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1.
Pediatr Int ; 65(1): e15703, 2023.
Article in English | MEDLINE | ID: mdl-38088499

ABSTRACT

BACKGROUND: The number of children with medical complexity (CMC) is increasing worldwide. For these children and their families, various forms of support are legislated; among them, short-stay respite care has a great unmet need. We examined such children's parents' preferences for respite care and their willingness to pay. METHODS: We used discrete choice experiments (DCEs) to estimate the parents' preferences and willingness to pay. Parents whose children used overnight short-stay respite services answered a questionnaire to compare two hypothetical facilities of respite care having seven attributes and three levels. The DCE data was analyzed using the conditional logit model. The willingness to pay was calculated based on DCE estimates. RESULTS: A total of 70 parents participated in this study and mean age of their children was 7.8 years (standard deviation [SD] 4.3). Among those children, 67 (96%) had the severest certification of disability, and 27 (38%) used a ventilator at home. We found that the parents' highest preferences was the best level of medical care level that can manage ventilators (coefficient 1.61, 95% confidence interval [CI]: 1.32-1.90). The better and best level of medical care, daily care, education/nursing, and emergency care were preferred over basic quality services. Willingness to pay for the best level of medical care was approximately 75,367 JPY per night. CONCLUSION: This study shows a need for respite care that can deliver high-level medical care, especially for the management of ventilators, to CMC. This finding can serve as a basis for promoting respite care services.


Subject(s)
Home Care Services , Respite Care , Child , Humans , Parents , Surveys and Questionnaires , Logistic Models
2.
Soc Psychiatry Psychiatr Epidemiol ; 57(4): 791-803, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34595562

ABSTRACT

PURPOSE: Lifestyle factors of children and adolescents' mental health problems are an emerging health issue in low- and middle-income countries (LMICs). However, there is a lack of studies on lifestyle factors in LMICs. This study examined the socioeconomic and lifestyle factors associated with mental health problems among school-age children in Mongolia. METHODS: A population-based cross-sectional survey was conducted among 4th-year students at public elementary schools in one district in Ulaanbaatar. The Strengths and Difficulties Questionnaire (SDQ) and a self-administrated socioeconomic and lifestyle questionnaire were completed by participants' guardians. A multivariate logistic regression analysis was performed. RESULTS: Of the 2301 children surveyed, 1694 without missing responses were included in the analysis. The multivariate logistic regression analysis showed that male gender [adjusted odds ratio (AOR) 1.64 (1.29-2.10)], low maternal education [AOR 1.89 (1.16-3.05)], short sleep [AOR 1.41 (1.10-1.80)], no physical activity [AOR 1.31 (1.03-1.67)], and long screen time (AOR 1.53 (1.20-1.94)) were associated with high risk of mental health problems. Low maternal education, low household income, no physical activity habit, and long screen time were associated with internalising problems. Meanwhile, male gender, low maternal education, and long screen time were associated with externalising problems. CONCLUSION: The results are consistent with previous studies in high-income countries, indicating that there are globally common socioeconomic and lifestyle risk factors. The findings of this study may help develop a targeted preventive intervention for high-risk groups, such as socioeconomically disadvantaged groups, as well as a universal preventive intervention to foster a healthy lifestyle in Mongolia.


Subject(s)
Mental Health , Schools , Adolescent , Child , Cross-Sectional Studies , Humans , Life Style , Male , Poverty , Socioeconomic Factors , Surveys and Questionnaires
3.
Popul Health Metr ; 19(1): 21, 2021 04 23.
Article in English | MEDLINE | ID: mdl-33892742

ABSTRACT

BACKGROUND: Disability weights (DWs) are weight factors that reflect the severity of health states for estimates of disability-adjusted life years. A new set of global DWs was published for the Global Burden of Diseases and Injuries (GBD) 2013 study, which relied on sampling from various world regions, but included little data for countries in East Asia. This study aimed to measure DWs in Japan using comparable methods, and compare the results with previous estimates from the GBD 2013 DW study. METHODS: We conducted a web-based survey in 2019 to estimate DWs for 231 health states for the Japanese population. The survey included five new health states but otherwise followed the method of the GBD DW measurement study. The survey consisted of 15 paired comparison (PC) questions and 3 population health equivalence questions (PHE) per respondent. We analyzed PC data using probit regression and rescaled results to DW units between 0 (equivalent to full health) and 1 (equivalent to death). FINDINGS: We considered 37,318 nationally representative respondents. The values of the resulting DWs ranged from 0.707 (95% uncertainty interval (UI) 0.527-0.842) for spinal cord injury at neck level (untreated) to 0.004 (UI 0.001-0.009) for mild anemia. High correlation between Japanese DW and GBD 2013 DW was observed, but there was considerable disagreement. Out of 226 comparable health states, 55 (24.3%) showed more than a factor-of-two difference, of which 41 (74.6%) had a higher value in Japanese DW. Many of the health states with higher DW in the Japan study were injuries, including amputation and fracture, and hearing and vision loss, while mental, behavioral, and substance use disorders generally tended to be lower. CONCLUSIONS: This study has created an empirical basis for assessment of Japanese DWs of health status. The findings from this study based on the Japanese population suggest that there might be contextual differences in rating the severity of health states compared to previous surveys conducted elsewhere.


Subject(s)
Disabled Persons , Global Burden of Disease , Health Status , Humans , Japan/epidemiology , Quality-Adjusted Life Years , Surveys and Questionnaires
4.
J Epidemiol ; 31(3): 220-230, 2021 Mar 05.
Article in English | MEDLINE | ID: mdl-32448822

ABSTRACT

BACKGROUND: This study aims to find evidence of the cost-effectiveness of gestational diabetes mellitus (GDM) screening and assess the quality of current economic evaluations, which have shown different conclusions with a variation in screening methods, data sources, outcome indicators, and implementation in diverse organizational contexts. METHODS: Embase, Medline, Web of Science, Health Technology Assessment, database, and National Health Service Economic Evaluation Database databases were searched through June 2019. Studies on economic evaluation reporting both cost and health outcomes of GDM screening programs in English language were selected, and the quality of the studies was assessed using Drummond's checklist. The general characteristics, main assumptions, and results of the economic evaluations were summarized. RESULTS: Our search yielded 10 eligible economic evaluations with different screening strategies compared in different settings and perspectives. The selected papers scored 81% (68-97%) on the items in Drummond's checklist on average. In general, a screening program is cost-effective or even dominant over no screening. The one-step screening, with more cases detected, is more likely to be cost-effective than the two-step screening. Universal screening is more likely to be cost-effective than screening targeting the high-risk population. Parameters affecting cost-effectiveness include: diagnosis criteria, epidemiological characteristics of the population, efficacy of screening and treatment, and costs. CONCLUSIONS: Most studies found GDM screening to be cost-effective, though uncertainties remain due to many factors. The quality assessment identified weaknesses in the economic evaluations in terms of integrating existing data, measuring costs and consequences, analyzing perspectives, and adjusting for uncertainties.


