The Development of a Survey to Measure Completeness of Response to Migraine Therapy

The Development of a Survey to Measure Completeness of Response to Migraine Therapy
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DOI:
10.1111/j.1526-4610.2012.02099.x
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发表时间:
2012-04-01
期刊:
影响因子:
5
通讯作者:
Cady, Roger K.
Cady, Roger K.
中科院分区:
医学3区
文献类型:
--
作者:
Coon, Cheryl D.;Fehnel, Sheri E.;Cady, Roger K.

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Objective.为了评估一种新的患者报告偏头痛仪器的心理测量特性,反应完整性调查(CORS),它测量了一组对患者决定开始和继续治疗的重要因素。传统上,偏头痛的治疗和用于证明其疗效的仪器都集中在缓解头痛上。随着新的治疗方法的出现,有可能更全面和一致地缓解偏头痛,需要更全面的工具来证明这些益处。CORS包括2个模块,静态CORS(在一个时间点对一种治疗进行全面评价)和比较CORS(在一个时间点对2种治疗进行更全面的比较)。这两个模块可以一起测量临床研究过程中未满足的治疗需求和改善。一项8个地点的研究比较了147名患者最近接受曲坦治疗和接受舒马曲坦/纳曲林钠单片剂治疗2个月的经验,该研究的数据用于对CORS进行初步的心理测量评估。该研究包括CORS的两个模块,头痛影响测试,修订的偏头痛患者感知问卷和偏头痛日记。静态和比较模块中的CORS响应类别均表现出有限的下限或上限效应,缺失值很少(< 3%)。项目间相关性,主成分分析(成分加载范围:0.62至0.95),和内部一致性的高估计值(α范围:0.88至0.94),为每个综合得分支持的结构和建议的评分算法的静态模块。CORS静态和比较项目之间的相关性模式和复合材料与修订后的偏头痛患者感知问卷项目和分量表之间的相关性,以及对选定静态CORS项目和偏头痛日记的反应之间的关系,支持CORS的结构效度。CORS能够证明更全面的偏头痛疗法优于传统疗法,传统疗法主要集中在头痛的解决,通过解决最常见的偏头痛症状解决和患者恢复正常功能的频率和速度。这项研究显示了CORS静态和比较项目和组件的价值和效用的证据,进一步的评估正在进行中。
Objective. To assess the psychometric properties of a new patient-reported migraine instrument, the Completeness of Response Survey (CORS), which measures a comprehensive set of factors important to patients' decisions regarding the initiation and continuation of treatment.Background.-Traditionally, migraine treatments and the instruments used to demonstrate their efficacy have focused on the relief of headache pain. As new treatments emerge with the potential for more complete and consistent migraine relief, more comprehensive tools are needed to demonstrate these benefits. The CORS includes 2 modules, the static CORS, which comprehensively evaluates one treatment at one time point, and the comparative CORS, which provides a more global comparison between 2 treatments at one time point. Together, the 2 modules can measure unmet treatment needs and improvements over the course of a clinical study.Methods.-Data from an 8-site study comparing 147 patients' recent experiences with their current triptan therapy and 2 months of study treatment with a single-tablet formulation of sumatriptan/naproxen sodium were used to conduct a preliminary psychometric evaluation of the CORS. The study included both modules of the CORS, the Headache Impact Test, the revised Patient Perception of Migraine Questionnaire, and a migraine diary.Results.-The CORS response categories in both the static and comparative modules demonstrated limited floor or ceiling effects and few missing values (< 3%). Inter-item correlations, principal components analysis ( component loading range: 0.62 to 0.95), and high estimates of internal consistency ( alpha range: 0.88 to 0.94) for each composite score supported the structure and proposed scoring algorithm for the static module. The pattern of correlations between the CORS static and comparative items and composites with the revised Patient Perception of Migraine Questionnaire items and subscales, as well as the relationships between responses to selected static CORS items and the migraine diary, supported the construct validity of the CORS.Conclusions.-The CORS is capable of demonstrating advantages of more comprehensive migraine therapies over traditional therapies, which are primarily focused on the resolution of headache pain, by addressing the frequency and speed with which the most common migraine symptoms are resolved and patients' return to normal functioning. This research shows evidence for the value and utility for the CORS static and comparative items and components, and further evaluation is underway.