title: It is better to be in a clinical trial than not: lessons learnt from clinical neurology--the management of acute multiple sclerosis relapses.
abstract: OBJECTIVE
  To compare being on-, or off-, a randomized controlled trial (RCT) for the same intervention.
  
  
  METHODS
  Cohort study.
  
  
  METHODS
  Ambulatory outpatient clinic in a clinical neurosciences centre.
  
  
  METHODS
  Patients experiencing a clinically significant multiple sclerosis (MS) relapse, who received a 3-day regimen of intravenous methylprednisolone as an ambulatory outpatient, were compared with a similar group of patients who had previously been treated exactly in the same way while participating in a RCT.
  
  
  METHODS
  The Multiple Sclerosis Relapse Management Scale (MSRMS) was used to measure patients' experiences of relapse management in both groups. The two groups were compared under four main headings: interpersonal care, access to care, information and coordination of care.
  
  
  RESULTS
  The principal finding was that interpersonal care was significantly worse in the off-trial group (P = 0.0001), implying a beneficial trial effect on patient experience.
  
  
  CONCLUSIONS
  The effect observed is likely secondary to trial participation; both groups had similar baseline features, and were treated in the same way. Likely mechanisms for the differences are protocol, care and Hawthorne effects. The findings support the incorporation of structured RCT-style practice into routine clinical management, in order to deliver a more patient-centred care in the treatment of MS relapses. This may have implications for other chronic neurological diseases.
authors.affiliation: National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust, Queen Square, London WC1N 3BG, UK. nualaamcnicholas@physicians.ie
authors.forename: N
authors.initials: N
authors.lastname: McNicholas
authors.forename: A
authors.initials: A
authors.lastname: Patel
authors.forename: J
authors.initials: J
authors.lastname: Chataway
mesh_terms: D000328:Adult; D000553:Ambulatory Care; D015331:Cohort Studies; D005260:Female; D006699:Home Care Services; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D018696:Neuroprotective Agents / Q000008:administration & dosage*; D017060:Patient Satisfaction; D011787:Quality of Health Care; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence
chemical_list: D018696:Neuroprotective Agents; D008775:Methylprednisolone