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免疫检查点抑制剂健康经济评估研究中的报告质量:一项系统评价。

Reporting Quality in Health Economic Evaluation Studies of Immune Checkpoint Inhibitors: A Systematic Review.

作者信息

Yoshioka Takashi, Azuma Shintaro, Funada Satoshi, Itaya Takahiro, Goto Rei

机构信息

Health Technology Assessment Unit, Department of Preventive Medicine and Public Health, Keio University School of Medicine, 35 Shinano-machi, Shinjuku-ku, Tokyo, 160-8582, Japan.

Institute of Clinical Epidemiology, Showa University, Tokyo, Japan.

出版信息

Clin Drug Investig. 2025 May;45(5):223-234. doi: 10.1007/s40261-025-01435-w. Epub 2025 Mar 27.

Abstract

BACKGROUND AND OBJECTIVE

The introduction of immune checkpoint inhibitors (ICIs) in oncology presents a critical healthcare policy challenge for resource allocation due to their substantial financial burden. This study assessed the reporting quality of health economic evaluation (HEE) studies of ICIs.

METHODS

This study conducted a systematic literature search of four databases (PubMed, EMBASE, Cochrane CENTRAL, and the International HTA Database) for studies published between January 1, 2014 and December 31, 2022. All ICIs approved up to December 31, 2022, in the USA, EU, China, and Japan were included. Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards published in 2013 (CHEERS 2013), which is the most widely recognised and implemented reporting guideline for HEE studies. Subgroup analyses were also performed based on the risk of sponsorship bias or citation of CHEERS 2013.

RESULTS

A total of 5368 records were identified, 252 of which were included after full-text review. The study design, setting, and ICIs most frequently observed were cost-effectiveness and cost-utility analyses (63.5%), the USA (46.0%), and pembrolizumab (38.1%), respectively. Of the 24 items of CHEERS 2013, fully reported items were limited, particularly in the Methods section. Setting and location were not reported in 94.4% of the records. Subgroup analyses also revealed insufficient reporting of items in the Methods section, particularly "Setting and location".

CONCLUSION

Health economic evaluation studies on ICIs between 2014 and 2022 had limited reporting across the 24 items of CHEERS 2013, regardless of sponsorship bias risk or citations. The items on setting and location in the Methods section were particularly underreported, emphasising the need for transparent reporting in HEE studies of ICIs.

摘要

背景与目的

免疫检查点抑制剂(ICI)在肿瘤学领域的应用因经济负担沉重,给卫生保健资源分配带来了严峻的政策挑战。本研究评估了ICI卫生经济评价(HEE)研究的报告质量。

方法

本研究对四个数据库(PubMed、EMBASE、Cochrane CENTRAL和国际卫生技术评估数据库)进行系统文献检索,查找2014年1月1日至2022年12月31日期间发表的研究。纳入截至2022年12月31日在美国、欧盟、中国和日本获批的所有ICI。使用2013年发布的《卫生经济评价报告标准合并版》(CHEERS 2013)评估报告质量,这是HEE研究中最广泛认可和实施的报告指南。还基于赞助偏倚风险或对CHEERS 2013的引用进行了亚组分析。

结果

共识别出5368条记录,经全文审查后纳入252条。最常观察到的研究设计、研究背景和ICI分别是成本效果分析和成本效用分析(63.5%)、美国(46.0%)和帕博利珠单抗(38.1%)。在CHEERS 2013的24项内容中,完整报告的项目有限,尤其是在“方法”部分。94.4%的记录未报告研究背景和地点。亚组分析还显示“方法”部分项目报告不足,尤其是“研究背景和地点”。

结论

2014年至2022年期间关于ICI的卫生经济评价研究在CHEERS 2013的24项内容上报告有限,无论赞助偏倚风险或引用情况如何。“方法”部分中关于研究背景和地点的项目报告尤其不足,这凸显了ICI的HEE研究中透明报告的必要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6923/12058961/e2ccc82a332c/40261_2025_1435_Fig1_HTML.jpg

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