Gulati Sumit, Coughlin Patrick A, Hatfield Josie, Chetter Ian C
Academic Department of Vascular Surgery, Hull Royal Infirmary, Hull, United Kingdom.
J Vasc Surg. 2009 Jan;49(1):122-6. doi: 10.1016/j.jvs.2008.08.011. Epub 2008 Oct 22.
Quality of life (QoL) is a crucial outcome measure in patients with lower limb ischemia (LLI). The Short Form 36 (SF36) has been proposed as the gold standard instrument for generic QoL analysis in patients with LLI. The Short Form 8 (SF8) was developed from the SF36 and we aim to compare these two instruments in terms of validity, reliability, and responsiveness.
One hundred ninety-three patients, 135 men and 58 women, median age 66 (range, 44-84) years with LLI completed the SF36 and the SF8. Disease severity was graded according to International Society of Cardiovascular Surgery (ISCVS) suggested reporting standards. Correlation between the two instruments' like domains and non-like domains reflects convergent and divergent validity respectively. A subgroup of 58 patients (44 men) completed two sets of questionnaires, with an intervening period of 2 weeks. Correlation between these two sets of questionnaires was used to analyze test/retest reliability. Spearman's rank correlation was used to analyze validity and reliability. Responsiveness of the individual domains across the whole group was analyzed using the Kruskall-Wallis analysis of variance (ANOVA) test, while responsiveness between the groups of patients with varying severity of LLI was analyzed using the Mann-Whitney U test.
There was greater correlation between like domains of SF36 and the SF8 than the non-like domains suggesting good convergent-divergent validity. Test/retest reliability was significant for both instruments (r(s) > 0.7). Increasing LLI resulted in a statistically significant deterioration in all eight domains of both instruments. The time taken was significantly shorter and less assistance was required to complete the SF8 than the SF36.
The SF8 is a valid and reliable QoL instrument in patients with LLI, and as it is simpler and quicker to complete, we suggest it may challenge the SF36 as the gold standard generic QoL analysis instrument in LLI.
生活质量（QoL）是下肢缺血（LLI）患者的一项关键结局指标。简短健康调查问卷36项版（SF36）已被提议作为LLI患者通用生活质量分析的金标准工具。简短健康调查问卷8项版（SF8）是从SF36衍生而来，我们旨在比较这两种工具在有效性、可靠性和反应性方面的差异。
193例LLI患者（135例男性和58例女性），年龄中位数为66岁（范围44 - 84岁），完成了SF36和SF8调查。疾病严重程度根据国际心血管外科学会（ISCVS）建议的报告标准进行分级。两种工具相似领域和非相似领域之间的相关性分别反映了收敛效度和区分效度。58例患者（44例男性）组成的亚组完成了两套问卷，间隔期为2周。通过这两套问卷之间的相关性来分析重测信度。采用Spearman等级相关分析效度和信度。使用Kruskal - Wallis方差分析（ANOVA）检验分析整个组中各个领域的反应性，而使用Mann - Whitney U检验分析不同严重程度LLI患者组之间的反应性。
SF36和SF8的相似领域之间的相关性高于非相似领域，表明具有良好的收敛 - 区分效度。两种工具的重测信度均显著（r(s)>0.7）。LLI病情加重导致两种工具的所有八个领域在统计学上均出现显著恶化。完成SF8所需的时间明显更短，且所需协助比完成SF36更少。
SF8是LLI患者有效的生活质量工具，并且由于其填写更简单、更快，我们建议它可能会挑战SF36作为LLI通用生活质量分析金标准工具的地位。
