Effect of the COVID-19 pandemic on outpatient care and rehabilitation in neuromuscular clinical practice in Japan: a health insurance claims database analysis.

OBJECTIVES: To evaluate the impact of the COVID-19 pandemic on outpatient care in Japanese patients with neuromuscular diseases (NMDs). DESIGN: This retrospective cohort study included patients between January 2018 and February 2019; the follow-up period was divided into 'before COVID-19' (March 2019-February 2020) and 'during COVID-19' (March 2020-February 2021). SETTING: JMDC claims database study. PARTICIPANTS: Of the 10 655 557 patients identified, we included patients with spinal muscular atrophy (SMA; n=82), neuromyelitis optica (NMO; n=342), myasthenia gravis (MG; n=1347), Guillain-Barré syndrome (GBS; n=442) or autoimmune encephalitis/encephalopathy (AIE; n=133). Patients were required to have ≥1 month of data available, have a diagnosis of NMD during the enrolment period and be available for follow-up. PRIMARY AND SECONDARY OUTCOME MEASURES: We estimated the proportion of patients with >30% change in outpatient consultation and rehabilitation visits before versus during the COVID-19 pandemic. RESULTS: Small reductions in the proportion of patients with outpatient consultation/rehabilitation visits were observed before versus during the pandemic. Compared with before the pandemic, 30.4%, 27.8%, 28.7%, 49.4% and 50.0% of patients showed a >30% decrease in outpatient consultation visits and 58.6%, 75.0%, 50.0%, 76.3% and 84.6% showed a >30% decrease in outpatient rehabilitation visits during the pandemic for SMA, NMO, MG, GBS and AIE, respectively. The median change in the number of outpatient consultation visits per year before versus during pandemic was -1.0 day for all NMDs, and that in outpatient rehabilitation visits per year was -6.0, -5.5, -1.5, -6.5 and -9.0 days for SMA, NMO, MG, GBS and AIE, respectively. The reduction in outpatient rehabilitation visits was greater in the absence versus presence of a neurology specialist. CONCLUSIONS: Outpatient consultation and rehabilitation visits during the COVID-19 pandemic were affected in Japanese patients with NMDs. Longer-term evaluations are required to understand if these reductions in outpatient care would affect patient prognosis.

Hospital-Level Variation in Cardiac Rehabilitation After Myocardial Infarction in Japan During Fiscal Years 2014-2015 Using the National Database.

Background: Cardiac rehabilitation (CR) is an evidence-based medical service for patients with acute myocardial infarction (AMI); however, its implementation is inadequate. We investigated the provision status and equality of CR by hospitals in Japan using a comprehensive nationwide claims database. Methods and Results: We analyzed data from the National Database of Health Insurance Claims and Specific Health Checkups in Japan for the period April 2014-March 2016. We identified patients aged ≥20 years with postintervention AMI. We calculated hospital-level proportions of inpatient and outpatient CR participation. The equality of hospital-level proportions of inpatient and outpatient CR participation was evaluated using the Gini coefficient. We included 35,298 patients from 813 hospitals for the analysis of inpatients and 33,328 patients from 799 hospitals for the analysis of outpatients. The median hospital-level proportions of inpatient and outpatient CR participation were 73.3% and 1.8%, respectively. The distribution of inpatient CR participation was bimodal; the Gini coefficients of inpatient and outpatient CR participation were 0.37 and 0.73, respectively. Although there were statistically significant differences in the hospital-level proportion of CR participation for several hospital factors, CR certification status for reimbursement was the only visually evident factor affecting the distribution of CR participation. Conclusions: The distributions of inpatient and outpatient CR participation by hospitals were suboptimal. Further research is warranted to determine future strategies.

Assessment of Efficacy and Safety of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years: A Systematic Review and Meta-analysis.