Subject(s)
Cost-Benefit Analysis/methods , Diabetes, Gestational/diagnosis , Diabetes, Gestational/prevention & control , Mass Screening/economics , Diabetes, Gestational/economics , Female , Humans , Mass Screening/methods , Pregnancy
5.
BMC Psychiatry ; 21(1): 218, 2021 04 29.
Article in English | MEDLINE | ID: mdl-33926396

ABSTRACT

BACKGROUND: Child and adolescent mental health problems are urgent health issues in low- and middle-income countries. To promote child and adolescent mental health services, simple validated screening tools are helpful. In Mongolia, the Strengths and Difficulties Questionnaire (SDQ), an internationally used child and adolescent mental health screening tool for children aged 4-17, was translated but not yet validated. To use the questionnaire appropriately, validation is necessary. METHODS: Children at 4th year at elementary school (community sample) and children visited psychiatric outpatient service (clinical sample) were recruited and their parental version of the SDQ was compared. The discriminating ability of the parental version of the SDQ was examined using Receiver Operating Characteristics (ROC) analysis on the SDQ total difficulties score. The area under the ROC curve (AUC) was used as a measure. Cut-off score was determined by normative banding that categorizes children with the highest 10% score range as abnormal and the second highest 10% as borderline following the original method; this cut-off score was compared with the cut-off score candidates with good balance between sensitivity and specificity using ROC analysis. RESULTS: We included 2301 children in the community sample, and 429 children in the clinical sample. Mean age was 9.7 years (SD 0.4, range 8.3-12.0) among the community sample and 10.4 years (SD 3.8, range 4.0-17.8) among the clinical sample. The mean total difficulties score was 12.9 (SD 4.8) among the community sample and 20.4 (SD 6.2) among the clinical sample. A total of 88.8% of the community sample and 98.8% of the clinical sample answered the SDQ. Using ROC analysis, the AUC was 0.82 (95% confident interval 0.80-0.85), which meant moderate discriminating ability. Using normative banding, the borderline cut-off score was 16/17 and abnormal cut-off score was 19/20. For cut-off scores of 16/17 and 19/20, sensitivity was 71.9 and 53.8% and specificity was 78.5 and 90.5%, respectively. The cut-off score candidates by ROC analysis were 16/17 and 17/18. CONCLUSIONS: The parental version of the SDQ had moderate discriminating ability among Mongolian school-age children. For the screening of mental health problems among community children, cut-off score of 16/17 is recommended.


Subject(s)
Mental Disorders , Mental Health , Adolescent , Child , Child, Preschool , Humans , Mental Disorders/diagnosis , Mongolia , Parents , Psychometrics , Reproducibility of Results , Schools , Surveys and Questionnaires
6.
Cochrane Database Syst Rev ; 7: CD009326, 2021 07 21.
Article in English | MEDLINE | ID: mdl-34286512

ABSTRACT

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.


Subject(s)
House Calls , Postnatal Care/organization & administration , Bias , Breast Feeding/statistics & numerical data , Depression, Postpartum/epidemiology , Female , Health Services Needs and Demand/statistics & numerical data , House Calls/statistics & numerical data , Humans , Infant , Infant Mortality , Infant, Newborn , Maternal Mortality , Patient Satisfaction , Perinatal Mortality , Postnatal Care/statistics & numerical data , Postpartum Period , Randomized Controlled Trials as Topic , Time Factors
7.
Pediatr Int ; 63(1): 94-101, 2021 Jan.
Article in English | MEDLINE | ID: mdl-32567109

ABSTRACT

BACKGROUND: Life expectancy in Japan has increased dramatically and is one of the longest in the world. However, the changes in lifespan in Japanese individuals with congenital diseases remain unknown. We investigated secular changes in the lifespan of people with Down syndrome over the last 20 years. METHODS: We observed secular trends in the number of stillbirths, deaths and the mortality rates at ages 20, 40, and 60 among all deaths registered with Down syndrome as the cause of death (ICD10 code: Q90) in the Japan national death registry database between 1995 and 2016. Changes in the median age at death between 1995-2005 and 2006-2016 were investigated based on sex and history of surgery. RESULTS: We identified 240 stillbirths and 1,099 deaths in this period. The annual number of stillbirths and deaths above the age of 1 year increased, whereas the number of deaths below 1 year did not change. The proportional mortality indicator at ages 20, 40, and 60 increased from 21.7%, 11.7%, and 1.7% in 1995 to 69.9%, 66.7%, and 36.6% in 2016, respectively. The median age at death was higher in females, individuals without a surgical history, and deaths occurring in 2006-2016. The median age at death increased over the period in those without a surgical history. CONCLUSIONS: The age at death among people with Down syndrome has increased over the last 20 years, with currently 1 in 3 persons living over 60 years, necessitating adequate social welfare services in this aging population.


Subject(s)
Down Syndrome , Life Expectancy , Longevity , Adult , Aging , Cause of Death , Down Syndrome/mortality , Female , Humans , Japan , Middle Aged , Young Adult
8.
Cochrane Database Syst Rev ; 10: CD012273, 2020 10 02.
Article in English | MEDLINE | ID: mdl-33006765

