首页|Participant Heterogeneity of Systemic Scleroderma Interventional Trials Worldwide

Participant Heterogeneity of Systemic Scleroderma Interventional Trials Worldwide

扫码查看
原文链接
  • NETL
  • NSTL
  • 万方数据
Objective:Heterogeneity of participants in clinical trials distorts intervention efficacy.However,factors associated with participant heterogeneity in randomized clinical trials(RCTs)focusing on systemic sclerosis(SSc)are not clear.We conducted this systematic review to establish normative standards for future research and help develop management guidelines.Methods:Three databases and 4 registries were searched to identify characteristics of SSc RCTs across different countries.Risk of bias was assessed by the Cochrane Collaboration's tool and logistic regression was performed to calculate crude and adjusted odds ratios.Results:In total,261 trials met our inclusion criteria.The quality of SSc RCTs worldwide was relatively poor,with no trend of improvement in recent years,and only 12.2％were ranked as having a low risk of bias.Trials with a low risk of bias as well as single-center,single-country,or open-label trials tended to have better participant adherence than trials with a high risk of bias and multiple-center,multiple-country,or double-blind trials.Interestingly,trial registration and primary outcome definition contributed to high withdrawal.National income was also relevant;participant adherence in high-income countries,but not in upper-and lower-middle-income countries,was significantly altered by different variables.Conclusion:Overall,the risk of bias,national income,and trial design may lead to participant heterogeneity of SSc RCTs and ultimately confound the general clinical utility of the results.Trials with a rigorous design and transparent conduction protocol are crucial for obtaining unbiased data that can serve as a reference and for maintaining the fundamental repeatability of SSc RCTs.

systemic sclerosisrandomized clinical trialsheterogeneityparticipant adherencenational incomerisk of bias

Li-Qing Shi、Shi-Hang Zhou、Ping-Lang Ruan、Bo Zhang、Yue Xin、Cheng Zhao、Xu Yao、Jing-Ru Tian、Qian-Jin Lu

展开 >

Hospital for Skin Diseases(Institute of Dermatology),Chinese Academy of Medical Sciences and Peking Union Medical College,Nanjing,Jiangsu 210042,China

Key Laboratory of Basic and Translational Research on Immune-Mediated Skin Diseases,Chinese Academy of Medical Sciences,Nanjing,Jiangsu 210042,China

Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and STIs,Nanjing,Jiangsu 210042,China

Department of Dermatology,Hunan Key Laboratory of Medical Epigenomics,the Second Xiangya Hospital,Central South University,Changsha,Hunan 410011,China

展开 >

Nonprofit Central Research Institute Fund of Chinese Academy of Medical SciencesNational Natural Science Foundation of China

2020-RC320-00381830097

2024

10.1097/JD9.0000000000000325

国际皮肤性病学杂志
中华医学会,中国医学科学院皮肤病研究所

国际皮肤性病学杂志

CSTPCD
影响因子：0.276
ISSN：1673-4173
年,卷(期)：2024.7(2)