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Objectives/Hypothesis: The 22‐item Sinonasal Outcome Test (SNOT‐22) is a validated chronic rhinosinusitis health‐related quality‐of‐life outcome (HRQoL) measure; however, SNOT‐22 domains have not been validated specifically for chronic rhinosinusitis with nasal polyps (CRSwNP). Study Design: Validation of SNOT‐22 domain structure, using data from 3 randomized, placebo‐controlled, double‐blinded, multicenter clinical trials of dupilumab in adults with moderate‐to‐severe CRSwNP. Methods: Preliminary dimensional structure was derived by exploratory factor analyses of SNOT‐22 data from a phase 2 trial (NCT01920893) of dupilumab for the treatment of CRSwNP. Data from 2 phase 3 clinical trials (NCT02912468 and NCT02898454) were then used for confirmatory factor analysis, and evaluated for reliability, construct validity, and responsiveness. In all three trials, the SNOT‐22 was administered electronically on a tablet and trial participants were required to answer all items. Results: Factor analysis supported five domains: Nasal, Ear/Facial, Sleep, Function, and Emotion. Correlations between domains were moderate to high, ranging from 0.53 (Nasal–Emotion) to 0.88 (Function–Sleep). Construct validity was mostly supported; relationships with other measures were almost always in the intended direction and magnitude. Internal consistency reliability also confirmed questionnaire structure with strong Cronbach's alpha values (all >0.80). Moderate‐to‐high correlations were observed between change in SNOT‐22 domain scores and other study patient‐reported outcome measures, along with large effect‐size estimates (≥0.7), demonstrating responsiveness of the Nasal, Sleep, and Function domains. Emotion and Ear/Facial domains had small‐to‐moderate effect sizes. Conclusions: Psychometric analyses support the validity, reliability, and responsiveness of five domains of SNOT‐22 (Nasal, Ear/Facial, Sleep, Function, and Emotion) for assessing symptoms and impact on HRQoL in patients with CRSwNP. Laryngoscope, 132:933–941, 2022 [ABSTRACT FROM AUTHOR]

To purchase or authenticate to the full-text of this article, please visit this link: http://dx.doi.org/10.1111/j.1467-9566.2007.00493.x Byline: Ruth McDonald (1), Nicola Mead (1), Sudeh Cheraghi-Sohi (1), Peter Bower (1), Diane Whalley (1), Martin Roland (1) Keywords: Foucault; identity; choice; consumer Abstract: Abstract Government policy promoting consumerism in healthcare can be seen as offering up certain preferred identities to which its citizens are encouraged to aspire. Whilst many commentators reject the notion that health services users should be conceived of as consumers, this paper outlines the relevance of the concept to our understanding of the ways in which individuals manage their health and service use. The paper examines the identity work undertaken by individuals in relation to decisions about healthcare preferences and assesses the extent to which this is compatible with the identities promoted in Government policy. We suggest that in circumstances where individuals feel both a sense of personal entitlement and a desire to be supportive of the needs of other members of the community, 'doing' ethical consumer can be fraught with discomfort and anxiety. These anxieties are exacerbated in a context where citizenship is increasingly being defined in terms of consumer identities, and making good (health) choices might be seen as distinguishing the civilised from the marginalised. Author Affiliation: (1)National Primary Care Research and Development Centre, University of Manchester Article note: Address for correspondence: Ruth McDonald, National Primary Care Research and Development Centre, University of Manchester, Williamson Building, Oxford Road, Manchester M13 9PL, e-mail: ruth.mcdonald@man.ac.uk

Objectives/Hypothesis: Clinical trials of biologics to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) have evaluated objective outcomes (e.g., University of Pennsylvania Smell Identification Test [UPSIT], nasal polyps score [NPS], and computed tomography Lund‐Mackay score [CT‐LMK]) and patient‐reported symptoms (e.g., nasal congestion/obstruction [NC], loss of smell [LoS], and total symptom score [TSS]). We estimated anchor‐based thresholds for clinically meaningful change in objective and patient‐reported outcomes in patients with CRSwNP using data from LIBERTY NP SINUS‐24 and SINUS‐52 trials (NCT02912468; NCT02898454). Methods: Target patient‐reported outcomes were NC, LoS, and TSS; target objective outcomes were UPSIT, NPS, and CT‐LMK. Anchor measures were the 22‐item sinonasal outcome test (SNOT‐22) rhinologic symptoms domain and total score and rhinosinusitis visual analog scale (VAS). The appropriateness of each anchor measure was evaluated by reviewing correlations between change in anchor measures and target outcomes and descriptive scores on target outcomes by levels of change in the anchor measure. Established thresholds for anchor measures (3.8 points for SNOT‐22 rhinologic symptoms, 8.9 points for SNOT‐22 total, 1‐category improvement for rhinosinusitis VAS) were used to estimate clinically meaningful score changes for each target outcome. Results: Based on correlations between change in anchor measures and target outcomes, SNOT‐22 rhinologic symptoms domain was deemed the most appropriate anchor measure. Using this anchor measure, thresholds for clinically meaningful within‐patient change were NC: 1 point; LoS: 1 point; TSS: 3 points; UPSIT: 8 points; NPS: 1 point; and CT‐LMK: 5 points. Conclusion: These thresholds support interpretation of efficacy results for target outcomes in CRSwNP trials. Level of Evidence: 2 Laryngoscope, 132:265–271, 2022 [ABSTRACT FROM AUTHOR]

Objective. Two 26-week US clinical trials of identical design were conducted to evaluate the efficacy and safety of pimecrolimus (Elidel, SDZ ASM 981) cream 1% in pediatric atopic dermatitis (AD). A secondary aim of both trials, and the focus of this article, was to evaluate the quality-of-life (QoL) impact of pimecrolimus compared with its vehicle. Methods. A 6-week randomized, double-blind treatment phase was followed by a 20-week open-label phase during which all patients received pimecrolimus (403 patients 2 to 17 years old with mild to moderate AD; 267 randomized to pimecrolimus and 136 to vehicle). QoL analyses were conducted on the intention-to-treat data and included patients 8 years old or younger. QoL was evaluated with the Parent's Index of Quality of Life in Atopic Dermatitis (PIQoL-AD) at baseline, 6 weeks, and 6 months. The PIQoL-AD is a 28-item measure completed by the parents of children with AD (0 to 8 years old). Results. PIQoL-AD scores were available for 241 cases at baseline (158 pimecrolimus, 83 vehicle), 193 at 6 weeks (132 pimecrolimus, 61 vehicle), and 161 at 6 months (113 pimecrolimus, 48 vehicle). Improvement in parents' QoL was seen for both groups between baseline and 6 weeks and 6 months. Analysis of covariance on PIQoL-AD scores at 6 weeks showed statistically significant superiority of pimecrolimus compared with vehicle. After all patients were switched to receive pimecrolimus at week 6, mean PIQoL-AD scores were the same across both groups at 6 months. Positive but low levels of association were observed between changes in PIQoL-AD scores and changes in severity of AD (Investigator's Global Assessment and parent-perceived severity of pruritus). Conclusion. The results showed that pimecrolimus had a beneficial effect on parents' QoL in pediatric AD. Pediatrics 2002;110:1133-1136; clinical trials, atopic dermatitis, eczema, child, quality of life, SDZ ASM 981, PIQoL-AD., ABBREVIATIONS. AD, atopic dermatitis; QoL, quality of life; PIQoL-AD, Parent's Index of Quality of Life-Atopic Dermatitis; IGA, Investigator's Global Assessment. A topic dermatitis (AD) is a common skin condition that [...]