肿瘤学中真实世界证据研究的特点和影响:对实体肿瘤靶向治疗评价出版物的综合制图回顾

A. Pellat , T. Grinda , P. Cresta Morgado , A. Prelaj , V. Miskovic , A. Valachis , I. Zerdes , D. Martins-Branco , L. Provenzano , A. Spagnoletti , G. Nader-Marta , B.E. Wilson , Y.-H. Yang , G. Pentheroudakis , S. Delaloge , L. Castelo-Branco , M. Koopman
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引用次数: 0

摘要

背景:对实体肿瘤靶向治疗(TT)的真实世界证据(RWE)出版物进行了一项绘图审查,以描述其特征、优势和局限性。方法srwe出版物被确定为:(i)专注于实体肿瘤患者的TTs;(ii)包括有效性、预测或预后因素、安全性或生活质量的研究目标;(iii)于2020年1月1日至2022年12月22日期间发布。通过回归和聚类网络分析探讨了研究变量与期刊影响因子(IF)之间的关系。结果在7775篇文献中,1251篇符合分析条件。每年的出版物数量随着时间的推移而增加。大多数研究在亚洲(50%)、欧洲(25%)和北美(17%)进行,只有8%的研究在一个以上的国家进行。数据来源主要是健康记录(55%)和登记处(11%)。大多数研究是回顾性的(85%),只有16%是基于人群的。胃肠道肿瘤是最常见的(30%),其次是肺(22%)和乳腺(21%)。杂志IF的中位数为4.4。在多变量分析中,来自欧洲的10个中心和研究与较高的IF(≥7)显著相关。网络分析表明,国家与特定肿瘤类型的出版物数量之间存在很强的关联。结论:关于TT治疗实体肿瘤的RWE出版物数量正在增加,但研究是异质性的,大多数是回顾性的,并且发表在低IF期刊上。国际合作和促进标准化数据源是加强RWE研究的相关性以补充临床指南和影响临床实践的必要条件。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Characteristics and impact of real-world evidence studies in oncology: comprehensive mapping review of publications evaluating targeted therapies in solid tumours

Background

A mapping review of real-world evidence (RWE) publications on targeted therapy (TT) for solid tumours was carried out to describe their characteristics, strengths, and limitations.

Methods

RWE publications were identified that: (i) focused on TTs in patients with solid tumours; (ii) included study objectives of effectiveness, predictive or prognostic factors, safety or quality of life; (iii) were published between 1 January 2020 and 22 December 2022. Associations between study variables and journal impact factor (IF) were explored through regression and cluster network analyses.

Results

Of 7775 publications identified, 1251 were eligible for analysis. The number of publications per year increased over time. Most studies were conducted in Asia (50%), Europe (25%), and North America (17%), with only 8% in more than one country. Data sources were mostly health records (55%) and registries (11%). Most studies were retrospective (85%) and only 16% were population based. Gastrointestinal tumours were the most frequently studied (30%), followed by lung (22%) and breast (21%). The median journal IF was 4.4. Involvement of >10 centres and studies originating from Europe were significantly associated with a higher IF (≥7) in multivariable analysis. Network analysis demonstrated strong associations between countries and the number of publications in specific tumour types.

Conclusions

The number of RWE publications on TT for solid tumours is increasing, but studies are heterogeneous, mostly retrospective, and published in low IF journals. International collaboration and promotion of standardised data sources is imperative to enhance the relevance of RWE research to complement clinical guidelines and impact clinical practice.
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