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Introduction Emotional problems are leading contributors to health burden among adolescents worldwide. There is an urgent need for evidence-based psychological interventions for young people. This study aims to evaluate the effectiveness of a school-based, group psychological intervention, Early Adolescent Skills for Emotions (EASE) developed by the WHO to improve psychosocial distress in Pakistani adolescents.Method and analysis A two-arm, single-blinded, cluster randomised controlled trial, with a wait-list control arm is being conducted in school settings of rural Pakistan. Forty eligible public-school clusters have been randomised (stratified by gender) on a 1:1 allocation ratio into intervention (n=20) and control arm (n=20). Following informed consent, 564 adolescents with psychosocial distress (Youth-reported Paediatric Symptoms Checklist, cut-off ≥28) from 40 schools have been enrolled into the trial (14±3 average cluster size) between 2 November 2021 and 30th November 2021. Participants in the intervention arm will receive EASE in 7-weekly adolescents and 3-biweekly caregivers group sessions in schools. The adolescent sessions involve the components of psychoeducation, stress management, behavioural activation, problem-solving and relapse prevention. Caregivers will receive training to learn and implement active listening; spending quality time and using praise as a strategy to help their children. The primary outcome is reduction in psychosocial distress at 3 months postintervention. Secondary outcomes include symptoms of depression and anxiety, caregiver–adolescent relationship and caregivers’ well-being. Outcomes will be assessed at baseline, immediate 1 week and 3-months postintervention. Qualitative process evaluation will explore barriers and facilitators to programme implementation in low-resource school settings.Ethics Ethics approval has been obtained from Central Ethics Committee of University of Liverpool, UK, Ethics Review Committee of WHO Geneva and from the Institutional Review Board of Human Development Research Foundation (HDRF), Pakistan.Dissemination The findings of the study will be disseminated by WHO and through peer-reviewed publications.Trial registration number ISRCTN17755448.

Introduction Despite widely available vaccinations, Streptococcus pneumoniae (SPN) remains a major cause of morbidity and mortality worldwide, causing community-acquired pneumonia, meningitis, otitis media, sinusitis and bacteraemia. Here, we summarise an ethically approved protocol for a double-blind, randomised controlled trial investigating the effect of the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPV23) on pneumococcal nasopharyngeal colonisation acquisition, density and duration using experimental human pneumococcal challenge (EHPC).Methods and analysis Healthy adult participants aged 18–50 years will be randomised to receive PCV13, PPV23 or placebo and then undergo one or two EHPCs involving intranasal administration of SPN at 1-month post-vaccination with serotype 3 (SPN3) and 6 months with serotype 6B (SPN6B). Participants randomised to PCV13 and placebo will also be randomised to one of two clinically relevant SPN3 strains from distinct lineages within clonal complex 180, clades Ia and II, creating five study groups. Following inoculation, participants will be seen on days 2, 7, 14 and 23. During the follow-up period, we will monitor safety, colonisation status, density and duration, immune responses and antigenuria. The primary outcome of the study is comparing the rate of SPN3 acquisition between the vaccinated (PCV13 or PPV23) and unvaccinated (placebo) groups as defined by classical culture. Density and duration of colonisation, comparison of acquisition rates using molecular methods and evaluation of the above measurements for individual SPN3 clades and SPN6B form the secondary objectives. Furthermore, we will explore the immune responses associated with these vaccines, their effect on colonisation and the relationship between colonisation and urinary pneumococcal antigen detection.Ethics and dissemination The study is approved by the NHS Research and Ethics Committee (Reference: 20/NW/0097) and by the Medicines and Healthcare products Regulatory Agency (Reference: CTA 25753/0001/001–0001). Findings will be published in peer-reviewed journals.Trial registration number ISRCTN15728847, NCT04974294.

