Cost-effectiveness Analysis of the Oncomine™ Dx Target Test MultiCDx System Using Next-generation Sequencing and Single-gene Test in Advanced and Recurrent Nonsquamous Non-small-cell Lung Cancer.

Introduction: To determine the appropriate treatment for patients with advanced/recurrent nonsquamous non‒small-cell lung cancer (NSCLC), a companion diagnostic was conducted to detect driver mutations through genetic testing. In Japan, Oncomine Dx Target Test (DxTT) using next-generation sequencing (NGS) that can comprehensively detect gene mutations or single-gene tests are conducted as companion diagnostics. Furthermore, cost-effectiveness analysis was conducted to compare the cost-effectiveness of Oncomine DxTT using NGS with that of single-gene test in Japan. Methods: The target population included patients with advanced/recurrent nonsquamous NSCLC. A model structure was constructed for the Oncomine DxTT strategy and three single-gene tests (i.e., epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK)/c-ros oncogene 1 (ROS1) rearrangements) with reference to previous studies and the Clinical Practice Guidelines of Lung Cancer 2022 in Japan. The model structure assumed that genetic testing would be conducted and first-line treatment used the drug most recommended in the 2022 Japanese Lung Cancer Clinical Practice Guidelines, depending on the driver mutation,. Model inputs were obtained from the literature and price list in Japan, and cost-utility analysis was conducted. Results: For the Oncomine DxTT strategy, the expected incremental costs and effectiveness were estimated to be approximately JPY 172,361 (JPY 12,285,228 vs. JPY 12,112,867 for strategies A and B, respectively) and -0.51 quality-adjusted life-year (QALY) per patient (21.93 QALY vs. 22.44 QALY for strategies A and B). As a result, the costs increased but the effectiveness decreased. Therefore, the Oncomine DxTT strategy was dominated by the three single-gene tests. Sensitivity and scenario analyses revealed that the test success rate of Oncomine DxTT affected the results. Conclusions: The genetic test using Oncomine DxTT before the first-line treatment is not cost-effective compared with the three single-gene tests (EGFR/ALK/ROS1) for patients with advanced/recurrent nonsquamous NSCLC.

Clarification of Factors Determining Discharge Destination Among Elderly Patients After Stroke With Low Levels of Independence in Activities of Daily Living: A Retrospective Study.

Objective: To determine factors influencing discharge destination of elderly patients after stroke with low levels of independence in activities of daily living (ADL). Design: Cross-sectional study. Setting: A community-based public hospital in a rural area in Japan. Participants: A total of 67 patients with low daily function among 205 elderly patients with stroke screened for eligibility (N=67). Interventions: Not applicable. Main Outcome Measures: Motor component of functional independence measure (M-FIM) at discharge and discharge destination-home or long-term care facility (LCF). Results: Among the 205 eligible patients, 147 were discharged home and 58 were discharged to LCFs. Patients with an M-FIM score of ≤30 at discharge were defined as patients deemed difficult to discharge home because of low independence levels in ADL. Of the 147 patients discharged home, 24 (16.3%) had M-FIM scores of ≤30. Of the 58 patients discharged to LCFs, 43 (74.1%) had M-FIM scores of ≤30. Patients with an M-FIM score of ≤30 at discharge significantly tended to be discharged home if they obtained oral intake vs tube feeding as a nutritional method (P=.047) and higher cognitive component of FIM scores at discharge (P=.002). All six patients who lived alone among patients with an M-FIM score of ≤30 were discharged to LCFs. Two patients on tube feeding were discharged home. Conclusions: Nutritional method, cognitive function at discharge, and the prestroke living situation with or without household caregivers are important factors of discharge among elderly patients after stroke with low independence levels in ADL. However, only a small number of severely disabled patients were successfully discharged home.

Factors Associated With Time to Achieve Physical Functional Recovery in Patients With Severe Stoke After Inpatient Rehabilitation: A Retrospective Nationwide Cohort Study in Japan.

