机构：[1]Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China.[2]Department of Rheumatology, the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.中山大学附属第六医院[3]Department of Rheumatology and Immunology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.[4]Department of Rheumatology and Immunology, the Second Xiangya Hospital of Central South University, Changsha, Hunan, China.[5]Department of Rheumatology and Immunology, Xuanwu Hospital Capital Medical University, Beijing, China.首都医科大学宣武医院[6]Department of Rheumatology and Immunology, Linyi People's Hospital, Linyi, Shandong, China.[7]Department of Rheumatology and Immunology, Peking University International Hospital, Zhongguancun Life Science Park, Beijing, China.[8]Department of Rheumatology and Immunology, Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China.江苏省人民医院[9]Department of Rheumatology and Immunology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.江苏省人民医院[10]Department of Rheumatology and Immunology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China.[11]Department of Rheumatology and Immunology, Mianyang Central Hospital, Mianyang, Sichuan, China.[12]Department of Rheumatology and Immunology, the First People's Hospital of Yunnan Province, Kunming, Yunnan, China.内科片风湿免疫科云南省第一人民医院[13]Department of Rheumatology and Immunology, the First Affiliated Hospital of USTC, Hefei, Anhui, China.[14]Department of Rheumatology and Immunology, Tianjin First Central Hospital, Tianjin, China.[15]Department of Rheumatology and Immunology, Tianjin Medical University General Hospital, Tianjin, China.[16]Department of Rheumatology and Immunology, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China.[17]Department of Rheumatology and Immunology, Bethune International Peace Hospital, Shijiazhuang, Hebei, China.[18]Department of Rheumatology and Immunology, the First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China.内蒙古科技大学包头医学院[19]Department of Rheumatology and Immunology, Hebei General Hospital, Shijiazhuang, Hebei, China.[20]Department of Rheumatology and Immunology, Tungwah Hospital of Sun Yat-sen University, Dongguan, Guangdong, China.[21]Department of Rheumatology and Immunology, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.[22]Department of Rheumatology and Immunology, Xijing Hospital, Xi'an, Shanxi, China.[23]School of Statistics and Mathematics, Nanjing Audit university, Nanjing, Jiangsu, China.[24]Shanghai Gothic Internet Technology Co, Shanghai, China.[25]Department of Rheumatology and Immunology, Peking University Third Hospital, Beijing, China.[26]State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Peking University, Beijing, China.[27]Peking-Tsinghua Center for Life Sciences, Peking University, Beijing, China.
Digital health applications have been shown to be effective in the management of chronic diseases with simple treatment targets. The potential clinical value of digital health applications in rheumatoid arthritis (RA) has not been well studied.To investigate whether assessing patient-reported outcomes using digital health applications could result in disease control for patients with RA.This is a multicenter, open-label randomized clinical trial in 22 tertiary hospitals across China. Eligible participants were adult patients with RA. Participants were enrolled from November 1, 2018, to May 28, 2019, with a 12-month follow-up. The statisticians and rheumatologists who assessed disease activity were blinded. Investigators and participants were not blind to group assignment. Analysis was conducted from October 2020 to May 2022.Participants were randomly assigned at a 1:1 ratio (block size of 4) to a smart system of disease management group (SSDM) or a conventional care control group. Upon the completion of the 6-month parallel comparison, patients in the conventional care control group were instructed to use the SSDM application for an extension of 6 months.The primary outcome was the rate of patients with disease activity score in 28 joints using the C-reactive protein (DAS28-CRP) of 3.2 or less at month 6.Of 3374 participants screened, 2204 were randomized, and 2197 patients with RA (mean [SD] age, 50.5 [12.4] years; 1812 [82.5%] female) were enrolled. The study included 1099 participants in the SSDM group and 1098 participants in the control group. At month 6, the rate of patients with DAS28-CRP of 3.2 or less was 71.0% (780 of 1099 patients) in the SSDM group vs 64.5% (708 of 1098 patients) in the control group (difference between groups, 6.6%; 95% CI, 2.7% to 10.4%; P = .001). At month 12, the rate of patients with DAS28-CRP of 3.2 or less in the control group increased to a level (77.7%) that was comparable with that (78,2%) in the SSDM group (difference between groups, -0.2%; 95% CI, -3.9% to 3.4%; P = .90).In this randomized clinical trial of RA, the use of a digital health application with patient-reported outcomes was associated with an increase in disease control rate.ClinicalTrials.gov Identifier: NCT03715595.
第一作者机构：[1]Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China.
通讯作者：
通讯机构：[1]Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China.[25]Department of Rheumatology and Immunology, Peking University Third Hospital, Beijing, China.[26]State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Peking University, Beijing, China.[27]Peking-Tsinghua Center for Life Sciences, Peking University, Beijing, China.[*1]Peking University People’s Hospital, 11 Xizhimen South St, Beijing, China[*2]Peking University Third Hospital, 49 N Garden Rd, Beijing, China
推荐引用方式(GB/T 7714)：
Li Chun,Huang Jianlin,Wu Huaxiang,et al.Management of Rheumatoid Arthritis With a Digital Health Application: A Multicenter, Pragmatic Randomized Clinical Trial[J].JAMA NETWORK OPEN.2023,6(4):e238343.doi:10.1001/jamanetworkopen.2023.8343.
APA：
Li Chun,Huang Jianlin,Wu Huaxiang,Li Fen,Zhao Yi...&Li Zhanguo.(2023).Management of Rheumatoid Arthritis With a Digital Health Application: A Multicenter, Pragmatic Randomized Clinical Trial.JAMA NETWORK OPEN,6,(4)
MLA：
Li Chun,et al."Management of Rheumatoid Arthritis With a Digital Health Application: A Multicenter, Pragmatic Randomized Clinical Trial".JAMA NETWORK OPEN 6..4(2023):e238343
医学