Cluster analysis and prediction of treatment outcomes for chronic rhinosinusitis.
ABSTRACT: Current clinical classifications of chronic rhinosinusitis (CRS) have weak prognostic utility regarding treatment outcomes. Simplified discriminant analysis based on unsupervised clustering has identified novel phenotypic subgroups of CRS, but prognostic utility is unknown.We sought to determine whether discriminant analysis allows prognostication in patients choosing surgery versus continued medical management.A multi-institutional prospective study of patients with CRS in whom initial medical therapy failed who then self-selected continued medical management or surgical treatment was used to separate patients into 5 clusters based on a previously described discriminant analysis using total Sino-Nasal Outcome Test-22 (SNOT-22) score, age, and missed productivity. Patients completed the SNOT-22 at baseline and for 18 months of follow-up. Baseline demographic and objective measures included olfactory testing, computed tomography, and endoscopy scoring. SNOT-22 outcomes for surgical versus continued medical treatment were compared across clusters.Data were available on 690 patients. Baseline differences in demographics, comorbidities, objective disease measures, and patient-reported outcomes were similar to previous clustering reports. Three of 5 clusters identified by means of discriminant analysis had improved SNOT-22 outcomes with surgical intervention when compared with continued medical management (surgery was a mean of 21.2 points better across these 3 clusters at 6 months, P < .05). These differences were sustained at 18 months of follow-up. Two of 5 clusters had similar outcomes when comparing surgery with continued medical management.A simplified discriminant analysis based on 3 common clinical variables is able to cluster patients and provide prognostic information regarding surgical treatment versus continued medical management in patients with CRS.
Project description:The decision to continue medical therapy or recommend endoscopic sinus surgery (ESS) can be challenging in patients with refractory chronic rhinosinusitis (CRS). The objective of this study was to evaluate continued medical therapy vs ESS for patients with refractory CRS who have severe reductions in baseline disease-specific quality of life (QoL).This was a prospective longitudinal crossover study between August 2011 and June 2013. All patients were >18 years old, diagnosed with CRS based on guideline recommendations, failed initial medical therapy and elected ESS. While waiting for ESS, all patients received continued medical therapy. The preoperative waiting period outcomes (continued medical therapy) were compared to the postoperative outcomes. The primary outcome was change in disease-specific QoL (22-item Sinonasal Outcome Test [SNOT-22]). Secondary outcomes were change in endoscopic grading (Lund-Kennedy score), medication consumption, and work days missed in the preceding 90 days.Thirty-one patients were enrolled. Mean baseline SNOT-22 score was 57.6. After a mean of 7.1 months of continued medical therapy, there was a worsening in SNOT-22 score (57.6 to 66.1; p = 0.006). After ESS, with a mean postoperative follow-up of 14.6 months, there was a significant improvement in SNOT-22 score (66.1 to 16.0; p < 0.001). There was also a significant improvement in endoscopic grading (p < 0.001) coupled with a reduction in both work days lost (p < 0.001) and medication consumption (p < 0.01).Results from the study suggest that ESS is a more effective intervention compared to continued medical therapy for patients with refractory CRS who have severe reductions in their baseline disease-specific QoL.
Project description:Symptoms burden in chronic rhinosinusitis (CRS) may be assessed by interviews or by means of validated tools such as the 22-item SinoNasal Outcome Test (SNOT-22). However, when only the total SNOT-22 scores are used, the pattern of symptom distribution and heterogeneity in patient symptoms is lost.To use a standardized symptom assessment tool (SNOT-22) on preoperative symptoms to understand symptom heterogeneity in CRS and to aid in characterization of distinguishing clinical features between subgroups.This was a retrospective review of 97 surgical patients with CRS. Symptom-based clusters were derived on the basis of presurgical SNOT-22 scores using unsupervised analysis and network graphs. Comparison between clusters was performed for clinical and demographic parameters, postsurgical symptom scores, and presence or absence of a history of aspirin sensitivity.Unsupervised analysis reveals coclustering of specific symptoms in the SNOT-22 tool. Using symptom-based clustering, patients with CRS were stratified into severe overall (mean total score, 90.8), severe sinonasal (score, 62), moderate sinonasal (score, 40), moderate nonsinonasal (score, 37) and mild sinonasal (score, 16) clusters. The last 2 clusters were associated with lack of history of aspirin sensitivity. The first cluster had a rapid relapse in symptoms postoperatively, and the last cluster demonstrated minimal symptomatic improvement after surgery.Symptom-based clusters in CRS reveal a distinct grouping of symptom burden that may relate to aspirin sensitivity and treatment outcomes.
