Population cause of death estimation using verbal autopsy methods in large-scale field trials of maternal and child health: lessons learned from a 20-year research collaboration in Central Ghana.

Low and middle-income countries continue to use Verbal autopsies (VAs) as a World Health Organisation-recommended method to ascertain causes of death in settings where coverage of vital registration systems is not yet comprehensive. Whilst the adoption of VA has resulted in major improvements in estimating cause-specific mortality in many settings, well documented limitations have been identified relating to the standardisation of the processes involved. The WHO has invested significant resources into addressing concerns in some of these areas; there however remains enduring challenges particularly in operationalising VA surveys for deaths amongst women and children, challenges which have measurable impacts on the quality of data collected and on the accuracy of determining the final cause of death. In this paper we describe some of our key experiences and recommendations in conducting VAs from over two decades of evaluating seminal trials of maternal and child health interventions in rural Ghana. We focus on challenges along the entire VA pathway that can impact on the success rates of ascertaining the final cause of death, and lessons we have learned to optimise the procedures. We highlight our experiences of the value of the open history narratives in VAs and the training and skills required to optimise the quality of the information collected. We describe key issues in methods for ascertaining cause of death and argue that both automated and physician-based methods can be valid depending on the setting. We further summarise how increasingly popular information technology methods may be used to facilitate the processes described. Verbal autopsy is a vital means of increasing the coverage of accurate mortality statistics in low- and middle-income settings, however operationalisation remains problematic. The lessons we share here in conducting VAs within a long-term surveillance system in Ghana will be applicable to researchers and policymakers in many similar settings.

Safety, Quality, and Acceptability of Contraceptive Implant Provision by Community Health Extension Workers versus Nurses and Midwives in Two States in Nigeria.

Task sharing is a strategy with potential to increase access to effective modern contraceptive methods. This study examines whether community health extension workers (CHEWs) can insert contraceptive implants to the same safety and quality standards as nurse/midwives. We analyze data from 7,691 clients of CHEWs and nurse/midwives who participated in a noninferiority study conducted in Kaduna and Ondo States, Nigeria. Adverse events (AEs) following implant insertions were compared. On the day of insertion AEs were similar among CHEW and nurse/midwife clients-0.5 percent and 0.4 percent, adjusted odds ratio (aOR) 0.92 (95 percent CI 0.38-2.23)-but noninferiority could not be established. At follow-up 6.6 percent of CHEW clients and 2.1 percent of nurse/midwife clients experienced AEs. There was strong evidence of effect modification by State. In the final adjusted model, odds of AEs for CHEW clients in Kaduna was 3.34 (95 percent CI 1.53-7.33) compared to nurse/midwife clients, and 0.72 (95 percent CI 0.19-2.72]) in Ondo. Noninferiority could not be established in either State. Implant expulsions were higher among CHEW clients (142/2987) compared to nurse/midwives (40/3517). Results show the feasibility of training CHEWs to deliver implants in remote rural settings but attention must be given to provider selection, training, supervision, and follow-up to ensure safety and quality of provision.

High HIV incidence and low uptake of HIV prevention services: The context of risk for young male adults prior to DREAMS in rural KwaZulu-Natal, South Africa.

