Plain language summary of the CARTITUDE-4 study of ciltacabtagene autoleucel for the treatment of people with relapsed or refractory multiple myeloma.

WHAT IS THIS SUMMARY ABOUT?: This is a summary of a phase 3 clinical trial called CARTITUDE-4. This trial compared the anti-cancer therapy ciltacabtagene autoleucel (or cilta-cel) with standard therapies in people who have multiple myeloma, a cancer that affects specific kinds of blood cells called plasma cells. The people in the study had been treated with 1 to 3 previous treatments for multiple myeloma, including a common anti-myeloma treatment called lenalidomide, but their multiple myeloma did not get better. HOW WAS THE STUDY IN THIS SUMMARY CONDUCTED?: About half of the 419 participants in this study received cilta-cel, while the other half received standard therapies, or therapies that are commonly used to treat multiple myeloma. Participants who received cilta-cel had a type of immune cell called T cells collected from their blood and genetically modified to recognize a specific protein found on myeloma cells. These modified T cells, which comprise cilta-cel, were then infused back into the bloodstream. WHAT WERE THE RESULTS OF THE STUDY?: After approximately 1 year in the study, more participants were alive without their cancer getting worse in the cilta-cel group (76%) than in the standard therapies group (49%). The most common side effects in both groups were infections and low blood cell counts. Cytokine release syndrome (a potentially serious side effect caused by overactivation of the immune system) was common but mostly mild. Neurotoxicities (including immune effector cell-associated neurotoxicity syndrome, which can cause symptoms such as headaches, changes in consciousness, and difficulty with memory, attention, speaking, or understanding others) were less common and were reported in 20.5% of participants treated with cilta-cel. WHAT WERE THE MAIN CONCLUSIONS REPORTED BY THE RESEARCHERS?: In CARTITUDE-4, more participants treated with cilta-cel showed improvements and were alive with control of their disease 12 months after receiving cilta-cel compared with participants who received standard therapies.Clinical Trial Registration: NCT04181827 (CARTITUDE-4) (ClinicalTrials.gov).

Comparative efficacy of ciltacabtagene autoleucel versus idecabtagene vicleucel in the treatment of patients with relapsed or refractory multiple myeloma previously treated with 2-4 prior lines of therapy: a matching-adjusted indirect comparison.

OBJECTIVE: To estimate the comparative efficacy of ciltacabtagene autoleucel (cilta-cel) versus idecabtagene vicleucel (ide-cel) in patients with relapsed/refractory multiple myeloma (RRMM) treated with 2-4 prior lines of therapy. METHODS: Matching adjusted indirect comparison (MAICs) were performed using individual patient-level data (IPD) for cilta-cel from CARTITUDE-1 and CARTITUDE-4 and published aggregated data for ide-cel from KarMMa-3. Cilta-cel patients who met inclusion criteria from KarMMa-3 were selected, and outcomes were compared against data for ide-cel using simulated IPD derived from aggregate-level data from KarMMa-3. Patient characteristics were adjusted by reweighting cilta-cel IPD to match the distribution of prognostic factors in KarMMa-3. Comparative efficacy was estimated for response outcomes using a weighted logistic regression analysis and for progression-free survival using a weighted Cox proportional hazards model. RESULTS: Patients treated with cilta-cel were 1.2 times more likely to achieve overall response (relative response ratio [RR]: 1.18 [95% confidence interval: 1.03-1.34]; p = 0.04), 1.3 times more likely to achieve very good partial response or better (RR: 1.34 [1.15-1.57]; p = 0.003), and 1.9 times more likely to achieve complete response or better (RR: 1.91 [1.54-2.37]; p < 0.0001) versus ide-cel patients from KarMMa-3. Cilta-cel was associated with a significant 49% reduction in risk of disease progression or death versus ide-cel (hazard ratio: 0.51 [95% confidence interval: 0.31, 0.84]; p = 0.0078). CONCLUSION: For patients with triple-class exposed RRMM treated with 2-4 prior lines of treatment, cilta-cel was found to provide superior clinical benefit over ide-cel in terms of response and progression-free survival.

Efficacy of CARVYKTI in CARTITUDE-4 versus other conventional treatment regimens for lenalidomide-refractory multiple myeloma using inverse probability of treatment weighting.

