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Augmented and virtual reality devices are being actively investigated and implemented for a wide range of medical uses. However, significant gaps in the evaluation of these medical devices and applications hinder their regulatory evaluation. Addressing these gaps is critical to demonstrating the devices' safety and effectiveness. We outline the key technical and clinical evaluation challenges discussed during the US Food and Drug Administration's public workshop, "Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine" and future directions for evaluation method development. Evaluation challenges were categorized into several key technical and clinical areas. Finally, we highlight current efforts in the standards communities and illustrate connections between the evaluation challenges and the intended uses of the medical extended reality (MXR) devices. Participants concluded that additional research is needed to assess the safety and effectiveness of MXR devices across the use cases., (© 2022. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)

Background: Thoracic aortic dissection (AD) is a rare occurrence in childhood and mostly associated with connective tissue disorders or congenital abnormalities. We examined the characteristics associated with AD and predictors of survival., Methods: The Kids' Inpatient Database (1997-2009) was used to identify thoracic ADs occurring in patients <20-y-old. Clinical characteristics, as well as determinants of survival, were analyzed using standard statistical methods., Results: One hundred sixty-eight cases of thoracic AD were identified during the study period. Overall survival was 83%. Average length of stay was 15.9 ± 16.9 d, with charges 181,867.92 ± $211,985.00. Thoracic dissection tended to affect adolescents aged 15-19 y (67%), males (76%), and Caucasians (56%) most frequently. Most patients were privately insured (64%) and treated at urban teaching centers (86%). Commonly associated diagnoses were hypertension (18%), Marfan syndrome (15%), and aortic valve disorders (8%). When repair was performed, open repair was more frequent (88%) than endovascular repair (6%). Hemorrhage was the most common complication (19%). Multiple determinants of survival were found. Girls (mortality odds ratio: 0.21 [0.05-0.91]) fared better than boys, P = 0.023. Patients with Medicaid (2.84 [1.21-6.69]) had higher mortality versus privately insured, P = 0.014. Income, race, and hospital characteristics, and type of repair were not significant predictors, even on sub-analyses of surgical and nonsurgical groups separately., Conclusions: Dissection of the thoracic aorta is a rare but significant condition affecting the pediatric population. Most repairs are performed using open technique. Payer status and gender are predictors of survival in these cases., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: To validate the American College of Rheumatology Classification (ACR) Criteria (2012) for the diagnosis of primary Sjogren's syndrome in Chinese patients., Methods: All patients involved in this study came from the Department of Oral Medicine Peking University Stomatology Hospital. They were devided into two groups of pSS and non-pSS according to the diagnoses made by two experts. Both groups of the patients had completed medical records kept in the hospital., Results: A total of 239 pSS patients (160 with labial salivary gland biopsy, and 79 without biopsy) and 52 age-matched non-pSS patients [(55.17±14.295),and (55.90±13.38) years old, P>0.05] (9 with biopsy, and 43 without biopsy) were involved in this study. The sensitivity and specificity of ACR criteria in diagnosing pSS were 90.37 % and 88.46 % respectively. The positive and negative likelihood ratios were 7.83 and 0.109, respectively. The sensitivities of ACR criteria in diagnosing pSS patients with and without labial biopsy were 88.75% and 93.67 %, respectively, with specificities of 88.89% and 88.37%, respectively. The most sensitive item adopted in ACR criteria was the ocular staining score with a sensitivity of 85.77%, and the most specific item was the labial salivary gland biopsy, with a specificity of 88.89%., Conclusion: The sensitivity and specificity of ACR criteria in diagnosing Chinese pSS patients were relatively high, and may serve as the diagnosis criteria in research and clinical practice. However, the ACR criteria need to be validated and further revised in the future .

