Development and validation of a self-completed HIV symptom index
Development and validation of a self-completed HIV symptom index
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DOI：
10.1016/s0895-4356(01)00449-8
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发表时间：
2001-12-01
影响因子：
7.2
通讯作者：
Wu, AW
中科院分区：
文献类型：
--
作者：
Justice, AC;Holmes, W;Wu, AW
传统的、开放式的提供者关于患者症状的问题是不敏感的。需要更好的方法来测量临床管理，以患者为导向的研究和不良药物事件报告的症状。我们的目标是开发并初步验证一个简短的，自我报告的艾滋病毒症状指数，为暴露于多药抗逆转录病毒治疗和蛋白酶抑制剂的患者量身定制，并比较新的指数与现有的症状措施。研究设计为多阶段设计，包括现有文献的定量综述、试点数据的定性和定量分析以及前瞻性样本的定量分析。统计分析包括频率、卡方显著性检验、线性和logistic回归。受试者来自艾滋病临床试验组的多中心便利样本（n = 73）和克利夫兰退伍军人事务医疗中心的前瞻性样本（n = 115）。措施包括患者报告的症状和健康相关的生活质量，医生评估的疾病严重程度，CD 4细胞计数和HIV-1 RNA病毒定量。一个20项，自我完成的艾滋病毒症状指数的基础上，以前的报告的症状频率和困扰和专家的意见。与之前的措施相比，该指数包括更频繁和令人烦恼的症状，但更容易使用（自我报告，而不是提供者访谈）。该指数需要不到5分钟的时间来完成，实现了出色的完成率，并被认为是全面和可理解的方便样本。它在患者的前瞻性样本中进行了进一步测试，并证明与身心健康总分和疾病严重程度有很强的相关性。这些关联独立于CD 4细胞计数和HIV-1 RNA病毒定量。这20项HIV症状指数已经证明了结构效度，并提供了一个简单而合理的方法来衡量HIV症状的临床管理，以病人为导向的研究，和不良药物报告。(C)2001 Elsevier Science Inc. All rights reserved.
Traditional, open-ended provider questions regarding patient symptoms are insensitive. Better methods are needed to measure symptoms for clinical management, patient-oriented research, and adverse drug-event reporting. Our objective was to develop and initially validate a brief, self-reported HIV symptom index tailored to patients exposed to multidrug antiretroviral therapies and protease inhibitors, and to compare the new index to existing symptom measures. The research design was a multistage design including quantitative review of existing literature, qualitative and quantitative analyses of pilot data, and quantitative analyses of a prospective sample, Statistical analyses include frequencies, chi-square tests for significance, linear and logistic regression. The subjects were from a multisite convenience sample (n = 73) within the AIDS Clinical Trials Group and a prospective sample from the Cleveland Veterans Affairs Medical Center (n = 115). Measures were patient-reported symptoms and health-related quality of life, physician-assessed disease severity, CD4 cell count, and HIV-1 RNA viral quantification. A 20-item, self-completed HIV symptom index was developed based upon prior reports of symptom frequency and bother and expert opinion. When compared with prior measures the index included more frequent and bothersome symptoms, yet was easier to use (self-report rather than provider interview). The index required less than 5 minutes to complete, achieved excellent completion rates, and was thought comprehensive and comprehensible in a convenience sample. It was further tested in a prospective sample of patients and demonstrated strong associations with physical and mental health summary scores and with disease severity. These associations were independent of CD4 cell count and HIV-1 RNA viral quantification. This 20-item HIV symptom index has demonstrated construct validity, and offers a simple and rational approach to measuring HIV symptoms for clinical management, patient-oriented research, and adverse drug reporting. (C) 2001 Elsevier Science Inc. All rights reserved.