Health-related quality of life of mothers and developmental characteristics of very low birth weight children at 2.5 years of age: results from the Japan Environment and Children's Study (JECS).

BACKGROUND: The level of child development may be associated with the risk of poor maternal health-related quality of life (HRQoL). The objective of this study was to describe the developmental characteristics of very low birth weight (VLBW) children at 2.5 years of age and to examine associations between maternal HRQoL and the degree of child development based on the Japanese version of Ages and Stages Questionnaire (J-ASQ-3). METHODS: A cross-sectional study was performed using the data from a nationwide prospective birth cohort study in Japan. Among a total of 104,062 fetal records, the VLBW infants (birth weight ≤ 1500 g) were analyzed using linear regression models, adjusted for potential covariates. Subgroup analysis was also conducted to assess the association between social connection or cooperation of the partner and maternal HRQoL by the level of child development. RESULTS: The final study subjects included 357 VLBW children and mothers. The suspected developmental delays (SDDs) in at least two domains was significantly associated with lower maternal mental HRQoL regression coefficient -2.314 (95%CI: -4.065 to -0.564). There was no association between the status of child development and maternal physical HRQoL. After adjusting for child and maternal covariates, the maternal HRQoL was not significantly associated with child development. Amongst women who indicated having some social support, having a child with a SDD in two or more domains was negatively associated with mental HRQoL compared with women whose child was less developmental delay, regression coefficient -2.337 (95%CI: -3.961 to -0.714). Amongst women who indicated having partner's cooperation to child-rearing, having a child with a SDD in two or more domains was negatively associated with mental HRQoL compared with women whose child was less developmental delay, regression coefficient -3.785 (95%CI: -6.647 to -0.924). CONCLUSIONS: Our findings indicate that the lower maternal mental HRQoL was independently associated with the SDDs evaluated by the J-ASQ-3, whereas there was no association after adjusting for covariates. Further research is warranted to elucidate the impact of social connection and partner's cooperation on maternal HRQoL and child development. This study urges that particular attention should be paid to mothers of VLBW children with SDDs and also to provide early intervention and continued support.

Longitudinal study of the relationship between number of prior miscarriages or stillbirths and changes in quality of life of pregnant women: the Japan Environment and Children's Study (JECS).

BACKGROUND: Although a history of miscarriage or stillbirth has been reported to negatively affect quality of life (QOL) during the subsequent pregnancy, the association between the number of previous miscarriages or stillbirths and QOL, as well as trends in QOL during pregnancy, has not been clarified. This study sought to determine this association during early and mid- to late pregnancy. METHODS: Data from 82,013 pregnant women who participated in the Japan Environment and Children's Study (JECS) from January 2011 to March 2014 were analyzed. In early and mid/late pregnancy, participants completed questionnaires and QOL was assessed using the Physical and Mental Component Summary (PCS and MCS, respectively) scores from the 8-item Short-Form Health Survey (SF-8). The pregnant women were divided into four groups according to number of previous miscarriages or stillbirths (0, 1, 2, and ≥ 3), and the PCS and MCS scores in early pregnancy and mid/late pregnancy were compared between group 0 and groups 1, 2, and ≥ 3. Generalized linear mixed models were used for analysis. RESULTS: PCS score in early pregnancy was lower in group 1 (ß = - 0.29, 95% confidence interval [CI] - 0.42 to - 0.15), group 2 (ß = - 0.45, 95% CI - 0.73 to - 0.18), and group ≥ 3 (ß = - 0.87, 95% CI - 1.39 to - 0.35) than in group 0. Group 1 and group ≥ 3 showed a trend for increased PCS score during pregnancy (ß = 0.22, 95% CI 0.07 to 0.37 and ß = 0.75, 95% CI 0.18 to 1.33, respectively) compared with group 0. CONCLUSIONS: PCS score in early pregnancy was lower with a more frequent history of miscarriage or stillbirth. However, in terms of changes in QOL during pregnancy, pregnant women with a history of miscarriage or stillbirth showed greater increases in PCS score during mid/late pregnancy than pregnant women with no history of miscarriage or stillbirth.

Association between pre-pregnancy weight status and dietary patterns during pregnancy: results from the Japan Environment and Children's Study.

