Disparities in Clinical Trial Enrollment and Reporting in Rectal Cancer: A Systematic Review and Demographic Comparison to the National Cancer Database.

BACKGROUND: Cancer care guidelines based on clinical trial data in homogenous populations may not be applicable to all rectal cancer patients. The aim of this study was to evaluate whether patients enrolled in rectal cancer clinical trials (CTs) are representative of United States (U.S.) rectal cancer patients. METHODS: Prospective rectal cancer CTs from 2010 to 2019 in the United States were systematically reviewed. In trials with multiple arms reporting separate demographic variables, each arm was considered a separate CT group in the analysis. Demographic variables considered in the analysis were age, sex, race/ethnicity, facility location throughout the United States, rural vs urban geography, and facility type. Participant demographics from trial and the National Cancer Database (NCDB) participants were compared using chi-squared goodness of fit and one-sample t-test where applicable. RESULTS: Of 50 CT groups identified, 42 (82%) studies reported mean or median age. Trial participants were younger compared to NCDB patients (P < .001 all studies). All but three trials had fewer female patients than NCDB (48.2% female, P < .001). Less than half the CT groups reported on race or ethnicity. Eighteen out of 22 trials (82%) had a smaller percentage of Black patients and 4 out of 8 (50%) trials had fewer Hispanic or Spanish origin patients than the NCDB. No CTs reported comorbidities, socioeconomic factors, or education. CT primary sites were largely at academic centers and in urban areas. CONCLUSION: The present study supports the need for improved demographic representation and transparency in rectal cancer clinical trials.

Work-related musculoskeletal disorders among otolaryngology-head and neck surgery residents.

PURPOSE: Surgical residents are at high risk for work-related musculoskeletal disorders which can impact surgical training and overall quality of life. We sought to assess musculoskeletal symptoms among current United States otolaryngology-head and neck surgery residents. We focused on the upper extremity given fine motor control for microsurgical procedures and increased keyboarding requirements. This study builds on previous research by evaluating setting attribution and attitudes toward ergonomics among otolaryngology residents. MATERIALS AND METHODS: A web-based, cross-sectional survey incorporating Nordic Musculoskeletal Questionnaire and ergonomics-related questions was sent to otolaryngology residency program directors in September of 2021. Descriptive statistics, Spearman's correlation, logistic regression, and comparison of proportions were utilized. RESULTS: Overall, 148 otolaryngology residents completed the survey; 70 were female (45 %), 83 male (54 %), and 1 non-binary (0.6 %). MSK symptoms were reported in the neck (77.0 %), lower back (45.5 %), and upper back (31.8 %) most frequently. Symptoms were work-related for 80 % of residents, with 84.7 % deemed operating-room-related. Some required treatment (14.5 %) or formal evaluation (11.0 %) of their injury. Injuries prevented residents from working (7.4 %), operating (9.5 %), and performing activities of daily living (27.0 %). Many reported they would use ergonomic equipment (94.2 %), dictation software (74.1 %), and scribes (81.3 %) if available. CONCLUSIONS: Despite increased surgical ergonomic awareness, musculoskeletal symptoms are still prevalent among otolaryngology residents. Nearly 1 in 9 residents required evaluation and treatment of their musculoskeletal symptoms, and one third reported lacking various ergonomic measures. Given the high prevalence of work-related musculoskeletal disorders, ergonomic practices for O-HNS trainees should be emphasized by residency programs.

A Systematic Review of Pharyngeal High-Resolution Manometry Normative Data.

