Effects on childhood infections of promoting safe and hygienic complementary-food handling practices through a community-based programme: A cluster randomised controlled trial in a rural area of The Gambia.

BACKGROUND: The Gambia has high rates of under-5 mortality from diarrhoea and pneumonia, peaking during complementary-feeding age. Community-based interventions may reduce complementary-food contamination and disease rates. METHODS AND FINDINGS: A public health intervention using critical control points and motivational drivers, delivered February-April 2015 in The Gambia, was evaluated in a cluster randomised controlled trial at 6- and 32-month follow-up in September-October 2015 and October-December 2017, respectively. After consent for trial participation and baseline data were collected, 30 villages (clusters) were randomly assigned to intervention or control, stratified by population size and geography. The intervention included a community-wide campaign on days 1, 2, 17, and 25, a reminder visit at 5 months, plus informal community-volunteer home visits. It promoted 5 key complementary-food and 1 key drinking-water safety and hygiene behaviours through performing arts, public meetings, and certifications delivered by a team from local health and village structures to all villagers who attended the activities, to which mothers of 6- to 24-month-old children were specifically invited. Control villages received a 1-day campaign on domestic-garden water use. The background characteristics of mother and clusters (villages) were balanced between the trial arms. Outcomes were measured at 6 and 32 months in a random sample of 21-26 mothers per cluster. There were no intervention or research team visits to villages between 6 and 32 months. The primary outcome was a composite outcome of the number of times key complementary-food behaviours were observed as a proportion of the number of opportunities to perform the behaviours during the observation period at 6 months. Secondary outcomes included the rate of each recommended behaviour; microbiological growth from complementary food and drinking water (6 months only); and reported acute respiratory infections, diarrhoea, and diarrhoea hospitalisation. Analysis was by intention-to-treat analysis adjusted by clustering. (Registration: PACTR201410000859336). We found that 394/571 (69%) of mothers with complementary-feeding children in the intervention villages were actively involved in the campaign. No villages withdrew, and there were no changes in the implementation of the intervention. The intervention improved behaviour adoption significantly. For the primary outcome, the rate was 662/4,351(incidence rate [IR] = 0.15) in control villages versus 2,861/4,378 (IR = 0.65) in intervention villages (adjusted incidence rate ratio [aIRR] = 4.44, 95% CI 3.62-5.44, p < 0.001), and at 32 months the aIRR was 1.17 (95% CI 1.07-1.29, p = 0.001). Secondary health outcomes also improved with the intervention: (1) mother-reported diarrhoea at 6 months, with adjusted relative risk (aRR) = 0.39 (95% CI 0.32-0.48, p < 0.001), and at 32 months, with aRR = 0.68 (95% CI 0.48-0.96, p = 0.027); (2) mother-reported diarrhoea hospitalisation at 6 months, with aRR = 0.35 (95% CI 0.19-0.66, p = 0.001), and at 32 months, with aRR = 0.38 (95% CI 0.18-0.80, p = 0.011); and (3) mother-reported acute respiratory tract infections at 6 months, with aRR = 0.67 (95% CI 0.53-0.86, p = 0.001), though at 32 months improvement was not significant (p = 0.200). No adverse events were reported. The main limitations were that only medium to small rural villages were involved. Obtaining laboratory cultures from food at 32 months was not possible, and no stool microorganisms were investigated. CONCLUSIONS: We found that low-cost and culturally embedded behaviour change interventions were acceptable to communities and led to short- and long-term improvements in complementary-food safety and hygiene practices, and reported diarrhoea and acute respiratory tract infections. TRIAL REGISTRATION: The trial was registered on the 17th October 2014 with the Pan African Clinical Trial Registry in South Africa with number (PACTR201410000859336) and 32-month follow-up as an amendment to the trial.

A cost-effectiveness analysis of early detection and bundled treatment of postpartum hemorrhage alongside the E-MOTIVE trial.

Timely detection and treatment of postpartum hemorrhage (PPH) are crucial to prevent complications or death. A calibrated blood-collection drape can help provide objective, accurate and early diagnosis of PPH, and a treatment bundle can address delays or inconsistencies in the use of effective interventions. Here we conducted an economic evaluation alongside the E-MOTIVE trial, an international, parallel cluster-randomized trial with a baseline control phase involving 210,132 women undergoing vaginal delivery across 78 secondary-level hospitals in Kenya, Nigeria, South Africa and Tanzania. We aimed to assess the cost-effectiveness of the E-MOTIVE intervention, which included a calibrated blood-collection drape for early detection of PPH and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination and escalation), compared with usual care. We used multilevel modeling to estimate incremental cost-effectiveness ratios from the perspective of the public healthcare system for outcomes of cost per severe PPH (blood loss ≥1,000 ml) avoided and cost per disability-adjusted life-year averted. Our findings suggest that the use of a calibrated blood-collection drape for early detection of PPH and bundled first-response treatment is cost-effective and should be perceived by decision-makers as a worthwhile use of healthcare budgets. ClinicalTrials.gov identifier: NCT04341662 .

Promoting hygienic weaning food handling practices through a community-based programme: intervention implementation and baseline characteristics for a cluster randomised controlled trial in rural Gambia.

