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Are men clients, catalysts or controllers of family planning?
Full text linkBACKGROUND: Family planning (FP) has moved from being used as a tool for population control to promoting individuals' and couples' reproductive rights. The narrative surrounding FP focuses on how providing modern contraception empowers women to control their fertility and space their children. However, the role of men in the decision-making process of women's access, and use of FP services is under-examined. Although international health organisations insist that FP programmes ensure free choice for both men and women, most programmes primarily target women. This paper explores the role of men in FP programmes and services in the Global South. METHODS: We conducted a qualitative study with 31 professionals from the international FP community, including academics, NGO workers, FP advocates, government officials, and international funding representatives. Interviews were conducted virtually and transcribed verbatim. Thematic analysis was applied to the dataset. RESULTS: Participants did not have clear or consistent opinions about the role of men in FP service provision. Yet, all emphasised the need to prioritise women's reproductive health needs within FP programmes. Almost all reflected on men's role in the decision-making process around FP, emphasising how power dynamics between men and women in heterosexual relationships can limit women's autonomy. Some argued that men should have no role in FP programmes, as they were described as "controllers of" women's reproductive choices. Some participants reflected described men as "catalysts" and encouraged their engagement in programmes to support women in accessing, using, and continuing FP services. Others argued that men should be viewed as "clients" requiring FP services themselves. While different roles for men were discussed, no consensus emerged on a single approach. Participants also described tensions between women-centered policies at higher levels and the social norms impacting care at the community level. CONCLUSION: International organizations recommend targeting both men and women in FP programmes, but most programs continue to focus on women. These findings explore the roles men play in FP decision-making and identify barriers to engaging men in FP programmes. They highlight the need for culturally sensitive, gender transformative approaches to address gender norms and ensure reproductive rights for all
The mechanisms by which a whole-school intervention might improve sexual health: qualitative realist research nested in a trial in English secondary schools.
Full text linkWhole-school interventions go beyond classroom education, promoting health by modifying school environments. These can be effective in delaying sexual debut and increasing contraception use but mechanisms are poorly understood. Qualitative research within realist evaluation can explore mechanisms via building 'context-mechanism-outcome configurations', describing how interventions trigger mechanisms that interact with context to generate outcomes. We explored these for the Positive Choices whole-school sexual health intervention within the intervention arm of a randomised trial conducted 2021-2025. Using 'dimensional analysis', we analysed 52 interviews with teachers and 40 focus-groups involving 266 students from 22 English secondary schools. Our results suggest seven mechanisms through which whole-school interventions might 'work': improving knowledge using diverse pedagogies; improving confidence and ability to talk by normalising talk about sexual health; changing gender attitudes through challenging stereotypes and providing insights and empathy with others' perspectives; promoting access to sexual health and other services via helping students understand their needs and entitlements; building school engagement by providing new student roles on decision-making groups; increasing inclusion of sexual-minority students by normalising consideration of non-heterosexual identities and practices; and reducing sexual harassment and abuse by helping students understand consent and when to intervene in harassment. Contextual contingencies included: high initial student needs; teacher skills and commitment; and school commitment and capacity. Our research suggests novel mechanisms via which whole-school interventions might promote sexual health. Quantitative analyses will now be conducted to examine these mechanisms and contingencies
Surveys of Concussion Knowledge, Management Practices, and Guideline Awareness in Gymnastics
Full text linkThese surveys were developed as part of a larger research project evaluating the implementation of the UK Concussion Guidelines for Non-Elite (Grassroots) Sport (hereafter, the UK Guidelines). The study comprises a set of online surveys designed to assess concussion knowledge, attitudes, management practices, and awareness of concussion guidelines among British Gymnastics stakeholders, with a specific focus on awareness and use of the UK Guidelines within the gymnastics context.
