Serum mass spectrometry for treatment monitoring in patients with multiple myeloma receiving ARI0002h CAR T-cells.

Chimeric antigen receptor (CAR) T-cell therapies have increased the patients with relapsed/refractory multiple myeloma (RRMM) in whom standard electrophoretic techniques fail to detect the M-protein. Quantitative immunoprecipitation mass spectrometry (QIP-MS) can accurately measure serum M-protein with high sensitivity, and identify interferences caused by therapeutic monoclonal antibodies. Here, we investigate the outcome of QIP-MS in 33 patients treated with the academic BCMA-directed CAR T-cell ARI0002h (Cesnicabtagene Autoleucel). QIP-MS offered more detailed insights than serum immunofixation (sIFE), identifying glycosylated M-proteins and minor additional peaks. Moreover, the potential interferences owing to daratumumab or tocilizumab treatments were successfully detected. When analysing different assay platforms during patient's monitoring after ARI0002h administration, we observed that QIP-MS showed a high global concordance (78.8%) with sIFE, whereas it was only moderate (55.6%) with bone marrow (BM)-based next-generation flow cytometry (NGF). Furthermore, QIP-MS consistently demonstrated the lowest negativity rate across the different timepoints (27.3% vs. 60.0% in months 1 and 12, respectively). Patients with QIP-MS(+)/BM-based NGF(-) showed a non-significant shorter median progression free survival than those with QIP-MS(-)/BM-based NGF(-). In summary, we show the first experience to our knowledge demonstrating that QIP-MS could be particularly useful as a non-invasive technique when evaluating response after CAR T-cell treatment in MM.

Reimagining general surgery resident selection: Collaborative innovation through design thinking.

Introduction: The process by which surgery residency programs select applicants is complex, opaque, and susceptible to bias. Despite attempts by program directors and educational researchers to address these issues, residents have limited ability to affect change within the process at present. Here, we present the results of a design thinking brainstorm to improve resident selection and propose this technique as a framework for surgical residents to creatively solve problems and generate actionable changes. Methods: Members of the Collaboration of Surgical Education Fellows (CoSEF) used the design thinking framework to brainstorm ways to improve the resident selection process. Members participated in one virtual focus group focused on identifying pain points and developing divergent solutions to those pain points. Pain points and solutions were subsequently organized into themes. Finally, members participated in a second virtual focus group to design prototypes to test the proposed solutions. Results: Sixteen CoSEF members participated in one or both focus groups. Participants identified twelve pain points and 57 potential solutions. Pain points and solutions were grouped into the three themes of transparency, fairness, and applicant experience. Members subsequently developed five prototype ideas that could be rapidly developed and tested to improve resident selection. Conclusions: The design thinking framework can help surgical residents come up with creative ideas to improve pain points within surgical training. Furthermore, this framework can supplement existing quantitative and qualitative methods within surgical education research. Future work will be needed to implement the prototypes devised during our sessions and turn them into complete interventions. Key message: In this paper, we demonstrate the results of a resident-led design thinking brainstorm on improving resident selection in which our team identified twelve pain points in resident selection, ideated 57 solutions, and developed five prototypes for further testing. In addition to sharing our results, we believe design thinking can be a useful framework for creative problem solving within surgical education.

How I GPT It: Development of Custom Artificial Intelligence (AI) Chatbots for Surgical Education.

Artificial Intelligence (AI) chatbots provide a novel format for individuals to interact with large language models (LLMs). Recently released tools allow nontechnical users to develop chatbots using natural language. Surgical education is an exciting area in which chatbots developed in this manner may be rapidly deployed, though additional work will be required to ensure their accuracy and safety. In this paper, we outline our initial experience with AI chatbot creation in surgical education and offer considerations for future use of this technology.

Expanded Access to Video-Based Laparoscopic Skills Assessments: Ease, Reliability, and Accuracy.

