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Background: There is limited literature available that provide information about fixation methods for minimally invasive hallux valgus osteotomies. Our objective was to evaluate the strength of different fixation methods for a percutaneous extracapsular transverse cervical metatarsal (PTCM) osteotomy in a sawbone model., Methods: Thirty solid foam sawbone foot models were used. Percutaneous extracapsular transverse cervical metatarsal osteotomies were performed and fixed in a standardized fashion in 6 different groups: (1) one 4.0-mm screw; (2) 2 (one 4.0-mm and one 3.0-mm) parallel screws; (3) 2 (one 4.0-mm and one 3.0-mm) divergent screws; (4) same as group 3, but with lateral metatarsal head cortex purchase with the 4.0-mm screw; (5) same as group 4, but with two 4.0-mm screws; (6) same as group 5, but with two 3.5-mm screws. Cyclic and load to failure testing were performed applying a plantar load to the metatarsal head. The measured variables were stiffness and force needed to create deformity using a Zwick Roell Universal Testing Machine., Results: Group 1 failed as a result of rotational instability in cyclic testing. In load to failure testing, group 3 did not achieve difference compared with group 2 ( P  = .09) (181 vs 131 N). Group 4 was stronger ( P  = .02) (250 N) than groups 1-3. Group 5 did not show differences relative to group 4 ( P  = .1) (223 N). Group 6 was stronger only than groups 1 and 2 ( P  = .01) (193 N)., Conclusion: In this sawbones-based study, we found that the use of two 4.0-mm screws or use of a 3.0-mm screw and a 4.0-mm screw with lateral first metatarsal head cortical purchase was superior to other screw configurations., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Disclosure forms for all authors are available online., (© The Author(s) 2024.)

Background and Objectives: Hemorrhagic transformation may be a potentially devastating complication of IV thrombolysis (IVT) in acute ischemic stroke, but what degree of hemorrhage indicates the greatest negative effect is not known. We aimed to define the associations between hemorrhagic transformation patterns, classified according to clinical and imaging categories, and clinical outcomes after IVT., Methods: We conducted a post hoc analysis from the international Enhanced Control of Hypertension and Thrombolysis Stroke Study. Symptomatic intracerebral hemorrhage (sICH) was defined based on established criteria, such as the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria. Asymptomatic intracerebral hemorrhage (aICH) was defined as any intracerebral hemorrhage that did not meet the criteria for sICH. Imaging subtypes of hemorrhagic transformation were assessed using the Heidelberg Bleeding Classification system. The primary outcome was death or major disability, defined by modified Rankin scale (mRS) scores 3-6 at 90 days. Secondary outcomes included death, death or disability (mRS 2-6), and poor health-related quality of life (HRQoL), defined as an overall heath utility score ≤0.7 (mean)., Results: Of the 4,370 participants, 779 (17.8%) developed any intracranial hemorrhage (ICH), with a median time from randomization to hemorrhage of 23.5 hours (interquartile range 18.92-26.07). According to the SITS-MOST criteria, 62 patients (1.4% of 4,370) were classified as sICH, and 717 patients (16.4% of 4,370) were classified as aICH. sICH per SITS-MOST criteria was associated with death or major disability (odds ratio [OR] 23.05, 95% CI 8.97-59.23), death (OR 20.14, 95% CI 11.32-35.84), death or disability (OR 61.36, 95% CI 8.40-448.01), and poor HRQoL (OR 17.87, 95% CI 7.47-42.71). Similarly, aICH per SITS-MOST criteria was also associated with death or major disability (OR 2.23, 95% CI 1.84-2.70), death (OR 1.82, 95% CI 1.39-2.38), death or disability (OR 2.29, 95% CI 1.87-2.80), and poor HRQoL (OR 1.81, 95% CI 1.50-2.18). Comparable associations were observed for sICH and aICH defined by other criteria, as well as for imaging subtypes based on Heidelberg Bleeding Classification system., Discussion: All forms of post-IVT hemorrhagic transformation in acute ischemic stroke are associated with increased odds of poor clinical outcomes. Of note, aICH after IVT should not be considered clinically innocuous., Trial Registration Information: ClinicalTrials.gov (NCT01422616).

Objective: The purpose of this study is to analyze composition of HMS (homemade CBD), NLS (non-licensed commercial products), and bioequivalent CBD (BES) collected from Chilean patients that voluntary accepted to analyze the "CBD-substance.", Methods: Samples were collected through an open invitation for different patients to anonymously and free of charge participate in the analysis of CBD oil. The analysis of the active principle was performed using High-Resolution Liquid Chromatography (HPLC)., Results: A total of 35 samples were collected between March 2020 and September 2021, including two BES, six NLS, and 27 HMS products. The BES had an average CBD concentration of 89.15 mg/mL and an average THC concentration of 0.015 mg/mL, which complied with the maximum THC levels required by regulatory authorities (<0.2% THC.). The NLS (six samples) exhibited significant variability in CBD concentrations, ranging from a maximum of 78.5 mg/mL to a minimum of 0.1 mg/mL, with an average of 25.41 mg/mL. The THC concentrations ranged from 0 mg/mL to 2.43 mg/mL with an average of 0.62 mg/mL. The HMS products exhibited even higher variations of CBD concentrations, ranging from 0 to a maximum of 6.6 mg/mL. THC concentrations were even more variable, ranging from 0 mg/mL to 388 mg/mL., Significance: The medical community and patients involved should be aware that Hemp products are not pure and/or innocuous. HMS are likely to have high levels of THC and very low CBD, far away from therapeutic doses of CBD. CBD used in epilepsy should be restricted to licensed products, especially in children where THC toxicity is much more harmful., Plain Language Summary: The study analyzed three types of CBD (cannabidiol) oils: homemade, non-licensed, and bioequivalent. Homemade and non-licensed products showed nonacceptable variance of CBD and THC concentration (tetrahydrocannabinol), in some cases with 0 mgs of CBD and many beyond THC maximum accepted. The THC is another component found in cannabis and is responsible for the neurotoxic effects. Only bioequivalent products showed concentrations of CBD and THC acceptable for epilepsy treatment, therefore are the only products recommended for such purpose., (© 2024 The Author(s). Epilepsia Open published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.)

