Citations

Abstract Objective To evaluate the effectiveness of multiple decision aid strategies in promoting high quality shared decision making for prevention of stroke in patients with non-valvular atrial fibrillation. Design Cluster randomized controlled trial. Setting Six academic medical centers in the United States. Participants Patient participants were aged ≥18 with a diagnosis of non-valvular atrial fibrillation, at risk for stroke (CHA 2 DS 2 -VASc ≥1 for men, ≥2 for women), and scheduled for a clinical appointment to discuss stroke prevention strategies. Participating clinicians were those who manage stroke prevention strategies for participating patients. Intervention Patients were randomized to use a patient decision aid or usual care; clinicians were randomized to use an encounter decision aid or usual care with all participating patients. Main outcome measures Primary outcome measures were quality of shared decision making measured by OPTION12, knowledge of atrial fibrillation and its management, and decisional conflict. Results 1117 participants across six sites were included in the analysis. Compared with usual care, the combined use of both the patient decision aid and the encounter decision aid improved the quality of shared decision making (adjusted mean difference 12.1 (95% confidence interval (CI) 8.0 to 16.2; P<0.001), improved patients’ knowledge (odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001), and reduced patients’ decisional conflict (adjusted mean difference −6.3 (95% CI −9.6 to −3.1; P<0.001). Statistically significant improvements were also observed with the encounter decision aid alone versus usual care for all three outcomes and with the patient decision aid alone versus usual care for quality of shared decision making and knowledge. No important differences were observed in treatment choices for stroke prevention or in participants’ satisfaction. No statistically significant difference in the length of visit across study groups was detected. Conclusion Patients who received any decision aid (encounter decision aid, patient decision aid, or both) had lower decisional conflict, better shared decision making, and greater knowledge than those receiving no decision aid, except for the effect of the patient decision aid on decisional conflict, which did not reach statistical significance. The study establishes that use of either pre-visit or in-visit decision aids individually or in combination is advantageous compared with usual care. Trial registration ClinicalTrials.gov NCT04357288 .

AbstractBackgroundAnti‐amyloid immunotherapies modestly slow disease progression in early symptomatic AD; addition of other therapeutic modalities may be necessary to achieve larger treatment effects. Therapies that directly target tau can potentially produce substantial clinical benefit because the accumulation of insoluble tau protein is strongly correlated with the progression of AD. Which tau therapies are likely to be efficacious, whether or not to combine them with anti‐amyloid therapies, and which individuals are most likely to benefit are important unresolved questions that would require multiple parallel design trials to answer. Platform (umbrella) trials test multiple therapies in the same trial, allowing for substantial savings in time, cost and participant burden.MethodATP is a new NIH‐funded Phase 2 clinical trial platform that will be conducted as part of the AD Clinical Trials Consortium (ACTC) in partnership with industry and philanthropic groups. The goal is to investigate the effects of tau therapies on the biological hallmarks of AD including insoluble and soluble tau species, amyloid and other biomarkers of neurodegeneration. ATP will initially evaluate two tau therapies alone or in combination with an anti‐amyloid therapy. 900 participants with late preclinical or early prodromal AD (CDR 0 or 0.5) will be randomized to six arms for two years of blinded treatment, followed by an optional open label extension (Figure 1). At least 20 percent of participants will be from underrepresented groups. The primary endpoint is 18F MK6240 tau PET, with key secondary endpoints including plasma P‐tau and MTBR243‐tau, amyloid PET and clinical assessments (CDR‐SB, PACC5). Inclusion criteria are based on plasma P‐tau217, clinical status and regional 18F MK6240 uptake.ResultTwo tau therapies and an anti‐amyloid therapy have been chosen for inclusion in ATP and startup is underway. The final design, choice of therapies and design as well as plans for inclusion of additional tau therapies after the trial begins and other details will be presented.ConclusionThe ATP is a six arm factorial design platform trial that is planned to begin in late 2024 or early 2025 that will support efficient development of tau and combination therapies for early, sporadic AD.

