• Disclosed incidental findings from MRI may lead to substantial psychosocial distress. • Subjective and radiological evaluations of incidental findings' severity differ strongly. • Disclosing incidental findings is strongly endorsed by study volunteers. • Study volunteers tend to have false expectations about potential benefits from MRI. • Minimizing stress in study volunteers should be a key aim in MRI research.

BackgroundIndividualized Medicine aims at providing optimal treatment for an individual patient at a given time based on his specific genetic and molecular characteristics. This requires excellent clinical stratification of patients as well as the availability of genomic data and biomarkers as prerequisites for the development of novel diagnostic tools and therapeutic strategies. The University Medicine Greifswald, Germany, has launched the “Greifswald Approach to Individualized Medicine” (GANI_MED) project to address major challenges of Individualized Medicine. Herein, we describe the implementation of the scientific and clinical infrastructure that allows future translation of findings relevant to Individualized Medicine into clinical practice.Methods/designClinical patient cohorts (N > 5,000) with an emphasis on metabolic and cardiovascular diseases are being established following a standardized protocol for the assessment of medical history, laboratory biomarkers, and the collection of various biosamples for bio-banking purposes. A multi-omics based biomarker assessment including genome-wide genotyping, transcriptome, metabolome, and proteome analyses complements the multi-level approach of GANI_MED. Comparisons with the general background population as characterized by our Study of Health in Pomerania (SHIP) are performed. A central data management structure has been implemented to capture and integrate all relevant clinical data for research purposes. Ethical research projects on informed consent procedures, reporting of incidental findings, and economic evaluations were launched in parallel.

Outpatient dementia healthcare is predominantly fragmented, and dementia networks (DNs) represent an integrated care concept to overcome this problem. Little is known about the patients of these networks with regard to utilisation of physicians and associated factors. We interviewed 560 caregivers of people with dementia in 13 different DNs in Germany in 2013 and assessed socio-demographics, clinical data and physician utilisation. Networks were categorised in predominantly medical DNs and community-oriented DNs. Descriptive and multivariate statistical models were used to identify associated factors between DNs and users' data. Overall, the users of networks received high rates of physician care; 93% of the sample stated at least one contact with a primary care physician within the last 6 months, and 74% had been treated by a specialist (neurology/psychiatry physician). Only 5% of the sample had no contact with a physician in the 6 months preceding the interview. Females showed a lower odds for physician specialist consultations (OR = 0.641). Users of medical DNs receive greater specialist consultations overall (OR = 8.370). Compared to the German general population and people with dementia in other settings, users of DNs receive physician care more regularly, especially with regard to the consultations of neurologist/psychiatrists. Therefore, DNs seem to perform a supportive role within the integration of physician healthcare. More research is needed on the appropriate relationship between the needs of the people with dementia and utilisation behaviour.

In the case of non-symptomatic volunteers, the result of the risk-benefit-assessment seems to be less distinctive. Given that disclosing results can, at least initially, cause severe distress and harm and taking into account that research examinations have a significantly increased risk of producing false-positive findings, we suggest to make use of a research-ethical "princple of caution" that supports a restrictive disclosure policy for the second group of potential study participants. This differentiated view on the benefits of disclosed findings in AD research is reflected in recommendations for the set-up of return of result processes.