The University of Southampton
University of Southampton Institutional Repository

Factors associated with potentially serious incidental findings and with serious final diagnoses on multi-modal imaging in the UK Biobank Imaging Study: a prospective cohort study

Factors associated with potentially serious incidental findings and with serious final diagnoses on multi-modal imaging in the UK Biobank Imaging Study: a prospective cohort study
Factors associated with potentially serious incidental findings and with serious final diagnoses on multi-modal imaging in the UK Biobank Imaging Study: a prospective cohort study

Background Feedback of potentially serious incidental findings (PSIFs) to imaging research participants generates clinical assessment in most cases. Understanding the factors associated with increased risks of PSIFs and of serious final diagnoses may influence individuals’ decisions to participate in imaging research and will inform the design of PSIFs protocols for future research studies. We aimed to determine whether, and to what extent, socio-demographic, lifestyle, other health-related factors and PSIFs protocol are associated with detection of both a PSIF and a final diagnosis of serious disease. Methods and findings Our cohort consisted of all UK Biobank participants who underwent imaging up to December 2015 (n = 7334, median age 63, 51.9% women). Brain, cardiac and body magnetic resonance, and dual-energy x-ray absorptiometry images from the first 1000 participants were reviewed systematically by radiologists for PSIFs. Thereafter, radiographers flagged concerning images for radiologists’ review. We classified final diagnoses as serious or not using data from participant surveys and clinical correspondence from GPs up to six months following imaging (either participant or GP correspondence, or both, were available for 93% of participants with PSIFs). We used binomial logistic regression models to investigate associations between age, sex, ethnicity, socio-economic deprivation, private healthcare use, alcohol intake, diet, physical activity, smoking, body mass index and morbidity, with both PSIFs and serious final diagnoses. Systematic radiologist review generated 13 times more PSIFs than radiographer flagging (179/1000 [17.9%] versus 104/6334 [1.6%]; age- and sex-adjusted OR 13.3 [95% confidence interval (CI) 10.3–17.1] p<0.001) and proportionally fewer serious final diagnoses (21/179 [11.7%]; 33/104 [31.7%]). Risks of both PSIFs and of serious final diagnoses increased with age (sex-adjusted ORs [95% CI] for oldest [67–79 years] versus youngest [44–58 years] participants for PSIFs and serious final diagnoses respectively: 1.59 [1.07–2.38] and 2.79 [0.86 to 9.0] for systematic radiologist review; 1.88 [1.14–3.09] and 2.99 [1.09–8.19] for radiographer flagging). No other factor was significantly associated with either PSIFs or serious final diagnoses. Our study is the largest so far to investigate the factors associated with PSIFs and serious final diagnoses, but despite this, we still may have missed some associations due to sparsity of these outcomes within our cohort and small numbers within some exposure categories. Conclusion Risks of PSIFs and serious final diagnosis are substantially influenced by PSIFs protocol and to a lesser extent by age. As only 1/5 PSIFs represent serious disease, evidence-based PSIFs protocols are paramount to minimise over-investigation of healthy research participants and diversion of limited health services away from patients in need.

1932-6203
1-17
Gibson, Lorna M.
eb0e5c31-21e3-419b-a97c-a7d063ec8780
Nolan, John
377e8b9a-f005-4528-8594-5964c7fc3fbc
Littlejohns, Thomas J.
ea8614d6-9dcd-4a9f-adfc-16cdc7942ab3
Mathieu, Edouard
0e49eb49-c61d-4a87-8611-3e1c388d34b5
Garratt, Steve
47585fbc-ff14-4efe-9154-e1e3a41a48f1
Doherty, Nicola
428b3f79-77e8-4d63-9b69-d61819114ebf
Petersen, Steffen
04f2ce88-790d-48dc-baac-cbe0946dd928
Harvey, Nicholas C.W.
ce487fb4-d360-4aac-9d17-9466d6cba145
Sellors, Jonathan
3cd139fe-1049-412a-9277-6c18adfc45c4
Allen, Naomi E.
1d4110d6-f1c5-43c8-9113-549a17340a5a
Wardlaw, Joanna M.
8e7202ad-0fd9-430c-b26a-05b1106ecaad
Jackson, Caroline A.
8466283f-8904-426f-99fc-9178268de1a5
Sudlow, Cathie L.M.
5939eef1-b204-4db2-af43-c86ab3388acb
Gibson, Lorna M.
eb0e5c31-21e3-419b-a97c-a7d063ec8780
Nolan, John
377e8b9a-f005-4528-8594-5964c7fc3fbc
Littlejohns, Thomas J.
ea8614d6-9dcd-4a9f-adfc-16cdc7942ab3
Mathieu, Edouard
0e49eb49-c61d-4a87-8611-3e1c388d34b5
Garratt, Steve
47585fbc-ff14-4efe-9154-e1e3a41a48f1
Doherty, Nicola
428b3f79-77e8-4d63-9b69-d61819114ebf
Petersen, Steffen
04f2ce88-790d-48dc-baac-cbe0946dd928
Harvey, Nicholas C.W.
ce487fb4-d360-4aac-9d17-9466d6cba145
Sellors, Jonathan
3cd139fe-1049-412a-9277-6c18adfc45c4
Allen, Naomi E.
1d4110d6-f1c5-43c8-9113-549a17340a5a
Wardlaw, Joanna M.
8e7202ad-0fd9-430c-b26a-05b1106ecaad
Jackson, Caroline A.
8466283f-8904-426f-99fc-9178268de1a5
Sudlow, Cathie L.M.
5939eef1-b204-4db2-af43-c86ab3388acb

