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Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh.

ABSTRACT: OBJECTIVE:To evaluate and compare the cost-effectiveness of two strategies for neonatal care in Sylhet division, Bangladesh. METHODS:In a cluster-randomized controlled trial, two strategies for neonatal care--known as home care and community care--were compared with existing services. For each study arm, economic costs were estimated from a societal perspective, inclusive of programme costs, provider costs and household out-of-pocket payments on care-seeking. Neonatal mortality in each study arm was determined through household surveys. The incremental cost-effectiveness of each strategy--compared with that of the pre-existing levels of maternal and neonatal care--was then estimated. The levels of uncertainty in our estimates were quantified through probabilistic sensitivity analysis. FINDINGS:The incremental programme costs of implementing the home-care package were 2939 (95% confidence interval, CI: 1833-7616) United States dollars (US$) per neonatal death averted and US$ 103.49 (95% CI: 64.72-265.93) per disability-adjusted life year (DALY) averted. The corresponding total societal costs were US$ 2971 (95% CI: 1844-7628) and US$ 104.62 (95% CI: 65.15-266.60), respectively. The home-care package was cost-effective--with 95% certainty--if healthy life years were valued above US$ 214 per DALY averted. In contrast, implementation of the community-care strategy led to no reduction in neonatal mortality and did not appear to be cost-effective. CONCLUSION:The home-care package represents a highly cost-effective intervention strategy that should be considered for replication and scale-up in Bangladesh and similar settings elsewhere.

SUBMITTER: LeFevre AE

PROVIDER: S-EPMC3791651 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh.

LeFevre Amnesty E AE Shillcutt Samuel D SD Waters Hugh R HR Haider Sabbir S El Arifeen Shams S Mannan Ishtiaq I Seraji Habibur R HR Shah Rasheduzzaman R Darmstadt Gary L GL Wall Steve N SN Williams Emma K EK Black Robert E RE Santosham Mathuram M Baqui Abdullah H AH

Bulletin of the World Health Organization 20130712 10

<h4>Objective</h4>To evaluate and compare the cost-effectiveness of two strategies for neonatal care in Sylhet division, Bangladesh.<h4>Methods</h4>In a cluster-randomized controlled trial, two strategies for neonatal care--known as home care and community care--were compared with existing services. For each study arm, economic costs were estimated from a societal perspective, inclusive of programme costs, provider costs and household out-of-pocket payments on care-seeking. Neonatal mortality in ...[more]

PMID: 24115797

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Project description:Admission to the neonatal intensive care unit (NICU) may disrupt parent-infant interaction with adverse consequences for infants and their families. Several family-centered care programs promote parent-infant interaction in the NICU; however, all of these retain the premise that health-care professionals should provide most of the infant's care. Parents play a mainly supportive role in the NICU and continue to feel anxious and unprepared to care for their infant after discharge. In the Family Integrated Care (FICare) model, parents provide all except the most advanced medical care for their infants with support from the medical team. Our hypothesis is that infants whose families complete the FICare program will have greater weight gain and better clinical and parental outcomes compared with infants provided with standard NICU care.FICare is being evaluated in a cluster randomized controlled trial among infants born at ??33 weeks' gestation admitted to 19 Canadian, 6 Australian, and 1 New Zealand tertiary-level NICU. Trial enrollment began in April, 2013, with a target sample size of 675 infants in each arm, to be completed by August, 2015. Participating sites were stratified by country, and by NICU size within Canada, for randomization to either the FICare intervention or control arm. In intervention sites, parents are taught how to provide most of their infant's care and supported by nursing staff, veteran parents, a program coordinator, and education sessions. In control sites standard NICU care is provided. The primary outcome is infants' weight gain at 21 days after enrollment, which will be compared between the FICare and control groups using Student's t-test adjusted for site-level clustering, and multi-level hierarchical models accounting for both clustering and potential confounders. Similar analyses will examine secondary outcomes including breastfeeding, clinical outcomes, safety, parental stress and anxiety, and resource use. The trial was designed, is being conducted, and will be reported according to the CONSORT 2010 guidelines for cluster randomized controlled trials.By evaluating the impact of integrating parents into the care of their infant in the NICU, this trial may transform the delivery of neonatal care.NCT01852695 , registered December 19, 2012.