This study investigated the impact of prior antidepressant and stimulant exposure on the age at onset (AAO) of first episode mania (FEM) or psychosis (FEP). Patients with FEP and FEM born after 1985 in Olmsted County, Minnesota, were identified using the Rochester Epidemiology Project. Duration and peak dose of antidepressant and stimulant exposure were quantified by review of the electronic health record. Peak doses were converted to defined daily dose (DDD), and cumulative exposure was calculated as DDD multiplied by treatment duration. Linear models were used to assess relationships between AAO with any exposures, and cumulative antidepressant and stimulant exposures. A total of 190 FEM/FEP patients (mean AAO=20.8 ± 3.7 years) were included. There was no significant difference in AAO with vs. without exposure to antidepressants or stimulants. Cumulative antidepressant exposure correlated with a later AAO in overall sample (r = 0.28, p < 0.001), and in FEP (r = 0.33, p < 0.001). No significant correlation emerged between cumulative stimulant exposure and AAO. Multivariable modeling confirmed that cumulative antidepressant exposure (Estimate=2.42, 95 %CI=1.66-3.18, p < 0.001), but not cumulative stimulant exposure (Estimate=-0.04, 95 %CI=-1.10-1.02, p = 0.94), was associated with later AAO. Antidepressant and stimulant exposures were not associated with earlier AAO. However, cumulative antidepressant exposure was associated with later AAO. Limitations include retrospective design and relatively small sample size. Our findings may inform adolescent treatment recommendations when assessing risk for psychotropic-related adverse events. Further risk modeling investigations of antidepressants and stimulants with larger sample sizes are needed to explore the role of antidepressant and stimulant exposure in the trajectory leading to FEM/FEP., Competing Interests: Declaration of competing interest JLVV has received grant-in-kind support for supplies and genotyping from Assurex Health. MAF received grant support from Assurex Health and Mayo Foundation, received CME travel and honoraria from Carnot Laboratories and American Physician Institute, and has Financial Interest/Stock ownership/Royalties from Chymia LLC. No other declaration of interests from other authors., (Copyright © 2024. Published by Elsevier B.V.)

Study Design: Literature review with clinical recommendations., Objective: To highlight important studies about osteoporotic spinal fractures (OF) that may be integrated into clinical practice based on the assessment of the AO Spine KF Trauma and Infection group key opinion leaders., Methods: 4 important studies about OF that may affect current clinical practice of spinal surgeons were selected and reviewed with the aim of providing clinical recommendations to streamline the journey of research into clinical practice. Recommendations were graded as strong or conditional following the GRADE methodology., Results: 4 studies were selected. Article 1: a validation of the Osteoporotic Fracture (OF)-score to treat OF fractures. Conditional recommendation to incorporate the OF score in the management of fractures to improve clinical results. Article 2: a randomized multicenter study comparing romosozumab/alendronate vs alendronate to decrease the incidence of new vertebral fractures. Strong recommendation that the group receiving romosozumab/alendronate had a decreased risk of new OF when compared with the alendronate only group only. Article 3: a systematic literature review of spinal orthoses in the management of. Conditional recommendation to prescribe a spinal orthosis to decrease pain and improve quality of life. Article 4: post-traumatic deformity after OF. A conditional recommendation that middle column injury and pre-injury use of steroids may lead to high risk of post-traumatic deformity after OF., Conclusions: Management of patients with OF is still complex and challenging. This review provides some recommendations that may help surgeons to better manage these patients and improve their clinical practice., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Prognostic models are becoming increasingly relevant in clinical trials as potential surrogate endpoints, and for patient management as clinical decision support tools. However, the impact of competing risks on model performance remains poorly investigated. We aimed to carefully assess the performance of competing risk and noncompeting risk models in the context of kidney transplantation, where allograft failure and death with a functioning graft are two competing outcomes., Methods: We included 11,046 kidney transplant recipients enrolled in 10 countries. We developed prediction models for long-term kidney graft failure prediction, without accounting (i.e., censoring) and accounting for the competing risk of death with a functioning graft, using Cox, Fine-Gray, and cause-specific Cox regression models. To this aim, we followed a detailed and transparent analytical framework for competing and noncompeting risk modelling, and carefully assessed the models' development, stability, discrimination, calibration, overall fit, clinical utility, and generalizability in external validation cohorts and subpopulations. More than 15 metrics were used to provide an exhaustive assessment of model performance., Results: Among 11,046 recipients in the derivation and validation cohorts, 1,497 (14%) lost their graft and 1,003 (9%) died with a functioning graft after a median follow-up post-risk evaluation of 4.7 years (IQR 2.7-7.0). The cumulative incidence of graft loss was similarly estimated by Kaplan-Meier and Aalen-Johansen methods (17% versus 16% in the derivation cohort). Cox and competing risk models showed similar and stable risk estimates for predicting long-term graft failure (average mean absolute prediction error of 0.0140, 0.0138 and 0.0135 for Cox, Fine-Gray, and cause-specific Cox models, respectively). Discrimination and overall fit were comparable in the validation cohorts, with concordance index ranging from 0.76 to 0.87. Across various subpopulations and clinical scenarios, the models performed well and similarly, although in some high-risk groups (such as donors over 65 years old), the findings suggest a trend towards moderately improved calibration when using a competing risk approach., Conclusions: Competing and noncompeting risk models performed similarly in predicting long-term kidney graft failure., (Copyright © 2024 by the American Society of Nephrology.)

