Quality of life with docetaxel plus cisplatin versus paclitaxel plus carboplatin in patients with completely resected non-small cell lung cancer: quality of life analysis of TORG 0503.

PURPOSE: The TORG0503 study was undertaken to select a preferred platinum-based third-generation regimen for patients with completely resected non-small cell lung cancer (NSCLC). This study aimed to describe the quality of life (QOL) analysis of that study. METHODS: Patients with completely resected NSCLC were randomized to receive three cycles of docetaxel plus cisplatin (DC) or paclitaxel plus carboplatin (PC) on day 1 every 3 weeks. QOL was assessed at three time points (baseline, after two cycles, and after three cycles) using the Functional Assessment of Cancer Therapy-taxane (FACT-Taxane). The adjusted odds ratio (OR) and 95% confidence interval (CI) were calculated by logistic regression analysis that was adjusted for the baseline score in the FACT-Taxane total score and each subscale to evaluate treatment (PC vs. DC) effectiveness. RESULTS: QOL data from 104 patients (DC, n = 56 patients; PC, n = 48) were analyzed. In the FACT-Taxane total score, the baseline-adjusted OR (95% CI) of not worse QOL for the DC group was 3.3 (1.4-8.3) compared with the PC group. In the taxane subscale, the baseline-adjusted OR (95% CI) was 6.2 (2.6-16.0). CONCLUSION: Total QOL was maintained better in the DC group than in the PC group, especially the taxane subscale that consists of neurotoxicity and taxane components in spite of no treatment-related death in both arms between DC and PC. We might recommend DC as the control regimen for the next clinical trial from the viewpoint of QOL, similar to the primary outcomes in TORG0503.

Risk of low birthweight associated with the timing and frequency of antenatal care visits in Lao PDR: a retrospective cohort study.

BACKGROUND: Antenatal care (ANC) plays an important role in preventing low birthweight (LBW). Whereas the government of Lao People's Democratic Republic (Lao PDR) has committed to increasing the usage of ANC, little attention has been given to the early initiation of ANC. The present study assessed the influence of delayed and fewer ANC visits on LBW in the country. METHODS: This is a retrospective cohort study conducted at Salavan Provincial Hospital. Study participants were all pregnant women who gave birth at the hospital between 1 August 2016 and 31 July 31 2017. Data were collected from medical records. Logistic regression analyses were performed to quantify the relationship between ANC visits and LBW. We also investigated factors associated with inadequate ANC visits: first ANC visit after the first trimester or < 4 ANC visits. RESULTS: The mean birth weight was 2808.7 g [standard deviation: SD 455.6]. Among 1804 participants, 350 (19.4%) had babies with LBW, and 147 (8.2%) had inadequate ANC visits. In multivariate analyses, compared to participants with adequate ANC visits, those with ≥ 4 ANC visits and the first ANC visit after the second trimester, those with < 4 ANC visits, and those with no ANC visits had higher odds ratios (ORs) of LBW: 3.77 (95% confidence interval: CI = 1.66-8.57), 2.39 (95% CI = 1.18-4.83) and 2.22 (95% CI = 1.08-4.56), respectively. Younger maternal age (OR 1.42; 95% CI = 1.07-1.89), government subsidisation (OR 2.69; 95% CI = 1.97-3.68) and ethnic minority (OR 1.88; 95% CI = 1.50-2.34) were associated with increased risk of insufficient number of ANC visits after adjusting for covariates. CONCLUSIONS: Frequent and early initiation of ANC was associated with a reduction in LBW in Lao PDR. Encouraging childbearing-aged women to receive sufficient ANC at proper timing may lead to a reduction in LBW and improvement in short- and long-term health outcomes of neonates. Special attention will be needed for ethnic minorities and women in lower socioeconomic classes.

Regional variation of pediatric interhospital critical care transport in Japan.

