ArticlePilot and feasibility studies2025
Sample size justification in feasibility studies: moving beyond published guidance.
Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
36 citing papers in PubMed.
- Personalized Transdiagnostic Cognitive Behavior Therapy With Midtreatment Stepped Care to Improve Mental Health Among University Students in Sweden: Feasibility Study for a Randomized Controlled Trial.JMIR formative research · 2026Trial
- Electronic Patient-Reported Health-Related Quality of Life Trajectories in ICU Survivors: A Multicentre Pilot Study-Within-a-Trial Protocol.Acta anaesthesiologica Scandinavica · 2026Article
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- Feasibility of an Online Shared Reading Intervention in Survivors of Gynecological Cancer: Protocol for a Multiple-Baseline Single-Case Study.JMIR research protocols · 2026Article
- Dietary Carotenoid Intake, Gut Microbial Diversity, and Community Composition in Latino Emerging Adults.Microorganisms · 2026Article
- Digital Patient-Controlled Follow-Up in Palliative Cancer Care: Protocol for a Mixed Methods Feasibility Study.JMIR research protocols · 2026Article
- A Multidimensional Digital Health Platform to Support Intrinsic Capacity and Healthy Aging: Pilot Feasibility Study.JMIR aging · 2026Article
- Exploring the Feasibility, Acceptability, and Safety of a 4:3 Intermittent Fasting Weight Loss Program Among Stage I-III Breast Cancer Survivors With Overweight or Obesity: Protocol for a 6-Month Proof-of-Concept Feasibility Trial.JMIR research protocols · 2026Article
- Phenobarbital as an Adjuvant to benzodiazepines when compared to Single-agent benzodiazepine Treatment (usual care) for Alcohol withdrawal syndrome in the intensive care unit (PASTA): a study protocol.Pilot and feasibility studies · 2026Article
- User Perspectives on a Clinical Decision Tool to Support Individualized Exercise Prescriptions for Breast Cancer Survivors Not Meeting Exercise Guidelines: Cross-Sectional Survey.JMIR formative research · 2026Article
- A health literacy intervention for registered nurses: Development and feasibility testing.International journal of nursing studies advances · 2026Article
- CareVR, a Virtual Reality assisted communication training programme to support informal carers of people with psychosis: a feasibility study.BMC psychiatry · 2026Article
- A comprehensive parent training program for parents of neurodivergent children with pathological demand avoidance: The Paradigm Shift ProgramPediatric investigation · 2026Article
- Pilot study protocol to increase resistance to peer pressure in tobacco use among nursing students (T-RESIST).Pilot and feasibility studies · 2026Article
- Building the mountain mama & baby cohort: study design, protocol, and early prenatal clinic-based recruitment outcomes.American journal of epidemiology · 2026Article
- Feasibility and preliminary effectiveness of the Individual Placement and Support (IPS) model for people with serious mental illness in Jalisco, Mexico: a pilot study protocol.Pilot and feasibility studies · 2026Article
- Touch-Based Partner Yoga for Gay, Bisexual, Transgender, and Queer Men in a Community Wellness Setting: Protocol for a Mixed Methods Program Evaluation of "The Studio".JMIR research protocols · 2026Article
- Sensory Integration Therapy for Preschool Children with Autism Spectrum Disorder and Co-Occurring Intellectual Disability: An Exploratory Single-Group Pre-Post Study.Children (Basel, Switzerland) · 2026Article
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pilot and feasibility studies are crucial for determining whether follow-up trials should be conducted. To be effective, these studies need to be properly designed and have large enough samples to make correct decisions about proceeding to a future trial at a high rate. However, there is significantly less clarity about best practices concerning sample size justifications compared to larger randomized controlled trials which are usually justified by power analyses. This has led to many feasibility studies justifying sample sizes based on pragmatic reasons (e.g., the ability to complete) or on published guidance and various rules of thumb. We argue that feasibility studies should be designed for, or at least report relevant operating characteristics, specifically, the probability of determining a future trial will be feasible when it is and the probability of determining a trial will be feasible when it is not and that sample size justifications should be based on these operating characteristics whenever possible. If relevant operating characteristics for a study are not reported, it is difficult to know whether the evidence from these trials can be used to claim a future trial would be feasible. In this paper, we review common methods for determining samples sizes in feasibility studies, report a narrative review of recently published feasibility studies and use two case-studies to highlight core issues we believe exist in the current design and reporting of these studies. Finally, we provide some suggestions that we believe will enhance the sample size justifications and overall effectiveness of these important trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.