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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Feasibility and Outcomes of a Psychocardiologic Retreat: A Trauma-Informed Intervention for Cardiovascular Risk Reduction
Youssef, M., Clay, S., Zaref, C., Harris, V. S., Clay, E., & Muchira, J. M. (2025) · The Journal of Cardiovascular Nursing · doi:10.1097/jcn.0000000000001257
Community-based Multimodal Rehabilitation Improves Function and Performance in Postural Orthostatic Tachycardia Syndrome (POTS)
Rich, E. M., Vas, A., Evetts, C. L., Kaplan-Smith, G., & Goodman, B. P. (2025) · Neurorehabilitation · doi:10.1177/10538135251395291
“In such cases, we relied on prior literature, previously described analyses, and clinical judgment to interpret relevance (Molino et al., 2022; Teresi et al., 2022) (cid:129) Additionally, qualitative feedback from participants supported perceived bene ﬁ t and acceptability, further underscoring…”
Electronic worksheet on global warming with ethno-socioscientific integration to promote deep learning
Rizal, H. P., Rahmadhani, A., Aira, C. D., & Tambing, A. A. (2025) · Indonesian Journal of Science and Mathematics Education · doi:10.24042/ijsme.v8i2.28659
Electronic worksheet on global warming with ethno-socioscientific issues integration to promote deep learning
Rizal, H. P., Rahmadhani, A., Aira, C. D., & Tambing, A. A. (2025) · Indonesian Journal of Science and Mathematics Education · doi:10.24042/ijsme.v8i3.28659
Telehealth-delivered person-centered support to increase physical activity through daily occupations in adults with chronic pain - a feasibility study
Nielsen, S. S., Christensen, J. R., Tang, L. H., Simonÿ, C., Skejø, S. D., & Skou, S. T. (2025) · Journal of Bodywork and Movement Therapies · doi:10.1016/j.jbmt.2025.09.028
Packaging-based visual-storytelling nudge to improve antibiotic adherence in uncomplicated urinary tract infection: a pilot randomized trial in Pakistan
Hussain, I., Xu, S., Dong, Y., Rasool, M. F., Ullah, J., Khan, A., Kadirhaz, M., Xu, M., Tang, C., Zhao, W. G., et al. (2025) · BMC Infectious Diseases · doi:10.1186/s12879-025-12246-x
“…for recruiting 30 participants for each arm (total n = 60), consistent with recommendations from methodological recommendations for pilot trials [25–27], which suggests sample sizes of approximately 12 to 35 participants per arm for pilot trials are typically sufficient to provide stable…”
Nursing Pipeline Program for High School Students in Career Technical Education: A Feasibility Pilot Study
Djukic, M., Miller, D. L., Hermosilla, A. M., Hulsey, S., & Pine, R. (2025) · Western Journal of Nursing Research · doi:10.1177/01939459251395389
“We designed this pilot feasibility study 34 to assess the feasibility of a nursing pipeline program involving high school students enrolled in CTE programs.”
Study Design Considerations
Savva, G. M., Ponsero, A. J., Adriaenssens, E. M., Hildebrand, F., & Carding, S. R. (2025) · Springer protocols handbooks/Springer protocols · doi:10.1007/978-1-0716-5009-7_2
An app-based physical activity intervention for people with hip and knee osteoarthritis: protocol for the PIANISSIMO feasibility study
Mura, M., Portugal, B., Mouton, C., Grimm, B. P., Seil, R., & Malisoux, L. (2025) · Pilot and Feasibility Studies · doi:10.1186/s40814-025-01744-z
“This protocol has been designed according to previously established guidelines [42].”
Internet-delivered cognitive behavioral therapy for pediatric functional abdominal pain disorders: Parental factors in treatment response
Nielsen, E. S., Kallesøe, K. H., Frostholm, L., Jønsson, I. M., Johansen, K. B., Lalouni, M., Bonnert, M., & Rask, C. U. (2026) · Internet Interventions · doi:10.1016/j.invent.2026.100941 · Cited by 1
Educational intervention effects on nurses’ knowledge, attitudes, and practice toward handling cytotoxic drugs in their workplace
Saker, M., Dayekh, A., Alrayshouni, Z., El‐Tassi, A., & Pakai, A. (2025) · BMC Nursing · doi:10.1186/s12912-025-04180-9
“This research underscores the significance of evaluating the practicality of implementing an educational intervention that has been successful in traditional settings and adapting it to a more diverse population [27, 28].”
