Improving Metformin Utilization And Diabetes Control Through Patient-Centered Outcomes Research

 描述（由申请人提供）：这是James Flory博士的K 08初始申请，他是一名内分泌学家和年轻的研究者，从事以患者为导向的2型糖尿病（T2 DM）护理的比较有效性研究。K 08奖将为他提供在三个关键职业发展领域获得技能的手段：1）临床流行病学，2）定性研究，3）临床试验设计。通过获得这些技能，Flory博士将实现成为独立临床研究者的长期职业目标。Flory博士有一位主要导师Alvin Mushlin博士，他是一位领先的流行病学家和内科医生，拥有丰富的指导K-格兰特获奖者的经验。他还将与一位共同导师Sean Hennessy博士合作，Sean Hennessy博士是一位领先的药物流行病学家。此外，弗洛里博士还有两位关键合作者：约书亚理查森博士，他是将定性研究应用于生物医学信息学的专家，以及大卫布里隆博士，他是专门研究糖尿病的内分泌学家和临床研究人员。该建议的临床问题是，尽管二甲双胍是T2 DM的一线药物治疗，并具有无与伦比的长期临床获益，但其利用率不足。特别是，16%的患者在6个月时停用二甲双胍，接近三分之一的患者在1年时停用二甲双胍。弗洛里博士的中心假设是，这种非持久性（即，早期停药）是由于二甲双胍特有的以患者为中心的因素，更好的处方实践和处方者与患者的沟通可以提高二甲双胍的持久性。为了验证这一假设并将其转化为实用的干预措施，Flory博士建议收集关于二甲双胍非持久性的流行病学和定性数据，然后在小型实用临床试验中设计和试点干预措施。这些活动将为K 08奖励期间R 01申请中提出的大规模实用随机试验奠定基础。目的1将检验二甲双胍非持续性很常见并导致短期临床结局明显恶化的假设。目的2将检验以下假设：非持续性患者及其提供者将为二甲双胍非持续性提供潜在可修改的原因。目的3将检验以下假设：一项以患者为中心的干预措施的实用临床试验，将二甲双胍重新引入既往非持续性患者是可行的，并且可能导致二甲双胍治疗T2 DM的适当使用增加。这项研究是重要的，因为积极的结果将导致确定一种干预措施，使更多的患者受益于二甲双胍。阴性结果将提供关于二甲双胍非持续性性质的信息，并为优化这些患者护理的替代方法奠定基础。

 DESCRIPTION (provided by applicant): This is a K08 initial application for Dr. James Flory, an endocrinologist and young investigator pursuing patient-oriented comparative effectiveness research on the care of type 2 diabetes mellitus (T2DM). A K08 award will provide him with the means to acquire skills in three key career development areas: 1) clinical epidemiology, 2) qualitative research, and 3) clinical trial design. By acquiring these skills, Dr. Flory will fulfil his long-term career goal of becoming an independent clinical investigator. Dr. Flory has a primary mentor, Dr. Alvin Mushlin, who is a leading epidemiologist and internist with extensive experience mentoring K-grant awardees. He will also work with a co-mentor, Dr. Sean Hennessy, a leading pharmacoepidemiologist. In addition, Dr. Flory has two key collaborators: Dr. Joshua Richardson, an expert in the application of qualitative research to biomedical informatics, and Dr. David Brillon, an endocrinologist and clinical researcher specializing in diabetes. The motivating clinical problem for this proposal is the fact that although metformin is the first-line drug therapy for T2DM and confers unequalled long-term clinical benefits, it is under-utilized. In particular, 16% of patients discontinue metformin at 6 months and close to a third discontinue it at one year. Dr. Flory's central hypothesis is that much of this non-persistence (i.e., early discontinuation) is due to patient-centered factors specific to metformin and that better prescribing practices and prescriber-patient communication can enhance metformin persistence. To test this hypothesis and translate it into a pragmatic intervention, Dr. Flory proposes to collect epidemiologic and qualitative data on metformin non-persistence and then design and pilot an intervention in a small pragmatic clinical trial. These activities will la the groundwork for a large-scale pragmatic randomized trial to be proposed in an R01 application during the K08 award period. Aim 1 will test the hypothesis that metformin non-persistence is common and leads to observably worse short-term clinical outcomes. Aim 2 will test the hypothesis that non-persistent patients and their providers will offer potentially modifiable reasons for metformin non-persistence. Aim 3 will test the hypothesis that a pragmatic clinical trial of a patient-centered intervention to reintroduce metformin to previously non-persistent patients is feasible and likely to result in increased appropriate use of metformin to treat T2DM. The proposed research is significant because positive results will lead to identification of an intervention to allow more patients to benefit from metformin. Negative results would provide information on the nature of metformin non-persistence and lay groundwork for alternative approaches to optimizing care of these patients.