Separate survey instruments were developed for four participant groups: coaches and welfare officers, parents of gymnasts under 11 years of age, gymnasts aged 11–15 years, and adult gymnasts aged 16 years and over. Each survey is tailored to reflect the roles and responsibilities assigned to these groups within the UK Guidelines.
Survey topics include awareness and understanding of concussion, recognition of concussion symptoms, immediate management and return-to-activity decisions, sources of concussion-related information, awareness of concussion guidelines (including the UK Guidelines), and experience of concussion-related training. Basic demographic information is also collected.
The surveys were developed based on a review of existing concussion survey instruments and were reviewed by an advisory group, public and patient involvement and engagement (PPIE) members, and British Gymnastics. The survey was additionally tested for understanding with children aged 11–15 years. These instruments are intended for use in research examining concussion knowledge, management practices, and guideline awareness in gymnastics and, with appropriate adaptation, in other sporting contexts
Estimating the population impact of new tuberculosis vaccines depending on efficacy against infectious asymptomatic tuberculosis: A modelling study.
Full text linkBACKGROUND: Tuberculosis (TB) remains a leading cause of infectious disease death. New TB vaccines are currently in late-stage trials and may be available before the end of the decade. Modelling predicts new TB vaccines may reduce global burden but rely on assumptions about vaccine efficacy by TB disease stage and TB natural history, which may be incorrect. We explored the sensitivity of estimates of the impact of new TB vaccines to uncertainties in efficacy by disease stage and natural history.
METHODS AND FINDINGS: We developed a dynamic compartmental TB model for India, including early TB disease stages (non-infectious disease, infectious asymptomatic disease, and infectious symptomatic disease). Scenarios assumed 50% vaccine efficacy for 10 years and prevented progression to (a) only infectious symptomatic disease, or (b) any infectious disease (infectious asymptomatic disease and infectious symptomatic disease), or (c) any disease (non-infectious disease, infectious asymptomatic disease, and infectious symptomatic disease). We estimated impact on averting disease episodes over 2030-2050, compared to no-new-vaccine introduction. Results suggest, over 3 years, there was little difference in the proportion of cumulative symptomatic disease episodes averted by vaccines preventing only infectious symptomatic disease, any infectious disease, or any disease (1.6%, 2.3%, and 2.3%, respectively). However, over 20 years, compared to vaccines preventing only infectious symptomatic disease, vaccines preventing any infectious disease, or any disease, averted a markedly higher proportion of symptomatic disease episodes (7.3%, 19.4%, and 23.3%, respectively), due to preventing continued transmission from infectious asymptomatic disease. A key limitation with any mathematical modelling study is the uncertainty associated with the inputs, and further data collection is required to better understand the transmissibility, morbidity, and dynamics of asymptomatic disease, to improve modelling estimates and inform wider policy.
CONCLUSIONS: Our modelling estimates that the population impact of new TB vaccines may depend on efficacy against infectious asymptomatic disease. TB vaccine trials should include analyses of participant sputum samples (collected during or at the end of trials and analysed at the end of trials) to enable better estimates of the potential value of new TB vaccines against infectious asymptomatic disease
Experiences of people from minoritised groups who report healthcare-related harm in the UK: a qualitative socioecological study exploring factors contributing to unsafe care.
