Should treatment effects be estimated in pilot and feasibility studies?

Sim, Julius

doi:10.1186/s40814-019-0493-7

Cited by 123Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsStatistical Methods in Epidemiology

Should treatment effects be estimated in pilot and feasibility studies?

Open access

Sim, Julius·2019·Pilot and Feasibility Studies

DOI 10.1186/s40814-019-0493-7PMC PMC6712606

Open this paper in CoChat — free account Open PDF

Abstract

BACKGROUND: Feasibility studies and external pilot studies are used increasingly to inform planning decisions related to a definitive randomized controlled trial. These studies can provide information on process measures, such as consent rates, treatment fidelity and compliance, and methods of outcome measurement. Additionally, they can provide initial parameter estimates for a sample size calculation, such as a standard deviation or the 'success' rate for a binary outcome in the control group. However, the issue of estimating treatment effects in pilot or feasibility studies is controversial. METHODOLOGICAL DISCUSSION: Between-group estimates of treatment effect from pilot studies are sometimes used to calculate the sample size for a main trial, alongside estimated standard deviations. However, whilst estimating a standard deviation is an empirical matter, a targeted treatment effect should be established in terms of clinical judgement, as a minimum important difference (MID), not through analysis of pilot data. Secondly, between-group effects measured in pilot studies are sometimes used to indicate the magnitude of an effect that might be obtained in a main trial, and a decision on progression made with reference to the associated confidence interval. Such estimates will be imprecise in typically small pilot studies and therefore do not allow a robust decision on a main trial; both a decision to proceed and a decision not to proceed may be made too readily. Thirdly, a within-group change might be estimated from a pilot or a feasibility study in a desire to assess the potential efficacy of a novel intervention prior to testing it in a main trial, but again such estimates are liable to be imprecise and do not allow sound causal inferences. CONCLUSION: Treatment effects calculated from pilot or feasibility studies should not be the basis of a sample size calculation for a main trial, as the MID to be detected should be based primarily on clinical judgement rather than statistics. Deciding on progression to a main trial based on these treatment effects is also misguided, as they will normally be imprecise, and may be biased if the pilot or feasibility study is unrepresentative of the main trial.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

Integrity signals

Registry

Crossref · 10.1186/s40814-019-0493-7

Cites

31 of 32 references verified1 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Hypothesis testing in pilot studies, particularly for effectiveness/efficacy of clinical outcomes, has been widely criticised due to the improper purpose and lack of statistical power of such evaluations.
“Hypothesis testing in pilot studies, particularly in the context of effectiveness/efficacy of clinical outcomes, has been widely criticised due to the improper purpose and lack of statistical power of such evaluations [2, 20, 21, 23].”
From Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! (2021) · cites this paper as [23]

