S1384 Exit Interviews Exploring Patients’ Experience of Changes in Their Fatigue During the Phase 3 Clinical Trial of Mirikizumab for Treatment of Moderately to Severely Active Crohn’s Disease
Bibliographic record
Abstract
Introduction: Fatigue is a common and debilitating symptom of Crohn’s disease (CD), associated with functional impairment and reduced quality of life. Here we qualitatively explore change in fatigue in participants with moderately to severely active CD who completed the phase 3, randomised, double-blind, placebo- and active-controlled, mirikizumab clinical trial (VIVID-1). Methods: Qualitative, web-assisted, semi-structured, 90-minute exit interviews were conducted in 62 trial participants within 3 weeks of the final trial visit (May 2022–July 2023). A sub-set of participants from either mirikizumab, ustekinumab or placebo arms were asked open-ended questions to explore changes in fatigue. Interview audio recordings were transcribed verbatim and analysed using a directed content analysis approach in ATLAS.ti v9. Results: Among the 31 participants who were interviewed (61.3% male [n=19], 90.3% white [n=28]), median age was 42 (n=30; range: 24–75) years, median CD duration was 5.9 (n=30; range: 1.4–54.3) years, 31.0% (n=9/29) had a college degree or higher and 41.4% (n=12/29) were employed full-time. Participants were from the United States (n=15), Czech Republic (n=5), Germany (n=5), Poland (n=3), Australia (n=2) and Canada (n=1). At the start of the trial, participants reported varied impact of fatigue in their daily life (Table 1). Although it was unknown which treatment the participants had received, most participants reported experiencing an improvement in fatigue (74%, n=23/31) during the trial; 7 reported experiencing no change in fatigue (23%, n=7/31), of these, 4 reported experiencing no/little fatigue at the start of the trial, which did not change until their last visit. One participant reported worsening of fatigue (3%, n=1/31) during the trial which impacted their daily activities (needed more day-time sleep). Among those who experienced an improvement in fatigue, 11 reported an improved emotional well-being such as feeling more relaxed, confident, independent, and motivated (Table 1). Overall, 10 of 13 participants reported a meaningful improvement in fatigue. Conclusion: Exit interview results showed that irrespective of the treatment received, most interviewed participants with moderately to severely active CD experienced an improvement in fatigue by end of the trial, resulting in better energy levels, physical function, daily functioning, and emotional well-being. Table 1. - The exit interview findings Participant-reported impact of fatigue at the start of trial Difficulty in performing daily activities (n) 7 Unable to feel well-rested from sleep (n) 3 Feeling worried (n) 3 Felt exhausted (n) 1 Difficulty in walking or climbing stairs (n) 3 Lacked energy (n) 2 Demotivated (n) 2 Frustrated (n) 1 Difficulty in completing outdoor tasks and activities (n) 2 Dozed off in evening (n) 1 Grumpy (n) 1 Socializing less (n) 1 Difficulty in concentrating or focusing (n) 2 Took breaks during the day (n) 1 Depressed (n) 1 During the trial 23 of 31 participants that reported improvement in fatigue, it resulted in: Better friendships or relationships (n) 4 Being more successful in work or school (n) 3 Sleeping better (n) 2 Napping less (n) 2 Being able to exercise more (n) 2 Go out for longer duration (n) 2 Being able to work (n) 1 Gaining more enjoyment in life (n) 1 Improved emotional well-being (feeling more relaxed, confident, independent, and motivated) (n) 11 Improvement in physical function and ability to walk further, had more energy and felt stronger (n) 9 Able to function more day-to-day (n) 8 n = number of participants.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.012 | 0.023 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.003 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".