Qualitative Analysis of Caregiver Experiences with a Child-Focused Intervention: Trauma-Informed Parenting Skills for Resource Parents (TIPS 4 RP)
Whitt‐Woosley, A., Sprang, G., & Gusler, S. (2025) · Journal of Child and Family Studies · doi:10.1007/s10826-025-03240-7
“Key domains of inter - est were established a priori based on the distinctive features of feasibility investigations and were used to develop the questions for the exit survey (National Institute for Health Research, 2012 ; Teresi et al., 2022 ).”
Commentary: Bridging the gap between emerging harms and evidence‐based care: a commentary on Bucci et al. (2025)
Steinberg, J. S., Toh, S. H. Y., Mair, P., & Weisz, J. R. (2025) · Child and Adolescent Mental Health · doi:10.1111/camh.70057
‘Thriving with bipolar disorder’: The co-design of a peer-delivered group psychoeducation program and single-arm pilot feasibility evaluation protocol
Morton, E. E., Kcomt, A., & Michalak, E. E. (2025) · PLoS ONE · doi:10.1371/journal.pone.0338306
“As per recommendations for pilot and feasibility studies, descriptive statistics will be used to characterise feasibility and acceptability [40,67].”
Additional file 2 of Psychoeducational group interventions for adults diagnosed with attention-deficit/ hyperactivity disorder: a scoping review of feasibility, acceptability, and outcome measures
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) · Figshare · doi:10.6084/m9.figshare.26074291
Additional file 3 of Psychoeducational group interventions for adults diagnosed with attention-deficit/ hyperactivity disorder: a scoping review of feasibility, acceptability, and outcome measures
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) · Figshare · doi:10.6084/m9.figshare.26736981
Additional file 2 of Systematic braiding of Smoke-Free Home SafeCare to address child maltreatment risk and secondhand smoke exposure: findings from a pilot study
Self‐Brown, S., Perry, E. W., Recinos, M., Cotner, M. A., Guastaferro, K., Owolabi, S., Spears, C. A., Whitaker, D. J., Huang, J., & Kegler, M. C. (2024) · Figshare · doi:10.6084/m9.figshare.26589048
Additional file 5 of Psychoeducational group interventions for adults diagnosed with attention-deficit/ hyperactivity disorder: a scoping review of feasibility, acceptability, and outcome measures
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) · Figshare · doi:10.6084/m9.figshare.26736987
Additional file 1 of The frail-LESS (LEss sitting and sarcopenia in frail older adults) remote intervention to improve sarcopenia and maintain independent living via reductions in sedentary behaviour: findings from a randomised controlled feasibility trial
Bailey, D. P., Harper, J. H., Kilbride, C., McGowan, L. J., Victor, C., Brierley, M. L., & Chater, A. (2024) · Figshare · doi:10.6084/m9.figshare.26974507
Additional file 2 of Evaluation of the usability and acceptability of the P-STEP® mobile app: feasibility study protocol
Worboys, H., Gray, L., Anthony, S., Hobson, R., Lucas, T. C. D., & Ng, A. (2024) · Figshare · doi:10.6084/m9.figshare.27019223
Additional file 1 of Can on-line gait training improve clinical practice? Study protocol for feasibility randomised controlled trial of an on-line educational intervention to improve clinician’s gait-related decision-making in ambulant children and young people with cerebral palsy
Hebda-Boon, A., Shortland, A. P., Birn‐Jeffery, A. V., & Morrissey, D. (2024) · Figshare · doi:10.6084/m9.figshare.25824741
Additional file 4 of The frail-LESS (LEss sitting and sarcopenia in frail older adults) remote intervention to improve sarcopenia and maintain independent living via reductions in sedentary behaviour: findings from a randomised controlled feasibility trial