ABSTRACT

BACKGROUND: Branched-chain amino acids (BCAAs) play a vital role in neonatal nutrition. Optimal BCAA supplementation might improve neonatal nutrient storage, leading to better physical and neurological development and other outcomes. OBJECTIVES: To determine the effect of BCAA supplementation on physical growth and neurological development in term and preterm neonates. We planned to make the following comparisons: parenteral nutrition with and without BCAA supplementation; enteral BCAA supplementation versus no supplementation; and any type of supplementation including enteral, parenteral and both ways versus no supplementation. To investigate the supplementation effectiveness for different dosages assessed in the eligible trials. SEARCH METHODS: We conducted comprehensive searches using Cochrane Neonatal's standard search strategies: Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 6), MEDLINE, Embase and CINAHL (up to July 2016). We updated the search with CENTRAL (2019, Issue 8), MEDLINE, Embase and CINAHL (up to August 2019). We also searched clinical trials registries and reference lists of retrieved articles. SELECTION CRITERIA: We planned to include individual and cluster-randomised and quasi-randomised controlled trials comparing BCAA supplementation versus placebo or no supplementation in term and preterm neonates. We excluded trials presented only as abstracts and cross-over trials. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility of all potential studies identified from the search strategy. We planned to extract data using a pilot-tested standard data extraction form and assess risk of bias of the included studies following the methods described in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to analyse treatment effects and report their effect estimates as per dichotomous or continuous data with 95% confidence intervals. We planned to conduct subgroup analysis to investigate heterogeneity, and perform sensitivity analysis where possible. We planned to use fixed-effect meta-analysis to combine data wherever appropriate. We planned to assess evidence quality using the GRADE approach. MAIN RESULTS: We did not identify any potentially eligible studies that met the inclusion criteria in this review. AUTHORS' CONCLUSIONS: We found no trial data to support or refute the idea that BCAA supplementation affects physical and neurological development and other outcomes in term and preterm neonates.


Subject(s)
Amino Acids, Branched-Chain/administration & dosage , Child Development/drug effects , Infant, Newborn/growth & development , Humans , Infant, Premature/growth & development
9.
Cochrane Database Syst Rev ; 12: CD009599, 2020 12 18.
Article in English | MEDLINE | ID: mdl-33336827

ABSTRACT

BACKGROUND: Stillbirth is generally defined as a death prior to birth at or after 22 weeks' gestation. It remains a major public health concern globally. Antenatal interventions may reduce stillbirths and improve maternal and neonatal outcomes in settings with high rates of stillbirth. There are several key antenatal strategies that aim to prevent stillbirth including nutrition, and prevention and management of infections. OBJECTIVES: To summarise the evidence from Cochrane systematic reviews on the effects of antenatal interventions for preventing stillbirth for low risk or unselected populations of women. METHODS: We collaborated with Cochrane Pregnancy and Childbirth's Information Specialist to identify all their published reviews that specified or reported stillbirth; and we searched the Cochrane Database of Systematic Reviews (search date: 29 Feburary 2020) to identify reviews published within other Cochrane groups. The primary outcome measure was stillbirth but in the absence of stillbirth data, we used perinatal mortality (both stillbirth and death in the first week of life), fetal loss or fetal death as outcomes. Two review authors independently evaluated reviews for inclusion, extracted data and assessed quality of evidence using AMSTAR (A Measurement Tool to Assess Reviews) and GRADE tools. We assigned interventions to categories with graphic icons to classify the effectiveness of interventions as: clear evidence of benefit or harm; clear evidence of no effect or equivalence; possible benefit or harm; or unknown benefit or harm or no effect or equivalence. MAIN RESULTS: We identified 43 Cochrane Reviews that included interventions in pregnant women with the potential for preventing stillbirth; all of the included reviews reported our primary outcome 'stillbirth' or in the absence of stillbirth, 'perinatal death' or 'fetal loss/fetal death'. AMSTAR quality was high in 40 reviews with scores ranging from 8 to 11 and moderate in three reviews with a score of 7. Nutrition interventions Clear evidence of benefit: balanced energy/protein supplementation versus no supplementation suggests a probable reduction in stillbirth (risk ratio (RR) 0.60, 95% confidence interval (CI) 0.39 to 0.94, 5 randomised controlled trials (RCTs), 3408 women; moderate-certainty evidence). Clear evidence of no effect or equivalence for stillbirth or perinatal death: vitamin A alone versus placebo or no treatment; and multiple micronutrients with iron and folic acid versus iron with or without folic acid. Unknown benefit or harm or no effect or equivalence: for all other nutrition interventions examined the effects were uncertain. Prevention and management of infections Possible benefit for fetal loss or death: insecticide-treated anti-malarial nets versus no nets (RR 0.67, 95% CI 0.47 to 0.97, 4 RCTs; low-certainty). Unknown evidence of no effect or equivalence: drugs for preventing malaria (stillbirth RR 1.02, 95% CI 0.76 to 1.36, 5 RCTs, 7130 women, moderate certainty in women of all parity; perinatal death RR 1.24, 95% CI 0.94 to 1.63, 4 RCTs, 5216 women, moderate-certainty in women of all parity). Prevention, detection and management of other morbidities Clear evidence of benefit: the following interventions suggest a reduction: midwife-led models of care in settings where the midwife is the primary healthcare provider particularly for low-risk pregnant women (overall fetal loss/neonatal death reduction RR 0.84, 95% CI 0.71 to 0.99, 13 RCTs, 17,561 women; high-certainty), training versus not training traditional birth attendants in rural populations of low- and middle-income countries (stillbirth reduction odds ratio (OR) 0.69, 95% CI 0.57 to 0.83, 1 RCT, 18,699 women, moderate-certainty; perinatal death reduction OR 0.70, 95% CI 0.59 to 0.83, 1 RCT, 18,699 women, moderate-certainty). Clear evidence of harm: a reduced number of antenatal care visits probably results in an increase in perinatal death (RR 1.14 95% CI 1.00 to 1.31, 5 RCTs, 56,431 women; moderate-certainty evidence). Clear evidence of no effect or equivalence: there was evidence of no effect in the risk of stillbirth/fetal loss or perinatal death for the following interventions and comparisons: psychosocial interventions; and providing case notes to women. Possible benefit: community-based intervention packages (including community support groups/women's groups, community mobilisation and home visitation, or training traditional birth attendants who made home visits) may result in a reduction of stillbirth (RR 0.81, 95% CI 0.73 to 0.91, 15 RCTs, 201,181 women; low-certainty) and perinatal death (RR 0.78, 95% CI 0.70 to 0.86, 17 RCTs, 282,327 women; low-certainty). Unknown benefit or harm or no effect or equivalence: the effects were uncertain for other interventions examined. Screening and management of fetal growth and well-being Clear evidence of benefit: computerised antenatal cardiotocography for assessing infant's well-being in utero compared with traditional antenatal cardiotocography (perinatal mortality reduction RR 0.20, 95% CI 0.04 to 0.88, 2 RCTs, 469 women; moderate-certainty). Unknown benefit or harm or no effect or equivalence: the effects were uncertain for other interventions examined. AUTHORS' CONCLUSIONS: While most interventions were unable to demonstrate a clear effect in reducing stillbirth or perinatal death, several interventions suggested a clear benefit, such as balanced energy/protein supplements, midwife-led models of care, training versus not training traditional birth attendants, and antenatal cardiotocography. Possible benefits were also observed for insecticide-treated anti-malarial nets and community-based intervention packages, whereas a reduced number of antenatal care visits were shown to be harmful. However, there was variation in the effectiveness of interventions across different settings, indicating the need to carefully understand the context in which these interventions were tested. Further high-quality RCTs are needed to evaluate the effects of antenatal preventive interventions and which approaches are most effective to reduce the risk of stillbirth. Stillbirth (or fetal death), perinatal and neonatal death need to be reported separately in future RCTs of antenatal interventions to allow assessment of different interventions on these rare but important outcomes and they need to clearly define the target populations of women where the intervention is most likely to be of benefit. As the high burden of stillbirths occurs in low- and middle-income countries, further high-quality trials need to be conducted in these settings as a priority.


