BACKGROUND:Individuals with HIV disease often must adhere to complex medication regimens. To date, regimen complexity has not been examined in the literature using standardized procedures incorporating all important elements of antiretroviral (ARV) regimens. OBJECTIVE:This article presents a novel method of quantifying regimen complexity using objective criteria addressing the factors that may complicate adherence to ARV regimens. METHODS:Part 1 of this article describes the development of the Antiretroviral Regimen Complexity (ARC) Index scoring system. Based on input from pediatric and adult patients, caregivers of pediatric patients, and health care professionals, this comprehensive system includes the number of medications, dosing schedules, administration methods, special instructions, and required preparations associated with ARV regimens. Weights are applied for each of these factors to produce an overall score representing the regimen's level of complexity. Part 2 of this article presents reliability and validity data for the system. RESULTS:The ARC Index demonstrates excellent test-retest and interrater reliability as well as strong construct and discriminant validity. An on-line version of this system minimizes computation errors. CONCLUSIONS:Although modifications may be necessary for patients requiring nonstandard dosing instructions, preliminary evidence supports the utility of this measure as a reliable and valid indicator of the complexity of antiretroviral treatment regimens.

译文

背景:艾滋病毒感染者通常必须遵守复杂的药物治疗方案。迄今为止,文献中尚未使用纳入抗逆转录病毒(ARV)方案所有重要要素的标准化程序来检查方案的复杂性。
目的:本文提出了一种新的量化方案复杂性的方法,该方法使用客观标准解决了可能使遵守ARV方案复杂化的因素。
方法:本文的第1部分描述了抗逆转录病毒药物复杂性(ARC)指数评分系统的开发。基于小儿和成年患者,小儿患者的看护者以及医疗保健专业人员的输入,此综合系统包括药物数量,给药方案,给药方法,特殊说明以及与ARV疗法相关的所需制剂。将权重应用于这些因素中的每一个,以产生代表方案复杂程度的总分。本文的第2部分介绍了系统的可靠性和有效性数据。
结果:ARC指数显示出优异的重测性和跨度可靠性,以及强大的构造和判别效度。该系统的在线版本最大程度地减少了计算错误。
结论:尽管对于需要非标准剂量指导的患者可能需要进行修改,但初步证据支持该措施可作为抗逆转录病毒治疗方案复杂性的可靠且有效的指标。

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