Child-Adult Contract for Prevention of Tobacco Use: "As-Treated" Analysis of a Cluster Randomized Controlled Trial (the TOPAS Study) at 3-Year Follow-Up.

To estimate the effect of a 3-year commitment to remain tobacco free on tobacco uptake among high school students in Sweden. The commitment is developed in the form of a contract between a child and a significant adult, constituting the core component of Tobacco-free Duo (T-Duo), a Swedish school-based tobacco prevention program. Secondary analysis of data from a cluster randomized controlled trial. Participants were 586 students in high schools assigned to the intervention arm of T-Duo. At inception, participants attended grade 7 (i.e., age 12-13). Only students who were tobacco naïve at baseline for the respective outcome and participated in all follow-ups were included. The exposure was defined as signing a 3-year contract with a significant adult, categorized as "stable contract" (3 years contract with the same contract partner), "unstable" (signed a contract sometime during follow-up but this was not sustained over time and/or with the same partner), and "no contract" at all during the intervention period. The primary outcome was having never tried cigarette smoking at the end of grade 9. Exposure and outcomes were self-reported in yearly questionnaires. Of 586 students, 321 (55%) held a stable contract, 204 (35%) an unstable contract, and 61 (10%) did not sign a contract at all. At the end of grade 9 (age 15-16), the relative risk (RR) to remain cigarette free was 1.11 (95% CI 1.00-1.22) (Number Needed to Treat = 10) among students in any type of contract compared to students that did not write a contract at all. The RRs for remaining tobacco free (secondary outcomes) ranged from 1.07 (0.98-1.16) for regular snus use to 1.16 (1.00-1.35) for any type of tobacco use. A commitment to remain tobacco free through a child-adult contract seems to exert a preventive effect on the uptake of tobacco use among Swedish adolescents over 3 school years. The current findings apply to a selected sample of both schools and students. Registration: Current Controlled Trials ISRCTN52858080 Date: January 4, 2019, retrospectively registered.

Health-related Quality of Life of Patients With Diabetes Mellitus Measured With the Bahasa Indonesia Version of EQ-5D in Primary Care Settings in Indonesia.

OBJECTIVES: Diabetes mellitus (DM) is a serious public health issue that places a heavy financial, social, and health-related burden on individuals, families, and healthcare systems. Self-reported health-related quality of life (HRQoL) is extensively used for monitoring the general population's health conditions and measuring the effectiveness of interventions. Therefore, this study investigated HRQoL and associated factors among patients with type 2 DM at a primary healthcare center in Indonesia. METHODS: A cross-sectional study was conducted in Klaten District, Central Java, Indonesia, from May 2019 to July 2019. In total, 260 patients with DM registered with National Health Insurance were interviewed. HRQoL was measured with the EuroQol Group's validated Bahasa Indonesia version of the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) with the Indonesian value set. Multivariate regression models were used to identify factors influencing HRQoL. RESULTS: Data from 24 patients were excluded due to incomplete information. Most participants were men (60.6%), were aged above 50 years (91.5%), had less than a senior high school education (75.0%), and were unemployed (85.6%). The most frequent health problems were reported for the pain/discomfort dimension (64.0%) followed by anxiety (28.4%), mobility (17.8%), usual activities (10.6%), and self-care (6.8%). The average EuroQoL 5-Dimension (EQ-5D) index score was 0.86 (95% confidence interval [CI], 0.83 to 0.88). In the multivariate ordinal regression model, a higher education level (coefficient, 0.08; 95% CI, 0.02 to 0.14) was a significant predictor of the EQ-5D-5L utility score. CONCLUSIONS: Patients with diabetes had poorer EQ-5D-5L utility values than the general population. DM patients experienced pain/discomfort and anxiety. There was a substantial positive relationship between education level and HRQoL.

Health and economic outcomes of a universal early intervention for parents and children from birth to age five: evaluation of the Salut Programme using a natural experiment.

