Reliability and validity of functional health status and health-related quality of life questionnaires in children with recurrent acute otitis media.
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.
Department of Paediatrics, Spaarne Hospital, Postbus 770, 2130 AT Hoofddorp, The Netherlands.
Carole N M
CN
Brouwer
Anne G M
AG
Schilder
Henk F
HF
van Stel
Maroeska M
MM
Rovers
Reinier H
RH
Veenhoven
Diederick E
DE
Grobbee
Elisabeth A M
EA
Sanders
A Rianne
AR
Maillé
D000208:Acute Disease; D000223:Adaptation, Psychological; D002648:Child; D002669:Child Welfare; D005260:Female; D006304:Health Status; D006306:Health Surveys; D006801:Humans; D008297:Male; D010033:Otitis Media / Q000523:psychology*; D011581:Psychological Tests; D011594:Psychometrics; D011788:Quality of Life; D012008:Recurrence; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires