Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III)

描述(由申请人提供)： 乔治·华盛顿大学生物统计中心将作为数据协调中心(DCC)参加“前瞻性调查肺栓塞诊断肺III(PIOPED III)”，该中心将评估磁共振血管成像(MRA)的诊断有效性。这项建议是由研究主席、医学博士保罗·斯坦和7名临床研究人员提交的申请。DCC首席研究员Sarah Fowler博士专门从事多中心研究的设计、实施和协调，并在涉及成像的研究方面拥有丰富的经验。她将与协作小组密切合作，确保及时进行研究，协调和跟踪图像读数，监督数据质量保证，维护研究数据中央数据库，并与其他调查人员合作，进行统计分析和发布研究结果。 调查人员的工作委员会将对图像进行阅读和解释，这样调查人员就不会从自己的中心审查图像，并将对每一张图像进行两次独立阅读(如有必要，可进行裁决)。DCC将负责设计和实施该研究的图像传输系统。疾病控制中心将提供一个基于网络的图像跟踪系统，通过该系统，疾病控制中心和图像阅读器将跟踪从始发临床中心通过疾病控制中心，到盲目的“中央”阅读器，再返回到疾病控制中心存档的图像交换过程。中央阅读器将对患者的临床评估和所有成像研究的结果视而不见，除了他们阅读的那一项。 这项研究将在最广泛的疑似PE患者群体中评估MRA。已经建立了阅读协议和裁决标准以及质量控制程序。

DESCRIPTION (provided by applicant): The Biostatistics Center of George Washington University will participate as the Data Coordinating Center (DCC) for the "Prospective Investigation Pulmonary Embolism Diagnosis Pulmonary III (PIOPED III)", which will assess the diagnostic validity of magnetic resonance angiography (MRA). This proposal is a companion application to that submitted by Paul Stein, MD, study chair, and 7 clinical investigators. The DCC Principal Investigator, Sarah Fowler, PhD, specializes in the design, conduct and coordination of multi-center studies, and has extensive experience in studies involving imaging. She will work closely with the collaborative group to assure the timely conduct of the study, coordinate and track the image reading, oversee data quality assurance, maintain a central database of study data, and collaborate with the other investigators on the statistical analysis and publication of study results. Working committees of the investigators will conduct reading and interpretation of images so that no investigator reviews images from his own center, and two independent readings (with adjudication if necessary) will be done for each image. The DCC will be responsible for designing and implementing the study's image transfer system. The DCC will provide a web-based image tracking system through which the DCC and image readers will track the exchange of images from the originating clinical center, through the DCC, to the blinded "central" readers, and back to the DCC for archiving. Central readers will be blind to the patient's clinical assessment, and the results of all imaging studies except the one for their reading. The study will evaluate MRA in the broadest possible group of patients with suspected PE. Reading agreement and adjudication criteria and quality control procedures have been established.