Rheumatology Service, Hospital Clinico Universitario, Santiago de Compostela, Spain.
Fundacion Ramon Dominguez, Hospital Clinico Universitario, Santiago de Compostela, Spain.
Pharmacol Res. 2019 Oct;148:104410. doi: 10.1016/j.phrs.2019.104410. Epub 2019 Aug 25.
Registries characterize the effectiveness and safety of therapeutic interventions in daily clinical practice. Data from registries enable mining the records of tens of thousands of patients towards determining the effectiveness, safety, and cost-benefit of any given therapeutic. The strengths of registries include real-life settings, greater power than clinical trials to detect rare events, and the study of multiple outcomes and several research questions. Registries also have their weaknesses. They are expensive, less accurate than clinical trials, affected by channelling bias, often require links to external sources or use historic and selected control cohorts or combine datasets to increase power, and have the risk of multiple confounders. Since the beginning of biological era, registries were developed to profile emerging treatments. This article reviews the role of registries in the treatment of rheumatoid arthritis with biologic disease-modifying anti-rheumatic drugs.
登记处描述了治疗干预措施在日常临床实践中的有效性和安全性。从登记处获取的数据可以挖掘成千上万患者的记录，以确定任何特定治疗方法的有效性、安全性和成本效益。登记处的优势包括真实环境、比临床试验更有能力检测罕见事件，以及研究多种结果和多个研究问题。登记处也有其弱点。它们很昂贵，准确性不如临床试验，受到渠道偏差的影响，通常需要与外部来源建立联系，或者使用历史和选择的对照队列，或者合并数据集以增加能力，并且存在多种混杂因素的风险。自生物时代开始以来，登记处就被开发出来以描绘新兴的治疗方法。本文回顾了登记处在生物疾病修饰抗风湿药物治疗类风湿关节炎中的作用。
