UPENN Scientific and Data Research Center for the HOPE Consortium to Reduce Pain and Opioid Use in HemodialysisÃÂÃÂ

项目摘要 这是临床流行病学和生物统计中心的申请，肾脏，电解质和 高血压科、神经病学系和加州大学精神病学系 宾夕法尼亚州佩雷尔曼医学院将担任科学和数据研究中心(SDRC) 血液透析阿片类药物处方努力(HOPE)联盟。通过这项HERE/NIDDK倡议， 希望联盟将合作设计和进行一项多中心临床试验，评估干预措施 解决接受治疗的个人的慢性疼痛和阿片类药物使用的挑战性问题 维持性血液透析。我们预计，希望财团调查人员将考虑行为， 辅助性和药理学干预，基于心理社会特征的个性化治疗， 最大限度提高效率的适应性设计，以及提供干预措施和获得 通过“将试验带给参与者”将患者的负担降至最低的数据。具体地说，发改委将： 1)为HOPE联盟临床项目的设计、实施和分析提供科学的领导 试验；2)为临床中心提供全面的业务支持，以协作实施 使用标准化流程和工具设计试验方案，用于培训、招募和数据管理； 3)建立和领导利益攸关方参与工作组，其中包括患者咨询小组和 透析提供商咨询小组，以确保将多个利益相关者的观点纳入 试验设计和实施方法；4)整合和分析电子健康档案的数据 参与的临床中心，以补充试验获得的数据，并能够确定 对试验干预的响应；5)建立、促进和维护整个联盟范围内的高标准 质量保证和实践；6)发起并监督与行业合作伙伴的合同，包括透析 供应商组织、制药公司和设备制造商；7)为数据准备报告 和安全监测委员会，并支持编写联合体的科学发现报告； 8)准备、记录并将联合体数据和生物样本传输到NIDDK中央储存库以供使用 更广泛的社区；以及9)制定向不同群体传播试验结果的方法 利益攸关方促进试验后采用经证实有益的干预措施。伊利诺伊大学 宾夕法尼亚州SDRC团队拥有专业知识、经验、建立的工作关系、资源和 基础设施，以实现上述每个目标，并满足RFA中规定的所有要求。

Project Summary This is an application from the Center for Clinical Epidemiology and Biostatistics and the Renal, Electrolyte and Hypertension Division, the Department of Neurology, and the Department of Psychiatry at the University of Pennsylvania Perelman School of Medicine to serve as the Scientific and Data Research Center (SDRC) for the Hemodialysis Opioid Prescription Effort (HOPE) Consortium. Through this HEAL / NIDDK initiative, the HOPE Consortium will collaboratively design and conduct a multicenter clinical trial evaluating interventions to address the challenging problems of chronic pain and opioid use in individuals receiving treatment with maintenance hemodialysis. We anticipate that the HOPE Consortium investigators will consider behavioral, complementary, and pharmacologic interventions, personalized treatments based on psychosocial profiles, adaptive designs to maximize efficiency, and approaches to the delivery of the interventions and acquisition of data that minimize burden for patients by “bringing the trial to the participant”. Specifically, the SDRC will: 1) provide scientific leadership for the design, implementation, and analysis of the HOPE Consortium clinical trial; 2) provide comprehensive operational support to the Clinical Centers for implementing the collaboratively designed trial protocol using standardized processes and tools for training, recruitment, and data management; 3) develop and lead a Stakeholder Engagement Working Group that includes a Patient Advisory Panel and a Dialysis Provider Advisory Panel to ensure that perspectives across multiple stakeholders are incorporated into the trial design and implementation approach; 4) integrate and analyze data from the electronic health records of the participating Clinical Centers to supplement trial-acquired data and enable identification of predictors of response to the trial interventions; 5) establish, promote, and maintain consortium-wide high standards for quality assurance and practices; 6) initiate and oversee contracts with industry partners including dialysis provider organizations, pharmaceutical companies, and device manufacturers; 7) prepare reports for the Data and Safety Monitoring Board, and support the preparation of Consortium reports of scientific findings; 8) prepare, document, and transfer Consortium data and biosamples to the NIDDK Central Repository for use by the broader community; and 9) develop approaches for disseminating the trial findings to diverse stakeholders to facilitate post-trial uptake of interventions found to be beneficial. The University of Pennsylvania SDRC team has the expertise, experience, established working relationships, resources, and infrastructure to accomplish each of these aims and fulfill all of the requirements specified in the RFA.