Literature DB >> 30545562

Development and Modification of an Outcome Measure to Follow Symptoms of Children with Sinusitis.

Nader Shaikh1, Ellen R Wald2, Jong-Hyeon Jeong3, Marcia Kurs-Lasky4, David Nash5, Michael E Pichichero6, Diana H Kearney4, Mary Ann Haralam4, A'Delbert Bowen7, Lynda L Flom7, Alejandro Hoberman4.   

Abstract

OBJECTIVE: To develop a parent-reported Pediatric Rhinosinusitis Symptom Scale (PRSS) that could be used to monitor symptoms of young children with acute sinusitis in response to therapy. STUDY
DESIGN: We developed an 8-item symptom severity scale and evaluated its internal reliability, construct validity, and responsiveness in children 2-12 years of age with acute sinusitis. Parents of 258 children with acute sinusitis completed the PRSS at the time of diagnosis, as a diary at home, and at the follow-up visit at days 10-12. Based on psychometric results and additional parent feedback, we revised the scale. We evaluated the revised version in 185 children with acute sinusitis.
RESULTS: Correlations between the scale and reference measures on the day of enrollment were in the expected direction and of the expected magnitude. PRSS scores at the time of presentation correlated with radiographic findings (P < .001), functional status (P < .001), and parental assessment of overall symptom severity (P < .001). Responsiveness (standardized response mean) and test-retest reliability of the revised scale were good (2.17 and 0.75, respectively).
CONCLUSIONS: We have developed an outcome measure to track the symptoms of acute sinusitis. Data presented here support the use of the PRSS as a measure of change in symptom burden in clinical trials of children with acute sinusitis.
Copyright © 2018 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  outcome measure; parent-reported outcome measure; pediatrics; sinusitis; symptoms

Mesh:

Year:  2018        PMID: 30545562      PMCID: PMC6440829          DOI: 10.1016/j.jpeds.2018.11.016

Source DB:  PubMed          Journal:  J Pediatr        ISSN: 0022-3476            Impact factor:   4.406


  20 in total

Review 1.  Intraclass correlations: uses in assessing rater reliability.

Authors:  P E Shrout; J L Fleiss
Journal:  Psychol Bull       Date:  1979-03       Impact factor: 17.737

2.  Effectiveness of amoxicillin/clavulanate potassium in the treatment of acute bacterial sinusitis in children.

Authors:  Ellen R Wald; David Nash; Jens Eickhoff
Journal:  Pediatrics       Date:  2009-07       Impact factor: 7.124

Review 3.  Microbiologic surrogate end points in clinical trials of infectious diseases: example of acute otitis media trials.

Authors:  John H Powers
Journal:  Pharmacotherapy       Date:  2005-12       Impact factor: 4.705

4.  Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation.

Authors:  R A Deyo; P Diehr; D L Patrick
Journal:  Control Clin Trials       Date:  1991-08

5.  Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease.

Authors:  Marianne de Vries; Rody Ouwendijk; Alphons G Kessels; Michiel W de Haan; Karin Flobbe; Maria G M Hunink; Jos M A van Engelshoven; Patricia J Nelemans
Journal:  J Vasc Surg       Date:  2005-02       Impact factor: 4.268

6.  The development and validation of an instrument to assess acute sinus disease in children.

Authors:  J M Garbutt; E F Gellman; B Littenberg
Journal:  Qual Life Res       Date:  1999-05       Impact factor: 4.147

7.  Responsiveness and construct validity of a symptom scale for acute otitis media.

Authors:  Nader Shaikh; Alejandro Hoberman; Jack L Paradise; Howard E Rockette; Marcia Kurs-Lasky; D Kathleen Colborn; Diana H Kearney; Lisa M Zoffel
Journal:  Pediatr Infect Dis J       Date:  2009-01       Impact factor: 2.129

8.  Responsiveness and minimal important differences for patient reported outcomes.

Authors:  Dennis A Revicki; David Cella; Ron D Hays; Jeff A Sloan; William R Lenderking; Neil K Aaronson
Journal:  Health Qual Life Outcomes       Date:  2006-09-27       Impact factor: 3.186

9.  How young can children reliably and validly self-report their health-related quality of life?: an analysis of 8,591 children across age subgroups with the PedsQL 4.0 Generic Core Scales.

Authors:  James W Varni; Christine A Limbers; Tasha M Burwinkle
Journal:  Health Qual Life Outcomes       Date:  2007-01-03       Impact factor: 3.186

10.  Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

Authors: 
Journal:  Health Qual Life Outcomes       Date:  2006-10-11       Impact factor: 3.186

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  1 in total

1.  Viral Coinfection and Nasal Cytokines in Children With Clinically Diagnosed Acute Sinusitis.

Authors:  Santiago M C Lopez; Nader Shaikh; Monika Johnson; Hui Liu; Judith M Martin; John V Williams
Journal:  Front Pediatr       Date:  2022-01-12       Impact factor: 3.418

  1 in total

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