Study Design: Cross-sectional survey., Objectives: Injury classifications are important tools to identify fracture patterns, guide treatment-decisions and aid to identify optimal treatment plans. The AO Spine-DGOU Osteoporotic Fracture (OF) classification system was developed, and the aim of this study was to assess the reliability of this new classification system., Methods: 23 Members of the AO Spine Knowledge Forum Trauma participated in the validation process. Participants were asked to rate 33 cases according to the OF classification at 2 time points, 4 weeks apart (assessment 1 and 2). The kappa statistic (κ) was calculated to assess inter-observer reliability and intra-rater reproducibility. The gold master key for each case was determined by approval of at least 5 out of 7 members of the DGOU., Results: A total of 1386 ratings (21 raters) were performed. The overall inter-rater agreement was moderate with a combined kappa statistic for the OF classification of 0.496 in assessment 1 and 0.482 in assessment 2. The combined percentage of correct ratings (compared to gold-standard) in assessment 1 was 71.4% and 67.4% in assessment 2. The average intra-rater reproducibility was substantial (κ = 0.74, median 0.76, range 0.55 to 1.00, SD 0.13) for the assessed fracture types., Conclusions: The assessed overall inter-rater reliability was moderate and substantial in some instances. The average intra-rater reproducibility is substantial. It seems that appropriate training of the classification system can enhance inter- and intra-rater reliability., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The AO Spine-DGOU Injury Classification System was developed and funded by AO Spine through the AO Spine Knowledge Forum Trauma, a focused group of international spine trauma experts. AO Spine is a clinical division of the AO Foundation, which is an independent medically-guided not-for-profit organization. Individual authors of this manuscript have no disclosures to declare regarding the proposed article.

A 51-year-old man with a medical history of recurrent anal carcinoma after chemoradiation underwent abdominoperineal resection in 2015. The patient presents with a bulging mass in the perineal zone, associated with pain. Physical examination and MRI during the workup reveal a large mass in the perineal region., (© 2024. Springer Nature Switzerland AG.)

Background: The learning curve for new operators performing ultrasound-guided transfemoral access (TFA) remains uncertain., Methods: We performed a pooled analysis of the FAUST (Femoral Arterial Access With Ultrasound Trial) and UNIVERSAL (Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures) trials, both multicenter randomized controlled trials of 1:1 ultrasound-guided versus non-ultrasound-guided TFA for coronary procedures. Outcomes included the composite of major bleeding or vascular complications and successful common femoral artery cannulation. Participants were stratified by the operators' accrued case volume. We used adjusted repeated-measurement logistic regression, with random intercepts for operator clustering, for comparison against the non-ultrasound-guided TFA group and to model the learning curve., Results: The FAUST and UNIVERSAL trials randomized a total of 1624 patients, of which 810 were randomized to non-ultrasound-guided TFA and 814 to ultrasound-guided TFA (cases 1-10, 391; 11-20, 183; and >20, 240). Participants who had operators who performed >20 ultrasound-guided TFAs had a decreased risk for the primary end point (5/240 [2.1%] versus 64/810 [7.9%]; adjusted odds ratio, 0.26 [95% CI, 0.09-0.61]) compared with non-ultrasound-guided TFA. Operators who performed >20 ultrasound-guided procedures had increased odds of successfully cannulating the common femoral artery (224/246 [91.1%] versus 327/382 [85.6%]; adjusted odds ratio, 1.76 [95% CI, 1.08-2.89]) compared with non-ultrasound-guided TFA. The learning curve plots demonstrated growing competence with increasing accrued cases., Conclusions: New operators should perform at least 20 ultrasound-guided TFA to decrease access site complications and increase proper cannulation compared with non-ultrasound-guided TFA. Additional accrued cases may lead to increased proficiency. Training programs should consider these findings in the transradial era., Competing Interests: Dr d’Entremont is a Canadian Institutes of Health Research Canada Graduate Scholarship awardee. Dr Jolly reports receiving grants or contracts from Boston Scientific and payment or honoraria for lectures, presentations, speaker’s bureaus, article writing, or educational events from Penumbra, Teleflex, and Abiomed. Dr Seto reports receiving grants or contracts from Arena Medical, Philips, and ACIST; payment or honoraria for speaker’s bureaus from Janssen, Terumo, Gettinge, and GE Healthcare; consulting fees from Medtronic and Medicure; and reports having equity in Frond Medical. The other authors report no conflicts.

