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. Design: Cohort study. Setting: Ambulatory outpatient clinic in a clinical neurosciences centre. Subjects: 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. Main outcome measures: 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. © The Author 2012. Published by Oxford University Press on behalf of the Association of Physicians. All rights reserved.