Treatment patterns and characteristics of patients with migraine: results from a retrospective database study in Japan.

BACKGROUND: Clinical characteristics and treatment practice of patients with migraine in Japan in real-world setting have not been fully investigated. We conducted a retrospective cohort study using claims database to understand the clinical practice of migraine in recent years and to characterize patients potentially not managed well by current treatment options. METHODS: Our study used data from the large claims database maintained by JMDC Inc. Patients with diagnosis of headache or migraine between January 1, 2018, and July 31, 2022, were defined as the headache cohort, and those with migraine diagnosis and prescription of migraine treatments among the headache cohort were included in the migraine cohort. In the headache cohort, characteristics of medical facilities and status of imaging tests to distinguish secondary headache were examined. Treatment patterns and characteristics of patients potentially not managed well by acute/preventive treatment were described in migraine cohort. RESULTS: In the headache cohort, 989,514 patients were included with 57.0% females and mean age of 40.3 years; 77.0% patients visited clinics (with ≤ 19 bed capacities) for their primary diagnosis, and 30.3% patients underwent imaging tests (computed tomography and/or magnetic resonance imaging). In the migraine cohort, 165,339 patients were included with 65.0% females and mean age of 38.8 years. In the migraine cohort, 95.6% received acute treatment while 20.8% received preventive treatment. Acetaminophen/non-steroidal anti-inflammatory drugs were most common (54.8%) as the initial prescription for migraine treatment followed by triptan (51.4%). First treatment prescription included preventive treatment in 15.6%, while the proportion increased to 82.2% in the fourth treatment prescription. Among patients with more than 12 months of follow-up, 3.7% had prescription patterns suggestive of risk of medication-overuse headache, and these patients were characterized by a higher percentage of females and a higher prevalence of comorbidities. CONCLUSIONS: This study revealed that approximately one-fifth of the patients with migraine visiting medical facilities use preventive drugs. The presence of potential patients at risk of medication-overuse headache and the role of clinics in migraine treatment were also described.

Real-world treatment patterns of novel drugs in relapsed or refractory acute lymphoblastic leukemia patients in Japan.

Aim: To evaluate treatment patterns of novel therapies (inotuzumab ozogamicin (inotuzumab), blinatumomab, and tisagenlecleucel) in patients with acute lymphoblastic leukemia (ALL) in a Japanese real-world setting. Patients & Methods: Patients with ALL diagnoses from a Japanese claims database were examined. Results: We included 194 patients (97 patients were prescribed inotuzumab; 97 patients were prescribed blinatumomab; and no patient was prescribed tisagenlecleucel); 81.4% in the inotuzumab group and 78.4% in the blinatumomab group were prescribed chemotherapy prior to the initiation of those drugs. Most patients were prescribed subsequent treatment (60.8 and 58.8%, respectively). A small number of patients were prescribed sequential treatment of inotuzumab-to-blinatumomab or blinatumomab-to-inotuzumab (20.3 and 10.5%, respectively). Conclusion: This study revealed inotuzumab and blinatumomab treatment features in Japan.

In acute lymphoblastic leukemia (ALL), the increase in leukemic cells prevents the production of normal blood cells. As a result, people with ALL become more susceptible to anemia, fatigue, infections, fever, bruising and bleeding easily. ALL progresses rapidly without treatment. In recent years, new therapeutic drugs, including inotuzumab and blinatumomab, have become available; however, it remains unclear how they have been used in clinical practice. In this report, we assess how they are used in clinical practice using a large database to collect the clinical data of ALL patients. To see the treatment pattern, we found that most of the patients (81.4% of patients who received inotuzumab and 78.4% of those who received blinatumomab) had received chemotherapy before starting treatment with inotuzumab or blinatumomab. After patients ended treatment with inotuzumab or blinatumomab, 60.8% of patients who received inotuzumab and 58.8% of those who received blinatumomab received the next therapies, including chemotherapy. However, a small number of patients had received inotuzumab-to-blinatumomab or blinatumomab-to-inotuzumab (20.3 and 10.5%, respectively). These findings show the real-world treatment patterns of inotuzumab and blinatumomab; that is, both inotuzumab and blinatumomab are more likely to be prescribed to patients who might not have enough efficacy from prior chemotherapy or might have had to stop chemotherapy early due to side effects. Overall, there is clinical meaningful information from our findings of how inotuzumab and blinatumomab have been used for treatment of ALL and this information could improve the clinical practice of ALL in Japan.

Evaluation of the efficacy and safety of romosozumab (evenity) for the treatment of osteoporotic vertebral compression fracture in postmenopausal women: A systematic review and meta-analysis of randomized controlled trials (CDM-J).