BACKGROUND: An in-depth understanding of the epidemiology of ill or injured children transported between hospitals is crucial in building regional medical transport services in public health. Although the epidemiological situation varies by nation and region, it has not been well documented in Japan. In this report we described the number of pediatric interhospital transportations and examined the regional variations and trends in the recent decade. METHODS: We performed repeated, cross-sectional analyses of children (<15 years) undergoing interhospital transportation in 2010, 2013, and 2016-19, using the national database of public ambulances of the Fire and Disaster Management Agency in Japan. We stratified the cases into critical care transport (CCT) or non-critical care transport (NonCCT) by the illness/injury severity of the transported children. We calculated the national population-adjusted number of CCTs and described prefectural variations in CCT numbers with analytical thinking. RESULTS: There were 23,506 CCTs and 138,347 NonCCTs. The national average of population-adjusted CCT numbers was 255 per 1,000,000 person-years. The statistics varied by prefectures, ranging from 25-536 per 1,000,000 person-years. The annual trends were also diverse across prefectures, increasing in nine, decreasing in six, and static in 31 prefectures. In analytical thinking of regional variations, potential contributing factors included available interhospital transport services and the threshold of direct admission and referral to tertiary-care hospitals, whereas regional variations were not well associated with geographical patterns or population size. CONCLUSIONS: Public ambulance services were substantially used for CCTs and NonCCTs in Japan. Regional variations should be taken into account for the future policymaking on pediatric interhospital transportation.

Effects of 'SPRAT' programme for dietary and lifestyle education to improve psychosomatic symptoms and dietary habits among adolescents: a cluster randomised controlled trial.

BACKGROUND: Dietary and lifestyle modifications to reduce subjective psychosomatic symptoms (SPS) have become an important topic worldwide. We developed a school-based dietary and lifestyle education programme that involved parents/guardians in reducing SPS in adolescents (SPRAT). The programme encouraged parents/guardians to participate in adolescents' healthy dietary and lifestyle modifications to reduce SPS, increase enjoyment of school life, and foster appropriate dietary intake. This study evaluated the effectiveness of SPRAT in reducing SPS and in altering dietary behaviour among adolescents. METHODS: A 6-month cluster randomised controlled trial using SPRAT and the usual school programme (control) was performed. Participants were middle school students in Japan who provided informed consent. Outcomes were SPS scores assessed at baseline and 2, 4, and 6 months after baseline and the proportions of dietary and lifestyle factors achieved such as enjoyment of school life and dietary intakes assessed by FFQW82. Change from baseline (CFB) at 6 months was the primary endpoint. A linear mixed-effects model was applied. As for dietary intake, the treatment effect was estimated as an interaction term between baseline and treatment "baseline*treatment". RESULTS: The intention-to treat analysis included 951 (94.7%) and 1035 (89.8%) individuals in the SPRAT and control groups, respectively. The CFB in the 6-month SPS score adjusted for baseline was lower in the SPRAT group (-0.29) than in the control group (0.62), but the difference was not statistically significant -0.91 (p = 0.093). CONCLUSIONS: Although the primary endpoint tended to denote improvement in the SPRAT group compared to the control group, the improvement was not significant. Favourable effects were observed in some secondary outcomes and statistically significant treatment*baseline interactions were observed for several dietary intakes. These results imply that CFBs of dietary intake were increased or decreased in a favourable direction depending on the baseline intake, especially in the SPRAT group. TRIAL REGISTRATION: UMIN000026715. (27/03/2017).

Perceptions of Japanese and Dutch women with early breast cancer about monitoring their quality of life.

OBJECTIVE: Monitoring quality of life (QoL) in patients with cancer can provide insight into functional, psychological and social consequences associated with illness and its treatment. The primary objective of this study is to examine the influence of cultural factors on the communication between the patient and the health care provider and the perceived QoL in women with breast cancer in Japan and the Netherlands. METHODS: In Japanese and Dutch women with early breast cancer, the number, content and frequency of QoL-related issues discussed at the medical encounter were studied. Patients completed questionnaires regarding QoL and evaluation of communication with the CareNoteBook. RESULTS: The total number, frequency and content of QoL-related issues discussed differed between the two countries. Japanese women (n = 134) were significantly more reticent in discussing QoL-issues than the Dutch women (n = 70) (p < .001). Furthermore, Dutch patients perceived the CareNoteBook methodology significantly more positively than the Japanese patients (p < .001). Both groups supported the regular assessment via a CareNoteBook methodology. CONCLUSIONS: Japanese women are more reluctant in expressing their problems with the illness, its treatment and patient-physician communication than Dutch women.

