Evidence map›Paper›PMID 34711210›Full record

ArticleBMC medical ethics2021

The impact of reporting magnetic resonance imaging incidental findings in the Canadian alliance for healthy hearts and minds cohort.

Judy M Luu, Anand K Sergeant, Sonia S Anand, Dipika Desai, Karleen Schulze, Bartha M Knoppers, Ma'n H Zawati, Eric E Smith, Alan R Moody, Sandra E Black and 7 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical ethics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02220582 (A Pan-Canadian, Multi-ethnic Cohort Study in Healthy Participants Aimed to Better Understand the Impact of Individual, Socioeconomic and Other Environmental Factors Leading to Cardiac and Vascular Disease), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT02220582 completednot on this map

A Pan-Canadian, Multi-ethnic Cohort Study in Healthy Participants Aimed to Better Understand the Impact of Individual, Socioeconomic and Other Environmental Factors Leading to Cardiac and Vascular Disease

TypeobservationalSponsorMontreal Heart InstituteRan2013 to 2019Enrolled7,900ConditionsCardiovascular DiseasesArmsMRI
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Returning Incidental Research Findings FromArthritis care & research · 2024
    Article
  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

17 authors.

Judy M Luu *Population Health Research Institute, Hamilton Health Sciences, McMaster University, 237 Barton St East, Hamilton, ON, L8L 2X2, Canada.
Anand K Sergeant *Arts and Science Program, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Sonia S AnandPopulation Health Research Institute, Hamilton Health Sciences, McMaster University, 237 Barton St East, Hamilton, ON, L8L 2X2, Canada. anands@mcmaster.ca.ORCID 0000-0003-3692-7441
Dipika DesaiPopulation Health Research Institute, Hamilton Health Sciences, McMaster University, 237 Barton St East, Hamilton, ON, L8L 2X2, Canada.
Karleen SchulzePopulation Health Research Institute, Hamilton Health Sciences, McMaster University, 237 Barton St East, Hamilton, ON, L8L 2X2, Canada.
Bartha M KnoppersCentre of Genomics and Policy, McGill University, 740 Dr Penfield Ave, Suite 5200, Montréal, QC, H3A 0G1, Canada.
Ma'n H ZawatiCentre of Genomics and Policy, McGill University, 740 Dr Penfield Ave, Suite 5200, Montréal, QC, H3A 0G1, Canada.
Eric E SmithDepartment of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, Alberta, Canada.
Alan R MoodyDepartment of Medical Imaging, Sunnybrook Health Science Centre, University of Toronto, Toronto, ON, Canada.
Sandra E BlackDepartment of Medicine (Neurology), Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Eric LaroseInstitut Universitaire de Cardiologie Et de Pneumologie de Québec - Université Laval, 2725 chemin Sainte-Foy, Québec, G1V 4G5, Canada.
Francois MarcotteSchool of Population and Public Health and Cancer Control Research, BC Cancer, University of British Columbia, 675 W 10th Avenue, Vancouver, BC, V5Z 1L3, Canada.
Erika KleidermanCentre of Genomics and Policy, McGill University, 740 Dr Penfield Ave, Suite 5200, Montréal, QC, H3A 0G1, Canada.
Jean-Claude TardifResearch Centre, Montreal Heart Institute, Université de Montréal, 5000 Belanger Street, Montreal, QC, H1T 1C8, Canada.
Douglas S LeeInstitute for Clinical Evaluative Sciences, Toronto, ON, Canada.ORCID 0000-0001-7078-745X
Matthias G FriedrichDepartment of Medicine and Diagnostic Radiology, McGill University, 1001 Decarie Boulevard, Montreal, QC, H4A 3J1, Canada.
CAHHM Study Investigators

Funding

CIHR Foundation Grant FDN-143255CIHR Foundation Grant FDN-143313CIHR Foundation Grant FDN 154317
6 · The paper itself

Abstract

backgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.

methodsBetween 2013 and 2019, 8252 participants (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.

resultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7-8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.

conclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies. Clinical trial registration https://clinicaltrials.gov/ct2/show/NCT02220582 .

Indexed as

Incidental FindingsQuality of LifeAgedBrainCanadaFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedEthicsIncidental findingsMagnetic resonance imagingQuality of life

Identifiers

PMID34711210
PMCPMC8551943

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Registered trials

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.