Acceptance Criteria for Clinical Effectiveness Pilot Trials (ACCEPT): Introducing a systematic approach for assessing pilot RCTs.

Georgina Charlesworth, Karen Burnell, Juanita Hoe, Ian Russell, Martin Orrell

    Research output: Contribution to journalArticle

    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.
    Original languageEnglish
    Article number78
    JournalBMC Medical Research Methodology
    Volume13
    Publication statusPublished - 2013

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