Assessing capacity of health facilities to provide routine maternal and newborn care in low-income settings: what proportions are ready to provide good-quality care, and what proportions of women receive it?

BACKGROUND: Good quality maternal and newborn care at primary health facilities is essential, but in settings with high maternal and newborn mortality the evidence for the protective effect of facility delivery is inconsistent. We surveyed samples of health facilities in three settings with high maternal mortality to assess their readiness to provide routine maternal and newborn care, and proportions of women using facilities that were ready to offer good quality care. Surveys were conducted in 2012 and 2015 to assess changes over time. METHODS: Surveys were conducted in Ethiopia, the Indian state of Uttar Pradesh and Gombe State in North-Eastern Nigeria. At each facility the staffing, infrastructure and commodities were quantified. These formed components of four "signal functions" that described aspects of routine maternal and newborn care. A facility was considered ready to perform a signal function if all the required components were present. Readiness to perform all four signal functions classed a facility as ready to provide good quality routine care. From facility registers we counted deliveries and calculated the proportions of women delivering in facilities ready to offer good quality routine care. RESULTS: In Ethiopia the proportion of deliveries in facilities classed as ready to offer good quality routine care rose from 40% (95% confidence interval (CI) 26-57) in 2012 to 43% (95% CI 31-56) in 2015. In Uttar Pradesh these estimates were 4% (95% CI 1-24) in 2012 and 39% (95% CI 25-55) in 2015, while in Nigeria they were 25% (95% CI 6-66) in 2012 and zero in 2015. Improved facility readiness in Ethiopia and Uttar Pradesh arose from increased supplies of commodities, while in Nigeria facility readiness fell due to depleted commodity supplies and fewer Skilled Birth Attendants. CONCLUSIONS: This study quantified the readiness of health facilities to offer good quality routine maternal and newborn care, and may help explain inconsistent outcomes of facility care in some settings. Signal function methodology can provide a rapid and inexpensive measure of such facility readiness. Incorporating data on facility deliveries and repeating the analyses highlighted adjustments that could have greatest impact upon routine maternal and newborn care.

Coverage and equity of maternal and newborn health care in rural Nigeria, Ethiopia and India.

BACKGROUND: Despite progress toward meeting the Sustainable Development Goals, a large burden of maternal and neonatal mortality persists for the most vulnerable people in rural areas. We assessed coverage, coverage change and inequity for 8 maternal and newborn health care indicators in parts of rural Nigeria, Ethiopia and India. METHODS: We examined coverage changes and inequity in 2012 and 2015 in 3 high-burden populations where multiple actors were attempting to improve outcomes. We conducted cluster-based household surveys using a structured questionnaire to collect 8 priority indicators, disaggregated by relative household socioeconomic status. Where there was evidence of a change in coverage between 2012 and 2015, we used binomial regression models to assess whether the change reduced inequity. RESULTS: In 2015, we interviewed women with a birth in the previous 12 months in Gombe, Nigeria (n = 1100 women), Ethiopia (n = 404) and Uttar Pradesh, India (n = 584). Among the 8 indicators, 2 positive coverage changes were observed in each of Gombe and Uttar Pradesh, and 5 in Ethiopia. Coverage improvements occurred equally for all socioeconomic groups, with little improvement in inequity. For example, in Ethiopia, coverage of facility delivery almost tripled, increasing from 15% (95% confidence interval [CI] 9%-25%) to 43% (95% CI 33%-54%). This change was similar across socioeconomic groups (p = 0.2). By 2015, the poorest women had about the same facility delivery coverage as the least poor women had had in 2012 (32% and 36%, respectively), but coverage for the least poor had increased to 60%. INTERPRETATION: Although coverage increased equitably because of various community-based interventions, underlying inequities persisted. Action is needed to address the needs of the most vulnerable women, particularly those living in the most rural areas.

Impact of Integrated Services on HIV Testing: A Nonrandomized Trial among Kenyan Family Planning Clients.

