National Database In Japan Research Articles

Body mass index is associated with disability at discharge as indicated by the modified Rankin Scale in patients with ischemic stroke: a JROAD-DPC study

ABSTRACT Background Body mass index (BMI) of patients with ischemic stroke (IS) has been associated with prognosis and disability in studies in the United States. Although the Asian population is leaner, the optimal BMI for stroke-related disability remains unknown. Objectives To clarify the association between BMI and disability in patients with IS from a national database in Japan. Methods The present study included 522,421 patients with IS identified in the JROAD-DPC database from April 2016 to March 2020. We used the WHO classification of BMI, which divides Asia-Pacific patients into five groups, to categorize BMI and the modified Rankin Scale (mRS) to assess stroke-related disability at admission and discharge. After multiple imputation for missing values, we conducted a multiple mixed-effect logistic regression analysis for poor mRS score (>2) in September 2023. In addition, we created a restricted cubic spline model between the odds ratio (OR) for poor mRS and BMI. Results The mRS score worsened during hospitalization in 60.1% of the patients with IS, and 45.7% had a poor mRS score at discharge. Overweight patients had the lowest OR of having a poor mRS score (OR: 0.898, 95% confidence interval: 0.895–0.902). The spline curve for the OR for poor mRS score was U-shaped with a BMI of 24.7 kg/m2as the apex value. Conclusion The present study revealed a U-shaped relationship between BMI and stroke-related disability, with overweight patients having the lowest OR for disability at discharge.

Significance of Multi-Cancer Genome Profiling Testing for Breast Cancer: A Retrospective Analysis of 3326 Cases from Japan's National Database.

Background: Breast cancer (BC) has the highest morbidity rate and the second-highest mortality rate of all cancers among women. Recently, multi-cancer genome profiling (multi-CGP) tests have become clinically available. In this study, we aimed to clarify the significance of multi-CGP testing of BC by using the large clinical dataset from The Center for Cancer Genomics and Advanced Therapeutics (C-CAT) profiling database in Japan. Materials and Methods: A total of 3744 BC cases were extracted from the C-CAT database, which enrolled 60,250 patients between June 2019 and October 2023. Of the 3744 BC cases, a total of 3326 cases for which the C-CAT included information on ER, PR, and HER2 status were classified into four subtypes, including TNBC, HR+/HER2-, HR+/HER2+, and HR-/HER2+. Comparisons between groups were performed by the χ2 test or Fisher's exact test using EZR. Kaplan-Meier curves were created using the log-rank test. Results: Of all 3326 cases analyzed, 1114 (33.5%) were TNBC cases, HR+/HER2- accounted for 1787 cases (53.7%), HR+/HER2+ for 260 cases (7.8%), and HR-/HER2+ for 165 cases (5.0%). Genetic abnormalities were most frequently detected in TP53 (58.0%), PIK3CA (35.5%), MYC (18.7%), FGF19 (15.5%), and GATA3 (15.1%) across all BCs. The rate of TMB-High was 12.3%, and the rate of MSI-High was 0.3%, in all BC cases. Therapeutic drugs were proposed for patients with mutations in six genes: PIK3CA, ERBB2, PTEN, FGFR1, ESR1, and AKT1. The prognoses of HR+/HER2- cases were significantly (p = 0.044) better in the treated group than in the untreated group. Conclusions: These findings suggest that cancer gene panel testing is useful for HR+/HER2- cases.

Surgical Risk in Elderly Patients with Meningiomas in Japan.

Background/Objective: No guidelines indicate surgical risk factors for the elderly because of the lack of data from general neurosurgeons. To better understand the management of surgical risk in elderly patients with meningiomas based on a national database in Japan. Methods: Results of surgically treated meningiomas were explored in 8138 patients registered in the Diagnosis Procedure Combination database in Japan during 2010-2015. Age (<65, 65-74, and ≥75 years), sex, Barthel index (BI), medical history, tumor location, oral medication prescriptions on admission, and stroke complications were evaluated. Multivariate logistic regression analysis identified risk factors for stroke complications, BI deterioration between admission and discharge, and in-hospital mortality. Results: Advanced age was the prominent risk factor for BI deterioration (odds ratio: 3.26; 95% confidence interval: 2.69-3.95) but not for in-hospital mortality. Lower BI (60-80) on admission increased the risk of BI deterioration in all age groups; however, BI < 60 demonstrated a significant inverse risk (0.47; 0.32-0.69) in the elderly (≥75 years). Location (falx, parasagittal, and deep) and anticoagulants were not significant risk factors for BI deterioration in patients aged ≥ 75 years, despite being significant risk factors in patients aged <65 and/or 65-74 years. Conclusions: Although advanced age could lead to postoperative functional decline at discharge, it was not sufficiently significant enough to be associated with in-hospital mortality. Because of the possibility of recovery even in elderly patients with severe disabilities, appropriate surgical selection and optimal management may lead to favorable functional outcomes in elderly patients with meningiomas.