Cost-effectiveness analysis of sedation and general anesthesia regimens for children undergoing magnetic resonance imaging in Japan.

PURPOSE: The anesthesiologist-directed sedation service has not been well established in Japan partly due to reimbursement issue. In this study, we compared the cost-effectiveness of sedation by non-anesthesiologists with that of sedation or general anesthesia by anesthesiologists under the Japanese medical fee schedule. METHODS: We conducted a single-center observational study with patients who required sedation or general anesthesia for magnetic resonance imaging (MRI) during a 12-month period. Costs per patient and failure rates of imaging were modeled in a decision analysis tree with sensitivity analysis. Costs were estimated from the health-care sector perspective. RESULTS: A total of 1546 patients were analyzed. The failure rate of sedation by non-anesthesiologists was 17.5% (264 out of 1506), whereas all the sedation and general anesthesia by anesthesiologists were successful. The cost-effectiveness analysis with setting successful sedation as outcomes showed that the mean cost per patient was 84.2 USD for sedation by anesthesiologists, followed by 74.2-92.7 USD for intravenous sedation by non-anesthesiologists, 112.1-458.3 USD for oral or rectal sedation by non-anesthesiologists, and 605.4 USD for general anesthesia by anesthesiologists. The one-way sensitivity analysis demonstrated that the cost per patient of sedation by a non-anesthesiologist would remain higher than that of sedation by an anesthesiologist, provided that the failure rate is over 11.3% for sedation via oral or rectal route, or over 3.6% for intravenous route, respectively. CONCLUSIONS: Anesthesia-directed sedation would be more cost-effective than oral or rectal sedation by non-anesthesiologists for children undergoing MRI in the Japanese medical fee schedule.

Clinical impact of implementing humidified high-flow nasal cannula on interhospital transport among children admitted to a PICU with respiratory distress: a cohort study.

BACKGROUND: There is a limited evidence for humidified high-flow nasal cannula (HHFNC) use on inter-hospital transport. Despite this, its use during transport is increasing in children with respiratory distress worldwide. In 2015 HHFNC was implemented on a specialized pediatric retrieval team serving for Victoria. The aim of this study is to investigate the effect of the HHFNC implementation on the retrieval team on the paediatric intensive care unit (PICU) length of stay and respiratory support use. METHODS: We performed a cohort study using a comparative interrupted time-series approach controlling for patient and temporal covariates, and population-adjusted analysis. We studied 3022 children admitted to a PICU in Victoria with respiratory distress January 2010-December 2019. Patients were divided in pre-intervention era (2010-2014) and post-intervention era (2015-2019). RESULTS: 1006 children following interhospital transport and 2016 non-transport children were included. Median (IQR) age was 1.4 (0.7-4.5) years. Pneumonia (39.1%) and bronchiolitis (34.3%) were common. On retrieval, HHFNC was used in 5.0% (21/420) and 45.9% (269/586) in pre- and post-intervention era. In an unadjusted model, median (IQR) PICU length of stay was 2.2 (1.1-4.2) and 1.7 (0.9-3.2) days in the pre- and post-intervention era in transported children while the figures were 2.4 (1.3-4.9) and 2.1 (1.2-4.5) days in non-transport children. In the multivariable regression model, the intervention was associated with the reduced PICU length of stay (ratio 0.64, 95% confidential interval 0.49-0.83, p = 0.001) with the predicted reduction of PICU length of stay being - 10.6 h (95% confidential interval - 16.9 to - 4.3 h), and decreased respiratory support use (- 25.1 h, 95% confidential interval - 47.9 to - 2.3 h, p = 0.03). Sensitivity analyses including a model excluding less severe children showed similar results. In population-adjusted analyses, respiratory support use decreased from 4837 to 3477 person-hour per year in transported children over the study era, while the reduction was 594 (from 9553 to 8959) person-hour per year in non-transport children. With regard to the safety, there were no escalations of respiratory support mode during interhospital transport. CONCLUSIONS: The implementation of HHFNC on interhospital transport was associated with the reduced PICU length of stay and respiratory support use among PICU admissions with respiratory distress.

