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BackgroundLittle is known about the impact of socioeconomic status (SES) on incidence of stroke in China. This study aimed to examine the association of SES, which was measured by different indicators, with incidence of stroke and gender differences in the association.Methods and resultsTwo prospective cohort studies were conducted including 2852 participants aged ≥60 years in Anhui province and 3016 participants in four other provinces in China. During a median follow-up of 7.1 years, 211 incident stroke cases occurred in the Anhui cohort. The risk of stroke increased with living in rural areas (adjusted HR 2.49, 95% CI 1.19 to 5.22; women 3.64, 95% CI 1.17 to 11.32, men 2.23, 95% CI 0.81 to 6.19), but not significantly with educational level, occupational class, satisfactory income and financial problems (except for women with low education). The four-province cohort had 113 incident stroke cases over the 3.1 years’ follow-up. The five SES indicators were not significantly associated with incident stroke (except for increased risk in men with high occupation), but additional measurement for actual income showed that incident stroke increased in women with low personal income and in men with high family income. Pooled data from the two cohorts demonstrated the impacts of rural living (1.66, 95% CI 1.08 to 2.57) and having high occupational class (1.56, 95% CI 1.01 to 2.38), and gender differences for women with low education (2.26, 95% CI 1.19 to 4.27).ConclusionsRural living and being female with low SES are associated with increased stroke risk in China. Strategies to improve public health in the rural communities and gender-specific targets for health inequality should be an integral component of stroke interventions.

IntroductionTo investigate the relationship between long-term change trajectory in body mass index (BMI) and the hazard of type 2 diabetes among Chinese adults.Research design and methodsData were obtained from the China Health and Nutrition Survey (CHNS). Type 2 diabetes was reported by participants themselves in each survey wave. The duration of follow-up was defined as the period from the first visit to the first time self-reported type 2 diabetes, death, or other loss to follow-up from CHNS. The patterns of change trajectories in BMI were derived by latent class trajectory analysis method. The Fine and Gray regression model was used to estimate HRs with corresponding 95% CIs for type 2 diabetes.ResultsFour patterns of the trajectories of change in BMI were identified among Chinese adults, 42.7% of participants had stable BMI change, 40.8% for moderate BMI gain, 8.9% for substantial BMI gain and 7.7% for weight loss. During the follow-up with mean 11.2 years (158 637 person-years contributed by 14 185 participants), 498 people with type 2 diabetes (3.7%) occurred. Risk of type 2 diabetes was increased by 47% among people who gained BMI more substantially and rapidly (HR: 1.47, 95% CI 1.08 to 2.02, p=0.016) and increased by 20% among those in people with the moderate BMI gain (HR: 1.20, 95% CI 0.98 to 1.48, p=0.078), compared with those with stable BMI change.ConclusionsLong-term substantial gain of BMI was significantly associated with an increased risk of type 2 diabetes in the Chinese adults.

Aims and objectives To verify the ability of infrared thermography in objectively identifying pressure injury and its application value in the early warning of pressure injury. Background There is subjectivity in assessing the risk of pressure injury as well as diagnosis in clinical settings, which makes early detection and prevention difficult. Design Prospective, cohort study. Method Four hundred and fifteen patients admitted to the adult intensive care units were enrolled by a convenience sampling method, and they received a follow‐up monitoring for 10 days. The risk of pressure injury was assessed via Braden scale, and thermal images of sacral area were obtained by infrared thermal imager once a day. The predictive effects of infrared thermography and Braden scale on pressure injury were compared by the receiver operating characteristic curve from which the optimal cutoff value of skin temperature for predicting pressure injury was determined. The effect of skin temperature on pressure injury was described and compared, using Kaplan‐Meier curve and Cox proportional hazard regression model respectively. We followed STROBE checklist for reporting the study. Results The relative temperature of sacral area was negatively correlated with the risk of pressure injury. The efficiency of infrared thermography for diagnosing pressure injury was better than that of Braden scale. Based on the relative temperature optimal cutoff value (‐0.1°C), Kaplan‐Meier curve and Cox proportional hazard regression model analysis showed the incidence of pressure injury with relative temperature below ‐0.1°C was higher than the group with relative temperature above ‐0.1°C. Conclusions Infrared thermography can objectively and accurately identify local hypothermia warnings of pressure injury before visual recognition. The application of infrared thermography into routine pressure injury risk assessment provides a timely and reliable method for nursing practitioners. Relevance to clinical practice Infrared thermography has great value of clinical application in daily pressure injury assessment. It is of great significance to make a faster and more objective clinical judgment for patients at risk of pressure injury.

Introduction\ud Pneumococcal colonisation is regarded as a pre-requisite for developing pneumococcal disease. In children previous studies have reported pneumococcal colonisation to be a symptomatic event and described a relationship between symptom severity/frequency and colonisation density. The evidence for this in adults is lacking in the literature. This study uses the experimental human pneumococcal challenge (EHPC) model to explore whether pneumococcal colonisation is a symptomatic event in healthy adults.\ud \ud Methods\ud Healthy participants aged 18–50 were recruited and inoculated intra-nasally with either Streptococcus pneumoniae (serotypes 6B, 23F) or saline as a control. Respiratory viral swabs were obtained prior to inoculation. Nasal and non-nasal symptoms were then assessed using a modified Likert score between 1 (no symptoms) to 7 (cannot function). The rate of symptoms reported between the two groups was compared and a correlation analysis performed.\ud \ud Results\ud Data from 54 participants were analysed. 46 were inoculated with S. pneumoniae (29 with serotype 6B, 17 with serotype 23F) and 8 received saline (control). In total, 14 became experimentally colonised (30.4%), all of which were inoculated with serotype 6B. There was no statistically significant difference in nasal (p = 0.45) or non-nasal symptoms (p = 0.28) between the inoculation group and the control group. In those who were colonised there was no direct correlation between colonisation density and symptom severity. In the 22% (12/52) who were co-colonised, with pneumococcus and respiratory viruses, there was no statistical difference in either nasal or non-nasal symptoms (virus positive p = 0.74 and virus negative p = 1.0).\ud \ud Conclusion\ud Pneumococcal colonisation using the EHPC model is asymptomatic in healthy adults, regardless of pneumococcal density or viral co-colonisation.

In an exploratory, block-randomised, parallel, double-blind, single-centre, placebo-controlled superiority study (ISRCTN12562026, funded by Cultech Ltd), 220 Bulgarian participants (30 to 65 years old) with BMI 25–34.9 kg/m2 received Lab4P probiotic (50 billion/day) or a matched placebo for 6 months. Participants maintained their normal diet and lifestyle. Primary outcomes were changes in body weight, BMI, waist circumference (WC), waist-to-height ratio (WtHR), blood pressure and plasma lipids. Secondary outcomes were changes in plasma C-reactive protein (CRP), the diversity of the faecal microbiota, quality of life (QoL) assessments and the incidence of upper respiratory tract infection (URTI). Significant between group decreases in body weight (1.3 kg, p 2, p p p p p = 0.0005). Greatest weight losses were among probiotic hypercholesterolaemic participants (−2.5%, p p = 0.0241). Improvements in QoL and the incidence rate ratio of URTI (0.60, p

Background: Primiparous mothers who lack experience and knowledge of child caring, are usually overwhelmed with multifarious stressors and challenges. Although support from professionals is needed for new mothers, there is indeed a gap between the necessary high-quality service and the currently provided poor services. This study aimed to explore Chinese primiparous mothers' views on professional services, identify barriers to mobilizing professional support, and further understand mothers' expectations of and preferences for the delivery of professional services. Method: A descriptive phenomenological study design was utilized in this study, and semi-structured interviews were conducted with 28 primiparous mothers selected from two community health centres in Xi' an city, Shannxi province, northwest part of China and who had given birth within one year before the interview. Each conversation lasted between 20-86 minutes. Colaizzi' s seven-step phenomenological approach was used for data analysis. Results: Three major themes were identified: (a) dissatisfying with current professional services for postpartum mothers, (b) likelihood of health care professional help- seeking behaviour, (c) highlighting demands for new health care services. Seven related subthemes including disappointment with hospital services, distrusting services provided by community health centres, private institutes and online platforms; seeking help from professional was not the first choice, hesitating to express their inner discourse to professionals, and considering practical factors prohibited mothers from seeking professional help; urgent needs for new baby-care-related services, and importance of mothers' self-needs. The necessity of professional support in the first month of confinement was highly emphasized by participants. Online professional guidance and support were perceived to be the best way to receive services in this study. Conclusion: The results of this descriptive phenomenological study suggested that the current maternal and child health care services were insufficient and could not meet the needs of primiparous mothers. The identified barriers should be analysed and highlighted by enhancing education and eliminating stigma. The results also indicated that providing service focused on mothers' needs may be an effective strategy to enhance primiparous mothers' well-being, and also suggested that feasibility, convenience, and the cultural adaptability of health care service should be considered during the delivery of postpartum interventions.

