How to report incidental findings from population whole-body MRI: view of participants of the German National Cohort

Hegedüs, P.; Stackelberg, Oyunbileg von; Neumann, Christoph; Selder, Sonja; Werner, N.; Erdmann, Pia; Granitza, Anja; Völzke, Henry; Bamberg, Fabian; Kaaks, Rudolf; Bertheau, Robert C.; Kauczor, Hans Ulrich; Schlett, Christopher L.; Weckbach, Sabine

doi:10.1007/s00330-019-06077-z

Cited by 19 publications

(12 citation statements)

References 25 publications

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“…Regarding psychosocial impact, only a small portion (3.4 %) reported that waiting for the IF disclosure added "definitely" or "very probably" additional stress burden, which is less than the 9.9 % of participants noticing strong distress while waiting for the IF report found by Schmidt et al in the Study of Health in Pomerania (SHIP) [9]. Our results are also congruent to findings of Hegedüs et al, who found not only that 95 % of participants considered the report of IF as very important and 55 % as beneficial to health status, but also that waiting for the IF report caused minimal stress levels, whereas high stress levels were reported when participants received an IF letter [17]. In our cohort only 9.1 % of participants with reported IF considered the results as "very burdening" and there was no increased rate of moderate or severe depression in the post-scan survey based on the PHQ-9 in participants with reported IF compared to participants without IF.…”

Section: Discussionsupporting

confidence: 90%

Incidental findings in whole-body MR imaging of a population-based cohort study: Frequency, management and psychosocial consequences

Schlett

Rospleszcz²,

Korbmacher

et al. 2021

European Journal of Radiology

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Management of incidental findings (IF) remains controversial but highly relevant. Our aim was to assess the frequency, management and psychosocial consequences of IF reporting in a population-based cohort study undergoing whole-body MR imaging. Methods: The study was nested in a prospective cohort from a longitudinal, population-based cohort (KORA-FF4) in southern Germany. All MR obtained on 3 T MR scanner were reviewed by board-certified radiologists regarding clinically relevant IF. A baseline and follow-up questionnaires including PHQ-9 were completed prior to and 6-month after to the scan. Results: Of 400 participants (56.3 ± 9.2years, 58 % male) undergoing whole-body MR, IF were found in 22 % of participants (n = 89); most frequently located in the abdominal sequences. In the pre-scan survey, most participants stated as the motivation that they wanted to "contribute to a scientific purpose" (91 %), while "knowing whether I'm healthy" was the most frequent motivation reported 6 months post-scan (88 %). The desire for IF reporting increased over time (pre-vs. 6-months-post-scan), also for clinically less important IF (72 % vs. 84 %, p = 0.001). Regarding psychosocial impact, a small portion (3.4 %) reported that awaiting the IF report added "definitely" or "very probably" additional stress burden. Of participants with reported IF, 56.8 % classified the results as "very helpful". In the post-scan survey moderate depression was observed in 3.3 % and severe depression in 1.2 %. This did not differ between participants with and without reported IF. Conclusion:In a cohort with whole-body MR imaging, the prevalence of IF was high. Participants considered reporting of IF highly important and added only minor psychological burden.

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Section: Discussionsupporting

confidence: 90%

Incidental findings in whole-body MR imaging of a population-based cohort study: Frequency, management and psychosocial consequences

Schlett

Rospleszcz²,

Korbmacher

et al. 2021

European Journal of Radiology

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“…21,22,23 A few research groups have looked into research participants' preferences, mapping the preferences and expectations of research participants regarding the disclosure of incidental findings. 24,25,26,27 This research showed that >90% of the participants would want to be informed about an incidental finding, regardless of its clinical relevance. 28 Also, most research participants expected that if they had abnormalities, these would be discovered through research imaging, despite being informed otherwise during the informed consent process.…”

Section: Introductionmentioning

confidence: 83%

The Impact of Incidental Findings Detected During Brain Imaging on Research Participants of the Rotterdam Study: An Interview Study

Bomhof¹,

Bodegom²,

Vernooij³

et al. 2020

Camb Q Healthc Ethics

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This interview study investigates the short- and long-term implications of incidental findings detected through brain imaging on research participants’ lives and their surroundings. For this study, nine participants of the Rotterdam Scan Study with an incidental finding were approached and interviewed. When examining research participants’ narratives on the impact of the disclosure of incidental findings, the authors identified five sets of tensions with regard to motivations for and expectations of research participation, preferences regarding disclosure, short- and long-term impacts and impacts on self and others. The paper shows: (1) that the impact of incidental findings may be greater than participants at first let on; (2) incidental findings can have significant effects on participants’ social environment; and (3) participants may not feel prepared for disclosure even if incidental findings have been discussed during the informed consent process. The authors call for investigators to be aware of research participants’ experiences and these short- and long-term impacts when designing suitable courses of action for the detection and management of incidental findings in research settings.