Effectiveness of self-managed continuous monitoring for maintaining high-quality early essential newborn care compared to supervision visit in Lao PDR: a cluster randomised controlled trial.

BACKGROUND: Thousands of neonatal deaths are expected to be averted by introducing the Early Essential Newborn Care (EENC) in the Western Pacific Region. In Lao People's Democratic Republic (Lao PDR), the government adopted the EENC programme and expanded it to district hospitals. With the expansion, maintaining the quality of EENC has become difficult for the government. METHODS: A cluster randomised controlled trial with four strata based on province and history of EENC coaching was implemented to evaluate the effectiveness of self-managed continuous monitoring compared with supervisory visit in Lao PDR between 20 July 2017 and 2 April 2019. Health workers who were routinely involved in maternity care were recruited from 15 district hospitals in Huaphanh (HP) and Xiangkhouang (XK) provinces. The primary endpoint was the score on the determinants of EENC performance measured by the Theory of Planned Behaviour (TPB). Secondary endpoints were set as the knowledge and skill scores. A linear mixed-effects model was applied to test the effects of intervention over time on the endpoints. RESULTS: Among 198 recruited health workers, 46 (23.2%) did not complete the final evaluation. TPB scores were 180.9 [Standard Deviation: SD 38.6] and 182.5 [SD 37.7] at baseline and 192.3 [SD 30.1] and 192.3 [SD 28.4] at the final evaluation in the intervention and control groups, respectively. There was no significant difference in changes between the groups in the adjusted model (2.4, p = 0.650). Interviews with participants revealed that district hospitals in HP regularly conducted peer reviews and feedback meetings, while few hospitals did in XK. Accordingly, in stratified analyses, the TPB score in the intervention group significantly increased in HP (15.5, p = 0.017) but largely declined in XK (- 17.7, p = 0.047) compared to the control group after adjusting for covariates. Skill scores declined sharper in the intervention group in XK (- 8.78, p = 0.026), particularly in the practice of managing nonbreathing babies. CONCLUSIONS: The study indicates that self-managed continuous monitoring is effective in improving behaviour among district health workers; however, additional measures are necessary to support its proper implementation. To maintain resuscitation skills, repeated practice is necessary. TRIAL REGISTRATION: This trial was registered at UMIN Clinical Trials Registry on 15/6/2017. Registration number is UMIN000027794 .

Spatial clustering of suicide mortality and associated community characteristics in Kanagawa prefecture, Japan, 2011-2017.

BACKGROUND: Suicide mortality is high in Japan and early interventional strategies to solve that problem are needed. An accurate evaluation of the regional status of current suicide mortality would be useful for community interventions. A few studies in Kanagawa prefecture, located next to Tokyo and with the second largest population in Japan, have identified spatial clusters of suicide mortality at regional levels. This study examined spatial clustering and clustering over time of such events using spatial data from regional statistics on suicide deaths. METHODS: Data were obtained from regional statistics (58 regions in Kanagawa prefecture) of the National Vital Statistics of Japan from 2011 to 2017. The standardized mortality ratio (SMR) and Empirical Bayes estimator for the SMR (EBSMR) were used as measures. Spatial clusters were examined by Kulldorff's circular spatial scan statistic, Tango-Takahashi's flexible spatial scan statistic and Tango's test. Linear regression and conditional autoregressive (CAR) models were used not only to adjust for covariates but also to estimate regional effects. The analyses were conducted for each year, inclusive. RESULTS: Among male suicide deaths, being unemployed (50%) was most frequently related to suicide while among female health problem (50%) were frequent. Spatial clusters with significance detected by FlexScan, SatScan and Tango's test were few and varied somewhat according to the method used. Spatial clusters were detected in some regions including Kawasaki ward after adjustment by covariates. By the linear regression models, selected variables with significance were different between the sexes. For males, unemployment, family size, and proportion of higher education were detected for several of the years studied while for females, family size and divorce rate were detected over this period. These variables were also observed by the CAR model with 5 covariates. Regional effects were much clearer by considering the spatial parameter for both males and females and especially, Kawasaki ward was detected as a high risk region in many years. CONCLUSION: The present results detected some spatial clustering of suicide deaths within certain regions. Factors related to suicide deaths were also indicated. These results would provide important information in policy making for suicide prevention.

