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PREgnancy Care Integrating translational Science, Everywhere (PRECISE): a prospective cohort study of African pregnant and non-pregnant women to investigate placental disorders - cohort profile.
Get PDFPURPOSE: The PREgnancy Care Integrating translational Science, Everywhere Network was established to investigate specific placental disorders (pregnancy hypertension, preterm birth, fetal growth restriction and stillbirth) in sub-Saharan Africa. We created a repository of clinical and social data with associated biological samples from pregnant and non-pregnant women. Alongside this, local infrastructure and expertise in the field of maternal and child health research were enhanced. PARTICIPANTS: Pregnant women were recruited in participating health facilities in The Gambia, Kenya and Mozambique at their first antenatal visit or at the time a placental disorder was diagnosed (Kenya and The Gambia only). Follow-up study visits were conducted in the third trimester, delivery and 6 weeks to 6 months postpartum. To elucidate the difference between pregnancy and non-pregnancy biology in these settings, non-pregnant nulliparous and parous women, aged 16-49 years, were recruited opportunistically primarily from family planning clinics in Kenya and Mozambique, and randomly through the Health and Demographic Surveillance System in The Gambia. Non-pregnant participants only had one study visit. Biological samples were processed rapidly and locally, stored initially in liquid nitrogen and then at -80°C, and details entered into an OpenSpecimen database linked to their social determinants and clinical research data. FINDINGS TO DATE: A total of 6932 pregnant and 1825 non-pregnant women were recruited to the study, providing a repository of clinical and social data and a biorepository of 482 448 samples. To date, baseline descriptive analysis of the cohort has been undertaken, as well as a substudy on the prevalence of COVID-19 in the cohort. FUTURE PLANS: Analysis of data and samples will include an analysis of biomarker and social and physical determinants of health and how these interact in a systemic approach to understanding the origins of common placental disorders. The data from non-pregnant women will provide control data for comparison with the data from normal and complicated pregnancies. Findings will be disseminated to local stakeholders and communities through meetings and ongoing community engagement and globally by publication and presentations at scientific meetings
A Comparison of Regulatory Maternity Unit Ratings With Clinical Outcomes and Practice Measures: An Observational Study Using Routinely Collected Data.
Get PDFOBJECTIVE: To compare inspection-informed ratings of individual maternity units published by the Care Quality Commission (CQC) with clinical outcomes and practice measures. DESIGN: Observational study using linked national maternity and administrative hospital data. SETTING: The English NHS. POPULATION: Women with singleton pregnancies who gave birth at term, April 2018-March 2019. METHODS: Outcomes and practice measures were compared with ratings using hierarchical models and empirical Bayes estimates adjusted for case-mix and unit characteristics. MAIN OUTCOME MEASURES: Severe maternal and severe neonatal morbidity. Practice measures included non-spontaneous birth (either caesarean birth before labour or the induction of labour) and intrapartum caesarean birth. RESULTS: Of 501 719 included women, 39 930 (8.0%) gave birth in 11 units rated 'outstanding', 357 114 (71.2%) in 110 units rated 'good', and 104 675 (20.9%) in 35 units rated 'requires improvement/inadequate'. Severe maternal morbidity did not vary by rating: 1.2% [95% confidence interval 0.87-1.5], 1.3% [1.1-1.4], and 1.0% [0.87-1.1], respectively (p = 0.59), nor did the risk of severe neonatal morbidity: 4.3% [3.3-5.6], 4.0% [3.6-4.5], and 3.4% [2.9-3.9], respectively (p = 0.48). There was no variation across the ratings in the rate of non-spontaneous birth (48.1% [42.2-53.9], 47.9% [46.4-49.4], and 47.9% [45.1-50.8], respectively; p = 0.87) nor intrapartum caesarean (16.8% [14.6-19.3], 16.6% [15.8-17.3], and 15.8% [14.9-16.7], respectively; p = 0.87). CONCLUSIONS: There was no association between ratings of maternity units published by the national healthcare regulator and clinical outcomes and practice measures derived from routinely collected data. Concerted action is urgently needed to improve the inspection-informed ratings of maternity services
How inclusive were strategies to prevent the spread of COVID-19 for people with disabilities? Evidence from qualitative research in eight low- and middle-income countries.
