Acceptance checklist for clinical effectiveness pilot trials: a systematic approach

Charlesworth, Georgina; Burnell, Karen; Hoe, Juanita; Orrell, Martin; Russell, Ian

doi:10.1186/1471-2288-13-78

Cited by 89Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsHealth Policy Implementation Science

Acceptance checklist for clinical effectiveness pilot trials: a systematic approach

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Charlesworth, Georgina, Burnell, Karen, Hoe, Juanita, Orrell, Martin, Russell, Ian·2013·BMC Medical Research Methodology

DOI 10.1186/1471-2288-13-78PMC PMC3702517

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Abstract

Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity is key, greater flexibility is written into trial protocols to allow for 'real life' variation in procedures. We describe the development of a checklist for use in decision-making on whether pilot data can be carried forward to the main trial dataset without compromising trial integrity. We illustrate the use of the checklist using a pragmatic trial of psychosocial interventions for family carers of people with dementia as a case study.

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Charlesworth et al. developed a checklist for intended use in decision-making on whether pilot data could be carried forward to a main trial.
“Charlesworth et al. [30] developed a checklist for intended use in decision-making on whether pilot data could be carried forward to a main trial.”
From Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! (2021) · cites this paper as [30]
The ACCEPT framework has a comprehensive guide for exploring the feasibility of a trial.
“we use the ACCEPT framework58 to explore the feasibility of the trial itself, as it has a comprehensive guide for how to do this”
From Novel ACT-based eHealth psychoeducational intervention for students with mental distress: A study protocol for a mixed-methodology pilot trial (2019) · cites this paper as [58]
The ACCEPT58 will be used to measure the feasibility of the study design and methods.
“The study is a pilot RCT; therefore, the primary outcome measure—the ACCEPT58—will be used to measure the feasibility of the study design and methods.”
From Novel ACT-based eHealth psychoeducational intervention for students with mental distress: A study protocol for a mixed-methodology pilot trial (2019) · cites this paper as [58]

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Additional file 2 of App-based telerehabilitation program for older adults on waiting list for physiotherapy after hospital discharge: a feasibility pragmatic randomized trial
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Acceptance Checklist for Clinical Effectiveness Pilot Trials: A Systematic Approach (ACCEPT). Copyright: Creative Commons License.
Charlesworth, G. M., Burnell, K., Hoe, J., Orrell, M., & Russell, I. (2013) · Open Scholarship Institutional Repository (Washington University in St. Louis)
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Additional file 2 of How are progression decisions made following external randomised pilot trials? A qualitative interview study and framework analysis
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Authors: Charlesworth, G., Burnell, K., Hoe, J., Orrell, M., & Russell, I.
Affiliations: North East London NHS Foundation Trust (GB)
University of Portsmouth (GB)
University College London (GB)
Swansea University (GB)
Corresponding author: Charlesworth, Georgina
ORCID: Charlesworth, Georgina
Burnell, Karen
Hoe, Juanita
Orrell, Martin
Russell, Ian
Venue: BMC Medical Research Methodology
Publisher: Springer Science and Business Media LLC
Published: 2013-06-13
Volume: 13
Issue: 1
Pages: 78-78
ISSN: 1471-2288 (ISSN-L)
DOI: 10.1186/1471-2288-13-78
PMC: PMC3702517
OpenAlex: W1991663299
Cited by: 87
References: 19
Citations by year: 2026: 3 · 2025: 8 · 2024: 9 · 2023: 3 · 2022: 6 · 2021: 11 · 2020: 9 · 2019: 6 · 2018: 9 · 2017: 9 · 2016: 8 · 2015: 3 · 2014: 3
FWCI: 4.12
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/2.0 (tdm)
Locations: BMC Medical Research Methodology (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
City Research Online (City University London) (acceptedVersion)
UCL Discovery (University College London) (submittedVersion)
Funders: National Institute for Health and Care Research (RP-PG-0606-1083, ISRCTN37956201)
Programme Grants for Applied Research
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
Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Keywords: pilot trial, data pooling, trial integrity, pragmatic trials, explanatory trials, trial protocol design, psychosocial interventions, family caregivers, dementia, generalizability
MeSH terms: Clinical Trials as Topic, Decision Making, Dementia, Humans, Pilot Projects, Research Design, Reproducibility of Results, Caregivers, Outcome Assessment, Health Care, Organizational Case Studies, Biomedical Research, Checklist

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