Ontology highlight
ABSTRACT: Objectives
Validation studies in oncology are limited in Japan. This study was conducted to evaluate the accuracy of diagnosis and adverse event (AE) definitions for specific cancers in a Japanese health administrative real-world database (RWD).Design and setting
Retrospective observational validation study to assess the diagnostic accuracy of electronic medical records (EMRs) and claim coding regarding oncology diagnosis and AEs based on medical record review in the RWD. The sensitivity and positive predictive value (PPV) with 95% CIs were calculated.Participants
The validation cohort included patients with lung (n=2257), breast (n=1121), colorectal (n=1773), ovarian (n=216) and bladder (n=575) cancer who visited the hospital between January 2014 and December 2018, and those with prostate cancer (n=3491) visiting between January 2009 and December 2018, who were identified using EMRs.Outcomes
Key outcomes included primary diagnosis, deaths and AEs.Results
For primary diagnosis, sensitivity and PPV for the respective cancers were as follows: lung, 100.0% (96.6 to 100.0) and 81.0% (74.9 to 86.2); breast, 100.0% (96.3 to 100.0) and 74.0% (67.3 to 79.9); colorectal, 100.0% (96.6 to 100.0) and 80.5% (74.3 to 85.8); ovarian, 89.8% (77.8 to 96.6) and 75.9% (62.8 to 86.1); bladder, 78.6% (63.2 to 89.7) and 67.3% (52.5 to 0.1); prostate, 100.0% (93.2 to 100.0) and 79.0% (69.7 to 86.5). Sensitivity and PPV for death were as follows: lung, 97.0% (84.2 to 99.9) and 100.0% (84.2 to 100.0); breast, 100.0% (1.3 to 100.0) and 100.0% (1.3 to 100.0); colorectal, 100.0% (28.4 to 100.0) and 100.0% (28.4 to 100.0); ovarian, 100.0% (35.9 to 100.0) and 100.0% (35.9 to 100.0); bladder, 100.0% (9.4-100.0) and 100.0% (9.4 to 100.0); prostate, 75.0% (19.4 to 99.4) and 100.0% (19.4 to 100.0). Overall, PPV tended to be low, with the definition based on International Classification of Diseases, 10th revision alone for AEs.Conclusion
Diagnostic accuracy was not so high, and therefore needs to be further investigated.Trial registration number
University Hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN000039345).
SUBMITTER: Fujiwara T
PROVIDER: S-EPMC9280899 | biostudies-literature |
REPOSITORIES: biostudies-literature