OBJECTIVE: Pre-pregnancy weight status is related to offspring health and may influence dietary patterns during pregnancy. We aimed to evaluate the link between pre-pregnancy weight status and dietary patterns during pregnancy. DESIGN: Dietary data were collected using a FFQ during middle or late pregnancy. Dietary patterns were identified using principal component analysis. Anthropometric data were extracted from medical charts. Multiple linear regression was used to assess associations between pre-pregnancy weight status (severely or moderately underweight, mildly underweight, normal weight, overweight and obese) and dietary patterns during pregnancy after adjusting for socio-demographic characteristics. SETTING: Nationwide Japan. PARTICIPANTS: Pregnant Japanese women enrolled in the Japan Environment and Children's Study, a prospective birth cohort study (n 90 765). RESULTS: We identified three dietary patterns. Compared with women with pre-pregnancy normal weight, those with pre-pregnancy obesity were less likely to habitually consume 'fruits and vegetables' pattern (coefficient, -0·18; 95 % CI, -0·21, -0·14) and 'confectionery' pattern (coefficient, -0·18; 95 % CI, -0·21, -0·14) and more likely to consume 'white rice and soy products' pattern (coefficient, 0·08; 95 % CI, 0·04, 0·11), and those with severely or moderately pre-pregnancy underweight were more likely to consume 'confectionery' pattern (coefficient, 0·06; 95 % CI, 0·03, 0·09) during pregnancy, after adjusting for confounders. CONCLUSION: We found that moderately and severely pre-pregnancy underweight women and those with obesity had unhealthy dietary patterns compared to those with pre-pregnancy normal weight. Our findings suggest that prenatal dietary advice is important and should be based on the pre-pregnancy weight status.

Mortality and neurodevelopmental outcomes in very low birth weight infants with esophageal atresia.

PURPOSE: Very low birth weight infants (VLBWIs) have been thought as risk of bad outcomes in the patients with esophageal atresia (EA). However, detailed outcomes of EA within VLBWIs were not fully understood. We aimed to reveal short- and long-term outcomes in VLBWIs with EA. METHODS: Clinical data regarding VLBWIs with EA registered in Neonatal Research Network Japan, a multicenter research database in Japan, were collected. Patients with chromosomal abnormality were excluded. Short term outcome was survival discharge from NICU and long-term outcome was neurodevelopmental impairment (NDI) at 3 years. RESULTS: A total of 103 patients were analyzed. the overall survival discharge rate from NICU was 68.0% (70/103). The risk of death was increased as the birth weight got reduced. The presence of associated anomaly increased the risk of death. Three-year neurodevelopmental information was available in 32.9% (23/70) of patients. Of the 23 included patients for 3-year follow-up, 34.8% had NDI. The risk of NDI was increased as the birth weight reduced. CONCLUSIONS: In VLBWIs with EA, survival discharge from NICU was still not high. More immature patients and patients with an associated anomaly had worse outcomes. Among patients who survived, NDI was confirmed in a certain number of patients.

Association of Maternal History of Allergic Features with Preterm Pregnancy Outcomes in the Japan Environment and Children's Study.

INTRODUCTION: Previous studies have reported that maternal asthma increases the risk of preterm birth. We hypothesized that inflammatory reactions caused by allergic diseases might affect the uterine environment and, subsequently, perinatal outcomes. The objective of this study was to examine the associations between allergic features among mothers and preterm pregnancy outcomes in a nationwide birth cohort. METHODS: We analyzed data from pregnant women obtained from the Japanese Environment and Children's Study (JECS), a nationwide general birth cohort study. We used binomial and multinomial logistic regression models to examine the associations between maternal allergic features and preterm birth, threatened preterm labor (TPL), and preterm premature rupture of the membrane (PPROM). RESULTS: A total of 97,683 pregnant women were included. Prevalence of preterm birth, TPL, and PPROM was 4.7, 19.6, and 1.2%, respectively. Maternal history of allergic diseases (asthma, allergic rhinitis, allergic conjunctivitis, food allergy, drug allergy, and contact dermatitis) increased the risk of TPL(adjusted odds ratio [aOR] = 1.11 [95% CI: 1.06-1.17], aOR = 1.12 [1.08-1.16], aOR = 1.10 [1.04-1.16], aOR = 1.17 [1.09-1.26], aOR = 1.35 [1.23-1.48], and aOR = 1.34 [1.20-1.49], respectively). Although some maternal allergic features showed a negative association with preterm birth, the variables affecting preterm birth differed according to the gestational age of the fetus (22-33 weeks vs. 34-36 weeks). There were no significant associations between maternal allergic features and PPROM. CONCLUSION: Maternal allergic disease, except atopic dermatitis, may increase the risk of TPL. Comorbidity of maternal allergic disorders and perinatal adverse outcomes require further investigation.

Use of antipyretics for preventing febrile seizure recurrence in children: a systematic review and meta-analysis.