PURPOSE: Osteoporotic vertebral compression fracture (OVCF) is a common fragile fracture resulting from osteoporosis. We compared the efficacy and safety of romosozumab and commonly used osteoporosis drug treatments for the treatment of OVCF in postmenopausal women. METHODS: Through searching and screening five databases, we included randomized controlled trials (RCTs) published through June 18, 2021 comparing different treatments. Following the Preferred Reporting Items for Systematic Reviews statement, the main objective was to evaluate the mean difference and risk ratio of the treatment effect. The primary measures of romosozumab efficacy used in this study were vertebral, non-vertebral, and clinical fracture events, and secondary outcomes were bone mineral density (BMD) changes at the lumbar spine, total hip, and femoral neck and the incidence of adverse events (AEs), RESULTS: Nine RCTs including 12 796 participants were included in the analysis, and romosozumab was compared with placebo, alendronate, and teriparatide in the treatment of osteoporosis in postmenopausal women. The incidence of fractures, low BMD, and AEs was analyzed. Compared with the controls, three doses of romosozumab were linked to evident advantages in the treatment of low BMD and fractures but associated with increased hypersensitivity and injection site reaction risks. Furthermore, fewer AEs were observed in the romosozumab arms (210 mg: risk ratio = 0.96, 95% confidence interval = 0.93-0.99; 140 mg: risk ratio = 0.28, 95% confidence interval = 0.08-0.98) than in the alendronate and placebo arms. CONCLUSIONS: Our meta-analysis revealed the evident advantages of romosozumab in the treatment of osteoporosis and low BMD in postmenopausal women and increased risks of hypersensitivity and injection site reactions.

Clinical picture of the duration of venoarterial extracorporeal membrane oxygenation: analysis from JROAD-DPC.

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has been widely used for critically ill patients all over the world; however, comprehensive survey regarding the relationship between VA-ECMO duration and prognosis is limited. We conducted a survey of VA-ECMO patients in the Japanese Registry of All Cardiac and Vascular Diseases-Diagnosis Procedure Combination (JROAD-DPC), which was a health insurance claim database study among cardiovascular centers associated with the Japan Circulation Society, between April 2012 and March 2016. Out of 13,542 VA-ECMO patients, we analyzed 5766 cardiovascular patients treated with VA-ECMO. 68% patients used VA-ECMO only for 1 day and 93% had VA-ECMO terminated within 1 week. In multivariate analysis, the hazard ratio of 1-day support was significantly high at 1.72 (95% confidence intervals; 95% CI 1.53-1.95) (p < 0.001), while that of 2-day [0.60 (95% CI 0.49-0.73)], 3-day [0.75 (95% CI 0.60-0.94)], 4-day [0.43 (95% CI 0.31-0.60)] and 5-day support [0.62 (95% CI 0.44-0.86)] was significantly low. Comprehensive database analysis of JROAD-DPC revealed that cardiovascular patients who were supported with VA-ECMO for 2-5 days showed lower mortality. The optimal VA-ECMO support window should be investigated in further studies.

A Retrospective Cohort Study on Mortality and Neurodevelopmental Outcomes of Preterm Very Low Birth Weight Infants Born to Mothers with Hypertensive Disorders of Pregnancy.

OBJECTIVE: We examined the effects of maternal hypertensive disorders of pregnancy (HDP) on the mortality and neurodevelopmental outcomes in preterm very low birth weight (VLBW) infants (BW ≤1,500 g) based on their intrauterine growth status and gestational age (GA). STUDY DESIGN: We included singleton VLBW infants born at <32 weeks' gestation registered in the Neonatal Research Network Japan database. The composite outcomes including death, cerebral palsy (CP), and developmental delay (DD) at 3 years of age were retrospectively compared among three groups: appropriate for GA (AGA) infants of mothers with and without HDP (H-AGA and N-AGA) and small for GA (SGA) infants of mothers with HDP (H-SGA). The adjusted odds ratios (AOR) and 95% confidence intervals (CI) stratified by the groups of every two gestational weeks were calculated after adjusting for the center, year of birth, sex, maternal age, maternal diabetes, antenatal steroid use, clinical chorioamnionitis, premature rupture of membranes, non-life-threatening congenital anomalies, and GA. RESULTS: Of 19,323 eligible infants, outcomes were evaluated in 10,192 infants: 683 were H-AGA, 1,719 were H-SGA, and 7,790 were N-AGA. Between H-AGA and N-AGA, no significant difference was observed in the risk for death, CP, or DD in any GA groups. H-AGA had a lower risk for death, CP, or DD than H-SGA in the 24 to 25 weeks group (AOR: 0.434, 95% CI: 0.202-0.930). The odds for death, CP, or DD of H-SGA against N-AGA were found to be higher in the 24 to 25 weeks (AOR: 2.558, 95% CI: 1.558-3.272) and 26 to 27 weeks (AOR: 1.898, 95% CI: 1.427-2.526) groups, but lower in the 30 to 31 weeks group (AOR: 0.518, 95% CI: 0.335-0.800). CONCLUSION: There was a lack of follow-up data; however, the outcomes of liveborn preterm VLBW infants of mothers with HDP depended on their intrauterine growth status and GA at birth. KEY POINTS: · The effects of HDP on preterm low birth weight infants need to be further examined.. · The outcomes were not different between AGA infants with and without maternal HDP.. · The outcomes of SGA infants with maternal HDP were dependent on their GA..

