Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2007 Oct;16(8):1357-73.
doi: 10.1007/s11136-007-9242-0. Epub 2007 Aug 1.

Reliability and validity of functional health status and health-related quality of life questionnaires in children with recurrent acute otitis media

Carole N M Brouwer  1 , Anne G M Schilder, Henk F van Stel, Maroeska M Rovers, Reinier H Veenhoven, Diederick E Grobbee, Elisabeth A M Sanders, A Rianne Maillé
Affiliations

Reliability and validity of functional health status and health-related quality of life questionnaires in children with recurrent acute otitis media

Carole N M Brouwer et al. Qual Life Res. 2007 Oct.

Abstract

In this study the reliability and validity of generic and disease-specific questionnaires has been assessed focusing on responsiveness. This is part of a study on the effects of recurrent acute otitis media (rAOM) on functional health status (FHS) and health-related quality of life (HRQoL) in 383 children with rAOM participating in a randomized clinical trial. The following generic questionnaires were studied: 1. RAND general health rating index, 2. Functional Status Questionnaire (FSQ Generic and FSQ Specific), 3. TNO-AZL Infant Quality of Life (TAIQOL), and the following disease-specific questionnaires: 1. Otitis Media-6 (OM-6), 2. Numerical rating scales (NRS) for child and caregiver (NRS Child and NRS Caregiver), and 3. a new Family Functioning Questionnaire (FFQ). Reliability was good to excellent (Cronbach's alpha range 0.80-0.90, intraclass correlation coefficient range 0.76-0.93). Moderate to strong correlations were found between the questionnaires as well as between questionnaires and relevant clinical indicators (r = 0.29-0.49), demonstrating construct validity. Discriminant validity for children with few versus frequent episodes of acute otitis media per year was good for most questionnaires (P < 0.004) but poor for the otitis media-related subscales of the TAIQOL (P = 0.10-0.97) and both NRS (P = 0.22 and 0.48). Except for the TAIQOL subscales, change scores were significant (P < 0.003) for generic and disease-specific questionnaires. Effect sizes were somewhat higher for disease-specific compared to generic questionnaires (0.55-0.95 versus 0.32-0.60) except for the TAIQOL subscales, which showed very poor sensitivity to change. Anchor-based methods resulted in a somewhat larger range of estimates of MCID than distribution-based methods. Combining distribution-based and anchor-based methods resulted in similar ranges for the minimally clinical important differences for generic and disease-specific questionnaires: 2-15 points on a 0-100 scale. Apart from the generic TAIQOL subscales, both generic and disease-specific questionnaires used in this study showed good psychometric qualities and responsiveness for use in clinical studies on children with rAOM.

PubMed Disclaimer

Figures

Graph 1
Graph 1
Responsiveness—change-scores per questionnaire corresponding with an anchor-based responsiveness index: (a) AOM frequency; (b) AOM severity (OM-FSQ score)
Graph 2
Graph 2
Minimally clinical important difference (MCID) per questionnaire according to distribution-based (ES-MCID and SEM-MCID) and anchor-based (AOM frequency and AOM severity) methods
See this image and copyright information in PMC

References

    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'PubMed', 'value': '2732519', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/2732519/'}]}
    2. Teele, D. W., Klein, J. O., & Rosner, B. (1989). Epidemiology of otitis media during the first seven years of life in children in greater Boston: A prospective, cohort study. The Journal of Infectious Diseases, 160, 83–94. - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1016/0165-5876(91)90001-R', 'is_inner': False, 'url': 'https://doi.org/10.1016/0165-5876(91)90001-r'}, {'type': 'PubMed', 'value': '1869373', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/1869373/'}]}
    2. Alho, O. P., Koivu, M., & Sorri, M. (1991). What is an ‘otitis-prone’ child? International Journal of Pediatric Otorhinolaryngology,21, 201–209. - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'PubMed', 'value': '9288255', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/9288255/'}]}
    2. Alho, O. P. (1997). How common is recurrent acute otitis media? Acta Oto-Laryngologica. Supplementum, 529, 8–10. - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1097/00006454-200107000-00004', 'is_inner': False, 'url': 'https://doi.org/10.1097/00006454-200107000-00004'}, {'type': 'PubMed', 'value': '11465836', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/11465836/'}]}
    2. Kilpi, T., Herva, E., Kaijalainen, T., Syrjanen, R., & Takala, A. K. (2001). Bacteriology of acute otitis media ina cohort of Finnish children followed for the first two years of life. The Pediatric Infectious Disease Journal, 20, 654–662. - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'PubMed', 'value': '7808842', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/7808842/'}]}
    2. Niemela, M., Uhari, M., Jounio-Ervasti, K., Luotonen, J., Alho, O. P., & Vierimaa, E. (1994). Lack of specific symptomatology in children with acute otitis media. Pediatric Infectious Disease Journal, 13, 765–768. - PubMed

Publication types