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评估强直性脊柱炎生活质量问卷:一种新的患者报告结局测量工具的反应性。

Evaluation of Ankylosing Spondylitis Quality of Life questionnaire: responsiveness of a new patient-reported outcome measure.

机构信息

Arthritis Research UK Primary Care Centre, Keele University, Staffordshire ST5 5BG, UK.

出版信息

Rheumatology (Oxford). 2012 Apr;51(4):707-14. doi: 10.1093/rheumatology/ker377. Epub 2011 Dec 16.

DOI:10.1093/rheumatology/ker377
PMID:22179735
Abstract

OBJECTIVE

To determine the responsiveness and minimal important change (MIC) of Evaluation of Ankylosing Spondylitis Quality of Life (EASi-QoL), a reliable and valid patient-reported measure of AS-specific quality of life with four domains: physical function (PF), disease activity (DA), emotional well-being (EWB) and social participation (SP).

METHODS

A total of 1000 UK AS patients received a postal questionnaire including EASi-QoL. Comparative responsiveness of EASi-QoL was assessed against measures reflecting similar health domains in patients self-reporting an improvement in their AS-specific health at 6 months on a health transition question. Effect size (ES) statistics were calculated for all measures and MIC was determined for EASi-QoL. Comparative responsiveness was determined in a randomized trial of AS patients receiving etanercept (ETN) 50 mg weekly or SSZ 3 g daily.

RESULTS

Of 470 patients, 80 responding at 6 months reported health improvement. Responsiveness (ES) for EASi-QoL domains was superior or similar to comparator measures: DA 0.72 vs BASDAI 0.58; SP 0.52 vs SF-36 social functioning 0.29; PF 0.32 vs BASFI 0.28 and SF-36 PF 0.24; EWB 0.40 vs HADS-anxiety 0.13, HADS-depression 0.21 and SF-36 mental health 0.35. ES for the ASQoL was 0.40. Superior ES was seen in those improving somewhat. In the randomized trial, all EASi-QoL domains had superior responsiveness to comparator measures following ETN treatment. Following SSZ treatment, all EASi-QoL domains were highly responsive, but BASDAI and BASFI was more responsive than EASi-QoL(DA) and (PF), respectively.

CONCLUSION

In patients reporting improvement during routine clinical practice or following treatment with ETN or SSZ, EASi-QoL domains have superior or comparable responsiveness than comparable measures.

摘要

目的

确定评估强直性脊柱炎生活质量(EASi-QoL)的反应性和最小重要变化(MIC),这是一种可靠且有效的针对强直性脊柱炎特定生活质量的患者报告测量工具,具有四个领域:身体功能(PF)、疾病活动(DA)、情绪健康(EWB)和社会参与(SP)。

方法

共有 1000 名英国 AS 患者收到了一份包含 EASi-QoL 的邮寄问卷。通过对自我报告 AS 特定健康状况改善的患者在健康过渡问题上的 6 个月内反映类似健康领域的措施进行比较,评估 EASi-QoL 的反应性。计算了所有措施的效应大小(ES)统计数据,并确定了 EASi-QoL 的 MIC。在接受依那西普(ETN)每周 50mg 或柳氮磺胺吡啶(SSZ)每日 3g 治疗的 AS 患者的随机试验中确定了比较反应性。

结果

在 470 名患者中,80 名在 6 个月时应答报告健康改善。EASi-QoL 领域的反应性(ES)优于或类似于比较措施:DA 0.72 与 BASDAI 0.58;SP 0.52 与 SF-36 社会功能 0.29;PF 0.32 与 BASFI 0.28 和 SF-36 PF 0.24;EWB 0.40 与 HADS 焦虑 0.13、HADS 抑郁 0.21 和 SF-36 心理健康 0.35。ASQoL 的 ES 为 0.40。在略有改善的患者中观察到更好的 ES。在随机试验中,在用 ETN 治疗后,所有 EASi-QoL 领域的反应性均优于比较措施。在用 SSZ 治疗后,所有 EASi-QoL 领域的反应性都很高,但 BASDAI 和 BASFI 比 EASi-QoL(DA)和(PF)的反应性更高。

结论

在常规临床实践中报告改善或接受 ETN 或 SSZ 治疗的患者中,EASi-QoL 领域的反应性优于或与可比措施相当。

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