Outcomes to be included in the COS at the consensus meeting
| Question | % In | Overall (%) | Patient vote alone (%) | Final consensus | |||
| Panel SuRa (%) | Panel GaNu (%) | Panel Pa (%) | |||||
| 1 | Patient-reported reduction in fistula drainage | 57.1 | 53.3 | 30.0 | 46.8 | ||
| 2 | Development of other perianal features | 53.8 | 73.3 | 70.0 | 65.7 | ||
| 3 | Complete fistula healing assessed clinically | 53.3 | 40.0 | 44.4 | 45.9 | ||
| 4 | Validated score to assess perianal disease activity | 100.0 | 93.8 | 77.8 | 90.5 | IN | |
| 5 | Development of a new fistula | 69.2 | 83.3 | 87.5 | 80.0 | IN | |
| 6 | Incontinence to solid stool | 26.7 | 33.3 | 40.0 | 33.3 | ||
| 7 | Pads for continence/leakage | 26.7 | 40.0 | 40.0 | 35.6 | ||
| 8 | Recurrence of fistula | 85.7 | 68.8 | 80.0 | 78.2 | ||
| 9 | Perianal abscess on clinical assessment after intervention | 86.7 | 100.0 | 90.0 | 92.2 | IN | |
| 10 | Incontinence to liquid stool | 71.4 | 93.3 | 100.0 | 88.3 | Combined† | |
| 11 | Perianal-related hospitalisation | 35.7 | 50.0 | 10.0 | 31.9 | ||
| 12 | Faecal diversion or proctectomy | 100.0 | 100.0 | 100.0 | 100.0 | IN | |
| 13 | Wound infection | 0.0 | 0.0 | 30.0 | 10.0 | ||
| 14 | Anal pain | 66.7 | 87.5 | 90.0 | 81.4 | ||
| 15 | Discrimination between passing stool and gas | 6.7 | 33.3 | 12.5 | 17.5 | ||
| 16 | Surgical reintervention | 93.3 | 93.8 | 80.0 | 89.0 | IN | |
| 17 | Anal bleeding | 0.0 | 14.3 | 60.0 | 24.8 | ||
| 18 | Reversal of defunctioning stoma | 33.3 | 37.5 | 22.2 | 31.0 | ||
| 19 | A global assessment of incontinence that covers all aspects of leakage | 92.9 | 100.0 | 100.0 | 97.6 | IN | |
| 20 | Fistula response on MRI | 85.7 | 86.7 | 80.0 | 84.1 | IN | |
| 21 | Hyperintensity on T2-weighted MRI | 46.7 | 38.5 | 62.5 | 49.2 | ||
| 22 | MRI assessment of fistula volume | 35.7 | 53.8 | 55.6 | 48.4 | ||
| 23 | Fistula T1 enhancement on MRI | 13.3 | 45.5 | 60.0 | 39.6 | ||
| 24 | Abscess on MRI following treatment | 66.7 | 87.5 | 60.0 | 71.4 | ||
| 25 | An activity-based MRI score | 86.7 | 93.3 | 88.9 | 89.6 | IN | |
| 26 | A global quality of life score | 100.0 | 93.8 | 100.0 | 97.9 | n/a | IN |
| 27 | Physically restricted in caring for oneself | 15.4 | 26.7 | 70.0 | 37.4 | 70.0 | |
| 28 | Change in lifestyle based on toileting needs | 23.1 | 53.3 | 87.5 | 54.6 | 90.0 | IN |
| 29 | Embarrassment and feeling bloated | 25.0 | 42.9 | 60.0 | 42.6 | 60.0 | |
| 30 | Unable to attend school/work | 36.4 | 86.7 | 100.0 | 74.3 | 100.0 | IN |
| 31 | Restriction of sexual activity | 58.3 | 80.0 | 90.0 | 76.1 | 100.0 | IN |
| 32 | Lethargy and fatigue | 0.0 | 20.0 | 66.7 | 28.9 | 60.0 | |
| 33 | Limitation to moderate activities | 8.3 | 12.5 | 30.0 | 16.9 | 40.0 | |
| 34 | Change in general health | 16.7 | 64.3 | 80.0 | 53.7 | 80.0 | |
| 35 | Avoidance of intimacy | 36.4 | 60.0 | 88.9 | 61.8 | 88.9 | Combined‡ |
| 36 | Anxiety and worries | 8.3 | 25.0 | 55.6 | 29.6 | 75.0 | |
| 37 | Change in physical ability to do things | 0.0 | 12.5 | 77.8 | 30.1 | 80 | |
| 38 | Feeling depressed, down, hopeless, unable to cope | 7.7 | 42.9 | 90.0 | 46.8 | 90 | IN |
| 39 | Modifying how you sit, walk and stand because of your fistula | 33.3 | 57.1 | 70.0 | 53.5 | 80 | |
| 40 | Lifestyle alterations (pain/restriction) | 25.0 | 53.8 | 80.0 | 52.9 | 100 | IN |
| 41 | Social interaction avoidance | 50.0 | 46.2 | 70.0 | 55.4 | 80 | |
| 42 | Duration of improvement | 53.8 | 80.0 | 88.9 | 74.2 | ||
| 43 | Death | 46.2 | 42.9 | 55.6 | 48.2 | ||
| 44 | Allergic reaction | 7.7 | 6.7 | 37.5 | 17.3 | ||
| 45 | Safety (adverse events) and toxicity | 7.7 | 7.1 | 50.0 | 21.6 | ||
| 46 | Urinary complications | 38.5 | 76.9 | 77.8 | 64.4 | ||
| 47 | Cardiorespiratory complications | 7.7 | 0.0 | 44.4 | 17.4 | ||
| 48 | Neurological complications | 0.0 | 8.3 | 60.0 | 22.8 | ||
| 49 | Medical complications specific to immunosuppression | 0.0 | 15.4 | 44.4 | 19.9 | ||
*‘Patient Priorities’ - consensus agreement by all to allow these items to be voted on by patient alone.
†Combined with ‘A global assessment of incontinence that covers all aspects of leakage’.
‡Combined with ‘Restriction of sexual activity’.
COS, core outcome set.