Impact of detecting potentially serious incidental findings during multi-modal imaging

Wellcome Open Research

article

Lorna M Gibson¹  Thomas J Littlejohns²  Ligia Adamska²  Steve Garratt³  Nicola Doherty³  Joanna M Wardlaw⁴  Giles Maskell⁵  Michael Parker⁶  Roger Brownsword⁷  Paul M Matthews³  Rory Collins²  Naomi E Allen²  Jonathan Sellors²  Cathie LM Sudlow¹ 

[1] Usher Institute of Population Health Sciences and Informatics, University of Edinburgh;Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford;UK Biobank Coordinating Centre;Centre for Clinical Brain Sciences, University of Edinburgh;Royal Cornwall Hospitals NHS Trust;Ethox Centre, Nuffield Department of Population Health, University of Oxford;The Dickson Poon School of Law, King’s College London;Division of Brain Sciences, Department of Medicine, Hammersmith Hospital, Imperial College London

关键词: incidental findings;    magnetic resonance imaging;    dual-energy X-ray absorptiometry;    false positives;    false negatives;    research ethics;   

DOI  :  10.12688/wellcomeopenres.13181.3

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Background: There are limited data on the impact of feedback of incidental findings (IFs) from research imaging.  We evaluated the impact of UK Biobank’s protocol for handling potentially serious IFs in a multi-modal imaging study of 100,000 participants (radiographer ‘flagging’ with radiologist confirmation of potentially serious IFs) compared with systematic radiologist review of all images.Methods: Brain, cardiac and body magnetic resonance, and dual-energy x-ray absorptiometry scans from the first 1000 imaged UK Biobank participants were independently assessed for potentially serious IFs using both protocols. We surveyed participants with potentially serious IFs and their GPs up to six months after imaging to determine subsequent clinical assessments, final diagnoses, emotional, financial and work or activity impacts.Results: Compared to systematic radiologist review, radiographer flagging resulted in substantially fewer participants with potentially serious IFs (179/1000 [17.9%] versus 18/1000 [1.8%]) and a higher proportion with serious final diagnoses (21/179 [11.7%] versus 5/18 [27.8%]). Radiographer flagging missed 16/21 serious final diagnoses (i.e., false negatives), while systematic radiologist review generated large numbers of non-serious final diagnoses (158/179) (i.e., false positives). Almost all (90%) participants had further clinical assessment (including invasive procedures in similar numbers with serious and non-serious final diagnoses [11 and 12 respectively]), with additional impact on emotional wellbeing (16.9%), finances (8.9%), and work or activities (5.6%).Conclusions: Compared with systematic radiologist review, radiographer flagging missed some serious diagnoses, but avoided adverse impacts for many participants with non-serious diagnoses. While systematic radiologist review may benefit some participants, UK Biobank’s responsibility to avoid both unnecessary harm to larger numbers of participants and burdening of publicly-funded health services suggests that radiographer flagging is a justifiable approach in the UK Biobank imaging study. The potential scale of non-serious final diagnoses raises questions relating to handling IFs in other settings, such as commercial and public health screening.

【 授权许可】

CC BY