Aim: The phase III randomized controlled trial (RCT) CARTITUDE-4 (NCT04181827) demonstrated superiority of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) over daratumumab, pomalidomide and dexamethasone (DPd) and pomalidomide, bortezomib and dexamethasone (PVd) for relapsed/refractory multiple myeloma (RRMM) patients who have received one to three prior line(s) of therapy (LOT[s]) including an immunomodulatory agent and a proteasome inhibitor, and are refractory to lenalidomide. These analyses estimate the relative efficacy between cilta-cel and other common treatment regimens, for which no direct comparative evidence is available. Materials & methods: Patient data were available from the CARTITUDE-4, CASTOR, CANDOR and APOLLO RCTs. Imbalances between cohorts on key patient characteristics were adjusted for using inverse probability of treatment weighting (IPTW). Relative efficacies were estimated with response rate ratios (RRs) and 95% confidence intervals (CIs) for overall response rate (ORR), very good partial response or better rate (≥VGPR) and complete response or better rate (≥CR), and with hazard ratios (HRs) and 95% CIs for progression-free survival (PFS). Sensitivity analyses using different analytical methods and additional covariates were explored. Results: Key characteristics were well balanced across cohorts after IPTW. Cilta-cel showed statistically significant benefit in PFS (HRs: 0.11-0.51), ≥VGPR (RRs: 1.51-5.13) and ≥CR (RRs: 2.90-35.24) versus all comparators, and statistically significant improvements in ORR over most comparator regimens (RRs: 1.22-1.90). Results were consistent across sensitivity analyses. Conclusion: Cilta-cel demonstrated benefit over other common treatment regimens, highlighting its potential to become a new standard of care option for lenalidomide-refractory RRMM patients with one to three prior LOT(s). These comparisons help to demonstrate the improved efficacy of cilta-cel in countries where the standard of care may differ from DPd/PVd.

Cilta-cel, a BCMA-targeting CAR-T therapy for patients with multiple myeloma.

INTRODUCTION: Ciltacabtagene autoleucel (cilta-cel), a BCMA-targeting CAR-T therapy, is approved in the United States and Europe for patients with relapsed/refractory multiple myeloma (RRMM) and ≥1 prior line of therapy (LOT), including a proteasome inhibitor and an immunomodulatory drug, and are lenalidomide refractory. AREAS COVERED: We examine recent long-term data in heavily pretreated RRMM (LEGEND-2, CARTITUDE-1) and earlier LOTs (CARTITUDE-4) compared with standard therapy and discuss the rationale for investigating cilta-cel as frontline therapy for transplant-eligible and transplant-ineligible patients (CARTITUDE-5, CARTITUDE-6). EXPERT OPINION: CAR-T therapies can improve outcomes for patients with MM across different LOTs. CARTITUDE-1 and CARTITUDE-4 have set a new bar for efficacy, with median PFS of 34.9 months in heavily pretreated patients (CARTITUDE-1) and a 74% relative risk reduction for progression/death versus standard care in patients with 1-3 prior LOTs (CARTITUDE-4), with manageable safety. Response rates were consistent between the two studies: 98% in CARTITUDE-1 and approaching 100% for infused patients in CARTITUDE-4. Cilta-cel could be a key treatment choice for patients with RRMM after first LOT. Clinical trials investigating frontline cilta-cel therapy will provide valuable insights into optimizing treatment pathways with the aim to potentially cure MM.

Development and experimental validation of 3D QSAR models for the screening of thyroid peroxidase inhibitors using integrated methods of computational chemistry.

