Patient perspectives on recall period and response options in patient-reported outcome measures for chronic rhinosinusitis symptomatology: An international multi-centered study.

BACKGROUND: Existing patient-reported outcome measures (PROMs) for chronic rhinosinusitis (CRS) use a variety of recall periods and response scales to assess CRS symptom burden. Global perspectives of CRS patients regarding optimal recall periods and response scales for CRS PROMs are unknown. METHODS: This was a multi-center, cross-sectional study recruiting 461 CRS patients from sites across the United States, Saudi Arabia, New Zealand, and Austria. Participants chose which CRS symptom recall period (1 day, 2 weeks, 1 month, >1 month) was most reflective of their current disease state and upon which to best base treatment recommendations (including surgery). Participants also chose which of six response scales (one visual analogue scale and five Likert scales ranging from four to eight items) was easiest to use, understand, and preferred. RESULTS: A plurality of participants (40.0%) felt their CRS symptoms' current state was best reflected by a 1-month recall period. However, most patients (56.9%) preferred treatment recommendations to be determined by symptoms experienced over a >1 month period. The four- and five-item Likert scales were the easiest to understand (26.0% and 25.4%, respectively) and use (23.4% and 26.7%, respectively). The five-item (26.4% rating it most preferred and 70.9% rating it preferred) and four-item Likert (22.3% rating it most preferred and 56.4% rating it preferred) response scales were most preferred. CONCLUSION: Future PROMs for CRS should consider assessment of symptoms over a 1-month period and use a four- or five-item Likert response scale to reflect global patient preferences. These findings also inform interpretation of current CRS PROMs.

Heterogeneity in the definition of chronic rhinosinusitis disease control: a systematic review of the scientific literature.

PURPOSE: Disease control is conceptually recognized to be an important outcome measure for chronic rhinosinusitis (CRS). However, inconsistent usage is a significant factor in disadoption of important concepts and it is presently unclear how consistently the construct of CRS 'control' is being defined/applied. The objective of this study was to determine the heterogeneity of CRS disease control definitions in the scientific literature. METHODS: Systematic review of PubMed and Web of Science databases from inception through December 31, 2022. Included studies used CRS disease control as an explicitly stated outcome measure. The definitions of CRS disease control were collected. RESULTS: Thirty-one studies were identified with more than half published in 2021 or later. Definitions of CRS control were variable, although 48.4% of studies used the EPOS (2012 or 2020) criteria to define control, 14 other unique definitions of CRS disease control were also implemented. Most studies included the burden CRS symptoms (80.6%), need for antibiotics or systemic corticosteroids (77.4%) or nasal endoscopy findings (61.3%) as criteria in their definitions of CRS disease control. However, the specific combination of these criteria and prior time periods over which they were assessed were highly variable. CONCLUSION: CRS disease control is not consistently defined in the scientific literature. Although many studies conceptually treated 'control' as the goal of CRS treatment, 15 different criteria were used to define CRS disease control, representing significant heterogeneity. Scientific derivation of criteria and collaborative consensus building are needed for the development of a widely-accepted and -applied definition of CRS disease control.

A validated model for the 22-item Sino-Nasal Outcome Test subdomain structure in chronic rhinosinusitis.

BACKGROUND: Previous studies have identified subdomains of the 22-item Sino-Nasal Outcome Test (SNOT-22), reflecting distinct and largely independent categories of chronic rhinosinusitis (CRS) symptoms. However, no study has validated the subdomain structure of the SNOT-22. This study aims to validate the existence of underlying symptom subdomains of the SNOT-22 using confirmatory factor analysis (CFA) and to develop a subdomain model that practitioners and researchers can use to describe CRS symptomatology. METHODS: A total of 800 patients with CRS were included into this cross-sectional study (400 CRS patients from Boston, MA, and 400 CRS patients from Reno, NV). Their SNOT-22 responses were analyzed using exploratory factor analysis (EFA) to determine the number of symptom subdomains. A CFA was performed to develop a validated measurement model for the underlying SNOT-22 subdomains along with various tests of validity and goodness of fit. RESULTS: EFA demonstrated 4 distinct factors reflecting: sleep, nasal, otologic/facial pain, and emotional symptoms (Cronbach's alpha, >0.7; Bartlett's test of sphericity, p < 0.001; Kaiser-Meyer-Olkin >0.90), independent of geographic locale. The corresponding CFA measurement model demonstrated excellent measures of fit (root mean square error of approximation, <0.06; standardized root mean square residual, <0.08; comparative fit index, >0.95; Tucker-Lewis index, >0.95) and measures of construct validity (heterotrait-monotrait [HTMT] ratio, <0.85; composite reliability, >0.7), again independent of geographic locale. CONCLUSION: The use of the 4-subdomain structure for SNOT-22 (reflecting sleep, nasal, otologic/facial pain, and emotional symptoms of CRS) was validated as the most appropriate to calculate SNOT-22 subdomain scores for patients from different geographic regions using CFA.