The impact of integrated reproductive health and HIV services on HIV testing and counseling (HTC) uptake was assessed among 882 Kenyan family planning clients using a nonrandomized cohort design within six intervention and six "comparison" facilities. The effect of integration on HTC goals (two tests over two years) was assessed using conditional logistic regression to test four "integration" exposures: a training and reorganization intervention; receipt of reproductive health and HIV services at recruitment; a functional measure of facility integration at recruitment; and a woman's cumulative exposure to functionally integrated care across different facilities over time. While recent receipt of HTC increased rapidly at intervention facilities, achievement of HTC goals was higher at comparison facilities. Only high cumulative exposure to integrated care over two years had a significant effect on HTC goals after adjustment (aOR 2.94, 95%CI 1.73-4.98), and programs should therefore make efforts to roll out integrated services to ensure repeated contact over time.

Fertility intentions and contraceptive practices among clinic-users living with HIV in Kenya: a mixed methods study.

BACKGROUND: Preventing unwanted pregnancies in Women Living with HIV (WLHIV) is a recognised HIV-prevention strategy. This study explores the fertility intentions and contraceptive practices of WLHIV using services in Kenya. METHODS: Two hundred forty women self-identifying as WLHIV who attended reproductive health services in Kenya were interviewed with a structured questionnaire in 2011; 48 were also interviewed in-depth. STATA SE/13.1, Nvivo 8 and thematic analysis were used. RESULTS: Seventy one percent participants did not want another child; this was associated with having at least two living children and being the bread-winner. FP use was high (92%) but so were unintended pregnancies (40%) while living with HIV. 56 women reported becoming pregnant "while using FP": all were using condoms or short-term methods. Only 16% participants used effective long-acting reversible contraceptives or permanent methods (LARC-PM). Being older than 25 years and separated, widowed or divorced were significant predictors of long-term method use. Qualitative data revealed strong motivation among WLHIV to plan or prevent pregnancies to avoid negative health consequences. Few participants received good information about contraceptive choices. CONCLUSIONS: WLHIV need better access to FP advice and a wider range of contraceptives including LARC to enable informed choices that will protect their fertility intentions, ensure planned pregnancies and promote safe child-bearing. TRIAL REGISTRATION: Integra is a non-randomised pre-post intervention trial registered with Current Controlled Trials ID: NCT01694862 .

Internet-based cohort study of HIV testing over 1 year among men who have sex with men living in England and exposed to a social marketing intervention promoting testing.

OBJECTIVES: Increasing HIV testing among men who have sex with men (MSM) is a major policy goal in the UK. Social marketing is a common intervention to increase testing uptake. We used an online panel of MSM to examine rates of HIV testing behaviour and the impact of a social marketing intervention on them. METHOD: MSM in England were recruited to a longitudinal internet panel through community websites and a previous survey. Following an enrolment survey, respondents were invited to self-complete 13 surveys at monthly intervals throughout 2011. A unique alphanumeric code linked surveys for individuals. Rates of HIV testing were compared relative to prompted recognition of a multi-part media campaign aiming to normalise HIV testing. RESULTS: Of 3386 unique enrolments, 2047 respondents were included in the analysis, between them submitting 15,353 monthly surveys (equivalent to 1279 years of follow-up), and recording 1517 HIV tests taken, giving an annual rate of tests per participant of 1.19 (95% CI 1.13 to 1.25). Tests were highly clustered in individuals (61% reported no test during the study). Testing rates were higher in London, single men and those aged 25-34 years. Only 7.6% recognised the intervention when prompted. After controlling for sociodemographic characteristics and exposure to other health promotion campaigns, intervention recognition was not associated with increased likelihood of testing. Higher rates of testing were strongly associated with higher number of casual sexual partners and how recently men had HIV tested before study enrolment. CONCLUSIONS: This social marketing intervention was not associated with increased rates of HIV testing. More effective promotion of HIV testing is needed among MSM in England to reduce the average duration of undiagnosed infection.

Protocol for an OpenSAFELY cohort study collecting patient-reported outcome measures using the TPP Airmid smartphone application and linked big data to quantify the health and economic costs of long COVID (OpenPROMPT).