The efficacy of antipyretics for preventing febrile seizure recurrence has been reported by a recent study, and the results might overturn previous evidence. We systematically reviewed the efficacy of antipyretics in the prevention of febrile seizure recurrence in children focused on the timing of its administration. We searched the Medline, Embase, and Cochrane Central Register of Controlled Trials databases for randomized and quasi-randomized trials and prospective non-randomized studies of aged up to 60 months, diagnosed with febrile seizure, who were treated with antipyretics. Data were extracted from eight studies. Only one study reported that antipyretics prevented the recurrence of febrile seizures within the same fever episode (9.1% in the acetaminophen group vs. 23.5% in the control group, p < 0.01). Four studies found no evidence for the efficacy of antipyretics in preventing febrile seizure recurrence in distant fever episodes (odds ratio, 0.92; 95% confidence interval, 0.57-1.48, for two randomized controlled studies).Conclusion: This review provides very limited support for the use of antipyretics in preventing febrile seizure recurrence within the same fever episode and no evidence for its use in distant fever episodes. New studies are required to evaluate this topic further and determine whether the effectiveness of antipyretics is based on intervention timing. What is Known: • Reviews of prophylactic drug management among febrile seizure children found that antipyretics had no significant benefits. • Recent data suggest that antipyretics are effective in preventing febrile seizures. What is New: • Weak evidence suggests a possible role in preventing febrile seizure recurrence within the same fever episode. • There is clearly no role for antipyretic prophylaxis in preventing febrile seizures during distant fever episodes.

25-Hydroxyvitamin D levels among 2-year-old children: findings from the Japan environment and Children's study (JECS).

BACKGROUND: The study aim was to obtain epidemiological data on vitamin D levels for the pediatric population in Japan. We assessed the prevalence of vitamin D deficiency and insufficiency in 2-year-old Japanese children using data from a large ongoing birth cohort study. METHODS: Data for analysis was obtained from the Japan Environment and Children's Study (JECS) and a Sub-Cohort Study (SCS) of JECS. We evaluated the children's serum 25(OH) D levels by 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles, and the rates of vitamin D deficiency or insufficiency. We also presented a weighted prevalence rate for vitamin D deficiency or insufficiency among all children in JECS. RESULTS: After excluding children with missing 25(OH)D2 or 25(OH)D3 data, we analyzed 4655 remaining children, of whom 24.7% (95% CI, 23.5-26.0%) had vitamin D deficiency (< 20 ng/mL), and 51.3% (95% CI, 49.8-52.7%) were at risk of vitamin D insufficiency (20-30 ng/mL). The estimated prevalence of vitamin D deficiency and insufficiency among all children in JECS were 25.4% (95% CI, 24.1-26.7%) and 50.9% (95% CI, 49.4-52.4%). Vitamin D deficiency was found in 22.9% of boys and 26.5% of girls. Median serum 25(OH) D concentrations were lower among participants measured during winter and spring than among those measured in summer and autumn. The highest rate of vitamin D deficiency was observed in Hokkaido, the northernmost prefecture of Japan. CONCLUSION: We analyzed data on serum 25(OH) D levels from a birth cohort study and found that vitamin D deficiency and insufficiency are very common among 2-year-old Japanese children. Sex, season, and latitude affect serum 25(OH) D concentrations.

Cumulative inactivated vaccine exposure and allergy development among children: a birth cohort from Japan.

BACKGROUND: Adjuvants used in inactivated vaccines often upregulate type 2 immunity, which is dominant in allergic diseases. We hypothesised that cumulative adjuvant exposure in infancy may influence the development of allergies later in life by changing the balance of type 1/type 2 immunity. We examined the relationship between immunisation with different vaccine types and later allergic disease development. METHODS: We obtained information regarding vaccinations and allergic diseases through questionnaires that were used in The Japan Environment and Children's Study (JECS), which is a nationwide, multicentre, prospective birth cohort study that included 103,099 pregnant women and their children. We examined potential associations between the initial vaccination before 6 months of age and symptoms related to allergies at 12 months of age. RESULTS: Our statistical analyses included 56,277 children. Physician-diagnosed asthma was associated with receiving three (aOR 1.395, 95% CI 1.028-1.893) or four to five different inactivated vaccines (aOR 1.544, 95% CI 1.149-2.075), compared with children who received only one inactivated vaccine. Similar results were found for two questionnaire-based symptoms, i.e. wheeze (aOR 1.238, 95% CI 1.094-1.401; three vaccines vs. a single vaccine) and eczema (aOR 1.144, 95% CI 1.007-1.299; four or five vaccines vs. a single vaccine). CONCLUSIONS: Our results, which should be cautiously interpreted, suggest that the prevalence of asthma, wheeze and eczema among children at 12 months of age might be related to the amount of inactivated vaccine exposure before 6 months of age. Future work should assess if this association is due to cumulative adjuvant exposure. Despite this possible association, we strongly support the global vaccination strategy and recommend that immunisations continue. TRIAL REGISTRATION: UMIN000030786 .

Assessing health-related quality of life in Japanese children with a chronic condition: validation of the DISABKIDS chronic generic module.

