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Low 22-item sinonasal outcome test scores in chronic rhinosinusitis: Why do patients seek treatment?

ABSTRACT: Patients with chronic rhinosinusitis (CRS) who experience minimal reductions in quality of life (QoL) may present for treatment despite QoL scores comparable to controls without CRS. This study seeks to identify cofactors influencing patients with CRS and low 22-item Sinonasal Outcome Test (SNOT-22) scores to seek care.Prospective, multicenter, observational cohort.Patients with CRS were enrolled between April 2011 and September 2015. Patients with sinonasal mucocele or unilateral sinus opacification were excluded. Control subjects without CRS were enrolled for comparison. Low-SNOT CRS was defined as a SNOT-22 score < 20.A total of 774 subjects (low-SNOT CRS, n = 38; high-SNOT CRS, SNOT-22 ? 20, n = 641; controls without CRS, n = 95) were enrolled. Low SNOT scores were identified in 6% of subjects with CRS. After adjustment, low-SNOT CRS and control groups without CRS reported similar baseline average SNOT-22 total scores (P = .879). Unexpectedly, compared to controls, low-SNOT CRS patients had significantly better average psychological (2.1 ± 2.3 vs. 5.8 ± 6.0; P = .030) and sleep dysfunction (2.7 ± 3.4 vs. 6.0 ± 5.2; P = .016) scores. Fourteen of 38 (37%) low-SNOT patients elected to undergo endoscopic sinus surgery (ESS), with a significantly lower likelihood of reporting a minimal clinically important difference (MCID) when compared to high-SNOT patients (43% vs. 82%; P < .001) after a mean follow-up of ?15 months.Low-SNOT CRS patients represent an outlier population for which measures of QoL fail to identify factors influencing the decision to seek treatment. Low-SNOT CRS patients electing ESS have a decreased likelihood of reporting MCIDs following ESS. Further study is required to identify novel factors associated with treatment-seeking behavior in this population.3B Laryngoscope, 127:22-28, 2017.

SUBMITTER: Levy JM

PROVIDER: S-EPMC5177462 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Low 22-item sinonasal outcome test scores in chronic rhinosinusitis: Why do patients seek treatment?

Levy Joshua M JM Mace Jess C JC Rudmik Luke L Soler Zachary M ZM Smith Timothy L TL

The Laryngoscope 20160705 1

<h4>Objectives/hypothesis</h4>Patients with chronic rhinosinusitis (CRS) who experience minimal reductions in quality of life (QoL) may present for treatment despite QoL scores comparable to controls without CRS. This study seeks to identify cofactors influencing patients with CRS and low 22-item Sinonasal Outcome Test (SNOT-22) scores to seek care.<h4>Study design</h4>Prospective, multicenter, observational cohort.<h4>Methods</h4>Patients with CRS were enrolled between April 2011 and September ...[more]

PMID: 27377575

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Project description:Objectives/hypothesisThe 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 designValidation 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.MethodsPreliminary 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.ResultsFactor 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.ConclusionsPsychometric 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.

Project description:Chronic rhinosinusitis (CRS) is an inflammatory disorder of the nose and paranasal sinuses. Staphylococcus aureus is increasingly linked with CRS exacerbations. Little is known about how bacteria activate inflammatory pathways that contribute to CRS.To develop an in vitro coculture system to explore how infection with S aureus stimulates innate immune responses of sinonasal epithelial cells (SNECs).Sinonasal epithelial cells were collected from 13 patients during endoscopic sinus surgery and grown in culture at the air-liquid interface from July 2014 through December 2014.Differentiated SNECs from control individuals, patients with CRS with nasal polyps (CRSwNPs), and patients with CRS without nasal polyps (CRSsNPs) were infected with S aureus at 3 different concentrations for 24 hours.Growth of S aureus and viability of SNECs were measured. Expression of inflammatory markers and innate immune genes was measured by reverse transcription-polymerase chain reaction. Basal secretion of interleukin 8 was determined by enzyme-linked immunosorbent assay.Cultured SNECs from patients with CRSsNPs demonstrated a significant increase (P?<?.05) in expression of interleukin 8 (23-fold to 82-fold) and tumor necrosis factor (11-fold to 61-fold) at all the tested concentrations of S aureus. Control or CRSwNP SNECs demonstrated a significant increase (P?<?.05) in expression of interleukin 8 (47-fold and 50-fold, respectively) and tumor necrosis factor (106-fold and 58-fold, respectively) at the higher inoculum of S aureus. Basal secretion of inflammatory markers correlated with expression changes. No significant changes in expression were observed for the helper T cell, subtype 2, inflammatory mediators tested.In this study, we developed a model to study early innate immune-mediated changes in SNECs cocultured at an air-liquid interface with bacteria. We also demonstrated that bacterial burden can be detected by SNECs in the absence of adaptive immune-mediated responses. The CRSsNP SNECs are more sensitive to S aureus burden than control or CRSwNP SNECs. Future studies will further develop this infection model and explore the SNEC innate immune response to bacteria.

