Davis Kimberly Hunt, Black Libby, Sleath Betsy
Global Health Outcomes, GlaxoSmithKline, PO Box 13398, Research Triangle Park, NC 27709-3398, USA.
Value Health. 2002 Sep-Oct;5(5):422-30. doi: 10.1046/J.1524-4733.2002.55120.x.
The purpose of this study was to assess the psychometric properties of the Patient Perception of Migraine Questionnaire (PPMQ), which measures patient satisfaction with migraine therapy.
The PPMQ was administered to 940 patients as part of a 3-month, multinational, open-label, clinical trial comparing the effects of oral naratriptan 2.5 mg with the patient's customary therapy for the treatment of migraine. Psychometric properties of the PPMQ were evaluated in terms of its latent factor structure, validity, reliability, sensitivity, and development of a scoring method. Classical Test theory and Item Response theory (IRT) modeling were both used to measure reliability.
The PPMQ was able to detect treatment differences (P >.001), and all items significantly correlated with diary ratings of headache pain (r =.18-.51, p >.0001) and the Medical Outcomes Short Form-36 pain scale (r =.27, p >.0001). A principal components factor analysis revealed that the items on the PPMQ were psychometrically distinct and unidimensional (loadings, 0.74-0.91), with the exclusion of two items. The reliability (i.e., internal item consistency) of the PPMQ post-trial was high in both treatment groups (Cronbach's alpha = 0.96). An IRT analysis also ensured the formation of homogenous items, which were stable on repeat administration. Items did not require weighting and can be simply summed to yield a total score.
Based on the data from this one clinical trial, the 15-item PPMQ was shown to be a valid and reliable instrument that seems to efficiently and comprehensively measure patient perception of drug attributes in relation to the treatment of symptoms associated with migraine headaches.
本研究旨在评估偏头痛患者问卷(PPMQ)的心理测量特性,该问卷用于衡量患者对偏头痛治疗的满意度。
作为一项为期3个月的多中心、开放标签临床试验的一部分,PPMQ被施用于940名患者,该试验比较了2.5毫克口服那拉曲坦与患者常规治疗方法对偏头痛的治疗效果。从潜在因子结构、效度、信度、敏感性以及评分方法的制定等方面对PPMQ的心理测量特性进行了评估。经典测试理论和项目反应理论(IRT)建模均用于测量信度。
PPMQ能够检测出治疗差异(P>.001),所有项目均与头痛疼痛的日记评分(r =.18 -.51,p>.0001)以及医学结局简表36疼痛量表(r =.27,p>.0001)显著相关。主成分因子分析表明,PPMQ上的项目在心理测量上是不同且单维的(载荷,0.74 - 0.91),排除了两个项目。试验后两个治疗组中PPMQ的信度(即项目内部一致性)都很高(Cronbach's alpha = 0.96)。IRT分析还确保了同质性项目的形成,这些项目在重复施测时是稳定的。项目不需要加权,可以简单相加得出总分。
基于这一临床试验的数据,15项的PPMQ被证明是一种有效且可靠的工具,似乎能够有效且全面地测量患者对与偏头痛头痛相关症状治疗的药物属性的认知。