Accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer-related adverse events in an administrative database: a validation study in an acute care hospital in Japan
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 validati...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e055459.full |
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| author | Takashi Fujiwara Yasuyuki Okumura Hironobu Tokumasu Takashi Kanemitsu Kosei Tajima Akinori Yuri Masahiro Iwasaku |
| author_facet | Takashi Fujiwara Yasuyuki Okumura Hironobu Tokumasu Takashi Kanemitsu Kosei Tajima Akinori Yuri Masahiro Iwasaku |
| author_sort | Takashi Fujiwara |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-fa71a60f5acb4b7eb68b08ed60d0b050 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-fa71a60f5acb4b7eb68b08ed60d0b0502025-02-02T15:35:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-055459Accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer-related adverse events in an administrative database: a validation study in an acute care hospital in JapanTakashi Fujiwara0Yasuyuki Okumura1Hironobu Tokumasu2Takashi Kanemitsu3Kosei Tajima4Akinori Yuri5Masahiro Iwasaku6Department of Management, Clinical Research Center, Kurashiki Central Hospital, Kurashiki, JapanReal world Data Co., Ltd, Kyoto, JapanDepartment of Management, Clinical Research Center, Kurashiki Central Hospital, Kurashiki, JapanMedical Affairs Division, Chugai Pharmaceutical Co Ltd, Tokyo, JapanClinical Development Division, Chugai Pharmaceutical Co Ltd, Tokyo, JapanDrug Safety Division, Chugai Pharmaceutical Co Ltd, Tokyo, JapanDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, JapanObjectives 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).https://bmjopen.bmj.com/content/12/7/e055459.full |
| spellingShingle | Takashi Fujiwara Yasuyuki Okumura Hironobu Tokumasu Takashi Kanemitsu Kosei Tajima Akinori Yuri Masahiro Iwasaku Accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer-related adverse events in an administrative database: a validation study in an acute care hospital in Japan BMJ Open |
| title | Accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer-related adverse events in an administrative database: a validation study in an acute care hospital in Japan |
| title_full | Accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer-related adverse events in an administrative database: a validation study in an acute care hospital in Japan |
| title_fullStr | Accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer-related adverse events in an administrative database: a validation study in an acute care hospital in Japan |
| title_full_unstemmed | Accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer-related adverse events in an administrative database: a validation study in an acute care hospital in Japan |
| title_short | Accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer-related adverse events in an administrative database: a validation study in an acute care hospital in Japan |
| title_sort | accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer related adverse events in an administrative database a validation study in an acute care hospital in japan |
| url | https://bmjopen.bmj.com/content/12/7/e055459.full |
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