Han Hye Sook, Lee Kyoung Eun, Suh Young Ju, Jee Hee-Jung, Kim Bum Jun, Kim Hyeong Su, Lee Keun-Wook, Ryu Min-Hee, Baek Sun Kyung, Park In Hae, Ahn Hee Kyung, Jeong Jae Ho, Kim Min Hwan, Lee Dae Hyung, Kim Siheon, Moon Hyemi, Son Serim, Byun Ji-Hye, Kim Dong Sook, An Hyonggin, Park Yeon Hee, Zang Dae Young
Department of Internal Medicine, Chungbuk National University College of Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea.
Department of Hematology and Oncology, Ewha Womans University Hospital, Seoul, Republic of Korea.
Ther Adv Med Oncol. 2022 Nov 2;14:17588359221132628. doi: 10.1177/17588359221132628. eCollection 2022.
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.
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.
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.
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.
电子病历（EMR）在真实世界数据（RWD）中具有最高价值。本研究的目的是提出一个基于EMR的RWD数据收集框架，通过开展一项基于韩国癌症研究组的全国性真实世界研究，来评估癌症药物的有效性和安全性。
我们纳入了韩国相关机构中所有接受雷莫西尤单抗联合紫杉醇（RAM/PTX）治疗胃癌以及接受曲妥珠单抗 emtansine（T-DM1）治疗乳腺癌的患者。前瞻性地制定了系统数据收集的标准操作程序。使用代表性虚拟病例的推荐输入值与每位研究者的输入值之间的一致性率来评估研究者的可靠性。在研究期间，对随机选择的三个机构收集的数据可靠性进行了两次评估，使用先前收集的数据与独立研究者收集的数据之间的一致性率。研究者和收集数据的可靠性结果用于电子数据采集系统的修订和现场培训。
在医疗保险覆盖起始日期至2018年12月期间，RAM/PTX队列中56个机构的1063例患者以及T-DM1队列中60个机构的824例患者被纳入。RAM/PTX和T-DM1队列中研究者的平均可靠性分别为73.5%和71.9%。RAM/PTX和T-DM1队列收集数据的平均可靠性在第一次分析中两个队列均为90.0%，在第二次分析中分别为89.0%和84.0%。在虚拟病例模拟和最终数据分析时，RAM/PTX和T-DM1队列的平均缺失值分别从20.7%降至0.46%以及从18.5%降至0.76%。
这项真实世界研究提供了一个框架，可确保基于EMR的RWD在评估癌症药物有效性和安全性方面的相关性和可靠性。
