Estimating and Communicating Risk about Biologic DMARDs for Rheumatoid Arthritis

评估和沟通生物 DMARD 治疗类风湿关节炎的风险

• 批准号: 8078912
• 负责人: Daniel Hal Solomon
• 金额: $ 15.03万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-08 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8078912
• 关键词: Admission activity; Algorithms; Antirheumatic Agents; Area; Arthritis; Biological Response Modifier Therapy; Cardiovascular system; Characteristics; Clinical Investigator; Cohort Studies; Communication; Congestive Heart Failure; Coxibs; Databases; Diclofenac; Disease; Disease-Modifying Second-Line Drugs; Drug Formulations; Drug Prescriptions; Drug usage; Education; Enrollment; Epidemiology; Evaluation; Event; Faculty; Financial Support; Goals; Hospitals; Ibuprofen; Infection; Ischemic Stroke; Medicare; Mentors; Methods; Myocardial Infarction; Naproxen; Non-Steroidal Anti-Inflammatory Agents; Oral; Osteoporosis; Patients; Perception; Pharmaceutical Preparations; Pharmacotherapy; Physicians; Publishing; Research; Research Training; Rheumatoid Arthritis; Risk; Risk Estimate; Rofecoxib; Running; Safety; Severities; Severity of illness; Subgroup; Surveys; System; Training Programs; Work; base; beneficiary; cancer risk; cardiovascular risk factor; celecoxib; cohort; drug withdrawal; hazard; health care service utilization; improved; next generation; patient oriented research; programs; risk perception; rituximab; salicylate

DESCRIPTION (provided by applicant): The specific goals of this K24 application are twofold. First, I will further develop a research training program to prepare the next generation of clinical investigators for pharmaco-epidemiologic analyses and improved communication about the safety of drugs used for arthritis and osteoporosis. Over the prior decade seven years, I have mentored 27 different trainees and junior faculty on many projects. This work has been gratifying and productive. This K24 proposal gives me the opportunity to develop a formal program of mentoring with financial support. The mentoring plan to achieve this goal includes detailed descriptions of potential trainees, a multi-faceted program of didactic and project- based education, as well as an evaluation system. Second, I will expand my current patient-oriented research program examining the safety of disease modifying anti-rheumatic drug (DMARD) therapy for rheumatoid arthritis (RA) and developing methods for better communication of potential drug risk. To achieve the second goal, I propose three aims pertaining to new research. The first aim will focus on improving the methods for studying drug safety among patients with RA when using large health care utilization databases. The methodologic issues include improving algorithms for defining RA, assessing for channeling bias among users of biologic DMARDs, and validating a method for assessing RA severity. The second aim will estimate the risk of cancer, infection and congestive heart failure (CHF) associated with biologic DMARDs compared with each other and compared with traditional DMARDs. I hypothesize that specific biologic DMARDs will be associated with increased risk of cancer, infection, and CHF. These analyses will focus on both the TNFa antagonists as well as the other emerging biologic therapies, such as abatacept and rituximab. While similar studies have been conducted in the past, they have generally included smaller cohorts of patients with RA than what we have proposed. Moreover, prior studies have not adequately dealt with the potential for channeling bias and for disease severity. The third aim proposes to survey patients and clinicians regarding their perceptions of DMARD risk and to explores how best to communicate risk. Risk communication is a poorly researched area. Recent high profile drug withdrawals underscore the need for better methods to communicate the potential risks associated with all medications and to place those risks in the proper context. I hypothesize a) that patient's perceptions of risk are associated with their use of specific biologic DMARDs and b) that physicians' perception of risk is much lower than patients'.

描述（由申请人提供）：这个K24申请的具体目标是双重的。首先，我将进一步制定一个研究培训计划，为下一代临床研究人员做好药物流行病学分析的准备，并改善有关关节炎和骨质疏松症药物安全性的交流。在过去的十年七年中，我指导了27名不同的学员和初级教师的许多项目。这项工作是令人满意和富有成效的。这个K24提案让我有机会开发一个正式的指导计划，并提供资金支持。实现这一目标的师徒计划包括对潜在受训者的详细描述，一个多方面的教学和项目教育计划，以及评估系统。其次，我将扩大我目前以患者为导向的研究项目，研究类风湿性关节炎（RA）的疾病修饰抗风湿药物（DMARD）治疗的安全性，并开发更好地沟通潜在药物风险的方法。为了实现第二个目标，我提出了与新研究相关的三个目标。第一个目标将集中在改进使用大型医疗保健利用数据库研究RA患者药物安全性的方法。方法学问题包括改进定义类风湿性关节炎的算法，评估生物dmard使用者之间的通道偏差，以及验证评估类风湿性关节炎严重程度的方法。第二个目标将评估与生物dmard相互比较以及与传统dmard比较相关的癌症、感染和充血性心力衰竭（CHF）的风险。我假设特定的生物dmard与癌症、感染和心力衰竭的风险增加有关。这些分析将集中在TNFa拮抗剂以及其他新兴的生物疗法，如阿巴接受和利妥昔单抗。虽然过去也进行过类似的研究，但它们通常包括的RA患者群体比我们提出的要小。此外，先前的研究没有充分处理潜在的通道偏倚和疾病严重程度。第三个目标是调查患者和临床医生对DMARD风险的看法，并探讨如何最好地沟通风险。风险沟通是一个研究较少的领域。最近引人注目的药物停药事件强调需要更好的方法来传达与所有药物相关的潜在风险，并将这些风险置于适当的背景下。我假设a)患者对风险的感知与他们使用特定生物dmard有关，b)医生对风险的感知远低于患者。