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Investigating the relationship between unmet need and utilisation of health care in European countries.
Access to health care is a multidimensional concept, influenced by individual and health system factors and the relationship between different access dimensions is not well understood. We used individual-level data from the 2019 wave of the European Health Interview Survey, covering 27 European Union member states, Iceland, and Norway (n = 269,799 individuals) and country-level data from the Eurostat, OECD and World Bank databases to explore this important research gap. We investigated six outcome measures: unmet need due to long wait, distance, affordability of medical care, and affordability of prescribed medicines, and the utilisation of general practitioner, or specialist care. We investigated the relationship between these outcomes and individual characteristics using a multilevel multivariate logit random effects model, which allowed us to model outcomes simultaneously. After controlling for individual socio-economic position, health status and health behaviour, we assessed the correlation between outcomes at individual and country levels to gain insight into the relationship between different dimensions of access. We investigated the association between each outcome measure and health system characteristics including health expenditure, physician density and primary care gatekeeping as well as macroeconomic characteristics (income and income inequality) using multilevel logit random effects models. We found that people with lower self-reported health status, multimorbidity and limitations due to health problems were more likely to report unmet need and utilisation. Higher household income was negatively associated with unmet need and positively associated with utilisation. After controlling for individual characteristics, correlations between unmet need and utilisation were very low (under 10%) at individual level. At country level, there was a negative correlation between unmet need due to the affordability of prescribed medicines and GP (-49%), and specialist (-42%) care. Individuals in countries that incentivised or required a referral from primary to specialist care were less likely to report use of specialist care. Our findings emphasise that unmet need and utilisation measure different dimensions of access, thus underscoring the importance of employing complementary measures of access to health care
The effect of prenatal balanced energy and protein supplementation on gestational weight gain: An individual participant data meta-analysis in low- and middle-income countries.
BACKGROUND: Understanding the effects of balanced energy and protein (BEP) supplements on gestational weight gain (GWG) and how the effects differ depending on maternal characteristics and the nutritional composition of the supplements will inform the implementation of prenatal BEP interventions. METHODS AND FINDINGS: Individual participant data from 11 randomized controlled trials of prenatal BEP supplements (N = 12,549, with 5,693 in the BEP arm and 6,856 in the comparison arm) in low- and middle-income countries were used. The primary outcomes included GWG adequacy (%) and the estimated total GWG at delivery as continuous outcomes, and severely inadequate (125% adequacy) as binary outcomes; all variables were calculated based on the Institute of Medicine recommendations. Linear and log-binomial models were used to estimate study-specific mean differences or risk ratios (RRs), respectively, with 95% confidence intervals (CIs) of the effects of prenatal BEP on the GWG outcomes. The study-specific estimates were pooled using meta-analyses. Subgroup analyses were conducted by individual characteristics. Subgroup analyses and meta-regression were conducted for study-level characteristics. Compared to the comparison group, prenatal BEP led to a 6% greater GWG percent adequacy (95% CI: 2.18, 9.56; p = 0.002), a 0.59 kg greater estimated total GWG at delivery (95% CI, 0.12, 1.05; p = 0.014), a 10% lower risk of severely inadequate GWG (RR: 0.90; 95% CI: 0.83, 0.99; p = 0.025), and a 7% lower risk of inadequate GWG (RR: 0.93; 95% CI: 0.89, 0.97; p = 0.001). The effects of prenatal BEP on GWG outcomes were stronger in studies with a targeted approach, where BEP supplements were provided to participants in the intervention arm under specific criteria such as low body mass index or low GWG, compared to studies with an untargeted approach, where BEP supplements were provided to all participants allocated to the intervention arm. CONCLUSIONS: Prenatal BEP supplements are effective in increasing GWG and reducing the risk of inadequate weight gain during pregnancy. BEP supplementation targeted toward pregnant women with undernutrition may be a promising approach to delivering the supplements
Mixed vulnerabilities: the biological risk of high parity is aggravated by emergency referral in Benin, Malawi, Tanzania and Uganda.
