervention.”
BackgroundMethodInfluentialWatkins, J. M., Brunnemer, J. E., Heeter, K. N., Medellin, A. M., Churchill, W. C., Goss, J. M., Hobson, J. M., Werner, N. E., Weaver, R. G., Kercher, V. M. M., et al. (2024) · BMC Public Health · doi:10.1186/s12889-024-19356-2 · Cited by 18
“This modest sample size could potentially constrain the generalizability of findings and hinder the statistical examination of effect size, as well as limit the scope of exploratory analyses [49].”
BackgroundSuchánek, P., & Kŕaĺová, M. (2025) · Journal of Innovation & Knowledge · doi:10.1016/j.jik.2025.100781 · Cited by 21
Cochran, G., Smid, M. C., Krans, E. E., Yu, Z., Carlston, K., White, A., Abdulla, W., Baylis, J. D., Charron, E. M., Okifugi, A., et al. (2023) · Addiction · doi:10.1111/add.16364 · Cited by 17
Suglo, J. N., Winkley, K., & Sturt, J. A. (2024) · PLoS ONE · doi:10.1371/journal.pone.0302385 · Cited by 21
Raza, F. A., Singh, A. D., Kovilpillai, J. J. S., Hamdan, A., & Rajaratnam, V. (2025) · European Journal of STEM Education · doi:10.20897/ejsteme/17307 · Cited by 16
“Conducting a pilot study was deemed crucial for refining the instrument’s clarity and reliability prior to large-scale distribution, particularly in a multinational setting where linguistic nuances can influence understanding (Aschbrenner et al., 2022; Teresi et al., 2022).”
Sood, E., Nees, S. N., Srivastava, S., Ng, S., Torres, C., Osorio, A. M., Canter, K. S., Braley, K. T., Spradley, L., Stein, J., et al. (2023) · Pediatric Cardiology · doi:10.1007/s00246-023-03209-7 · Cited by 15
Yang, N., Wang, Y., Wei, Z., & Wu, F. (2025) · Cartography and Geographic Information Science · doi:10.1080/15230406.2025.2531055 · Cited by 15
“We conducted a user study with 60 participants (P1-P60) aged between 18 and 44 years, a sample size determined based on relevant research conclusions to ensure result reliability (Julious, 2005; Lancaster et al., 2004; Teresi et al., 2022).”
Augmented Intelligence Framework for Human–Artificial Intelligence Teaming in Cybersecurity
Malatji, M. (2025) · Human-Centric Intelligent Systems · doi:10.1007/s44230-025-00103-8 · Cited by 18
“Pilot studies test the feasibility of methods and procedures for larger-scale studies [106].”
Liu, S., Li, M., Ding, J., Ji, Q., Niu, Y., Yang, X. Y., Ai, S., & Li, S. (2025) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2025.07.004 · Cited by 13
Armas-Salazar, A., Téllez-León, N., García-Jerónimo, A. I., Villegas-López, F. A., Navarro-Olvera, J. L., & Carrillo-Ruiz, J. D. (2022) · Pain Research and Management · doi:10.1155/2022/5660462 · Cited by 13
Ong, A. D., Wilcox, K. T., Moskowitz, J. T., Wethington, E., Addington, E. L., Sanni, M. O., Kim, P., & Reid, M. C. (2023) · Innovation in Aging · doi:10.1093/geroni/igad070 · Cited by 13
“…feasibility and acceptability of the methods and procedures to be used in a larger, fully powered trial of LARKSPUR, the sample size was chosen based on feasibility indicators rather than formal power calculations for tests of between-group differences (Teresi et al., 2022; Whitehead et al., 2016).”
MethodLongitudinal changes in objective sleep parameters during pregnancy
Guo, Y., Xu, Q., Dutt, N. D., Kehoe, P., & Qu, A. (2023) · Women s Health · doi:10.1177/17455057231190952 · Cited by 13
Crocetti, E., Lise, F. D., Pagano, M., Bobba, B., Maratia, F., Meeus, W., & Bacaro, V. (2024) · Identity · doi:10.1080/15283488.2024.2394861 · Cited by 13
“For instance, it would be valuable to understand participants’ acceptance of these interventions, the challenges involved in recruiting and training professionals to deliver them, the fidelity of the treatment, and the overall resources needed (Teresi et al., 2022).”