The intricate network of glands and organs that makes up the endocrine system. Hormones are used to regulate and synchronize the nervous and physiological systems. The agents which perturbate an endocrine system are called endocrine disruptors and they can eventually affect cellular proliferation and differentiation in target tissues. A subclass of endocrine disruptors known as thyroid disruptors (TDs) or thyroid disrupting chemicals (TDCs) influence the hypothalamo-pituitary-thyroid axis or directly interfere with thyroid function by binding to thyroid hormone receptors. Thyroid hormone levels in circulation are now included in more test guidelines (OECD TG 441, 407, 408, 414, 421/422, 443/416). Although these might be adequate to recognize thyroid adversity, they are unable to explain the underlying mechanism of action. Thyroid peroxidase (TPO) and sodium iodide symporter (NIS), two proteins essential in the biosynthesis of thyroid hormones, are well-accepted molecular targets for inhibition. The screening of a large number of molecules using high throughput screening (HTS) requires a minimum quantity of sample, cost, and time consuming. Whereas 3-dimensional quantitative structure-activity relationship (3D-QSAR) analysis can screen the TDCs before synthesizing a compound. In the present study, the human TPO (hTPO) and NIS (hNIS) structures were modelled using homology modeling and the quality of the structures was validated satisfactorily using MD simulation for 100ns. Further, 190 human TPO inhibitors with IC50 were curated from Comptox and docked with the modelled structure of TPO using D238, H239 and D240 centric grid. The binding conformation of a molecule with low binding energy was used as a reference and the rest other molecules were aligned after generating the possible conformers. The activity-stratified partition was performed for aligned molecules and training set (139), test set (51) were defined. The machine learning models such as k Nearest Neighbor (kNN) and Random Forest (RF) models were built and validated using external experimental dataset containing 10 molecules. Among the 10 molecules, all 10 molecules were identified as TPO inhibitors and demonstrated 100 % accuracy qualitatively. To confirm the selective TPO inhibition all 10 molecules were docked with the modelled structure of hNIS and the results have demonstrated the selective TPO inhibition.

Effects of User-Reported Risk Factors and Follow-Up Care Activities on Satisfaction With a COVID-19 Chatbot: Cross-Sectional Study.

BACKGROUND: The COVID-19 pandemic influenced many to consider methods to reduce human contact and ease the burden placed on health care workers. Conversational agents or chatbots are a set of technologies that may aid with these challenges. They may provide useful interactions for users, potentially reducing the health care worker burden while increasing user satisfaction. Research aims to understand these potential impacts of chatbots and conversational recommender systems and their associated design features. OBJECTIVE: The objective of this study was to evaluate user perceptions of the helpfulness of an artificial intelligence chatbot that was offered free to the public in response to COVID-19. The chatbot engaged patients and provided educational information and the opportunity to report symptoms, understand personal risks, and receive referrals for care. METHODS: A cross-sectional study design was used to analyze 82,222 chats collected from patients in South Carolina seeking services from the Prisma Health system. Chi-square tests and multinomial logistic regression analyses were conducted to assess the relationship between reported risk factors and perceived chat helpfulness using chats started between April 24, 2020, and April 21, 2022. RESULTS: A total of 82,222 chat series were started with at least one question or response on record; 53,805 symptom checker questions with at least one COVID-19-related activity series were completed, with 5191 individuals clicking further to receive a virtual video visit and 2215 clicking further to make an appointment with a local physician. Patients who were aged >65 years (P<.001), reported comorbidities (P<.001), had been in contact with a person with COVID-19 in the last 14 days (P<.001), and responded to symptom checker questions that placed them at a higher risk of COVID-19 (P<.001) were 1.8 times more likely to report the chat as helpful than those who reported lower risk factors. Users who engaged with the chatbot to conduct a series of activities were more likely to find the chat helpful (P<.001), including seeking COVID-19 information (3.97-4.07 times), in-person appointments (2.46-1.99 times), telehealth appointments with a nearby provider (2.48-1.9 times), or vaccination (2.9-3.85 times) compared with those who did not perform any of these activities. CONCLUSIONS: Chatbots that are designed to target high-risk user groups and provide relevant actionable items may be perceived as a helpful approach to early contact with the health system for assessing communicable disease symptoms and follow-up care options at home before virtual or in-person contact with health care providers. The results identified and validated significant design factors for conversational recommender systems, including triangulating a high-risk target user population and providing relevant actionable items for users to choose from as part of user engagement.

Criterion-Based Rehabilitation and Return to Play in Fast Bowlers Following Arthroscopic Bankart Repair: Recommendations Based on a Detailed Clinical Review.

