Increased contact with clinical trial participants may improve confirmed multiple sclerosis relapse detection.

BACKGROUND

Accurate accounting of relapses is critical for MS trials, but they are often under-detected.

OBJECTIVE

To evaluate whether scheduled check-ins with trial participants improve relapse capture.

METHODS

In 165 VIDAMS trial participants, we evaluated whether systematic between-visit contact in which coordinators asked specific questions about symptoms were temporally associated with detection of relapses.

RESULTS

The odds of detecting confirmed relapse in the 2 weeks after, versus the 2 weeks before, scheduled contact with coordinators were almost 3-fold higher (odds ratio (OR) = 2.93, 95% confidence interval (CI) = 1.3-6.60, p = 0.01).

CONCLUSIONS

Systematic symptom screening between study visits may improve relapse detection in MS trials.