Article type
Year
Abstract
Background: Most of the 117 trials included in the five Cochrane reviews on this topic are small (84 (72%) have fewer than 100 participants) and methodologically flawed (allocation was clearly concealed in only 13 (11%)). A protocol-based study was set up to examine other aspects of trial conduct, such as a lack of statistical support, that might help explain the generally inadequate quality of these trials. This paper presents the analysis of personal acknowledgements as part of that study.
Objectives: To examine the 'Acknowledgements' of trial reports as a potential source of insights on trial conduct.
Methods: A data extraction form was prepared and the trial materials of all 117 included trials were reviewed. The information in the 'Acknowledgements' and equivalent sections was extracted and categorised. Only personal acknowledgements were included.
Results: At least one of the reports identified for each of 35 (30%) trials acknowledged contributions or help from either specific individuals or a group of people, or both. Of 16 acknowledgements referring to support with statistical or trial methods, 15 were to named individuals, primarily for providing statistical advice. Four acknowledged specific help with study design. Of 22 acknowledgements relating to trial conduct, 17 thanked groups of individuals at various locations for various contributions. Nine trials acknowledged named individuals, usually for specific tasks. A research co-ordinator was acknowledged in only one trial. There were 16 acknowledgements for various aspects of manuscript preparation. Ten trials acknowledged consultants for giving their permission to study their patients. Just two trials acknowledged the contribution of the patients.
Conclusions: The findings of this study add support to the impression of insufficient input from trial methodologists. Some insights are provided on the clinical context of these trials and particularly the dependency on cooperation from other clinicians. The key role of trial patients appears underappreciated.
Objectives: To examine the 'Acknowledgements' of trial reports as a potential source of insights on trial conduct.
Methods: A data extraction form was prepared and the trial materials of all 117 included trials were reviewed. The information in the 'Acknowledgements' and equivalent sections was extracted and categorised. Only personal acknowledgements were included.
Results: At least one of the reports identified for each of 35 (30%) trials acknowledged contributions or help from either specific individuals or a group of people, or both. Of 16 acknowledgements referring to support with statistical or trial methods, 15 were to named individuals, primarily for providing statistical advice. Four acknowledged specific help with study design. Of 22 acknowledgements relating to trial conduct, 17 thanked groups of individuals at various locations for various contributions. Nine trials acknowledged named individuals, usually for specific tasks. A research co-ordinator was acknowledged in only one trial. There were 16 acknowledgements for various aspects of manuscript preparation. Ten trials acknowledged consultants for giving their permission to study their patients. Just two trials acknowledged the contribution of the patients.
Conclusions: The findings of this study add support to the impression of insufficient input from trial methodologists. Some insights are provided on the clinical context of these trials and particularly the dependency on cooperation from other clinicians. The key role of trial patients appears underappreciated.