21 October, 2019
An article published by Wellcome Open Research, titled 'Impact of Detecting Potentially Serious Incidental Findings During Multi-modal Imaging', has noted that participants of UK Biobank Limited have been incorrectly flagged as having potential life threatening conditions and resulted in unnecessary surgeries.
UK Biobank Limited, a UK company and registered charity based in Stockport, recruited more than 500,000 participants aged from 40 to 69 during 2006-2010, who answered questions, had physical measurements taken including height, weight, BMI, blood pressure, lung capacity and bone density, gave samples of blood, urine and saliva, had MRI scans and underwent cognitive and physical tests.
This data is now a resource for accredited researches anywhere in the world and since 2012 UK Biobank Limited have approved over 10,000 registrations from researchers working in over 1,375 institutes in 68 countries. UK Biobank Limited's goal is to improve the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses - including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. It is funded by the Wellcome Trust charity and the government's Medical Research Council (MRC) and also supported by the NHS.
The Wellcome Open Research article evaluated the impact of UK Biobank Limited's protocol for handling potentially serious incidental findings in an imaging study of 100,000 participants. Incidental findings are those discovered in the course of research that were beyond the aim of the study.
Wellcome Open used scans including brain, cardiac and body MRIs, and also DEXA scans, which measures bone density, from the first 1,000 participants, who were independently assessed for potentially serious incidental findings. The images from these first 1,000 participants were assessed using two protocols which ran simultaneously. Firstly, Radiography Flagging (RF), in which if a radiographer noticed a potentially serious incidental finding during the scanning or quality assessment, these were flagged for review by a radiologist. Secondly, under a Systematic Radiologist Review (SRR), in which all images were systematically reviewed by a radiologist. Compared to SRR, RF resulted in substantially fewer participants with potentially serious incidental findings.
Of these first 1,000 participants, it was found that 179 had potential abnormalities which could include tumours or cardiac problems. Of these 179, it was concluded that 158 had nothing wrong but only after further clinical assessments during which 12 had invasive medical procedures or operations. 16 were missed. The full publication can be read here.
A missed diagnosis can lead to a delay in treatment and a worsening of the condition. An incorrect diagnosis and unnecessary treatment may be regarded as clinical negligence. If you have concerns about your previous care leading to a misdiagnosis or unnecessary treatment please contact the Clinical Negligence team on 01254 872111 to discuss the matter further.