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Open Access Highly Accessed Correspondence

Acceptance checklist for clinical effectiveness pilot trials: a systematic approach

Georgina Charlesworth12*, Karen Burnell3, Juanita Hoe4, Martin Orrell24 and Ian Russell5

Author Affiliations

1 Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK

2 Research and Development Department, North East London NHS Foundation Trust, Goodmayes Hospital, Barley Lane, Ilford, Essex IG3 8XJ, England

3 School of Health Sciences and Social Work, James Watson (West), 2 King Richard 1st Road, Portsmouth PO1 2FR, England

4 UCL Mental Health Sciences Unit, University College London, Charles Bell House, 67-73 Riding House Street, London W1W 7EJ, UK

5 West Wales Organization for Rigorous Trials in Health, Swansea University College of Medicine, Singleton Park, Swansea SA2 8PP, Wales

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BMC Medical Research Methodology 2013, 13:78  doi:10.1186/1471-2288-13-78

Published: 13 June 2013

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.

Keywords:
Pilot trial; Internal pilot; Randomized controlled trial; Feasibility; CONSORT; ACCEPT; SHIELD; Carer supporter programme