BACKGROUND: Young men are less likely than young women to engage with HIV prevention and care, and their HIV-related mortality is higher. We describe HIV incidence and uptake of HIV services in men 20-29 years(y) in rural KwaZulu-Natal, South Africa, before the roll-out of DREAMS. METHODS: We used data from a population-based demographic and HIV surveillance cohort. HIV incidence was estimated from anonymised testing in an annual serosurvey. Service uptake was assessed in 2011 and 2015, through two self-reported outcomes: 1) HIV testing in the past 12 months(m); 2) voluntary medical male circumcision(VMMC). Logistic regression was used to estimate odds ratios(OR) and 95% confidence intervals(CI) for factors associated with each outcome. RESULTS: HIV incidence in 2011-2015 was 2.6/100 person-years (95%CI = 2.0-3.4) and 4.2 (95%CI = 3.1-5.6) among men 20-24y and 25-29y, respectively, with no significant change from 2006-2010. N = 1311 and N = 1221 young men participated in the 2011 and 2015 surveys, respectively. In both years, <50% reported testing for HIV in the past 12m. In 2011, only 5% reported VMMC, but coverage in 2015 increased to 40% and 20% in men 20-24y and 25-29y, respectively. HIV testing was positively associated with higher education and mobility. Testing uptake was higher in men reporting >1 partner in the past 12m, or condom use at last sex, but lower in those reporting a casual partner (adjusted (a)OR = 0.53, 95%CI = 0.37-0.75). VMMC uptake was associated with survey year and higher education. Men aged 25-29y and those who were employed (aOR = 0.66; 95%CI = 0.49-0.89) were less likely to report VMMC. CONCLUSIONS: HIV incidence in men 20-29y was very high, and pre-exposure prophylaxis (PrEP) should be considered in this population. Uptake of services was low. VMMC coverage increased dramatically from 2011 to 2015, especially among younger men, suggesting a demand for this service. Interventions designed with and for young men are urgently needed.

Persistently high incidence of HIV and poor service uptake in adolescent girls and young women in rural KwaZulu-Natal, South Africa prior to DREAMS.

BACKGROUND: Adolescent girls and young women (AGYW) bear the brunt of the HIV epidemic in South Africa. 'DREAMS' aims to reduce HIV incidence through multi-level combination prevention. We describe HIV incidence and uptake of HIV and sexual reproductive health (SRH) by AGYW in KwaZulu-Natal (KZN), prior to DREAMS. METHODS: Longitudinal and cross-sectional analysis of women (15-24 year old) in a population-based HIV incidence cohort within a demographic surveillance site in KZN. Observation time for HIV incidence was person-years at risk while resident. "Current use of contraceptives" and "having an HIV test in the past 12 months" was compared between 2011 and 2015. RESULTS: In 2015, HIV prevalence was 11.0% and 34.1% and HIV incidence (2011-2015) was 4.54% (95%CI:3.89-5.30) and 7.45% (95%CI:6.51-8.51) per year in 15-19 and 20-24 year olds respectively, with no significant decline compared to 2006-2010. In 2015, 90.7% of 20-24-year-olds were unemployed, 36.4% and 51.7% of 15-19 and 20-24 year olds reported recent migration; 20.9% and 72.6% of 15-19 and 20-24 year olds had ever been pregnant. In 2015, less than 50% reported condom-use at last sex, 15.0% of 15-19 year olds and 48.9% of 20-24 year olds were currently using contraception and 32.0% and 66.7% of 15-19 and 20-24 year olds had tested for HIV in the past 12 months. There had been no improvement compared to 2011. Factors associated with AGYW testing for HIV in the past 12 months were, survey year-2011 more likely than 2015 (aOR = 0.50), number of partners (aOR = 3.25), ever been pregnant (aOR = 2.47) and knowing where to find ART (aOR = 1.54). Factors associated with contraception use were being older (aOR = 4.83); ever been pregnant (aOR = 12.62); knowing where to get ART (aOR = 1.79) and having had an HIV test in past 12 months (aOR = 1.74). CONCLUSION: Prior to DREAMS, HIV incidence in AGYW was high. HIV and SRH service uptake did not improve and was suboptimal. Findings highlight the need for combination HIV prevention programmes for AGYW in this economically vulnerable area.

Integration of HIV and reproductive health services in public sector facilities: analysis of client flow data over time in Kenya.

