Table 2.
Patient-reported outcome scores for core items following organ preservation and UK age-matched general population data
| EORTC cohort* | Baseline | 3 months | 6 months | 12 months | 24 months | 36 months | ||
|---|---|---|---|---|---|---|---|---|
| EORTC-QLQ-C30 core item scores | ||||||||
| Quality of life (global health status)† | ||||||||
| EORTC cohort* | 64·2 (1·0); 540 (100%) | .. | .. | .. | .. | .. | .. | |
| Randomised patients | .. | 83·7 (13·6);26 (96%) | 75·5 (15·0);18 (67%) | 80·4 (15·1);20 (74%) | 78·3 (15·6);20 (74%) | 76·2 (23·6);20 (74%) | 84·5 (6·4);14 (52%) | |
| Non-randomised patients | .. | 78·4 (17·1);51 (84%) | 70·9 (22·9);41 (67%) | 76·6 (14·8);42 (69%) | 73·4 (22·2);42 (69%) | 75·8 (20·0);42 (69%) | 74·5 (18·9);33 (54%) | |
| Physical functioning† | ||||||||
| EORTC cohort | 78·0 (1·0); 540 (100%) | .. | .. | .. | .. | .. | .. | |
| Randomised patients | .. | 88·6 (16·7);26 (96%) | 86·0 (14·9);19 (70%) | 85·7 (18·8);20 (74%) | 83·9 (19·8);20 (74%) | 80·0 (23·0);20 (74%) | 88·7 (6·9);13 (48%) | |
| Non-randomised patients | .. | 85·1 (20·2);53 (87%) | 76·5 (21·6);40 (66%) | 81·5 (19·5);42 (69%) | 79·4 (22·5);42 (69%) | 79·4 (23·3);39 (64%) | 78·2 (22·5);36 (59%) | |
| Role functioning† | ||||||||
| EORTC cohort | 76·8 (1·2); 540 (100%) | .. | .. | .. | .. | .. | .. | |
| Randomised patients | .. | 93·6 (15·0);26 (96%) | 77·2 (27·9);19 (70%) | 84·2 (27·8);20 (74%) | 87·5 (18·6);20 (74%) | 78·3 (28·7);20 (74%) | 89·7 (14·5);13 (48%) | |
| Non-randomised patients | .. | 84·6 (28·5);53 (87%) | 70·3 (31·5);41 (67%) | 81·3 (26·1);42 (69%) | 79·8 (26·7);42 (69%) | 77·6 (26·8);41 (67%) | 72·7 (35·0);36 (59%) | |
| Social functioning† | ||||||||
| EORTC cohort | 85·5 (1·1); 540 (100%) | .. | .. | .. | .. | .. | .. | |
| Randomised patients | .. | 94·9 (12·3);26 (96%) | 82·4 (25·2);18 (67%) | 90·8 (17·5);20 (74%) | 91·7 (11·5);20 (74%) | 83·3 (26·5);20 (74%) | 90·5 (15·6);14 (52%) | |
| Non-randomised patients | .. | 88·6 (23·7);51 (84%) | 73·2 (30·2);41 (67%) | 83·7 (23·4);42 (69%) | 80·6 (27·3);42 (69%) | 85·3 (21·8);42 (69%) | 86·4 (20·6);33 (54%) | |
| Diarrhoea | ||||||||
| EORTC cohort | 8·8 (0·9); 540 (100%) | .. | .. | .. | .. | .. | .. | |
| Randomised patients | .. | 11·5 (18·7);26 (96%) | 9·3 (15·4);18 (67%) | 11·7 (19·6);20 (74%) | 8·8 (21·8);19 (70%) | 8·3 (14·8);20 (74%) | 4·8 (12·1);14 (52%) | |