Safety risk associated with use of nonsteroidal anti-inflammatory drugs in Japanese elderly compared with younger patients with osteoarthritis and/or chronic low back pain: A retrospective database study.

PURPOSE: This study aimed to assess the safety risks associated with using nonsteroidal anti-inflammatory drugs (NSAIDs) in elderly patients (≥65 years) compared with younger patients (<65 years) with osteoarthritis (OA) and/or chronic low back pain (CLBP). METHODS: A retrospective analysis was conducted on anonymized claims data of patients prescribed NSAIDs for OA and/or CLBP from 2009 to 2018 using hospital-based administrative database-Medical Data Vision (MDV). The key outcome was the incidence of developing gastrointestinal (GI), renal, and acute myocardial infarction (AMI) that are well-known events associated with NSAID use. RESULTS: Of 288,715 patients included, 23.7%, 60.5%, and 15.8% had OA, CLBP, or both, respectively. Elderly patients used non-oral NSAIDs more frequently than oral NSAIDs (57.8% and 38.7%, respectively), whereas younger patients showed comparable use (50.7% and 52.8%, respectively). The incidence of events per 10,000 person-years (95% CI) was higher in the elderly than in younger patients: GI, 29.68(27.67-31.68) vs. 16.61(14.60-18.63); renal, 124.77(120.56-128.99) vs. 39.88(36.72-43.03); and AMI, 27.41(25.48-29.35) vs. 10.90(9.27-12.53), respectively. After adjusting for covariates, the increase in risk for these events was seen in patients >70 years compared with younger patients (18-30 years) and was remarkable in patients >80 years with 2-fold, 10-fold, and 7-fold higher risk for developing GI, renal, and AMI events, respectively. CONCLUSION: Risk for developing NSAID-associated events was higher in the elderly; particularly, renal and AMI events that remarkably increased in patients >80 years. To reduce them, NSAIDs should be prescribed at the lowest effective dose for the shortest duration possible.

Impact of Induced Therapeutic Hypothermia by Intravenous Infusion of Ice-Cold Fluids After Hospital Arrival in Comatose Survivors of Out-of-Hospital Cardiac Arrest With Initial Shockable Rhythm.

BACKGROUND: The effect of in-hospital rapid cooling by intravenous ice-cold fluids for comatose survivors of out-of-hospital cardiac arrest (OHCA) is unclear.Methods and Results:From the J-PULSE-HYPO study registry, data for 248 comatose survivors with return of spontaneous circulation (ROSC) who were treated with therapeutic hypothermia (34℃ for 12-72 h) after witnessed shockable OHCA were extracted. Patients were divided into 2 groups by the median collapse-to-ROSC interval (18 min), and then into 2 groups by cooling method (rapid cooling by intravenous ice-cold fluids vs. standard cooling). The primary endpoint was favorable neurological outcome (Cerebral Performance Category of 1 or 2) at 30 days after OHCA. In the whole cohort, the shorter collapse-to-ROSC interval group had significantly higher favorable neurological outcome than the longer collapse-to-ROSC interval group (78.2% vs. 46.8%, P<0.001). In the shorter collapse-to-ROSC interval group, no significant difference was observed in favorable neurological outcome between the 2 cooling groups (rapid cooling group: 79.4% vs. standard cooling group: 77.0%, P=0.75). In the longer collapse-to-ROSC interval group, however, favorable neurological outcome was significant higher in the rapid cooling group than in the standard cooling group (60.7% vs. 33.3%, P<0.01) and the adjusted odds ratio after rapid cooling was 3.069 (95% confidence interval 1.423-6.616, P=0.004). CONCLUSIONS: In-hospital rapid cooling by intravenous ice-cold fluids improved neurologically intact survival in comatose survivors whose collapse-to-ROSC interval was delayed over 18 min after shockable OHCA.

Institutional Characteristics and Prognosis of Acute Myocardial Infarction With Cardiogenic Shock in Japan　- Analysis From the JROAD/JROAD-DPC Database.