Background: This study evaluates the efficacy and safety of robotic-assisted surgical techniques in the treatment of gallbladder cancer, comparing it with traditional open and laparoscopic methods., Methods: A systematic review of the literature searched for comparative analyses of patient outcomes following robotic, open, and laparoscopic surgeries, focusing on oncological results and perioperative benefits., Results: Five total studies published between 2019 and 2023 were identified. Findings indicate that robotic-assisted surgery for gallbladder cancer is as effective as traditional methods in terms of oncological outcomes, with potential advantages in precision and perioperative recovery., Conclusions: Robotic surgery offers a viable and potentially advantageous alternative for gallbladder cancer treatment, warranting further research to confirm its benefits and establish comprehensive surgical guidelines., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Andes virus (ANDV) is a zoonotic Orthohantavirus leading to hantavirus cardiopulmonary syndrome. Although most transmissions occur through environmental exposure to rodent faeces and urine, rare person-to-person transmission has been documented, mainly for close contacts. This study investigates the presence and infectivity of ANDV in body fluids from confirmed cases and the duration of viraemia., Methods: In this prospective study, 131 participants with confirmed ANDV infection were enrolled in Chile in a prospective study between 2008 and 2022. Clinical samples (buffy coat, plasma, gingival crevicular fluid [GCF], saliva, nasopharyngeal swabs [NPS], and urine) were collected weekly for 3 weeks together with clinical and epidemiological data. Samples were categorised as acute or convalescent (up to and after 16 days following onset of symptoms). Infectivity of positive fluids was assessed after the culture of samples on Vero E6 cells and use of flow cytometry assays to determine the production of ANDV nucleoprotein., Findings: ANDV RNA was detected in 100% of buffy coats during acute phase, declining to 95% by day 17, and to 93% between days 23-29. ANDV RNA in GCF and saliva decreased from 30% and 12%, respectively, during the acute phase, to 12% and 11% during the convalescent phase. Successful infectivity assays of RT-qPCR-positive fluids, including GCF, saliva, NPS, and urine, were observed in 18 (42%) of 43 samples obtained during the acute phase of infection. After re-culture, the capacity to infect Vero E6 cells was maintained in 16 (89%) of 18 samples. Severity was associated with the presence of ANDV RNA in one or more fluids besides blood (odds ratio 2·58 [95% CI 1·42-5·18])., Interpretation: ANDV infection is a systemic and viraemic infection, that affects various organs. The presence of infectious particles in body fluids contributes to our understanding of potential mechanisms for person-to-person transmission, supporting the development of preventive strategies. Detection of ANDV RNA in additional fluids at hospital admission is a predictor of disease severity., Funding: National Institutes of Health and Agencia de Investigación y Desarrollo., Translation: For the Spanish translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Study Design: Delayed diagnosis of degenerative cervical myelopathy (DCM) is likely due to a combination of its subtle symptoms, incomplete neurological assessments by clinicians and a lack of public and professional awareness. Diagnostic criteria for DCM will likely facilitate earlier referral for definitive management., Objectives: This systematic review aims to determine (i) the diagnostic accuracy of various clinical signs and (ii) the association between clinical signs and disease severity in DCM?, Methods: A search was performed to identify studies on adult patients that evaluated the diagnostic accuracy of a clinical sign used for diagnosing DCM. Studies were also included if they assessed the association between the presence of a clinical sign and disease severity. The QUADAS-2 tool was used to evaluate the risk of bias of individual studies., Results: This review identified eleven studies that used a control group to evaluate the diagnostic accuracy of various signs. An additional 61 articles reported on the frequency of clinical signs in a cohort of DCM patients. The most sensitive clinical tests for diagnosing DCM were the Tromner and hyperreflexia, whereas the most specific tests were the Babinski, Tromner, clonus and inverted supinator sign. Five studies evaluated the association between the presence of various clinical signs and disease severity. There was no definite association between Hoffmann sign, Babinski sign or hyperreflexia and disease severity., Conclusion: The presence of clinical signs suggesting spinal cord compression should encourage health care professionals to pursue further investigation, such as neuroimaging to either confirm or refute a diagnosis of DCM., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Study Design: Delayed diagnosis of degenerative cervical myelopathy (DCM) is associated with reduced quality of life and greater disability. Developing diagnostic criteria for DCM has been identified as a top research priority., Objectives: This scoping review aims to address the following questions: What is the diagnostic accuracy and frequency of clinical symptoms in patients with DCM?, Methods: A scoping review was conducted using a database of all primary DCM studies published between 2005 and 2020. Studies were included if they (i) assessed the diagnostic accuracy of a symptom using an appropriate control group or (ii) reported the frequency of a symptom in a cohort of DCM patients., Results: This review identified three studies that discussed the diagnostic accuracy of various symptoms and included a control group. An additional 58 reported on the frequency of symptoms in a cohort of patients with DCM. The most frequent and sensitive symptoms in DCM include unspecified paresthesias (86%), hand numbness (82%) and hand paresthesias (79%). Neck and/or shoulder pain was present in 51% of patients with DCM, whereas a minority had back (19%) or lower extremity pain (10%). Bladder dysfunction was uncommon (38%) although more frequent than bowel (23%) and sexual impairment (4%). Gait impairment is also commonly seen in patients with DCM (72%)., Conclusion: Patients with DCM present with many different symptoms, most commonly sensorimotor impairment of the upper extremities, pain, bladder dysfunction and gait disturbance. If patients present with a combination of these symptoms, further neuroimaging is indicated to confirm the diagnosis of DCM., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Purpose: Improper utilization of surgical antimicrobial prophylaxis frequently leads to increased risks of morbidity and mortality.This study aims to understand the common causative organism of postoperative orthopedic infection and document the surgical antimicrobial prophylaxis protocol across various institutions in to order to strengthen surgical antimicrobial prophylaxis practice and provide higher-quality surgical care., Methods: This multicentric multinational retrospective study, includes 24 countries from five different regions (Asia Pacific, South Eastern Africa, Western Africa, Latin America, and Middle East). Patients who developed orthopedic surgical site infection between January 2021 and December 2022 were included. Demographic details, bacterial profile of surgical site infection, and antibiotic sensitivity pattern were documented., Results: 2038 patients from 24 countries were included. Among them 69.7 % were male patients and 64.1 % were between 20 and 60 years. 70.3 % patients underwent trauma surgery and instrumentation was used in 93.5 %. Ceftriaxone was the most common preferred in 53.4 %. Early SSI was seen in 55.2 % and deep SSI in 59.7 %. Western Africa (76 %) and Asia-Pacific (52.8 %) reported a higher number of gram-negative infections whereas gram-positive organisms were predominant in other regions. Most common gram positive organism was Staphylococcus aureus (35 %) and gram-negative was Klebsiella (17.2 %). Majority of the organisms showed variable sensitivity to broad-spectrum antibiotics., Conclusion: Our study strongly proves that every institution has to analyse their surgical site infection microbiological profile and antibiotic sensitivity of the organisms and plan their surgical antimicrobial prophylaxis accordingly. This will help to decrease the rate of surgical site infection, prevent the emergence of multidrug resistance and reduce the economic burden of treatment., (© 2024 Professor P K Surendran Memorial Education Foundation. Published by Elsevier B.V. All rights reserved.)

