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随机静脉曲张治疗试验中三个月和五年的 Discord 结局分析(DOA)作为报告标准。

The Discord Outcome Analysis (DOA) as a Reporting Standard at Three Months and Five Years in Randomised Varicose Vein Treatment Trials.

机构信息

Josef Pflug Vascular Laboratory, Ealing Hospital, Middlesex, UK; Department of Surgery and Cancer, Imperial College, London, UK; West London Vascular and Interventional Centre, Northwick Park Hospital, Harrow, UK.

Josef Pflug Vascular Laboratory, Ealing Hospital, Middlesex, UK.

出版信息

Eur J Vasc Endovasc Surg. 2019 Feb;57(2):267-274. doi: 10.1016/j.ejvs.2018.09.013. Epub 2018 Oct 17.

DOI:10.1016/j.ejvs.2018.09.013
PMID:30342999
Abstract

OBJECTIVES

Treatment success for chronic superficial venous insufficiency could be defined as an improvement in three domains: (i) disease specific quality of life, (ii) clinical severity, (iii) reflux. The aim was to report these at five years using a Venn diagram to profile the outcomes: a discord outcome analysis (DOA).

METHODS

Patients (n = 50 patients/legs in each treated group) were randomised to endovenous laser ablation (EVLA) with concurrent phlebectomies vs. ultrasound guided foam sclerotherapy (UGFS). Outcomes were assessed using three domains: (i) Aberdeen varicose vein questionnaire (AVVQ), (ii) venous clinical severity score (VCSS), (iii) venous filling index (VFI) of air plethysmography. Change scores were calculated by subtracting the final score after treatment from the baseline score before treatment to quantify the improvement. This was followed by a DOA profile for each patient where a discord was defined as the percentage of patients with a numerical deterioration in one or two domains.

RESULTS

The median [interquartile range] follow up was 68 [64-72] months. Follow up in all three domains was EVLA: 45/50, UGFS: 42/50. On ultrasound examination, GSV occlusion at some point above the knee was 93% for EVLA and 64% for UGFS (p = .001). There was no significant difference in improvement between the two treatment groups in the VCSS and the VFI. However, the EVLA group had a statistically significant AVVQ improvement (p = .004). Using a DOA, only 76% EVLA versus 60% UGFS had success in all three domains. Using improvement thresholds, this reduced to 54% and 39%, respectively. The commonest discord pattern was an improvement in the VCSS and VFI but deterioration in the AVVQ.

CONCLUSIONS

A DOA demonstrated that the definition of success is reduced if deterioration in one or two domains is taken into account. A DOA should be considered as a reporting standard for comparative analyses.

摘要

目的

慢性浅静脉功能不全的治疗成功可以定义为三个方面的改善:(i)疾病特异性生活质量,(ii)临床严重程度,(iii)反流。目的是使用韦恩图报告五年时的这些结果:不和谐结果分析(DOA)。

方法

将患者(每组 50 例患者/腿)随机分配到静脉内激光消融(EVLA)联合静脉切除术与超声引导泡沫硬化疗法(UGFS)。使用三个方面评估结果:(i)阿伯丁静脉曲张问卷(AVVQ),(ii)静脉临床严重程度评分(VCSS),(iii)空气体积描记法静脉充盈指数(VFI)。通过从治疗前的基线评分中减去治疗后的最终评分来计算变化分数,以量化改善程度。然后对每位患者进行 DOA 分析,其中不和谐定义为一个或两个领域数值恶化的患者百分比。

结果

中位数[四分位数范围]随访时间为 68[64-72]个月。在所有三个领域均进行了 EVLA 随访:45/50,UGFS:42/50。在超声检查中,EVLA 治疗后膝上以上 GSV 闭塞率为 93%,UGFS 为 64%(p=0.001)。两组治疗组在 VCSS 和 VFI 方面的改善无显著差异。然而,EVLA 组的 AVVQ 改善具有统计学意义(p=0.004)。使用 DOA,只有 76%的 EVLA 组与 60%的 UGFS 组在所有三个领域均取得成功。使用改善阈值,这分别降低到 54%和 39%。最常见的不和谐模式是 VCSS 和 VFI 改善但 AVVQ 恶化。

结论

DOA 表明,如果考虑到一个或两个领域的恶化,成功的定义会降低。DOA 应被视为比较分析的报告标准。

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