The effects of incidental findings from whole-body MRI on the frequency of biopsies and detected malignancies or benign conditions in a general population cohort study

Abstract

Magnetic resonance imaging (MRI) yields numerous tumor-related incidental findings (IFs) which may trigger diagnostics such as biopsies. To clarify these effects, we studied how whole-body MRI IF disclosure in a population-based cohort affected biopsy frequency and the detection of malignancies. Laboratory disclosures were also assessed. Data from 6753 participants in the Study of Health in Pomerania (SHIP) examined between 2008 and 2012 were utilized. All underwent laboratory examinations and 3371 (49.9%) a whole-body MRI. Electronic biopsy reports from 2002 to 2017 were linked to participants and assigned to outcome categories. Biopsy frequency 2 years pre- and post-SHIP was investigated using generalized estimating equations with a negative-binomial distribution. Overall 8208 IFs (laboratory findings outside reference limits: 6839; MRI: 1369) were disclosed to 4707 participants; 2271 biopsy reports belonged to 1200 participants (17.8%). Of these, 938 biopsies occurred pre-SHIP; 1333 post-SHIP (event rate/100 observation years = 6.9 [95% CI 6.5; 7.4]; 9.9 [9.3; 10.4]). Age, cancer history, recent hospitalization, female sex, and IF disclosure were associated with higher biopsy rates. Nonmalignant biopsy results increased more in participants with disclosures (post-/pre-SHIP rate ratio 1.39 [95% CI 1.22; 1.58]) than without (1.09 [95% CI 0.85; 1.38]). Malignant biopsy results were more frequent post-SHIP (rate ratio 1.74 [95% CI 1.27; 2.42]). Biopsies increased after participation in a population-based cohort study with MRI and laboratory IF disclosure. Most biopsies resulted in no findings and few malignancies were diagnosed, indicating potential overtesting and overdiagnosis. A more restrictive policy regarding IF disclosure from research findings is required.

Effects of whole-body MRI on outpatient health service costs: a general-population prospective cohort study in Mecklenburg-Vorpommern, Germany

“…From a clinical perspective, overtesting and overdiagnosis are likely. 3 13 These results underscore in line with previous findings, 14 15 that restrictive communication policies seem recommendable to protect research participants and the public from questionable clinical actions and costs while safeguarding observational research aims.…”

“…The methods descriptions in MRI examination and Disclosure of IFs have been taken from previous SHIP publications. 14 15 …”

“…2 On the other hand, another study analysing biopsy results within the SHIP cohort found that despite the large numbers of tumour-related findings, few additional malignancies were detected. 14 This is likely related to the low pretest probability of finding severe, previously undiagnosed clinical conditions in a general population sample. Other analyses of SHIP data found that participants experienced increased psychosocial distress after the disclosure of IFs, 16 yet no effects on quality of life were found 2-3 years after the wb-MRI examination.…”

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

“…Presently, the inconsistent management of IF in imaging studies can certainly be attributed to the different expectations of stakeholders involved in balancing disclosure and associated ethical problems and withholding information from participants because of potential harm caused by IF [21][22][23][24][25]. As a consequence, and consistent with Bunnik et al, a stringent strategy of reviewing study scans and disclosing IF should be established taking into account seven steps, which include a reasonable cost management, researchers` moral obligations and the principle of reciprocity to address the participants` wish for reporting IF [26].…”

SHIP-MR and Radiology: 12 Years of Whole-Body Magnetic Resonance Imaging in a Single Center

“…In 2020, Richter et al [ 13 ] examined the relationship of disclosing incidental findings (IFs) to MRI participants and subsequent biopsies and histologic examinations. Biopsies increased in participants with disclosed IFs and abnormal laboratory values after examination.…”