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UAE FIBROID Registry Introduction This report describes the progress of the registry over the first six months of data collection. It provides an overview of site status, enrollment, and data quality efforts regarding the registry. Site Status and Enrollment Enrollment began with two sites that enrolled patients in December 2000 and January 2001. In March 2001, the Duke Clinical Research Institute (DCRI) released the web-based data entry interface and the majority of sites began Internal Review Board (IRB) application and approval activity. By the end of May, 17 core sites had obtained IRB approval, and the DCRI had activated all 17. By the end of June, 15 of these sites had begun to submit data. As of August 31, 24 of 25 expected core sites were approved to enroll patients and submit data to the registry. Of these sites, 21 submitted data to the registry. As of September 30, 2001, all 25 core sites were approved for participation in the registry. In addition, as of September 30 the DCRI had initiated three sites at the participating site level. Since site initiation and case submission began in March, procedure submission and enrollment have made steady progress as anticipated. As of the August 31, 2001 case submission cutoff for this reporting period, 20 core sites submitted 665 procedures to the registry overall procedure volume. Of these, sites enrolled 95% (629) of cases into the registry. As of September 30, the overall case volume from all sites contributing data had reached 789 procedures with a total enrollment of 746. The graph below highlights case submission progress through August 2001. The bars represent the number of enrolled cases submitted per month with the number of enrolled cases submitted shown in the bar. The number on the top of each bar represents the number of sites submitting for the given month.
Data Quality During the first six months of the data submissions to the registry since March 2001, CIRREF and DCRI made data quality a primary focus in site initiation calls and in communication with sites via the monthly newsletter. Data quality efforts through July and August substantially improved the completeness of data in most of the required fields. CIRREF and the DCRI continually monitor the registry’s data quality in an effort to produce the most complete and accurate data set possible. Results Aggregate results will be provided to core and participating sites semi-annually during the first year of the registry and quarterly in subsequent years. Results from the registry will be presented at scientific meeting and submitted for publication in peer-reviewed journals consistent with the data access and publication policy. Please visit this site for updated progress reports and publication announcements.
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