Background: Anterior shoulder instability due to labral tears in the dominant arm of cricket fast bowlers can be particularly disabling and results in significant match time loss. This often follows injuries sustained during fielding and training, although micro-instability following repetitive throwing progressing to overt anterior shoulder instability is also known. To ensure ball release speeds of over 140 km/h with different ball variations, these athletes require not only physical fitness and technical skill, but also a completely stable shoulder. Methods: A literature search of "MEDLINE", "SPORT DISCUSS", and "GOOGLE SCHOLAR" was done to identify relevant articles published till the year 2023. Results: A treatment approach that involves anatomic restoration of the shoulder via an arthroscopic Bankart capsulo-labral repair, followed by functional and biomechanical restoration via rehabilitation is the most predictable method to ensure a successful return to pre-injury fast-bowling status. A post-operative rehabilitation program that ensures a quick return to fast bowling without disrupting the surgical repair is crucial. Timely integration of exercises to recruit and strengthen the kinetic chain used for bowling and throwing plays a key role in this faster recovery. This current review provides a phase-wise, evidence-based rehabilitation guideline for return to competitive cricket after arthroscopic Bankart repair in a fast bowler. This review also highlights a structured return to bowling, throwing, and fielding program with a clinical decision-making process. Conclusion: Exercise selection at an early stage that does not compromise the healing tissue, and timely integration of workouts to recruit and strengthen the kinetic chain used for bowling and throwing is the key strategy to allow faster recovery. Supplementary Information: The online version contains supplementary material available at 10.1007/s43465-023-00931-5.

Novel markers of COVID-19 mortality-A comparative study with patients of acute coronary syndrome.

Background: COVID-19 can cause severe pneumonia that can progress to multiple organ failure. It is believed that dysregulation of inflammation and cytokine storm, contributes to severe COVID-19. As inflammatory mediators play an important role in the pathogenesis of the severe disease, inflammatory markers like fever, leucocytosis, and C-reactive protein are known to predict severe disease. Various other biomarkers have been known to have prognostic value in patients with COVID-19 infection. Inflammation, both local and systemic plays an important role in the pathogenesis of acute coronary syndrome (ACS). Thus in this study, we aimed to compare and describe the various biomarkers, and mortality between patients admitted with COVID-19 infection and ACS patients without COVID-19 infection. Methods: In a retrospective observational case-control study, a total of 108 patients admitted to our hospital during the month of May 2021 with COVID-19 were enrolled. Patients of the acute coronary syndrome (tested negative for COVID-19 infection) admitted during the same month were enrolled (including both the intensive care unit and ward) as controls. Results: The median age of patients with COVID was significantly lower than that of patients with acute coronary syndrome [49 years (IQR, 36-62 years) and 60 years (IQR, 52-66 years)]. Left ventricular ejection fraction was significantly higher among patients with COVID infection (58.5 ± 6.3% versus 36.9 ± 9.3%). The total leukocyte count was significantly higher among patients with COVID-19 compared to those with acute coronary syndrome [13200 per microliter (8625-17500) vs 9800 per microliter (8150-12150), P < 0.001]. The blood urea level was significantly higher among patients with COVID infection [52.5 (IQR, 34.7-81.5) versus 20 (IQR, 16-31)]. Levels of C-reactive protein were significantly higher among patients with COVID [39 (IQR, 7.7-100) versus 2 (1.4-3.5)]. The mortality of patients hospitalized with COVID was 4 times higher than those with acute coronary syndrome [25.9% (28) versus 6.1% (6)]. Survivors of COVID-19 had higher hemoglobin levels than those who did not [12.5 g/dLvs 11.5 g/dL, P = 0.03]. Conclusions: Elevated total leukocyte counts reflect underlying secondary bacterial infection among patients with COVID-19 and help initiate appropriate antibiotics. Depletion of intravascular volume reflected by an increased urea/creatinine ratio increases the risk of mortality and warrants aggressive measures of rehydration and albumin infusion.

Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma.

