Engler Kim, Vicente Serge, Mate Kedar K V, Lessard David, Ahmed Sara, Lebouché Bertrand
Center for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, 5252 de Maisonneuve Blvd, Montreal, QC, H4A 3S5, Canada.
Department of Mathematics and Statistics, University of Montreal, Montreal, QC, Canada.
J Patient Rep Outcomes. 2022 Mar 26;6(1):28. doi: 10.1186/s41687-022-00435-0.
Over a third of people living with HIV (PLHIV) have suboptimal adherence to antiretroviral therapy (ART). Measures of barriers to ART adherence often lack comprehensiveness. To help manage ART adherence barriers in HIV care, we are developing a new patient-reported outcome measure (PROM) of these barriers (the I-Score).
We assessed the content validity of 100 items (distinct barriers) to retain only those most relevant to both PLHIV and HIV health/social service providers. A web-based Delphi was conducted in Canada and France, collecting data from December 2018 to October 2019. Items were evaluated on relevance (the combined rated importance and actionability for HIV care of items among both PLHIV and providers); comprehensibility (rated item clarity); comprehensiveness (examined against our conceptual framework); cross-cultural equivalence (based on comparisons by questionnaire language (English, French) and country of residence). Pearson's chi-square tests were used for comparisons by language, country, gender, and stakeholder group (PLHIV, providers).
Panelists included 40 PLHIV and 57 providers (66% response rate). Thirty-one items were retained based on consensus thresholds for relevance (minimum: 50% for PLHIV, 60% for providers) and showed good comprehensibility and comprehensiveness, when compared to our conceptual framework (representation of: 6/6 domains, 15/20 subdomains). No significant difference in relevance based on language or country was found among retained items, suggestive of cross-cultural equivalence. Among all 100 items, only 6 significant differences on relevance were observed for gender. For 62 items, the relevance ratings of PLHIV and providers differed significantly, with providers showing greater endorsement of all items but one.
The Delphi led to a much-needed item reduction. Remaining items highlight the panel's multidimensional priorities for the PROM on ART adherence barriers, with few, if any, differences by language, country, and gender. While the analyses may lack generalizability and power, the sample size is considered adequate for a PROM validation study.
Retained items showed good content validity. The different patterns of item endorsement observed underscore the utility of engaging multiple stakeholder groups in PROM development for use in clinical practice. The greater endorsement of items by providers versus patients merits further investigation, including the implications of such differentials for measure development.
超过三分之一的艾滋病毒感染者对抗逆转录病毒疗法（ART）的依从性欠佳。衡量抗逆转录病毒疗法依从性障碍的指标往往缺乏全面性。为了帮助管理艾滋病毒护理中抗逆转录病毒疗法的依从性障碍，我们正在开发一种针对这些障碍的新的患者报告结局指标（PROM）（即I评分）。
我们评估了100项（不同的障碍）的内容效度，仅保留那些对艾滋病毒感染者和艾滋病毒健康/社会服务提供者都最相关的项目。在加拿大和法国开展了基于网络的德尔菲法，收集2018年12月至2019年10月的数据。对项目进行相关性评估（艾滋病毒感染者和提供者对项目在艾滋病毒护理方面的综合重要性评分和可操作性）；可理解性（项目清晰度评分）；全面性（对照我们的概念框架进行检查）；跨文化等效性（基于问卷语言（英语、法语）和居住国家的比较）。使用Pearson卡方检验按语言、国家、性别和利益相关者群体（艾滋病毒感染者、提供者）进行比较。
小组成员包括40名艾滋病毒感染者和57名提供者（回复率66%）。根据相关性的共识阈值（最低：艾滋病毒感染者为50%，提供者为60%）保留了31个项目，与我们的概念框架（6/6个领域、15/20个子领域的代表性）相比，这些项目显示出良好的可理解性和全面性。在保留的项目中，未发现基于语言或国家的相关性存在显著差异，表明具有跨文化等效性。在所有100个项目中，仅观察到6个项目在相关性上存在性别显著差异。对于62个项目，艾滋病毒感染者和提供者的相关性评分存在显著差异，除一个项目外，提供者对所有项目的认可度更高。
德尔菲法实现了急需的项目精简。其余项目突出了小组对关于抗逆转录病毒疗法依从性障碍的患者报告结局指标的多维度优先事项，在语言、国家和性别方面几乎没有差异。虽然分析可能缺乏普遍性和效力，但样本量被认为对于患者报告结局指标验证研究是足够的。
保留的项目显示出良好的内容效度。观察到的项目认可模式差异凸显了让多个利益相关者群体参与患者报告结局指标开发以用于临床实践的效用。提供者对项目的认可度高于患者这一点值得进一步研究，包括这种差异对指标开发的影响。
