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Does Medical Therapy Improve SinoNasal Outcomes Test-22 Domain Scores? An Analysis of Clinically Important Differences.

ABSTRACT: OBJECTIVES/HYPOTHESIS:Minimum clinically important differences (MCIDs) for the 22-item SinoNasal Outcomes Test (SNOT-22) in patients with chronic rhinosinusitis (CRS) electing endoscopic sinus surgery (ESS) are well described. However, similar estimations for the MCID have not been investigated for patients electing continued appropriate medical therapy (CAMT). We sought to determine MCID values for a medically treated CRS cohort and compare them to historical MCIDs associated with ESS. STUDY DESIGN:Prospective observational cohort study. METHODS:One hundred twenty patients with refractory CRS electing CAMT were prospectively enrolled from academic referral clinics into an observational cohort study. Baseline and posttreatment SNOT-22 survey responses were collected. Four distribution-based methods for calculating MCIDs (e.g., half-standard deviation, Cohen's d, standard error of measurement, and minimum detectable change) were used to identify a range of MCID values for SNOT-22 total and domain scores. RESULTS:The average MCID value for SNOT-22 total scores was 8.0, whereas mean MCID values for rhinologic, extranasal rhinologic, ear/facial, psychological, and sleep symptom domain scores were 3.9, 2.5, 3.3, 3.4, and 2.9, respectively, comparable to previously reported values for patients electing ESS. Although change in SNOT-22 total scores following CAMT exceeded the MCID, none of the average SNOT-22 domain score improvements surpassed their respective MCID thresholds. CONCLUSIONS:MCID values for SNOT-22 total and domain scores in patients electing CAMT are similar to previously published MCID values associated with ESS, indicating that MCID values are independent of treatment modality selection. Therefore, despite evidence of statistical significance, CAMT for CRS may not be associated with clinically discernable improvements in average SNOT-22 domain scores. LEVEL OF EVIDENCE:2c Laryngoscope, 129:31-36, 2019.

SUBMITTER: Chowdhury NI

PROVIDER: S-EPMC6320311 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Does Medical Therapy Improve SinoNasal Outcomes Test-22 Domain Scores? An Analysis of Clinically Important Differences.

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

The Laryngoscope 20180912 1

<h4>Objectives/hypothesis</h4>Minimum clinically important differences (MCIDs) for the 22-item SinoNasal Outcomes Test (SNOT-22) in patients with chronic rhinosinusitis (CRS) electing endoscopic sinus surgery (ESS) are well described. However, similar estimations for the MCID have not been investigated for patients electing continued appropriate medical therapy (CAMT). We sought to determine MCID values for a medically treated CRS cohort and compare them to historical MCIDs associated with ESS.< ...[more]

