Title |
Acceptance checklist for clinical effectiveness pilot trials: a systematic approach
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Published in |
BMC Medical Research Methodology, June 2013
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DOI | 10.1186/1471-2288-13-78 |
Pubmed ID | |
Authors |
Georgina Charlesworth, Karen Burnell, Juanita Hoe, Martin Orrell, Ian Russell |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United Kingdom | 5 | 36% |
Malaysia | 1 | 7% |
Unknown | 8 | 57% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 7 | 50% |
Scientists | 4 | 29% |
Practitioners (doctors, other healthcare professionals) | 3 | 21% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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United Kingdom | 4 | 3% |
France | 1 | <1% |
Brazil | 1 | <1% |
Unknown | 134 | 96% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 31 | 22% |
Student > Ph. D. Student | 22 | 16% |
Student > Master | 20 | 14% |
Other | 8 | 6% |
Lecturer | 7 | 5% |
Other | 23 | 16% |
Unknown | 29 | 21% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 28 | 20% |
Psychology | 24 | 17% |
Nursing and Health Professions | 19 | 14% |
Agricultural and Biological Sciences | 6 | 4% |
Social Sciences | 5 | 4% |
Other | 18 | 13% |
Unknown | 40 | 29% |