Bailey, D. P., Harper, J. H., Kilbride, C., McGowan, L. J., Victor, C., Brierley, M. L., & Chater, A. (2024) · Figshare · doi:10.6084/m9.figshare.26974519
Additional file 1 of Sedentary behaviors and physical activity of the working population measured by accelerometry: a systematic review and meta-analysis
Park, S., Lee, S., Woo, S., Webster, K., Chen, W., Veliz, P., & Larson, J. L. (2024) · Figshare · doi:10.6084/m9.figshare.26758105
Additional file 2 of The frail-LESS (LEss sitting and sarcopenia in frail older adults) remote intervention to improve sarcopenia and maintain independent living via reductions in sedentary behaviour: findings from a randomised controlled feasibility trial
Bailey, D. P., Harper, J. H., Kilbride, C., McGowan, L. J., Victor, C., Brierley, M. L., & Chater, A. (2024) · Figshare · doi:10.6084/m9.figshare.26974510
Additional file 4 of Psychoeducational group interventions for adults diagnosed with attention-deficit/ hyperactivity disorder: a scoping review of feasibility, acceptability, and outcome measures
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) · Figshare · doi:10.6084/m9.figshare.26736984
Additional file 1 of Psychoeducational group interventions for adults diagnosed with attention-deficit/ hyperactivity disorder: a scoping review of feasibility, acceptability, and outcome measures
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) · Figshare · doi:10.6084/m9.figshare.26074063
Additional file 2 of Can on-line gait training improve clinical practice? Study protocol for feasibility randomised controlled trial of an on-line educational intervention to improve clinician’s gait-related decision-making in ambulant children and young people with cerebral palsy
Hebda-Boon, A., Shortland, A. P., Birn‐Jeffery, A. V., & Morrissey, D. (2024) · Figshare · doi:10.6084/m9.figshare.25824814
Additional file 2 of Sedentary behaviors and physical activity of the working population measured by accelerometry: a systematic review and meta-analysis
Park, S., Lee, S., Woo, S., Webster, K., Chen, W., Veliz, P., & Larson, J. L. (2024) · Figshare · doi:10.6084/m9.figshare.26758108
Additional file 3 of The frail-LESS (LEss sitting and sarcopenia in frail older adults) remote intervention to improve sarcopenia and maintain independent living via reductions in sedentary behaviour: findings from a randomised controlled feasibility trial
Bailey, D. P., Harper, J. H., Kilbride, C., McGowan, L. J., Victor, C., Brierley, M. L., & Chater, A. (2024) · Figshare · doi:10.6084/m9.figshare.26974516
Additional file 1 of Systematic braiding of Smoke-Free Home SafeCare to address child maltreatment risk and secondhand smoke exposure: findings from a pilot study
Self‐Brown, S., Perry, E. W., Recinos, M., Cotner, M. A., Guastaferro, K., Owolabi, S., Spears, C. A., Whitaker, D. J., Huang, J., & Kegler, M. C. (2024) · Figshare · doi:10.6084/m9.figshare.26589045
Additional file 1 of Evaluation of the usability and acceptability of the P-STEP® mobile app: feasibility study protocol
Worboys, H., Gray, L., Anthony, S., Hobson, R., Lucas, T. C. D., & Ng, A. (2024) · Figshare · doi:10.6084/m9.figshare.27019220
A preliminary investigation on digital surveillance literacy among dental academicians
Shukla, B., Panda, A., & Chari, D. N. (2025) · Revista Facultad de Odontología Universidad de Antioquia · doi:10.17533/udea.rfo.v37n2e361036
The Mediating Role of Internet of Things among Small and Medium-Sized Logistics Enterprises: A Pilot Study
Liu, Y., Mahidin, F. B. A. M. @., & bin Ismail, H. (2025) · International Conference on Management Science and Computer Engineering (MSCE) · doi:10.1145/3760023.3760063
“To ensure data accuracy, pilot studies serve as an effective instrument test, and their outcomes will inform subsequent data analysis in this research [18].”