Identification of interacting vulnerabilities is essential to reduce maternal and perinatal mortality in sub-Saharan Africa (SSA). High parity (≥ 5 previous births) is an underemphasized biological vulnerability linked to poverty and affecting a sizeable proportion of SSA births. Despite increased risk, high parity women rarely use hospitals for childbirth. We assessed whether emergency referral during childbirth was associated with adverse events in high parity women in hospitals in Benin, Malawi, Tanzania and Uganda. We used e-registry data collected in 16 hospitals included in the Action Leveraging Evidence to Reduce perinatal morbidity and morTality (ALERT) trial. Main outcomes were severe maternal outcomes and in-facility peripartum death (fresh stillbirth or very early neonatal death). Main exposure was parity; emergency (in-labour) referral was included as effect modifier with potential confounders. We used multivariable logistic regression including parity/referral interaction and post-regression margins analysis. Among 80,663 births, 4,742 (5.9%) were to high parity women. One third reached hospital following emergency referral. Severe maternal outcomes and peripartum mortality were over 2.5-fold higher in high parity women with emergency referral compared to the lowest risk group. To avert these adverse events, emergency referral must be avoided by ensuring high parity women give birth in hospitals. Trial registration Pan African Clinical Trial Registry ( www.pactr.org ): PACTR202006793783148. Registered on 17th June 2020
Ethical issues surrounding the implementation of long-acting injectable antiretroviral therapy in sub-Saharan Africa.
BACKGROUND: This article discusses the ethical issues surrounding the integration of long-acting injectable antiretroviral therapy (LA-ART) in the programmatic management of human immunodeficiency virus (HIV). As the medical landscape evolves, implementing LA-ART introduces many ethical issues that should be considered for the success of scale-up in diverse settings. METHODS: This article examines key issues such as bioethical concerns around the rollout of LA-ART, including regulatory requirements, a person's autonomy, informed consent, privacy and confidentiality; the societal implications of providing LA-ART, including the impact on stigma and discrimination; ethics around who receives LA-ART, financial accessibility, equitable access, inclusive decision-making and cultural sensitivity; and the ethics of providing an expensive intervention, including cost-effectiveness, supply chain sustainability and resource allocation. By critically analysing the ethical issues, we aim to guide policymakers and identify areas for further research. CONCLUSION: Our overarching aim is to ensure that the rights of people living with HIV are protected as implementors plan for the rollout of LA-ART with a focus on eastern and southern Africa. The utilization of LA-ART in resource-limited settings poses significant ethical challenges, necessitating careful consideration of autonomy, access and equity, stigma, discrimination, sustainability and treatment adherence
"Butterflies in a jar": How girls and young women conceptualise wellbeing in conflict-affected Myanmar
Since the 2021 coup in Myanmar, the country has been driven into further social, political and economic turmoil. The United Nations estimates that 18.6 million people need humanitarian support. Among those most affected are adolescent girls aged 10–19 years who, as adolescents and young women, face unique risks to their health and wellbeing and require tailored interventions to promote their health and wellbeing both now and in the future. Supporting adolescent girls and young women during conflict means addressing their increased risk of gender-based violence, forced marriage, disrupted education, and access to health services. There is limited evidence on the effects of Myanmar's current political situation on adolescent girls and young women, and even less on what can be done to support their health and wellbeing during this period of protracted instability. In this qualitative study, we used the capabilities approach to conceptualise wellbeing from the perspectives of adolescent girls and young women in Myanmar. Collaborating with four young female peer-researchers, we conducted 12 participatory focus group discussions with 73 girls from Yangon, Sagaing and Mandalay. Our findings identified key themes of wellbeing that were prioritised by our study population: education, agency, hope and happiness, which were being undermined by gender inequality and the ongoing conflict. This study highlights the benefits of the capabilities approach in identifying the complex wellbeing needs of adolescent girls and young women in crisis settings as a basis for programme design and implementation
Women's informal group participation and intimate partner violence in Mwanza, Tanzania: A longitudinal study.