OBJECTIVE: Video-based performance assessments provide essential feedback to surgical residents, but in-person and remote video-based assessment by trained proctors incurs significant cost. We aimed to determine the reliability, accuracy, and difficulty of untrained attending staff surgeon raters completing video-based assessments of a basic laparoscopic skill. Secondarily, we aimed to compare reliability and accuracy between 2 different types of assessment tools. DESIGN: An anonymous survey was distributed electronically to surgical attendings via a national organizational listserv. Survey items included demographics, rating of video-based assessment experience (1 = have never completed video-based assessments, 5 = often complete video-based assessments), and rating of favorability toward video-based and in-person assessments (0 = not favorable, 100 = favorable). Participants watched 2 laparoscopic peg transfer performances, then rated each performance using an Objective Structured Assessment of Technical Skill (OSATS) form and the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS). Participants then rated assessment completion ease (1 = Very Easy, 5 = Very Difficult). SETTING: National survey of practicing surgeons. PARTICIPANTS: Sixty-one surgery attendings with experience in laparoscopic surgery from 10 institutions participated as untrained raters. Six experienced laparoscopic skills proctors participated as expert raters. RESULTS: Inter-rater reliability was substantial for both OSATS (k = 0.75) and MISTELS (k = 0.85). MISTELS accuracy was significantly higher than that of OSATS (κ: MISTELS = 0.18, 95%CI = [0.06,0.29]; OSATS = 0.02, 95%CI = [-0.01,0.04]). While participants were inexperienced with completing video-based assessments (median = 1/5), they perceived video-based assessments favorably (mean = 73.4) and felt assessment completion was "Easy" on average. CONCLUSIONS: We demonstrate that faculty raters untrained in simulation-based assessments can successfully complete video-based assessments of basic laparoscopic skills with substantial inter-rater reliability without marked difficulty. These findings suggest an opportunity to increase access to feedback for trainees using video-based assessment of fundamental skills in laparoscopic surgery.

Incidence of adult rib fracture injuries and changing hospitalization practice patterns: a 10-year analysis.

PURPOSE: Rib fractures are common after blunt thoracic trauma and can be associated with significant morbidity and mortality. We investigated trends of rib fracture injuries among adults presenting to United States (US) emergency departments, factors related to increased likelihood of hospitalization, and hospitalization practice patterns. METHODS: We queried the National Electronic Injury Surveillance System database between 2012 and 2021 for all patients 18 years of age and older with rib fractures. These data were extrapolated to provide national estimates. Regression analysis was performed to identify trends for injury and risk factors for hospitalization. RESULTS: We identified 32,233 adult patients with rib fractures; this extrapolated to a national estimate of 1,430,270 patients with rib fractures during the 10-year period. Between 2012 and 2021, there was a 52% increase in the incidence rate per 100,000 persons (R2 = 0.94, p < 0.001). Males accounted for 58% of patients with rib fractures, and 50% of patients were 65 years or older. Hospitalization was required in 38% of patients, and the hospitalization rate increased by 96% during the study period (R2 = 0.96, p < 0.001). When comparing hospitals of different sizes, a 20% greater increase in the odds of hospitalization over time was identified among patients presenting to "larger" hospitals compared to "smaller" hospitals. CONCLUSION: The incidence of rib fractures and the associated hospitalization rates are both increasing nationally, with half of cases occurring in patients aged 65 years or older. Our findings emphasize the urgent need to implement evidence-based preventive measures and current management guidelines when managing the increasing caseload of rib fracture injuries.

INHIBITORS OF INORGANIC POLYPHOSPHATE AND NUCLEIC ACIDS ATTENUATE IN VITRO THROMBIN GENERATION IN PLASMA FROM TRAUMA PATIENTS.

