A Study for Building a Real-World Database of Cancer Patients in Japan
Ontology highlight
ABSTRACT:
DISEASE(S): Esophageal Cancer, Stomach, And Esophagogastric Junction Cancers, Colorectal Cancer, Hepatocellular Carcinoma, Pancreatic Cancer
PROVIDER: 2724054 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:ObjectivesChronic rhinosinusitis (CRS) is a heterogeneous disease, which can be subdivided into CRS with (CRSwNP) or without (CRSsNP) nasal polyps. An intractable form of CRSwNP that is associated with an eosinophil-dominant inflammatory cell infiltration (eosinophilic CRS) has become more prevalent in Japan. There is currently limited information on the burden of CRS in Japan and treatment approaches used in real-world practice.MethodsThis retrospective, observational, comparative cohort study used information from the Japanese JMDC insurance claims database (study period April 1, 2015, to March 31, 2020). A CRS cohort was identified and matched with a control group without CRS. The primary objective was to clarify disease burden and treatment approaches by comparing comorbidities, healthcare resource utilization (HRU), and drug prescriptions in the CRS and non-CRS groups.ResultsIn total, 23,256 individuals with CRS (1762 with CRSwNP and 21,494 with CRSsNP) were matched with 23,256 controls. The mean age was 45 years and the majority of individuals were male (57%). Individuals with CRS had a higher disease burden than controls, with more frequent comorbidities (particularly, type 2 inflammatory disease [e.g., allergic rhinitis and asthma], and those caused by systemic corticosteroids [SCS]), and higher HRU (including outpatient visits, laboratory examinations and surgical procedures). Further, individuals with CRS were prescribed more medications, both for CRS (including SCS) and non-CRS conditions, than controls.ConclusionIn Japan, CRS is associated with a high disease burden, and multiple treatment approaches are used in affected individuals, including long-term SCS, which is generally not recommended.Level of evidence3.
| S-EPMC10116956 | biostudies-literature
Project description:The aim of this article is to help develop a common understanding of the current status, challenges, and future perspectives of real-world data (RWD) and real-world evidence (RWE) in Japan. RWD and RWE are very widely used terms, but standardized definitions are lacking. Given broad and growing applications of RWD/RWE from the perspective of clinical development and medical affairs, the PhRMA Japan Medical Affairs Committee Working Group 1 have proposed the following definitions: "RWD are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources" and "RWE is the evidence derived from analysis of RWD." The key challenges for RWD and RWE in Japan include restricted access and linkage of RWD, as well as a lack of universally accepted methodological approaches, which reduces the potential for patient and healthcare benefits. These challenges for RWD/RWE are by no means unique to Japan and similar challenges exist for countries in Europe and the USA. The quality of data and analysis, study design, and the transparency of reporting should be discussed more to ensure credibility and acceptance by decision-makers as the demand for RWD and RWE increases. The future developments around Japan's RWD and RWE are expected to include improved RWD access, data linkage, and increased acceptance by decision-makers, all supported by innovative technology. Improvements in RWD access and database linkage will enable both public and private sectors to assemble more comprehensive health information in Japan.
