Determining MS Relapses in Clinical Practice: How Do Clinicians Decide?

Background: Relapsing-remitting multiple sclerosis (RRMS) is a complex condition in which patients experience episodic worsening of neurologic symptoms, known as "relapses.” In MS clinical trials, to be considered a “true” relapse, patients must have symptoms and a documented change in the neurologic examination. However, subjective symptoms that are not typically incorporated into the neurologic exam, such as fatigue, commonly worsen during relapses and are of great concern for patients.

Objectives: Using interview transcripts conducted to examine how MS specialists determine if a person with MS is experiencing a relapse in clinical practice, we evaluated how clinicians incorporate patients’ reports into their determination of whether a relapse has occurred.

Methods: Interviews were conducted with 10 MS specialists (nine neurologists and one nurse practitioner). Seven were interviewed one-on-one, while three were interviewed in a focus group setting. All interviews were conducted with the same interview guide, designed to explore how MS specialists establish relapses in their clinic patients.

Results: The specialists presented the process of identifying MS relapses in the clinical setting as complex, defying simple explanations. Clinicians reported taking the patients’ self-reported symptoms as the starting point for considering relapse, and some determine that a relapse had occurred without an in-person evaluation. Regardless of whether an in-person evaluation occurs, clinicians are more confident that a relapse has occurred when symptoms or signs are anatomically localizable within the nervous system (e.g. sensory level) than when symptoms are more diffuse or subjective (e.g. worsening fatigue or cognition).

Conclusions: Even in the clinical setting, MS specialists find it easier to determine a relapse has occurred when symptoms or signs point clearly to an anatomical lesion within the nervous system. While acknowledging the importance of the patient’s perspective, clinicians were less confident that a relapse was occurring when symptoms did not fit into this construct. However, an increase in diffuse symptoms such as fatigue is common during relapses. Given that subclinical central nervous system lesions occur at a much higher rate than confirmed relapses, further work should evaluate if new inflammatory lesions are detectable during discrete episodes of worsening diffuse symptoms even without changes in the neurologic exam.

Study supported by Biogen.