The Mayo Clinic Arizona Spasmodic Dysphonia Experience: A Demographic Analysis of 718 Patients.

OBJECTIVE: Analyze demographic data collected over a 25-year experience of 718 patients with spasmodic dysphonia (SD) who have been treated with botulinum toxin-A (BoNT-A) and compare our data with previously published studies. METHODS: Seven hundred eighteen patients with SD were treated with 6621 BoNT-A injections at Mayo Clinic Arizona between 1989 and 2014. All patients were treated by the same physician team. Background demographic data for each patient were recorded. RESULTS: Of 718 patients, 557 patients were female (77.6%). Six hundred sixty of 718 (91.8%) patients had adductor SD (AdSD), and 58 of 718 (8.1%) patients had abductor SD (AbSD). Average age of onset was 51 years. Of 718 patients, 378 (52.6%) had vocal tremor (VT); VT was present in 54.4% of AdSD patients and 32.1% of AbSD patients. Thirty-seven of 718 (5.2%) patients had other dystonias, including cervical dystonia (2.3%), blepharospasm (1.4%), limb dystonia (1.1%), and oromandibular dystonia (0.3%). A positive family history of SD was present in only 6 of 718 patients (0.8%) and of other dystonias in 11 of 718 patients (1.5%). CONCLUSIONS: Spasmodic dysphonia is a chronic and potentially disabling focal laryngeal dystonia. The Mayo Clinic Arizona SD experience compares to prior reports and reveals a female preponderance, onset in middle age, infrequent hereditary pattern, high co-occurrence of VT, and low co-occurrence of other dystonias.

Validated Symptom Outcomes Following Septal Perforation Repair: Application of the NOSE-Perf Scale.

OBJECTIVE: The Nasal Obstruction Symptom Evaluation (NOSE)-Perf scale was developed and validated to measure symptoms associated with nasal septal perforations. This study reports the application of the NOSE-Perf scale to evaluate symptom change following septal perforation repair. METHODS: Patients with NOSE-Perf evaluations ≥6 months following attempted perforation closure from July 2018 to December 2021 utilizing bilateral nasal mucosal flaps with an interposition graft were eligible for study inclusion. Change in NOSE-Perf scores were noted. Patient demographics, perforation size, and concurrent functional procedures were analyzed for impact on symptom outcomes. RESULTS: One-hundred and seventeen patients met the study criteria. Seventy-nine (67.5%) of the patients were female and the mean (range) age at surgery was 47.3 (14-78) years. Repair failure was noted in 7 (6.0%) patients. Mean (SD) preoperative NOSE-Perf score was 25.3 (95% CI, 23.5-27.1) and postoperative score was 7.9 (95% CI, 6.5-9.3). Minimal clinically important difference (MCID) was estimated and greater than 91% of patients had improvement above this threshold. Patient age, perforation size, or concurrent functional procedures did not impact outcomes. Postoperative scores at short (2-4 months), intermediate (5-8 months), and long-term (≥9 months) time periods showed significant improvement (all p < 0.001) compared to preoperative NOSE-Perf scores. CONCLUSION: Significant reduction in nasal symptoms as measured by the NOSE-Perf scale is noted following bilateral mucosal flap repair. Although the nose does not completely normalize following repair, clinically important improvement was noted in at least 91% of patients. The NOSE-Perf scale is positioned to play a role in the standardization of septal perforation evaluation and outcomes assessment. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:3067-3072, 2024.

Combined endoscopic sinus surgery and endonasal septal perforation repair: Symptom outcomes and perforation closure rates.

KEY POINTS: Combined endoscopic sinus surgery and nasal septal perforation repair is technically feasible. NOSE-Perf is a recently developed patient-reported outcome measure for nasal septal perforation. The decision to perform combined ESS and NSP repair should be made on a case-by-case basis.

Autologous Interposition Grafts for Mucosal Flap Septal Perforation Repair.

Background: Nasal septal perforation repair is commonly attempted utilizing bilateral nasal mucosal flaps supported with an interposition graft. Objectives: To compare the failure rates for bilateral flap repairs utilizing four different autologous interposition grafts. Methods: This is a retrospective review of a single surgeon's bilateral flap perforation repairs supported with an autologous interposition graft. Study inclusion over the 18-year review period required at least one examination 1 month after surgery. Repair failure rates were calculated and compared for each graft type, and logistic regression was performed for multivariate analysis. Results: For the 356 study patients, median (range) age was 51 years (14-81) and 63.0% were women. Mean (range) perforation length was 13.9 mm (1-45). Median (range) at last follow-up was 11.2 months (1-192). Graft types used (percentage of patients and failure rate) were temporalis fascia (58.7/4.4), septal cartilage (23.3/7.3), auricular perichondrium (13.8/4.1), and septal bone (4.2/6.7) (p > 0.05). Conclusion: There was no significant difference in bilateral mucosal flap perforation repair failure rate when either a temporalis fascia, septal cartilage, auricular perichondrium, or septal bone interposition graft was used.

Assessment of a Novel Tool for the Clinical Grading of Nasal Septal Perforation.

BACKGROUND: Nasal septal perforations (NSP) can have a heterogeneous appearance on endoscopic examination with varying degrees of crusting, inflammatory change, and associated septal deviation. The clinical applicability of these findings as contributors to patient symptoms may be enhanced by use of a standardized assessment. METHODS: Video nasal endoscopy recordings were obtained from 40 patients with NSP. Five raters with varied levels of training ranging from a senior resident to an experienced septal perforation surgeon independently reviewed the videos for the following exam findings: crusting, scarring, granulation tissue, septal deviation, and edema. Scoring for each item was reported on a 3-point (0-2) scale, and each reviewer repeated scoring at a 14-day interval. Interrater and intrarater agreement were calculated using Fleiss kappa for each item and the total scores. Additionally, endoscopy scores were correlated with patient-reported NOSE-Perf symptom scores. RESULTS: Interrater agreement for the overall instrument was in the "fair-to-moderate" range with the following interrater agreement for each item: crusting (0.458-0.575), scarring (0.286-0.308), granulation (0.403-0.406), deviation (0.487-0.494), and edema (0.253-0.406). Intrarater agreement was generally "substantial" for individual items as well as the overall instrument (0.688). The NSP endoscopy scores were moderately correlated with NOSE-Perf scores (r = 0.44, p = 0.008). CONCLUSIONS: An endoscopic evaluation of NSP comprising five exam findings has acceptable interrater and intrarater reliability and correlates with patient-reported outcomes. NSP endoscopy may be applied to future clinical studies for characterization of NSP and assessment of treatment outcomes. LEVEL OF EVIDENCE: 3 Laryngoscope, 134:3049-3053, 2024.

Nasal Septal Perforation Dimensional Analysis.

OBJECTIVE: To describe and illustrate septal perforation shape through the documentation and analysis of length and height measurements. A secondary objective is to correlate perforation size to surgical and nonsurgical etiologies. STUY DESIGN: Retrospective case series. SETTING: Tertiary academic medical center. METHODS: Length and height of consecutively treated perforations over a 3-year period were measured directly or through computed tomography. Mean differences in length and height measurements were compared and regression analysis used to determine perforation shape and the effect of etiology on perforation size. Perforations were classified by length into small (1-5 mm), medium (6-15 mm), and large (>15 mm) and correlated to shape and etiology. RESULTS: One hundred twenty-four patients (mean age 50.4 years, 60.5% female) met study inclusion criteria. Height was less than length in 93% of perforations 5 mm or greater in length. Mean perforation height was significantly less than length for medium and large perforations (P < .001). Mean length and height measurements of nonsurgical perforations were greater than those for surgical perforations (P < .001). CONCLUSION: Height is less than length in over 90% of septal perforations. Most perforations assume an elliptical shape as they enlarge. Accurate measurement and presentation of length and height is relevant information to perforation management decisions and for the evaluation of treatment outcomes.

Tremor Makes a Difference: A Comparative Study of the Demographics and Treatment Outcomes in Patients With Adductor Spasmodic Dysphonia With or Without Vocal Tremor.

OBJECTIVES: This study aims to evaluate the demographic differences between those with adductor spasmodic dysphonia with vocal tremor (AdSD(+)VT) and those without vocal tremor (AdSD(-)VT) and to analyze their response to treatment with botulinum neurotoxin (BoNT-A). STUDY DESIGN: Retrospective cohort study. METHODS: A database review of all spasmodic dysphonia patients treated with BoNT from 1989 to 2018 at the Mayo Clinic in Arizona was performed. Only patients who had received ≥4 injections of BoNT-A for AdSD were included. Patients were divided into two cohorts: those with coexistent vocal tremor (AdSD(+)VT) and those without vocal tremor (AdSD(-)VT). RESULTS: The final analysis included 398 patients, with 210 AdSD(+)VT patients (53%) and 188 AdSD(-)VT patients (47%). The length of follow-up and median number of treatments were similar between cohorts. AdSD(+)VT patients were more likely to be female (P < 0.001), and older at onset (P < 0.001) and first injection (P < 0.001). The mean maximal benefit was significantly lower for the AdSD(+)VT cohort (P < 0.01), however the mean length of benefit was similar (P = 0.70). CONCLUSIONS: Demographic differences exist between AdSD(+)VT and AdSD(-)VT patients. AdSD(+)VT patients benefit from BoNT-A treatment; however, our analysis suggests that the degree of their maximal benefit is less than in those without VT.

Presenting Symptomatology for Patients With Nasal Septal Perforation: Application of the NOSE-Perf Scale.

OBJECTIVE: To objectively identify and quantitate presenting nasal symptoms in patients with a septal perforation using the validated NOSE-Perf scale. STUDY DESIGN: Case series retrospective review. METHODS: The medical records from August 2018 through January 2022 of patients at a tertiary care academic center with a septal perforation, and who completed the NOSE-Perf questionnaire, were reviewed. Perforation symptoms were identified and quantified using the 12-item NOSE-Perf scale (score range 0-48). NOSE-Perf findings were correlated to patient demographics, perforation etiology, and perforation length. NOSE-Perf scores of patients who pursued treatment were compared with those who did not. RESULTS: NOSE-Perf data were collected from 202 patients. Nasal crusting was noted in 94.1% of patients and was the most severe symptom reported (mean 2.9 of 4.0). Nasal congestion, difficulty breathing, and nasal obstruction followed in prevalence and severity. The mean total NOSE-Perf score was 23.7. Linear regression analysis demonstrated a weakly negative association of NOSE-Perf score with patient age and weakly positive association with increasing perforation length. NOSE-Perf scores were significantly higher in women and in patients pursuing treatment. CONCLUSION: This is the first study to use the validated NOSE-Perf scale to objectively characterize and establish baseline septal perforation symptomatology. The NOSE-Perf scale can play a role in the standardization of perforation evaluation and treatment outcomes assessment. Laryngoscope, 133:1315-1320, 2023.

Nasal Septal Perforation Due to Desmopressin Nasal Spray Use.

Perforations of the nasal septum have many etiologies and occasionally result from intranasal medicated spray use. This case report describes a perforation related to the use of desmopressin nasal spray, which has not been previously reported in the literature. Clinical considerations presented in this article include appropriate technique of nasal spray application, appropriate monitoring of patients on intranasal sprays, and indications for evaluation by an otolaryngologist. Septal perforation treatment success is improved with an early diagnosis.

Septal Perforation Repair Quality of Life Outcomes Using the Revised 15-item Glasgow Benefit Inventory.

BACKGROUND: The 18-item Glasgow Benefit Inventory (GBI) has been widely used to measure patient general health response to otorhinolaryngologic and facial plastic interventions. The GBI was recently reorganized into 15 questions with 5 sub-scale factors (GBI-5F) to improve its utility. Application of the GBI-5F to septal perforation treatments may improve our understanding of quality of life outcomes. METHODOLOGY/PRINCIPAL: The GBI was given to patients seen from August 2018 through October 2021 who were at least 6 months postoperative attempted perforation surgical closure using bilateral nasal mucosal flaps with an interposition graft. Original GBI and GBI-5F scores were computed and subgroup analysis performed in this retrospective medical record review. RESULTS: Of the 98 patients (mean age 45.5 years) who met study criteria, 65 were female. Mean perforation length was 12.9, and height 9.7 mm. The mean postoperative time to GBI completion was 12.7 months. Highest GBI-5F scores were noted in the Quality of Life factor, followed by Self-confidence and Social Involvement. Females reported significantly higher scores than men. Total GBI scores were similar to those recorded for other rhinologic procedures. CONCLUSIONS: The GBI-5F provides measurable insight into patient quality of life benefit following septal perforation repair.

Nasal Swell Body Characteristics in Patients With Septal Perforation.

Objective: To determine whether septal perforations have an effect on nasal swell body (NSB) size. Study Design: Retrospective cohort study. Setting: Two tertiary academic medical centers. Methods: Computed tomography maxillofacial scans of 126 patients with septal perforation and 140 control patients from November 2010 to December 2020 were evaluated. Perforation etiology was determined. Measurements included perforation length and height and swell body width, height, and length. Swell body volume was calculated. Results: The width and volume of the NSB are significantly smaller in perforation patients when compared to controls. The swell body is significantly smaller and thinner in perforations exceeding 14 mm in height compared to small perforations. Perforation etiology groupings into prior septal surgery, septal trauma, septal inflammatory, and mucosal vasoconstriction categories all demonstrated decreased swell body volume and width compared to controls. Inflammatory etiology had the greatest decrease in swell body size. The hemi-swell body on the contralateral side of a septal deviation is significantly thicker than the ipsilateral side. Conclusion: The NSB is smaller in patients with septal perforation regardless of perforation size or etiology.

Significance of age and sex in botulinum neurotoxin dosing for adductor spasmodic dysphonia.

Objectives: This study aims to analyze the impact of age and sex on botulinum neurotoxin (BoNT-A) dosing and outcomes in adductor spasmodic dysphonia (AdSD). Methods: A database review of all spasmodic dysphonia patients treated with BoNT from 1989 to 2018 at the Mayo Clinic in Arizona was performed. Only patients who had received ≥4 injections of BoNT-A for AdSD were included. Patients were divided into two cohorts to analyze age, with an age of first treatment cutoff of 60 years. Patients were divided into male and female cohorts to analyze sex. Results: The final analysis included 398 patients. The mean dose of BoNT-A per treatment was significantly higher in the younger cohort (4.4 vs. 3.9 units, p = 0.048). The mean maximal benefit was similar (72% vs. 70%, p = 0.48); however, the mean length of benefit was significantly shorter in younger patients (3.0 vs. 3.6 months, p < 0.01). The mean BoNT-A dose was significantly higher in the female cohort (4.2 vs. 3.6 units, p = 0.02). The mean maximal benefit was similar (69% vs. 75%, p = 0.58), as was the mean length of benefit (3.2 vs. 3.5 months, p = 0.11). Conclusions: This study suggests that age and sex influence BoNT-A dosing and outcomes in AdSD.

Repair of Large Nasal Septal Perforations Using the Upper Lateral Cartilage Mucosal Flap.

OBJECTIVES/HYPOTHESIS: To describe the surgical technique and closure outcomes of larger septal perforation repair incorporating mucosa from the undersurface of the upper lateral cartilage into a superiorly positioned advancement flap. STUDY DESIGN: Retrospective case series. METHODS: A chart review was performed for patients who underwent perforation repair utilizing bilateral nasal mucosal flaps which incorporated mucosa from the undersurface of the upper lateral cartilage into the superior flap between January 2009 and December 2020. RESULTS: Sixty-six patients met study criteria. Prior septal surgery was the most common (28.8%) etiology. Mean perforation length and height were 18.9 and 14.4 mm, respectively. Complete perforation closure was noted in 91.2% of patients followed for a minimum of 6 months (mean follow-up time 32.1 months). Twelve patients underwent secondary surgery for persistent nasal obstruction. Postoperative loss of dorsal height was noted in seven patients. The NOSE-perf scores were available for the last 15 repairs and demonstrated significant symptom improvement from a mean score of 26.4 (95% confidence interval [CI], 5.2) to 14.5 (95% CI, 5.2) (P < .0001). CONCLUSION: The ventral surface of the upper lateral cartilage can provide additional mucosa for incorporation into a superior advancement flap to achieve successful closure for larger septal perforations. Optimization of surgical outcomes for this challenging condition may require secondary functional or aesthetic procedures. LEVEL OF EVIDENCE: 4 Laryngoscope, 132:973-979, 2022.

Auricular Perichondrium Graft for Septal Perforation Repair.

OBJECTIVES: Procedures which utilize bilateral mucosal flaps with an interposition graft are frequently used when attempting closure of a septal perforation. Concurrent surgical management of the nasal valve or an aesthetic deformity may be indicated. The objective of this study is to report our experience using auricular perichondrium for the interposition graft when auricular cartilage is harvested for structural or aesthetic graft material. METHODS: A retrospective medical record review was performed for septal perforation repairs performed at Mayo Clinic in Arizona from January 2010 through January 2020. Patients identified for this study underwent a procedure utilizing bilateral nasal mucosal flaps with an auricular perichondrium interposition graft. RESULTS: Forty-four patients (31 females) with a mean age of 53.3 years met study criteria. The most common presenting symptoms were nasal obstruction, crusting, and epistaxis. Prior septal surgery was the most common perforation etiology (45.5%). Mean perforation length was 11.8 (range, 3-26) mm and height, 9.1 (range, 2-16) mm. Auricular cartilage was harvested for nasal valve surgery in 43 patients. Complete perforation closure was noted in 95.3% (41/43) of patients with a minimum post-operative follow-up of 3 (mean, 20.4) months. Four patients underwent revision surgery for persistent postoperative nasal obstruction. CONCLUSION: The ear can provide both cartilage and perichondrium for use in septal perforation surgery. Our study demonstrates the successful use of auricular perichondrium as the interposition graft for a perforation closure procedure utilizing bilateral nasal mucosal flaps.

Assessing Patient Symptoms Due to Nasal Septal Perforation: Development and Validation of the NOSE-Perf Scale.

OBJECTIVE: Reporting patient symptoms due to nasal septal perforation (NSP) has been hindered by the lack of a validated disease-specific symptom score. The purpose of this study was to develop and validate an instrument for assessing patient-reported symptoms related to NSP. STUDY DESIGN: Validation study. SETTING: A tertiary care center. METHODS: The Nasal Obstruction Symptom Evaluation (NOSE) scale was used as an initial construct to which 7 nonobstruction questions were added to measure septal perforation symptoms. The proposed NOSE-Perf instrument was distributed to consecutive patients evaluated for NSP, those with nasal obstruction without NSP, and a control group without rhinologic complaints. Questionnaires were redistributed to the subgroup with NSP prior to treatment of the perforation. RESULTS: The study instrument was completed by 31 patients with NSP, 17 with only nasal obstruction, and 22 without rhinologic complaint. Internal consistency was high throughout the entire instrument (Cronbach α = 0.935; 95% CI, 0.905-0.954). Test-retest reliability was demonstrated by very strong correlation between questionnaires completed by the same patient at least 1 week apart (r = 0.898, P < .001). Discriminant validity was confirmed via a receiver operating characteristic (P < .001, area under the curve = 0.700). The NOSE-Perf scale was able to distinguish among all 3 study groups (P < .001) and between NSP and nasal obstruction (P = .024). When used alone, the NOSE scale could not discriminate between NSP and nasal obstruction (P = .545). CONCLUSIONS: The NOSE-Perf scale is a validated and reliable clinical assessment tool that can be applied to adult patients with NSP.

Outcomes of Septal Perforation Repair With Concurrent Endoscopic Sinus Surgery.

OBJECTIVE: This study reviews a cohort of patients in whom septal perforation repair was performed concurrently with endoscopic sinus surgery. We present an endonasal perforation repair technique using bilateral mucosal flaps with an autogenous interposition graft. Intraoperative and postoperative management of the combined surgical patient is discussed and perforation closure outcomes are reported. STUDY DESIGN: Case series. SETTING: Tertiary care center. METHODS: In this institutional review board-approved retrospective chart review, adult patients who underwent concurrent bilateral mucosal flap septal perforation repair and endoscopic sinus surgery from March 1992 to March 2020 were identified. Data on demographics, clinical presentations, perforation size, surgical techniques, and outcomes were extracted and analyzed for patients with a minimum of 3 months of follow-up. RESULTS: Fifty-six patients met study inclusion criteria. Nasal obstruction/congestion was the most frequent symptom reported (80.4%), followed by crusting and epistaxis. Mean perforation size measured at the time of surgery was 14.7 (range, 3-41) mm in length by 9.3 (range, 2-23) mm in height. Temporalis fascia was the most frequent (57.9%) interposition graft material used. Complete perforation closure at the time of the last follow-up was noted in 51 (91.1%) patients. Only 1 failure was noted in the last 48 attempted repairs. CONCLUSION: Patients with a perforated septum may have coexistent chronic sinusitis. The feasibility of attempting concurrent sinus surgery and perforation repair has been questioned. Our review demonstrates a high perforation closure rate when a bilateral mucosal flap procedure is performed after sinus surgery is performed at the same setting.

Bilateral mucosal flap septal perforation repair in the adolescent.

INTRODUCTION: Perforations of the nasal septum are rare in the pediatric age group. High success rates for attempted perforation closure utilizing mucosal flap techniques in adults are frequently reported. This study reviews our experience with pediatric patients diagnosed with a septal perforation who underwent attempted closure during adolescence. Our endonasal bilateral mucosal flap technique is present. METHODS: This study is an observational case series with retrospective chart review of a single surgeon's experience of attempted septal perforation repair utilizing bilateral mucosal flaps with an interposition graft in patients diagnosed with a perforation prior to age 19. The study period was from November 1991 to April 2019. Patient demographics, perforation characteristics (etiology, symptoms and size), surgical closure technique and outcomes are presented. RESULTS: Twenty-three patients (13 females) met the study criteria. Mean age at diagnosis was 14.3 (range, 3-18) years. Crusting (82.6%), nasal obstruction/congestion (60.9%) and epistaxis (47.8%) were the most frequent reported symptoms at presentation. Fourteen patients who underwent attempted closure during adolescence had a minimum of three months follow-up. Mean age at the time of bilateral mucosal flap repair was 17.4 (range, 13-19) years. Mean perforation length was 14.2 (range, 8-22) mm and mean height 10.6 (range, 5-15) mm. Complete closure was noted in all but one patient (92.8%) at the time of last follow-up, mean 16.9 (range, 3-92) months. Every patient noted partial to complete resolution in presenting symptoms. Four patients required revision surgery to address persistent postoperative obstruction. CONCLUSION: Our experience demonstrates septal perforation repair utilizing a bilateral mucosal flap technique can be successfully employed in the adolescent patient.

The Nasal Swell Body and Septal Perforation Repair.

OBJECTIVES: To review our experience with secondary surgery for persistent nasal obstruction following successful septal perforation repair and describe the potential contribution of the nasal swell body (NSB) to obstruction. STUDY DESIGN: Retrospective chart review. METHODS: IRB-approved retrospective chart review of perforation repairs utilizing bilateral mucosal flaps performed by the senior author from October 2008 through April 2019 was performed. Patients who underwent secondary surgery for persistent nasal obstruction were identified. Data regarding patient demographics, perforation characteristics, primary closure technique, and secondary surgical procedures for persistent postoperative obstruction were analyzed. Nasal Obstruction Symptom Evaluation (NOSE) scores were assessed pre and post revision surgery. RESULTS: Thirty-four patients (14.7% of 232 successful repairs) met study criteria. Of those, 30 patients underwent revision septal surgery. An inferiorly advanced NSB was surgically reduced in 9.9% (23/232) of patients following successful closure to improve persistent obstruction. There was no incidence of reperforation. All patients undergoing NSB reduction reported improved nasal airflow postoperatively and 13 completed the NOSE questionnaire. The mean preoperative NOSE score (95% CI) was 52.7 (42.2-63.2; median, 50). The mean postoperative NOSE score (95% CI) was 19.2 (12.8-25.6; median, 15). The difference between the preoperative and postoperative NOSE scores was statistically significant (P < .001). CONCLUSIONS: Repair of a septal perforation using a superior bipedicle flap carries the potential for the NSB to contribute to persistent postoperative nasal obstruction. The swell body can be surgically reduced, without re-perforation, to relieve obstructive symptoms in the patient with a successful perforation repair. LEVEL OF EVIDENCE: IV Laryngoscope, 2020.