BACKGROUND: This study examined the reliability and validity of the Japanese versions of the DISABKIDS-37 generic modules, a tool for assessing the health-related quality of life (HRQOL) of children and adolescents with a chronic condition. METHODS: The study was conducted using a sample of 123 children/adolescents with a chronic medical condition, aged 8-18 years, and their parents. Focus interviews were performed to ensure content validity after translation. The classical psychometric tests were used to assess reliability and scale intercorrelations. The factor structure was examined with confirmatory factor analysis (CFA). Convergent validity was assessed by the correlation between the total score and the sub-scales of DISABKIDS-37 as well as the total score of KIDSCREEN-10. RESULTS: Both the children/adolescent and parent versions of the score showed good to high internal consistency, and the test-retest reliability correlations were r = 0.91 or above. The CFA revealed that the modified models for all domains were better fit than the original 37 item scale model for both self-report and proxy-report. Moderate to high positive correlations were found for the associations within DISABKIDS-37 sub-scales and between the subscales and total score, except for the treatment sub-scale, which correlated weakly with the remaining sub-scales. The total score of the child-reported version of KIDSCREEN-10 correlated significantly and positively with the total score and all the sub-scales of the child-reported version of DISABKIDS-37 except the Treatment sub-scale in adolescents. CONCLUSIONS: The modified models of Japanese version of DISABKIDS generic module were psychometrically robust enough to assess the HRQOL of children with a chronic condition.

Leukotriene receptor antagonists for eczema.

BACKGROUND: Eczema is a common, chronic, inflammatory skin condition that is frequently associated with atopic conditions, including asthma. Leukotriene receptor antagonists (LTRAs) have a corticosteroid-sparing role in asthma, but their role in eczema remains controversial. Currently available topical therapies for eczema are often poorly tolerated, and use of systemic agents is restricted by their adverse effect profile. A review of alternative treatments was therefore warranted. OBJECTIVES: To assess the possible benefits and harms of leukotriene receptor antagonists for eczema. SEARCH METHODS: We searched the following databases to September 2017: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and the GREAT database. We also searched five trial registries, and handsearched the bibliographies of all extracted studies for further relevant trials. SELECTION CRITERIA: Randomised controlled trials of LTRAs alone or in combination with other (topical or systemic) treatments compared with other treatments alone such as topical corticosteroids or placebo for eczema in the acute or chronic (maintenance) phase of eczema in adults and children. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. The primary outcome measures were change in disease severity, long-term symptom control, and adverse effects of treatment. Secondary outcomes were change in corticosteroid requirement, reduction of pruritis, quality of life, and emollient requirement. We used GRADE to assess the quality of the evidence for each outcome. MAIN RESULTS: Only five studies (including a total of 202 participants) met the inclusion criteria, all of which assessed oral montelukast; hence, we found no studies assessing other LTRAs. Treatment ranged from four to eight weeks, and outcomes were assessed at the end of treatment; therefore, we could only report short-term measurements (defined as less than three months follow-up from baseline). Montelukast dosing was 10 mg for adults (age 14 years and above) and 5 mg for children (age 6 years to 14 years). One study included children (aged 6 years and above) among their participants, while the remaining studies only included adults (participant age ranged from 16 to 70 years). The participants were diagnosed with moderate-to-severe eczema in four studies and moderate eczema in one study. The study setting was unclear in two studies, multicentre in two studies, and single centre in one study; the studies were conducted in Europe and Bangladesh. Two studies were industry funded. The comparator was placebo in three studies and conventional treatment in two studies. The conventional treatment comparator was a combination of antihistamines and topical corticosteroids (plus oral antibiotics in one study).Four of the studies did not adequately describe their randomisation or allocation concealment method and were considered as at unclear risk of selection bias. Only one study was at low risk of performance and detection bias. However, we judged all studies to be at low risk of attrition and reporting bias.We found no evidence of a difference in disease severity of moderate-to-severe eczema after short-term use of montelukast (10 mg) when compared with placebo. The outcome was assessed using the modified EASI (Eczema Area and Severity Index) score and SASSAD (Six Area, Six Sign Atopic Dermatitis) severity score (standardised mean difference 0.29, with a positive score showing montelukast is favoured, 95% confidence interval (CI) -0.23 to 0.81; 3 studies; n = 131; low-quality evidence).When short-term montelukast (10 mg) treatment was compared with conventional treatment in one study, the mean improvement in severity of moderate-to-severe eczema was greater in the intervention group (measured using SCORAD (SCORing of Atopic Dermatitis) severity index) (mean difference 10.57, 95% CI 4.58 to 16.56; n = 31); however, another study of 32 participants found no significant difference between groups using the same measure (mean improvement was 25.2 points with montelukast versus 23.9 points with conventional treatment; no further numerical data provided). We judged the quality of the evidence as very low for this outcome, meaning the results are uncertain.All studies reported their adverse event rate during treatment. Four studies (136 participants) reported no adverse events. In one study of 58 participants with moderate eczema who received montelukast 10 mg (compared with placebo), there was one case of septicaemia and one case of dizziness reported in the intervention group, both resulting in study withdrawal, although whether these effects were related to the medication is unclear. Mild side effects (e.g. headache and mild gastrointestinal disturbances) were also noted, but these were fairly evenly distributed between the montelukast and placebo groups. The quality of evidence for this outcome was low.No studies specifically evaluated emollient requirement or quality of life. One study that administered treatment for eight weeks specifically evaluated pruritus improvement at the end treatment and topical corticosteroid use during treatment. We found no evidence of a difference between montelukast (10 mg) and placebo for both outcomes (low-quality evidence, n = 58). No other study assessed these outcomes. AUTHORS' CONCLUSIONS: The findings of this review are limited to montelukast. There was a lack of evidence addressing the review question, and the quality of the available evidence for most of the measured outcomes was low. Some primary and secondary outcomes were not addressed at all, including long-term control.We found no evidence of a difference between montelukast (10 mg) and placebo on disease severity, pruritus improvement, and topical corticosteroid use. Very low-quality evidence means we are uncertain of the effect of montelukast (10 mg) compared with conventional treatment on disease severity. Participants in only one study reported adverse events, which were mainly mild (low-quality evidence).There is no evidence that LTRA is an effective treatment for eczema. Serious limitations were that all studies focused on montelukast and only included people with moderate-to-severe eczema, who were mainly adults; and that each outcome was evaluated with a small sample size, if at all.Further large randomised controlled trials, with a longer treatment duration, of adults and children who have eczema of all severities may help to evaluate the effect of all types of LTRA, especially on eczema maintenance.

