The FLUENT study design: investigating immune cell subset and neurofilament changes in patients with relapsing multiple sclerosis treated with fingolimod.

BACKGROUND: Fingolimod is a sphingosine 1-phosphate receptor modulator for the treatment of patients with relapsing forms of multiple sclerosis (RMS). Fingolimod sequesters lymphocytes within lymphoid tissue thereby reducing the counts of circulating lymphocytes. However, fingolimod's effects on the innate and adaptive components of the immune system are incompletely understood. OBJECTIVE: The FLUENT study will investigate temporal changes in circulating immune cell subsets in patients with RMS treated with fingolimod. Secondary objectives include examining the association between anti-John Cunningham virus (JCV) antibody status/index and phenotypic changes in innate and T and B cell subsets in patients on fingolimod therapy, and the association between serum neurofilament levels and clinical outcomes. METHODS: FLUENT is a prospective, multicenter, two-cohort, nonrandomized, open-label Phase IV study. Cohort 1 will include fingolimod-naïve patients and Cohort 2 will include patients who have received fingolimod 0.5 mg/day continuously for ≥2 years. Changes in the cellular components of the innate and adaptive immune system will be characterized over 12 months. RESULTS: The study is ongoing. CONCLUSION: FLUENT may provide evidence for the use of immunologic profiling in predicting efficacy and risk of infection in patients with RMS treated with fingolimod.

Does waiver of written informed consent from the institutional review board affect response rate in a low-risk research study?

BACKGROUND: Requiring written informed consent for a minimal-risk survey may result in limited participation rates. METHODS: Data from a cross-sectional survey of 177 older patients (87 blacks and 90 whites) with hypertension enrolled in the managed care Medicare risk product were used to assess participation rates pre- and postwaiver of written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. Prior to the waivers being granted, patients were contacted two times via mail with an introductory letter and an informed consent document. Those who completed and returned the informed consent document were administered the questionnaire. After 6 weeks, a waiver of written informed consent and HIPAA authorization was obtained from the Institutional Review Board. Nonparticipants were reapproached and asked to complete the questionnaire. Participation rates were recorded before and after receiving the waivers. RESULTS: Participation rates increased from 21.5% in the prewaiver period to 57.4% in the postwaiver period (p < .001). Prewaiver participation differed by demographic subgroup and was higher among whites (26.7%) versus blacks (16.1%; p = .087), men (31.6%) versus women (16.7%; p = .024), and participants > or = 75 years old (28.4%) versus < 75 years old (14.6%; p = .025). In contrast, the postwaiver participation rate did not differ significantly across race, gender, or age subgroupings. Significant increases in participation rates from the pre- to the postwaiver time period were noted within each demographic subgroup (all p < .01). CONCLUSIONS: We identified a substantial increase in participation rates postwaiver of written informed consent and HIPAA authorization in a minimal-risk survey. The need for written documentation for minimal-risk surveys may negatively impact recruitment of blacks, women, and patients < 75 years old.

Reliability of a medication adherence measure in an outpatient setting.

BACKGROUND: Reliable approaches for measuring antihypertensive medication compliance in the outpatient setting are not readily available. The objective of the current study was to determine the reliability of the Hill-Bone Compliance Scale among elderly hypertensive patients. METHODS: We conducted a cross-sectional survey of community-dwelling patients attending the hypertension section of the Internal Medicine Clinic in a large multispecialty group practice. Participants (n=239) completed a self-administered questionnaire consisting of demographic questions and the Hill-Bone Compliance to High Blood Pressure Therapy Scale, which includes a nine-item medication compliance subscale. RESULTS: The mean age of respondents was 69 years; 51% of patients were men, 73% were white, 86% had at least a high school education, and 61% were married. The Cronbach alpha was 0.68 for the medication compliance subscale. All nine items of the medication compliance subscale maintained higher correlations with their own subscale total than with the salt intake and appointment keeping subscale totals. After adjusting for other demographic variables, the odds ratio (95% confidence interval) of perfect medication compliance as reported on the medication compliance subscale was 1.71 (0.95-3.07) for participants 65 years of age and older versus those younger than 65 years of age, 2.53 (1.37-4.66) for whites versus nonwhites, 1.27 (0.73-2.20) for males versus females, 1.30 (0.73-2.29) for married versus unmarried participants, and 1.63 (0.74-3.62) for those with at least a high school education versus those with less education. CONCLUSION: The medication compliance subscale of the Hill-Bone Compliance Scale appears reliable and may be a useful tool for detecting noncompliant patients in outpatient settings.