Publication: Methods for Economic Evaluation of a Factorial-Design Cluster Randomised Controlled Trial of a Nutrition Supplement and an Exercise Programme among Healthy Older People Living in Santiago, Chile : The CENEX Study
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Published
2009
ISSN
1472-6963
Date
2012-03-30
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Abstract
Background: In an effort to promote healthy ageing and preserve health and function, the government of Chile has formulated a package of actions into the Programme for Complementary Food in Older People (Programa de Alimentacion Complementaria para el Adulto Mayor - PACAM). The CENEX study was designed to evaluate the impact, cost and cost-effectiveness of the PACAM and a specially designed exercise programme on pneumonia incidence, walking capacity and body mass index in healthy older people living in low- to medium-socio-economic status areas of Santiago. The purpose of this paper is to describe in detail the methods that will be used to estimate the incremental costs and cost-effectiveness of the interventions. Methods and design: The base-case analysis will adopt a societal perspective, including the direct medical and non-medical costs borne by the government and patients. The cost of the interventions will be calculated by the ingredients approach, in which the total quantities of goods and services actually employed in applying the interventions will be estimated, and multiplied by their respective unit prices. Relevant information on costs of interventions will be obtained mainly from administrative records. The costs borne by patients will be collected via exit and telephone interviews. An annual discount rate of 8% will be used, consistent with the rate recommended by the Government of Chile. All costs will be converted from Chilean Peso to US dollars with the 2007 average period exchange rate of US$1 = 522.37 Chilean Peso. To test the robustness of model results, we will vary the assumptions over a plausible range in sensitivity analyses. Discussion: The protocol described here indicates our intent to conduct an economic evaluation alongside the CENEX study. It provides a detailed and transparent statement of planned data collection methods and analyses.
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Publication Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial(2009)OBJECTIVE: To compare the efficacy of 100 mg and 200 mg of mifepristone and 24- and 48-hour intervals to administration of 800 microg vaginal misoprostol for termination of early pregnancy. DESIGN: Placebo-controlled, randomized, equivalence trial, stratified by centre. SETTING: 13 departments of obstetrics and gynecology in nine countries. POPULATION: 2,181 women with 63 days or less gestation requesting medical abortion. METHODS: Two-sided 95% CI for the risk differences of failure to complete abortion were calculated and compared with 5% equivalence margin between two doses of mifepristone and two intervals to misoprostol administration. Proportions of women with adverse effects were compared between the regimens using standard testes for proportions. OUTCOME MEASURES: Rates of complete abortion without surgical intervention and adverse effects associated with the regimens. RESULTS: Efficacy outcome was analysed for 2,126 women (97.5%) excluding 55 lost to follow up. Both mifepristone doses were found to be similar in efficacy. The rate of complete abortion was 92.0% for women assigned 100 mg of mifepristone and 93.2% for women assigned 200 mg of mifepristone (difference 1.2%, 95% CI: -1.0 to 3.5). Equivalence was also evident for the two intervals of administration: the rate of complete abortion was 93.5% for 24-hour interval and 91.7% for the 48-hour interval (difference -1.8%, 95% CI: -4.0 to 0.5). Interaction between doses and interval to misoprostol administration was not significant (P = 0.92). Adverse effects related to treatments did not differ between the groups. CONCLUSIONS: Both the 100 and 200 mg doses of mifepristone and the 24- and 48-hour intervals have a similar efficacy to achieve complete abortion in early pregnancy when mifepristone is followed by 800 micrograms of vaginally administered misoprostol.Publication Impact of Intermittent Screening and Treatment for Malaria among School Children in Kenya : A Cluster Randomized Trial(World Bank, Washington, DC, 2014-02)This paper investigates the effects of intermittent screening and treatment of malaria on the health and education of school children in an area of low-to-moderate malaria transmission. A cluster randomized trial was implemented with 5,233 children in 101 government primary schools on the south coast of Kenya in 2010-12. The intervention was delivered to children randomly selected from classes 1 and 5 who were followed up twice across 24 months. Once during each school term, public health workers used malaria rapid diagnostic tests to screen the children. Children who tested positive were treated with a six-dose regimen of artemether-lumefantrine. Given the nature of the intervention, the trial was not blinded. The primary outcomes were anemia and sustained attention and the secondary outcomes were malaria parasitaemia and educational achievement. The data were analyzed on an intention-to-treat basis. Anemia in this setting in Kenya, intermittent screening and treatment, as implemented in this study, is not effective in improving the health or education of school children. Possible reasons for the absence of an impact are the marked geographical heterogeneity