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

A tutorial on pilot studies: the what, why and how
Thabane, L., Ma, J., Chu, R., Cheng, J., Ismaila, A., Rios, L. P., Robson, R., Thabane, M., Giangregorio, L., & Goldsmith, C. H. (2010) · BMC Medical Research Methodology · doi:10.1186/1471-2288-10-1 · Cited by 3,384 · see citing works
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 · see citing works
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 · see citing works
Fundamentals of Clinical Trials
Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015) · doi:10.1007/978-3-319-18539-2 · Cited by 2,237 · see citing works
Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable
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 · cited 1× · see citing works
“They may also function to estimate parameters required for a sample size calculation, such as the standard deviation of a continuous outcome measure [5, 6], or possibly the control group proportion for a binary”
Background
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 · see citing works
Defining feasibility and pilot studies in preparation for randomised controlled trials: development of a conceptual framework
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 · see citing works
What is a pilot or feasibility study? A review of current practice and editorial policy
Arain, M., Campbell, M. J., Cooper, C. L., & Lancaster, G. A. (2010) · BMC Medical Research Methodology · doi:10.1186/1471-2288-10-67 · Cited by 1,483 · see citing works
The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency
Sim, J., & Lewis, M. (2012) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2011.07.011 · Cited by 1,036 · see citing works
Self-citation
. Caution regarding the use of pilot studies to guide power calculations for study proposals.
Kraemer, H. C., Mintz, J., Noda, A., Tinklenberg, J., & Yesavage, J. A. (2006) · Archives of General Psychiatry · doi:10.1001/archpsyc.63.5.484 · Cited by 702 · see citing works
The statistical interpretation of pilot trials: should significance thresholds be reconsidered?
Lee, E. C., Whitehead, A. L., Jacques, R. M., & Julious, S. A. (2014) · BMC Medical Research Methodology · doi:10.1186/1471-2288-14-41 · Cited by 423 · see citing works
Understanding controlled trials: Baseline imbalance in randomised controlled trials
Roberts, C., & Torgerson, D. J. (1999) · BMJ · doi:10.1136/bmj.319.7203.185 · Cited by 287 · see citing works
Questions asked and answered in pilot and feasibility randomized controlled trials
Shanyinde, M., Pickering, R. M., & Weatherall, M. (2011) · BMC Medical Research Methodology · doi:10.1186/1471-2288-11-117 · Cited by 229 · see citing works
The design and interpretation of pilot trials in clinical research in critical care
Arnold, D. M., Burns, K. E. A., Adhikari, N. K. J., Kho, M. E., Meade, M. O., & Cook, D. J. (2008) · Critical Care Medicine · doi:10.1097/ccm.0b013e3181920e33 · Cited by 214 · see citing works
The Distinction Between Randomized Clinical Trials (RCTs) and Preliminary Feasibility and Pilot Studies: What They Are and Are Not
Abbott, J. H. (2014) · Journal of Orthopaedic & Sports Physical Therapy · doi:10.2519/jospt.2014.0110 · Cited by 204 · see citing works
DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial
Cook, J. A., Julious, S. A., Sones, W., Hampson, L. V., Hewitt, C., Berlin, J. A., Ashby, D., Emsley, R., Fergusson, D. A., Walters, S. J., et al. (2018) · Trials · doi:10.1186/s13063-018-2884-0 · Cited by 197 · see citing works
How big should the pilot study for my cluster randomised trial be?
Eldridge, S. M., Costelloe, C. E., Kahan, B. C., Lancaster, G. A., & Kerry, S. M. (2016) · Statistical Methods in Medical Research · doi:10.1177/0962280215588242 · Cited by 135 · see citing works
Sample size re‐estimation in clinical trials
Proschan, M. A. (2009) · Biometrical Journal · doi:10.1002/bimj.200800266 · Cited by 132 · see citing works
Pitfalls in reporting sample size calculation in randomized controlled trials published in leading anaesthesia journals: a systematic review
Abdulatif, M., Mukhtar, A. M., & Obayah, G. M. (2015) · British Journal of Anaesthesia · doi:10.1093/bja/aev166 · Cited by 84 · see citing works
Eccentric calf muscle training compared with therapeutic ultrasound for chronic Achilles tendon pain—A pilot study
Chester, R., Costa, M. L., Shepstone, L., Cooper, A., & Donell, S. T. (2007) · Manual Therapy · doi:10.1016/j.math.2007.05.014 · Cited by 73 · see citing works
The Physiotherapy for Femoroacetabular Impingement Rehabilitation STudy (physioFIRST): A Pilot Randomized Controlled Trial
Kemp, J., Coburn, S. L., Jones, D. M., & Crossley, K. (2018) · Journal of Orthopaedic and Sports Physical Therapy · doi:10.2519/jospt.2018.7941 · Cited by 69 · see citing works
Tai chi for well-being of breast cancer survivors with aromatase inhibitor-associated arthralgias: a feasibility study.
Galantino, M. L., Callens, M. L., Cardena, G. J., Piela, N. L., & Mao, J. J. J. (2013) · PubMed · Cited by 56 · see citing works
Where have all the pilot studies gone? A follow-up on 30 years of pilot studies in Clinical Rehabilitation
Kaur, N., Figueiredo, S. M., Bouchard, V., Moriello, C., & Mayo, N. E. (2017) · Clinical Rehabilitation · doi:10.1177/0269215517692129 · Cited by 51 · see citing works
Moving statistics beyond the individual clinical trial: applying decision science to optimize a clinical development plan
Julious, S. A., & Swank, D. J. (2005) · Pharmaceutical Statistics · doi:10.1002/pst.149 · Cited by 40 · see citing works
The Nonuse, Misuse, and Proper Use of Pilot Studies in Experimental Evaluation Research
Westlund, E., & Stuart, E. A. (2016) · American Journal of Evaluation · doi:10.1177/1098214016651489 · Cited by 39 · see citing works
Acupuncture for Treatment of Uncontrolled Pain in Cancer Patients
Garcia, M. K., Driver, L., Haddad, R., Lee, R. T., Palmer, J. L., Wei, Q., Frenkel, M. A., & Cohen, L. G. (2013) · Integrative Cancer Therapies · doi:10.1177/1534735413510558 · Cited by 37 · see citing works
Methods for Specifying the Target Difference in a Randomised Controlled Trial: The Difference ELicitation in TriAls (DELTA) Systematic Review
Hislop, J., Adewuyi, T. E., Vale, L. D., Harrild, K., Fraser, C. M., Gurung, T., Altman, D. G., Briggs, A. H., Fayers, P. M., Ramsay, C. R., et al. (2014) · PLoS Medicine · doi:10.1371/journal.pmed.1001645 · Cited by 36 · see citing works
A randomized controlled pilot study to obtain the best estimate of the size of the effect of a thermoplastic resting splint on spasticity in the stroke-affected wrist and fingers
Sheehan, J., Winzeler‐Mercay, U., & Mudie, M. H. (2006) · Clinical Rehabilitation · doi:10.1177/0269215506071267 · Cited by 28 · see citing works
Comparing the effects of whole-body vibration to standard exercise in ambulatory people with Multiple Sclerosis: a randomised controlled feasibility study
Uszynski, M., Purtill, H., Donnelly, A., & Coote, S. B. (2015) · Clinical Rehabilitation · doi:10.1177/0269215515595522 · Cited by 17 · see citing works
A feasibility randomised controlled trial of acupressure to assist spontaneous labour for primigravid women experiencing a post-date pregnancy
Mollart, L. J., Skinner, V., & Foureur, M. J. (2016) · Midwifery · doi:10.1016/j.midw.2016.02.020 · Cited by 10 · see citing works
Thiazide diuretic-caused hyponatremia in the elderly hypertensive: will a bottle of Nepro a day keep hyponatremia and the doctor away? Study protocol for a proof-of-concept feasibility trial
Ruzicka, M., McCormick, B. B., Magner, P. O. C., Ramsay, T., Edwards, C., Bugeja, A. L., & Hiremath, S. S. (2018) · Pilot and Feasibility Studies · doi:10.1186/s40814-018-0263-y · Cited by 4 · see citing works
Untitled work
Lancaster (2004) · doi:10.1111/j.2002.384.doc.x