We established a framework for collecting radiation doses for head, chest and abdomen-pelvis computed tomography (CT) in children scanned at multiple imaging sites across Latin America with an aim towards establishing diagnostic reference levels (DRLs) and achievable doses (ADs) in pediatric CT in Latin America. Our study included 12 Latin American sites (in Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Honduras and Panama) contributing data on the four most common pediatric CT examinations (non-contrast head, non-contrast chest, post-contrast chest and post-contrast abdomen-pelvis). Sites contributed data on patients' age, sex and weight, scan factors (tube current and potential), volume CT dose index (CTDIvol) and dose length product (DLP). Data were verified, leading to the exclusion of two sites with missing or incorrect data entries. We estimated overall and site-specific 50th (AD) and 75th (diagnostic reference level [DRL]) percentile CTDIvol and DLP for each CT protocol. Non-normal data were compared using the Kruskal-Wallis test. Sites contributed data from 3,934 children (1,834 females) for different CT exams (head CT 1,568/3,934, 40%; non-contrast chest CT 945/3,934, 24%; post-contrast chest CT 581/3,934, 15%; abdomen-pelvis CT 840/3,934, 21%). There were significant statistical differences in 50th and 75th percentile CTDIvol and DLP values across the participating sites (P<0.001). The 50th and 75th percentile doses for most CT protocols were substantially higher than the corresponding doses reported from the United States of America. Our study demonstrates substantial disparities and variations in pediatric CT examinations performed in multiple sites in Latin America. We will use the collected data to improve scan protocols and perform a follow-up CT study to establish DRLs and ADs based on clinical indications., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction: Careful monitoring of patients who receive intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is resource-intensive, and potentially less relevant in those with mild degrees of neurological impairment who are at low risk of symptomatic intracerebral hemorrhage (sICH) and other complications., Methods: OPTIMISTmain is an international, multicenter, prospective, stepped wedge, cluster randomized, blinded outcome assessed trial aims to determine whether a less-intensity monitoring protocol is at least as effective, safe, and efficient as standard post-IVT monitoring in patients with mild deficits post-AIS. Clinically stable adult patients with mild AIS (defined by a NIHSS &lt;10) who do not require intensive care within 2 h post-IVT are recruited at hospitals in Australia, Chile, China, Malaysia, Mexico, UK, USA, and Vietnam. An average of 15 patients recruited per period (overall 60 patient participants) at 120 sites for a total of 7,200 IVT-treated AIS patients will provide 90% power (one-sided α 0.025). The initiation of eligible hospitals is based on a rolling process whenever ready, stratified by country. Hospitals are randomly allocated using permuted blocks into 3 sequences of implementation, stratified by country and the projected number of patients to be recruited over 12 months. These sequences have four periods that dictate the order in which they are to switch from control (usual care) to intervention (implementation of low intensity monitoring protocol) to different clusters of patients in a stepped manner. Compared to standard monitoring, the low-intensity monitoring protocol includes assessments of neurological and vital signs every 15 min for 2 h, 2 hourly (vs. every 30 min) for 8 h, and 4 hourly (vs. every 1 h) until 24 h, post-IVT. The primary outcome measure is functional recovery, defined by the modified Rankin scale (mRS) at 90 days, a seven-point ordinal scale (0 [no residual symptom] to 6 [death]). Secondary outcomes include death or dependency, length of hospital stay, and health-related quality of life, sICH, and serious adverse events., Conclusion: OPTIMISTmain will provide level I evidence for the safety and effectiveness of a low-intensity post-IVT monitoring protocol in patients with mild severity of AIS., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Aortic aneurysms, which may dissect or rupture acutely and be lethal, can be a part of multisystem disorders that have a heritable basis. We report four patients with deficiency of selenocysteine-containing proteins due to selenocysteine Insertion Sequence Binding Protein 2 (SECISBP2) mutations who show early-onset, progressive, aneurysmal dilatation of the ascending aorta due to cystic medial necrosis. Zebrafish and male mice with global or vascular smooth muscle cell (VSMC)-targeted disruption of Secisbp2 respectively show similar aortopathy. Aortas from patients and animal models exhibit raised cellular reactive oxygen species, oxidative DNA damage and VSMC apoptosis. Antioxidant exposure or chelation of iron prevents oxidative damage in patient's cells and aortopathy in the zebrafish model. Our observations suggest a key role for oxidative stress and cell death, including via ferroptosis, in mediating aortic degeneration., (© 2023. The Author(s).)

Background: Ankle arthritis that develops after fracture accounts for a significant portion of ankle arthritis necessitating total ankle arthroplasty (TAA). It remains unknown whether TAA in postfracture patients produces equivalent outcomes to those without fracture history. The purpose of this study was to evaluate the medium-term outcomes of TAA in postfracture ankle arthritis compared to those without fracture history., Methods: This study reviewed 178 ankles from 171 consecutive patients who underwent TAA in our institution between 2007 and 2017 and completed a minimum 5-year follow-up. Four different TAA systems were utilized by 6 surgeons. Based on fracture history, patients were divided into 2 groups: the postfracture group (n = 63; median age 65.7 years; median follow-up 5.9 years) and the nonfracture group (n = 115; median age 64.4 years; median follow-up 6.2 years). Types and rates of complications including revision and reoperation were compared. Minimum 5-year Foot and Ankle Outcome Score (FAOS) and postoperative improvement were investigated. A subgroup analysis was performed to determine whether outcomes differ between intraarticular fracture patients (n = 43) and extraarticular fracture patients (n = 20)., Results: Both groups exhibited comparable postoperative improvement and final FAOS scores. The postfracture group had a significantly higher reoperation rate than the nonfracture group (20 of 63, 31.7%, vs 17 of 115, 14.8%; P  = .011), with gutter impingement being the most common cause. There were 3 revisions in each group. In the subgroup analysis, we found no evidence of statistical difference between the intraarticular fracture group and the extraarticular fracture group in terms of FAOS scores, revision, and reoperation rates., Conclusion: In this single-center, retrospective comparative study, we found total ankle arthroplasty in patients with a history of fractures around the ankle joint had no evidence of statistical difference in patient-reported outcomes and implant survivorship but led to a higher rate of nonrevision reoperation following surgery. In the much smaller subset of patients with previous fracture, we did not find that those with a history of intraarticular fracture had inferior outcomes after TAA when compared to those with a history of extraarticular fracture., Level of Evidence: Level III, case-control study., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. ICMJE forms for all authors are available online.