in transmission, the rapid rate of reinfection following artemether-lumefantrine treatment, the variable reliability of malaria rapid diagnostic tests, and the relative contribution of malaria to the etiology of anemia in this setting.Publication Can Midlevel Health-Care Providers Administer Early Medical Abortion as Safely and Effectively as Doctors? A Randomised Controlled Equivalence Trial in Nepal(2011)BACKGROUND: Medical abortion is under-used in developing countries. We assessed whether early fi rst-trimester medical abortion provided by midlevel providers (government-trained, certified nurses and auxiliary nurse midwives) was as safe and effective as that provided by doctors in Nepal. METHODS: This multicentre randomised controlled equivalence trial was done in fi ve rural district hospitals in Nepal. Women were eligible for medical abortion if their pregnancy was of less than 9 weeks (63 days) and if they resided less than 90 min journey away from the study clinic. Women were ineligible if they had any contraindication to medical abortion. We used a computer-generated randomisation scheme stratified by study centre with a block size of six. Women were randomly assigned to a doctor or a midlevel provider for oral administration of 200 mg mifepristone followed by 800 mug misoprostol vaginally 2 days later, and followed up 10-4 days later. The primary endpoint was complete abortion without manual vacuum aspiration within 30 days of treatment. The study was not masked. Abortions were recorded as complete, incomplete, or failed (continuing pregnancy). Analyses for primary and secondary endpoints were by intention to treat, supplemented by per-protocol analysis of the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT01186302. FINDINGS: Of 1295 women screened, 535 were randomly assigned to a doctor and 542 to a midlevel provider. 514 and 518, respectively, were included in the analyses of the primary endpoint. Abortions were judged complete in 504 (97.3%) women assigned to midlevel providers and in 494 (96.1%) assigned to physicians. The risk difference for complete abortion was 1.24% (95% CI -0.53 to 3.02), which falls within the predefined equivalence range (-5% to 5%). Five cases (1%) were recorded as failed abortion in the doctor cohort and none in the midlevel provider cohort; the remaining cases were recorded as incomplete abortions. No serious complications were noted. INTERPRETATION: The provision of medical abortion up to 9 weeks' gestation by midlevel providers and doctors was similar in safety and effectiveness. Where permitted by law, appropriately trained midlevel health-care providers can provide safe, low-technology medical abortion services for women independently from doctors. FUNDING: UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization.Publication The Effects of Home-based HIV Counseling and Testing on HIV/AIDS Stigma among Individuals and Community Leaders in Western Kenya : Evidence from a Cluster-randomized Trial(Taylor and Francis, 2013-06-09)HIV counseling and testing services play an important role in HIV treatment and prevention efforts in developing countries. Community-wide testing campaigns to detect HIV earlier may additionally impact community knowledge and beliefs about HIV. We conducted a cluster-randomized evaluation of a home-based HIV testing campaign in western Kenya and evaluated the effects of the campaign on community leaders’ and members’ stigma toward people living with HIV/AIDS. We find that this type of large-scale HIV testing can be implemented successfully in the presence of stigma, perhaps due to its “whole community” approach. The home-based HIV testing intervention resulted in community leaders reporting lower levels of stigma. However, stigma among community members reacted in mixed ways, and there is little evidence that the program affected beliefs about HIV prevalence and prevention.Publication Do Sanitation Improvements Reduce Fecal Contamination of Water, Hands, Food, Soil, and Flies? Evidence from a Cluster-Randomized Controlled Trial in Rural Bangladesh(American Chemical Society, 2018-09-26)Sanitation improvements have had limited effectiveness in reducing the spread of fecal pathogens into the environment. We conducted environmental measurements within a randomized controlled trial in Bangladesh that implemented individual and combined water treatment, sanitation, handwashing (WSH) and nutrition interventions (WASH Benefits, NCT01590095). Following approximately 4 months of intervention, we enrolled households in the trial’s control, sanitation and combined WSH arms to assess whether sanitation improvements, alone and coupled with water treatment and handwashing, reduce fecal contamination in the domestic environment. We quantified fecal indicator bacteria in samples of drinking and ambient waters, child hands, food given to young children, courtyard soil and flies. In the WSH arm, Escherichia coli prevalence in stored drinking water was reduced by 62% (prevalence ratio = 0.38 (0.32, 0.44)) and E. coli concentration by 1-log (Δlog10 = −0.88 (−1.01, −0.75)). The interventions did not reduce E. coli along other sampled pathways. Ambient contamination remained high among intervention households. Potential reasons include noncommunity-level sanitation coverage, child open defecation, animal fecal sources, or naturalized E. coli in the environment. Future studies should explore potential threshold effects of different levels of community sanitation coverage on environmental contamination.
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