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基于电子患者报告结果的症状管理对比肺癌手术后常规护理:一项多中...

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傲娇女医生 发表于 2024-4-25 08:51:16 | 显示全部楼层 |阅读模式
作者:SCI天天读

SCI

24 April 2024

Electronic Patient-Reported Outcome–Based Symptom Management Versus Usual Care After Lung Cancer Surgery: Long-Term Results of a Multicenter, Randomized, Controlled Trial

(IF: JCO., 45.4)

    Dai W, Wang Y, Liao J, Wei X, Dai Z, Xu W, Liu Y, Wang XS, Pompili C, Yu H, Pu Y, Zhao Y, Cao B, Wang Q, Feng W, Zhang Y, Liu F, Deng Y, Zhou J, Li J, Xie S, Xiang R, Wang X, Tian B, Yang X, Hu B, Liu X, Xie T, Yang X, Zhuang X, Qiao G, Li Q, Shi Q. Electronic Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: Long-Term Results of a Multicenter, Randomized, Controlled Trial. J Clin Oncol. 2024 Apr 4:JCO2301854.

    CORRESPONDING AUTHOR :Qiuling Shi, MD, PhD; e-mail: qshi@cqmu.edu.cn.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We previously reported superior symptom control of electronic patient-reported outcome (ePRO)–based symptom management after lung cancer surgery for up to 1 month postdischarge. Here, we present the long-term results (1-12 months) of this multicenter, randomized trial, where patients were assigned 1:1 to receive postoperative ePRO-based symptom management or usual care daily postsurgery, twice weekly postdischarge until 1 month, and at 3, 6, 9, and 12 months postdischarge. Long-term patient-reported outcomes were assessed with MD Anderson Symptom Inventory-Lung Cancer module. Per-protocol analyses were performed with 55 patients in the ePRO group and 57 in the usual care group. At 12 months postdischarge, the ePRO group reported significantly fewer symptom threshold events (any of the five target symptom scored ≥4; median [IQR], 0 [0-0] v 0 [0-1]; P 5 .040) than the usual care group. From 1 to 12 months postdischarge, the ePRO group consistently reported significantly lower composite scores for physical interference (estimate, –0.86 [95% CI, –1.32 to –0.39]) and affective interference (estimate, –0.70 [95% CI, –1.14 to –0.26]). Early intensive ePRO-based symptom management after lung cancer surgery reduced symptom burden and improved functional status for up to 1 year postdischarge, supporting its integration into standard care.

临床试验通常包括在不同时间成熟的多个终点。当关键计划的联合主要或次要分析尚未可用时,通常可能会发布基于主要终点的初始报告。临床试验更新提供了一种机会,用以传播来来自JCO或其他地方发表的研究的额外结果,这些研究的主要终点此前已经报告过。我们之前报道过,基于电子患者报告结果(ePRO)的症状管理在肺癌手术出院后长达1个月的时间内,具有更好的症状控制效果。在这里,我们介绍了这项多中心随机试验的长期结果(1-12个月),其中患者以1:1的比例被分配接受术后基于ePRO的症状管理或常规护理,出院后每周两次直到1个月,以及在出院后3、6、9和12个月。使用MD安德森症状清单-肺癌模块评估了长期的患者报告结果。对ePRO组的55名患者和常规护理组的57名患者进行了方案分析。在出院后12个月,ePRO组报告的症状阈值事件(五个目标症状中的任何一个得分≥4;中位数[四分位数范围],0 [0-0] v 0 [0-1];P = 0.040)明显少于常规护理组。出院后1个月到12个月,ePRO组持续报告的身体干扰综合评分(估计值,-0.86 [95% CI,-1.32至-0.39])和情感干扰综合评分(估计值,-0.70 [95% CI,-1.14至-0.26])显著低于常规护理组。肺癌手术后基于ePRO的早期强化症状管理可减轻症状负担并改善出院后长达1年的功能状态,因此支持将其纳入标准护理。

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