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The development and initial validation of IgG4-related disease damage index: a consensus report from Chinese IgG4-RD Consortium

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单位： [1]Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), State Key Laboratory of Complex Severe and Rare Diseases, The Ministry of Education Key Laboratory, Beijing, China [2]Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China [3]Department of Rheumatology and Immunology, Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, China [4]Medical Research Center, State Key laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [5]Department of Epidemiology and Bio-statistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & School of Basic Medicine, Peking Union Medical College, Beijing, China [6]Department of Rheumatology, General Hospital of Ningxia Medical University, Yinchuan, China [7]Department of Rheumatology, Beijing Hospital, Beijing, China [8]Department of Rheumatology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China [9]Department of Rheumatology and Immunology, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen People’s Hospital, Shenzhen, Guangdong, China [10]Department of Rheumatology and Immunology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China [11]Department of Rheumatology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China [12]Department of Rheumatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China [13]Department of Rheumatology and Immunology, The First Affiliated Hospital of China Medical University, Shenyang, China [14]Department of Rheumatology, the Second Affiliated Hospital of Dalian Medical University, Dalian, China [15]Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai, China [16]Department of Rheumatology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China [17]Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China [18]Department of Rheumatology, The First Hospital of Jilin University, Changchun, China [19]Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China [20]Department of Pathology and Shenzhen Institute of Research and Innovation, The University of Hong Kong, Hong Kong, China

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To develop and conduct an initial validation of the Damage Index for IgG4-related disease (IgG4-RD DI).A draft of index items for assessing organ damages in patients with IgG4-RD was generated by experts from the Chinese IgG4-RD Consortium (CIC). The preliminary DI was refined using the Delphi method, and a final version was generated by consensus. 40 IgG4-RD cases representing four types of clinical scenarios were then selected, each with two time points of assessment for at least 3 years of follow-up. 48 rheumatologists from 35 hospitals nationwide were invited to evaluate organ damage using the CIC IgG4-RD DI. The intraclass correlation coefficient (ICC) and the Kendall-W coefficient of concordance (KW) were used to assess the inter-rater reliability. The criterion validity of IgG4-RD DI was tested by calculating the sensitivity and specificity of raters.IgG4-RD DI is a cumulative index consisting of 14 domains of organ systems, including a total of 39 items. The IgG4-RD DI was capable of distinguishing stable and increased damage across the active disease subgroup and stable disease subgroup. In terms of scores at baseline and later observations by all raters, overall consistency in scores at baseline and later observations by all raters was satisfactory. ICC at the two time points was 0.69 and 0.70, and the KW was 0.74 and 0.73, respectively. In subgroup analysis, ICC and KW in all subgroups were over 0.55 and 0.61, respectively. The analysis of criterion validity showed a good performance with a sensitivity of 0.86 (95% CI 0.82 to 0.88), a specificity of 0.79 (95% CI 0.76 to 0.82) and an area under the curve of 0.88 (95% CI 0.85 to 0.91).The IgG4-RD DI is a useful approach to analyse disease outcomes, and it has good operability and credibility. It is anticipated that the DI will become a useful tool for therapeutic trials and studies of prognosis in patients with IgG4-RD.© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.

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出版当年[2023]版：

大类 | 2 区医学

小类 | 2 区风湿病学

最新[2025]版：

大类 | 2 区

医学

小类 | 2 区风湿病学

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出版当年[2022]版：

Q1 RHEUMATOLOGY

最新[2023]版：

Q1 RHEUMATOLOGY

影响因子： 5.1 最新[2023版] 5 最新五年平均 6.2 出版当年[2022版] 5.7 出版当年五年平均 5.806 出版前一年[2021版] 5.1 出版后一年[2023版]

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第一作者单位： [1]Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), State Key Laboratory of Complex Severe and Rare Diseases, The Ministry of Education Key Laboratory, Beijing, China

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