Genomic Landscape and Clinical Features of Advanced Thyroid Carcinoma: A National Database Study in Japan.

The relationship between the genomic profile and prognosis of advanced thyroid carcinoma requiring drug therapy has not been reported. To evaluate the treatment period and overall survival time for each genetic alteration in advanced thyroid carcinoma that requires drug therapy. We conducted a retrospective observational study using a national database in Japan, which included 552 cases of thyroid carcinoma out of 53 543 patients in the database. The database included anaplastic thyroid carcinoma (23.6%), poorly differentiated thyroid carcinoma (10.0%), and differentiated thyroid carcinoma (66.4%). The most common genetic abnormalities were TERT promoter (66.3%), BRAF (56.7%), and TP53 (32.2%). The typical driver genes were BRAF V600E (55.0%), RAS (18.5%), RET fusion (4.7%), NTRK fusion (1.6%), and ALK fusion (0.4%). The most common regimen was lenvatinib, and the time to treatment failure was not different despite the presence of BRAF or RAS mutations. In differentiated thyroid carcinoma and poorly differentiated thyroid carcinoma, TP53 alterations independently predicted worse overall survival (hazard ratio = 2.205, 95% confidence interval: 1.135-4.283). In anaplastic thyroid carcinoma, no genetic alterations were associated with overall survival. Genetic abnormalities with treatment options were found in 62.7% of advanced thyroid carcinomas. TP53 abnormality was an independent poor prognostic factor for overall survival in differentiated thyroid carcinoma. The time to treatment failure for lenvatinib was not different based on genetic profile.

Disease Trends in Children and Adolescents in Japan: A Retrospective Observational Study Using the Nationwide Claims Data for 2012-2016.

This study aimed to clarify diseases that occur more frequently by age and identify the peaks and trends of each disease from infancy to adolescence for early detection and treatment. This retrospective observational study was conducted using Japan's National Database of Health Insurance Claims Specific Health Checkups from January 2012 to December 2016. Using peak ages and trends in the number of patients, we grouped diseases by the International Classification of Diseases chapters. Although diseases that peaked during infancy were the most common (10 disease chapters), other diseases peaked at school-going age and adolescence. Diseases in four chapters peaked during adolescence and continued to increase toward the age of 18. These four chapters included mental, behavioral, and neurodevelopmental disorders; diseases of the nervous system; the genitourinary system; and pregnancy, childbirth, and the puerperium. Childhood-onset diseases can affect long-term health and healthcare needs, and timely screening and guidance based on disease trends can provide an effective intervention. To establish a child healthcare system that provides preventive support for children and adolescents' physical, psychological, and social health, further research is needed to comprehensively understand the issues per age and developmental stage.

The Assessment and Response of Rehabilitation Professionals to Sudden Deterioration in Symptoms: An Analysis of the National Database in Japan.

There are few analyses of the current status of and responses to acute deteriorations encountered by physiotherapists, occupational therapists, and speech-language pathologists (rehabilitation professions [RPs]). The purpose of this study was to analyze the responses of RPs to acute deterioration in patients using the functional resonance analysis method (FRAM) based on the descriptions in "the Medical Accident Database". Subjects were 413 cases with medical incidents reported by RPs to the database from 2012 to 2021. Life-threatening cases with changes in consciousness, circulation, and respiration were selected. Descriptions regarding findings assessed by RPs and support team, and requests for assistance were extracted. We also attempted to construct appropriate respond in RPs by using the FRAM. Thirty-nine cases of acute deterioration were included in the analysis, and descriptions by RPs of consciousness (35 cases), circulation (18 cases), and respiration (36 cases) were identified. Blood pressure and percutaneous oxygen saturation measurement were frequently presented in the assessment by RPs, whereas the support team assessed cardiac arrest and respiratory arrest in high frequency. The FRAM analysis indicated that appropriate and rapid post-response by RPs requires patient information in prior, appropriate assessment and integration/interpretation. We attempted to identify problems analyzing the response by RPs to acute deterioration using the database and construct an appropriate response model. It resulted that RPs need to obtain patient information in advance and integrate/interpret it appropriately based on accurate assessment of conscious, circulation and respiration for rapid response. A model including integration/interpretation for appropriate post-response by RPs was constructed using the FRAM.

