Integrating Process with Outcome Data in a Randomized Controlled Trial of Sex Education

Integration of process with outcome evaluations has been recommended as a way of addressing some of the criticisms of Randomized Controlled Trials (RCTs) for evaluating social interventions. This is the second of two articles (the first was published in issue 10(4) of this journal) discussing the design, implementation and analysis of a process evaluation as an integral part of the RIPPLE (Randomized Intervention of Pupil Peer-Led sex Education) Study. The methods for integrating process and outcome data are outlined and findings are presented to illustrate how integration of process and outcome data enabled exploration of: 1) variation between schools in the extent and quality of the intervention implemented, and any impact of this on outcomes; 2) the processes by which the intervention might affect outcomes; and 3) the extent to which different subgroups of students or schools may have responded differently to the intervention. The article concludes with a discussion of the methodological issues arising from this attempt at integrating process and outcome evaluations within the design of an RCT

The Long-Term Effects of a Peer-Led Sex Education Programme (RIPPLE): A Cluster Randomised Trial in Schools in England

Judith Stephenson and colleagues report on a cluster randomized trial in London of school-based peer-led sex education and whether it reduced unintended teenage pregnancy

The long-term effects of a peer-led sex education programme (RIPPLE): a cluster randomised trial in schools in England.

BACKGROUND: Peer-led sex education is widely believed to be an effective approach to reducing unsafe sex among young people, but reliable evidence from long-term studies is lacking. To assess the effectiveness of one form of school-based peer-led sex education in reducing unintended teenage pregnancy, we did a cluster (school) randomised trial with 7 y of follow-up. METHODS AND FINDINGS: Twenty-seven representative schools in England, with over 9,000 pupils aged 13-14 y at baseline, took part in the trial. Schools were randomised to either peer-led sex education (intervention) or to continue their usual teacher-led sex education (control). Peer educators, aged 16-17 y, were trained to deliver three 1-h classroom sessions of sex education to 13- to 14-y-old pupils from the same schools. The sessions used participatory learning methods designed to improve the younger pupils' skills in sexual communication and condom use and their knowledge about pregnancy, sexually transmitted infections (STIs), contraception, and local sexual health services. Main outcome measures were abortion and live births by age 20 y, determined by anonymised linkage of girls to routine (statutory) data. Assessment of these outcomes was blind to sex education allocation. The proportion of girls who had one or more abortions before age 20 y was the same in each arm (intervention, 5.0% [95% confidence interval (CI) 4.0%-6.3%]; control, 5.0% [95% CI 4.0%-6.4%]). The odds ratio (OR) adjusted for randomisation strata was 1.07 (95% CI 0.80-1.42, p = 0.64, intervention versus control). The proportion of girls with one or more live births by 20.5 y was 7.5% (95% CI 5.9%-9.6%) in the intervention arm and 10.6% (95% CI 6.8%-16.1%) in the control arm, adjusted OR 0.77 (0.51-1.15). Fewer girls in the peer-led arm self-reported a pregnancy by age 18 y (7.2% intervention versus 11.2% control, adjusted OR 0.62 [95% CI 0.42-0.91], weighted for non-response; response rate 61% intervention, 45% control). There were no significant differences for girls or boys in self-reported unprotected first sex, regretted or pressured sex, quality of current sexual relationship, diagnosed sexually transmitted diseases, or ability to identify local sexual health services. CONCLUSION: Compared with conventional school sex education at age 13-14 y, this form of peer-led sex education was not associated with change in teenage abortions, but may have led to fewer teenage births and was popular with pupils. It merits consideration within broader teenage pregnancy prevention strategies

The association of breastfeeding with cognitive development and educational achievement in sub-Saharan Africa: A systematic review.

Background: Systematic reviews and meta-analyses of studies mainly from high-income countries suggest that breastfeeding improves cognitive function and educational achievement. However, these associations may be a manifestation of who breastfeeds in these settings rather than an actual effect of breastfeeding. We investigated the association of breastfeeding with cognitive development and educational achievements in sub-Saharan Africa, where breastfeeding is the norm, and socioeconomic status is not strongly correlated with ever breastfeeding. Methods: We searched Medline, Embase, PsycINFO, Cochrane Central Register of Controlled Trials (CENTRAL), and Africa-Wide Information in January 2021 for studies that assessed the cognitive and educational benefits of breastfeeding in children and adolescents in sub-Saharan Africa. Two reviewers independently screened, extracted, and critically appraised the included studies. Results: After reviewing 5552 abstracts and 151 full-text articles, seventeen studies on cognitive development and two on educational achievements met our predefined inclusion criteria. The included studies were from ten sub-Saharan African countries and published between 2013 and 2021, with sample sizes ranging from 54 to 6573. Most of the studies (n = 14) were prospective cohort studies, but only nine collected data on breastfeeding prospectively. The studies differed in analytic approaches and cognitive and educational achievements measurements. Of the 17 studies on cognitive development, only four adjusted sufficiently for key confounders. None of these four studies found an overall association between breastfeeding and cognitive development in children or adolescents in sub-Saharan Africa. The two studies on education measured achievements based on the highest grade of school attained, 12 or more years of education, or grade repetition at age 7-11 years. Both studies adjusted for a range of sociodemographic factors and found no evidence that children exclusively breastfed or breastfed for a longer duration have a better educational outcome than sub-optimally breastfed children. Conclusions: The current evidence from sub-Saharan Africa is limited but does not corroborate previous findings that breastfeeding is associated with improved cognitive development and educational achievement. Registration: This study is registered with PROSPERO, CRD42021236009

Association between breastfeeding duration and educational attainment in rural Southwest Uganda: a population-based cohort study.

BACKGROUND: Breastfeeding is important for early childhood nutrition and health. The positive effects on educational outcomes may be attributed to socioeconomic factors. Socioeconomic status is not a strong predictor of breastfeeding in sub-Saharan African countries. Yet, few studies have investigated the association between breastfeeding and educational outcomes in these countries. OBJECTIVE: This study investigated the association between breastfeeding duration and children's educational attainment in rural Southwest Uganda. METHODS: We analysed longitudinal data on 3018 children who had information on breastfeeding and were followed for at least 5 years, with at least one primary school grade recorded by 2005. Data on breastfeeding duration were collected from mothers. The highest school grade was recorded repeatedly between ages 6 and 12 years. We calculated age-for-grade based on whether a child was on, over, or under the official age for a grade. Generalised estimating equations and binary logistic regression estimated the effect of breastfeeding duration on being 2 years, 3 or more years, or any years over-age for grade in primary school, adjusting for socioeconomic status and maternal-child characteristics. RESULTS: Most mothers breastfed for more than a year. Just over one-third breastfed for 18-23 months, and 30% breastfed for longer. By age eight, 42% of the children were two years over-age for their grade. Three or more years over-age for grade increased from 19% at age nine to 56% at age 12. Both adjusted and unadjusted estimates were consistent in showing reduced odds for children being 2 years, 3 or more years, or any years over-age for grade among children breastfed for 7-12, 13-17, 18-23, and > 23 months compared to those breastfed for 0-6 months. There was no evidence to support an overall association between breastfeeding duration and being over-age for grade. There was no evidence of association in the sex and age sub-group analyses. CONCLUSION: Although we found no association between breastfeeding duration and educational attainment, breastfeeding remains important for children's health and nutrition, and mothers should be encouraged and supported to breastfeed for the recommended duration