INTRODUCTION: The impact of long COVID on health-related quality of-life (HRQoL) and productivity is not currently known. It is important to understand who is worst affected by long COVID and the cost to the National Health Service (NHS) and society, so that strategies like booster vaccines can be prioritised to the right people. OpenPROMPT aims to understand the impact of long COVID on HRQoL in adults attending English primary care. METHODS AND ANALYSIS: We will ask people to participate in this cohort study through a smartphone app (Airmid), and completing a series of questionnaires held within the app. Questionnaires will ask about HRQoL, productivity and symptoms of long COVID. Participants will be asked to fill in the questionnaires once a month, for 90 days. Questionnaire responses will be linked, where possible, to participants' existing health records from primary care, secondary care, and COVID testing and vaccination data. Analysis will take place using the OpenSAFELY data platform and will estimate the impact of long COVID on HRQoL, productivity and cost to the NHS. ETHICS AND DISSEMINATION: The Proportionate Review Sub-Committee of the South Central-Berkshire B Research Ethics Committee has reviewed and approved the study and have agreed that we can ask people to take part (22/SC/0198). Our results will provide information to support long-term care, and make recommendations for prevention of long COVID in the future. TRIAL REGISTRATION NUMBER: NCT05552612.

Association of impaired kidney function with mortality in rural Uganda: results of a general population cohort study.

OBJECTIVE: To determine the association between baseline kidney function and subsequent all-cause mortality. DESIGN AND SETTING: A general population-based cohort study from rural Uganda. PARTICIPANTS: People aged 18 years and above with measured baseline estimated glomerular filtration rate (eGFR), recruited from survey rounds in 2011-2012 or 2014-2015 and followed up to March 2019. OUTCOME MEASURE: The primary outcome was all-cause mortality, identified through reports from community health workers and verified by verbal autopsy. The association between baseline eGFR category and mortality was determined using multivariable Cox regression. RESULTS: Of 5812 participants in both rounds, we included 5678 (97.7%) participants with kidney function and mortality data; the median age was 36 years (IQR 24-50), 60.7% were female, 10.3% were hypertensive, 9.8% were HIV-positive and 1.5% were diabetic. During a median follow-up of 5.0 years (IQR 3.7-6.0) there were 140 deaths. In age-adjusted and sex-adjusted analyses, eGFR <45 mL/min/1.73 m2 at baseline was associated with a 5.97 (95% CI 2.55 to 13.98) increased risk of mortality compared with those with baseline eGFR >90 mL/min/1.73 m2. After inclusion of additional confounders (HIV, body mass index, diabetes, hypertension, alcohol and smoking status) into the model, eGFR <45 mL/min/1.73 m2 at baseline remained strongly associated with mortality (HR 6.12, 95% CI 2.27 to 16.45), although the sample size fell to 3102. Test for trend showed strong evidence (p<0.001) that the rate of mortality increased progressively as the category of baseline kidney function decreased. When very high eGFR was included as a separate category in age-adjusted and sex-adjusted analyses, baseline eGFR ≥120 mL/min/1.73 m2 was associated with increased risk of mortality (HR 2.68, 95% CI 1.47 to 4.87) compared with the reference category of 90-119 mL/min/1.73 m2. CONCLUSION: In a prospective cohort in rural Uganda we found that impaired baseline kidney function was associated with subsequently increased total mortality. Improved understanding of the determinants of kidney disease and its progression is needed in order to inform interventions for prevention and treatment.

Embedding Community-Based Newborn Care in the Ethiopian health system: lessons from a 4-year programme evaluation.

Despite remarkable gains, improving neonatal survival globally remains slow paced. Innovative service-delivery packages have been developed for community health workers (CHWs) to maximize system efficiency and increase the reach of services. However, embedding these in health systems needs structural and procedural alignment. The Community-Based Newborn Care (CBNC) programme was a response to high neonatal mortality in Ethiopia. Key aspects include simplified treatment for neonatal illness, integrated outreach services and task-shifting. Using the CHW functionality model by WHO, this study evaluates the health system response to the programme, including quality of care. A before-and-after study was conducted with three survey time points: baseline (November 2013), midline (December 2015) and follow-up (December 2017-4 years after the programme started). Data were collected at a sample of primary healthcare facilities from 101 districts across four regions. Analysis took two perspectives: (1) health system response, through supplies, infrastructure support and supervision, assessed through interviews and observations at health facilities and (2) quality of care, through CHWs' theoretical capacity to deliver services, as well as their performance, assessed through functional health literacy and direct observation of young infant case management. Results showed gains in services for young infants, with antibiotics and job aids available at over 90% of health centres. However, services at health posts remained inadequate in 2017. In terms of quality of care, only 37% of CHWs correctly diagnosed key conditions in sick young infants at midline. CHWs' functional health literacy declined by over 70% in basic aspects of case management during the study. Although the frequency of quarterly supportive supervision visits was above 80% during 2013-2017, visits lacked support for managing sick young infants. Infrastructure and resources improved over the course of the CBNC programme implementation. However, embedding and scaling up the programme lacked the systems-thinking and attention to health system building-blocks needed to optimize service delivery.

