冠状动脉介入试验的核心结果集报告分析

IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Open Heart Pub Date : 2024-04-01 DOI:10.1136/openhrt-2023-002581

Aaron Duncan, Frances Shiely

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The secondary outcomes included; the number of primary outcomes reported per study, the proportion of studies which use patient and public involvement (PPI) during trial design, outcome variability and outcome consistency. Results 9580 trials were screened and 115 studies met inclusion/exclusion criteria. Our study demonstrated that 55% (34/62) of PCI trials used a COS when it was available, compared with 40% (21/53) before the availability of a PCI COS set, p=0.121. Fewer primary outcomes were reported after the implementation of the COS, 2 compared with 2.3, p=0.014. There was no difference in the use of PPI between either group. There was a higher level of variability in outcomes reported before the availability of the COS, while the consistency of outcome reporting remained similar. Conclusion The use of a COS in PCI trials is low. This study provides evidence that there still is a lack of awareness of the COS among those who design clinical trials. 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引用次数: 0

摘要

背景本文将重点讨论经皮冠状动脉介入治疗（PCI）试验中的结果报告。核心结果集（COS）是建议在每项临床试验中报告的一组标准化结果。使用 COS 有助于确保在各项临床试验中一致地报告所有相关结果。2018 年，欧洲心脏病学会概述了唯一针对 PCI 试验发布的 COS。方法我们检索了 2014 年至 2022 年间发表的所有随机对照试验文献。纳入的 PCI 试验均为晚期试验，且必须研究冠状动脉介入治疗。主要结果是在其发表的论文中将所有 COS 定义的结果作为主要、次要或安全终点进行报告的试验比例。次要结果包括：每项研究报告的主要结果数量、在试验设计过程中利用患者和公众参与（PPI）的研究比例、结果的可变性和结果的一致性。结果筛选出 9580 项试验，115 项研究符合纳入/排除标准。我们的研究表明，55%（34/62）的PCI试验在COS可用时使用了COS，而在PCI COS集可用之前，只有40%（21/53）的试验使用了COS，P=0.121。使用 COS 后报告的主要结果较少，仅为 2 例（2.3 例），P=0.014。两组在使用 PPI 方面没有差异。在使用 COS 之前，结果报告的可变性较高，而结果报告的一致性保持相似。结论 PCI 试验中 COS 的使用率较低。本研究提供的证据表明，临床试验设计者对 COS 仍缺乏认识。我们还介绍了临床试验结果报告的不一致性和异质性。最后，PCI 试验中明显缺乏对 PPI 的使用。由于本研究未生成和/或分析数据集，因此不适用数据共享。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Analysis of core outcome set reporting in coronary intervention trials

Background This paper will focus on outcome reporting within percutaneous coronary intervention (PCI) trials. A core outcome set (COS) is a standardised set of outcomes that are recommended to be reported in every clinical trial. Using a COS can help to ensure that all relevant outcomes are consistently reported across clinical trials. In 2018, the European Society of Cardiology outlined the only COS published for PCI trials. Methods We searched the literature for all randomised controlled trials published between 2014 and 2022. PCI trials included were late-phase trials and must investigate coronary intervention. The primary outcome was the proportion of trials that reported all of the COS-defined outcomes within their publication as either a primary, secondary or safety endpoint. The secondary outcomes included; the number of primary outcomes reported per study, the proportion of studies which use patient and public involvement (PPI) during trial design, outcome variability and outcome consistency. Results 9580 trials were screened and 115 studies met inclusion/exclusion criteria. Our study demonstrated that 55% (34/62) of PCI trials used a COS when it was available, compared with 40% (21/53) before the availability of a PCI COS set, p=0.121. Fewer primary outcomes were reported after the implementation of the COS, 2 compared with 2.3, p=0.014. There was no difference in the use of PPI between either group. There was a higher level of variability in outcomes reported before the availability of the COS, while the consistency of outcome reporting remained similar. Conclusion The use of a COS in PCI trials is low. This study provides evidence that there still is a lack of awareness of the COS among those who design clinical trials. We also presented the inconsistency and heterogenicity in reporting clinical trial outcomes. Finally, there was a clear lack of PPI utilisation in PCI trials. Data sharing not applicable as no data sets generated and/or analysed for this study.

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来源期刊

Open Heart CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

4.60

自引率

3.70%

发文量

145

审稿时长

20 weeks

期刊介绍： Open Heart is an online-only, open access cardiology journal that aims to be “open” in many ways: open access (free access for all readers), open peer review (unblinded peer review) and open data (data sharing is encouraged). The goal is to ensure maximum transparency and maximum impact on research progress and patient care. The journal is dedicated to publishing high quality, peer reviewed medical research in all disciplines and therapeutic areas of cardiovascular medicine. Research is published across all study phases and designs, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Opinionated discussions on controversial topics are welcomed. Open Heart aims to operate a fast submission and review process with continuous publication online, to ensure timely, up-to-date research is available worldwide. The journal adheres to a rigorous and transparent peer review process, and all articles go through a statistical assessment to ensure robustness of the analyses. Open Heart is an official journal of the British Cardiovascular Society.