Improving Outcome Measurement for Medical Rehabilitaiton Clinical Trials

描述(由申请人提供)：波士顿当代康复结果测量网络(The Boston CRO Network)是波士顿大学、哈佛医学院/斯波尔丁康复医院和塔夫茨大学的研究人员合作建立的，将极大地提高医疗康复研究人员了解结果测量、开发和完善关键康复结果测量的能力，并改进其在康复医学临床试验和相关研究中的使用。鉴于付款人、政策制定者、临床医生和消费者要求证据支持康复干预措施的有效性，这一主题尤其相关。它的形成时机是理想的，因为最近在患者报告的结果方面取得了进展，基于绩效的结果测量的创新，以及仪器化的结果测量使克服传统结果测量的许多局限性成为可能。临床试验结果指标的选择仍然是一个复杂的过程，大多数康复临床医生和研究人员缺乏培训，以确保使用适当的措施。波士顿CRO网络将为医疗康复研究人员提供获得资源、培训和技术支持的途径，以改进康复临床试验中CRO的选择和使用，以帮助提高医疗康复领域成功完成的随机对照试验的数量和质量。 波士顿CRO网络由一个研究核心、一个技术开发部门、一个培训和教学核心以及一个管理核心组成。研究核心将包括患者报告结果核心、基于绩效的测量核心、仪器结果测量核心以及先导研究和访问科学家计划。培训和传播核心将对CRO进行系统审查，建立一个基于网络的CRO仪器信息交换所；举办培训讲习班和网络广播，并广泛传播波士顿CRO网络资源、试点项目成果和培训活动。波士顿社区康复组织网络的目标是提供资源、培训和技术支持，目的是增加成功完成的康复社区康复治疗的数量和质量。 公共卫生相关性：选择结果指标来评估康复干预措施的益处是设计康复临床试验的关键一步。这是一项艰巨的任务，因为可用的不同结果衡量标准数量众多，可评估的概念或领域多种多样，而且缺乏衡量理论和方法方面的培训。波士顿CRO网络将为康复研究人员提供资源和培训，帮助他们在临床研究中选择和使用适当的CRO。

DESCRIPTION (provided by applicant): The Boston Network for contemporary rehabilitation outcome measurement (the Boston CRO Network), a collaboration among researchers from Boston University, Harvard Medical School/ Spaulding Rehabilitation Hospital, and Tufts University, would greatly enhance the capability of medical rehabilitation researchers to understand outcome measures, develop and refine measures of key rehabilitation outcomes, and improve their use in rehabilitation medicine clinical trials and related research. This theme is particularly relevant given the demand from payers, policy makers, clinicians and consumers for evidence to support the effectiveness of rehabilitation interventions. The timing of its formation is ideal, given the recent advances in patient reported outcomes, innovations in performance-based outcome measures, and instrumented outcome measures have made it possible to overcome many of the limitations of traditional outcome measures. The selection of outcome measures for clinical trials remains a complex process, and most rehabilitation clinicians and researchers lack training to ensure the appropriate measures are used. The Boston CRO Network would provide medical rehabilitation researchers with access to resources, training and technical support to improve the selection and use of CROs in rehabilitation clinical trials to assist with increasing the number and quality of successfully completed RCTs in the field of medical rehabilitation. The Boston CRO Network consists of a Research Core, a Techniques Development Section, a Training & Didactic Core, and an Administrative Core. The Research Core would include a Patient Reported Outcomes Core, a Performance-based Measures Core, and an Instrumented Outcomes Measurement Core along with Pilot Studies and Visiting Scientist Programs. The Training & Dissemination Core will conduct systematic reviews of CROs, establish a web-based CRO Instrument Clearinghouse; conduct training workshops & webcasts, and widely disseminate Boston CRO Network resources, pilot project results and training activities. The goal of the Boston CRO Network is to provide resources, training and technical support with the aim of increasing the number and quality of successfully completed rehabilitation RCTs. PUBLIC HEALTH RELEVANCE: Selecting outcome measures to assess the benefits of rehabilitation interventions is a crucial step in designing rehabilitation clinical trials. This is a daunting task due to the number of different outcome measures that are available, the variety of concepts or domains that may be assessed, and the lack of training in measurement theory and methods. The Boston CRO Network will provide rehabilitation researchers with resources and training to help them select and use appropriate CROs in clinical research.