title: Difficulties with recruiting into neurosurgical clinical trials: the Surgical Trial in IntraCerebral Haemorrhage II as an example.
abstract: BACKGROUND
  Spontaneous supratentorial intracerebral haemorrhage (ICH) is a devastating condition with a high morbidity and mortality, and uncertainty remains regarding the role of surgery in many cases. The Surgical Trial in IntraCerebral Haemorrhage II (STICH II) was initiated to look at subjects with superficial lobar ICH, as the initial STICH trial showed the greatest benefit from early surgery in this subgroup. Our aim was to estimate how many patients with ICH referred to the Greater Manchester Neurosciences Centre (GMNC) met the inclusion and exclusion criteria of the STICH II trial.
  
  
  METHODS
  The number of patients eligible for STICH II was determined from the GMNC referral database and admissions to the stroke unit over 1 year (2008). Eligibility was determined by predefined criteria, and equipoise was agreed by two consultant neurosurgeons.
  
  
  RESULTS
  One hundred and sixty-eight (38.7%) of 434 ICH referrals were lobar ICH; 53 (31.5% of lobar ICH) of these met the radiological and Glasgow Coma Scale (GCS) criteria for STICH II, but only 16 (9.5% of lobar ICH; 3.7% of all ICH) had equipoise agreed on by two neurosurgeons. Thirty-five ICH patients were admitted to the stroke unit, and 12 (34.3%) of these had lobar ICH; none were eligible for STICH II.
  
  
  CONCLUSIONS
  The number of patients eligible for recruitment into STICH II is small, necessitating an aggressive recruitment approach. Recruitment should focus on neuroscience centres with neurosurgical units as opposed to stroke units.
authors.affiliation: Brain Injury Research Group, The University of Manchester, Greater Manchester Neurosciences Centre, Salford Royal NHS Foundation Trust, Salford, UK. matthew.kirkman@doctors.org.uk
authors.forename: Matthew Anthony
authors.initials: MA
authors.lastname: Kirkman
authors.forename: Naomi
authors.initials: N
authors.lastname: Greenwood
authors.forename: Navneet
authors.initials: N
authors.lastname: Singh
authors.forename: Pippa J
authors.initials: PJ
authors.lastname: Tyrrell
authors.forename: Andrew T
authors.initials: AT
authors.lastname: King
authors.forename: Hiren C
authors.initials: HC
authors.lastname: Patel
mesh_terms: D002543:Cerebral Hemorrhage / Q000453:epidemiology / Q000601:surgery*; D003399:Craniotomy / Q000706:statistics & numerical data*; D016208:Databases, Factual; D004739:England / Q000453:epidemiology; D005260:Female; D015600:Glasgow Coma Scale; D006406:Hematoma / Q000453:epidemiology / Q000601:surgery*; D006801:Humans; D008297:Male; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012017:Referral and Consultation / Q000706:statistics & numerical data*