Subject(s)
Fetal Death/prevention & control , Perinatal Death/prevention & control , Prenatal Care/methods , Stillbirth , Cardiotocography , Female , Fetal Development , Humans , Infant, Newborn , Insecticide-Treated Bednets , Midwifery , Nutrition Assessment , Pregnancy , Prenatal Care/statistics & numerical data , Randomized Controlled Trials as Topic , Systematic Reviews as Topic
10.
Mod Rheumatol ; 30(1): 116-124, 2020 Jan.
Article in English | MEDLINE | ID: mdl-30557100

ABSTRACT

Objectives: Thrombocytopenia is frequently observed in antiphospholipid antibody (aPL) carriers. Due to the paradoxical risks of thrombosis and hemorrhage, the management of aPL-associated thrombocytopenia (APAT) is often deductive. We aimed to investigate the efficacy and safety of therapeutic approaches for APAT through a systematic review.Methods: Four therapeutic approaches for APAT, including antiplatelet agents, glucocorticoids, splenectomy and thrombopoietin receptor agonists, were selected. Clinical trials evaluating therapeutic outcomes including the remission, complications, mortality and relapse, were searched in MEDLINE, EMBASE and CENTRAL from the inception dates to 28 November 2016. A meta-analysis was performed to calculate risk ratios (RRs) and 95% confidence intervals (CIs) using random-effects models.Results: Out of 1407 papers, eight controlled clinical trials were included. In patients with APAT, the remission rates were higher in patients on glucocorticoids (RR 8.33 [95% CI 3.07-22.6]) or splenectomy (RR 8.37 [95% CI 1.61-43.7]) than in patients without those treatments. There was no significant association between glucocorticoids and thrombosis (RR 1.57 [95% CI, 0.17-14.9]) or between splenectomy and hemorrhage (RR 0.17 [95% CI 0.02-1.28]). The extracted data of mortality and relapse rate were not available for synthesis.Conclusion: Glucocorticoids or splenectomy seemed suitable therapeutic approaches for APAT.


Subject(s)
Antibodies, Antiphospholipid/immunology , Glucocorticoids/therapeutic use , Hemorrhage/prevention & control , Platelet Aggregation Inhibitors/therapeutic use , Splenectomy/methods , Thrombocytopenia/therapy , Thrombosis/prevention & control , Antibodies, Antiphospholipid/blood , Hemorrhage/etiology , Humans , Receptors, Thrombopoietin/agonists , Thrombocytopenia/blood , Thrombocytopenia/immunology , Thrombosis/etiology
11.
Cochrane Database Syst Rev ; 12: CD012803, 2019 12 04.
Article in English | MEDLINE | ID: mdl-31797360

ABSTRACT

BACKGROUND: Ischaemic heart disease including heart failure is the most common cause of death in the world, and the incidence of the condition is rapidly increasing. Heart failure is characterised by symptoms such as fatigue and breathlessness during light activity, as well as disordered breathing during sleep. In particular, sleep disordered breathing (SDB), including central sleep apnoea (CSA) and obstructive sleep apnoea (OSA), is highly prevalent in people with chronic heart failure. A previous meta-analysis demonstrated that positive airway pressure (PAP) therapy dramatically increased the survival rate of people with heart failure who had CSA, and thus could contribute to improving the prognosis of these individuals. However, recent trials found that adaptive servo-ventilation (ASV) including PAP therapy had a higher risk of all-cause mortality and cardiovascular mortality. A meta-analysis that included recent trials was therefore needed. OBJECTIVES: To assess the effects of positive airway pressure therapy for people with heart failure who experience central sleep apnoea. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, and Web of Science Core Collection on 7 February 2019 with no limitations on date, language, or publication status. We also searched two clinical trials registers in July 2019 and checked the reference lists of primary studies. SELECTION CRITERIA: We excluded cross-over trials and included individually randomised controlled trials, reported as full-texts, those published as abstract only, and unpublished data. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted outcome data from the included studies. We double-checked that data had been entered correctly by comparing the data presented in the systematic review with study reports. We analysed dichotomous data as risk ratios (RRs) with 95% confidence intervals (CIs) and continuous data as mean difference (MD) or standardised mean difference (SMD) with 95% CIs. Furthermore, we performed subgroup analysis in the ASV group or continuous PAP group separately. We used GRADEpro GDT software to assess the quality of evidence as it relates to those studies that contribute data to the meta-analyses for the prespecified outcomes. MAIN RESULTS: We included 16 randomised controlled trials involving a total of 2125 participants. The trials evaluated PAP therapy consisting of ASV or continuous PAP therapy for 1 to 31 months. Many trials included participants with heart failure with reduced ejection fraction. Only one trial included participants with heart failure with preserved ejection fraction. We are uncertain about the effects of PAP therapy on all-cause mortality (RR 0.81, 95% CI 0.54 to 1.21; participants = 1804; studies = 6; I2 = 47%; very low-quality evidence). We found moderate-quality evidence of no difference between PAP therapy and usual care on cardiac-related mortality (RR 0.97, 95% CI 0.77 to 1.24; participants = 1775; studies = 5; I2 = 11%). We found low-quality evidence of no difference between PAP therapy and usual care on all-cause rehospitalisation (RR 0.95, 95% CI 0.70 to 1.30; participants = 1533; studies = 5; I2 = 40%) and cardiac-related rehospitalisation (RR 0.97, 95% CI 0.70 to 1.35; participants = 1533; studies = 5; I2 = 40%). In contrast, PAP therapy showed some indication of an improvement in quality of life scores assessed by all measurements (SMD -0.32, 95% CI -0.67 to 0.04; participants = 1617; studies = 6; I2 = 76%; low-quality evidence) and by the Minnesota Living with Heart Failure Questionnaire (MD -0.51, 95% CI -0.78 to -0.24; participants = 1458; studies = 4; I2 = 0%; low-quality evidence) compared with usual care. Death due to pneumonia (N = 1, 3% of PAP group); cardiac arrest (N = 18, 3% of PAP group); heart transplantation (N = 8, 1% of PAP group); cardiac worsening (N = 3, 9% of PAP group); deep vein thrombosis/pulmonary embolism (N = 1, 3% of PAP group); and foot ulcer (N = 1, 3% of PAP group) occurred in the PAP therapy group, whereas cardiac arrest (N = 16, 2% of usual care group); heart transplantation (N = 12, 2% of usual care group); cardiac worsening (N = 5, 14% of usual care group); and duodenal ulcer (N = 1, 3% of usual care group) occurred in the usual care group across three trials. AUTHORS' CONCLUSIONS: The effect of PAP therapy on all-cause mortality was uncertain. In addition, although we found evidence that PAP therapy did not reduce the risk of cardiac-related mortality and rehospitalisation, there was some indication of an improvement in quality of life for heart failure patients with CSA. Furthermore, the evidence was insufficient to determine whether adverse events were more common with PAP than with usual care. These findings were limited by low- or very low-quality evidence. PAP therapy may be worth considering for individuals with heart failure to improve quality of life.