| Non-randomised patients | .. | 15·7 (25·3);51 (84%) | 20·8 (27·9);40 (66%) | 11·4 (21·9);41 (67%) | 10·3 (18·8);42 (67%) | 8·7 (20·9);42 (69%) | 17·2 (31·3);33 (54%) | |
| EQ-5D-3L scores | ||||||||
| EQ-5D-3L index value | 0·779‡ | .. | .. | .. | .. | .. | .. | |
| Randomised patients | .. | 0·87 (0·19);26 (96%) | 0·89 (0·17);18 (67%) | 0·84 (0·24);19 (70%) | 0·89 (0·13);20 (74%) | 0·82 (0·26);20 (74%) | 0·89 (0·12);14 (52%) | |
| Non-randomised patients | .. | 0·82 (0·23);52 (85%) | 0·79 (0·25);41 (67%) | 0·84 (0·22);42 (69%) | 0·81 (0·25);40 (66%) | 0·83 (0·16);42 (69%) | 0·76 (0·26);36 (59%) | |
| EORTC-QLQ-C29 core item scores | ||||||||
| Faecal incontinence§ | ||||||||
| Randomised patients | .. | 2·9 (9·6);23 (85%) | 17·6 (31·4);17 (63%) | 15·8 (28·0);19 (70%) | 17·6 (29·1);17 (63%) | 12·5 (16·7);16 (59%) | 19·0 (21·5);14 (52%) | |
| Non-randomised patients | .. | 3·7 (10·6);45 (74%) | 41·4 (33·7);37 (61%) | 27·4 (28·5);39 (64%) | 25·4 (27·3);38 (62%) | 22·9 (25·3);35 (57%) | 21·1 (30·9);30 (49%) | |
| Stool frequency§ | ||||||||
| Randomised patients | .. | 9·4 (12·1);23 (85%) | 26·5 (21·3);17 (63%) | 18·4 (19·2);19 (70%) | 18·5 (17·0);18 (67%) | 14·6 (14·8);16 (59%) | 14·3 (15·8);14 (52%) | |
| Non-randomised patients | .. | 13·7 (17·1);45 (74%) | 27·6 (22·0);38 (62%) | 22·2 (16·8);39 (64%) | 21·9 (22·6);38 (62%) | 18·5 (18·6);36 (59%) | 21·4 (20·2);28 (46%) | |
| Embarrassment about bowel function§ | ||||||||
| Randomised patients | .. | 5·8 (12·9);23 (85%) | 17·6 (33·6);17 (63%) | 12·3 (25·4);19 (70%) | 16·7 (26·2);18 (67%) | 10·4 (23·5);16 (59%) | 7·1 (14·2);14 (52%) | |
| Non-randomised patients | .. | 2·2 (8·4);45 (74%) | 30·6 (32·8);37 (61%) | 23·1 (34·3);39 (64%) | 22·8 (30·1);38 (62%) | 25·0 (33·2);36 (59%) | 27·2 (34·6);27 (44%) | |
| Anal, rectal, or buttock pain | ||||||||
| Randomised patients | .. | 3·8 (10·9);26 (96%) | 14·0 (25·6);19 (70%) | 10·0 (19·0);20 (74%) | 5·0 (12·2);20 (74%) | 13·3 (19·9);20 (74%) | 7·1 (14·2);14 (52%) | |
| Non-randomised patients | .. | 8·2 (19·5);53 (87%) | 17·5 (29·2);40 (66%) | 11·1 (21·7);42 (69%) | 7·9 (19·2);42 (69%) | 6·5 (18·6);41 (67%) | 10·5 (22·5);35 (57%) | |
| Blood and mucus in stool | ||||||||
| Randomised patients | .. | 16·7 (20·5);26 (96%) | 8·8 (14·0);19 (70%) | 6·7 (12·6);20 (74%) | 5·0 (7·8);20 (74%) | 5·8 (16·5);20 (74%) | 2·4 (6·1);14 (52%) | |
| Non-randomised patients | .. | 21·7 (25·4);53 (87%) | 17·9 (22·2);41 (67%) | 11·5 (17·5);42 (69%) | 4·8 (9·2);42 (69%) | 5·3 (10·2);41 (67%) | 11·0 (14·5);35 (57%) | |