Flagged first, then by citations

Sorted by citations

Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!
Lewis, M., Bromley, K., Sutton, C. J., McCray, G., Myers, H. L., & Lancaster, G. A. (2021) · Pilot and Feasibility Studies · doi:10.1186/s40814-021-00770-x · Cited by 330 · see citing works
A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020
Totton, N., Lin, J., Julious, S. A., Chowdhury, M., & Brand, A. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01416-w · Cited by 160 · see citing works
Incorporating feasibility protocols in intervention research
Gadke, D. L., Kratochwill, T. R., & Gettinger, M. (2020) · Journal of School Psychology · doi:10.1016/j.jsp.2020.11.004 · Cited by 140 · see citing works
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 65 · see citing works
Determining sample size for pilot trials: a tutorial
Ying, X., Freedland, K. E., Powell, L. H., Stuart, E. A., Ehrhardt, S., & Mayo‐Wilson, E. (2025) · BMJ · doi:10.1136/bmj-2024-083405 · Cited by 57 · see citing works
Feasibility and potential efficacy of a guided internet- and mobile-based CBT for adolescents and young adults with chronic medical conditions and comorbid depression or anxiety symptoms (youthCOACHCD): a randomized controlled pilot trial
Geirhos, A., Domhardt, M., Lunkenheimer, F., Temming, S., Holl, R. W., Minden, K., Warschburger, P., Meissner, T., Mueller-Stierlin, A. S., & Baumeister, H. (2022) · BMC Pediatrics · doi:10.1186/s12887-022-03134-3 · Cited by 37 · see citing works
Mental health specialist video consultations versus treatment-as-usual for patients with depression or anxiety disorders in primary care: randomized controlled feasibility trial.
Tönnies, J., Hartmann, M., Wensing, M., Szecsenyi, J., Peters-Klimm, F., Brinster, R., Weber, D., Vomhof, M., Icks, A., Friederich, H.-C., et al. (2021) · JMIR Mental Health · doi:10.2196/22569 · Cited by 40 · see citing works
Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse: the EMPOWER feasibility cluster RCT
Gumley, A. I., Bradstreet, S., Ainsworth, J. D., Allan, S., Álvarez‐Jiménez, M., Birchwood, M. J., Briggs, A. H., Bucci, S., Cotton, S., Engel, L., et al. (2022) · Health Technology Assessment · doi:10.3310/hlze0479 · Cited by 37 · see citing works
ACT with CF: A telehealth and in-person feasibility study to address anxiety and depressive symptoms among people with cystic fibrosis
O'Hayer, C. V., O'Loughlin, C. M., Nurse, C. N., Smith, P. J., & Stephen, M. J. (2021) · Journal of Cystic Fibrosis · doi:10.1016/j.jcf.2020.11.013 · Cited by 34 · see citing works
A physical activity intervention to improve the quality of life of patients with a stoma: a feasibility study protocol
Hubbard, G., Beeken, R. J., Taylor, C., Watson, A. J. M., Munro, J., & Goodman, W. (2019) · Pilot and Feasibility Studies · doi:10.1186/s40814-019-0461-2 · Cited by 26 · see citing works
Feasibility and Effectiveness of Self-Management Education and Coaching on Patient Activation for Managing Cancer Treatment Toxicities
Howell, D., Pond, G. R., Bryant‐Lukosius, D., Powis, M., McGowan, P., Makuwaza, T., Kukreti, V., Rask, S., Hack, S., & Krzyzanowska, M. K. (2023) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2022.7095 · Cited by 24 · see citing works
Integrating the Digital and the Traditional to Deliver Therapy for Depression
Stawarz, K., Preist, C., Tallon, D., Thomas, L., Turner, K. M., Wiles, N., Kessler, D. S., Shafran, R., & Coyle, D. (2020) · CHI Conference on Human Factors in Computing Systems · doi:10.1145/3313831.3376510 · Cited by 24 · see citing works
A Brief Online Implicit Bias Intervention for School Mental Health Clinicians
Liu, F. F., Coifman, J., McRee, E., Stone, J., Law, A., Gaias, L. M., Reyes, R., Lai, C., Blair, I., Yu, C.-L., et al. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph19020679 · Cited by 16 · see citing works
Pilot Trial Characteristics, Postpilot Design Modifications, and Feasibility of Full-Scale Trials
Ying, X., & Ehrhardt, S. (2023) · JAMA Network Open · doi:10.1001/jamanetworkopen.2023.33642 · Cited by 20 · see citing works
A physical activity intervention to improve the quality of life of patients with a stoma: a feasibility study
Hubbard, G., Taylor, C., Watson, A. J. M., Munro, J., Goodman, W., & Beeken, R. J. (2020) · Pilot and Feasibility Studies · doi:10.1186/s40814-020-0560-0 · Cited by 23 · see citing works
Precision Implementation: An Approach to Mechanism Testing in Implementation Research
Frank, H. E., Kemp, J. J., Benito, K., & Freeman, J. B. (2022) · Administration and Policy in Mental Health and Mental Health Services Research · doi:10.1007/s10488-022-01218-x · Cited by 20 · see citing works
Reducing cardiovascular disease risk among families with familial hypercholesterolaemia by improving diet and physical activity: a randomised controlled feasibility trial
Kinnear, F. J., Lithander, F. E., Searle, A., Bayly, G. R., Wei, C. H., Stensel, D. J., Thackray, A. E., Hunt, L. P., & Hamilton-Shield, J. P. (2020) · BMJ Open · doi:10.1136/bmjopen-2020-044200 · Cited by 17 · see citing works
Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey
Hagström, J., Woodford, J., von Essen, A., Lähteenmäki, P. M., & von Essén, L. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-056758 · Cited by 17 · see citing works
Treating patients with severe mental illness with narrative exposure therapy for comorbid post-traumatic stress disorder
Mauritz, M. W., van Gaal, B. G. I., Goossens, P. J. J., Jongedijk, R. A., & Vermeulen, H. (2020) · BJPsych Open · doi:10.1192/bjo.2020.124 · Cited by 16 · see citing works
Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions
von Klinggraeff, L., Dugger, R., Okely, A. D., Lubans, D. R., Jago, R., Burkart, S. A., Weaver, R. G., Armstrong, B., Pfledderer, C. D., & Beets, M. W. (2022) · Pilot and Feasibility Studies · doi:10.1186/s40814-022-00991-8 · Cited by 17 · see citing works
Home-Based Preoperative Exercise Training for Lung Cancer Patients Undergoing Surgery: A Feasibility Trial
Machado, P., Pimenta, S., Garcia, A. L., Nogueira, T., Silva, S., Oliveiros, B., Martins, R. A., & Cruz, J. (2023) · Journal of Clinical Medicine · doi:10.3390/jcm12082971 · Cited by 18 · see citing works
