Psychometric evaluation of the Dysphagia Symptom Questionnaire for adults and adolescents with eosinophilic esophagitis.

Background: Eosinophilic esophagitis (EoE) is a chronic, inflammatory disease of the esophagus leading to symptoms of esophageal dysfunction; dysphagia is the most common symptom experienced by adults and adolescents. Objective: We sought to perform a psychometric evaluation of the Dysphagia Symptom Questionnaire (DSQ), a patient-reported outcome measure for patients with EoE. Methods: Using baseline and week 24 data from the randomized, interventional, multinational phase 3 R668-EE-1774 trial (NCT03633617), the measurement properties of the DSQ-including reliability, construct and known-groups validity, responsiveness, and interpretation of change-were evaluated. Results: The analysis population comprised 239 patients with EoE (age [mean ± SD], 28.1 ± 13.14 years; 63.6% male; 90.4% White). Intraclass correlation coefficients of 0.92 and 0.97 exceeded the acceptable reliability threshold (≥0.70). Construct validity correlations with EoE symptom and impact measures were moderate at baseline (|r| = 0.44-0.55) and week 24 (|r| = 0.55-0.69), and the DSQ biweekly total score discriminated among groups defined by disease severity. Analyses exploring interpretation of change from baseline on the DSQ biweekly total score indicated thresholds for within-patient improvement ranging from 9 to 23 points; a within-patient improvement from baseline of 13 points or greater could be considered clinically meaningful. Conclusions: This analysis confirmed that the DSQ has acceptable distributional properties, test-retest reliability, construct validity, and ability to detect change. Therefore, the DSQ is a valid and reliable measure to assess the patient-reported symptom of dysphagia among adult and adolescent patients with EoE in the context of a clinical trial setting.

Dupilumab Improves Health-Related Quality of Life and a Range of Symptoms in Patients With Eosinophilic Esophagitis.

INTRODUCTION: Improvements in symptomatic experience and health-related quality of life (HRQoL) are among the most important treatment benefits in patients with eosinophilic esophagitis (EoE). We assessed the impact of dupilumab treatment on HRQoL, patients' impression of dysphagia, and symptoms beyond dysphagia in adults/adolescents (≥12 years) with EoE in parts A and B of the LIBERTY EoE TREET (NCT03633617) study. METHODS: The EoE Symptom Questionnaire (EoE-SQ; frequency and severity of nondysphagia symptoms), EoE Impact Questionnaire (impact of EoE on HRQoL), and Patient Global Impression of Severity and Patient Global Impression of Change of dysphagia were used to assess the efficacy of weekly dupilumab 300 mg vs placebo. RESULTS: At week 24, dupilumab reduced EoE-SQ Frequency (least squares mean difference vs placebo [95% confidence interval] part A -1.7 [-2.9, -0.5], part B -1.4 [-2.3, -0.5]; both P < 0.01) and EoE-SQ Severity (part A -2.0 [-3.9, 0.0], P < 0.05, part B -1.5 [-3.0, 0.1], P = 0.07) overall scores, and improved scores across all individual items. Improvement in the dupilumab group was clinically meaningful to patients. Dupilumab also meaningfully improved EoE Impact Questionnaire average scores and improved individual item scores at week 24, particularly emotional and sleep disturbance. More dupilumab-treated patients reported improvement in the Patient Global Impression of Change of dysphagia vs placebo or reported having no symptoms per the Patient Global Impression of Severity of dysphagia at week 24. DISCUSSION: Dupilumab reduced the impact of EoE on multiple aspects of HRQoL, patients' impression of dysphagia, and frequency and severity of symptoms beyond dysphagia in adults/adolescents with EoE.

Validation of the novel Eosinophilic Esophagitis Impact Questionnaire.