Regional Variation in End-of-Life Care just before Death among the oldest old in Japan : A descriptive study.

The use of life-sustaining treatment (LST) in the final stage of life is a major policy concern due to increased costs, while its intensity does not correlate with quality. Previous reports have shown declining trends in LST use in Japan. However, regional practice variations remain unclear. This study aims to describe regional variations in LST use before death among the oldest old in Japan. A descriptive study was conducted among patients aged 85 or older who passed away between April 2013 and March 2014. The study utilized health insurance claims from Japan's National Database (NDB) to examine the use of cardiopulmonary resuscitation (CPR), mechanical ventilation (MV), and admission to the acute care ward (ACW) in the last 7 days of life. Among 224,391 patients, the proportion of patients receiving LST varied by region. CPR ranged from 8.6% (Chubu) to 12.9% (Shikoku), MV ranged from 7.1% (Chubu) to 12.3% (Shikoku), and admission to ACW ranged from 4.5% (Chubu) to 10.1% (Kyushu-Okinawa). The adjusted odds ratios (AOR) for regional variation compared with Kanto were as follows: CPR (in Shikoku, 1.85 [95% CI 1.73 - 1.98]), MV (in Shikoku, 1.75 [1.63 - 1.87]), and ACW admission (in Kyushu-Okinawa, 1.69 [1.52 - 1.88]). The study presents descriptive information regarding regional differences in the utilization of LST for the oldest old. Further research is necessary to identify the factors that contribute to these variations and to address the challenge of improving the quality of end-of-life care.

Factors predictive of second-line chemotherapy in soft tissue sarcoma: An analysis of the National Genomic Profiling Database.

Of the drugs used in second-line chemotherapy for soft tissue sarcoma (STS), trabectedin is effective for liposarcoma and leiomyosarcoma (L-sarcoma), eribulin for liposarcoma, and pazopanib for non-liposarcoma. The indications for these drugs in STS other than L-sarcoma have not been established. Here we explored the prognosis, mutation profiles, and drug-response factors in STS using real-world big data. Clinicogenomic data on 1761 patients with sarcoma who underwent FoundationOne CDx were obtained from a national database in Japan. Patients with TP53 and KDM2D mutations had a significantly shorter survival period of 253 (95% CI, 99-404) and 330 (95% CI, 20-552) days, respectively, than those without mutations. Non-supervised clustering based on mutation profiles generated 13 tumor clusters. The response rate (RR) to trabectedin was highest in an MDM2-amplification cluster (odds ratio [OR]: 2.2; p = 0.2). The RR was lowest for eribulin in an MDM2-amplification cluster (OR: 0.4; p = 0.03) and highest in a TERT-mutation cluster (OR: 3.0; p = 0.03). The RR was highest for pazopanib in a PIK3CA/PTEN-wild type cluster (OR: 2.1; p = 0.03). In particular, patients harboring mutations in genes regulating the PI3K/Akt/mTOR pathway had a lower RR than patients without mutations (OR: 0.3; p = 0.04). In STS, mutation profiles were more useful in predicting the drug response than histology. The present study demonstrated the potential of tailored therapy guided by mutation profiles established by comprehensive genomic profiling testing in optimizing second-line chemotherapy for STS. The findings of this study will hopefully contribute some valuable insights into enhancing STS treatment strategies and outcomes.

