Richard Stephanie A, Epsi Nusrat J, Pollett Simon, Lindholm David A, Malloy Allison M W, Maves Ryan, Utz Gregory C, Lalani Tahaniyat, Smith Alfred G, Mody Rupal M, Ganesan Anuradha, Colombo Rhonda E, Colombo Christopher J, Chi Sharon W, Huprikar Nikhil, Larson Derek T, Bazan Samantha, Madar Cristian, Lanteri Charlotte, Rozman Julia S, English Caroline, Mende Katrin, Tribble David R, Agan Brian K, Burgess Timothy H, Powers John H
Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, Maryland, USA.
Open Forum Infect Dis. 2021 Oct 8;8(12):ofab517. doi: 10.1093/ofid/ofab517. eCollection 2021 Dec.
The inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) is a patient-reported outcome data collection instrument assessing symptoms of viral respiratory tract infections across 8 body systems. This study evaluated the measurement properties of FLU-PRO Plus in a study enrolling individuals with coronavirus disease 2019 (COVID-19).
Data from a prospective cohort study (EPICC) in US Military Health System beneficiaries evaluated for COVID-19 was utilized. Adults with symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with FLU-PRO Plus survey information within 1 week of symptom onset were included. Reliability of FLU-PRO Plus was estimated using intraclass correlation coefficient (ICC; 2 days' reproducibility). Known-groups validity was assessed using patient global assessment (PGA) of disease severity. Patient report of return to usual health was used to assess responsiveness (day 1-6/7).
Two hundred twenty-six SARS-CoV-2-positive participants were included in the analysis. Reliability among those who reported no change in their symptoms from one day to the next was high for most domains (ICC range, 0.68-0.94 for day 1 to day 2). Construct validity was demonstrated by moderate to high correlation between the PGA rating of disease severity and domain and total scores (eg, total scores correlation: 0.69 [influenza-like illness severity], 0.69 [interference in daily activities], and -0.58 [physical health]). In addition, FLU-PRO Plus demonstrated good known-groups validity, with increasing domain and total scores observed with increasing severity ratings.
FLU-PRO Plus performs well in measuring signs and symptoms in SARS-CoV-2 infection with excellent construct validity, known-groups validity, and responsiveness to change. Standardized data collection instruments facilitate meta-analyses, vaccine effectiveness studies, and other COVID-19 research activities.
流感患者报告结局增强版（FLU-PRO Plus）是一种患者报告结局数据收集工具，用于评估8个身体系统的病毒性呼吸道感染症状。本研究在一项纳入2019冠状病毒病（COVID-19）患者的研究中评估了FLU-PRO Plus的测量特性。
利用美国军事卫生系统受益人中一项针对COVID-19进行评估的前瞻性队列研究（EPICC）的数据。纳入症状性严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的成年人，这些人在症状出现后1周内有FLU-PRO Plus调查信息。使用组内相关系数（ICC；2天再现性）估计FLU-PRO Plus的可靠性。使用疾病严重程度的患者整体评估（PGA）评估已知组效度。患者报告恢复到正常健康状态用于评估反应性（第1 - 6/7天）。
226名SARS-CoV-2阳性参与者纳入分析。对于大多数领域，那些报告症状从一天到下一天没有变化的人的可靠性很高（第1天到第2天的ICC范围为0.68 - 0.94）。疾病严重程度的PGA评分与各领域及总分之间存在中度到高度相关性，证明了结构效度（例如，总分相关性：0.69[流感样疾病严重程度]，0.69[对日常活动的干扰]，以及 - 0.58[身体健康]）。此外，FLU-PRO Plus显示出良好的已知组效度，随着严重程度评分增加，各领域及总分也增加。
FLU-PRO Plus在测量SARS-CoV-2感染的体征和症状方面表现良好，具有出色的结构效度、已知组效度和对变化的反应性。标准化的数据收集工具便于进行荟萃分析、疫苗有效性研究及其他COVID-19研究活动。
