作者
NS Blencowe, N Mills, JA Cook, JL Donovan, CA Rogers, P Whiting, JM Blazeby
发表日期
2016/9
期刊
Journal of British Surgery
卷号
103
期号
10
页码范围
1377-1384
出版商
Oxford University Press
简介
Background
The complexity of surgical interventions has major implications for the design of RCTs. Trials need to consider how and whether to standardize interventions so that, if successful, they can be implemented in practice. Although guidance exists for standardizing non-pharmaceutical interventions in RCTs, their application to surgery is unclear. This study reports new methods for standardizing the delivery of surgical interventions in RCTs.
Methods
Descriptions of 160 surgical interventions in existing trial reports and protocols were identified. Initially, ten reports were scrutinized in detail using a modified framework approach for the analysis of qualitative data, which informed the development of a preliminary typology. The typology was amended with iterative sequential application to all interventions. Further testing was undertaken within ongoing multicentre RCTs …
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NS Blencowe, N Mills, JA Cook, JL Donovan… - Journal of British Surgery, 2016