Project description:BackgroundApproximately half of preterm births are attributable to maternal infections, which are commonly undetected and untreated in low-income settings. Our primary aim is to determine the impact of early pregnancy screening and treatment of maternal genitourinary tract infections on the incidence of preterm live birth in Sylhet, Bangladesh. We will also assess the effect on other adverse pregnancy outcomes, including preterm birth (stillbirth and live birth), late miscarriage, maternal morbidity, and early onset neonatal sepsis.Methods/designWe are conducting a cluster randomized controlled trial that will enroll 10,000 pregnant women in Sylhet district in rural northeastern Bangladesh. Twenty-four clusters, each with ~4000 population (120 pregnant women/year) and served by a community health worker (CHW), are randomized to: 1) the control arm, which provides routine antenatal and postnatal home-based care, or 2) the intervention arm, which includes routine antenatal and postnatal home-based care plus screening and treatment of pregnant women between 13 and 19 weeks of gestation for abnormal vaginal flora (AVF) and urinary tract infection (UTI). CHWs conduct monthly pregnancy surveillance, make 2 antenatal and 4 postnatal home visits for all enrolled pregnant women and newborns, and refer mothers or newborns with symptoms of serious illness to the government sub-district hospital. In the intervention clusters, CHWs perform home-based screening of AVF and UTI. Self-collected vaginal swabs are plated on slides, which are Gram stained and Nugent scored. Women with AVF (Nugent score ?4) are treated with oral clindamycin, rescreened and retreated, if needed, after 3 weeks. Urine culture is performed and UTI treated with nitrofurantoin. Repeat urine culture is performed after 1 week for test of cure. Gestational age is determined by maternal report of last menstrual period at study enrollment using prospectively completed study calendars, and in a subset by early (<20 week) ultrasound. CHWs prospectively collect data on all pregnancy outcomes, maternal and neonatal morbidity and mortality.Implications/discussionFindings will enhance our understanding of the burden of AVF and UTI in rural Bangladesh, the impact of a maternal screening-treatment program for genitourinary tract infections on perinatal health, and help formulate public health recommendations for infection screening in pregnancy in low-resource settings.Trial registrationThe study was registered on ClinicalTrials.gov:NCT01572532 on December 15, 2011. The study was funded by NICHD: R01HD066156 .

Project description:BACKGROUND:Every year, about 15 million of the world's infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [320/7] to 336/7 weeks) and late preterm (340/7 to 366/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs. METHODS:We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study. DISCUSSION:Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.

Project description:BACKGROUND:Although achieved development goals on maternal and child health, in the era of Sustainable Development Goals (SDGs), Bangladesh still needs to promote skilled attendance at birth as well as a continuum of care for mothers and babies. How to implement effective interventions by strengthening the community health system also remains as a crucial policy issue. The objective of the proposed study is to evaluate the impact of a community-based intervention as part of a bilateral development aid project on utilization of maternal and neonatal care provided by skilled providers and qualified facilities. METHODS:A cluster randomized trial was conducted in Kalaroa Upazila of Satkhira District. Community Clinics (CCs) in the study setting were randomly allocated to either intervention or control. We recruited all eligible women covered by CC catchment areas who gave a birth during the past 12 months of data collection at the baseline and end-line surveys. In the intervention areas, three Community Support Groups (CSGs) were developed in each of the CC areas. The members of CSG were trained to identify pregnant women, educate community people on pregnancy related danger signs, and encourage them for utilization of skilled services in the community and health facilities. The primary outcomes were the utilization of services for antenatal care, delivery, postnatal care and sick newborns. Difference-in-Difference (DID) analysis was performed to identify the changes by the intervention with adjustment of cluster effects by generalized mixed effects regression models. RESULT:The major indicators of the utilization of maternal and neonatal care among pregnant women with different wealth status showed significant improvement after the intervention. The impacts of the intervention were in particular significant among the women of 2nd and 3rd quintiles of household wealth status. The use of CCs increased after the intervention and private hospitals / clinics served as the major health providers. The study also identified increased practices of cesarean section. CONCLUSION:The success of the intervention suggests a potential of the government efforts to strengthen the community support system for promotion of safe motherhood. The intervention helps to identify and remove existing and emerging barriers that lie between women and healthcare providers for safe motherhood and continuum of care. TRIAL REGISTRATION:UMIN Clinical Trial Registry UMIN000031789.

