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与基于医疗机构的直接观察短程治疗(DOTS)相比,药物敏感型结核病自我管理治疗(SAT)的患者成本研究:一项系统评价方案。

Patient-cost studies on self-administered treatment (SAT) for drug-sensitive tuberculosis compared to facility-based directly observed treatment, short-course (DOTS): a protocol for a systematic review.

作者信息

Ndlangalavu Yonela Faith, Christian Carmen Sue

机构信息

Economics, University of the Western Cape, Cape Town, Western Cape, South Africa

Economics, University of the Western Cape, Cape Town, Western Cape, South Africa.

出版信息

BMJ Open. 2025 Aug 12;15(8):e099124. doi: 10.1136/bmjopen-2025-099124.

Abstract

INTRODUCTION

Many patients with tuberculosis (TB) suffer from a huge economic burden, even though TB services are often provided free of charge at the point of care. Costs can create significant barriers, hindering patients' access to TB treatment. These costs include direct medical costs (such as consultation fees), direct non-medical costs (such as transportation costs) and indirect costs (such as wages foregone). This systematic review aims to synthesise the best available evidence on economic evaluations of patient-cost studies on self-administered treatment (SAT) for drug-sensitive TB compared with facility-based directly observed treatment, short-course (FB DOTS), globally.

METHODS AND ANALYSIS

We will conduct a systematic review following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and search PubMed, Academic Search Complete, Scopus, CINAHL Plus (EBSCO) and Google Scholar for articles published up to 2025, without date restrictions. Eligible studies must be full or partial (cost analyses without effectiveness data) economic evaluations conducted globally, comparing SAT to FB DOTS regarding TB patient costs. Grey literature will be included. Exclusion criteria include studies not reporting patient costs between SAT and FB DOTS, and non-economic evaluations (non-original research). Two independent reviewers will conduct the screening, data extraction and quality assessment. A quality assessment will be performed using the Consolidated Health Economic Evaluation Reporting Standards statement, the Consensus on Health Economic Criteria checklist and the ROBINS-I tool.

ETHICS AND DISSEMINATION

Ethics approval is not required for this systematic review because it does not use individual patient data. Instead, we will use publicly available economic evaluation research studies. Findings will be presented at international and national conferences and published in open-access, peer-reviewed journals.

PROSPERO REGISTRATION NUMBER

CRD42024591221.

摘要

引言

许多结核病患者承受着巨大的经济负担,尽管结核病服务在医疗点通常是免费提供的。费用可能会造成重大障碍,阻碍患者获得结核病治疗。这些费用包括直接医疗费用(如诊疗费)、直接非医疗费用(如交通费)和间接费用(如工资损失)。本系统评价旨在综合全球范围内关于药物敏感性结核病自我管理治疗(SAT)与基于医疗机构的直接观察短程治疗(FB DOTS)相比的患者费用经济评价的最佳现有证据。

方法与分析

我们将按照系统评价和Meta分析方案的首选报告项目指南进行系统评价,并检索PubMed、学术搜索完整版、Scopus、CINAHL Plus(EBSCO)和谷歌学术,查找截至2025年发表的文章,无日期限制。符合条件的研究必须是在全球范围内进行的全面或部分(无有效性数据的成本分析)经济评价,比较SAT和FB DOTS在结核病患者费用方面的差异。将纳入灰色文献。排除标准包括未报告SAT和FB DOTS之间患者费用的研究以及非经济评价(非原创研究)。两名独立评审员将进行筛选、数据提取和质量评估。将使用《卫生经济评价报告标准合并声明》、《卫生经济标准共识清单》和ROBINS-I工具进行质量评估。

伦理与传播

本系统评价无需伦理批准,因为它不使用个体患者数据。相反,我们将使用公开可用的经济评价研究。研究结果将在国际和国内会议上展示,并发表在开放获取、同行评审的期刊上。

PROSPERO注册号:CRD42024591221。

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