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风湿病学研究中的可重复性和严谨性。

Reproducibility and rigor in rheumatology research.

作者信息

Alnaimat Fatima, Sweis Nadia J, Sweis Jaleel Jerry G, Ascoli Christian, Korsten Peter, Rubinstein Israel, Sweiss Nadera J

机构信息

Division of Rheumatology, Department of Medicine, The University of Jordan, Amman, Jordan.

Department of Business Administration, King Talal School of Business Technology, Princess Sumaya University for Technology, Amman, Jordan.

出版信息

Front Med (Lausanne). 2023 Jan 6;9:1073551. doi: 10.3389/fmed.2022.1073551. eCollection 2022.

DOI:10.3389/fmed.2022.1073551
PMID:36687429
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9853178/
Abstract

The pillars of scientific progress in rheumatology are experimentation and observation, followed by the publication of reliable and credible results. These data must then be independently verified, validated, and replicated. Peer and journal-specific technical and statistical reviews are paramount to improving rigor and reproducibility. In addition, research integrity, ethics, and responsible conduct training can help to reduce research misconduct and improve scientific evidence. As the number of published articles in rheumatology grows, the field has become critical for determining reproducibility. Prospective, longitudinal, randomized controlled clinical trials are the gold standard for evaluating clinical intervention efficacy and safety in this space. However, their applicability to larger, more representative patient populations with rheumatological disorders worldwide could be limited due to time, technical, and cost constraints involved with large-scale clinical trials. Accordingly, analysis of real-world, patient-centered clinical data retrieved from established healthcare inventories, such as electronic health records, medical billing reports, and disease registries, are increasingly used to report patient outcomes. Unfortunately, it is unknown whether this clinical research paradigm in rheumatology could be deployed in medically underserved regions.

摘要

风湿病学科学进步的支柱是实验和观察,随后是发表可靠且可信的结果。这些数据必须经过独立验证、确认和复制。同行以及特定期刊的技术和统计评审对于提高严谨性和可重复性至关重要。此外,研究诚信、伦理和负责任行为培训有助于减少研究不当行为并改善科学证据。随着风湿病学领域发表文章数量的增加,该领域对于确定可重复性变得至关重要。前瞻性、纵向、随机对照临床试验是评估该领域临床干预疗效和安全性的金标准。然而,由于大规模临床试验涉及的时间、技术和成本限制,它们在全球范围内更具代表性的风湿病患者群体中的适用性可能有限。因此,从既定医疗保健库存(如电子健康记录、医疗账单报告和疾病登记处)中检索的以患者为中心的真实世界临床数据分析越来越多地用于报告患者结局。不幸的是,尚不清楚这种风湿病学临床研究范式是否可以在医疗服务不足的地区应用。

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Clin Rheumatol. 2022 Jul;41(7):2241-2248. doi: 10.1007/s10067-022-06198-9. Epub 2022 May 6.
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Using real-world data to dynamically predict flares during tapering of biological DMARDs in rheumatoid arthritis: development, validation, and potential impact of prediction-aided decisions.利用真实世界数据动态预测类风湿关节炎生物 DMARDs 减量过程中的 flares:预测辅助决策的开发、验证和潜在影响。
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The Rigor and Transparency Index Quality Metric for Assessing Biological and Medical Science Methods.用于评估生物医学科学方法的严谨性与透明度指数质量指标
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How do we use biologics in rheumatoid arthritis patients with a history of malignancy? An assessment of treatment patterns using Scandinavian registers.我们如何在有恶性肿瘤病史的类风湿性关节炎患者中使用生物制剂?使用斯堪的纳维亚登记册对治疗模式进行评估。
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Risk of neuroinflammatory events in arthritis patients treated with tumour necrosis factor alpha inhibitors: a collaborative population-based cohort study from Denmark and Sweden.丹麦和瑞典基于人群的合作队列研究:肿瘤坏死因子-α抑制剂治疗关节炎患者的神经炎症事件风险。
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BMC Med Ethics. 2019 Oct 16;20(1):72. doi: 10.1186/s12910-019-0410-x.
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