Project description:BackgroundPsychological distress is highly prevalent among patients with metastatic colorectal cancer.AimsTo perform an economic evaluation of a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer in comparison with usual care.DesignSocietal costs were collected alongside a cluster randomized controlled trial for 48 weeks. A total of 349 participants were included.SettingParticipants were recruited from oncology departments at 16 participating hospitals in the Netherlands.MethodsOutcome measures were the Hospital Anxiety and Depression Scale and quality-adjusted life-years. Missing data were imputed using multiple imputation. Uncertainty was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty surrounding the cost-effectiveness estimates. Sensitivity analyses were performed to check robustness of results.ResultsBetween treatment arms, no significant differences were found in Hospital Anxiety and Depression Scale score (mean difference: -0.058; 95% confidence interval: -0.13 to 0.011), quality-adjusted life-years (mean difference: 0.042; 95% confidence interval: -0.015 to 0.099), and societal costs (mean difference: -1152; 95% confidence interval: -5058 to 2214). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was 0.64 and 0.74 at willingness-to-pay values of €0 and €10,000 per point improvement on the Hospital Anxiety and Depression Scale, respectively. The probability that the intervention was cost-effective compared to usual care for quality-adjusted life-years was 0.64 and 0.79 at willingness-to-pay values of €0 and €20,000 per quality-adjusted life-year, respectively.ConclusionThe intervention is dominant over usual care, primarily due to lower costs in the intervention group. However, there were no statistically significant differences in clinical effects and the uptake of the intervention was quite low. Therefore, widespread implementation cannot be recommended.

Project description:BACKGROUND:To evaluate a delivery strategy for newborn interventions in rural Bangladesh. METHODS:A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality. FINDINGS:A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80-1.30) at baseline and 0.87 (95% CI: 0.68-1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported. CONCLUSION:Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management. TRIAL REGISTRATION:Clinicaltrials.gov NCT00198627.

Project description:BackgroundShort birth intervals are associated with increased risk of adverse maternal and neonatal health (MNH) outcomes. Improving postpartum contraceptive use is an important programmatic strategy to improve the health and well-being of women, newborns, and children. This article documents the intervention package and evaluation design of a study conducted in a rural district of Bangladesh to evaluate the effects of an integrated, community-based MNH and postpartum family planning program on contraceptive use and birth-interval lengths.InterventionThe study integrated family planning counseling within 5 community health worker (CHW)-household visits to pregnant and postpartum women, while a community mobilizer (CM) led community meetings on the importance of postpartum family planning and pregnancy spacing for maternal and child health. The CM and the CHWs emphasized 3 messages: (1) Use of the Lactational Amenorrhea Method (LAM) during the first 6 months postpartum and transition to another modern contraceptive method; (2) Exclusive, rather than fully or nearly fully, breastfeeding to support LAM effectiveness and good infant breastfeeding practices; (3) Use of a modern contraceptive method after a live birth for at least 24 months before attempting another pregnancy (a birth-to-birth interval of about 3 years) to support improved infant health and nutrition. CHWs provided only family planning counseling in the original study design, but we later added community-based distribution of methods, and referrals for clinical methods, to meet women's demand.MethodsUsing a quasi-experimental design, and relying primarily on pre/post-household surveys, we selected pregnant women from 4 unions to receive the intervention (n = 2,280) and pregnant women from 4 other unions (n = 2,290) to serve as the comparison group. Enrollment occurred between 2007 and 2009, and data collection ended in January 2013.Preliminary resultsFormative research showed that women and their family members generally did not perceive birth spacing as a priority, and most recently delivered women were not using contraception. At baseline, women in the intervention and comparison groups were similar in terms of age, husband's education, religion, and parity. CHWs visited over 90% of women in both intervention and comparison groups during pregnancy and the first 3 months postpartum.DiscussionThis article provides helpful intervention-design details for program managers intending to add postpartum family planning services to community-based MNH programs. Outcomes of the intervention will be reported in a future paper. Preliminary findings indicate that the package of 5 CHW visits was feasible and did not compromise worker performance. Adding doorstep delivery of contraceptives to the intervention package may enhance impact.

Dataset Information

Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh.

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Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh.

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