Publications by authors named "Andrew Lee"

1,511 Publications

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Assessment of Costs and Care Quality Associated With Major Surgical Procedures After Implementation of Maryland's Capitated Budget Model.

JAMA Netw Open 2021 Sep 1;4(9):e2126619. Epub 2021 Sep 1.

Department of Plastic Surgery, University of Texas MD Anderson Cancer Center, Houston.

Importance: In 2014, Maryland implemented the all-payer model, a distinct hospital funding policy that applied caps on annual hospital expenditures and mandated reductions in avoidable complications. Expansion of this model to other states is currently being considered; therefore, it is important to evaluate whether Maryland's all-payer model is achieving the desired goals among surgical patients, who are an at-risk population for most potentially preventable complications.

Objective: To examine the association between the implementation of Maryland's all-payer model and the incidence of avoidable complications and resource use among adult surgical patients.

Design, Setting, And Participants: This comparative effectiveness study used hospital discharge records from the Healthcare Cost and Utilization Project state inpatient databases to conduct a difference-in-differences analysis comparing the incidence of avoidable complications and the intensity of health resource use before and after implementation of the all-payer model in Maryland. The analytical sample included 2 983 411 adult patients who received coronary artery bypass grafting (CABG), carotid endarterectomy (CEA), spinal fusion, hip or knee arthroplasty, hysterectomy, or cesarean delivery between January 1, 2008, and December 31, 2016, at acute care hospitals in Maryland (intervention state) and New York, New Jersey, and Rhode Island (control states). Data analysis was conducted from July 2019 to July 2021.

Exposures: All-payer model.

Main Outcomes And Measures: Complications (infectious, cardiovascular, respiratory, kidney, coagulation, and wound) and health resource use (ie, hospital charges).

Results: Of 2 983 411 total patients in the analytical sample, 525 262 patients were from Maryland and 2 458 149 were from control states. Across Maryland and the control states, there were statistically significant but not clinically relevant differences in the preintervention period with regard to patient age (mean [SD], 49.7 [19.0] years vs 48.9 [19.3] years, respectively; P < .001), sex (22.7% male vs 21.4% male; P < .001), and race (0.3% vs 0.4% American Indian, 2.8% vs 4.5% Asian or Pacific Islander, 25.9% vs 12.7% Black, 4.7% vs 11.9% Hispanic, and 63.5% vs 63.4% White; P < .001). After implementation of the all-payer model in Maryland, significantly lower rates of avoidable complications were found among patients who underwent CABG (-11.3%; 95% CI, -13.8% to -8.7%; P < .001), CEA (-1.6%; 95% CI, -2.9% to -0.3%; P = .02), hip arthroplasty (-0.8%; 95% CI, -1.0% to -0.5%; P < .001), knee arthroplasty (-0.4%; 95% CI, -0.7% to -0.1%; P = .01), and cesarean delivery (-1.0%; 95% CI, -1.3% to -0.7%; P < .001). In addition, there were significantly lower increases in index hospital costs in Maryland among patients who underwent CABG (-$6236; 95% CI, -$7320 to -$5151; P < .001), CEA (-$730; 95% CI, -$1367 to -$94; P = .03), spinal fusion (-$3253; 95% CI, -$3879 to -$2627; P < .001), hip arthroplasty (-$328; 95% CI, -$634 to -$21; P = .04), knee arthroplasty (-$415; 95% CI, -$643 to -$187; P < .001), cesarean delivery (-$300; 95% CI, -$380 to -$220; P < .001), and hysterectomy (-$745; 95% CI, -$974 to -$517; P < .001). Significant changes in patient mix consistent with a younger population (eg, a shift toward private/commercial insurance for orthopedic procedures, such as spinal fusion [4.3%; 95% CI, 3.4%-5.2%; P < .001] and knee arthroplasty [1.6%; 95% CI, 1.0%-2.3%; P < .001]) and a lower comorbidity burden across surgical procedures (eg, CABG: -0.7% [95% CI, -0.1% to -0.5%; P < .001]; hip arthroplasty: -3.0% [95% CI, -3.6% to -2.3%; P < .001]) were also observed.

Conclusions And Relevance: In this study, patients who underwent common surgical procedures had significantly fewer avoidable complications and lower hospital costs, as measured against the rate of increase throughout the study, after implementation of the all-payer model in Maryland. These findings may be associated with changes in the patient mix.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.26619DOI Listing
September 2021

Frontal Bone Cranioplasty for Facial Feminization: Long-Term Follow-Up of Postoperative Sinonasal Symptoms.

Facial Plast Surg Aesthet Med 2021 Sep 24. Epub 2021 Sep 24.

Department of Otolaryngology-Head and Neck Surgery, Boston Medical Center, Boston, Massachusetts, USA.