A feasibility investigation of mindfulness-based cognitive therapy for people with Huntington’s disease
Eccles, F. J. R., Craufurd, D., Smith, A. M. S., Davies, R., Glenny, K., Homberger, M., Peeren, S., Rogers, D., Rose, L., Skitt, Z., et al. (2020) · Pilot and Feasibility Studies · doi:10.1186/s40814-020-00631-z · Cited by 16 · see citing works
The influence of the simulation environment on teamwork and cognitive load in novice trauma professionals at the emergency department: Piloting a randomized controlled trial
Lapierre, A., Lavoie, P., Castonguay, V., Lonergan, A.-M., & Arbour, C. (2023) · International Emergency Nursing · doi:10.1016/j.ienj.2022.101261 · Cited by 16 · see citing works
A randomised controlled feasibility study of interpersonal art psychotherapy for the treatment of aggression in people with intellectual disabilities in secure care
Hackett, S., Zubala, A., Doorn, K. A., Chadwick, T. J., Harrison, T. L., Bourne, J., Freeston, M. H., Jahoda, A. J., Taylor, J. L., Ariti, C. A., et al. (2020) · Pilot and Feasibility Studies · doi:10.1186/s40814-020-00703-0 · Cited by 15 · see citing works
HAPPi Kneecaps! A double‐blind, randomised, parallel group superiority trial investigating the effects of sHoe inserts for adolescents with patellofemoral PaIn: phase II feasibility study
O’Sullivan, I. C., Crossley, K. M., Kamper, S. J., van Middelkoop, M., Vicenzino, B., Smith, M. M. F., Menz, H. B., Smith, A. J., Tucker, K. J., O'Leary, K. T., et al. (2021) · Journal of Foot and Ankle Research · doi:10.1186/s13047-021-00498-0 · Cited by 14 · see citing works
Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): a randomised controlled pilot feasibility trial for low mood in acquired brain injury
Kusec, A., Murphy, F. C., Peers, P. V., Lawrence, C., Cameron, E., Morton, C., Bateman, A., Watson, P., & Manly, T. (2020) · Pilot and Feasibility Studies · doi:10.1186/s40814-020-00660-8 · Cited by 13 · see citing works
A pilot and feasibility study of a randomized clinical trial testing a self-compassion intervention aimed to increase physical activity behaviour among people with prediabetes
Signore, A., Jung, M. E., Semenchuk, B. N., Kullman, S. M., Tefft, O., Webber, S. C., Ferguson, L. J., Kowalski, K. C., Fortier, M., McGavock, J., et al. (2022) · Pilot and Feasibility Studies · doi:10.1186/s40814-022-01072-6 · Cited by 13 · see citing works
An Individual Cognitive Stimulation Therapy App for People With Dementia and Their Carers: Protocol for a Feasibility Randomized Controlled Trial
Kaur, H., Schneider, J. M., & Orrell, M. W. (2020) · JMIR Research Protocols · doi:10.2196/24628 · Cited by 13 · see citing works
A systematic review and meta-analysis of sample size methodology for traumatic hemorrhage trials
Ghossein, J., Fernando, S., Rochwerg, B., Inaba, K., Lampron, J., & Tran, A. (2023) · Journal of Trauma and Acute Care Surgery · doi:10.1097/ta.0000000000003944 · Cited by 11 · see citing works
Adaptation and Feasibility of the Mandarin Version of PEERS® for Autistic Adolescents
Lao, U., Li, Y., Bai, W., Wang, Y., Li, Y., Xie, Y., Huang, X., Zhu, H., & Zou, X. (2023) · Journal of Autism and Developmental Disorders · doi:10.1007/s10803-023-06056-w · Cited by 11 · see citing works
Sensory Stimulation of the Foot and Ankle Early Post-stroke: A Pilot and Feasibility Study
Aries, A., Pomeroy, V. M., Sim, J., Read, S. M., & Hunter, S. M. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2021.675106 · Cited by 11 · see citing works
Self-citation
Evaluating the impact of Community-Based Sociotherapy on social dignity in post-genocide Rwanda: study protocol for a cluster randomized controlled trial
Jansen, S., Niyonsenga, J., Ingabire, M. C., Jansen, A., Nzabonimpa, E., Ingabire, N., Kangabe, J., Sarabwe, E., Richters, A., Rutayisire, T., et al. (2022) · Trials · doi:10.1186/s13063-022-06994-3 · Cited by 10 · see citing works
A pragmatic feasibility trial of the Primary Care Intervention for PTSD: A health service delivery model to reduce health disparities for low-income and BIPOC youth
Ng, L. C., Miller, A. N., Bowers, G., Cheng, Y., Brigham, R., Tai, M. H., Smith, A. M., Mueser, K. T., Fortuna, L. R., & Coles, M. S. (2023) · Behaviour Research and Therapy · doi:10.1016/j.brat.2023.104310 · Cited by 10 · see citing works
Feasibility, Acceptability, and Potential Impact of a Novel mHealth App for Smokers Ambivalent About Quitting: Randomized Pilot Study
McClure, J. B., Heffner, J. L., Krakauer, C. A., Mun, S., Klasnja, P., & Catz, S. L. (2023) · JMIR mhealth and uhealth · doi:10.2196/46155 · Cited by 9 · see citing works
Multimodal agility-based exercise training (MAT) versus strength and endurance training (SET) to improve multiple sclerosis-related fatigue and fatigability during inpatient rehabilitation: a randomized controlled pilot and feasibility study [ReFEx]
Wolf, F., Nielsen, J., Saliger, J., Hennecken, E., Kröber, P., Eschweiler, M., Folkerts, A., Karbe, H., & Zimmer, P. (2023) · BMC Neurology · doi:10.1186/s12883-023-03436-8 · Cited by 10 · see citing works
Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial
Mosher, C. E., Seçinti, E., Kroenke, K., Helft, P. R., Turk, A. A., Loehrer, P. J., Sehdev, A., Al-Hader, A. A., Champion, V. L., & Johns, S. A. (2021) · Pilot and Feasibility Studies · doi:10.1186/s40814-021-00837-9 · Cited by 10 · see citing works
Principles of Experimental Design
Kaltenbach, H. (2021) · Statistics for biology and health · doi:10.1007/978-3-030-69641-2_1 · Cited by 10 · see citing works
The mysterious case of the disappearing pilot study: a review of publication bias in preliminary behavioral interventions presented at health behavior conferences
von Klinggraeff, L., Ramey, K. T., Pfledderer, C. D., Burkart, S. A., Armstrong, B., Weaver, R. G., & Beets, M. W. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01345-8 · Cited by 9 · see citing works
Re-evaluating the role of pilot trials in informing effect and sample size estimates for full-scale trials: a meta-epidemiological study
Ying, X., Robinson, K. A., & Ehrhardt, S. (2023) · BMJ Evidence-Based Medicine · doi:10.1136/bmjebm-2023-112358 · Cited by 9 · see citing works
