Patients, Physicians Largely Agree on Presence of MS Relapse, Analysis Finds

The voice and preferences of the patient have become increasingly important in healthcare decisions as well as for endpoints in studies for a myriad of conditions, including multiple sclerosis (MS). However, more data comparing patient-reported relapses with physician-documented relapses is needed.

Seeking this out, researchers compared 2 years’ worth of data from 2 prospective, noninterventional, multicenter studies in Germany, finding that patients and physicians data on the occurrence of MS relapse was generally in line, although patients on average reported more relapses.

The 2 studies were comprised of 1921 patients with relapsing remitting MS being treated with interferon-beta preparations, glatiramer acetate, or fingolimod. Every 3 months, both patients and their neurologists documented the presence and absence of relapses for an average of 2 years per patient.

Analyzing these assessments, the researchers of the current study found an overwhelming agreement between the 2 groups, with an absolute agreement of 96.7%. The researchers adjusted for chance and interrater reliability, determining a good agreement between patients and their neurologists (κ = 0.78, 95% CI, 0.76–0.80).

Generally, patients were more likely to report more relapses, with an average number of 0.55 relapses during follow-up compared with an average number of 0.44 physician-reported relapses. Overreporting of relapses was more common among patients who were younger and had greater disability levels, as well as lower health-related quality of life or treatment satisfaction.

The overreporting by patients could be explained by pseudo-relapses, which are characterized by symptoms representing physiological processes other than true relapses, according to the researchers. While differential diagnoses are considered by the neurologist in clinical practice, patients might interpret pseudo-relapses, symptom fluctuation, or single paroxysmal symptoms as true relapses.

However, despite the slight difference in relapse reporting, both the patient- and neurologist-reported relapses were in concurrence with the ranges observed in previous studies, noted the researchers.

“Not only do definitions of what constitutes a relapse differ, but also fixed protocol definitions can remain susceptible to varying interpretations by physicians, especially at different levels of clinical experience,” noted the researchers, reflecting on the difference in reporting. “To date, there is no ‘gold standard’ for MS relapse that ensures a fully objective relapse assessment. Whether in clinical trials or in clinical practice, relapses may be undetected, and even experienced MS clinicians may sometimes have difficulty in identifying relapses.”

Reference

Schriefer D, Haase R, Ettle B, Ziemssen T. Patient- versus physician-reported relapses in multiple sclerosis: insights from a large observational study. Eur J Neurol. Published online July 9, 2020. doi: 10.1111/ene.14432.