Data collection framework for electronic medical record-based real-world data to evaluate the effectiveness and safety of cancer drugs: a nationwide real-world study of the Korean Cancer Study Group
- 주제(키워드) cancer drug , data collection , medical record , real-world data , relevance , reliability
- 주제(기타) Oncology
- 설명문(일반) [Kim, Bum Jun; Zang, Dae Young] Hallym Univ, Coll Med, Dept Internal Med, Sacred Heart Hosp, 22 Gwanpyeong Ro 170 Beon Gil, Anyang Si 14068, Gyeonggi Do, South Korea; [Park, Yeon Hee] Sungkyunkwan Univ, Dept Med, Div Hematol Oncol, Samsung Med Ctr,Sch Med, 81 Irwon Ro, Seoul 06351, South Korea; [Jee, Hee-Jung; Kim, Siheon; Moon, Hyemi; Son, Serim; An, Hyonggin] Korea Univ, Dept Biostat, Coll Med, Anam Dong 5 Ga, Seoul 02841, South Korea; [Han, Hye Sook] Chungbuk Natl Univ, Dept Internal Med, Coll Med, Chungbuk Natl Univ Hosp, Cheongju, South Korea; [Lee, Kyoung Eun] Ewha Womans Univ Hosp, Dept Hematol & Oncol, Seoul, South Korea; [Suh, Young Ju] Inha Univ, Coll Med, Dept Biomed Sci, Incheon, South Korea; [Kim, Hyeong Su] Hallym Univ, Kangnam Sacred Heart Hosp, Dept Internal Med, Coll Med, Seoul, South Korea; [Lee, Keun-Wook] Seoul Natl Univ, Bundang Hosp, Dept Internal Med, Coll Med, Seongnam, South Korea; [Ryu, Min-Hee; Jeong, Jae Ho] Univ Ulsan, Asan Med Ctr, Dept Oncol, Coll Med, Seoul, South Korea; [Baek, Sun Kyung] Kyung Hee Univ, Dept Internal Med, Med Ctr, Seoul, South Korea; [Park, In Hae] Korea Univ, Coll Med, Dept Internal Med, Guro Hosp, Seoul, South Korea; [Ahn, Hee Kyung] Gachon Univ, Dept Internal Med, Gil Med Ctr, Incheon, South Korea; [Kim, Min Hwan] Yonsei Univ, Yonsei Canc Ctr, Dept Internal Med, Coll Med, Seoul, South Korea; [Lee, Dae Hyung] Inha Univ Hosp, Incheon, South Korea; [Byun, Ji-Hye] Hlth Insurance Review & Assessment Serv, Innovat Res Dept, Wonju, South Korea; [Kim, Dong Sook] Hlth Insurance Review & Assessment Serv, Review & Assessment Res Dept, Wonju, South Korea
- 등재 SCIE, SCOPUS
- OA유형 Green Published, gold
- 발행기관 SAGE PUBLICATIONS LTD
- 발행년도 2022
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000203124
- 본문언어 영어
- Published As https://doi.org/10.1177/17588359221132628
- PubMed https://pubmed.ncbi.nlm.nih.gov/36339930
초록/요약
Background: Electronic medical records (EMRs) have the highest value among real-world data (RWD). The aim of the present study was to propose a data collection framework of EMR-based RWD to evaluate the effectiveness and safety of cancer drugs by conducting a nationwide real-world study based on the Korean Cancer Study Group. Methods: We considered all patients who received ramucirumab plus paclitaxel (RAM/PTX) for gastric cancer and trastuzumab emtansine (T-DM1) for breast cancer at relevant institutions in South Korea. Standard operating procedures for systematic data collection were prospectively developed. Investigator reliability was evaluated using the concordance rate between the recommended input value for representative fictional cases and the input value of each investigator. Reliability of collected data was evaluated twice during the study period at three institutions randomly selected using the concordance rate between the previously collected data and data collected by an independent investigator. The reliability results of the investigators and collected data were used for revision of the electronic data capture system and site training. Results: Between the starting date of medical insurance coverage and December 2018, a total of 1063 patients at 56 institutions in the RAM/PTX cohort and 824 patients at 60 institutions in the T-DM1 cohort were included. Mean investigator reliability in the RAM/PTX and T-DM1 cohorts was 73.5% and 71.9%, respectively. Mean reliability of collected data in the RAM/PTX and T-DM1 cohort was 90.0% for both cohorts in the first analysis and 89.0% and 84.0% in the second analysis, respectively. Mean missing values of the RAM/PTX and T-DM1 cohorts at the time of simulation of fictional cases and final data analysis decreased from 20.7% to 0.46% and from 18.5% to 0.76%, respectively. Conclusion: This real-world study provides a framework that ensures relevance and reliability of EMR-based RWD for evaluating the effectiveness and safety of cancer drugs.
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