INTRODUCTION: Integration of HIV/AIDS with reproductive health (RH) services can increase the uptake and efficiency of services, but gaps in knowledge remain about the practice of integration, particularly how provision can be expanded and performance enhanced. We assessed the extent and nature of service integration in public sector facilities in four districts in Kenya. METHODS: Between 2009 and 2012, client flow assessments were conducted at six time points in 24 government facilities, purposively selected as intervention or comparison sites. A total of 25 539 visits were tracked: 15 270 in districts where 6 of 12 facilities received an intervention to strengthen HIV service integration with family planning (FP); and 10 266 visits in districts where half the facilities received an HIV-postnatal care intervention in 2009-2010. We tracked the proportion of all visits in which: (1) an HIV service (testing, counselling or treatment) was received together with an RH service (FP counselling or provision, antenatal care, or postnatal care); (2) the client received HIV counselling. RESULTS: Levels of integrated HIV-RH services and HIV counselling were generally low across facilities and time points. An initial boost in integration was observed in most intervention sites, driven by integration of HIV services with FP counselling and provision, and declined after the first follow-up. Integration at most sites was driven by temporary rises in HIV counselling. The most consistent combination of HIV services was with antenatal care; the least common was with postnatal care. CONCLUSIONS: These client flow data demonstrated a short-term boost in integration, after an initial intervention with FP services providing an opportunity to expand integration. Integration was not sustained over time highlighting the need for ongoing support. There are multiple opportunities for integrating service delivery, particularly within antenatal, FP and HIV counselling services, but a need for sustained systems and health worker support over time. TRIAL REGISTRATION NUMBER: NCT01694862.

Impact of integration of sexual and reproductive health services on consultation duration times: results from the Integra Initiative.

The lack of human resources is a key challenge in scaling up of HIV services in Africa's health care system. Integrating HIV services could potentially increase their effectiveness and optimize the use of limited resources and clinical staff time. We examined the impact of integration of provider initiated HIV counselling and testing (PITC) and family planning (FP counselling and FP provision) services on duration of consultation to assess the impact of PITC and FP integration on staff workload. This study was conducted in 24 health facilities in Kenya under the Integra Initiative, a non-randomized, pre/post intervention trial to evaluate the impact of integrated HIV and sexual and reproductive health services on health and service outcomes. We compared the time spent providing PITC-only services, FP-only services and integrated PITC/FP services. We used log-linear regression to assess the impact of plausible determinants on the duration of clients' consultation times. Median consultation duration times were highest for PITC-only services (30 min), followed by integrated services (10 min) and FP-only services (8 min). Times for PITC-only and FP-only services were 69.7% higher (95% Confidence Intervals (CIs) 35.8-112.0) and 43.9% lower (95% CIs -55.4 to - 29.6) than times spent on these services when delivered as an integrated service, respectively. The reduction in consultation times with integration suggests a potential reduction in workload. The higher consultation time for PITC-only could be because more pre- and post-counselling is provided at these stand-alone services. In integrated PITC/FP services, the duration of the visit fell below that required by HIV testing guidelines, and service mix between counselling and testing substantially changed. Integration of HIV with FP services may compromise the quality of services delivered and care must be taken to clearly specify and monitor appropriate consultation duration times and procedures during the process of integrating HIV and FP services.

Impact of the national rotavirus vaccination programme on acute gastroenteritis in England and associated costs averted.

BACKGROUND: Introduction of infant oral rotavirus vaccination in the UK in July 2013 has resulted in decreased hospitalisations and Emergency Department (ED) visits for acute gastroenteritis (AGE), for both adults and children. We investigated reductions in AGE incidence seen in primary care in the two years after vaccine introduction, and estimated the healthcare costs averted across healthcare settings in the first year of the vaccination programme. METHODS: We used primary care data from the Clinical Practice Research Datalink and age-stratified time-series analyses to derive adjusted incidence rate ratios (IRRa) for AGE in the first two years of the post-vaccination era (July 2013-April 2015) compared to the pre-vaccination era (July 2008-June 2013). We estimated cases averted among children aged <5years in the first year of the vaccination programme by comparing observed numbers of AGE cases in 2013-2014 to numbers predicted from the time-series models. We then estimated the healthcare costs averted for general practice consultations, ED visits and hospitalisations. RESULTS: In general practice, AGE rates in infants (the target group for vaccination) decreased by 15% overall after vaccine introduction (IRRa=0.85; 95%CI=0.76-0.95), and by 41% in the months of historically high rotavirus circulation (IRRa=0.59; 95%CI=0.53-0.66). Rates also decreased in other young children and to a lesser degree in older individuals, indicating herd immunity. Across all three settings (general practice, EDs, and hospitalisations) an estimated 87,376 (95% prediction interval: 62,588-113,561) AGE visits by children aged <5years were averted in 2013-14, associated with an estimated £12.5million (9,209-16,198) reduction in healthcare costs. CONCLUSIONS: The marked decreases in the general practice AGE burden after rotavirus vaccine introduction mirror decreases seen in other UK healthcare settings. Overall, these decreases are associated with substantial averted healthcare costs.

