The development of a quality-controlled PCI registry requires a careful diagnostic and data quality assessment system to significantly reduce data entry errors over time.
The technical challenges in the development of a quality-controlled registry of percutaneous coronary interventions (PCIs) are currently unknown. This article describes the authors' experience in the development of a regional, quality-controlled PCI registry. In 1996, 16 centers in Michigan were invited to participate in a multicenter PCI registry. Nine centers agreed to a pilot data collection and, as of July 2001, eight centers are still actively collecting data. An Oracle database was developed by the coordinating center. A common data collection form and a standard set of definitions were agreed on during several meetings. Data validity was insured through review of each form by a trained nurse, by automatic database diagnostic routines, and by site visits that included a review of the catheterization laboratory logs and a review of randomly selected charts. The average number of forms requiring query resolution was 33% in 1997 (range 7-76%), and it decreased to 5% in 1999 (range 1.4-10%). The most commonly queried variables were outcomes prior to discharge, lesion category, lesion complexity, date of birth, device used, gender, postprocedural percent stenosis, presence of left main disease, and MI date. Invalid dates, identification of the doctor, the presence of duplicate forms, and of duplicate outcomes were additional common queries generated by the internal diagnostic routines. In conclusion, the number of queries and diagnostic reports generated in the database suggests that the development of a quality-controlled PCI registry requires the institution of a careful diagnostic and data quality assessment system.
Kline‐Rogers et al. (2002) studied this question.