BACKGROUND: Ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)-directed CAR T-cell therapy, is effective in heavily pretreated patients with relapsed or refractory multiple myeloma. We investigated cilta-cel in earlier treatment lines in patients with lenalidomide-refractory disease. METHODS: In this phase 3, randomized, open-label trial, we assigned patients with lenalidomide-refractory multiple myeloma to receive cilta-cel or the physician's choice of effective standard care. All the patients had received one to three previous lines of treatment. The primary outcome was progression-free survival. RESULTS: A total of 419 patients underwent randomization (208 to receive cilta-cel and 211 to receive standard care). At a median follow-up of 15.9 months (range, 0.1 to 27.3), the median progression-free survival was not reached in the cilta-cel group and was 11.8 months in the standard-care group (hazard ratio, 0.26; 95% confidence interval [CI], 0.18 to 0.38; P<0.001). Progression-free survival at 12 months was 75.9% (95% CI, 69.4 to 81.1) in the cilta-cel group and 48.6% (95% CI, 41.5 to 55.3) in the standard-care group. More patients in the cilta-cel group than in the standard-care group had an overall response (84.6% vs. 67.3%), a complete response or better (73.1% vs. 21.8%), and an absence of minimal residual disease (60.6% vs. 15.6%). Death from any cause was reported in 39 patients and 46 patients, respectively (hazard ratio, 0.78; 95% CI, 0.5 to 1.2). Most patients reported grade 3 or 4 adverse events during treatment. Among the 176 patients who received cilta-cel in the as-treated population, 134 (76.1%) had cytokine release syndrome (grade 3 or 4, 1.1%; no grade 5), 8 (4.5%) had immune effector cell-associated neurotoxicity syndrome (all grade 1 or 2), 1 had movement and neurocognitive symptoms (grade 1), 16 (9.1%) had cranial nerve palsy (grade 2, 8.0%; grade 3, 1.1%), and 5 (2.8%) had CAR-T-related peripheral neuropathy (grade 1 or 2, 2.3%; grade 3, 0.6%). CONCLUSIONS: A single cilta-cel infusion resulted in a lower risk of disease progression or death than standard care in lenalidomide-refractory patients with multiple myeloma who had received one to three previous therapies. (Funded by Janssen and Legend Biotech; CARTITUDE-4 ClinicalTrials.gov number, NCT04181827.).

High-throughput optofluidic screening of single B cells identifies novel cross-reactive antibodies as inhibitors of uPAR with antibody-dependent effector functions.

The urokinase-type plasminogen activator receptor (uPAR) is an essential regulator for cell signaling in tumor cell proliferation, adhesion, and metastasis. The ubiquitous nature of uPAR in many aggressive cancer types makes uPAR an attractive target for immunotherapy. Here, we present a rapid and successful workflow for developing cross-reactive anti-uPAR recombinant antibodies (rAbs) using high-throughput optofluidic screening of single B-cells from human uPAR-immunized mice. A total of 80 human and cynomolgus uPAR cross-reactive plasma cells were identified, and selected mouse VH/VL domains were linked to the trastuzumab (Herceptin®) constant domains for the expression of mouse-human chimeric antibodies. The resulting rAbs were characterized by their tumor-cell recognition, binding activity, and cell adhesion inhibition on triple-negative breast cancer cells. In addition, the rAbs were shown to enact antibody-dependent cellular cytotoxicity (ADCC) in the presence of either human natural killer cells or peripheral blood mononuclear cells, and were evaluated for the potential use of uPAR-targeting antibody-drug conjugates (ADCs). Three lead antibodies (11857, 8163, and 3159) were evaluated for their therapeutic efficacy in vivo and were shown to suppress tumor growth. Finally, the binding epitopes of the lead antibodies were characterized, providing information on their unique binding modes to uPAR. Altogether, the strategy identified unique cross-reactive antibodies with ADCC, ADC, and functional inhibitory effects by targeting cell-surface uPAR, that can be tested in safety studies and serve as potential immunotherapeutics.

Post-operative tension spinal subdural extra-arachnoid hygroma of the lumbar spine: case series, literature review, and recommendations for clinical management.

