Histopathological diagnosis Other Histopathological diagnosis
Conditions
Interventions
The study involves exploring concordance between the results of histopathological sample analysis performed by pathologists examining the same series of samples using both light microscopy (LM) and di
Sponsors
University Hospital Coventry and Warwickshire (UHCW) NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 17/03/2022: Histopathology samples: Case identification and selection will take place between September 2019 - October 2021 at five participating NHS histopathology departments. All samples are collected for the purpose of routine histopathology reporting and only entered into the validation study on completion of their clinical review at the respective NHS participating site, with the following specification: 1. Breast (Belfast, Lincoln & Nottingham) – A total of 600 sequential samples including 200 cancer screening biopsies enriched with at least 10% resected tumours (moderately difficult) and 10% difficult cases: low grade ductal carcinoma in situ, atypical hyperplasia, screening category B3 and B4, lesions with calcium oxalate (Weddellite calcification), sclerosing and papillary lesions, and micrometastases. 2. GI (Coventry, Belfast & Nottingham): – A total of 600 sequential samples including 200 cancer screening biopsies enriched with at least 10% resected tumours (moderately difficult) and 10% difficult: oesophageal dysplasia, polyp cancers, inflammatory bowel disease, minimal change colitis, graft versus host disease, giardiasis, cytomegalovirus, H. pylori and herpes virus infection. 3. Skin (Coventry, Belfast & Lincoln) : A total of 600 sequential samples enriched with at least 10% non-basal cell carcinoma cancer resections (moderately difficult) and 10% difficult: sentinel nodes, dysplastic naevi, spitz naevi, lentigo maligna, early and desmoplastic melanoma, herpes virus infection, leischmaniasis, leprosy, amyloid, angioscaroma, and Kaposis sarcoma. 4. Renal (Coventry, Nottingham & Oxford): A total of 200 sequential native biopsies for glomerular, tubulointerstitial and vascular disease and transplant biopsies for graft rejection. No enrichment is planned in the renal biopsy group as all of these biopsies are difficult to report. Staff (for the qualitative part of the study): Staff employed at the participating sites, including any of the following: 1. Pathologists 2. Trainee doctors 3. Biomedical scientists 4. Biomedical assistants 5. Advanced practitioners 6. Medical laboratory assistants Previous participant inclusion criteria: Histopathology samples: Case identification and selection will take place between January 2019 – January 2022 at five participating NHS histopathology departments. All samples are collected for the purpose of routine histopathology reporting and only entered into the validation study on completion of their clinical review at the respective NHS participating site, with the following specification: 1. Breast (Belfast, Lincoln & Nottingham) – A total of 600 sequential samples including 200 cancer screening biopsies enriched with at least 10% resected tumours (moderately difficult) and 10% difficult cases: low grade ductal carcinoma in situ, atypical hyperplasia, screening category B3 and B4, lesions with calcium oxalate (Weddellite calcification), sclerosing and papillary lesions, and micrometastases. 2. GI (Coventry, Belfast & Nottingham): – A total of 600 sequential samples including 200 cancer screening biopsies enriched with at least 10% resected tumours (moderately difficult) and 10% difficult: oesophageal dysplasia, polyp cancers, inflammatory bowel disease, minimal change colitis, graft versus host disease, giardiasis, cytomegalovirus, H. pylori and herpes virus infection. 3. Skin (Coventry, Belfast & Lincoln) : A total of 600 sequential samples
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 17/03/2022: 1. Cases with either broken or missing slides 2. Cases with missing clinical data 3. Megablocks or oversized slide sets 4. Cases where a prior sample is important to the interpretation of the study sample Previous participant exclusion criteria: Cases with either broken or missing slides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intra-pathologist agreement between digital pathology and light microscopy diagnoses, measured by comparing the concordance between the results of pathologists’ diagnoses made by assessment of LM of breast, GI, skin and renal samples, with the same pathologists’ diagnoses of the same samples (intra-rater (pathologists) reliability) using DP. There will be three categories for the level of agreement; complete agreement, clinically unimportant difference and clinically important difference. For each sample, three sets of agreements will be reported: 1. Whether for each pathologist’s DP and LM diagnoses agree 2. Whether each of the four DP diagnoses agree with the ground truth (GT) 3. Whether each of the four LM diagnoses agree with the GT. This will be completed after all results have been completed and analysed (20-30 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 17/03/2022: 1. Inter-pathologist level of agreement across the four DP diagnoses and the ground truth (GT). 2. Inter-pathologist level of agreement across the four LM diagnoses and the GT. 3. Individual pathologist non-concordance rates will be measured throughout the study. 4. Costs and benefits associated with DP when compared with LM will be measured for all samples, if feasible, once all samples have been analysed. If not, analysis will be carried out for a purposive sample selected on the basis of clinical materiality and the availability of decision-analytic models in the literature to support cost-benefit calculations. 4.1. The throughput efficiencies of DP vs LM will be measured using simulation models of the pathway to diagnosis and establishment of a fully specified treatment plan. 4.1.1. Pathologists will be asked to provide time and motion data and anonymised summary data from the pathology service will be collected. 4.2. The effect of increased accuracy on choice of treatment will be made using estimates of the cost and health impact of the treatment strategies suggested as a result of DM or LM use. 5. Experiences of pathologists and laboratory staff 5.1. Focus groups / key informant interviews will be undertaken during the pilot study. 5.2. Semi-structured interviews at baseline will explore staff experiences and perspectives on DP. 5.3. Semi-structured interviews at mid-point of study will explore staff experiences over time, training needs and the perceived impact on day-to-day working in multidisciplinary teams. Previous secondary outcome measures: 1. Pathologist agreement to GT and LM vs GT and DP will be measured using using text reports. 1.1. For each pathologist it will be recorded if DP and LM have complete agreement, have clinically unimportant differences or clinically important differences. 1.2. Discordant samples will be circulated to each of the subspecialty pathologists, along with the reference d | — |
Countries
England, Northern Ireland, United Kingdom
Outcome results
None listed