Trial reportBMJ open2021
Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting.
Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07722442 (Feasibility, Acceptability and Preliminary Efficacy of a Personalised Behavioural Intervention to Improve Adherence to Dietary and Lifestyle Cancer Prevention Recommendations in Adults Attending Breast and Colorectal Cancer Screening Programmes), which is not on this map. Cited by 25 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Feasibility, Acceptability and Preliminary Efficacy of a Personalised Behavioural Intervention to Improve Adherence to Dietary and Lifestyle Cancer Prevention Recommendations in Adults Attending Breast and Colorectal Cancer Screening Programmes: A Three-Arm Randomised Pilot Trial (CANVIA)
Who cites it
25 citing papers in PubMed.
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- Development of and satisfaction with a short-term outpatient preventive medical service for working informal caregivers: a study protocol of a non-randomized prospective pilot study.Pilot and feasibility studies · 2026Article
- Do we consider scalability from the outset? A methodological review of pilot randomised controlled health trials.BMJ open · 2026Review
- Current Practices and a Novel Operational Framework for Planning Research on Digital Health Promotion Interventions From Development to Implementation: Scoping Review.Journal of medical Internet research · 2026Article
- Key Features of Contemporary Pilot and Feasibility Trials: Protocol for a Methodological Study.Acta anaesthesiologica Scandinavica · 2026Review
- Community health workers serving Veterans with chronic obstructive pulmonary disease: a pilot intervention development and feasibility study.Pilot and feasibility studies · 2026Article
- Development of a nurse-led, evidence-based, and theory-informed dietary intervention to modify multiple unhealthy dietary behaviors in gastric cancer survivors.Asia-Pacific journal of oncology nursing · 2025Article
- Psychometric validation of the Indonesian verbal abuse questionnaire (I-VAQ) for adolescents using rasch analysis.Journal of education and health promotion · 2025Article
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- The role of intermediaries in connecting individuals to local physical activity - protocol for a pilot feasibility trial.Contemporary clinical trials communications · 2024Article
- Balancing best practice and reality in behavioral intervention development: A survey of principal investigators funded by the National Institutes of Health.Translational behavioral medicine · 2024Article
- Use of guidelines, checklists, frameworks, and recommendations in behavioral intervention preliminary studies and associations with reporting comprehensiveness: a scoping bibliometric review.Pilot and feasibility studies · 2023Article
- Pilot Trial Characteristics, Postpilot Design Modifications, and Feasibility of Full-Scale Trials.JAMA network open · 2023Article
- IMproving facial PRosthesis construction with contactlESs Scanning and Digital workflow (IMPRESSeD): study protocol for a feasibility crossover randomised controlled trial of digital versus conventional manufacture of facial prostheses in patients with orbital or nasal facial defects.Pilot and feasibility studies · 2023Article
- Empirical progression criteria thresholds for feasibility outcomes in HIV clinical trials: a methodological study.Pilot and feasibility studies · 2023Article
- Feasibility and preliminary efficacy of structured programming and a parent intervention to mitigate accelerated summer BMI gain: a pilot study.Pilot and feasibility studies · 2023Article
- Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting.Pilot and feasibility studies · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
objectivesPrespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports. STUDY
designMethodological review.
methodsWe searched four journals through PubMed:
resultsWe included 160 publications (123 protocols and 37 completed trials). Recruitment and retention were the most frequent indicators contributing to progression criteria. Progression criteria were mostly reported as distinct thresholds (eg, achieving a specific target; 133/160, 83%). Less than a third of the planned and completed pilot trials that included qualitative research reported how these findings would contribute towards progression criteria (34/108, 31%). The publications seldom stated who established the progression criteria (12/160, 7.5%) or provided rationale or justification for progression criteria (44/160, 28%). Most completed pilot trials reported the intention to proceed to a definitive trial (30/37, 81%), but less than half strictly met all of their progression criteria (17/37, 46%). Prepublication peer reviewer reports were available for 153/160 publications (96%). Peer reviewer reports for 86/153 (56%) publications mentioned progression criteria, with peer reviewers of 35 publications commenting that progression criteria appeared not to be specified.
conclusionsMany external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial.
Indexed as
Identifiers
What Socratic holds
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 Socratic graph.