Psychometric testing of the Skull Base Inventory health-related quality of life questionnaire in a multi-institutional study of patients undergoing open and endoscopic surgery.

PURPOSE: The skull base inventory (SBI) was developed to better assess health-related quality of life (HR-QOL) in patients with anterior and central skull base neoplasms treated by endoscopic and open approaches. The primary objective of this study was to prospectively assess the psychometric properties of the SBI. METHODS: This study is part of a multi-center study of patients undergoing endoscopic and open procedures completed between 2012 and 2018. Participants were eligible if they were over 18 years of age; had benign or malignant anterior, antero-lateral, or central skull base tumors; and required either an open or endoscopic skull base surgical approach. In order to assess the psychometric properties of the SBI, patients completed the instrument at six time points (preoperative, 2 weeks, 3 months, 6 months, 12 months postoperative). Patients also completed the Anterior Skull Base (ASB) questionnaire and the Sinonasal Outcome Test (SNOT-22) to allow comparison to the SBI. RESULTS: One hundred and eighty-seven patients were included across five centers, with 121 having an endoscopic procedure. Internal consistency (Cronbach's alpha = 0.95) and test-retest at 12 months and 12 months plus 2 weeks (intraclass correlation > 0.90) were excellent. Concurrent validity was demonstrated by very strong correlation between total SBI scores and ASB scores (r = 0.810 to 0.869, p < 0.001) and moderate correlation between nasal domain SBI scores and SNOT-22 scores (r = - 0.616 to - 0.738, p < 0.001). Convergent validity was demonstrated by moderate correlation between change in SBI scores and global QOL change (rs = 0.4942, p < 0.001). The minimally important clinical difference (global HR-QOL change of "a little better" or "a little worse") was 6.0. CONCLUSION: The SBI questionnaire is reliable and valid for patients treated by both endoscopic and open approaches and can be used for assessment of HR-QOL in these settings.

Development of an evidence-based decision pathway for vestibular schwannoma treatment options.

OBJECTIVE: To integrate multiple sources of clinical information with patient feedback to build evidence-based decision support model to facilitate treatment selection for patients suffering from vestibular schwannomas (VS). METHODS: This was a mixed methods study utilizing focus group and survey methodology to solicit feedback on factors important for making treatment decisions among patients. Two 90-minute focus groups were conducted by an experienced facilitator. Previously diagnosed VS patients were recruited by clinical investigators at the University of Pittsburgh Medical Center (UPMC). Classical content analysis was used for focus group data analysis. Providers were recruited from practices within the UPMC system and were surveyed using Delphi methods. This information can provide a basis for multi-criteria decision analysis (MCDA) framework to develop a treatment decision support system for patients with VS. RESULTS: Eight themes were derived from these data (focus group + surveys): doctor/health care system, side effects, effectiveness of treatment, anxiety, mortality, family/other people, quality of life, and post-operative symptoms. These data, as well as feedback from physicians were utilized in building a multi-criteria decision model. DISCUSSION: The study illustrated steps involved in the development of a decision support model that integrates evidence-based data and patient values to select treatment alternatives. CONCLUSIONS: Studies focusing on the actual development of the decision support technology for this group of patients are needed, as decisions are highly multifactorial. Such tools have the potential to improve decision making for complex medical problems with alternate treatment pathways.

Multi-center study on sellar reconstruction after endoscopic transsphenoidal pituitary surgery.

