PURPOSE: Patient 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).
METHODS: We 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 1.2) 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.
RESULTS: Domains of the TSQM demonstrated evidence of strong internal consistency at baseline and at 12 weeks (Cronbach α=0.89-0.93). Transition from iILO to iTRE was associated with an improvement in 3 of 4 TSQM domains: effectiveness (+20 ± 20, p<0.0001), side effects (0 ± 22, p=0.97), convenience (+39 ± 26, p<0.0001), and global satisfaction (+16 ± 35, 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).
CONCLUSIONS: The TSQM scores correlated with 6MWD and adverse events in the expected manner supporting its validity as a measure of treatment satisfaction in PAH. Changes in treatment satisfaction resulting from transitioning from iILO to iTRE were associated with improvements in PAH-specific QoL.
CLINICAL IMPLICATIONS: TSQM may be a useful tool for assessing treatment satisfaction in PAH.
DISCLOSURE: Hubert Chen: Consultant fee, speaker bureau, advisory committee, etc.: United Therapeutics, Grant monies (from industry related sources): Pfizer
Erika Rosenzweig: Grant monies (from industry related sources): United Therapeutics, Consultant fee, speaker bureau, advisory committee, etc.: United Therapeutics
Karl Gotzkowsky: Employee: United Therapeutics
Carl Arneson: Employee: United Therapeutics
Andrew Nelsen: Employee: United Therapeutics
Robert Bourge: Grant monies (from industry related sources): United Therapeutics, Consultant fee, speaker bureau, advisory committee, etc.: United Therapeutics, Grant monies (from industry related sources): Actelion, Consultant fee, speaker bureau, advisory committee, etc.: Actelion
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