Insights from the trends of omalizumab and mepolizumab utilization in patients with asthma: A population-based cohort study using the National Database in Japan

BackgroundBiologics are increasingly being used in patients with severe uncontrolled asthma. However, the trends in their use for treating severe asthma in Japan remain unclear. MethodsThe number of patients with asthma prescribed omalizumab or mepolizumab between April 2017 and March 2018 was estimated according to sex, age, and geographical region using data from the National Database of Health Insurance Claims and Specific Health Checkups of Japan. ResultsOverall, 5,014, 3,449 and 7,977 patients were prescribed omalizumab, mepolizumab, or either combination, respectively. The total number of patients prescribed biologics displayed a bimodal distribution with peaks in their early teens and seventies. Biologics were most commonly used by male and female patients in their seventies. Prescription was 1.24 times higher in males than in females up to the teenage years, whereas it was 1.95 times higher in females than in males from their twenties onwards. Omalizumab was prescribed 1.45 times more frequently than mepolizumab, especially in pediatric patients, and was prescribed 1.96 times more often to female patients than to male patients. Regional differences were observed in the proportion of patients prescribed biologics. Correlation analysis suggested a weak relationship (r = 0.3226, p = 0.0270) between the proportion of patients prescribed biologics and board-certified allergists according to the geographic region. ConclusionsIn Japan, biologics are prescribed more often to older patients with severe asthma compared to those in other countries. Thus, eliminating the regional disparities in asthma treatment by specialists is necessary to provide appropriate medical care to patients with severe asthma.

Lifestyle factors associated with a rapid decline in the estimated glomerular filtration rate over two years in older adults with type 2 diabetes–Evidence from a large national database in Japan

Background The present study investigated lifestyle risk factors from metabolic syndrome-related lifestyles for a rapid decline in the estimated glomerular filtration rate (eGFR) among adults aged 40–74 years with treated and untreated type 2 diabetes. Methods and results This study analyzed data from the National Database of Health Insurance Claims and Specific Health Checkups of Japan, encompassing the period from fiscal year (FY) 2017 to FY2020. We established FY2018 as our baseline year. The subjects of this study were adults aged 40–74 in FY2018(baseline) who had type 2 diabetes and underwent specific health checkups in FY2020. We excluded adults with a medical record of kidney dialysis between FY2017 and FY2018, records of suspected type 1 diabetes between FY2017 and FY2020, or a baseline eGFR &gt;85 mL/min/1.73 m2 or missing eGFR data as of FY2020. Eventually we analyzed 573,860 individuals. The outcome variable was a rapid decline in eGFR (≥30%) during the follow-up. Exposure lifestyle factors included skipping breakfast, late-night dinners, regular smoking, a high alcohol intake, non-refreshing sleep, and a lack of habitual exercise. Logistic regression models were stratified by age (40–59 and 60–74 years) and baseline eGFR levels (60–85, 30–59, and &lt;30 mL/min/1.73 m2). Covariates included sex, a history of heart disease, a history of stroke, a history of renal failure, anemia, low-density lipoprotein, systolic blood pressure, hemoglobin A1C, body mass index, antidiabetic medications, antihypertension drugs, lipid-lowering drugs, the oral adsorbent Kremezin, non-steroidal anti-inflammatory drugs, and drugs for the treatment of renal anemia. A rapid decline in eGFR was detected in approximately 1.3% of participants (7,683 cases). In the baseline eGFR &gt;30 subgroups (60–85 or 30–59 mL/min/1.73 m2), skipping breakfast and regular smoking were associated with a rapid decline in eGFR in both age groups, while a lack of habitual exercise and late-night dinners in the 60–74 age group and non-refreshing sleep in the 40–59 age group were identified as risk factors. Additionally, skipping breakfast was a risk factor for a rapid decline in eGFR in the 60–74 age group regardless of baseline eGFR levels. In the baseline eGFR &lt;30 mL/min/1.73 m2 subgroup, skipping breakfast and non-refreshed sleep were risk factors for a rapid decline in eGFR. Conclusions We found specific lifestyle risk factors were associated with a rapid eGFR decline among people with type 2 diabetes from a nationwide database in Japan. The associations varied by baseline eGFR level, age, and sex. Lifestyle modifications may effectively prevent the aggravation of diabetic kidney disease.

Real-world trends in pre-dialysis blood pressure levels of patients undergoing dialysis in Japan using a web-based national database.