ABSTRACT: Background: Inorganic polyphosphate (polyP) is a procoagulant polyanion. We assessed the impact of polyP inhibition on thrombin generation after trauma using the novel polyP antagonists, macromolecular polyanion inhibitor 8 (MPI 8), and universal heparin reversal agent 8 (UHRA-8). Methods: Plasma thrombin generation (calibrated automated thrombogram, CAT), in 56 trauma patients and 39 controls +/- MPI 8 and UHRA-8 (50 µg/mL), was expressed as lag time (LT, minutes), peak height (PH, nM), and time to peak (ttPeak, minutes), with change in LT (ΔLT) and change in ttPeak (ΔttPeak) quantified. Results expressed in median and quartiles [Q1, Q3], Wilcoxon matched-pairs testing, P < 0.05 significant. Results: Trauma patients had greater baseline PH than controls (182.9 [121.0, 255.2]; 120.5 [62.1, 174.8], P < 0.001). MPI 8 treatment prolonged LT and ttPeak in trauma (7.20 [5.88, 8.75]; 6.46 [5.45, 8.93], P = 0.020; 11.28 [8.96, 13.14]; 11.00 [8.95, 12.94], P = 0.029) and controls (7.67 [6.67, 10.50]; 6.33 [5.33, 8.00], P < 0.001; 13.33 [11.67, 15.33]; 11.67 [10.33, 13.33], P < 0.001). UHRA-8 treatment prolonged LT and ttPeak and decreased PH in trauma (9.09 [7.45, 11.33]; 6.46 [5.45, 8.93]; 14.02 [11.78, 17.08]; 11.00 [8.95, 12.94]; 117.4 [74.5, 178.6]; 182.9 [121.0, 255.2]) and controls (9.83 [8.00, 12.33]; 6.33 [5.33, 8.00]; 16.67 [14.33, 20.00]; 11.67 [10.33, 13.33]; 55.3 [30.2, 95.9]; 120.5 [62.1, 174.8]), all P < 0.001. Inhibitor effects were greater for controls (greater ΔLT and ΔttPeak for both inhibitors, P < 0.001). Conclusion: PolyP inhibition attenuates thrombin generation, though to a lesser degree in trauma than in controls, suggesting that polyP contributes to accelerated thrombin generation after trauma.

Barriers and facilitators for breast cancer early diagnosis in an indigenous community in Mexico: voices of otomí women.

BACKGROUND: Literature on barriers and facilitators for early detection of Breast Cancer (BC) among indigenous women is very scarce. This study aimed to identify barriers and facilitators for BC early diagnosis as perceived by women of the otomí ethnic group in Mexico. METHODS: We performed an exploratory qualitative study. Data was collected in 2021 through three focus group interviews with 19 otomí women. The interview transcripts were analyzed using the constant comparison method and guided by a conceptual framework that integrates the Social Ecological Model (SEM), the Health Belief Model and the Institute of Medicine's Healthcare Quality Framework. RESULTS: Barriers and facilitators were identified at several levels of the SEM. Among the main barriers reported by the study participants were: beliefs about illness, cancer stigma, cultural gender norms, access barriers to medical care, and mistreatment and discrimination by health care personnel. Our participants perceived as facilitators: information provided by doctors, social support, perceived severity of the disease and perceived benefits of seeking care for breast symptoms. CONCLUSIONS: Healthcare policies need to be responsive to the particular barriers faced by indigenous women in order to improve their participation in early detection and early help-seeking of care for breast symptoms. Measures to prevent and eradicate all forms of discrimination in healthcare are required to improve the quality of healthcare provided and the trust of the indigenous population in healthcare practitioners.

A murine multiple-injury model for the study of thromboinflammation.

INTRODUCTION: Neutrophil extracellular traps (NETs) contribute to trauma-induced coagulopathy. We aimed to develop a murine multiple-injury model that induces thrombo-inflammatory response, that is, NETosis and accelerated thrombin generation. METHODS: Wild-type male mice (n = 10, aged 8-12 weeks) underwent multiple injuries (gastrocnemius crush, femur fracture, and laparotomy) and were compared with an uninjured control group (n = 10). Mice were euthanized by cardiac puncture performed 3 hours after injury. Whole blood samples were immediately processed to platelet poor plasma for thrombin generation kinetics (calibrated automated thrombogram), myeloperoxidase (MPO), and von Willebrand factor quantification. Immunohistochemistry of lung tissue was performed to assess for citrullinated histone 3 (CitH3) and MPO. A NETosis cluster was defined as 3+ neutrophils staining for CitH3 at 400× magnification (CitH3 cluster). Data were presented either as mean (SD) or median (interquartile range) with p < 0.05 significant. Sham and trauma treated animals were compared by the two-sample Wilcoxon rank-sum test. RESULTS: Animals subjected to multiple injuries had accelerated thrombin generation compared with controls with greater peak height (61.3 [41.2-73.2] vs. 28.4 [19.5-37.5] nM, p = 0.035) and shorter time to peak (3.37 [2.81-3.81] vs. 4.5 [4.08-4.75] minutes, p = 0.046). Markers of neutrophil activation were greater following multiple injuries than in controls (MPO, 961.1 [858.1-1116.8] vs. 481.3 [438.0-648.9] ng/mL; p = 0.004). NETosis, as evidenced by the aforementioned defined number of CitH3 clusters in the lung, was greater in multiple-injury animals than in controls (mean [SD], 3 [2.9] vs. 0.2 [0.7]; p = 0.009). CONCLUSION: This is the first study to demonstrate that NETosis and accelerated thrombin generation can be induced using a murine multiple-injury model, as early as 3 hours following injury.