Contains fulltext : 220640.pdf (Publisher’s version ) (Closed access) BACKGROUND: Late initiation of HIV antiretroviral therapy (ART) in pregnancy is associated with not achieving viral suppression before giving birth and increased mother-to-child transmission of HIV. We aimed to investigate virological suppression before giving birth with dolutegravir compared with efavirenz, when initiated during the third trimester. METHODS: In this randomised, open-label trial, DolPHIN-2, we recruited pregnant women in South Africa and Uganda aged at least 18 years, with untreated but confirmed HIV infection and an estimated gestation of at least 28 weeks, initiating ART in third trimester. Participants were randomly assigned (1:1) to dolutegravir-based or efavirenz-based therapy. HIV viral load was measured 7 days and 28 days after antiretroviral initiation, at 36 weeks' gestation, and at the post-partum visit (0-14 days post partum). The primary efficacy outcome was a viral load of less than 50 copies per mL at the first post-partum visit, and the primary safety outcome was the occurrence of drug-related adverse events in mothers and infants until the post-partum visit. Longer-term follow-up of mothers and infants continues. This study is registered with ClinicalTrials.gov, NCT03249181. FINDINGS: Between Jan 23, and Aug 15, 2018, we randomly assigned 268 mothers to dolutegravir (135) or efavirenz (133). All mothers and their infants were included in the safety analysis, and 250 mothers (125 in the dolutegravir group, 125 in the efavirenz group) and their infants in efficacy analyses, by intention-to-treat analyses. The median duration of maternal therapy at birth was 55 days (IQR 33-77). 89 (74%) of 120 in the dolutegravir group had viral loads less than 50 copies per mL, compared with 50 (43%) of 117 in the efavirenz group (risk ratio 1·64, 95% CI 1·31-2·06). 30 (22%) of 137 mothers in the dolutegravir group reported serious adverse events compared with 14 (11%) of 131 in the efavirenz group (p=0·013), particularly surrounding pregnancy and puerperium. We found no differences in births less than 37 weeks and less than 34 weeks gestation (16·4% vs 3·3%, across both groups). Three stillbirths in the dolutegravir group and one in the efavirenz group were considered unrelated to treatment. Three infant HIV infections were detected, all in the dolutegravir group, and were considered likely to be in-utero transmissions. INTERPRETATION: Our data support the revision to WHO guidelines recommending the transition to dolutegravir in first-line ART for all adults, regardless of pregnancy or child-bearing potential. FUNDING: Unitaid.

Background: COVID-19 has become a major health event that endangers public health throughout China and the world raising international concern This study aims

Background: Respiratory failure is the leading cause of death in patients with COVID-19. This study aimed to assess the incidence and risk factors for respiratory failure in patients with COVID-19 in Jiangsu province, China. Methods: We did a multicentre retrospective cohort study of all patients with COVID-19 diagnosed at 24 hospitals in Jiangsu province, China between 10 January and 18 February 2020. The demographic, clinical, laboratory, and radiologic features at admission were collected. Clinical outcomes were collected at 8 time points over 14 days from hospital admission. The primary outcome was the occurrence of acute respiratory failure within 14 days from admission, defined as oxygen saturation < 93% and/or partial pressure of oxygen in arterial blood < 60 mm Hg on room air and/or requirement of high-flow nasal cannula therapy, non-invasive or invasive mechanical ventilation. Findings: Of the 626 patients with confirmed COVID-19 infection during the study period, 620 (99.0%) had accessible medical records and were included in the study. Respiratory failure (mainly type I) occurred in 53 of 620 (8.6%) patients. As of 18 February 2020, no patients had died and 252 (40.6%) patients had been discharged. Some differences were observed in demographic and clinical characteristics, laboratory parameters, and radiological findings between patients with and without respiratory failure. Multivariate logistic analysis indicated that age (year) (odds ratio [OR], 1.07; 95% confidence interval [CI]: 1.04-1.11; p < 0.0001), respiratory rate (OR, 1.19; 95% CI: 1.05-1.35; p = 0.0052), lymphocyte count (10 -9 /L) (OR, 0.19; 95% CI: 0.06-0.64, p = 0.0089), and pulmonary opacity (per 5%) (OR, 1.29, 95% CI: 1.09-1.52; p = 0.0052) at admission were associated with the occurrence of respiratory failure. Interpretation: The rate of respiratory failure and death was lower in patients with COVID-19 in Jiangsu than in Wuhan city and lower than previously seen in patients with SARS and MERS. Age, lymphocyte count, respiratory rate, and pulmonary opacity score at admission were identified as independent risk factors for developing respiratory failure. Funding Statement: This work was supported, in part, by the research Grant 2020YFC0843700 67 from Ministry of Science and Technology of the People’s Republic of China. Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: The Ethics Committee of Zhongda Hospital Affiliated to Southeast University approved this study (2020ZDSYLL013–P01 and 2020ZDSYLL019–P01). Informed consent was waived due to the emergent event of the pandemic.

Lack of adequate dietary knowledge may result in poor health conditions. This study aims to measure income-related inequality in dietary knowledge, and to explain the sources of the inequality. Data were from the China Health and Nutrition Survey (CHNS) conducted in 2015. A summary of the dietary knowledge score and dietary guideline awareness was used to measure the dietary knowledge of respondents. The concentration index was employed as a measure of socioeconomic inequality and was decomposed into its determining factors. The study found that the proportion of respondents who correctly answered questions on dietary knowledge was significantly low for some questions. Compared to rural residents, urban residents had a higher proportion of correctly answered dietary knowledge questions. In addition, there are pro-rich inequalities in dietary knowledge. This observed inequality is determined not only by individual factors but also high-level area factors. Our study recommends that future dietary education programs could take different strategies for individuals with different educational levels and focus more on disadvantaged people. It would be beneficial to consider local dietary habits in developing education materials.

Objective. To classify the infection risk of human papillomavirus (HPV) among human immunodeficiency virus- (HIV-) negative men who have sex with men (MSM) using group-based trajectory modeling (GBTM). Methods. This study collected data on demographic and sexual behavior characteristics by questionnaires at semiannual visits from March 1st, 2016 to December 31th, 2017. Researchers collected anal exfoliated cells to finish HPV testing and blood samples to finish HIV testing at baseline and follow-up visits. Accumulative infection numbers of different types of HPV as the primary outcome and the follow-up visits as the independent predicator to build a GBTM model. Results. There were 500 potentially eligible HIV-negative participants at baseline, 361 (72.2%) of whom were included in this study after screening. Three trajectory groups were identified as the best-fitted GBTM model. Trajectory 1, defined as decreased group (DG) accounted for 44.6% (161/361) of the sample, showed a declining pattern with visits. Trajectory 2, defined as flat group (FG) accounted for 49.6% (179/361) of the sample, showed a flat pattern with visits. Trajectory 3, regarded as the increased group (IG) accounted for 5.8% (21/361) of the sample, showed an uptrend. Compared to the DG, risk factors for the FG included receptive anal intercourse (AOR, 2.24; 95% CI, 1.36-3.71), occasional condom use in anal sex during the past six months (AOR, 1.90; 95% CI, 1.16-3.14), experience of transactional sex with males in the past year (AOR, 3.60; 95% CI, 1.12-11.54), and substance use (AOR, 1.81; 95% CI, 1.08-3.04). Risk factors for the IG included receptive anal intercourse (AOR, 2.81; 95% CI, 1.04-7.70), occasional condom use in anal sex during the past six months (AOR, 3.93; 95% CI, 1.40-11.01), and history of other STIs (AOR, 5.72; 95% CI, 1.40-23.46). Conclusion. The MSM data in this study showed three distinct developmental trajectories (DG, FG, and IG) of HPV infection among HIV-negative MSM, with receptive anal intercourse and occasional condom use in anal sex during the past six months being the risk factors associated with FG and IG.

Additional file 1: Table S1. Demographic and clinical characteristics of patients at admission by disease severity*.

