Evidence map›Paper›PMID 34907503›Full record

ArticleCanadian journal of anaesthesia = Journal canadien d'anesthesie2022

Consent models in Canadian critical care randomized controlled trials: a scoping review.

Katie O'Hearn, Jess Gibson, Karla Krewulak, Rebecca Porteous, Victoria Saigle, Margaret Sampson, Anne Tsampalieros, Nick Barrowman, Saoirse Cameron, Canadian Critical Care Trials Group

Abstract readScoping Review
PubMed Publisher
In one paragraph

Article in Canadian journal of anaesthesia = Journal canadien d'anesthesie, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 28% of its field
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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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

10 authors at 4 institutions in 1 country.

Katie O'HearnChildren's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada. kohearn@cheo.on.ca.ORCID http://orcid.org/0000-0002-1149-2843
Jess GibsonChildren's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.
Karla KrewulakDepartment of Critical Care Medicine, Alberta Health Services & University of Calgary, Calgary, AB, Canada.
Rebecca PorteousDepartment of Critical Care Medicine, The Ottawa Hospital, Ottawa, ON, Canada.
Victoria SaigleClinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Margaret SampsonChildren's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.
Anne TsampalierosClinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
Nick BarrowmanClinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
Saoirse CameronChildren's Hospital - London Health Sciences Centre, London, ON, Canada.
Canadian Critical Care Trials Group
Children's Hospital of Eastern Ontario · CAOttawa Hospital · CAAlberta Health Services · CALondon Health Sciences Centre · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOur primary objective was to describe consent models used in Canadian-led adult and pediatric intensive care unit (ICU/PICU) randomized controlled trials (RCTs). Our secondary objectives were to determine the consent rate of ICU/PICU RCTs that did and did not use an alternate consent model to describe consent procedures. SOURCE: Using scoping review methodology, we searched MEDLINE, Embase, and CENTRAL databases (from 1998 to June 2019) for trials published in English or French. We included Canadian-led RCTs that reported on the effects of an intervention on ICU/PICU patients or their families. Two independent reviewers assessed eligibility, abstracted data, and achieved consensus. PRINCIPAL

findingsWe identified 48 RCTs of 17,558 patients. Included RCTs had ethics approval to use prior informed consent (43/48; 90%), deferred consent (13/48; 27%), waived consent (5/48; 10%), and verbal consent (1/48; 2%) models. Fifteen RCTs (15/48; 31%) had ethics approval to use more than one consent model. Twice as many trials used alternate consent between 2010 and 2019 (13/19) than between 2000 and 2009 (6/19). The consent rate for RCTs using only prior informed consent ranged from 54 to 91% (ICU) and 43 to 94% (PICU) and from 78 to 100% (ICU) and 74 to 87% (PICU) in trials using an alternate/hybrid consent model.

conclusionAlternate consent models were used in the minority of Canadian-led ICU/PICU RCTs but have been used more frequently over the last decade. This suggests that Canadian ethics boards and research communities are becoming more accepting of alternate consent models in ICU/PICU trials.

Indexed as

Critical CareIntensive Care Units, PediatricAdultCanadaChildHumansInformed ConsentRandomized Controlled Trials as Topiccritical caredeferred consentinformed consentintensive care unitpediatric intensive care unit

Identifiers

PMID34907503
OpenAlexW4200365535

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.