Kupcu, C., Bodur, G., Küçükkaya, A., & Göktaş, P. (2024) · Nurse Education in Practice · doi:10.1016/j.nepr.2024.104179 · Cited by 14
Maddison, R., Nourse, R. A., Daryabeygi‐Khotbehsara, R., Tegegne, T. K., Jansons, P., Rawstorn, J. C., Atherton, J. J., Driscoll, A. L., Oldenburg, B. F., Vasa, R., et al. (2025) · JMIR Research Protocols · doi:10.2196/62964 · Cited by 14
Kim, Y., Seo, G., Koopman, J. J. E., & Yee, J. (2025) · Clinical & Experimental Allergy · doi:10.1111/cea.70125 · Cited by 12
“The cutoff of 10 was chosen to ensure adequate statistical power and to avoid instability from small sample sizes based on previous literature [14, 15].”
Skliarova, T., Pedersen, H., Holsbrekken, Å., Pedersen, S. A., Mandal, A., Cuevas, C. D. L., Havnen, A., Gråwe, R. W., & Lara‐Cabrera, M. L. (2024) · BMC Psychiatry · doi:10.1186/s12888-024-05908-8 · Cited by 14
“…recommended methodology guidelines for scoping reviews [47] and conforms with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) [49] and the frameworks for reporting the feasibility [50] and acceptability of health interventions [51].”
BackgroundMethodSchaab, B. L., Cunha, L. F., Silveira, D. C., da Silva, P. C., Ballejos, K. G., Diaz, G. B., Kaiser, V., Calvetti, P. Ü., Cazella, S. C., Barros, H. M. T., et al. (2024) · Frontiers in Psychology · doi:10.3389/fpsyg.2024.1414948 · Cited by 16
“Consequently, methodological guidelines propose the prior evaluation of indicators, such as the initial benefits of the intervention, its acceptability, interest, and participant’s satisfaction (Lancaster, 2015; Teresi et al., 2022).”
BackgroundDeGroot, L. G., Gillette, R. A., Villalobos, J. P., Harger, G., Doyle, D. T., Bull, S. S., Bekelman, D. B., Boxer, R. S., Kutner, J. S., & Portz, J. D. (2024) · BMC Palliative Care · doi:10.1186/s12904-024-01561-w · Cited by 12
“Third, recent guidelines suggest that potentially a minimum sample of 70 participants is required to examine the feasibility on process outcomes such as acceptance and participation rates [55].”
Backgroundde Graaff, A. M., Habashneh, R., Fanatseh, S., Keyan, D., Akhtar, A., Abualhaija, A., Faroun, M., Aqel, I. S., Dardas, L. A., Servili, C., et al. (2024) · JMIR Mental Health · doi:10.2196/63515 · Cited by 24
“We aimed to recruit 60 participants (30 in each condition; cf [24]) through IFH peer educators (educators and volunteers at IFH who provide health-related information to youth through various activities), universities, and online advertising on Facebook and Instagram.”
Hruska, B. J., Piccirillo, M. L., Lenferink, L. I. M., Pacella‐LaBarbara, M. L., Contractor, A. A., Price, M., & Greene, T. (2025) · European Journal of Psychotraumatology · doi:10.1080/20008066.2025.2477423 · Cited by 12
“To determine which sampling design is most appropriate, trauma EMA researchers should consult past research to determine the expected frequency of their focal variables or perform a pilot study to estimate these parameters (Teresi et al., 2022).”
Herrera, Y. M., Vadiveloo, M. K., Blau, S., Oaks, B. M., Quashie, N. T., & Tovar, A. (2024) · Appetite · doi:10.1016/j.appet.2024.107647 · Cited by 11
Eliacin, J., Burgess, D. J., Rollins, A. L., Patterson, S. M., Damush, T. M., Bair, M. J., Salyers, M. P., Spoont, M. R., Chinman, M., Slaven, J. E., et al. (2023) · Translational Behavioral Medicine · doi:10.1093/tbm/ibad027 · Cited by 12
Efendiev, K. T., Shiryaev, A., Rakhmanova, A., Pisareva, T., Mamedova, A., Ивановна, С. С., Reshetov, I. V., Skobeltsin, A., Krivetskaya, A. A., Ryabova, A. V., et al. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26178640 · Cited by 10
“Formal power calculations are not required in pilot studies; the sample size is chosen based on the goal of practicing the procedure, assessing tolerability, identifying possible technical problems, and obtaining initial data for a larger subsequent study [83].”
