Evaluating the Measurement Properties of the Self-Assessment of Treatment Version II, Follow-Up Version, in Patients with Painful Diabetic Peripheral Neuropathy

Q2 Medicine
F. V. van Nooten, D. Trundell, D. Staniewska, Jun Chen, E. Davies, D. Revicki
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引用次数: 2

Abstract

Background. The Self-Assessment of Treatment version II (SAT II) measures treatment-related improvements in pain and impacts and impressions of treatment in neuropathic pain patients. The measure has baseline and follow-up versions. This study assesses the measurement properties of the SAT II. Methods. Data from 369 painful diabetic peripheral neuropathy (PDPN) patients from a phase III trial assessing capsaicin 8% patch (Qutenza®) efficacy and safety were used in these analyses. Reliability, convergent validity, known-groups validity, and responsiveness (using the Brief Pain Inventory-Diabetic Neuropathy [BPI-DN] and Patient Global Impression of Change [PGIC]) analyses were conducted, and minimally important differences (MID) were estimated. Results. Exploratory factor analysis supported a one-factor solution for the six impact items. The SAT II has good internal consistency (Cronbach's alpha: 0.96) and test-retest reliability (intraclass correlation coefficients: 0.62–0.88). Assessment of convergent validity showed moderate to strong correlations with change in other study endpoints. Scores varied significantly by level of pain intensity and sleep interference (p < 0.05) defined by the BPI-DN. Responsiveness was shown based on the PGIC. MID estimates ranged from 1.2 to 2.4 (pain improvement) and 1.0 to 2.0 (impact scores). Conclusions. The SAT II is a reliable and valid measure for assessing treatment improvement in PDPN patients.
评估疼痛型糖尿病周围神经病变患者自我评估治疗版本II(随访版本)的测量特性
背景。治疗自我评估第二版(SAT II)测量治疗相关的疼痛改善和神经性疼痛患者治疗的影响和印象。该措施有基线和后续版本。本研究评估了SAT II的测量特性。方法。来自369名疼痛性糖尿病周围神经病变(PDPN)患者的III期试验数据用于评估辣椒素8%贴剂(Qutenza®)的疗效和安全性。进行了信度、收敛效度、已知组效度和反应性(使用简短疼痛量表-糖尿病神经病变[BPI-DN]和患者总体变化印象[PGIC])分析,并估计了最小重要差异(MID)。结果。探索性因素分析支持六个影响项目的单因素解决方案。SAT II具有良好的内部一致性(Cronbach's alpha: 0.96)和重测信度(类内相关系数:0.62-0.88)。收敛效度评估显示与其他研究终点的变化有中等到强的相关性。由BPI-DN定义的疼痛强度和睡眠干扰水平的评分差异显著(p < 0.05)。反应性以PGIC为基础。MID估计范围从1.2到2.4(疼痛改善)和1.0到2.0(影响评分)。结论。SAT II是评估PDPN患者治疗改善的可靠和有效的措施。
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来源期刊
Pain Research and Treatment
Pain Research and Treatment Medicine-Anesthesiology and Pain Medicine
CiteScore
3.60
自引率
0.00%
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