Cure8 research brief
Patient-informed refinements to ePRO design and study operations could reduce burden and missing data in high-frequency daily symptom reporting, which matters for study quality and for patients asked to report symptoms frequently during biologic induction.
Patients with ulcerative colitis, clinicians and researchers designing ePROs or running observational/clinical studies, and teams conducting studies of biologic induction (ustekinumab).
The study team interviewed 26 adults with UC before starting the SIRIUS study to test usability and acceptability of a planned daily ePRO app and related materials.
Patient feedback led to concrete changes: simplified/question wording (especially for stool-frequency questions), an overall condition scale that allowed reporting of both improvement and worsening, tiered manuals for different technology comfort levels, in-person onboarding, a troubleshooting hotline, and adjusted participant compensation.
In the subsequent SIRIUS observational cohort of patients starting ustekinumab, the authors report very high retention (135/136 completed induction) and a 94.2% daily ePRO completion rate. The paper notes that causality cannot be inferred from this uncontrolled case study but suggests patient-informed refinements may support adherence and data completeness.
Practical takeaways If you participate in or design high-frequency ePRO studies, early structured patient interviews can identify wording or usability problems and inform practical supports (onboarding, help lines, compensation) that may improve completion. For patients, this approach aims to reduce burden and make daily symptom reporting easier and clearer.
This is a journal article reporting an uncontrolled case study and feasibility outcomes from a single observational study (SIRIUS). The authors explicitly state that causality between pre-study interviews and high completion/retention cannot be proven. The trial is registered (NCT04963725).
Review the original publication for the complete reporting, methods, and context.
Funding disclosed by the source: Johnson & Johnson
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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