Forehead feminization cranioplasty (FFC) risks entering the frontal sinus to achieve the desired contour. To date, no study has investigated long-term FFC complications. Determine if long-term sinus and headache symptoms worsen secondary to frontal sinus mucosal violation, measured by patient-reported outcomes. Single database retrospective chart review of patients who underwent forehead contouring between August 2012 and August 2019 was conducted. Two cohorts-frontal sinus mucosal violation versus mucosal preservation-were surveyed postprocedurely for postprocedure SNOT (Sinonasal Outcome Test)-22 scores and pre- and postprocedure sinus and headache symptoms. Frontal sinus violation, mean time between surgery and response was 4.16 ± 1.88 years (range: 1-8). Without violation, mean time between surgery and response was 2.5 ± 1.10 years (range: 1-5). Postoperative SNOT-22 severity scores were not different (12.55 vs. 8.6,  = 0.20). Postoperative SNOT-22 scores were equivalent to a control nonrhinosinusitis population. No difference was found between violation of the frontal sinus with worse postoperative sinus (22 vs. 5,  = 0.60) or headache symptoms. Our data did not detect a difference in sinus or headache outcomes in patients who experienced violation of the anterior frontal table compared with a similar population with preservation of the frontal sinus, over an 8-year follow-up.
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http://dx.doi.org/10.1089/fpsam.2021.0037DOI Listing
September 2021

Universal Use of Surgical Masks is Tolerated and Prevents Respiratory Viral Infection in Stem Cell Transplant Recipients.

J Hosp Infect 2021 Sep 17. Epub 2021 Sep 17.

School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.

Prevention of respiratory viral infection in stem cell transplant patients is important due to its high risk of adverse outcome. This single centre, mixed methods study, conducted before the SARS-CoV-2 pandemic, explored the barriers and facilitators to a policy of universal mask wearing by visitors and healthcare workers and examined the impact of the first year of introduction of the policy on respiratory viral infection rates compared to preceding years adjusted for overall incidence. Education around universal mask wearing was highlighted as being particularly important in policy implementation. A statistically significant fall in respiratory viral infection was observed following introduction.
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http://dx.doi.org/10.1016/j.jhin.2021.09.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8447542PMC
September 2021

Low Environmental Temperature Exacerbates Severe Acute Respiratory Syndrome Coronavirus 2 Infection in Golden Syrian Hamsters.

Clin Infect Dis 2021 Sep 18. Epub 2021 Sep 18.

State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.

Background: The effect of low environmental temperature on viral shedding and disease severity of COVID-19 is uncertain.

Methods: We investigated the virological, clinical, pathological, and immunological changes in hamsters housed at room (21 oC), low (12-15 oC), and high (30-33 oC) temperature after challenge by 10 5 plaque-forming units of SARS-CoV-2.

Results: The nasal turbinate, trachea, and lung viral load and live virus titre were significantly higher (~0.5-log10 gene copies/β-actin, p<0.05) in the low temperature group at 7 days post-infection (dpi). The low temperature group also demonstrated significantly higher level of TNF-α, IFN-γ, IL-1β, and CCL3, and lower level of the antiviral IFN-α in lung tissues at 4dpi than the other two groups. Their lungs were grossly and diffusely haemorrhagic, with more severe and diffuse alveolar and peribronchiolar inflammatory infiltration, bronchial epithelial cell death, and significantly higher mean total lung histology scores. By 7dpi, the low temperature group still showed persistent and severe alveolar inflammation and haemorrhage, and little alveolar cell proliferative changes of recovery. The viral loads in the oral swabs of the low temperature group were significantly higher from 10-17dpi by about 0.5-1.0-log10 gene copies/β-actin. The mean neutralizing antibody titre of the low temperature group was significantly (p<0.05) lower than that of the room temperature group at 7dpi and 30dpi.

Conclusions: This study provided in-vivo evidence that low environmental temperature exacerbated the degree of virus shedding, disease severity, and tissue proinflammatory cytokines/chemokines expression, and suppressed the neutralizing antibody response of SARS-CoV-2-infected hamsters. Keeping warm in winter may reduce the severity of COVID-19.
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http://dx.doi.org/10.1093/cid/ciab817DOI Listing
September 2021

Delayed Diagnosis of Autosomal Dominant Optic Atrophy Diagnosis until the Seventh Decade of Life.

Can J Ophthalmol 2021 Sep 14. Epub 2021 Sep 14.

Blanton Eye Institute, Houston Methodist Hospital, Houston, Tex.;; Weill Cornell Medicine, New York, NY;; University of Texas Medical Branch, Galveston, Tex.;; University of Texas MD Anderson Cancer Center, Houston, Tex.;; Texas A&M College of Medicine, Bryan, Tex.;; University of Iowa Hospitals and Clinics, Iowa City, Iowa;. Electronic address:

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http://dx.doi.org/10.1016/j.jcjo.2021.08.007DOI Listing
September 2021

Papilledema associated with COVID-19 multisystem inflammatory syndrome in children.

Can J Ophthalmol 2021 Aug 25. Epub 2021 Aug 25.

Washington University School of Medicine, St. Louis, Mo.. Electronic address:

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http://dx.doi.org/10.1016/j.jcjo.2021.08.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8384577PMC
August 2021

Efficient Correction of a Hypertrophic Cardiomyopathy Mutation by ABEmax-NG.

Circ Res 2021 Sep 16. Epub 2021 Sep 16.

Anzhen Hospital, Capital Medical University, CHINA.

