Real-World Outcomes of Systemic Therapy in Japanese Patients with Cancer (Tokushukai REAl-World Data Project: TREAD): Study Protocol for a Nationwide Cohort Study

Abstract

Cohort studies using large-scale databases have become increasingly important in recent years. The Tokushukai Medical Group is a leading medical group in Japan that includes 71 general hospitals nationwide from Hokkaido to Okinawa, with a total of 18,000 beds, and a unified electronic medical record system. This retrospective cohort study aims to evaluate the real-world outcomes of systemic therapy for Japanese patients with cancer using this merit of scale. All adult patients with cancer who received systemic therapy using a centrally registered chemotherapy protocol system at 46 hospitals from April 2010 to March 2020 will be identified (~48,850 patients). Key exclusion criteria include active double cancer and inadequate data extraction. Data will be obtained through electronic medical records, diagnosis procedure combination data, medical prescription data, and the national cancer registration system that includes sociodemographic variables, diagnostic and laboratory tests, concomitant drug prescriptions, cost, and overall survival. Kaplan–Meier estimates will be calculated for time-to-event analyses. Stratified/conventional Cox proportional hazards regression analyses will be conducted to examine the relationships between overall survival and related factors. Our findings provide important insights for future research directions, policy initiatives, medical guidelines, and clinical decision-making.

Inflammation‑based prognostic markers of metastatic pancreatic cancer using real‑world data in Japan: The Tokushukai REAl‑world Data (TREAD) project

“…The study utilizes a shared medical record system across these hospitals. (e-Karte and Newtons2; Software Service Inc., Osaka, Japan) and chemotherapy protocol system (srvApmDrop; Software Service Inc., Osaka, Japan), the details of which can be found in a separate article ( 13 ). The project adhered to the ethical guidelines for medical and biological research involving human subjects in Japan ( 14 ) and followed the principles of the Declaration of Helsinki.…”

Real‑world treatment outcomes among patients with metastatic pancreatic cancer in Japan: The Tokushukai real‑world data project

“…Study overview. This nationwide retrospective cohort study was conducted as part of the TREAD project, the outline of which has been described elsewhere (28). This project was approved by the Ethics Committee of the Tokushukai Group in April 2020 (No.…”

“…Third, several prognostic factors, such as metastatic sites, tumor markers, prognostic scores based on laboratory data, comorbidities, and complications, were not examined. Finally, in the current study, treatment data were extracted from the protocol system; hence, only data on treatment duration could be extracted, and it was not possible to distinguish between treatment discontinuation due to disease progression or adverse events (28). As this is an RWD study, periodic imaging assessment were ---------------------------------------------------------------------- These P-values were reported in the previous studies.…”