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REVEAL Registry: Best Practice Guidelines for Electronic Data Capture

Louise Durst

Prieya Wason


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Conference: 2009 PH Resource Network Symposium

Release Date: 09.24.2009

Presentation Type: Abstracts

Louise Durst, RN1; Prieya Wason, CCRP2
1. Mayo Clinic, Rochester, MN 

2. Actelion Pharmaceuticals US, Inc., South San Francisco, CA

PURPOSEThe Registry to EValuate Early And Long-term Pulmonary Arterial Hypertension (PAH) Disease Management (REVEAL) Registry is a 54-center, observational, US-based registry collecting demographic, clinical, and disease management data on 3500 WHO group I PAH patients. Consistent data entry is crucial in order to maximize the clinical information collected.

BACKGROUNDREVEAL provides important clinical information about patients with PAH. Data derived from the study may offer important tools for assessing current management practices of clinicians, as well as changes in the PAH population over time. Additionally, relationships between patient- and disease-specific parameters to patient outcomes will be assessed through analysis of this data. A description of best practice concerning documentation of patient information in the electronic data capture (EDC) system provided by MedNet Solutions, Inc. is described for one of the study sites.

METHODSEnrollment is expected to be complete in December 2009. Patient information is entered by study coordinators or designees at participating sites. Data includes New York Heart Association functional class, demographic information, medical history, 6-minute walk distance, cardiopulmonary exercise testing, pulmonary function test results, hemodynamic measurements, functional status, employment status, medications, lab information, hospitalizations, blood stream infection and death. All data is collected at time of enrollment and quarterly thereafter for 5 years.

FINDINGSAs of June 2009, the Mayo Clinic has enrolled 243 of the ~3400 PAH patients currently enrolled in REVEAL and proved to be an example of best practice for entering timely registry information. The data collection techniques and standard procedures used include: updating the registry daily using time specifically set aside from clinic time; dividing queries by patient, and completing all queries for each patient before moving onto the next patient to avoid discrepancies; and using the EDC-derived "TO DO LIST" or "Patient Schedule" to keep track of specifics on data collection and entry. The EDC "TO DO LIST" provides a list of outstanding patient quarterly updates, incomplete or discrepant items, and monitoring queries. The "Patient Schedule" provides a comprehensive list of due dates for all patients' next quarterly update. Keeping track of queries (sent from the sponsor via email) and detailed entry of resolutions helps to track workflow. Having the resolutions available may decrease further outbound questions if the similar query arises for a different patient. Open communication with the sponsor study monitors assigned to the site is important for asking questions and obtaining clarifications on queries. Using these procedures, the Mayo Clinic REVEAL study site is up-to-date on data entry for all enrolled patients and quickly resolves collection discrepancies, which significantly contributes to the data quality and quantity available for analyses.

IMPLICATIONSAccurate and timely completion of data entry will provide a large central data source for the largest registry of WHO group I PAH patients ever compiled. The study coordinator's role of ensuring the accuracy and comprehensiveness of the data is key to the success of the REVEAL registry. 22