Abstract Aldosterone, a hormone synthesized by the adrenal glands, plays a pivotal role in regulating both blood pressure and electrolyte balance and may contribute to long term cardiovascular risk. Recent findings suggest that adipose tissue might serve as a source for aldosterone production and secretion. Patients suffering from obstructive sleep apnea (OSA) often exhibit elevated blood pressure levels and increased cardiovascular risk. Therefore, we sought to investigate whether increased aldosterone synthesis in fat tissue could contribute to the increase in hypertension and cardiovascular disease in OSA patients. To address this, we conducted a comparative analysis of adipocyte aldosterone level in OSA patients versus Age and BMI matched healthy individuals. Our data revealed no significant differences in aldosterone content between the two groups. Further examination involved measuring the expression of the key enzyme CYP11B2 responsible for aldosterone synthesis. We observed comparable expression levels of CYP11B2 in both the OSA and control groups. To corroborate these findings, we isolated stromal vascular fraction (SVF) from human fat tissues. The SVF cells were cultured in preadipocyte medium and subjected to normoxia and intermittent hypoxia (IH), mimicking OSA conditions as per established protocol. Subsequent analysis of aldosterone levels in cell lysates and conditioned medium revealed no significant differences. Similarly, in vitro examination of CYBP11B2 expression was not different in normoxic versus IH conditions. In conclusion, our study did not discern significant differences in adipocyte aldosterone production and secretion between patients with OSA and matched control subjects, nor in human preadipocytes under normoxic versus IH conditions.

AbstractObjective(s)To evaluate the otolaryngology surgical capacity in Harare, Zimbabwe by analyzing procedural volumes across four hospitals, one private and three public, from 2019 to 2022.MethodsA retrospective review of hand‐written surgical case logs was conducted at Harare Eye, Ear, Nose, and Throat Institute (HEENT), Parirenyatwa Group of Hospitals (PGH), Sally Mugabe Children's Hospital (SMCH), and Sally Mugabe Adult's Hospital (SMAH). Patient age and surgical intervention for all otolaryngology surgeries performed in the operating room from 2019 to 2022 were recorded. Procedures were categorized into six groups: head and neck malignancy, laryngeal surgery, oropharyngeal surgery, otologic surgery, rhinology/sinus surgery, and other. Data were analyzed using descriptive statistics to identify trends in surgical volume and types of procedures across hospitals.ResultsA total of 2626 procedures were recorded: 1470 at HEENT, 377 at PGH, 625 at SMCH, and 154 at SMAH. Of these, 39.5% were performed on pediatric patients and 60.5% on adult patients. The most common procedures were adenotonsillectomy/adenoidectomy/tonsillectomy (38.9%), diagnostic endoscopies (10.4%), and endoscopic sinus surgery (8.3%). HEENT performed the highest volume and widest range of procedures. HEENT had higher surgical volumes across all groups of procedure, except for laryngeal surgery.ConclusionThis study found disparities in otolaryngology surgical capacity between a private hospital, HEENT, and three public tertiary hospitals—SMCH, SMAH, and PGH, the largest hospital in the country—in Harare, Zimbabwe. Additionally, it highlights areas for targeted interventions in capacity building. This study establishes a foundation for understanding otolaryngologic surgical capacity in the country, supporting international collaboration, guiding future research, and serving as a model for similar assessments in other LMICs.Level of evidenceLevel VI.

ObjectiveTo examine implementation of virtual reality (VR) and Fitbit wearable activity devices in postoperative recovery.MethodsThis was a prospective, 4‐arm, randomized controlled trial of patients undergoing inpatient head and neck surgery at a tertiary academic center from November 2021 to July 2022. Patients were randomized to Control, VR, Fitbit, or combined VR + Fitbit groups. Patients in the VR groups were brought VR headsets to use throughout each day, and patients in the Fitbit groups wore Fitbit devices and were encouraged to achieve 2,000 daily steps. The primary outcome was average daily opioid use, measured as milligram morphine equivalents (MME).ResultsThere were 80 patients included. The majority of patients were male (68.8%), and mean age was 58.8 ± 14.4 years. Only the combined VR + Fitbit cohort was associated with reduced average daily opioid use (VR + Fitbit: 8.8 [20.6] MME vs. Control: 26.4 [37.4] MME, p = 0.02). Patients in intervention groups also had higher hospital satisfaction (p = 0.02). VR was utilized 26% of the time it was provided, with mean use time of 23.8 ± 7.8 min. Mean post‐VR subjective pain reduction was 1.0 ± 1.3, and there were three mild adverse events of neck or nasal discomfort. Among the Fitbit groups, there were no adverse events and daily step counts ≥2,000 steps were achieved 45% of the time.ConclusionImplementation of VR and wearable activity devices in postoperative recovery appears well tolerated and may facilitate further development of Enhanced Recovery After Surgery (ERAS) protocols, though there are challenges to maximizing device usage.Level of Evidence2 Laryngoscope, 135:2044–2050, 2025

