Abstract
Objective
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. This review examines the reporting standards of complex interventions involving a medical device, in the context of AVB RCTs.
Study design
Searches were undertaken from the start of indexing to March 2021, and limited to RCTs, feasibility and pilot studies including at least one device for AVB. RCTs were selected if they included participants having an AVB with any device, with or without a comparator group. Reporting details were assessed according to the Consolidating Standards of Reporting Trials extension for non-pharmacological treatments (CONSORT-NPT), focusing on intervention descriptions, standardization, adherence and clinician expertise. Screening of abstracts, full-text articles and data extraction was performed by two independent reviewers.
Results
Of 4,098 abstracts and 83 full-text articles, 39 papers were included, investigating 80 interventions. Twenty-seven different named devices were identified. Intervention descriptions were provided in 20(51%) papers with varying levels of detail and with only one covering the entire procedure. Standardization of interventions was mentioned in 25 papers(64%). Only eight(21%) papers reported any form of adherence to the intended procedure. Some data regarding expertise were reported in 25(64%) papers.
Conclusions
Despite some compliance with reporting standards, there is a lack of detail regarding intervention description, standardization, adherence and expertise in RCTs of AVB. This creates difficulties in understanding how intervention delivery was intended and what actually occurred. Clearer guidelines for the reporting of invasive procedures and devices are required.
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. This review examines the reporting standards of complex interventions involving a medical device, in the context of AVB RCTs.
Study design
Searches were undertaken from the start of indexing to March 2021, and limited to RCTs, feasibility and pilot studies including at least one device for AVB. RCTs were selected if they included participants having an AVB with any device, with or without a comparator group. Reporting details were assessed according to the Consolidating Standards of Reporting Trials extension for non-pharmacological treatments (CONSORT-NPT), focusing on intervention descriptions, standardization, adherence and clinician expertise. Screening of abstracts, full-text articles and data extraction was performed by two independent reviewers.
Results
Of 4,098 abstracts and 83 full-text articles, 39 papers were included, investigating 80 interventions. Twenty-seven different named devices were identified. Intervention descriptions were provided in 20(51%) papers with varying levels of detail and with only one covering the entire procedure. Standardization of interventions was mentioned in 25 papers(64%). Only eight(21%) papers reported any form of adherence to the intended procedure. Some data regarding expertise were reported in 25(64%) papers.
Conclusions
Despite some compliance with reporting standards, there is a lack of detail regarding intervention description, standardization, adherence and expertise in RCTs of AVB. This creates difficulties in understanding how intervention delivery was intended and what actually occurred. Clearer guidelines for the reporting of invasive procedures and devices are required.
| Original language | English |
|---|---|
| Pages (from-to) | 166-173 |
| Number of pages | 8 |
| Journal | European Journal of Obstetrics and Gynecology and Reproductive Biology |
| Volume | 262 |
| Early online date | 14 May 2021 |
| DOIs | |
| Publication status | Published - 1 Jul 2021 |
Bibliographical note
Funding Information:EJH, SR, JFC, TJD are employees of North Bristol NHS Trust, which receives funding from PROMPT Maternity Foundation (PMF) to pay part of their salaries. PMF has received funds from Becton Dickinson, manufacturer of the Odon Device to run pre-clinical simulation studies on the device. EL is an employee of the University of Bristol, which receives funding from PMF to pay part of EL’s salary. NSB is an MRC Clinician Scientist.
Funding Information:
This study was supported by the Bill & Melinda Gates Foundation [grant number OPP1184825 / INV-010180]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care, and the MRC ConDuCT-II (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1).
Funding Information:
This study was supported by the Bill & Melinda Gates Foundation [grant number OPP1184825 / INV-010180 ]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care, and the MRC ConDuCT-II (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1).
Publisher Copyright:
© 2021 The Author(s)
Keywords
- reporting standards
- complex interventions
- assisted vaginal birth
- ventouse
- forceps
- Odon Device
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Dive into the research topics of 'Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: a systematic review'. Together they form a unique fingerprint.Student theses
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Understanding novel device introduction: an exploratory study of the Odon Device for assisted vaginal birth with implications for trials, training and clinical practice
Author: Hotton, E., 27 Sep 2022Supervisor: Blencowe, N. (Supervisor), Lenguerrand, E. (Supervisor) & Wade, J. (Supervisor)
Student thesis: Doctoral Thesis › Doctor of Philosophy (PhD)
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