Importance: Evidence of the efficacy and safety of messenger RNA (mRNA) COVID-19 vaccines in children aged 5 to 11 years has been emerging. Collecting these data will inform clinicians, families, and policy makers. Objective: To evaluate the efficacy and safety of mRNA COVID-19 vaccines in children aged 5 to 11 years in a systematic review and meta-analysis. Data Sources: PubMed and Embase databases were searched on September 29, 2022, without language restrictions. Study Selection: Randomized clinical trials and observational studies comparing vaccinated vs unvaccinated children aged 5 to 11 years and reporting efficacy or safety outcomes were included. Studies reporting safety outcomes in vaccinated children only (ie, no control group) were also included. Data Extraction and Synthesis: Two investigators independently extracted relevant data from each study. Odds ratios (ORs) for efficacy and safety outcomes and incidences of adverse events (AEs) following vaccination were synthesized using a random-effects model. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses and Meta-analysis of Observational Studies in Epidemiology reporting guidelines. Main Outcomes and Measures: The primary outcome was SARS-CoV-2 infections with or without symptoms. The secondary outcomes included symptomatic SARS-CoV-2 infections, hospitalizations, and multisystem inflammatory syndrome in children. The incidences of each AE following vaccination were also evaluated. Results: Two randomized clinical trials and 15 observational studies involving 10 935 541 vaccinated children (median or mean age range, 8.0-9.5 years) and 2 635 251 unvaccinated children (median or mean age range, 7.0-9.5 years) were included. Two-dose mRNA COVID-19 vaccination compared with no vaccination was associated with lower risks of SARS-CoV-2 infections with or without symptoms (OR, 0.47; 95% CI, 0.35-0.64), symptomatic SARS-CoV-2 infections (OR, 0.53; 95% CI, 0.41-0.70), hospitalizations (OR, 0.32; 95% CI, 0.15-0.68), and multisystem inflammatory syndrome in children (OR, 0.05; 95% CI, 0.02-0.10). Two randomized clinical trials and 5 observational studies investigated AEs among vaccinated children. Most vaccinated children experienced at least 1 local AE following the first injection (32 494 of 55 959 [86.3%]) and second injection (28 135 of 46 447 [86.3%]). Vaccination was associated with a higher risk of any AEs compared with placebo (OR, 1.92; 95% CI, 1.26-2.91). The incidence of AEs that prevented normal daily activities was 8.8% (95% CI, 5.4%-14.2%) and that of myocarditis was estimated to be 1.8 per million (95% CI, 0.000%-0.001%) following the second injection. Conclusions and Relevance: In this systematic review and meta-analysis, COVID-19 mRNA vaccines among children aged 5 to 11 years were associated with measures of efficacy in preventing SARS-CoV-2 infection and severe COVID-19-related illnesses. While most children developed local AEs, severe AEs were rare, and most of AEs resolved within several days. These data provide evidence for future recommendations.

A post-marketing safety assessment of COVID-19 mRNA vaccination for serious adverse outcomes using administrative claims data linked with vaccination registry in a city of Japan.

INTRODUCTION: The safety profiles of COVID-19 vaccines are incompletely evaluated in Japan. OBJECTIVES: To examine the risk of serious adverse effects after COVID-19 mRNA vaccination (BNT162b2 and mRNA-1273) in cohort studies and self-controlled case series (SCCS). METHODS: Using an administrative claims database linked with the COVID-19 vaccination registry in a city in Japan between September 2020 and September 2021, we identified health insurance enrolees aged ≥ 18 years. We evaluated the risk of acute myocardial infarction, appendicitis, Bell's palsy, convulsions/seizures, disseminated intravascular coagulation, immune thrombocytopenia, pulmonary embolism, haemorrhagic or ischemic stroke, venous thromboembolism, and all-cause mortality, 21 days following any COVID-19 mRNA vaccination, compared with non-vaccination periods. For the cohort studies, we estimated incidence rate ratios (IRRs) by Poisson regression and rate differences (IRDs) by weighted least-squares regression, adjusting for sex, age, and Charlson comorbidity index. We applied a modified SCCS design to appropriately treat outcome-dependent exposures. For the modified SCCS, we estimated within-subject IRRs by weighted conditional Poisson regression. Subgroup analyses stratified by sex and age were also conducted. RESULTS: We identified 184,491 enrolees [male: 87,218; mean (standard deviation) age: 64.2 (19.5) years] with 136,667 first and 127,322 s dose vaccinations. The risks of any outcomes did not increase in any analyses, except for the fact that the modified SCCS indicated an increased risk of pulmonary embolism after the first dose in women (within-subject IRR [95%CI]: 3.97 [1.18-13.32]). CONCLUSION: The findings suggested that the COVID-19 mRNA vaccine was generally safe, whilst a signal of pulmonary embolism following the first dose of the COVID-19 mRNA vaccine was observed.