Introduction: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is performed worldwide to treat blood cancer and other life-threatening blood disorders. As successful transplantation requires an HLA-compatible donor, unrelated donor centers and registries have been established worldwide to identify donors for patients without a family match. Ethnic minorities are underrepresented in large donor registries. Matching probabilities are higher when donors and patients share the same ethnic background, making it desirable to increase the diversity of the global donor pool by recruiting donors in new regions. Here, we report the establishment and the first 5 years of operation of the first unrelated stem cell donor center in Chile, a high-income country in South America with a population of over 19 million., Methods: We used online and in-person donor recruitment practices through patient appeals and donor drives in companies, universities, the armed forces, and public services. After confirmatory typing donors were subjected to medical work-up and cleared for donation., Results: We recruited almost 170,000 donors in 5 years. There were 1,488 requests received for confirmatory typing and donor availability checks, of which 333 resulted in medical work-up, leading to 194 stem cell collections. Products were shipped to Chile (48.5%) and abroad. Even when the COVID-19 pandemic challenged our activities, the number of donors recruited and shipped stem cell products remained steady. In Chile there was an almost 8-fold increase in unrelated donor transplantation activity from 16 procedures in 2016-2018 to 124 procedures in 2019-2021, mainly for pediatric patients following the center's establishment. We estimate that 49.6% of Chilean patients would find at least one matched unrelated donor in the global DKMS donor pool., Discussion: Establishing a DKMS donor center in Chile has significantly increased donor availability for Chilean patients and contributed to an increase of unrelated donor stem cell transplant activity., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Barriga, Solloch, Giani, Palma, Wietstruck, Sarmiento, Carvallo, Mosso, Ramirez, Sanchez, Rojas, Alfaro, Saldaña, Ende, Flaig, Pattillo and Schmidt.)

Background: Every year, millions of patients suffer injuries or die due to unsafe and poor-quality healthcare. A culture of safety care is crucial to prevent risks, errors and harm that may result from medical assistance. Measurement of patient safety culture (PSC) identifies strengths and weaknesses, serving as a guide to improvement interventions; nevertheless, there is a lack of studies related to PSC in Latin America., Aim: To assess the PSC in South American hospitals., Methods: A multicentre international cross-sectional study was performed between July and September 2021 by the Latin American Alliance of Health Institutions, composed of four hospitals from Argentina, Brazil, Chile and Colombia. The Hospital Survey on Patient Safety Culture (HSOPSC V.1.0) was used. Participation was voluntary. Subgroup analyses were performed to assess the difference between leadership positions and professional categories., Results: A total of 5695 records were analysed: a 30.1% response rate (range 25%-55%). The highest percentage of positive responses was observed in items related to patient safety as the top priority (89.2%). Contrarily, the lowest percentage was observed in items regarding their mistakes/failures being recorded (23.8%). The strongest dimensions (average score ≥75%) were organisational learning, teamwork within units and management support for patient safety (82%, 79% and 78%, respectively). The dimensions 'requiring improvement' (average score <50%) were staffing and non-punitive responses to error (41% and 37%, respectively). All mean scores were higher in health workers with a leadership position except for the hospital handoff/transitions item. Significant differences were found by professional categories, mainly between physicians, nurses, and other professionals., Conclusion: Our findings lead to a better overview of PSC in Latin America, serving as a baseline and benchmarking to facilitate the recognition of weaknesses and to guide quality improvement strategies regionally and globally. Despite South American PSC not being well-exploited, local institutions revealed a strengthened culture of safety care., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The importance of the deltoid ligament in the congruency and coupling of the tibiotalar joint is well known. The current trend is to repair it in cases of acute injuries in the context of ankle fractures; however, there is limited information on how it should be reconstructed. The objective of this study was to compare different deltoid ligament repair types in an ankle fracture cadaveric model., Methods: Sixteen cadaveric foot-ankle-distal tibia specimens were used. All samples were prepared as a supination external rotation ankle fracture model. Axial load and cyclic axial rotations were applied on every specimen using a specifically designed frame. This test was performed without deltoid injury, with deltoid injury, and after repair. The reconstruction was performed in 4 different ways (anterior, posterior, middle, and combined). Medial clear space (MCS) was measured for each condition on simulated weightbearing (WB) and gravity stress (GS) radiographs. Reflective markers were used in tibia and talus, registering the kinematics through a motion analysis system to record the tibiotalar uncoupling., Results: After deltoid damage, in all cases the MCS increased significantly on GS radiographs, but there was no increase in the MCS on WB radiographs. After repair, in all cases, the MCS was normalized. Kinematically, after deltoid damage, the tibiotalar uncoupling increased significantly. All isolated repairs achieved a similar tibiotalar uncoupling value as its baseline condition. The combined repair resulted in a significant decrease in tibiotalar uncoupling., Conclusion: Our results show that deltoid repair recovers the tibiotalar coupling mechanism in an ankle fracture model. Isolated deltoid repairs recovered baseline MCS and tibiotalar uncoupling values. Combined repairs may lead to overconstraint, which could lead to postoperative stiffness. Clinical studies are needed to prove these results and show clinically improved outcomes., Clinical Relevance: This study helps in finding the optimum deltoid repair to use in an acute trauma setting.

