Survey items
| Category | Item (questionnaire) |
| Items completed by physicians (timing of assessment) | |
| Patient characteristics (baseline) | Age (years); sex; body weight (kg); smoking history (never, past, current); family history of inflammatory bowel disease; cancer history (never, past, current); extraintestinal complications (never, past, current). |
| UC diagnosis and history (baseline) | Date of initial UC diagnosis; prior UC surgery; previous indicators of severe disease; hospital admission in last 12 months for UC exacerbations or complications; Mayo endoscopy score and UC classification based on extent of disease (only if endoscopy undertaken in last 12 months); previous therapy(ies) for UC; list of all treatment types previously used for UC (including apheresis but excluding over-the-counter treatments), at any time before baseline. |
| Prior therapy (baseline) | Treatment type and name of the ‘prior therapy’; date of last dose of the ‘prior therapy’; duration of the ‘prior therapy’ from initiation up to date of cessation or study baseline (whichever is later); only if the ‘prior therapy’ is a corticosteroid, the most recent dosage of the ‘prior therapy’ (dose, frequency, route); whether the ‘prior therapy’ is being continued (ie, supplemented with ustekinumab) or has been discontinued; reason for discontinuation or supplementation of that ‘prior therapy’ (inadequate response, intolerance). |
| Symptom evaluation (baseline and postbaseline visits) | pMayo score; body weight (kg); blood data (if any). |
| Treatment pattern of ustekinumab maintenance therapy (all postbaseline visits) | Dosing interval (selection of once every 8 weeks and once every 12 weeks) and the reason for selecting this interval; concomitant medications taken during treatment of UC with ustekinumab. |
| Items reported by patients (timing) | |
| Patient-reported outcomes (daily for 8 weeks) | Rectal bleeding and stool frequency (as assessed by the pMayo score)—primary end point; abdominal pain (NRS scale); presence or absence of tenesmus; any awakening due to nocturnal diarrhoea; evaluation of perception of UC symptoms (NRS scale). |
NRS, numerical rating scale; pMayo, partial Mayo; UC, ulcerative colitis.