Genetic editing has shown great potential for the treatment of human hereditary disorders via the elimination of mutations in embryos. However, the efficiency and safety of germline gene editing are not well understood. We aimed to examine the preclinical efficacy/safety of embryonic base editing in a mouse model of hypertrophic cardiomyopathy (HCM) using a novel adenine base editor (ABE) platform. Here, we described the use of an ABEmax-NG to directly correct the pathogenic R404Q/+ mutation (Myh6 c.1211C>T) in embryos for a mouse model of HCM, increasing the number of wild-type embryos for in vitro fertilization. Delivery of the ABEmax-NG mRNA to embryos from R404Q/+ HCM mice resulted in 62.5-70.8% correction of the Myh6 c.1211C>T, reducing the level of mutant RNA and eliminating HCM in the post-natal mice as well as their offspring. In addition, the same sgRNA was also used to target an intronic locus (TGG PAM) with an overall editing rate of 86.7%, thus confirming that ABEmax-NG can efficiently edit target loci with different PAMs (NG) and genomic distribution in vivo. Compared with CRISPR/ssODN-mediated correction, ABEmax-NG displayed a much higher correction rate without introducing indels. DNA and RNA off-target analysis did not detect off-target editing in treated embryos and founder mice. In utero injection of adeno-associated virus 9 (AAV9) encoding the ABEmax-NG also resulted in around 25.3% correction of the pathogenic mutation and reduced of mutant RNA, thereby indicating ABEmax-NG has the potential to correct the HCM mutation in vivo. We developed an ABEmax-NG system, which efficiently corrected a pathogenic Myh6 HCM mutation in mouse embryos without off target lesions, thus safely eliminating HCM in derived mice and their progeny.
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http://dx.doi.org/10.1161/CIRCRESAHA.120.318674DOI Listing
September 2021

Fibroepithelial tumours of the breast-a review.

Virchows Arch 2021 Sep 10. Epub 2021 Sep 10.

Division of Pathology, Singapore General Hospital, Singapore, Singapore.

Fibroepithelial tumours of the breast are biphasic neoplasms composed of both epithelial and stromal elements, including the common fibroadenoma and the infrequent phyllodes tumour. The admixture of epithelium and stroma in the fibroadenoma shows intra- and pericanalicular patterns, and may display a variety of histological changes. Fibroadenoma variants include the cellular, juvenile, myxoid and complex forms. The cellular fibroadenoma may be difficult to distinguish from the benign phyllodes tumour. Stromal mitotic activity can be increased in fibroadenomas in the young and pregnant patients. Phyllodes tumours, neoplasms with the potential for recurrence, show an exaggerated intracanalicular growth pattern with broad stromal fronded architecture and stromal hypercellularity. They are graded into benign, borderline and malignant forms based on histological assessment of stromal features of hypercellularity, atypia, mitotic activity, overgrowth and the nature of the tumour borders. Classification of phyllodes tumours is imperfect, compounded by tumour heterogeneity with overlapping microscopic features among the different grades, especially in the borderline category. Malignant phyllodes tumours can metastasise and cause death. Determining which phyllodes tumours may behave aggressively has been difficult. The discovery of MED12 mutations in the pathogenesis of fibroepithelial tumours, together with other gene abnormalities in the progression pathway, has allowed refinements in diagnosis and prognosis.
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http://dx.doi.org/10.1007/s00428-021-03175-6DOI Listing
September 2021

Upper instrumented vertebra-femoral angle and correlation with proximal junctional kyphosis in adult spinal deformity.

Spine Deform 2021 Sep 3. Epub 2021 Sep 3.

Department of Orthopaedic Surgery, University of California, San Francisco, 500 Parnassus Avenue, MU 320-W, San Francisco, CA, 94143, USA.

Introduction: Although matching lumbar lordosis (LL) with pelvic incidence (PI) is an important surgical goal for adult spinal deformity (ASD), there is concern that overcorrection may lead to proximal junctional kyphosis (PJK). We introduce the upper instrumented vertebra-femoral angle (UIVFA) as a measure of appropriate postoperative position in the setting of lower thoracic to pelvis surgical correction for patients with sagittal imbalance. We hypothesize that a more posterior UIV position in relation to the center of the femoral head is associated with an increased risk of PJK given compensatory hyperkyphosis above the UIV.

Methods: In this retrospective cohort study, adult patients undergoing lower thoracic (T9-T12) to pelvis correction of ASD with a minimum of 2-year follow-up were included. UIVFA was measured as the angle subtended by a line from the UIV centroid to the femoral head center to the vertical axis. Patients who developed PJK and those who did not were compared with preoperative and postoperative UIVFA as well as change between postoperative and preoperative UIVFA (deltaUIVFA).

Results: Of 119 patients included with an average 3.6-year follow-up, 51 (42.9%) had PJK and 24 (20.2%) had PJF. Patients with PJK had significantly higher postoperative UIVFA (12.6 ± 4.8° vs. 9.4 ± 6.6°, p = 0.04), deltaUIVFA (6.1 ± 7.6° vs. 2.1 ± 5.6°, p < 0.01), postoperative pelvic tilt (27.3 ± 9.2 vs. 23.3 ± 11, p = 0.04), postoperative lumbar lordosis (47.7 ± 13.9° vs. 42.4 ± 13.1, p = 0.04) and postoperative thoracic kyphosis (44.9 ± 13.2 vs. 31.6 ± 18.8) than patients without PJK. With multivariate logistic regression, postoperative UIVFA and deltaUIVFA were found to be independent risk factors for PJK (p < 0.05). DeltaUIVFA was found to be an independent risk factor for PJF (p < 0.05). A receiver operating characteristic (ROC) curve for UIVFA as a predictor for PJK was established with an area under the curve of 0.67 (95% CI 0.59-0.76). Per the Youden index, the optimal UIVFA cut-off value is 11.5 degrees.

