Evidence map›Paper›PMID 35509502›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2022

Ethical considerations within pragmatic randomized controlled trials in dementia: Results from a literature survey.

Stuart G Nicholls, Kelly Carroll, Hayden P Nix, Fan Li, Spencer Phillips Hey, Susan L Mitchell, Charles Weijer, Monica Taljaard

Abstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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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.

Stuart G NichollsClinical Epidemiology Program Ottawa Hospital Research Institute Ottawa Ontario Canada.ORCID https://orcid.org/0000-0003-0485-9069
Kelly CarrollClinical Epidemiology Program Ottawa Hospital Research Institute Ottawa Ontario Canada.
Hayden P NixSchulich School of Medicine & Dentistry Western University London Ontario Canada.
Fan LiDepartment of Biostatistics Yale School of Public Health New Haven Connecticut USA.
Spencer Phillips HeyCenter for Bioethics Harvard Medical School Boston Massachusetts USA.
Susan L MitchellHebrew SeniorLife Hinda and Arthur Marcus Institute for Aging Research Boston Massachusetts USA.
Charles WeijerDepartment of Medicine Western University London Ontario Canada.
Monica TaljaardClinical Epidemiology Program Ottawa Hospital Research Institute Ottawa Ontario Canada.

Funding

Training Core (I)U54AG063546 · NIA · BROWN UNIVERSITY · PI JOSEPH E. GAUGLER · 2019 to 2026
$125.9M
NIA NIH HHS U54 AG063546
6 · The paper itself

Abstract

Introduction: This review aims to describe the landscape of pragmatic randomized controlled trials (RCTs) in the context of Alzheimer's disease (AD) and related dementias with respect to ethical considerations. Methods: Searches of MEDLINE were performed from January 2014 until April 2019. Extracted information included: trial setting, interventions, data collection, study population, and ethical protections (including ethics approvals, capacity assessment, and informed consent). Results: We identified 62 eligible reports. More than two-thirds (69%) included caregivers or health-care professionals as research participants. Fifty-eight (94%) explicitly identified at least one vulnerable group. Two studies did not report ethics approval. Of 57 studies in which patients were participants, 55 (96%) reported that consent was obtained but in 37 studies (67%) no mention was made regarding assessment of the patients' capacity to consent to research participation. Discussion: Few studies reported protections implemented when vulnerable participants were included. Shortcomings remain when reporting consent approaches and capacity assessment.

Indexed as

capacityconsentethicsresearch participant

Identifiers

PMID35509502
PMCPMC9060321

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.