BACKGROUND: The high mortality of acute myocardial infarction (AMI) with cardiogenic shock (i.e., Killip class IV AMI) remains a challenge in emergency cardiovascular care. This study aimed to examine institutional factors, including the number of JCS board-certified members, that are independently associated with the prognosis of Killip class IV AMI patients.Methods and Results:In the Japanese registry of all cardiac and vascular diseases-diagnosis procedure combination (JROAD-DPC) database (years 2012-2016), the 30-day mortality of Killip class IV AMI patients (n=21,823) was 42.3%. Multivariate analysis identified age, female sex, admission by ambulance, deep coma, and cardiac arrest as patient factors that were independently associated with higher 30-day mortality, and the numbers of JCS board-certified members and of intra-aortic balloon pumping (IABP) cases per year as institutional factors that were independently associated with lower mortality in Killip class IV patients, although IABP was associated with higher mortality in Killip classes I-III patients. Among hospitals with the highest quartile (≥9 JCS board-certified members), the 30-day mortality of Killip class IV patients was 37.4%. CONCLUSIONS: A higher numbers of JCS board-certified members was associated with better survival of Killip class IV AMI patients. This finding may provide a clue to optimizing local emergency medical services for better management of AMI patients in Japan.

A Retrospective Database Study of Gastrointestinal Events and Medical Costs Associated with Nonsteroidal Anti-Inflammatory Drugs in Japanese Patients of Working Age with Osteoarthritis and Chronic Low Back Pain.

CONTEXT: The real-world burden of gastrointestinal (GI) events associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in Japanese patients with osteoarthritis (OA) and/or chronic low back pain (CLBP) remains unreported. OBJECTIVE: To assess the incidence and economic burden of NSAID-induced GI events by using data from large-scale real-world databases. METHODS: We used the Japanese Medical Data Center database to retrospectively evaluate anonymized claims data of medical insurance beneficiaries employed by middle- to large-size Japanese companies who were prescribed NSAIDs for OA and/or CLBP between 2009 and 2018. RESULTS: Overall, 180,371 patients were included in the analysis, of whom 32.9% had OA, 53.8% had CLBP, and 13.4% had both OA and CLBP. NSAIDs were administered as first-line analgesics to 161,152 (89.3%) of the patients in the sample, in oral form to 90.3% and as topical patches to 80.4%. A total of 65.1% used combined oral/topical patches. Of the 21.0% of patients consistently using NSAIDs (percentage of days supplied ≥70%), 54.5% received patches. A total of 51.5% patients used NSAIDs for >1 to ≤6 months. The incidence of GI events was 9.97 per 10,000 person-years (95% confidence interval: 8.92-11.03). The risk of developing GI events was high in elderly patients and patients with comorbidities and remained similar for patients receiving oral vs. topical NSAIDs. Longer treatment duration and consistent NSAID use increased the risk of GI events. The cost (median [interquartile range]) of medications (n = 327) was US$ 80.70 ($14.10, $201.40), that of hospitalization (n = 33) was US$ 2,035.50 ($1,517.80, $2,431.90), and that of endoscopic surgery (n = 52) was US$ 418.20 ($418.20, $418.20). CONCLUSION: NSAID-associated GI toxicity imposes a significant health and economic burden on patients with OA and/or CLBP, irrespective of whether oral or topical NSAIDs are used.

Schedules for home visits in the early postpartum period.