Integration of HIV and maternal healthcare in a high HIV-prevalence setting: analysis of client flow data over time in Swaziland.

OBJECTIVE: Maternal and child health (MCH) care may provide an entry point for HIV services in high HIV-prevalence settings. Our objective was to assess integration of HIV with MCH services in public sector facilities in Swaziland. DESIGN: In 2009, 2010 and 2012, client flow assessments (CFAs) were conducted over 5 days in the MCH units of eight government facilities, purposively selected as intervention or comparison sites. PARTICIPANTS: 8263 MCH visits with female clients were tracked: 3261 in 2009, 2086 in 2010 and 2916 in 2012. INTERVENTION: Activities and resources to strengthen integration of HIV services into postnatal care (PNC), 2009-2010. MAIN OUTCOME MEASURES: The proportion of all visits in which an HIV/sexually transmitted infection (STI) testing, counselling or treatment was received together with an MCH service; the proportion of all visits in which a client receives HIV counselling. RESULTS: Across facilities, the proportion of visits in which HIV/STI and MCH services were received varied considerably, for example, from 9% to 49% in 2009. HIV/STI services were integrated most frequently with child health (CH), antenatal care (ANC) and family planning (FP)-the most common reasons for women's attendance-and least often with PNC and cervical screening (CS). There was no meaningful difference in integration over time by design group and considerable heterogeneity across facilities. Receipt of integrated services increased in one intervention and two comparison facilities, where HIV counselling also rose, and fell in one intervention and two comparison facilities. CONCLUSIONS: Provision of HIV/STI services with MCH care occurred at all facilities, yet relatively few women receive integrated services. Increases in integration were driven by increases in HIV counselling, while sharp declines in some facilities indicate that integration is difficult to sustain. Opportunities for intensifying HIV integration lie with ANC, CH and FP, while HIV-PNC integration will remain limited until more women attend PNC. TRIAL REGISTRATION NUMBER: Current Controlled Trials NCT01694862.

Effect of household and community interventions on the burden of tuberculosis in southern Africa: the ZAMSTAR community-randomised trial.