Background: High-quality surgery plays a central role in the delivery of excellent oncologic care. Benchmark values indicate the best achievable results. We aimed to define benchmark values for gallbladder cancer (GBC) surgery across an international population., Patients and Methods: This study included consecutive patients with GBC who underwent curative-intent surgery during 2000-2021 at 13 centers, across seven countries and four continents. Patients operated on at high-volume centers without the need for vascular and/or bile duct reconstruction and without significant comorbidities were chosen as the benchmark group., Results: Of 906 patients who underwent curative-intent GBC surgery during the study period, 245 (27%) were included in the benchmark group. These were predominantly women (n = 174, 71%) and had a median age of 64 years (interquartile range 57-70 years). In the benchmark group, 50 patients (20%) experienced complications within 90 days after surgery, with 20 patients (8%) developing major complications (Clavien-Dindo grade ≥ IIIa). Median length of postoperative hospital stay was 6 days (interquartile range 4-8 days). Benchmark values included ≥ 4 lymph nodes retrieved, estimated intraoperative blood loss ≤ 350 mL, perioperative blood transfusion rate ≤ 13%, operative time ≤ 332 min, length of hospital stay ≤ 8 days, R1 margin rate ≤ 7%, complication rate ≤ 22%, and rate of grade ≥ IIIa complications ≤ 11%., Conclusions: Surgery for GBC remains associated with significant morbidity. The availability of benchmark values may facilitate comparisons in future analyses among GBC patients, GBC surgical approaches, and centers performing GBC surgery., (© 2023. Society of Surgical Oncology.)

Previous analyses of the phase 2 KEYNOTE-170 (NCT02576990) study demonstrated effective antitumor activity and acceptable safety of pembrolizumab 200 mg given every 3 weeks for up to 35 cycles (∼2 years) in patients with relapsed/refractory (R/R) primary mediastinal B-cell lymphoma (PMBCL) whose disease progressed after or who were ineligible for autologous stem cell transplantation. The end points included objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR) according to the investigator per 2007 Response Criteria; overall survival (OS); and safety. In this final analysis, median duration of follow-up was 48.7 months (range, 41.2-56.2). The ORR was 41.5% (complete response, 20.8%; partial response, 20.8%). The median DOR was not reached; no patients who achieved a complete response progressed at the data cutoff. The median PFS was 4.3 months; the 4-year PFS rate was 33.0%. The median OS was 22.3 months; the 4-year OS rate was 45.3%. At the data cutoff, 30 patients (56.6%) had any-grade treatment-related adverse events (AEs); the most common were neutropenia, asthenia, and hypothyroidism. Grade 3/4 treatment-related AEs occurred in 22.6% of the patients; no grade 5 AEs occurred. After 4 years of follow-up, pembrolizumab continued to provide durable responses, with promising trends for long-term survival and acceptable safety in R/R PMBCL., (© 2023 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)

Introduction: Acute kidney injury requiring renal replacement therapy (AKI-RRT) is common in the intensive care unit (ICU) and is associated with significant morbidity and mortality. Continuous RRT (CRRT) non-selectively removes large amounts of amino acids from plasma, lowering serum amino acid concentrations and potentially depleting total-body amino acid stores. Therefore, the morbidity and mortality associated with AKI-RRT may be partly mediated through accelerated skeletal muscle atrophy and resulting muscle weakness. However, the impact of AKI-RRT on skeletal muscle mass and function during and following critical illness remains unknown. We hypothesise that patients with AKI-RRT have higher degrees of acute muscle loss than patients without AKI-RRT and that AKI-RRT survivors are less likely to recover muscle mass and function when compared with other ICU survivors., Methods and Analysis: This protocol describes a prospective, multicentre, observational trial assessing skeletal muscle size, quality and function in ICU patients with AKI-RRT. We will perform musculoskeletal ultrasound to longitudinally evaluate rectus femoris size and quality at baseline (within 48 hours of CRRT initiation), day 3, day 7 or at ICU discharge, at hospital discharge, and 1-3 months postdischarge. Additional skeletal muscle and physical function tests will be performed at hospital discharge and postdischarge follow-up. We will analyse the effect of AKI-RRT by comparing the findings in enrolled subjects to historical controls of critically ill patients without AKI-RRT using multivariable modelling., Ethics and Dissemination: We anticipate our study will reveal that AKI-RRT is associated with greater degrees of muscle loss and dysfunction along with impaired postdischarge recovery of physical function. These findings could impact the in-hospital and postdischarge treatment plan for these patients to include focused attention on muscle strength and function. We intend to disseminate findings to participants, healthcare professionals, the public and other relevant groups via conference presentation and publication without any publication restrictions., Trial Registration Number: NCT05287204., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Whether ultrasound (US)-guided femoral access compared to femoral access without US guidance decreases access site complications in patients receiving a vascular closure device (VCD) is unclear., Aims: We aimed to compare the safety of VCD in patients undergoing US-guided versus non-US-guided femoral arterial access for coronary procedures., Methods: We performed a prespecified subgroup analysis of the UNIVERSAL trial, a multicentre randomised controlled trial of 1:1 US-guided femoral access versus non-US-guided femoral access, stratified for planned VCD use, for coronary procedures on a background of fluoroscopic landmarking. The primary endpoint was a composite of major Bleeding Academic Research Consortium 2, 3 or 5 bleeding and vascular complications at 30 days., Results: Of 621 patients, 328 (52.8%) received a VCD (86% ANGIO-SEAL, 14% ProGlide). In patients who received a VCD, those randomised to US-guided femoral access compared to non-US-guided femoral access experienced a reduction in major bleeding or vascular complications (20/170 [11.8%] vs 37/158 [23.4%], odds ratio [OR] 0.44, 95% confidence interval [CI]: 0.23-0.82). In patients who did not receive a VCD, there was no difference between the US- and non-US-guided femoral access groups, respectively (20/141 [14.2%] vs 13/152 [8.6%], OR 1.76, 95% CI: 0.80-4.03; interaction p=0.004)., Conclusions: In patients receiving a VCD after coronary procedures, US-guided femoral access was associated with fewer bleeding and vascular complications compared to femoral access without US guidance. US guidance for femoral access may be particularly beneficial when VCD are used.