INTRODUCTION: Women's groups have emerged as an essential platform for implementing violence prevention interventions across diverse settings because they can serve as a powerful catalyst for promoting gender equality, empowering women, and providing a safe space for them. Given the limited empirical evidence on the impact of women's informal group participation on male-perpetrated intimate partner violence, this longitudinal study examines how such participation influences women's experiences of physical, emotional, sexual, and economic IPV in Mwanza, Tanzania. METHODS: Data from four waves of the MAISHA study, which followed up the control groups (n = 1122) of the two MAISHA trials, were analysed. Women aged 18-70 who had been in a relationship within the last 12 months were included. Using mixed effects logistic regression models, we examined the association between women's active participation in religious, ethnic, microcredit, street and support groups and community meetings, with four types of IPV, adjusting for cohabitation status, age and enrolment in previous MAISHA trials. Participants' unique identification number was used as a random effect variable, and dummies for each survey round were used to account for time. RESULTS: The prevalence of religious, ethnic, microcredit, support and street groups, and community meeting participation at baseline were 41.8%, 17.5%, 41.1%, 20.1%, 42.9%, and 20.1%, respectively. Adjusted multivariable models showed that participants who engaged in community meetings reported lower odds of experiencing economic IPV (AOR = 0.68, CI: 0.56-0.82) and higher odds of experiencing emotional IPV (AOR = 1.21, CI: 1.00-1.46). Further, active participants of support groups reported lower odds of experiencing both economic (AOR = 0.77, CI: 0.60-0.99) and sexual IPV (AOR = 0.72, CI: 0.58-0.90). Participants in ethnic groups also reported lower odds of economic IPV (AOR = 0.79, CI: 0.62-1.00). No predictor was associated with physical IPV. CONCLUSION: This study underscores the potential of informal community group participation to mitigate sexual and economic IPV among women in Mwanza, Tanzania, while also indicating a possible increase in the risk of emotional IPV. It emphasises the necessity for tailored, context-sensitive, and gender-transformative interventions to address power imbalances and restrictive norms effectively. Future research should delve into nuanced measures of group participation, including attendance, meeting frequency and duration, participants' influence within groups, the strength of social ties, and their implications for IPV experiences
BREATHER Plus clinical trial design: A randomised non-inferiority trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily ART in virologically suppressed adolescents living with HIV aged 12 to <20 years in sub-Saharan Africa.
BACKGROUND: Novel strategies to improve ART adherence, retention in care and quality of life among adolescents living with HIV (ALHIV) are needed. Short-Cycle Therapy (SCT) with 4/5 sequential days on ART, 2/3 days off ART per week has shown non-inferior virological outcomes and high acceptability, but most data are in adults and are very limited for dolutegravir (DTG)-based SCT. METHODS: BREATHER Plus is an ongoing 96-week non-inferiority randomised trial evaluating efficacy, safety and acceptability of SCT (5 sequential days on, 2 days off at the weekend) with DTG/tenofovir (TNV)-based triple ART versus continuous (daily) therapy (CT) in ALHIV. Participants are aged 12 to <20 years in Kenya/South Africa/Uganda/Zimbabwe, virologically suppressed (Viral Load (VL) <50copies/mL) for ≥12 months at enrollment, with no prior treatment failure. Randomisation is 1:1 to SCT versus CT. VL monitoring for clinical management is 6-12 monthly aligning with standard-of-care. The primary outcome is confirmed virological rebound ≥50 copies/mL by 96 weeks. The trial employs the Smooth Away From Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event risk in the CT arm. Secondary outcomes include HIV resistance, toxicities, patient-reported outcomes and cost-effectiveness. Enrolment of 470 participants completed in June 2023. DISCUSSION: BREATHER Plus is the first randomised trial specifically evaluating DTG/TNV-triple based SCT. Rapid roll-out of DTG and a pragmatic approach to VL monitoring mean results will be generalisable to ALHIV across sub-Saharan Africa. If SCT provides non-inferior virological suppression to CT, it may offer choice for ALHIV on how they take their ART
A repeated cross-sectional analysis of SARS-CoV-2 seroprevalence in Manila, the Philippines after implementation of the national COVID-19 vaccination program.
