Tracy Mitchell, Izabela Andrzejewska, Cheryl Battersby, Christina Cole, Zoe Daskalopoulou, Jon Dorling, Chris Gale, Michaela Graham, Marie Hubbard, Pollyanna Hardy, Madeleine Hurd, Andrew Robert King, Brett James Manley, David Murray, Elizabeth Nuthall, Heather O'Connor, Shalini Ojha, Calum T Roberts, Amy Rodriquez, Charles Christoph Roehr, Kayleigh Stanbury, Lyvonne Tume, Lauren Young, Kerry Woolfall
{"title":"新生儿重症监护中家长和医生选择退出同意的经验:一项试验中的混合方法研究。","authors":"Tracy Mitchell, Izabela Andrzejewska, Cheryl Battersby, Christina Cole, Zoe Daskalopoulou, Jon Dorling, Chris Gale, Michaela Graham, Marie Hubbard, Pollyanna Hardy, Madeleine Hurd, Andrew Robert King, Brett James Manley, David Murray, Elizabeth Nuthall, Heather O'Connor, Shalini Ojha, Calum T Roberts, Amy Rodriquez, Charles Christoph Roehr, Kayleigh Stanbury, Lyvonne Tume, Lauren Young, Kerry Woolfall","doi":"10.1136/archdischild-2025-328693","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In neonatal trials, verbal opt-out consent has been used to reduce burden on families and make recruitment more efficient and representative. It involves information provision through posters and leaflets before randomisation, and parents can verbally 'opt out' of their baby being randomised to the trial. There is limited understanding of how opt-out consent is operationalised in a multicentre neonatal trial, and its acceptability to staff and parents.</p><p><strong>Objective: </strong>To explore views and experiences of verbal opt-out consent in neoGASTRIC, a neonatal randomised trial comparing routine and no routine measurements of gastric contents in preterm babies.</p><p><strong>Methods: </strong>A mixed methods (questionnaires, interviews and focus groups) process evaluation within a trial.</p><p><strong>Setting: </strong>Four UK neonatal units.</p><p><strong>Participants: </strong>253 participants: 167 staff (149 questionnaires; 18 across two focus groups), 86 parents (85 questionnaires; 15 interviews; 14 took part in both).</p><p><strong>Results: </strong>Parents and staff supported opt-out consent in neoGASTRIC as interventions were viewed as low risk and non-invasive. Parents appreciated an appropriately timed research conversation; only 21% noticed study information banners/posters. Operationalisation of opt-out consent varied in terms of when information was provided and randomisation timing. Women approached during labour or within hours of birth reported feeling overwhelmed and lacking capacity to consider research. Some staff operationalised a modified opt-in approach.</p><p><strong>Conclusions: </strong>An appropriately timed verbal opt-out approach to consent was seen acceptable as proportionate in the neonatal context in a low-risk trial comparing different accepted clinical, non-pharmaceutical, practices. Findings informed neoGASTRIC and will guide approaches to consent in this setting.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.6000,"publicationDate":"2025-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Parent and practitioner experiences of opt-out consent in neonatal intensive care: a mixed methods study within a trial.\",\"authors\":\"Tracy Mitchell, Izabela Andrzejewska, Cheryl Battersby, Christina Cole, Zoe Daskalopoulou, Jon Dorling, Chris Gale, Michaela Graham, Marie Hubbard, Pollyanna Hardy, Madeleine Hurd, Andrew Robert King, Brett James Manley, David Murray, Elizabeth Nuthall, Heather O'Connor, Shalini Ojha, Calum T Roberts, Amy Rodriquez, Charles Christoph Roehr, Kayleigh Stanbury, Lyvonne Tume, Lauren Young, Kerry Woolfall\",\"doi\":\"10.1136/archdischild-2025-328693\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>In neonatal trials, verbal opt-out consent has been used to reduce burden on families and make recruitment more efficient and representative. It involves information provision through posters and leaflets before randomisation, and parents can verbally 'opt out' of their baby being randomised to the trial. There is limited understanding of how opt-out consent is operationalised in a multicentre neonatal trial, and its acceptability to staff and parents.</p><p><strong>Objective: </strong>To explore views and experiences of verbal opt-out consent in neoGASTRIC, a neonatal randomised trial comparing routine and no routine measurements of gastric contents in preterm babies.</p><p><strong>Methods: </strong>A mixed methods (questionnaires, interviews and focus groups) process evaluation within a trial.