Coverage of antenatal, intrapartum, and newborn care in 104 districts of Ethiopia: A before and after study four years after the launch of the national Community-Based Newborn Care programme.

BACKGROUND: Access to health services across the continuum of care improves maternal and newborn health outcomes. Ethiopia launched the Community-Based Newborn Care programme in 2013 to increase the coverage of antenatal care, institutional delivery, postnatal care and newborn care. The programme also introduced gentamicin and amoxicillin treatment by health extension workers for young infants with possible serious bacterial infection when referral was not possible. This study aimed to assess the extent to which the coverage of health services for mothers and their young infants increased after the initiation of the programme. METHODS: A baseline survey was conducted in October-December 2013 and a follow-up survey four years later in November-December 2017. At baseline, 10,224 households and 1,016 women who had a live birth in the 3-15 months prior to the survey were included. In the follow-up survey, 10,270 households and 1,057 women with a recent live birth were included. Women were asked about their experience of care during pregnancy, delivery and postpartum periods, as well as the treatment provided for their child's illness in the first 59 days of life. RESULTS: Between baseline and follow-up surveys the proportion of women reporting at least one antenatal care visit increased by 15 percentage points (95% CI: 10,19), four or more antenatal care visits increased by 17 percentage points (95%CI: 13,22), and institutional delivery increased by 40 percentage points (95% CI: 35,44). In contrast, the proportion of newborns with a postnatal care visit within 48 hours of birth decreased by 6 percentage points (95% CI: -10, -3) for home deliveries and by 14 percentage points (95% CI: -21, -7) for facility deliveries. The proportion of mothers reporting that their young infant with possible serious bacterial infection received amoxicillin for seven days increased by 50 percentage points (95% CI: 37,62) and gentamicin for seven days increased by 15 percentage points (95% CI: 5,25). Concurrent use of both antibiotics increased by 12 percentage points (95% CI: 4,19). CONCLUSION: The Community-Based Newborn Care programme was an ambitious initiative to enhance the access to services for pregnant women and newborns. Major improvements were seen for the number of antenatal care visits and institutional delivery, while postnatal care remained alarmingly low. Antibiotic treatment for young infants with possible serious bacterial infection increased, although most treatment did not follow national guidelines. Improving postnatal care coverage and using a simplified antibiotic regimen following recent World Health Organization guidelines could address gaps in the care provided for sick young infants.

Age patterns of HIV incidence in eastern and southern Africa: a modelling analysis of observational population-based cohort studies.

BACKGROUND: As the HIV epidemic in sub-Saharan Africa matures, evidence about the age distribution of new HIV infections and how this distribution has changed over the epidemic is needed to guide HIV prevention. We aimed to assess trends in age-specific HIV incidence in six population-based cohort studies in eastern and southern Africa, reporting changes in mean age at infection, age distribution of new infections, and birth cohort cumulative incidence. METHODS: We used a Bayesian model to reconstruct age-specific HIV incidence from repeated observations of individuals' HIV serostatus and survival collected among population HIV cohorts in rural Malawi, South Africa, Tanzania, Uganda, and Zimbabwe, in a collaborative analysis of the ALPHA network. We modelled HIV incidence rates by age, time, and sex using smoothing splines functions. We estimated incidence trends separately by sex and study. We used estimated incidence and prevalence results for 2000-17, standardised to study population distribution, to estimate mean age at infection and proportion of new infections by age. We also estimated cumulative incidence (lifetime risk of infection) by birth cohort. FINDINGS: Age-specific incidence declined at all ages, although the timing and pattern of decline varied by study. The mean age at infection was higher in men (cohort mean 27·8-34·6 years) than in women (24·8-29·6 years). Between 2000 and 2017, the mean age at infection per cohort increased slightly: 0·5 to 2·8 years among men and -0·2 to 2·5 years among women. Across studies, between 38% and 63% (cohort medians) of the infections in women were among those aged 15-24 years and between 30% and 63% of infections in men were in those aged 20-29 years. Lifetime risk of HIV declined for successive birth cohorts. INTERPRETATION: HIV incidence declined in all age groups and shifted slightly to older ages. Disproportionate new HIV infections occur among women aged 15-24 years and men aged 20-29 years, supporting focused prevention in these groups. However, 40-60% of infections were outside these ages, emphasising the importance of providing appropriate HIV prevention to adults of all ages. FUNDING: Bill & Melinda Gates Foundation.

