Published in:
Open Access
01-12-2013 | Correspondence
Acceptance checklist for clinical effectiveness pilot trials: a systematic approach
Authors:
Georgina Charlesworth, Karen Burnell, Juanita Hoe, Martin Orrell, Ian Russell
Published in:
BMC Medical Research Methodology
|
Issue 1/2013
Login to get access
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.