INTRODUCTION: Surgical techniques for sellar reconstruction include no reconstruction, use of synthetic materials, autologous grafts, and/or vascularized flaps. The aim of this study was to conduct a multi-center study comparing the efficacy and postoperative morbidity associated with different sellar reconstruction techniques. METHODS: A retrospective chart review of patients who underwent endoscopic transsphenoidal surgery for pituitary tumors from five participating sites between January 2021 and March 2023 was performed. The variables included demographics, tumor characteristics, reconstruction technique, postoperative cerebrospinal fluid leak (CSF) leak, and 22-item Sino-Nasal Outcome Test (SNOT-22) scores. Comparisons of postoperative complications, SNOT-22 scores, and duration of surgery by type of onlay reconstruction were evaluated using Fisher's exact test, analysis of variance, and Kruskal‒Wallis test. RESULTS: Five hundred and one patients were identified. The median tumor size was 2.1 cm, and 64% were non-functioning. Intraoperative CSF leak was identified in 38% of patients. A total of 89% of patients underwent onlay reconstruction: 49% were reconstructed with mucosal grafts, 35% with nasoseptal flaps, and 5% with other onlay techniques. Nasoseptal flaps were utilized more frequently in the setting of giant pituitary adenomas (>3 cm), medial cavernous sinus wall resection, and high-flow intraoperative CSF leaks. Cases who utilized mucosal grafts had an overall shorter operating time (median: 183 min vs. 240 min; p < 0.001). Five postoperative CSF leaks were identified, and therefore, statistical analysis could not be performed for this complication. CONCLUSION: The effectiveness and morbidity of different sellar reconstruction techniques are comparable. Vascularized flaps were utilized more frequently in the setting of larger tumors and high-flow intraoperative CSF leaks.

Multicenter Registry of Adenomas of the Pituitary and Related Disorders: Initial Description of Cushing Disease Cohort, Surgical Outcomes, and Surgeon Characteristics.

BACKGROUND AND OBJECTIVES: To address the lack of a multicenter pituitary surgery research consortium in the United States, we established the Registry of Adenomas of the Pituitary and Related Disorders (RAPID). The goals of RAPID are to examine surgical outcomes, improve patient care, disseminate best practices, and facilitate multicenter surgery research at scale. Our initial focus is Cushing disease (CD). This study aims to describe the current RAPID patient cohort, explore surgical outcomes, and lay the foundation for future studies addressing the limitations of previous studies. METHODS: Prospectively and retrospectively obtained data from participating sites were aggregated using a cloud-based registry and analyzed retrospectively. Standard preoperative variables and outcome measures included length of stay, unplanned readmission, and remission. RESULTS: By July 2023, 528 patients with CD had been treated by 26 neurosurgeons with varying levels of experience at 9 academic pituitary centers. No surgeon treated more than 81 of 528 (15.3%) patients. The mean ± SD patient age was 43.8 ± 13.9 years, and most patients were female (82.2%, 433/527). The mean tumor diameter was 0.8 ± 2.7 cm. Most patients (76.6%, 354/462) had no prior treatment. The most common pathology was corticotroph tumor (76.8%, 381/496). The mean length of stay was 3.8 ± 2.5 days. The most common discharge destination was home (97.2%, 513/528). Two patients (0.4%, 2/528) died perioperatively. A total of 57 patients (11.0%, 57/519) required an unplanned hospital readmission within 90 days of surgery. The median actuarial disease-free survival after index surgery was 8.5 years. CONCLUSION: This study examined an evolving multicenter collaboration on patient outcomes after surgery for CD. Our results provide novel insights on surgical outcomes not possible in prior single-center studies or with national administrative data sets. This collaboration will power future studies to better advance the standard of care for patients with CD.

Impact of Reverse Septal Flap on Morbidity of Nasoseptal Flap Reconstruction of Skull Base Defects.

BACKGROUND: The workhorse for endonasal reconstruction of skull base defects is the posteriorly-based nasoseptal flap (NSF). Postoperative nasal deformities and decreased olfaction are potential complications of NSF. The reverse septal flap (RSF) minimizes the donor site morbidity of the NSF by covering the exposed cartilage of the anterior septum. Currently, there are minimal data examining its effect on outcomes including nasal dorsum collapse and olfaction. OBJECTIVE: Our study aims to clarify whether the RSF should be utilized when the option exists. METHODS: Adult patients undergoing endoscopic endonasal approach (EEA) surgery of the skull base (transsellar/transplanum/transclival approaches) with NSF reconstruction were identified. Data from 2 separate cohorts, one retrospective and one prospective, were collected. Follow-up was at least 6 months. Patients were photographed preoperatively and postoperatively using standard rhinoplastic nasal views. Patients completed the University of Pennsylvania Smell Identification Test (UPSIT) and the 22-item Sino-Nasal Outcome Test (SNOT-22) preoperatively and postoperatively and were also queried regarding subjective changes in nasal appearance and plans for cosmetic surgery following EEA. RESULTS: There were no statistically significant differences in the change in UPSIT and SNOT-22 scores between patients receiving RSF and other reconstructive groups (either NSF without RSF or no NSF). One of 25 patients who were reconstructed with an NSF with RSF reported a change in nasal appearance; none were considering reconstructive surgery. The proportion of patients reporting changes in appearance was significantly lower in the NSF with RSF group as compared to the NSF without RSF group (P = .012). CONCLUSION: The use of an RSF to limit donor site morbidity of the NSF was shown to significantly decrease the proportion of patients who reported nasal deformities and did not show a significant difference in patient-reported sinonasal outcomes. Given these findings, RSF should be considered whenever an NSF is used for reconstruction.

