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Objective The primary objective was to estimate the national prevalence of psoriasis and palmoplantar pustulosis (PPP) in Japan. Secondary objectives were to determine (1) whether psoriasis and PPP disease activity varies by season, and (2) whether disease severity is associated with concurrent diabetes mellitus, hyperlipidaemia and hypertension. Settings Patients with a psoriasis or PPP diagnosis code between April 2010 and March 2011 were identified using a Japanese national database. Participants 565 903 patients with psoriasis or PPP were identified. No patient was excluded. Primary and secondary outcome measures National prevalence was calculated using census data. We estimated the difference in the proportion of patients who used healthcare services, as a proxy for disease activity, between the hot and cold seasons and the difference in the standardised prevalence of comorbidities between severe and mild disease. The measures were estimated separately for the two broad disease categories of psoriasis and PPP but not in all patients as planned because the two disease categories had major differences. Results The national prevalence of psoriasis and PPP was 0.34% (95% CI 0.34% to 0.34%) and 0.12% (0.12% to 0.12%), respectively. The difference in the proportion of patients who used healthcare services in the hot compared to the cold season was −0.3% (−0.5% to −0.1%) for psoriasis and 10.0% (9.8% to 10.3%) for PPP. The difference in the standardised prevalence between severe and mild psoriasis was 3.1% (2.7% to 3.4%), 3.2% (2.8% to 3.6%) and 5.1% (4.7% to 5.6%) for concurrent diabetes mellitus, hyperlipidaemia and hypertension, respectively. No significant difference in the prevalence of comorbidity was observed for PPP. Conclusions The national prevalence, seasonal variation in disease activity and prevalence of comorbidities in Japanese patients with psoriasis and PPP estimated in this descriptive study may be used as basic information for future studies.

Backgrounds: Current guidelines recommend routine nephropathy monitoring, including microalbuminuria or proteinuria testing, for people with diabetes mellitus; however, its effect in terms of preserving renal function remains unclear. We conducted this study to examine the impact of routine nephropathy monitoring on subsequent changes in estimated glomerular filtration rate. Methods: We retrospectively identified non-elderly individuals with diabetes mellitus based on the prescription of hypoglycemic agents from a large Japanese database (JMDC, Tokyo, Japan) of screening for lifestyle diseases linked with administrative claims data. We collected data on baseline characteristics including age, sex, comorbidity, and laboratory data. We then examined the association between routine nephropathy monitoring results and change in estimated glomerular filtration rate using a propensity-score inverse probability of treatment weighting method. Results: Among 1,602 individuals who started taking hypoglycemic agents between 2005 and 2016, 102 (6.0%) underwent routine nephropathy monitoring during the first year of medication for diabetes mellitus. After adjusting for multiple confounding factors, there was no significant difference in subsequent estimated glomerular filtration rate changes between individuals with and without routine nephropathy monitoring (difference in percent change 0.11; 95% confidence interval −2.74 to 2.95). Conclusion: Routine nephropathy monitoring was not associated with preserved renal function. Current recommendations for the universal application of nephropathy monitoring may have limited value to prevent renal dysfunction in non-elderly individuals with diabetes mellitus.

Background In Japan, several large healthcare databases have become available for research since the early 2000’s. However, validation studies to examine the accuracy of these databases remain scarce. We conducted a validation study in order to estimate the positive predictive value (PPV) of local or ICD-10 codes for acute myocardial infarction (AMI) in Japanese claims. In particular, we examined whether the PPV differs between claims in the Diagnosis Procedure Combination case mix scheme (DPC claims) and in non-DPC claims. Methods We selected a random sample of 200 patients from all patients hospitalized at a large tertiary-care university hospital between January 1, 2009 and December 31, 2011 who had an inpatient claim assigned a local or ICD-10 code for AMI. We used a standardized data abstraction form to collect the relevant information from an electronic medical records system. Abstracted information was then categorized by a single cardiologist as being either definite or not having AMI. Results In a random sample of 200 patients, the average age was 67.7 years and the proportion of males was 78.0%. The PPV of the local or ICD-10 code for AMI was 82.5% in this sample of 200 patients. Further, of 178 patients who had an ICD-10 code for AMI based on any of the 7 types of condition codes in the DPC claims, the PPV was 89.3%, whereas of the 161 patients who had an ICD-10 code for AMI based on any of 3 major types of condition codes in the DPC claims, the PPV was 93.8%. Conclusion The PPV of the local or ICD-10 code for AMI was high for inpatient claims in Japan. The PPV was even higher for the ICD-10 code for AMI for those patients who received AMI care through the DPC case mix scheme. The current study was conducted in a single center, suggesting that a multi-center study involving different types of hospitals is needed in the future. The accuracy of condition codes for DPC claims in Japan may also be worth examining for conditions other than AMI such as stroke.