The prevalence of hypertension is high among patients undergoing dialysis. We extracted data of patients undergoing dialysis between 2012 and 2020 with recorded pre-dialysis systolic blood pressure (SBP) using a web-based national database in Japan. Following the 2019 Japanese Society of Hypertension guidelines, we classified SBP and assessed its trends over time based on sex, age, diabetes status, and the anti-hypertensive medication use. Using the 2020 database, we examined 336,759 Japanese patients undergoing dialysis (114,249 female; 222,510 male). The mean age was 69.4±12.5years, and the mean SBP was 152.3±24.7mm Hg. The prevalence rate of pre-dialysis hypertension was 70.2%, with 32.5%, 24.5%, and 13.2% of patients having grade I, grade II, and grade III hypertension, respectively. From 2014 to 2020, prevalence rate of pre-dialysis hypertension and absolute values of pre-dialysis SBP were higher in dialysis patients with diabetes than in those without diabetes across all age groups and sexes. Younger patients with diabetes or those on anti-hypertensive medication exhibited an SBP of approximately 160mm Hg. Cerebrovascular death in patients with diabetes was associated with a higher rate of pre-dialysis hypertension than that in those without diabetes, and there was a significant difference in the prevalence of grade III hypertension between the two groups. In conclusion, the mean pre-dialysis SBP among patients undergoing dialysis remained high, and younger patients with diabetes or those receiving anti-hypertensive medications had poor blood pressure control. Optimal blood pressure management may be necessary to reduce the risk of cardiovascular mortality.

Dose reduction of olaparib in older patients: Insights from an analysis of a National Database in Japan.

Although the advent of a poly polymerase inhibitors has greatly advanced the tailoring of cancer treatment, there is a dearth of real-world evidence on the actual use of olaparib in aging populations, especially those using national-level data. We extracted and analyzed all prescriptions of olaparib in female outpatients from the National Database Open Data Japan (NDB Open Data) from April 2019 to March 2021. The recommended standard dose of olaparib is four tablets of the 150 mg formulation per day, while the 100 mg formulation of olaparib can be considered as an alternative dose in the occurrence of hematologic toxicity. We calculated the proportion of 100 mg compared to the 150 mg prescriptions across age groups. A Cochrane-Armitage trend test was used to examine the association of age groups with the proportion of 100 mg prescriptions. The total number of prescriptions of the 100 mg formulation and the 150 mg formulation were 1449 222, and 4233 625, respectively. Overall, 45.1% (2567 513/5682 847 prescriptions) of olaparib were prescribed for patients 65 years of age or older in females. Stratified by age group, the proportion of 100 mg compared to the 150 mg prescriptions significantly increased with age (p < 0.0001). Given that the 100 mg formulation of olaparib can be considered as an alternative dose in Japan in the occurrence of hematologic toxicity, our observations indicate the dose reduction of olaparib in older patients in Japan. Further investigations are necessary to assess its efficacy and safety at a reduced dose.

Regional differences in epidermal growth factor receptor-tyrosine kinase inhibitor therapy in lung cancer treatment using a national database in Japan

Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) are extensively used in the treatment of non-small cell lung cancer (NSCLC); hence, equal access to them is important. Therefore, this study aimed to identify regional differences in the prescription of EGFR-TKIs and the factors contributing to these differences. In this ecological study, we collected data using the National Database Open Data and the National Cancer Registry. The standardized claim ratio (SCR) was used as an indicator of the number of EGFR-TKI prescriptions. Additionally, we examined the association between SCR and various factors to identify the factors associated with this difference. The average SCR for the top three provinces was 153.4, while the average for the bottom three provinces was 61.6. Multivariate analysis used for evaluating the association of SCR with variables revealed that the number of designated cancer hospitals and radiation therapies were independent factors associated with the SCR of EGFR-TKIs. There were significant regional differences in the prescriptions of EGFR-TKIs in Japan based on the number of coordinated designated cancer hospitals and the number of patients receiving radiotherapy alone. These findings emphasize the need to implement policies to increase the number of hospitals to reduce regional differences.

Association between types of home healthcare and emergency house calls, hospitalization, and end-of-life care in Japan.

To meet the increasing demand for home healthcare in Japan, as part of the national healthcare system, home care support clinics/hospitals (HCSCs) and enhanced HCSCs were introduced in 2006 and 2012 respectively. This study aimed to evaluate whether HCSCs has succeeded in providing 24-h home care services through the end of life. A retrospective cohort study was conducted using the national database in Japan. Participants were ≥ 65 years of age, had newly started regular home visits between July 2014 and September 2015, and used general clinics, conventional HCSCs, or enhanced HCSCs. Each patient was followed up for 6months after the first visit. The outcome measures were (i) emergency house call(s), (ii) hospitalization(s), and (iii) end-of-life care defined as in-home death. Multivariable logistic regression analyses were performed for statistical analysis. The analysis included 160,674 patients, including 13,477, 64,616, and 82,581 patients receiving regular home visits by general clinics, conventional HCSCs, and enhanced HCSCs respectively. Compared to general clinics, the use of conventional and enhanced HCSCs was associated with an increased likelihood of emergency house calls (adjusted odds ratio [aOR] and 95% confidence intervals [CIs] of 1.62 [1.56-1.69] and 1.86 [1.79-1.93], respectively) and a decreased likelihood of hospitalizations (aOR [95% CIs] of 0.86 [0.82-0.90] and 0.88 [0.84-0.92] respectively). Among 39,082 patients who died during the follow-up period, conventional and enhanced HCSCs had more in-home deaths (aOR [95% CIs] of 1.46 [1.33-1.59] and 1.60 [1.46-1.74], respectively) compared to general clinics. HCSCs (especially enhanced HCSCs) provided more emergency house calls, reduced hospitalization, and enabled expected deaths at home, suggesting that further promotion of HCSCs (especially enhanced HSCSs) would be advantageous.

Trends and Regional Differences in the Prevalence of Dyslipidemia before and after the Great East Japan Earthquake: A Population-Based 10-Year Study Using the National Database in Japan.

Since the Great East Japan Earthquake in March 2011, an increase in lifestyle-related diseases due to changes in living environment following the nuclear power plant accident has been reported in Fukushima Prefecture, especially among evacuees. However, no long-term studies covering the entire Fukushima Prefecture have been conducted. The study aim was to investigate the effects of post-disaster evacuation life on the prevalence of dyslipidemia in Fukushima Prefecture using a national database. The data from 3,866,674 people who underwent specific health checkups between fiscal year (FY) 2008 and FY2017 were analyzed. Fukushima Prefecture was divided into four areas, and the prevalence of dyslipidemia and related parameters were compared. The prevalence of dyslipidemia increased overall, with a particularly sharp increase after FY2011 in the evacuation area. The sex- and age-adjusted odds ratio (95% confidence intervals) of having dyslipidemia in the evacuation area compared with that in the control area was 0.951 (0.929-0.973) in FY2008-2010, which increased to 1.130 (1.105-1.155) in FY2012-2014 and 1.117 (1.092-1.143) in FY2015-2017. Since the prevalence of dyslipidemia has increased and remained high after the earthquake in Fukushima Prefecture, especially in the evacuation area, continued measures to prevent cardiovascular diseases among the residents are needed.

P141 Analysis of Gender Difference for Critical Illness and Death in a House by Using an Emergency Transportation National Database in Japan

P141 Analysis of Gender Difference for Critical Illness and Death in a House by Using an Emergency Transportation National Database in Japan

Analysis of antiretroviral therapy switch rate and switching pattern for people living with HIV from a national database in Japan

To report the status of switch rates and time-to-switch of antiretroviral therapy (ART) regimens by evaluating anchor drug classes and common switching patterns in Japanese people living with human immunodeficiency virus (HIV, PLWH). This cross-sectional cohort study extracted data of 28,089 PLWH from the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), which contains data representing the entire population of Japan. PLWH with first prescription records of ART administered between January 2011 and March 2019 were identified (n = 16,069). The median time-to-switch and switch rates of anchor drug classes were estimated by Kaplan–Meier analysis. Brookmeyer–Crowley and Greenwood methods were used to estimate 95% confidence intervals for switch rates and median days, respectively. Switch rates were compared between anchor drug classes by year using log-rank tests. A total of 3108 (19.3%) PLWH switched anchor drug classes from first to second regimens. Switch rates increased continuously over 8 years for non-nucleoside reverse transcriptase inhibitors (NNRTIs) (14.9–65.5%) and protease inhibitors (PIs) (13.2–67.7%), with median time-to-switch of 1826 and 1583 days, respectively. Integrase strand transfer inhibitors (INSTIs) maintained a low switch rate (3.0–7.6%), precluding median-days calculation. Overall, the majority of patients treated initially with NNRTIs and PIs switched to INSTIs regardless of switching times (< 1 year: 67.3% and 85.9%, respectively; ≥ 1 year: 95.5% and 93.6%, respectively). The foremost switching strategies for first-to-second ART regimens are from NNRTIs or PIs to INSTIs regimens that maintain low switch rates long term. There was no observable difference in trend between sex, age and status of AIDS disease at first ART regimen. INSTIs HIV agents may be the most durable anchor drug class for PLWH receiving ART.