OBJECTIVE: Case series presentation and literature review of patient group suffering from symptomatic tension subdural extra-arachnoid hygroma following decompressive surgery for degenerative lumbar stenosis or disc disease. The purpose was to better understand this rare post-operative complication with a pathognomic radiological sign to help recommend optimal strategies for clinical management. METHODS: Retrospective case series comprising seven cases from one tertiary Neurosurgical centre spanning a 10-year period from 2011 to 2021. Patients included were those known to have undergone a spinal procedure and subsequently to have developed a symptomatic spinal subdural extra-arachnoid hygroma (SSEH). A literature review was conducted using PubMed, MEDLINE and EMBASE (keywords 'subdural hygroma', 'lumbar CSF hygroma', 'extra arachnoid hygroma', 'extra-arachnoid CSF collection', 'CSF tension hygroma', 'lumbar extra arachnoid hygroma', 'lumbar spinal hygroma', 'post-operating spinal hygroma', 'post-operative spinal CSF collection') and through reading references cited in relevant articles. Articles involving post-operative SSEH following lumbar spinal surgery were included. RESULTS: Rare complication with only five other cases in the literature. Dural breach described intra-operatively in only 5 of 12 total cases from our series and the literature. 5 patients in our series were managed surgically with 2 being managed conservatively. All patients in our series improved symptomatically and radiologically following surgical or conservative management. CONCLUSIONS: This is a rare post-lumbar surgery complication that can cause rapidly deteriorating lower limb and sphincteric function. Surgical management with wide durotomy and arachnoid marsupialisation can lead to reversal of neurological deterioration and excellent clinical results. A delayed presentation with pseudomeningocele formation may be managed conservatively if neurology is stable or improving. It is a condition that it is important for the clinician to recognise in order to instigate appropriate management in a time-dependent fashion.

Rapidly Progressive Granulomatous Amoebic Encephalitis in a Diabetic Individual.

We present a case of rapidly progressive granulomatous amoebic encephalitis caused by Balamuthia mandrillaris in an individual with diabetes mellitus. Our patient presented with occipital headache, blurry vision, confusion, and gait imbalance of one week's duration. Brain imaging revealed numerous peripheral ring-enhancing lesions concerning malignancy. Brain biopsy was consistent with Balamuthia mandrillaris infection. He passed away 45 days after presentation despite being treated with a five-drug regimen. This case highlights the importance of considering amoebic brain infections, especially with ring-enhancing lesions on imaging. There are opportunities to design modalities for rapid diagnosis and better treatment.

Acute myocardial infarction in a young patient with triple valve replacement.

Rheumatic heart disease is an important cause of mortality and morbidity in developing countries, and is the leading cause of triple valve replacement. Myocardial infarction (MI) in such cases can be due to the coronary embolism from the prosthetic valves or due to atherosclerotic vascular disease. Intravascular imaging helps in delineating the cause. We present a case of a 34-year-old premenopausal woman with no conventional cardiovascular risk factors and had triple valve replacement 4 years ago and anterior wall MI with cardiogenic shock and left ventricular failure. She was managed with mechanical ventilation, thrombolysis, diuretics, double antiplatelets and anticoagulation with low molecular weight heparin. Intravascular ultrasound showed a lipid-rich plaque with associated plaque rupture and thrombosis. Intravascular imaging helps in delineating the cause of MI and further management. Atherosclerotic MI in a patient with no conventional risk factors is rare and needs to be considered.

Perioperative Blood Loss after Preoperative Prostatic Artery Embolization in Patients Undergoing Simple Prostatectomy: A Propensity Score‒Matched Study.

PURPOSE: To assess perioperative blood loss following prostatic artery embolization (PAE) before surgery in patients undergoing simple prostatectomy. METHODS: A retrospective chart review was used to identify 63 patients (mean age, 65.3 ± 8.0 years) with prostatic hypertrophy and severe lower urinary tract symptoms who underwent prostatectomy from September 2014 to December 2019, 18 (28.5%) of whom underwent PAE before surgery. Demographic data, pertinent laboratory results, procedural or operative information, hospital course details, and pathology reports were obtained. A 2:1 propensity score‒matching analysis was performed to compare intraoperative blood loss in patients who underwent prostatectomy alone with intraoperative blood loss in those who first underwent bilateral PAE before surgery. RESULTS: Sixteen (89%) of the 18 patients underwent bilateral PAE before surgery. Thirty-two patients who underwent prostatectomy without embolization before surgery were selected for the 2:1 propensity score‒matched analysis based on age, race, surgery type, prostate gland size, and comorbidities. The mean estimated blood loss (EBL) for prostatectomy alone was 545 ± 380 mL (mean ± standard deviation). There was a statistically significant reduction in the EBL for patients who underwent bilateral PAE (303 ± 227 mL, P < .01). The operative time was also significantly decreased for patients who underwent PAE before surgery (P < .05). For patients who underwent PAE, there were no complications related to the procedure. CONCLUSIONS: Bilateral PAE before surgery appears to be safe and may be effective in reducing perioperative bleeding and operative time.