Regional variation in long-term care spending in Japan.

BACKGROUND: Health inequalities are widening in Japan, and thus, it is important to understand whether (and to what extent) there is a regional variation in long-term care (LTC) spending across municipalities. This study assesses regional variation in LTC spending and identifies the drivers of such variation. METHODS: We conducted a cross-sectional study using publicly available municipality-level data across Japan in 2019, in which the unit of analysis was municipality. The outcome of interest was per-capita LTC spending, which was estimated by dividing total LTC spending in a municipality by the number of older adults (people aged ≥ 65). To further identify drivers of regional variation in LTC spending, we conducted linear regression of per-capita spending against a series of demand, supply, and structural factors. Shapley decomposition approach was used to highlight the contribution of each independent variable to the goodness of fit of the regression model. RESULTS: In Fiscal 2019, per-capita LTC spending varied from 133.1 to 549.9 thousand yen (max/min ratio 4.1) across the 1460 municipalities analyzed, showing considerable regional variation. The included covariates explained 84.0% of the total variance in LTC spending, and demand-determined variance was remarkably high, which contributed more than 85.7% of the overall R2. Specifically, the highest contributing factor was the proportion of severe care-need level and care level certification rate. CONCLUSIONS: Our results demonstrate that, even after adjusting for different municipalities' age and sex distribution, there is a large variation in LTC spending. Furthermore, our findings highlight that, to reduce the spending gap between municipalities, the issues underlying large variations in LTC spending across municipalities must be identified and addressed.

Regional Inequality in Dental Care Utilization in Japan: An Ecological Study Using the National Database of Health Insurance Claims.

BACKGROUND: This study examined regional inequalities in dental care utilization in Japan and the association of dental care utilization with socioeconomic factors. METHODS: Using the Fourth National Database of Health Insurance Claims and Specific Health Checkups of Japan Open data, this ecological study analyzed 216 million pieces of aggregated data from April 2017 to March 2018. Nine indicators of dental care utilization were used: outpatient visits, outreach services, cavity fillings, pulpectomies, dental calculus removals, periodontal surgeries, tooth extractions, dental bridges, and dentures. Standardized claim ratios (SCRs) for these indicators were calculated for Japan's 47 prefectures, which were divided into three groups based on the number of dental clinics per population, average income per capita, and the proportion of university enrollments. Associations of the dental care utilization with dental supply and regional socioeconomic factors were examined. FINDINGS: The ratios of maximum to minimum of SCRs were 1·4 for outpatient visits, 19·3 for outreach services, and 17·6 for periodontal surgeries. Dental supply was positively associated with outpatient visits, outreach services, dental calculus removal, and periodontal surgeries. Regional average income and educational level were positively associated with dental calculus removals, and negatively associated with pulpectomies, tooth extractions, dental bridges, and dentures. INTERPRETATION: In Japan, regional inequalities in dental care utilization exist for periodontal care and outreach services but are smaller for urgent and substantial dental care. Regional income and educational levels appear to have influence on dental care utilization. FUNDING: Ministry of Health, Labour and Welfare of Japan (H31-19FA1001).