PURPOSE: The utilization of high-resolution pharyngeal manometry (HRPM) in the evaluation of pharyngeal dysphagia has been increasing; however, standardization of its use has lagged behind. Without standardization using normative values, it is difficult for clinicians to adopt this emerging technology into meaningful use. Our goal is to map and compare the published normative values for common HRPM metrics in order to help establish consensus reference values. METHOD: A systematic review was conducted on prospective and retrospective studies that included HRPM metrics, defined by an international working group consensus, in healthy adult populations. Data on the following variables were extracted when available: contractile integrals of the pharynx (PhCI), velopharynx, mesopharynx, and hypopharynx, as well as the upper esophageal sphincter (UES) integrated relaxation pressure (IRP), relaxation time (RT), maximum admittance, and hypopharyngeal intrabolus pressure. RESULTS: Thirty studies were included. Significant variation existed in the technique and equipment used to perform procedures between the different studies. Lower PhCIs and UES IRPs were seen in younger compared to older individuals. Higher UES RTs were found in individuals in the upright position compared to the supine position and in those using larger boluses sizes or smaller catheters. CONCLUSIONS: Due to the wide variety of protocols, catheter configurations, manufacturers, and software used in the existing literature, it is difficult to formulate consensus on HPRM normative values using pooled data. Prospective studies adhering to standardized HRPM protocols for specific catheter configurations and manufacturers with larger cohorts of normal individuals are necessary to establish proper reference values for HRPM metrics. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.24843753.

The Efficacy of Superior Laryngeal Nerve Block for Neurogenic Cough: A Placebo-Controlled Trial.

OBJECTIVES: Chronic cough is a common and debilitating problem. The objective of this study is to assess the efficacy and safety of superior laryngeal nerve (SLN) block for neurogenic cough through a placebo-controlled, prospective trial. METHODS: Patients were recruited in an outpatient tertiary care center. Inclusion criteria included a history consistent with neurogenic cough and age ≥ 18. Exclusion criteria included patients with untreated other etiologies of chronic cough (i.e., uncontrolled reflux) and current neuromodulating medication use. Patients were randomized into the treatment (1-2 mL of a 1:1 triamcinolone 40 mg: 1% lidocaine with 1:200,000 epinephrines) or placebo (saline) group and received two unilateral injections at approximately 2-week intervals. Outcomes were measured primarily by the Leicester Cough Questionnaire (LCQ) and a patient symptom log including a visual analog scale of cough severity. RESULTS: 17 patients completed the study, including 10 in the treatment group and seven in the placebo group. Eight (80%) patients in the treatment group reported improvement with at least one of the injections, whereas only 1 (14.3%) patient reported improvement in the placebo group (p < 0.0001). Average total LCQ scores increased in the treatment group from 10.09 to 13.15 (p = 0.03), with the most change occurring in the social domain. There was no statistically significant change in LCQ scores for the placebo group. There were no serious adverse events. CONCLUSION: An SLN block is a safe and efficacious procedure for the treatment of neurogenic cough. Further studies are needed to optimize treatment protocol and assess long-term follow-up of patient outcomes. LEVEL OF EVIDENCE: 2 Laryngoscope, 133:3068-3074, 2023.

The Impact of Cervical Spinal Disease on Pharyngeal Swallowing Function.

PURPOSE: Spinal pathology is very common with advancing age and can cause dysphagia; however, it is unclear how frequently these pathologies affect swallowing function. This study evaluates how cervical spinal pathology may impact swallowing function in dysphagic individuals observed during videofluoroscopic swallowing studies (VFSSs). METHOD: A retrospective case-control study was performed on 100 individuals with dysphagia as well as age-/gender-matched healthy controls (HCs) with available VFSS. Spinal anatomy of patients was classified into two predetermined categories, and a consensus decision of whether spinal pathology influenced swallowing physiology was made. Validated swallow metrics, including Modified Barium Swallow Impairment Profile (MBSImP) component scores, Penetration-Aspiration Scale (PAS) maximum scores, and 10-item Eating Assessment Tool (EAT-10) scores, were compared between the spine-associated dysphagia (SAD), non-SAD (NSAD), and HC groups using Kruskal-Wallis one-way analysis of variance. RESULTS: Most patients with dysphagia had spinal pathology. Spinal pathology was judged to be the primary etiology of dysphagia in 16.9% of patients with abnormal spine pathology. Median EAT-10 scores were statistically different among the three groups, with the NSAD group scoring the highest and the HC group scoring the lowest. Similarly, median PAS scores were significantly different between dysphagic groups and HCs. Median MBSImP Oral Total scores were significantly different only between the NSAD group and HCs, whereas Pharyngeal Total score was not significantly different among the groups. CONCLUSIONS: Spinal pathology is commonly observed during VFSS and can contribute to dysphagia, resulting in worse swallowing-related outcomes when compared with HCs. Patients judged to have SAD tended to have better outcomes than patients with dysphagia from other etiologies, perhaps due to the progressive nature of spinal disease that allows for compensatory swallowing physiology over time.