Johnson, G. U., Towell‐Barnard, A., McLean, C., & Ewens, B. A. (2024) · Nursing in Critical Care · doi:10.1111/nicc.13210 · Cited by 11
Pedestrian Perceptions of Sidewalk Paving Attributes: Insights from a Pilot Study in Braga
da Fonseca, F. P., Rodrigues, A., & da Silva, H. M. R. D. (2025) · Infrastructures · doi:10.3390/infrastructures10040079 · Cited by 13
Raizman, R., Ramírez-GarcíaLuna, J. L., Newaz, T., Wang, S. C., Berry, G. K., Kong, L. Y., Mohammed, H. T., & Fraser, R. D. J. (2025) · Journal of Participatory Medicine · doi:10.2196/69470 · Cited by 10
“According to established feasibility study guidelines, sample sizes of 30 or fewer participants may be appropriate for qualitative feasibility studies [16].”
Binion, K., Rode, A. U., Nortey, G., Miller, A., Misseri, R., Kaefer, M. A., Ross, S. S., Preisser, J. S., Hu, D., & Chan, K. H. (2023) · Journal of Pediatric Urology · doi:10.1016/j.jpurol.2023.01.018 · Cited by 10
Mulawa, M. I., Hoare, J., Knippler, E. T., Mtukushe, B., Matiwane, M., Muessig, K. E., Al-Mujtaba, M., Wilkinson, T. H., Platt, A. C., Egger, J. R., et al. (2023) · JMIR Research Protocols · doi:10.2196/47137 · Cited by 10
Croff, R. L., Aron, S., Wachana, A., Fuller, P., Mattek, N., Towns, J., & Kaye, J. A. (2024) · The Gerontologist · doi:10.1093/geront/gnae019 · Cited by 9
Islam, M. T., Herjanto, H., Kumar, J., & Amin, M. (2025) · Tourism Review International · doi:10.3727/194344225x17315216888907 · Cited by 15
Smith, J. A., van der Groen, O., & Learmonth, Y. C. (2023) · International Journal of Qualitative Methods · doi:10.1177/16094069231180162 · Cited by 12
“The idea of assessing multiple aspects of feasibility (Bowen et al., 2009; Craig et al., 2008; Medical Research Council), has recently been updated and advocated within the latest guidelines (Teresi et al., 2022).”
BackgroundMethodInfluentialImplementation of hospital-based sickle cell newborn screening and follow-up programs in Haiti
Alvarez, O. A., Dély, N. S. V., Hanna, M. P., Fleur, R. S., Cetoute, M., Metalonis, S. W., Hustace, T., Brown, E. C., Marcelin, L. H., Muscadin, E., et al. (2023) · Blood Advances · doi:10.1182/bloodadvances.2023010104 · Cited by 9
Santini, S., Merizzi, A., Caciula, I., Azevedo, M. J., Hera, A., Napradean, L., Rosa, M. D., & Quattrini, S. (2024) · Frontiers in Psychology · doi:10.3389/fpsyg.2024.1327272 · Cited by 9
Watkins, J. M., Goss, J. M., Major, M. G., Kwaiser, M. M., Medellin, A. M., Hobson, J. M., Kercher, V. M. M., & Kercher, K. A. (2024) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph21070913 · Cited by 10
“This e ff ect size was chosen to align with the scope of a feasibility study and to ensure that meaningful di ff erences could be detected without overestimating the e ff ect [36].”
MethodSeery, C., Leonard-Curtin, A., Naismith, L., King, N., O'Donnell, F., Byrne, B., Boyd, C., Kilbride, K., Wrigley, M., McHugh, L., et al. (2024) · BJPsych Open · doi:10.1192/bjo.2024.743 · Cited by 8
“SPSS version 28 for Mac OS 30 was used to clean the data, conduct pre-liminary analysis, analyse missing data, and conduct multiple imputation and hypothesis testing.”
