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Protocol for an economic evaluation alongside a cluster randomised controlled trial: cost-effectiveness of Learning Clubs, a multicomponent intervention to improve women's health and infant's health and development in Vietnam.

ABSTRACT: INTRODUCTION:Economic evaluations of complex interventions in early child development are required to guide policy and programme development, but a few are yet available. METHODS AND ANALYSIS:Although significant gains have been made in maternal and child health in resource-constrained environments, this has mainly been concentrated on improving physical health. The Learning Clubs programme addresses both physical and mental child and maternal health. This study is an economic evaluation of a cluster randomised controlled trial of the impact of the Learning Clubs programme in Vietnam. It will be conducted from a societal perspective and aims to identify the cost-effectiveness and the economic and social returns of the intervention. A total of 1008 pregnant women recruited from 84 communes in a rural province in Vietnam will be included in the evaluation. Health and cost data will be gathered at three stages of the trial and used to calculate incremental cost-effectiveness ratios per percentage point improvement of infant's development, infant's health and maternal common mental disorders expressed in quality-adjusted life years gained. The return on investment will be calculated based on improvements in productivity, the results being expressed as benefit-cost ratios. ETHICS AND DISSEMINATION:The trial was approved by Monash University Human Research Ethics Committee (Certificate Number 2016-0683), Australia, and approval was extended to include the economic evaluation (Amendment Review Number 2018-0683-23806); and the Institutional Review Board of the Hanoi School of Public Health (Certificate Number 017-377IDD- YTCC), Vietnam. Results will be disseminated through academic journals and conference presentations. TRIAL REGISTRATION NUMBER:ACTRN12617000442303.

SUBMITTER: Nguyen T

PROVIDER: S-EPMC6924726 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Protocol for an economic evaluation alongside a cluster randomised controlled trial: cost-effectiveness of Learning Clubs, a multicomponent intervention to improve women's health and infant's health and development in Vietnam.

Nguyen Trang T Sweeny Kim K Tran Thach T Luchters Stanley S Hipgrave David B DB Hanieh Sarah S Tran Tuan T Tran Ha H Biggs Beverley-Ann BA Fisher Jane J

BMJ open 20191215 12

<h4>Introduction</h4>Economic evaluations of complex interventions in early child development are required to guide policy and programme development, but a few are yet available.<h4>Methods and analysis</h4>Although significant gains have been made in maternal and child health in resource-constrained environments, this has mainly been concentrated on improving physical health. The Learning Clubs programme addresses both physical and mental child and maternal health. This study is an economic eva ...[more]

PMID: 31843831

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Project description:BackgroundLearning Clubs is a multi-component intervention to address the eight common risk factors for women's health, and infant's health and development in resource-constrained settings. We are testing in a cluster randomized controlled trial in rural Vietnam whether this intervention improves cognitive development in children when they are aged two. There are few comprehensive process evaluations of complex interventions to optimise early childhood development. The aim is to conduct a planned process evaluation of the Learning Clubs intervention in Vietnam.MethodsThe evaluation will be conducted alongside the Learning Clubs trial using both qualitative and quantitative methods. Four domains will be included in the evaluation: [1] Context - how contextual factors affect the implementation and outcomes; [2] Implementation - what aspects of the Learning Clubs intervention are actually delivered and how well the intervention is delivered; [3] Mechanism of impact - how the intervention produces changes in the primary and secondary outcomes; and [4] National integration - how the intervention can be scaled up for application nationally. Purposive sampling will be used to recruit project stakeholders from commune, provincial and national levels. Results of the process evaluation will be integrated with those of the outcome and economic evaluations to provide a comprehensive picture of the effectiveness of the Learning Clubs intervention for early childhood development in rural Vietnam.DiscussionResults of the evaluation will provide evidence about the implementation of the intervention and explanations for any differences in the outcomes between participants in intervention and control conditions. The evaluation will be integrated into each stage of the outcome assessments, but will be implemented by a bilingual team independent of the team implementing the intervention. It will therefore provide evidence which will not be influenced by or influence the intervention and will inform both generalisation to other settings and scalability in Vietnam.Trial registrationTrial registration number ACTRN12617000442303 on the Australian New Zealand Clinical Trials Registry. Registered 27/03/2017. Prospectively registered.

