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（Boston Network for contemporary rehabilitation outcomes measurement，简称Boston CRO Network）是由波士顿大学、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，它将极大地提高医学康复研究人员理解结果测量、开发和完善关键康复结果测量的能力，并改善其在康复医学临床试验和相关研究中的应用。鉴于付款人、政策制定者、临床医生和消费者需要证据来支持康复干预措施的有效性，这一主题尤为重要。鉴于最近在患者报告结果方面的进展，基于绩效的结果测量的创新和仪器结果测量使得克服传统结果测量的许多局限性成为可能，因此其形成的时机是理想的。临床试验结果测量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资源、培训和技术支持，以改进康复临床试验中CRO的选择和使用，协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。

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.