Abstract
Objectives
To describe the implementation and protocol of cerebral magnetic resonance imaging (MRI) in the longitudinal BiDirect study and to report rates of study participation as well as management of incidental findings.
Methods
Data came from the BiDirect study that investigates the relationship between depression and arteriosclerosis and comprises 2258 participants in three cohorts: 999 patients with depression, 347 patients with manifest cardiovascular disease (CVD) and 912 population-based controls. The study program includes MRI of the brain. Reasons for non-participation were systematically collected. Incidental findings were categorized and disclosed according to clinical relevance.
Results
At baseline 2176 participants were offered MRI, of whom 1453 (67 %) completed it. Reasons for non-participation differed according to cohort, age and gender with controls showing the highest participation rate of 79 %. Patient cohorts had higher refusal rates and CVD patients a high prevalence of contraindications. In the first follow-up examination 69 % of participating subjects completed MRI.
Incidental findings were disclosed to 246 participants (17 %). The majority of incidental findings were extensive white matter hyperintensities requiring further diagnostic work-up.
Conclusions
Knowledge about subjects and sensible definition of incidental findings are crucial for large-scale imaging projects. Our data offer practical and concrete information for the design of future studies.
Key points
• Willingness to participate in MRI is generally high, also in follow-up examinations.
• Rates of refusal and prevalence of contraindications differ according to subject characteristics.
• Extensive white matter hyperintensities considerably increase the disclosure rates of incidental findings.
• MRI workflow requires continuous case-by-case handling by an interdisciplinary team.
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Abbreviations
- BL:
-
Baseline
- CI:
-
Contraindication
- CVD:
-
Cardiovascular disease
- fMRI:
-
Functional magnetic resonance imaging
- FU:
-
Follow-up
- IF:
-
Incidental finding
- MRI:
-
Magnetic resonance imaging
- OR:
-
Odds ratio
- rs-fMRI:
-
Resting-state functional magnetic resonance imaging
- WMH:
-
White matter hyperintensity
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Acknowledgments
We would like to thank all study participants for their time and engagement. Further words of gratitude are owed to each and everyone who tirelessly contributes to cope with organisational challenges, data collection, data maintenance and data processing on a daily basis. The scientific guarantor of this publication is Klaus Berger. The authors of this manuscript declare relationships with the following companies: Klaus Berger reports grants from the German Federal Ministry of Education and Research (BMBF) and multiple institutions outside of the submitted work.
The remaining authors (Anja Teuber, Benedikt Sundermann, Harald Kugel, Walter Heindel, Jens Minnerup, Udo Dannlowski and Heike Wersching) of this manuscript declare no relationships with any companies whose products or services may be related to the subject matter of the article.
This study has received funding from the German Federal Ministry of Education and Research (BMBF, grants FKZ-01ER0816 and FKZ-01ER1205). Several authors (Anja Teuber, Klaus Berger, Heike Wersching) have significant statistical expertise. Institutional review board approval was obtained. Written informed consent was obtained from all subjects (patients) in this study. Some study subjects or cohorts have been previously reported in BMC Psychiatry (2014) 14:174. Methodology: prospective, observational, performed at one institution
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Teuber, A., Sundermann, B., Kugel, H. et al. MR imaging of the brain in large cohort studies: feasibility report of the population- and patient-based BiDirect study. Eur Radiol 27, 231–238 (2017). https://doi.org/10.1007/s00330-016-4303-9
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DOI: https://doi.org/10.1007/s00330-016-4303-9