BACKGROUND: The aim of this study was to investigate the health and economic outcomes of a universal early intervention for parents and children, the Salut Programme, from birth to when the child completed five years of age. METHODS: This study adopted a retrospective observational design using routinely collected linked register data with respect to both exposures and outcomes from Västerbotten county, in northern Sweden. Making use of a natural experiment, areas that received care-as-usual (non-Salut area) were compared to areas where the Programme was implemented after 2006 (Salut area) in terms of: (i) health outcomes, healthcare resource use and costs around pregnancy, delivery and birth, and (ii) healthcare resource use and related costs, as well as costs of care of sick child. We estimated total cumulative costs related to inpatient and specialised outpatient care for mothers and children, and financial benefits paid to mothers to stay home from work to care for a sick child. Two analyses were conducted: a matched difference-in difference analysis using the total sample and an analysis including a longitudinal subsample. RESULTS: The longitudinal analysis on mothers who gave birth in both pre- and post-measure periods showed that mothers exposed to the Programme had on average 6% (95% CI 3-9%) more full-term pregnancies and 2% (95% CI 0.03-3%) more babies with a birth weight ≥ 2500 g, compared to mothers who had care-as-usual. Savings were incurred in terms of outpatient care costs for children of mothers in the Salut area ($826). The difference-in-difference analysis using the total sample did not result in any significant differences in health outcomes or cumulative resource use over time. CONCLUSIONS: The Salut Programme achieved health gains, as a health promotion early intervention for children and parents, in terms of more full-term pregnancies and more babies with a birth weight ≥ 2500 g, at reasonable cost, and may lead to lower usage of outpatient care. Other indicators point towards positive effects, but the small sample size may have led to underestimation of true differences.

Multifaceted determinants of social-emotional problems in preschool children in Sweden: An ecological systems theory approach.

Social-emotional problems occurring early in life can place children at future risk of adverse health, social and economic outcomes. Determinants of social-emotional problems are multi-layered and originate from different contexts surrounding children, though few studies consider them simultaneously. We adopted a holistic approach by using Bronfenbrenner's process-person-context-time model as a structuring device. We aimed to assess what characteristics of families and children from pregnancy, over birth, and up to 3 years of age are associated with social-emotional problems in boys and girls. This study used regional data from the Salut Programme, a universal health promotion programme implemented in Antenatal and Child Health Care, and data from national Swedish registers. The study population included 6033 3-year-olds and their parents during the period 2010-2018. Distinct logistic regression models for boys and girls were used to assess associations between the family social context, parents' lifestyle, parent's mental health, children's birth characteristics, and indicators of proximal processes (the independent variables); and children's social-emotional problems as measured by the parent-completed Ages and Stages Questionnaire: Social-Emotional between 33 and 41 months of age (the outcome). Overall, a less favourable family social context, detrimental lifestyle of the parents during pregnancy, and parents' mental illness from pregnancy onwards were associated with higher odds of social-emotional problems in 3-year-olds. Higher screentime and infrequent shared book-reading were associated with higher odds of social-emotional problems. The multifaceted determinants of children's social-emotional problems imply that many diverse targets for intervention exist. Additionally, this study suggests that Bronfenbrenner's process-person-context-time theoretical framework could be relevant for public health research and policy.

Social inequalities in social-emotional problems among preschool children: a population-based study in Sweden.

BACKGROUND: Social-emotional ability is important for overall health and wellbeing in early childhood. Recognizing preschool children in need of extra support, especially those living in unfavourable conditions, can have immediate positive effects on their health and benefit their wellbeing in the long-term. OBJECTIVES: The aim of this study is to investigate whether there are social inequalities in preschool children's social-emotional problems, and whether inequalities differ between boys and girls. METHOD: This study utilized repeated measures from cross-sectional population-based surveys of three-year old children (2014-2018). The final study population comprised of 9,099 children which was 61% of all the eligible children in Västerbotten County during the study period. The Ages and Stages Questionnaires: Social-Emotional (ASQ:SE) 36-month interval was used to measure children's social-emotional ability. Social inequalities were studied with respect to parents' income, education, and place of birth, for which data was obtained from Statistics Sweden. Multiple logistic and ordered regressions were used. RESULTS: Among 3-year-olds, social-emotional problems were more common in the most vulnerable social groups, i.e. parents in the lowest income quintile (OR: 1.45, p < 0.001), parents with education not more than high school (OR: 1.51, p < 0.001), and both parents born outside Sweden (OR: 2.54, p < 0.001). Notably, there was a larger difference in social-emotional problems between the lowest and highest social categories for girls compared to boys. Higher odds of social-emotional problems were associated with boys not living with both parents and girls living in the areas of Skellefteå and Umeå, i.e. more populated geographical areas. CONCLUSION: Already at 3-years of age social-emotional problems were more common in children with parents in the most vulnerable social groups. This does not fulfil the ambition of an equitable start in life for every child and might contribute to reproduction of social inequalities across generations.

