Dataset Information

PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity.

ABSTRACT: 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.The PedsQL EoE Module was completed in a multisite study by 196 pediatric patients with EoE and 262 parents of patients with EoE.The PedsQL EoE Module scales evidenced excellent feasibility (0.6%-3.1% missing), excellent group comparison reliability across total scale scores (patient ? 0.93; parent proxy ? 0.94), good reliability for the 7 individual scales (patient ? 0.75-0.87; parent proxy ? 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]).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.

SUBMITTER: Franciosi JP

PROVIDER: S-EPMC4115583 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity.

Franciosi James P JP Hommel Kevin A KA Bendo Cristiane B CB King Eileen C EC Collins Margaret H MH Eby Michael D MD Marsolo Keith K Abonia J Pablo JP von Tiehl Karl F KF Putnam Philip E PE Greenler Alexandria J AJ Greenberg Allison B AB Bryson Ronald A RA Davis Carla M CM Olive Anthony P AP Gupta Sandeep K SK Erwin Elizabeth A EA Klinnert Mary D MD Spergel Jonathan M JM Denham Jolanda M JM Furuta Glenn T GT Rothenberg Marc E ME Varni James W JW

Journal of pediatric gastroenterology and nutrition 20130701 1

<h4>Objective</h4>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.<h4>Methods</h4>The PedsQL EoE Module was completed in a multisite study by 196 pediatric patients with EoE and 262 parents of patients with EoE.<h4>Results</h4>The PedsQL EoE Module scales evidenced excellent feasibility (0.6%-3.1% mi ...[more]

PMID: 23478422

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Project description:BackgroundDetecting change in health status over time and ascertaining meaningful changes are critical elements when using health-related quality of life (HRQL) instruments to measure patient-centered outcomes. The PedsQL™ Sickle Cell Disease module, a disease specific HRQL instrument, has previously been shown to be valid and reliable. Our objectives were to determine the longitudinal validity of the PedsQL™ Sickle Cell Disease module and the change in HRQL that is meaningful to patients.MethodsAn ancillary study was conducted utilizing a multi-center prospective trial design. Children ages 4-21 years with sickle cell disease admitted to the hospital for an acute painful vaso-oclusive crisis were eligible. Children completed HRQL assessments at three time points (in the Emergency Department, one week post-discharge, and at return to baseline (One to three months post-discharge). The primary outcome was change in HRQL score. Both distribution (effect size, standard error of measurement (SEM)) and anchor (global change assessment) based methods were used to determine the longitudinal validity and meaningful change in HRQL. Changes in HRQL meaningful to patients were identified by anchoring the change scores to the patient's perception of global improvement in pain.ResultsModerate effect sizes (0.20-0.80) were determined for all domains except the Communication I and Cognitive Fatigue domains. The value of 1 SEM varied from 3.8-14.6 across all domains. Over 50% of patients improved by at least 1 SEM in Total HRQL score. A HRQL change score of 7-10 in the pain domains represented minimal perceived improvement in HRQL and a HRQL change score of 18 or greater represented moderate to large improvement.ConclusionsThe PedsQL™ Sickle Cell Disease Module is responsive to changes in HRQL in patients experiencing acute painful vaso-occlusive crises. The study data establish longitudinal validity and meaningful change parameters for the PedsQL™ Sickle Cell Disease Module.Trial registrationClinicalTrials.gov (study identifier: NCT01197417 ). Date of registration: 08/30/2010.

Dataset Information

PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity.

Publications

PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity.

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