A Comprehensive Assessment Tool for Patient Registry Software Systems: The CIPROS Checklist.

Abstract

Patient registries are an important instrument in medical research. Often their structure is complex and their implementation uses composite software systems to meet the wide spectrum of challenges. For the implementation of a registry, there is a wide range of commercial, open source, and self-developed systems available and a minimal standard for the critical appraisal of their architecture is needed. We performed a systematic review of the literature to define a catalogue of relevant criteria to construct a minimal appraisal standard. The CIPROS list is developed based on 64 papers which were found by our systematic review. The list covers twelve sections and contains 72 items. The CIPROS list supports developers to assess requirements on existing systems and strengthens the reporting of patient registry software system descriptions. It can be a first step to create standards for patient registry software system assessments.