Assessment and support during early labour for improving birth outcomes.

BACKGROUND: The progress of labour in the early or latent phase is usually slow and may include painful uterine contractions. Women may feel distressed and lose their confidence during this phase. Support and assessment interventions have been assessed in two previous Cochrane Reviews. This review updates and replaces these two reviews, which have become out of date. OBJECTIVES: To investigate the effectiveness of assessment and support interventions for women during early labour.In order to measure the effectiveness of the interventions, we compared the duration of labour, the rate of obstetrical interventions, and the rate of other maternal or neonatal outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (31 October 2016) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials of any assessment or support intervention in the latent phase of labour. We planned to include cluster-randomised trials if they were eligible. We did not include quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We resolved any disagreement by discussion or by involving a third assessor. The quality of the evidence was assessed using the GRADE approach. MAIN RESULTS: We included five trials with a total of 10,421 pregnant women in this review update. The trials were conducted in the UK, Canada and America. The trials compared interventions in early labour versus usual care. We examined three comparisons: early labour assessment versus immediate admission to hospital; home visits by midwives versus usual care (telephone triage); and one-to-one structured midwifery care versus usual care. These trials were at moderate- risk of bias mainly because blinding women and staff to these interventions is not generally feasible. For important outcomes we assessed evidence using GRADE; we downgraded evidence for study design limitations, imprecision, and where we carried out meta-analysis, for inconsistency.One trial with 209 women compared early labour assessment with direct admission to hospital. Duration of labour from the point of hospital admission was reduced for women in the assessment group (mean difference (MD) -5.20 hours, 95% confidence interval (CI) -7.06 to -3.34; 209 women, low-quality evidence). There were no clear differences between groups for the number of women undergoing caesarean section or instrumental vaginal birth (risk ratio (RR) 0.72, 95% CI 0.30 to 1.72, very low quality evidence; and, RR 0.86, 95% CI 0.58 to 1.26, very low quality evidence, respectively). Serious maternal morbidity was not reported. Women in the early assessment group were slightly less likely to have epidural anaesthesia (RR 0.87, 95% CI 0.78 to 0.98, low-quality evidence), and considerably less likely to have oxytocin for labour augmentation (RR 0.57, 95% CI 0.37 to 0.86) and this group also had increased satisfaction with their care compared with women in the immediate admission group (MD 16.00, 95% CI 7.53 to 24.47). No babies were born before admission to hospital and only one infant had a low Apgar score at five minutes after the birth (very low quality evidence). Admission to neonatal special care was not reported.Three studies examined home assessment and midwifery support versus telephone triage. One trial reported the duration of labour; home visits did not appear to have any clear impact compared with usual care (MD 0.29 hours, 95% CI -0.14 to 0.72; 1 trial, 3474 women, low-quality evidence). There was no clear difference for the rate of caesarean section (RR 1.05, 95% CI 0.95 to 1.17; 3 trials, 5170 women; I² = 0%; moderate-quality evidence) or the rate of instrumental vaginal birth (average RR 0.95, 95% CI 0.79 to 1.15; 2 trials, 4933 women; I² = 69%; low-quality evidence). One trial reported birth before arrival at hospital or unplanned home birth; there was no clear difference between the groups (RR 1.33, 95% CI 0.30 to 5.95; 1 trial, 3474 women). No clear differences were identified for serious maternal morbidity (RR 0.93, 95% CI 0.61 to 1.42; 1 trial, 3474 women; low-quality evidence), or use of epidural (average RR 0.95, 95% CI 0.87 to 1.05; 3 trials, 5168 women; I² = 60%; low-quality evidence). There were no clear differences for neonatal admission to special care (average RR 0.84, 95% CI 0.50 to 1.42; 3 trials, 5170 infants; I² = 71%; very low quality evidence), or for Apgar score less than seven at five minutes after birth (RR 1.19, 95% CI 0.71 to 1.99; 3 trials, 5170 infants; I² = 0%; low-quality evidence).One study, with 5002 women, examined one-to-one structured care in early labour versus usual care. Length of labour was not reported. There were no clear differences between groups for the rate of caesarean section (RR 0.93, 95% CI 0.84 to 1.02; 4996 women, high-quality evidence), or for instrumental vaginal birth (RR 0.94, 95% CI 0.82 to 1.08; 4996 women, high-quality evidence). No clear differences between groups were reported for serious maternal morbidity (RR 1.13, 95% CI 0.84 to 1.52; 4996 women, moderate-quality evidence). Use of epidural was similar in the two groups (RR 1.00, 95% CI 0.99 to 1.01; 4996 women, high-quality evidence). For infant outcomes, there were no clear differences between groups (admission to neonatal intensive care unit: RR 0.98, 95% CI 0.80 to 1.21; 4989 infants, high-quality evidence; Apgar score less than seven at five minutes: RR 1.07, 95% CI 0.64 to 1.79; 4989 infants, moderate-quality evidence). AUTHORS' CONCLUSIONS: Assessment and support in early labour does not have a clear impact on rate of caesarean section or instrumental vaginal birth, or whether the baby was born before arrival at hospital or in an unplanned home birth. However, evidence suggested that interventions may have an impact on reducing the use of epidural anaesthesia, labour augmentation and on increasing maternal satisfaction with giving birth. Evidence about the effectiveness of early labour assessment versus immediate admission was very limited and more research is needed in this area.

