Inter-disciplinary Program for Training and Mentoring in CER Methods and Practice

CER 方法和实践培训和指导跨学科计划

• 批准号: 8053130
• 负责人: AMY P. ABERNETHY
• 金额: $ 243.39万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-28 至 2013-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8053130
• 关键词: Advisory Committees; Area; Bioinformatics; Biometry; Cardiology; Clinical; Clinical Research; Commit; Communication; Complex; Development; Discipline; Disease; Doctor of Philosophy; Education; Educational Curriculum; Enrollment; Faculty; Fostering; Future; Goals; Grant; Growth; Healthcare; Institutes; Language; Leadership; Learning; Malignant Neoplasms; Manuscripts; Mediation; Medical; Mentors; Methodology; Methods; Outcome; Patients; Public Speaking; Recruitment Activity; Research; Research Activity; Research Infrastructure; Research Methodology; Research Personnel; Research Project Grants; Research Training; Resources; Risk; Science; Structure; Training; Training Programs; Writing; career; career development; clinical practice; cohort; comparative effectiveness; cost effective; design; effectiveness research; experience; insight; meetings; next generation; novel therapeutics; programs; skills

DESCRIPTION (provided by applicant): Because Comparative Effectiveness Research (CER) relies on broad assessments of complex healthcare issues, appropriate methods and applications are paramount. The ability to obtain, evaluate, interpret, and effectively disseminate evidence must necessarily integrate understanding of the medical problems under study with appropriate analytic strategies. To meet these challenges, CER training requires an approach that includes investigators and mentors who speak the various methodological and clinical languages of CER, building from a common experience. Hence, we propose an interdisciplinary CER KM1 training program, focused on Biostatistics, Cancer, and Cardiology that matches mentors from diverse CER methodological backgrounds with mentees committed to a career in CER. A leadership team of experienced Duke CE researchers will organize, catalyze and perpetuate this effort. This application proposes a "team science" approach, emphasizing statistical methodology, medical insight, and cross-discipline communication. We have created a methods hub in the Department of Biostatistics and Bioinformatics (B&B), with close ties to two major disease areas: cancer and cardiology. Didactic training in both existing and developing curricula will be available to Scholars, who will also gain experience in two dynamic high-volume clinical areas that each are substantially impacted by CER activities. The KM1 program is structured so that each Scholar will benefit from the following: " Mentoring team: An individualized mentoring team that will include at least two senior leaders: a clinician researcher with expertise in CER and a PhD methodologist (typically, a biostatistician) with expertise that matches the proposed research program. " Education: Formal didactic training in CER or targeted coursework, with several options, including coursework in the Duke Clinical Research Training Program (CRTP) and Duke Masters in Biostatistics. "Research experience: A primary research project and up to one secondary project, approved by the mentor, the PIs, and an internal advisory committee, to be completed within the timeframe. Projects will be designed to achieve academic recognition as well as have meaningful impact on healthcare. "Academic career development: Enrollment in Duke's new CTSA-supported faculty career skills program for K-awardees, incorporating grantsmanship, public speaking, manuscript writing, negotiating, navigating the institutional research landscape, and keys to successful mentoring. We anticipate that each scholar will devote 50% effort to the KM1 for a period of two years in order to achieve maximum benefit from the research and didactic experiences, as well as recently established resources available to trainees at Duke. Four scholars will be recruited in the first year of the program and six in the second. By the end of the third year of the program, ten Duke CER KM1 Scholars will have completed a research project, prepared accompanying manuscripts, and developed an independent grant. Further, our Scholars will be part of a larger team of investigators and institutional leaders, readying them for a productive, collaborative career. Our immediate objectives are to recruit the initial classes of Scholars, focusing first on biostatistics, cancer and cardiology, and to provide them with a top-flight educational experience in CER. As our capacity and capabilities expand, we look forward to adding new therapeutic areas to the portfolio of Scholars. In addition to a variety of ongoing research projects available to scholars, new courses focusing on CER are being developed in the B&B Department and new training modules have been instituted in the Duke CTSA. Duke's resources, mentors, and commitment to CER will give our CER KM1 Scholars a truly outstanding opportunity for a rich learning experience and long-term career path. At an institutional level, our long-term objective is to foster the training and growth of the next generation of the nation's leading clinical and outcomes researchers. At a programmatic level, our long-term objective is to use the KM1 program to help expand and more explicitly coordinate our efforts in mentoring and faculty development as they pertain to CER. We now have the infrastructure, the ability, and the desire to refine our training programs to support a unique cohort of Scholars who will become the future leaders in CER that will make a difference in healthcare. PUBLIC HEALTH RELEVANCE: There are many steps between initial evidence that some therapy might be effective in treating a certain disease and the final assessment of how effective it actually is, which patients are likely to benefit from it, whether the benefits outweigh the risks, and whether it can be implemented into clinical practice in a cost- effective manner. All of these steps require researchers who understand the underlying issues, can frame the appropriate questions, and know the right methods for obtaining answers. The goal of this training grant is to expand the number of researchers who have this type of expertise.