BACKGROUND: Southern Africa has had an unprecedented increase in the burden of tuberculosis, driven by the HIV epidemic. The Zambia, South Africa Tuberculosis and AIDS Reduction (ZAMSTAR) trial examined two public health interventions that aimed to reduce the burden of tuberculosis by facilitating either rapid sputum diagnosis or integrating tuberculosis and HIV services within the community. METHODS: ZAMSTAR was a community-randomised trial done in Zambia and the Western Cape province of South Africa. Two interventions, community-level enhanced tuberculosis case-finding (ECF) and household level tuberculosis-HIV care, were implemented between Aug 1, 2006, and July 31, 2009, and assessed in a 2×2 factorial design between Jan 9, 2010, and Dec 6, 2010. All communities had a strengthened tuberculosis-HIV programme implemented in participating health-care centres. 24 communities, selected according to population size and tuberculosis notification rate, were randomly allocated to one of four study groups using a randomisation schedule stratified by country and baseline prevalence of tuberculous infection: group 1 strengthened tuberculosis-HIV programme at the clinic alone; group 2, clinic plus ECF; group 3, clinic plus household intervention; and group 4, clinic plus ECF and household interventions. The primary outcome was the prevalence of culture-confirmed pulmonary tuberculosis in adults (≥18 years), defined as Mycobacterium tuberculosis isolated from one respiratory sample, measured 4 years after the start of interventions in a survey of 4000 randomly selected adults in each community in 2010. The secondary outcome was the incidence of tuberculous infection, measured using tuberculin skin testing in a cohort of schoolchildren, a median of 4 years after a baseline survey done before the start of interventions. This trial is registered, number ISRCTN36729271. FINDINGS: Prevalence of tuberculosis was evaluated in 64,463 individuals randomly selected from the 24 communities; 894 individuals had active tuberculosis. Averaging over the 24 communities, the geometric mean of tuberculosis prevalence was 832 per 100,000 population. The adjusted prevalence ratio for the comparison of ECF versus non-ECF intervention groups was 1·09 (95% CI 0·86-1·40) and of household versus non-household intervention groups was 0·82 (0·64-1·04). The incidence of tuberculous infection was measured in a cohort of 8809 children, followed up for a median of 4 years; the adjusted rate ratio for ECF versus non-ECF groups was 1·36 (95% CI 0·59-3·14) and for household versus non-household groups was 0·45 (0·20-1·05). INTERPRETATION: Although neither intervention led to a statistically significant reduction in tuberculosis, two independent indicators of burden provide some evidence of a reduction in tuberculosis among communities receiving the household intervention. By contrast the ECF intervention had no effect on either outcome. FUNDING: Bill & Melinda Gates Foundation.

Effect of vitamin A supplementation on cause-specific mortality in women of reproductive age in Ghana: a secondary analysis from the ObaapaVitA trial.

OBJECTIVE: To determine the effect of weekly low-dose vitamin A supplementation on cause-specific mortality in women of reproductive age in Ghana. METHODS: A cluster-randomized, triple-blind, placebo-controlled trial was conducted in seven districts of the Brong Ahafo region of Ghana. Women aged 15-45 years who were capable of giving informed consent and intended to live in the trial area for at least 3 months were enrolled and randomly assigned, according to their cluster of residence, to receive oral vitamin A (7500 µg) or placebo once a week. Randomization was blocked, with two clusters in each fieldwork area allocated to vitamin A and two to placebo. Every 4 weeks, fieldworkers distributed capsules and collected data during home visits. Verbal autopsies were conducted by field supervisors and reviewed by physicians, who assigned a cause of death. Cause-specific mortality rates in both arms were compared by means of random-effects Poisson regression models to allow for the cluster randomization. Analysis was by intention-to-treat, based on cluster of residence, with women eligible for inclusion once they had consistently received the supplement or placebo capsules for 6 months. FINDINGS: The analysis was based on 581 870 woman-years and 2624 deaths. Cause-specific mortality rates were found to be similar in the two study arms. CONCLUSION: Low-dose vitamin A supplements administered weekly are of no benefit in programmes to reduce mortality in women of childbearing age.