Subject(s)
Heart Failure/complications , Positive-Pressure Respiration/methods , Sleep Apnea, Central/therapy , Humans , Quality of Life , Randomized Controlled Trials as Topic , Sleep Apnea, Central/etiology , Sleep Apnea, Obstructive/etiology , Sleep Apnea, Obstructive/therapy
12.
Cochrane Database Syst Rev ; 4: CD011337, 2019 Apr 27.
Article in English | MEDLINE | ID: mdl-31032884

ABSTRACT

BACKGROUND: Hypertension (high blood pressure) in pregnancy carries a high risk of maternal morbidity and mortality. Although antihypertensive drugs are commonly used, they have adverse effects on mothers and fetuses. Guided imagery is a non-pharmacological technique that has the potential to lower blood pressure among pregnant women with hypertension. Guided imagery is a mind-body therapy that involves the visualisation of various mental images to facilitate relaxation and reduction in blood pressure. OBJECTIVES: To determine the effect of guided imagery as a non-pharmacological treatment of hypertension in pregnancy and its influence on perinatal outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, and two trials registers (October 2018). We also searched relevant conference proceedings and journals, and scanned the reference lists of retrieved studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs). We would have included RCTs using a cluster-randomised design, but none were identified. We excluded quasi-RCTs and cross-over trials.We sought intervention studies of various guided imagery techniques performed during pregnancy in comparison with no intervention or other non-pharmacological treatments for hypertension (e.g. quiet rest, music therapy, aromatherapy, relaxation therapy, acupuncture, acupressure, massage, device-guided slow breathing, hypnosis, physical exercise, and yoga). DATA COLLECTION AND ANALYSIS: Three review authors independently assessed the trials for inclusion, extracted data, and assessed risk of bias for the included studies. We checked extracted data for accuracy, and resolved differences in assessments by discussion. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included two small trials (involving a total of 99 pregnant women) that compared guided imagery with quiet rest. The trials were conducted in Canada and the USA. We assessed both trials as at high risk of performance bias, and low risk of attrition bias; one trial was at low risk for selection, detection, and reporting bias, while the other was at unclear risk for the same domains.We could not perform a meta-analysis because the two included studies reported different outcomes, and the frequency of the intervention was slightly different between the two studies. One study performed guided imagery for 15 minutes at least twice daily for four weeks, or until the baby was born (whichever came first). In the other study, the intervention included guided imagery, self-monitoring of blood pressure, and thermal biofeedback-assisted relaxation training for four total hours; the participants were instructed to practice the procedures twice daily and complete at least three relief relaxation breaks each day. The control groups were similar - one was quiet rest, and the other was quiet rest as bed rest.None of our primary outcomes were reported in the included trials: severe hypertension (either systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher); severe pre-eclampsia, or perinatal death (stillbirths plus deaths in the first week of life). Only one of the secondary outcomes was measured.Low-certainty evidence from one trial (69 women) suggests that guided imagery may make little or no difference in the use of antihypertensive drugs (risk ratio 1.27, 95% confidence interval 0.72 to 2.22). AUTHORS' CONCLUSIONS: There is insufficient evidence to inform practice about the use of guided imagery for hypertension in pregnancy.The available evidence for this review topic is sparse, and the effect of guided imagery for treating hypertension during pregnancy (compared with quiet rest) remains unclear. There was low-certainty evidence that guided imagery made little or no difference to the use of antihypertensive drugs, downgraded because of imprecision.The two included trials did not report on any of the primary outcomes of this review. We did not identify any trials comparing guided imagery with no intervention, or with another non-pharmacological method for hypertension.Large and well-designed RCTs are needed to identify the effects of guided imagery on hypertension during pregnancy and on other relevant outcomes associated with short-term and long-term maternal and neonatal health. Trials could also consider utilisation and costs of health service.


Subject(s)
Hypertension/therapy , Imagery, Psychotherapy , Female , Humans , Pregnancy , Treatment Outcome
13.
Cochrane Database Syst Rev ; 8: CD012448, 2019 08 16.
Article in English | MEDLINE | ID: mdl-31425625

