Exploring the reporting standards of RCTs involving invasive procedures
for assisted vaginal birth: a systematic review
Abstract
Background Assisted vaginal birth (AVB) is a complex intervention
involving medical devices, comprising multiple components. This
complexity creates difficulties when designing and conducting randomised
controlled trials (RCTs), in terms of describing, standardising and
monitoring the intervention, and accounting for differing clinician
expertise. Objectives This review examines the reporting standards of
complex interventions involving a medical device, in the context of AVB
RCTs. Search Strategy Searches were undertaken from the start of
indexing to November 2018, and limited to RCTs, feasibility and pilot
studies including at least one device for AVB. Selection Criteria RCTs
were selected if they included participants having an AVB with any
device, with or without a comparator group. Data Collection and Analysis
Reporting details were assessed according to the Consolidating Standards
of Reporting Trials extension for non-pharmacological treatments
(CONSORT-NPT), focusing on intervention descriptions, standardisation,
adherence and clinician expertise. Main Results Of 2,510 abstracts and
74 full-text articles, 36 papers were included, investigating 73
interventions. Twenty-eight different named devices were identified.
Intervention descriptions were provided in 20(56%) papers with varying
levels of detail and none covered the entire procedure. Standardisation
of interventions was mentioned in 23 papers (64%). Only seven(19%)
papers reported any form of adherence to the intended procedure. Some
data regarding expertise were reported in 23(64%) papers. Conclusions
Despite some compliance with reporting standards, there is a lack of
detail regarding intervention description, standardisation, adherence
and expertise in RCTs of AVB. This creates difficulties in understanding
how intervention delivery was intended and what actua