Subpectoral implantation of the hypoglossal nerve stimulator: An effective technical modification.

Upper airway stimulation is now a well-established treatment option for selected patients with obstructive sleep apnea. The implanted pulse generator of this system activates the hypoglossal nerve and is routinely placed in a subcutaneous pocket overlying the pectoralis muscle. This case report describes a patient with a history of bilateral mastectomy and radiation for breast cancer who required explantation due to device exposure and infection. The patient was successfully reimplanted by placing the implantable pulse generator deep to the pectoralis major muscle. Clinical circumstances involving the chest wall may warrant subpectoral placement of the implanted pulse generator. Laryngoscope, 129:2420-2423, 2019.

Consensus-Based Attributes for Identifying Patients With Spasmodic Dysphonia and Other Voice Disorders.

Importance: A roadblock for research on adductor spasmodic dysphonia (ADSD), abductor SD (ABSD), voice tremor (VT), and muscular tension dysphonia (MTD) is the lack of criteria for selecting patients with these disorders. Objective: To determine the agreement among experts not using standard guidelines to classify patients with ABSD, ADSD, VT, and MTD, and develop expert consensus attributes for classifying patients for research. Design, Setting and Participants: From 2011 to 2016, a multicenter observational study examined agreement among blinded experts when classifying patients with ADSD, ABSD, VT or MTD (first study). Subsequently, a 4-stage Delphi method study used reiterative stages of review by an expert panel and 46 community experts to develop consensus on attributes to be used for classifying patients with the 4 disorders (second study). The study used a convenience sample of 178 patients clinically diagnosed with ADSD, ABSD, VT MTD, vocal fold paresis/paralysis, psychogenic voice disorders, or hypophonia secondary to Parkinson disease. Participants were aged 18 years or older, without laryngeal structural disease or surgery for ADSD and underwent speech and nasolaryngoscopy video recordings following a standard protocol. Exposures: Speech and nasolaryngoscopy video recordings following a standard protocol. Main Outcomes and Measures: Specialists at 4 sites classified 178 patients into 11 categories. Four international experts independently classified 75 patients using the same categories without guidelines after viewing speech and nasolaryngoscopy video recordings. Each member from the 4 sites also classified 50 patients from other sites after viewing video clips of voice/laryngeal tasks. Interrater κ less than 0.40 indicated poor classification agreement among rater pairs and across recruiting sites. Consequently, a Delphi panel of 13 experts identified and ranked speech and laryngeal movement attributes for classifying ADSD, ABSD, VT, and MTD, which were reviewed by 46 community specialists. Based on the median attribute rankings, a final attribute list was created for each disorder. Results: When classifying patients without guidelines, raters differed in their classification distributions (likelihood ratio, χ2 = 107.66), had poor interrater agreement, and poor agreement with site categories. For 11 categories, the highest agreement was 34%, with no κ values greater than 0.26. In external rater pairs, the highest κ was 0.23 and the highest agreement was 38.5%. Using 6 categories, the highest percent agreement was 73.3% and the highest κ was 0.40. The Delphi method yielded 18 attributes for classifying disorders from speech and nasolaryngoscopic examinations. Conclusions and Relevance: Specialists without guidelines had poor agreement when classifying patients for research, leading to a Delphi-based development of the Spasmodic Dysphonia Attributes Inventory for classifying patients with ADSD, ABSD, VT, and MTD for research.