ABSTRACT

BACKGROUND: Kawasaki disease (KD) is an acute inflammatory vasculitis (inflammation of the blood vessels) that mainly affects children between six months and five years of age. The vasculitis primarily impacts medium-sized blood vessels, especially in the coronary arteries. In most children, intravenous immunoglobulin (IVIG) and aspirin therapy rapidly reduce inflammatory markers, fever, and other clinical symptoms. However, approximately 15% to 20% of children receiving the initial IVIG infusion show persistent or recurrent fever and are classified as IVIG-resistant. Tumor necrosis factor-alpha (TNF-α) is an inflammatory cytokine that plays an important role in host defence against infections and in immune responses. Several studies have established that blocking TNF-α is critical for obtaining anti-inflammatory effects in children with KD, thus, there is a need to identify benefits and risks of TNF-α blockers for the treatment of KD. OBJECTIVES: To evaluate the efficacy and safety of using TNF-α blockers (i.e. infliximab and etanercept) to treat children with Kawasaki disease. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 19 September 2018. We also undertook reference checking of grey literature. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared TNF-α blockers (i.e. infliximab and etanercept) to placebo or other drugs (including retreatment with IVIG) in children with KD, reported in abstract or full-text. DATA COLLECTION AND ANALYSIS: Two review authors independently applied the study selection criteria, assessed risk of bias and extracted data. When necessary, we contacted study authors for additional information. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included five trials from 14 reports, with a total of 494 participants. All included trials were individual RCTs that examined the effect of TNF-α blockers for KD.Five trials (with 494 participants) reported the incidence of treatment resistance. TNF-α blockers reduced the incidence of treatment resistance (TNF-α blocker intervention group 30/237, control group 58/257; risk ratio (RR) 0.57, 95% confidence interval (CI) 0.38 to 0.86; low-certainty evidence).Four trials reported the incidence of coronary artery abnormalities (CAAs). Three trials (with 270 participants) contributed data to the meta-analysis, since we could not get the data needed for the analysis from the fourth trial. There was no clear difference between groups in the incidence of CAAs (TNF-α blocker intervention group 8/125, control group 9/145; RR 1.18, 95% CI 0.45 to 3.12; low-certainty evidence).Three trials with 250 participants reported the adverse effect 'infusion reactions' after treatment initiation. The TNF-α blocker intervention decreased infusion reactions (TNF-α blocker intervention group 0/126, control group 15/124; RR 0.06, 95% CI 0.01 to 0.45; low-certainty evidence).Two trials with 227 participants reported the adverse effect 'infections' after treatment initiation. There was no clear difference between groups (TNF-α blocker intervention group 7/114, control group 10/113; RR 0.68, 95% CI 0.33 to 1.37; low-certainty evidence).One trial (with 31 participants) reported the adverse effect 'cutaneous reactions' (rash and contact dermatitis). There was no clear difference between the groups for incidence of rash (TNF-α blocker intervention group 2/16, control group 0/15; RR 4.71, 95% CI 0.24 to 90.69; very low-certainty evidence) or for incidence of contact dermatitis (TNF-α blocker intervention group 1/16, control group 3/15; RR 0.31, 95% CI 0.04 to 2.68; very low-certainty evidence).No trials reported other adverse effects such as injection site reactions, neutropenia, infections, demyelinating disease, heart failure, malignancy, and induction of autoimmunity. AUTHORS' CONCLUSIONS: We found a limited number of RCTs examining the effect of TNF-α blockers for KD. In summary, low-certainty evidence indicates that TNF-α blockers have beneficial effects on treatment resistance and the adverse effect 'infusion reaction' after treatment initiation for KD when compared with no treatment or additional treatment with IVIG. Further research will add to the evidence base. Due to the small number of underpowered trials contributing to the analyses, the results presented should be treated with caution. Further large high quality trials with timing and type of TNF-α blockers used are needed to determine the effects of TNF-α blockers for KD.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Mucocutaneous Lymph Node Syndrome/drug therapy , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Child, Preschool , Humans , Immunologic Factors , Infant , Randomized Controlled Trials as Topic , Vasculitis/drug therapy
14.
BMC Public Health ; 19(1): 707, 2019 Jun 07.
Article in English | MEDLINE | ID: mdl-31174509

ABSTRACT

BACKGROUND: Fruit and vegetable consumption was considered a protective effect against cardiovascular and cerebrovascular diseases (CVDs). This study aimed to project the reduction in the CVD burden under different scenarios of increased fruit and vegetable intake in Japan by 2060. METHODS: Population attributable fractions (PAF) were calculated by gender and age in 2015. The projection considered five scenarios for 2015, 2030, 2045, and 2060: 1) a baseline of no changes in intake; 2) a moderate increase in fruit intake (extra 50 g/day or 1/2 serving); 3) an high increase in fruit intake (extra 100 g/day or 1 serving); 4) a moderate increase in vegetable intake (extra 70 g/day or 1 serving); and 5) an high increase in vegetable intake (extra 140 g/day or 2 servings). Potentially preventable disability-adjusted life years (DALYs) for CVDs were estimated for each scenario. Monte Carlo simulations were performed to calculate the 95% confidence intervals of the estimates. RESULTS: Across all age groups, men had a higher daily vegetable intake than women (292.7 g/d > 279.3 g/d) but a lower daily fruit intake (99.3 g/d < 121.0 g/d). Comparing with recommended intake level (350 g/d of vegetable and 200 g/d of fruit), the total CVD burden was estimated to be 302,055 DALYs attributable to inadequate fruit consumption in 2015, which accounted for 12.6% of the total CVD burden (vegetable: 202,651 DALYs; 8.5%). In 2060, the percentage of the CVD burden due to insufficient intake of fruit is estimated to decrease to 7.9% under the moderate increase scenario and to decrease to 4.5% under the high increase scenario (vegetable: 5.4%; 2.4%). CONCLUSIONS: The study suggested that a relevantly large percentage of the CVD burden can be alleviated by promoting even modest increases in fruit and vegetable consumption in Japan.


Subject(s)
Coronary Disease/epidemiology , Diet/adverse effects , Fruit , Stroke/epidemiology , Vegetables , Adult , Aged , Coronary Disease/etiology , Cost of Illness , Female , Humans , Japan/epidemiology , Male , Middle Aged , Quality-Adjusted Life Years , Stroke/etiology
15.
BMC Public Health ; 19(1): 697, 2019 Jun 06.
Article in English | MEDLINE | ID: mdl-31170967

ABSTRACT

BACKGROUND: Many studies have demonstrated positive effects of physical activity on children's health such as improved cardiorespiratory function and decreased obesity. Physical activity has also been found to have positive effects on academic achievement and cognitive function. However, there are few high quality RCT studies on this topic at present and the findings remain controversial. METHODS: This protocol describes cluster randomized controlled trials assessing the impact of school-based exercise intervention among children in Mongolia. The intervention consists of 3-min sessions of high intensity interval training combined with music implemented two times a week at school during study periods. The participants are children in the fourth grade in public elementary schools in the Sukhbaatar district in Ulaanbaatar, Mongolia. The participants are cluster randomized by school and allocated either to the intervention or control group. The primary outcome is academic achievement. Secondary outcomes are obesity/overweight, physical fitness function, lifestyle, mental health, and cognitive function. DISCUSSION: This cluster-RCT is designed and implemented to assess the effectiveness of exercise intervention on academic achievement, cognitive function, and physical and mental health among school-age children in Mongolia. This study will provide evidence to promote physical activities among children in low- and middle- income countries. TRIAL REGISTRATION: UMIN: UMIN000031062 . Registered on 1st February 2018.