| S-EPMC8605941 | biostudies-literature
Project description:Many descriptive epidemiological and comparative studies using big data have been reported recently from outside Japan. Within Japan, diagnosis procedure combination (DPC) data and medical receipt data are being stored in electronic media, and real‐world evidence in various fields has started to be reported. We reviewed clinical studies on disseminated intravascular coagulation (DIC) using DPC data obtained from an insurance database with large numbers of cases and a related commercially available dataset including DPC and laboratory data. After DPC was introduced in 2003, 19 studies on DIC using Japanese national DPC data and two studies using the Medical Data Vision database were reported. Epidemiological findings in seven studies showed that the proportion of drugs administered for each underlying disease differed, with antithrombin and recombinant thrombomodulin (rTM) being used more frequently in clinical settings. In 14 comparative studies on anti‐DIC agents, antithrombin for severe pneumonia, postoperative intestinal perforation, and severe burn, and rTM for acute cholangitis were associated with improved survival rates. Large‐scale observational studies using big data can show results similar to those of randomized control trials if the quality of individual research is high. Real‐world data analysis will be increasingly necessary to complement the evidence gap unfilled by randomized control trials. Within Japan, diagnosis procedure combination (DPC) data and medical receipt data are being stored in electronic media, and real‐world evidence in various fields has started to be reported. We reviewed clinical studies on disseminated intravascular coagulation using DPC data obtained from an insurance database with large numbers of cases and a related commercially available dataset including DPC and laboratory data. Real‐world data analysis will be increasingly necessary to complement the evidence gap unfilled by randomized control trials.
| S-EPMC10083461 | biostudies-literature
Project description:IntroductionThe persistence of golimumab (GLM) treatment in Japanese patients with rheumatoid arthritis (RA) has been evaluated previously, but evidence of long-term real-world use is lacking. This study assessed the long-term persistence of GLM use, its influencing factors, and impact of prior medications in patients with RA in actual clinical practice in Japan.MethodsThis is a retrospective cohort study of patients with RA using data from a hospital insurance claims database in Japan. The identified patients were stratified as only GLM treatment (naïve), had one biological disease-modifying anti-rheumatic drug (bDMARD)/Janus kinase (JAK) inhibitor treatment prior to GLM [switch (1)] and had at least two bDMARDs/JAK prior to GLM treatment [switch (≥ 2)]. Patient characteristics were evaluated using descriptive statistics. Kaplan-Meier survival and Cox regression methods were used to analyze GLM persistence at 1, 3, 5, and 7 years and the associated factors. Treatment differences were compared using a log-rank test.ResultsGLM persistence rate in the naïve group was 58.8%, 32.1%, 21.4%, and 11.4% at 1, 3, 5, and 7 years, respectively. Overall persistence rates in the naïve group were higher than in switch groups. Higher GLM persistence was observed among patients aged 61-75 years and those concomitantly using methotrexate (MTX). Also, women were less likely to discontinue treatment compared to men. Higher Charlson Comorbidity Index score, initial GLM dose of 100 mg, and switch from bDMARDs/JAK inhibitor were related to a lower persistence rate. As a prior medication, infliximab showed the longest persistence for subsequent GLM, and using this as a reference, tocilizumab, sarilumab, and tofacitinib subgroups had significantly shorter persistence, respectively (p = 0.001, 0.025, 0.041).ConclusionThis study presents the long-term real-world results for persistence of GLM and its potential determinants. These most recent and long-term observations demonstrated that GLM and other bDMARDs continue to benefit patients with RA in Japan.
| S-EPMC10140228 | biostudies-literature
Project description:BackgroundChemotherapy-induced nausea and vomiting (CINV) is a major concern of patients with cancer, leading to suboptimal treatment.AimThis study assessed the emetic risk associated with intravenous and oral chemotherapy and the prophylactic antiemetic drugs by cancer type in a real-world setting.Methods and resultsWe used the health services utilisation data for patients with cancer diagnosed in 2016. Patients aged at least 20 years at the time of diagnosis and who started their first course of chemotherapy were included. The emetic risk of chemotherapy was determined according to the cancer type and was classified based on clinical practice guidelines. The prescription of antiemetic drugs was assessed. Overall, 172 133 patients were evaluated, of whom 121 103 (70.4%) received intravenous chemotherapy. High-emetic-risk chemotherapy (HEC) was prescribed in 46 458 (27.0%) patients. HEC was prescribed most for patients with oesophageal cancer (80.3%), followed by malignant lymphoma (60.2%) and breast cancer (53.8%). Moderate-emetic-risk chemotherapy (MEC) was prescribed in 60 528 (35.2%) patients and was mostly prescribed for small cell lung cancer (59.9%). Meanwhile, more than 50% of the chemotherapy prescribed for patients with gastric, colorectal, and pancreatic cancer was low-emetic-risk chemotherapy. HEC was accompanied by three-drug antiemetic prophylaxis in more than 90% of patients with small cell lung, non-small cell lung, breast, and oesophageal cancer, whereas only 13.5% of patients with malignant lymphoma were administered CHOP (cyclophosphamide, doxorubicin, vincristine sulphate, and prednisolone) with prophylaxis.ConclusionThe risk of CINV differs with cancer type. HEC was less prescribed compared with MEC. Most patients received the recommended anti-emetic prophylaxis.