Nationwide survey of the coronavirus disease 2019 prevention and treatment systems for kidney disease patients: a study of Japanese Society of Nephrology-certified educational facilities.

BACKGROUND: There are no reports of a large-scale survey on the infection prevention measures against coronavirus disease 2019 (COVID-19) in nephrology facilities. This study investigated the facility-level nephrology practices adopted during the COVID-19 pandemic and their associated challenges. Additionally, the treatment patterns and outcomes of chronic kidney disease (CKD) patients with COVID-19 were reviewed. METHODS: We conducted a nationwide questionnaire survey of 704 educational facilities that were certified by the Japanese Society of Nephrology (JSN) from October 20, 2020 to November 16, 2020. The questionnaire reviewed the facility characteristics, infection prevention measures taken during routine nephrology practice, impact of COVID-19 on nephrology practice, experiences in managing CKD patients with COVID-19, and nosocomial transmission in the nephrology unit. RESULTS: Of the 347 facilities that responded, 95.1% checked outpatients' body temperatures and COVID-19 symptoms at their visits. To reduce face-to-face contact, 80% and 70% of the facilities lengthened the intervals between outpatient visits and introduced online/telephonic consultations, respectively. As a result, more than half of the hospitals experienced a decrease in the numbers of outpatients and inpatients (64% and 50%, respectively). During the study period, 347 facilities managed 479 CKD patients with COVID-19. Oxygen administration and mechanical ventilation were performed for 47.8% and 16.5% of the patients, respectively, with a 9.2% total mortality rate. CONCLUSION: This survey demonstrated that JSN-certified educational nephrology facilities adopted multiple measures to manage the COVID-19 pandemic; however, they faced several challenges. Sharing these experiences could standardize these approaches and prepare us better for the future.

Outcomes of a financial incentive scheme for dementia care by dementia specialist teams in acute-care hospitals: A difference-in-differences analysis of a nationwide retrospective cohort study in Japan.

OBJECTIVES: The quality of care for dementia in acute-care settings has been criticised. In 2016, the Japanese universal health insurance system introduced a financial incentive scheme for dementia care by dementia specialist teams in acute-care hospitals. This study aimed to investigate the effectiveness of this financial incentive scheme on short-term outcomes (in-hospital mortality and 30-day readmission). DESIGN AND METHODS: Using a Japanese nationwide inpatient database, we identified older adult patients with moderate-to-severe dementia admitted for pneumonia, heart failure, cerebral infarction, urinary tract infection, intracranial injury or hip fracture from April 2014 to March 2018. We selected 180 propensity score-matched pairs of hospitals that adopted (n = 180 of 185) and that did not adopt (n = 180 of 744) the financial incentive scheme. We then conducted a patient-level difference-in-differences analysis. In a sensitivity analysis, we restricted the postintervention group to patients who actually received dementia care. RESULTS: There was no association between a hospital's adoption of the incentive scheme and in-hospital mortality (adjusted odds ratio [aOR]: 0.97; 95% confidence interval [CI]: 0.88-1.06; p = 0.48) or 30-day readmission (aOR: 1.04; 95% CI: 0.95-1.14; p = 0.37). Only 29% of patients in hospitals adopting the scheme actually received dementia care. The sensitivity analysis showed that receiving dementia care was associated with decreased in-hospital mortality. CONCLUSIONS: The financial incentive scheme to enhance dementia care by dementia specialist teams in Japan may not be working effectively, but the results do suggest that individual dementia care was associated with decreased in-hospital mortality.

Number of consulting medical institutions and risk of polypharmacy in community-dwelling older people under a healthcare system with free access: a cross-sectional study in Japan.