BACKGROUND: Maternal complications, including psychological/mental health problems and neonatal morbidity, have commonly been observed in the postpartum period. Home visits by health professionals or lay supporters in the weeks following birth may prevent health problems from becoming chronic, with long-term effects. This is an update of a review last published in 2017. OBJECTIVES: The primary objective of this review is to assess the effects of different home-visiting schedules on maternal and newborn mortality during the early postpartum period. The review focuses on the frequency of home visits (how many home visits in total), the timing (when visits started, e.g. within 48 hours of the birth), duration (when visits ended), intensity (how many visits per week), and different types of home-visiting interventions. SEARCH METHODS: For this update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (19 May 2021), and checked reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) (including cluster-, quasi-RCTs and studies available only as abstracts) comparing different home-visiting interventions that enrolled participants in the early postpartum period (up to 42 days after birth) were eligible for inclusion. We excluded studies in which women were enrolled and received an intervention during the antenatal period (even if the intervention continued into the postnatal period), and studies recruiting only women from specific high-risk groups (e.g. women with alcohol or drug problems). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included 16 randomised trials with data for 12,080 women. The trials were carried out in countries across the world, in both high- and low-resource settings. In low-resource settings, women receiving usual care may have received no additional postnatal care after early hospital discharge. The interventions and controls varied considerably across studies. Trials focused on three broad types of comparisons, as detailed below. In all but four of the included studies, postnatal care at home was delivered by healthcare professionals. The aim of all interventions was broadly to assess the well-being of mothers and babies, and to provide education and support. However, some interventions had more specific aims, such as to encourage breastfeeding, or to provide practical support. For most of our outcomes, only one or two studies provided data, and results were inconsistent overall. All studies had several domains with high or unclear risk of bias. More versus fewer home visits (five studies, 2102 women) The evidence is very uncertain about whether home visits have any effect on maternal and neonatal mortality (very low-certainty evidence). Mean postnatal depression scores as measured with the Edinburgh Postnatal Depression Scale (EPDS) may be slightly higher (worse) with more home visits, though the difference in scores was not clinically meaningful (mean difference (MD) 1.02, 95% confidence interval (CI) 0.25 to 1.79; two studies, 767 women; low-certainty evidence). Two separate analyses indicated conflicting results for maternal satisfaction (both low-certainty evidence); one indicated that there may be benefit with fewer visits, though the 95% CI just crossed the line of no effect (risk ratio (RR) 0.96, 95% CI 0.90 to 1.02; two studies, 862 women). However, in another study, the additional support provided by health visitors was associated with increased mean satisfaction scores (MD 14.70, 95% CI 8.43 to 20.97; one study, 280 women; low-certainty evidence). Infant healthcare utilisation may be decreased with more home visits (RR 0.48, 95% CI 0.36 to 0.64; four studies, 1365 infants) and exclusive breastfeeding at six weeks may be increased (RR 1.17, 95% CI 1.01 to 1.36; three studies, 960 women; low-certainty evidence). Serious neonatal morbidity up to six months was not reported in any trial. Different models of postnatal care (three studies, 4394 women) In a cluster-RCT comparing usual care with individualised care by midwives, extended up to three months after the birth, there may be little or no difference in neonatal mortality (RR 0.97, 95% CI 0.85 to 1.12; one study, 696 infants). The proportion of women with EPDS scores ≥ 13 at four months is probably reduced with individualised care (RR 0.68, 95% CI 0.53 to 0.86; one study, 1295 women). One study suggests there may be little to no difference between home visits and telephone screening in neonatal morbidity up to 28 days (RR 0.97, 95% CI 0.85 to 1.12; one study, 696 women). In a different study, there was no difference between breastfeeding promotion and routine visits in exclusive breastfeeding rates at six months (RR 1.47, 95% CI 0.81 to 2.69; one study, 656 women). Home versus facility-based postnatal care (eight studies, 5179 women) The evidence suggests there may be little to no difference in postnatal depression rates at 42 days postpartum and also as measured on an EPDS scale at 60 days. Maternal satisfaction with postnatal care may be better with home visits (RR 1.36, 95% CI 1.14 to 1.62; three studies, 2368 women). There may be little to no difference in infant emergency health care visits or infant hospital readmissions (RR 1.15, 95% CI 0.95 to 1.38; three studies, 3257 women) or in exclusive breastfeeding at two weeks (RR 1.05, 95% CI 0.93 to 1.18; 1 study, 513 women). AUTHORS' CONCLUSIONS: The evidence is very uncertain about the effect of home visits on maternal and neonatal mortality. Individualised care as part of a package of home visits probably improves depression scores at four months and increasing the frequency of home visits may improve exclusive breastfeeding rates and infant healthcare utilisation. Maternal satisfaction may also be better with home visits compared to hospital check-ups. Overall, the certainty of evidence was found to be low and findings were not consistent among studies and comparisons. Further well designed RCTs evaluating this complex intervention will be required to formulate the optimal package.

Prognostic benefits of prior amiodarone or ß-blocker use before the onset of ventricular arrhythmia with hemodynamic collapse.

Although antiarrhythmic drugs have long been used for the suppression of various types of arrhythmias, their prior use before the onset of ventricular arrhythmia with hemodynamic collapse and the effect on prognosis is not well known. Data from 1004 consecutive patients with cardiovascular shock in the Japanese Circulation Society's Shock Registry were analyzed. Eighty-four cases of ventricular arrhythmia-induced shock and ROSC (return of spontaneous circulation) were divided into the prior amiodarone or ß-blockers use group (Aß group, n = 27) and the non-amiodarone and non-ß-blockers use group (non-Aß group; n = 57) based on treatment before the onset of those arrhythmias. Clinical outcomes related to hemodynamic collapse such as OHCA (out-of-hospital cardiovascular arrest) was less in the Aß group [Aß group, 11/26 (42%) vs. non-Aß group, 41/56 (73%); p = 0.007]. Similarly, syncope was less common in the Aß group than in the non-Aß group [Aß group 4/27 (15%) vs. non-Aß group 27/57 (47%); p = 0.004]. Furthermore, prior amiodarone or ß-blockers use before the onset of ventricular arrhythmias was strongly associated with both survival at discharge (odds ratio 3.19; 95% confidence interval 1.06-9.67; p = 0.040) and neurological outcomes at discharge (odds ratio 3.96; 95% confidence interval 1.32-11.85; p = 0.014) based on multivariate logistic regression analysis. Prior amiodarone or ß-blockers use before the onset of malignant ventricular arrhythmia and maintaining appropriate blood concentrations in advance is associated with a good survival rate and better neurological outcomes after recovery from ventricular arrhythmia with hemodynamic collapse.

The association between neuromuscular blockade use during target temperature management and neurological outcomes.

