Clinical registries data quality attributes to support registry-based randomised controlled trials: A scoping review

Area of Science:

• Health Services Research
• Clinical Informatics
• Epidemiology

Background:

• Clinical registries are vital for performance measurement, quality improvement, and clinical research.
• Registry-based randomized controlled trials (RRCTs) rely heavily on the quality of the underlying registry.
• Identifying high-quality registries is essential for the successful implementation of RRCTs.

Purpose of the Study:

• To conduct a scoping review to identify key characteristics of high-quality clinical registries.
• To determine the essential attributes for registries supporting registry-based randomized controlled trials (RRCTs).

Main Methods:

• A comprehensive literature search was performed across four databases and grey literature.
• A narrative synthesis approach was employed to summarize findings.
• Focus was placed on registry characteristics and data collection mechanisms for high-quality data.

Main Results:

• Fifty articles were included in the review.
• Essential data attributes for high-quality registries include accuracy, completeness, population capture, standardization, and timeliness.
• Factors influencing high-quality data collection encompass the legal/ethical environment, infrastructure support, and healthcare provider participation.

Conclusions:

• A framework (Registry Attributes Framework) is proposed to assess registry suitability for RRCTs.
• Certification of registries may serve as a future standard for identifying suitable platforms.
• Establishing minimum acceptable standards for registry performance indicators is recommended for new and existing registries.