| S-EPMC8955058 | biostudies-literature
Project description:The present study aimed to investigate temporal trends in treatment patterns and prognostic factors for overall survival (OS) among patients with metastatic pancreatic cancer. From the Tokushukai REAl-world Data project, 1,093 patients with metastatic pancreatic cancer treated with gemcitabine, tegafur/gimeracil/oteracil (S-1), gemcitabine plus S-1, gemcitabine plus nab-paclitaxel, or fluorouracil, folic acid, oxaliplatin and irinotecan (FOLFIRINOX) between April 2010 and March 2020 were identified. Stratified/conventional Cox regression analyses were conducted to examine associations between patient- and tumor-related factors, study period, hospital volume, hospital type and first-line chemotherapy regimens. Overall, 846 patients were selected (503 male patients; median age, 70 years) after excluding ineligible patients. Over a median follow-up of 5.4 months, the median OS was 6.8 months (95% confidence interval, 6.3-7.4). The median OS for gemcitabine, S-1, gemcitabine plus S-1, gemcitabine plus nab-paclitaxel and FOLFIRINOX regimens was 5.9, 5.3, 7.7, 9.0 and 9.5 months, respectively. The median OS for 2010-2013, 2014-2017 and 2017-2020 was 6.2, 7.1 and 7.8 months, respectively. Performance status, body mass index and first-line chemotherapy regimens were identified to be significant prognostic factors. In summary, the real-world data indicated that standard care, including chemotherapy, for metastatic pancreatic cancer was widely used in hospitals throughout Japan and verified the survival benefits of gemcitabine plus nab-paclitaxel and FOLFIRINOX observed in prior clinical trials. This trial has been registered in the University Hospital Medical Information Network Clinical Trials Registry as UMIN000050590 on April 1, 2023.
| S-EPMC10636700 | biostudies-literature
Project description:The advent of next-generation sequencing (NGS) has provided unprecedented insight into the molecular complexity of pancreatic ductal adenocarcinoma (PDAC). This has led to the emergence of biomarker-driven treatment paradigms that challenge empiric treatment approaches. However, the growth of sequencing technologies is outpacing the development of the infrastructure required to implement precision oncology as routine clinical practice. Addressing these logistical barriers is imperative to maximize the clinical impact of molecular profiling initiatives. In this review, we examine the evolution of precision oncology in PDAC, spanning from germline testing for cancer susceptibility genes to multi-omic tumor profiling. Furthermore, we highlight real-world challenges to delivering precision oncology for PDAC, and propose strategies to improve the generation, interpretation, and clinical translation of molecular profiling data.