Verteporfin photodynamic therapy cohort study: report 3: cost effectiveness and lessons for future evaluations.

PURPOSE: To report (1) the costs of verteporfin photodynamic therapy (VPDT) in routine treatment of neovascular age-related macular degeneration (nAMD), (2) the relationship between health and social service costs and best-corrected visual acuity (BCVA), (3) the cost-effectiveness of VPDT versus a best supportive care (BSC) group who were assumed to have no active treatment, and (4) lessons for future cost-effectiveness analyses (CEAs). DESIGN: The CEA of VPDT versus BSC that uses health-related quality of life (HrQoL), resource use, and visual acuity data from the United Kingdom (UK) VPDT Cohort Study. PARTICIPANTS: Data on VPDT use were collected from patients attending 45 ophthalmology provider units in the UK National Health Service, 15 units collected data on self-reported use of services. METHODS: Incremental costs of VPDT versus BSC were calculated from treatment costs, change in cost associated with declining BCVA, and difference in BCVA previously attributed to VPDT. Similarly, incremental quality-adjusted life years (QALYs) were calculated from change in HRQoL associated with declining BCVA, giving an incremental cost per QALY of VPDT versus BSC over 2 years. MAIN OUTCOME MEASURES: Incremental costs (UK pounds [ pound]; United States dollars [$]); incremental QALYs; costs per QALY. RESULTS: The treatment costs of VDPT were pound 3026 ($4544) in year 1 and pound 845 ($1269) in year 2. For patients who used services, a 5-letter decrease in BCVA was associated with an increase in annual costs of approximately pound 110 ($165; 95% confidence intervals, approximately pound 48 [$72] to pound 174 [$261]). The incremental costs and QALYs for VPDT were pound 3514 ($5276) and 0.021, respectively, giving incremental costs per QALY gained of pound 170000 ($255000). CONCLUSIONS: Verteporfin photodynamic therapy is unlikely to be cost effective for patients with nAMD. This article provides realistic estimates of VPDT costs and the costs associated with declining vision. Future studies can follow this approach to assess accurately the cost effectiveness of new interventions for nAMD.

Verteporfin photodynamic therapy cohort study: report 2: clinical measures of vision and health-related quality of life.

PURPOSE: To quantify decreases in health-related quality of life (HRQoL) for given deterioration in clinical measures of vision; to describe the shape of these relationships; and to test whether the gradients of these relationships change with duration of visual loss. DESIGN: A prospective, longitudinal study of patients treated with verteporfin photodynamic therapy in the United Kingdom National Health Service. PARTICIPANTS: Patients with neovascular age-related macular degeneration (AMD) treated in 18 ophthalmology departments in the United Kingdom with expertise in management of neovascular AMD. METHODS: Responses to HRQoL questionnaires (Short Form 36 [SF-36] and National Eye Institute Visual Functioning Questionnaire [NEIVFQ]) and clinical measures of vision were recorded at baseline and at follow-up visits. Mixed regression models were used to characterize the relationships of interest. MAIN OUTCOME MEASURES: Measures of vision were best-corrected visual acuity (BCVA) and contrast sensitivity (CS). The SF-36 physical and mental component scores (PCS and MCS), SF-6D utility, and distance, near, and composite NEIVFQ scores were derived to characterize HRQoL. RESULTS: The SF-6D, PCS, and MCS were linearly associated with BCVA; predicted decreases for a 5-letter drop in BCVA in the better-seeing eye were 0.0058, 0.245, and 0.546, respectively (all P<0.0001). Gradients were not influenced by duration of follow-up. Models predicting distance, near, and composite NEIVFQ scores from BCVA were quadratic; predicted decreases for a 5-letter drop in BCVA in the better-seeing eye were 5.08, 5.48, and 3.90, respectively (all P<0.0001). The BCVA predicted HRQoL scores more strongly than CS. CONCLUSIONS: Clinically significant deterioration in clinical measures of vision is associated with small decreases in generic and vision-specific HRQoL. Our findings are important for further research modeling the cost effectiveness of current and future interventions for neovascular AMD.