Development and Initial Validation of the Perceptual Assessment of Memory (PASSOM): A Simulator Study.

OBJECTIVE: Performance validity tests (PVTs) are an integral component of neuropsychological assessment. There is a need for the development of more PVTs, especially those employing covert determinations. The aim of the present study was to provide initial validation of a new computerized PVT, the Perceptual Assessment of Memory (PASSOM). METHOD: Participants were 58 undergraduate students randomly assigned to a simulator (SIM) or control (CON) group. All participants were provided written instructions for their role prior to testing and were administered the PASSOM as part of a brief battery of neurocognitive tests. Indices of interest included response accuracy for Trials 1 and 2, and total errors across Trials, as well as response time (RT) for Trials 1 and 2, and total RT for both Trials. RESULTS: The SIM group produced significantly more errors than the CON group for Trials 1 and 2, and committed more total errors across trials. Significantly longer response latencies were found for the SIM group compared to the CON group for all RT indices examined. Linear regression modeling indicated excellent group classification for all indices studied, with areas under the curve ranging from 0.92 to 0.95. Sensitivity and specificity rates were good for several cut scores across all of the accuracy and RT indices, and sensitivity improved greatly by combining RT cut scores with the more traditional accuracy cut scores. CONCLUSION: Findings demonstrate the ability of the PASSOM to distinguish individuals instructed to feign cognitive impairment from those told to perform to the best of their ability.

Integrated Digital Patient Education at the Bedside for Patients with Chronic Conditions: Observational Study.

BACKGROUND: Patient education delivered by a health care provider increases patients' understanding and adherence to medical instructions, which helps to improve patient health. Multiple challenges exist to delivering effective patient education to patients with multiple chronic conditions, including giving the necessary time, range, and types of learning materials, and assessing the level of understanding. To help overcome these challenges, it is important to study new electronic means to assist in patient education, such as the use of mobile devices, interactive media, 3-dimensional images, and multimedia educational content at the bedside. OBJECTIVE: The goal of this study was to address the need for blended learning strategies combining technical and workflow integration of digital patient education systems for patients with chronic conditions within and across the regular process of care. Studies are needed to evaluate the utility and benefits of these technologies for providers and patients alike. METHODS: A mixed-methods approach was employed including survey administration to 178 patients after they received digital patient education in person with a health care provider, and qualitative interviews with 16 nurse educators who used the mobile digital health education technology to deliver instruction to patients. Patient survey data were analyzed using chi-square statistical tests. Qualitative interviews were analyzed for user acceptance and perceived value themes. RESULTS: Patients who were counseled using a blended digital health education approach reported improved understanding of educational content (P=.034) and chronic health conditions (P<.001), were more motivated to care for themselves at home (P<.001), were more likely to say that they felt capable of making health care decisions with their doctors (P<.001) and on their own (P=.001), and were more likely to report their intention to follow their doctor's instructions (P<.001) than were patients whose education was not computer-based. Nurse educators felt that the digital education system and content enhanced their education efforts and could be easily integrated into the outpatient clinical workflow. CONCLUSIONS: Patient education for individuals with chronic conditions may be more effective than traditional formats when provided in blended digital formats supervised by a health care provider.

Bilateral facial cutaneous angiomyolipomas: First case in the literature and a possible correlation with human immunodeficiency virus.

Angiomyolipomas (AMLs) are benign tumors consisting of smooth muscle-like cells, adipocyte-like cells, and epithelioid cells. They are usually renal in origin, and extrarenal AMLs are rare. Cutaneous AMLs are even more rare. We present a case of 65 year old female, with no underlying genetic condition, who developed bilateral facial cutaneous AMLs. To the best of our knowledge, this is the first case in the literature. In addition, we investigate and suggest a correlation between human immunodeficiency virus and AMLs.

