Table 2 Reasons for withdrawal and exclusion for patients in NHS sites A, B, D and E
Reasons for withdrawal and exclusion from invitation to first clinical assessment | 1520 |
Did not confirm interest | 963 |
No sciatica | 210 |
Symptoms persisting for longer than 6 months | 173 |
Widespread pain throughout body | 25 |
No response or no longer interested | 23 |
No leg pain | 20 |
Complicated symptoms | 18 |
Previous lumbar spinal surgery | 16 |
Trial closed early to recruitment | 14 |
Previous surgery | 11 |
Symptoms resolved/improved | 10 |
Pain in both legs | 7 |
Contraindications to MRI | 6 |
Expressed interest but delay in telescreening due to site staffing issues means no longer meet criteria for inclusion (e.g. no longer in pain or have recently breached the > 22-week exclusion window since replying) | 6 |
Serious spinal pathology | 4 |
Unable to communicate in English or Welsh | 3 |
Mental health problems | 3 |
Current leg pain worse than or as bad as back pain | 3 |
Previous episode of sciatica in the last 6 months | 2 |
Incidental serious pathology identified by MRI | 1 |
Previous use of biological agents targeting TNF-α | 1 |
Contraindications to adalimumab | 1 |
Pregnant or breastfeeding | 1 |
Reasons for withdrawal and exclusion from first clinical assessment to second clinical assessment | 17 |
Mild symptoms – discharged to GP care | 7 |
Study closure | 5 |
Over time limit for second clinical assessment | 1 |
TB screening failed | 1 |
Participant revealed long term history of widespread pain at screening – particularly in shoulders | 1 |
No positive neurological test | 1 |
Patient did not attend appointment and could not be contacted | 1 |
Reasons for withdrawal and exclusion from 6-week follow-up to 6-month follow-up | 4 |
Study closure | 4 |