Subject(s)
Academic Success , Cognition , Exercise Therapy/psychology , Exercise/psychology , School Health Services , Child , Cluster Analysis , Exercise Therapy/methods , Female , Humans , Life Style , Male , Mental Health , Mongolia , Obesity/prevention & control , Obesity/psychology , Overweight/prevention & control , Overweight/psychology , Physical Fitness/psychology , Program Evaluation , Randomized Controlled Trials as Topic , Schools
16.
BMC Pediatr ; 19(1): 166, 2019 05 27.
Article in English | MEDLINE | ID: mdl-31132994

ABSTRACT

BACKGROUND: 2500 g has been used worldwide as the definition of low birthweight (LBW) for almost a century. While previous studies have used statistical approaches to define LBW cutoffs, a LBW definition using an outcome-based approach has not been evaluated. We aimed to identify an outcome-based definition of LBW for live births in low- and middle-income countries (LMICs), using data from a WHO cross-sectional survey on maternal and perinatal health outcomes in 23 countries. METHODS: We performed a secondary analysis of all singleton live births in the WHO Global Survey (WHOGS) on Maternal and Perinatal Health, conducted in African and Latin American countries (2004-2005) and Asian countries (2007-2008). We used a two-level logistic regression model to assess the risk of early neonatal mortality (ENM) associated with subgroups of birthweight (< 1500 g, 1500-2499 g with 100 g intervals; 2500-3499 g as the reference group). The model adjusted for potential confounders, including maternal complications, gestational age at birth, mode of birth, fetal presentation and facility capacity index (FCI) score. We presented adjusted odds ratios (aORs) with 95% confidence intervals (CIs). A lower CI limit of at least two was used to define a clinically important definition of LBW. RESULTS: We included 205,648 singleton live births at 344 facilities in 23 LMICs. An aOR of at least 2.0 for the ENM outcome was observed at birthweights below 2200 g (aOR 3.8 (95% CI; 2.7, 5.5) of 2100-2199 g) for the total population. For Africa, Asia and Latin America, the 95% CI lower limit aORs of at least 2.0 were observed when birthweight was lower than 2200 g (aOR 3.6 (95% CI; 2.0, 6.5) of 2100-2199 g), 2100 g (aOR 7.4 (95% CI; 5.1, 10.7) of 2000-2099 g) and 2200 g (aOR 6.1 (95% CI; 3.4, 10.9) of 2100-2199 g) respectively. CONCLUSION: A birthweight of less than 2200 g may be an outcome-based threshold for LBW in LMICs. Regional-specific thresholds of low birthweight (< 2200 g in Africa, < 2100 g in Asia and < 2200 g in Latin America) may also be warranted.


Subject(s)
Birth Weight , Infant, Low Birth Weight , Africa/epidemiology , Asia/epidemiology , Classification , Confounding Factors, Epidemiologic , Developing Countries , Health Surveys , Humans , Infant , Infant Mortality , Infant, Newborn , Latin America/epidemiology , Odds Ratio , World Health Organization
17.
J Allergy Clin Immunol ; 141(6): 1997-2001.e3, 2018 06.
Article in English | MEDLINE | ID: mdl-29522845

ABSTRACT

The Learning Early About Peanut Allergy (LEAP) study proved that early introduction of peanut significantly prevented the development of peanut allergy. However, in regard to similar attempts to prevent egg allergy through early egg introduction, the Prevention of Egg Allergy in High-risk Infants with Eczema (PETIT) study is the only randomized intervention trial to show a statistically significant effect. Meta-analysis of those studies indicated that neither the total amount nor pretreatment of egg showed any effect on egg allergy at the age of 12 months. However, raw egg powder resulted in a significantly higher prevalence of allergic reactions at initial introduction, whereas use of boiled egg was much safer. The prevalence of atopic dermatitis/eczema at introduction of egg correlated significantly with the subsequent prevalence of allergic reactions at initial introduction. In addition, the prevalence of egg allergy in the late introduction group correlated significantly with the prevalence of atopic dermatitis at introduction, even when the atopic dermatitis was proactively treated with a topical corticosteroid ointment. It is definitely true that the number of trials and number of participants in each trial are insufficient for drawing firm conclusions, especially regarding the optimal dose, raw versus boiled, when to start, and for whom to intervene. Therefore we propose various studies that should be performed to generate stronger data and conclusions. However, on the basis of the most recent results, we postulate that simultaneous intervention by both early boiled egg introduction and eczema treatment is probably indispensable for primary prevention of egg allergy.


Subject(s)
Desensitization, Immunologic/methods , Eczema/complications , Egg Hypersensitivity/complications , Egg Hypersensitivity/prevention & control , Anti-Inflammatory Agents/therapeutic use , Dermatitis, Atopic/complications , Dermatitis, Atopic/drug therapy , Dermatitis, Atopic/epidemiology , Eczema/diet therapy , Eczema/epidemiology , Female , Humans , Infant , Male , Meta-Analysis as Topic , Prevalence , Randomized Controlled Trials as Topic
18.
Health Qual Life Outcomes ; 16(1): 85, 2018 May 02.
Article in English | MEDLINE | ID: mdl-29720193

ABSTRACT

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.