Background HIV, diabetes and hypertension have a high disease burden in sub-Saharan Africa. Healthcare is organised in separate clinics, which may be inefficient. In a cohort study, we evaluated integrated management of these conditions from a single chronic care clinic.Objectives To determined the feasibility and acceptability of integrated management of chronic conditions in terms of retention in care and clinical indicators.Design and setting Prospective cohort study comprising patients attending 10 health facilities offering primary care in Dar es Salaam and Kampala.Intervention Clinics within health facilities were set up to provide integrated care. Patients with either HIV, diabetes or hypertension had the same waiting areas, the same pharmacy, were seen by the same clinical staff, had similar provision of adherence counselling and tracking if they failed to attend appointments.Primary outcome measures Retention in care, plasma viral load.Findings Between 5 August 2018 and 21 May 2019, 2640 patients were screened of whom 2273 (86%) were enrolled into integrated care (832 with HIV infection, 313 with diabetes, 546 with hypertension and 582 with multiple conditions). They were followed up to 30 January 2020. Overall, 1615 (71.1%)/2273 were female and 1689 (74.5%)/2266 had been in care for 6 months or more. The proportions of people retained in care were 686/832 (82.5%, 95% CI: 79.9% to 85.1%) among those with HIV infection, 266/313 (85.0%, 95% CI: 81.1% to 89.0%) among those with diabetes, 430/546 (78.8%, 95% CI: 75.4% to 82.3%) among those with hypertension and 529/582 (90.9%, 95% CI: 88.6 to 93.3) among those with multimorbidity. Among those with HIV infection, the proportion with plasma viral load

Introduction Millions of children in low resource settings are at high risk of poor development due to factors such as under nutrition, inadequate stimulation and maternal depression. Evidence-based interventions to address these risk factors exist, but often as a separate and overlapping package. The current study aims to evaluate the effectiveness of a common elements-based intervention to improve mother–infant interaction at 12 months post-partum.Method and analysis A two-arm, single-blinded, individual randomised controlled trial is being carried out in the community settings of the rural subdistrict of Gujar Khan in Rawalpindi, Pakistan. 250 pregnant women in third trimester with distress (Self-Reporting Questionnaire, cut-off score >9) have been randomised on 1:1 allocation ratio into intervention (n=125) and treatment-as-usual arms (n=125). The participants in the intervention arm will receive 15 individual sessions of intervention on a monthly basis by non-specialist facilitators. The intervention involves components of early stimulation, learning through play, responsive feeding, guided discovery using pictures, behavioural activation and problem solving. The primary outcome is caregiver–infant interaction at 12 months postpartum. The secondary outcomes include maternal psychological well-being, quality of life, social support and empowerment. Infant secondary outcomes include growth, nutrition and development. The data will be collected at baseline, 6 and 12 months postpartum. A qualitative process evaluation will be conducted to inform the feasibility of intervention delivery.Ethics Ethics approval for the present study was obtained from the Human Development Research Foundation Institutional Review Board, Islamabad Pakistan.Dissemination If proven effective, the study will contribute to scale-up care for maternal and child mental health in low resource settings, globally. The findings of the present study will be published in peer-reviewed journals and presented at conferences and community forums.Trial registration number NCT04252807.

Background Intravenous recombinant tissue plasminogen activator (r-tPA) and urokinase (UK) are both recommended for the treatment of acute ischaemic stroke (AIS) in China, but with few comparative outcome data being available. We aimed to compare the outcomes of these two thrombolytic agents for the treatment of patients within 4.5 hours of onset of AIS in routine clinical practice in China.Methods A pre-planned, prospective, nationwide, multicentre, real-world registry of consecutive patients with AIS (age ≥18 years) who received r-tPA or UK within 4.5 hours of symptom onset according to local decision-making and guideline recommendations during 2017–2019. The primary effectiveness outcome was the proportion of patients with an excellent functional outcome (defined by modified Rankin scale scores 0 to 1) at 90 days. The key safety endpoint was symptomatic intracranial haemorrhage according to standard definitions. Multivariable logistic regression was used for comparative analysis, with adjustment according to propensity scores to ensure balance in baseline characteristics.Results Overall, 4130 patients with AIS were registered but 320 had incomplete or missing data, leaving 3810 with available data for analysis of whom 2666 received r-tPA (median dose 0.88 (IQR 0.78–0.90) mg/kg) and 1144 received UK (1.71 (1.43–2.00)×104 international unit per kilogram). There were several significant intergroup differences in patient characteristics: r-tPA patients were more educated, had less history of stroke, lower systolic blood pressure, greater neurological impairment and shorter treatment times from symptom onset than UK patients. However, in adjusted analysis, the frequency of excellent outcome (OR 1.18, 95% CI 1.00 to 1.40, p=0.052) and symptomatic intracranial haemorrhage (OR 0.70, 95% CI 0.33 to 1.47, p=0.344) were similar between groups.Conclusions UK may be as effective and carry a similar safety profile as r-tPA in treating mild to moderate AIS within guidelines in China.Registration http://www.clinicaltrials.gov. unique identifier: NCT02854592.