OBJECTIVE: Contamination of weaning food leads to diarrhoea in children under 5 years. Public health interventions to improve practices in low-income and middle-income countries are rare and often not evaluated using a randomised method. We describe an intervention implementation and provide baseline data for such a trial. DESIGN: Clustered randomised controlled trial. SETTING: Rural Gambia. PARTICIPANTS: 15 villages/clusters each with 20 randomly selected mothers with children aged 6-24 months per arm. INTERVENTION: To develop the public health intervention, we used: (A) formative research findings to determine theoretically based critical control point corrective measures and motivational drives for behaviour change of mothers; (B) lessons from a community-based weaning food hygiene programme in Nepal and a handwashing intervention programme in India; and (C) culturally based performing arts, competitions and environmental clues. Four intensive intervention days per village involved the existing health systems and village/cultural structures that enabled per-protocol implementation and engagement of whole villager communities. RESULTS: Baseline village and mother's characteristics were balanced between the arms after randomisation. Most villages were farming villages accessing health centres within 10 miles, with no schools but numerous village committees and representing all Gambia's three main ethnic groups. Mothers were mainly illiterate (60%) and farmers (92%); 24% and 10% of children under 5 years were reported to have diarrhoea and respiratory symptoms, respectively, in the last 7 days (dry season). Intervention process engaged whole village members and provided lessons for future implementation; culturally adapted performing arts were an important element. CONCLUSION: This research has potential as a new low-cost and broadly available public health programme to reduce infection through weaning food. The theory-based intervention was widely consulted in the Gambia and with experts and was well accepted by the communities. Baseline analysis provides socioeconomic data and confirmation of Unicefs Multiple Indicator Cluster Survey (MICS) data on the prevalence of diarrhoea and respiratory symptoms in the dry season in the poorest region of Gambia. TRIAL REGISTRATION NUMBER: PACTR201410000859336; Pre-results.

Common dental infections in the primary care setting.

Family physicians commonly encounter patients with dental infections, such as dental caries and periodontal disease. Dental caries is caused by bacteria that destroy the enamel and dentin; it can be detected by an oral examination that shows stained pits or fissures on the tooth surface. Use of fluoride is the most effective prevention measure for dental caries. Untreated caries may progress to pulpitis and, eventually, to necrosis of the pulp. In irreversible pulpitis, the tooth dies and the patient may have a localized abscess that can spread to surrounding tissue. Periodontal infections are caused by bacteria in the subgingival dental plaque. In gingivitis, the inflamed gums bleed easily with brushing or flossing; the condition can be controlled with good oral hygiene. Periodontitis is characterized by a loss of supportive bone structure caused by chronic gingivitis; it is also associated with some systemic diseases. Localized periodontitis is treated with mechanical debridement and good oral hygiene, whereas generalized periodontitis requires adjunct antibiotic therapy. Pericoronitis results when food particles become trapped under the gum of an impacted tooth. This condition can be controlled by removal of food debris and good oral hygiene. For patients in whom dental infections are disseminated and have invaded the deeper oral spaces, antibiotic treatment should be initiated at the time of referral.

Hand asymmetry in heterosexual and homosexual men and women: relationship to 2D:4D digit ratios and other sexually dimorphic anatomical traits.

Sexual differentiation leads to the development of distinctive anatomical structures (e.g., gonads and genitalia); it also produces less obvious anatomical shifts in brain, bones, muscles, etc. This study is a retrospective analysis of growth patterns in the hands in relation to sex and sexual orientation. Using data from three published studies, we analyzed four hand traits in adults: hand width, hand length, second digit length, and fourth digit length. Using these measurements, we derived estimates of trait laterality (directional asymmetry or DA) and developmental instability (fluctuating asymmetry or FA). High FA is a putative indicator of interference with the cellular and molecular mechanisms regulating development. We focused on how these derived variables were related to sex, sexual orientation, and putative markers of early sex steroid exposure (e.g., the second to fourth digit ratio or 2D:4D). Our data point to three principal conclusions. First, individual differences in DA appeared to be a major source of variation in the 2D:4D ratio. The 2D:4D ratios of heterosexual men differed depending on whether they had leftward or rightward DA in their digits. Homosexual women showed the same pattern. Individuals with leftward DA in both digits had lower 2D:4D ratios than those with rightward DA. This effect was absent in heterosexual women and homosexual men. This led to sex differences in 2D:4D and sexual orientation differences in 2D:4D in the leftward DA group, but not in the rightward DA group. The second conclusion was that DA in digit length and hand width varied with sex; women were more likely to have rightward asymmetry than men. Homosexual men and women were generally sex typical in DA. The third conclusion was that homosexuality is unlikely to be a result of increased developmental instability. Although limited in scope, the present evidence actually suggests that homosexuals have lower FA than heterosexuals, raising the question of whether the positive fitness components associated with low FA may contribute to selection that maintains homosexuality in a population.

Anthropometric analysis of homosexuals and heterosexuals: implications for early hormone exposure.

Early exposure to sex steroids is thought to be important in mediating the differentiation of male-typical sexual orientation. Bone morphology is a marker of childhood sex steroid exposure, because estrogens and androgens control sexual dimorphism in skeletal size. Anthropometric analysis of heterosexuals and homosexuals indicates that those bones, which become sexually dimorphic in childhood, but not those which become sexually dimorphic after puberty, are different in length in homosexuals and heterosexuals. Persons with a sexual preference for males have less long bone growth in the arms, legs and hands, than those with sexual preference for females. The data support the hypothesis that male homosexuals have had less steroid exposure during development than male heterosexuals and that female homosexuals have had greater steroid exposure during development than their heterosexual counterparts.