RTI Health Solutions, Research Triangle Park, NC, USA.
Janssen Research and Development, Beerse, Belgium.
J Patient Rep Outcomes. 2023 Jan 26;7(1):7. doi: 10.1186/s41687-023-00542-6.
The Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome measure to evaluate the presence and severity of COVID-19 signs/symptoms in adults. This study expanded the context of use of the adult SIC among adolescents aged 12-17 years and supported a pediatric adaptation (the Pediatric SIC [PedSIC]) for caregiver assessment of signs/symptoms in children aged < 12 years.
Draft versions of the PedSIC and reference materials containing sign/symptom definitions for adolescents, based on an assessment of the reading level of SIC items by a professional linguist, were developed to facilitate accurate completion of the SIC by adolescents and observer-report (PedSIC) by caregivers. For adolescents, reference materials were intended to provide definitions for selected signs/symptoms identified to have a higher reading level. Iterative rounds of cognitive debriefing interviews were conducted from November 2020 to January 2021 to evaluate adolescent understanding of the SIC reference materials and inform refinement of the PedSIC for caregivers of children too young to reliably self-report. Participants were identified via databases of individuals who previously expressed interest in participating in qualitative research and were then screened for eligibility. Recruitment quotas were established to improve sample diversity. Thematic analysis and descriptive statistics were used to assess qualitative and demographic data, respectively.
Nine healthy adolescents (mean [SD, range] age, 14 [1.76, 12-17] years, 56% female, 22% non-White; round 1, n = 6; round 2, n = 3) and 17 caregivers (mean [SD, range] age, 34 [6.28, 26-41] years, 59% female, 35% non-White; round 1, n = 9; round 2, n = 8) were interviewed. Adolescents understood the majority of signs/symptoms (22 of the 30 SIC items) without assistance or use of the reference materials during the cognitive debriefing interview. Definitions were added to the reference materials for 5 additional items, and clarifications provided to existing definitions for 3 items. Seven observer-report (PedSIC) items were modified following feedback from caregivers of healthy young children. Reference materials (similar to those for adolescent use) were developed to support caregiver understanding of the intent of the PedSIC items collecting input from children ages ≥ 5- < 12 years.
Results support using the SIC, PedSIC, and their associated reference materials to evaluate the presence and severity of COVID-19 signs/symptoms in adolescents and children aged < 12 years via caregiver-supported report, respectively.
冠状病毒-19 症状（SIC）是一个 30 项的患者报告结局测量工具，用于评估成年人中 COVID-19 体征/症状的存在和严重程度。本研究扩展了成人 SIC 在 12-17 岁青少年中的使用范围，并支持了儿科适应（儿科 SIC [PedSIC]），用于评估<12 岁儿童的体征/症状。
根据专业语言学家对 SIC 项目阅读水平的评估，制定了儿科 SIC 的草案版本和参考资料，其中包含了青少年体征/症状的定义，以方便青少年准确完成 SIC 和照顾者报告（儿科 SIC）。对于青少年，参考资料旨在为确定阅读水平较高的选定体征/症状提供定义。从 2020 年 11 月到 2021 年 1 月，进行了几轮认知访谈，以评估青少年对 SIC 参考资料的理解，并为照顾者报告（儿童太小而无法可靠地自我报告）的儿童的儿科 SIC 提供信息。通过对以前表示有兴趣参与定性研究的个人的数据库进行识别，参与者被确定，然后对其进行资格筛选。确定了招募配额，以提高样本多样性。使用主题分析和描述性统计分别评估定性和人口统计数据。
共对 9 名健康青少年（平均[SD，范围]年龄 14 [1.76，12-17]岁，56%为女性，22%为非白人；第 1 轮 n=6；第 2 轮 n=3）和 17 名照顾者（平均[SD，范围]年龄 34 [6.28，26-41]岁，59%为女性，35%为非白人；第 1 轮 n=9；第 2 轮 n=8）进行了访谈。青少年在认知访谈中无需帮助或使用参考资料即可理解大多数体征/症状（30 项 SIC 项目中的 22 项）。参考资料中添加了 5 项其他项目的定义，并为 3 项现有定义提供了说明。根据健康幼儿照顾者的反馈，修改了 7 项观察者报告（儿科 SIC）项目。为了支持照顾者理解从 5-<12 岁儿童收集输入的儿科 SIC 项目的意图，制定了参考资料（与青少年使用的参考资料类似）。
结果支持使用 SIC、儿科 SIC 及其相关参考资料，分别通过照顾者支持报告，评估青少年和<12 岁儿童的 COVID-19 体征/症状的存在和严重程度。
