Study design for a comprehensive assessment of biologic safety using multiple healthcare data systems
Study design for a comprehensive assessment of biologic safety using multiple healthcare data systems
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DOI：
10.1002/pds.2196
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发表时间：
2011-11-01
影响因子：
2.6
通讯作者：
Saag, Kenneth G.
中科院分区：
文献类型：
--
作者：
Herrinton, Lisa J.;Curtis, Jeffrey R.;Saag, Kenneth G.
背景虽然生物治疗对许多自身免疫性疾病有很好的疗效，但安全性问题仍然存在。了解患者和疾病亚群中不良事件的绝对和相对风险对于生物制剂的最佳处方至关重要。目的生物制剂治疗安全性评估合作由联邦政府资助，使用国家医疗补助和医疗保险加医疗补助双重资格计划，田纳西州医疗补助，凯撒永久医疗保险，以及补充新泽西和宾夕法尼亚州医疗保险计划的州药物援助计划。本报告介绍了协作的组织结构和研究人口和methods.Methods这一回顾性队列研究（1998-2007年）研究的七类不良事件的风险，与生物治疗规定的七种自身免疫性疾病。倾向评分用于控制混杂因素，并在隐藏个人健康信息的同时，在数据系统中合并个人水平的数据。结果本研究共纳入风湿性疾病159000例，银屑病33000例，炎症性肠病46000例。本报告总结了人口统计学特征和药物暴露。单独的报告将提供结果的定义和估计的风险比为不良事件。结论这种全面的研究将提高这些治疗的安全性的理解。所描述的方法可能对其他计划进行类似评价的人有用。版权所有（C）2011约翰威利父子有限公司
Background Although biologic treatments have excellent efficacy for many autoimmune diseases, safety concerns persist. Understanding the absolute and comparative risks of adverse events in patient and disease subpopulations is critical for optimal prescribing of biologics.Purpose The Safety Assessment of Biologic Therapy collaborative was federally funded to provide robust estimates of rates and relative risks of adverse events among biologics users using data from national Medicaid and Medicare plus Medicaid dual-eligible programs, Tennessee Medicaid, Kaiser Permanente, and state pharmaceutical assistance programs supplementing New Jersey and Pennsylvania Medicare programs. This report describes the organizational structure of the collaborative and the study population and methods.Methods This retrospective cohort study (1998-2007) examined risks of seven classes of adverse events in relation to biologic treatments prescribed for seven autoimmune diseases. Propensity scores were used to control for confounding and enabled pooling of individual-level data across data systems while concealing personal health information. Cox proportional hazard modeling was used to analyze study hypotheses.Results The cohort was composed of 159000 subjects with rheumatic diseases, 33000 with psoriasis, and 46000 with inflammatory bowel disease. This report summarizes demographic characteristics and drug exposures. Separate reports will provide outcome definitions and estimated hazard ratios for adverse events.Conclusion This comprehensive research will improve understanding of the safety of these treatments. The methods described may be useful to others planning similar evaluations. Copyright (C) 2011 John Wiley & Sons, Ltd.