Subarachnoid Hemorrhage Trials: Cutting, Sliding, or Keeping mRS Scores and WFNS Grades.

Rigorous evidence generation with randomized controlled trials has lagged for aneurysmal subarachnoid hemorrhage (SAH) compared with other forms of acute stroke. Besides its lower incidence compared with other stroke subtypes, the presentation and outcome of patients with SAH also differ. This must be considered and adjusted for in designing pivotal randomized controlled trials of patients with SAH. Here, we show the effect of the unique expected distribution of the SAH severity at presentation (World Federation of Neurological Surgeons grade) on the outcome most used in pivotal stroke randomized controlled trials (modified Rankin Scale) and, consequently, on the sample size. Furthermore, we discuss the advantages and disadvantages of different options to analyze the outcome and control the expected distribution of the World Federation of Neurological Surgeons grades in addition to showing their effects on the sample size. Finally, we offer methods that investigators can adapt to more precisely understand the effect of common modified Rankin Scale analysis methods and trial eligibility pertaining to the World Federation of Neurological Surgeons grade in designing their large-scale SAH randomized controlled trials.

Usage of mineralocorticoids and isotonic crystalloids in subarachnoid hemorrhage patients in the United States.

BACKGROUND: The usage rates of mineralocorticoids (fludrocortisone) to treat hyponatremia and isotonic crystalloids (saline and balanced crystalloids) to maintain intravascular volume in patients with aneurysmal subarachnoid hemorrhage (aSAH) patients across the United States are unknown. METHODS: We surveyed National Institute of Neurologic Disorders and Stroke (NINDS) StrokeNet sites in 2023, which are mostly large, tertiary, academic centers, and analyzed subarachnoid hemorrhage encounters from 2010 to 2020 in the Premier Healthcare Database that is representative of all types of hospitals and captures about 20 % of all acute inpatient care in the United States. RESULTS: Although mineralocorticoids are used by 70 % of the NINDS StrokeNet sites, it is used in less than 20 % of the aSAH encounters in the Premier Database. Although saline is ubiquitously used, balanced crystalloids are increasingly used for fluid therapy in aSAH patients. Its use in the NINDS StrokeNet sites and the Premier Healthcare Database is 41 and 45 %, respectively. CONCLUSIONS: The use of mineralocorticoids remains low, and balanced crystalloids are increasingly used as fluid therapy in aSAH patients. The effectiveness of mineralocorticoids and balanced crystalloids in improving outcomes for aSAH patients must be rigorously tested in randomized clinical trials.

Normal Variations in Upper Esophageal Sphincter Function During Deglutition: A Secondary Analysis of Videofluoroscopic Data.

OBJECTIVE: Cricopharyngeal dysfunction is a common potential cause of pharyngoesophageal dysphagia. Contextual factors (i.e., personal demographics and bolus properties) appear to impact upper esophageal sphincter (UES) function but have yet to be assessed collectively in a large-scale study using psychometrically sound swallow task procedures. Using a standardized and validated videofluoroscopic approach, we investigated the collective effects of age, sex, and swallow task on UES opening duration (UESOdur) and UES maximum distension (UESmax) in a large sample of healthy adults. METHODS: UESOdur and UESmax data were analyzed from existing videofluoroscopic images of 195 healthy adults (21-89 years old) across seven swallow tasks (thin liquid to viscous liquids, puree, and a solid). Generalized estimating equation modeling captured the effects of the aforementioned contextual factors (α = 0.05). RESULTS: UESOdur significantly increased with age, while UESmax had an inverse relationship. Females had significantly wider UESmax. UESOdur of 5 mL thin liquid was significantly shorter than all other liquid swallow tasks, while solid had an inverse effect. Compared to 5 mL thin liquid, all other swallow tasks resulted in significantly wider UESmax. Mildly and moderately thick liquid significantly increased UESOdur when isolating viscosity. UESmax was significantly wider with mildly and moderately thick liquid and puree than thin liquid. When isolating volume, cup sip thin liquid increased both measures significantly relative to 5 mL. CONCLUSION: Age, sex, and swallow task can influence the normal timing and extent of UES movement. These collective effects contribute to normal variability in UES function and should be considered for clinical decision-making. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:2306-2315, 2024.