The academic point-of-care anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel (ARI-0001 cells) shows efficacy and safety in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma.

Varnimcabtagene autoleucel (var-cel) is an academic anti-CD19 chimeric antigen receptor (CAR) product used for the treatment of non-Hodgkin lymphoma (NHL) in the CART19-BE-01 trial. Here we report updated outcomes of patients with NHL treated with var-cel. B-cell recovery was compared with patients with acute lymphoblastic leukaemia (ALL). Forty-five patients with NHL were treated. Cytokine release syndrome (any grade) occurred in 84% of patients (4% grade ≥3) and neurotoxicity in 7% (2% grade ≥3). The objective response rate was 73% at Day +100, and the 3-year duration of response was 56%. The 3-year progression-free and overall survival were 40% and 52% respectively. High lactate dehydrogenase was the only covariate with an impact on progression-free survival. The 3-year incidence of B-cell recovery was lower in patients with NHL compared to ALL (25% vs. 60%). In conclusion, in patients with NHL, the toxicity of var-cel was manageable, while B-cell recovery was significantly prolonged compared to ALL. This trial was registered as NCT03144583.

Medical Students' Perceptions of Clinical and Research Training: An International Needs Assessment of 26 Countries.

Objective: Despite calls to incorporate research training into medical school curriculum, minimal research has been conducted to elucidate trends in research knowledge, opportunities, and involvement globally. This study aims to: (1) assess medical students' perceptions of the level of training they received on research based on their medical school training, and (2) evaluate the obstacles related to conducting research as part of medical students' training. Methods: A 94-question, bilingual survey designed by a small focus group of individuals from medical schools across the globe and administered to medical students from different parts of the world, distributed via social media networks (Twitter, Now X, Facebook) and email distributions via international partnerships from November 1 to December 31, 2020. The survey collected demographic information including age, gender, medical institution and country, degree, year in training, clinical rotations completed, plans for specialization, and additional graduate degrees completed. Statistical analysis included a summary of survey participant characteristics, and a comparison between regions, with a variety of comparison and logistic regression models used. Results: A total of 318 medical students from 26 countries successfully completed the survey. Respondents were majority female (60.1%), from Latin America (LA) (53.1%), North America (NA) (28.6%), and Other world regions (Other) (18.2%). Students felt research was an important component of medical training (87.7%), although many reported lacking research support from their institution (47.5%). There were several reported barriers to research, including lack of research opportunities (69.4%), lack of mentors (56.6%), lack of formal training (54.6%), and barriers due to the coronavirus disease 2019 (COVID-19) pandemic (49.3%). Less frequent were barriers related to financial resources (41.6%), physical resources (computer or internet access) (18%), and English language ability (6.9%). Students from Latin America and Other were more likely to report a desire to pursue research later in their medical careers compared with students from North America. Conclusions and Implications for Translation: Despite significant interest in research, medical students globally report a lack of formal research training, opportunities, and several barriers to conducting research, including the COVID-19 pandemic. The study highlights the need for student research training internationally and the role of further regional-specific and institutional-specific evaluation of research training needs.

Spontaneous splenic rupture due to Peliosis and the association with malignancy: A case series and literature review.

