Trial reportArchives of disease in childhood. Fetal and neonatal edition2021
Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents' and health professionals' views and experiences.
Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed.
- Trial
- Parent and practitioner experiences of opt-out consent in neonatal intensive care: a mixed methods study within a trial.Archives of disease in childhood. Fetal and neonatal edition · 2026Trial
- Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III.Trials · 2024Trial
- Preterm Formula, Fortified or Unfortified Human Milk for Very Preterm Infants, the PREMFOOD Study: A Parallel Randomised Feasibility Trial.Neonatology · 2024Trial
- Parent perspectives on neonatal research without prior consent: a mixed-methods interview study.BMC medical ethics · 2026Article
- The Impact of Opt-In versus Opt-Out Consent Process for the Use of Donor Human Milk on Feeding Practice and Growth Pattern in Preterm Neonates.American journal of perinatology · 2026Article
- Article
- Parental involvement in neonatal decision-making: a narrative review.Frontiers in pediatrics · 2026Review
- Empirical research related to the ethics of pragmatic clinical trials: A scoping review.Learning health systems · 2026Article
- The view of Hong Kong parents on secondary use of dried blood spots in newborn screening program.BMC medical ethics · 2022Article
- Neonatal stroke surveillance study protocol in the United Kingdom and Republic of Ireland.Open medicine (Warsaw, Poland) · 2022Article
- Incorporating parent, former patient and clinician perspectives in the design of a national UK double-cluster, randomised controlled trial addressing uncertainties in preterm nutrition.BMJ paediatrics open · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundMore effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. The trial used simplified opt-out consent with concise parent information and no consent form.
objectiveTo explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials.
methodsA qualitative, descriptive interview-based study nested within a randomised trial. Semistructured interview transcripts were analysed using inductive thematic analysis.
settingEleven neonatal units in England.
participantsEleven parents and ten health professionals with experience of simplified consent.
resultsFive 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'.
conclusionIntroducing a novel form of consent proved challenging in practice. The principle of a 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.