Acceptance checklist for clinical effectiveness pilot trials: a systematic approach

Charlesworth, G., Burnell, K., Hoe, J., Orrell, M. & Russell, I. (2013). Acceptance checklist for clinical effectiveness pilot trials: a systematic approach. BMC Medical Research Methodology, 13, doi: 10.1186/1471-2288-13-78

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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.

Item Type: Article
Additional Information: © Charlesworth et al.; licensee BioMed Central Ltd. 2013 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Uncontrolled Keywords: Pilot trial, Internal pilot, Randomized controlled trial, Feasibility, CONSORT, ACCEPT, SHIELD, Carer supporter programme
Subjects: R Medicine
Divisions: School of Health Sciences
URI: http://openaccess.city.ac.uk/id/eprint/16411

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