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Enhancing requirements engineering for patient registry software systems with evidence-based components.

Doris Lindoerfer1, Ulrich Mansmann1

  • 1Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig-Maximilians-Universität München, Munich, Germany.

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|May 25, 2017
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Summary

We developed an evidence-based checklist for patient registry software systems (CIPROS) to streamline development. This checklist accelerates the requirements engineering process for medical research software.

Keywords:
ChecklistEvidence-based requirements engineeringPatient registry software systemTechnical requirements

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Area of Science:

  • Medical Informatics
  • Software Engineering
  • Health Research Methodology

Background:

  • Patient registries are crucial for medical research, often requiring complex software solutions.
  • Developing or selecting appropriate software for patient registries presents significant challenges.
  • Existing software development approaches may not fully address the unique needs of patient registries.

Purpose of the Study:

  • To propose an evidence-based checklist to aid in the requirements engineering process for patient registry software.
  • To accelerate the development and selection of software systems for patient registries.
  • To provide a standardized tool for assessing patient registry software requirements.

Main Methods:

  • A systematic literature review was conducted to gather technical concepts.
  • Qualitative content analysis was used to define relevant criteria.
  • A multistep procedure resulted in the creation of the CIPROS checklist.

Main Results:

  • The developed checklist, CIPROS, is based on 64 publications and includes 72 items across twelve sections.
  • CIPROS defines specific software requirements for patient registry systems.
  • The checklist shows consensus with traditional methods but highlights registry-specific aspects.

Conclusions:

  • An evidence-based approach, like CIPROS, enhances traditional methods for registry software engineering.
  • CIPROS aids developers in assessing and formulating requirements, improving software descriptions.
  • This checklist may serve as a foundation for future standards in patient registry software assessment.