</p><p><strong>Setting: </strong>Four UK neonatal units.</p><p><strong>Participants: </strong>253 participants: 167 staff (149 questionnaires; 18 across two focus groups), 86 parents (85 questionnaires; 15 interviews; 14 took part in both).</p><p><strong>Results: </strong>Parents and staff supported opt-out consent in neoGASTRIC as interventions were viewed as low risk and non-invasive. Parents appreciated an appropriately timed research conversation; only 21% noticed study information banners/posters. Operationalisation of opt-out consent varied in terms of when information was provided and randomisation timing. Women approached during labour or within hours of birth reported feeling overwhelmed and lacking capacity to consider research. Some staff operationalised a modified opt-in approach.</p><p><strong>Conclusions: </strong>An appropriately timed verbal opt-out approach to consent was seen acceptable as proportionate in the neonatal context in a low-risk trial comparing different accepted clinical, non-pharmaceutical, practices. Findings informed neoGASTRIC and will guide approaches to consent in this setting.</p>\",\"PeriodicalId\":8177,\"journal\":{\"name\":\"Archives of Disease in Childhood - Fetal and Neonatal Edition\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.6000,\"publicationDate\":\"2025-08-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Archives of Disease in Childhood - Fetal and Neonatal Edition\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/archdischild-2025-328693\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PEDIATRICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of Disease in Childhood - Fetal and Neonatal Edition","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/archdischild-2025-328693","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}
Parent and practitioner experiences of opt-out consent in neonatal intensive care: a mixed methods study within a trial.
Background: In neonatal trials, verbal opt-out consent has been used to reduce burden on families and make recruitment more efficient and representative. It involves information provision through posters and leaflets before randomisation, and parents can verbally 'opt out' of their baby being randomised to the trial. There is limited understanding of how opt-out consent is operationalised in a multicentre neonatal trial, and its acceptability to staff and parents.
Objective: To explore views and experiences of verbal opt-out consent in neoGASTRIC, a neonatal randomised trial comparing routine and no routine measurements of gastric contents in preterm babies.
Methods: A mixed methods (questionnaires, interviews and focus groups) process evaluation within a trial.
Setting: Four UK neonatal units.
Participants: 253 participants: 167 staff (149 questionnaires; 18 across two focus groups), 86 parents (85 questionnaires; 15 interviews; 14 took part in both).
Results: Parents and staff supported opt-out consent in neoGASTRIC as interventions were viewed as low risk and non-invasive. Parents appreciated an appropriately timed research conversation; only 21% noticed study information banners/posters. Operationalisation of opt-out consent varied in terms of when information was provided and randomisation timing. Women approached during labour or within hours of birth reported feeling overwhelmed and lacking capacity to consider research. Some staff operationalised a modified opt-in approach.
Conclusions: An appropriately timed verbal opt-out approach to consent was seen acceptable as proportionate in the neonatal context in a low-risk trial comparing different accepted clinical, non-pharmaceutical, practices. Findings informed neoGASTRIC and will guide approaches to consent in this setting.
期刊介绍:
Archives of Disease in Childhood is an international peer review journal that aims to keep paediatricians and others up to date with advances in the diagnosis and treatment of childhood diseases as well as advocacy issues such as child protection. It focuses on all aspects of child health and disease from the perinatal period (in the Fetal and Neonatal edition) through to adolescence. ADC includes original research reports, commentaries, reviews of clinical and policy issues, and evidence reports. Areas covered include: community child health, public health, epidemiology, acute paediatrics, advocacy, and ethics.