Gibson, Lorna M., Nolan, John, Littlejohns, Thomas J., Mathieu, Edouard, Garratt, Steve, Doherty, Nicola, Petersen, Steffen, Harvey, Nicholas C.W., Sellors, Jonathan, Allen, Naomi E., Wardlaw, Joanna M., Jackson, Caroline A. and Sudlow, Cathie L.M. (2019) Factors associated with potentially serious incidental findings and with serious final diagnoses on multi-modal imaging in the UK Biobank Imaging Study: a prospective cohort study. PLoS ONE, 14 (6), 1-17, [e0218267]. (doi:10.1371/journal.pone.0218267).

Record type: Article

Abstract

Background Feedback of potentially serious incidental findings (PSIFs) to imaging research participants generates clinical assessment in most cases. Understanding the factors associated with increased risks of PSIFs and of serious final diagnoses may influence individuals’ decisions to participate in imaging research and will inform the design of PSIFs protocols for future research studies. We aimed to determine whether, and to what extent, socio-demographic, lifestyle, other health-related factors and PSIFs protocol are associated with detection of both a PSIF and a final diagnosis of serious disease. Methods and findings Our cohort consisted of all UK Biobank participants who underwent imaging up to December 2015 (n = 7334, median age 63, 51.9% women). Brain, cardiac and body magnetic resonance, and dual-energy x-ray absorptiometry images from the first 1000 participants were reviewed systematically by radiologists for PSIFs. Thereafter, radiographers flagged concerning images for radiologists’ review. We classified final diagnoses as serious or not using data from participant surveys and clinical correspondence from GPs up to six months following imaging (either participant or GP correspondence, or both, were available for 93% of participants with PSIFs). We used binomial logistic regression models to investigate associations between age, sex, ethnicity, socio-economic deprivation, private healthcare use, alcohol intake, diet, physical activity, smoking, body mass index and morbidity, with both PSIFs and serious final diagnoses. Systematic radiologist review generated 13 times more PSIFs than radiographer flagging (179/1000 [17.9%] versus 104/6334 [1.6%]; age- and sex-adjusted OR 13.3 [95% confidence interval (CI) 10.3–17.1] p<0.001) and proportionally fewer serious final diagnoses (21/179 [11.7%]; 33/104 [31.7%]). Risks of both PSIFs and of serious final diagnoses increased with age (sex-adjusted ORs [95% CI] for oldest [67–79 years] versus youngest [44–58 years] participants for PSIFs and serious final diagnoses respectively: 1.59 [1.07–2.38] and 2.79 [0.86 to 9.0] for systematic radiologist review; 1.88 [1.14–3.09] and 2.99 [1.09–8.19] for radiographer flagging). No other factor was significantly associated with either PSIFs or serious final diagnoses. Our study is the largest so far to investigate the factors associated with PSIFs and serious final diagnoses, but despite this, we still may have missed some associations due to sparsity of these outcomes within our cohort and small numbers within some exposure categories. Conclusion Risks of PSIFs and serious final diagnosis are substantially influenced by PSIFs protocol and to a lesser extent by age. As only 1/5 PSIFs represent serious disease, evidence-based PSIFs protocols are paramount to minimise over-investigation of healthy research participants and diversion of limited health services away from patients in need.

Text
journal.pone.0218267 - Version of Record
Available under License Creative Commons Attribution.
Download (1MB)

More information

Accepted/In Press date: 29 May 2019
Published date: 17 June 2019

Identifiers

Local EPrints ID: 432139
URI: http://eprints.soton.ac.uk/id/eprint/432139
ISSN: 1932-6203
PURE UUID: af44d179-6451-4487-8e0e-81b0e3acb563
ORCID for Nicholas C.W. Harvey: ORCID iD orcid.org/0000-0002-8194-2512

Catalogue record

Date deposited: 03 Jul 2019 16:30
Last modified: 07 Oct 2020 01:49

Export record

Altmetrics

Contributors

Author: Lorna M. Gibson
Author: John Nolan
Author: Thomas J. Littlejohns
Author: Edouard Mathieu
Author: Steve Garratt
Author: Nicola Doherty
Author: Steffen Petersen
Author: Jonathan Sellors
Author: Naomi E. Allen
Author: Joanna M. Wardlaw
Author: Caroline A. Jackson
Author: Cathie L.M. Sudlow

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×