描述（由申请人提供）：由于比较有效性研究（CER）依赖于对复杂医疗保健问题的广泛评估，因此适当的方法和应用至关重要。获得、评估、解释和有效传播证据的能力必须将对研究中的医学问题的理解与适当的分析策略结合起来。为了应对这些挑战，CER培训需要一种方法，其中包括研究者和导师，他们会说CER的各种方法和临床语言，并根据共同的经验建立。因此，我们提出了一个跨学科的CER KM 1培训计划，重点是生物统计学，癌症和心脏病学，将来自不同CER方法背景的导师与致力于CER职业生涯的学员相匹配。一个由经验丰富的杜克CE研究人员组成的领导团队将组织、促进和延续这一努力。这个应用程序提出了一个“团队科学”的方法，强调统计方法，医学洞察力和跨学科的沟通。我们在生物统计学和生物信息学系（B&B）创建了一个方法中心，与两个主要疾病领域密切相关：癌症和心脏病。现有和正在开发的课程的教学培训将提供给学者，他们还将获得两个动态的高容量临床领域的经验，每个领域都受到CER活动的重大影响。KM1计划的结构使每个学者都能从以下方面受益：“指导团队：一个个性化的指导团队，至少包括两名高级领导人：一名具有CER专业知识的临床研究员和一名具有与拟议研究计划相匹配的专业知识的博士方法学家（通常是生物统计学家）。“教育：CER或目标课程的正式教学培训，有几个选项，包括杜克临床研究培训计划（CRTP）和杜克生物统计学硕士课程。“研究经验：一个主要研究项目和一个次要项目，由导师，PI和内部咨询委员会批准，在时间范围内完成。项目将被设计为实现学术认可，以及对医疗保健有意义的影响。“学术职业发展：在杜克的新的CTSA支持的教师职业技能计划K获奖者注册，纳入granitarian，公开演讲，手稿写作，谈判，导航机构的研究景观，并成功的指导关键。我们预计，每个学者将投入50%的精力在KM 1为期两年，以实现从研究和教学经验，以及最近建立的资源提供给学员在杜克的最大利益。该计划第一年将招募四名学者，第二年将招募六名学者。到该计划的第三年年底，十个杜克CER KM 1学者将完成一个研究项目，准备随附的手稿，并制定了独立的补助金。此外，我们的学者将成为一个更大的调查人员和机构领导人团队的一部分，为他们的富有成效的合作职业做好准备。我们的近期目标是招募首批学者，首先关注生物统计学，癌症和心脏病学，并为他们提供CER的顶级教育经验。随着我们的能力和能力的扩大，我们期待着增加新的治疗领域的学者组合。除了各种正在进行的研究项目提供给学者，新的课程集中在CER正在开发中的B&B部门和新的培训模块已在杜克CTSA设立。杜克的资源、导师和对CER的承诺将为我们的CER KM 1学者提供真正出色的机会，让他们获得丰富的学习经验和长期的职业道路。在机构层面，我们的长期目标是促进下一代国家领先的临床和成果研究人员的培训和成长。在计划层面上，我们的长期目标是利用KM 1计划来帮助扩大和更明确地协调我们在指导和教师发展方面的努力，因为它们与CER有关。我们现在有基础设施，有能力和愿望来完善我们的培训计划，以支持一批独特的学者，他们将成为CER的未来领导者，这将在医疗保健方面发挥作用。 公共卫生关系：从最初的证据表明某些疗法可能有效治疗某种疾病到最终评估其实际有效性，哪些患者可能从中受益，收益是否超过风险，以及是否可以以成本效益的方式实施到临床实践中，有许多步骤。所有这些步骤都需要研究人员了解潜在的问题，可以提出适当的问题，并知道获得答案的正确方法。这项培训补助金的目标是扩大拥有此类专业知识的研究人员的数量。

项目成果

Increasing Rates of Imaging in Failed Back Surgery Syndrome Patients: Implications for Spinal Cord Stimulation.

背部手术失败综合征患者成像率的提高：对脊髓刺激的影响。

• 发表时间: 2017
• 期刊: Pain physician
• 影响因子: 3.7
• 作者: Farber,SHarrison;Han,JingL;PetragliaIii,FrankW;Gramer,Robert;Yang,Siyun;Pagadala,Promila;Parente,Beth;Xie,Jichun;Petrella,JeffreyR;Lad,ShivanandP
• 通讯作者: Lad,ShivanandP

Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome.

背部手术失败综合征患者脊髓刺激的长期成本效用。

• 发表时间: 2017
• 期刊: Pain physician
• 影响因子: 3.7
• 作者: Farber,SHarrison;Han,JingL;Elsamadicy,AladineA;Hussaini,Qasim;Yang,Siyun;Pagadala,Promila;Parente,Beth;Xie,Jichun;Lad,ShivanandP
• 通讯作者: Lad,ShivanandP

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation.

• DOI: 10.1111/ner.12370
• 发表时间: 2016-01
• 期刊: Neuromodulation : journal of the International Neuromodulation Society
• 作者: Petraglia FW 3rd;Farber SH;Gramer R;Verla T;Wang F;Thomas S;Parente B;Lad SP
• 通讯作者: Lad SP

Persistence with secondary prevention medications after acute myocardial infarction: Insights from the TRANSLATE-ACS study.

• DOI: 10.1016/j.ahj.2015.03.019
• 发表时间: 2015-07
• 期刊: American heart journal
• 影响因子: 4.8
• 作者: Mathews R;Wang TY;Honeycutt E;Henry TD;Zettler M;Chang M;Fonarow GC;Peterson ED;TRANSLATE-ACS Study Investigators
• 通讯作者: TRANSLATE-ACS Study Investigators

Comparison of Bilateral vs. Staged Unilateral Deep Brain Stimulation (DBS) in Parkinson's Disease in Patients Under 70 Years of Age.

• DOI: 10.1111/ner.12351
• 发表时间: 2016-01
• 期刊: Neuromodulation : journal of the International Neuromodulation Society
• 作者: Petraglia FW 3rd;Farber SH;Han JL;Verla T;Gallis J;Lokhnygina Y;Parente B;Hickey P;Turner DA;Lad SP
• 通讯作者: Lad SP