Pearson inter-item correlation matrix.

Adherence to antiretroviral therapy (ART) is a priority in HIV care. Our goal was to develop and validate a new, short patient-reported outcome measure to screen for barriers to daily oral ART adherence in HIV care in Canada and France. The overarching design was that of a multi-phase, multi-site instrument development project. It involved a previously published qualitative research synthesis (to develop a conceptual framework from which to generate items). Here, we present the results of cognitive interviews (for content validity testing of the preliminary items) and of a longitudinal survey-based study where the revised 7-item instrument (the I-Score) was administered at two timepoints (baseline, 4 weeks), along with five indirect measures of ART adherence, including self-reported HIV viral load and, for a subset of Montreal participants, plasma viral load. The survey data was used to analyze the instrument’s measurement properties, namely structural validity (e.g., with Pearson inter-item correlations); construct validity, including cross-cultural validity, for a variety of sociodemographic groups (with receiver operating curve (ROC) analyses and areas under the curve (AUC); reliability (with the intraclass correlation coefficient (ICC)); and measurement error (with the standard error of measurement (SEM)). Study participants were adults living with HIV on antiretroviral therapy recruited from hospital-based infectious disease centers and community-based organizations in Montreal, Toronto, and Paris. The qualitative synthesis of 41 studies led to a framework composed of 6 barrier domains. One item was generated per domain. The 6-item measure was submitted to cognitive testing with 12 adults living with HIV, leading to several changes, including the division of one item into two, creating a 7-item measure. Overall, 305 adults living with HIV participated in the survey. Inter-item correlations were low to moderate, suggesting no redundant items. Among conclusive results, AUC’s were all above the predefined threshold (≥ 0.70) for self-reported viral load and plasma viral load for the global sample and across all subgroups examined. The ICC, at 0.81, was also above the predefined threshold (≥ 0.70). The SEM was 0.43. Overall, the evidence generated supports the 7-item I-Score measure’s content validity, construct validity/cross-cultural validity, reliability, and acceptable measurement error, in its specified context of use.

抗逆转录病毒治疗（antiretroviral therapy, ART）依从性是艾滋病（HIV）诊疗中的核心要务。本研究旨在开发并验证一款全新的简短患者报告结局量表，用于筛查加拿大与法国艾滋病诊疗场景下，患者每日口服ART治疗依从性的阻碍因素。本研究的总体设计为多阶段、多中心的量表开发项目，前期依托一项已发表的定性研究综合分析，构建了用于生成量表条目的概念框架。本次研究报告了两部分结果：一是针对初始条目开展内容效度检验的认知访谈结果；二是基于纵向调查的研究结果。该纵向调查中，修订后的7条目量表（I-Score）在两个时间节点（基线、4周）进行施测，同时辅以5项ART依从性间接评估指标，包括自我报告的HIV病毒载量，以及蒙特利尔地区部分受试者的血浆病毒载量。本研究利用调查数据分析了该量表的测量学属性，具体包括：结构效度（采用Pearson条目间相关系数进行分析）、针对不同社会人口学群体的构念效度（含跨文化效度，采用受试者工作特征（receiver operating curve, ROC）曲线下面积（areas under the curve, AUC）分析）、信度（采用组内相关系数（intraclass correlation coefficient, ICC）分析）以及测量误差（采用测量标准误（standard error of measurement, SEM）分析）。本研究的受试者为来自蒙特利尔、多伦多及巴黎的医院感染病中心与社区组织的、接受ART治疗的HIV成年感染者。通过对41项研究的定性综合分析，研究团队构建了包含6个阻碍因素维度的概念框架，每个维度对应生成1个量表条目。初始6条目量表针对12名HIV成年感染者开展认知测试，经修订后将其中1个条目拆分为2个，最终形成7条目量表。本次纵向调查共纳入305名HIV成年感染者作为受试者。条目间相关系数呈低至中度水平，提示量表无冗余条目。在已得出的确定性结果中，整体样本及所有分析亚组的自我报告病毒载量与血浆病毒载量对应的AUC值均高于预设阈值（≥0.70）。组内相关系数（ICC）为0.81，同样高于预设阈值（≥0.70）；测量标准误（SEM）为0.43。综上，本研究生成的证据表明，7条目I-Score量表在指定使用场景下具有良好的内容效度、构念效度/跨文化效度、信度及可接受的测量误差。