Project description:BackgroundAcute otitis media (AOM) is among the most common paediatric conditions managed in primary care. Most recent estimates of the cost of AOM date from a decade ago and lack a full societal perspective. We therefore explored the societal cost of childhood AOM in the Netherlands within the setting of a trial comparing the effectiveness of an intervention aimed at educating general practitioners (GPs) about pain management in AOM compared to usual care.MethodsEconomic analysis alongside a cluster randomised controlled trial conducted between February 2015 and May 2018 in 37 practices (94 GPs). In total, 224 children with AOM were included of which 223 (99%) completed the trial (intervention: n =?94; control: n =?129). The cost of AOM due to health care costs, patient and family costs, and productivity losses by parent caregivers were retrieved from study diaries and primary care electronic health records, during 28-day follow-up. We calculated mean cost (€ and $) per AOM episode per patient with standard deviations (SD, in €) regardless of study group assignment because there was no clinical effect of the trial intervention. In sensitivity analysis, we calculated cost in the intervention and usual care group, after exclusion of extreme outliers.ResultsMean total AOM cost per patient were €565.93 or $638.78 (SD €1071.01); nearly 90% of these costs were due to productivity losses experienced by parents. After exclusion of outliers, AOM cost was €526.70 or $594.50 (SD €987.96) and similar in the intervention and usual care groups: €516.10 or $582.53 (SD €949.69) and €534.55 or $603.36 (SD €920.55) respectively.ConclusionsAt €566 or $639 per episode, societal cost of AOM is higher than previously known and mainly driven by productivity losses by children's parents. Considering its high incidence, AOM poses a significant economic burden that extends beyond direct medical costs.Trial registrationNetherlands Trial Register no. NTR4920: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4920 .

Project description:OBJECTIVE:To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. DESIGN:A two-armed cluster randomised trial with occupational physicians (OPs) (n=62), clustered and randomised by region into an experimental and a control group, to conduct a health-economic investment appraisal. Online self-reported data were collected from employees at baseline, after 3, 6, 9 and 12 months. SETTING:Occupational health care in the Netherlands. PARTICIPANTS:Employees from small-sized and medium-sized companies (?18 years), sick-listed between 4 and 26 weeks with (symptoms of) common mental disorders visiting their OP. INTERVENTIONS:In the intervention group, employees (N=131) received an eHealth module aimed at changing cognitions regarding return to work, while OPs were supported by a decision aid for treatment and referral options. Employees in the control condition (N=89) received usual sickness guidance. OUTCOMES MEASURES:Net benefits and return on investment based on absenteeism, presenteeism, health care use and quality-adjusted life years (QALYs) gained. RESULTS:From the employer's perspective, the incremental net benefits were €3187 per employee over a single year, representing a return of investment of €11 per invested Euro, with a break-even point at 6 months. The economic case was also favourable from the employee's perspective, partly because of QALY health gains. The intervention was costing €234 per employee from a health service financier's perspective. The incremental net benefits from a social perspective were €4210. This amount dropped to €3559 in the sensitivity analysis trimming the 5% highest costs. CONCLUSIONS:The data suggest that the ECO intervention offers good value for money for virtually all stakeholders involved, because initial investments were more than recouped within a single year. The sometimes wide 95% CIs suggest that the costs and benefits are not always very precise estimates and real benefits could vary considerably. TRIAL REGISTRATION:NTR2108; Results.

Project description:OBJECTIVES:To evaluate the cost-effectiveness and cost-utility of an internet-based perioperative care programme compared with usual care for gynaecological patients. DESIGN:Economic evaluation from a societal perspective alongside a stepped-wedge cluster-randomised controlled trial with 12 months of follow-up. SETTING:Secondary care, nine hospitals in the Netherlands, 2011-2014. PARTICIPANTS:433 employed women aged 18-65 years scheduled for a hysterectomy and/or laparoscopic adnexal surgery. INTERVENTION:The intervention comprised an internet-based care programme aimed at improving convalescence and preventing delayed return to work (RTW) following gynaecological surgery and was sequentially rolled out. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or to the intervention (n=227). MAIN OUTCOME MEASURES:The primary outcome was duration until full sustainable RTW. Secondary outcomes were quality-adjusted life years (QALYs), health-related quality of life and recovery. RESULTS:At 12 months, there were no statistically significant differences in total societal costs (€-647; 95%?CI €-2116 to €753) and duration until RTW (-4.1; 95%?CI -10.8 to 2.6) between groups. The incremental cost-effectiveness ratio (ICER) for RTW was 56; each day earlier RTW in the intervention group was associated with cost savings of €56 compared with usual care. The probability of the intervention being cost-effective was 0.79 at a willingness-to-pay (WTP) of €0 per day earlier RTW, which increased to 0.97 at a WTP of €76 per day earlier RTW. The difference in QALYs gained over 12 months between the groups was clinically irrelevant resulting in a low probability of cost-effectiveness for QALYs. CONCLUSIONS:Considering that on average the costs of a day of sickness absence are €230, the care programme is considered cost-effective in comparison with usual care for duration until sustainable RTW after gynaecological surgery for benign disease. Future research should indicate whether widespread implementation of this care programme has the potential to reduce societal costs associated with gynaecological surgery. TRIAL REGISTRATION NUMBER:NTR2933; Results.