INTRODUCTION AND IMPORTANCE: Isolated splenic peliosis is an extremely rare condition. The associations of splenic peliosis with various infections, medications, and conditions have unclear significance. We present three patients from the past twenty years with spontaneous splenic rupture due to peliosis, two of whom had hematologic malignancy, to draw attention to a possible correlation. CASE PRESENTATION: A 31-year-old male with essential thrombocytopenia and antiphospholipid-antibody syndrome presented with worsening abdominal pain and hypotension. The patient denied any trauma. Computed-tomography demonstrated hemoperitoneum and splenic rupture with innumerable blood-filled splenic cysts. An uncomplicated emergency open splenectomy was performed with shed-blood reinfusion. The patient was discharged on postoperative day five. The patient developed acute myelogenous leukemia and died six years later. A 44-year-old otherwise healthy male presented with left upper-quadrant and shoulder pain without reported trauma. Computed-tomography (CT) imaging revealed splenomegaly, multiple splenic cystic lesions, and free intraperitoneal blood. A laparoscopic splenectomy, complicated by a pancreatic leak that was managed with a drain, was performed. The patient was discharged on postoperative day three and was well at 37 months follow-up. A 78-year-old male with splenomegaly and chronic anemia on warfarin for atrial fibrillation presented in shock with a distended abdomen after falling from a standing height. The patient was resuscitated with two units of packed red blood cells and underwent emergent abdominal exploration. The spleen was ruptured. An open splenectomy was performed and four liters of intraperitoneal blood were evacuated. Pathology confirmed splenic peliosis and historic diffuse large B-cell lymphoma. The patient had an excellent response to chemotherapy but died 12 years later. CLINICAL DISCUSSION: Splenic peliosis is a rare vascular phenomenon of unclear etiology. Several toxic and pharmaceutical agents have been associated with spontaneous splenic rupture in patients with peliosis. There are also a number of reported patients who were noted to have hematologic disorders, suggestive of a potential association to the pathophysiology of peliosis. CONCLUSION: Based on our clinical experience and focused literature review, it appears likely that there is a relationship between splenic peliosis and hematologic malignancy.

Development of a Machine Learning Model to Predict Outcomes and Cost After Cardiac Surgery.

BACKGROUND: Machine learning (ML) algorithms may enhance outcomes prediction and help guide clinical decision making. This study aimed to develop and validate a ML model that predicts postoperative outcomes and costs after cardiac surgery. METHODS: The Society of Thoracic Surgeons registry data from 4874 patients who underwent cardiac surgery (56% coronary artery bypass grafting, 42% valve surgery, 19% aortic surgery) at our institution were divided into training (80%) and testing (20%) datasets. The Extreme Gradient Boosting decision-tree ML algorithms were trained to predict three outcomes: operative mortality, major morbidity or mortality, and Medicare outlier high hospitalization cost. Algorithm performance was determined using accuracy, F1 score, and area under the precision-recall curve (AUC-PR). The ML algorithms were validated in index surgery cases with The Society of Thoracic Surgeons risk scores for mortality and major morbidities and with logistic regression and were then applied to nonindex cases. RESULTS: The ML algorithms with 25 input parameters predicted operative mortality (accuracy 95%; F1 0.31; AUC-PR 0.21), major morbidity or mortality (accuracy 71%, F1 0.47; AUC-PR 0.47), and high cost (accuracy 84%; F1 0.62; AUC-PR 0.65). Preoperative creatinine, complete blood count, patient height and weight, ventricular function, and liver dysfunction were important predictors for all outcomes. For patients undergoing nonindex cardiac operations, the ML model achieved an AUC-PR of 0.15 (95% CI, 0.05-0.32) for mortality and 0.59 (95% CI, 0.51-0.68) for major morbidity or mortality. CONCLUSIONS: The extreme gradient boosting ML algorithms can predict mortality, major morbidity, and high cost after cardiac surgery, including operations without established risk models. These ML algorithms may refine risk prediction after cardiac surgery for a wide range of procedures.

Surgical applications of ultrasound use in low- and middle-income countries: A systematic review.