Project description:BACKGROUND:For patients with chronic rhinosinusitis (CRS), the decision to elect continued medical management vs surgery is complex and involves tradeoffs between benefits, risks, and overall effectiveness of each therapy. The purpose of this study is to investigate whether baseline disease-specific quality of life (QOL) can assist in predicting outcomes in patients with refractory CRS who elect continued medical management. METHODS:CRS patients electing medical management were enrolled in a prospective, multi-institutional cohort study. Patients were stratified into pretreatment 22-item Sino-Nasal Outcome Test (SNOT-22) subgroups based on 10-point score increments (eg, 10 to 19, 20 to 29, 30 to 39, etc.) to capture potential outcome differences by baseline SNOT-22 disease burden. The proportion of patients achieving minimal clinically important difference (MCID?9 points) and relative improvement (%) for each score category were calculated. RESULTS:Seventy-five CRS patients with a mean ± standard deviation pretreatment SNOT-22 score of 45.2 ± 16.6 were followed for a mean of 14.9 months. The majority of participants electing medical therapy failed to improve 1 MCID (57%) with a mean relative score improvement of 16%. Overall, 37% of patients maintained baseline SNOT-22 QOL status, whereas 20% of patients deteriorated >1 MCID. When treatment crossover patients (to endoscopic sinus surgery [ESS]) were included (n = 117), approximately 1 in 4 (27%) patients achieved an MCID. CONCLUSION:Results from this study suggest that the majority of CRS patients electing ongoing medical management with low baseline disease-specific QOL impairment maintain stable QOL with continued medical management. Furthermore, of CRS patients electing ongoing medical therapy, approximately 1 in 4 patients achieved MCID, whereas 1 in 5 experienced deterioration by >1 MCID.
Project description:Chronic rhinosinusitis (CRS) has been defined as inflammation of the paranasal sinuses lasting at least 12 weeks with corresponding 2 or more "cardinal symptoms" that include: (1) nasal obstruction; (2) thick nasal discharge; (3) facial pain/pressure; and (4) reduction or loss of sense of smell. Although prior studies have investigated symptoms of CRS after sinus surgery, none have compared the outcomes of these specific symptoms to ongoing medical therapy.Patients with CRS were prospectively enrolled into a multi-institutional, comparative effectiveness, cohort study. Subjects elected either continued medical management or endoscopic sinus surgery (ESS). Baseline characteristics and objective clinical findings were collected. Cardinal symptoms of CRS were operationalized by 4 questions on the 22-item Sino-Nasal Outcome Test (SNOT-22). Symptom improvement was evaluated in subjects with at least 6-month follow-up.A total of 342 subjects were enrolled, with 69 (20.2%) electing continued medical management, whereas 273 (79.8%) elected ESS. Subjects electing surgical therapy were more likely to have a higher baseline aggregate SNOT-22 score (44.3 (18.9) vs 53.6 (18.8); p < 0.001). All subjects improved across all cardinal symptoms; however, subjects undergoing ESS were significantly more likely (p ? 0.013) to experience improvement in thick nasal discharge (odds ratio [OR] = 4.36), facial pain/pressure (OR = 3.56), and blockage/congestion of nose (OR = 2.76). Subjects with nasal polyposis were significantly more likely to report complete resolution of smell/taste following ESS compare to medical management (23.8% vs 4.0%; p = 0.026).Across a large population, surgical management is more effective at resolving the cardinal symptoms of CRS than ongoing medical management with the exception of sense of smell/taste.
