Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial.
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ABSTRACT: Background
Endoscopic sinus surgery (ESS) has been used for decades to treat recurrent acute rhinosinusitis episodes (RARS) in adults. RARS results in infectious symptoms, antibiotic courses, sick leaves, and impaired quality of life. Theoretically, the ESS procedure, through improving the drainage of the paranasal sinuses, decreases the symptoms and enhances the quality of life of the RARS patients. Whether this is true has not been reported in a randomized trial yet.Methods
We conduct a single-center, non-blinded, randomized, 6-month, parallel group superiority clinical study including 80 adult participants referred to surgical treatment for RARS. The participants will either have ESS or conservative medical treatment (control group). The primary outcome will be the difference between the mean disease-specific Sinonasal Outcome Test 22 (quality of life questionnaire) change scores (from baseline to 6 months) of ESS and control group.Discussion
This study will add significant new information to the effect and harms of ESS procedure in the treatment of adults with RARS.Trial registration
ClinicalTrials.gov NCT04241016 . Registered on 17 January 2020.
SUBMITTER: Kaski HM
PROVIDER: S-EPMC8424164 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Patient-reported measures are designed to detect a true change in outcome, but they are also subject to change from biases inherent to self-reporting: changing internal standards, changing priorities, and changing interpretations of a given instrument. These biases are collectively known as "response shifts" and can obscure true change after medical interventions.To determine the presence of response shifts in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery.Multisite, prospective, observational cohort study conducted at academic tertiary care centers between February 2011 and May 2013. Study participants comprised a population-based sample of 514 adults (age ?18 years) with CRS, who elected surgical intervention for continuing medically refractory symptoms.Endoscopic sinus surgery.Preoperative and postoperative data from the 22-item Sinonasal Outcome Test (SNOT-22) survey instrument was characterized using exploratory factor analysis. Subsequent longitudinal structural equation models were estimated to test structure, potential response shifts, and true change in the SNOT-22 scores.A total of 339 participants (66.0%) provided survey evaluations at baseline and 6-month follow-up. Factor analysis of the SNOT-22 revealed 5 correlated, yet distinguishable, underlying factors. Endoscopic sinus surgery had a differential impact across these factors, with the largest effect size in rhinologic symptoms (mean [SD] SNOT-22 scores before and after surgery, 13.18 [5.11] and 7.37 [5.48], respectively; d?=?-1.13 [P?<?.001]) and extranasal rhinologic symptoms (8.31 [3.46] and 4.83 [3.68], respectively; d?=?-1.00 [P?<?.05]) (d is an effect size measure defined as the difference in means divided by the presurgery SD). Endoscopic sinus surgery had a smaller, yet significant, effect size on the remaining 3 factors: ear/facial symptoms (7.32 [4.6]) and 3.90 [4.07], respectively; d?=?-0.74 [P?<?.001]), psychological dysfunction (11.90 [7.21] and 6.50 [6.69], respectively; d?=?-0.75 [P?<?.05]), and sleep dysfunction (10.12 [5.59] and 5.88 [5.37], respectively; d?=?-0.76 [P?<?.001]). Participants were found to undergo recalibration, reprioritization, and reconceptualization of symptoms after intervention; however, the magnitude of these response shifts was small and not clinically significant.The SNOT-22 measures 5 distinct factors, not a single construct. Reporting of individual subscale scores may improve sensitivity of this instrument in future studies. Participants undergoing endoscopic sinus surgery experience only clinically insignificant response shifts, validating assessment of change through use of presurgery and postsurgery SNOT-22 responses.clinicaltrials.gov Identifier: NCT01332136.
| S-EPMC4151456 | biostudies-literature
Project description:We sought to evaluate preoperative and postoperative productivity losses and quality of life (QOL) impairment reported by patients with recurrent acute rhinosinusitis (RARS) as compared to patients with chronic rhinosinusitis without nasal polyposis (CRSsNP).Prospective, multi-institutional, nested case-control.Participants with RARS (n = 20) and CRSsNP (n = 20) undergoing endoscopic sinus surgery (ESS) were enrolled as part of a prospective cohort study. For comparison, participants diagnosed with RARS cases were age/gender-matched to control participants diagnosed with CRSsNP using a 1:1 ratio.RARS and CRSsNP participants were followed for ?14 months postoperatively. Productivity losses were reported as the number of days missed from normal productive activities out of the previous 90 days. RARS participants reported similar baseline productivity losses (12.6 ± 27.1 [standard deviation]) as participants with CRSsNP (11.7 ± 20.9; P = .314). Postoperatively, improvement in productivity losses was similar between RARS participants and CRSsNP controls (-6.7 ± 20.0 vs. -9.8 ± 19.1; P = .253). Preoperative and postoperative disease-specific QOL measures (Sino-Nasal Outcomes Test-22 and Rhinosinusitis Disability Index) were similar between the two groups. RARS participants reported a significant decrease in days of previous antibiotic (P = .009) and nasal decongestant (P = .004) use following ESS, whereas participants with CRSsNP reported a significant decrease in antibiotic (P = .002) and oral corticosteroid use (P = .002).RARS patients report baseline productivity losses and disease-specific QOL impairment to levels that parallel those with CRSsNP. Patients with RARS report improvement in QOL following ESS in all disease-specific QOL measures and in several medication measures. Productivity losses and postoperative improvements are similar between patients with RARS and CRSsNP.3b Laryngoscope, 126:1046-1053, 2016.
