Cost Utility Analysis of End Stage Renal Disease Treatment in Ministry of Health Dialysis Centres, Malaysia: Haemodialysis Versus Continuous Ambulatory Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 5
- 主要终点
- Incremental cost effectiveness ratio
研究概览
简要总结
End-stage renal disease represents a major problem for public health, and is a severe disease affecting hundreds of millions of people in the world and increasing rapidly. It brings about complex implications to social and economic structures of every nation. Providing renal replacement therapy including , peritoneal dialysis and renal transplants for ESRD patients are resource intensive. Possible options have been proposed to ease the burden include early medical intervention to slow the progression of chronic kidney disease in high-risk patients, promotion of renal transplantation, and use of the most cost-effective dialysis therapy without compromising outcome. In Malaysia, despite growing financial pressure in health care system, cost-effectiveness studies of RRT modalities are scarce.The prevalence of ESRD patients on dialysis are approximately 34, 767 as of 2014 and expected to rise significantly in the foreseeable future. Thus, the sustainability of dialysis therapy is uncertain. This study aimed to assess the cost utility of hemodialysis and continuous ambulatory peritoneal dialysis treatment from Malaysia Ministry of Health perspective. One hundred and eighty patients will be recruited from five state hospitals via National Renal Registry. Patients' resource utilization including overhead costs, medications, dialysis consumables and hospitalizations will be recorded using specially designed case report form. Patients' quality of life will be assessed using validated EQ-5D-3L questionnaire. Survival analysis will be conducted based on NRR data. Next, a hypothetical cohort Markov model will be constructed to assess the cost utility of HD and CAPD using varying levels of CAPD use versus current practice. The data collection period is from 1st October 2016 to 30th September 2017. Incremental cost effectiveness ratio is the primary outcome of this study.
详细描述
BACKGROUND AND SIGNIFICANCE
I. Background
End-stage renal disease (ESRD) represents a major problem for public health, and is a severe disease affecting hundreds of millions of people in the world and increasing rapidly. It brings about complex implications to social and economic structures of every nation. Renal replacement therapy (RRT) is a standard choice of treatment in patients suffering from ESRD which include hemodialysis (HD), peritoneal dialysis (PD) and transplant. The National Center for Chronic Disease Prevention and Health Promotion estimated that in 2014, more than 20 million people in the US may have different levels of Chronic Kidney Disease (CKD). According to Fresenius Medical Care, information gathered from 150 countries worldwide showed number of patients being treated globally for ESRD was estimated to be 3,200,000 at the end of 2013 and, with approximately 6% growth rate, continues to increase at a significantly higher rate than the world population.
Among these patients, 2,522,000 were undergoing dialysis treatment HD or PD and around 678,000 people were living with kidney transplants. The annual growth rate of HD, PD and transplant were estimated around 6-7%, 8% and 4-5% respectively. Reported incidence of ESRD across the globe showed an important trend ranging from under 100 to over 2,000 patients per million populations (pmp) in 2013. Taiwan, Japan and the USA continue to have some of the highest rates with 3170 pmp, 2,620 pmp and 2,080 pmp respectively. It averages about 1,090 p.m.p. in the 28 countries that make up the European Union (EU). From a global view, most dialysis patients can be allocated to three major geographical regions: the USA, the EU and Japan. Around 44% of all dialysis patients are treated in these 30 countries. Estimates on the Global Burden of Disease (GBD) for years 2000-2012, conducted by the World Health Organization (WHO), indicated that kidney diseases were responsible for 864,226 deaths (1.5% of the total number of global deaths) and 29,685,826 disability adjusted life years (DALYs) lost, corresponding to 1.1% of all global DALYs lost in 2012. In Malaysia, according to the 22nd Report of the Malaysian Dialysis and Transplant Registry (MDTR) 2014, 6107 new HD cases were reported representing an acceptance rate of 203 pmp while new peritoneal dialysis cases totaled 948, representing an acceptance rate of 31 pmp in 2014. Overall, the total number of HD and PD patients increased to 31,497 and 3270 respectively, giving a prevalence rate of 1046 pmp and 109pmp respectively from 2004 to 2014. A total of 3521 patients of HD and 494 of PD were reported died in 2014. In addition, the number of dialysis centres for the whole of Malaysia increased from 205 in 2000 to 758 in 2014 giving a rate of 13 pmp in 2004 and 25 pmp in 2014. The increase in dialysis centres was mainly contributed by the private dialysis centres which had tripled from 6 pmp in 2005 to 14 pmp in 2014.
The 22nd MDTR report also stated the number of new transplant patients was 172 in 2005 and this decreased to 81 (3 pmp) in 2014. The reduction in the number of new transplants was mainly due to reduction in commercial transplantation performed overseas. The number of functioning renal transplants increased from 1716 in 2005 to 1907 in 2011 but declined to 1844 in 2014. The Global Burden of Disease Study (GBD) 2010 conducted by Institute of Health Metrics and Evaluation (IHME) revealed that among the total number of years of life lost (YLLs) due to premature death in Malaysia, kidney disease ranked 14th from 25 causes of death with 62 YLL per thousand population which accounted for 1.1% of the total premature death. Ischemic heart disease, cerebrovascular disease, and lower respiratory infections were the highest ranking causes in 2010. Besides, the figures also show the Malaysia ranked 13th relative to the same comparator countries for the leading causes of DALYs for kidney disease in 2010 with 1 as the best performance and 15 as the worst.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incremental cost effectiveness ratio
时间窗: 1st October 2016-30th September 2017
Obtained by dividing the difference between the costs of the two dialysis modalities by the difference in the outcomes (QALY).
次要结局
- Incremental cost effectiveness ratio of varying levels of CAPD use versus current practice(1st October 2016-30th September 2017)
研究者
Naren Kumar Surendra
PhD Student
National University of Malaysia