Potential factors associated with institutional childbirth among women in rural villages of Lao People's Democratic Republic: a preliminary study.

BACKGROUND: The provision of quality health services has been a global priority to reduce neonatal and maternal deaths. In Lao People's Democratic Republic (Lao PDR), the coverage of institutional childbirth stayed at a low level regardless of a sharp increase in the coverage of antenatal care (ANC) and fee exemption. The aim of the present study was to preliminary explore factors associated with increased institutional childbirth and the association between ANC attendance and maternal knowledge among women in rural villages of Lao PDR. METHODS: A secondary data analysis was conducted using data collected through a pilot survey in Sekong province in Lao PDR. The study participants were women with children under 5 years of age in villages within 10 km (km) from health centers staffed with skilled birth attendants. Data were collected via a face-to-face interview using a semi-structured questionnaire and were analysed using logistic regression models to estimate odds ratios (ORs) and their 95% confidence intervals (CIs) for having institutional childbirth in relation to potential factors. RESULTS: A total of 302 women, 203 (67.2%) of whom gave birth at a health facility. 277 (91.7%) attended ANC at least once. Sixty-nine women (22.9%) had received no formal education, 272 (90.1%) were of an ethnic minority, 174 (57.6%) were unwaged and 99 (32.8%) lived more than 6 km from the nearest health facility. 51 (16.6%) did not know about birth complications at interview. Institutional childbirth was negatively associated with a lack of maternal knowledge about birth complications (OR, 0.27; 95% Cl, 0.14-0.54) after adjusting for covariates. Although there were few women who did not received ANC, the results suggested ANC might not be associated with maternal knowledge about birth complications (OR, 1.87; 95% Cl, 0.43-8.12). CONCLUSIONS: The present study suggests that maternal knowledge about birth complications is an important factor in increasing the institutional childbirth in rural villages of Lao PDR where majority of residents were ethnic minority. Improving quality of ANC and attitude among health care providers may be key to increasing health-seeking behavior. However, further research is needed to understand factors influencing choice of place of childbirth.

Relation of High Social Capital to Preferable Emotional Response to News Media Broadcasting of Natural Disasters: A Nationwide Cross-Sectional Study in Japan.

Media coverage of disasters potentially damages mental health. Moreover, its effects may differ as recipients may have different emotional responses toward media. The present study examined whether social capital, known to be protective against mental problems, influences a recipient's emotional response toward news media broadcasting of natural disasters via newspapers, television and internet in Japan. Three social capital components, social participation, social support and cognitive social capital, were considered in the present study as each component reportedly had different effect on mental health. This nationwide cross-sectional survey was undertaken in 2015 among 1,200 Japanese citizens aged 15 to 79 years who were selected using the multi-stage sampling procedure. Data were collected via the drop-off pick-up method using a printed structured questionnaire. Negative and positive emotions were classified based on recipients' responses against news media. Among 1,190 participants who reported emotions toward news media, 30.9% (368) had experienced any natural disasters, 37.4% (445) belonged to at least one formal or informal organization (social participation), 40.2% (478) had high social support, and 68.8% (819) had high cognitive social capital. High social support was associated with both reduced negative emotional response (OR 0.66, 95% Confidence Interval (CI) 0.47-0.93) and increased positive emotional response (OR 1.48, 95% CI 1.04-2.12) in multivariate analyses, while high cognitive social capital was only associated with increased positive emotional response (OR 1.62, 95% CI 1.11-2.37). These results suggest protective effects of social support and cognitive social capital against news media coverage of natural disasters.

Validity and Reliability of the Japanese Version of the 10-Item Perceived Efficacy in Patient-Physician Interactions (PEPPI-10) Scale in Breast Cancer Outpatients.

