To err is human: lessons from prolapse studies to identify and strategies to reduce data errors.

Abstract

The aim of this manuscript is to describe the quality improvement auditing process developed by the Pelvic Floor Disorders Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development for assessing the primary outcome of pelvic organ prolapse quantification measurements in their prolapse research trials and provide the reader with the most iterative pelvic organ prolapse quantification form. We reviewed the Pelvic Floor Disorders Network steering committee minutes, data coordinating center audit reports, and the case report forms for studies related to prolapse and summarized findings. Errors found were related to data entry and documentation of pelvic organ prolapse quantification data with sign errors and inaccurate Ba/Bp point assessments being most common. Quality tools implemented included improved case report forms and staff education to prevent errors, internal/central data audits with an electronic data monitoring system, clinical review for plausibility, and protocols to oversee source changes. This manuscript provides a framework of quality tools not only for best practices in data collection and quality improvement in prolapse research but also for primary outcomes of any research trial.