Résumé OBJECTIF: Déterminer l'effet de la supplémentation hebdomadaire en vitamine A à faible dose sur la mortalité spécifique des femmes en âge de procréer au Ghana. MÉTHODES: Une étude randomisée, en triple aveugle, contrôlée contre placebo, a été menée dans sept districts de la région de Brong Ahafo au Ghana. Les femmes âgées de 15 à 45 ans, capables de donner un consentement éclairé et amenées à vivre dans la région de l'étude pendant au moins 3 mois, ont été incluses et il a été déterminé qu'elles recevraient une fois par semaine, au hasard selon leur groupe de résidence, de la vitamine A par voie orale (7 500 µg) ou un placebo. La randomisation a été fixée par deux groupes dans chaque zone recevant la vitamine A et deux groupes recevant le placebo. Toutes les 4 semaines, les agents de terrain distribuaient les capsules et recueillaient les données lors de visites à domicile. Des autopsies orales ont été effectuées par les superviseurs sur le terrain et analysées par des médecins, qui déterminaient la cause du décès. Les taux de mortalité spécifique dans les deux groupes ont été comparés à l'aide d'une régression de Poisson pour valider la randomisation des groupes. L'analyse, basée sur l'intention de traiter, était basée sur le groupe de résidence, pour des femmes éligibles à l'étude ayant reçu les capsules de supplément ou de placebo de manière constante pendant 6 mois. RÉSULTATS: L'analyse s'est basée sur 581 870 années-femmes et 2624 décès. Les taux de mortalité spécifique ont été jugés similaires dans les deux groupes de l'étude. CONCLUSION: Les suppléments en vitamine A à faible dose administrés hebdomadairement ne sont d'aucune utilité dans les programmes visant à réduire la mortalité chez les femmes en âge de procréer.

Resumen OBJETIVO: Determinar el efecto de la administración semanal de dosis bajas de vitamina A en la mortalidad por causas específicas de mujeres en edad reproductiva en Ghana. MÉTODOS: Se realizó un ensayo aleatorio de grupos, triple ciego y controlado por placebo en siete distritos de la región de Brong Ahafo, en Ghana. Se inscribieron mujeres de entre 15 y 45 años de edad capaces de dar su consentimiento informado y que tuvieran previsto vivir en el área de ensayo durante al menos tres meses. De acuerdo con el grupo de residencia al que habían sido asignadas de forma aleatoria, recibieron semanalmente vitamina A por vía oral (7500 µg) o placebo. La distribución aleatoria se limitó en cada área de trabajo a dos grupos a los que se les administró vitamina A y dos grupos que recibieron placebo. Cada cuatro semanas, los investigadores de campo distribuyeron cápsulas y recogieron datos durante las visitas a los hogares. Las autopsias verbales realizadas por los supervisores de campo fueron revisadas por médicos, quienes determinaron la causa de la muerte. Se compararon las tasas de mortalidad por causas específicas de ambos brazos mediante los modelos de regresión de Poisson con efectos aleatorios para facilitar la distribución aleatoria de los grupos. El análisis fue por intención de tratar, según el grupo de residencia y con mujeres que cumplieron las condiciones de inclusión una vez habían recibido de forma constante las cápsulas de suplemento o placebo durante seis meses. RESULTADOS: El análisis se basó en 581 870 años-mujer y 2624 muertes. Se descubrió que las tasas de mortalidad por causas específicas fueron similares en ambos brazos del estudio. CONCLUSIÓN: Los suplementos de dosis bajas de vitamina A administrados semanalmente no presentan ninguna ventaja en los programas para reducir la mortalidad de las mujeres en edad reproductiva.

Impact of free delivery care on health facility delivery and insurance coverage in Ghana's Brong Ahafo Region.

BACKGROUND: Many sub-Saharan countries, including Ghana, have introduced policies to provide free medical care to pregnant women. The impact of these policies, particularly on access to health services among the poor, has not been evaluated using rigorous methods, and so the empirical basis for defending these policies is weak. In Ghana, a recent report also cast doubt on the current mechanism of delivering free care--the National Health Insurance Scheme. Longitudinal surveillance data from two randomized controlled trials conducted in the Brong Ahafo Region provided a unique opportunity to assess the impact of Ghana's policies. METHODS: We used time-series methods to assess the impact of Ghana's 2005 policy on free delivery care and its 2008 policy on free national health insurance for pregnant women. We estimated their impacts on facility delivery and insurance coverage, and on socioeconomic differentials in these outcomes after controlling for temporal trends and seasonality. RESULTS: Facility delivery has been increasing significantly over time. The 2005 and 2008 policies were associated with significant jumps in coverage of 2.3% (p = 0.015) and 7.5% (p<0.001), respectively after the policies were introduced. Health insurance coverage also jumped significantly (17.5%, p<0.001) after the 2008 policy. The increases in facility delivery and insurance were greatest among the poorest, leading to a decline in socioeconomic inequality in both outcomes. CONCLUSION: Providing free care, particularly through free health insurance, has been effective in increasing facility delivery overall in the Brong Ahafo Region, and especially among the poor. This finding should be considered when evaluating the impact of the National Health Insurance Scheme and in supporting the continuation and expansion of free delivery care.

