How to report incidental findings from population whole-body MRI: view of participants of the German National Cohort.
Eur Radiol
; 29(11): 5873-5878, 2019 Nov.
Article
em En
| MEDLINE
| ID: mdl-30915558
ABSTRACT
OBJECTIVES:
In the German National Cohort (GNC), 30,000 individuals are examined with whole-body MRI (wbMRI), of which about 3000 participants are expected to receive an incidental finding (IF) disclosure. In order to get feedback from participants and to evaluate the IF-management procedure of the wbMRI substudy, a follow-up questionnaire was developed. This single-center pilot trial was aimed to get a first impression on feasibility reproducibility and validity of such a survey in order to take necessary adjustments before initiating the survey among several thousand participants.METHODS:
The questionnaires were sent out in test-retest manner to 86 participants who received a wbMRI examination in January-February 2016 at the imaging center in Neubrandenburg. The ratio of participants with and without IF notification was 11. Descriptive statistics was performed.RESULTS:
A first response of 94% and completion proportion of 99% were achieved. Participants were satisfied with the examination procedure. Ninety-five percent of participants considered it very important to receive notification of IFs. Participants reported minimal stress levels while waiting for a possible IF notification letter, but high stress levels when an IF letter was received. Phrasing of the IF reports was rated in 97% as well understandable and in 55% as beneficial to health status.CONCLUSIONS:
This 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-based imaging. KEY POINTS ⢠Evidence-based guidelines for reporting incidental findings in population whole-body MRI are lacking. ⢠Pilot-testing of a questionnaire for the evaluation of practical and ethical aspects of the procedure to report incidental findings in the German National Cohort shows a high level of acceptance and high return rate by participants. ⢠Participants reported minimal stress levels while waiting for a possible incidental finding notification letter, which increased significantly, when such a letter was received.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imageamento por Ressonância Magnética
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Achados Incidentais
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Imagem Corporal Total
Tipo de estudo:
Diagnostic_studies
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Guideline
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Observational_studies
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Prognostic_studies
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Qualitative_research
Limite:
Female
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Humans
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Male
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Middle aged
País/Região como assunto:
Europa
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article