Department of Surgery, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, VIC, Australia.
Department of Medicine, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, VIC, Australia.
Eur J Vasc Endovasc Surg. 2022 Dec;64(6):666-683. doi: 10.1016/j.ejvs.2022.07.051. Epub 2022 Aug 8.
To assess the comparative effectiveness and temporal changes in quality of life (QoL) outcomes after revascularisation, major lower extremity amputation (MLEA), and conservative management (CM) in chronic limb threatening ischaemia (CLTI).
MEDLINE, Embase, PsycINFO, CINAHL, and Web of Science.
A systematic review and meta-analysis were performed on QoL measured by any QoL instrument in adult patients with CLTI after open surgery (OS), endovascular intervention (EVI), MLEA, or CM. Randomised controlled trials and prospective observational studies published in any language between 1 January 1990 and 21 May 2021 were included. There was a pre-specified measurement time point of six months. Random effects meta-analysis was conducted on total scores for each QoL instrument. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations approach (PROSPERO registration: CRD42021253953).
Fifty-five studies with 8 909 patients were included. There was significant heterogeneity in the methods used to measure QoL, and the study characteristics. In particular, 14 different QoL instruments were used with various combinations of disease specific and generic instruments within each study. A narrative summary is therefore presented. Comparative effectiveness data showed there was reasonable certainty that QoL was similar between OS and EVI at six months. Temporal outcomes suggested small to moderate improvements in QOL six months after OS and EVI compared with baseline. Limited data indicated that QoL can be maintained or slightly improved after MLEA or CM. Treatment effects were overestimated owing to small study effects, selective non-reporting, attrition, and survivorship bias.
QoL after OS and EVI appears to be similar. Revascularisation may provide modest QoL benefits, while MLEA or CM can maintain QoL. However, certainty of evidence is generally low or very low, and interpretation is hampered by significant heterogeneity. There is a need for a CLTI specific QoL instrument and methodological standardisation in QoL studies.
评估在慢性肢体威胁性缺血（CLTI）患者中，血运重建、大肢体截肢（MLEA）和保守治疗（CM）后生活质量（QoL）结果的比较效果和时间变化。
MEDLINE、Embase、PsycINFO、CINAHL 和 Web of Science。
对 1990 年 1 月 1 日至 2021 年 5 月 21 日期间发表的任何语言的随机对照试验和前瞻性观察研究进行了系统评价和荟萃分析，使用 CLTI 成年患者的任何 QoL 工具测量 QoL。纳入了开放手术（OS）、血管内介入（EVI）、MLEA 或 CM 后接受 OS、EVI、MLEA 或 CM 的患者。有一个预先指定的 6 个月测量时间点。使用每个 QoL 工具的总分进行随机效应荟萃分析。使用推荐评估、制定与评估分级方法（PROSPERO 注册：CRD42021253953）评估证据的确定性。
纳入了 55 项研究，共 8909 例患者。在用于测量 QoL 的方法和研究特征方面存在显著的异质性。特别是，在每个研究中，使用了 14 种不同的 QoL 工具，并且每种工具都结合了疾病特异性和通用工具。因此，呈现了一个叙述性总结。比较有效性数据表明，在 6 个月时，OS 和 EVI 之间的 QoL 相似，具有合理的确定性。时间结果表明，与基线相比，OS 和 EVI 后 6 个月 QOL 有较小到中等程度的改善。有限的数据表明，MLEA 或 CM 后可以维持或稍微改善 QoL。由于小研究效应、选择性非报告、失访和存活者偏倚，治疗效果被高估。
OS 和 EVI 后 QoL 似乎相似。血运重建可能会带来适度的 QoL 益处，而 MLEA 或 CM 可以维持 QoL。然而，证据的确定性通常较低或非常低，并且由于存在显著的异质性，解释受到阻碍。需要 CLTI 专用的 QoL 工具和 QoL 研究中的方法标准化。
