Digital Pathology
Research type
Research Study
Full title
Multi-centre validation of digital whole slide imaging for routine diagnosis
IRAS ID
258799
Contact name
David Snead
Contact email
Sponsor organisation
University Hospitals Coventry and Warwickshire NHS Trust
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
There is a major pathologist capacity issue in the NHS where in the next 5 years there will be more pathologists retiring from pathology than those entering the discipline. Digital pathology (DP) offers an innovative solution to this problem leading to less waiting time for results by patients.
DP refers to the use of high throughput slide scanners to digitise diagnostic histopathology slides that are then reported on computer workstations, as opposed to traditional Light Microscopy (LM). It allows electronic distribution of work to pathologists helping to address the pathologist capacity problem in many NHS hospitals. Sharing difficult cases more easily could reduce error, and improve high complexity specialties such as renal pathology which requires out of hours reporting. However, the image produced in DP systems is inferior to resolution provided by LM, therefore DP may not be suitable for specialties requiring fine resolution such as renal biopsy interpretation. The majority of existing studies comparing DP with LM have not been adequately powered to provide data of non-inferiority.
This study aims to enrol 2000 link-anonymised samples/cases in total: 600 each of breast, gastrointestinal and skin, and 200 renal samples/cases. Teams of 4 pathologists across 6 research sites will each examine the same series of samples on both LM and DP. Samples/cases will be batched and randomised to which modality is used first, and there will be a 6 week washout period between viewings to maintain objectivity. Reports will then be scrutinised by a trained Research Fellow independent of the reporting pathologists. Differences in concordance will be classified by an independent pathologist taking into account the reference diagnosis if needed.
A qualitative sub-study will examine perceptions and experiences of pathologists; Eye tracking software will be used to examine pathologists’ examination techniques; and a Health Economic analysis will also be undertaken.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
19/WM/0215
Date of REC Opinion
29 Aug 2019
REC opinion
Further Information Favourable Opinion