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Building a Robust Investigator-Initiated Platform: The I-CARE Experience.

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Patient involvement in research is growing. The I-CARE study found that while most inflammatory bowel disease patients completed electronic patient-reported outcomes, younger males and students were more likely to withdraw early. Investigator data validation is crucial.

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Area of Science:

  • Clinical Research
  • Patient-Reported Outcomes
  • Inflammatory Bowel Disease Research

Background:

  • Investigator-initiated studies utilizing patient-collected data are increasing.
  • Limited understanding exists regarding patient and investigator experiences in these studies.
  • The I-CARE cohort aimed to address this gap in inflammatory bowel disease (IBD) research.

Purpose of the Study:

  • To describe patient and investigator involvement in the I-CARE cohort study.
  • To identify predictors of early patient withdrawal due to non-engagement.
  • To assess the accuracy and investigator modifications of electronic patient-reported outcomes (ePROs).

Main Methods:

  • A prospective cohort study involving 12,846 IBD patients across 15 countries.
  • Monthly collection of clinical information and ePROs for up to 6 years.
  • Logistic regression analysis to identify predictors of early withdrawal; assessment of data coding and investigator corrections.

Main Results:

  • 79.3% of patients completed more than one ePRO; 72.8% completed all ePROs in year 1.
  • Younger age (<20), male gender, unemployment/student status, and no prior abdominal surgery predicted early withdrawal.
  • Investigators corrected 52.5% of reported cancer/dysplasia and modified treatment sequences for 19.6% of patients on biologics.

Conclusions:

  • Patient engagement in research is significant, but challenges like early withdrawal exist.
  • Investigator validation of patient-reported data is essential for data accuracy.
  • Findings offer insights for future patient-involved research initiatives in various diseases.