Should Propranolol Remain the Gold Standard for Treatment of Infantile Hemangioma? A Systematic Review and Meta-Analysis of Propranolol Versus Atenolol.

BACKGROUND: Although propranolol has been established as the gold standard when treatment is sought for infantile hemangioma, concerns over its side effect profile have led to increasing usage of atenolol, a beta-1 selective blocker. METHODS: A systematic review of PubMed, Scopus, CINAHL, Google Scholar, and Cochrane was conducted following PRISMA guidelines using MeSH terms and keywords for the terms propranolol, atenolol, and infantile hemangioma, including alternative spellings. All randomized control trials (RCTs) or cohort studies directly comparing outcomes of hemangioma treatment with atenolol and propranolol were included. A meta-analysis with pooled mean differences, pooled odds ratios, and analysis of proportions was performed. RESULTS: A total of 669 participants in 7 studies (3 RCTs and 4 cohort) were included. Propranolol showed a significantly higher rate of complete response compared to atenolol (73.3% vs 85.4%, P = .0004). The pooled mean difference of 0.07 (95% CI -0.12, 0.27) in Hemangioma Activity Score (HAS) was not statistically significant. In terms of side effects, there were significantly more agitation and bronchial hyperreactivity events in the propranolol group (P = .0245 and P < .0001, respectively). Overall, there was a significantly greater number of adverse events in the propranolol group compared to the atenolol group (185 vs 117, P < .00001). The overall pooled odds ratio was 2.70 (95% CI 1.90, 3.84), indicating that there is 2.7 times higher odds of adverse events in the propranolol group. CONCLUSION: Propranolol treatment leads to a significantly higher rate of complete response than atenolol. However, its use must be weighed against its greater side effect profile.

Trismus intra-operative release and expansion (TIRE): A novel operative treatment for trismus.

BACKGROUND: Trismus is a common symptom for patients with head and neck cancer. This study aimed to evaluate outcomes using the novel Trismus Intra-operative Release and Expansion (TIRE). METHODS: All patients from 2012 to 2022 with histories of head and neck cancers and trismus treated with TIRE were included. Data examined included measured interincisal distance (IID) before and after treatment, and improvement or worsening of trismus. RESULTS: Thirty-eight patients with trismus were identified, and fourteen underwent TIRE. All had undergone surgery, and 13 had completed radiation therapy prior to TIRE. Mean improvement of IID immediately after TIRE was 18.44 ± 6.02 mm (p < 0.0001). At first follow-up (2.51 ± 3.23 months, n = 8), mean improvement from pre-operational measurements was 11.14 ± 9.17 mm (p = 0.018). CONCLUSION: TIRE was initially successful in increasing IID in some patients, but sustained improvements were not consistently seen past 1 year follow-up. TIRE could help resolve trismus enough to proceed with options for trismus therapy using devices and/or mouth opening exercises.

The Cost Impact of Telehealth Interventions in Pediatric Surgical Specialties: A Systematic Review.