Usage of Mineralocorticoids and Isotonic Crystalloids in Subarachnoid Hemorrhage Patients in the United States.

Background: The usage rates of mineralocorticoids (fludrocortisone) to treat hyponatremia and isotonic crystalloids (saline and balanced crystalloids) to maintain intravascular volume in patients with aneurysmal subarachnoid hemorrhage (aSAH) patients across the United States are unknown. Methods: We surveyed National Institute of Neurologic Disorders and Stroke (NINDS) StrokeNet sites, which are mostly large, tertiary, academic centers, and analyzed subarachnoid hemorrhage encounters in the Premier Healthcare Database that is representative of all types of hospitals and captures about 20% of all acute inpatient care in the United States. Results: Although mineralocorticoids are used by 70% of the NINDS StrokeNet sites in aSAH patients, it is used in less than 25% of the aSAH encounters in the Premier Database. Although saline is ubiquitously used, balanced crystalloids are increasingly used for fluid therapy in aSAH patients. Its use in the NINDS StrokeNet sites and the Premier Healthcare Database is 41% and 45%, respectively. Conclusions: The use of mineralocorticoids remains low, and balanced crystalloids are increasingly used as fluid therapy in aSAH patients. The effectiveness of mineralocorticoids and balanced crystalloids in improving outcomes for aSAH patients must be rigorously tested in randomized clinical trials.

Subarachnoid Hemorrhage Trials: Cutting, Sliding, or Keeping mRS Scores and WFNS Grades.

Rigorous evidence generation with randomized controlled trials (RCTs) has lagged for aneurysmal subarachnoid hemorrhage (SAH) compared to other forms of acute stroke. Besides its lower incidence compared to other stroke subtypes, the presentation and outcome of SAH patients also differ. This must be considered and adjusted for in designing pivotal RCTs of SAH patients. Here, we show the effect of the unique expected distribution of the SAH severity at presentation (World Federation of Neurological Surgeons, WFNS, grade) on the outcome most used in pivotal stroke RCTs (modified Rankin Scale, mRS) and consequently on the sample size. Further, we discuss the advantages and disadvantages of different options to analyze the outcome and control the expected distribution of WFNS grades in addition to showing their effects on the sample size. Last, we offer methods that investigators can adapt to more precisely understand the effect of common mRS analysis methods and trial eligibility pertaining to the WFNS grade in designing their large-scale SAH RCTs.

Factors Influencing Laryngeal Vestibular Closure in Healthy Adults.

PURPOSE: Our study aims were (a) to examine laryngeal vestibular closure (LVC) temporal measures in healthy adults across tasks used in the Modified Barium Swallow Impairment Profile (MBSImP) protocol to establish normative reference values and (b) to examine influences of age, gender, and swallow task on LVC temporal measures. METHOD: A retrospective analysis of 195 healthy adults (85 men, 110 women; age range: 21-89 years) who participated in a videofluoroscopic swallowing study was completed. Seven swallow tasks of standardized viscosities and volumes, as per the MBSImP protocol, were analyzed to measure time-to-LVC and LVC duration (LVCd). Descriptive statistics were employed for all measures of interest. Regression modeling was used to explore relationships between LVC temporal measures (time-to-LVC, LVCd) with age, gender, and swallow task. The relationship between time-to-LVC and LVCd was also explored. RESULTS: Significant findings included an increasing trend in LVCd across age (older individuals had a longer LVCd), with women demonstrating a greater increase. Related to viscosity, LVCd was significantly shorter for pudding compared to thin liquid. Furthermore, when compared to 5-ml tasks, LVCd was significantly longer in cup tasks, while time-to-LVC was significantly shorter. An association was also observed between time-to-LVC and LVCd: As time-to-LVC decreased, LVCd increased. CONCLUSIONS: LVCd was influenced by age, gender, and swallow task. Longer time-to-LVC was observed in older individuals, particularly older women, and with thin liquids. Study findings contribute to adult normative reference values for LVC temporal measures (time-to-LVC and LVCd) across MBSImP swallowing tasks. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.24126432.

101 30-Day Outcomes of Resolute Onyx Stent for Symptomatic Intracranial Stenosis: A Multicenter Propensity-Score Matched Comparison With SAMMPRIS Trial.

