Harding Gale, Coyne Karin, Barrett Richard J, Pixton Glenn C
United BioSource Corporation, Bethesda, Maryland 20814, USA.
Clin Ther. 2009 Apr;31(4):889-901. doi: 10.1016/j.clinthera.2009.04.009.
Drugs used to induce stress for cardiac imaging studies often cause discomfort. Patient-reported intensity of discomfort should be considered when comparing such agents.
The purpose of this study was to assess the psychometric properties of a modified visual analog scale (VAS) symptom-intensity measure and an overall-bother measure adapted to assess patient-reported intensity of the adverse events (AEs) associated with pharmacologic stress testing with adenosine, a pharmacologic stress myocardial perfusion imaging (PS-MPI) agent.
Data were based on 2 complementary, open-label, multicenter, naturalistic, observational studies among patients completing a PS-MPI procedure. Content, concurrent, and discriminant validity was examined by correlating modified VAS symptom-intensity scores obtained from patients with investigator-rated intensity at time of event, overall bother, and patient-reported measures obtained during a structured interview. Test-retest reliability of the overall-bother measure was examined using 1- and 2-hour assessments, and concurrent validity was assessed by correlating counts of symptoms and other patient-reported measures. Responsiveness was examined by calculating change scores of the VAS symptom-intensity measures from baseline to 1 hour among patients who reported symptoms during the 1-hour monitoring period after PS infusion. Low to moderate correlation was defined as a coefficient between 0.3 and 0.5.
A total of 324 patients enrolled in the 2 studies. Content validity of the VAS symptom-intensity and overall-bother measures was established, with nearly all patients reporting that they were a useful way to rate symptom intensity and overall bother. VAS ratings were moderately to highly correlated with physician-rated AE intensity, and patient-reported assessments of symptom intensity, discomfort, and concern (r(s) = 0.21 r(s) = 0.84). Findings to support discriminant validity were inconclusive because of small sample size. Responsiveness was demonstrated with VAS symptom-intensity change scores ranging from 2.8 for headache to 4.9 for chest pain; effect sizes for these differences were large, ranging from 1.6 to 7.3, respectively.
Findings support the validity, reliability, and responsiveness of the modified VAS symptom-intensity measure, and the reliability and validity of the overall-bother measure for use in patients completing PS procedures.
用于心脏成像研究的诱发应激药物常常会引起不适。在比较此类药物时，应考虑患者报告的不适强度。
本研究旨在评估一种改良的视觉模拟量表（VAS）症状强度测量法和一种整体困扰测量法的心理测量特性，这两种方法适用于评估与使用腺苷（一种药物应激心肌灌注成像（PS-MPI）药物）进行药物应激测试相关的不良事件（AE）的患者报告强度。
数据基于两项互补的、开放标签的、多中心的、自然主义的、观察性研究，研究对象为完成PS-MPI程序的患者。通过将患者获得的改良VAS症状强度评分与事件发生时研究者评定的强度、整体困扰以及在结构化访谈中获得的患者报告测量值进行关联，来检验内容效度、同时效度和区分效度。使用1小时和2小时评估来检验整体困扰测量法的重测信度，并通过将症状计数与其他患者报告测量值进行关联来评估同时效度。通过计算PS输注后1小时监测期内报告有症状的患者从基线到1小时的VAS症状强度测量值的变化分数来检验反应度。低至中度相关性定义为系数在0.3至0.5之间。
两项研究共纳入324例患者。确立了VAS症状强度和整体困扰测量法的内容效度，几乎所有患者都报告说它们是评估症状强度和整体困扰的有用方法。VAS评分与医生评定的AE强度以及患者报告的症状强度、不适和担忧评估呈中度至高度相关（r(s)=0.21至r(s)=0.84）。由于样本量小，支持区分效度的结果尚无定论。VAS症状强度变化分数显示出反应度，头痛为2.8，胸痛为4.9；这些差异的效应大小较大，分别为1.6至7.3。
研究结果支持改良VAS症状强度测量法的效度、信度和反应度，以及整体困扰测量法在完成PS程序患者中的信度和效度。
