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Table 2 Reasons for withdrawal and exclusion for patients in NHS sites A, B, D and E

From: Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC)

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
  1. Abbreviations: GP General practitioner, MRI Magnetic resonance imaging, NHS National Health Service, TB Tuberculosis, TNF Tumour necrosis factor