Objective: D-dimer might serve as a marker of thrombogenesis and a hypercoagulable state following plaque rupture. Few studies explore the association between baseline D-dimer levels and the incidence of heart failure (HF), all-cause mortality in an acute myocardial infarction (AMI) population. We aimed to explore this association.Methods: We enrolled 4504 consecutive patients with AMI with complete data in a prospective cohort study and explored the association of plasma D-dimer levels on admission and the incidence of HF, all-cause mortality.Results: Over a median follow-up of 1 year, 1112 (24.7%) patients developed in-hospital HF, 542 (16.7%) patients developed HF after hospitalisation and 233 (7.1%) patients died. After full adjustments for other relevant clinical covariates, patients with D-dimer values in quartile 3 (Q3) had 1.51 times (95% CI 1.12 to 2.04) and in Q4 had 1.49 times (95% CI 1.09 to 2.04) as high as the risk of HF after hospitalisation compared with patients in Q1. Patients with D-dimer values in Q4 had more than a twofold (HR 2.34; 95% CI 1.33 to 4.13) increased risk of death compared with patients in Q1 (p<0.001). But there was no association between D-dimer levels and in-hospital HF in the adjusted models.Conclusions: D-dimer was found to be associated with the incidence of HF after hospitalisation and all-cause mortality in patients with AMI. [ABSTRACT FROM AUTHOR]

Objectives This study explored the relationship between self-management and blood pressure (BP) control in China. Design A cross-sectional study. Setting Eight community health centres from four cities in the Northeast (Shenyang), Northwest (Xi'an), Southwest (Chengdu) and South (Changsha) of China. Participants A total of 873 adults with hypertension, including 360 men and 513 women. Hypertension was defined as systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg. Outcome measurements BP control was the primary outcome variable. This was categorised as good control if individuals with hypertension reduced their BP to <140/90 mm Hg, otherwise, it was categorised as poor control. Secondary outcomes included self-management, defined as: (1) context or condition-specific factors or physical/social environments (eg, age, sex, marital status, education, personal income and health insurance) and (2) process or knowledge/beliefs, self-regulation skills/abilities and social facilitation (eg, treatment, diet, exercise and risk factor management). Data were analysed using logistic regression models using SPSS V.20. Results A total of 67.1% (n=586) participants had poor BP control. Limited outpatient care benefits in mainly rural residents (OR 2.26, 95% CI 1.06 to 4.81) and longer disease duration (OR 1.03, 95% CI 1.01 to 1.04) were associated with poor BP control. Self-management practices reduced the odds of having poor BP control (OR 0.98, 95% CI 0.97 to 0.99). Conclusions The individual and family self-management theory can serve as an effective theory for understanding the key contexts, processes and outcomes essential for BP control in China. Future research should evaluate the effect of a self-management intervention (eg, self-monitoring, medication adherence, regular and routine doctor visits, and social supports) for BP control in China using a multisite cluster randomised controlled trial. Sex and gender difference, cost and patient-reported outcomes should also be examined. [ABSTRACT FROM AUTHOR]

Objectives: Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes. Design: 3-arm single-site open cluster randomised controlled pilot study. Setting: 30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System. Participants: Primary schoolgirls 14-16 years, experienced 3 menses, no precluding disability, and resident in the study area. Interventions: 1 insertable menstrual cup, or monthly sanitary pads, against 'usual practice' control. All participants received puberty education preintervention, and hand wash soap during intervention. Schools received hand wash soap. Primary and secondary outcome measures: Primary: school attrition (drop-out, absence); secondary: sexually transmitted infection (STI) (Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoea), reproductive tract infection (RTI) (bacterial vaginosis, Candida albicans); safety: toxic shock syndrome, vaginal Staphylococcus aureus. Results: Of 751 girls enrolled 644 were followed-up for a median of 10.9 months. Cups or pads did not reduce school dropout risk (control=8.0%, cups=11.2%, pads=10.2%). Self-reported absence was rarely reported and not assessable. Prevalence of STIs in the end-of-study survey among controls was 7.7% versus 4.2% in the cups arm (adjusted prevalence ratio (aPR) 0.48, 0.24 to 0.96, p=0.039), 4.5% with pads (aPR=0.62; 0.37 to 1.03, p=0.063), and 4.3% with cups and pads pooled (aPR=0.54, 0.34 to 0.87, p=0.012). RTI prevalence was 21.5%, 28.5% and 26.9% among cup, pad and control arms, 71% of which were bacterial vaginosis, with a prevalence of 14.6%, 19.8% and 20.5%, per arm, respectively. Bacterial vaginosis was less prevalent in the cups (12.9%) compared with pads (20.3%, aPR=0.65, 0.44 to 0.97, p=0.034) and control (19.2%, aPR=0.67, 0.43 to 1.04, p=0.075) arm girls enrolled for 9 months or longer. No adverse events were identified. Conclusions: Provision of menstrual cups and sanitary pads for ~1 school-year was associated with a lower STI risk, and cups with a lower bacterial vaginosis risk, but there was no association with school dropout. A large-scale trial on menstrual cups is warranted. [ABSTRACT FROM AUTHOR]

Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebocontrolled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20; total of 1010 organisms/day) or matching placebo. Main outcome measure Diagnosed eczema at age 2 years. Infants were followed up by questionnaire. Clinical examination and skin prick tests to common allergens were done at 6 months and 2 years. Results The cumulative frequency of diagnosed eczema at 2 years was similar in the probiotic (73/214, 34.1%) and placebo arms (72/222, 32.4%; OR 1.07, 95% CI 0.72 to 1.6). Among the secondary outcomes, the cumulative frequency of skin prick sensitivity at 2 years was reduced in the probiotic (18/171; 10.5%) compared with the placebo arm (32/173; 18.5%; OR 0.52, 95% CI 0.28 to 0.98). The statistically significant differences between the arms were mainly in sensitisation to cow's milk and hen's egg proteins at 6 months. Atopic eczema occurred in 9/171 (5.3%) children in the probiotic arm and 21/173 (12.1%) in the placebo arm (OR 0.40, 95% CI 0.18 to 0.91). Conclusions The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity. However, the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood. Trial registration Number ISRCTN26287422. [ABSTRACT FROM AUTHOR]

Objectives Cadmium is known to be a significant health hazard, but most information comes from studies of adults. The effects of exposure to cadmium during fetal life on early growth and development remain uncertain. In this study we investigated the placental transport of cadmium and the effects of prenatal cadmium exposure on fetal and child growth in Taiwan. Methods The data in this study were from a birth cohort study in Taiwan which started in 2004. Pregnant women were recruited from four hospitals and interviewed after delivery to collect information on themselves and their infants. Children were followed up to obtain information on growth up to 3 years of age. Whole blood cadmium concentrations in maternal and cord blood samples were measured and the relationship with birth size and growth assessed using linear regression and mixed models. Results 321 maternal blood samples and 402 cord blood samples were eligible for analysis. Among 289 pairs with maternal and cord blood suitable for measurement, the median cadmium concentration in cord blood (0.31 μg/l) was less than that in maternal blood (1.05 μg/l), with low correlation between the two (r=0.04). An increase in cord blood cadmium was found to be associated with newborn decreased head circumference and to be significantly and consistently associated with a decrease in height, weight and head circumference up to 3 years of age. Conclusions Placental transport of cadmium is limited. However, prenatal cadmium exposure may have a detrimental effect on head circumference at birth and child growth in the first 3 years of life. [ABSTRACT FROM AUTHOR]

Background Polypharmacy represents a growing public health concern for its associations with drug-related adverse events, poor adherence, medication errors and increased healthcare costs. Aim To assess the occurrence of polypharmacy prescribing and to identify the correlates in terms of doctors and patients characteristics in rural Western China. Methods 20⇔125 prescriptions were collected from 680 primary health clinics in villages from 40 counties in 10 provinces of Western China. Two outcome variables are used in the analysis: number of drug items prescribed and use of five or more drugs (polypharmacy). A multilevel Poisson regression model and a multilevel logistic regression model were employed to examine the socio-economic, demographic determinants of the above two outcome variables, respectively. Results The average drug number per prescription was 2.36, and the percentage of polypharmacy was 5.8%. The odds for polypharmacy were higher for village doctors with a heavier workload than those with less workload (OR=1.70; 95% CI 1.26 to 2.29). Patients with injections prescribed had higher odds for polypharmacy than patients without injections (OR=4.61; 95% CI 3.93 to 5.42). Village doctor's workload, subsidy for doctors from government and injection in prescriptions, patient's age and gender were also significant predictors of number of drug items prescribed in the studied areas. Conclusions Polypharmacy seems to be associated with the village doctors' and patients' background and government policy. Intervention studies are needed to promote rational use of drugs in rural China. [ABSTRACT FROM AUTHOR]