评估肺癌核心结果集的采用情况:横断面分析

IF 3 Q2 ONCOLOGY
Andrew V. Tran BS , Brody Dennis BS , Matthew Rashid BS , Kyle Fitzgerald BS , Garrett Jones BS , Kimberly Magana MEd , Jay Modi BS , Trevor Magee BS , Shaelyn Ward BS , Griffin Hughes BA, BS , Alicia Ito Ford PhD , Matt Vassar PhD
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引用次数: 0

摘要

导言:核心研究结果集(COS)有助于实现临床试验结果测量的标准化。尽管肺癌是癌症相关死亡的主要原因,但对肺癌试验中 COS 实施情况的探索研究仍然有限。我们的目的是分析肺癌COS的采用情况,并找出COS遵守方面的潜在差距。方法2023年6月26日,我们对评估肺癌干预措施的临床试验进行了横断面分析。我们的样本包括 2011 年 9 月至 2023 年 6 月期间在 ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台上注册的研究。调查人员以蒙面和重复的方式提取了有关试验特征和 COS 采用情况的数据。结果 在观察到的 626 项试验中,我们发现肺癌 COS 采用率在发表前后总体上没有显著差异(0.01%,95% 置信区间:-0.16% 至 0.19%,P=0.85)。最常测量的结果是 "总生存率"(91.69%)和 "治疗相关死亡率"(54.69%)。健康相关生活质量问卷通常用于评估 "健康程度 "领域的结果(49.20%)。与 "从诊断到治疗的时间"(0%)、"死亡地点"(0.16%)和 "生命终结时在医院度过的时间"(1.60%)相关的结果很少被测量。我们的研究结果表明了这些不一致性,并强调需要采取积极主动的方法来提高采纳率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Assessing the Uptake of the Lung Cancer Core Outcome Set: A Cross-Sectional Analysis

Introduction

A core outcome set (COS) helps standardize outcome measurements across clinical trials. Although lung cancer is the leading cause of cancer-related deaths, research exploring COS implementation across lung cancer trials remains limited. We aim to analyze the uptake of the lung cancer COS and identify potential gaps in COS adherence.

Methods

On June 26, 2023, we conducted a cross-sectional analysis of clinical trials that evaluated lung cancer interventions. Our sample consisted of studies registered on ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform between September 2011 and June 2023. In a masked and duplicate fashion, investigators extracted data regarding trial characteristics and COS adoption. An interrupted time series analysis was conducted to evaluate the adherence of lung cancer COS before and after its publication.

Results

Of the 626 observed trials, we found no overall significant difference in lung cancer COS uptake pre- and post-publication (0.01%, 95% confidence interval: −0.16% to 0.19%, p=0.85). The most frequently measured outcomes were “overall survival” (91.69%%) and “treatment-related mortalities” (54.69%). Health-related quality of life questionnaires were typically used to evaluate outcomes in the “Degree of health” domain (49.20%). Outcomes related to “time from diagnosis to treatment” (0%), “place of death” (0.16%), and “duration of time spent in the hospital at the end of life” (1.60%) were rarely measured.

Conclusions

Despite the advantages of COS implementation, adherence across lung cancer clinical trials remains alarmingly low—which could compromise data reliability and patient care. Our findings showcase these inconsistencies and emphasize the need for proactive approaches to improve uptake.
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来源期刊
CiteScore
4.20
自引率
0.00%
发文量
145
审稿时长
19 weeks
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