Imperial College London
Alternate

ProfessorSudhinThayyil

Faculty of Medicine, Department of Brain Sciences

Professor of Perinatal Neuroscience
 
 
 
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Contact

 

+44 (0)20 3313 8515s.thayyil

 
 
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Location

 

529Hammersmith HouseHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Patterson:2021:10.1371/journal.pone.0248263,
author = {Patterson, JK and Pant, S and Jones, DF and Taha, S and Jones, MS and Bauserman, MS and Montaldo, P and Bose, CL and Thayyil, S},
doi = {10.1371/journal.pone.0248263},
journal = {PLoS One},
pages = {1--14},
title = {Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: a systematic review},
url = {http://dx.doi.org/10.1371/journal.pone.0248263},
volume = {16},
year = {2021}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Objective: Legal, ethical, and regulatory requirements of medical research uniformly call for informed consent. We aimed to characterize and compare consent rates for neonatal randomized controlled trials in low- and lower middle-income countries versus high-income countries, and to evaluate the influence of study characteristics on consent rates.Methods: In this systematic review, we searched MEDLINE, EMBASE and Cochrane for randomized controlled trials of neonatal interventions in low- and lower middle-income countries or high-income countries published 01/01/2013 to 01/04/2018. Our primary outcome was consent rate, the proportion of eligible participants who consented amongst those approached, extracted from the article or email with the author. Using a generalised linear model for fractional dependent variables, we analysed the odds of consenting in low- and lower middle-income countries versus high-income countries across control types and interventions.Findings: We screened 3523 articles, yielding 300 eligible randomized controlled trials with consent rates available for 135 low- and lower middle-income country trials and 65 high-income country trials. Median consent rates were higher for low- and lower middle-income countries (95.6%; interquartile range (IQR) 88.2–98.9) than high-income countries (82.7%; IQR 68.6–93.0; p<0.001). In adjusted regression analysis comparing low- and lower middle-income countries to high-income countries, the odds of consent for no placebo-drug/nutrition trials was 3.67 (95% Confidence Interval (CI) 1.87–7.19; p = 0.0002) and 6.40 (95%CI 3.32–12.34; p<0.0001) for placebo-drug/nutrition trials.Conclusion: Neonatal randomized controlled trials in low- and lower middle-income countries report consistently higher consent rates compared to high-income country trials. Our study is limited by the overrepresentation of India among randomized controlled trials in low- and lower middle-income countries. This st
AU  - Patterson,JK
AU  - Pant,S
AU  - Jones,DF
AU  - Taha,S
AU  - Jones,MS
AU  - Bauserman,MS
AU  - Montaldo,P
AU  - Bose,CL
AU  - Thayyil,S
DO  - 10.1371/journal.pone.0248263
EP  - 14
PY  - 2021///
SN  - 1932-6203
SP  - 1
TI  - Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: a systematic review
T2  - PLoS One
UR  - http://dx.doi.org/10.1371/journal.pone.0248263
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000627855600034&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0248263
UR  - http://hdl.handle.net/10044/1/88115
VL  - 16
ER  -
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