Verteporfin photodynamic therapy cohort study: report 1: effectiveness and factors influencing outcomes.

PURPOSE: To compare the visual outcomes after verteporfin photodynamic therapy (VPDT) administered in routine clinical practice with those observed in the Treatment of Age-related macular degeneration with Photodynamic therapy (TAP) trials and to quantify the effects of clinically important baseline covariates on outcome. DESIGN: A prospective longitudinal study of patients treated with VPDT in 45 ophthalmology departments in the United Kingdom with expertise in the management of neovascular age-related macular degeneration (nAMD). PARTICIPANTS: Patients with wholly or predominantly classic choroidal neovascularization (CNV) of any cause with a visual acuity >or=20/200 in the eye to be treated. METHODS: Refracted best-corrected visual acuity (BCVA) and contrast sensitivity were measured in VPDT-treated eyes at baseline and subsequent visits. Eyes were retreated at 3 months if CNV was judged to be active. Baseline angiograms were graded to quantify the percentages of classic and occult CNV. Treated eyes were categorized as eligible or ineligible for TAP, or unclassifiable. MAIN OUTCOME MEASURES: Best-corrected visual acuity and contrast sensitivity during 1 year of follow-up after initial treatment. RESULTS: A total of 7748 treated patients were recruited. Data from 4043 patients with a diagnosis of nAMD were used in the present analysis. Reading center determination of lesion type showed that 87% were predominantly classic CNV. Eyes received 2.4 treatments in year 1 and 0.4 treatments in year 2. Deterioration of BCVA over 1 year was similar to that observed in the VPDT arms of the TAP trials and was not influenced by TAP eligibility classification. Best-corrected visual acuity deteriorated more quickly in current smokers; with increasing proportion of classic CNV, increasing age, and better baseline BCVA; and when the fellow eye was the better eye. CONCLUSIONS: Patients in the cohort who would have been eligible for the TAP trials demonstrated deterioration in BCVA similar to VPDT-treated TAP participants but with fewer treatments. Clinical covariates with a significant impact on BCVA outcomes were identified.

Does facility birth reduce maternal and perinatal mortality in Brong Ahafo, Ghana? A secondary analysis using data on 119 244 pregnancies from two cluster-randomised controlled trials.

BACKGROUND: Maternal and perinatal mortality are still unacceptably high in many countries despite steep increases in facility birth. The evidence that childbirth in facilities reduces mortality is weak, mainly because of the scarcity of robust study designs and data. We aimed to assess this link by quantifying the influence of major determinants of facility birth (cluster-level facility birth, wealth, education, and distance to childbirth care) on several mortality outcomes, while also considering quality of care. METHODS: Our study is a secondary analysis of surveillance data on 119 244 pregnancies from two large population-based cluster-randomised controlled trials in Brong Ahafo, Ghana. In addition, we specifically collected data to assess quality of care at all 64 childbirth facilities in the study area. Outcomes were direct maternal mortality, perinatal mortality, first-day and early neonatal mortality, and antepartum and intrapartum stillbirth. We calculated cluster-level facility birth as the percentage of facility births in a woman's village over the preceding 2 years, and we computed distances from women's regular residence to health facilities in a geospatial database. Associations between determinants of facility birth and mortality outcomes were assessed in crude and multivariable multilevel logistic regression models. We stratified perinatal mortality effects by three policy periods, using April 1, 2005, and July 1, 2008, as cutoff points, when delivery-fee exemption and free health insurance were introduced in Ghana. These policies increased facility birth and potentially reduced quality of care. FINDINGS: Higher proportions of facility births in a cluster were not linked to reductions in any of the mortality outcomes. In women who were wealthier, facility births were much more common than in those who were poorer, but mortality was not lower among them or their babies. Women with higher education had lower mortality risks than less-educated women, except first-day and early neonatal mortality. A substantially higher proportion of women living in areas closer to childbirth facilities had facility births and caesarean sections than women living further from childbirth facilities, but mortality risks were not lower despite this increased service use. Among women who lived in areas closer to facilities offering comprehensive emergency obstetric care (CEmOC), emergency newborn care, or high-quality routine care, or to facilities that had providers with satisfactory competence, we found a lower risk of intrapartum stillbirth (14·2 per 1000 deliveries at >20 km from a CEmOC facility vs 10·4 per 1000 deliveries at ≤1 km; odds ratio [OR] 1·13, 95% CI 1·06-1·21) and of composite mortality outcomes than among women living in areas where these services were further away. Protective effects of facility birth were restricted to the two earlier policy periods (from June 1, 2003, to June 30, 2008), whereas there was evidence for higher perinatal mortality with increasing wealth (OR 1·09, 1·03-1·14) and lower perinatal mortality with increasing distance from childbirth facilities (OR 0·93, 0·89-0·98) after free health insurance was introduced in July 1, 2008. INTERPRETATION: Facility birth does not necessarily convey a survival benefit for women or babies and should only be recommended in facilities capable of providing emergency obstetric and newborn care and capable of safe-guarding uncomplicated births. FUNDING: The Baden-Württemberg Foundation, the Daimler and Benz Foundation, the European Social Fund and Ministry of Science, Research, and the Arts Baden-Württemberg, WHO, US Agency for International Development, Save the Children, the Bill & Melinda Gates Foundation, and the UK Department for International Development.