Background: Ultrasound is a portable technology able to deploy health care effectively in low resource settings. This study presents a systematic review to determine trends in the utility and applicability of this technology in low- and middle-income countries (LMIC), specifically for surgical applications. The review includes characterising and evaluating trends in the geographic and specialty-specific use of ultrasound pertaining to surgical disease. Methods: The databases such as Medline OVID, EMBASE and Cochrane were searched from 2010 through March 2019 for studies available in English, French and Spanish. Commentaries, opinion articles, reviews and book chapters were excluded. A categorical analysis of ultrasound use for surgical disease in LMICs was conducted. Results: A total of 6276 articles were identified, with 4563 studies included for the final review. A total of 221 studies were selected researching ultrasound use in LMICs to treat surgical disease. Most studies identified ultrasound usage focused on general surgery, acute care surgery and surgical ICU topics (52%, 115) followed by computed tomography surgery studies (20%, 44). Most studies were retrospective in nature, with 81% (180) of research studies generated in four countries (India, Pakistan, Nigeria and Egypt). Ultrasound proved to be a feasible technique for utility in pre-operative diagnosis, cost-effectiveness and prediction of surgical outcomes. Findings are limited by the limited number of randomised clinical trials reported. Conclusion and global health implications: Our systematic literature review of ultrasound use in LMICs demonstrates the growing utilisation of this relatively low-cost, portable imaging technology in low resource settings for surgical disease.

Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial.

BACKGROUND: The Ad5-nCoV vaccine is a single-dose adenovirus type 5 (Ad5) vectored vaccine expressing the SARS-CoV-2 spike protein that was well-tolerated and immunogenic in phase 1 and 2 studies. In this study, we report results on the final efficacy and interim safety analyses of the phase 3 trial. METHODS: This double-blind, randomised, international, placebo-controlled, endpoint-case driven, phase 3, clinical trial enrolled adults aged 18 years older at study centres in Argentina, Chile, Mexico, Pakistan, and Russia. Participants were eligible for the study if they had no unstable or severe underlying medical or psychiatric conditions; had no history of a laboratory-confirmed SARS-CoV-2 infection; were not pregnant or breastfeeding; and had no previous receipt of an adenovirus-vectored, coronavirus, or SARS-CoV-2 vaccine. After informed consent was obtained, 25 mL of whole blood was withdrawn from all eligible participants who were randomised in a 1:1 ratio to receive a single intramuscular dose of 0·5 mL placebo or a 0·5 mL dose of 5 × 1010 viral particle (vp)/mL Ad5-nCoV vaccine; study staff and participants were blinded to treatment allocation. All participants were contacted weekly by email, telephone, or text message to self-report any symptoms of COVID-19 illness, and laboratory testing for SARS-CoV-2 was done for all participants with any symptoms. The primary efficacy objective evaluated Ad5-nCoV in preventing symptomatic, PCR-confirmed COVID-19 infection occurring at least 28 days after vaccination in all participants who were at least 28 days postvaccination on Jan 15, 2021. The primary safety objective evaluated the incidence of any serious adverse events or medically attended adverse events postvaccination in all participants who received a study injection. This trial is closed for enrolment and is registered with ClinicalTrials.gov (NCT04526990). FINDINGS: Study enrolment began on Sept 22, 2020, in Pakistan, Nov 6, 2020, in Mexico, Dec 2, 2020, in Russia and Chile, and Dec 17, 2020, in Argentina; 150 endpoint cases were reached on Jan 15, 2021, triggering the final primary efficacy analysis. One dose of Ad5-nCoV showed a 57·5% (95% CI 39·7-70·0, p=0·0026) efficacy against symptomatic, PCR-confirmed, COVID-19 infection at 28 days or more postvaccination (21 250 participants; 45 days median duration of follow-up [IQR 36-58]). In the primary safety analysis undertaken at the time of the efficacy analysis (36 717 participants), there was no significant difference in the incidence of serious adverse events (14 [0·1%] of 18 363 Ad5-nCoV recipients and 10 [0·1%] of 18 354 placebo recipients, p=0·54) or medically attended adverse events (442 [2·4%] of 18 363 Ad5-nCoV recipients and 411 [2·2%] of 18 354 placebo recipients, p=0·30) between the Ad5-nCoV or placebo groups, or any serious adverse events considered related to the study product (none in both Ad5-nCoV and placebo recipients). In the extended safety cohort, 1004 (63·5%) of 1582 of Ad5-nCoV recipients and 729 (46·4%) of 1572 placebo recipients reported a solicited systemic adverse event (p<0·0001), of which headache was the most common (699 [44%] of Ad5-nCoV recipients and 481 [30·6%] of placebo recipients; p<0·0001). 971 (61·3%) of 1584 Ad5-nCoV recipients and 314 (20·0%) of 1573 placebo recipients reported an injection-site adverse event (p<0·0001), of which pain at the injection site was the most frequent; reported by 939 (59%) Ad5-nCoV recipients and 303 (19%) placebo recipients. INTERPRETATION: One dose of Ad5-nCoV is efficacious and safe in healthy adults aged 18 years and older. FUNDING: CanSino Biologics and the Beijing Institute of Biotechnology.

