Shen Biyu, Shi Songsong, Cui Hengmei, Li Yunyun, Chen Haoyang, Jin Huan, Xu Jia, Liu Zuojia, Jin Yanliang
Department of Nursing, Shanghai Children's Medical Center, Shanghai, China.
School of Nursing, Shanghai Jiao Tong University, Shanghai, China.
Front Pediatr. 2022 Jul 6;10:905182. doi: 10.3389/fped.2022.905182. eCollection 2022.
Juvenile idiopathic arthritis (JIA) is a common chronic rheumatic disease with no known cures, affecting children with the age of onset under 16 years. Patient-reported outcome (PRO) measures are an important basis for evaluating the impact of JIA and associated therapies, however, which is particular challenge in the pediatric setting. At present, no randomized controlled studies have investigated the effect and usability of ePROs symptom management for children with JIA.
This longitudinal, randomized, controlled trial will be carried out at outpatient and pediatric wards of the Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University School of Medicine. A total of one hundred children with JIA diagnosed according to the International League of Associations for Rheumatology (ILAR) patients are randomized to receive individualized symptom management based on ePROs or routine management. The primary outcome is the mean C-Ped-PROMIS T-scores of patients in the ePROs-based group and the control group. The secondary outcomes are the trajectories of C-Ped-PROMIS T-scores and HRQOL scores, and changing relationship between them. Data were collected at 5 time points: at enrollment ("baseline") and at the time of follow-up visits scheduled at 1, 3, 6, and 12 months.
The findings are expected to conclude that the symptom management based on ePROs for children with JIA can improve the symptom of JIA, and it is a feasible and effective way to monitor and intervene children with JIA.
http://www.chictr.org.cn/showproj.aspx?proj=132769; (ChiCTR2100050503).
幼年特发性关节炎（JIA）是一种常见的慢性风湿性疾病，目前尚无治愈方法，影响发病年龄在16岁以下的儿童。患者报告结局（PRO）指标是评估JIA及其相关治疗影响的重要依据，然而，这在儿科环境中是一项特殊挑战。目前，尚无随机对照研究调查电子PRO症状管理对JIA患儿的效果和可用性。
本纵向、随机、对照试验将在上海交通大学医学院附属上海儿童医学中心的门诊和儿科病房进行。根据国际风湿病联盟（ILAR）标准诊断的100例JIA患儿被随机分为两组，分别接受基于电子PRO的个性化症状管理或常规管理。主要结局是基于电子PRO的组和对照组患者的平均C-Ped-PROMIS T评分。次要结局是C-Ped-PROMIS T评分和健康相关生活质量（HRQOL）评分的轨迹，以及它们之间的变化关系。在5个时间点收集数据：入组时（“基线”）以及在1、3、6和12个月安排的随访时。
预期研究结果将得出结论，基于电子PRO的JIA患儿症状管理可改善JIA症状，是监测和干预JIA患儿的一种可行且有效的方法。
http://www.chictr.org.cn/showproj.aspx?proj=132769; (ChiCTR2100050503)