Full text linkOBJECTIVES: To capture the experiences of people from minoritised groups who self-report healthcare-related harm and their views on contributory factors to the harm. DESIGN: In-depth one-to-one qualitative interviews, analysed using inductive and deductive methods to explore and then organise factors participants associated with healthcare-related harm and map these factors onto a socioecological framework (SEF). SETTING: People from minoritised groups in the United Kingdom (UK) self-reporting harm arising from the National Health Service (NHS), recruited from community groups, social media and a survey of the general public. PARTICIPANTS: 48 participants currently minoritised in the UK based on one or more of faith, ethnicity, disability, sexual orientation or gender modality who have experienced harm in the NHS. RESULTS: Heterogeneous and interacting factors contribute to healthcare-related harms, spanning all five levels of the SEF: individual, interpersonal, community, organisational and societal. Multiple factors from powerlessness and low trust to unwelcoming NHS environments reinforce each other to increase risk of harm in minoritised populations. The SEF helped draw out less visible factors associated with the experience of unsafe care, including a health service designed around the needs of the majority population and societal attitudes to minoritised groups. CONCLUSIONS: Multiple individual factors are already known drivers of disparities in safety among minoritised groups such as language barriers and cultural differences in beliefs. The SEF enabled an expanded view of contributory factors to harm in these groups, thereby providing a wider set of potential interventions to address safety inequities. A narrow focus on improving the quality of interpersonal, relational care is unlikely to have a significant impact on safety improvement in minoritised groups without addressing structural and institutionalised processes that drive discrimination and exclusion
Unravelling the dengue surge in South Asia during 2000-2023: pattern, trend, genomics, and key determinants.
Full text linkThis study aimed to analyse the patterns, trends, genomic characteristics, and key determinants of dengue virus (DENV) infections and associated deaths in South Asia from 2000 to 2023. We collected data from the World Health Organization dengue surveillance dashboard and the health ministries of respective countries, and publicly available data from eight South Asian (SA) countries. Descriptive measures, data visualization techniques, and time series analysis were used to identify key patterns and trends of DENV. A time-scaled phylogenetic analysis was carried out to explore the genomic epidemiology and evolution of DENV. A generalized linear model (GLM) was fitted to identify climatic, demographic, and socioeconomic factors. Between 2000 and 2023, SA countries showed a sharp increase in dengue cases and deaths, contributing to 6.5% of cases and 11.07% of deaths caused by DENV globally. The total cases in the region are projected to grow by approximately 40%, and total deaths by 61% by 2033. The predominant genotypes were DENV2/II, DENV3/I, and DENV3/III. GLM underscores climatic, demographic, and socioeconomic factors associated with DENV infection and deaths. The findings urge intensified public health measures emphasising the need for comprehensive interventions, including vector control, climate adaptation, and strengthened healthcare systems to de-escalate the situation
Accreditation science-the need for evidence to guide the global expansion of medical education accreditation.
No full textAccreditation systems create and enforce the rules for medical education. When accreditors expand their scope or change their standards or protocols, every medical school they regulate must change, with lasting impacts on large numbers of graduating physicians. Because the accreditation of undergraduate medical education (UME) has become globally accepted and widespread, one may assume it is supported by strong evidence. Such is not the case. This article recounts the origins of accreditation in the U.S. over 100 years ago as an effort to distinguish allopathic physicians from their competitors. It describes how the U.S. model for UME accreditation formed the basis for approaches endorsed by global organizations, and accreditation expanded without research demonstrating that a specific combination of standards, self-studies, and site visits was optimal or necessary. Allowing assumptions about accreditation to go unchecked can create problems, such as the misalignment of accreditation systems with needs, wasted resources, and lack of trust. Accreditation science-systematic inquiry that directly interrogates and informs accreditation policies and practices-offers a way to test assumptions and generate evidence that leads to higher quality accreditation practices. We describe resources that can be used for accreditation science and examples of accreditation science so that more of the global medical education community can participate in this emerging field. We also suggest priority areas of investigation, such as how accreditation judgments are made and the economics of accreditation and international accreditor marketplaces. The scientific method has for centuries proven to be the most efficient way to generate knowledge that improves the lives of people. It is past time for accreditation to move from its longstanding basis in tradition and assumption into an era defined by scientific inquiry
Multicohort assessment of plasma metabolic signatures of tuberculosis disease in children: a retrospective cross-sectional study.