BackgroundMethodCenit-García, J., Buendia-Gilabert, C., Contreras-Molina, C., Puente‐Fernández, D., Castillo, R. F., & García‐Caro, M. P. (2024) · Healthcare · doi:10.3390/healthcare12040420 · Cited by 10
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The impact of restaurant safety measures on customer revisit intentions in the post-covid era
Kumar, J., Islam, M. T., Mehmood, W., & Sangaran, G. (2024) · Journal of Foodservice Business Research · doi:10.1080/15378020.2024.2423108 · Cited by 8
“The questionnaire was then subjected to a pilot test involving 30 respondents, confirming its robustness and appropriateness for the intended research (Teresi et al., 2022).”
Moyen, A., Keane, C., Chen, Y., Tahasildar, B., Lambert, G., Drummond, K., Carli, F., & Gillis, C. (2025) · Clinical Nutrition ESPEN · doi:10.1016/j.clnesp.2025.01.024 · Cited by 8
Turkstra, L. S., Ray, M. R., LeBlanc, M., Lu, L. H., Curtiss, G., Bowles, A. O., Eapen, B. C., & Cooper, D. B. (2025) · American Journal of Speech-Language Pathology · doi:10.1044/2024_ajslp-24-00306 · Cited by 8
Vestin, M., Wallin, L., Naesström, M., Blomqvist, I., Svedin, C. G., Beaumont, E., Jokinen, J., & Dennhag, I. (2025) · Frontiers in Psychology · doi:10.3389/fpsyg.2025.1547046 · Cited by 8
“It was also important to assess whether the CFT leaders found the intervention acceptable and if they were able to deliver it as intended, and to identify any difficulties in implementing program elements or other challenges (Teresi et al., 2022).”
Dávidovics, A., Dávidovics, K., Hillebrand, P., Rendeki, S., & Németh, T. (2025) · BMC Medical Education · doi:10.1186/s12909-025-08507-7 · Cited by 12
“Recent methodological literature emphasizes that pilot studies are exploratory in nature and not designed primarily for hypothesis testing, therefore, formal power calculations or inferential analyses are not required [30, 31].”
Liu, J., Ito, S., Ngo, T. M., Lawate, A., Ong, Q. C., Fox, T. E., Chang, S. Y., Phung, D., Nair, E., Palaiyan, M., et al. (2024) · Digital Health · doi:10.1177/20552076241241244 · Cited by 8
“56,57 The feasibility of the study procedure measured the following: (a) recruitment rate (as calculated by the percentage of people who agree to participate in the study among those who are approached and are eligible to participate); (b) retention rate (as calculated by the percentage of…”
MethodGyldenvang, H. H., Piil, K., Dahl, T. H., Paulsen, T. G., Finecke, C. E. C. V. B., Mathiesen, U. B., Møller, T., & Andersen, C. (2025) · European Journal of Oncology Nursing · doi:10.1016/j.ejon.2025.102807 · Cited by 8
Martorella, G., Hanley, A. W., Tong, H., Miao, H., Worts, P. R., Bellamy, D., & Ahn, H. B. (2024) · Mindfulness · doi:10.1007/s12671-024-02329-2 · Cited by 7
“Regarding feasibility and acceptability, we set the following benchmarks (National Center for Complementary and Integrative Health, 2023; Teresi et al., 2022): at least 80% of participants in the experimental group will complete the 4 weekly sessions as well as the post-treatment assessment.”
Pontiroli, A. E., Dino, G. D., Capra, F., & Pozza, G. (1990) · PubMed · Cited by 8
Ong, A. D., Moskowitz, J. T., Wethington, E., Addington, E. L., Sanni, M. O., Goktas, S., Sluys, E., Swong, S., Kim, P., & Reid, M. C. (2022) · PsyArXiv (OSF Preprints) · doi:10.1016/j.cct.2022.106880 · Cited by 8
“…assess the feasibility of methods and procedures to be used in a larger, fully powered trial of LARKSPUR, sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power calculations, as appropriate for the pilot nature of the study [see 90].”