Conclusion: The more posterior the UIV is from the femoral head center after lower thoracic to pelvis surgical correction for ASD, the more patients are at risk for PJK. The greater the magnitude of posterior translation of the UIV from the femoral head center from preop to postop, the greater the likelihood for PJF.
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http://dx.doi.org/10.1007/s43390-021-00408-1DOI Listing
September 2021

Healthcare professionals' views on factors influencing shared decision-making in primary health care centres in Saudi Arabia: A qualitative study.

J Eval Clin Pract 2021 Aug 31. Epub 2021 Aug 31.

Health Economics and Decision Science, The University of Sheffield, Sheffield, UK.

Objective: To describe the perspectives of healthcare professionals regarding the implementation of Shared decision-making (SDM) in primary healthcare centres (PHCCs) in Saudi Arabia.

Methods: Qualitative semi-structured interviews were conducted with a purposive and snowball sample of healthcare professionals in PHCCs. Interviews have been recorded, transcribed, translated and thematically analysed. Themes were mapped to the COM-B model.

Results: Sixteen healthcare professionals were interviewed. The data analysis identified six themes and 14 sub-themes. The six themes are patient related factors, health professional related factors, environmental context and resources, patient-physician communication, patient-physician preferences toward SDM and physicians' perceived value and benefits of SDM. Physicians are unlikely to practice SDM in the context of time pressures, shortage of physicians, lack of treatment options, and decision-making aids. The findings also underscored the importance of building a trustworthy physician-patient relationship through the use of effective conversation techniques.

Conclusions: There are multiple barriers to SDM in primary care. Unless these barriers are addressed, it is unlikely that physicians will effectively or fully engage in SDM with patients.
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http://dx.doi.org/10.1111/jep.13616DOI Listing
August 2021

Bitemporal hemianopsia secondary to ischemic chiasmopathy following mechanical thrombectomy.

Am J Ophthalmol Case Rep 2021 Sep 13;23:101191. Epub 2021 Aug 13.

Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St., Houston, TX, 77030, USA.

Purpose: To report a case of bitemporal hemianopsia due to ischemic chiasmopathy after mechanical thrombectomy of a right distal internal carotid artery (ICA) occlusion.

Observations: A 60-year-old female presented with left sided weakness and difficulty speaking and was found to have suffered a right internal carotid artery occlusion 10 days after tricuspid valve replacement for severe symptomatic tricuspid valve disease. She underwent mechanical thrombectomy and in hospital and at further follow ups was noted to have a bitemporal hemianopsia, consistent with an ischemic optic chiasmopathy.

Conclusions And Importance: The optic chiasm is vascularized by multiple arteries of the Circle of Willis. As such, ischemic optic chiasmopathy is rare. Clinicians should consider ischemic chiasmopathy following cardiac and other surgical procedures including mechanical thrombectomy of the ICA or its branches.
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http://dx.doi.org/10.1016/j.ajoc.2021.101191DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8379665PMC
September 2021

Metastatic Breast Cancer Presenting as Progressive Ophthalmoplegia 30 Years After Initial Cancer Diagnosis.

J Neuroophthalmol 2021 Aug 17. Epub 2021 Aug 17.

McGovern Medical School (SK), the University of Texas Health Science Center at Houston, Houston, Texas; Department of Ophthalmology (SR, PWM, AM, AGL), Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas; Departments of Ophthalmology, Neurology, and Neurosurgery (AGL), Weill Cornell Medicine, New York, New York; Department of Ophthalmology (AGL), University of Texas Medical Branch, Galveston, Texas; University of Texas MD Anderson Cancer Center (AGL), Houston, Texas; Texas A and M College of Medicine (AGL), Bryan, Texas; and Department of Ophthalmology (AGL), the University of Iowa Hospitals and Clinics, Iowa City, Iowa.

Abstract: A 60 year-old woman presented with painless progressive ophthalmoplegia of the right eye. She had a history of left-sided breast carcinoma 30 years ago that was managed with mastectomy only, with appropriate serial follow-up investigations. On examination, her visual acuity was 20/400 in the right eye and 20/20 in the left. She had a right relative afferent pupillary defect. Ocular examination was significant for 2 mm of ptosis, complete ophthalmoplegia, and 2+ chemosis in the right eye. The left eye was normal. MRI of the brain and orbits showed bilateral retrobulbar infiltrative disease in the right eye greater than that in the left eye. Right orbitotomy and biopsy confirmed an infiltrative signet ring cell/histiocytoid carcinoma consistent with metastatic lobular breast carcinoma. Given that recurrence of breast cancer is most common during the second year after the initial disease and rarely reported beyond 20 years after the initial diagnosis, our patient's delayed recurrence 30 years after the treatment of initial disease is unusual and rare. However, it highlights the importance of including metastatic cancer in the differential diagnosis for ophthalmoplegia.
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http://dx.doi.org/10.1097/WNO.0000000000001385DOI Listing
August 2021

Postoperative Vision Loss.

J Neuroophthalmol 2021 Aug 17. Epub 2021 Aug 17.

School of Medicine (AA), University of Texas Medical Branch, Galveston, Texas; Department of Ophthalmology (SR, AGL), Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas; Departments of Ophthalmology (AGL), Neurology, and Neurosurgery, Weill Cornell Medicine, New York, New York; Department of Ophthalmology (AS, AGL), University of Texas Medical Branch, Galveston, Texas; University of Texas MD Anderson Cancer Center (AGL), Houston, Texas; Texas A and M College of Medicine (AGL), Bryan, Texas; and Department of Ophthalmology (AGL), the University of Iowa Hospitals and Clinics, Iowa City, Iowa.