Full text linkMicrobiological tests for tuberculosis (TB) disease in children have suboptimal accuracy and respiratory samples are often challenging to obtain. Using liquid chromatography/mass spectrometry, we performed plasma high-resolution metabolomics (HRM) to identify blood-based biomarkers associated with TB disease in children. We analyzed plasma samples from 438 children 0-14 years being evaluated for TB disease in India, Peru, Uganda, The Gambia, and South Africa. All children underwent a standard clinical evaluation and were followed up after 3 months. Children were classified as Confirmed (n = 104), Unconfirmed (n = 108), or Unlikely TB (n = 226) as per NIH consensus definitions. Controlling for age and study site, we found creatine, alanine, retinol, citrulline, fumarate, and tryptophan to be significantly decreased in children with Confirmed TB disease versus those with Unlikely TB, while cortisol, nicotinamide, and butyrylcarnitine were increased (FDR-corrected p-value < 0.2). Using logistic regression, we found this nine-metabolite signature had an area under the receiver operator characteristic curve (AUC) of 0.72 (95% CI (0.67 - 0.82) in the test set of participants with Confirmed and Unlikely TB and an AUC of 0.49 (95% CI 0.42 - 0.55) in the Unconfirmed TB group. These results show a nine-metabolite plasma signature has moderate accuracy for identification of Confirmed TB disease in children
A comparison of F/TAF and F/TDF as HIV pre-exposure prophylaxis in a predominantly cisgender women population in East and South Africa: a randomised, factorial, non-inferiority trial.
Full text linkBACKGROUND: F/TAF was shown to be non-inferior to F/TDF as pre-exposure prophylaxis (PrEP) in men, but approval was not extended to cisgender women. We report the results of PrEPVacc, in which a predominantly female population was randomly allocated to receive daily oral F/TDF or F/TAF for ∼6 months within a HIV-1 prophylactic vaccine trial. SETTING: Five study sites in three African countries (Uganda, Tanzania, South Africa). METHODS: The two regimens were compared by the averted infections ratio (AIR) - the proportion of infections averted by F/TAF relative to F/TDF. The counterfactual HIV incidence, an essential component of this metric, was derived from a preceding registration cohort. Dried blood spots (DBS) were collected at regular timepoints for later assessment of tenofovir diphosphate levels in selected sub-populations. RESULTS: 1380 participants (697 F/TDF, 683 F/TAF) were included in the primary analysis (total follow-up 709.2 person-years); 87% were cisgender women. Three HIV infections (0.86/100 person-years) occurred in the F/TAF group versus two in the F/TDF group (0.56/100 person-years). The counterfactual HIV incidence was estimated to be 2.59/100 person-years (90% CI 1.86-3.52), giving an AIR of 0.85 (90% CI 0.31-1.66). Based on the week 8 DBS sample , only an estimated 14% of participants were classified as taking 2-3 tablets per week and 9% ≥4 tablets per week. CONCLUSIONS: Despite similar HIV incidence rates, the non-inferiority of F/TAF was not demonstrated, probably due to low statistical power primarily driven by low adherence. However, there is compelling evidence from multiple studies supporting the efficacy of F/TAF as PrEP regardless of sex
Weight gain, body composition, and metabolic parameters of dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: an ancillary analysis of the ODYSSEY trial.