The 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-10) questionnaire was used as an indirect measure of the patients' perception of the strength of their therapeutic connection with their physician. The English version of the PEPPI-10 could serve as a valuable research tool for analyzing the relationship between patient and physician. The incidence of breast cancer is amongst the highest in Japan, and Patient Reported Outcome is often used as an outcome measure for breast cancer. It is particularly important to establish a strong patient-physician interaction for patients with breast cancer, since these patients require long-term treatment. We designed the present study to assess the reliability and validity of the Japanese version of the PEPPI-10 in female Japanese breast cancer outpatients. A cross-sectional study was performed at the Saitama Cancer Center, Japan. From August 2014 to August 2015, the Japanese versions of the PEPPI-10 that measure patient-perceived self-efficacy and the Brief Illness Perception Questionnaire (BIPQ) that measure illness perception were used for 92 breast cancer patients who received outpatient chemotherapy (mean age: 52.9 years, Cancer Stage I or Stage II : 82.6%, receiving adjuvant chemotherapy: 69.6%). We found that the Japanese version of the PEPPI-10 scale had a high coefficient of internal consistency (Cronbach's α coefficient, 0.83) for reliability, and concurrent validity analysis indicated that the utility of PEPPI-10 was moderately correlated with that of the BIPQ. In conclusion, the Japanese version of the PEPPI-10 is a useful tool that can empower breast cancer outpatients during the course of their treatment.

Study protocol of a cluster randomized controlled trial to evaluate effectiveness of a system for maintaining high-quality early essential newborn care in Lao PDR.

BACKGROUND: Reduction in neonatal deaths has been a major challenge globally. To prevent neonatal deaths, improvements in newborn care have been promoted worldwide. The World Health Organization Western Pacific Regional Office has been promoting the Early Essential Newborn Care (EENC), a package of specific simple and cost-effective interventions, in their region. However, mere introduction of EENC cannot reduce neonatal deaths unless quality of care is ensured. In Lao PDR, the government introduced self-managed continuous monitoring as a sustainable way to improve the quality of care described in the EENC. METHODS: A clustered randomized controlled trial was designed to compare the effectiveness of self-managed continuous monitoring with external supervisory visits to monitor health workers' satisfactory EENC performance and their knowledge and skills related to the EENC in Lao PDR. Determinants of EENC performance will be measured with a structured questionnaire developed based on the Theory of Planned Behaviour, which predicts future behaviour. During self-managed continuous monitoring activities, health workers in each district hospital will conduct periodical peer reviews and feedback sessions. Fifteen district hospitals will be randomly allocated into the self-managed continuous monitoring (intervention) and the supervision (control) groups. Fifteen health workers routinely involved in maternity and newborn care including physicians, midwives and other health staff will be recruited from each hospital (effect size 0.6, intra-cluster correlation coefficient 0.06, 5% alpha error and 80% power). We will compare the change in the mean score of the determinants before and one year after randomisation between the two groups. We will also compare the retention of knowledge and skills related to the EENC between the two groups. The expected enrolment period is July 20th, 2017 to July 20th, 2018. DISCUSSION: This is the first cluster randomized trial to evaluate a self-managed continuous monitoring system for quality maintenance of newborn care in a resource-limited country. This research is conducted in collaboration with the Ministry of Health and international organizations; therefore, if effective, this intervention would be applied in larger areas of the country and the region. TRIAL REGISTRATION: This trial was registered at UMIN-CTR on 15th of June, 2017. Registration number is UMIN000027794 .

Beneficial Roles of Social Support for Mental Health Vary in the Japanese Population depending on Disaster Experience: A Nationwide Cross-Sectional Study.

The purpose of the present study was to assess the effects of social capital on mental health among the Japanese population with or without natural disaster experience. A nationwide cross-sectional study was performed in the population aged 15 to 79 years old. We collected data on psychological status, social capital, disaster experience in ten years prior to the survey, and socio-demographic information. We assessed cognitive social capital (perceptions of support, reciprocity and trust), social support (support from individuals in the community), and social participation (participation in social activities) as components of social capital. The study outcome was mild mood or anxiety disorder (hereafter mood/anxiety disorder), defined as the score of 5 or higher in the Kessler Psychological Distress Scale (K6). Using logistic regression models, we tested whether each component of social capital was associated with mood/anxiety disorder with or without disaster experience. Out of 1,200 participants, 1,183 had available K6 score data and were considered. Among three components of social capital, only social support significantly interacted with disaster experience (p = 0.019). In the population without disaster experience, those with high social support were less likely to have mood/anxiety disorder (OR 0.45, 95% Cl 0.28-0.73); however, no such association was observed among those with disaster experience (OR 1.11, 95% CI 0.64-1.90). Thus, the protective effects of social support against mood/anxiety disorder vary in the Japanese population depending on disaster experience. The present study provides important insight into the role of social capital on mental health after natural disaster.

