A randomized controlled study of adenotonsillectomy for children

University Of Pennsylvania, Philadelphia PA

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): [unreadable] [unreadable] This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Medical Center to serve as the Data Coordinating Center (DCC) for the study titled A Randomized Controlled Study for Childhood Sleep Apnea. The proposed DCC will provide administrative, biostatistical, data management and research computing leadership for this randomized multicenter clinical trial. The proposed DCC is uniquely positioned with experience-based scientific, technical and administrative leadership to coordinate and provide statistical leadership for this study. The DCC currently coordinates a study entitled Functional Outcomes of CPAP Compared to Placebo for OSA, an NIH-funded study in adults with obstructive sleep apnea, and is experienced in developing programs and systems to collect and manage the specialized data required for sleep studies, such as those resulting from polysomnography. To support this multicenter RCT, the DCC will provide the technical expertise necessary to design and implement data collection, quality assurance (QA), and reporting via a secure World Wide Web (www)-based data management system (DMS), deployed at the clinical sites on existing hardware, to facilitate data entry, verification, validation and query resolution, and data transmission over the Internet to servers at the DCC. This DMS will support subject screening and enrollment, randomization and data collection at the clinical sites, and tracking of subjects and data at the DCC. The DCC will execute procedures for data security and access, QA, storage, back-up, disaster recovery, and will provide periodic monitoring and QA reports. The DCC will provide the scientific design and analysis, logistical and administrative support by organizing meetings of Steering Committees, assisting with the development and distribution of the RCT Protocol and Manual of Operations, and providing the NHLBI Program Office, Steering Committees, and the Data and Safety Monitoring Board (DSMB) with interim data summaries, interim and final statistical analyses, and collaboration on all scientific publications. [unreadable] [unreadable] [unreadable]