Effect of 6-month adherence to a very low carbohydrate diet program.

To determine the effect of a 6-month very low carbohydrate diet program on body weight and other metabolic parameters.Fifty-one overweight or obese healthy volunteers who wanted to lose weight were placed on a very low carbohydrate diet (<25 g/d), with no limit on caloric intake. They also received nutritional supplementation and recommendations about exercise, and attended group meetings at a research clinic. The outcomes were body weight, body mass index, percentage of body fat (estimated by skinfold thickness), serum chemistry and lipid values, 24-hour urine measurements, and subjective adverse effects.Forty-one (80%) of the 51 subjects attended visits through 6 months. In these subjects, the mean (+/- SD) body weight decreased 10.3% +/- 5.9% (P <0.001) from baseline to 6 months (body weight reduction of 9.0 +/- 5.3 kg and body mass index reduction of 3.2 +/- 1.9 kg/m(2)). The mean percentage of body weight that was fat decreased 2.9% +/- 3.2% from baseline to 6 months (P <0.001). The mean serum bicarbonate level decreased 2 +/- 2.4 mmol/L (P <0.001) and blood urea nitrogen level increased 2 +/- 4 mg/dL (P <0.001). Serum total cholesterol level decreased 11 +/- 26 mg/dL (P = 0.006), low-density lipoprotein cholesterol level decreased 10 +/- 25 mg/dL (P = 0.01), triglyceride level decreased 56 +/- 45 mg/dL (P <0.001), high-density lipoprotein (HDL) cholesterol level increased 10 +/- 8 mg/dL (P <0.001), and the cholesterol/HDL cholesterol ratio decreased 0.9 +/- 0.6 units (P <0.001). There were no serious adverse effects, but the possibility of adverse effects in the 10 subjects who did not adhere to the program cannot be eliminated.A very low carbohydrate diet program led to sustained weight loss during a 6-month period. Further controlled research is warranted.

Reasons for receiving or not receiving HPV vaccination in primary schoolgirls in Tanzania: a case control study.

BACKGROUND: There are few data on factors influencing human papillomavirus (HPV) vaccination uptake in sub-Saharan Africa. We examined the characteristics of receivers and non-receivers of HPV vaccination in Tanzania and identified reasons for not receiving the vaccine. METHODS: We conducted a case control study of HPV vaccine receivers and non-receivers within a phase IV cluster-randomised trial of HPV vaccination in 134 primary schools in Tanzania. Girls who failed to receive vaccine (pupil cases) and their parents/guardians (adult cases) and girls who received dose 1 (pupil controls) of the quadrivalent vaccine (Gardasil™) and their parents/guardians (adult controls) were enrolled from 39 schools in a 1∶1 ratio and interviewed about cervical cancer, HPV vaccine knowledge and reasons why they might have received or not received the vaccine. Conditional logistic regression was used to determine factors independently associated with not receiving HPV vaccine. RESULTS: We interviewed 159 pupil/adult cases and 245 pupil/adult controls. Adult-factors independently associated with a daughter being a case were older age, owning fewer household items, not attending a school meeting about HPV vaccine, and not knowing anyone with cancer. Pupil-factors for being a case included having a non-positive opinion about the school de-worming programme, poor knowledge about the location of the cervix, and not knowing that a vaccine could prevent cervical cancer. Reasons for actively refusing vaccination included concerns about side effects and infertility. Most adult and pupil cases reported that they would accept the HPV vaccine if it were offered again (97% and 93% respectively). CONCLUSIONS: Sensitisation messages, especially targeted at older and poorer parents, knowledge retention and parent meetings are critical for vaccine acceptance in Tanzania. Vaccine side effects and fertility concerns should be addressed prior to a national vaccination program. Parents and pupils who initially decline vaccination should be given an opportunity to reconsider their decision.