Effect of vitamin A supplementation in women of reproductive age on cause-specific early and late infant mortality in rural Ghana: ObaapaVitA double-blind, cluster-randomised, placebo-controlled trial.

Objectives To assess the effect of vitamin A supplementation in women of reproductive age in Ghana on cause- and age-specific infant mortality. In addition, because of recently published studies from Guinea Bissau, effects on infant mortality by sex and season were assessed. Design Double-blind, cluster-randomised, placebo-controlled trial. Setting 7 contiguous districts in the Brong Ahafo region of Ghana. Participants All women of reproductive age (15-45 years) resident in the study area randomised by cluster of residence. All live born infants from 1 June 2003 to 30 September 2008 followed up through 4-weekly home visits. Intervention Weekly low-dose (25 000 IU) vitamin A. Main outcome measures Early infant mortality (1-5 months); late infant mortality (6-11 months); infection-specific infant mortality (0-11 months). Results 1086 clusters, 62 662 live births, 52 574 infant-years and 3268 deaths yielded HRs (95% CIs) comparing weekly vitamin A with placebo: 1.04 (0.88 to 1.05) early infant mortality; 0.99 (0.84 to 1.18) late infant mortality; 1.03 (0.92 to 1.16) infection-specific infant mortality. There was no evidence of modification of the effect of vitamin A supplementation on infant mortality by sex (Wald statistic =0.07, p=0.80) or season (Wald statistic =0.03, p=0.86). Conclusions This is the largest analysis of cause of infant deaths from Africa to date. Weekly vitamin A supplementation in women of reproductive age has no beneficial or deleterious effect on the causes of infant death to age 6 or 12 months in rural Ghana. Trial registration number http://ClinicalTrials.gov: NCT00211341.

Improving hygiene in home deliveries in rural Ghana: how to build on current attitudes and practices.

INTRODUCTION: Clean delivery of newborns is a key intervention for reducing infection-related neonatal mortality. Understanding local practices and beliefs is important for designing appropriate interventions. There are few data from Africa. This study explored delivery practices in Ghana to identify behaviors for intervention and to determine behavioral influencers. METHODS: Data on the prevalence of clean delivery behaviors, collected through a demographic surveillance system, were analyzed for 2631 women who delivered at home within a 1-year period. Qualitative data on delivery practices were collected through birth narratives, in-depth interviews, and focus groups with recently delivered/pregnant women, traditional birth attendants, grandmothers, and husbands. RESULTS: Most women delivered on a covered surface (79%), had birth attendants who washed their hands (79%), cut the cord with a new blade (98%), and tied it with a new thread (90%). Eight percent of families practiced dry cord care. Families understood the importance of a clean delivery surface and many birth attendants knew the importance of hand-washing. Delivering on an uncovered surface was linked to impromptu deliveries and a belief that a swept floor is clean. Not washing hands was linked to rushing to help the woman, not being provided with soap, forgetfulness, and a belief among some that the babies are born dirty. The frequent application of products to the cord was nearly universal and respondents believed that applying nothing to the cord would have serious negative consequences. CONCLUSIONS: Delivery surfaces, hand-washing, and cord cutting and tying appear appropriate for the majority of women. Changing cord care practices is likely to be difficult unless replacement products are provided.

Effect of vitamin A supplementation in women of reproductive age on maternal survival in Ghana (ObaapaVitA): a cluster-randomised, placebo-controlled trial.