Social inequalities in healthcare utilization during Ecuadorian healthcare reform (2007-2017): a before-and-after cross-sectional study.

BACKGROUND: Limited research is available about the impact of healthcare reforms on healthcare utilization according to socioeconomic group. Although most health reforms in Latin America have focused on reducing the gap between the most advantaged and disadvantaged groups and improving the quality of health services, the available information has shown limited progress. Therefore, this study assessed whether the recent Ecuadorian healthcare reform (2007-2017) contributed to decreasing the socioeconomic inequalities in healthcare utilization. METHODS: We used data from the National Living Standards Measurement surveys conducted in 2006 and 2014. Unmet healthcare needs (UHCN) were used as the dependent variable and proxy for difficulties in accessing health services. Place of residence, ethnicity, education and wealth were selected as indicators of socioeconomic status. The slope and relative inequality indexes were calculated for adult men and women for each period and socioeconomic variable. A multiplicative interaction term between midpoint scores and time was applied to estimate changes in inequalities over time. Sample weights were applied to all analyses, and 95% confidence intervals were calculated to assess statistical significance in the regression analysis. RESULTS: In 2006, the poor, Indigenous, those living in rural areas and with low education had lower access to health services. In 2014, the overall prevalence of UHCN decreased from 27 to 18% and was higher in women than men. Statistically significant reductions of refraining were observed in absolute and relative terms in all social groups, both in men and women. CONCLUSIONS: Our results showed remarkable and significant decreases in inequalities in all examined socioeconomic groups in absolute and relative terms in this period. Although a new model of healthcare was established to achieve universal health coverage, its performance must be continuously evaluated and monitored with specific indicators. Further studies are also needed to identify the main barriers that contribute to UHCN among socially disadvantaged groups.

Evaluation of the Swedish school-based program "tobacco-free DUO" in a cluster randomized controlled trial (TOPAS study). Results at 2-year follow-up.

Friends' and parents' tobacco use are strong predictors of tobacco uptake among adolescents, however the effectiveness of interventions based on public commitments and agreements to remain tobacco-free are not established. Here, we evaluated the effectiveness of the school-based Swedish program Tobacco-Free Duo (T-Duo) in preventing adolescents from initiating tobacco use (TOPAS study). T-Duo is a multi-component intervention witha formal agreement between a student and an adult partner to remain tobacco-free during the entire 3-year study period as core component. The standardized educational component of the same program was used as comparator (control). Primary outcome was the probability to "remain a non-user" of i) cigarettes and secondary outcomes ii) other types of tobacco at second (21-month) follow-up. Analysis was conducted according to Intention To Treat. In total 1776 adolescents (51% female) aged 12-13 in grade 7 from 34 participating high schools in Sweden were included at baseline in 2018, of which 1489 were retained after 21 months. The Risk Ratio (RR) of not having tried cigarettes 21-months after initiation of the intervention was 1.03(CI 0.98-1.08), Bayes Factor(BF) = 0.93, Absolute Risk Difference(ARD) = 3.1%. Similar associations were found for never smoked a whole cigarette and never use of other tobacco/nicotine products. There was a minimal reduction of tobacco use initiation among Swedish adolescents assigned to a multi-component intervention (T-Duo) compared to those assigned to standardized classroom education after 2 schoolyears. However, for most outcomes' findings were inconclusive and not reliably different from zero. Trial registration: ISRCTN5285808 (doi:https://doi.org/10.1186/ISRCTN52858080); Study protocol: DERR1-https://doi.org/10.2196/21100. Registration: Current Controlled Trials ISRCTN52858080 Date: January 4, 2019, retrospectively registered. Protocol: Galanti, M.R., Pulkki-Brännström, A.-M., Nilsson, M., 2020. Tobacco-free duo adult-child contract for prevention of tobacco use among adolescents and parents: protocol for a mixed-design evaluation. JMIR Res. Protoc. 9, e21100. doi:10.2196/21100.

Cost-effectiveness of Radiofrequency Denervation for Zygapophyseal Joint Pain.