BACKGROUND: SARS-CoV-2 seroepidemiological studies, which have been used to describe population-level immunity, are limited in the Philippines, despite the protracted course of the epidemic in the country. We follow-up on our previous work and aimed to estimate SARS-CoV-2 seroprevalence and infection rate among outpatient clinic attendees in Metro Manila, a year after the implementation of the national COVID-19 vaccination program. METHODS: We conducted four repeated cross-sectional surveys at the outpatient department of San Lazaro Hospital between March 2022 and January 2023. We performed χ2 test and analysis of variance to assess the differences in characteristics across different data collection periods. RESULTS: A total of 765 participants were enrolled, ranging from 170 to 200 per period. Participant demographic, socioeconomic, and medical history were comparable across all data collection periods. Between March and October 2022, the proportion of participants who received a vaccine or booster dose significantly increased, from 77.9% to 90%. Seroprevalence across all data collection periods was consistently high, ranging from 97.8% to 99.5%. However, the geometric mean concentration of antibodies was highest in the data collection period following the Omicron-dominant wave. Infection rates were comparably low (< 10%) across periods, except for a peak at 16.7% in September to October 2022, which followed the rise in reported cases in Metro Manila. CONCLUSION: Population-level seroprevalence among clinic attendees in Manila was consistently high a year after implementation of the national COVID-19 vaccination program, but analyses of antibody concentrations showed potential waning within a 3-month period
A Prospective Evaluation of the Diagnostic Accuracy of the Point-of-Care VISITECT CD4 Advanced Disease Test in 7 Countries.
BACKGROUND: CD4 measurement is pivotal in the management of advanced human immunodeficiency virus (HIV) disease. VISITECT CD4 Advanced Disease (VISITECT; AccuBio, Ltd) is an instrument-free, point-of-care, semiquantitative test allowing visual identification of CD4 ≤ 200 cells/µL or >200 cells/ µL from finger-prick or venous blood. METHODS: As part of a diagnostic accuracy study of FUJIFILM SILVAMP TB LAM, people with HIV ≥18 years old were prospectively recruited in 7 countries from outpatient departments if a tuberculosis symptom was present, and from inpatient departments. Participants provided venous blood for CD4 measurement using flow cytometry (reference standard) and finger-prick blood for VISITECT (index text), performed at point-of-care. Sensitivity, specificity, and positive and negative predictive values of VISITECT to determine CD4 ≤ 200 cells/ µL were evaluated. RESULTS: Among 1604 participants, the median flow cytometry CD4 was 367 cells/µL (interquartile range, 128-626 cells/µL) and 521 (32.5%) had CD4 ≤ 200 cells/µL. VISITECT sensitivity was 92.7% (483/521; 95% confidence interval [CI], 90.1%-94.7%) and specificity was 61.4% (665/1083; 95% CI, 58.4%-64.3%). For participants with CD4 0-100, 101-200, 201-300, 301-500, and >500 cells/µL, VISITECT misclassified 4.5% (95% CI, 2.5%-7.2%), 12.5 (95% CI, 8.0%-18.2%), 74.1% (95% CI, 67.0%-80.5%), 48.0% (95% CI, 42.5%-53.6%), and 22.6% (95% CI, 19.3%-26.3%), respectively. CONCLUSIONS: VISITECT's sensitivity, but not specificity, met the World Health Organization's minimal sensitivity and specificity threshold of 80% for point-of-care CD4 tests. VISITECT's quality needs to be assessed and its accuracy optimized. VISITECT's utility as CD4 triage test should be investigated. Clinical Trials Registration. NCT04089423
Adjusting for switches to multiple treatments: Should switches be handled separately or combined?
Treatment switching is common in randomised controlled trials (RCTs). Participants may switch onto a variety of different treatments, all of which may have different treatment effects. Adjustment analyses that target hypothetical estimands - estimating outcomes that would have been observed in the absence of treatment switching - have focused primarily on a single type of switch. In this study, we assess the performance of applications of inverse probability of censoring weights (IPCW) and two-stage estimation (TSE) which adjust for multiple switches by either (i) adjusting for each type of switching separately ('treatments separate') or (ii) adjusting for switches combined without differentiating between switched-to treatments ('treatments combined'). We simulate 48 scenarios in which RCT participants may switch to multiple treatments. Switch proportions, treatment effects, number of switched-to treatments and censoring proportions were varied. Method performance measures included mean percentage bias in restricted mean survival time and the frequency of model convergence. Similar levels of bias were produced by treatments combined and treatments separate in both TSE and IPCW applications. In the scenarios examined, there was no demonstrable advantage associated with adjusting for each type of switch separately, compared with adjusting for all switches together