Full text linkBACKGROUND: ODYSSEY trial showed superior efficacy of dolutegravir-based antiretroviral therapy (ART) versus then-current, non-dolutegravir standard of care over 96 weeks in children and adolescents living with HIV. The aim of this ancillary analysis was to compare anthropometric and body composition outcomes, including weight, height, BMI-for-age Z score, weight-for-age and height-for-age Z scores (<14 kg), mid-upper-arm circumference (MUAC), waist circumference, hip circumference, and body fat percentage, as well as metabolic outcomes (lipids and glucose), between dolutegravir and standard of care over approximately 5 years of follow-up. METHODS: In this open-label, randomised, non-inferiority trial, children (aged ≥4 weeks and <18 years), weighing 3 kg or more, starting first-line ART (ODYSSEY-A) or switching to second-line ART (ODYSSEY-B) were enrolled in 29 centres in Germany, Portugal, South Africa, Spain, Thailand, Uganda, Zimbabwe, and the UK in two cohorts (children weighing ≥14 kg and children weighing <14 kg). Treatment effects (dolutegravir vs standard of care) were estimated on randomised allocation, accounting for treatment switches (substantial in standard of care arm during extended follow-up) through censoring and inverse-probability-of-censoring-weights. Changes in continuous outcomes were compared using linear mixed models, accounting for correlated slope and baseline value. Proportions of participants with unfavourable outcomes were compared using logistic mixed models. ODYSSEY is registered with ClinicalTrials.gov, NCT02259127, EUDRACT, 2014-002632-14, and ISRCTN, ISRCTN91737921. FINDINGS: Between Sept 20, 2016, and Aug 26, 2019, 792 children were randomly assigned (392 to dolutegravir and 400 to standard of care). Of 707 children in the 14 kg or more cohort, 311 received first-line ART (ODYSSEY-A; 145 [92%] of 157 received efavirenz-based ART as standard of care) and 396 received second-line ART (ODYSSEY-B; 195 [98%] of 200 received boosted protease inhibitors as standard of care). Of 85 children in the less than 14 kg cohort, 72 received first-line ART (32 [74%] of 43 received lopinavir-ritonavir as first-line or second-line standard of care). Median follow-up on randomised allocation was 287 weeks (IQR 240-311) on dolutegravir-based ART and 205 weeks (168-240) on standard of care in the 14 kg or more cohort, and 220 weeks (208-232) on dolutegravir-based ART and 144 weeks (127-192) on standard of care in the less than 14 kg cohort. In the 14 kg or more cohort, 345 (49%) were female and 362 (51%) were male, 623 (88%) were Black African, median enrolment age was 12·2 years (IQR 9·1 to 14·9), weight 30·7 kg (23·4 to 43·0), and BMI-for-age Z score -0·6 (-1·4 to 0·1); 35 (5%) were overweight and six (1%) were obese. At week 240, adjusted mean differences (dolutegravir minus standard of care) were 1·0 kg for weight (95% CI -0·2 to 2·2; p=0·095) and 0·4 cm for MUAC (0·0 to 0·8; p=0·030), driven by differences in first-line participants, where higher increases were also observed in height, waist circumference, and hip circumference. Increases in BMI-for-age Z score, body fat percentage, and cross-sectional waist-to-height ratio were similar on dolutegravir-based ART and standard of care. Total cholesterol (-15·3 mg/dL [-21·0 to -9·5]; p<0·0001), triglycerides (-14·4 mg/dL [-25·2 to -3·6]; p=0·0089), and glucose (-4·4 mg/dL [-6·8 to -1·9]; p=0·0004) were lower with dolutegravir than standard of care. In the less than 14 kg cohort, 44 (52%) were female and 41 (48%) were male, 83 (98%) were Black African, median enrolment age was 1·4 years (IQR 0·6 to 2·0), weight 8·1 kg (5·4-10·0) and BMI-for-age Z score -0·8 (-1·9 to 0·2); three (4%) were overweight and none obese. Changes in weight, weight-for-age, BMI-for-age and height-for-age Z scores by 192 weeks were similar on dolutegravir and standard of care; there were small differences in MUAC (0·6 cm [-0·1 to 1·3]; p=0·070) and height (-2·5 cm [-4·5 to -0·5]; p=0·016). No significant differences in lipid biomarkers were observed; glucose decreased with standard of care but not with dolutegravir. INTERPRETATION: Over approximately 5 years, indices defining excessive weight gain and central adiposity were similar with dolutegravir and other anchor drugs, and lipid and glycaemia profiles with dolutegravir were reassuring, providing supporting evidence for dolutegravir-based ART as the preferred treatment in children and adolescents. FUNDING: Fondazione Penta ETS, ViiV Healthcare, and UK Medical Research Council