Table 1

Acceptance checklist for clinical effectiveness pilot trials (ACCEPT): trial components, exemplar monitoring methods and exemplar outcomes
Component of trial Monitoring methods (exemplars) Amend? Outcomes (exemplars)
Trial design Review research protocol especially balance of scientific & practical needs Yes/No Amend trial design & dependent components. Submit amendment to Research Ethics Committee
Sample size Test assumptions within protocol on: number of (active) centres; recruitment rates; retention rates; & SD of primary outcomes Yes/No Revise if necessary: sample size calculation; trial period; & funding
Interventions Clinical governance Assess compliance with: formal training in intervention; Health & Safety regulations; & other clinical governance requirements Yes/No Enhance formal training of intervention providers
Intervention fidelity Measure & assess adherence to intervention manual by video, observation or audio Yes/No Enhance clinical supervision of intervention providers
Participants Recruitment strategy Assess: flows of participants; cost & productivity of each route Yes/No Refine recruitment strategy, generally & locally
Eligibility criteria Assess: characteristics of sample; barriers to recruitment; update of intervention Yes/No Refine eligibility criteria
Consent procedures Participant Information Sheets (PIS) Consult participants & refusers Yes/No Refine PIS especially to address frequently asked questions
Taking informed consent Audit consent documentation. Measure & assess adherence to consent procedures by video, observation or audio Yes/No Enhance training of research team
Randomisation process Check quality especially: accessibility by researchers; validity of CONSORT flowchart; & accuracy of stratifying variables Yes/No Refine: randomisation procedure & parameters; & training of research team
Blinding Check whether assessors can predict individual allocations. Test whether unblinded researchers can keep other researchers blind Yes/No Refine blinding procedures, e.g. by reallocating responsibilities within research team
Data Data collection Assess adherence to interview schedules & fieldwork handbook, including duration of assessments, by video, observation or audio Yes/No Refine schedules to reduce assessment burden. Enhance training of research team
Data quality Test missing data procedures within draft analysis plan Yes/No Refine data collection tools & missing data procedures
Data management Test trial database, related procedures & link to analytical software Yes/No Refine trial database & procedures
Research Governance Research protocol adherence Enable quality assurance officer (QAO) to test adherence as widely as possible Yes/No Refine: protocol; quality assurance plan & training of team
Adverse events (AE) QAO to test procedures for: reporting AEs; assessing severity, causality & expectedness monitor at management group; report to DMEC Yes/No Refine AE reporting & assessment procedures
Health & Safety Test H&S procedures, e.g. for lone working Yes/No Refine H&S procedures
Data analysis Test draft analysis plan on pilot data Yes/No Refine analysis plan to address research aims in full
Trial management Review role descriptions of research team. Review remits of trial management group, trial research team etc. Yes/No Review role descriptions of research team. Refine roles e.g. if workloads vary. Refine remits e.g. if inadequate reporting of any component

Charlesworth et al.

Charlesworth et al. BMC Medical Research Methodology 2013 13:78   doi:10.1186/1471-2288-13-78

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