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http://dx.doi.org/10.1097/WNO.0000000000001401DOI Listing
August 2021

Should Lumbar Puncture Be Required to Diagnose Every Patient With Idiopathic Intracranial Hypertension?

J Neuroophthalmol 2021 Sep;41(3):379-384

Departments of Ophthalmology and Neurology & Neurological Sciences (HEM), Stanford University, Stanford, California; Department of Ophthalmology and Visual Sciences (EM), University of Toronto, Toronto, Ontario; Blanton Eye Institute (AGL), Houston Methodist Hospital, Houston, Texas; and Department of Ophthalmology and Visual Sciences (GPVS), Washington University in St. Louis School of Medicine, St. Louis, Missouri.

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http://dx.doi.org/10.1097/WNO.0000000000001373DOI Listing
September 2021

The Cost-Effectiveness of Tocilizumab (Actemra) Therapy in Giant Cell Arteritis.

J Neuroophthalmol 2021 Sep;41(3):342-350

University of Texas Medical School at Houston (AVJ), Houston, Texas; Department of Ophthalmology (AK), Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas; Houston Methodist Hospital (LI), Houston, Texas; Department of Ophthalmology and Visual Sciences (AGL), University of Texas Medical Branch, Galveston, Texas; Department of Ophthalmology (AGL), Baylor College of Medicine, Houston, Texas; Departments of Ophthalmology, Neurology, and Neurosurgery (AGL), Weill Cornell Medicine, New York, New York; Section of Ophthalmology (AGL), University of Texas Maryland Anderson Cancer Center, Houston, Texas; and Department of Ophthalmology (AGL), the University of Iowa Hospitals and Clinics, Iowa City, Iowa.

Background: Tocilizumab (Actemra) is a humanized anti-interleukin-6 receptor antibody that has been used as a steroid-sparing agent in giant cell arteritis (GCA). Although the clinical effects are well described in GCA, the cost-effectiveness of the use of tocilizumab in GCA is ill defined. The purpose of this study was to determine the cost-effectiveness of tocilizumab in GCA compared with prednisone alone.

Methods: A retrospective study of 32 patients with biopsy-proven GCA comparing prednisone alone (16 patients) and prednisone with tocilizumab (16 patients) was performed. The cost for tocilizumab therapy for 26 weeks with mild and severe side effects (Groups 1 and 2, respectively) and for 52 weeks with mild and severe side effects (Group 3 and 4, respectively) was compared with estimated costs of mild and severe steroid-induced side effects (Groups 5 and 6, respectively). Statistical analysis between groups was conducted using independent sample t tests.

Results: Three out of the 4 group combinations of tocilizumab with prednisone demonstrated a statistically significant (P < 0.05) difference in cost compared with prednisone alone for GCA. Group 2 (26-week tocilizumab therapy with severe steroid-induced side effects), with no statically significant difference in price when compared with steroid therapy alone and far fewer side effects, demonstrated the potential use of tocilizumab in GCA therapy. As expected, longer treatment duration with tocilizumab was associated with greater cost. With respect to side effect severity, the number of side effects of steroid therapy was inversely associated with difference in cost between tocilizumab therapy and steroid side effect treatment.

Conclusion: This study demonstrates that combination therapy of tocilizumab and prednisone is significantly more expensive than steroids alone with or without accounting for the cost of steroid-induced side effects in treated GCA. The difference in cost between the 2 therapy types is directly related to tocilizumab therapy duration and inversely related to the number or severity of steroid side effects. Patients with GCA who require a shorter duration of steroid therapy and are at risk for a high number of side effects from steroid use may be potential candidates for tocilizumab therapy, from an economic perspective.
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http://dx.doi.org/10.1097/WNO.0000000000001220DOI Listing
September 2021

Factors Compromising Glucuronidase Performance in Urine Drug Testing Potentially Resulting in False Negatives.

J Anal Toxicol 2021 Aug 17. Epub 2021 Aug 17.

Dominion Diagnostics, LLC, North Kingstown, RI 02852, USA.

Next generation β-glucuronidases can effectively cleave glucuronides in urine at room temperature. However, during the discovery studies, additional challenges were identified for urine drug testing across biologically relevant pH extremes and patient urine specimens. Different enzymes were evaluated across clinical urine specimens and commercially available urine control matrices. Each enzyme shows distinct substrate preferences, pH optima, and variability across clinical specimens. These results demonstrate how reliance on a single glucuronidated substrate as the internal hydrolysis control cannot ensure performance across a broader panel of analytes. Moreover, sample specific urine properties compromise β-glucuronidases to varying levels, more pronounced for some enzymes, and thereby lower the recovery of some drug analytes in an enzyme-specific manner. A minimum of 3-fold dilution of urine with buffer yields measurable improvements in achieving target pH and reducing the impact of endogenous compounds on enzyme performance. After subjecting the enzymes to pH extremes and compromising chemicals, one particular β-glucuronidase was identified that addressed many of these challenges and greatly lower the risk of failed hydrolyses. In summary, we present strategies to evaluate glucuronidases that aid in higher accuracy urine drug tests with lower potential for false negatives.
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http://dx.doi.org/10.1093/jat/bkab090DOI Listing
August 2021

Accelerated Hypofractionated Image-Guided vs Conventional Radiotherapy for Patients With Stage II/III Non-Small Cell Lung Cancer and Poor Performance Status: A Randomized Clinical Trial.