INTRODUCTION: Symptomatic intracranial atherosclerotic disease (sICAD) is estimated to cause over 10% of strokes annually in the US alone. Previous investigations employing stenting, most notably SAMMPRIS trial, have produced unfavorable results in regards to both periprocedural complications and risk of recurrent stroke. However, newer generation balloon-mounted drug-eluting stents (BM-DES) have been hypothesized to harbor several technical advantages that may confer improvements in these critical metrics. METHODS: Prospectively maintained databases from eight comprehensive stroke centers were reviewed to identify adult patients undergoing RO-ZES for the treatment of sICAD between January,2019 and December,2021. Only patients that presented with either recurrent stroke or TIA, intracranial stenosis 70-99%, with at least one stroke on best medical management were included. The primary outcome was 30-days composite of stroke, ICH, and/or mortality. A propensity-score matched analyses was performed comparing the results of RO-ZES to the intervention arm of SAMMPRIS. RESULTS: A total of 132 patients met the inclusion criteria for analysis (mean age:64.2 years). Mean severity of stenosis (±SD) was 81.4% (±11.4%). Four (3.03%) stroke and/or deaths were reported within 30 days in RO-ZES group. A propensity-score matched analysis based on age, HLD, HTN, DMII, and smoking demonstrated a statistically significant decreased risk of 30-day stroke and/or death rate in RO-ZES in comparison to SAMMPRIS (2.6% vs. 15.6%, respectively; OR 6.88, 95% CI 1.92-37.54, p < 0.001). CONCLUSIONS: Patients treated with RO-ZES had a decreased rate of 30-day major complications in comparison to SAMMPRIS. Further large-scale prospective studies are warranted to evaluate the safety and efficacy of RO-ZES for the treatment of sICAD.

Staged vs Complete Repair in Tetralogy of Fallot With Pulmonary Atresia.

BACKGROUND: We sought to compare outcomes for infants with tetralogy of Fallot with pulmonary atresia (TOF/PA) and confluent pulmonary arteries who underwent staged or primary complete surgical repair. METHODS: This retrospective study included infants undergoing initial surgical intervention between 0 and 60 days of age with TOF/PA without aortopulmonary collaterals from 2009 to 2018 at 20 centers. The primary outcome was days alive and out of the hospital in the first year of life (DAOH365). Secondary outcomes were mortality at 1 year of age and a composite major complication outcome. Multivariable modeling with generalized estimating equations were used to compare outcomes between groups. RESULTS: Of 221 subjects, 142 underwent staged repair and 79 underwent primary complete repair. There was no significant difference in median DAOH365 between the staged and primary repair groups (317 days [interquartile range, 278-336] vs 338 days [interquartile range, 314-348], respectively; adjusted P = .13). Nine staged repair patients (7%) died in the first year of life vs 5 primary repair patients (6%; adjusted odds ratio, 1.00; 95% CI, 0.25-3.95). At least 1 major complication occurred in 37% of patients who underwent staged repair vs 41% of patients who underwent primary complete repair (P = .75), largely driven by the need for unplanned cardiac reinterventions. CONCLUSIONS: For infants with TOF/PA with confluent pulmonary arteries, a surgical strategy of staged or primary complete repair resulted in statistically similar DAOH365, early mortality, and morbidity.

Association Between Birth Weight Z-Scores and Early Outcomes Following Truncus Arteriosus Repair.

In infants undergoing truncus arteriosus (TA) repair, we sought to determine associations between fetal growth restrictions as measured by birth weight Z-score and early outcomes. We utilized the Pediatric Health Information System (PHIS) database to identify infants < 90 days old who underwent TA repair from 2004 to 2019. The primary exposure variable was birth weight Z-score, calculated based on gestational age at birth, gender, and birth weight. The primary outcome was postoperative hospital mortality. Secondary outcomes included major complications, prolonged postoperative length of hospital stay (LOS; > 30 days), and hospital readmission within 1 year. Generalized estimating equation (GEE) models were used to identify adjusted associations between birth weight Z-score, small for gestational age (SGA) status, and mortality and included were 1039 subjects. Median birth weight was 2960 g, gestational age at birth was 38 weeks, and birth weight Z-score was - 0.47. SGA was present in 21% of subjects. Hospital mortality occurred in 104 patients (10%). By multivariable analysis, lower birth weight Z-score was associated with higher hospital mortality [for each unit decrease in birth weight Z-score below - 1.0, adjusted OR 1.71 (95% CI 1.10-4.25)]. SGA status was associated with increased hospital mortality (adjusted OR 2.17; 95% CI 1.39-3.40). Birth weight Z-scores and SGA status were not significantly associated with occurrence of cardiac arrest, ECMO use, gastrostomy tube placement, tracheostomy, seizures, infection, prolonged postoperative LOS, or hospital readmission. In infants undergoing TA repair, lower birth weight Z-scores and SGA status were strongly associated with increased hospital mortality.