Get PDFBACKGROUND: From the outset of the pandemic there were calls to ensure people with disabilities were included in prevention and response measures, given their increased risk of health consequences from COVID-19 infection. This study sought to explore people with disabilities' experiences of inclusion in the response to the COVID-19 pandemic, to understand how such responses can be more inclusive in the future. METHODS: Qualitative interviews were conducted with 372 people with disabilities and their caregivers in Bangladesh, Ghana, India, Peru, Thailand, Türkiye (with Syrian refugees), Viet Nam, and Zimbabwe between 1 December 2020 and 28 February 2023, and analysed using thematic analysis. RESULTS: The study found that people with disabilities demonstrated high levels of knowledge about COVID-19 and were willing to adhere to prevention measures. However, participants noted that countries' COVID-19 responses were largely not inclusive of people with disabilities; that pandemic information was seldom available in accessible formats; and that adhering to social distancing and other mandates was challenging and incurred personal and economic costs. CONCLUSIONS: Consequently, the pandemic compounded existing barriers and inaccessibility experienced by people with disabilities and contributed to inequality
Safety of RTS,S/AS01E malaria vaccine up to 1 year after the third dose in Ghana, Kenya, and Malawi (EPI-MAL-003): a phase 4 cohort event monitoring study.
Get PDFBACKGROUND: RTS,S/AS01E has been successfully administered to over two million children since 2019 through the Malaria Vaccine Implementation Programme (MVIP). In this Article, we report the safety results of a study evaluating RTS,S/AS01E safety and effectiveness in real-world settings. METHODS: EPI-MAL-003 is an ongoing phase 4 disease surveillance study with prospective cohort event monitoring and hospital-based surveillance, done in the setting of routine health-care practice in Ghana, Kenya, and Malawi and fully embedded in the MVIP. The study design was dependent on the cluster-randomised vaccine implementation. In active surveillance, we enrolled children younger than 18 months from exposed (where RTS,S/AS01E was offered) and unexposed clusters. The coprimary endpoints were the occurrence of predefined adverse events of special interest and aetiology-confirmed meningitis. We report primary and secondary safety results up to 1 year after the primary vaccine schedule (three doses). The study is registered with ClinicalTrials.gov, NCT03855995. FINDINGS: The first participant was enrolled on March 21, 2019. The cutoff date for the current analysis was 1 year after the third RTS,S/AS01E dose for each participant. In total, 44 912 children (19 993 in Ghana, 11 990 in Kenya, and 12 929 in Malawi) were included in the analysis set for the cluster-randomised comparison: 22 508 from exposed clusters and 22 404 from unexposed clusters. Incidence rates (expressed per 100 000 person-years) for generalised convulsive seizures and intussusception were similar between vaccinated and unvaccinated children. Aetiology-confirmed meningitis was reported in two children: one case of bacterial meningitis due to Streptococcus pneumoniae in an RTS,S/AS01E-vaccinated child in the exposed clusters, and one case of viral meningitis due to human herpesvirus 6 in an unvaccinated child in the unexposed clusters. Both cases occurred within 12 months after vaccination in children in the cluster-design analysis set, leading to incidence rates of 4·1 (95% CI 0·1-23·0) per 100 000 person-years in RTS,S/AS01E-vaccinated children and 4·0 (0·1-22·6) per 100 000 person-years in unvaccinated children, and a country-adjusted incidence rate ratio (IRR) of 0·96 (95% CI 0·06-15·34; p=0·98). Cerebral malaria cases were reported for four (<0·1%) of 20 639 RTS,S/AS01E-vaccinated children in the exposed clusters and two (<0·1%) of 22 137 unvaccinated children in the unexposed clusters. These included three and two cases occurring within 12 months after the primary vaccination, in RTS,S/AS01E-vaccinated children and unvaccinated children, respectively (IRR 1·43, 95% CI 0·24-8·58, p=0·70). Incidence rates for all-cause mortality were 659·7 (95% CI 561·5-770·3) in vaccinated children versus 724·5 (622·3-838·8) in unvaccinated children, with similar incidence rates for boys and girls. INTERPRETATION: We found no evidence of vaccination being associated with an increased risk of meningitis, cerebral malaria, or mortality among vaccinated children, and no new safety risks were identified. FUNDING: GSK
Safety and Immunogenicity of a Modified Self-Amplifying Ribonucleic Acid (saRNA) Vaccine Encoding SARS-CoV-2 Spike Glycoprotein in SARS-CoV-2 Seronegative and Seropositive Ugandan Individuals.
