Evidence map›Paper›PMID 36750278›Full record

ArticleBMJ open2023

Advance consent for participation in randomised controlled trials for emergency conditions: a scoping review.

Naomi Niznick, Ronda Lun, Brian Dewar, Jeffrey Perry, Dar Dowlatshahi, Michel Shamy

Abstract readScoping Review
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Article
  2. 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

6 authors.

Naomi NiznickDivision of Neurology, Department of Medicine, Ottawa Hospital, Ottawa, Ontario, Canada naniznick@toh.ca.ORCID 0000-0003-0935-9135
Ronda LunDivision of Neurology, Department of Medicine, Ottawa Hospital, Ottawa, Ontario, Canada.ORCID 0000-0001-8455-8201
Brian DewarOttawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID 0000-0002-9222-5420
Jeffrey PerryOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Dar DowlatshahiDivision of Neurology, Department of Medicine, Ottawa Hospital, Ottawa, Ontario, Canada.
Michel ShamyDivision of Neurology, Department of Medicine, Ottawa Hospital, Ottawa, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAdvance consent is a recognised method of obtaining informed consent for participation in research, whereby a potential participant provides consent for future involvement in a study contingent on qualifying for the study's inclusion criteria on a later date. The goal of this study is to map the existing literature on the use of advance consent for enrolment in randomised controlled trials (RCTs) for emergency conditions.

designScoping review designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Extension for Scoping Reviews guidelines. DATA SOURCES: We searched electronic databases including MEDLINE, Embase, Web of Science and the Cochrane Register of Clinical Trials from inception to 10 February 2020. ELIGIBILITY CRITERIA: Eligible studies included articles that discussed or employed the use of advance consent for enrolment in RCTs related to emergency conditions. There were no restrictions on the type of eligible study. Data were extracted directly from included papers using a standardised data charting form. We produced a narrative review including article type and authors' dispositions towards advance consent.

resultsOur search yielded 1039 titles with duplicates removed. Six articles met inclusion criteria. Three articles discussed the theoretical use of research advance directives in emergency conditions; one article evaluated stakeholders' perceptions of advance consent; and one article described a method for patients to document their preferences for participation in future research. Only one study employed advance consent to enrol participants into a clinical trial for an emergency condition.

conclusionOur review demonstrates that there has been minimal exploration of advance consent for enrolment in RCTs for emergency conditions. Future studies could aim to assess the acceptability of advance consent to participants, along with the feasibility of enrolling research participants using this method of consent. PROTOCOL: The protocol for this scoping review was published a priori.

Indexed as

Informed ConsentHumansRandomized Controlled Trials as TopicACCIDENT & EMERGENCY MEDICINEMEDICAL ETHICSNEUROLOGY

Identifiers

PMID36750278
PMCPMC9906254

What OpenQuestion holds

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LicenceCC BY-NC
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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.