Thirty-Day Outcomes of Resolute Onyx Stent for Symptomatic Intracranial Stenosis: A Multicenter Propensity Score-Matched Comparison With Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial.

BACKGROUND: Symptomatic intracranial atherosclerotic disease (sICAD) is estimated to cause 10% of strokes annually in the United States. However, treatment remains a challenge with several different stenting options studied in the past with unfavorable results. OBJECTIVE: To report the 30-day stroke and/or death rate associated with intracranial stent placement for sICAD using Resolute Onyx Zotarolimus-Eluting Stent (RO-ZES) and provide a comparison with the results of Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial. METHODS: Prospectively maintained databases across 8 stroke centers were used to identify adult patients treated with RO-ZES for sICAD between January 2019 and December 2021. Primary end point was composite of 30-day stroke, intracerebral hemorrhage, and/or death. Propensity score matching was performed using age, hypertension, lipid disorder, cigarette smoking, and symptomatic target vessel to create a matched group for comparison between RO-ZES and the SAMMPRIS medical management and treatment groups (SAMMPRIS percutaneous angioplasty and stenting [S-PTAS]). RESULTS: A total of 132 patients met the inclusion criteria for analysis (mean age: 64.2 years). Mean severity of stenosis was 81.4% (±11.4%). A total of 4 (3.03%) stroke and/or deaths were reported within 30 days of treatment in the RO-ZES group compared with 6.6% in the SAMMPRIS medical management group (OR [odds ratio] 2.26, 95% CI 0.7-9.56, P = .22) and 15.6% in the S-PTAS group (OR 5.9, 95% CI 2.04-23.4, P < .001). Propensity score match analysis of 115 patients in each group demonstrated 30-day stroke and/or death rate of 2.6% in the RO-ZES group and 15.6% in the S-PTAS group (OR 6.88, 95% CI 1.92-37.54, P < .001). CONCLUSION: Patients treated with RO-ZES had a relatively low 30-day stroke and/or death rate compared with the S-PTAS group. Further large-scale prospective studies are warranted to evaluate the safety and efficacy of RO-ZES for the treatment of sICAD.

Effect of Cilostazol in Animal Models of Cerebral Ischemia and Subarachnoid Hemorrhage: A Systematic Review and Meta-Analysis.

BACKGROUND: Cilostazol, a phosphodiesterase III inhibitor, appears to be a promising agent for preventing cerebral ischemia in patients with aneurysmal subarachnoid hemorrhage. Here, the authors perform a systematic review and meta-analysis to quantitatively assess the effects of cilostazol on brain structural and functional outcomes in animal models of cerebral ischemia and subarachnoid hemorrhage-induced cerebral vasospasm. METHODS: By using the PRISMA guidelines, a search of the PubMed, Scopus, and Web of Science was conducted to identify relevant studies. Study quality of each included study for both systematic reviews were scored by using an adapted 15-item checklist from the Collaborative Approach to Meta-Analysis of Animal Data from Experimental Studies. We calculated a standardized mean difference as effect size for each comparison. For each outcome, comparisons were combined by using random-effects modeling to account for heterogeneity, with a restricted maximum likelihood estimate of between-study variance. RESULTS: A total of 22 (median [Q1, Q3] quality score of 7 [5, 8]) and 6 (median [Q1, Q3] quality score of 6 [6, 6]) studies were identified for cerebral ischemia and subarachnoid hemorrhage-induced cerebral vasospasm, respectively. Cilostazol significantly reduced the infarct volume in cerebral ischemia models with a pooled standardized mean difference estimate of - 0.88 (95% confidence interval [CI] [- 1.07 to - 0.70], p < 0.0001). Cilostazol significantly reduced neurofunctional deficits in cerebral ischemia models with a pooled standardized mean difference estimate of - 0.66 (95% CI [- 1.06 to - 0.28], p < 0.0001). Cilostazol significantly improved the basilar artery diameter in subarachnoid hemorrhage-induced cerebral vasospasm with a pooled standardized mean difference estimate of 2.30 (95% CI [0.94 to 3.67], p = 0.001). Cilostazol also significantly improved the basilar artery cross-section area with a pooled standardized mean estimate of 1.88 (95% CI [0.33 to 3.43], p < 0.05). Overall, there was between-study heterogeneity and asymmetry in the funnel plot observed in all comparisons. CONCLUSIONS: Published animal data support the overall efficacy of cilostazol in reducing infarct volume and neurofunctional deficits in cerebral ischemia models and cerebral vasospasm in subarachnoid hemorrhage models.

