Evidence map›Paper›PMID 34651279›Full record

ReviewPaediatric drugs2021

Deferred Consent in Neonatal Clinical Research: Why, When, How?

Dilini I Imbulana, Louise S Owen, Trisha M Prentice, Peter G Davis, Brett J Manley

Abstract readReview
PubMed Publisher
In one paragraph

Review in Paediatric drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Dilini I ImbulanaNewborn Research Centre, The Royal Women's Hospital, Melbourne, VIC, Australia. dilini.imbulana2@thewomens.org.au.ORCID http://orcid.org/0000-0001-9413-1543
Louise S OwenNewborn Research Centre, The Royal Women's Hospital, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0002-9490-6377
Trisha M PrenticeNeonatal Medicine, The Royal Children's Hospital, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0003-4271-7950
Peter G DavisNewborn Research Centre, The Royal Women's Hospital, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0001-6742-7314
Brett J ManleyNewborn Research Centre, The Royal Women's Hospital, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0003-0212-7956

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Deferred consent has gained traction in some countries as a possible adjunct to prospective consent for evaluating emergency therapies in the neonatal population. This form of consent has been shown to increase recruitment of acutely and critically unwell patients, potentially reduce parent decision-making burden, and provide more robust evidence for clinical treatments where equipoise exists. However, deferred consent raises complex ethical concerns and guidelines for its use vary across different jurisdictions. The views of all stakeholders, including neonatal providers and parents, are important in determining the appropriateness of deferred consent in high-risk patients. Deferred consent may be ethically justifiable for assessing various treatments, particularly those used in emergency medical management. We present a framework based on neonatal deferred consent trials that assess both non-drug and drug interventions, our experience conducting deferred consent neonatal studies in Australia, and the views of providers and parents on how to best implement deferred consent in the neonatal research setting.

Indexed as

Informed ConsentParentsHumansInfant, NewbornProspective Studies

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.