MethodClarifying the Importance of Pilot Studies
Morin, K. H. (2023) · Journal of Nursing Education · doi:10.3928/01484834-20230712-03 · Cited by 8
vanDellen, M. R., Wright, J. W. C., Zhao, B., Cullinan, C. A., Beach, S. R. H., Shen, Y., Haskins, L. B., Schiavone, W. M., & MacKillop, J. M. (2023) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntad183 · Cited by 7
Brooks, D., Wyles, K., Pachana, N. A., Beattie, E., & Gaugler, J. E. (2024) · BMC Geriatrics · doi:10.1186/s12877-024-04907-4 · Cited by 7
“• Multiple outcomes are acceptable for use in feasibility studies, to help ascertain acceptability of measures for use in a future full scale RCT [38].”
BackgroundSkliarova, T., Gråwe, R., Vaag, J., Mandahl, A., Kolltveit, I., Løvås, I., Torgersen, T., & Lara-Cabrera, M. (2025) · BMC Psychiatry · doi:10.1186/s12888-025-06570-4 · Cited by 6
“Based on the 2022 guidelines by Teresi et al. [39], feasibility was evaluated across the following domains: Consent to participate (1) was established in advance, with feasibility set at 50% of eligible patients accepting participation.”
Methodological challenges in pilot trials of herbal medicine: barriers to evidence-based practice
Li, Y., Xu, Z., Du, P., Gao, J., Wang, S., Pang, X., Ren, C., Liu, Y., & Zhang, C. (2025) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2025.111754 · Cited by 7
Wu, V. S., Smith, A. B., Russell, H., Bamgboje‐Ayodele, A., Beatty, L., Pearce, A. M., Dhillon, H. M., Shaw, J., Antony, J., Fardell, J. E., et al. (2025) · BMC Cancer · doi:10.1186/s12885-025-13639-6 · Cited by 8
“They help determine whether the intervention is feasible for individuals from the new population to engage with, acceptable in content and format, and safe to use [31].”
Increasing Uptake of Lung Cancer Screening Among Emergency Department Patients: A Pilot Study
Adler, D. H., Wood, N. E., Fiscella, K. A., Rivera, M. P., Hernandez‐Romero, B., Chamberlin, S., & Abar, B. W. (2024) · Journal of Emergency Medicine · doi:10.1016/j.jemermed.2024.03.034 · Cited by 10
Oladayo, A., Lawal, F. B., Sofola, O. O., Uti, O. G., Oyapero, A., Aborisade, A., Olujitan, M., Fagbule, O. F., Williams, A. T., Dedeke, A., et al. (2025) · International Dental Journal · doi:10.1016/j.identj.2025.100891 · Cited by 14
Lawson, G. M., Owens, J. S., Mandell, D. S., Tavlin, S., Rufe, S. A., Lyon, A. R., Eiraldi, R. B., & Power, T. J. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01381-4 · Cited by 8
“These sample sizes were selected to be consistent with guidelines for pilot studies to determine the feasibility of recruiting participants, collecting outcome data, and retaining participants in the protocol [34].”
MethodMoscato, S., Orlandi, S., Gregorio, F. D., Lullini, G., Pozzi, S., Sabattini, L., Chiari, L., & Porta, F. L. (2023) · BMJ Open · doi:10.1136/bmjopen-2023-073534 · Cited by 12
“However, the decision to include at least 15 participants is in line with the previous literature on pilot and feasibility study design, based on practical considerations 41 as well as the specific aims of this study.”
Barroso-Hurtado, M., López-Durán, A., Martínez-Vispo, C., Suárez-Castro, D., & Becoña, E. (2024) · Internet Interventions · doi:10.1016/j.invent.2024.100737 · Cited by 6
Matthews, N. L., Mitchell, M. M., Honda, H., Malligo, A., Boyd, S., Pagni, B. A., & Blair Braden, B. (2025) · Autism · doi:10.1177/13623613251328484 · Cited by 9
Chong, Y. Y., Chien, W. T., Mou, H., Ip, C. K., & Bressington, D. T. (2024) · Schizophrenia Research · doi:10.1016/j.schres.2024.11.007 · Cited by 9
Sevinc, G., Knox, K., George, M., Evans, L. M., Kaiser, A. J. E., Paltell, K. C., Myers, L. S., Ludwig, N. N., Wojnaroski, M., Conecker, G., et al. (2024) · Value in Health · doi:10.1016/j.jval.2024.12.004 · Cited by 6
Lei, Y., Li, Z., Bui, Q. V. P., DePaul, O., Nicol, G. E., Mohr, D. C., Fong, M. W. M., Metts, C. L., Lee, S. I., Tomazin, S. E., et al. (2025) · Topics in Stroke Rehabilitation · doi:10.1080/10749357.2025.2450950 · Cited by 6
“52 However, consistent with a comparable mobile health post-stroke intervention study, 53 the sample size of 10 per group was the target number.”