JAMA Oncol 2021 Aug 12. Epub 2021 Aug 12.

Department of Radiation Oncology, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas.

Importance: A significant subset of patients with stage II/III non-small cell lung cancer (NSCLC) cannot receive standard concurrent chemoradiotherapy owing to the risk of toxic effects outweighing potential benefits. Without concurrent chemotherapy, however, the efficacy of conventional radiotherapy is reduced.

Objective: To determine whether hypofractionated image-guided radiotherapy (IGRT) would improve overall survival in patients with stage II/III NSCLC who could not receive concurrent chemoradiotherapy and therefore were traditionally relegated to receiving only conventionally fractionated radiotherapy (CFRT).

Design, Setting, And Participants: This nonblinded, phase 3 randomized clinical study enrolled 103 patients and analyzed 96 patients with stage II/III NSCLC and Zubrod performance status of at least 2, with greater than 10% weight loss in the previous 6 months, and/or who were ineligible for concurrent chemoradiotherapy after oncology consultation. Enrollment occurred at multiple US institutions. Patients were enrolled from November 13, 2012, to August 28, 2018, with a median follow-up of 8.7 (3.6-19.9) months. Data were analyzed from September 14, 2018, to April 11, 2021.

Interventions: Eligible patients were randomized to hypofractionated IGRT (60 Gy in 15 fractions) vs CFRT (60 Gy in 30 fractions).

Main Outcomes And Measures: The primary end point was 1-year overall survival.

Results: A total of 103 patients (96 of whom were analyzed [63 men (65.6%); mean (SD) age, 71.0 (10.2) years (range, 50-90 years)]) were randomized to hypofractionated IGRT (n = 50) or CFRT (n = 46) when a planned interim analysis suggested futility in reaching the primary end point, and the study was closed to further accrual. There was no statistically significant difference between the treatment groups for 1-year overall survival (37.7% [95% CI, 24.2%-51.0%] for hypofractionated IGRT vs 44.6% [95% CI, 29.9%-58.3%] for CFRT; P = .29). There were also no significant differences in median overall survival, progression-free survival, time to local failure, time to distant metastasis, and toxic effects of grade 3 or greater between the 2 treatment groups.

Conclusions And Relevance: This phase 3 randomized clinical trial found that hypofractionated IGRT (60 Gy in 15 fractions) was not superior to CFRT (60 Gy in 30 fractions) for patients with stage II/III NSCLC ineligible for concurrent chemoradiotherapy. Further studies are needed to verify equivalence between these radiotherapy regimens. Regardless, for well-selected patients with NSCLC (ie, peripheral primary tumors and limited mediastinal/hilar adenopathy), the convenience of hypofractionated radiotherapy regimens may offer an appropriate treatment option.

Trial Registration: ClinicalTrials.gov Identifier: NCT01459497.
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http://dx.doi.org/10.1001/jamaoncol.2021.3186DOI Listing
August 2021

Morphological changes after lower eyelid epiblepharon surgery in Asian children.

BMC Ophthalmol 2021 Aug 6;21(1):293. Epub 2021 Aug 6.

Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.

Background: This study aimed to determine the morphological changes in Asian lower eyelid epiblepharon patients after surgery.

Methods: The medical records of 59 patients who underwent lower eyelid epiblepharon repair were reviewed retrospectively. Eighty-nine patients who underwent strabismus surgery were set as the control group. The photographs for each group were analyzed based on the following factors: inferior half area (IHA) of the eye, eyelash angular direction (EAD), angle between the eyelashes and the cornea, marginal reflex distance 1 (MRD) and marginal reflex distance 2 (MRD).

Results: After surgery, the medial EAD changed from 92.45° ± 20.21° (mean ± SD) to 79.43° ± 23.31°, while the central and lateral EADs were unchanged. IHA increased from 36.33 ± 9.78 mm to 43.06 ± 10.57 mm, and MRD increased from 1.92 ± 0.99 mm to 2.50 ± 0.93 mm, whereas MRD did not change. The mean angle between the eyelashes and the cornea increased from 39.64° to 72.19° immediately postoperatively, but had reduced to 58.75° 3 months later, followed by no further significant change at the 6-month and 9-month postoperative follow-ups.

Conclusions: There is morphological changes of the eyelid after lower eyelid epiblepharon surgery, with increases in the IHA and MRD In addition, contact between the eyelashes and the cornea occurred mainly in the medial portion of the eyelid the position, which everted and stabilized over 3 months. Thus, follow-up observations are required for at least 3 months to properly evaluate the surgical outcome.
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http://dx.doi.org/10.1186/s12886-021-02052-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8348859PMC
August 2021

Intradermal vaccination of live attenuated influenza vaccine protects mice against homologous and heterologous influenza challenges.

NPJ Vaccines 2021 Aug 4;6(1):95. Epub 2021 Aug 4.

Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.