Background: Guidelines recommend against all codeine use in children for its common indications of analgesia and cough suppression because of uncertain benefits and potential risk of death. However, because of its rarity, the occurrence of severe respiratory depression associated with codeine-containing antitussives has been poorly investigated. The objective of this study was to investigate the association between codeine-containing antitussives and severe respiratory depression in children. Methods: We retrospectively identified Japanese children who were prescribed antitussives for respiratory diseases from a large Japanese administrative claims database (JMDC, Tokyo, Japan). We collected data on baseline characteristics including age, sex, and comorbidity. Each case was matched with four controls with the same sex and age in the same year from the same type of medical institution. We then examined the association between codeine-containing antitussives and subsequent severe respiratory depression using multivariable conditional logistic regression analysis. Results: Of 164,047 children, 18,210 (11.1%) were prescribed codeine-containing antitussives. Of the children who took codeine-containing drugs, seven experienced severe respiratory depression. After adjusting for confounding factors, there was no significant difference in the proportion of severe respiratory depression between children with and without codeine-containing antitussives (odds ratio 1.15; 95% confidence interval, 0.48–2.78). Conclusion: Occurrence of respiratory depression was very rare, and the association of codeine with respiratory depression was insignificant, even in a large sample of children in Japan.

Anticoagulant therapy is recommended in patients with atrial fibrillation (AF) but remains underused. The proper use of anticoagulants has been encouraged in guidelines frequently published over the past two decades. In this study, we used insurance claims data collected from 2005 to 2014 to investigate the prevalence and incidence of non-valvular AF (NVAF) patients aged 20 to 74 years standardized to the Japanese population in 2012 and subdivided by stroke prevention drug type. We estimated the frequency of coagulation monitoring in patients with incident NVAF undergoing warfarin therapy in 2011 and later. From 2005 to 2014, the standardized prevalence of NVAF increased from 117/100,000 to 278/100,000 and the proportion of anticoagulant users increased from 38.4% to 58.0%, while that of antiplatelet monotherapy decreased from 32.3% to 12.0%. The standardized incidence of NVAF was stable at ~40/100,000 patient-years. The proportion of those patients who started anticoagulant soon after the initial diagnosis increased from 19.9% to 49.1% from 2006 to 2013. Among patients who started warfarin, switchers to DOAC had more frequent coagulation monitoring than non-switchers. The use of anticoagulant therapy has gradually increased in patients with NVAF in Japan during the study period from 2005 to 2014.

Real-world data (RWD) and real-world evidence (RWE) are playing increasingly important roles in clinical research and health care decision-making. To leverage RWD and generate reliable RWE, data should be well defined and structured in a way that is semantically interoperable and consistent across stakeholders. The adoption of data standards is one of the cornerstones supporting high-quality evidence for the development of clinical medicine and therapeutics. Clinical Data Interchange Standards Consortium (CDISC) data standards are mature, globally recognized, and heavily used by the pharmaceutical industry for regulatory submissions. The CDISC RWD Connect Initiative aims to better understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance needed to more easily implement them. The aim of this study is to understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance that may be needed to implement CDISC standards more easily for this purpose. We conducted a qualitative Delphi survey involving an expert advisory board with multiple key stakeholders, with 3 rounds of input and review. Overall, 66 experts participated in round 1, 56 in round 2, and 49 in round 3 of the Delphi survey. Their inputs were collected and analyzed, culminating in group statements. It was widely agreed that the standardization of RWD is highly necessary, and the primary focus should be on its ability to improve data sharing and the quality of RWE. The priorities for RWD standardization included electronic health records, such as data shared using Health Level 7 Fast Health care Interoperability Resources (FHIR), and the data stemming from observational studies. With different standardization efforts already underway in these areas, a gap analysis should be performed to identify the areas where synergies and efficiencies are possible and then collaborate with stakeholders to create or extend existing mappings between CDISC and other standards, controlled terminologies, and models to represent data originating across different sources. There are many ongoing data standardization efforts around human health data-related activities, each with different definitions, levels of granularity, and purpose. Among these, CDISC has been successful in standardizing clinical trial-based data for regulation worldwide. However, the complexity of the CDISC standards and the fact that they were developed for different purposes, combined with the lack of awareness and incentives to use a new standard and insufficient training and implementation support, are significant barriers to setting up the use of CDISC standards for RWD. The collection and dissemination of use cases, development of tools and support systems for the RWD community, and collaboration with other standards development organizations are potential steps forward. Using CDISC will help link clinical trial data and RWD and promote innovation in health data science.

Introduction A new algorithm for causality assessment of drugs and fatal cerebral haemorrhage (ACAD-FCH) was published in 2021. However, its use in clinical practice has not been verified. Objectives This study aimed to explore the practical value of the ACAD-FCH when applying information available in clinical practice. Methods The medical records of patients who died at the University of Tokyo Hospital in 2020 were reviewed, and cases with intracranial haemorrhage were selected. Two evaluators independently assessed these cases using three methods (the ACAD-FCH, Naranjo algorithm, and WHO-UMC scale). The number of ‘Yes’, ‘No’, and ‘No information/Do not know’ responses to each question by both evaluators were summed and compared. Inter-rater reliability was evaluated for each method using agreement rates and kappa coefficients with 95% confidence intervals (CI). Results Among 316 deaths, 24 cases with intracranial haemorrhage were evaluated. The proportion of ‛No information/Do not know’ responses for each question was 35.6% (95% CI 31.4–40.6%) for the ACAD-FCH and 66.9% (95% CI 62.5–71.1%) for the Naranjo algorithm. The respective agreement rates and kappa coefficients were 0.917 (0.798–1.00) and 0.867 (0.675–1.00) for the ACAD-FCH, 0.708 (0.512–0.904) and 0.139 (−0.236 to 0.513) for the Naranjo algorithm, and 0.50 (0.284–0.716) and 0.326 (0.110–0.541) for the WHO-UMC scale, respectively. Conclusion Our findings suggest the utility of the ACAD-FCH when assessing death cases with intracranial haemorrhage. However, larger studies including intra-rater assessments are warranted for further validation of this algorithm.