Lapid, M. I., Pagali, S. R., Basso, M. R., Croarkin, P. E., Geske, J. R., Huston, J., Islam, K., Joseph, B., Kennebeck, W. W., Kang, D., et al. (2025) · Pilot and Feasibility Studies · doi:10.1186/s40814-025-01625-5 · Cited by 7
“Similar studies have included sample sizes of fewer than 30 participants [51].”
Swallow, V. M., Horsman, J. M., Mazlan, E., Campbell, F., Zaidi, R., Julian, M., Branchflower, J., Martin-Kerry, J., Monks, H., Soni, A., et al. (2025) · JMIR Diabetes · doi:10.2196/74032 · Cited by 6
“As this was a feasibility study, a power calculation was not required, and significance was not calculated because of the small sample size [14].”
Castanho, L., Martinho, D. V., Saial, A. C., de Gouveia, B. R. F. O., Gouveia, É. R., & Ribeiro, F. (2025) · Applied Psychophysiology and Biofeedback · doi:10.1007/s10484-025-09730-0 · Cited by 10
“This provides relevant data to inform possible improvements and increase the success (Teresi et al., 2022).”
Salve, J., Kale, S., Prajapati, B. L., Sparavigna, A., Savant, M., Ademola, J., & Langade, D. (2025) · Phytotherapy Research · doi:10.1002/ptr.70096 · Cited by 11
Koskan, A. M., Larkey, L., Todd, M. W., & Kim, S. W. (2024) · PLoS ONE · doi:10.1371/journal.pone.0299787 · Cited by 6
“Formal and informal testing of intervention efficacy testing is inappropriate in feasibility studies as is the derivation of effect size estimates [34–37].”
BackgroundGrant, S. J., Kay, S., Lacey, J., Kumar, S. S., Kerin‐Ayres, K., Stehn, J. R., Gonzalez, M., Templeton, S., Heller, G. Z., Cockburn, J., et al. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-080239 · Cited by 6
Oladayo, A., Lawal, F. B., Sofola, O. O., Uti, O. G., Oyapero, A., Aborisade, A., Stewart, B., Daep, C. A., Hines, D., Beard, J., et al. (2024) · Frontiers in Public Health · doi:10.3389/fpubh.2024.1398869 · Cited by 6
“For the feasibility of pilot studies, research has shown that a sample size consisting of 30 participants in a group is sufficient (44, 45).”
Mitropoulos, A., Anifanti, M., Koukouvou, G., Ntovoli, A., Alexandris, K., & Kouidi, E. J. (2024) · BMC Sports Science Medicine and Rehabilitation · doi:10.1186/s13102-024-00992-5 · Cited by 7
“The sample size calculation for our study estimated the critical metrics needed to assess the feasibility of conducting the definitive study, with sufficient precision [27].”
Kaul, U., Scher, C. J., Henderson, C., Kim, P., Dyhrberg, M., Rudin, V., Lytle, M., Bundy, N., & Reid, M. C. (2022) · Frontiers in Pain Research · doi:10.3389/fpain.2022.921428 · Cited by 6
Virtual Reality as an Innovative Tool for Youth Mental Health
Blondell, V. J., & Thomson, N. D. (2025) · Encyclopedia · doi:10.3390/encyclopedia5040215 · Cited by 6
“Furthermore, because these early feasibility and pilot studies traditionally have smaller sample sizes [107], the majority of existing studies supporting the use of VR for adolescent mental health are based on limited samples.”
Chua, S. H., Rajasegeran, D. D., Gunasegaran, N., Fan, P. E. M., Mei, D., Oo, F. A., Nagalingam, S., Lee, T. T., Ng, L. J. K., Yong, S. L. B., et al. (2024) · Journal of Tissue Viability · doi:10.1016/j.jtv.2024.05.011 · Cited by 5
Lai, B. W., Wright, A., Hutchinson, B., Bright, L., Young, R., Davis, D., Malik, S. A., Rimmer, J. H., & Pelham High Community Engagement Group (2025) · JMIR Formative Research · doi:10.2196/65801 · Cited by 6
“This feasibility study aimed to recruit a convenient sample of 12 participants, which is a general recommendation for exploratory studies targeting implementation process metrics [21], as opposed to group-effect comparisons that would need larger samples [22].”
