title: Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes.
abstract: BACKGROUND
  Data sources for MS research are numerous but rarely provide an objective measure of drug therapy compliance coupled with patient-reported health outcomes. The objective of this paper is to describe the methods and baseline characteristics of the Therapy Optimization in MS (TOP MS) study designed to investigate the relationship between disease-modifying therapy compliance and health outcomes.
  
  
  METHODS
  TOP MS was designed as a prospective, observational, nationwide patient-focused study using an internet portal for data entry. The protocol was reviewed and approved by Sterling IRB. The study was registered with ClinicalTrials.gov. It captured structured survey data monthly from MS patients recruited by specialty pharmacies. Data collection included the clinical characteristics of MS such as MS relapses. Disability, quality of life and work productivity and activity impairment were assessed quarterly with well-validated scales. When events like severe fatigue or new or worsening depression were reported, feedback was provided to treating physicians. The therapy compliance measure was derived from pharmacy drug shipment records uploaded to the study database. The data presented in this paper use descriptive statistics.
  
  
  RESULTS
  The TOP MS Study enrolled 2966 participants receiving their disease-modifying therapy (DMT) from specialty pharmacies. The mean age of the sample was 49 years, 80.4% were female, 89.9% were Caucasian and 55.7% were employed full or part time. Mean time since first symptoms was 11.5 years; mean duration since diagnosis was 9.5 years. Patient-reported EDSS was 3.5; 72.2% had a relapsing-remitting disease course. The most commonly reported symptoms at the time of enrollment were fatigue (74.7%), impaired coordination or balance (61.8%) and numbness and tingling (61.2%). Half of the sample was using glatiramer acetate and half was using beta-interferons.
  
  
  CONCLUSIONS
  Demographic and clinical characteristics of the TOP MS sample at enrollment are consistent with other community-based MS samples, and the sample appears to be representative of DMT users in the US. TOP MS data can be used to explore the associations between disease-modifying therapy compliance and health outcomes.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT00819000).
authors.forename: Patricia K
authors.initials: PK
authors.lastname: Coyle
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Cohen
authors.forename: Thomas
authors.initials: T
authors.lastname: Leist
authors.forename: Clyde
authors.initials: C
authors.lastname: Markowitz
authors.affiliation: Health Outcomes Research Consulting and Writing, Outcomes Scribe, LLC, 664 Wynding Oaks, Kalamazoo, MI 49006, USA. OutcomesScribe@gmail.com.
authors.forename: MerriKay
authors.initials: M
authors.lastname: Oleen-Burkey
authors.forename: Marc
authors.initials: M
authors.lastname: Schwartz
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Tullman
authors.forename: Howard
authors.initials: H
authors.lastname: Zwibel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D010349:Patient Compliance / Q000523:psychology; D011446:Prospective Studies; D016896:Treatment Outcome