An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial.

Ordinal outcomes are common in medicine and can be analyzed in many ways, but the distribution of ordinal data can present unique challenges. The proposed KESETT study is a three-armed, randomized trial comparing two doses of ketamine plus levetiracetam to levetiracetam alone for treating patients with benzodiazepine-refractory status epilepticus. A Bayesian, adaptive clinical trial is proposed employing an ordinal primary outcome at 60 minutes ranging from 1 (improving consciousness and seizure cessation) to 5 (life-threatening event/death). Based on a previous study, the ordinal outcome is expected to have a bimodal distribution, with the effect of treatment expected to be non-proportional across the outcome scale. As such, approaches relying on assuming proportionality of the odds are not appropriate. We propose for this scenario an analytic approach to compare ordinal outcomes using the expected score derived from the posterior distribution for each treatment group. This approach requires minimal assumptions, maintains the benefit of using the full ordinal scale, is interpretable, and can be used in a Bayesian analysis framework. We compare this new approach under multiple simulated scenarios to 3 traditional frequentist approaches. The new approach controls type I error and power, resulting in a sizable reduction in sample size relative to a non-parametric test.

Interpreting a Bayesian phase II futility clinical trial.

BACKGROUND: A resurgence of research into phase II trial design in the mid-2000s led to the use of futility designs in a wide variety of disease areas. Phase II futility studies differ from efficacy studies in that their null hypothesis is that treatment, relative to control, does not meet or exceed the level of benefit required to justify additional study. A rejection of the null hypothesis indicates that the treatment should not proceed to a larger confirmatory trial. METHODS: Bayesian approaches to the design of phase II futility clinical trials are presented and allow for the quantification of key probabilities, such as the predictive probability of current trial success or even the predictive probability of a future trial's success. RESULTS: We provide an illustration of the design and interpretation of a phase II futility study constructed in a Bayesian framework. We focus on the operating characteristics of our motivating trial based on a simulation study, as well as the general interpretation of trial outcomes, type I, and type II errors in this framework. CONCLUSIONS: Phase II futility clinical trials, when designed under in a Bayesian framework, offer an alternative approach to the design of mid-phase studies which provide unique benefits relative to trials designed in a frequentist framework and designs which focus on treatment efficacy.

Post-traumatic endophthalmitis prophylaxis: a systematic review and meta-analysis.

PURPOSE: The goal of this study is to determine if certain aspects of endophthalmitis prophylaxis strategies are superior to others. DESIGN: This investigation is a systematic review and meta-analysis. METHODS: All studies specifying a type of prophylaxis strategy and resulting rates of endophthalmitis were included. Time course, method of administration, and antibiotic regimen, and confounding factors were collected and included for meta-regression. RESULTS: Time courses greater than 24 h did not significantly improve outcomes. Likewise, intraocular and/or intravenous antibiotic administration methods did not significantly outperform oral administration. No antibiotic regimens performed differently from vancomycin/ ≥ 3rd generation cephalosporin except for ciprofloxacin monotherapy which yielded significantly worse outcomes. CONCLUSIONS: Future antibiotic strategies should strongly consider the risks of antibiotic treatment > 24 h and administration methods other than the oral antibiotic forms. In addition, providers should be wary of using ciprofloxacin monotherapy for endophthalmitis prophylaxis when treating open globe injuries.

