ArticlePilot and feasibility studies2019
The reporting of progression criteria in protocols of pilot trials designed to assess the feasibility of main trials is insufficient: a meta-epidemiological study.
Article in Pilot and feasibility studies, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers.
What it found
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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
38 citing papers in PubMed.
- Evaluation of a Digital, Self-Administered, Cognitive Test Battery in Older Adult Patients Undergoing Abdominal Surgery: Nonrandomized Feasibility Trial.JMIR formative research · 2025Trial
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- Internet-administered, low-intensity cognitive behavioral therapy for parents of children treated for cancer: A feasibility trial (ENGAGE).Cancer medicine · 2023Trial
- Trial
- Trial
- Trial
- Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting.BMJ open · 2021Trial
- Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: the DiaPROM randomised controlled pilot trial.BMJ open · 2021Trial
- 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
- Examining predictors of scale-up penalty in preliminary studies of health behavior interventions and subsequent larger trials: a meta-epidemiological review of diverse fields.Pilot and feasibility studies · 2026Review
- Key Features of Contemporary Pilot and Feasibility Trials: Protocol for a Methodological Study.Acta anaesthesiologica Scandinavica · 2026Review
- Concurrent cognitive and physical training for cognition in men with prostate cancer: a study protocol for a pilot randomized controlled trial.Frontiers in medicine · 2026Article
- Feasibility of a dietary life skills course aimed at fostering cooking skills and a healthy diet among university students.Pilot and feasibility studies · 2025Article
- Feasibility and acceptability of a self-management intervention supporting return to work for women with breast cancer.The British journal of occupational therapy · 2025Article
- Design, analysis, and reporting of pilot and feasibility trials in anesthesiology: a methodological study.Pilot and feasibility studies · 2025Review
- Three-outcome designs for external pilot trials with progression criteria.BMC medical research methodology · 2024Article
- The role of intermediaries in connecting individuals to local physical activity - protocol for a pilot feasibility trial.Contemporary clinical trials communications · 2024Article
- Delayed cold-stored vs. room temperature stored platelet transfusions in bleeding adult cardiac surgery patients-a randomized multicentre pilot study (PLTS-1).Pilot and feasibility studies · 2024Article
- A community-based advanced nurse practitioner-led integrated oncology care model for adults receiving oral anticancer medication: a pilot study.Pilot and feasibility studies · 2024Article
- Involving parents of children treated for cancer in Sweden as public contributors to inform the design and conduct of an evaluation of internet-administered self-help for parents of children treated for cancer: a protocol.Research involvement and engagement · 2024Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPilot and feasibility trials are conducted to determine feasibility or to collect information that would inform the design of a larger definitive trial. Clear progression criteria are required to determine if a definitive or main trial is feasible and how it should be designed. We sought to determine how often progression criteria are reported and the associated factors.
methodsWe conducted a methodological review of protocols for pilot randomised trials published in three journals that publish research protocols (
resultsOur search retrieved 276 articles, of which 49 were not eligible. We included 227 articles. Overall, 45/227 (19.8%; 95% confidence interval [CI] 14.8-25.6) reported progression criteria. Protocols published in more recent years were significantly associated with higher odds of reporting progression criteria (adjusted odds ratio [aOR] 1.40; 95% CI 1.03-1.92;
conclusionProgression criteria are not often explicitly stated in protocols of pilot trials leaving room for varied interpretation of findings. The development of formal guidance for progression criteria in protocols of pilot trials is warranted.
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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.