PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity

Abstract

Objective: Eosinophilic esophagitis (EoE) is a chronic esophageal inflammatory condition with a paucity of information on health-related quality of life (HRQOL). The objective of the study was to report on the measurement properties of the PedsQL EoE Module.

Methods: The PedsQL EoE Module was completed in a multisite study by 196 pediatric patients with EoE and 262 parents of patients with EoE.

Results: The PedsQL EoE Module scales evidenced excellent feasibility (0.6%-3.1% missing), excellent group comparison reliability across total scale scores (patient α 0.93; parent proxy α 0.94), good reliability for the 7 individual scales (patient α 0.75-0.87; parent proxy α 0.81-0.92), excellent test-retest reliability (patient intraclass correlation coefficient 0.88; parent intraclass correlation coefficient 0.82), demonstrated no floor effects and low ceiling effects, and demonstrated a high percentage of scaling success for most scales. Intercorrelations with the PedsQL Generic Core Scales were in the medium (0.30) to large (0.50) range. PedsQL EoE Module scores were worse among patients with active histologic disease (≥ 5 eos/hpf) compared with those in remission (patient self-report: 63.3 vs 69.9 [P < 0.05]; parent proxy report: 65.1 vs 72.3 [P < 0.01]), and those treated with dietary restrictions compared with those with no restrictions (patient self-report: 61.6 vs 74.3 [P < 0.01]; parent proxy report: 65.5 vs 74.7 [P < 0.01]).

Conclusions: The results demonstrate excellent measurement properties of the PedsQL EoE Module. Patients with active histologic disease and those treated with dietary restrictions demonstrated worse PedsQL scores. The PedsQL EoE Module may be used in the evaluation of pediatric EoE disease-specific HRQOL in clinical research and practice.

Conflict of interest statement

Competing Interests

Dr. Varni holds the copyright and the trademark for the PedsQL™ and receives financial compensation from the Mapi Research Trust, which is a nonprofit research institute that charges distribution fees to for-profit companies that use the Pediatric Quality of Life Inventory™. Dr. Rothenberg has an equity interest in Teva Pharmaceuticals reslizumab, is Chief Scientific Officer of Immune Pharmaceuticals, and is inventor of several EoE-related patents owned by Cincinnati Children’s Hospital Medical Center. The other authors report no conflicts of interest.

Figures

Figure 1

PedsQL™ EoE Module Total Scale Scores, Total Symptom Scores and individual Scale Scores among EoE patients as child self-report (A.) and parent proxy-report (B.) comparing those with no dietary restrictions and those with strict dietary antigen elimination.

Figure 1

PedsQL™ EoE Module Total Scale Scores, Total Symptom Scores and individual Scale Scores among EoE patients as child self-report (A.) and parent proxy-report (B.) comparing those with no dietary restrictions and those with strict dietary antigen elimination.