The reporting of progression criteria in protocols of pilot trials designed to assess the feasibility of main trials is insufficient: a meta-epidemiological study

Mbuagbaw, Lawrence; Kosa, Sarah Daisy; Lawson, Daeria O.; Stalteri, Rosa; Olaiya, Oluwatobi R.; Alotaibi, Ahlam; Thabane, Lehana

doi:10.1186/s40814-019-0500-z

Cited by 57Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsDelphi Technique in Research

The reporting of progression criteria in protocols of pilot trials designed to assess the feasibility of main trials is insufficient: a meta-epidemiological study

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Mbuagbaw, Lawrence, Kosa, Sarah Daisy, Lawson, Daeria O., Stalteri, Rosa, Olaiya, Oluwatobi R., Alotaibi, Ahlam, Thabane, Lehana·2019·Pilot and Feasibility Studies

DOI 10.1186/s40814-019-0500-zPMC PMC6827233

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Abstract

Introduction: Pilot 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. Methods: We conducted a methodological review of protocols for pilot randomised trials published in three journals that publish research protocols ( BMJ Open , Trials , Pilot and Feasibility Studies ), using a PubMed search (2013–2017). We extracted bibliometric information including the country in which the study was conducted, source of funding, type of intervention, use of a primary feasibility outcome, sample size reporting, and justification. We used generalised linear models to determine the factors associated with reporting progression criteria. Results: Our 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; p = 0.034). Pilot trials from Europe (aOR 0.19; 95% CI 0.08–0.48; p < 0.001) and the rest of the world (aOR 0.05; 95% CI 0.01–0.18; p < 0.003) compared to North America were significantly associated with lower odds of reporting progression criteria. Journal, source of funding, sample size, intervention type, and having a primary outcome related to feasibility were not significantly associated with reporting progression criteria. Conclusion: Progression 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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Preregistered progression criteria were defined as per formal guidelines.
“As per formal guidelines [52], preregistered progression criteria were defined as follows”
From Feasibility and Preliminary Efficacy of Web-Based and Mobile Interventions for Common Mental Health Problems in Working Adults: Multi-Arm Randomized Pilot Trial (2022) · cites this paper as [52]
The Background recommends specifying progression criteria at the protocol stage, but says there is currently no guidance on how to report a pilot-trial protocol. The Conclusion calls for formal guidance to be developed, contrary to citing this paper as existing formal guidelines for defining the criteria. (LLM, conf=0.86)
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If progression criteria are not set a priori, there is a risk that pilot trials may progress to a definitive RCT without modification or acknowledgement of potential limitations.
“If progression criteria are not set a priori, there is a risk that pilot trials may be optimistic in reporting that a future RCT is feasible [11] and progress to a definitive RCT without modification or acknowledgement of potential limitations [12].”
From Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting (2023) · cites this paper as [12]
Progression criteria for a definitive trial were predefined in line with recent recommendations and included full recruitment within 1 month, ≥30% intervention completion rates, ≥50% satisfaction/quality ratings, and between-group effect sizes of at least small for PHQ-8 at t1.
“Progression criteria for a definitive trial were predefined in line with recent recommendations [54] and included full recruitment within 1 month, ≥30% intervention completion rates for interventions, ≥50% of participants reporting being “satisfied” or “very satisfied” with the brief intervention and rating the quality as “good” or “excellent,””
From Feasibility and Preliminary Efficacy of Digital Interventions for Depressive Symptoms in Working Adults: Multiarm Randomized Controlled Trial (2023) · cites this paper as [54]

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Authors: Mbuagbaw, L., Kosa, S. D., Lawson, D. O., Stalteri, R., Olaiya, O. R., Alotaibi, A., & Thabane, L.
Affiliations: St. Joseph’s Healthcare Hamilton (CA)
University Health Network (CA)
McMaster University (CA)
Population Health Research Institute (CA)
Corresponding author: Mbuagbaw, Lawrence
ORCID: Mbuagbaw, Lawrence
Kosa, Sarah Daisy
Lawson, Daeria O.
Olaiya, Oluwatobi R.
Alotaibi, Ahlam
Thabane, Lehana
Venue: Pilot and Feasibility Studies
Publisher: Springer Science and Business Media LLC
Published: 2019-11-03
Volume: 5
Issue: 1
Pages: 120-120
ISSN: 2055-5784 (ISSN-L)
DOI: 10.1186/s40814-019-0500-z
PMC: PMC6827233
OpenAlex: W2988645757
Cited by: 57
References: 33
Citations by year: 2026: 5 · 2025: 5 · 2024: 12 · 2023: 10 · 2022: 11 · 2021: 10 · 2020: 4
FWCI: 4.18
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)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Sociology and Political Science › Delphi Technique in Research
Keywords: progression criteria, pilot trial, feasibility trial, trial protocol reporting, reporting quality, sample size reporting

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The reporting of progression criteria in protocols of pilot trials designed to assess the feasibility of main trials is insufficient: a meta-epidemiological study

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