| S-EPMC4842089 | biostudies-literature
Project description:ObjectivesTo compare the outcome of patients with unilateral CRSsNP (U CRSsNP) and bilateral CRSsNP (B CRSsNP) undergoing FESS. Also, we evaluate the impact of SNOT-22 domains to predict their quality of life (QOL) outcomes and compare these factors with those of CRSwNP group, published in previous work.MethodsA prospective cohort study was performed in the hospital 20 August,66 patients who were presented between January 2016 and December 2017 were diagnosed with CRS according to guideline recommendations, and were beforehand refractory to initial medical therapy and elected to FESS. The Sino Nasal Outcome Test-22 (SNOT-22) was used to evaluate QOL.ResultsA higher significant improvement was observed between preoperative and postoperative SNOT-22 scores in U CRSsNP group [37.13 ± 9.307 versus 14.11 ± 8.531] and in B CRSsNP group [41.76 ± 6.949 versus 18.57 ± 8.495]. In the U CRSsNP group, patients having a preoperative SNOT-22 score higher than 20 points attained MCID in 88%. For the other group, patients having preoperative SNOT-22 score superior to 40 points achieved MCID in 66%. A multivariate logistic regression model found preoperative predictors that have impact on QOL outcomes.ConclusionsOutcomes from this study suggest that patients with U CRSsNP having a preoperative SNOT-22 scores between 10 and 19, and patients with B CRSsNP having a preoperative SNOT-22 scores between 10 and 19 or 20-29 had no chance of achieving an MCID improvement after FESS. Also, preoperative rhinologic symptoms and preoperative psychological dysfunction domains of SNOT-22 are helpful tools to predict improvement after FESS unlike the unilateral character of CRS.
| S-EPMC6423302 | biostudies-literature
Project description:BackgroundApproximately 25% of patients with chronic rhinosinusitis (CRS) have comorbid anxiety and both conditions independently decrease quality of life (QOL). QOL outcomes for CRS and depression have garnered the majority of research attention, but efforts to better understand the impact of anxiety disorders on QOL are increasing. We evaluated the role of comorbid anxiety in patients with CRS undergoing endoscopic sinus surgery (ESS).MethodsAdult patients (n = 148) with CRS with and without comorbid anxiety were prospectively enrolled into a treatment outcomes investigation. History of comorbid anxiety was retrospectively identified (n = 30; 20%) and preoperative and postoperative QOL (Rhinosinusitis Disability Index [RSDI], and 22-item Sino-Nasal Outcome Test [SNOT-22]) scores were compared to patients without comorbid anxiety.ResultsCompared to patients without anxiety, patients with anxiety were found to be younger (p = 0.02) and have a higher prevalence of female gender (p = 0.05), diabetes mellitus (p < 0.001), depression (p < 0.001), and tobacco use (p = 0.03). Participants with comorbid anxiety reported significantly worse preoperative psychological dysfunction as measured by SNOT-22 subdomain scores (p = 0.02), as well as worse preoperative functional (p = 0.04) and emotional (p = 0.001) impairment as evaluated by RSDI subdomain scores. After adjustment for other cofactors, patients with anxiety improved significantly less on SNOT-22 total scores compared to participants without anxiety after ESS (p = 0.02).ConclusionAnxiety occurs with higher prevalence in patients with CRS and the presence of comorbid anxiety is associated with worse preoperative QOL and reduced QOL improvement following ESS. These findings warrant improvement in screening, diagnosis, and treatment for patients with CRS and comorbid anxiety.