BACKGROUND: Eosinophilic esophagitis (EoE) has a detrimental effect on health-related quality of life (HRQOL). The Eosinophilic Esophagitis Impact Questionnaire (EoE-IQ) is a novel patient-reported outcome (PRO) measure assessing the impact of EoE on HRQOL. To assess suitability of the EoE-IQ, its measurement properties were evaluated. METHODS: Using baseline and week 24 data from the pivotal, randomized, placebo-controlled, multinational phase 3 R668-EE-1774 trial (NCT03633617) of dupilumab, we evaluated EoE-IQ's measurement properties (including reliability, construct and known-groups validity, and ability to detect change) and established the threshold for change in scores that can be considered clinically meaningful. RESULTS: The analysis population comprised 239 adults and adolescents with EoE. Mean age was 28.1 (standard deviation, 13.14) years; 63.6% were male, and 90.4% were White. Reliability estimates for the EoE-IQ average score exceeded acceptable thresholds for patients who were stable as indicated by ratings of Patient Global Impression of Severity (PGIS) and Change (PGIC) (intraclass correlation coefficients, 0.75 and 0.81). Construct validity correlations with other EoE-specific PRO scores were moderate at baseline (|r|= 0.44-0.60) and moderate to strong at week 24 (|r|= 0.61-0.72). In known-groups analysis, EoE-IQ average score discriminated among groups of patients at varying EoE severity levels defined by PGIS scores. A ≥ 0.6-point reduction in EoE-IQ average score (where scores range from 1 to 5, with higher scores indicating worse HRQOL) from baseline to week 24 can be considered clinically meaningful. CONCLUSIONS: The EoE-IQ's measurement properties are acceptable, making it a valid, reliable measure of the HRQOL impacts of EoE among adults and adolescents. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03633617. Registered August 14, 2018, https://clinicaltrials.gov/study/NCT03633617 .

Development of a measure of prescriber satisfaction with academic detailing: the PSAD.

INTRODUCTION: Academic detailing (AD) is an educational outreach strategy to provide clinicians with current evidence-based information, which has been shown to change prescribing behaviours. The overall effectiveness of AD interventions is associated with prescriber satisfaction; however, most approaches use single items or non-validated measures. This study aims to develop and validate an instrument to assess prescriber satisfaction with AD interventions. METHODS: A group of candidate items was generated and refined based on constructs identified through a literature review and in consultation with an expert panel. The initial instrument was piloted with 183 primary care providers who participated in an AD intervention on opioid-related pain management. To support the validity and reliability of the measure, psychometric properties were examined. RESULTS: Ten candidate items were developed based on the following themes: acceptability, feasibility of implementation, usefulness, perception of efficacy, overall satisfaction, willingness to repeat and willingness to change. One item related to willingness to change did not contribute to assessing an individual's ability and lowered the measure's internal consistency and was therefore dropped. CONCLUSION: Results supported the validity and reliability of a refined 9-item measure of Provider Satisfaction with Academic Detailing (the PSAD). This measure should be considered for broad use across educational outreach programmes as a standardized measure to assess provider satisfaction and provide continuous quality improvement.

Identification of barriers to safe opioid prescribing in primary care: a qualitative analysis of field notes collected through academic detailing.

BACKGROUND: Understanding barriers to safe opioid prescribing in primary care is critical amid the epidemic of prescription opioid abuse, misuse, and overdose in the US. Educational outreach strategies, such as academic detailing (AD), provide a forum for identification of barriers to, and strategies to facilitate, safe opioid prescribing in primary care. AIM: To identify barriers to safe opioid prescribing among primary care providers (PCPs) through AD. DESIGN AND SETTING: Qualitative analysis of data was collected through an existing AD intervention to improve safe opioid prescribing in primary care. The AD intervention was delivered from June 2018 to August 2018 to licensed PCPs with prescriptive authority within a large independent health system in the metropolitan Chicagoland area. METHOD: The AD intervention involved visits by trained detailers to PCPs who contemporaneously documented details from each visit via field notes. Using qualitative analysis, field notes were analysed to identify recurring themes related to opioid prescribing barriers. RESULTS: Detailer-entered field notes from 186 AD visits with PCPs were analysed. Barriers to safe opioid prescribing were organised into six themes: 1) gaps in knowledge; 2) lack of prescription monitoring programme (PMP) utilisation; 3) patient pressures to prescribe opioids; 4) insurance coverage policies; 5) provider beliefs; and 6) health system pain management practices. CONCLUSION: Barriers to safe opioid prescribing in primary care, identified through AD visits among this large group of PCPs, support the need for continued efforts to enhance pain-management education, maximise PMP utilisation, and increase access to, and affordability of, non-opioid treatments.