BACKGROUND: To date, no study has comprehensively analyzed the association between neuromuscular blockade (NMB) during target temperature management (TTM) and the neurological outcomes after out-of-hospital cardiac arrest (OHCA) using a multicenter dataset. We aimed to examine the association between NMB during TTM after cardiac arrest and neurological outcomes after OHCA. METHODS: This study was a secondary analysis of the Japanese Population-based Utstein-style study with defibrillation and basic/advanced Life Support Education and implementation-Hypothermia (J-PULSE-HYPO) study registry. The exposure of the current study was the use of NMB during TTM. The primary outcome was favorable neurological outcome, i.e., a cerebral performance category of 1-2, at hospital discharge. RESULTS: Of the 452 patients with OHCA enrolled in the J-PULSE-HYPO study, 431 were analyzed. NMB was used in 353 patients (81.9%). Multivariable logistic regression analysis revealed that NMB use was not independently associated with favorable outcomes [odds ratio (OR), 0.96; 95% confidence interval (CI), 0.42-2.18; p = .918)] or survival at discharge (OR, 0.83; 95% CI, 0.31-2.02; p = .688). After adjusting the covariates, the predicted probabilities did not reveal significant differences between NMB use and non-NMB use in the respective mean (95% CI) values for favorable neurological outcomes [53.6 (50.2-57.0) % vs. 58.0 (50.4-65.6) %, p = .304], and survival rates [77.1 (74.7-79.5) % vs. 75.8 (70.5-81.0) %, p = .647]. CONCLUSIONS: The NMB use during TTM was not associated with favorable neurological outcomes and survival rate in patients with OHCA.

Issues of infant feeding for postnatal prevention of human T-cell leukemia/lymphoma virus type-1 mother-to-child transmission.

BACKGROUND: Nationwide antenatal human T-cell leukemia/lymphoma virus type-1 (HTLV-1) antibody screening has been conducted in Japan. The purpose of our study was to clarify the issues related to feeding options to prevent postnatal mother-to-child transmission. METHODS: Of the pregnant carriers at 92 facilities in Japan between 2012 and 2015, 735 were followed prospectively. Among the children born to them, 313 (42.6%) children were followed up to the age of 3 and tested for HTLV-1 antibodies. The mother-to-child transmission rate was calculated for each feeding option selected before birth. RESULTS: Among the 313 pregnant carriers, 55.0, 35.1, 6.1, and 3.8% selected short-term breast-feeding (≤3 months), exclusive formula feeding, frozen-thawed breast-milk feeding, and longer-term breast-feeding, respectively. Despite short-term breast-feeding, 8-18% of the mothers continued breast-feeding for 4-6 months. The mother-to-child transmission rate with short-term breast-feeding was 2.3% (4/172), and its risk ratio compared with that of exclusive formula feeding was not significantly different (0.365; 95% CI: 0.116-1.145). Because of the small number of children who were fed by frozen-thawed breast-milk, their mother-to-child transmission rate was not statistically reliable. CONCLUSIONS: Pregnant HTLV-1 carriers tended to select short-term breast-feeding in Japan. While short-term breast-feeding was not always easy to wean within 3 months, it may be a viable option for preventing postnatal mother-to-child transmission because the vertical transmission rate with short-term breast-feeding was not significantly higher than that with exclusive formula feeding. Increasing the follow-up rates for children born to pregnant carriers may provide clearer evidence of preventative effects by short-term breast-feeding and frozen-thawed breast-milk feeding.

Public-access defibrillation and neurological outcomes in patients with out-of-hospital cardiac arrest in Japan: a population-based cohort study.

BACKGROUND: More than 80% of public-access defibrillation attempts do not result in sustained return of spontaneous circulation in patients who have had an out-of-hospital cardiac arrest (OHCA) and a shockable heart rhythm before arrival of emergency medical service (EMS) personnel. Neurological and survival outcomes in such patients have not been evaluated. We aimed to assess the neurological status and survival outcomes in such patients. METHODS: This is a retropective analysis of a cohort study from a prospective, nationwide, population-based registry of 1 299 784 patients who had an OHCA event between Jan 1, 2005, and Dec 31, 2015 in Japan. The primary outcome was favourable neurological outcome (Cerebral Performance Category of 1 or 2) at 30 days after the OHCA and the secondary outcome was survival at 30 days following the OHCA. This study is registered with the University Hospital Medical Information Network Clinical Trials Registry, UMIN000009918. FINDINGS: We identified 28 019 patients with bystander-witnessed OHCA and shockable heart rhythm who had received CPR from a bystander. Of these, 2242 (8·0%) patients did not achieve return of spontaneous circulation with CPR plus public-access defibrillation, and 25 087 (89·5%) patients did not achieve return of spontaneous circulation with CPR alone before EMS arrival. The proportion of patients with a favourable neurological outcome was significantly higher in those who received public-access defibrillation than those who did not (845 [37·7%] vs 5676 [22·6%]; adjusted odds ratio [OR] after propensity score-matching, 1·45 [95% CI 1·24-1·69], p<0·0001). The proportion of patients who survived at 30 days after the OHCA was also significantly higher in those who received public-access defibrillation than those who did not (987 [44·0%] vs 7976 [31·8%]; adjusted OR after propensity score-matching, 1·31 [95% CI 1·13-1·52], p<0·0001). INTERPRETATION: Our findings support the benefits of public-access defibrillation and greater accessibility and availability of automated external defibrillators in the community. FUNDING: None.