Risk Factors in a Pediatric Population for Postoperative Intracranial Infection Following Endoscopic Endonasal Skull Base Surgery and the Role of Antibiotic Prophylaxis.

BACKGROUND: Endoscopic endonasal skull base surgery (EESBS) is performed through a non-sterile corridor. Intracranial infection rates in a pediatric population have not been extensively studied and the exact effect of antibiotic prophylaxis on rates of infection after EESBS in pediatric patients remains unclear. OBJECTIVE: The purpose of our study is to investigate risk factors for postoperative intracranial infection during EESBS in a pediatric population and help elucidate the role of antibiotic prophylaxis. METHODS: We conducted a retrospective chart review of 99 consecutive patients under the age of 18 who underwent EESBS at our institution from 2013 to 2021. Centers for Disease Control and Prevention/National Healthcare Safety Network criteria for diagnosis of meningitis were used to identify postoperative intracranial infections. RESULTS: The average age was 12.3 years (range 1.6-18) with 66 male patients and 33 female patients. 49 patients had an intraoperative cerebrospinal fluid (CSF) leak, of which 4 had a postoperative CSF leak. We identified 3 postoperative intracranial infections (3%), which were all meningitis cases. The infection rate was 6% (3/49) among those with intraoperative CSF leaks. All patients with meningitis had a postoperative CSF leak. All infections were transclival approaches (2 chordoma and 1 neurenteric cyst). CONCLUSION: This investigation represents one of the largest pediatric endoscopic skull base surgery cohorts. EESBS is safe to perform in pediatric populations, but transclival approaches and postoperative CSF leaks are risk factors for postoperative meningitis.

Dural Sealants Do Not Reduce Postoperative Cerebrospinal Fluid Leak after Endoscopic Endonasal Skull Base Surgery.

Introduction The application of cranial tissue sealants to assist with postoperative closure is widespread, but data are lacking regarding its utility in endoscopic endonasal surgery (EEA). A prospective study was conducted to assess the effect of sealant usage on postoperative cerebrospinal fluid (CSF) leak rate following standard reconstruction. Methods A prospective trial of sealant usage after endoscopic endonasal skull base surgery was performed from May 2016 to June 2019 at a tertiary referral cranial base center. This study enrolled 300 consecutive adult and pediatric patients with skull base pathology who underwent EES in which an intraoperative CSF leak occurred. Patients were sequentially stratified into equally sized groups who did or did not receive sealant as part of their reconstruction. Results Three hundred consecutive adult and pediatric patients were enrolled in the study and had a confirmed intraoperative CSF leak. The intervention cohort with sealant (first 150 patients) had 21 postoperative CSF leaks (14% rate) compared with 9 postoperative CSF leaks (6% rate) in the control group without sealant ( p = 0.02). On multivariate analysis, sealant usage was associated with a higher rate of postoperative CSF leak (odds ratio [OR] = 2.7; p = 0.025). Male gender (OR = 2.4; p = 0.04) and high-flow intraoperative CSF leak (OR = 3.1; p = 0.038) were also found to be associated with postoperative CSF leak. Conclusion Among all patients undergoing EES with an intraoperative CSF leak, the addition of sealant to standard closure techniques did not reduce the rate of postoperative CSF leaks.