Locoregional control of tongue base adenoid cystic carcinoma with primary resection and radial forearm free flap reconstruction.

Adenoid cystic carcinoma of the minor salivary glands can be challenging and marked by high rates of local recurrence despite appropriate surgical resection. Management of this pathology in the base of the tongue is particularly difficult given the poor functional outcomes traditionally associated with an aggressive surgical approach. This article presents a case series of patients who underwent up-front surgical resection followed by free tissue transfer reconstruction. A retrospective analysis was performed of patients with adenoid cystic carcinoma of the base of the tongue who underwent composite resection and reconstruction with a radial forearm free flap. Three patients met inclusion criteria and underwent analysis. All patients achieved locoregional control after at least 4 years of surveillance. In addition, all patients were decannulated and were swallowing without the need for gastrostomy tube feeding. This series demonstrates that for select patients with adenoid cystic carcinoma of the base of the tongue, excellent locoregional control can be achieved with acceptable functional outcomes and prolonged survival when appropriate reconstructive measures are employed.

The impact of surgical trainee participation on sinus surgery outcomes.

OBJECTIVES/HYPOTHESIS: To determine the effect of otolaryngology trainee participation on clinical outcomes in patients who undergo endoscopic sinus surgery (ESS) for chronic rhinosinusitis. STUDY DESIGN: Secondary analysis of prospectively collected data. METHODS: Patients enrolled in a sinus surgery outcomes study between May 2011 and March 2013 were stratified into two groups--those who were operated on by an attending alone and those operated on by an attending with a trainee present (resident, fellow, or both). Patients completed quality of life (QOL) surveys including the Chronic Sinusitis Survey (CSS), 22-item Sino-Nasal Outcome Test (SNOT-22), and EuroQol 5-dimension survey preoperatively and 1 year postoperatively. Operative time, estimated blood loss (EBL), complication rates, and survey scores were compared between groups. RESULTS: The study population consisted of 452 patients. The attending alone (n = 119) and trainee (n = 333) groups were statistically comparable in terms of patient demographics, disease severity, and extent of surgery. Mean operative time was significantly shorter in the attending-alone group (80.0 vs. 90.6 minutes, P < .01). Mean EBL (105 mL attending vs. 117 mL trainee, P = .39) and complication rates (3.3% attending vs. 0.6% trainee, P = .07) were similar between groups. Observed changes in QOL measures following ESS were comparable between groups, although absolute improvement in the SNOT-22 scores (19.0 attending vs. 24.5 trainee, P = .05) did show a trend toward greater improvement in the trainee group. CONCLUSIONS: Trainee participation in ESS is associated with prolongation in surgical time; however, such participation was not found to adversely affect patient safety or clinical outcomes. LEVEL OF EVIDENCE: 2b.

Skull base erosion and associated complications in sphenoid sinus fungal balls.

BACKGROUND: Sphenoid sinus fungal balls (SSFB) are rare entities that can result in serious orbital and intracranial complications. There are few published reports of complications that result from SSFB. OBJECTIVE: To review the incidence of skull base erosion and orbital or intracranial complications in patients who present with SSFB. METHODS: A retrospective review was performed of all the patients with SSFB who were treated at the Massachusetts Eye and Ear Infirmary from 2006 to 2014. Presenting clinical data, radiology, operative reports, pathology, and postoperative course were reviewed. RESULTS: Forty-three patients with SSFB were identified. Demographic data were compared between patients with (39.5%) and those without (61.5%) skull base erosion. Two patients underwent emergent surgery for acute complications of SSFB (one patient with blindness, one patient who had a seizure). Both patients with acute complications had evidence of skull base erosion, whereas no patients with an intact skull base developed an orbital or intracranial complication (p = 0.15). All the patients were surgically managed via an endoscopic approach. CONCLUSION: SSFBs are rare but may cause significant skull base erosion and potentially severe orbital and intracranial complications if not treated appropriately. Endoscopic sphenoidotomy is effective in treating SSFB and should be performed emergently in patients who presented with associated complications.

EQ-5D-derived health utility values in patients undergoing surgery for chronic rhinosinusitis.