Optimizing a Bayesian hierarchical adaptive platform trial design for stroke patients.

BACKGROUND: Platform trials are well-known for their ability to investigate multiple arms on heterogeneous patient populations and their flexibility to add/drop treatment arms due to efficacy/lack of efficacy. Because of their complexity, it is important to develop highly optimized, transparent, and rigorous designs that are cost-efficient, offer high statistical power, maximize patient benefit, and are robust to changes over time. METHODS: To address these needs, we present a Bayesian platform trial design based on a beta-binomial model for binary outcomes that uses three key strategies: (1) hierarchical modeling of subgroups within treatment arms that allows for borrowing of information across subgroups, (2) utilization of response-adaptive randomization (RAR) schemes that seek a tradeoff between statistical power and patient benefit, and (3) adjustment for potential drift over time. Motivated by a proposed clinical trial that aims to find the appropriate treatment for different subgroup populations of ischemic stroke patients, extensive simulation studies were performed to validate the approach, compare different allocation rules, and study the model operating characteristics. RESULTS AND CONCLUSIONS: Our proposed approach achieved high statistical power and good patient benefit and was also robust against population drift over time. Our design provided a good balance between the strengths of both the traditional RAR scheme and fixed 1:1 allocation and may be a promising choice for dichotomous outcomes trials investigating multiple subgroups.

Phase I Trial Characterizing the Pharmacokinetic Profile of N-803, a Chimeric IL-15 Superagonist, in Healthy Volunteers.

The oncotherapeutic promise of IL-15, a potent immunostimulant, is limited by a short serum t 1/2 The fusion protein N-803 is a chimeric IL-15 superagonist that has a >20-fold longer in vivo t 1/2 versus IL-15. This phase 1 study characterized the pharmacokinetic (PK) profile and safety of N-803 after s.c. administration to healthy human volunteers. Volunteers received two doses of N-803, and after each dose, PK and safety were assessed for 9 d. The primary endpoint was the N-803 PK profile, the secondary endpoint was safety, and immune cell levels and immunogenicity were measures of interest. Serum N-803 concentrations peaked 4 h after administration and declined with a t 1/2 of ∼20 h. N-803 did not cause treatment-emergent serious adverse events (AEs) or grade ≥3 AEs. Injection site reactions, chills, and pyrexia were the most common AEs. Administration of N-803 was well tolerated and accompanied by proliferation of NK cells and CD8+ T cells and sustained increases in the number of NK cells. Our results suggest that N-803 administration can potentiate antitumor immunity.

Classification of Physiologic Swallowing Impairment Severity: A Latent Class Analysis of Modified Barium Swallow Impairment Profile Scores.

Purpose Our objectives were to (a) identify oral and pharyngeal physiologic swallowing impairment severity classes based on latent class analyses (LCAs) of the Modified Barium Swallow Impairment Profile (MBSImP) swallow task scores and (b) quantify the probability of severity class membership given composite MBSImP oral total (OT) and pharyngeal total (PT) scores. Method MBSImP scores were collected from a patient database of 319 consecutive modified barium swallow studies. Because of missing swallow task scores, LCA was performed using 25 multiply imputed data sets. Results LCA revealed a three-class structure for both oral and pharyngeal models. We identified OT and PT score intervals to assign subjects to oral and pharyngeal impairment latent severity classes, respectively, with high probability (probability of class membership ≥ 0.9 given OT or PT scores within specified ranges) and high confidence (95% credible interval [CI] widths ≤ 0.24 for all total scores within specified ranges). OT scores ranging from 0 to 10 and from 14 to 18 yielded assignments in Oral Latent Classes 1 and 2, respectively, while OT = 22 was assigned to Oral Latent Class 3. PT scores ranging from 0 to 13 and from 18 to 24 yielded assignments in Pharyngeal Latent Classes 1 and 2, respectively, while PT = 26 was assigned to Pharyngeal Latent Class 3. Conclusions LCA of MBSImP task-level data revealed significant underlying oral and pharyngeal ordinal class structures representing increasingly severe gradations of physiologic swallow impairment. Clinically meaningful OT and PT score ranges were derived facilitating latent class assignment. Supplemental Material https://doi.org/10.23641/asha.12315677.