Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III)

描述（由申请人提供）： 乔治华盛顿大学的生物统计中心将作为“前瞻性研究肺栓塞诊断肺III（PIOPED III）"的数据协调中心（DCC）参与，该研究将评估磁共振血管造影（MRA）的诊断有效性。本提案是研究主席Paul Stein（医学博士）和7名临床研究者提交的申请的伴随申请。 DCC主要研究者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。她将与合作小组密切合作，以确保及时开展研究，协调和跟踪图像阅读，监督数据质量保证，维护研究数据的中央数据库，并与其他研究者合作进行统计分析和研究结果的发表。 研究者工作委员会将对图像进行阅读和解释，以避免研究者审查来自其所在中心的图像，并对每张图像进行两次独立阅读（必要时进行裁定）。 DCC将负责设计和实施研究的图像传输系统。DCC将提供一个基于网络的图像跟踪系统，通过该系统，DCC和图像阅片人将跟踪从原始临床中心、通过DCC、到设盲的“中心”阅片人、再返回到DCC进行存档的图像交换。中心阅片员将对患者的临床评估和所有影像学检查结果（阅读除外）设盲。 本研究将在最广泛的疑似PE患者组中评价MRA。已经建立了阅读协议和裁定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.