| Impotence | ||||||||
| Randomised patients | .. | 31·4 (32·2);17 (63%) | 36·4 (37·9);11 (41%) | 42·9 (30·5;14 (52%) | 51·3 (37·6);13 (48%) | 48·1 (44·4);9 (33%) | 48·5 (45·6);11 (41%) | |
| Non-randomised patients | .. | 44·0 (42·6);28 (46%) | 55·6 (43·4);27 (44%) | 56·8 (45·1);27 (44%) | 51·2 (44·9);28 (46%) | 57·6 (41·4);22 (36%) | 61·9 (36·6);14 (23%) | |
| Dyspareunia | ||||||||
| Randomised patients | .. | 0·0 (0·0);4 (15%) | 8·3 (16·7);4 (15%) | 0·0 (0·0);2 (7%) | 0·0 (0·0);2 (7%) | 22·2 (38·5);3 (11%) | 0·0 (0·0);2 (7%) | |
| Non-randomised patients | .. | 6·7 (21·1);10 (16%) | 22·2 (38·5);3 (5%) | 8·3 (15·4);8 (13%) | 10·0 (31·6);10 (16%) | 18·5 (33·8);9 (15%) | 12·5 (35·4);8 (13%) | |
| Body image issues† | ||||||||
| Randomised patients | .. | 94·7 (10·2);25 (93%) | 93·6 (10·0);19 (70%) | 94·7 (8·7);20 (74%) | 94·2 (8·6);19 (70%) | 93·3 (9·8);20 (74%) | 92·1 (10·2);14 (52%) | |
| Non-randomised patients | .. | 89·3 (16·5);52 (85%) | 83·9 (22·8);40 (66%) | 82·9 (13·9);42 (69%) | 86·5 (18·3);42 (69%) | 88·8 (17·2);41 (67%) | 83·7 (29·8);35 (57%) | |
| Sexual interest (male)† | ||||||||
| Randomised patients | .. | 43·1 (28·3);17 (63%) | 25·6 (24·2);13 (48%) | 35·7 (20·5);14 (52%) | 31·0 (20·5);14 (52%) | 30·8 (31·8);13 (48%) | 21·2 (22·5);11 (41%) | |
| Non-randomised patients | .. | 28·9 (25·9);30 (49%) | 23·3 (25·0);30 (49%) | 33·3 (32·7);28 (46%) | 28·7 (35·3);29 (48%) | 33·3 (35·8);27 (44%) | 36·5 (34·8);21 (34%) | |
| Sexual interest (female)† | ||||||||
| Randomised patients | .. | 13·3 (29·8);5 (19%) | 0·0 (0·0);5 (19%) | 0·0 (0·0);4 (15%) | 0·0 (0·0);2 (7%) | 11·1 (19·2);3 (11%) | 0·0 (0·0);2 (7%) | |
| Non-randomised patients | .. | 11·1 (20·6);15 (25%) | 0·0 (0·0);6 (10%) | 13·3 (23·3);10 (16%) | 10·0 (16·1);10 (16%) | 20·5 (32·0);13 (21%) | 12·1 (22·5);11 (18%) | |
| Colorectal Functional Outcome scores | ||||||||
| Incontinence§ | ||||||||
| Randomised patients | .. | 9·5 (21·5);24 (89%) | 17·0 (29·1);18 (67%) | 14·1 (27·5);17 (63%) | 12·8 (24·5);19 (70%) | 14·4 (26·1);20 (74%) | 18·0 (28·4);14 (52%) | |
| Non-randomised patients | .. | 14·1 (27·9);47 (77%) | 30·6 (37·7);38 (62%) | 24·2 (33·9);42 (69%) | 23·3 (32·5);40 (66%) | 20·6 (31·0);42 (69%) | 22·3 (34·0);34 (56%) | |
| Social impact§ | ||||||||
| Randomised patients | .. | 13·1 (24·0);24 (89%) | 24·0 (34·4);18 (67%) | 18·8 (30·5);17 (63%) | 14·6 (26·7);19 (70%) | 22·1 (30·7);20 (74%) | 26·2 (32·3);14 (52%) | |