Get PDFBACKGROUND: The COVID-19 pandemic highlighted the need for innovative vaccine platforms that elicit durable immunity. Self-amplifying RNA (saRNA) vaccines offer rapid production and dose-sparing advantages over traditional mRNA platforms. In Uganda's first SARS-CoV-2 vaccine trial (NCT04934111), we assessed the safety and immunogenicity of a saRNA vaccine encoding the SARS-CoV-2 spike (S) glycoprotein in seronegative and seropositive adults. METHODS: This non-randomised phase 1 trial (December 2021-April 2022) enrolled 42 healthy adults (18-45 years), including 12 seronegative and 30 seropositive for SARS-CoV-2. Participants received two 5 μg doses of saRNA vaccine, four weeks apart. Reactogenicity was assessed using diary cards for seven days post-vaccination, and adverse events were monitored throughout the 24-week study. Binding and neutralising antibody levels were quantified using ELISA and pseudovirus neutralisation assays. FINDINGS: The vaccine was well tolerated, with only mild-to-moderate adverse events, including fatigue, headache, and chills. No serious vaccine-related events occurred. Among seronegative participants, 91.6% seroconverted after two doses (median S-IgG: 3695 ng/mL, p < 0.001). In the seropositive participants, S-IgG rose modestly from 7496 to 11,028 ng/mL after the second dose. Neutralising titres increased modestly across WT, BA.2, and A.23.1 variants, with no significant differences between groups. CONCLUSION: The saRNA SARS-CoV-2 vaccine was safe and immunogenic, inducing robust spike glycoprotein-specific antibody responses, particularly in seronegative participants. This trial demonstrates the potential of saRNA vaccines for broader use
Voices of youth: youth participation in the CO-CREATE project.
Get PDFINTRODUCTION: Applying youth participatory action research (YPAR) has become common practice in public health. However, there are challenges in applying YPAR and there is a need for improving the process by learning from youth that has participated in such projects. This study explores youth involvement in the CO-CREATE project which focused on developing overweight and obesity prevention policies. METHODS: This is a qualitative study, based on three data sources: 1) fieldnotes taken by project staff during observation of youth (approximately 150 observations) 2) semi-structured interviews with project staff (n = 12) 3) direct feedback from participating youth through feedback forms (n = 51). Data was analyzed in NVivo, following the principles of reflexive thematic analysis. RESULTS: Five themes were generated which showcase youth involvement in CO-CREATE: 1) an inspired and engaged youth; 2) insights through respectful interactions; 3) a strength of voice and call to action; 4) challenges in understanding project and disengagement; and 5) interpersonal conflict and pressure to participate. CONCLUSION: Taking the time to build trust and create a feeling of equality is important. It is also important to allow youth to take the lead when they wish so and have clear ideas of how to do so. Voices of rebelliousness can be a show of strength and help reach the goals of the project. Participation in CO-CREATE may have contributed toward individual empowerment of youth
Efficacy of digital cognitive behavioral therapy for treating insomnia in adults aged 65 and older: a secondary analysis using individual participant data from three randomized controlled trials.
Get PDFOBJECTIVES: Insomnia prevalence increases with age. Although cognitive behavioral therapy (CBT) for insomnia is the first-line treatment, limited accessibility leaves many older adults with few effective treatment options. This study assessed the efficacy of digital CBT (dCBT) for treating insomnia, anxiety, and depression symptoms in adults aged 65 and older. METHOD: Data from three published randomized controlled trials of dCBT for insomnia (Sleepio) versus controls were combined for those aged 65+ with insomnia disorder (N = 315). Insomnia, anxiety, and depression scores were standardized into z-scores for comparison. Mixed-effects models estimated the treatment effect on insomnia, depression, and anxiety outcomes at post-treatment (8-10 wk) and follow-up (24 wk). Chi-squared tests of Sleep Condition Indicator (SCI-8) scores evaluated post-treatment insomnia remission rates between groups. RESULTS: Compared with controls, dCBT generated significantly greater improvements at post-treatment and follow-up in insomnia (gs ≤ -1.88, ps < 0.001) and depression (gs ≤ -0.44, ps ≤ 0.001) and significantly greater improvements in anxiety at post-treatment (g = -0.33, p < 0.001). dCBT generated higher post-treatment insomnia remission rates (60% vs. 16%, p < 0.001). CONCLUSION: dCBT can effectively improve symptoms of insomnia, anxiety, and depression in adults aged 65+. Digital CBT may serve as an accessible means for older adults to receive guideline-concordant treatment at scale and avoid adverse side effects from common pharmacologic interventions
Post-market quality assessment of antibiotics: findings from a cross-sectional study using standardised patients in Tabalong and Bekasi districts, Indonesia.