Project description:The chronic inflammatory nature of chronic rhinosinusitis (CRS) makes it a morbid condition for individuals with the disease and one whose pathogenesis is poorly understood. To date, proteomic approaches have been applied successfully in a handful of CRS studies. In this study we use a multifaceted approach, including proteomics (iTRAQ labeling) and microbiome (bacterial 16S rRNA gene sequencing) analyses of middle meatus swabs, as well as immune cell analysis of the underlying tissue, to investigate the host-microbe interaction in individuals with CRS (n = 10) and healthy controls (n = 9). Of the total 606 proteins identified in this study, seven were significantly (p < 0.05) more abundant and 104 were significantly lower in the CRS cohort compared with healthy controls. The majority of detected proteins (82% of proteins identified) were not significantly correlated with disease status. Elevated levels of blood and immune cell proteins in the CRS cohort, together with significantly higher numbers of B-cells and macrophages in the underlying tissue, confirmed the inflammatory status of CRS individuals. Protein PRRC2C and Ras-related protein (RAB14) (two of the seven elevated proteins) showed the biggest fold difference between the healthy and CRS groups. Validation of the elevated levels of these two proteins in CRS samples was provided by immunohistochemistry. Members of the bacterial community in the two study cohorts were not associated with PRRC2C, however members of the genus Moraxella did correlate with RAB14 (p < 0.0001, rho = -0.95), which is a protein involved in the development of basement membrane. In addition, significant correlations between certain members of the CRS bacterial community and 33 lower abundant proteins in the CRS cohort were identified. Members of the genera Streptococcus, Haemophilus and Veillonella were strongly correlated with CRS and were significantly associated with a number of proteins with varying functions. The results from this study reveal a strong association between the host and microbes in the sinonasal cavity. Proteins identified as associated with CRS could be new targets for drug therapies and biomarkers for assessment of treatment efficacy.

Project description:ObjectiveThe objective of the analyses described here was to develop thresholds defining clinically meaningful response on the total and item scores of the 6-item short-form Headache Impact Test (HIT-6) in a population of patients with chronic migraine (CM).BackgroundThe HIT-6 is a short, easily understood, and useful measure of the impact of headache on daily life. Though widely used, limited literature supports a threshold value for clinically meaningful response within individuals over time for the HIT-6 total score and for the item scores, especially in the CM population.MethodsPROMISE-2 is a randomized, double-blind, multicenter study comparing intravenous eptinezumab 100 and 300 mg with placebo for the preventive treatment of CM. Responder definitions for HIT-6 total and items scores using data from PROMISE-2 study were calculated via distribution-based and anchor-based methods. Distribution-based methods included half of the baseline standard deviation and baseline standard error of measurement. The change from baseline to week 12 in HIT-6 scores was assessed using the following anchors: patient global impression of change, reduction in migraine frequency, and change in EuroQol 5 dimensions 5 levels visual analog scale. Values from the literature and PROMISE-2 analyses were plotted against the cumulative distribution function of change values (baseline to week 12) and used to triangulate to empirically support clinically meaningful change definitions for the HIT-6 total and item scores in patients with CM.ResultsFrom the literature, 5 articles provided 7 candidate values for a responder threshold for the HIT-6 total score. From distribution- and anchor-based methods, 5 candidate values were derived from PROMISE-2 data. Using the median of all candidate values, a HIT-6 total score responder definition estimate of -6 (ie, ≥6-point improvement in the total score) appears most appropriate for discriminating between individuals with CM who have experienced meaningful change over time and those who have not. For item-level analyses using anchor-based methods, the responder definition for items 1-3 ("severe pain," "limits daily activities," and "lie down") was a 1-category improvement in response (eg, from Sometimes to Rarely); for items 4-6 ("too tired," "felt fed up or irritated," and "limits concentration"), a 2-category improvement in response (eg, from Always to Sometimes) was clinically meaningful.ConclusionsUsing a multifaceted, statistically-based approach, the recommended responder definition for the HIT-6 total score in the CM population is a ≥6-point decrease, consistent with previous literature. Anchor-based item-level responder thresholds were defined as a decrease of 1 or 2 categories, depending on the item. These CM-specific values will provide researchers and clinicians a means to interpret clinically meaningful change in the HIT-6 total and item scores and may facilitate the measurement of treatment benefits in specific functional domains of the HIT-6.

Project description:Objectives/hypothesisPrevious studies have shown declines in productivity due to chronic rhinosinusitis (CRS) are correlated with disease-specific quality-of-life (QOL) measures. However, it is unclear which symptom domains contribute primarily to productivity loss. This investigation sought to assess the association between CRS-specific QOL subdomain impairment and productivity loss.Study designProspective, multi-institutional, observational cohort study.MethodsThere were 198 patients with refractory CRS enrolled between August 2012 and June 2015. Baseline QOL measures were obtained across five subdomains of the 22-item SinoNasal Outcome Test (SNOT-22). Lost productivity time was determined from patient-reported measures of annual absenteeism, presenteeism, and lost leisure time, and then monetized using annual daily wage rates from the 2012 US National Census and 2013 Department of Labor statistics.ResultsProductivity losses correlated with impairments in both SNOT-22 psychological dysfunction (Spearman correlation coefficient [Rs] = 0.428, P < .001), and sleep dysfunction domain scores (Rs = 0.355, P < .001). Higher SNOT-22 total scores also significantly correlated with increased monetized productivity losses (Rs = 0.366, P < .001). The mean annual productivity cost was $11,820/patient, whereas patients with comorbid immunodeficiency ($23,285/patient), tobacco use ($23,195/patient), and steroid dependency ($18,910/patient) reported higher than average annual productivity costs. Multivariate linear regression found maximum annual productivity costs in adjusted psychological ($13,300/patient, P < .001) and sleep dysfunction ($9,275/patient, P < .001) domains.ConclusionsImpairments in sleep and psychological SNOT-22 domains correlate with productivity losses. Patients with comorbid immunodeficiency, smoking, and steroid dependency had higher than average productivity losses. Targeted management of psychological and sleep dysfunction in combination with standard symptom control may improve patient-centered care and reduce the annual economic burden of CRS.Level of evidence2c. Laryngoscope, 128:23-30, 2018.

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Low 22-item sinonasal outcome test scores in chronic rhinosinusitis: Why do patients seek treatment?

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Low 22-item sinonasal outcome test scores in chronic rhinosinusitis: Why do patients seek treatment?

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