Objective: The purpose of this study is to estimate the effect of parent migration on intellectual and physical development of early school-aged children in rural China. Design: setting and participants: The present cross-sectional study participants were a subset from a controlled, cluster-randomized, double-blind trial. From October 2012 to September 2013, the offspring of women who participated in a large trial were examined in the present study. Wechsler intelligence scale for children (WISC-IV) in which validity and reliability were shown to be satisfactory was used to measure the intellectual function and trained anthropometrists measured weight and height of children using standard procedures. Results: The mean difference of FSIQ scores between non-migration and both-parent migration groups was &minus, 3.68 (95%CI: &minus, 5.49, &minus, 1.87). After adjusting for the confounders, the mean difference of full-scale IQ between non-migration and both-parent migration group was &minus, 1.97 (95%CI: &minus, 3.92, &minus, 0.01), the mean differences of perceptual reasoning index and processing speed index were &minus, 2.41 (95%CI: &minus, 4.50, &minus, 0.31) and &minus, 2.39 (95%CI: &minus, 4.42, &minus, 0.35) between two groups respectively. Conclusion: Our results emphasized the impairment of both-parental migration in intellectual function (FSIQ, PRI, PSI) of children. These findings have important policy implications for the Chinese government to prevent the impairment of left-behind children. Further research is required to clarify the mechanisms by which both-parental migration influence the impairment in intellectual function of children.

Additional file 1: Supplementary Questionnaire S1. The household questionnaire of the fourth National Health Service Survey. Supplementary Questionnaire S2. The household questionnaire of the fifth National Health Service Survey.

Background The prevalence of perinatal depression in China ranges from 15 to 20% and the vast majority of prenatally depressed women do not receive the intervention they require. Recent research evidence shows that evidence based, culturally–adapted psychosocial interventions are effective in reducing mental health problems. The World Health Organization (WHO) has endorsed the Thinking Healthy Programme (THP), which is an evidence based psychosocial intervention that can be delivered by non-mental health specialists. The aim of this study was to translate and adapt THP for the Chinese population and to establish its acceptability when delivered by non-specialists to a group of mothers with perinatal depression. Methods The study was conducted in two phases. The THP manual, handbook, and health calendar was translated and adapted based on 8 domains of the Bernal framework (language, metaphors, content, concepts, goals, context, people and methods). Pre-testing was done using cognitive interviewing in the first phase. In second phase of field-testing, THP sessions were delivered to the depressed women by local THP trained nurses. Post intervention, programme survey was used for evaluation. Results This study showed that the core structure, process and techniques of the THP were culturally compatible with the target Chinese population and did not require major changes. It was found that the adapted version of THP manual, handbook, and health calendar were acceptable, understandable, and culturally relevant to the Chinese women and their family members. Nurses were found as a suitable delivery agent by the mothers and their families. Conclusion The Thinking Healthy Programme is acceptable and transferable to the Chinese cultural and healthcare context and nurses are a suitable delivery agent. The translated and adapted version of THP can be used for further implementation and evaluation studies in the Chinese context. Further evaluation can help establish the effectiveness of the programme and barriers to scale-up in China.

Background Exposure to household air pollution is associated with an increased risk of pneumonia in children in low- and middle-income countries; however, exposure-response data are limited, and there are uncertainties around the extent to which biomass-fueled cookstoves can reduce these exposures. Research Question What is the association between exposure to household air pollution and pneumonia in children under the age of 5 years in rural Malawi and what are the effects of a biomass-fueled cookstove intervention on personal exposure to household air pollution? Study Design and Methods We measured personal exposure to carbon monoxide (CO; 48 hours of continuous measurement and transcutaneous carboxyhemoglobin) every 6 months in children who participated in a cluster-randomized controlled trial of a cleaner burning biomass-fueled cookstove intervention to prevent pneumonia in children under the age of 5 years in rural Malawi (the Cooking And Pneumonia Study). Exposure-response and multivariable analyses were done. Results We recruited 1805 (928 intervention; 877 control) children (mean age, 25.6 months; 50.6% female). We found no evidence of an association between exposure to CO (incident rate ratio, 1.0; 95% CI, 0.967 to 1.014; P = .53) or carboxyhemoglobin (incident rate ratio, 1.00; 95% CI, 0.993 to 1.003; P = .41) in children who experienced pneumonia vs those who did not. Median exposure to CO in the intervention and control groups was was 0.34 (interquartile range, 0.15 to 0.81) and 0.37 parts per million (interquartile range, 0.15 toa 0.97), respectively. The group difference in means was 0.46 (95% CI, −0.95 to 0.012; P = .06). Interpretation Exposure to CO in our population was low with no association seen between exposure to CO and pneumonia incidence and no effect of the Cooking And Pneumonia Study intervention on these exposures. These findings suggest that CO may not be an appropriate measure of household air pollution exposure in settings such as rural Malawi and that there is a need to develop ways to measure particulate matter exposures directly in young children instead. Clinical Trial Registration ISRCTN59448623.

The aim of this study was to assess the effect of low maternal weight at pre-pregnancy and the average gestational weight gain on undernourished children and their intellectual development. From October 2012 to September 2013, we followed 1744 offspring of women who participated in a trial conducted from 2002 to 2006. Pregnant women recruited in the original trial could receive three prenatal health checks for free, at which maternal weight and height were measured. WISC-IV was used to estimate the intellectual development of children. Weight and height of both pregnant women and children were measured by trained anthropometrists using standard procedures. Having low maternal weight at pre-pregnancy was associated with an increased risk of undernutrition amongst children (underweight: OR = 2.02, 95%CI: 1.14–3.56, thinness: OR = 2.79, 95%CI: 1.50–5.17) and a decrease in verbal comprehension index (−2.70 points, 95%CI: −4.95–0.44) of children. The effect of average gestational weight gain on occurrences of underweight children (OR = 0.08, 95%CI: 0.01–0.55) was also found. We identified the effect of maternal pre-pregnancy underweight on impairment of the separate intellectual domains (verbal comprehension index) and increasing occurrence of undernourished children. Average gestational weight gain was positively associated with a decreased prevalence of underweight children but not with the intellectual development of children in rural China.

Evidence about the effect of maternal vitamin BIn an ongoing cluster randomized controlled trial conducted in three rural counties in northwest China, pregnant women 20 weeks of gestation were randomized to three treatment groups: blank control, iron supplements, or vitamin B complex supplements. All women were administered folic acid supplements during the periconceptional period. In a sub-study, we collected cord blood samples of 331 participants from the control or vitamin B complex groups in the Xunyi county from January 2017 to December 2017. Plasma concentrations of folate, vitamin BCompared with newborns whose mothers were in the control group, newborns of the vitamin B complex-supplemented women had significantly higher cord plasma vitamin BMaternal vitamin B complex supplementation during pregnancy was associated with better neonatal vitamin B

Background: Ivermectin is being considered for mass drug administration for malaria due to its ability to kill mosquitoes feeding on recently treated individuals. However, standard, single doses of 150–200 μg/kg used for onchocerciasis and lymphatic filariasis have a short-lived mosquitocidal effect (2 ; women: 2 ), with permuted blocks of three, to receive 3 days of ivermectin 300 μg/kg per day, ivermectin 600 μg/kg per day, or placebo, all co-administered with 3 days of dihydroartemisinin-piperaquine. Blood of patients taken on post-treatment days 0, 2 + 4 h, 7, 10, 14, 21, and 28 was fed to laboratory-reared Anopheles gambiae sensu stricto mosquitoes, and mosquito survival was assessed daily for 28 days after feeding. The primary outcome was 14-day cumulative mortality of mosquitoes fed 7 days after ivermectin treatment (from participants who received at least one dose of study medication). The study is registered with ClinicalTrials.gov, number NCT02511353. Findings: Between July 20, 2015, and May 7, 2016, 741 adults with malaria were assessed for eligibility, of whom 141 were randomly assigned to receive ivermectin 600 μg/kg per day (n=47), ivermectin 300 μg/kg per day (n=48), or placebo (n=46). 128 patients (91%) attended the primary outcome visit 7 days post treatment. Compared with placebo, ivermectin was associated with higher 14 day post-feeding mosquito mortality when fed on blood taken 7 days post treatment (ivermectin 600 μg/kg per day risk ratio [RR] 2·26, 95% CI 1·93–2·65, p