BACKGROUND: Telehealth is a rapidly expanding care modality in the United States. Pediatric surgical patients often require complex care which can incur significant expenses, some of which may be alleviated by telehealth. We performed a systematic review comparing telehealth and in-person visits, and telehealth's impacts on the cost of healthcare across pediatric surgical specialties. METHODS: A systematic review was performed using the following databases: PubMed (MEDLINE), Scopus (Elsevier), and CINAHL (EBSCOHost), searched from inception to July 10th, 2022. Studies were included per the following criteria: (1) investigated a telehealth intervention for pediatric surgical care and (2) provided some metric of telehealth cost compared to an in-person visit. Non-English or studies conducted outside of the U.S. were excluded. RESULTS: Fourteen manuscripts met inclusion criteria and presented data on 7992 visits, including patients with a weighted average age of 7.5 ± 3.5 years. Most (11/14) studies used telehealth in a synchronous, or "real-time" context. Of the studies which calculated dollar cost savings for telehealth visits compared to in-person appointments we found a substantial range of savings per visit, from $48.50 to $344.64. Cost savings were frequently realized in terms of reduced travel expenditures, lower opportunity costs (e.g. lost wages), and decreased hospital labor requirements. CONCLUSIONS: This review suggests that telehealth provides cost incentives to pediatric surgical care in many scenarios, including post-operative visits and some routine clinic visits. Future work should focus on standardizing the metrics by which cost impacts are analyzed and detailing which visits are most appropriately facilitated by telehealth. LEVEL OF EVIDENCE: V.

Parent and provider satisfaction of telehealth in pediatric surgical subspecialty care: A systematic review.

INTRODUCTION: Telehealth is becoming an increasingly common presence in health care, particularly amidst the coronavirus disease 2019 pandemic. We aimed to investigate ways in which telehealth has been implemented in pediatric surgical specialties, as well as the success and satisfaction rates of these interventions. METHODS: A systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using PubMed, Scopus, and CINAHL databases for telehealth and pediatric surgical specialties on August 20th, 2021. There were 1227 studies screened and 17 studies met final inclusion criteria for patient, parent/guardian, or physician satisfaction measures of a telehealth intervention in the United States. RESULTS: Studies implementing telehealth interventions included all major pediatric surgical subspecialties with a total of 2926 patients. Of the 17 studies, common themes were the use of telehealth for synchronous video and/or telephone virtual visits, including comparing virtual visits to in-person clinic visits (nine studies) and postoperative virtual visits (six studies). Telehealth was also used in the perioperative setting to deliver care instructions via mobile application or text message (two studies). Telehealth interventions had a high rate of parent satisfaction (75%-98%), and 57%-75% of parents stated they would choose or prefer virtual appointments in the future, often citing travel and cost savings as benefits. Provider satisfaction was also high with satisfaction scores ranging from 7.5 to 9.4/10. DISCUSSION: This systematic review suggests that both parent and physician satisfaction with telehealth in pediatric surgical specialties is generally high. Expanding telehealth applications allow greater access to care, particularly for specialized surgical services which often pose significant costs and travel burdens.

Tissue Doppler echocardiography in children with OSA before and after tonsillectomy and adenoidectomy: A systematic review and meta-analysis.

BACKGROUND: When to order an echocardiogram in children with obstructive sleep apnea (OSA) is debated. Studies evaluating the utility of pre-operative standard echocardiography are inconsistent. Tissue Doppler imaging (TDI) is an additional technique that quantifies the velocity of myocardial motion to assess cardiac function. The utility of TDI in pediatric OSA remains unclear. METHODS: A systematic review and meta-analysis were performed in accordance with PRISMA guidelines using PubMed, Scopus, CINAHL, and Cochrane Library databases. Studies of echocardiographic findings using TDI in children with polysomnogram confirmed OSA before and after tonsillectomy and adenoidectomy (T&A) were included. 1,423 studies were screened, and 4 studies met inclusion criteria. Meta-analysis of echocardiographic findings was performed. RESULTS: Data from 560 children were analyzed. Study groups included pre- and post-T&A children with OSA and non OSA controls. Pre-T&A S' wave at the tricuspid annulus (S' RV) was decreased with a mean difference of -1.04 [95% CI -1.57, -0.52, p < 0.001] and E'/A' ratio at the mitral annulus (E'/A' LV) was decreased with a mean difference of -0.74 [95% CI -0.85, -0.64, p < 0.001] when compared to controls. These variables were not statistically different when comparing post-T&A to controls. CONCLUSIONS: TDI appears to successfully detect subclinical changes in cardiac function in children with OSA. However, echocardiography parameters of post-T&A and non OSA control children were similar. Further prospective studies stratified by OSA severity are needed with both TDI and standard echocardiography to define the utility of pre-operative cardiac imaging.