Effects of a lifestyle modification programme to reduce the number of risk factors for metabolic syndrome: a randomised controlled trial.

OBJECTIVE: To determine the effectiveness of a personal support lifestyle education programme (PSMetS) for reducing risk factors in individuals with metabolic syndrome (MetS). DESIGN: A two-arm randomised controlled trial. SETTING: Companies in metropolitan Tokyo, Japan. SUBJECTS: Male workers with diagnosed MetS or a high risk for MetS according to the Counselling Guidance Program, Japan (n 193). RESULTS: The reduction in the number of risk factors for MetS (as defined according to the criteria published by the Japanese Ministry of Health, Labor and Welfare in April 2007 (MHLW-MetS)) in the PSMetS group was not significantly different from that in the usual care group by van Elteren's test (baseline-adjusted P=0·075) for intention-to-treat (ITT), while it was significant (baseline-adjusted P=0·038) for per-protocol set (PPS). The proportion of MHLW-MetS was significantly different between groups by van Elteren's test (baseline-adjusted P=0·031). Two components of MHLW-MetS showed significant reductions in the PSMetS group: waist circumference (baseline-adjusted P=0·001) and BMI (baseline-adjusted P=0·002). PPS and ITT analyses showed similar results. CONCLUSIONS: For male workers with MHLW-MetS or a high risk of MHLW-MetS, PSMetS reduced the number of risk factors for MHLW-MetS.

A Bayesian Approach for Population Pharmacokinetic Modeling of Alcohol in Japanese Individuals.

BACKGROUND: Blood alcohol concentration data that were previously obtained from 34 healthy Japanese subjects with limited sampling times were reanalyzed. Characteristics of the data were that the concentrations were obtained from only the early part of the time-concentration curve. OBJECTIVE: To explore significant covariates for the population pharmacokinetic analysis of alcohol by incorporating external data using a Bayesian method, and to estimate effects of the covariates. METHODS: The data were analyzed using a Markov chain Monte Carlo Bayesian estimation with NONMEM 7.3 (ICON Clinical Research LLC, North Wales, Pennsylvania). Informative priors were obtained from the external study. RESULTS: A 1-compartment model with Michaelis-Menten elimination was used. The typical value for the apparent volume of distribution was 49.3 L at the age of 29.4 years. Volume of distribution was estimated to be 20.4 L smaller in subjects with the ALDH2*1/*2 genotype than in subjects with the ALDH2*1/*1 genotype. CONCLUSIONS: A population pharmacokinetic model for alcohol was updated. A Bayesian approach allowed interpretation of significant covariate relationships, even if the current dataset is not informative about all parameters. This is the first study reporting an estimate of the effect of the ALDH2 genotype in a PPK model.

Chronological, geographical, and seasonal trends of human cases of avian influenza A (H5N1) in Vietnam, 2003-2014: a spatial analysis.