Effect of assertive case management intervention on suicide attempters with comorbid Axis I and II psychiatric diagnoses: secondary analysis of a randomised controlled trial.

BACKGROUND: Most suicide attempters suffer from psychiatric disorders, which are often comorbid with personality disorders. The effects of intervention on patients who have attempted suicide with comorbid Axis I and II diagnoses have not been fully elucidated. We evaluated whether assertive case management can reduce the repetition of suicidal behaviours in patients who had attempted suicide with comorbid Axis I and II diagnoses. METHODS: This study was a secondary analysis of a randomised controlled trial investigating whether assertive case management could reduce the repetition of suicide attempts, compared with enhanced usual care. Subjects were divided into those who had comorbid Axis I and II diagnoses (Axis I + II group), and those who had an Axis I diagnosis without Axis II comorbidity (Axis I group). Outcome measures were compared between patients receiving a case management intervention and patients receiving enhanced usual care, as allocated. The primary outcome measure was the incidence proportion of the first episode of recurrent suicidal behaviour at 6 months after randomisation. We calculated risk ratios (RR) with 95% confidence intervals (CI) at 6 months and 12 months after randomisation of patients in the Axis I and Axis I + II groups. RESULTS: Of 914 enrolled patients, 120 (13.1%) were in the Axis I + II group, and 794 (86.9%) were in the Axis I group. Assertive case management was significantly effective for the Axis I group on the primary outcome at 6 months (risk ratio [RR] 0.51, 95% confidence intervals [CI] 0.31 to 0.84). The RR of the Axis I + II group was 0.44 (95% CI 0.14 to 1.40). CONCLUSIONS: Assertive case management not only had an effect on patients who had attempted suicide with only Axis I disorders but may also have a similar effect on patients with comorbid Axis I and II disorders.

Implementation of nationwide screening of pregnant women for HTLV-1 infection in Japan: analysis of a repeated cross-sectional study.

BACKGROUND: Screening of pregnant women carrying human T-lymphotropic virus type 1 (HTLV-1) has a crucial role in reducing the number of HTLV-1 carriers. A national HTLV-1 screening program for pregnant women was started in 2011 in Japan. The purpose of this study is to report on the implementation of this nationwide screening program. METHODS: This was a retrospective repeated cross-sectional study. We used datasets from surveys of HTLV-1-antibody-positive pregnant women performed by the Japan Association of Obstetricians and Gynecologists in 2011, 2013, and 2016. Outcomes for evaluation included the number of persons (pregnant women) who conducted the screening test, the number of positive persons (women) identified by these tests, and the proportion of positive persons to the number of persons (women) who conducted the tests. RESULTS: Numbers of target facilities changed yearly: 1857 in 2011, 2544 in 2013, and 2376 in 2016. The mean number of screening-test participants increased per facility, but the median increased or decreased. The mean number of positive individuals identified decreased. Multivariate analysis results revealed the number of screenings was slightly reduced yearly, although areas (Kanto and Kinki) and high volume in facility types increased. Regarding the positive rates, some areas (Hokkaido/Tohoku, Kanto, and Chugoku/Shikoku) exhibited decreases or increases by facility type. The number of western blotting (WB) implementations decreased in 2016, positive rates identified by WB decreased in 2016 in all areas, and the number of facility types increased. The number of PCR participants increased in 2016 in Kanto and Kinki, but a decrease in facility type was observed. Positive rates were decreased in all areas (except the central region) but facility types were increased. CONCLUSIONS: The nationwide screening program for HTLV-1 in Japan was almost fully implemented. However, regional variations in screening tests were observed during this implementation. Thus, some incentives are needed to encourage proper implementation across all regions.

Correction to: Implementation of nationwide screening of pregnant women for HTLV-1 infection in Japan: analysis of a repeated cross-sectional study.

An amendment to this paper has been published and can be accessed via the original article.

Two-day assertive-case-management educational program for medical personnel to prevent suicide attempts: A multicenter pre-post observational study.

