印度 0-2 月龄低出生体重儿益生菌干预预防新生儿败血症的经济学评价研究方案：ProSPoNS 试验

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.

机构信息

Reproductive, Child Health and Nutrition, Indian Council of Medical Research, New Delhi, Delhi, India

Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research School of Public Health, Chandigarh, India.

出版信息

BMJ Open. 2023 Mar 29;13(3):e068215. doi: 10.1136/bmjopen-2022-068215.

DOI:10.1136/bmjopen-2022-068215

PMID:36990484

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10069556/

Abstract

INTRODUCTION

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.

METHODS AND ANALYSIS

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.

ETHICS AND DISSEMINATION

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.

REGISTRATION

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.

TRIAL REGISTRATION NUMBER

CTRI/2019/05/019197; Clinical Trial Registry.

摘要

引言

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措施与对照试验同时进行的成本效用数据和方法。

方法和分析

经济评估将采用社会视角。在干预组和对照组中，将确定与新生儿败血症及其治疗相关的直接医疗和非医疗成本。干预成本将通过原始数据收集和方案预算记录来确定。新生儿败血症和相关疾病的治疗费用将从印度国家成本数据库中获取，该数据库用于估计医疗保健系统的成本。将采用成本效用设计，以避免每残疾调整生命年增加的成本作为结果。考虑到 6 个月的时间范围，将对试验估计值进行外推，以对印度高危新生儿人群的成本和后果进行建模。将使用 3%的贴现率。通过确定性和概率敏感性分析来解决分析中存在的不确定性的影响。

伦理和传播

已从六个参与地点的 EC（Wardha 的 MGIMS、Pune 的 KEM、Puducherry 的 JIPMER、AIPH、Bhubaneswar、新德里的 LHMC、Meerut 的 SMC）以及英国 LSTM 的 ERC 获得了批准。研究完成后将发表经过同行评审的文章。研究结果将在研究地点的社区、学术机构和政策制定者中进行传播。