SummaryBackground: Growing interest in health-related quality of life (HRQoL) in children with otitis media has brought the need to study the currently available HRQoL instruments with respect to their results and their applicability in clinical practice and research of otitis media. Objective: To review existing literature on health-related quality of life research in children with otitis media with respect to: (1) the measured impact of otitis media on HRQoL; and (2) the applicability of HRQoL instruments used in research and clinical practice based on their characteristics and contents.

Chronic non-specific lung disease (CNSLD) encompasses asthma as well as chronic obstructive pulmonary disease (COPD). Recently in health care, there has been increasing awareness in the functional, psychological and social aspects of the health of patients; their quality of life (QOL). Quality-of-life research addressing CNSLD patients has been rather underdeveloped for a long period of time. Recently, however, the importance of QOL is being increasingly recognized, and several research groups have started to study QOL in CNSLD patients in more detail. This paper describes the construction of a disease-specific QOL instrument for patients with mild to moderately severe CNSLD. Items relating to several domains of QOL were listed, and 171 CNSLD patients in general practice were asked how much of a problem each item had been (assessed on a seven-point Likert scale). After applying an item-selection procedure, a uni-dimensional QOL questionnaire was constructed consisting of 55 items divided into seven domain subscales: breathing problems, physical problems, emotions, situations triggering or enhancing breathing problems, general activities, daily and domestic activities, and social activities, relationships and sexuality. Reliability estimates of the domain subscales of the constructed questionnaire varied from 0.68 to 0.89, and was 0.92 for the QOL for Respiratory Illness Questionnaire (QOL-RIQ) total scale. A first impression of the construct validity of the questionnaire was gained by investigation of the relationship between the QOL domain subscales and several indicators of illness severity, as well as the relative contribution of illness severity variables, background characteristics and symptoms to QOL, using regression analysis. Further research to validate the questionnaire to a greater extent (construct validity, test-retest reliability and responsiveness to change) is currently taking place.

Recurrent AOM has a considerable negative impact on the quality of life of children and causes concern to their caregivers. These effects are proportional to the severity of the condition. Professionals involved in the care of children with OM should be aware that OM not only affects physical functioning but also general well-being of the child and its family. These outcomes should therefore be included in the evaluation of the child with otitis media both in the clinical and research setting.

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 a 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.

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