Feasibility of a self-management intervention to improve mobility in the community after stroke (SIMS): A mixed-methods pilot study
Sahely, A., Sintler, C., Soundy, A., & Rosewilliam, S. (2024) · PLoS ONE · doi:10.1371/journal.pone.0286611 · Cited by 10 · see citing works
Sample size planning for pilot studiesPreprint
Tseng, C., & Sim, D. (2021) · arXiv (Cornell University) · doi:10.48550/arxiv.2105.05483 · Cited by 21 · see citing works
Feasibility and cost description of highly intensive rehabilitation involving new technologies in patients with post-acute stroke—a trial of the Swiss RehabTech Initiative
Schuster‐Amft, C., Kool, J., Möller, J. C., Schweinfurther, R., Ernst, M. J., Reicherzer, L., Ziller, C., Schwab, M. E., Wieser, S., Wirz, M., et al. (2022) · Pilot and Feasibility Studies · doi:10.1186/s40814-022-01086-0 · Cited by 8 · see citing works
Video-guided exercise after stroke: a feasibility randomised controlled trial
Kenny, M., Gilmartin, J., & Thompson, C. A. (2020) · Physiotherapy Theory and Practice · doi:10.1080/09593985.2020.1790072 · Cited by 8 · see citing works
No effect of nitrate-rich beetroot juice on microvascular function and blood pressure in younger and older individuals: a randomised, placebo-controlled double-blind pilot study
Rogerson, D., Mora, F. A. A., Young, J. S., & Klonizakis, M. (2022) · European Journal of Clinical Nutrition · doi:10.1038/s41430-022-01115-4 · Cited by 8 · see citing works
Distinctive aspects of consent in pilot and feasibility studies
Sim, J. (2021) · Journal of Evaluation in Clinical Practice · doi:10.1111/jep.13556 · Cited by 7 · see citing works
Self-citation
Extremity Exercise Program in Breast Cancer Survivors Suffering from Chemotherapy-Induced Peripheral Neuropathy: A Feasibility Pilot Study
Wu, C., Chan, Y., Yen, L.-Y., Chen, Y.-H., Lo, C., Tseng, L., & Wang, Y. (2022) · Healthcare · doi:10.3390/healthcare10040688 · Cited by 7 · see citing works
The feasibility of the adapted H-GRASP program for perceived and actual daily-life upper limb activity in the chronic phase post-stroke
Essers, B., Veerbeek, J. M., Luft, A. R., & Verheyden, G. (2024) · Disability and Rehabilitation · doi:10.1080/09638288.2024.2313121 · Cited by 7 · see citing works
Remote measurement based care (RMBC) interventions for mental health—Protocol of a systematic review and meta-analysis
Machleid, F., Michnevich, T., Huang, L., Schröder-Frerkes, L., Wiegmann, C., Muffel, T., & Kaminski, J. A. (2024) · PLoS ONE · doi:10.1371/journal.pone.0297929 · Cited by 7 · see citing works
Lessons learned from eight teams: The value of pilot and feasibility studies in self-management science
Danesh, V. C., Zuniga, J. A., Timmerman, G. M., Radhakrishnan, K., Cuevas, H. E., Young, C. C., Henneghan, A. M., Morrison, J., & Kim, M. T. (2020) · Applied Nursing Research · doi:10.1016/j.apnr.2020.151345 · Cited by 7 · see citing works
Feasibility of a blended therapy approach in the treatment of patients with inflammatory myopathies
Pfister, P. B., Knols, R. H., de Bie, R. A., & de Bruin, E. D. (2021) · Archives of Physiotherapy · doi:10.1186/s40945-021-00108-z · Cited by 7 · see citing works
A pilot randomized controlled double-blind trial of intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS) to improve memory in mild cognitive impairment (MCI): a study protocol
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 · see citing works
Protocol for a community-based digital storytelling pilot intervention to reduce Hispanic parents’ vaccine hesitancy to immunize their children against COVID-19
Koskan, A. M., Larkey, L., Todd, M. W., & Kim, S. W. (2024) · PLoS ONE · doi:10.1371/journal.pone.0299787 · Cited by 6 · see citing works
FLUID trial: a hospital-wide open-label cluster cross-over pragmatic comparative effectiveness randomised pilot trial comparing normal saline to Ringer’s lactate
McIntyre, L., Fergusson, D. A., McArdle, T., Fox‐Robichaud, A., English, S. W., Martin, C. M., Marshall, J. C., Cook, D. J., Graham, I. D., Hawken, S., et al. (2023) · BMJ Open · doi:10.1136/bmjopen-2022-067142 · Cited by 6 · see citing works
A website for pilot and feasibility studies: giving your research the best chance of success
Chan, C. L. (2019) · Pilot and Feasibility Studies · doi:10.1186/s40814-019-0522-6 · Cited by 6 · see citing works
Volunteering via Smart-Phone for People With Psychosis—Protocol of a Feasibility Trial
da Costa, M. P., & Groups, P. P. A. (2021) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2021.742202 · Cited by 5 · see citing works
A Mixed Methods Feasibility Study of Machine-Based Resistance Training With Prefrail Older Adults in Residential Care: The Keeping Active in Residential Elderly Trial II
Swales, B., Ryde, G. C., & Phillips, A. C. (2024) · Journal of Aging and Physical Activity · doi:10.1123/japa.2022-0170 · Cited by 5 · see citing works
Treatment Effect Estimates From Pilot Trials Are Unreliable
Troy, J. D., Neely, M. L., Pomann, G., Grambow, S. C., & Samsa, G. P. (2023) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2023.08.020 · Cited by 4 · see citing works
A wellbeing program to promote mental health in paediatric burn patients: Study protocol
Wickens, N., McGivern, L., Belinelo, P. D. G., Milroy, H., Martin, L. J., Wood, F. M., Bullman, I., van Rensburg, E. J., & Woolard, A. J. (2024) · PLoS ONE · doi:10.1371/journal.pone.0294237 · Cited by 4 · see citing works
Michigan Model for HealthTM Learning to Enhance and Adapt for Prevention (Mi-LEAP): protocol of a pilot randomized trial comparing Enhanced Replicating Effective Programs versus standard implementation to deliver an evidence-based drug use prevention curriculum
Eisman, A. B., Palinkas, L. A., Koffkey, C., Herrenkohl, T. I., Abbasi, U., Fridline, J., Lundahl, L. H., & Kilbourne, A. M. (2022) · Pilot and Feasibility Studies · doi:10.1186/s40814-022-01145-6 · Cited by 4 · see citing works
Usability and Feasibility Testing of an Atrial Fibrillation Educational Website with Patients Referred to an Atrial Fibrillation Specialty Clinic
Rush, K. L., Burton, L., Seaton, C. L., Loewen, P. S., O’Connor, B. P., Corman, K., Phillips, R., Moroz, L., & Andrade, J. G. (2023) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph20186792 · Cited by 4 · see citing works
Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol
Moradian, S., Krzyzanowska, M. K., Maguire, R., Kukreti, V., Amir, E., Morita, P. P., Liu, G., & Howell, D. (2020) · BMJ Open · doi:10.1136/bmjopen-2019-035648 · Cited by 4 · see citing works
Evaluation of Interventions: Feasibility, Efficacy and Effectiveness Trials
Kwakkenbos, L. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-818697-8.00219-3 · Cited by 5 · see citing works
A blended e-health intervention for improving functional capacity in elderly patients on haemodialysis: A feasibility study
Zemp, D. D., Pfister, P. B., Knols, R. H., Quadri, P., Bianchi, G., Giunzioni, D., Lavorato, S., Giannini, O., & de Bruin, E. D. (2022) · Frontiers in Digital Health · doi:10.3389/fdgth.2022.1054932 · Cited by 4 · see citing works
Set up and assessment of progression criteria for internal pilots: the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial example
Ainsworth, H. R., Marshman, Z., Whiteside, K., Sykes, D., Fairhurst, C. M., Turner, E., Chestnutt, I. G., Day, P. F., Dey, D., Elliott, L., et al. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01243-z · Cited by 3 · see citing works
Small numbers, big decisions: guidance for sample size in pilot trials
Lewis, M., Bromley, K., & Joseph, R. (2025) · BMJ · doi:10.1136/bmj.r1885 · Cited by 3 · see citing works
Assessing the effects of distinct biologic therapies on rheumatoid arthritis pain by nociceptive, neuropathic and nociplastic pain components: a randomised feasibility study
Ahmed, L., Biddle, K., Blundell, A., Koushesh, S., Kiely, P. D. W., Mein, G., Sedgwick, P. M., & Sofat, N. (2024) · Pilot and Feasibility Studies · doi:10.1186/s40814-024-01505-4 · Cited by 4 · see citing works
Pilot and feasibility trials in traditional Chinese medicine: a literature review of current practice
Li, G., Wu, D., Chen, X., Zeng, J., Li, Z., & Thabane, L. (2020) · Pilot and Feasibility Studies · doi:10.1186/s40814-020-00602-4 · Cited by 3 · see citing works
A Feasibility Study Investigating Mechanisms of Change in Public Mental Health Dialectical Behaviour Therapy Programmes
Frost, G., Strodl, E. S., Swannell, S., Macdonald, K., & Madson, K. (2023) · Behaviour Change · doi:10.1017/bec.2023.1 · Cited by 3 · see citing works
A protocol for a feasibility study of Cognitive Bias Modification training (IVY) countering fatigue in people with breast cancer
Geerts, J. A., Siemerink, E., Sniehotta, F. F., Loman, L. J. M., Bode, C., & Pieterse, M. E. (2024) · Pilot and Feasibility Studies · doi:10.1186/s40814-024-01571-8 · Cited by 3 · see citing works
A scoping review of insomnia treatments for people living with HIV
Miranda, J., Sidani, S., Côté, J., & Fredericks, S. (2021) · International Health Trends and Perspectives · doi:10.32920/ihtp.v1i1.1422 · Cited by 2 · see citing works
Neurofeedback Training for Managing Neuropathic Pain–Like Features in Chronic Musculoskeletal Pain: Protocol for an Open-Label Pilot Feasibility Clinical Trial
Bialostocki, L. S., Adhia, D. B., Mudiyanselage, D. R., Smith, M. L., Çakmak, Y. Ö., Ridder, D. D., Mani, R., & Mathew, J. (2025) · JMIR Research Protocols · doi:10.2196/78806 · Cited by 2 · see citing works
El Cálculo del Tamaño Muestral en Ciencias de la Salud: Recomendaciones y Guía Práctica
Fernández-Matías, R. (2023) · Journal of MOVE and Therapeutic Science · doi:10.37382/jomts.v5i1.915 · Cited by 4 · see citing works
Randomised controlled pilot and feasibility study of multimodal agility-based exercise training (MAT) versus strength and endurance training (SET) to improve multiple sclerosis-related fatigue and fatigability during inpatient rehabilitation (ReFEx): study protocol
Wolf, F., Nielsen, J., Saliger, J., Hennecken, E., Eschweiler, M., Folkerts, A., Karbe, H., & Zimmer, P. (2022) · BMJ Open · doi:10.1136/bmjopen-2022-062160 · Cited by 2 · see citing works
Optimising error rates in programmes of pilot and definitive trials using Bayesian statistical decision theory
Wilson, D. T., Hall, A., Brown, J. M., & Walwyn, R. E. A. (2025) · Statistical Methods in Medical Research · doi:10.1177/09622802251322987 · Cited by 1 · see citing works
WeChat-based Messaging and Behavioral Counseling for Smoking Cessation for People with HIV in China: a Randomized Controlled Pilot Trial
Huang, J., Yang, S., Xie, Z., Guo, B., Lan, Y., Li, Y., Jiang, Y., Forman, L. S., Lunze, K., Liang, B., et al. (2025) · AIDS and Behavior · doi:10.1007/s10461-025-04823-7 · Cited by 1 · see citing works
Pursuing Reduction in Fatigue After COVID-19 via Exercise and Rehabilitation (PREFACER): a protocol for a randomised feasibility trial
Billias, N., Pouliopoulou, D. V., Lawson, A., D’Alessandro, V., Bryant, D., Peters, S., Rushton, A. B., Miller, E., Brunton, L. K., McGuire, S., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2025-102112 · Cited by 1 · see citing works
Randomised controlled trials for the prevention of venous thromboembolism in critically ill patients: A systematic review of sample size methodologies
Bitonti, T. M., Durr, K. M., Fernando, S. M., Rochwerg, B. N., Carrier, M., Siegal, D. M., & Tran, A. (2025) · Anaesthesia and Intensive Care · doi:10.1177/0310057x251397167 · Cited by 1 · see citing works
Accounting for Pilot Study Uncertainty in Sample Size Determination of Randomized Controlled Trials
Shi, Y., Liu, F., Li, S., & Chen, J. (2020) · Statistics in Biopharmaceutical Research · doi:10.1080/19466315.2020.1831951 · Cited by 2 · see citing works
Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS)
Cadilhac, D. A.-M., Ross, A. G., Bagot, K. L., Blennerhassett, J. M., Kilkenny, M. F., Kim, J., Purvis, T. L., Barclay, K. M., Ellery, F., Morrison, J., et al. (2024) · Pilot and Feasibility Studies · doi:10.21203/rs.3.rs-3708649/v1 · Cited by 1 · see citing works
Quantitative results of SonoSpeech Cleft Pilot: a mixed-methods pilot randomised control trial of ultrasound visual biofeedback versus standard intervention for children with cleft palate ± cleft lip
