Keywords:
Management, Computer applications, Professional issues, MR, Ethics, Decision analysis, Diagnostic procedure, Epidemiology
Authors:
P. Hegedüs1, O. von Stackelberg1, C. Neumann1, S. Selder2, N. Werner3, R. C. Bertheau1, H. U. Kauczor1, C. L. Schlett1, S. Weckbach1; 1Heidelberg/DE, 2Munich/DE, 3Greifswald/DE
DOI:
10.26044/ecr2019/C-3688
Aims and objectives
The German National Cohort (GNC) is an interdisciplinary,
multicentre,
population-based cohort study currently undertaken by a network of over 25 institutions in Germany.
Its main goal is the investigation of the development of common chronic diseases (including cancer,
diabetes,
cardiovascular,
neurodegenerative/psychiatric,
respiratory and infectious diseases).
While all 200,000 volunteers of the GNC undergo an initial extended 2.5 hours exam including interviews,
questionnaires and a variety of physical exams,
a subgroup of 30,000 examinees will undergo whole-body magnetic resonance imaging (wbMRI) of which about 3,000 participants are expected to receive an incidental finding (IF) disclosure.
Image acquisition for the MRI Study is conducted at five imaging centres across Germany.
wbMRI is comprised of a set of scientific sequences.
Reading for IFs is performed at the imaging sites by board certified and especially trained radiologists and quality assurance procedures are in place.
In the GNC IF management policy includes an established list of IFs developed by a scientific board,
that classifies IFs as „urgent notification required” (type 1),
„notification required” (type 2) and „no notification required” (type 3) [1] similarly to the classification matrix proposed by Wolf and her colleagues [2].
Participants with detected IFs are informed by a standardised letter and in case of a type 1 finding by an additional phone call [3].
As main advantage of this “positive list” it is assumed that the communication of clinically relevant findings is in the best interest and of benefit to the study participants mainly regarding possible treatment options and that adverse effects from reporting of non-relevant findings are reduced to a minimum.
IFs detected in wbMRI research exams are quite challenging due to the lack of sufficient data for the development of a uniform international management strategy.
Leading international committees therefore point out the importance of extensive examination of the ethical and scientific aspects regarding IF [4-6],
but still,
there is no consented (fully validated,
reliable and objective) measure of these aspects.
In order to get feedback from participants and to evaluate the IF-management procedure of the wbMRI substudy,
a follow-up questionnaire was developed.
With the primary objective of internal quality management (optimization of processes,
analysis of participants’ contentment) and with the scientific and ethical interest to contribute to the development of evidence-based practice guidelines concerning the complex approach to IFs,
a follow-up (FU) questionnaire was developed.
This instrument will be sent to all participants who received a report of an IF (along with a control group) 6-7 months following a wbMRI in any of the GNC study centres in order to channel their feed-back regarding attitude,
experiences and cooping with disclosed IFs.
This single centre pilot trial was aimed to get a first impression on feasibility and response rate of such a survey and take necessary adjustments before initiating the survey among several thousand participants.