Assessing health-related quality of life in young Japanese children with chronic conditions: Preliminary validation of the DISABKIDS smiley measure.

BACKGROUND: Although there is an increasing need to investigate the health-related quality of life (HRQOL) of children and adolescents with chronic conditions in Japan, there is currently no standardized measure in which young children can directly answer questions about their HRQOL. The DISABKIDS Smiley measure uses face emoticons to measure HRQOL and distress caused by illness and related treatments among young children. We tested the reliability and validity of the DISABKIDS Smiley measure in a sample of young Japanese children. METHODS: After translating the child and parent questionnaires into Japanese, a pre-test was performed to test the content validity in accordance with guidelines from the DISABKIDS Group. In total, 60 child-parent pairs were recruited to participate in the survey. We measured internal consistency of the scales using Cronbach's alpha as well as Guttman split-half, test-retest reliability using intraclass correlation coefficients (ICCs) at a two-week interval, and ICCs between child- and parent-reported scores. Convergent validity of the scale was also examined against the Kiddy-KINDL scale. RESULTS: Both child-reported and parent-reported scales showed good internal consistency and split-half reliability. Test-retest reliability of the child-reported version (ICC = 0.53, p = 0.004) was lower than that of the parent-reported version (ICC = 0.80, p < 0.001). Moderate to good agreement between child- and parent- reported scales was observed in both the first (ICC = 0.75, p < 0.001) and second administration (ICC = 0.71, p < 0.001). Moderate to very strong positive correlations were observed with the total score of the Kiddy-KINDL child-reported version (r = 0.51, p < 0.001), and facets of the Kiddy-KINDL parent-reported version (ranging from r = 0.364 to r = 0.60, p < 0.001) and total score (r = 0.71, p < 0.001). CONCLUSIONS: The psychometric property of the instrument showed that the Japanese version of the DISABKIDS Smiley can be applied to assess the HRQOL of Japanese children with chronic conditions. Further investigation will be needed to explore the reliability and validity for repeated use of the instrument in clinical practice as an indicator of clinical significance.

Assessing archetypes of organizational culture based on the Competing Values Framework: the experimental use of the framework in Japanese neonatal intensive care units.

OBJECTIVE: To assess organizational culture in neonatal intensive care units (NICUs) in Japan. DESIGN: Cross-sectional survey of organizational culture. SETTING: Forty NICUs across Japan. PARTICIPANTS: Physicians and nurses who worked in NICUs (n = 2006). MAIN OUTCOME MEASURES: The Competing Values Framework (CVF) was used to assess the organizational culture of the study population. The 20-item CVF was divided into four culture archetypes: Group, Developmental, Hierarchical and Rational. We calculated geometric means (gmean) and 95% bootstrap confidence intervals of the individual dimensions by unit and occupation. The median number of staff, beds, physicians' work hours and work engagement were also calculated to examine the differences by culture archetypes. RESULTS: Group (gmean = 34.6) and Hierarchical (gmean = 31.7) culture archetypes were higher than Developmental (gmean = 16.3) and Rational (gmean = 17.4) among physicians as a whole. Hierarchical (gmean = 36.3) was the highest followed by Group (gmean = 25.8), Developmental (gmean = 16.3) and Rational (gmean = 21.7) among nurses as a whole. Units with dominant Hierarchical culture had a slightly higher number of physicians (median = 7) than dominant Group culture (median = 6). Units with dominant Group culture had a higher number of beds (median = 12) than dominant Hierarchical culture (median = 9) among physicians. Nurses from units with a dominant Group culture (median = 2.8) had slightly higher work engagement compared with those in units with a dominant Hierarchical culture (median = 2.6). CONCLUSIONS: Our findings revealed that organizational culture in NICUs varies depending on occupation and group size. Group and Hierarchical cultures predominated in Japanese NICUs. Assessing organizational culture will provide insights into the perceptions of unit values to improve quality of care.

