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
Conclusion
In this pilot trial we observed a very high response rate and low rate of missing answers with no difference regarding the presence of IF.
This result encourages us to conduct this survey in a larger group of participants.
Our questionnaire was developed by experts,
based on the questionnaire developed by Erdmann et al.
used in the SHIP study along with its modifications for the KORA study.
All questions were designed with the primary objective to receive feedback on ethically and scientifically relevant questions.
The nature of some questions does not exclusively aim at statistical or numerical values but rather takes other aspects into account,
e.g.
open questions regarding the responders’ free opinions or multiple choice questions regarding the processes of clinical verification of disclosed IFs. A strong external validity can be appraised as the result of an extensive contribution of experts in further improvement of Erdmann´s questionnaire.
However,
it contains questions which are not fully validated with regards to ethical aspects of IF-reporting.
In line with this we must emphasize the close relation to the only measure that is in a quality state exceeding preliminary stages of work from Erdmann [9] within the SHIP study.
This close relation accounts for a good internal validity of the current instrument.
The established external and reasonable internal validity,
the quality criteria of feasibility and effectivity through a high response ratio make it a promising instrument.
With this follow-up instrument researchers of the GNC will be able to acquire feedback to methodological questions regarding the examination setup and logistics,
as well as to ethical questions regarding,
e.g.,
diagnostic misconception or distress through written IF disclosure.
The questionnaire will also enable us to assess radiological questions such as the frequency of true and false positive IFs,
e.g.,
the proven incidence of malignant masses among participants with reported suspicious lesions.
In summary,
the IF FU questionnaire will serve researchers within the GNC as a fundamental instrument not only for quality management analyses,
but also for the investigation of still unacknowledged scientific and ethical questions contributing to evidence-based guidelines concerning the complex approach to IFs in future population-bases imaging.
The experience gained from the pilot trial was very helpful to improve the questionnaire and overall implementation process.
In April 2017,
we started to distribute the FU questionnaire to selected participants of the wbMRI substudy.
Until the end of 2020 we expect to receive feedback from more than 3,000 participants.