Table 7

Outcomes to be included in the COS at the consensus meeting

Question% InOverall (%)Patient vote alone (%)Final consensus
Panel SuRa (%)Panel GaNu (%)Panel Pa (%)
1 Patient-reported reduction in fistula drainage57.153.330.046.8
2 Development of other perianal features53.873.370.065.7
3 Complete fistula healing assessed clinically53.340.044.445.9
4 Validated score to assess perianal disease activity100.093.877.890.5IN
5 Development of a new fistula69.283.387.580.0IN
6 Incontinence to solid stool26.733.340.033.3
7 Pads for continence/leakage26.740.040.035.6
8 Recurrence of fistula85.768.880.078.2
9 Perianal abscess on clinical assessment after intervention86.7100.090.092.2IN
10 Incontinence to liquid stool71.493.3100.088.3Combined†
11 Perianal-related hospitalisation35.750.010.031.9
12 Faecal diversion or proctectomy100.0100.0100.0100.0IN
13 Wound infection0.00.030.010.0
14 Anal pain66.787.590.081.4
15 Discrimination between passing stool and gas6.733.312.517.5
16 Surgical reintervention93.393.880.089.0IN
17 Anal bleeding0.014.360.024.8
18 Reversal of defunctioning stoma33.337.522.231.0
19 A global assessment of incontinence that covers all aspects of leakage92.9100.0100.097.6IN
20 Fistula response on MRI85.786.780.084.1IN
21 Hyperintensity on T2-weighted MRI46.738.562.549.2
22 MRI assessment of fistula volume35.753.855.648.4
23 Fistula T1 enhancement on MRI13.345.560.039.6
24 Abscess on MRI following treatment66.787.560.071.4
25 An activity-based MRI score86.793.388.989.6IN
26 A global quality of life score100.093.8100.097.9n/aIN
27 Physically restricted in caring for oneself15.426.770.037.470.0
28 Change in lifestyle based on toileting needs23.153.387.554.690.0IN
29 Embarrassment and feeling bloated25.042.960.042.660.0
30 Unable to attend school/work36.486.7100.074.3100.0IN
31 Restriction of sexual activity58.380.090.076.1100.0IN
32 Lethargy and fatigue0.020.066.728.960.0
33 Limitation to moderate activities8.312.530.016.940.0
34 Change in general health16.764.380.053.780.0
35 Avoidance of intimacy36.460.088.961.888.9Combined‡
36 Anxiety and worries8.325.055.629.675.0
37 Change in physical ability to do things0.012.577.830.180
38 Feeling depressed, down, hopeless, unable to cope7.742.990.046.890IN
39 Modifying how you sit, walk and stand because of your fistula33.357.170.053.580
40 Lifestyle alterations (pain/restriction)25.053.880.052.9100IN
41 Social interaction avoidance50.046.270.055.480
42 Duration of improvement53.880.088.974.2
43 Death46.242.955.648.2
44 Allergic reaction7.76.737.517.3
45 Safety (adverse events) and toxicity7.77.150.021.6
46 Urinary complications38.576.977.864.4
47 Cardiorespiratory complications7.70.044.417.4
48 Neurological complications0.08.360.022.8
49 Medical complications specific to immunosuppression0.015.444.419.9
  • *‘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.