The efficacy of a brief intervention in reducing hazardous drinking in working age men in Russia: the HIM (Health for Izhevsk men) individually randomised parallel group exploratory trial.

BACKGROUND: Russia has particularly low life expectancy for an industrialised country, with mortality at working ages having fluctuated dramatically over the past few decades, particularly among men. Alcohol has been identified as the most likely cause of these temporal variations. One approach to reducing the alcohol problem in Russia is 'brief interventions' which seek to change views of the personal acceptability of excessive drinking and to encourage self-directed behaviour change. Very few studies to evaluate the efficacy of brief interventions in Russia have been conducted. Motivational Interviewing (MI) is a person-centred counselling style which can be adapted to brief interventions in which help is offered in thinking through behaviour in the context of values and goals, to decide whether change is needed, and if so, how it may best be achieved. METHODS: This paper reports on an individually randomised two-armed parallel group exploratory trial. The primary hypothesis is that a brief adaptation of MI will be effective in reducing self-reported hazardous and harmful drinking at 3 months. Participants were drawn from the Izhevsk Family Study II, with eligibility determined based on proxy reports of hazardous and harmful drinking in the past year. All participants underwent a health check, with MI subsequently delivered to those in the intervention arm. Signed consent was obtained from those in the intervention arm only at this point. Both groups were then invited for 3 and 12 month follow ups. The control group did not receive any additional intervention. RESULTS: 441 men were randomised. Of these 61 did not have a health check leaving 190 in each trial arm. Follow up at 3 months was high (97% of those having a health check), and very similar in the two trial arms (183 in the intervention and 187 in the control). No significant differences were detected between the randomised groups in either the primary or the secondary outcomes at three months in the intention to treat analyses. The unadjusted odds ratio (95% CI) for the effect of MI on hazardous and harmful drinking was 0.77 (0.51, 1.16). An adjusted odds ratio of 0.52 (0.28, 0.94) was obtained in the pre-specified per protocol analysis. CONCLUSIONS: This trial demonstrates that it is possible to engage Russian men who drink hazardously in a brief intervention aimed at reducing alcohol related harm. However the results with respect to the efficacy are equivocal and further, larger-scale trials are warranted. TRIAL REGISTRATION: ISRCTN: ISRCTN82405938.

Respiratory function during infancy in survivors of the INNOVO trial.

RATIONALE: Despite encouraging reports suggesting that inhaled nitric oxide (iNO) appear to improve outcome in hypoxemic term and near term infants by improving oxygenation and reducing need for ECMO, the long-term benefits of iNO remain unclear. This study aimed to compare lung function at approximately 1 year in infants who were and were not randomly allocated to iNO as part of their neonatal management for severe respiratory failure at birth. Furthermore, results were compared to lung function of healthy infants. METHODS: Maximal expiratory flow at functional residual capacity (V'maxFRC) was measured at approximately 1 year of age (corrected for any prematurity) in survivors of the INNOVO trial. Results were expressed as Z-scores, adjusted for sex and body size, based on data from healthy controls using identical techniques. RESULTS: Technically satisfactory results were obtained in 30 infants (53% < 34 weeks gestation), 19 of whom were randomized to receive iNO V'maxFRC. Z-score was significantly reduced in infants with prior respiratory failure, whether or not they had been allocated to iNO (mean (SD) Z-score: -2.0 (1.2) and -2.6 (1.1), respectively, 95% CI difference; iNO vs. no iNO: -0.3; 1.6, P = 0.2). There was significant respiratory morbidity in both groups during the first year of life. CONCLUSIONS: These results suggest that airway function remains reduced at 1 year of age following severe respiratory failure at birth, whether or not iNO is administered.