Louis S Matza1, Katherine Kim2, Glenn Phillips3, Kelsey Zorn4, Kitty S Chan5, Katherine C Smith6, Ellen M Mowry7. 1. Evidera, Bethesda, MD, USA. Electronic address: louis.matza@evidera.com. 2. Formerly employed by Evidera, Bethesda, MD, USA. Electronic address: kim.katherinej@gmail.com. 3. Akcea Therapeutics, Cambridge, MA, USA. Electronic address: gphillips@akceatx.com. 4. Akcea Therapeutics, Cambridge, MA, USA. Electronic address: Kelsey.zorn@ucsf.edu. 5. Akcea Therapeutics, Cambridge, MA, USA. Electronic address: Kitty.S.Chan@medstar.net. 6. Akcea Therapeutics, Cambridge, MA, USA. Electronic address: ksmit103@jhu.edu. 7. Akcea Therapeutics, Cambridge, MA, USA. Electronic address: emowry1@jhmi.edu.
Abstract
BACKGROUND: In patients with relapsing forms of multiple sclerosis (MS), relapses are often unrecognized. These missed relapses have broad implications for the conduct of clinical trials as well as for the care and prognosis of people with multiple sclerosis (MS). With the ultimate goal of developing new methods to identify relapse, the purpose of this qualitative research with patients and clinicians was to examine the definition, symptoms, and impact of relapse. METHODS: This qualitative study involved semi-structured interviews with clinicians specializing in MS and people with relapsing-remitting (RR) MS. A brief literature review was conducted to inform the development of interview guides. Qualitative data were gathered from 10 clinicians in a series of individual interviews and one focus group, followed by a series of interviews with 20 patients. Thematic analysis was conducted using ATLAS.ti to identify concepts emerging from the interviews. RESULTS: Both clinicians and people with MS tend to describe classic neurologic symptoms that are confirmable on exam as indicative of relapses (e.g., sensory changes, vision issues, and walking difficulties), while also acknowledging that several less quantifiable symptoms are common (e.g., fatigue, pain, and cognitive issues). Patients described far-reaching impacts of relapse beyond just the quantifiable manifestations of the disease evaluated by commonly-used measures of MS severity and disability. CONCLUSION: MS relapses, which have substantial impact on patient functioning, appear to include symptoms beyond those in typical definitions of relapse. Incorporating such constructs into new measures of relapse could lead to improved recognition of relapse episodes.
BACKGROUND: In patients with relapsing forms of multiple sclerosis (MS), relapses are often unrecognized. These missed relapses have broad implications for the conduct of clinical trials as well as for the care and prognosis of people with multiple sclerosis (MS). With the ultimate goal of developing new methods to identify relapse, the purpose of this qualitative research with patients and clinicians was to examine the definition, symptoms, and impact of relapse. METHODS: This qualitative study involved semi-structured interviews with clinicians specializing in MS and people with relapsing-remitting (RR) MS. A brief literature review was conducted to inform the development of interview guides. Qualitative data were gathered from 10 clinicians in a series of individual interviews and one focus group, followed by a series of interviews with 20 patients. Thematic analysis was conducted using ATLAS.ti to identify concepts emerging from the interviews. RESULTS: Both clinicians and people with MS tend to describe classic neurologic symptoms that are confirmable on exam as indicative of relapses (e.g., sensory changes, vision issues, and walking difficulties), while also acknowledging that several less quantifiable symptoms are common (e.g., fatigue, pain, and cognitive issues). Patients described far-reaching impacts of relapse beyond just the quantifiable manifestations of the disease evaluated by commonly-used measures of MS severity and disability. CONCLUSION: MS relapses, which have substantial impact on patient functioning, appear to include symptoms beyond those in typical definitions of relapse. Incorporating such constructs into new measures of relapse could lead to improved recognition of relapse episodes.
Authors: Andrew J Solomon; Georgina Arrambide; Wallace Brownlee; Anne H Cross; María I Gaitan; Fred D Lublin; Naila Makhani; Ellen M Mowry; Daniel S Reich; Àlex Rovira; Brian G Weinshenker; Jeffrey A Cohen Journal: Neurol Clin Pract Date: 2022-06
Authors: Elisabeth G Celius; Heidi Thompson; Maija Pontaga; Dawn Langdon; Alice Laroni; Stanca Potra; Trishna Bharadia; David Yeandle; Jane Shanahan; Pieter van Galen; Nektaria Alexandri; Jürg Kesselring Journal: Patient Prefer Adherence Date: 2021-01-08 Impact factor: 2.711