BACKGROUND: Chronic pain is a leading cause of disability. Radiofrequency denervation (RFD) is effective when performed according to guidelines for patients with correctly diagnosed zygapophyseal joint pain (ZJP). However, the cost-effectiveness of this method has not been fully explored. OBJECTIVE: The aim of this study was to analyze whether RFD is cost-effective for ZJP from a societal perspective. STUDY DESIGN: Cost effectiveness study based on an observational study. SETTING: An interventional pain management clinic in central Sweden. METHODS: Patients - This cost-effectiveness study was performed for all patients (n = 873) assessed between 2010 and 2016 at a specialized interventional pain clinic in Sweden. Those diagnosed with ZJP (n = 331, 37.9%) were treated with RFD and followed up for 1 year after the RFD. Using data collected from national registers, we determined the health care costs, medication costs, the patients' time and travel costs, and the patients' ability to work. The effects of RFD on quality-adjusted life years (QALY) and cost/QALY gained were calculated. RESULTS: On average, patients reported very low health-related quality of life (HRQoL; EQ-5D index: 0.212). After RFD, HRQoL increased significantly to 0.530 (P < 0.0001). Drug consumption and specialized health care consumption were reduced by 54% and 81%, respectively, and the cost/QALY gained from a societal perspective was 221,324 Swedish krona (USD ~26,008). The sensitivity analysis showed that the treatment was cost-effective in all scenarios evaluated, using the patients as their own controls. The cost/QALY gained from a health care perspective was 72,749 Swedish krona (USD ~8,548). LIMITATIONS: The results are based on data collected at one center. The results need to be compared with those from pain rehabilitation programs and should be confirmed using data from other centers. CONCLUSIONS: Patients referred for RFD in Sweden report extremely low HRQoL. HRQoL significantly increased following RFD in patients with ZJP. Medications and health care consumption decreased after RFD. RFD was cost-effective, and the sensitivity analysis yielded stable results in different scenarios. Therefore, RFD is a cost-effective treatment that meets the Swedish National Board of Health and Welfare criteria for a high priority treatment. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (NCT01835704) with Protocol ID SE-Dnr-2012-446-31M-1.  https://clinicaltrials.gov/ct2/show/NCT01835704.

Protocol for the evaluation of cost-effectiveness and health equity impact of a school-based tobacco prevention programme in a cluster randomised controlled trial (the TOPAS study).

INTRODUCTION: Despite a long-term downward trend in smoking prevalence, tobacco remains the number one risk factor for death and disability in Sweden. Globally, tobacco use generates a substantial economic burden for health systems and is also a major driver of socioeconomic inequalities in health. This article describes the planned cost-effectiveness and health equity impact evaluation of a multicomponent school-based programme to prevent the onset of tobacco use in adolescents. METHODS AND ANALYSIS: Cost-effectiveness of the multicomponent Tobacco-Free Duo programme will be evaluated against the educational component of the same programme only. An incremental cost-effectiveness ratio (ICER) will be calculated in terms of the cost per case prevented using the trial primary outcome and within-trial payer costs. If the ICER is negative, an incremental net benefit ratio will be calculated. Robustness of the results will be assessed through one-way sensitivity analyses. The slope index of inequality will be computed to assess the potential impact of the Tobacco-free Duo programme on education-related inequalities in the onset of smoking and in adult smoking cessation, comparing the two trial arms. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Regional Ethics Review Board, Umeå (registration number 2017/255-31). The Public Health Agency of Sweden commissioned the study. The findings will be disseminated internationally within academia and to national and local policy-makers. TRIAL REGISTRATION NUMBER: ISRCTN52858080; Pre-results.

Copula Models for Addressing Sample Selection in the Evaluation of Public Health Programmes: An Application to the Leeds Let's Get Active Study.

Sample selectivity is a recurrent problem in public health programmes and poses serious challenges to their evaluation. Traditional approaches to handle sample selection tend to rely on restrictive assumptions. The aim of this paper is to illustrate a copula-based selection model to handle sample selection in the evaluation of public health programmes. Motivated by a public health programme to promote physical activity in Leeds (England), we describe the assumptions underlying the copula selection, and its relative advantages compared with commonly used approaches to handle sample selection, such as inverse probability weighting and Heckman's selection model. We illustrate the methods in the Leeds Let's Get Active programme and show the implications of method choice for estimating the effect on individual's physical activity. The programme was associated with increased physical activity overall, but the magnitude of its effect differed according to adjustment method. The copula selection model led to a similar effect to the Heckman's approach but with relatively narrower 95% confidence intervals. These results remained relatively similar when different model specifications and alternative distributional assumptions were considered. The copula selection model can address important limitations of traditional approaches to address sample selection, such as the Heckman model, and should be considered in the evaluation of public health programmes, where sample selection is likely to be present.