Benefits of a Specific and Supervised Rehabilitation Program in Femoroacetabular Impingement Patients Undergoing Hip Arthroscopy: A Randomized Control Trial.

(1) To assess the efficacy of a specific rehabilitation protocol for femoroacetabular impingement syndrome (FAIS), patients who underwent hip arthroscopy (HA) were compared with a control group. (2) Patients with symptomatic FAIS who were scheduled for HA were randomized either to a control group (n = 45, 66.6% men, 41.8 ± 12.4 years) following a general post-surgical treatment protocol or to an experimental group (n = 45, 71.2% men, 40.9 ± 7.6 years) following a specific rehabilitation protocol supervised by a physiotherapist. Range of motion (ROM), orthopedic tests and pain were assessed immediately before surgery and at 4 and 14 weeks after surgery. The hip functional status was assessed by the modified Harris Hip Score (mHHS) before surgery and at the end of follow-up. (3) At 14 weeks after surgery and compared with the control group, the experimental group showed a lower percentage of positives for hip provocation tests (15.6% vs. 46.6% on Faber test; 15.6% vs. 77.8% on Fadir test; 2.2% vs. 20% on Ober test, experimental vs. control group, p < 0.001), a greater improvement in mHHS (27.2 vs. 10.7 points, p < 0.001) and higher ROM for all the movements evaluated: flexion (99.6 ± 12.2 vs. 89.6 ± 4.5, p < 0.001), extension (20.6 ± 5.8 vs. 13.3 ± 2.6, p < 0.001), adduction (30.6 ± 5.7 vs. 23.4 ± 8.4, p < 0.001), abduction (43.4 ± 10.7 vs. 32.8 ± 8.4, p < 0.001) and both internal (28.2 ± 8.5 vs. 18.7 ± 6.1, p < 0.001) and external hip rotation (36.8 ± 9.3 vs. 27.4 ± 5.6. p < 0.001). The pain decreased after surgery for both groups, although the reduction was greater in the experimental group at the end of intervention (13.8 ± 16.1 vs. 34.9 ± 16.3 mm, experimental vs. control group, p < 0.001). (4) The specific and supervised rehabilitation program in patients with FAIS undergoing HA showed better benefits at 14 weeks of treatment than the benefits achieved by a care protocol in terms of pain reduction and recovery of hip motion.

Illeal conduit associated parastomal hernias: A novel laparoscopic top hat repair.

Parastomal hernias (PH) are a well-known complication following ileal conduit urinary diversion. We present a case report of a woman in her mid-nineties with a symptomatic parastomal hernia at the site of her ileal conduit which was repaired laparoscopically by an inverted top-hat technique. The "top hat" is constructed by assembling a transected ring of synthetic mesh with a secondary mesh cylinder and laparoscopically securing this mesh construct in an underlay fashion. At eighteen months follow-up, the patient remains pain free and without evidence of hernia recurrence.

Willingness to Be Vaccinated against COVID-19 in Spain before the Start of Vaccination: A Cross-Sectional Study.

Vaccine hesitancy has increased in the past few years, influenced by the socio-cultural differences, political populism, or concerns related to the effectiveness and safety of some vaccines, resulting a feeling of distrust. This feeling can become a barrier against the achievement of the immunity necessary to stop the expansion of COVID-19. The aim of this study was to evaluate the acceptance of the vaccine against COVID-19 in Spain, as well as to identify the factors that have an influence on the concerns and attitudes of people against accepting the vaccine in the months prior to the start of vaccination on December 2020. An online questionnaire was created to obtain information about (1) sociodemographic characteristics; (2) concerns and sources of information about vaccines; and (3) attitudes about vaccination and state of health. A multivariate logistic regression was performed to identify the influencing factors. Of the 2501 participants, 1207 (48.3%) would accept the COVID-19 vaccine, 623 (24.9%) were hesitant, and 671 (26.8%) would reject it. The logistic regression showed that being male, older than 60, married, retired, with a high level of education, or with a leftist political inclination, could increase the probability of accepting the COVID-19 vaccine. Disinformation and the lack of political consensus were the main sources of distrust. The patients with hypertension, immunodepression, hypercholesterolemia, or respiratory disease, or were overweight, showed a greater acceptance to the vaccine, while those with cancer took the longest to accept it. A low acceptance of the vaccine against COVID-19 was observed among the Spanish population in the phase prior to its availability, and the main fears of the population were identified. It is necessary to offer correct and transparent information about these vaccines to reduce the concerns and increase the trust of the population, to thereby guarantee the success of the vaccination campaigns.