OBJECTIVE The objective of this study was to compare a multiple pelvic screw fixation strategy (dual bilateral 4 pelvic screw fixation [4PvS]) with the use of single bilateral 2 pelvic screw fixation (2PvS), with the aim of addressing lumbosacral junction stability. METHODS This analysis is a single-center, retrospective review of ASD patients treated between 2015 and 2021. All patients had a minimum 2-year follow-up and spinal fusion to the sacrum without sacroiliac fusion and met at least one radiographic and procedural criterion: pelvic incidence–lumbar lordosis ≥ 20°, T1 pelvic angle ≥ 20°, sagittal vertical axis ≥ 7.5 cm, scoliosis ≥ 50°, three-column osteotomy, or spinal fusion of ≥ 8 levels. Two sacropelvic fixation methods were compared: 4PvS versus 2PvS. Primary outcomes included spinal implant-related reoperation and screw breakage, while secondary outcomes included reoperation for symptomatic pelvic screws, screw loosening or bending, L5–S1 pseudarthrosis, and patient-reported outcomes. Propensity score matching and inverse probability of treatment weighting (IPTW) were used to minimize selection bias and estimate causal treatment effects. Clinical outcomes were assessed using conditional multivariable logistic regression. RESULTS In this study of 406 patients (67.98% female, mean age 64.48 years), 349 patients (85.96%) received 2PvS and 57 (14.04%) received 4PvS. Age (OR 1.081, 95% CI 1.027–1.145) and total number of osteotomies (OR 1.180, 95% CI 1.048–1.355) emerged as independent predictors of receiving the 4PvS technique. In unmatched cohorts (n = 406), 2-year implant-related reoperation rates (p = 0.1896) and pelvic screw breakage rates (p = 0.2498) were not significantly different between groups. However, in the 4:1 propensity score–matched cohort, the 2-year reoperation rate (10.53% for 2PvS vs 3.51% for 4PvS; OR 3.27, 95% CI 1.10–9.74 [p = 0.0312]) and the pelvic screw breakage rate (9.21% for 2PvS vs 3.51% for 4PvS; OR 2.87, 95% CI 1.08–7.63 [p = 0.0349]) were significantly higher among the 2PvS groups. The IPTW analysis confirmed these findings, with reoperation rates of 10.45% for 2PvS and 1.18% for 4PvS (p = 0.0244) and pelvic screw breakage rates of 8.72% and 1.18%, respectively (p = 0.0477). A safety assessment revealed comparable operative times and intra- and perioperative complications between the two techniques. CONCLUSIONS Patients who underwent 4PvS demonstrated significantly lower 2-year implant-related reoperation and pelvic screw breakage rates compared with 2PvS, with no differences in intraoperative or perioperative complications.

Introduction: External ear malformations represent a spectrum of congenital anomalies that may involve the external auditory canal (EAC), tympanic membrane (TM), or associated structures. A rare anomaly, the EAC skin wedge, results from incomplete canalization during embryologic development. This report presents the clinical presentation, diagnostic evaluation, and surgical management of this condition. Objective: To detail the successful surgical management of an isolated EAC skin wedge and demonstrate the applicability of argon laser in treating these congenital anomalies. Methods: A 13-month-old female presented with recurrent otitis media and mild bilateral conductive hearing loss. Physical examination revealed a fan-like skin wedge spanning the EAC to the TM. Imaging with temporal bone computed tomography confirmed the extent of the anomaly. Under general anesthesia, the skin wedge was ablated using an argon laser, followed by antibiotic-soaked packing to prevent scarring and recurrence. Follow-up audiometry and endoscopic evaluations assessed outcomes. Results: The procedure was well-tolerated, with no intraoperative complications. At 3 weeks and 3 months postoperatively, no recurrence of the skin wedge was observed, and audiometry normalized. The patient demonstrated improved middle ear ventilation and resolution of conductive hearing loss. Conclusions: This case demonstrates the successful use of argon laser in the management of a rare congenital EAC anomaly. Argon lasers offer precise ablation and excellent hemostasis, making them a valuable option for similar cases. This report emphasizes the importance of tailored surgical approaches for rare pediatric ear malformations.

