Patient Voices Before the Trial: How 26 Interviews Helped Push Daily ePRO Completion to 94% in Ulcerative Colitis Research

When researchers ask patients to log their symptoms every single day for eight weeks, they are asking for something far more demanding than a lab test. They are asking people with a chronic, unpredictable disease to open an app on their smartphone, interpret carefully worded questions about stool frequency and bleeding, and answer honestly, day after day, whether they feel well or miserable. A new report on the SIRIUS study, a prospective observational study of ustekinumab induction in Japanese patients with ulcerative colitis, shows what can happen when scientists take that burden seriously before the trial even begins, and the numbers are striking: 135 of 136 enrolled patients completed the full induction period, and daily electronic patient-reported outcome entries were completed at a rate of 94.2%.

The study, published in Advances in Therapy, describes a structured pre-study interview program in which 26 adults with ulcerative colitis were recruited by an operationally independent nonprofit organization, ASrid, to critique the draft ePRO application, questionnaire items, manuals, and compensation plans before any SIRIUS participant was enrolled. The approach reflects a broader shift in pharmaceutical research, in which patients are increasingly treated as informed collaborators rather than passive subjects, and in which patient engagement is seen as a lever for improving recruitment, retention, and the quality of the data that clinical studies depend on.

The technical rationale for daily ePRO collection in ulcerative colitis is straightforward. The disease is characterized by fluctuating symptoms, including diarrhea, rectal bleeding, urgency, and abdominal pain, and among these, stool frequency and rectal bleeding are core symptoms that strongly influence patients’ daily functioning and perceived disease activity. These symptom components show moderate-to-strong correlations with endoscopic activity, and international treatment guidelines such as STRIDE-II have emphasized the importance of symptom-based outcomes in monitoring inflammatory bowel disease. Periodic outpatient visits and endoscopies simply cannot capture the day-to-day variability that defines the patient experience, which is why the SIRIUS team set out to record symptom data every day for 56 days using a smartphone application.

But high-frequency data collection carries its own risks. If questionnaire items are confusing, if the reporting burden feels excessive, or if patients cannot get help when the app misbehaves, missing data and dropout can accumulate quickly, undermining the very precision that daily measurement is meant to provide. Previous reports on patient engagement have rarely documented how patient input is actually translated into concrete changes to patient-facing materials and procedures before a study starts, which is the gap the SIRIUS team set out to fill.

The interview framework was deliberately insulated from the study team. ASrid, a nonprofit with experience in qualitative health research in Japan, was selected to conduct the interviews, but a written agreement stipulated that the study team would have no involvement in interview design, recruitment, data collection, access to raw data, or analysis. The team received only an anonymized, aggregated summary after the interviews were complete. Recruitment ran through Mikumo-sha, a company operated by patients with inflammatory bowel disease, and the NPO IBD Network, a patient council, and participants were neither patients under the care of SIRIUS investigators nor eligible for later enrollment in the study itself. Interviews were conducted online in February 2021 and continued until major usability issues began recurring and no substantively new issues emerged, a saturation-based stopping rule common in qualitative research.

The 26 participants, 13 men and 13 women ranging in age from their twenties to their seventies with an average age of 43.6 years, were well positioned to judge the draft materials, since 92.3% had previously recorded their ulcerative colitis symptoms using notes or applications. Their feedback was thematically analyzed and proved remarkably consequential. Perhaps the most psychologically significant finding concerned the stool frequency item, which originally asked patients to compare their current bowel habits with their condition before disease onset. Participants with long disease histories reported that recalling their pre-onset state was difficult and emotionally burdensome, and they suggested using a remission or well-being period as a more meaningful reference point instead. The item was revised accordingly, reducing the psychological weight of a question patients would face every day for two months.

Participants also caught a subtle but important flaw in the overall condition scale: its anchors only allowed for improvement, yet symptoms can worsen after starting a new therapy, and a patient whose condition deteriorated beyond the top anchor would have no valid way to report it. The scale was adjusted to capture both improvement and worsening, a change that directly improves the content validity of the outcome measure. On the operational side, participants found the manual confusing, noting that the technical term ePRO appeared without explanation and that the very need for a manual signaled a level of complexity that could erode willingness to complete daily entries. They proposed tiered documentation, a concise one-page guide alongside a more detailed version, tailored to different levels of smartphone familiarity, along with in-person walk-through support from a clinical research coordinator at first use, initial setup completed at the hospital, and a dedicated hotline for troubleshooting.

Even compensation was put to the patients. Most participants considered 100 to 500 yen per submission, roughly 0.70 to 3.37 US dollars, appropriate for daily symptom entry over eight weeks, given the number of questions and the time required per entry. But they added a caution that is easy to overlook: excessively high compensation, whether per day or in total, could raise suspicions about the study’s motives and actually deter participation, particularly since the daily input consisted of multiple-choice responses rather than detailed narrative reporting. The study team incorporated these findings, revising questionnaire items, simplifying the manual, adding one-on-one instruction by a coordinator on the first day of the study, and establishing a dedicated call center for questions about the smartphone or application throughout the study period.

The downstream feasibility indicators are the most eye-catching part of the report. Despite running during the COVID-19 pandemic, the SIRIUS study enrolled 136 of its planned 140 patients, and 99.3% of enrollees completed the eight-week ustekinumab induction period, with a daily ePRO completion rate of 94.2%. The authors are careful about causality: this was a single case study without a comparator group, so the favorable retention and completion rates cannot be definitively attributed to the pre-study interviews. Still, they argue that sustaining such high data completion over more than 50 consecutive days of reporting would be difficult to achieve without adequate patient understanding of both the application and the purpose of the research, and that the interviews identified modifiable barriers that the resulting refinements plausibly addressed.

The interviews also surfaced a deeper insight about motivation. Many participants said the perceived value of entering data would increase if the information were used by their attending physicians rather than solely by the patients themselves, pointing toward a future in which ePRO data flows back into routine care rather than disappearing into research databases. Participants also expressed appreciation for the independent intermediary model, with some noting that they felt reassured by strict confidentiality and by an organization that properly understood the disease, suggesting that operationally separate intermediaries may facilitate more candid feedback than direct sponsor-led interviews. The authors acknowledge limitations, including the small number of interview participants, the possibility that some participants inferred sponsor involvement from the medication name, and the lack of generalizability beyond this specific context. Even so, the case offers a practical template: structured patient input before study initiation, translated into item-level and procedure-level refinements, may help ensure data quality in the growing number of clinical studies that depend on long-duration, high-frequency patient-reported data collection.

Subject of Research: Using pre-study patient interviews to refine electronic patient-reported outcome collection in a clinical study of ustekinumab induction for ulcerative colitis

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

Article References: Nagano, K., Emoto, S., Nishimura, Y., Sugi, M., Amano, M., Yoshigoe, S., Nishimura, K., & Matsuoka, K. (2026). Using Pre-Study Patient Interviews to Refine Electronic Patient-Reported Outcomes in Clinical Research of Ustekinumab Induction for Ulcerative Colitis (SIRIUS Study). Advances in Therapy. https://doi.org/10.1007/s12325-026-03770-6

Image Credits: AI Generated

DOI: 10.1007/s12325-026-03770-6

Keywords: electronic patient-reported outcomes, ePRO, ulcerative colitis, ustekinumab, patient engagement, SIRIUS study, patient-centered trial design, clinical research, inflammatory bowel disease, qualitative interviews, data completion, retention