Khan, A., & Madihie, A. (2025) · Journal of EMDR Practice and Research · doi:10.34133/jemdr.0005 · Cited by 5
RetractedKang, G., Ji, H., & Yoon, J. Y. (2025) · BMC Nursing · doi:10.1186/s12912-025-03372-7 · Cited by 10
Pang, T. Y., Cheng, C., Feltham, F. G., Rahman, A., McCarney, L., & Rodriguez, C. Q. (2025) · Biosensors · doi:10.3390/bios15100698 · Cited by 5
“According to Teresi et al. [53] feasibility studies should prioritize estimating outcomes such as protocol completion and acceptability, rather than hypothesis testing.”
Wang, B., Zeng, X., Deng, H., Qiu, B., Xu, K., Tao, M., Zhang, Y., Zheng, H., Xu, Q., Li, S., et al. (2026) · Metabolism · doi:10.1016/j.metabol.2026.156677 · Cited by 6
Rognsvåg, T., Bergvad, I. B., Furnes, O. N., Indrekvam, K., Lerdal, A., Lindberg, M. F., Skou, S. T., Stubberud, J., & Badawy, M. (2024) · Pilot and Feasibility Studies · doi:10.1186/s40814-024-01470-y · Cited by 6
“Thus, a sample of less than 30 may be adequate [29].”
BackgroundLoy, M. H., & Fatato, T. (2024) · Global Advances in Integrative Medicine and Health · doi:10.1177/27536130241283789 · Cited by 5
Pagán, A. F., Ortiz, M., Bernal, E., Loveland, K. A., Esparza, A., Montiel‐Nava, C., & Acierno, R. E. (2025) · Journal of Developmental and Physical Disabilities · doi:10.1007/s10882-025-10008-w · Cited by 4
Dhumal, T., Scott, V., Powers, R. L., & Kelly, K. M. (2023) · Journal of the American Pharmacists Association · doi:10.1016/j.japh.2023.09.004 · Cited by 5
Sousa, H., Ribeiro, Ó. M., Bártolo, A., Costa, E. M., Ribeiro, F., Rodrigues, M., Paúl, C., & de Figueiredo, D. M. P. (2024) · British Journal of Health Psychology · doi:10.1111/bjhp.12715 · Cited by 5
Hanley, A. W., Zingg, R. W., Smith, B., Zappa, M., White, S., Davis, A., Worts, P. R., Culjat, C., & Martorella, G. (2024) · Journal of Integrative and Complementary Medicine · doi:10.1089/jicm.2024.0020 · Cited by 5
“34 This recommendation guided our sample size in Study 3.”
InfluentialKolck, J., Hosse, C., Leimbach, A., Beetz, N. L., Auer, T. A., Collettini, F., Fehrenbach, U., Pille, C., & Geisel, D. (2024) · European journal of medical research · doi:10.1186/s40001-024-01884-7 · Cited by 6
“It is recognized that for such feasibility studies, sample sizes of 30 individuals per group (here survival vs. non-survival) are considered appropriate [3].”
BackgroundPinto, B. M., Patel, A., Ostendorf, D. M., Huebschmann, A. G., DUNSIGER, S. I., & Kindred, M. M. (2024) · JMIR Research Protocols · doi:10.2196/52494 · Cited by 5
“According to the current recommendations [46], we will consider webMFT feasible if >75% of the scheduled calls are delivered and survivor and coach and acceptability or satisfaction exceed 80% on rating scales (ratings of “moderately” to “very satisfied/acceptable”).”
MethodMatos, L. A., & Lujan, R. A. (2023) · Hispanic Health Care International · doi:10.1177/15404153231210436 · Cited by 5
Kim, M., Patrick, K., Nebeker, C., Godino, J., Stein, S., Klasnja, P., Perski, O., Viglione, C., Coleman, A., & Hekler, E. B. (2022) · doi:10.31219/osf.io/8t5xy · Cited by 5
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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