Pilot testing
Gitlin, L. N., & Czaja, S. J. (2025) · Elsevier eBooks · doi:10.1016/b978-0-443-21664-0.00012-x
Co-design, feasibility and acceptability testing of a digital falls prevention programme (KOKU) for older adults: a mixed methods study (Preprint)Preprint
Stanmore, E., Fisher, K., Dewick, P. M., Choi, N., & Munford, L. A. (2025) · doi:10.2196/preprints.84368
Feasibility and Acceptability of Collaborative Augmented Reality for Older Adults and Companions: Protocol for a Randomized Controlled Trial
Sarkar, N., Tate, J. A., Tauseef, M., Ullal, A., Maxwell, C. A., Juckett, L., Scharre, D. W., Tan, A., Zhang, R., Ingram, Z., et al. (2025) · JMIR Research Protocols · doi:10.2196/83864
“Feasibility, defined as the practicality of conducting the study [64], was measured by observation and documentation of recruitment and retention rates, data completion, and session attendance (ie, intervention completion).”
Strong, Positive, and Resilient Kids (SPARK): Adaptation and Pilot of a Youth Wellness Program
Gerdes, A. C., & Scott, L. N. (2025) · Journal of Child and Family Studies · doi:10.1007/s10826-025-03246-1 · Cited by 1
“Feasibility of SPARK was determined by employ - ing pilot study guidelines related to the examination of data collection protocols, the maintenance of fidelity to the pro - gram, and the adherence and retention of students (Teresi et al., 2022).”
Influential
A community-based behavioural change intervention on the knowledge of herbal medicine use: pretest–posttest study
Tsele-Tebakang, T. (2025) · International Journal of Africa Nursing Sciences · doi:10.1016/j.ijans.2025.100960
Development, Feasibility, and Acceptability of a Culturally Tailored Telenovela for Puerto Rican Hospice Family Caregivers
Cruz-Oliver, D. M., Blinka, M. D., Sloan, D. H., Saylor, M. A., Reyes, J., Akid, I., Park, T., & Phongtankuel, V. (2025) · Hispanic Health Care International · doi:10.1177/15404153251407300
“This pilot study examined feasibility and acceptability; therefore, it was not appropriate to assess the effect sizes of the intervention (Teresi et al., 2022) due to small sample size.”
Enhancing Self-Regulated Learning Through an Academic Self-Regulation Program and Mobile App
Ham, P. (2025) · OTJR Occupational Therapy Journal of Research · doi:10.1177/15394492251400292
Community Support Network Rehabilitation Intervention Improves Cognitive Functions in Women Who Experienced Intimate Partner Violence-Caused Brain Injury: A Preliminary Study
Adhikari, S. P., McLennan, C., Kriitmaa, K., Rothlander, K., Mason, K., & van Donkelaar, P. (2025) · Women s Health Reports · doi:10.1177/26884844251405060
“12,28,29 Feedback and anecdotal information.”
Feasibility and potential effects of mental imagery training on subjective cognitive function and brain connectivity in people with Parkinson’s disease: A randomized pilot trial
Cherry, J., Nelson, A. M., Robinson, L. A., Goldstein, J., Vives‐Rodriguez, A., Sharp, E. S., & Tinaz, S. (2026) · Neuropsychological Rehabilitation · doi:10.1080/09602011.2025.2608220
“We determined the total sample size of 30 participants (15 in each group) in this pilot trial based on pragmatic considerations regarding recruitment within the set timeframe and budget constraints (Teresi et al., 2022).”
CarieCheck: An mHealth App for Caries-Risk Self-Assessment—User-Perceived Usability and Quality in a Pilot Study
Guerreiro, E., Souza, G., Mendes, J. J., Manso, A. C., & Botelho, J. (2026) · Dentistry Journal · doi:10.3390/dj14010031
“According to current methodological guidelines, pilot studies aiming to test procedures or acceptability may adequately operate with samples of around 30 participants, as they are not intended to estimate effect sizes or perform inferential analyses [20,21].”
Optimizing Measurement Parameters for Ocular Surface Temperature Assessment Using ResearchIR Software
Monfared, M., & Murphy, P. J. (2026) · Translational Vision Science & Technology · doi:10.1167/tvst.15.1.3
“31,32 In the present study, each participant underwent repeated testing across multiple IBIs and ocular surface locations, generating a large number of individual measurements.”
Feasibility of a Psychoeducational Intervention for Empowering Parents to Optimise Feeding Practices in China: A Randomised Controlled Feasibility Trial
Wang, J., Chang, Y., Wei, X., Cao, Y. H., & Winkley, K. (2026) · Maternal and Child Nutrition · doi:10.1111/mcn.70155

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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