Participatory learning and action cycles with women's groups to prevent neonatal death in low-resource settings: A multi-country comparison of cost-effectiveness and affordability.

WHO recommends participatory learning and action cycles with women's groups as a cost-effective strategy to reduce neonatal deaths. Coverage is a determinant of intervention effectiveness, but little is known about why cost-effectiveness estimates vary significantly. This article reanalyses primary cost data from six trials in India, Nepal, Bangladesh and Malawi to describe resource use, explore reasons for differences in costs and cost-effectiveness ratios, and model the cost of scale-up. Primary cost data were collated, and costing methods harmonized. Effectiveness was extracted from a meta-analysis and converted to neonatal life-years saved. Cost-effectiveness ratios were calculated from the provider perspective compared with current practice. Associations between unit costs and cost-effectiveness ratios with coverage, scale and intensity were explored. Scale-up costs and outcomes were modelled using local unit costs and the meta-analysis effect estimate for neonatal mortality. Results were expressed in 2016 international dollars. The average cost was $203 (range: $61-$537) per live birth. Start-up costs were large, and spending on staff was the main cost component. The cost per neonatal life-year saved ranged from $135 to $1627. The intervention was highly cost-effective when using income-based thresholds. Variation in cost-effectiveness across trials was strongly correlated with costs. Removing discounting of costs and life-years substantially reduced all cost-effectiveness ratios. The cost of rolling out the intervention to rural populations ranges from 1.2% to 6.3% of government health expenditure in the four countries. Our analyses demonstrate the challenges faced by economic evaluations of community-based interventions evaluated using a cluster randomized controlled trial design. Our results confirm that women's groups are a cost-effective and potentially affordable strategy for improving birth outcomes among rural populations.

Tobacco-Free Duo Adult-Child Contract for Prevention of Tobacco Use Among Adolescents and Parents: Protocol for a Mixed-Design Evaluation.

BACKGROUND: Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important social influences. Commitment not to use tobacco, or to quit use, as a formal contract between an adolescent and a significant adult is a preventive model that has not been widely practiced or explored and has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent's commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves. OBJECTIVE: To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program's implementation. METHODS: A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and an as-treated approach complemented with a whole school repeated cross-sectional approach was devised as analytical methods of the trial data. Second, an observational study was added in order to compare smoking incidence in the schools participating in the experiment with that of a convenience sample of schools that were not part of the experimental study. Diverse secondary outcomes at both adolescent and adult levels were also included. RESULTS: The study was approved by the Umeå Regional Ethics Review Board (registration number 2017/255-31) in 2017. Recruitment of schools started in fall 2017 and continued until June 2018. In total, 43 schools were recruited to the experimental study, and 16 schools were recruited to the observational study. Data collection started in the fall 2018, is ongoing, and is planned to be finished in spring 2021. CONCLUSIONS: Methodological, ethical, and practical implications of the evaluation protocol were discussed, especially the advantage of combining several sources of data, to triangulate the study questions. The results of these studies will help revise the agenda of this program as well as those of similar programs. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 52858080; https://doi.org/10.1186/ISRCTN52858080. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21100.

Socioeconomic inequalities in women's access to health care: has Ecuadorian health reform been successful?

BACKGROUND: Over the last 12 years, Ecuador has implemented comprehensive health sector reform to ensure equitable access to health care services according to need. While there have been important achievements in terms of health care coverage, the effects of these reforms on socioeconomic inequalities in health care have not been analysed. The present study assesses whether the health care reforms implemented in the decade between 2007 and 2017 have contributed to reducing the socioeconomic inequalities in women's health care access. METHODS: The present study was based on two waves (2006 and 2014) of the Living Standards Measurement Survey conducted in Ecuador. Data from women of reproductive age (15 to 49 years) were analysed to evaluate health care coverage across three indicators: skilled birth attendance, cervical cancer screening, and the use of modern contraceptives. Absolute risk differences were calculated between the heath care indicators and the socioeconomic variables using binomial regression analysis for each time period. The Slope Index of Inequality (SII) was also calculated for each socioeconomic variable and period. A multiplicative interaction term between the socioeconomic variables and period was included to assess the changes in socioeconomic inequalities in health care over time. RESULTS: Access to health care increased in the three studied outcomes during the health sector reform. Significant reductions in inequality in skilled birth attendance were observed in all socioeconomic variables except in the occupational class. Cervical cancer screening inequalities increased according to education and occupation, but decreased by wealth. Only a poorer education was observed for modern contraceptive use. CONCLUSIONS: While most socioeconomic inequalities in skilled birth attendance decreased during the reform period, this was not the case for inequalities in cervical cancer screening or the use of modern contraceptives. Further studies are needed to address the social determinants of these health inequalities.