The Suprasellar Meningioma Patient-Reported Outcome Survey: a disease-specific patient-reported outcome measure for resection of suprasellar meningioma.

OBJECTIVE: Suprasellar meningioma resection via either the transcranial approach (TCA) or the endoscopic endonasal approach (EEA) is an area of controversy and active evaluation. Skull base surgeons increasingly consider patient-reported outcomes (PROs) when choosing an approach. No PRO measure currently exists to assess quality of life for suprasellar meningiomas. METHODS: Adult patients undergoing suprasellar meningioma resection between 2013 and 2019 via EEA (n = 14) or TCA (n = 14) underwent semistructured interviews. Transcripts were coded using a grounded theory approach to identify themes as the basis for a PRO measure that includes all uniquely reported symptoms. To assess content validity, 32 patients and 15 surgeons used a Likert scale to rate the relevance of items on the resulting questionnaire and the general Patient-Reported Outcomes Measurement Information System-29 (PROMIS29). The mean scores were calculated for all items and compared for TCA versus EEA patient cohorts by using unpaired t-tests. Items on either questionnaire with mean scores ≥ 2.0 from patients were considered meaningful and were aggregated to form the novel Suprasellar Meningioma Patient-Reported Outcome Survey (SMPRO) instrument. RESULTS: Qualitative analyses resulted in 55 candidate items. Relative to patients who underwent the EEA, those who underwent the TCA reported significantly worse future outlook before surgery (p = 0.01), tiredness from medications 2 weeks after surgery (p = 0.001), and word-finding and memory difficulties 3 months after surgery (p = 0.05 and < 0.001, respectively). The items that patients who received a TCA were most concerned about included medication-induced lethargy after surgery (2.9 ± 1.3), blurry vision before surgery (2.7 ± 1.5), and difficulty reading due to blurry vision before surgery (2.7 ± 2.7). Items that patients who received an EEA were most concerned about included blurry vision before surgery (3.5 ± 1.3), difficulty reading due to blurry vision before surgery (2.4 ± 1.3), and problems with smell postsurgery (2.9 ± 1.3). Although surgeons overall overestimated how concerned patients were about questionnaire items (p < 0.0005), the greatest discrepancies between patient and surgeon relevance scores were for blurry vision pre- and postoperatively (p < 0.001 and < 0.001, respectively) and problems with taste postoperatively (p < 0.001). Seventeen meningioma-specific items were considered meaningful, supplementing 8 significant PROMIS29 items to create the novel 25-item SMPRO. CONCLUSIONS: The authors developed a disease- and approach-specific measure for suprasellar meningiomas to compare quality of life by operative approach. If demonstrated to be reliable and valid in future studies, this instrument may assist patients and providers in choosing a personalized surgical approach.

Variations in Surgical Outcomes of Carotid Body Tumors by Surgical Specialty.

OBJECTIVES/HYPOTHESIS: A carotid body tumor (CBT) is a rare type of tumor that is divided among multiple surgical specialties. Individual surgeons may have limited experience in treating these tumors. We aim to compare different surgical specialties within a single healthcare system to detect variations in management and outcome. STUDY DESIGN: Retrospective chart review. METHODS: A chart review of all patients who underwent surgery for CBT at the University of Pittsburgh Medical Center (UPMC) from 2000 to 2019 was carried out. Univariate and multivariate analysis was used for descriptive statistics, comparison of outcomes, and identification of risk factors. RESULTS: Fifty-eight CBT resection surgeries were performed at UPMC. Patients with advanced tumor were 6.7 (95% confidence interval [CI]: 1.36-32.7) times more likely to undergo preoperative embolization and 8.53 (95% CI: 2.011-36.19) times more likely to sustain carotid artery injury. Advanced-stage tumor resections were associated with greater blood loss (P = .03) and longer hospitalization (P = .02). Collaborative surgeries were associated with higher rates of carotid artery injury (P = .003), residual tumor (P < .001), and longer hospitalization (P = .003), as these combined cases were generally reserved for advanced-stage tumors (P = .02). There were no differences in outcomes between specialties. Of 22 surgeons, the median number of surgeries per surgeon was one (range = 1-12, 54.5%). CONCLUSIONS: Surgeons who completed only one surgery for CBT had a greater rate of hospital readmission and greater length of hospital stay. Collaborative surgeries had worse outcomes due to more advanced tumors requiring more complex surgeries. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E190-E195, 2021.

