Global Evidence, BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.
Patient Centered Solutions, IQVIA, Courbevoie, France.
JMIR Res Protoc. 2024 Aug 13;13:e52643. doi: 10.2196/52643.
Immunocompromised individuals are known to respond inadequately to SARS-CoV-2 vaccines, placing them at high risk of severe or fatal COVID-19. Thus, immunocompromised individuals and their caregivers may still practice varying degrees of social or physical distancing to avoid COVID-19. However, the association between physical distancing to avoid COVID-19 and quality of life has not been comprehensively evaluated in any study.
We aim to measure physical distancing behaviors among immunocompromised individuals and the association between those behaviors and person-centric outcomes, including health-related quality of life (HRQoL) measures, health state utilities, anxiety and depression, and work and school productivity impairment.
A patient-informed protocol was developed to conduct the EAGLE Study, a large cross-sectional, observational study, and this paper describes that protocol. EAGLE is designed to measure distancing behaviors and outcomes in immunocompromised individuals, including children (aged ≥6 mo) and their caregivers, and nonimmunocompromised adults in the United States and United Kingdom who report no receipt of passive immunization against COVID-19. We previously developed a novel self- and observer-reported instrument, the Physical Distancing Scale for COVID-19 Avoidance (PDS-C19), to measure physical distancing behavior levels cross-sectionally and retrospectively. Using an interim or a randomly selected subset of the study population, the PDS-C19 psychometric properties will be assessed, including structural validity, internal consistency, known-group validity, and convergent validity. Associations (correlations) will be assessed between the PDS-C19 and validated HRQoL-related measures and utilities. Structural equation modeling and regression will be used to assess these associations, adjusting for potential confounders. Participant recruitment and data collection took place from December 2022 to June 2023 using direct-to-patient channels, including panels, clinician referral, patient advocacy groups, and social media, with immunocompromising diagnosis confirmation collected and assessed for a randomly selected 25% of immunocompromised participants. The planned total sample size is 3718 participants and participant-caregiver pairs. Results will be reported by immunocompromised status, immunocompromising condition category, country, age group, and other subgroups.
All data analyses and reporting were planned to be completed by December 2023. Results are planned to be submitted for publication in peer-reviewed journals in 2024-2025.
This study will quantify immunocompromised individuals' physical distancing behaviors to avoid COVID-19 and their association with HRQoL as well as health state utilities.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/52643.
已知免疫功能低下的个体对 SARS-CoV-2 疫苗的反应不足，使他们面临 COVID-19 严重或致命的高风险。因此，免疫功能低下的个体及其护理人员可能仍然会实施不同程度的社会或身体距离以避免 COVID-19。然而，任何研究都没有全面评估避免 COVID-19 的身体距离与生活质量之间的关联。
我们旨在衡量免疫功能低下个体的身体距离行为，以及这些行为与以人为中心的结果之间的关联，包括健康相关生活质量（HRQoL）措施、健康状态效用、焦虑和抑郁以及工作和学校生产力受损。
制定了患者知情方案来开展 EAGLE 研究，这是一项大型横断面观察性研究，本文介绍了该方案。EAGLE 旨在衡量免疫功能低下个体（包括年龄≥6 个月的儿童及其护理人员）以及在美国和英国报告未接受 COVID-19 被动免疫的非免疫功能低下成年人的隔离行为和结果。我们之前开发了一种新的自我和观察者报告工具，即 COVID-19 避免身体距离量表（PDS-C19），以横向和回顾性地衡量身体距离行为水平。使用研究人群的中期或随机子集，将评估 PDS-C19 的心理测量学特性，包括结构有效性、内部一致性、已知组有效性和收敛有效性。将评估 PDS-C19 与经过验证的 HRQoL 相关措施和效用之间的关联（相关性）。将使用结构方程模型和回归来调整潜在混杂因素后评估这些关联。参与者招募和数据收集于 2022 年 12 月至 2023 年 6 月期间通过直接向患者的渠道进行，包括小组、临床医生推荐、患者权益组织和社交媒体，对随机选择的 25%免疫功能低下的参与者进行免疫功能低下诊断确认和评估。计划的总样本量为 3718 名参与者和参与者-护理人员对。结果将按免疫功能低下状态、免疫功能低下状况类别、国家、年龄组和其他亚组进行报告。
所有数据分析和报告计划于 2023 年 12 月完成。计划于 2024 年至 2025 年在同行评议期刊上提交研究结果供发表。
本研究将量化免疫功能低下个体避免 COVID-19 的身体距离行为及其与 HRQoL 以及健康状态效用的关联。
国际注册报告标识符（IRRID）：RR1-10.2196/52643。
