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Investigating the minimal clinically important difference for SNOT-22 symptom domains in surgically managed chronic rhinosinusitis.

ABSTRACT: Prior work has described 5 domains within the 22-item Sino-Nasal Outcomes Test (SNOT-22) that allow for stratification of symptoms into similar clusters and that can be used to direct therapy. Although the outcomes of various interventions on these symptom domains have been reported, minimal clinically important difference (MCID) values have not been investigated, which has limited clinical interpretation of these results.This study was designed as a secondary analysis of a prospective, multi-institutional, observational cohort. A total of 276 patients with medically refractory CRS who underwent surgical management were enrolled. Distribution-based methods (half-standard deviation, standard error of measurement, Cohen's d, and the minimum detectable change) were used to compute MCID values for both SNOT-22 total and domain scores. The Medical Outcomes Study Short Form 6D (SF-6D) health utility score was used to operationalize anchor-based associations using receiver-operating characteristic (ROC) curves.The mean MCID of several distribution-based methods for total SNOT-22 scores was 9.0, in agreement with previously published metrics. Average MCID values for the rhinologic, extranasal rhinologic, ear/facial, psychological, and sleep domain scores were 3.8, 2.4, 3.2, 3.9, and 2.9, respectively. Anchor-based approaches with the SF-6D did not have strong predictive accuracy across total SNOT-22 scores or domains (ROC areas under-the-curve ? 0.71), indicating weak associations between improvement in SNOT-22 scores and health utility as measured by the SF-6D.This estimation of MCID values for the SNOT-22 symptom domains allows for improved clinical interpretation of results from past, present, and future rhinologic outcomes research.

SUBMITTER: Chowdhury NI

PROVIDER: S-EPMC5716928 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Investigating the minimal clinically important difference for SNOT-22 symptom domains in surgically managed chronic rhinosinusitis.

Chowdhury Naweed I NI Mace Jess C JC Bodner Todd E TE Alt Jeremiah A JA Deconde Adam S AS Levy Joshua M JM Smith Timothy L TL

International forum of allergy & rhinology 20171020 12

<h4>Background</h4>Prior work has described 5 domains within the 22-item Sino-Nasal Outcomes Test (SNOT-22) that allow for stratification of symptoms into similar clusters and that can be used to direct therapy. Although the outcomes of various interventions on these symptom domains have been reported, minimal clinically important difference (MCID) values have not been investigated, which has limited clinical interpretation of these results.<h4>Methods</h4>This study was designed as a secondary ...[more]

PMID: 29053911

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Project description:OBJECTIVES/HYPOTHESIS:Previous 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 DESIGN:Prospective, multi-institutional, observational cohort study. METHODS:There 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. RESULTS:Productivity 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. CONCLUSIONS:Impairments 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 EVIDENCE:2c. Laryngoscope, 128:23-30, 2018.

Project description:Prior study demonstrated that baseline 22-item Sino-Nasal Outcome Test (SNOT-22) aggregate scores accurately predict selection of surgical intervention in patients with chronic rhinosinusitis (CRS). Factor analysis of the SNOT-22 survey has identified five distinct domains that are differentially impacted by endoscopic sinus surgery (ESS). This study sought to quantify SNOT-22 domains in patient cohorts electing both surgical or medical management and postinterventional change in these domains.CRS patients were prospectively enrolled into a multi-institutional, observational cohort study. Subjects elected continued medical management or ESS. SNOT-22 domain scores at baseline were compared between treatment cohorts. Postintervention domain score changes were evaluated in subjects with at least six-month follow-up.A total of 363 subjects were enrolled with 72 (19.8%) electing continued medical management, whereas 291 (80.2%) elected ESS. Baseline SNOT-22 domain scores were comparable between treatment cohorts in sinus-specific domains (rhinologic, extranasal rhinologic, and ear/facial symptoms; p > 0.050); however, the surgical cohort reported significantly higher psychological (mean ± standard deviation [SD]: 16.0 ± 8.4 vs 12.0 ± 7.1; p < 0.001) and sleep dysfunction (13.7 ± 6.8 vs 10.5 ± 6.2; p < 0.001) than the medical cohort. Effect sizes for ESS varied across domains with rhinologic and extranasal rhinologic symptoms experiencing the greatest gains (1.067 and 0.997, respectively), whereas psychological and sleep dysfunction experiencing the smallest improvements (0.805 and 0.818, respectively). Patients experienced greater mean improvements after ESS in all domains compared to medical management (p < 0.001).Subjects electing ESS report higher sleep and psychological dysfunction compared to medical management but have comparable sinus-specific symptoms. Subjects undergoing ESS experience greater gains compared to medical management across all domains; however, these gains are smallest in the psychological and sleep domains.

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:BackgroundA minimal clinically important difference has not been established for the Abnormal Involuntary Movement Scale in patients with tardive dyskinesia. Valbenazine is a vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. Efficacy in randomized, double-blind, placebo-controlled trials was defined as the change from baseline in Abnormal Involuntary Movement Scale total score (sum of items 1-7).ObjectivesTo estimate an minimal clinically important difference for the Abnormal Involuntary Movement Scale using valbenazine trial data and an anchor-based method.MethodsData were pooled from three 6-week double-blind, placebo-controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558). Valbenazine doses were pooled for analyses as follows: "low dose," which includes 40 or 50 mg/day; and "high dose," which includes 75 or 80 mg/day. Mean changes from baseline in Abnormal Involuntary Movement Scale total score were analyzed in all participants (valbenazine- and placebo-treated) with a Clinical Global Impression of Change-Tardive Dyskinesia or Patient Global Impression of Change score of 1 (very much improved) to 3 (minimally improved).ResultsThe least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose: -2.4; high dose: -3.2; both, P < 0.001) versus placebo (-0.7). An minimal clinically important difference of 2 points was estimated based on least squares mean changes in Abnormal Involuntary Movement Scale total score in participants with a Clinical Global Impression of Change-Tardive Dyskinesia score ≤3 at week 6 (mean change: -2.2; median change: -2) or Patient Global Impression of Change score ≤3 at week 6 (mean change: -2.0; median change: -2).ConclusionsResults from an anchor-based method indicate that a 2-point decrease in Abnormal Involuntary Movement Scale total score may be considered clinically important. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Dataset Information

Investigating the minimal clinically important difference for SNOT-22 symptom domains in surgically managed chronic rhinosinusitis.

Publications

Investigating the minimal clinically important difference for SNOT-22 symptom domains in surgically managed chronic rhinosinusitis.

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