Experience With the Endoscopic Contralateral Transmaxillary Approach to the Petroclival Skull Base.

OBJECTIVES/HYPOTHESIS: The contralateral transmaxillary (CTM) approach is a new surgical approach that improves the surgical trajectory relative to the petrous segment of the internal carotid artery (ICA). Here, we present our clinical experience with the CTM approach to the petroclival region of the skull base. STUDY DESIGN: Retrospective review. METHODS: A retrospective review of 29 patients who underwent a CTM approach for skull base pathology from 2015 to 2020 was performed. Assessment of gross total resection (GTR) was based on postoperative imaging. RESULTS: The male:female ratio was 15:14, with an average age of 52 years (range = 19-78 years). Diagnoses included: 12 chondrosarcomas, 11 chordomas, two meningiomas, one schwannoma, one metastasis, one petrous apicitis, and one arachnoid cyst. CTM was performed in addition to a transclival approach and ipsilateral transpterygoid approach in all patients. Reconstruction of surgical defects included a vascularized flap in all but two patients: 24 nasoseptal flaps and three lateral nasal wall flaps. The reconstructive flap was on the same side as the CTM approach in 22 of 28 (79%) patients. There were no ICA injuries. In a subset of patients with chondromatous tumors, GTR of the targeted area was achieved in 16 of 22 (73%) evaluable chondromatous tumors. With a median follow-up of 13 months, 64% of these patients are without disease or dead of other causes; the remainder are alive with disease. CONCLUSIONS: The CTM approach improves the degree of resection of skull base tumors involving the petroclival region using an endoscopic endonasal approach and may minimize risk to the ICA. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:294-298, 2021.

The Effect of Nasoseptal Flap Elevation on Post-Operative Olfaction and Sinonasal Quality of Life: A Prospective Double-Blinded Randomized Controlled Trial.

BACKGROUND: The use of nasoseptal flaps (NSF) for defect reconstruction in endoscopic endonasal approaches (EEA) to cranial base pathology has markedly reduced rates of cerebrospinal fluid leak. However, the effect of NSF use on post-operative olfaction remains unclear. OBJECTIVE: To evaluate the impact of NSF use during EEA on binarial and uninarial olfaction, and sinonasal quality of life (QOL). METHODS: This was a prospective double-blinded randomized controlled trial. Patients undergoing EEA for sellar pathology were recruited from the University of Pittsburgh Medical Center from December 2014 to May 2017. Subjects were randomized pre-operatively to a side of NSF harvest. Olfaction and QOL were assessed pre-operatively and 6 to 12 months post-operatively using the University of Pennsylvania Smell Identification Test, "Sniffin' Sticks," and Sinonasal Outcomes Test 22. The side of dominant uninarial olfaction was determined using "Sniffin' Sticks." RESULTS: Thirty-one patients were enrolled. Sixteen underwent EEA without NSF (control group) and 15 with NSF. A dominant side of olfaction was identified in 14 patients with NSF; 8 patients were randomized to NSF harvest on the dominant side and the remaining 6 on the non-dominant side. NSF elevation resulted in a 4% decrease in University of Pennsylvania Smell Identification Test scores, but was not statistically significant compared to controls. Similarly, NSF elevation on the side of dominant olfaction resulted in a 6% decrease, but was not statistically significant when compared to the non-dominant elevation group. Change in rhinologic QOL as determined by the Sinonasal Outcomes Test 22 was not significantly different between any of the groups. CONCLUSIONS: The use of NSF during EEA for sellar pathology does not have a significant effect on olfaction or rhinologic QOL. The presence of a dominant side of olfaction is not a primary consideration when deciding the side of NSF harvest.

Prospective characterization of postoperative nasal deformities in patients undergoing endoscopic endonasal skull-base surgery.