The equity impact of a universal child health promotion programme.

BACKGROUND: Real-world evaluations of complex interventions are scarce. We evaluated the effect of the Salut Programme, a universal child health promotion intervention in northern Sweden, on income-related inequalities in positive birth outcomes and healthcare utilisation up to 2 years after delivery. METHODS: Using the mother's place of residence at delivery, the child and the mother were classified as belonging to either the control area (received care-as-usual) or the intervention area (where the intervention was implemented from 2006) and either the premeasure (children born between 2002 and 2004) or the postmeasure (children born between 2006 and 2008) period. Parents' earned income was used as the socioeconomic ranking variable. The Relative Concentration Index was computed for six binary birth outcome indicators and for inpatient and day patient care for children and their mothers. Changes in inequality over time were compared using a difference-in-difference approach. RESULTS: Income-related inequalities in birth outcomes and child healthcare utilisation were absent, except that full-term pregnancies were concentrated among the poor at premeasure in the intervention area. In contrast, mothers' healthcare utilisation was significantly pro-poor in the control area. The extent of inequality changed differentially between premeasure and postmeasure for two birth outcomes: full-term pregnancies and infants with normal birth weight. Inequalities in healthcare utilisation did not change significantly in either area over time. CONCLUSION: In northern Sweden, income-related inequalities in birth outcomes and child healthcare utilisation are largely absent. However, relative inequalities in mothers' healthcare utilisation are large. We found no evidence that the Salut Programme affected changes in inequality over time.

"Cheaper and better": Societal cost savings and budget impact of changing from systemic to intralesional pentavalent antimonials as the first-line treatment for cutaneous leishmaniasis in Bolivia.

INTRODUCTION: Cutaneous leishmaniasis (CL), endemic in Bolivia, mostly affects poor people in rainforest areas. The current first-line treatment consists of systemic pentavalent antimonials (SPA) for 20 days and is paid for by the Ministry of Health (MoH). Long periods of drug shortages and a lack of safe conditions to deliver treatment are challenges to implementation. Intralesional pentavalent antimonials (ILPA) are an alternative to SPA. This study aims to compare the cost of ILPA and SPA, and to estimate the health and economic impacts of changing the first-line treatment for CL in a Bolivian endemic area. METHODS: The cost-per-patient treated was estimated for SPA and ILPA from the perspectives of the MoH and society. The quantity and unit costs of medications, staff time, transportation and loss of production were obtained through a health facility survey (N = 12), official documents and key informants. A one-way sensitivity analysis was conducted on key parameters to evaluate the robustness of the results. The annual number of patients treated and the budget impact of switching to ILPA as the first-line treatment were estimated under different scenarios of increasing treatment utilization. Costs were reported in 2017 international dollars (1 INT$ = 3.10 BOB). RESULTS: Treating CL using ILPA was associated with a cost-saving of $248 per-patient-treated from the MoH perspective, and $688 per-patient-treated from the societal perspective. Switching first-line treatment to ILPA while maintaining the current budget would allow two-and-a-half times the current number of patients to be treated. ILPA remained cost-saving compared to SPA in the sensitivity analysis. CONCLUSIONS: The results of this study support a shift to ILPA as the first-line treatment for CL in Bolivia and possibly in other South American countries.

Incremental cost and health gains of the 2016 WHO antenatal care recommendations for Rwanda: results from expert elicitation.