AIM: Suicide attempters have a high risk of repeated suicide attempts and completed suicide. There is evidence that assertive case management can reduce the incidence of recurrent suicidal behavior among suicide attempters. This study evaluated the effect of an assertive-case-management training program. METHODS: This multicenter, before-and-after study was conducted at 10 centers in Japan. Participants were 274 medical personnel. We used Japanese versions of the Attitudes to Suicide Prevention Scale, the Gatekeeper Self-Efficacy Scale, the Suicide Intervention Response Inventory (SIRI), and the Attitudes Toward Suicide Questionnaire. We evaluated the effects with one-sample t-tests, and examined prognosis factors with multivariable analysis. RESULTS: There were significant improvements between pre-training and post-training in the Attitudes to Suicide Prevention Scale (mean: -3.07, 95% confidence interval [CI]: -3.57 to -2.57, P < 0.001), the Gatekeeper Self-Efficacy Scale (mean: 10.40, 95%CI: 9.48 to 11.32, P < 0.001), SIRI-1 (appropriate responses; mean: 1.15, 95%CI: 0.89 to 1.42, P < 0.001), and SIRI-2 (different to the expert responses; mean: -4.78, 95%CI: -6.18 to -3.38, P < 0.001). Significant improvements were found on all Attitudes Toward Suicide Questionnaire subscale scores, except Unjustified Behavior. The effect of training was influenced by experience of suicide-prevention training and experience of working with suicidal patients. CONCLUSION: The training program (which was developed to implement and disseminate evidence-based suicide-prevention measures) improved attitudes, self-efficacy, and skills for suicide prevention among medical personnel. Specialized suicide-prevention training and experience with suicidal patients are valuable for enhancing positive attitudes and self-efficacy; furthermore, age and clinical experience alone are insufficient for these purposes.

Association Between Prehospital Supraglottic Airway Compared With Bag-Mask Ventilation and Glasgow-Pittsburgh Cerebral Performance Category 1 in Patients With Out-of-Hospital Cardiac Arrest.

BACKGROUND: This study examined the association between prehospital supraglottic airway (SGA) and/or epinephrine compared with bag-mask ventilation (BMV) and Glasgow-Pittsburgh cerebral performance category (CPC) 1 status in patients with out-of-hospital cardiac arrest (OHCA) using a large, nationwide, population-based registry dataset.Methods and Results:This was a post hoc analysis of the All-Japan Utstein Registry. We included patients with OHCA of cardiac origin aged ≥18 years with resuscitation performed by emergency medical services (EMS) between January 2011 and December 2015. The primary endpoint was favorable neurological outcome (CPC 1). The patients were divided into 4 groups according to the prehospital management performed by EMS: BMV group received only basic life support (BLS); epinephrine group received BLS plus epinephrine; SGA group received BLS plus SGA; and combined group received BLS plus epinephrine and SGA. Univariate and multivariable logistic regression analyses were performed for the primary endpoint. Among the 106,434 patients with OHCA, 48,847 received only BMV, 8,958 received BLS+epinephrine, 25,467 received BLS+SGA, and 15,551 received BLS+epinephrine+SGA. Using the BMV group as the reference, multivariable analysis showed that the epinephrine, SGA, and combined groups were independently associated with a reduced incidence of favorable neurological outcomes. CONCLUSIONS: Our results indicated that compared with BLS, patients in the prehospital SGA and/or epinephrine groups had a significantly reduced incidence of CPC 1 status.

Prognostic Value of Neurological Status on Hospital Arrival for Short-Term Outcome in Patients With Cardiovascular Shock　- Sub-analysis of the Japanese Circulation Society Cardiovascular Shock Registry.

BACKGROUND: Consciousness disturbance is one of the major clinical signs associated with shock state, but its prognostic value has not been previously evaluated in cardiovascular shock patients. We aimed to evaluate the prognostic value of neurological status for 30-day mortality in cardiovascular shock patients without out-of-hospital cardiac arrest (OHCA). Methods and Results: Patients with out-of-hospital onset cardiovascular shock were recruited from the Japanese Circulation Society Shock Registry. Neurological status upon hospital arrival was evaluated using the Japan Coma Scale (JCS). Patients were divided into 4 groups according to the JCS: alert, JCS 0; awake, JCS 1-3 (not fully alert but awake without any stimuli); arousable, JCS 10-30 (arousable with stimulation); and coma JCS 100-300 (unarousable). The primary endpoint was 30-day all-cause death. In total, 700 cardiovascular shock patients without OHCA were assessed. The coma group was associated with a higher incidence of 30-day all-cause death compared with other groups (alert, 15.3%; awake, 24.4%; arousable, 36.8%; coma, 48.5%, P<0.001). Similar trends were observed in etiologically divergent subgroups (acute coronary syndrome, non-ischemic arrhythmia, and aortic disease). On multivariate Cox regression analysis, arousable (hazard ratio [HR], 1.82; 95% CI: 1.16-2.85, P=0.009) and coma (HR, 2.72; 95% CI: 1.76-4.22, P<0.001) (reference: alert) independently predicted 30-day mortality. CONCLUSIONS: Neurological status upon hospital arrival was useful to predict 30-day mortality in cardiovascular shock patients without OHCA.