Project description:BackgroundGlobally, the status of women's health falls short of its potential. In addition to the deleterious ethical and human rights implications of this deficit, the negative economic impact may also be consequential, but these mechanisms are poorly understood. Building on the literature that highlights health as a driver of economic growth and poverty alleviation, we aim to systematically investigate the broader economic benefits of investing in women's health.MethodsUsing the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, we systematically reviewed health, gender, and economic literature to identify studies that investigate the impact of women's health on micro- and macroeconomic outcomes. We developed an extensive search algorithm and conducted searches using 10 unique databases spanning the timeframe 01/01/1970 to 01/04/2013. Articles were included if they reported on economic impacts stemming from changes in women's health (table of outcome measures included in full review, Table 1). In total, the two lead investigators independently screened 20,832 abstracts and extracted 438 records for full text review. The final review reflects the inclusion of 124 articles.ResultsThe existing literature indicates that healthier women and their children contribute to more productive and better-educated societies. This study documents an extensive literature confirming that women's health is tied to long-term productivity: the development and economic performance of nations depends, in part, upon how each country protects and promotes the health of women. Providing opportunities for deliberate family planning; healthy mothers before, during, and after childbirth, and the health and productivity of subsequent generations can catalyze a cycle of positive societal development.ConclusionsThis review highlights the untapped potential of initiatives that aim to address women's health. Societies that prioritize women's health will likely have better population health overall, and will remain more productive for generations to come.

Project description:BackgroundCommunity health clubs are multi-session village-level gatherings led by trained facilitators and designed to promote healthy behaviours mainly related to water, sanitation, and hygiene. They have been implemented in several African and Asian countries but have never been evaluated rigorously. We aimed to evaluate the effect of two versions of the community health club model on child health and nutrition outcomes.MethodsWe did a cluster-randomised trial in Rusizi district, western Rwanda. We defined villages as clusters. We assessed villages for eligibility then randomly selected 150 for the study using a simple random sampling routine in Stata. We stratified villages by wealth index and by the proportion of children younger than 2 years with caregiver-reported diarrhoea within the past 7 days. We randomly allocated these villages to three study groups: no intervention (control; n=50), eight community health club sessions (Lite intervention; n=50), or 20 community health club sessions (Classic intervention; n=50). Households in these villages were enrolled in 2013 for a baseline survey, then re-enrolled in 2015 for an endline survey. The primary outcome was caregiver-reported diarrhoea within the previous 7 days in children younger than 5 years. Analysis was by intention to treat and per protocol. This trial is registered with ClinicalTrials.gov, number NCT01836731.FindingsAt the baseline survey undertaken between May, 2013, and August, 2013, 8734 households with children younger than 5 years of age were enrolled. At the endline survey undertaken between Sept 21, 2015, and Dec 22, 2015, 7934 (91%) of the households were re-enrolled. Among children younger than 5 years, the prevalence of caregiver-reported diarrhoea in the previous 7 days was 514 (14%) of 3616 assigned the control, 453 (14%) of 3196 allocated the Lite intervention (prevalence ratio compared with control 0·97, 95% CI 0·81-1·16; p=0·74), and 495 (14%) of 3464 assigned the Classic intervention (prevalence ratio compared with control 0·99, 0·85-1·15; p=0·87).InterpretationCommunity health clubs, in this setting in western Rwanda, had no effect on caregiver-reported diarrhoea among children younger than 5 years. Our results question the value of implementing this intervention at scale for the aim of achieving health gains.FundingBill & Melinda Gates Foundation.