OBJECTIVES: High-quality evidence of effectiveness and cost-effectiveness is rarely available and relevant for health policy decisions in low-resource settings. In such situations, innovative approaches are needed to generate locally relevant evidence. This study aims to inform decision-making on antenatal care (ANC) recommendations in Rwanda by estimating the incremental cost-effectiveness of the recent (2016) WHO antenatal care recommendations compared to current practice in Rwanda. METHODS: Two health outcome scenarios (optimistic, pessimistic) in terms of expected maternal and perinatal mortality reduction were constructed using expert elicitation with gynaecologists/obstetricians currently practicing in Rwanda. Three costing scenarios were constructed from the societal perspective over a 1-year period. The two main inputs to the cost analyses were a Monte Carlo simulation of the distribution of ANC attendance for a hypothetical cohort of 373,679 women and unit cost estimation of the new recommendations using data from a recent primary costing study of current ANC practice in Rwanda. Results were reported in 2015 USD and compared with the 2015 Rwandan per-capita gross domestic product (US$ 697). RESULTS: Incremental health gains were estimated as 162,509 life-years saved (LYS) in the optimistic scenario and 65,366 LYS in the pessimistic scenario. Incremental cost ranged between $5.8 and $11 million (an increase of 42% and 79%, respectively, compared to current practice) across the costing scenarios. In the optimistic outcome scenario, incremental cost per LYS ranged between $36 (for low ANC attendance) and $67 (high ANC attendance), while in the pessimistic outcome scenario, it ranged between $90 (low ANC attendance) and $168 (high ANC attendance) per LYS. Incremental cost effectiveness was below the GDP-based thresholds in all six scenarios. DISCUSSION: Implementing the new WHO ANC recommendations in Rwanda would likely be very cost-effective; however, the additional resource requirements are substantial. This study demonstrates how expert elicitation combined with other data can provide an affordable source of locally relevant evidence for health policy decisions in low-resource settings.

Impact on birth weight and child growth of Participatory Learning and Action women's groups with and without transfers of food or cash during pregnancy: Findings of the low birth weight South Asia cluster-randomised controlled trial (LBWSAT) in Nepal.

BACKGROUND: Undernutrition during pregnancy leads to low birthweight, poor growth and inter-generational undernutrition. We did a non-blinded cluster-randomised controlled trial in the plains districts of Dhanusha and Mahottari, Nepal to assess the impact on birthweight and weight-for-age z-scores among children aged 0-16 months of community-based participatory learning and action (PLA) women's groups, with and without food or cash transfers to pregnant women. METHODS: We randomly allocated 20 clusters per arm to four arms (average population/cluster = 6150). All consenting married women aged 10-49 years, who had not had tubal ligation and whose husbands had not had vasectomy, were monitored for missed menses. Between 29 Dec 2013 and 28 Feb 2015 we recruited 25,092 pregnant women to surveillance and interventions: PLA alone (n = 5626); PLA plus food (10 kg/month of fortified wheat-soya 'Super Cereal', n = 6884); PLA plus cash (NPR750≈US$7.5/month, n = 7272); control (existing government programmes, n = 5310). 539 PLA groups discussed and implemented strategies to improve low birthweight, nutrition in pregnancy and hand washing. Primary outcomes were birthweight within 72 hours of delivery and weight-for-age z-scores at endline (age 0-16 months). Only children born to permanent residents between 4 June 2014 and 20 June 2015 were eligible for intention to treat analyses (n = 10936), while in-migrating women and children born before interventions had been running for 16 weeks were excluded. Trial status: completed. RESULTS: In PLA plus food/cash arms, 94-97% of pregnant women attended groups and received a mean of four transfers over their pregnancies. In the PLA only arm, 49% of pregnant women attended groups. Due to unrest, the response rate for birthweight was low at 22% (n = 2087), but response rate for endline nutritional and dietary measures exceeded 83% (n = 9242). Compared to the control arm (n = 464), mean birthweight was significantly higher in the PLA plus food arm by 78·0 g (95% CI 13·9, 142·0; n = 626) and not significantly higher in PLA only and PLA plus cash arms by 28·9 g (95% CI -37·7, 95·4; n = 488) and 50·5 g (95% CI -15·0, 116·1; n = 509) respectively. Mean weight-for-age z-scores of children aged 0-16 months (average age 9 months) sampled cross-sectionally at endpoint, were not significantly different from those in the control arm (n = 2091). Differences in weight for-age z-score were as follows: PLA only -0·026 (95% CI -0·117, 0·065; n = 2095); PLA plus cash -0·045 (95% CI -0·133, 0·044; n = 2545); PLA plus food -0·033 (95% CI -0·121, 0·056; n = 2507). Amongst many secondary outcomes tested, compared with control, more institutional deliveries (OR: 1.46 95% CI 1.03, 2.06; n = 2651) and less colostrum discarding (OR:0.71 95% CI 0.54, 0.93; n = 2548) were found in the PLA plus food arm but not in PLA alone or in PLA plus cash arms. INTERPRETATION: Food supplements in pregnancy with PLA women's groups increased birthweight more than PLA plus cash or PLA alone but differences were not sustained. Nutrition interventions throughout the thousand-day period are recommended. TRIAL REGISTRATION: ISRCTN75964374.

