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盆腔静脉疾病临床研究结局的识别。

Identification of outcomes in clinical studies for pelvic venous disorders.

机构信息

Academic Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.

Section of Vascular Surgery, Department of Surgery and Cancer, London, UK.

出版信息

J Vasc Surg Venous Lymphat Disord. 2024 Nov;12(6):101865. doi: 10.1016/j.jvsv.2024.101865. Epub 2024 Mar 5.

DOI:10.1016/j.jvsv.2024.101865
PMID:38452895
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11523326/
Abstract

OBJECTIVE

There is increasing recognition that health systems need to measure and improve the value of patient care by measuring outcomes. Chronic pelvic pain secondary to pelvic venous insufficiency can have a significant impact on the quality of life (QOL) of women affected. Despite growing recognition, pelvic venous disorders (PeVDs), an important cause of chronic pelvic pain, remain underdiagnosed. Developing a core outcome set (COS) for benchmarking care delivery enhances the standardization of care. However, there is no consensus regarding a standardized minimum set of outcomes for PeVD. We aimed to generate a list of outcomes reported in previous PeVD treatment studies to lay the foundation for developing a COS for PeVD.

METHODS

This scoping review was undertaken according to the PRISMA-ScR guidelines. Initially, screening, full-text review and extraction was conducted on studies published between 2018 and 2023. Subsequently, the search was expanded using 1-year intervals, until, over a 1-year interval, no new outcomes were recorded. Closely related outcomes were classified into domains, and domains into three core areas: disease-specific, treatment-related, and QOL-related outcomes.

RESULTS

Of the 1579 records identified, 51 publications were included. From these studies, 108 different outcomes were identified. The median number of outcomes per study was 8 (interquartile range, 6-13). Closely related outcomes were organized into 42 outcome domains, which were then categorized into 3 core outcome areas; 47.6% (20/42) were disease specific, 35.7% (15/42) treatment related, and 16.7% (7/42) were QOL related. Of the 51 included studies, disease-specific outcomes were identified in 96.1% of the studies (49/51), treatment-related outcomes in 94.1% (48/51), and QOL outcomes in only 13.7% (7/51).

CONCLUSIONS

There was significant heterogeneity in outcomes reported in PeVD studies. Most PeVD treatment studies evaluated disease-specific and treatment-related outcomes of PeVD, but few reported outcomes that measured the impact on QOL. These findings will inform the next steps in developing a COS for PeVD.

摘要

目的

人们越来越认识到,医疗系统需要通过衡量结果来衡量和提高患者护理的价值。盆腔静脉功能不全引起的慢性盆腔疼痛会对受影响女性的生活质量(QOL)产生重大影响。尽管越来越受到重视,但作为慢性盆腔疼痛的重要原因之一的盆腔静脉疾病(PeVD)仍然诊断不足。制定核心结局集(COS)以进行护理提供基准可增强护理的标准化。然而,对于 PeVD 的标准化最小结局集尚无共识。我们旨在生成一份以前 PeVD 治疗研究中报告的结局清单,为 PeVD 的 COS 制定奠定基础。

方法

本范围综述按照 PRISMA-ScR 指南进行。最初,对 2018 年至 2023 年期间发表的研究进行了筛选、全文审查和提取。随后,使用 1 年间隔扩展了搜索,直到在 1 年间隔内没有记录到新的结局。密切相关的结局被归类为不同的领域,并将领域分为三个核心领域:疾病特异性、治疗相关和 QOL 相关结局。

结果

在确定的 1579 条记录中,有 51 篇文献被纳入。从这些研究中,确定了 108 种不同的结局。每项研究的平均结局数为 8 个(四分位距,6-13)。密切相关的结局被组织成 42 个结局领域,然后分为 3 个核心领域;47.6%(20/42)为疾病特异性,35.7%(15/42)为治疗相关,16.7%(7/42)为 QOL 相关。在纳入的 51 项研究中,96.1%(49/51)的研究确定了疾病特异性结局,94.1%(48/51)的研究确定了治疗相关结局,只有 13.7%(7/51)的研究确定了 QOL 结局。

结论

PeVD 研究报告的结局存在显著的异质性。大多数 PeVD 治疗研究评估了 PeVD 的疾病特异性和治疗相关结局,但很少有研究报告衡量对 QOL 影响的结局。这些发现将为制定 PeVD 的 COS 提供下一步的信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c9d/11523326/332b18e19768/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c9d/11523326/332b18e19768/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c9d/11523326/332b18e19768/gr1.jpg

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