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

@inproceedings{Pant:2021:10.1136/jech-2021-SSMabstracts.23,
author = {Pant, S and Elias, MA and Woolfall, K and Thayyil, S},
doi = {10.1136/jech-2021-SSMabstracts.23},
pages = {A11--A11},
publisher = {BMJ Publishing Group},
title = {OP23Parental consent for time-critical neonatal trials in low and middle-income countries: is it truly informed? FREE},
url = {http://dx.doi.org/10.1136/jech-2021-SSMabstracts.23},
year = {2021}
}
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RIS format (EndNote, RefMan)

TY  - CPAPER
AB  - Background Parental consent rates for neonatal interventional trials are significantly higher in Low and middle-income countries (LMIC) than in high-income countries, raising concerns about the credibility of the consent processes (Patterson et al PLOS One 2021). We conducted a mixed-methods study to understand the informed consent process in a neonatal cooling trial [Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial] conducted in India, Sri Lanka and Bangladesh.Methods Term infants with neonatal encephalopathy, aged less than six hours were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed the A-V records of the consent process using a 5-point Likert scale on three parameters – Empathy, Information, Autonomy. Additionally, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 health care professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.Results In HELIX trial, a total of 475 parents were approached, of which 408 (86%) consented. Of these, 294 A-V records were analysed. Median (Interquartile range) score for empathy, information, autonomy was 5 (0), 5 (1) and 5 (1) respectively. However, thematic analysis suggested that the parental decision to participate was based on a unreserved trust in the treating doctors, therapeutic misconception, and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial, nor the nature of the intervention. Lower levels of parental education and misinformation further convoluted the voluntary informed consent process. Parents were visibly incapacitated, and many told the doctor to do whatever is best for the
AU  - Pant,S
AU  - Elias,MA
AU  - Woolfall,K
AU  - Thayyil,S
DO  - 10.1136/jech-2021-SSMabstracts.23
EP  - 11
PB  - BMJ Publishing Group
PY  - 2021///
SN  - 0143-005X
SP  - 11
TI  - OP23Parental consent for time-critical neonatal trials in low and middle-income countries: is it truly informed? FREE
UR  - http://dx.doi.org/10.1136/jech-2021-SSMabstracts.23
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000720947000024&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - https://jech.bmj.com/content/75/Suppl_1/A11.1
ER  -
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