Early first-trimester medical abortion (MA) service (≤ 63 days) has been provided by doctors and nurses under doctors’ supervision since 2009 in Nepal. This paper assesses whether MA services provided by specifically trained and certified nurses and auxiliary nurse-midwives independently from doctors’ supervision, is considered as satisfactory by women as those provided by doctors. The data come from a multi-center, randomized, controlled equivalence trial conducted between April 2009 and March 2010 in five district hospitals in Nepal. Women seeking MA were randomly assigned to doctors or nurses and auxiliary nurse-midwives(ANMs).Eligible women were administered 200 mg mifepristone orally followed by 800 μg misoprostol vaginally two days later by their assigned providers and followed up 10–14 days later. At the follow-up visit women’s reported satisfaction with MA service they received was measured. Of 1295 women screened for eligibility, 535 were randomly assigned to a doctor and 542 to a nurse or ANM. Nineteen women were lost-to-follow up in the former group and 27 were lost-to-follow up or did not complete the acceptability interview in the latter group. This study is, therefore, based on516womenin the doctor’s group and 515 women in the nurse or ANM group. All women in the nurse or ANM group reported being satisfied or highly satisfied by MA compared to 99% in the doctor’s group. Satisfaction was similar regardless of the type of provider; 38% among nurse or ANM and 35% among the doctor group were “highly satisfied”, and 62% and 64%, respectively, were “satisfied”. Women’s experiences such as ‘less than expected amount or duration of bleeding following MA’, ‘shorter than expected duration of the abortion process’, and ‘able to manage symptoms’, were found to be associated with women’s higher satisfaction with MA. Counseling and information on the method, potential complications of MA and post-abortion contraception was nearly universal. No statistically significant differences were found in the level of satisfaction by age, parity, marital status, education or occupation of women. Women’s satisfaction with MA service provided by trained nurses or auxiliary nurse-midwives was similar to that provided by doctors. The findings, therefore, provide support for extending safe and accessible medical abortion services by government-trained nurses and auxiliary nurse midwives to women seeking early first trimester pregnancy termination. The trial was retrospectively registered with ClinicalTrials.gov (identifier: NCT01186302 ). Registered August 20, 2010.

Background: A reduction in the density of capillaries (rarefaction) is known to occur in many tissues in patients with essential hypertension and play a role in increasing Blood Pressure (BP). The aim of this trial was to assess in a randomized, double blind, design the effects of treatment of hypertension with candesartan versus amlodipine on microvascular rarefaction and other indices of vascular function.\ud \ud Methods: We recruited twenty-two individuals with mild-to-moderate hypertension. After a 2-week placebo run-in period, patients who remained hypertensive (≥140/90 mmHg) were randomized to 8-weeks treatment with Candesartan tablets 8mg daily (with forced titration to 16mg) or Amlodipine tablets 5mg daily (with forced titration to 10mg). The capillary microcirculation was studied using CapiScope system CAM1. Pulse wave velocity, central BP and aortic Augmentation Index were also measured.\ud \ud Results: We observed significant reductions in brachial BP, and central BP after 4 and 8 weeks treatment with either candesartan or amlodipine but there was no significant effect on basal (functional) or maximal (structural) capillary densities, or pulse wave velocity.\ud \ud Conclusion: Eight weeks treatment of hypertension with either amlodipine or candesartan significantly reduced brachial and central BP but was not sufficient to induce a regression in functional or structural microvascular abnormalities.

Background Adolescence is a sensitive time for girls’ sexual and reproductive health (SRH), as biological changes occur concurrently with heightening pressures for sexual activity. In western Kenya, adolescent girls are vulnerable to acquiring sexually transmitted infections (STIs), such as HIV and herpes simplex virus type 2 (HSV-2), and to becoming pregnant prior to reaching adulthood. This study examines associations between individual, household, and partner-related risk factors and the prevalence of sex, adolescent pregnancy, HIV, and HSV-2. Methods and findings We report baseline findings among 4,138 girls attending secondary school who were enrolled between 2017 and 2018 in the Cups or Cash for Girls (CCG) cluster randomized controlled trial in Siaya County, rural western Kenya. Laboratory confirmed biomarkers and survey data were utilized to assess the effects of girls’ individual, household, and partner characteristics on the main outcome measures (adolescent reported sex, prior pregnancy, HIV, and HSV-2) through generalized linear model (GLM) analysis. Complete data were available for 3,998 girls (97%) with median age 17.1 years (interquartile range [IQR] 16.3 to 18.0 years); 17.2% were HSV-2 seropositive (n = 686) and 1.7% tested positive for HIV (n = 66). Sexual activity was reported by 27.3% girls (n = 1,090), of whom 12.2% had been pregnant (n = 133). After adjustment, orphanhood (adjusted risk ratio [aRR] 2.81, 95% confidence interval [CI] 1.18 to 6.71, p-value [p] = 0.020), low body mass index (BMI) (aRR 2.07; CI: 1.00 to 4.30, p = 0.051), and age (aRR 1.34, 1.18 to 1.53, p < 0.001) were all associated with HIV infection. Girls reporting light menstrual bleeding (aRR 2.42, 1.22 to 4.79, p = 0.012) for fewer than 3 days (aRR 2.81, 1.16 to 6.82, p = 0.023) were over twice as likely to have HIV. Early menarche (aRR 2.05, 1.33 to 3.17, p = 0.001) was associated with adolescent pregnancy and HSV-2–seropositive girls reported higher rates of pregnancy (aRR 1.62, CI: 1.16 to 2.27, p = 0.005). High BMI was associated with HSV-2 (aRR 1.24, 1.05 to 1.46, p = 0.010) and sexual activity (aRR 1.14, 1.02 to 1.28, p = 0.016). High levels of harassment were detected in the cohort (41.2%); being touched indecently conveyed the strongest association related to reported sexual activity (aRR 2.52, 2.26 to 2.81, p < 0.001). Study limitations include the cross-sectional design of the study, which informs on the SRH burdens found in this population but limits causal interpretation of associations, and the self-reported exposure ascertainment, which may have led to possible underreporting of risk factors, most notably prior sexual activity. Conclusions Our findings indicate that adolescent girls attending school in Kenya face frequent harassment for sex and are at high risk of pregnancy and HSV-2, with girls experiencing early menarche particularly vulnerable. Targeted interventions, such as earlier sexual education programs, are warranted to address their vulnerability to SRH harms. Trial registration ClinicalTrials.gov NCT03051789., In a cross sectional analysis, Garazi Zulaika and colleagues study associations between risk factors and prevalence of sexual activity, pregnancy, and HIV and HSV-2 infections among adolescent girls in rural Kenya., Author summary Why was this study done? Girls in low- and middle-income countries (LMICs) face severe health risks from becoming pregnant prior to reaching adulthood and from exposure to sexually transmitted infections (STIs) such as HIV and herpes simplex virus type 2 (HSV-2). Key factors found to be linked to adolescent sexual and reproductive health (SRH) in LMICs include household wealth, age at first sex, and schooling. Evidence of a positive association between girls’ SRH, and their education and economic potential has strengthened international resolve to identify risks and improve conditions that adolescent girls face in these settings. What did the researchers do and find? We collected data from 3,998 girls attending 96 public secondary day schools in 2017 and 2018 as part of the baseline assessment of a randomized controlled study. We explored whether girls’ personal characteristics were associated with SRH harms, namely adolescent sex, early pregnancy, and acquisition of HIV and HSV-2. We found biological factors including girls experiencing early menarche, having lighter periods, and body mass index (BMI); household level factors including being unhappy at home, being orphaned, and coming from poorer households; and social factors including experiencing harassment for sex both in and out of school or being touched indecently were significantly associated with girls’ sexual and reproductive harms, such as pregnancy, HSV-2, and/or HIV. What do these findings mean? These findings illustrate that the burden of SRH harms faced by adolescent girls attending school in rural western Kenya is high. Interventions and programs to improve SRH and continued education need to address both environmental and biological risk factors among vulnerable populations.

The geographical variation of maternal dietary patterns related to birth outcomes is important for improving the health of mothers and children; however, it is currently unknown. Thus, the objective of the study was to investigate geographical variations of maternal dietary pattern during pregnancy, and evaluate the spatial varying association of maternal dietary patterns in pregnancy with abnormal birth weight. A population-based cross-sectional study was conducted in Shaanxi province in Northwest China in 2013 to evaluate the relationship between abnormal birth weight and dietary pattern using the Geographically Weighted Logistic Regression (GWLR). Three dietary patterns during pregnancy were extracted through factor analysis, explaining approximately 45.8% of the variability of food intake. Approximately 81.6% of mothers with higher scores on the equilibrium pattern was more unlikely to have small for gestational age (SGA) infants, with the lower OR observed in Central and South Shaanxi. The snacks pattern was positively associated with low birth weight (LBW) for 23.2% of participants, with the highest OR in Central Shaanxi. Among about 80.0% of participants with higher scores on the snacks pattern living in South and Central Shaanxi, there was a higher risk for SGA. The OR values tend to descend from South to North Shaanxi. The OR values of the negative association between prudent pattern and LBW decreased from South to North Shaanxi among approximately 59.3% of participants. The prudent pattern was also negatively associated with the increasing risk of fetal macrosomia among 19.2% of participants living mainly in South Shaanxi. The association of maternal dietary patterns during pregnancy with abnormal birth weight varied geographically across Shaanxi province. The findings emphasize the importance of geographical distribution to improve the dietary patterns among disadvantaged pregnant women.