| S-EPMC4560611 | biostudies-literature
Project description:Antibiotics are a mainstay of treatment for chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis(RARS). Although quality-of-life outcomes following endoscopic sinus surgery (ESS) have been studied, the change in antibiotic utilization following ESS is less wellknown.We aimed to determine the effect of ESS on antibiotic utilization in CRS and RARS.A multi-institutional, prospective cohort of patients with CRS and RARS was enrolled between January 2001 and January 2009. Patients completed the medication subscale of the Chronic Sinusitis Survey (CSS), and the Wilcoxon signed-rank test was used to compare differences in the overall reported time of antibiotic between preoperative and postoperative time points.A total of 503 patients were followed for an average 17.3 months. Overall, patients reported a 57.2% reduction in time on antibiotics following ESS. The majority of patients (60.4%) reported significantly less antibiotic utilization after ESS (p < 0.001) consisting of an 83.7% reduction in the time on antibiotics. Subgroup analysis also revealed a significant reduction in antibiotic utilization for patients with and without nasal polyposis (59.0% and 58.2%; both p < 0.001) as well as RARS (61.2%; p = 0.001).ESS significantly reduces antibiotic utilization for CRS and RARS. This finding demonstrates potential for lower health care expenditures related to antibiotics, as well as reduced risk of both antibiotic related morbidity and development of bacterial resistance.
| S-EPMC3110704 | biostudies-literature
Project description:OBJECTIVES:There is little consensus regarding the prognostic value of symptom duration in predicting clinical disease severity or quality-of-life (QOL) outcomes in patients with chronic rhinosinusitis (CRS). Our objectives were to: 1) determine if patients with longer symptom duration have worse preoperative disease severity and/or QOL, and 2) determine if delayed surgical intervention influences outcomes of endoscopic sinus surgery (ESS). METHODS:Patients diagnosed with CRS were prospectively enrolled into a multicenter cohort study and observed 14.7 (standard deviaton {SD}?±?4.8) months on average following primary ESS. Preoperative symptom duration was stratified into short-term (<?12 months), middle-term (12-60 months), and long-term (>?60 months). Disease severity was assessed using endoscopy and computed tomography. Disease-specific QOL was measured with the 22-item Sinonasal Outcome Test (SNOT-22) and Rhinosinusitis Disability Index. Adjusted bivariate and multivariate associations between symptom duration, disease severity, and QOL scores were evaluated. RESULTS:One hundred and thirteen patients met inclusion criteria with 35 patients lost to postoperative follow-up. No significant differences in preoperative disease severity or QOL scores were reported between symptom duration subgroups. Participants in the long-term symptom subgroup reported significantly greater mean postoperative improvement on SNOT-22 total scores (n?=?28; -36.3[±?22.2]) compared to both short-term (n?=?27; -23.4[SD?±?11.3]; P?=?0.039) and middle-term (n?=?23; -23.5[SD?±?20.1]; P?=?0.050) subgroups. Postoperative QOL improvements in the long-term symptom subgroup remained significantly greater (P???0.036) after multivariate adjustment. CONCLUSIONS:Symptom duration was not associated with mean preoperative disease severity or QOL. Patients with long-term symptom duration reported the greatest mean postoperative QOL improvement, suggesting that delayed surgical intervention may not reduce QOL improvements following ESS. LEVEL OF EVIDENCE:2c Laryngoscope, 129:303-311, 2019.
| S-EPMC6344235 | biostudies-literature
Project description:The objective of this investigation was to evaluate endoscopic sinus surgery (ESS) outcomes for chronic rhinosinusitis (CRS) between medical centers to determine if differences in quality-of-life outcomes were detectable. In addition, we sought to identify significant, independent cofactors toward the development of an ESS-specific risk-adjustment model so that ESS outcomes may be appropriately compared between institutions and healthcare providers.Prospective, multicenter, observational cohort.Study participants electing ESS for CRS were enrolled and randomly selected in equal numbers from three academic clinical practices in North America between April 2011 and May 2015. The magnitude of average 6-month postoperative improvement in patient-related outcome measures (PROMs) was compared between enrollment sites using multivariate linear regression modeling.A total of 228 participants met inclusion criteria and were included for final analyses (n = 76 per site). The prevalence of septal deviation/septoplasty and oral corticosteroid-dependent conditions was significantly different between enrollment sites (P ? 0.004). Each enrollment site generated significant within-subject improvement across all PROMs after ESS (P < 0.001); however, average unadjusted magnitudes of improvement were significantly different between sites for the primary outcome measure. After controlling for baseline PROMs, septal deviation, steroid-dependent conditions, and medication use variables, enrollment site was no longer associated with significant outcome differences (P = 0.535).Comparison of surgeon outcomes of ESS is feasible and must take into account a number of baseline patient characteristics. Further studies will be critical toward developing an ESS-specific risk-adjustment model and enabling a robust comparison of surgeon outcomes.2c. Laryngoscope, 127:14-21, 2017.