Cairney, M. V., Crampin, L., Campbell, L., & Cleland, J. (2025) · Pilot and Feasibility Studies · doi:10.1186/s40814-025-01640-6 · Cited by 1 · see citing works
Supporting the mental health of adolescent mothers in Kenya and Mozambique: pilot protocol for the Thriving Mamas programme
Salisbury, T. T., Maguele, M. S. B., Chissale, F., de Melo, M. S. I., Hanselmann, M., Lamahewa, K., Langat, E. C., Mandlate, F., Nyaga, L., Seward, N., et al. (2025) · Pilot and Feasibility Studies · doi:10.1186/s40814-025-01617-5 · Cited by 1 · see citing works
Pilot and feasibility studies in ophthalmology: fundamental keys to success
Nanji, K., Phillips, M., Thabane, L., Tham, Y. C., Wong, T. Y., STEEL, D. H., Munk, M. R., Wykoff, C. C., Chaudhary, V., On behalf of the Retina Evidence and Trials INternational Alliance (R.E.T.I.N.A.) Study Group, et al. (2024) · Eye · doi:10.1038/s41433-024-03413-6 · Cited by 1 · see citing works
False Safety Behavior Elimination Therapy for Social Anxiety Disorder in Japanese: A Pilot, Single-arm Uncontrolled StudyPreprint
Arai, H., Okawa, S., Seki, Y., Shimizu, E., Takahashi, S., Korte, K. J., & Schmidt, N. B. (2020) · Research Square · doi:10.21203/rs.3.rs-107578/v1
Examining the impact of a self-compassion intervention on physical activity behaviour among people with prediabetes: a pilot and feasibility study
Signore, A., & Strachan, S. M. (2021) · Mspace (University of Manitoba)
Nurses' research literacy: A multi-methods exploration
Hines, S. J. (2022) · Queensland University of Technology · doi:10.5204/thesis.eprints.229970
False Safety Behavior Elimination Therapy for Social Anxiety Disorder in Japanese: A Pilot, Single‐Arm Uncontrolled Study1
Arai, H., Seki, Y., Okawa, S., Shimizu, E., Takahashi, S., Ishikawa, S., Korte, K. J., & Schmidt, N. B. (2021) · Japanese Psychological Research · doi:10.1111/jpr.12366
The Impact of Abdominal Body Contouring Surgery on Physical Function After Massive Weight Loss: A Pilot Prospective Matched Comparison
Mardan-Dezfouli, S., Reid, O. G., Fliss, M. D., Stevenson, J., Harris, D., Lyon, M. R., Koehle, M. S., & Mitchell, C. J. (2022) · Aesthetic Surgery Journal · doi:10.1093/asj/sjac220
At-Home Virtual Reality Mindfulness for Insomnia: a Feasibility Randomized Controlled Trial (Preprint)Preprint
Hitching, R., Kluge, M. G., Walker, F. R., Gordon, C. J., & Lampe, L. A. (2025) · doi:10.2196/preprints.77094
Feasibility and acceptability of safer gambling interventions (social norms and goal setting) delivered via text message for those at low-to-moderate risk of gambling harm: a four-arm randomised controlled feasibility study
Arden-Close, E. J., Thomas, S., Bush‐Evans, R., Hamson-Ford, A., Bolat, E., Hodge, S., Phalp, K. T., Wang, R., & McAlaney, J. (2025) · BMJ Open · doi:10.1136/bmjopen-2025-104784 · Cited by 1 · see citing works
Assessing the impact of a nutrition educational video on health-related quality of life in older home-living adults after discharge from a surgical hospital department: a randomised controlled pilot trial
Hansen, M. C., Ingstad, K., Uhrenfeldt, L., & Pedersen, P. U. (2025) · BMC Nutrition · doi:10.1186/s40795-025-01203-1
Additional file 1 of Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial
Mosher, C. E., Seçinti, E., Kroenke, K., Helft, P. R., Turk, A. A., Loehrer, P. J., Sehdev, A., Al-Hader, A. A., Champion, V. L., & Johns, S. A. (2021) · Figshare · doi:10.6084/m9.figshare.14457122
Additional file 1 of Pilot and feasibility trials in traditional Chinese medicine: a literature review of current practice
Li, G., Wu, D., Chen, X., Zeng, J., Li, Z., & Thabane, L. (2020) · Figshare · doi:10.6084/m9.figshare.12177828
Additional file 1 of A pilot and feasibility study of a randomized clinical trial testing a self-compassion intervention aimed to increase physical activity behaviour among people with prediabetes
Signore, A., Jung, M. E., Semenchuk, B. N., Kullman, S. M., Tefft, O., Webber, S., Ferguson, L. J., Kowalski, K. C., Fortier, M., McGavock, J., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19914936
Additional file 1 of Multimodal agility-based exercise training (MAT) versus strength and endurance training (SET) to improve multiple sclerosis-related fatigue and fatigability during inpatient rehabilitation: a randomized controlled pilot and feasibility study [ReFEx]
Wolf, F., Nielsen, J., Saliger, J., Hennecken, E., Kröber, P., Eschweiler, M., Folkerts, A.-K., Karbe, H., & Zimmer, P. (2023) · Figshare · doi:10.6084/m9.figshare.24454957
Additional file 1 of Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!
Lewis, M., Bromley, K., Sutton, C., McCray, G., Myers, H. L., & Lancaster, G. A. (2021) · Figshare · doi:10.6084/m9.figshare.13710841
Additional file 2 of Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions
von Klinggraeff, L., Dugger, R., Okely, A. D., Lubans, D., Jago, R., Burkart, S., Weaver, R. G., Armstrong, B., Pfledderer, C. D., & Beets, M. W. (2022) · Figshare · doi:10.6084/m9.figshare.19136116
Additional file 1 of A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020
Totton, N., Lin, J., Julious, S., Chowdhury, M., & Brand, A. (2024) · Figshare · doi:10.6084/m9.figshare.26643079
Additional file 2 of The mysterious case of the disappearing pilot study: a review of publication bias in preliminary behavioral interventions presented at health behavior conferences
von Klinggraeff, L., Ramey, K. T., Pfledderer, C. D., Burkart, S. A., Armstrong, B., Weaver, R. G., & Beets, M. W. (2023) · Figshare · doi:10.6084/m9.figshare.23647454
Additional file 1 of Evaluating the impact of Community-Based Sociotherapy on social dignity in post-genocide Rwanda: study protocol for a cluster randomized controlled trial
Jansen, S., Niyonsenga, J., Ingabire, M. C., Jansen, A., Nzabonimpa, E., Ingabire, N., Kangabe, J., Sarabwe, E., Richters, A., Rutayisire, T., et al. (2023) · Figshare · doi:10.6084/m9.figshare.22599410
Additional file 1 of Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions
von Klinggraeff, L., Dugger, R., Okely, A. D., Lubans, D., Jago, R., Burkart, S., Weaver, R. G., Armstrong, B., Pfledderer, C. D., & Beets, M. W. (2022) · Figshare · doi:10.6084/m9.figshare.19136113