IntroductionCalcium dobesilate (CaD) has been used in the treatment of diabetic retinopathy (DR) due to its potential in protecting against retinal vascular damage. However, there is limited evidence exploring its efficacy in combating DR progression. This study is aimed at evaluating whether CaD could prevent DR progression into an advanced stage among Chinese patients with mild-to-moderate non-proliferative DR (NPDR).Methods and analysisThis study is a single-blind, multicentre, cluster-randomised, controlled superiority trial. A total of 1272 patients with mild-to-moderate NPDR will be enrolled and randomly assigned at a 1:1 ratio into the control group (conventional treatment group) and the intervention group (conventional treatment plus CaD (500 mg three times per day) for 12 months). Patients will be followed at 1, 3, 6 and 12 months after randomisation and receiving treatments, with the severity of DR assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. The primary endpoint is the progression of DR during follow-up, which is defined as an increase of two or more steps in the ETDRS scale. The secondary endpoints include the concomitant changes in visual acuity, presence, number, location and type of retinal lesions, and retinal blood vessel diameter as well as the arteriovenous ratio at different visits.Ethics and disseminationEach local ethics committee (first Vote: Ethical Review Committees of Zhongda Hospital of Southeast University (2019ZDSYLL132-P01)) has approved the study. The results will be published in high impact peer-reviewed scientific journals aimed at the general reader.Trial registration numbersNCT04283162.

Summary Adding low-dose primaquine to malaria treatment reduced gametocyte carriage by 73%. Patients who received primaquine had more frequent hemoglobinuria and there was a greater reduction in haemoglobin concentration in G6PD-deficient patients. One patient who received primaquine developed moderately severe anemia., Introduction More information is needed about the safety of low-dose primaquine in populations where G6PD deficiency is common. Methods Adults with Plasmodium falciparum malaria were randomized to receive 1 of 3 artemisinin combination therapies (ACTs) with or without primaquine (0.25 mg/kg). Glucose-6-phosphate dehydrogenase (G6PD) status was determined using a rapid test. Patients were followed for 28 days to record hemoglobin concentration, adverse events, and gametocyte carriage. The primary end point was the change in Hb at day 7. Results In sum, 274 patients were randomized, 139 received an ACT alone, and 135 received an ACT + primaquine. The mean reduction in Hb at day 7 was similar in each group, a difference in the ACT + PQ versus the ACT alone group of −0.04 g/dL (95% confidence interval [CI] −0.23, 0.31), but the effect of primaquine differed according to G6PD status. In G6PD-deficient patients the drop in Hb was 0.63 g/dL (95% CI 0.03, 1.24) greater in those who received primaquine than in those who received an ACT alone. In G6PD-normal patients, the reduction in Hb was 0.22 g/dL (95% CI −0.08, 0.52) less in those who received primaquine (interaction P = .01). One G6PD normal patient who received primaquine developed moderately severe anaemia (Hb < 8 g/dL). Dark urine was more frequent in patients who received primaquine. Primaquine was associated with a 73% (95% CI 24–90) reduction in gametocyte carriage (P = .013). Conclusion Primaquine substantially reduced gametocyte carriage. However, the fall in Hb concentration at day 7 was greater in G6PD-deficient patients who received primaquine than in those who did not and one patient who received primaquine developed moderately severe anemia. Clinical Trial registration PACTR201411000937373 (www.pactr.org)

INTRODUCTION\ud Antimicrobial resistance threatens to undermine treatment for severe infection; new therapeutic strategies are urgently needed. Pre-clinical work shows that augmented passive immunotherapy with P4 peptide increases phagocytic activity and shows promise as a novel therapeutic strategy. Our aim was to determine ex vivo P4 activity in a target population of patients admitted to critical care with severe infection.\ud \ud METHODS\ud We prospectively recruited UK critical care unit patients with severe sepsis and observed clinical course (≥3 months post discharge). Blood samples were taken in early (≤ 48hrs post-diagnosis, n = 54), latent (seven days post-diagnosis, n = 39) and convalescent (3-6 months post-diagnosis, n = 18) phases of disease. The primary outcome measure was killing of opsonised S.pneumoniae by neutrophils with and without P4 peptide stimulation. We also used a flow cytometric whole blood phagocytosis assay to determine phagocyte association and oxidation of intraphagosomal reporter beads.\ud \ud RESULTS\ud P4 peptide increased neutrophil killing of opsonised pneumococci by 8.6% (C.I. 6.35 - 10.76, p

Background. The concept that people with pulmonary tuberculosis are at risk of developing diabetes mellitus has been raised. However, the prevalence of diabetes mellitus in patients with pulmonary tuberculosis have not been well established. We aim to estimate the global, regional, and national prevalence of diabetes mellitus in population with pulmonary tuberculosis. Methods. In this systematic review and meta-analysis, we assessed observational studies of diabetes mellitus in people with pulmonary tuberculosis, using PubMed and Embase electronic bibliographic databases in English language, to identify articles published until August 31, 2018. We included original research studies published in a peer-reviewed journal and reported the prevalence of diabetes mellitus or had enough data to compute these estimates. Studies were excluded if they did not provide primary data or were case studies and reviews. Independent extraction of articles and collected detailed information by 2 authors using predefined questionnaire, including study quality indicators. The country-specific random-effects meta-analyses for countries with two or more available studies and a fractional response regression model to predict individual studies prevalence of diabetes mellitus in patients with pulmonary tuberculosis for countries with one or no study. The study is registered with PROSPERO, registration number CRD42018101989. Results. We identified 18042 studies, and 127 were retained for data extraction across 46 countries. The global prevalence of diabetes mellitus in patients with pulmonary tuberculosis were estimated to be 12.07% (95%CI: 10.43-14.85). The prevalence of diabetes mellitus in patients with pulmonary tuberculosis was 13.38% (95%CI: 11.16-16.05) in region of Americas, 13.34% (95%CI: 12.82-14.61) in European region, 12.68% (95%CI: 9.15-16.37) in South-East Asia, 12.56% (95%CI: 11.79-22.70) in Western Pacific region, 10.95% (95%CI: 9.04-17.83) in Eastern Mediterranean region and 7.54% (95%CI: 6.51-8.77)in African region. The country with the highest estimated prevalence of pulmonary tuberculosis combined diabetes mellitus were Mauritius (39.65%, 95%CI: 4.22-90.74). Conclusion. Our findings suggest that pulmonary tuberculosis combined diabetes mellitus is still prevalent. As such, diabetes mellitus deserves more attention from PTB health-care providers, researchers, policy makers, and stakeholders for improved detection, overall proper management, and efficient control of diabetes mellitus in people with pulmonary tuberculosis.

Randomized trials have shown that complete revascularization in patients with ST-segment elevation myocardial infarction (MI) with multivessel disease results in lower major adverse cardiovascular events (MACE) (all-cause death, MI, ischemia-driven revascularization, heart failure).The goal of this study was to determine whether the benefits of complete revascularization are sustained long-term and their impact on hard endpoints.CvLPRIT (Complete versus Lesion-only Primary PCI Trial) was a randomized trial of complete inpatient revascularization versus infarct-related artery revascularization only at the index admission. Randomized patients have been followed longer-term. The components of the original primary endpoint were collected from physical and electronic patient records, and from local databases for all readmissions.The median follow-up (achieved in90% patients) from randomization to first event or last follow-up was 5.6 years (0.0 to 7.3 years). The primary MACE endpoint rate at this time point was 24.0% in the complete revascularization group but 37.7% of the infarct-related artery-only group (hazard ratio: 0.57; 95% confidence interval: 0.37 to 0.87; p = 0.0079). The composite endpoint of all-cause death/MI was 10.0% in the complete revascularization group versus 18.5% in the infarct-related artery-only group (hazard ratio: 0.47; 95% confidence interval: 0.25 to 0.89; p = 0.0175). In a landmark analysis (from 12 months to final follow-up), there was no significant difference between MACE, death/MI, and individual components of the primary endpoint.Long-term follow-up of the CvLPRIT trial shows that the significantly lower rate of MACE in the complete revascularization group, previously seen at 12 months, is sustained to a median of 5.6 years. A significant difference in composite all-cause death/MI favoring the complete revascularization was also observed. (Complete versus Lesion-only Primary PCI Trial; ISRCTN70913605).