Background: The direct anterior approach (DAA) is a popular approach for primary total hip arthroplasty (THA). However, the contemporary outcomes for DAA THA need further elucidation. Therefore, we aimed to describe implant survivorship, complications, and clinical outcomes after DAA THA. Methods: From our multi-institutional total joint registry, 3,184 patients who had undergone 3,698 primary DAA THA between 2010 and 2019 were identified. The identified patients had a mean age of 65 years and a mean body mass index (BMI) of 29 kg/m 2 , and 53% of patients were female. The indications for revision and reoperation and the incidence of complications were collected and analyzed. Potential risk factors, including age, sex, BMI, and high-volume compared with low-volume operating surgeons, were examined. Descriptive statistics and Kaplan-Meier survivorship with Cox regression analyses were performed. Results: At 10 years following primary DAA THA, the cohort had 96% (95% confidence interval [CI], 95% to 98%) survivorship free of any revision and 94% (95% CI, 92% to 96%) survivorship free of any reoperation. The leading indications for revision were periprosthetic joint infection (PJI) (n = 24; 5-year cumulative incidence, 0.93% [95% CI, 0.6% to 1.5%]), periprosthetic fracture (n = 20; 5-year cumulative incidence, 0.62% [95% CI, 0.4% to 1.0%]), and aseptic loosening (n = 14; 11 femoral, 3 acetabular; 5-year cumulative incidence, 0.84% [95% CI, 0.5% to 1.5%]). A BMI of ≥40 kg/m 2 was found to be significantly associated with PJI (hazard ratio [HR], 6.4; p < 0.001), reoperation (HR, 3.5; p < 0.001), and nonoperative complications (HR, 2.3; p = 0.018). Survivorship free of recurrent instability was 99.6% (95% CI, 99.4% to 99.8%) at 5 and 10 years, and the cumulative incidence of revision for instability was 0.14% at 5 years. Conclusions: In one of the largest published series to date, survivorship following DAA THA was satisfactory at early to intermediate follow-up. The leading indications for revision were PJI, periprosthetic fracture, and aseptic loosening. Instability after DAA THA was uncommon and infrequently led to revision. As a note of caution, a BMI of ≥40 kg/m 2 was identified as a risk factor for adverse outcome after DAA THA. Level of Evidence: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.

Abstract Background We sought to evaluate key performance indicators related to an internally developed and deployed artificial intelligence (AI)-augmented kidney stone composition test system for potential improvements in test quality, efficiency, cost-effectiveness, and staff satisfaction. Methods We compared quality, efficiency, staff satisfaction, and financial data from the 6 months after the AI-augmented laboratory test system was deployed (test period) with data from the same 6-month period in the previous year (control period) to determine if AI-augmentation improved key performance indicators of this laboratory test. Results In the 6 months following the deployment (test period) of the AI-augmented kidney stone composition test system, 44 830 kidney stones were analyzed. Of these, 92% of kidney stones were eligible for AI-assisted interpretation. Out of these AI-eligible stones, 45% were able to be auto-released by the AI-augmented test system without human secondary review. Furthermore, the new AI-augmented kidney stone test system resulted in an apparent 40% reduction in incorrect laboratory results. Additionally, the new AI-augmented test system improved laboratory efficiency by 20%, improved staff satisfaction, and reduced the average analysis cost per kidney stone by $0.23. Conclusions The AI-augmented test system improved test quality, efficiency, cost-effectiveness and staff satisfaction related to this kidney stone composition test.

Inconsistency in the calculation of time spent in moderate to vigorous physical activity (MVPA) limits interstudy comparability and interpretation of surveillance data. This study assesses whether combining multiple individual methods results in a more accurate estimate of MVPA, while considering the influence of device brand and wear location. Participants (n = 30, age = 49.2 ± 19.5 years) wore two accelerometers (GENEActiv, ActiGraph) on each wrist during two laboratory visits. Individual classification methods (11 for left wrist, eight for right wrist) estimated minutes of MVPA using three approaches (cut-point, two-regression, and machine learning), two types of input (count and raw), and five epoch lengths (1, 5, 15, 30, and 60 s). The consensus estimate was calculated as the mean or median (due to skew) across all individual estimates. No individual or consensus estimates were statistically equivalent to direct observation (mean 38.2 min), with 81%–95% of individual methods overestimating MVPA. The best-performing individual methods were raw acceleration cut-points, with a bias of −3.2 to 2.4 min across devices and wrists. Correlation coefficients between individual methods and the criterion were .35–.71 for the left and .12–.67 for the right wrist, compared to .65–.70 and .58–.66 for consensus methods, respectively. Correlations between device brands were .23–.99 for individual methods and .70–.86 for consensus methods, while correlations between locations were .55–.86 and .73–.87, respectively. Better methods are required for estimating MVPA from wrist-worn accelerometers given the consistent overestimation of MVPA observed. While a consensus method for wrist-worn data was not able to fully resolve these issues, it improves interwrist or interbrand comparability.