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Table 1 Acceptance checklist for clinical effectiveness pilot trials (ACCEPT): trial components, exemplar monitoring methods and exemplar outcomes

From: Acceptance checklist for clinical effectiveness pilot trials: a systematic approach

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