. 2021 Oct 28;22(1):145.

doi: 10.1186/s12910-021-00706-3.

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

Judy M Luu^#¹, Anand K Sergeant^#², Sonia S Anand^{3

4}, Dipika Desai¹, Karleen Schulze^{1

5}, Bartha M Knoppers⁶, Ma'n H Zawati⁶, Eric E Smith⁷, Alan R Moody⁸, Sandra E Black⁹, Eric Larose¹⁰, Francois Marcotte¹¹, Erika Kleiderman⁶, Jean-Claude Tardif¹², Douglas S Lee^{13

14}, Matthias G Friedrich¹⁵; CAHHM Study Investigators

Collaborators, Affiliations

Collaborators

CAHHM Study Investigators:
S Anand, M Friedrich, J Tu, P Awadalla, T Dummer, J Vena, P Broet, J Hicks, J-C Tardif, K Teo, B-M Knoppers, D Desai, S Nandakumar, M Thomas, S Zafar, K Schulze, L Dyal, A Casanova, S Bangdiwala, C Ramasundarahettige, K Ramakrishnana, Q Ibrahim, D Desai, H Truchon, N Tusevljak, K McDonald, N Noisel, J Chu, J Hicks, H Whelan, S Rangarajan, D Busseuil, J Leipsic, S Lear, V de Jong, M Noseworthy, K Teo, E Ramezani, N Konyer, P Poirier, A-S Bourlaud, E Larose, K Bibeau, J Leipsic, S Lear, V de Jong, E Smith, R Frayne, A Charlton, R Sekhon, A Moody, V Thayalasuthan, A Kripalani, G Leung, M Noseworthy, S Anand, R de Souza, N Konyer, S Zafar, G Paraga, L Reid, A Dick, F Ahmad, D Kelton, H Shah, F Marcotte, H Poiffaut, M Friedrich, J Lebel, E Larose, K Bibeau, R Miller, L Parker, D Thompson, J Hicks, J-C Tardif, H Poiffaut, J Tu, K Chan, A Moody, V Thayalasuthan, M Friedrich, E Smith, C McCreary, S E Black, C Scott, S Batool, F Gao, A Moody, V Thayalasuthan, E Larose, K Bibeau, F Marcotte, F Henriques, Jean Rouleau, Pierre Boyle, Caroline Wong, Eldon Smith, Bob Reid, Ian Janssen, Amy Subar, Rhian Touyz

Affiliations

¹ Population Health Research Institute, Hamilton Health Sciences, McMaster University, 237 Barton St East, Hamilton, ON, L8L 2X2, Canada.
² Arts and Science Program, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
³ Population Health Research Institute, Hamilton Health Sciences, McMaster University, 237 Barton St East, Hamilton, ON, L8L 2X2, Canada. anands@mcmaster.ca.
⁴ Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada. anands@mcmaster.ca.
⁵ Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
⁶ Centre of Genomics and Policy, McGill University, 740 Dr Penfield Ave, Suite 5200, Montréal, QC, H3A 0G1, Canada.
⁷ Department of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, Alberta, Canada.
⁸ Department of Medical Imaging, Sunnybrook Health Science Centre, University of Toronto, Toronto, ON, Canada.
⁹ Department of Medicine (Neurology), Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
¹⁰ Institut Universitaire de Cardiologie Et de Pneumologie de Québec - Université Laval, 2725 chemin Sainte-Foy, Québec, G1V 4G5, Canada.
¹¹ School of Population and Public Health and Cancer Control Research, BC Cancer, University of British Columbia, 675 W 10th Avenue, Vancouver, BC, V5Z 1L3, Canada.
¹² Research Centre, Montreal Heart Institute, Université de Montréal, 5000 Belanger Street, Montreal, QC, H1T 1C8, Canada.
¹³ Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.
¹⁴ Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
¹⁵ Department of Medicine and Diagnostic Radiology, McGill University, 1001 Decarie Boulevard, Montreal, QC, H4A 3J1, Canada.

^# Contributed equally.

PMID: 34711210
PMCID: PMC8551943
DOI: 10.1186/s12910-021-00706-3

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

Judy M Luu et al. BMC Med Ethics. 2021.

. 2021 Oct 28;22(1):145.

doi: 10.1186/s12910-021-00706-3.