Objective: To describe characteristics of patient with severe stroke (FIM motor score [FIM motor] 20-49 at admission) and examine association between pre-specified factors (age, sex, modified Rankin Scale before stroke onset, body mass index, FIM motor, and FIM cognitive) and time to achieve FIM motor ≥70, that is, self-independent level. Design: Retrospective cohort study using a large database in Japan. Setting: Rehabilitation wards. Participants: Patients with severe stroke (N=1422) who received inpatient rehabilitation were included (median age: 76 years; interquartile range [IQR]: 68.0-84.0). A total of 54.6% were men, and 65.8% were ischemic stroke. Interventions: Not applicable. Main Outcome Measures: Time to achieve FIM motor ≥70. Results: After inpatient rehabilitation, 40.4% (N=575) achieved FIM motor ≥70 (admission FIM motor 20-29, 30-39 and 40-49: 18.6%, 33.6%, and 47.8%, respectively). Patients who achieved FIM motor ≥70 stayed median 81.0 days [IQR, 51.0-120.0]) and received median: 6.94 units per day [IQR, 5.48-7.78], 1 unit=20 minutes). Adjusted Fine-Gray regression revealed that shorter time to achieve FIM motor ≥70 was associated with higher admission FIM motor (hazard ratio [HR] 2.87 [95% confidence interval [CI] 2.27-3.62]: 20-29 vs 40-49), higher admission FIM cognitive (HR 1.81 [95% CI: 1.39-2.35]: 5-14 vs 25-35), and younger (HR 3.20 [95% CI: 2.32-4.42]: ≥85 years vs 20-69 years). Conclusions: Most patients with severe stroke did not achieve FIM motor ≥70 after inpatient rehabilitation. Older patients and patients with lower admission FIM motor require more attention. They should be prioritized for state-of-the-art rehabilitation therapy.

Cost of postoperative complications of lower anterior resection for rectal cancer: a nationwide registry study of 15,187 patients.

PURPOSE: To assess the increase in hospital costs associated with postoperative complications after lower anterior resection (LAR) for rectal cancer. METHODS: The subjects of this retrospective analysis were patients who underwent elective LAR surgery between April, 2015 and March, 2017, collected from a Japanese nationwide gastroenterological surgery registry linked to hospital-based claims data. We evaluated total and category-specific hospitalization costs based on the level of postoperative complications categorized using the Clavien-Dindo (CD) classification. We assessed the relative increase in hospital costs, adjusting for preoperative factors and hospital case volume. RESULTS: We identified 15,187 patients (mean age 66.8) treated at 884 hospitals. Overall, 71.8% had no recorded complications, whereas 7.6%, 10.8%, 9.0%, 0.6%, and 0.2% had postoperative complications of CD grades I-V, respectively. The median (25th-75th percentiles) hospital costs were $17.3 K (16.1-19.3) for the no-complications group, and $19.1 K (17.3-22.2), $21.0 K (18.5-25.0), $27.4 K (22.4-33.9), $41.8 K (291-618), and $22.7 K (183-421) for the CD grades I-V complication groups, respectively. The multivariable model identified that complications of CD grades I-V were associated with 11%, 21%, 61%, 142%, and 70% increases in in-hospital costs compared with no complications. CONCLUSIONS: Postoperative complications and their severity are strongly associated with increased hospital costs and health-care resource utilization. Implementing strategies to prevent postoperative complications will improve patients' clinical outcomes and reduce hospital care costs substantially.

End-of-life care for cancer patients in Japanese acute care hospitals: A nationwide retrospective administrative database survey.

BACKGROUND: End-of-life (EOL) cancer care in Japanese acute care hospitals has not been well described. METHODS: We aimed to assess the aggressiveness of EOL care and examine common treatments administered to cancer patients using a health administrative database. Subjects are adult cancer patients who died at acute care hospitals between April 2011 and March 2014. Data from the Japanese Diagnosis Procedure Combination database were analysed to measure the aggressiveness of care (chemotherapy, intensive care unit [ICU] admission and cardiopulmonary resuscitation [CPR]) and describe procedures and prescriptions administered in the last 14 and 30 days of life, disaggregated by hospital case volume: high, intermediate and low volumes. RESULTS: Of 248,978 cancer decedents, 170,024 died in high-, 70,231 in intermediate- and 8,723 in low-volume hospitals. Aggressive treatment in the last 14 days of life included chemotherapy (9.4%, 7.3%, and 5.4%, respectively), ICU admission (3.0%, 2.0%, and 2.4%) and CPR (5.8%, 6.4%, and 8.3%). Opioids were administered to 66.0%, 59.0% and 49.4% patients, while Palliative Care Team intervention was performed for 8.5%, 2.2% and 2.0% of patients, respectively in the last 30 days. In high-volume hospitals, radiotherapy and certified outpatient chemotherapy fees were more frequent. Catecholamines and hyperalimentation were more frequently administered in low-volume hospitals. CONCLUSION: This is the first study to assess EOL care among Japanese acute care hospitals. More frequent use of chemotherapy at high-volume hospitals may reflect a well-established cancer treatment system. The approach for low-volume hospitals might improve the EOL care for all cancer patients in Japan.

