背景:已知免疫功能低下的个体对SARS-CoV-2疫苗反应不足,使他们处于严重或致命的COVID-19的高风险中。因此,免疫功能低下的个体及其护理人员可能仍会进行不同程度的社交或身体距离,以避免COVID-19。然而,在任何研究中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.
目的:我们旨在测量免疫受损个体之间的身体距离行为,以及这些行为与以人为中心的结果之间的关联。包括与健康相关的生活质量(HRQoL)测量,健康国家公用事业,焦虑和抑郁,工作和学校生产力受损。
方法:制定了一个患者知情的方案来进行EAGLE研究,一个大的横截面,观察性研究,本文描述了该协议。EAGLE旨在测量免疫受损个体的距离行为和结果,包括儿童(年龄≥6个月)及其照顾者,以及美国和英国报告未接受COVID-19被动免疫接种的非免疫功能低下的成年人。我们以前开发了一种新颖的自我和观察者报告的仪器,避免COVID-19(PDS-C19)的物理距离量表,横向和回顾性地测量身体距离行为水平。使用研究人群的临时或随机选择的子集,PDS-C19心理测量特性将被评估,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与验证的HRQoL相关措施和实用程序之间的关联(相关性)。结构方程建模和回归将用于评估这些关联,调整潜在的混杂因素。参与者招募和数据收集于2022年12月至2023年6月使用直接对患者的渠道进行,包括面板,临床医生转诊,患者倡导团体,和社交媒体,收集并评估了随机选择的25%的免疫受损参与者的免疫受损诊断确认。计划的总样本量为3718名参与者和参与者-护理人员对。结果将通过免疫受损状态报告,免疫受损状态类别,国家,年龄组,和其他子组。
结果:所有数据分析和报告计划于2023年12月完成。计划于2024-2025年提交结果在同行评审期刊上发表。
结论:这项研究将量化免疫受损个体的身体疏远行为,以避免COVID-19及其与HRQoL和健康状态效用的关联。
■RR1-10.2196/52643。
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: This study will quantify immunocompromised individuals\' physical distancing behaviors to avoid COVID-19 and their association with HRQoL as well as health state utilities.
UNASSIGNED: RR1-10.2196/52643.