Background: Health anxiety may be an increasing problem because of the focus on monitoring health and increasing use of the Internet for self-diagnosis (cyberchondria). There is very little information about changes in the prevalence of health anxiety. Aim: We compared the prevalence of health anxiety in four medical clinics in one hospital over a 4-year period using the Health Anxiety Inventory (HAI) as a diagnostic marker. Method: Patients attending cardiology, endocrine, gastroenterology and respiratory medicine clinics at King’s Mill Hospital, North Nottinghamshire, completed the HAI while waiting for their appointments. There were eight research assistants involved in collecting data, two in the 2006–2008 period and six in the 2008–2010 period. As a consequence, more data were collected on the second occasion. Results: There was an increase in the prevalence of health anxiety from 14.9% in 2006–2008 (54 positive of 362 assessed) to 19.9% (1,132 positive out of 5,704 assessed) in 2008–2010. This increase was primarily noted in gastroenterology clinics (increase of 10%) and not shown in endocrine ones. Conclusion: The prevalence of health anxiety is increasing in those who attend medical out-patient clinics. Reasons are given that this may be a possible result of cyberchondria, as the excessive use of the Internet to interpret troubling symptoms is growing. Further studies are needed in other populations, but there is reason to be concerned at this trend as it is likely to increase the number of medical consultations unnecessarily.

ObjectivesTo report the situation of maternal micronutrient supplementation before and during pregnancy in Northwest China and to examine the rates of and factors related to the adherence to micronutrient supplementation among pregnant women in this region, where dietary micronutrient intake is commonly insufficient.DesignA large-scale population-based cross-sectional survey.SettingTwenty counties and ten districts of Shaanxi Province.ParticipantsA sample of 30 027 women were selected using a stratified multistage random sampling method. A total of 28 678 women were chosen for the final analysis after excluding those who did not provide clear information about nutritional supplementation before and during pregnancy.Main outcome measuresMaternal adherence to micronutrient supplementation (high and low) were the outcomes. They were determined by the start time and duration of use according to Chinese guidelines (for folic acid (FA) supplements) and WHO recommendations (for iron, calcium and multiple-micronutrient (MMN) supplements).ResultsIn total, 83.9% of women took at least one kind of micronutrient supplement before or during pregnancy. FA (67.6%) and calcium (57.5%) were the primarily used micronutrient supplements; few participants used MMN (14.0%) or iron (5.4%). Adherence to supplementation of all micronutrients was low (7.4% for FA, 0.6% for iron, 11.7% for calcium and 2.7% for MMN). Higher educational levels, higher income levels, urban residence and better antenatal care (including pregnancy consultation and a higher frequency of antenatal visits) were associated with high adherence to micronutrient supplementation.ConclusionMaternal micronutrient supplementation before and during pregnancy in Northwest China was way below standards recommended by the Chinese guidelines or WHO. Targeted health education and future nutritional guidelines are suggested to improve this situation, especially in pregnant women with disadvantaged sociodemographic conditions.

Key Points Question Does primary outcome change between trial registration and publication alter a randomized clinical trial’s reported intervention effect size? Findings In this cross-sectional study that included 389 trials, 130 of them had at least 1 primary outcome change between registration and publication. This significantly overestimated the reported intervention effect size by 16% compared with those without primary outcome change. Meaning Inconsistencies between registered and published primary outcomes in clinical trials are common, with a larger reported intervention effect size among those with primary outcome change than those without., This cross-sectional study examines the status of randomized clinical trials (RCTs) whose primary outcome changed between trial registration and publication and quantifies the association of this change with the reported intervention effect size., Importance Primary outcome change could threaten the validity of a clinical trial; however, evidence about the consequences on the reported intervention effect size is unclear. Objectives To examine the status of randomized clinical trials whose primary outcome changed between trial registration and publication and to quantify the association of this change with the reported intervention effect size. Design, Setting, and Participants In this cross-sectional study on the primary report of randomized clinical trials with clear prospectively registered primary outcomes, PubMed and Embase were searched for articles published between January 1, 2011, and December 31, 2015. The search was conducted in January 2016, identifying randomized clinical trials and the combination of keywords and text words related to registry. Main Outcomes and Measures Based on the developed approach, trials were classified as having primary outcome change when there was a major discrepancy between the registered and published primary outcomes. Intervention effect was estimated or recalculated using the odds ratio (OR) for each comparison. Each component OR is structured so that an OR is less than 1 if the intervention group has a more favorable result than the control group. The ratio of ORs (ROR), which is the summary OR for trials with primary outcome change divided by those without, and its 95% CI were calculated, with a value less than 1 indicating a larger reported intervention effect size in trials with primary outcome change than those without. Results Among 29 749 searched articles (28 810 MEDLINE and 939 Embase), 1488 articles were randomly selected for review. Of 389 trials with clear primary outcomes prospectively described in the registry (416 outcomes reported), 33.4% (130 of 389) of trials had at least 1 primary outcome change. Most (66 of 130) of the changes were either not reporting or omitting the primary outcome. In total, 338 trials (365 outcomes and 487 comparisons) were available for quantitative analysis on the reported intervention effect size bias assessment. Compared with those without primary outcome change, trials with primary outcome change showed a 16% (pooled ROR, 0.84; 95% CI, 0.73-0.96) larger reported intervention effect size. The result persisted after adjustment for potential confounders (ROR, 0.81; 95% CI, 0.71-0.93) and other sensitivity and subgroup analyses. Conclusions and Relevance Results of this study suggest that inconsistencies between registered and published primary outcomes of clinical trials are common, and trials with primary outcome change are likely to have a larger intervention effect than those without.

Background Ensuring equal access to preventive care has always been given a priority in health system throughout world. This study aimed to decompose inequality in utilization of preventive care services into its contributing factors and then explore its changes over the period of China’s 2009–2015 health system reform. Methods The concentration index (CI) and decomposition of the CI was performed to capture income-related inequalities in preventive services utilization and identify contribution of various determinants to such inequality using data from China Health and Nutrition Survey. Then, changes in inequality from 2009 to 2015 were estimated using Oaxaca-type decomposition technique. Results The CI for preventive services utilization dropped from 0.2240 in 2009 to 0.1825 in 2015. Residential location and household income made the biggest contributions to income-related inequalities in these two years. Oaxaca decomposition revealed changes in residential location, regions and medical insurance made positive contributions to decline in inequality. However, alternation in household income, age and medical services utilization pushed the equality toward deterioration. Conclusion The pro-rich inequality in preventive healthcare services usage is evident in China despite a certain decline in such inequality during observation period. Policy actions on eliminating urban-rural and income disparity should be given the priority to equalize preventive healthcare.

BackgroundThe World Health Organization (WHO) End TB Strategy has established a milestone to reduce the number of tuberculosis (TB)- affected households facing catastrophic costs to zero by 2020. The role of active case finding (ACF) in reducing patient costs has not been determined globally. This study therefore aimed to compare costs incurred by TB patients diagnosed through ACF and passive case finding (PCF), and to determine the prevalence and intensity of patient-incurred catastrophic costs in Nepal.MethodsThe study was conducted in two districts of Nepal: Bardiya and Pyuthan (Province No. 5) between June and August 2018. One hundred patients were included in this study in a 1:1 ratio (PCF: ACF, 25 consecutive ACF and 25 consecutive PCF patients in each district). The WHO TB patient costing tool was applied to collect information from patients or a member of their family regarding indirect and direct medical and non-medical costs. Catastrophic costs were calculated based on the proportion of patients with total costs exceeding 20% of their annual household income.The intensity of catastrophic costs was calculated using the positive overshoot method. The chi-square and Wilcoxon-Mann-Whitney tests were used to compare proportions and costs. Meanwhile, the Mantel Haenszel test was performed to assess the association between catastrophic costs and type of diagnosis.ResultsNinety-nine patients were interviewed (50 ACF and 49 PCF). Patients diagnosed through ACF incurred lower costs during the pre-treatment period (direct medical: USD 14 vs USD 32,P = 0.001; direct non-medical: USD 3 vs USD 10,P = 0.004; indirect, time loss: USD 4 vs USD 13,P P = 0.002) and non-medical (USD 30 vs USD 54,P = 0.022) costs among ACF patients. The prevalence of catastrophic direct costs was lower for ACF patients for all thresholds. A lower intensity of catastrophic costs was also documented for ACF patients, although the difference was not statistically significant.ConclusionsACF can reduce patient-incurred costs substantially, contributing to the End TB Strategy target. Other synergistic policies, such as social protection, will also need to be implemented to reduce catastrophic costs to zero among TB-affected households.

