Digital Pathology Using Primary Case Sign-Out

Key Messages

• 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.