Evidence map›Paper›PMID 38459367›Full record

ArticleCanadian journal of anaesthesia = Journal canadien d'anesthesie2024

Public perception of participation in low-risk clinical trials in critical care using waived consent: a Canadian national survey.

Dawn Opgenorth, D'Arcy J Duquette, Linda Tyre, Robyn Auld, Kim Crowder, Peggy Gilchrist, Paul J Young, Sean M Bagshaw

Abstract read
PubMed Publisher
In one paragraph

Article in Canadian journal of anaesthesia = Journal canadien d'anesthesie, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

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

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

  1. Pooled it
  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

8 authors.

Dawn OpgenorthDepartment of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, and Alberta Health Services, Edmonton, AB, Canada.
D'Arcy J DuquetteIntensive Care Patient and Family Partnership Committee, Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Linda TyreIntensive Care Patient and Family Partnership Committee, Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Robyn AuldIntensive Care Patient and Family Partnership Committee, Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Kim CrowderIntensive Care Patient and Family Partnership Committee, Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Peggy GilchristIntensive Care Patient and Family Partnership Committee, Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Paul J YoungIntensive Care Unit, Wellington Hospital, Wellington, New Zealand.
Sean M BagshawDepartment of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, and Alberta Health Services, Edmonton, AB, Canada. bagshaw@ualberta.ca.ORCID 0000-0003-3633-6596

Funding

Institute of Circulatory and Respiratory Health 399343
6 · The paper itself

Abstract

purposeThe acceptability of waiver of consent for participation in clinical research in intensive care unit (ICU) settings is uncertain. We sought to survey the Canadian public to assess levels of support, comfort, and acceptability for waived consent for low-risk clinical trials.

methodsWe performed a prospective cross-sectional survey of the Canadian public aged 18 yr or older. The survey was conducted by Ipsos between 19 and 23 November 2020. The survey content was derived from a literature review and in consultation with a patient and family partnership committee. The survey focused on attitudes and beliefs on waived consent for participation in low-risk clinical trials in ICU settings. The survey contained 35 items focused on sociodemographics, general health status, participation in medical research, and levels of support and comfort with research and with waived consent. The survey used a case study of a low-risk clinical trial intervention in ICU patients. Analysis was descriptive.

resultsWe included 2,000 participants, 38% of whom reported experience with ICU and 16% with medical research. Participation in medical research was more common among those with postsecondary education, those with chronic disease, and those who were employed in health care. Most (80%) would support a model of waived consent for low-risk clinical trials, citing medical benefits (36%) and low perceived risk (34%). Most (77%) were comfortable with personally participating in a low-risk clinical trial. Most (80%) believed waived consent approaches were acceptable. Half (52%) believed the waived consent process should provide information about the research and include the option of opting out. When asked whether participants should always give full informed consent, regardless of the practicality or level of risk, 74% and 72% agreed, respectively.

conclusionsThere is public support for models of waived consent for participation in low-risk pragmatic clinical trials in ICU settings in Canada; however, this is not universal. This information can inform and guide education, ethics, policy, and legal discussion on consent models.

Indexed as

Clinical Trials as TopicCritical CareInformed ConsentAdolescentAdultAgedCanadaCross-Sectional StudiesFemaleHumansIntensive Care UnitsMaleMiddle AgedProspective StudiesPublic OpinionSurveys and Questionnairesbed capacityhealth care providerintensive care unitspatient-centred carephysician-patient relationsquality

Identifiers

PMID38459367

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.