Guidelines for designing and evaluating feasibility pilot studies
Teresi, J. A., Yu, X., Stewart, A. L., & Hays, R. D. (2022) · Medical Care · doi:10.1097/mlr.0000000000001664 · Cited by 734 · see citing works
Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study
Teare, M. D., Dimairo, M., Shephard, N., Hayman, A., Whitehead, A., & Walters, S. J. (2014) · Trials · doi:10.1186/1745-6215-15-264 · Cited by 773 · see citing works
Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!
Lewis, M., Bromley, K., Sutton, C. J., McCray, G., Myers, H. L., & Lancaster, G. A. (2021) · Pilot and Feasibility Studies · doi:10.1186/s40814-021-00770-x · Cited by 330 · see citing works
Sample size calculations for pilot randomized trials: a confidence interval approach
Cocks, K., & Torgerson, D. J. (2013) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2012.09.002 · Cited by 431 · see citing works
Re-evaluating the role of pilot trials in informing effect and sample size estimates for full-scale trials: a meta-epidemiological study
Ying, X., Robinson, K. A., & Ehrhardt, S. (2023) · BMJ Evidence-Based Medicine · doi:10.1136/bmjebm-2023-112358 · Cited by 9 · see citing works

Authors: Sim, J.
Affiliations: Keele University (GB)
Corresponding author: Sim, Julius
ORCID: Sim, Julius
Venue: Pilot and Feasibility Studies
Publisher: Springer Science and Business Media LLC
Published: 2019-08-28
Volume: 5
Issue: 1
Pages: 107-107
ISSN: 2055-5784 (ISSN-L)
DOI: 10.1186/s40814-019-0493-7
PMC: PMC6712606
OpenAlex: W2970940014
Cited by: 123
References: 31
Citations by year: 2026: 15 · 2025: 13 · 2024: 13 · 2023: 23 · 2022: 20 · 2021: 18 · 2020: 19 · 2019: 2
FWCI: 11.51
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (tdm)
creativecommons.org/licenses/by/4.0/ (vor)
Locations: Pilot and Feasibility Studies (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Keele Research Repository (Keele University) (submittedVersion, cc-by)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
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
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Keywords: pilot study, feasibility study, treatment effect estimation, sample size determination, minimal clinically important difference, clinical judgment, trial planning, confidence intervals

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

Should treatment effects be estimated in pilot and feasibility studies?

Abstract

Integrity signals

Claims the paper makes

Claims other papers make about this one

Self-check

Cites

Cited by

Related

Record

About these checks