BACKGROUND: Human cases of highly pathogenic avian influenza A (H5N1) virus infection continue to occur in Southeast Asia. The objective of this study was to identify when and where human H5N1 cases have occurred in Vietnam and how the situation has changed from the beginning of the H5N1 outbreaks in 2003 through 2014, to assist with implementing methods of targeted disease management. METHODS: We assessed the disease clustering and seasonal variation of human H5N1 cases in Vietnam to evaluate the geographical and monthly timing trends. The clustering of H5N1 cases and associated mortality were examined over three time periods: the outbreak period (2003-2005), the post-outbreak (2006-2009), and the recent period (2010-2014) using the flexibly shaped space-time scan statistic. The most likely cases to co-cluster and the elevated risks for incidence and mortality were assessed via calculation of the relative risk (RR). The H5N1 case seasonal variation was analysed as the cyclic trend in incidence data using Roger's statistical test. RESULTS: Between 2003 and 2005, H5N1 cases (RR: 2.15, p = 0.001) and mortality (RR: 2.49, p = 0.021) were significantly clustered in northern Vietnam. After 2010, H5N1 cases tended to occur on the border with Cambodia in the south, while H5N1 mortality clustered significantly in the Mekong delta area (RR: 6.62, p = 0.002). A significant seasonal variation was observed (p < 0.001), with a higher incidence of morbidity in December through April. CONCLUSIONS: These findings indicate that clinical preparedness for H5N1 in Vietnam needs to be strengthened in southern Vietnam in December-April.

A randomized clinical study on postoperative pain comparing the Polysoft patch to the modified Kugel patch for transinguinal preperitoneal inguinal hernia repair.

PURPOSE: The transinguinal preperitoneal approach is a relatively new technique for inguinal hernia repair. Two types of memory-ring mesh are available in Japan: the modified Kugel patch (MK) and the Polysoft patch (PP). We tested the hypothesis that the PP is noninferior to the MK with respect to chronic postoperative pain. METHODS: An unblinded randomized controlled trial was conducted to assess the noninferiority of PP compared to MK with a 5 % noninferiority margin. A total of 442 inguinal hernia patients operated on from November 2010 to December 2012 were included in this study. The primary endpoint was the pain score assessed by the visual analog scale (VAS) (0-1 vs. 2-10) 1 year after surgery. RESULTS: The patients were randomized to the PP and MK groups (n = 221 each). One year after surgery, 206 patients (95.4 %) in the PP group and 182 patients (89.6 %) in the MK group rated pain at 0-1 on the VAS scale. According to this rating, the PP group appeared not to be inferior to the MK group (95 % confidence interval, 0.7-10.7 %, P < 0.05). Furthermore, crude superiority tests, adjusting for 1 month of pain, denoted that the outcomes were significantly improved with the PP compared to the MK. CONCLUSIONS: The use of the PP was noninferior to the MK with respect to the severity of postoperative chronic pain scores 12 months after surgery.

Influence of pneumonia complications on the prognosis of patients with autopsy-confirmed Alzheimer's disease, dementia with Lewy bodies, and vascular dementia.

BACKGROUND: Pneumonia is a major, complicated disease in patients with dementia. However, the influence of pneumonia on the prognosis of patients with varying types of dementia has not been fully evaluated. METHODS: We retrospectively analyzed the data from medical and autopsy reports. All study patients had been hospitalized and underwent brain autopsy in a hospital in Toyohashi, Japan, between 2005 and 2014. The patients with subtypes of dementia, specifically Alzheimer's disease (AD), dementia with Lewy bodies (DLB), or vascular dementia (VaD), were neuropathologically diagnosed and examined. Pneumonia incidence, cause of death, and the clinical time-course of dementia were compared among the dementia subtypes. The time to death from dementia onset (survival time) was compared by the Kaplan-Meier method among subtypes of dementia with or without pneumonia. Risk factors for survival time on all study patients were analyzed with the Cox proportional hazard model. RESULTS: Of the 157 eligible patients, 63 (40.1%) had AD, 42 (26.8%) had DLB, and 52 (33.1%) had VaD. Pneumonia complication was observed with high incidence in each subtype of dementia, especially in DLB (90.5%). The median total duration from dementia onset to death was 8 years in AD and DLB, and 5 years in VaD. The VaD subtype had more male patients than AD or DLB (P = 0.010), and age of death in this group was the youngest among the three groups (P = 0.018). A significant difference was observed in the survival time by the Kaplan-Meier method among the three groups (P < 0.001) and among the groups with pneumonia (P = 0.002). The factors associated with shorter survival time were male gender, pneumonia complications, diabetes mellitus, age of dementia onset ≥ 75 years, and VaD. CONCLUSIONS: Pneumonia complications shortened the survival time of patients with AD, DLB, and VaD.