Project description:ImportanceMany Vietnam-era women veterans served in or near war zones and may have experienced stressful or traumatic events during their service. Although posttraumatic stress disorder (PTSD) is well studied among men who served in Vietnam, no major epidemiologic investigation of PTSD among women has been performed.ObjectivesTo assess (1) the onset and prevalence of lifetime and current PTSD for women who served during the Vietnam era, stratified by wartime location (Vietnam, near Vietnam, or the United States), and (2) the extent to which wartime location was associated with PTSD, with adjustment for demographics, service characteristics, and wartime exposures.Design, setting, and participantsSurvey of 8742 women who were active-duty military personnel in the US Armed Forces at any time from July 4, 1965, through March 28, 1973, and alive as of survey receipt as part of Department of Veterans Affairs Cooperative Study 579, HealthVIEWS. Data were obtained from mailed and telephone surveys from May 16, 2011, through August 5, 2012, and analyzed from June 26, 2013, through July 30, 2015.Main outcomes and measuresLifetime and current PTSD as measured by the PTSD module of the Composite International Diagnostic Interview, version 3.0; onset of PTSD; and wartime experiences as measured by the Women's Wartime Exposure Scale-Revised.ResultsAmong the 4219 women (48.3%) who completed the survey and a telephone interview, the weighted prevalence (95% CI) of lifetime PTSD was 20.1% (18.3%-21.8%), 11.5% (9.1%-13.9%), and 14.1% (12.4%-15.8%) for the Vietnam, near-Vietnam, and US cohorts, respectively. The weighted prevalence (95% CI) of current PTSD was 15.9% (14.3%-17.5%), 8.1% (6.0%-10.2%), and 9.1% (7.7%-10.5%) for the 3 cohorts, respectively. Few cases of PTSD among the Vietnam or near-Vietnam cohorts were attributable to premilitary onset (weighted prevalence, 2.9% [95% CI, 2.2%-3.7%] and 2.9% [95% CI, 1.7%-4.2%], respectively). Unadjusted models for lifetime and current PTSD indicated that women who served in Vietnam were more likely to meet PTSD criteria than women who mainly served in the United States (odds ratio [OR] for lifetime PTSD, 1.53 [95% CI, 1.28-1.83]; OR for current PTSD, 1.89 [95% CI, 1.53-2.33]). When we adjusted for wartime exposures, serving in Vietnam or near Vietnam did not increase the odds of having current PTSD (adjusted ORs, 1.05 [95% CI, 0.75-1.46] and 0.77 [95% CI, 0.52-1.14], respectively).Conclusions and relevanceThe prevalence of PTSD for the Vietnam cohort was higher than previously documented. Vietnam service significantly increased the odds of PTSD relative to US service; this effect appears to be associated with wartime exposures, especially sexual discrimination or harassment and job performance pressures. Results suggest long-lasting mental health effects of Vietnam-era service among women veterans.

Project description:ObjectiveTo undertake a cost-utility analysis of a motivational multicomponent lifestyle-modification intervention in a community setting (the Healthy Eating Lifestyle Programme (HELP)) compared with enhanced standard care.DesignCost-utility analysis alongside a randomised controlled trial.SettingCommunity settings in Greater London, England.Participants174 young people with obesity aged 12-19 years.InterventionsIntervention participants received 12 one-to-one sessions across 6?months, addressing lifestyle behaviours and focusing on motivation to change and self-esteem rather than weight change, delivered by trained graduate health workers in community settings. Control participants received a single 1-hour one-to-one nurse-delivered session providing didactic weight-management advice.Main outcome measuresMean costs and quality-adjusted life years (QALYs) per participant over a 1-year period using resource use data and utility values collected during the trial. Incremental cost-effectiveness ratio (ICER) was calculated and non-parametric bootstrapping was conducted to generate a cost-effectiveness acceptability curve (CEAC).ResultsMean intervention costs per participant were £918 for HELP and £68 for enhanced standard care. There were no significant differences between the two groups in mean resource use per participant for any type of healthcare contact. Adjusted costs were significantly higher in the intervention group (mean incremental costs for HELP vs enhanced standard care £1003 (95% CI £837 to £1168)). There were no differences in adjusted QALYs between groups (mean QALYs gained 0.008 (95% CI -0.031 to 0.046)). The ICER of the HELP versus enhanced standard care was £120?630 per QALY gained. The CEAC shows that the probability that HELP was cost-effective relative to the enhanced standard care was 0.002 or 0.046, at a threshold of £20?000 or £30?000 per QALY gained.ConclusionsWe did not find evidence that HELP was more effective than a single educational session in improving quality of life in a sample of adolescents with obesity. HELP was associated with higher costs, mainly due to the extra costs of delivering the intervention and therefore is not cost-effective.Trial registration numberISRCTN9984011.

Dataset Information

Protocol for an economic evaluation alongside a cluster randomised controlled trial: cost-effectiveness of Learning Clubs, a multicomponent intervention to improve women's health and infant's health and development in Vietnam.

Publications

Protocol for an economic evaluation alongside a cluster randomised controlled trial: cost-effectiveness of Learning Clubs, a multicomponent intervention to improve women's health and infant's health and development in Vietnam.

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