Authors

Collaborators

CAHHM Study Investigators:
S Anand, M Friedrich, J Tu, P Awadalla, T Dummer, J Vena, P Broet, J Hicks, J-C Tardif, K Teo, B-M Knoppers, D Desai, S Nandakumar, M Thomas, S Zafar, K Schulze, L Dyal, A Casanova, S Bangdiwala, C Ramasundarahettige, K Ramakrishnana, Q Ibrahim, D Desai, H Truchon, N Tusevljak, K McDonald, N Noisel, J Chu, J Hicks, H Whelan, S Rangarajan, D Busseuil, J Leipsic, S Lear, V de Jong, M Noseworthy, K Teo, E Ramezani, N Konyer, P Poirier, A-S Bourlaud, E Larose, K Bibeau, J Leipsic, S Lear, V de Jong, E Smith, R Frayne, A Charlton, R Sekhon, A Moody, V Thayalasuthan, A Kripalani, G Leung, M Noseworthy, S Anand, R de Souza, N Konyer, S Zafar, G Paraga, L Reid, A Dick, F Ahmad, D Kelton, H Shah, F Marcotte, H Poiffaut, M Friedrich, J Lebel, E Larose, K Bibeau, R Miller, L Parker, D Thompson, J Hicks, J-C Tardif, H Poiffaut, J Tu, K Chan, A Moody, V Thayalasuthan, M Friedrich, E Smith, C McCreary, S E Black, C Scott, S Batool, F Gao, A Moody, V Thayalasuthan, E Larose, K Bibeau, F Marcotte, F Henriques, Jean Rouleau, Pierre Boyle, Caroline Wong, Eldon Smith, Bob Reid, Ian Janssen, Amy Subar, Rhian Touyz

Affiliations

¹ Population Health Research Institute, Hamilton Health Sciences, McMaster University, 237 Barton St East, Hamilton, ON, L8L 2X2, Canada.
² Arts and Science Program, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
³ Population Health Research Institute, Hamilton Health Sciences, McMaster University, 237 Barton St East, Hamilton, ON, L8L 2X2, Canada. anands@mcmaster.ca.
⁴ Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada. anands@mcmaster.ca.
⁵ Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
⁶ Centre of Genomics and Policy, McGill University, 740 Dr Penfield Ave, Suite 5200, Montréal, QC, H3A 0G1, Canada.
⁷ Department of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, Alberta, Canada.
⁸ Department of Medical Imaging, Sunnybrook Health Science Centre, University of Toronto, Toronto, ON, Canada.
⁹ Department of Medicine (Neurology), Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
¹⁰ Institut Universitaire de Cardiologie Et de Pneumologie de Québec - Université Laval, 2725 chemin Sainte-Foy, Québec, G1V 4G5, Canada.
¹¹ School of Population and Public Health and Cancer Control Research, BC Cancer, University of British Columbia, 675 W 10th Avenue, Vancouver, BC, V5Z 1L3, Canada.
¹² Research Centre, Montreal Heart Institute, Université de Montréal, 5000 Belanger Street, Montreal, QC, H1T 1C8, Canada.
¹³ Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.
¹⁴ Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
¹⁵ Department of Medicine and Diagnostic Radiology, McGill University, 1001 Decarie Boulevard, Montreal, QC, H4A 3J1, Canada.

^# Contributed equally.

PMID: 34711210
PMCID: PMC8551943
DOI: 10.1186/s12910-021-00706-3

Abstract

Background: In 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.

Methods: Between 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.

Results: Severe 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.

Conclusion: The 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 .

Keywords: Ethics; Incidental findings; Magnetic resonance imaging; Quality of life.

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Figures

**Fig. 1**
Reported change in quality of life in respondents with incidental findings of severe structural abnormalities (overall N = 74)

**Fig. 2**
Degree of stress caused in respondents with incidental findings of severe structural abnormalities (overall N = 74)

See this image and copyright information in PMC

References

1. Miller CG, Krasnow J, Schwartz LH. Medical imaging in clinical trials. London: Springer; 2014.
1. Wolf SM, Crock BN, Van Ness B, et al. Managing incidental findings and research results in genomic research involving biobanks and archived data sets. Genet Med. 2012;14(4):361–384. doi: 10.1038/gim.2012.23. - DOI - PMC - PubMed
1. Wolf SM, Paradise J, Caga-anan C. The law of incidental findings in human subjects research: establishing researchers' duties. J Law Med Ethics. 2008;36(2):361–383. doi: 10.1111/j.1748-720X.2008.00281.x. - DOI - PMC - PubMed
1. Government of Canada Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. How to Address Material Incidental Findings. Guidance in Applying TCPS 2 (2018) Article 3.4. 2018.
1. Oren O, Blankstein R, Bhatt DL. Incidental imaging findings in clinical trials. Jama. 2020. - PubMed

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

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

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