IntroductionPneumococcal colonisation is regarded as a pre-requisite for developing pneumococcal disease. In children previous studies have reported colonisation to be a symptomatic event and described a relationship between symptom severity/frequency and colonisation density. The evidence for this in adults is lacking in the literature. This study uses an experimental human pneumococcal challenge model to explore whether pneumococcal colonisation (or co-colonisation with a respiratory virus) is a symptomatic event in healthy adults.MethodsHealthy volunteers aged 18-50 were recruited and inoculated intra-nasally with either Streptococcus pneumoniae (serotypes 6B, 23F) or saline as a control. Respiratory viral swabs were obtained prior to inoculation. Nasal and non-nasal symptoms were then assessed using a modified Likert score between 1 (no symptoms) to 7 (cannot function). The rate of symptoms reported between groups was compared and a correlation analysis performed.ResultsData from 54 participants were analysed. 46 were inoculated with S. pneumoniae (29 with 6B, 17 with 23F) and 8 received saline. In total, 14 became experimentally colonised (30.4%), all of which were inoculated with 6B serotype. There was no statistically significant difference in nasal (p= 0.45) or non-nasal symptoms (p=0.28) between the pneumococcal inoculation group and the saline group. There was no direct correlation between colonisation density and symptom severity in those who were colonised. In the 22% (12/52) who were co-colonised with pneumococcus and respiratory viruses there was no statistical difference in either nasal or non-nasal symptoms (virus positive p=0.74 and virus negative p=1.0).ConclusionPneumococcal colonisation is asymptomatic in healthy adults, regardless of bacterial density or viral co-colonisation.

BACKGROUND Capillary rarefaction (CR) is an established hallmark of essential hypertension (EH). The aim of this study was to examine early changes in capillary density (CD) and blood pressure (BP) in low birth weight (LBW) infants who are at risk of developing EH in later life. METHODS We studied 77 LBW infants and 284 normal birth weight (NBW) infants, all born to mothers with normotension, in a longitudinal multicenter study. Intravital capillaroscopy was used to measure functional basal capillary density (BCD) and maximal capillary density (MCD) at birth, 3, 6, and 12 months. RESULTS We found that LBW infants, born preterm and at term, had a significantly higher CD at birth, then underwent significant CR in the 1st 3 months culminating in a CD similar to that seen in NBW infants. NBW infants showed a gradual reduction in CD between birth and 12 months. Non-Caucasian ethnicity and preterm birth were significant predictors of a higher CD at birth. Systolic BP in NBW infants increased significantly from birth to 3 months, and we identified a significant negative correlation between systolic BP and MCD. CONCLUSIONS This study has identified a process of early “accelerated capillary remodeling” in LBW infants, which corrects their higher CD at birth. This remodeling is unlikely to explain the CR seen in adult individuals with, or at risk of developing EH. Further follow-up studies are required to determine the timing and mechanisms involved in CR, which is likely to occur after the 1st year of life but before early adulthood.

Background Hypertensive disorders of pregnancy (HDP) increase the risk of future cardiovascular disease including hypertension, stroke and diabetes mellitus not only in the affected women but in their offspring as well. Microcirculatory abnormalities and in particular capillary rarefaction (CR) are a hallmark of essential hypertension. We have previously reported that CR is found in individuals with established and borderline hypertension, and in normotensive individuals with a familial predisposition to hypertension. In a previous pilot study, we found that infants born pre-term to mothers with an HDP have significant CR at birth when compared to infants of normotensive mothers. Methods In this BHF funded research, we studied 110 infants born to mothers with an HDP (87 were born with a normal birth weight (NBW) and 23 had low birth weight (LBW) and compared them to 284 NBW infants born at term to normotensive mothers (control group). We used intravital capillary microscopy to measure basal i.e. functional (BCD) and maximal i.e. structural (MCD) skin capillary densities according to a well-validated protocol. We used the Welch Allyn VSM 300TM monitor to measure the infants’ BP. All infants were studied at birth, 3 months, 6 months and 12 months. We report here the results at birth. Results Systolic BP was significantly higher in LBW (81.04±9.99mmHg, p=0.013) and NBW (76.91±11.64mmHg, p=0.043) infants of HDP mothers compared to infants of normotensive mothers (73.69±10.71mmHg). There were no significant differences in diastolic BP. Both LBW and NBW infants born to HDP mothers had significantly higher BCD (mean difference of 13.66, 95%CI 6.82 to 20.51 cap/field; p Conclusion Infants born to mothers with an HDP have significantly higher systolic BP at birth compared to infants of normotensive mothers. Furthermore, LBW infants of HDP mothers have a significantly higher BCD and MCD compared to NBW of normotensive mothers. Further follow-up studies of these infants are required to investigate the role of the microcirculation in the pathogenesis of essential hypertension. Acknowledgement We thank the BHF for funding this research (PG/13/87/30550) Conflict of Interest None

BACKGROUND\ud \ud Many women are affected by anxiety and depression after armed conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan.\ud \ud METHODS\ud \ud In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants.\ud \ud FINDINGS\ud \ud From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94%) of 306 women in the intervention group and 290 (95%) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95% CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95% CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group.\ud \ud INTERPRETATION\ud \ud Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings.\ud \ud FUNDING\ud \ud WHO through a grant from the Office for Foreign Disaster Assistance.

The association between folic acid supplementation and birth defects other than neural tube defects remains unclear. We utilized data from a large population-based survey to examine the association between folic acid supplementation and birth defects in Northwestern China. A total of 29,204 women with infants born between 2010 and 2013 were surveyed in Shaanxi province, Northwestern China, using a stratified multistage sampling method. Propensity scores were used to match 9,293 women with optimal folic acid supplementation with 9,293 women with nonoptimal folic acid supplementation, and the effects of optimal folic acid supplementation on birth defects were assessed by a conditional logistic regression model. After propensity score matching, the overall birth defect rate, cardiovascular system defect rate and nervous system defect rate for the women with optimal folic acid supplementation were lower than those for the women with nonoptimal folic acid supplementation (overall birth defects: OR = 0.71, 95% CI = 0.57–0.89, P = 0.003; cardiovascular system defects: OR = 0.65, 95% CI = 0.44–0.96, P = 0.032; nervous system defects: OR = 0.13, 95% CI = 0.02–0.99, P = 0.049). Optimal folic acid supplementation was associated with a decreased prevalence of birth defects, especially in the cardiovascular system and nervous system. Our findings have important implications for birth defect intervention with folic acid supplementation for countries with a high prevalence of birth defects, such as China.

The associations between growth during early life and subsequent cognitive development and physical outcomes are not widely known in low-resource settings. We examined postnatal weight and height gain through early life and related these measurements to the nutritional status and intellectual development of the same children when they were between 7 and 9 years old. Mothers had enrolled in an randomised controlled trial to evaluate the effect of prenatal micronutrient supplementation on birth weight. Their children were born in 2004, their height and weight were measured at 6, 12, 18 and 24 months of age and were followed up between October 2012 and September 2013 (at ages 7–9 years, n 650). Height-for-age, weight-for-age and BMI-for-age were used to describe the nutritional status, and the Wechsler Intelligence Scale for Children fourth edition was used to measure the intellectual function. Multilevel linear and logistic modelling was used to estimate the association between early growth and subsequent growth and intellectual function. After adjustment, weight gain from 6 to 12 months of age was associated with Full-scale Intelligence Quotient, Verbal Comprehension Index, Working Memory Index and Perceptual Reasoning Index. Weight gain during early life was associated with subsequent nutritional status. For every 1 kg increase in weight during the 0- to 6-month period, the OR for underweight, thinness and stunting at 7–9 years of age were 0·19 (95 % CI 0·09, 0·37), 0·34 (95 % CI 0·19, 0·59) and 0·40 (95 % CI 0·19, 0·83), respectively. Weight gain during the periods of 6–12 months of age and 18–24 months of age was also associated with a lower risk of being underweight. Weight gain during early life was associated with better growth outcomes and improved intellectual development in young school-aged children.

