Abstract
BackgroundSymptom constructs included in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS®: COPD) tool may be relevant to patients with asthma. The purpose of this study was to evaluate content validity and psychometric performance of the E-RS: COPD in moderate/severe asthma patients.MethodsContent validity of the E-RS: COPD was evaluated in patients with moderate/severe asthma using concept elicitation and cognitive debriefing interviews. Secondary analyses using data from two clinical trials in patients with moderate/severe asthma evaluated the factor structure of the E-RS: COPD plus two supplementary items (wheeze; shortness of breath with strenuous physical activity) and assessed psychometric properties of the tool, which will be referred to as E-RS®: Asthma when used in asthma populations.ResultsQualitative interviews (N = 25) achieved concept saturation for asthma respiratory symptoms. Concepts in the E-RS: COPD were relevant to patients and instructions were understood. Most patients (19/25; 76%) reported experiencing all concepts in the E-RS: COPD; no patients indicated missing symptoms. Secondary analyses of clinical trial data supported the original factor structure (RS-Total and three symptom-specific subscales). The two supplemental items did not fit with this factor structure and were not retained. RS-Total and subscale score reliability was high (internal consistency [α] > 0.70). Validity was demonstrated through significant (P < 0.0001) relationships with the St George’s Respiratory Questionnaire (SGRQ) and Asthma Symptom Severity scale. E-RS: Asthma was responsive to change when evaluated using SGRQ, Patient Global Impression of Change and Asthma Quality of Life Questionnaire as anchors (P < 0.0001). Clinically meaningful change thresholds were also identified (RS-Total: − 2.0 units).ConclusionsThe E-RS: Asthma is reliable and responsive for evaluating respiratory symptoms in patients with moderate/severe asthma.
Highlights
Symptom constructs included in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS®: Chronic obstructive pulmonary disease (COPD)) tool may be relevant to patients with asthma
The psychometric properties of the tool, referred to as the E-RS: Asthma when used in asthma populations, was assessed using the best fitting factor structure
We hypothesized that the E-RS: COPD could be a suitable candidate for use in patients with asthma due to the overlap in symptoms reported in the literature and the use of other tools for the periodic assessment of asthma and COPD [7,8,9]
Summary
Symptom constructs included in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS®: COPD) tool may be relevant to patients with asthma. Respiratory symptoms are often only assessed periodically using diaries in individual studies, making betweenstudy comparisons difficult. This variation in methods used for symptom assessment indicates a need for improved patient-reported measures of symptomatic experience in asthma. The Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS®: COPD) measure is an 11-item patient-reported diary derived from the 14-item The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT®) [5]. The E-RS: COPD assesses the cardinal respiratory symptoms of COPD as a total score through three symptom-specific domains: cough and sputum, chest symptoms, and breathlessness [6]
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