@article{McLeish:2021:10.1136/archdischild-2020-319545,
author = {McLeish, J and Alderdice, F and Robberts, H and Cole, C and Dorling, J and Gale, C},
doi = {10.1136/archdischild-2020-319545},
journal = {Archives of Disease in Childhood: Fetal and Neonatal Edition},
pages = {244--250},
title = {Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: a qualitative study of parents’ and health professionals’ views and experiences},
url = {http://dx.doi.org/10.1136/archdischild-2020-319545},
volume = {106},
year = {2021}
}

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TY  - JOUR
AB  - Background: More effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. WithHolding Enteral feeds Around Transfusion (WHEAT) was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis (NEC). The trial used simplified opt-out consent with concise parent information and no consent form.Objective: To explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials.Methods: A qualitative, descriptive interview-based study nested within a randomised trial. Semi-structured interview transcripts were analysed using inductive thematic analysis.Setting: Eleven neonatal units in England.Participants: Eleven parents and ten health professionals with experience of simplified consent. Results: Five themes emerged: ‘Opt-out consent operationalised as verbal opt-in consent’, ‘Opt-out consent normalises participation while preserving parental choice’, ‘Opt-out consent as an ongoing process of informed choice’, ‘Consent without a consent form’ and ‘Choosing to opt out of a comparative effectiveness trial’, with two subthemes: ‘Wanting “normal care”’ and ‘A belief that feeding is better’. Conclusions: Introducing a novel form of consent proved challenging in practice. The principle of simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as ‘opt-out’ can help to normalise participation and emphasise that parents can withdraw consent.
AU  - McLeish,J
AU  - Alderdice,F
AU  - Robberts,H
AU  - Cole,C
AU  - Dorling,J
AU  - Gale,C
DO  - 10.1136/archdischild-2020-319545
EP  - 250
PY  - 2021///
SN  - 1359-2998
SP  - 244
TI  - Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: a qualitative study of parents’ and health professionals’ views and experiences
T2  - Archives of Disease in Childhood: Fetal and Neonatal Edition
UR  - http://dx.doi.org/10.1136/archdischild-2020-319545
UR  - https://fn.bmj.com/content/106/3/244
UR  - http://hdl.handle.net/10044/1/82398
VL  - 106
ER  - 

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