Effect of Budesonide Added to Large-Volume, Low-pressure Saline Sinus Irrigation for Chronic Rhinosinusitis: A Randomized Clinical Trial.

Importance: Recent studies suggest that budesonide added to saline nasal lavage can be an effective treatment for patients with chronic rhinosinusitis (CRS). Objective: To evaluate the incremental effect of adding budesonide to large-volume, low-pressure saline sinus irrigation. Design, Setting, and Participants: This double-blind, placebo-controlled, randomized clinical trial was conducted at a quaternary care academic medical center between January 1, 2016, and February 16, 2017. A total of 80 adult patients with CRS were enrolled; 74 completed baseline assessments; and 61 remained in the trial to complete all analyses. Data analysis was conducted from March 2017 to August 2017. Interventions: All study participants were provided with a sinus rinse kit including saline and identical-appearing capsules that contained either budesonide (treatment group) or lactose (control group). Patients were instructed to dissolve the capsules in the saline and use the resulting solution to irrigate both nasal cavities, using half the solution for each cavity, once daily for 30 days. Main Outcomes and Measures: The primary outcome measure was the change in Sino-Nasal Outcome Test (SNOT-22) scores, pretreatment to posttreatment, in the budesonide group compared with the control group. Secondary outcome measures included patient-reported response to treatment, as measured with a modification of the Clinical Global Impressions scale, and endoscopic examination scored by the Lund-Kennedy grading system. Results: Of the 74 participants who completed baseline assessments (37 in each study arm), mean (SD) age, 51 (14.7) years, 50 (68%) were women. Of the 61 who remained in the trial to complete all analyses, 29 were randomized to budesonide treatment, and 32 to saline alone. The average change in SNOT-22 scores was 20.7 points for those in the budesonide group and 13.6 points for those in the control group, for a mean difference of 7 points in favor of the budesonide group (95% CI, -2 to 16). A total of 23 participants (79%) in the budesonide group experienced a clinically meaningful reduction in their SNOT-22 scores compared with 19 (59%) in the control group, for a difference of 20% (95% CI, -2.5% to 42.5%). The average change in endoscopic scores was 3.4 points for the budesonide group and 2.7 points for the control group. There were no related adverse events. Conclusions and Relevance: This study shows that budesonide in saline nasal lavage results in clinically meaningful benefits beyond the benefits of saline alone for patients with CRS. Given the imprecision in the treatment effect, further research is warranted to define the true effect of budesonide in saline nasal lavage. Trial Registration: ClinicalTrials.gov Identifier: NCT02696850.

Reporting of Effect Size and Confidence Intervals in JAMA Otolaryngology-Head & Neck Surgery.

Importance: Effect sizes and confidence intervals (CIs) are critical for the interpretation of the results for any outcome of interest. Objective: To evaluate the frequency of reporting effect sizes and CIs in the results of analytical studies. Design, Setting, and Participants: Descriptive review of analytical studies published from January 2012 to December 2015 in JAMA Otolaryngology-Head & Neck Surgery. Methods: A random sample of 121 articles was reviewed in this study. Descriptive studies were excluded from the analysis. Seven independent reviewers participated in the evaluation of the articles, with 2 reviewers assigned per article. The review process was standardized for each article; the Methods and Results sections were reviewed for the outcomes of interest. Descriptive statistics for each outcome were calculated and reported accordingly. Main Outcomes and Measures: Primary outcomes of interest included the presence of effect size and associated CIs. Secondary outcomes of interest included a priori descriptions of statistical methodology, power analysis, and expectation of effect size. Results: There were 107 articles included for analysis. The majority of the articles were retrospective cohort studies (n = 36 [36%]) followed by cross-sectional studies (n = 18 [17%]). A total of 58 articles (55%) reported an effect size for an outcome of interest. The most common effect size used was difference of mean, followed by odds ratio and correlation coefficient, which were reported 17 (16%), 15 (13%), and 12 times (11%), respectively. Confidence intervals were associated with 29 of these effect sizes (27%), and 9 of these articles (8%) included interpretation of the CI. A description of the statistical methodology was provided in 97 articles (91%), while 5 (5%) provided an a priori power analysis and 8 (7%) provided a description of expected effect size finding. Conclusions and Relevance: Improving results reporting is necessary to enhance the reader's ability to interpret the results of any given study. This can only be achieved through increasing the reporting of effect sizes and CIs rather than relying on P values for both statistical significance and clinically meaningful results.