OBJECTIVES/HYPOTHESIS: Health utility value (HUV) is an index used to measure health-related quality of life for the valuation and comparison of treatments. The Euroqol 5-Dimension (EQ-5D) questionnaire is a widely used method for determining HUV, but it has not been applied for this purpose in patients with chronic rhinosinusitis (CRS) who undergo sinus surgery. STUDY DESIGN: Prospective cohort study. METHODS: Patients with CRS, who were recruited from 11 different otolaryngologic practices, completed the EQ-5D questionnaire at baseline, as well as 3, 12, and 24 months after surgery. HUVs calculated from the results of this questionnaire were compared to those reported in the general U.S. population and to patients suffering from other chronic diseases. RESULTS: Baseline EQ-5D surveys were completed by 242 patients. Mean baseline HUV (standard deviation) was 0.81 (0.13). Female gender, revision surgery, and the use of intraoperative image guidance were associated was significantly lower baseline values. HUV rose at 3 months to 0.89 (0.12) and remained improved at 12 months 0.88 (0.10) and 24 months 0.89 (0.10) (P < 0.001). Baseline HUV in CRS (0.81[0.13]) is lower than the general U.S. population (0.85 [0.18]) and appears appropriately positioned among other common chronic conditions including asthma (0.82-0.92), migraine (0.81-0.91), and seasonal allergies (0.94). CONCLUSIONS: Sinus surgery provides improvement in HUV in patients with CRS. These values may be paired with costs of care to perform cost-utility analysis on this group of patients. LEVEL OF EVIDENCE: 2c.

A new model for collection of clinical outcomes data in patients with chronic rhinosinusitis.

BACKGROUND: The need for objective assessment of patient outcomes is becoming an essential component of clinical practice for both private and academic otolaryngologists. The purpose of this study is to describe the implementation of an online model for collection of clinical outcomes data in patients with chronic rhinosinusitis (CRS). METHODS: Patients completed the Sinonasal Outcome Test (SNOT-22), Chronic Sinusitis Survey (CSS), and EuroQol 5-dimension assessment (EQ-5D), before and after sinus surgery. One year after initial patient enrollment, an online tool was developed to facilitate collection of postoperative data. Response rates preimplementation and postimplementation of online data collection were compared. RESULTS: A total of 520 sinus surgery patients provided outcomes data from the practices of 7 private practice (n = 308) and 4 academic otolaryngologists (n = 212). With implementation of the online collection instrument, the response rate at 3 months increased from 67% to 78.8% (p = 0.004). The overall follow-up rate at 3 months was higher in patients recruited from private as compared to academic practices (77.9% vs 69.8%, respectively, p = 0.04). CONCLUSION: Quality of life data can be effectively collected from CRS patients in both the private and academic practice setting. The addition of an online data collection tool can significantly increase response rates, and allow a comprehensive capture of meaningful clinical outcomes. Such a model is not difficult to implement and has increasing relevance as payers begin to request outcome data from providers.

Hearing results using the SMart piston prosthesis.

OBJECTIVE: SMart, a newly introduced piston prosthesis for stapedotomy, is a nitinol-based, heat-activated, self-crimping prosthesis. We review our hearing results and postoperative complications using this self-crimped piston prosthesis and compare them with those obtained using stainless steel or platinum piston prostheses. HYPOTHESIS: Audiometric results using the SMart piston are identical to those obtained using a conventional piston prosthesis. STUDY DESIGN: Retrospective chart review. SETTING: Private neurotologic tertiary referral center. PATIENTS: The 416 ears reviewed included 306 with a SMart prosthesis and 110 conventional prostheses. 61% were women. Mean follow-up time was 5.6 (standard deviation [SD], 6.3 mo) and 6.9 months (SD, 7.0 mo) for the 2 groups, respectively. INTERVENTION: Stapedotomy using the SMart or a conventional (non-SMart) prosthesis. MAIN OUTCOME MEASURES: Audiometric hearing results, including pure-tone average (PTA) and air-bone gap (ABG), and prevalence of postoperative complications. RESULTS: Mean postoperative PTA was 32.6 (SD, 16.8) dB for the SMart group and 29.4 (SD, 13.5) dB for the non-SMart group, with ABGs of 7.6 (SD, 8.9) and 6.0 (SD, 5.2) dB, respectively. Mean change (decrease) in ABG was 18.7 (SD, 13.1) dB for the SMart group and 19.9 (SD, 10.3) dB for the non-SMart group. High-frequency bone PTAs showed overclosure of 2.0 (SD, 7.9) dB for the SMart group and 3.6 (SD, 8.6) dB for the non-SMart group. Postoperative vertigo and tinnitus were infrequent. No significant differences in these audiometric outcomes or complication rates were noted between groups. There was no significant difference in rate of gap closure to within 10 dB (78.3 versus 84.2%, SMart and non-SMart, respectively) or 20 dB (94.2 and 98.0%). CONCLUSION: Compared with conventional stapes prostheses, the nitinol-based SMart is a safe and reliable stapes prosthesis that eliminates manual crimping without significantly altering the audiometric outcome. Complications are rare, but longer follow-up is needed before establishing long-term stability.