Using Pre-Study Patient Interviews to Refine Electronic Patient-Reported Outcomes in Clinical Research of Ustekinumab Induction for Ulcerative Colitis (SIRIUS Study).

INTRODUCTION: Daily electronic patient-reported outcome (ePRO) collection enables assessment of symptom fluctuations in ulcerative colitis (UC); however, high-frequency data entry can impose operational and psychological burdens that may affect data quality and feasibility. Incorporating patient perspectives during study preparation may help mitigate these challenges. Structured pre-study patient interviews were conducted to inform potential refinements to ePRO questionnaire design and operational procedures in the SIRIUS study, a prospective observational study in Japanese patients with UC, and to explore their potential impact on study feasibility, including retention and ePRO completion. METHODS: Before initiating the SIRIUS study, pre-study patient interviews were conducted by an operationally independent external organization. The pre-study interviews assessed the usability and acceptability of the planned ePRO application and materials. Patient feedback was thematically analyzed to inform potential refinements to questionnaire wording, manuals, onboarding support, troubleshooting procedures, and compensation. These refinements were considered for inclusion in the SIRIUS study. RESULTS: Twenty-six adults with UC participated in interviews. Patient input identified key usability and burden-related issues and led to several modifications: questionnaire items were revised to reduce the burden associated with recalling pre-onset bowel habits for stool frequency, and the overall condition scale was adjusted to allow for both improvement and worsening. Manuals were simplified and tailored to varying levels of technological literacy, onboarding included in-person support, and a dedicated troubleshooting hotline was established. Compensation was set at an appropriate level. A total of 135/136 enrolled patients (99.3%) completed the ustekinumab induction period in the SIRIUS study, and the daily ePRO completion rate was 94.2%. CONCLUSIONS: Structured patient input prior to study initiation identified modifiable barriers to high-frequency ePRO collection and informed concrete refinements to study design and operations. While causality cannot be inferred from this uncontrolled case study, high retention and ePRO completion rates were observed, suggesting that patient-informed refinements may have supported participant understanding and adherence. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04963725 (registered July 8, 2021). https://clinicaltrials.gov/study/NCT04963725?cond=Ulcerative%20Colitis&term=daily&intr=Ustekinumab&rank=2.