Background: Carotid endarterectomy (CEA) is the gold standard for the treatment of carotid stenosis, but carotid angioplasty and stenting has been advocated in high-risk patients. The definition of such a population has been elusive, particularly because the data are largely retrospective. Our study examined results for CEA in the National Surgical Quality Improvement Program database (both Veterans Affairs and private sector)., Methods: National Surgical Quality Improvement Program data were gathered prospectively for all patients undergoing primary isolated CEA during the interval 2000 to 2003 at 123 Veterans Affairs and 14 private sector academic medical centers. Study end points included the 30-day occurrence of any stroke, death, or cardiac event. A variety of clinical, demographic, and operative variables were assessed with multivariate models to identify risk factors associated with the composite (stroke, death, or cardiac event) end point. Adjudication of end points was by trained nurse reviewers (previously validated)., Results: A total of 13,622 CEAs were performed during the study period; 95% were on male patients, and 91% of cases were conducted within the Veterans Affairs sector. The average age was 68.6 +/- 0.1 years, and 42.1% of the population had no prior neurologic event. The composite stroke, death, or cardiac event rate was 4.0%; the stroke/death rate was 3.4%. Multivariate correlates of the composite outcome were (odds ratio, P value) as follows: deciles of age (1.13, .018), insulin-requiring diabetes (1.73, <.001), oral agent-controlled diabetes (1.39, .003), decade of pack-years smoking (1.04, >.001), history of transient ischemic attack (1.41, >.001), history of stroke (1.51, >.001), creatinine >1.5 mg/dL (1.48, >.001), hypoalbuminemia (1.49, >.001), and fourth quartile of operative time (1.44, >.001). Cardiopulmonary comorbid features did not affect the composite outcome in this model. Regional anesthesia was used in 2437 (18%) cases, with a resultant relative risk reduction for stroke (17%), death (24%), cardiac event (33%), and the composite outcome (31%; odds ratio, 0.69; P = .008)., Conclusions: Carotid endarterectomy results across a spectrum of Veterans Affairs and private sector hospitals compare favorably to contemporary studies. These data will assist in selecting patients who are at an increased risk for adverse outcomes. Use of regional anesthetic significantly reduced perioperative complications in a risk-adjusted model, thus suggesting that it is the anesthetic of choice when CEA is performed in high-risk patients.

Background: There remains no consensus on the appropriate application of endovascular abdominal aortic aneurysm repair (EVAR). Information from administrative databases, industry-sponsored trials, and single institutions has inherent deficiencies. This study was designed to compare early outcomes of open (OPEN) versus EVAR in a contemporary (2000 to 2003) large, multicenter prospective cohort., Methods: Fourteen academic medical centers contributed data to the National Surgical Quality Improvement Program-Private Sector (NSQIP-PS), which ensures uniform, comprehensive, prospective, and previously validated data entry by trained, independent nurse reviewers. A battery of clinical and demographic features was assessed with multivariate analysis for association with the principal study end points of 30-day operative mortality and morbidity., Results: One thousand forty-two patients underwent elective infrarenal abdominal aortic aneurysm (AAA) repairs: 460 EVAR and 582 OPEN. EVAR patients were older (74 vs 71 years, P < .0001), included more men (84.6% vs 79.6%, P < .05), and had a higher incidence of chronic obstructive pulmonary disease (25.4% vs 17.9%, P < .01). EVAR resulted in significantly reduced overall morbidity (24% vs 35%, P < .0001) and hospital stay (4 vs 9 days, P < .0001). Cardiopulmonary and renal function-related comorbidities had the expected significant impact on mortality for both procedures at univariate analysis ( P < .05). While crude mortality rates between EVAR and OPEN did not differ significantly (2.8% vs 4.0%) ( P = 0.32). After multivariate analysis, correlates of operative mortality included OPEN (odds ratio [OR], 2.44; 95% confidence interval [CI], 1.03 to 5.78; P < .05), advanced age (OR, 1.11; P < .001), history of angina (OR, 5.54; P < .01), poor functional status (OR, 5.78; P < .001), history of weight loss (OR, 7.42; P < .01), and preoperative dialysis (OR, 51.4; P < .0001). EVAR also compared favorably to OPEN (OR, 2.14; 95% CI, 1.58 to 2.89; P < .0001) for overall morbidity., Conclusion: Significant morbidity accompanies AAA repair, even at major academic medical centers. These data strongly endorse EVAR as the preferred approach in the presence of significant cardiopulmonary or renal comorbidities, or poor preoperative functional status.