Theorizing black (African) transnational masculinities

Just as masculinity is crucial in the construction of nationhood, masculinity is also significant in the making and unmaking of transnational communities. This article focuses on how black African men negotiate and perform respectable masculinity in transnational settings such as the workplace, community and family. Moving away from conceptualizations of black transnational forms of masculinities as in perpetual crisis and drawing on qualitative data collected from members of the new African diaspora in London, the article explores the diverse ways notions of masculinity and gender identities are being challenged, re-affirmed and reconfigured. The article argues that men experience a loss of status as breadwinners and a rupture of their sense of masculine identity in the reconstruction of life in the diaspora. Conditions in the hostland, in particular, women's breadwinner status and the changing gender relations, threaten men’s ‘hegemonic masculinity’ and consequently force men to negotiate respectable forms of masculinity

Common mouse models of tauopathy reflect early but not late human disease

BACKGROUND: Mouse models that overexpress human mutant Tau (P301S and P301L) are commonly used in preclinical studies of Alzheimer’s Disease (AD) and while several drugs showed therapeutic effects in these mice, they were ineffective in humans. This leads to the question to which extent the murine models reflect human Tau pathology on the molecular level. METHODS: We isolated insoluble, aggregated Tau species from two common AD mouse models during different stages of disease and characterized the modification landscape of the aggregated Tau using targeted and untargeted mass spectrometry-based proteomics. The results were compared to human AD and to human patients that suffered from early onset dementia and that carry the P301L Tau mutation. RESULTS: Both mouse models accumulate insoluble Tau species during disease. The Tau aggregation is driven by progressive phosphorylation within the proline rich domain and the C-terminus of the protein. This is reflective of early disease stages of human AD and of the pathology of dementia patients carrying the P301L Tau mutation. However, Tau ubiquitination and acetylation, which are important to late-stage human AD are not represented in the mouse models. CONCLUSION: AD mouse models that overexpress human Tau using risk mutations are a suitable tool for testing drug candidates that aim to intervene in the early formation of insoluble Tau species promoted by increased phosphorylation of Tau. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13024-023-00601-y

Socioeconomic inequalities in pregnancy outcome associated with Down syndrome: a population-based study.

OBJECTIVE: To investigate socioeconomic inequalities in outcome of pregnancy associated with Down syndrome (DS) compared with other congenital anomalies screened for during pregnancy. DESIGN AND SETTING: Retrospective population-based registry study (East Midlands & South Yorkshire in England). PARTICIPANTS: All registered cases of DS and nine selected congenital anomalies with poor prognostic outcome (the UK Fetal Anomaly Screening Programme (FASP)9) with an end of pregnancy date between 1 January 1998 and 31 December 2007. MAIN OUTCOME MEASURES: Poisson regression models were used to explore outcome measures, including socioeconomic variation in rates of anomaly; antenatal detection; pregnancy outcome; live birth incidence and neonatal mortality. Deprivation was measured using the Index of Multiple Deprivation 2004 at super output area level. RESULTS: There were 1151 cases of DS and 1572 cases of the nine severe anomalies combined. The overall rate of antenatal detection was 57% for DS, which decreased with increasing deprivation (rate ratio comparing the most deprived tenth with the least deprived: 0.76 (0.60 to 0.97)). Antenatal detection rates were considerably higher for FASP9 anomalies (86%), with no evidence of a trend with deprivation (0.99 95% CI (0.84 to 1.17)). The termination of pregnancy rate following antenatal diagnosis was higher for DS (86%) than the FASP9 anomalies (70%). Both groups showed wide socioeconomic variation in the termination of pregnancy rate (rate ratio: DS: 0.76 (0.58 to 0.99); FASP9 anomalies: 0.80 (0.65 to 0.97)). Consequently, socioeconomic inequalities in live birth and neonatal mortality rates associated with these anomalies arise that were not observed in utero. CONCLUSIONS: Socioeconomic inequalities exist in the antenatal detection of DS, and subsequent termination rates are much higher for DS than other anomalies. Termination rates for all anomalies are lower in more deprived areas leading to wide socioeconomic inequalities in live born infants with a congenital anomaly, particularly DS, and subsequent neonatal mortality