Underutilization of a Validated Treatment Satisfaction Instrument in Inflammatory Bowel Disease

OBJECTIVES: Patient satisfaction with treatment is an increasingly recognized element of value, particularly for patients with chronic conditions, such as Crohn’s disease (CD) and ulcerative colitis (UC), who require long-term treatment and may exhibit poor adherence and associated negative outcomes. The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument measuring patient satisfaction with medication that may predict adherence. We aimed to explore the employment of the TSQM in inflammatory bowel disease (IBD).

METHODS: We conducted a search of PubMed and clinicaltrials.gov using the index terms “ulcerative colitis”, “Crohn’s disease”, "inflammatory bowel disease”, and TSQM. No year or language limits were applied. Withdrawn, suspended, terminated, or unknown status trials were excluded.

RESULTS: Of a total of 1981 IBD trial records identified (905 UC and 1076 CD), only 12 employed the TSQM (8 UC, 4 CD). In UC, 7 studies were observational; the single interventional study was a phase 3 study of adalimumab. The most common outcome was mean change from baseline TSQM score; 2 studies specified TSQM items (modalities, satisfaction, effectiveness, side effects). For CD, all 4 studies were observational. Identified studies were completed with the exception of 2, a long-term registry and a study of ozanimod in UC. Overall, 2 studies also employed measures of adherence: Morisky Medication Adherence Scale and percentage of patients with medication possession ratio ≥80%. Only 4 resulting publications were identified: 1 multicenter cross-sectional adalimumab dose-escalation study; 1 real-world, observational study of golimumab in UC; 1 cross-sectional, retrospective preference study in UC; and 1 validation of another satisfaction instrument in CD.

CONCLUSIONS: TSQM is a validated patient-reported outcome measure that quantifies perceived effectiveness and global satisfaction, which may provide early insight into adherence to treatment in IBD. Despite its potential value, only a small fraction of identified studies employed the measure and only 2 examined adherence simultaneously.