Transoral Resection of Human Papillomavirus (HPV)-Positive Squamous Cell Carcinoma of the Oropharynx: Outcomes with and Without Adjuvant Therapy.

BACKGROUND: With the rise of oropharyngeal squamous cell carcinoma associated with human papillomavirus (HPV), appropriate treatment strategies continue to be tailored toward minimizing treatment while preserving oncologic outcomes. This study aimed to compare the outcomes for those undergoing transoral resection with or without adjuvant therapy for HPV-related oropharyngeal carcinoma. METHODS: A case-match cohort analysis was performed at two institutions on patients with HPV-related oropharyngeal squamous cell carcinoma. All the subjects underwent transoral surgery and neck dissection. The patients treated with surgery alone were matched 1:1 to those treated with surgery and adjuvant therapy using two groups identified as confounders: T-stage (T1/2 or T3/4) and number of pathologically positive lymph nodes (≤4 or >4). RESULTS: The study identified 105 matched pairs, with a median follow-up period of 42 months (range 3.1-102.3 months). The patients were staged as T1/T2 (86%) or T3/4 (14%). Each group had five patients with more than four positive lymph nodes. Adjuvant therapy significantly improved disease-free survival (hazard ratio [HR] 0.067; 95% confidence interval [CI] 0.01-0.62) and was associated with a lower risk of local and regional recurrence (risk ratio [RR] 0.096; 95% CI 0.02-0.47). No difference in disease-specific survival (HR 0.22; 95% CI 0.02-2.57) or overall survival (HR 0.18; 95% CI 0.01-2.4) was observed with the addition of adjuvant therapy. The risk of the gastrostomy tube was higher for those receiving adjuvant therapy (RR 7.3; 95% CI 2.6-20.6). CONCLUSIONS: Transoral surgery is an effective approach for the treatment of HPV-related oropharyngeal carcinoma. The addition of adjuvant therapy appears to decrease the risk of recurrence and improve disease-free survival but may not significantly improve overall survival.

Postoperative hemorrhage and hospital revisit after transoral robotic surgery.

OBJECTIVES/HYPOTHESIS: To investigate the incidence and complications related to postoperative hemorrhage (POH) after transoral robotic surgery (TORS). STUDY DESIGN: Retrospective review of the State Inpatient Database (SID), the State Ambulatory Surgery Database (SASD), and the State Emergency Department Database (SEDD) from the Healthcare Cost and Utilization Project. METHODS: Patients were identified from the SID, SASD, and SEDD for the states of Florida, New York, and California from 2005 to 2013 who had an International Classification of Diseases, Ninth Edition code for a surgical procedure on the upper aerodigestive tract associated with a code for robotic-assisted surgery. Univariate logistic regression was used to explore factors associated with POH. RESULTS: Five hundred nine patients underwent TORS. Indications for surgery included neoplastic disease in 376 (74%) and sleep apnea in 74 (15%). Forty-one (8%) had an episode of POH at a median of 9 days postoperatively (range = 0-21 days). Twenty-four (5%) required an intervention related to their POH. Sixteen (3%) required return to the operating room for control of hemorrhage; 11 (2%) had a severe complication that required embolization or tracheostomy. Charlson Comorbidity Score of ≥3 (odds ratio [OR] = 3.02, 95% confidence interval [CI] = 1.45-6.30) and a tonsillar neoplasm (OR = 1.96, 95% CI = 1.03-3.74) were significantly associated with POH. CONCLUSIONS: The incidence of POH after TORS was low, and few of these patients had a severe complication related to this event. Medical comorbidity and tonsillar subsite may be independent risk factors for POH. These data provide a benchmark for informed decision making in TORS and a basis for further study. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:2287-2292, 2017.