BACKGROUND: A previous trial in Nepal showed that supplementation with vitamin A or its precursor (betacarotene) in women of reproductive age reduced pregnancy-related mortality by 44% (95% CI 16-63). We assessed the effect of vitamin A supplementation in women in Ghana. METHODS: ObaapaVitA was a cluster-randomised, double-blind, placebo-controlled trial undertaken in seven districts in Brong Ahafo Region in Ghana. The trial area was divided into 1086 small geographical clusters of compounds with fieldwork areas consisting of four contiguous clusters. All women of reproductive age (15-45 years) who gave informed consent and who planned to remain in the area for at least 3 months were recruited. Participants were randomly assigned by cluster of residence to receive a vitamin A supplement (25 000 IU retinol equivalents) or placebo capsule orally once every week. Randomisation was blocked and based on an independent, computer-generated list of numbers, with two clusters in each fieldwork area allocated to vitamin A supplementation and two to placebo. Capsules were distributed during home visits undertaken every 4 weeks, when data were gathered on pregnancies, births, and deaths. Primary outcomes were pregnancy-related mortality and all-cause female mortality. Cause of death was established by verbal post mortems. Analysis was by intention to treat (ITT) with random-effects regression to account for the cluster-randomised design. Adverse events were synonymous with the trial outcomes. This trial is registered with ClinicalTrials.gov, number NCT00211341. FINDINGS: 544 clusters (104 484 women) were randomly assigned to vitamin A supplementation and 542 clusters (103 297 women) were assigned to placebo. The main reason for participant drop out was migration out of the study area. In the ITT analysis, there were 39 601 pregnancies and 138 pregnancy-related deaths in the vitamin A supplementation group (348 deaths per 100 000 pregnancies) compared with 39 234 pregnancies and 148 pregnancy-related deaths in the placebo group (377 per 100 000 pregnancies); adjusted odds ratio 0.92, 95% CI 0.73-1.17; p=0.51. 1326 women died in 292 560 woman-years in the vitamin A supplementation group (453 deaths per 100 000 years) compared with 1298 deaths in 289 310 woman-years in the placebo group (449 per 100 000 years); adjusted rate ratio 1.01, 0.93-1.09; p=0.85. INTERPRETATION: The body of evidence, although limited, does not support inclusion of vitamin A supplementation for women in either safe motherhood or child survival strategies. FUNDING: UK Department for International Development, and USAID.

Trends in national incidence, lifetime prevalence and adrenaline prescribing for anaphylaxis in England.

BACKGROUND: Analysis of primary healthcare datasets offers the possibility to increase understanding of the epidemiology of acute uncommon conditions such as anaphylaxis, but these datasets remain under-exploited. AIM: To investigate recent trends in the recorded incidence, lifetime prevalence and prescribing of adrenaline for anaphylaxis in England. METHODS: QRESEARCH is one of the world's largest national aggregated health databases containing the records of over nine million patients. We extracted data on all patients with a recorded diagnosis of anaphylaxis and calculated annual age-sex standardized incidence and lifetime period prevalence rates for each year from 2001-2005. We also analysed trends in adrenaline prescribing in those with a recorded diagnosis of anaphylaxis. National population figures were used to estimate numbers of people in England that have experienced anaphylaxis at some point in their lives. RESULTS: The age-sex standardized incidence of anaphylaxis was 6.7 per 100,000 person-years in 2001 and increased by 19% to 7.9 in 2005. Lifetime age-sex standardized prevalence of a recorded diagnosis of anaphylaxis was 50.0 per 100,000 in 2001 and increased by 51% to 75.5 in 2005. Prescribing of adrenaline increased by 97% over this period. By the end of 2005 there were an estimated 37,800 people that had experienced anaphylaxis at some point in their lives. CONCLUSIONS: Recorded incidence, lifetime prevalence and prescribing of adrenaline for anaphylaxis all showed substantial increases in recent years. An estimated 1 in 1,333 of the English population have at some point in their lives experienced anaphylaxis.