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

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 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.

Assessing methods to specify the target difference for a randomised controlled trial: DELTA (Difference ELicitation in TriAls) review

“…Dubois and colleagues 404 found a variable range of estimates across methods and suggested the use of cumulative distribution curves rather than single values. Brouwer and colleagues 327 provided a point estimate across multiple instruments that used a 0-100 scale.…”

“…323 However, several of the studies that had used multiple methods, of which one was a SES approach, had used alternative proportions of the SD for small (minimal) change, including a quarter of a SD (0.25 SDs), 82,114,324 a third of a SD (~0.33 SDs) 325,326 or even 0.3 SDs. 327 Occasionally, studies considered multiple levels as being of interest for interpretation of an important difference, for example both 0.5 SDs and 0.2 SDs. [328][329][330][331] Sometimes larger values were used, and two studies 332,333 used 1 SD as an effect size cut-off, of which the study by Hurst and Bolton 332 had also used 0.6 SDs.…”

Quality of Life Following Endoscopic Resection of Skull Base Tumors

“…17 The α score varies from 0 to 1 and a score of 0.70 or higher is considered to be predictive of the reliability of the questionnaire. 2 In this study, we found α-Cornbach values of 0.69 to 1 with most values being !0.75 for each domain, suggesting a good reliability of the ASBS-Q instrument in studying patients undergoing endoscopic skull base surgery.…”

Assessment of Surgical Results in Patients With Empty Nose Syndrome Using the 25-Item Sino-Nasal Outcome Test Evaluation

“…In addition to the standard SNOT-20, we also included the 5 additional items from Houser (2001), 8 which are particularly relevant for patients with ENS. The participants completed the SNOT-25 at the initial visit and at each subsequent clinic visit (3,6, and 12 months after surgery). The sum of all items scores gives each patient a summary score, the total SNOT-25 score.…”

“…A health-related and disease-specific instrument for QOL evaluation called the 20-Item SinoNasal Outcome Test (SNOT-20) was created and validated for use to evaluate the impact of a variety of situations such as cystic fibrosis, otitis media, obstructive sleep apnea, and rhinosinusitis. [5][6][7][8][9] The SNOT-20 is a validated 20-item survey that examines general nasal symptoms and can be used to compare preintervention and postintervention outcomes. It describes the health burden of ENS and is sensitive to clinical changes.…”