BACKGROUND: Under the Japanese free access healthcare system, patients are allowed to consult multiple medical institutions (including clinics and hospitals for general or specialist consultation) without primary care referral. This potentially increases the risk of polypharmacy. We examined the association between the number of consulting medical institutions and polypharmacy under a healthcare system with free access. METHODS: Via a self-administered questionnaire, we identified people aged ≥65 years with ≥1 disease and ≥1 consulting medical institution in a Japanese city in 2016. The exposure of interest was the number of consulting medical institutions (1, 2, or ≥3) and the outcome was polypharmacy (use of ≥6 types of drugs). We performed a multivariate logistic regression analysis, adjusting for age, sex, household economy, and the number and type of comorbidities. To minimize confounding effects, we also performed propensity-score-matched analysis, categorizing patients into two groups: 1 and ≥2 consulting medical institutions. RESULTS: Of 993 eligible individuals (mean (standard deviation) age: 75.1 (6.5) years, men: 52.6%), 15.7% (156/993) showed polypharmacy. Proportions of polypharmacy were 9.7% (50/516), 16.6% (55/332), and 35.2% (51/145) for people who consulted 1, 2, and ≥3 medical institutions, respectively. Relative to people who consulted 1 medical institution, adjusted odds ratios (95% confidence intervals) for polypharmacy were 1.50 (0.94-2.37) and 3.34 (1.98-5.65) for those who consulted 2 and ≥3 medical institutions, respectively. In propensity score matching, of 516 and 477 patients who consulted 1 and ≥2 medical institutions, 307 pairs were generated. The proportion of polypharmacy was 10.8% (33/307) and 17.3% (53/307), respectively (P = 0.020). The odds ratio for polypharmacy (≥2 vs. 1 consulting medical institution) was 1.73 (95% confidence interval 1.09-2.76). CONCLUSIONS: Patients who consulted more medical institutions were more likely to show polypharmacy. The results could encourage physicians and pharmacists to collect medication information more actively and conduct appropriate medication reviews. Strengthening primary care is needed to address the polypharmacy issue, especially in countries with healthcare systems with free access.

Comparing the Japanese Version of the Ocular Surface Disease Index and Dry Eye-Related Quality-of-Life Score for Dry Eye Symptom Assessment.

The aim of this study was to compare patient-reported symptoms of dry eye disease (DED) between the Japanese version of the Ocular Surface Disease Index (J-OSDI) and the Dry Eye-Related Quality-of-Life Score (DEQS). A total of 169 participants were enrolled between September 2017 and May 2018. Patients were administered the J-OSDI and DEQS questionnaires at their first (baseline) and follow-up visits to evaluate DED-related symptoms. The correlations between the J-OSDI total score and DEQS (Frequency and Degree) scores were evaluated using Pearson's correlation coefficient, and their clinical differences were assessed using the Bland-Altman analysis. At the baseline visit, the J-OSDI score and DEQS (Frequency and Degree) were significantly correlated (r = 0.855, r = 0.897, respectively). Moreover, a significant correlation was found between the J-OSDI score and DEQS (Frequency and Degree) at the follow-up visit (r = 0.852, r = 0.888, respectively). The Bland-Altman analysis revealed a difference (bias) of 4.18 units at the baseline and 4.08 units at the follow-up between the scores of the two questionnaires. The J-OSDI and DEQS were significantly correlated with negligible score differences, suggesting that the J-OSDI can be reliably used for Japanese patients, allowing for cross-country comparisons.

Shortened cataract surgery by standardisation of the perioperative protocol according to the Joint Commission International accreditation: a retrospective observational study.