Get PDFOBJECTIVES: In Indonesia, antibiotics are often purchased without a prescription at community pharmacies, contrary to current regulations. This practice may increase the risk of out-of-specification (OOS) medicines being dispensed, potentially contributing to treatment failure and antibiotic resistance. To address this concern, we assessed the quality of antibiotics purchased without a prescription at private drug retail outlets (PDROs) in Indonesia. DESIGN AND SETTING: We conducted a cross-sectional study in Tabalong and Bekasi, Indonesia, using standardised patients (SPs) who purchased antibiotics without a prescription for three clinical scenarios: upper respiratory tract infection (URTI), tuberculosis (TB) and child diarrhoea. The pharmacies and drug stores were randomly selected from each subdistrict based on the probability proportional method. We measured the active pharmaceutical ingredient (API) content of the antibiotic samples using high-performance liquid chromatography (HPLC). SAMPLES AND ANALYSIS: The quality of 183 antibiotics including amoxicillin tablets (148/183, 80.9%, 95% CI 74.7% to 86.1%), amoxicillin dry syrup (12/183, 6.6%, 95% CI 3.6% to 10.8%), ampicillin tablets (5/183, 2.7%, 95% CI 1.1% to 5.9%) and ciprofloxacin tablets (18/183, 9.8%, 95% CI 6.2% to 14.8%) obtained from 117/166 (70.5%, 95% CI 62.8 to 77.2) PDROs were tested. Descriptive statistics were used to describe the characteristics of the purchased antibiotics, and the API content of each antibiotic was compared against the United States Pharmacopeia 43-National Formulary 38 (USP 43-NF 38) standards in absolute values and percentages. RESULTS: Almost all samples produced in Indonesia (182/183, 99.5%, 95% CI 97.5% to 99.9%) were unbranded (123/183, 67.2%, 95% CI 60.2% to 73.7%) or branded generic (60/183, 32.8%, 95% CI 26.3% to 39.8%) and packaged in strips (165/183, 90.2%, 95% CI 85.2% to 93.8%). Around 12/183 (6.6%, 95% CI 3.6% to 10.8%) antibiotics were found to be OOS; these were mostly amoxicillin 125 mg dry syrup (6/12, 50%, 95% CI 24.3% to 75.7%) and ciprofloxacin 500 mg tablet (5/18, 27.8%, 95% CI 11.5% to 50.6%). Around 33% (4/12, 95% CI 12.5% to 61.2%) of amoxicillin 125 mg dry syrup samples had an API content above the label claim, the highest being 187%, whereas 16.7% (2/12, 95% CI 3.6% to 43.6%) were below the label claim, the lowest being 64%. About 27.8% (5/18, 95% CI 11.5% to 50.6%) of ciprofloxacin samples tested had an API content above the label claim; the highest was 120%. CONCLUSION: While the proportion of OOS antibiotics identified was relatively small, at a population level, it represents a significant proportion of sub-optimally treated infections
A heterogeneity analysis of health-related quality of life in early adults born very preterm or very low birthweight across the sociodemographic spectrum.
Get PDFPreterm birth and very low birthweight (VP/VLBW) are associated with poorer health-related quality of life (HRQoL) outcomes extending into adulthood, yet it remains unclear how these effects differ across sociodemographic subgroups. This study aimed to identify heterogeneity in the association of VP/VLBW on HRQoL in early adulthood, specifically examining maternal age, education, and ethnicity. Individual-level data from three longitudinal cohorts within the Research on European Children and Adults Born Preterm Consortium were analysed, including adults born VP (< 32 weeks' gestation) or VLBW (< 1500g), compared to term-born or normal birthweight controls. HRQoL was assessed using the Health Utilities Index Mark 3 (HUI3) at mean ages of 18-26 years. Bayesian Causal Forest and Shrinkage Bayesian Causal Forest methodologies were employed to estimate conditional average treatment effects. Results indicated significant heterogeneity in the effects of VP/VLBW birth on HRQoL by maternal age and education. Individuals born to mothers aged ≤25 years experienced the largest decrement in HUI3 scores (-0.08; 95 % CI -0.13, -0.02), compared to minimal or no decrements for individuals born to mothers aged ≥26 years. Similarly, lower maternal education was associated with larger decrements (-0.05; 95 % CI -0.09, -0.01), whereas high maternal education showed negligible impact (0.01; 95 % CI -0.04, 0.06). These findings highlight maternal sociodemographic characteristics as critical modifiers of VP/VLBW impacts on adult HRQoL, emphasizing the need for targeted health interventions for disadvantaged groups. Future research is warranted to examine whether modern neonatal care and changes in socioeconomic conditions can mitigate these HRQoL disparities across the life course
School Meals Case Study: Latvia
Get PDFThis school meals case study forms part of a collection led by the Research Consortium for School Health and Nutrition’s "Good Examples" Community of Practice. The School Meals Case Study of Latvia serves to document how the national school meals programme is organized, funded, and monitored throughout the country. The objectives of this case study include presenting an introduction to the country profile, outlining the design and implementation of school feeding programmes, describing their monitoring and evaluation processes, and highlighting lessons learned, best practices, and challenges. This case study is written as a working paper, and can be updated to reflect evolving circumstances. The ‘Good Examples’ Community of Practice supports the evidence generation of the Research Consortium for School Health and Nutrition, the evidence-generating arm of the School Meals Coalition. The Research Consortium’s objective is to carry out independent research across diverse sectors and generate solid, compelling, and actionable evidence regarding the benefits of school food programs to inform evidence-based decision-making on school health and nutrition policies and practices