| Non-randomised patients | .. | 15·6 (26·4);47 (77%) | 31·0 (37·0);38 (62%) | 27·2 (33·5);42 (69%) | 24·1 (31·8);40 (66%) | 21·7 (29·9);42 (69%) | 23·0 (31·6);35 (57%) | |
| Bowel frequency§ | ||||||||
| Randomised patients | .. | 10·4 (15·3);24 (89%) | 18·1 (21·2);18 (67%) | 13·9 (19·3);18 (67%) | 16·2 (20·3);17 (63%) | 18·1 (20·4);18 (67%) | 14·4 (14·4);13 (48%) | |
| Non-randomised patients | .. | 12·5 (19·3);47 (77%) | 20·7 (22·7);38 (62%) | 15·8 (20·1);42 (69%) | 17·4 (19·8);40 (66%) | 15·2 (16·6);41 (69%) | 16·1 (19·1);35 (57%) | |
| Stool-related aspects§ | ||||||||
| Randomised patients | .. | 14·9 (26·2);24 (89%) | 7·9 (21·1);18 (67%) | 3·3 (14·7);18 (67%) | 2·3 (12·0);19 (70%) | 3·2 (11·8);19 (70%) | 6·2 (18·6);14 (52%) | |
| Non-randomised patients | .. | 17·3 (28·4);47 (77%) | 13·5 (25·9);38 (62%) | 9·5 (17·8);41 (67%) | 10·8 (22·2);40 (66%) | 9·7 (22·5);42 (69%) | 11·1 (25·1);35 (57%) | |
| Need for medication§ | ||||||||
| Randomised patients | .. | 3·3 (15·4);23 (85%) | 18·8 (32·0);18 (67%) | 6·4 (21·1);17 (63%) | 13·2 (25·9);19 (70%) | 13·6 (29·5);19 (70%) | 20·8 (35·3);14 (52%) | |
| Non-randomised patients | .. | 11·7 (25·7);45 (74%) | 16·0 (30·8);36 (59%) | 14·1 (29·8);41 (67%) | 15·8 (31·6);40 (66%) | 20·2 (32·9);40 (66%) | 9·3 (25·4);33 (54%) | |
| Total§ | ||||||||
| Randomised patients | .. | 10·7 (22·1);24 (89%) | 18·6 (30·4);18 (67%) | 13·5 (26·6);18 (67%) | 12·5 (24·3);19 (70%) | 15·9 (27·2);20 (74%) | 19·6 (29·5);14 (52%) | |
| Non-randomised patients | .. | 14·6 (26·6);47 (77%) | 26·3 (35·1);38 (62%) | 21·7 (31·5);42 (69%) | 20·8 (30·6);40 (66%) | 19·2 (29·3);42 (69%) | 19·2 (30·7);35 (57%) | |
Data are mean (SD); n (%), unless otherwise indicated. For scaled items, if at least half of the items from the scale were answered, the missing items were assumed to have values equal to the mean of those items, which were present for that respondent (EORTC QLQ-C30 scoring manual). EORTC=European Organisation for Research and Treatment of Cancer. QLQ=quality of life. C30=core module. EQ-5D-3L=EuroQol-5 Dimensions-3 Level. C29=colorectal cancer module.
*
Data from a cohort of age-matched individuals without a cancer diagnosis from the UK general population.
†
For function scores, higher scores indicated improved function (0–100); with symptoms, higher scores indicated worse symptoms (0–100).
‡
EQ-5D-3L data from an aged-matched patient population.
§
Scores for patients with and without a stoma combined.