Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials.

ABSTRACT:

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 seq

SUBMITTER: Blencowe NS 

PROVIDER: S-EPMC5132147 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature