OBJECTIVE: To compare being on-, or off-, a randomized controlled trial (RCT) for the same intervention.
DESIGN: 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. 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.
CONCLUSION: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.
We have always believed that it is be better to be part of a trial than not as you invariably will get some placebo effect even if you do not get the active drug. The Hawthorne effect is a form of reaction whereby subjects improve or modify an aspect of their behaviior being experimentally measured simply in response to the fact that they know they are being studied,not in response to any particular experimental manipulation.