Digital Pathology Using Primary Case Sign-Out


Project Status:
Project Line:
Health Technology Review
Project Sub Line:
Rapid Review
Project Number:


  1. What is the clinical utility for digital pathology using primary case sign-out?
  2. What is the diagnostic accuracy of digital pathology using primary case sign-out?
  3. What is the cost-effectiveness of digital pathology using primary case sign-out?

Key Message

The applicability of the identified findings and the potential impact on patient outcomes for any individual diagnostic setting was unclear. In the majority of the identified studies, the authors reported diagnostic accuracy and clinical utility outcomes that supported digital pathology systems as a valuable diagnostic modality, comparable to conventional microscopy. These studies lacked statistical power calculations, making the accuracy of these statements unclear. One systematic review and 1 diagnostic study reported clinical utility outcomes of digital pathology. This evidence supported digital pathology using primary case sign-out for accurate prognosis of patient outcomes; however, the clinical utility compared to conventional microscopy was unclear in the identified evidence. One systematic review and 13 diagnostic cohort studies reported on the diagnostic accuracy of whole slide image (WSI). The identified outcomes indicated that WSI is a valuable diagnostic modality; however, a large range of diagnostic accuracy in different settings, and a lack of clear statistical power in all studies make comparator conclusions to conventional microscopy unclear. One systematic review and 4 diagnostic cohort studies reported diagnostic areas that can present challenges for a digital pathology implementation, the most common being the interpretation and grading of dysplasia. One identified systematic review stressed the importance of whole-system validation to identify strengths and weaknesses of specific digital pathology implementations. The range of diagnostic accuracy across studies also indicated that implementation of digital pathology primary case sign-out systems is associated with unclear diagnostic accuracy until appropriately validated. No relevant cost-effectiveness evidence for digital pathology using primary case sign-out was identified.