Subject(s)
Chronic Disease/psychology , Quality of Life , Self Report/standards , Adolescent , Child , Factor Analysis, Statistical , Female , Humans , Japan , Male , Parents/psychology , Psychometrics , Reproducibility of Results , Severity of Illness Index , Translations
19.
Cochrane Database Syst Rev ; 9: CD012222, 2018 09 30.
Article in English | MEDLINE | ID: mdl-30270428

ABSTRACT

BACKGROUND: Heart failure is the end stage of heart disease, and the prevalence and incidence of the condition is rapidly increasing. Although heart transplantation is one type of surgical treatment for people with end-stage heart failure, donor availability is limited. Implantable ventricular assist devices (VADs) therefore offer an alternative treatment to heart transplantation. Although two studies reported the beneficial effects of exercise-based cardiac rehabilitation (CR) on functional capacity and quality of life (QOL) by performing systematic reviews and meta-analyses, both systematic reviews included studies with limited design (e.g. non-randomised, retrospective studies) or participants with implantable or extracorporeal VADs. OBJECTIVES: To determine the benefits and harms of exercise-based CR for people with implantable VADs. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, PsycINFO, Conference Proceedings Citation Index-Science (CPCI-S) on Web of Science, CINAHL, and LILACS on 3 October 2017 with no limitations on date, language, or publication status. We also searched two clinical trials registers on 10 August 2017 and checked the reference lists of primary studies and review articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) regardless of cluster or individual randomisation, and full-text studies, those published as abstract only, and unpublished data were eligible. However, only individually RCTs and full-text publications were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted outcome data from the included studies. We double-checked that data were entered correctly by comparing the data presented in the systematic review with the study reports. We had no dichotomous data to analyse and used mean difference or standardised mean difference with 95% confidence intervals (CIs) for continuous data. Furthermore, we assessed the quality of evidence as it relates to those studies that contribute data to the meta-analyses for the prespecified outcomes, using GRADEpro software. MAIN RESULTS: We included two studies with a total of 40 participants in the review. Exercise-based CR consisted of aerobic or resistance training or both three times per week for six to eight weeks. Exercise intensity was 50% of oxygen consumption (VO2) reserve, or ranged from 60% to 80% of heart rate reserve. Two serious adverse events were observed in one trial, in which participants did not complete the study due to infections. Furthermore, a total of four participants in each group required visits to the emergency department, although these participants did complete the study. Summary scores from the 36-item Short Form Health Survey (SF-36) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) were measured as quality of life. One trial reported that the KCCQ summary score improved by 14.4 points in the exercise group compared with 0.5 points in the usual care group. The other trial reported that the SF-36 total score improved by 29.2 points in the exercise group compared with 16.3 points in the usual care group. A large difference in quality of life was observed between groups at the end of follow-up (standardised mean difference 0.88, 95% CI -0.12 to 1.88; 37 participants; 2 studies; very low-quality of evidence). However, there was no evidence for the effectiveness of exercise-based CR due to the young age of the participants, high risk of performance bias, very small sample size, and wide confidence intervals, which resulted in very low-quality evidence. Furthermore, we were not able to determine the effect of exercise-based CR on mortality, rehospitalisation, heart transplantation, and cost, as these outcomes were not reported. AUTHORS' CONCLUSIONS: The evidence is currently inadequate to assess the safety and efficacy of exercise-based CR for people with implantable VADs compared with usual care. The amount of RCT evidence was very limited and of very low quality. In addition, the training duration was very short term, that is from six to eight weeks. Further high-quality and well-reported RCTs of exercise-based CR for people with implantable VADs are needed. Such trials need to collect data on events (mortality and rehospitalisation), patient-related outcomes (including quality of life), and cost-effectiveness.


Subject(s)
Cardiac Rehabilitation/methods , Exercise , Heart-Assist Devices , Resistance Training , Heart-Assist Devices/adverse effects , Humans , Oxygen Consumption , Quality of Life , Randomized Controlled Trials as Topic
20.
Cochrane Database Syst Rev ; 12: CD011315, 2018 12 22.
Article in English | MEDLINE | ID: mdl-30577083

ABSTRACT

BACKGROUND: Amphetamine-type stimulants (ATS) refer to a group of synthetic stimulants including amphetamine, methamphetamine, 3,4-methylenedioxy-methamphetamine (MDMA) and related substances. ATS are highly addictive and prolonged use may result in a series of mental and physical symptoms including anxiety, confusion, insomnia, mood disturbances, cognitive impairments, paranoia, hallucinations and delusion.Currently there is no widely accepted treatment for ATS-use disorder. However, cognitive-behavioural treatment (CBT) is the first-choice treatment. The effectiveness of CBT for other substance-use disorders (e.g. alcohol-, opioid- and cocaine-use disorders) has been well documented and as such this basic treatment approach has been applied to the ATS-use disorder. OBJECTIVES: To investigate the efficacy of cognitive-behavioural treatment for people with ATS-use disorder for reducing ATS use compared to other types of psychotherapy, pharmacotherapy, 12-step facilitation, no intervention or treatment as usual. SEARCH METHODS: We identified randomised controlled trials (RCT) and quasi-RCTs comparing CBT for ATS-use disorders with other types of psychotherapy, pharmacotherapy, 12 step facilitation or no intervention. We searched the Cochrane Drugs and Alcohol Group Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE via PubMed, Embase and five other databases up to July 2018. In addition, we examined reference lists of eligible studies and other systematic reviews. We contacted experts in the field. SELECTION CRITERIA: Eligibility criteria consisted of RCTs and quasi-RCTs comparing CBT versus other types of interventions with adult ATS users (aged 18 years or older) diagnosed by any explicit diagnostic system. Primary outcomes included abstinence rate and other indicators of drug-using behaviours. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: Only two studies met the eligibility criteria. Both studies were at low risk of selection bias and reporting bias. In one study, almost half of participants in the intervention group dropped out and this study was at high risk of attrition bias. The studies compared a single session of brief CBT or a web-based CBT to a waiting-list control (total sample size across studies of 129). Results were mixed across the studies. For the single-session brief CBT study, two out of five measures of drug use produced significant results, percentage of abstinent days in 90 days (odds ratio (OR) 0.22, 95% confidence interval (CI) 0.02 to 2.11) and dependence symptoms (standardised mean difference (SMD) -0.59, 95% CI -1.16 to -0.02). Little confidence could be placed in the results from this study give the small sample size (25 participants per group) and corresponding large CIs around the observed effects. For the web-based CBT, there was no significant difference across different outcomes. Neither study reported adverse effects. The meta-analytic mean across these two trials for drug use was not significant (SMD -0.28, 95% CI -0.69 to 0.14). In summary, overall quality of evidence was low and there was insufficient evidence to conclude that CBT is effective, or ineffective, at treating ATS use. AUTHORS' CONCLUSIONS: Currently, there is not enough evidence to establish the efficacy of CBT for ATS-use disorders because of a paucity of high-quality research in this area.


Subject(s)
Amphetamine-Related Disorders/therapy , Amphetamines , Cognitive Behavioral Therapy/methods , Adult , Amphetamine-Related Disorders/complications , Amphetamines/adverse effects , Female , Humans , Male , Patient Dropouts/statistics & numerical data , Randomized Controlled Trials as Topic , Sample Size , Waiting Lists
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