Table 1 Overview of items analyzed for physician-assessed and patient-reported toxicity
Consistently recorded CTCAE items and EORTC questions; pairwise | |
CTCAE item | Question(s) |
Abdominal pain | CX24 Q31 / EN24 Q41 |
Diarrhea | C30 Q17 |
Rectal hemorrhage | PR25 Q42 / CX24 Q33 |
Constipation | C30 Q16 |
Fecal incontinence | PR25 Q41 / CX24 Q32 / EN24 Q39 |
Urinary incontinence | PR25 Q36 / CX24 Q36 / EN24 Q36 |
Urinary tract pain | PR25 Q37 / CX24 Q35 / EN24 Q37 |
Urinary frequency/urgency | PR25 Q31-35 / CX24 Q34 / EN24 Q34-35 |
Urinary retention | CX24 Q37 |
Vaginal inflammation/mucositis | CX24 Q41, 43 |
Consistently recorded CTCAE items and EORTC questions; non-pairwise remainder | |
CTCAE item | Question(s) |
Hematuria | Feeling bloated PR25 Q43 / EN24 Q42 |
Gastrointestinal and urinary fistula | Passing wind EN24 Q40 |
Open space where any other event most likely related to radiotherapy could be documented | Urge to defecate EN24 Q38 |
Limited in daily life by urinary symptoms PR25 Q39 | |
Limited in daily life by bowel symptoms PR25 Q40 | |
Baseline corrections | |
No symptoms: CTCAE grade 0 versus questionnaire outcome 1 (‘not at all’). CTCAE example: rectal hemorrhage grade 3 at time X and no rectal hemorrhage at baseline? → 3 minus 0 = 3 → Severe physician-assessed toxicity Questionnaire example: urinary incontinence outcome 4 (‘very much’) at time X and no urinary incontinence at baseline? → 4 minus 1 = 3 → Severe patient-reported toxicity | |