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Multi-site research using electronic health record data: Lessons learned from a case study.

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Multi-site cancer research faces challenges in data management and regulatory processes. Early planning, standardized data use agreements (DUAs), and shared data dictionaries are crucial for successful collaboration and improved cancer care outcomes.

Keywords:
access log datadata use agreementselectronic health record (EHR)multi‐site researchresearch challenges

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Area of Science:

  • Health Services Research
  • Oncology Research
  • Health Informatics

Background:

  • Multi-site research collaborations are vital for enhancing generalizability, diversity, and innovation in scientific studies.
  • However, these collaborations present significant complexities in research processes, including regulatory oversight, data management, and data sharing.
  • This report addresses challenges encountered in a federally funded multi-site study to inform future collaborative research endeavors.

Purpose of the Study:

  • To determine the impact of interprofessional teamwork on quality outcomes in cancer care.
  • To develop practical tools aimed at improving teamwork within cancer care settings.
  • To identify and address challenges in multi-site research collaborations.

Main Methods:

  • A multi-site research team of 23 members across five academic institutions was assembled.
  • The study cohort comprised approximately 20,000 adult patients diagnosed with breast, colorectal, or non-small cell lung cancer between 2016 and 2021.
  • Electronic health record (EHR) access log data and California All-Payer Claims database outcomes (emergency visits, hospitalizations) were extracted.

Main Results:

  • Significant challenges were identified in single institutional review board processes, contract agreement establishment, and data management, analysis, acquisition, and transfer.
  • Key lessons learned include the importance of early research planning with IT and compliance teams, developing shared data dictionaries, and optimizing the timing of data use agreement (DUA) contracts.
  • Ensuring research team members are updated on Health Insurance Portability and Accountability Act (HIPAA) and institutional guidelines is essential.

Conclusions:

  • Multi-site research utilizing big data from EHRs necessitates extensive planning and execution time.
  • Implementing a single, standardized DUA can streamline the contracting process.
  • Developing and sharing comprehensive data dictionaries is critical for improving the data acquisition phase in multi-site research studies.