BACKGROUND: Surgeons have become increasingly aware of the impact of endoscopic endonasal surgery (EES) of the skull base on sinonasal-related quality of life. Prior retrospective investigation described a correlation between nasoseptal flap (NSF) reconstruction in EES with postoperative nasal deformities, such as nasal dorsum collapse. The primary objective of this study was to prospectively evaluate the incidence of, and contributing factors to, postoperative changes in nasal structure following EES. Secondary goals included assessing subjective changes in nasal appearance as well as objective nasal analysis. METHODS: Clinical demographics and detailed perioperative information was prospectively collected for patients undergoing transsellar/suprasellar EES for skull-base tumors. Preoperatively, 1-month and 6-month photographs were completed for objective photographic nasal analysis and blinded assessment by surgeons. Subjective patient feedback was also solicited. RESULTS: Overall, 14.7% (5/34) of patients subjectively reported postoperative nasal deformities, whereas both blinded-surgeon and objective nasal measurements identified deformities in 12.9% (4/31) of patients. Patients with postoperative deformities were more likely to have skull-base reconstruction with an NSF (p = 0.01) and trended toward an increased incidence in patients with nonpituitary neoplasms (p = 0.07). There were no other associations between clinical or operative characteristics and external deformities. No patients planned to undergo corrective repair. CONCLUSION: External nasal deformities following EES are more frequent than previously acknowledged. Postoperative deformities appear to be associated with NSF reconstruction and may be associated with surgery for nonpituitary neoplasms. Patients should be counseled on this potential outcome, and future studies should investigate how to minimize postoperative sequela.

Injury of the Carotid Artery during Endoscopic Endonasal Surgery: Surveys of Skull Base Surgeons.

Objectives This study aimed to review endoscopic skull base surgeon experience with internal carotid artery (ICA) injuries during endoscopic endonasal surgery (EES) to provide an estimate of the incidence of ICA injury, the associated factors and identify the best training modalities for the management of this complication. Design Anonymous electronic survey of past participants at a well-established endoscopic skull base surgery course and a global online community of skull base surgeons. Main Outcome Measures Relative incidence of ICA injuries during EES, associated anatomic and intraoperative factors, and surgeon experience. Results At least 20% of surgeons in each surveyed population experienced a carotid artery injury. Reported carotid artery injuries were most common during tumor exposure and removal (48%). The parasellar carotid artery was the most commonly injured segment (39%). Carotid artery injuries were more common in high-volume surgeons, but only statistically significant in one of the two populations. Attendance at a skull base course or courses did not change the incidence of carotid artery injury in either surveyed population. In both surveys, respondents preferred live surgeries or active (not computer simulated) training models. Conclusions ICA injury is underreported and most common when manipulating the parasellar carotid artery for exposure and tumor dissection. Given the high morbidity and mortality associated with these injuries, vascular injury management should be prioritized and taught in a graduated approach by modern endoscopic skull base courses.

Sealants and dental caries: insight into dentists' behaviors regarding implementation of clinical practice recommendations.

BACKGROUND: The authors conducted a qualitative study of private-practice dentists in their offices by using vignette-based interviews to assess barriers to the use of evidence-based clinical recommendations in the treatment of noncavitated carious lesions. METHODS: The authors recruited 22 dentists as a convenience sample and presented them with two patient vignettes involving noncavitated carious lesions. Interviewers asked participants to articulate their thought processes as they described treatment recommendations. Participants compared their treatment plans with the American Dental Association's recommendations for sealing noncavitated carious lesions, and they described barriers to implementing these recommendations in their practices. The authors recorded and transcribed the sessions for accuracy and themes. RESULTS: Personal clinical experience emerged as the determining factor in dentists' treatment decisions regarding noncavitated carious lesions. Additional factors were lack of reimbursement and mistrust of the recommendations. The authors found that knowledge of the recommendations did not lead to their adoption when the recommendation was incongruent with the dentist's personal experience. CONCLUSIONS: The authors found that ingrained practice behavior based on personal clinical experience that differed substantially from evidence-based recommendations resulted in a rejection of these recommendations. PRACTICAL IMPLICATIONS: Attempts to improve the adoption of evidence-based practice must involve more than simple dissemination of information to achieve a balance between personal clinical experience and scientific evidence.