We previously developed a temperature-sensitive, and NS1 gene deleted live attenuated influenza vaccine (DelNS1-LAIV) and demonstrated its potent protective efficacy in intranasally vaccinated mice. Here we investigated whether intradermal (i.d.) vaccination induces protective immunity. Our results showed that DelNS1-LAIV intradermal vaccination conferred effective and long-lasting protection against lethal virus challenge in mice. A single intradermal injection of DelNS1-LAIV conferred 100% survival with no weight loss in mice after A(H1N1)09 influenza virus (H1N1/415742Md) challenge. DelNS1-LAIV injection resulted in a significant reduction of lung viral load and reduced airway epithelial cell death and lung inflammatory cytokine responses at day 2 and 4 post challenge. Full protections of mice lasted for 6 months after immunization. In vitro infection of DelNS1-LAIV in monocyte-derived dendritic cells (MoDCs) demonstrated activation of antigen-presenting cells at 33 °C, together with the results of abortive replication of DelNS1-LAIV in skin tissue and strong upregulation of inflammatory cytokines/chemokines expression, our results suggested the strong immunogenicity of this vaccine. Further, we demonstrate that the underlying protection mechanism induced by intradermal DelNS1-LAIV is mainly attributed to antibody responses. Together, this study opens up an alternative route for the administration of LAIV, which may benefit individuals not suitable for intranasal LAIV immunization.
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http://dx.doi.org/10.1038/s41541-021-00359-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8339132PMC
August 2021

Should Exogenous Estrogens Be Stopped for Surgery in Transgender Women?

Laryngoscope 2021 Jul 29. Epub 2021 Jul 29.

Department of Otolaryngology - Head and Neck Surgery, Boston Medical Center, Boston, Massachusetts, U.S.A.

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http://dx.doi.org/10.1002/lary.29786DOI Listing
July 2021

Central nervous system hemorrhage due to chronic lymphocytic leukemia.

Can J Ophthalmol 2021 Jul 22. Epub 2021 Jul 22.

Blanton Eye Institute, Houston Methodist Hospital, Houston, TX; Weill Cornell Medicine, New York, New York; University of Texas MD Anderson Cancer Center, Houston, Texas; University of Texas Medical Branch, Galveston, Texas; Texas A and M College of Medicine, Bryan, Texas; The University of Iowa Hospitals and Clinics, Iowa City, Iowa. Electronic address:

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http://dx.doi.org/10.1016/j.jcjo.2021.06.021DOI Listing
July 2021

Papilledema and intracranial hypertension in leukemia: case series report and review.

Can J Ophthalmol 2021 Jul 21. Epub 2021 Jul 21.

Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, Houston, Tex.; Departments of Ophthalmology, Neurology, and Neurosurgery, Weill Cornell Medicine, New York, NY; Department of Ophthalmology, University of Texas Medical Branch (UTMB), Baylor College of Medicine; the University of Texas MD Anderson Cancer Center (UTMDACC), Texas A and M College of Medicine; and the University of Iowa Hospitals and Clinics; Department of Ophthalmology, The University of Iowa Hospitals and Clinics, Iowa City, Iowa.

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http://dx.doi.org/10.1016/j.jcjo.2021.06.022DOI Listing
July 2021

Dynamic loading of human engineered heart tissue enhances contractile function and drives a desmosome-linked disease phenotype.

Sci Transl Med 2021 07;13(603)

Regenerative Biomaterials and Therapeutics Group, Department of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, PA 15213, USA.

The role that mechanical forces play in shaping the structure and function of the heart is critical to understanding heart formation and the etiology of disease but is challenging to study in patients. Engineered heart tissues (EHTs) incorporating human induced pluripotent stem cell (hiPSC)-derived cardiomyocytes have the potential to provide insight into these adaptive and maladaptive changes. However, most EHT systems cannot model both preload (stretch during chamber filling) and afterload (pressure the heart must work against to eject blood). Here, we have developed a new dynamic EHT (dyn-EHT) model that enables us to tune preload and have unconstrained contractile shortening of >10%. To do this, three-dimensional (3D) EHTs were integrated with an elastic polydimethylsiloxane strip providing mechanical preload and afterload in addition to enabling contractile force measurements based on strip bending. Our results demonstrated that dynamic loading improves the function of wild-type EHTs on the basis of the magnitude of the applied force, leading to improved alignment, conduction velocity, and contractility. For disease modeling, we used hiPSC-derived cardiomyocytes from a patient with arrhythmogenic cardiomyopathy due to mutations in the desmoplakin gene. We demonstrated that manifestation of this desmosome-linked disease state required dyn-EHT conditioning and that it could not be induced using 2D or standard 3D EHT approaches. Thus, a dynamic loading strategy is necessary to provoke the disease phenotype of diastolic lengthening, reduction of desmosome counts, and reduced contractility, which are related to primary end points of clinical disease, such as chamber thinning and reduced cardiac output.
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http://dx.doi.org/10.1126/scitranslmed.abd1817DOI Listing
July 2021

Beam-Specific Spot Guidance and Optimization for PBS Proton Treatment of Bilateral Head and Neck Cancers.

Int J Part Ther 2021 25;8(1):50-61. Epub 2021 Jun 25.

California Protons Cancer Therapy Center, San Diego, CA, USA.

Purpose: A multi-field optimization (MFO) technique that uses beam-specific spot placement volumes (SPVs) and spot avoidance volumes (SAVs) is introduced for bilateral head and neck (H&N) cancers. These beam-specific volumes are used to guide the optimizer to consistently achieve optimal organ-at-risk (OAR) sparing with target coverage and plan robustness.

