Patient-specific problems
| Potential problems | Severity of problem | Trial | Hospital type | Role type | ||||
|---|---|---|---|---|---|---|---|---|
| HOPON (n=27†) | PET-Neck (n=31) | SEND (n=27‡) | DGH (n=44§) | Teaching hospital (n=41¶) | Medical practitioners (n=49¶) | Research nurses (n=22**) | ||
| Consent refusal because of expressed treatment | No problem | 7 (31) | 9 (29) | 2 (8) | 10 (24) | 8 (21) | 5 (11) | 6 (29) |
| Mild | 6 (26) | 13 (42) | 6 (23) | 16 (39) | 9 (23) | 16 (34) | 7 (33) | |
| Moderate | 9 (39) | 4 (13) | 14 (54) | 11 (27) | 16 (41) | 20 (43) | 5 (24) | |
| Severe | 1 (4) | 5 (16) | 4 (15) | 4 (10) | 6 (15) | 6 (13) | 3 (14) | |
| p Value* | 0.03 | 0.35 | 0.17 | |||||
| Consent refusal because of aversion to randomisation | No problem | 9 (39) | 15 (48) | 3 (12) | 18 (44) | 9 (23) | 9 (19) | 12 (57) |
| Mild | 9 (39) | 12 (39) | 10 (38) | 14 (34) | 17 (44) | 21 (45) | 6 (29) | |
| Moderate | 5 (22) | 3 (10) | 11 (42) | 8 (20) | 11 (28) | 14 (30) | 3 (14) | |
| Severe | 0 (0) | 1 (3) | 2 (8) | 1 (2) | 2 (5) | 3 (6) | 0 (0) | |
| p Value* | 0.002 | 0.28 | 0.003 | |||||
| Concerns about safety of either of trial treatments | No problem | 13 (56) | 22 (71) | 13 (50) | 27 (66) | 21 (54) | 24 (51) | 17 (81) |
| Mild | 8 (35) | 8 (26) | 9 (35) | 11 (27) | 14 (36) | 19 (40) | 3 (14) | |
| Moderate | 2 (9) | 1 (3) | 4 (15) | 3 (7) | 4 (10) | 4 (9) | 1 (5) | |
| Severe | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| p Value* | 0.19 | 0.59 | 0.04 | |||||
| Additional trial demands such as travelling and extra appointments | No problem | 6 (26) | 18 (58) | 16 (64) | 18 (44) | 22 (58) | 19 (41) | 13 (62) |
| Mild | 7 (31) | 10 (32) | 7 (28) | 14 (34) | 10 (26) | 18 (39) | 5 (24) | |
| Moderate | 6 (26) | 2 (6) | 2 (8) | 7 (17) | 3 (8) | 6 (13) | 2 (10) | |
| Severe | 4 (17) | 1 (3) | 0 (0) | 2 (5) | 3 (8) | 3 (7) | 1 (5) | |
| p Value* | 0.002 | 0.02 | 0.54 | |||||
| Additional financial costs to the patient because of the trial | No problem | 13 (57) | 22 (71) | 18 (72) | 26 (63) | 27 (71) | 29 (63) | 15 (71) |
| Mild | 7 (30) | 7 (23) | 5 (20) | 12 (29) | 7 (18) | 12 (26) | 5 (24) | |
| Moderate | 2 (9) | 2 (6) | 2 (8) | 3 (7) | 3 (8) | 4 (9) | 1 (5) | |
| Severe | 1 (4) | 0 (0) | 0 (0) | 0 (0) | 1 (3) | 1 (2) | 0 (0) | |
| p Value* | 0.41 | 0.4 | 0.63 | |||||
| Language or cultural barrier | No problem | 18 (78) | 25 (81) | 22 (85) | 35 (85) | 30 (77) | 35 (74) | 20 (95) |
| Mild | 5 (22) | 6 (19) | 3 (12) | 6 (15) | 8 (21) | 12 (26) | 0 (0) | |
| Moderate | 0 (0) | 0 (0) | 1 (4) | 0 (0) | 1 (3) | 0 (0) | 1 (5) | |
| Severe | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| p Value* | 0.88 | 0.28 | 0.07 | |||||
*p Value from ordinal logistic regression model (adjusted for trial in hospital type and role type analyses).
†Four missing responses.
‡One or two missing responses.
§Three missing responses.
¶Two or three missing responses.
**One missing response.
DGH, district general hospital; HOPON, Hyperbaric Oxygen in the Prevention of Osteoradionecrosis; SEND, Selective Elective Neck Dissection.