A scoping review of palliative care for children in low- and middle-income countries.

BACKGROUND: Ninety-eight percent of children needing palliative care live in low- and middle-income countries (LMICs), and almost half of them live in Africa. In contrast to the abundance of data on populations in high income countries, the current data on populations in LMICs is woefully inadequate. This study aims to identify and summarize the published literature on the need, accessibility, quality, and models for palliative care for children in LMICs. METHODS: A scoping review was performed following the method of Arksey and O'Malley. Systematic searches were conducted on PubMed and Google Scholar using the main keywords, 'children AND palliative care OR terminal care OR hospice OR end of life AND developing countries OR LMICs.' Additional publications were obtained by handsearching. Papers were only included if they reported on the need, accessibility, quality, and models for palliative care for children in LMICs. RESULTS: Fifteen papers met the inclusion criteria for review. Of these, 10 assessed need, seven examined availability and/or accessibility, one assessed quality, and one examined the models. We found an urgent need for palliative care, particularly in the training for health workers and improving poor availability and/or accessibility to palliative care in terms of factors such as medication and bereavement support. The best practice models demonstrated feasibility and sustainability through cooperation with governments and community organizations. The quality of pain management and emotional support was lower in LMICs compared to HICs. CONCLUSION: Although we found limited evidence in this review, we identified common challenges such as the need for further training for health workers and greater availability of opioid analgesics. While efforts to change the current systems and laws applying to children in LMICs are important, we should also tackle underlying factors including the need to raise awareness about palliative care in public health and improve the accuracy of data collection.

Needs assessment for collaborative network in pediatric clinical research and education.

BACKGROUND: A collaborative network for pediatric research has not been fully established in Japan. To identify the network infrastructure, we conducted a survey on the support and education for clinical research currently available in children's hospitals. METHODS: In November 2014, a 27-question survey was distributed to 31 hospitals belonging to the Japanese Association of Children's Hospitals and Related Institutions (JACHRI) to assess clinical research support, research education, research achievements, and their expectations. RESULTS: All the hospitals responded to the survey. Overall, 74.2% of hospitals had clinical research support divisions. Although all hospitals had ethics committees, <30% of the hospitals had a data manager, intellectual property management unit, biostatistician, and English-language editor. Seven hospitals had education programs for clinical research. The number of seminars and workshops for clinical research had significant correlations with the number of physicians (r = 0.927), pediatricians (r = 0.922), and clinical trial management physicians (r = 0.962). There was a significant difference in the number of clinical trials initiated by physicians between hospitals with research education programs and those without (P < 0.01). The number of education programs was significantly correlated with the number of original articles and case reports in English (r = 0.788), and the number of publications in Japanese (r = 0.648). All hospitals recognized the need for a leader to establish a collaborative network for clinical research. CONCLUSIONS: Important factors for creating a collaborative system for pediatric research in Japan were identified. Human resources to support clinical research are a key factor to improve clinical research education and research achievements.

Impact of comprehensive quality improvement program on outcomes in very-low-birth-weight infants: A cluster-randomized controlled trial in Japan.

BACKGROUND: Differences in outcomes among neonatal intensive care units (NICUs) in Japan have been noted, prompting the need for quality improvement. AIM: To assess a comprehensive quality improvement program on outcomes in very-low-birth-weight (VLBW) infants. STUDY DESIGN: A cluster-randomized clinical trial. SUBJECTS: Forty hospitals and VLBW infants born in 2012-2014 and admitted to those hospitals were study subjects. OUTCOME MEASURES: The intervention group (IG) received a comprehensive quality improvement program involving clinical practice guidelines, educational outreach visits, workshops, opinion leader training, audits, and feedback. The control group (CG) was provided only with the guidelines. The primary outcome was survival without neurological impairment at three years of age. RESULTS: IG consisted of 19 hospitals and 1735 infants, while CG included 21 hospitals and 1700 infants. There were no significant differences in gestational weeks, 29.1(26.9-31.3) vs. 29.1(26.7-31.1) or birth weights (g), 1054(789-1298) vs. 1084(810-1309) between the two groups. Both groups showed survival rates without neurological impairment of 67.2 % (1166) and 66.9 % (1137), respectively, without a significant difference. There was no significant difference in mortalities at NICU discharge between the groups, with rates of 4.0 % (70) and 4.2 % (72) respectively. Several clinically relevant improvements were observed in IG, including reduced rates of sepsis, adrenal insufficiency, transfusion for anemia, and a shorter interval to achieve full enteral feeding. However, these did not lead to improvements in the primary outcome. CONCLUSION: The comprehensive quality improvement program to Japanese NICUs did not result in a significant improvement in survival without neurological impairment in VLBW infants.