Materials And Methods: Implementation of this technique using a 4-beam, 5-beam, and variant 5-beam arrangement is discussed. The generation of beam-specific SPVs and SAVs derived from target and OARs are shown. The SPVs for select fields are further partitioned into optimization volumes for uniform dose distributions that resemble those of single-field optimization (SFO). A conventional MFO plan that does not use beam-specific spot placement guidance (MFOcon) and an MFO plan that uses only beam-specific SPV (MFOspv) are compared with current technique (MFOspv/sav), using both simulated scenarios and forward-calculated plans on weekly verification computed tomography (VFCT) scans.

Results: Dose distribution characteristics of the 4-beam, 5-beam, and variant 5-beam technique are demonstrated with discussion on OAR sparing. When comparing the MFOcon, MFOspv, and MFOspv/sav, the MFOspv/sav is shown to have superior OAR sparing in 9 of the 14 OARs examined. It also shows clinical plan robustness when evaluated by using both simulated uncertainty scenarios and forward-calculated weekly VFCTs throughout the 7-week treatment course.

Conclusion: The MFOspv/sav technique is a systematic approach using SPVs and SAVs to guide the optimizer to consistently reach desired OAR dose values and plan robustness.
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http://dx.doi.org/10.14338/IJPT-20-00060.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8270101PMC
June 2021

Molecular Testing for Thyroid Nodules Including Its Interpretation and Use in Clinical Practice.

Ann Surg Oncol 2021 Jul 18. Epub 2021 Jul 18.

Department of Surgery, Division of Surgical Oncology, University of Pittsburgh, Pittsburgh, PA, USA.

Despite advances in imaging and biopsy techniques, the management of thyroid nodules often remains a diagnostic and clinical challenge. In particular, patients with cytologically indeterminate nodules often undergo diagnostic thyroidectomy although only a minority of patients are found to have thyroid malignancy on final pathology. More recently, several molecular testing platforms have been developed to improve the stratification of cancer risk for patients with cytologically indeterminate thyroid nodules. Based on numerous studies demonstrating its accuracy, molecular testing has been incorporated as an important diagnostic adjunct in the management of indeterminate thyroid nodules in the National Comprehensive Cancer Network Guidelines as well as in the American Thyroid Association (ATA) and American Association of Endocrine Surgeons (AAES) guidelines. This overview describes the currently available molecular testing platforms and highlights the published data to date on the clinical validity and utility of molecular testing in the contemporary management of thyroid nodules.
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http://dx.doi.org/10.1245/s10434-021-10307-4DOI Listing
July 2021

Articaine in dentistry: an overview of the evidence and meta-analysis of the latest randomised controlled trials on articaine safety and efficacy compared to lidocaine for routine dental treatment.

BDJ Open 2021 Jul 17;7(1):27. Epub 2021 Jul 17.

Anatomy, College of Medicine and Dentistry, James Cook University, Cairns, QLD, Australia.

Objectives: To comprehensively review the existing studies of articaine in dentistry and conduct a systematic review and meta-analysis to answer the following Population, Intervention, Comparison and Outcome question: "Is articaine a safe and efficacious local anaesthetic for routine dental treatment compared to lidocaine?"

Methods: Database searches were conducted in Medline Ovid, Medline Pubmed, Scopus, Emcare, Proquest and the Cochrane Central register of Controlled Trials. Inclusion criteria were all existing English, human, randomised controlled trials of interventions involving 4% articaine and 2% lidocaine in routine dental treatment. Twelve studies were included for meta-analysis using Cochrane Review Manager 5 software. Anaesthetic success odds ratios were calculated using a random-effects model.

Results: Articaine had a higher likelihood of achieving anaesthetic success than lidocaine overall and in all subgroup analyses with varying degrees of significance. Overall (OR: 2.17, 95% CI: 1.50, 3.15, I = 62%) articaine had 2.17 times the likelihood of anaesthetic success of lidocaine (P < 0.0001). For mandibular blocks (OR: 1.50, 95% CI: 1.14, 1.98, I = 0%) articaine had 1.5 times the likelihood of anaesthetic success of lidocaine (P = 0.004). For all infiltrations, maxillary and mandibular (OR: 2.78, 95% CI: 1.61, 4.79, I = 66%) articaine had 2.78 times the likelihood of anaesthetic success of lidocaine (P = 0.0002). None of the studies reported any major local anaesthetic-related adverse effects as a result of the interventions.

Conclusions: Articaine is a safe and efficacious local anaesthetic for all routine dental procedures in patients of all ages, and more likely to achieve successful anaesthesia than lidocaine in routine dental treatment. Neither anaesthetic has a higher association with anaesthetic-related adverse effects.
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http://dx.doi.org/10.1038/s41405-021-00082-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8286260PMC
July 2021

Bilateral Abducens Nerve Palsies After Middle Meningeal Artery Embolization for Chronic Subdural Hematoma.

J Neuroophthalmol 2021 Jul 2. Epub 2021 Jul 2.

Department of Ophthalmology (SR, PWM), Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas; Department of Neurosurgery (YJZ, AGL), Houston Methodist Hospital and Weill Cornell Medicine, New York, New York; Department of Ophthalmology (AGL), University of Texas Medical Branch, Galveston, Texas; University of Texas MD Anderson Cancer Center (AGL), Houston, Texas of Ophthalmology; Texas A and M College of Medicine (AGL), Bryan, Texas; and Department of Ophthalmology (AGL), The University of Iowa Hospitals and Clinics, Iowa City, Iowa.

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http://dx.doi.org/10.1097/WNO.0000000000001305DOI Listing
July 2021
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