Aims:The aim of this feasibility trial was to evaluate the feasibility and acceptability of the locally adapted Group Problem Management Plus (PM+) intervention for women in the conflict affected settings in Swat, Pakistan.Methods:This mixed-methods study incorporated a quantitative component consisting of a two arm cluster randomised controlled feasibility trial, and qualitative evaluation of the acceptability of the Group PM+ to a range of stakeholder groups. For the quantitative component, on average from each of the 20 Lady Health Workers (LHWs) catchment area (20 clusters), six women were screened and recruited for the trial with score of >2 on the General Health Questionnaire and score of >16 on the WHO Disability Assessment Schedule. These LHW clusters were randomised on a 1 : 1 allocation ratio using a computer-based software through a simple randomisation method to the Group PM+ intervention or Enhanced Usual Care. The Group PM+ intervention consisted of five weekly sessions of 2 h duration delivered by local non-specialist females under supervision. The primary outcome was individual psychological distress, measured by levels of anxiety and depression on the Hospital Anxiety and Depression Scale at 7th week after baseline. Secondary outcomes include symptoms of depression, post-traumatic stress disorder (PTSD), general psychological profile, levels of functioning and generalised psychological distress. Intervention acceptability was explored through in-depth interviews.Results:The results show that lay-helpers with no prior mental health experience can be trained to achieve the desired competency to successfully deliver the intervention in community settings under supervision. There was a good intervention uptake, with Group PM+ considered useful by participants, their families and lay-helpers. The outcome evaluation, which was not based on a large enough study to identify statistically significant results, indicated statistically significant improvements in depression, anxiety, general psychological profile and functioning. The PTSD symptoms and depressive disorder scores showed a trend in favour of the intervention.Conclusion:This trial showed robust acceptance in the local settings with delivery by non-specialists under supervision by local trained females. The trial paves the way for further adaptation and exploration of the outcomes through larger-scale implementation and definitive randomised controlled trials in the local settings.

Objective The aim of the present study is to identify the average effect across different time points and to specify the time effects of maternal pre-pregnancy BMI and weekly gestational weight gain on the mental development and physical growth of infants. Methods The present cohort study used a repeated measures study design that began in 2004 with follow up at 3, 6, 12, 18, and 24 months of age. The participants were a subset from a controlled, cluster-randomized, double-blind trial. Bayley Scales of Infant Development (BSID) were used to estimate the mental development of infants. A generalized estimating equation linear model was used to estimate the effects of maternal BMI and weight gain. Results The average effect of maternal BMI and weight gain on the weight for age Z scores (WAZ), length for age Z scores (LAZ) and mental development index (MDI) across the different time points of infants was significant. In addition, the maternal BMI and weight gain were positively and significantly associated with the WAZ and LAZ in infants of different ages. However, the effect of weekly gestational weight gain was significant only during the earlier period of life (3 months, Coefficient: 11.15, 95%CI: 4.89–17.41). Conclusions Our results indicate positive effects of pre-pregnancy and prenatal nutrition on the physical growth of infants. Weekly gestational weight gain of the pregnant women had a positive effect on the mental development of the infants, but this effect appears to decline over time. Electronic supplementary material The online version of this article (10.1186/s12937-019-0432-8) contains supplementary material, which is available to authorized users.

High out-of-pocket (OOP) payments for chronic disease care often contribute directly to household poverty. Although previous studies have explored the determinants of impoverishment in China, few published studies have compared levels of impoverishment before and after the New Health Care Reform (NHCR) in households with members with chronic diseases (hereafter referred to as chronic households). Our study explored this using data from the fourth and fifth National Health Service Surveys conducted in Shaanxi Province. In total, 1938 households in 2008 and 7700 households in 2013 were included in the analysis. Rates of impoverishment were measured using a method proposed by the World Health Organization. Multilevel logistic modeling was used to explore the influence of the NHCR on household impoverishment. Our study found that the influence of NHCR on impoverishment varied by residential location. After the reform, in rural areas, there was a significant decline in impoverishment, although the impoverishment rate remained high. There was little change in urban areas. In addition, impoverishment in the poorest households did not decline after the NHCR. Our findings are important for policy makers in particular for evaluating reform effectiveness, informing directions for health policy improvement, and highlighting achievements in the efforts to alleviate the economic burden of households that have members with chronic diseases.

Cryptococcal meningitis (CM) is a major cause of mortality in HIV programmes in Africa despite increasing access to antiretroviral therapy (ART). Mortality is driven in part by limited availability of amphotericin-based treatment, drug-induced toxicities of amphotericin B deoxycholate and prolonged hospital admissions. A single, high-dose of liposomal amphotericin (L-AmB, Ambisome) on a fluconazole backbone has been reported as non-inferior to 14 days of standard dose L-AmB in reducing fungal burden. This trial examines whether single, high-dose L-AmB given with high-dose fluconazole and flucytosine is non-inferior to a seven-day course of amphotericin B deoxycholate plus flucytosine (the current World Health Organization [WHO] recommended treatment regimen).An open-label phase III randomised controlled non-inferiority trial conducted in five countries in sub-Saharan Africa: Botswana, Malawi, South Africa, Uganda and Zimbabwe. The trial will compare CM induction therapy with (1) a single dose (10 mg/kg) of L-AmB given with 14 days of fluconazole (1200 mg/day) and flucytosine (100 mg/kg/day) to (2) seven days amphotericin B deoxycholate (1 mg/kg/day) given alongside seven days of flucytosine (100 mg/kg/day) followed by seven days of fluconazole (1200 mg/day). The primary endpoint is all-cause mortality at ten weeks with a non-inferiority margin of 10% and 90% power. Secondary endpoints are early fungicidal activity, proportion of grade III/IV adverse events, pharmacokinetic parameters and pharmacokinetic/pharmacodynamic associations, health service costs, all-cause mortality within the first two and four weeks, all-cause mortality within the first ten weeks (superiority analysis) and rates of CM relapse, immune reconstitution inflammatory syndrome and disability at ten weeks. A total of 850 patients aged ≥ 18 years with a first episode of HIV-associated CM will be enrolled (425 randomised to each arm). All patients will be followed for 16 weeks. All patients will receive consolidation therapy with fluconazole 800 mg/day to complete ten weeks of treatment, followed by fluconazole maintenance and ART as per local guidance.A safe, sustainable and easy to administer regimen of L-AmB that is non-inferior to seven days of daily amphotericin B deoxycholate therapy may reduce the number of adverse events seen in patients treated with amphotericin B deoxycholate and shorten hospital admissions, providing a highly favourable and implementable alternative to the current WHO recommended first-line treatment.ISRCTN, ISRCTN72509687 . Registered on 13 July 2017.

Additional file 2. Algorithm for TB REACH active case finding through contact tracing, Nepal, 2018.

Background: The prevalence of perinatal depression is 16.3% in China and has shown a rising trend in the last decade. However, very few studies were found comparing and summarizing psychosocial interventions for perinatal depression. This study aimed at evaluating and characterizing psychosocial interventions for perinatal depression in Mainland China. Methods: In this systematic review and meta-analysis, ten major English and Chinese language electronic bibliographic databases were searched for randomized controlled trials examining the effect of psychosocial interventions for perinatal depressed women in Mainland China. Studies meeting eligibility criteria and published before 25th February 2019 were included, while those focusing on a very specific sub-population or reporting non-psychosocial interventions were excluded. Data was extracted from articles by a standard form. Meta-analysis was conducted to obtain a summary measure of the effectiveness of the interventions in reducing perinatal depressive symptoms. The theoretical underpinnings and implementation processes of the interventions were also characterised. Findings: A total of 6,857 articles were identified in the initial database searching, of which, 26 studies were eligible for data analysis, representing a sample size of 4,673. Meta-analysis indicated that psychosocial interventions in China significantly reduced perinatal depressive symptoms (standard difference in means 0·81, 95% confidence intervals -1·03 to -0·58, P

Objective. The use of cumulative live birth rate (CLBR) per ovarian stimulation cycle is proving to be an accurate method to calculate the success of IVF; however, the cycle outcome is closely associated with the number of embryos transferred (ET). Our aim was to report CLBR after IVF according to the number of embryos required to achieve a live birth in women aged ≥35 years, considering age, body mass index (BMI), and ethnicity. Methods. We conducted a retrospective cohort study including 1344 patients who underwent IVF between January 2013 and June 2016 at the First Affiliated Hospital of Xinjiang Medical University. The cumulative probability of live birth for each couple was estimated using the Kaplan–Meier method, and survival curves were compared according to age, BMI, and ethnicity using the log-rank test. Results. CLBR increased rapidly from 1 to 5 ETs, moderately from 6 to 10 ETs, and slowly thereafter. CLBR was significantly different across 4 categories based on BMI as well as across those based on age; low CLBR was significantly associated with the age of ≥42 years and obesity. Conclusion. The association between CLBR and number of ET provides realistic and precise information regarding the success of IVF and can be applied to guide clinicians and patients.

Table S1. Baseline characteristics of participants in excluded and included groups. Table S2. Association between gestational weekly weight gain and development of infants. Table S3. Association between maternal pre-pregnancy BMI and development of infant (sensitivity analysis, multiple imputation method). Table S4. Association between gestational weekly weight gain and development of infant (sensitivity analysis, multiple imputation method). (DOCX 33 kb)