Medical Big Data for Research Use: Current Status and Related Issues.

Advances in the computerization of information and development of technology have mitigated restrictions on handling of a large amount of information. This has resulted in growth of expectations for the use of large-scale databases, or so-called "big data." This is also the case in the field of healthcare. Projects that involve building of the national receipt database (NDB) of medical fee bill (receipt) information and special health check-up information based on the Act on Assurance of Medical Care for Elderly People and the development of medical information databases have been pursued by the national government, and considerable attention has also been focused on researches conducted through the secondary uses of publicly collected data. Aside from these trends, there are numerous projects which collect diagnosis procedure combination (DPC) data to build large-scale databases for research purposes. Following to the ethics guidelines for epidemiologic studies, they collect and analyze anonymized DPC data from cooperating institutions. This communication concentrates on the use of DPC data, and outlines the scale of data currently available for research use. Examples on the use of DPC data will be shown for analysis on the current status of clinical practice from the microscopic perspective and macroscopic analysis of community medical care provision. Additionally, potential for extending studies to long-term outcomes research, limitations and issues related to the use of medical big data will also be discussed.

Comparative quality of laparoscopic and open cholecystectomy in the elderly using propensity score matching analysis.

The safety of laparoscopic cholecystectomy (LC) in patients ≥65 years of age requires further investigation of postoperative outcomes before it becomes more widely accepted as a safe technique. The advantages of using LC versus open cholecystectomy (OC) in elderly patients were analyzed using propensity score matching. The demographics, cholecystitis severity, comorbidities, complications, and admission and discharge Barthel Index (BI) scores of patients with benign gallbladder diseases were analyzed. Outcomes were analyzed by age, length of stay (LOS), total charges (TCs), BI improvement, and postoperative complications. OC, which was indicated in severe disease cases, increased hospital resource use and caused more complications than LC, but did not improve BI. Advanced age and OC resulted in greater LOS and TCs and was the best indicator of BI deterioration. Whenever possible, surgeons should use LC in elderly patients to minimize postoperative complications and allow them to regain a good quality of life.

[Chemotherapy and DPC, prospective payment].

In 2003, the Japanese government introduced a prospective payment methodology into acute inpatient care services by developing a new, national patient grouping, called Diagnosis Procedure Combination(DPC). It raised issues relating to; 1) settling charges for combinations of treatment modalities in a single admission, 2) large practice variations in chemotherapeutic regimens and its pharmaceutical costs, 3) effects of shorter length of stays and outpatient chemotherapy, 4) payment adjustment for hospitals providing care to terminally ill, relapse and metastatic cases. In order to overcome these issues; a) oncologists need to develop treatment guidelines and standardize chemotherapeutic regimens, b) refine DPC to incorporate chemotherapy protocols, c) develop adjustment measures for different densities of care and casemix.

[DPC and its implications for clinical practice in cancer treatment].

In April 2003, the Japanese government introduced a casemix classification based reimbursement methodology into acute inpatient care services by developing a new, national patient grouping, called Diagnosis Procedure Combination (DPC). The result, so far, has been successful, but analysis of data gathered using DPC revealed; 1) large deficit accumulating in short-term chemotherapy and examination admissions, 2) great variation in practice patterns within academic medical centers adopting the new system. Such phenomenon may lead to rapid shift of related services to outpatient setting, initiate debate over standardization of practice in cancer treatment. Efforts are needed to overcome these issues before the next reform planned in 2006.