Project description:To explore possible factors that might impact a patient's choice to pursue endoscopic sinus surgery (ESS) or continue with medical management for treatment of refractory chronic rhinosinusitis (CRS).Cross-sectional evaluation of a multicenter prospective cohort.Two hundred forty-two subjects with CRS were prospectively enrolled within four academic tertiary care centers across North America with ongoing symptoms despite prior medical treatment. Subjects either self-selected continued medical management (n = 62) or ESS (n = 180) for treatment of sinonasal symptoms. Differences in demographics, comorbid conditions, and clinical measures of disease severity between subject groups were compared. Validated metrics of social support, personality, risk aversion, and physician-patient relationships were compared using bivariate analyses, predicted probabilities, and receiver operating characteristic curves at the 0.05 alpha level.No significant differences were found between treatment groups for any demographic characteristic, clinical cofactor, or measure of social support, personality, or the physician-patient relationship. Subjects electing to pursue sinus surgery did report significantly worse average quality-of-life (QOL) scores on the 22-item Sinonasal Outcome Test (SNOT-22; P < .001) compared to those electing continued medical therapy (54.6 ± 18.9 vs. 39.4 ± 17.7), regardless of surgical history or polyp status. SNOT-22 score significantly predicted treatment selection (odds ratio, 1.046; 95% confidence interval, 1.028-1.065; P < .001) and was found to accurately discriminate between subjects choosing endoscopic sinus surgery and those electing medical management 72% of the time.Worse patient-reported disease severity, as measured by the SNOT-22, was significantly associated with the treatment choice for CRS. Strong consideration should be given for incorporating CRS-specific QOL measures into routine clinical practice.2b.
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: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.
Project description: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.
Project description:A number of factors are critical when considering the expected benefit of surgical intervention in patients with chronic rhinosinusitis (CRS) who have failed medical therapy.To evaluate the Sino-nasal Outcome Test (SNOT-22) and other patient demographic characteristics as predictors of postsurgical improvement in patients with CRS.Consecutive adult subjects presenting to the Otolaryngology Clinics at the University of Virginia with refractory CRS that required surgery were included. Patients were excluded if they had not completed both preoperative and postoperative SNOT-22 evaluations. Demographic and baseline measures, including asthma and smoking status, total immunuglobulin E (IgE), absolute eosinophil counts, and Lund-Mackay computed tomography (CT) scoring were also obtained for each subject. Regression analyses were performed.One hundred four subjects met criteria and were included. These subjects showed a 51% overall improvement in postsurgical SNOT-22 evaluations (95% confidence interval [CI]: [45, 57%], P < .001). Multivariate regression analysis revealed that SNOT-22 items related to "runny nose," "cough," and "sadness" were independent predictors of postsurgical SNOT-22 improvement (P < .05, for all). Although "runny nose" had a direct correlation with improvement, more severe "sadness" and "cough" scores had a negative impact on degree of improvement. Similarly, analyses indicated that questions categorized as pertaining to nasal or ear symptoms were uniquely associated with postsurgical improvement in SNOT-22 scores (P < .001 and P = .015, respectively). Neither Lund-Mackay CT scoring, total IgE, nor absolute eosinophil counts correlated with improvement in postsurgical SNOT-22 scores.Physicians can use components of the SNOT-22 to predict likelihood of symptom improvement after surgical intervention in subjects with CRS.
Project description:OBJECTIVES:Appropriateness criteria to determine surgical candidacy for chronic rhinosinusitis (CRS) have recently been described. This study stratified patients who underwent endoscopic sinus surgery (ESS) according to these new appropriateness criteria and evaluated postoperative improvements among appropriateness categories. METHODS:Adult patients with uncomplicated CRS electing ESS were prospectively enrolled in a multi-institutional cohort study between March 2011 and June 2015 to assess outcomes. Subsequently, appropriateness criteria that consider preoperative medical therapy, 22-item SinoNasal Outcome Test (SNOT-22) scores, and Lund-Mackay computed tomography scores were retrospectively applied. RESULTS:A total of 92.6% (436 of 471) were categorized as "appropriate" ESS candidates, 3.8% (18 of 471) as "uncertain," and 3.6% (17 of 471) as "inappropriate." Among uncertain patients, two-thirds (12 of 18) had identifiable reasons for undergoing ESS, most commonly oral corticosteroid intolerance (n?=?6). Postoperative follow-up was available for 79% (n?=?372). Clinically significant SNOT-22 improvements occurred in both appropriate and uncertain groups (all P?<?0.050) but not among the inappropriate group. The inappropriate group reported less mean improvement in SNOT-22 total score compared to appropriate (P?=?0.008) and uncertain (P?=?0.006) groups. CONCLUSION:The vast majority of patients (?93%) who underwent ESS in a multi-institutional research program were identified as appropriate candidates for surgical intervention, as defined by current appropriateness criteria. Valid considerations frequently exist for offering ESS to patients categorized as uncertain. Appropriate and uncertain candidates report similar, clinically significant SNOT-22 improvements following surgery. Patients classified as inappropriate reported significantly less improvement following ESS. Surgical appropriateness criteria may assist in predicting outcomes of ESS. LEVEL OF EVIDENCE:2b. Laryngoscope, 2448-2454, 2018.