| S-EPMC5156587 | biostudies-literature
Project description:Patients with chronic rhinosinusitis (CRS) have been found to have cognitive deficit, as identified using the Cognitive Failures Questionnaire (CFQ), but the exact etiology of cognitive decline is unknown. In this study we aimed to determine whether improvement in concomitant inflammation and disease burden in CRS, using endoscopic sinus surgery (ESS), improves cognitive deficit. We also sought to identify comorbid conditions that effect improvement likelihood.Study participants (n = 247) with and without nasal polyposis (CRSwNP, CRSsNP) were prospectively enrolled in this multi-institutional, observational outcomes study. Pre- and postoperative cognitive dysfunction was evaluated using the CFQ instrument. Quality of life (QOL) and disease burden was also evaluated using the Rhinosinusitis Disability Index (RSDI), the 22-item SinoNasal Outcome Test (SNOT-22), nasal endoscopy, computed tomography, and the 2-item Patient Health Questionnaire (PHQ-2).Average CFQ total scores improved significantly (p = 0.012) after ESS for patients with follow-up (n = 141). Participants with CRSwNP (n = 51) reported significant postoperative improvements in mean CFQ total scores (p = 0.002) and CFQ distractibility and blunders domain scores (p ? 0.006). No significant postoperative improvement for any average CFQ score was found in CRSsNP (p > 0.086). The magnitude of postoperative improvement in CFQ total and domain mean scores was statistically similar between CRSsNP and CRSwNP (p > 0.115). Depressive disorder, identified using PHQ-2 screening, was the only comorbid condition significantly associated with measurable cognitive deficit (p < 0.001).Patients with CRS have measurable cognitive decline, and ESS may modestly improve cognitive deficit/CFQ scores. Future investigations are needed to further elucidate the underlying mechanisms responsible for cognitive deficit in patients with CRS and significant associations with depression.
| S-EPMC5140732 | biostudies-literature
Project description:The primary objective of this pilot study was to define the change in productivity costs following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). Secondary objectives were to identify CRS-related characteristics that may influence the degree of productivity improvement after ESS.Prospective, multi-institutional, observational cohort study.The human capital approach was used to define productivity costs. Annual absenteeism, presenteeism, and lost leisure time were quantified to define annual lost productive time (LPT). LPT was monetized using the annual daily wage rates obtained from the 2012 US Census and the 2013 US Department of Labor statistics.Twenty-seven patients with refractory CRS who underwent ESS were followed for a mean of 15 months (range, 8-25 months). Following ESS, there were improvements in annual absenteeism (22 days reduced to 3 days), annual presenteeism (41 days reduced to 19 days), and annual household days lost (12 days reduced to 6 days). Overall, the preoperative productivity costs were reduced after ESS ($9,190 vs. $3,373, respectively; P < .001).Daily productivity is negatively impacted by the presence of CRS. The outcomes from this study provide the first insights into the reduced productivity costs associated with receiving ESS for refractory CRS. Future studies with larger sample sizes will need to validate the results from this pilot study.2c Laryngoscope, 126:570-574, 2016.
| S-EPMC4755836 | biostudies-literature
Project description:Health utility scores quantify an individual's valuation of particular health states and are vital components of health economic studies and cost-effectiveness research. We sought to characterize health utility values for patients with recurrent acute rhinosinusitis (RARS) both before and after endoscopic sinus surgery (ESS), as well as compare health utility to chronic rhinosinusitis without nasal polyposis (CRSsNP).Patients with RARS (n = 20) and CRSsNP (n = 20) undergoing ESS were enrolled as part of a longitudinal, observational, prospective cohort. Case patients diagnosed with RARS were age- and gender-matched to controls with CRSsNP using a nested case-control design at a 1:1 ratio. Health utility was measured using the Medical Outcomes Study Short Form-6D (SF-6D) survey.Patients with RARS were followed for an average of 14.0 ± 6.1 (mean ± standard deviation) months compared to an average of 14.4 ± 5.3 months for CRSsNP controls (p = 0.779). Mean preoperative SF-6D health utility scores were statistically comparable between RARS (0.71 ± 0.14) and CRSsNP (0.66 ± 0.12; p = 0.341). Both patients with RARS and CRSsNP reported significant postoperative improvement in SF-6D scores from 0.71 ± 0.14 to 0.79 ± 0.13 (p = 0.031) and from 0.66 ± 0.12 to 0.77 ± 0.13 (p = 0.004), respectively. No difference in last postoperative SF-6D scores were found between RARS and CRSsNP (p = 0.583) or in the average magnitude of postoperative improvement (0.08 ± 0.16 vs 0.11 ± 0.13; p = 0.620).Patients with RARS and CRSsNP report significant impairment in health utility as measured by the SF-6D. ESS significantly improves health utility in patients with RARS and CRSsNP to near normative values. These data will help inform future economic analysis and cost-effectiveness research.
| S-EPMC5096975 | biostudies-literature