Methods for administering subcutaneous heparin during pregnancy.

BACKGROUND: Pregnant women with a history of venous thromboembolism (VTE), antithrombin deficiency, or other risk factors for VTE, need heparin (unfractionated heparin (UFH) or low-molecular weight heparin (LMWH)) prophylaxis, mainly through administering subcutaneously. Several methods of administering heparin (UFH or LMWH) subcutaneously have been introduced to prevent adverse pregnant outcomes. The effectiveness and safety of different methods administering subcutaneous heparin (UFH or LMWH) during pregnancy have not been systematically evaluated. OBJECTIVES: To compare the effectiveness and safety of different methods of administering subcutaneous heparin (UFH or LMWH) to pregnant women. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2013) and reference lists of retrieved studies. SELECTION CRITERIA: All randomised controlled trials (individual and cluster) comparing the effectiveness and safety of different methods of administering subcutaneous heparin (UFH or LMWH) during pregnancy. Studies reported only as abstracts were eligible for inclusion and would have been placed in studies awaiting assessment, pending the full publication of their results. Quasi-randomised studies and cross-over trials were not eligible for inclusion..Methods of administering subcutaneous heparin include intermittent injections versus indwelling catheters or programmable (auto) external infusion pumps, or any other devices to facilitate the subcutaneous administration of heparin (UFH or LMWH) during pregnancy. DATA COLLECTION AND ANALYSIS: If eligible trials had been identified, trial quality would have been assessed and data extracted, unblinded by review authors independently. MAIN RESULTS: No trials met the inclusion criteria for the review. AUTHORS' CONCLUSIONS: There is no evidence from randomised controlled trials to evaluate the effectiveness and safety of different methods of administering subcutaneous heparin (UFH or LMWH) to pregnant women.

Hydrochlorothiazide increases risk of nonmelanoma skin cancer in an elderly Japanese cohort with hypertension: The Shizuoka study.

Background: Hydrochlorothiazide (HCT), a widely used hypertensive drug, has photocarcinogenic potential, leading to concerns about the development of nonmelanoma skin cancers (SCs) after intake. Despite substantial numbers of observational studies, the results remain inconsistent especially among Asian countries. Objective: To assess the incidence of nonmelanoma SCs in hypertensive Japanese HCT users compared with nonusers. Methods: A population-based, cohort nested, propensity score-matched study was conducted using the Shizuoka Kokuho database. All participants were patients aged ≥60 years. Hazard ratios for SC incidence were calculated in the matched cohorts using the propensity scores of potential confounders, sex, age category, comorbidities, and administration of methotrexate, cyclosporin, and statins. Results: The risk of SC was higher in HCT users than in nonusers (hazard ratio, 1.58; 95% confidence interval, 1.04-2.40), with preferential sun-exposed location and a tendency to develop squamous cell carcinoma, but not basal cell carcinoma or Bowen disease. Limitations: No additional information was available from other than medical records. The data were confined to a Japanese population. Conclusion: HCT use increases the risk of SC in Japanese patients with hypertension and a dark skin type, highlighting the increased risk of SC among HCT users in the aging society worldwide.

Identification of subgroups within a Japanese older adult population for whom statin therapy is effective in reducing mortality.

Use of statins for primary prevention can reduce all-cause mortality in Asian elderly populations, but their effect and the specific effective subgroups in the elderly Japanese population remain unclear. This study examined the relationship between statin therapy for primary prevention and mortality reduction in older Japanese adults, and investigated the effective subgroups. The cohort study was conducted using the Shizuoka Kokuho Database (SKDB). Data were compared between the statin-treated group and a non-statin-treated (control) group using the inverse probability of treatment weighting (IPTW) method. In the SKDB cohort aged ≥65 years, new statin use was associated with a decreased risk of all-cause mortality (hazard ratio, 0.40; 95% confidence interval [CI], 0.33-0.48) after IPTW adjustment. The risk difference for mortality at 5 years in the statin-treated group compared with that in the control group was 0.05 (95% CI, 0.04-0.06), and the number needed to treat was 21.20 (95% CI, 18.10-24.70). In conclusion, statin use for primary prevention in older adults may reduce the risk of all-cause mortality in the population without atherosclerotic disease. Furthermore, statin use for primary prevention is feasible in patients aged 75 to <85 years and in patients with comorbidities such as diabetes, or dementia.