Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study.

Background: The demographics and management of patients with multiple sclerosis (MS) differ across geographical regions, but it is unclear whether/how these differences affect treatment outcomes. The aim of this post-hoc analysis was to assess teriflunomide use and patient-reported outcomes in the United States (US) and the rest of the world (ROW) in the phase 4 Teri-PRO study (NCT01895335).

Methods: In the phase 4, real-world, Teri-PRO study, patients with relapsing forms of MS received teriflunomide for 48 weeks according to local labeling.

Patient-reported outcomes in patients with relapsing forms of MS switching to teriflunomide from other disease-modifying therapies: Results from the global Phase 4 Teri-PRO study in routine clinical practice.

Background: Patient-reported outcomes (PROs) can assist clinicians in understanding the impact of disease-modifying therapy (DMT) on the daily lives of patients with multiple sclerosis (MS). With an increased number of DMTs becoming available, patients are now switching treatments more frequently in clinical practice. The effects of switching DMTs on a patient's daily life and their disease course may be reflected in PROs.

Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study.

Background: Patient-reported outcomes (PROs) provide clinicians with further understanding of the impact of treatment on patients' daily lives. In addition, real-world studies, which employ broader inclusion criteria than randomized trials, may help to inform prescribing decisions when selecting a disease-modifying therapy (DMT) to treat relapsing forms of MS (RMS). We sought to use PROs to determine patient treatment satisfaction and other treatment outcomes, and report safety and tolerability associated with teriflunomide, in the global, phase 4 Teri-PRO study (NCT01895335).

Adolescent smokers screened for a nicotine replacement treatment trial: correlates of eligibility and enrollment.

The enrollment process determines the study sample and external validity of clinical trial results; however, few reports describe the process and outcome of screening efforts for smoking cessation studies among adolescents. We describe and evaluate a screening protocol to enroll adolescent smokers for a randomized clinical trial of nicotine replacement therapy. Adolescent smokers obtained the recruitment call-in number (1-800-NO-SMOKE) via media and other advertisements.

Safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction.

Objectives: To determine the safety and efficacy of the nicotine patch and gum for adolescents who want to quit smoking.

Design: Double-blind, double-dummy, randomized, 3-arm trial with a nicotine patch (21 mg), nicotine gum (2 and 4 mg), or a placebo patch and gum; all participants received cognitive-behavioral group therapy.

Setting: Inner-city, outpatient clinic on the East Coast.

Smoking topography and trajectory of asthmatic adolescents requesting cessation treatment.

Background: Teenage smokers cite health concerns as their primary motivators for tobacco smoking cessation. Smoke exposure aggravates the clinical course of asthma, yet few reports have examined the association between asthma and smoking topography and trajectory.

Methods: Before their enrollment in a smoking cessation trial, we assessed the smoking topography (i.

Tobacco smoking trajectory and associated ethnic differences among adolescent smokers seeking cessation treatment.

Purpose: To examine smoking trajectories in a clinical sample of adolescent smokers seeking cessation treatment, including: (a) smoking onset (initial, daily) and time intervals from initial to daily smoking and from daily smoking to treatment request, (b) associations between current level of tobacco dependence and smoking history, and (c) differences in smoking trajectory between African-American and non-African-American youth.

Methods: Four hundred and thirty-two adolescent smokers (aged 13-17 years, 61.8% female, 32% African-American) responding to various media advertisement completed a telephone interview as part of pre-eligibility screening for a smoking cessation trial.

Characteristics of African American teenage smokers who request cessation treatment: implications for addressing health disparities.

Background: Ethnoracial disparities in both tobacco-related mortality and treatment outcome for smoking cessation have been reported among adults, but there is a dearth of information on ethnoracial differences among adolescent smokers.

Objective: To compare smoking-related characteristics in African American and non-African American teenaged applicants for a smoking cessation trial.

Participants, Design, And Setting: Four hundred thirty-two teenaged smokers (mean [SD] age, 15.