PMID: 30208209

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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:BackgroundFailure of THA or TKA to meet a patient's expectations may result in patient disappointment and litigation. However, there is little evidence to suggest that surgeons can consistently anticipate which patients will benefit from those interventions.Questions/purposesTo determine the ability of surgeons to identify, in advance of surgery, patients who will benefit from THA or TKA and those who will not, where 'benefit' is defined as a clinically important improvement in a validated patient-reported outcomes score.MethodsIn this prospective study, eight high-volume orthopaedic surgeons completed validated THA and TKA expectations questionnaires (score 0-100, 100 being the highest expectation) as part of preoperative assessment of all their patients scheduled for a THA or TKA and enrolled in the Hospital for Special Surgery institutional registry. Enrolled patients completed the WOMAC preoperatively and at 2 years. Successful outcomes were defined as achieving the minimum clinically important difference (MCID) in WOMAC pain and function subscales. Sensitivity, specificity, and receiver operating characteristic (ROC) curves were used to evaluate the ability of surgeons' expectation scores to identify patients likely to achieve the MCID on the WOMAC scale. Analyses were run separately for patients having THA and TKA. We enrolled 259 patients undergoing THA and 247 undergoing TKA, of whom 77% (n = 200) and 77% (n = 191) completed followup surveys 2 years after their procedures, respectively.ResultsSurgeons' expectation scores effectively anticipated patients who would improve after THA, but they were no better than chance in identifying patients who would achieve the MCID on the WOMAC score 2 years after TKA. For patients having THA, the areas under the ROC curve were 0.67 (95% CI, 0.53-0.82; p = 0.02) and 0.74 (95% CI, 0.63-0.85; p < 0.01) for WOMAC function and pain outcomes, respectively, indicating good accuracy. Sensitivity and specificity were maximized on WOMAC pain and function scores (sensitivity = 0.69, specificity = 0.72, both for pain and function) at an expectations score of 83 or greater of 100. Surgeons' expectations were more accurate for patients who were men, who had a BMI less than 30 kg/m2, who had more than one comorbidity, and who were older than 65 years. For patients having TKA, surgeons' expectation scores were not better than chance for identifying those who would experience a clinically important improvement on the WOMAC scale (area under ROC curve: Function = 0.51, [95% CI, 0.42-0.61], p = 0.78; Pain = 0.51, [95% CI, 0.40-0.61], p = 0.92).ConclusionsMost patients having THA and TKA achieved the MCID improvement after surgery. However, the inability of surgeons' expectation scores to discriminate accurately between patients who benefit and those who do not among patients scheduled for THA who are young, with no comorbidities, and with elevated BMIs, and among all patients scheduled for TKA, calls for surgeons to spend more time with these patients to fully understand and address their needs and expectations. Using standardized assessment tools to compare surgeons' expectations and those of their patients may help focus the surgeon-patient discussion further, and address patients' expectations more effectively.Level of evidenceLevel II, therapeutic study.

Project description:Autism Spectrum Disorder (ASD) is associated with persistent impairments in adaptive abilities across multiple domains. These social, personal, and communicative impairments become increasingly pronounced with development, and are present regardless of IQ. The Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) is the most commonly used instrument for quantifying these impairments, but minimal clinically important differences (MCIDs) on Vineland-II scores have not been rigorously established in ASD. We pooled data from several consortia/registries (EU-AIMS LEAP study, ABIDE-I, ABIDE-II, INFOR, Simons Simplex Collection and Autism Treatment Network [ATN]) and clinical investigations and trials (Stanford, Yale, Roche) resulting in a data set of over 9,000 individuals with ASD. Two approaches were used to estimate MCIDs: distribution-based methods and anchor-based methods. Distribution-based MCID [d-MCID] estimates included the standard error of the measurement, as well as one-fifth and one-half of the covariate-adjusted standard deviation (both cross-sectionally and longitudinally). Anchor-based MCID [a-MCID] estimates include the slope of linear regression of clinician ratings of severity on the Vineland-II score, the slope of linear regression of clinician ratings of longitudinal improvement category on Vineland-II change, the Vineland-II change score maximally differentiating clinical impressions of minimal versus no improvement, and equipercentile equating. Across strata, the Vineland-II Adaptive Behavior Composite standardized score MCID estimates range from 2.01 to 3.2 for distribution-based methods, and from 2.42 to 3.75 for sample-size-weighted anchor-based methods. Lower Vineland-II standardized score MCID estimates were observed for younger and more cognitively impaired populations. These MCID estimates enable users of Vineland-II to assess both the statistical and clinical significance of any observed change. Autism Res 2018, 11: 270-283. © 2017 International Society for Autism Research, Wiley Periodicals, Inc.Lay summaryThe Vineland Adaptive Behavior Scales (2nd edition; Vineland-II) is the most widely used scale for assessing day-to-day "adaptive" skills. Yet, it is unknown how much Vineland-II scores must change for those changes to be regarded as clinically significant. We pooled data from over 9,000 individuals with ASD to show that changes of 2-3.75 points on the Vineland-II Composite score represent the "minimal clinically-important difference." These estimates will help evaluate the benefits of potential new treatments for ASD.

Dataset Information

Does Medical Therapy Improve SinoNasal Outcomes Test-22 Domain Scores? An Analysis of Clinically Important Differences.

Publications

Does Medical Therapy Improve SinoNasal Outcomes Test-22 Domain Scores? An Analysis of Clinically Important Differences.

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