Study protocol for economic evaluation of probiotic intervention for prevention of neonatal sepsis in 0-2-month old low-birth weight infants in India: the ProSPoNS trial.
Study protocol for economic evaluation of probiotic intervention for prevention of neonatal sepsis in 0-2-month old low-birth weight infants in India: the ProSPoNS trial.
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DOI：
10.1136/bmjopen-2022-068215
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发表时间：
2023-03-29
期刊：
影响因子：
2.9
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中科院分区：
文献类型：
--
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ProSPoNS试验是一项多中心、双盲、安慰剂对照试验，旨在评估益生菌在预防新生儿败血症中的作用。本方案描述了益生菌干预的成本效用以及对照试验的数据和方法。在经济评估中将采用社会视角。将在干预组和对照组中确定与新生儿败血症及其治疗相关的直接医疗和非医疗费用。将通过原始数据收集和方案预算记录促进干预费用。新生儿败血症和相关疾病的治疗成本将从印度国家成本计算数据库中获取，估计医疗保健系统成本。将采用成本效用设计，其结果为避免的每残疾调整生命年的增量成本。考虑到6个月的时间范围，将外推试验估计值，以模拟印度高危新生儿人群的成本和后果。将使用3%的折扣率。分析中存在的不确定性的影响将通过确定性和概率敏感性分析来解决。已从6个参与研究中心（MGIMS Wardha、KEM Pune、JIPMER普杜谢里、AIPH、Bhubaneswar、LHMC新德里、SMC Meerut）的EC以及英国LSTM的ERC获得。研究完成后将发表同行评审文章。调查结果将分发给研究地点的社区、学术机构和决策者。该方案已获得印度监管机构（中央药品标准控制组织; CDSCO）的批准（CT-NOC编号CT/NOC/17/2019，日期为2019年3月1日）。ProSPoNS试验在印度临床试验注册处（CTRI）注册。于2019年5月16日注册。CTRI/2019/05/019197;临床试验登记研究。
The ProSPoNS trial is a multicentre, double-blind, placebo-controlled trial to evaluate the role of probiotics in prevention of neonatal sepsis. The present protocol describes the data and methodology for the cost utility of the probiotic intervention alongside the controlled trial. A societal perspective will be adopted in the economic evaluation. Direct medical and non-medical costs associated with neonatal sepsis and its treatment would be ascertained in both the intervention and the control arm. Intervention costs will be facilitated through primary data collection and programme budgetary records. Treatment cost for neonatal sepsis and associated conditions will be accessed from Indian national costing database estimating healthcare system costs. A cost–utility design will be employed with outcome as incremental cost per disability-adjusted life year averted. Considering a time-horizon of 6 months, trial estimates will be extrapolated to model the cost and consequences among high-risk neonatal population in India. A discount rate of 3% will be used. Impact of uncertainties present in analysis will be addressed through both deterministic and probabilistic sensitivity analysis. Has been obtained from EC of the six participating sites (MGIMS Wardha, KEM Pune, JIPMER Puducherry, AIPH, Bhubaneswar, LHMC New Delhi, SMC Meerut) as well as from the ERC of LSTM, UK. A peer-reviewed article will be published after completion of the study. Findings will be disseminated to the community of the study sites, with academic bodies and policymakers. The protocol has been approved by the regulatory authority (Central Drugs Standards Control Organisation; CDSCO) in India (CT-NOC No. CT/NOC/17/2019 dated 1 March 2019). The ProSPoNS trial is registered at the Clinical Trial Registry of India (CTRI). Registered on 16 May 2019. CTRI/2019/05/019197; Clinical Trial Registry.
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