Abstract
BackgroundPatient treatment satisfaction is likely to be a highly relevant outcome measure in pulmonary arterial hypertension (PAH), a condition for which the benefits of treatment must be weighed against frequent, undesirable side effects, inconvenience, and complications associated with therapy. In this study, we sought to evaluate the psychometric properties of a patient-reported treatment satisfaction measure and its relationship to quality of life (QoL) among patients transitioning from inhaled iloprost (iILO) to inhaled treprostinil (iTRE).MethodsWe studied treatment satisfaction among 66 subjects with PAH in a single-arm, open-label, multi-center trial of iTRE following transition from iILO. Treatment satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM, version 1.4) administered to subjects immediately before and 12 weeks after transition of inhaled therapy. The TSQM is comprised of 4 domains: effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100 with higher scores indicating greater satisfaction. Six-minute walk distance (6MWD), functional class, adverse events, drug administration time, and PAH-specific QoL (CAMPHOR) were concurrently assessed.ResultsDomains of the TSQM demonstrated evidence of strong internal consistency at baseline and at 12 weeks (Cronbach α = 0.88-0.93). Transition from iILO to iTRE was associated with an improvement in 3 of 4 TSQM domains: effectiveness (+20 ± 21, p < 0.0001), side effects (0 ± 22, p = 0.97), convenience (+39 ± 26, p < 0.0001), and global satisfaction (+20 ± 24, p = 0.0005). Change in effectiveness scores correlated with change in 6MWD (r = 0.43, p = 0.0004) and side effects scores at 12 weeks correlated inversely with number of severity-weighted treatment-emergent adverse events (r = −0.44, p = 0.0002). In multiple regression models adjusted for baseline characteristics, changes in effectiveness and convenience satisfaction scores were significantly associated with improvement in PAH-specific QoL (p = 0.002 and p = 0.01).ConclusionsThe TSQM demonstrated acceptable performance characteristics in patients with PAH. Changes in treatment satisfaction resulting from transitioning from iILO to iTRE were associated with improvements in PAH-specific QoL.
Highlights
Pulmonary arterial hypertension (PAH) is a life-threatening disorder of the pulmonary vasculature historically associated with poor survival [1]
Using data collected within the context of a clinical trial, we sought to evaluate the psychometric characteristics of the Treatment Satisfaction Questionnaire for Medication (TSQM) assessed among patients with pulmonary arterial hypertension (PAH) transitioning from inhaled iloprost to inhaled treprostinil
Subjects For this analysis, we utilized clinical and patient-reported outcome data obtained from a multicenter, prospective, open-label trial in patients with stable PAH rapidly transitioned from inhaled iloprost to inhaled treprostinil [17,18]
Summary
Subjects For this analysis, we utilized clinical and patient-reported outcome data obtained from a multicenter, prospective, open-label trial in patients with stable PAH rapidly transitioned from inhaled iloprost to inhaled treprostinil [17,18]. Study assessments Analysis was restricted to key outcomes of interest collected at baseline and week 12: 6MWD, QoL, treatment satisfaction, and medication administration time. Medication administration time was assessed using a drug administration activities survey for which patients were asked to provide information related to the frequency of daily administration activities and time required by each activity (e.g., gathering and setting up supplies, preparing drug delivery system, delivering inhalation treatment, and cleaning drug delivery system) for inhaled iloprost (baseline) and inhaled treprostinil (week 12). Convergent validity of TSQM domains was assessed in relation to absolute change in 6MWD from baseline to week 12, percent change in total medication administration time from baseline to week 12, and severity-weighted AE score calculated for all AEs collected up to week 12.
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