Health-related quality of life determinants among Rwandan women after delivery: does antenatal care utilization matter? A cross-sectional study.

BACKGROUND: Despite the widespread use of antenatal care (ANC), its effectiveness in low-resource settings remains unclear. In this study, self-reported health-related quality of life (HRQoL) was used as an alternative to other maternal health measures previously used to measure the effectiveness of antenatal care. The main objective of this study was to determine whether adequate antenatal care utilization is positively associated with women's HRQoL. Furthermore, the associations between the HRQoL during the first year (1-13 months) after delivery and socio-economic and demographic factors were explored in Rwanda. METHODS: In 2014, we performed a cross-sectional population-based survey involving 922 women who gave birth 1-13 months prior to the data collection. The study population was randomly selected from two provinces in Rwanda, and a structured questionnaire was used. HRQoL was measured using the EQ-5D-3L and a visual analogue scale (VAS). The average HRQoL scores were computed by demographic and socio-economic characteristics. The effect of adequate antenatal care utilization on HRQoL was tested by performing two multivariable linear regression models with the EQ-5D and EQ-VAS scores as the outcomes and ANC utilization and socio-economic and demographic variables as the predictors. RESULTS: Adequate ANC utilization affected women's HRQoL when the outcome was measured using the EQ-VAS. Social support and living in a wealthy household were associated with a better HRQoL using both the EQ-VAS and EQ-5D. Cohabitating, and single/unmarried women exhibited significantly lower HRQoL scores than did married women in the EQ-VAS model, and women living in urban areas exhibited lower HRQoL scores than women living in rural areas in the ED-5D model. The effect of education on HRQoL was statistically significant using the EQ-VAS but was inconsistent across the educational categories. The women's age and the age of their last child were not associated with their HRQoL. CONCLUSIONS: ANC attendance of at least four visits should be further promoted and used in low-income settings. Strategies to improve families' socio-economic conditions and promote social networks among women, particularly women at the reproductive age, are needed.

Cost of antenatal care for the health sector and for households in Rwanda.

BACKGROUND: Rwanda has made tremendous progress in reduction of maternal mortality in the last twenty years. Antenatal care is believed to have played a role in that progress. In late 2016, the World Health Organization published new antenatal care guidelines recommending an increase from four visits during pregnancy to eight contacts with skilled personnel, among other changes. There is ongoing debate regarding the cost implications and potential outcomes countries can expect, if they make that shift. For Rwanda, a necessary starting point is to understand the cost of current antenatal care practice, which, according to our knowledge, has not been documented so far. METHODS: Cost information was collected from Kigali City and Northern province of Rwanda through two cross-sectional surveys: a household-based survey among women who had delivered a year before the interview (N = 922) and a health facility survey in three public, two faith-based, and one private health facility. A micro costing approach was used to collect health facility data. Household costs included time and transport. Results are reported in 2015 USD. RESULTS: The societal cost (household + health facility) of antenatal care for the four visits according to current Rwandan guidelines was estimated at $160 in the private health facility and $44 in public and faith-based health facilities. The first visit had the highest cost ($75 in private and $21 in public and faith-based health facilities) compared to the three other visits. Drugs and consumables were the main input category accounting for 54% of the total cost in the private health facility and for 73% in the public and faith-based health facilities. CONCLUSIONS: The unit cost of providing antenatal care services is considerably lower in public than in private health facilities. The household cost represents a small proportion of the total, ranging between 3% and 7%; however, it is meaningful for low-income families. There is a need to do profound equity analysis regarding the accessibility and use of antenatal care services, and to consider ways to reduce households' time cost as a possible barrier to the use of antenatal care.