Universal health-care coverage has attracted the interest of policy makers as a way of achieving health equity. However, previous reports have shown that despite universal coverage, socioeconomic disparity persists in access to high-tech invasive care, such as cardiac treatment. In this study, we aimed to investigate the association between socioeconomic status and care of aortic stenosis in the context of Japan's health-care system, which is mainly publicly funded. We chose aortic stenosis in older people as a target because such patients are likely to be affected by socioeconomic disparity. Using a large Japanese claim-based inpatient database, we identified 12,893 isolated aortic stenosis patients aged over 65 years who were hospitalized between July 2010 and March 2012. Municipality socioeconomic status was represented by the mean household income of the patients' residential municipality, categorized into quartiles. The likelihood of undergoing aortic valve surgery and in-hospital mortality was regressed against socioeconomic status level with adjustments for hospital volume, regional number of cardiac surgeons per 1 million population, and patients' clinical status. We found no significant differences between the highest and lowest quartile groups in surgical indication (odds ratio, 0.84; 95% confidence interval, 0.69-1.03) or in-hospital mortality (1.00; 0.68-1.48). Hospital volume was significantly associated with lower postoperative mortality (odds ratio of the highest volume tertile to the lowest, 0.49; 0.34-0.71). Under Japan's current universal health-care coverage, municipality socioeconomic status did not appear to have a systematic relationship with either treatment decision for surgical intervention or postoperative survival following aortic valve surgery among older patients. Our results imply that universal health-care coverage with high publicly funded coverage offers equal access to high-tech cardiovascular care.

CO 2 methanation is a promising technology to enable the use of CO 2 as a resource. Thermal control of CO 2 methanation, which is a highly active exothermic reaction, is important to avoid thermal runaway and subsequent degradation of the catalyst. Using the heat storage capacity of a phase change material (PCM) for thermal control of the reaction is a novel passive approach. In this study a novel structure was developed, wherein catalysts were directly loaded onto a micro-encapsulated PCM (MEPCM). The MEPCM was prepared in three steps consisting of a boehmite treatment, precipitation treatment, and heat oxidation treatment, and an impregnation process was adopted to prepare a Ni catalyst. The catalyst-loaded MEPCM did not show any breakage or deformation of the capsule or a decrease in the heat storage capacity after the impregnation treatment. MEPCM demonstrated a higher potential as an alternative catalyst support in CO 2 methanation than the commercially available α-Al 2 O 3 particle. In addition, the heat storage capacity of the catalyst-loaded MEPCM suppressed the temperature rise of the catalyst bed at a high heat absorption rate (2.5 MW m −3 ). In conclusion, the catalyst-loaded MEPCM is a high-speed, high-precision thermal control device because of its high-density energy storage and resolution of a spatial gap between the catalyst and cooling devices. This novel concept has the potential to overcome the technical challenges faced by efficiency enhancement of industrial chemical reactions.

PurposeWe fabricated and characterized polyvinyl alcohol (PVA)-based dissolving microneedles (MNs) for transdermal drug delivery of apomorphine hydrochloride (APO), which is used in treating the wearing-off phenomenon observed in Parkinson’s disease.MethodsWe fabricated MN arrays with 11 × 11 needles of four different lengths (300, 600, 900, and 1200 μm) by micromolding. The APO-loaded dissolving MNs were characterized in terms of their physicochemical and functional properties. We also compared the pharmacokinetic parameters after drug administration using MNs with those after subcutaneous injection by analyzing the blood concentration of APO in rats.ResultsPVA-based dissolving MNs longer than 600 μm could effectively puncture the stratum corneum of the rat skin with penetrability of approximately one-third of the needle length. Although APO is known to have chemical stability issues in aqueous solutions, the drug content in APO-loaded MNs was retained at 25°C for 12 weeks. The concentration of APO after the administration of APO-loaded 600-μm MNs that dissolved completely in skin within 60 min was 81%. The absorption of 200-μg APO delivered by MNs showed a Tmax of 20 min, Cmax of 76 ng/mL, and AUC0–120 min of 2,829 ng・min/mL, compared with a Tmax of 5 min, Cmax of 126 ng/mL, and AUC0–120 min of 3,224 ng・min/mL for subcutaneous injection. The bioavailability in terms of AUC0–120 min of APO delivered by MNs was 88%.ConclusionAPO-loaded dissolving MNs can deliver APO via skin into the systemic circulation with rapid absorption and high bioavailability.