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

Area of Science:

• Urogynecology
• Clinical Research Methodology
• Data Quality Assurance

Background:

• Pelvic organ prolapse (POP) research requires accurate measurement of prolapse quantification (POP-Q) data.
• The Pelvic Floor Disorders Network (PFDN) developed a quality improvement auditing process to ensure data integrity in POP trials.

Purpose of the Study:

• To describe the PFDN's quality improvement auditing process for POP-Q measurements.
• To present an updated POP-Q form for standardized data collection in prolapse research.

Main Methods:

• Review of PFDN steering committee minutes.
• Analysis of data coordinating center audit reports.
• Examination of case report forms from prolapse studies.

Main Results:

• Common errors included data entry mistakes, incorrect documentation, sign errors, and inaccurate Ba/Bp point assessments.
• Quality tools implemented: improved case report forms, staff education, internal/central data audits, electronic data monitoring, clinical review, and source change protocols.

Conclusions:

• The described framework offers best practices for data collection and quality improvement in POP research.
• The quality tools can be applied to primary outcomes in various research trials beyond pelvic floor disorders.