PubMed-Indexed Research Productivity of Students Matching at Top Urology Programs: 2017-2020.

OBJECTIVE: To evaluate the number of PubMed-indexed research projects of medical students matching at top-ranked urology programs as compared to the average publications reported in the Electronic Residency Applicant Service (ERAS). METHODS: Doximity Residency Navigator was used to generate the top 50 residency programs when sorted by reputation. Residents were then found using program websites. PubMed was queried for peer-reviewed publications of incoming interns through post graduate year 3 residents as of February 2020. All PubMed-indexed research was recorded before September 15th of the residents' fourth year of medical school. We recorded the number of publications, first/last author publications, and urology-specific publications. RESULTS: The average number of publications across all 4 years was 2.38 ± 4.19. The average for urology-specific publications was 1.05 ± 3.19 and for first/last author publications was 0.80 ± 1.77. Most matched applicants had at least one PubMed-indexed publication (61.2%) and having over 3 placed them in the 75th percentile. It is uncommon for students to have urology specific or first/last author publications (34.0%, 36.5%). Top 10 programs matched applicants with significantly more research in each of the aforementioned categories and as program reputation declined, so did the publications of the applicants they matched. CONCLUSION: Most research that matched urology applicant's report in ERAS is not PubMed Indexed. Most had at least one PubMed-indexed publication by the time they submitted ERAS and those at top programs had more. It would be helpful to students and faculty advisors if ERAS published research metrics for matched and unmatched applicants separating PubMed-indexed work from posters and presentations.

Using Electronic Data Collection Platforms to Assess Complementary and Integrative Health Patient-Reported Outcomes: Feasibility Project.

BACKGROUND: The Veteran Administration (VA) Office of Patient-Centered Care and Cultural Transformation is invested in improving veteran health through a whole-person approach while taking advantage of the electronic resources suite available through the VA. Currently, there is no standardized process to collect and integrate electronic patient-reported outcomes (ePROs) of complementary and integrative health (CIH) into clinical care using a web-based survey platform. This quality improvement project enrolled veterans attending CIH appointments within a VA facility and used web-based technologies to collect ePROs. OBJECTIVE: This study aimed to (1) determine a practical process for collecting ePROs using patient email services and a web-based survey platform and (2) conduct analyses of survey data using repeated measures to estimate the effects of CIH on patient outcomes. METHODS: In total, 100 veterans from one VA facility, comprising 11 cohorts, agreed to participate. The VA patient email services (Secure Messaging) were used to manually send links to a 16-item web-based survey stored on a secure web-based survey storage platform (Qualtrics). Each survey included questions about patient outcomes from CIH programs. Each cohort was sent survey links via Secure Messaging (SM) at 6 time points: weeks 1 through 4, week 8, and week 12. Process evaluation interviews were conducted with five primary care providers to assess barriers and facilitators to using the patient-reported outcome survey in usual care. RESULTS: This quality improvement project demonstrated the usability of SM and Qualtrics for ePRO collection. However, SM for ePROs was labor intensive for providers. Descriptive statistics on health competence (2-item Perceived Health Competence Scale), physical and mental health (Patient-Reported Outcomes Measurement Information System Global-10), and stress (4-item Perceived Stress Scale) indicated that scores did not significantly change over time. Survey response rates varied (18/100, 18.0%-42/100, 42.0%) across each of the 12 weekly survey periods. In total, 74 of 100 participants provided ≥1 survey, and 90% (66/74) were female. The majority, 62% (33/53) of participants, who reported the use of any CIH modality, reported the use of two or more unique modalities. Primary care providers highlighted specific challenges with SM and offered solutions regarding staff involvement in survey implementation. CONCLUSIONS: This quality improvement project informs our understanding of the processes currently available for using SM and web-based data platforms to collect ePROs. The study results indicate that although it is possible to use SM and web-based survey platforms for ePROs, automating scheduled administration will be necessary to reduce provider burden. The lack of significant change in ePROs may be due to standard measures taking a biomedical approach to wellness. Future work should focus on identifying ideal ePRO processes that would include standardized, whole-person measures of wellness.