OBJECTIVES: To investigate the impact of standardisation of the perioperative protocol based on the Joint Commission International (JCI) accreditation guidelines for operating time in cataract surgery. DESIGN: Retrospective observational study. SETTING: Single centre in Japan. PARTICIPANTS: Between March 2014 and June 2016, 3127 patients underwent cataract surgery under topical anaesthesia including 2581 and 546 patients before and after JCI accreditation, respectively. PRIMARY AND SECONDARY OUTCOMES: We compared three time periods, comprising the preprocedure/surgery time (pre-PT), PT and post-PT, and total PT (TPT) of cataract surgery between patients before and after JCI accreditation, by regression analysis adjusted for age, sex and cataract surgery-associated confounders. RESULTS: The main outcomes were pre-PT, PT, post-PT and TPT. Pre-PT (19.8±10.5 vs 13.9±8.5 min, p<0.001) and post-PT (3.5±4.6 vs 2.6±2.1 min, p<0.001) significantly decreased after JCI accreditation, while PT did not significantly change (16.8±6.7 vs 16.2±6.3 min, p=0.065). Consequently, TPT decreased on average by 7.3 min per person after JCI accreditation (40.1±13.4 vs 32.8±10.9 min, p<0.001). After adjusting for confounders, pre-PT (ß=-5.82 min, 95% CI -6.75 to -4.88), PT (ß=-0.76 min, 95% CI -1.34 to -1.71), post-PT (ß=-0.85 min, 95% CI -1.24 to -0.45) and TPT (ß=-7.43 min, 95% CI -8.61 to -6.24) were significantly shortened after JCI accreditation. CONCLUSION: Perioperative protocol standardisation, based on JCI accreditation, shortened TPT in cataract surgery under local anaesthesia.

Factors associated with long-term urinary catheterisation and its impact on urinary tract infection among older people in the community: a population-based observational study in a city in Japan.

OBJECTIVES: This study aimed to identify factors associated with long-term urinary catheterisation (LTUC) in community-dwelling older adults and to evaluate the risk of urinary tract infection (UTI) among people with LTUC. DESIGN: Population-based observational study. SETTING: Medical and long-term care insurance claims data from one municipality in Japan. PARTICIPANTS: People aged ≥75 years living at home who used medical services between October 2012 and September 2013 (n=32 617). OUTCOME MEASURES: (1) Use of LTUC, defined as urinary catheterisation for at least two consecutive months, to identify factors associated with LTUC and (2) the incidence of UTI, defined as a recorded diagnosis of UTI and prescription of antibiotics, in people with and without LTUC. RESULTS: The 1-year prevalence of LTUC was 0.44% (143/32 617). Multivariable logistic regression analysis showed that the male sex, older age, higher comorbidity score, previous history of hospitalisation with in-hospital use of urinary catheters and high long-term care need level were independently associated with LTUC. The incidence rate of UTI was 33.8 and 4.7 per 100 person-years in people with and without LTUC, respectively. According to multivariable Poisson regression analysis, LTUC was independently associated with UTI (adjusted rate ratio 2.58, 95% CI 1.68 to 3.96). Propensity score-matched analysis yielded a similar result (rate ratio 2.41, 95% CI 1.45 to 4.00). CONCLUSIONS: We identified several factors associated with LTUC in the community, and LTUC was independently associated with the incidence of UTI.

Associations of Polyethylenimine-Coated AN69ST Membrane in Continuous Renal Replacement Therapy with the Intensive Care Outcomes: Observations from a Claims Database from Japan.

BACKGROUND/AIMS: Polyethylenimine-coated polyacrylonitrile (AN69ST) membrane is expected to improve the outcomes of critically ill patients treated by continuous renal replacement therapy (CRRT). METHODS: Using a Japanese health insurance claim database, we identified adult patients receiving CRRT in intensive care units (ICUs) from April 2014 to October 2015. We used a multivariable logistic regression model to assess in-hospital mortality and Fine and Gray's proportional subhazards model to assess the ICU length of stay (ICU-LOS) accounting for the competing risks. RESULTS: Of 2,469 ICU patients, 156 were treated by AN69ST membrane. Crude in-hospital mortality was 50.0% in the AN69ST group and 54.0% in the non-AN69ST group. Adjusted odds ratio (OR) of AN69ST membrane use for in-hospital mortality was 0.65 (95% CI 0.45-0.93). The use of AN69ST membrane was also independently associated with shorter ICU-LOS. CONCLUSION: This retrospective observational study suggested that CRRT with AN69ST membrane might be associated with better in-hospital outcomes.