title: Acceptance checklist for clinical effectiveness pilot trials: a systematic approach.
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.
authors.affiliation: Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK. g.charlesworth@ucl.ac.uk
authors.forename: Georgina
authors.initials: G
authors.lastname: Charlesworth
authors.forename: Karen
authors.initials: K
authors.lastname: Burnell
authors.forename: Juanita
authors.initials: J
authors.lastname: Hoe
authors.forename: Martin
authors.initials: M
authors.lastname: Orrell
authors.forename: Ian
authors.initials: I
authors.lastname: Russell
mesh_terms: D035843:Biomedical Research; D017028:Caregivers / Q000523:psychology; D057189:Checklist / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards; D003657:Decision Making; D003704:Dementia / Q000175:diagnosis / Q000628:therapy; D006801:Humans; D019982:Organizational Case Studies; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010865:Pilot Projects; D015203:Reproducibility of Results; D012107:Research Design