Development of a New Method to Trace Patient Data Using the National Database in Japan

Development of a New Method to Trace Patient Data Using the National Database in Japan

Change in clinical practice variations for antibiotic prescriptions across different pediatric clinics: A Japan's nationwide observational study

BackgroundIn 2016, the Japanese government set the National Action Plan on antimicrobial resistance to reduce antibiotic prescriptions. However, the trends and variations of antibiotic prescription patterns in a routine healthcare setting during the fiscal year 2013–2018 across different clinics at a national level are unclear. MethodsThis retrospective cohort study included all clinics with >100 pediatric outpatients with infectious diseases per month during the fiscal year 2013–2018 using a national database in Japan. We investigated the trends in antibiotic prescription rates and their patterns and variations across different clinics over the six years following the 2019 World Health Organization Access, Watch, Reserve antibiotic groups, and Amoxicillin Index. ResultsA total of 2278 clinics with 94,414,170 infectious disease-related visits were eligible for the study. Most clinics showed higher Watch percentages (median 85.4%; IQR, 68.5–95.1) than Access percentages (median, 13.8%; IQR, 4.2–30.7) and Amoxicillin Index (median, 13.3%; IQR, 3.9–30.4). The introduction of the Action Plan changed annual absolute reductions in the antibiotic prescription rates from −16.0 DOTs/1000 visitors (95%CI, −16.4–15.6) to −239.3 per 1000 visitors (95%CI, −240.0–238.6). However, these impacts were heterogeneous across clinics. From 2013 to 2018, 41.4% reduced the antibiotic prescription rates by >33.3% (median, −1035.5 DOTs/1000 visitors; IQR, −1519.4–680.2), 18.7% did not change the rates (median, −40.3 DOTs/1000 visitors; IQR, −168.4–68.6), and 7.3% increased the rates by >10% (499.5 DOTs per 1000 visitors; IQR, 232.6–837.5). ConclusionsWe observed the National Action Plan's impacts and extensive prescription variations across different pediatric clinics. However, one-fourth of clinics did not improve antibiotic prescription patterns even after introducing the Action Plan.

The validity of the claims-based definition of rheumatoid arthritis evaluated in 64 hospitals in Japan

BackgroundAn administrative database covering a whole population such as the national database in Japan may be used to estimate the nationwide prevalence of diseases including rheumatoid arthritis (RA) when a well-validated definition of the disease is available. In Japan, the record linkage between the administrative database and medical charts in hospitals is strictly prohibited. A “hospital-based” validation study is one of few possible validation studies where claims kept inside the study hospital are rearranged into the database structure.MethodsWe selected random samples of 19,734 patients from approximately 1.6 million patients who received medical care between February 2018 and January 2019 in one of the 64 hospitals of the Tokushukai Medical Group. We excluded patients whose observation period was less than 365 days and identified 334 patients who met the definition of “possible cases of RA” whose medical charts were then independently evaluated by two rheumatologists. In a sensitivity analysis, we assessed bias due to misclassifying some patients with RA who did not meet the definition of “possible cases of RA” as a patient with no RA.ResultsThe kappa coefficient between the two rheumatologists was 0.80. The prevalence of RA in the study population was estimated to be 0.56%. We found that [condition code of RA] and ([any disease-modifying antirheumatic drug] or [oral corticosteroid with no systemic autoimmune diseases (other than RA) and no polymyalgia rheumatica]) had a relatively high sensitivity (approximately 73%) and a high positive predictive value (approximately 80%). In a sensitivity analysis, we found that when some patients with RA who did not meet the definition of “possible cases of RA” were misclassified as a patient with no RA, then this would lead to underestimation of the prevalence of the definition-positive patients and the adjusted prevalence.ConclusionsWe recommend using the claims-based definition of RA (found in the current validation study) to estimate the prevalence of RA in Japan. We also suggest estimating the adjusted prevalence using the quantitative bias analysis method, since the prevalence of the disease in the “hospital-based” validation study is different from that in the administrative database.Trial registrationThe current study is not a clinical trial and hence not subject to trial registration.