Innovación pedagógica para mejorar la calidad del trato en la atención de la salud de mujeres indígenas / Pedagogical innovation to improve the quality-responsiveness in the health care of indigenous women

Resumen: Objetivo: Presentar los resultados de una intervención pedagógica para mejorar la calidad en el trato que brindan los prestadores de servicios de salud en regiones indígenas. Material y métodos: Se diseñó una metodología didáctica con enfoque crítico-constructivista dirigida a personal de salud que atiende a población indígena en cinco entidades de México. Resultados: Entre 09/2016 a 01/2020 se capacitó a 1 825 trabajadores de la salud que deconstruyeron las creencias que determinan prácticas de discriminación y maltrato durante la atención a la salud de los usuarios indígenas. La intervención logró un aprendizaje significativo transformador de las valoraciones y prácticas sociales, con propuestas para evitar cualquier forma de maltrato y garantizar el trato digno. Conclusiones: Para la construcción de un sistema de salud universal y equitativo, es necesario incluir intervenciones que actúen sobre las creencias determinantes de las prácticas de discriminación y maltrato en los servicios de salud hacia grupos sociales vulnerables.

Abstract: Objective: Present the results of a pedagogical intervention to improve the quality-responsiveness in healthcare provided by health service providers in indigenous regions. Materials and methods: A didactic methodology with a critical-constructivist approach was designed aimed to health personnel who attend to the indigenous population in five entities of Mexico. Results: Between 09/2016 and 01/2020, 1 825 health workers were trained, who deconstructed the beliefs that determine practices of discrimination and abuse during the health care of indigenous users. The intervention achieved significant transformative learning of social beliefs and practices, with proposals to avoid any form of abuse and guarantee dignified treatment. Conclusions: For the construction of a universal and equitable health system, it is necessary to include interventions that act on the beliefs that determine discrimination and mistreatment practices in health services towards vulnerable social groups.

Social Media Perceptions of Surgical Cancer Care in the Era of COVID-19: A Global Cross-Sectional Study.

PURPOSE: The rapid dissemination of information through social media renders a profound lens to evaluate perceptions of emerging topics, especially in the context of a global pandemic. The primary objective of this cross-sectional study was to elucidate trends on social media in the setting of surgical cancer care affected by the COVID-19 pandemic across the globe. METHODS: A public search of Twitter from April 1 to 30, 2020, was conducted, which yielded 996 posts related to COVID-19 and cancer. Two authors (E.J.K. and H.S.) individually reviewed all posts and recorded the post category, engagement, author category, and geographic location. Data were then analyzed through descriptive analyses. Only English-language posts were included, and any noncancer- or non-COVID-related posts were excluded from the analysis. RESULTS: A total of 734 unique authors from 26 different countries wrote 996 relevant posts that averaged 12.0 likes, 4.7 retweets, and 0.5 hashtags per post. Only 2.3% (23 of 996) of posts included a video. Authors of the included tweets most frequently were friends and families of patients (183; 18.4%), academic institutions or organizations (182; 18.3%), and physicians (138; 13.9%). Topics of importance were cancellations of surgeries (299; 40.1%), COVID-19 education (211; 121.2%), and research studies (93; 9.3%). The United Kingdom and the United States made up 81.5% of the cohort, followed by Canada (6.6%) and India (2.4%). Of posts where a specific type of surgery was identified (196), the most common type mentioned was breast cancer (50; 25.5%), followed by lung cancer (37; 18.9%) and urologic cancer (22; 11.2%). CONCLUSION: This analysis provides insight into the resulting impacts of COVID-19 on the global discussion of surgical cancer care.