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“…general practitioner appointments and specialist referrals, or further investigations including imaging and invasive procedures) in almost all cases [2]. Information on the factors associated with increased risk of detection and feedback of a PSIF (and therefore of subsequent clinical assessment), and with increased risk of eventually receiving a serious final diagnosis may influence individuals’ decisions to consent to participate in imaging research [3–5] and inform researchers’ designs of appropriate PSIFs policies, which are required by major research funders [6, 7].…”

Section: Introductionmentioning

confidence: 99%

Factors associated with potentially serious incidental findings and with serious final diagnoses on multi-modal imaging in the UK Biobank Imaging Study: A prospective cohort study

et al. 2019

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Background Feedback of potentially serious incidental findings (PSIFs) to imaging research participants generates clinical assessment in most cases. Understanding the factors associated with increased risks of PSIFs and of serious final diagnoses may influence individuals’ decisions to participate in imaging research and will inform the design of PSIFs protocols for future research studies. We aimed to determine whether, and to what extent, socio-demographic, lifestyle, other health-related factors and PSIFs protocol are associated with detection of both a PSIF and a final diagnosis of serious disease. Methods and findings Our cohort consisted of all UK Biobank participants who underwent imaging up to December 2015 (n = 7334, median age 63, 51.9% women). Brain, cardiac and body magnetic resonance, and dual-energy x-ray absorptiometry images from the first 1000 participants were reviewed systematically by radiologists for PSIFs. Thereafter, radiographers flagged concerning images for radiologists’ review. We classified final diagnoses as serious or not using data from participant surveys and clinical correspondence from GPs up to six months following imaging (either participant or GP correspondence, or both, were available for 93% of participants with PSIFs). We used binomial logistic regression models to investigate associations between age, sex, ethnicity, socio-economic deprivation, private healthcare use, alcohol intake, diet, physical activity, smoking, body mass index and morbidity, with both PSIFs and serious final diagnoses. Systematic radiologist review generated 13 times more PSIFs than radiographer flagging (179/1000 [17.9%] versus 104/6334 [1.6%]; age- and sex-adjusted OR 13.3 [95% confidence interval (CI) 10.3–17.1] p<0.001) and proportionally fewer serious final diagnoses (21/179 [11.7%]; 33/104 [31.7%]). Risks of both PSIFs and of serious final diagnoses increased with age (sex-adjusted ORs [95% CI] for oldest [67–79 years] versus youngest [44–58 years] participants for PSIFs and serious final diagnoses respectively: 1.59 [1.07–2.38] and 2.79 [0.86 to 9.0] for systematic radiologist review; 1.88 [1.14–3.09] and 2.99 [1.09–8.19] for radiographer flagging). No other factor was significantly associated with either PSIFs or serious final diagnoses. Our study is the largest so far to investigate the factors associated with PSIFs and serious final diagnoses, but despite this, we still may have missed some associations due to sparsity of these outcomes within our cohort and small numbers within some exposure categories. Conclusion Risks of PSIFs and serious final diagnosis are substantially influenced by PSIFs protocol and to a lesser extent by age. As only 1/5 PSIFs represent serious disease, evidence-based PSIFs protocols are paramount to minimise over-investigation of healthy research participants and diversion of limited health services away from patients in need.

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How to report incidental findings from population whole-body MRI: view of participants of the German National Cohort

Cited by 19 publications

References 25 publications

Incidental findings in whole-body MR imaging of a population-based cohort study: Frequency, management and psychosocial consequences

Incidental findings in whole-body MR imaging of a population-based cohort study: Frequency, management and psychosocial consequences

The Impact of Incidental Findings Detected During Brain Imaging on Research Participants of the Rotterdam Study: An Interview Study

Factors associated with potentially serious incidental findings and with serious final diagnoses on multi-modal imaging in the UK Biobank Imaging Study: A prospective cohort study

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