| S-EPMC7563487 | biostudies-literature
Project description:BackgroundBiological therapies (BTs) including infliximab (IFX), adalimumab (ADL), secukinumab (SCK) and ustekinumab (UST) are approved in Japan for the treatment of psoriasis. Although the persistence rates and medical costs of BTs treatment have been investigated in multiple foreign studies in recent years, few such studies have been conducted in Japan and the differences between patients who adhered to treatment and those who did not have not been reported. This study is aimed at investigating the persistence rates and medical costs of BTs in the treatment of psoriasis in Japan, using the real-world data from a large-scale claims database.MethodsClaims data from the JMDC database (August 2009 to December 2016) were used for this analysis. Patient data were extracted using the ICD10 code for psoriasis and claims records of BT injections. Twelve-month and 24-month persistence rates of BTs were estimated by Kaplan-Meier methodology, and 12-month-medical costs before and after BT initiation were compared between persistent and non-persistent patient groups at 12 months.ResultsA total of 205 psoriasis patients treated with BTs (BT-naïve patients: 177) were identified. The 12-month/24-month persistence rates for ADL, IFX, SCK, and UST in BT-naïve patients were 46.8%?±?16.6%/46.8?±?16.6%, 53.0%?±?14.9%/41.0%?±?15.5%, 55.4%/55.4% (95% CI not available) and 79.4%?±?9.9%/71.9%?±?12.2%, respectively. Statistically significant differences in persistence were found among different BT treatments, and UST was found to have the highest persistence rate. The total medical costs during the 12 months after BT initiation in BT-naïve patients were (in 1000 Japanese Yen): 2218 for ADL, 3409 for IFX, 465 for SCK, 2824 for UST (average: 2828). Compared with the 12-month persistent patient group, the total medical costs in the persistent group was higher (?:+?118), but for some medications such as IFX or UST cost increases were lower for persistent patients.ConclusionsUST was found to have the highest persistence rate among all BTs for psoriasis treatment in Japan. The 12-month medical costs after BT initiation in the persistent patient group may not have increased as much as in the non-persistent patient group for some medications.
| S-EPMC6042444 | biostudies-literature
Project description:IntroductionAn abnormal serum potassium (S-K) level is an important electrolyte disturbance. However, its relation to clinical outcomes in real-world patients, particularly hyperkalemia burden, is not extensively studied.MethodsAn observational retrospective cohort study using a Japanese hospital claims database was done (April 2008-September 2017; N = 1,022,087). Associations between index S-K level and 3-year survival were modeled using cubic spline regression. Cox regression model was applied to estimate the time to death according to different S-K levels. Prevalence, patient characteristics, treatment patterns, and management of patients with hyperkalemia from first episode were assessed.ResultsHyperkalemia prevalence was 67.9 (95% confidence interval [CI]: 67.1-68.8) per 1000 and increased in patients with chronic kidney disease (CKD) (227.9; 95% CI: 224.3-231.5), heart failure (134.0; 95% CI: 131.2-136.8), and renin-angiotensin-aldosterone system inhibitor (RAASi) use (142.2; 95% CI: 139.6-144.7). U-shaped associations between S-K level and 3-year survival were observed with nadir 4.0 mEq/l. The risk of death was increased at S-K 5.1-5.4 mEq with hazard ratio of 7.6 (95% CI: 7.2-8.0). The 3-year mortality rate in patients with CKD stages 3a, 3b, 4, and 5 with normokalemia were 1.51%, 3.93%, 10.86%, and 12.09%, whereas that in patients with CKD stage 3a at S-K 5.1-5.4, 5.5-5.9, and ≥6.0 mEq/l increased to 10.31%, 11.43%, and 22.64%, respectively. Despite treatment with loop diuretics (18.5%) and potassium binders (5.8%), >30% of patients had persistently high S-K (≥5.1 mEq/l).ConclusionThis study provides real-world insight on hyperkalemia based on a large number of patients with various medical backgrounds.
| S-EPMC6734103 | biostudies-literature
Project description:Bottom-up proteomics database search algorithms used for peptide identification cannot comprehensively identify posttranslational modifications (PTMs) in a single-pass because of high false discovery rates (FDRs). A new approach to database searching enables Global PTM (G-PTM) identification by exclusively looking for curated PTMs, thereby avoiding the FDR penalty experienced during conventional variable modification searches. We identified nearly 2500 unique, high-confidence modified peptides comprising 31 different PTM types in single-pass database searches.
2015-07-31 | GSE59956 | GEO