Purpose: Despite strong induction chemotherapy response rates, only 30%-40% of patients with adult B-cell acute lymphoblastic leukemia (ALL) attain long-term remission. This study analyzes ALL in Latin America (LA) and recommends diagnosis, treatment, and management protocols., Methods: The Americas Health Foundation organized a panel of hematologists from Argentina, Brazil, Chile, Colombia, and Mexico to examine ALL diagnosis and therapy and produce recommendations., Results: Lack of regional data, unequal access to diagnosis and therapy, inadequate treatment response, and uneven health care distribution complicate adult ALL management. The panel recommended diagnosis, first-line and refractory treatment, and post-transplantation maintenance. Targeted treatments, including rituximab, blinatumomab, and inotuzumab ozogamicin, are becoming available in LA and must be equitably accessed., Conclusion: This review adapts global information on treating ALL to LA. Governments, the medical community, society, academia, industry, and patient advocates must work together to improve policies.

Background Context: The complex anatomy of the upper cervical spine resulted in numerous separate classification systems of upper cervical spine trauma. The AOSpine upper cervical classification system (UCCS) was recently described; however, an independent agreement assessment has not been performed., Purpose: To perform an independent evaluation of the AOSpine UCCS., Study Design: Agreement study., Patient Sample: Eighty-four patients with upper cervical spine injuries., Outcome Measures: Inter-observer agreement; intra-observer agreement., Methods: Complete imaging studies of 84 patients with upper cervical spine injuries, including all morphological types of injuries defined by the AOSpine UCCS were selected and classified by six evaluators (from three different countries). The 84 cases were presented to the same raters randomly after a 4-week interval for repeat evaluation. The Kappa coefficient (κ) was used to determine inter- and intra-observer agreement., Results: The interobserver agreement was almost perfect when considering the fracture site (I, II or III), with κ=0.82 (0.78-0.83), but the agreement according to the site and type level was moderate, κ=0.57 (0.55-0.65). The intra-observer agreement was almost perfect considering the injury, with κ=0.83 (0.78-0.86), while according to site and type was substantial, κ=0.69 (0.67-0.71)., Conclusions: We observed only a moderate inter-observer agreement using this classification. We believe our results can be explained because this classification attempted to organize many different injury types into a single scheme., Competing Interests: Declaration of competing interest One or more of the authors declare financial or professional relationships on ICMJE-TSJ disclosure forms., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Degenerative cervical myelopathy (DCM) is a common and disabling condition. Early effective treatment is limited by late diagnosis. Conventional descriptions of DCM focus on motor and sensory limb disability, however, recent work suggests the true impact is much broader. This study aimed to characterise the symptomatic presentation of DCM from the perspective of people with DCM and determine whether any of the reported symptoms, or groups of symptoms, were associated with early diagnosis., Methods: An internet survey was developed, using an established list of patient-reported effects. Participants (N = 171) were recruited from an online community of people with DCM. Respondents selected their current symptoms and primary presenting symptom. The relationship of symptoms and their relationship to time to diagnosis were explored. This included symptoms not commonly measured today, termed 'non-conventional' symptoms., Results: All listed symptoms were experienced by >10% of respondents, with poor balance being the most commonly reported (84.2%). Non-conventional symptoms accounted for 39.7% of symptomatic burden. 55.4% of the symptoms were reported as an initial symptom, with neck pain the most common (13.5%). Non-conventional symptoms accounted for 11.1% of initial symptoms. 79.5% of the respondents were diagnosed late (>6 months). Heavy legs was the only initial symptom associated with early diagnosis., Conclusions: A comprehensive description of the self-reported effects of DCM has been established, including the prevalence of symptoms at disease presentation. The experience of DCM is broader than suggested by conventional descriptions and further exploration of non-conventional symptoms may support earlier diagnosis., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: CFM has declared that no competing interests exist. RY has declared that no competing interests exist. ZCM has declared that no competing interests exist. MGF currently serves as an academic editor at PLOS ONE. RRP has declared that no competing interests exist. JM has declared that no competing interests exist. KM has declared that no competing interests exist. MRNK has declared that no competing interests exist. BMD is supported by NIHR POLYFIX DCM and NIHR Clinical Doctoral Research Fellowship grants. BMD is a founder of MoveMed (a digital therapeutics platform which develops assessments and treatments using software). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Munro et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Epidermolysis bullosa (EB) is an inherited disorder characterised by skin fragility and the appearance of blisters and wounds. Patient wounds are often colonised or infected with bacteria, leading to impaired healing, pain and high risk of death by sepsis. Little is known about the impact of bacterial composition and susceptibility in wound resolution, and there is a need for longitudinal studies to understand healing outcomes with different types of bacterial colonisation. A prospective longitudinal study of 70 wounds from 15 severe EB patients (Junctional and Recessive Dystrophic EB) from Chile. Wounds were selected independently of their infected status. Wound cultures, including bacterial species identification, composition and Staphylococcus aureus (SA) antibiotic susceptibility were registered. Wounds were separated into categories according to their healing capacity, recognising chronic, and healing wounds. Hundred-one of the 102 wound cultures were positive for bacterial growth. From these, 100 were SA-positive; 31 were resistant to Ciprofloxacin (31%) and only seven were methicillin-resistant SA (7%). Ciprofloxacin-resistant SA was found significantly predominant in chronic wounds (**P < .01). Interestingly, atoxigenic Corynebacterium diphtheriae (CD) was identified and found to be the second most abundant recovered bacteria (31/101), present almost always in combination with SA (30/31). CD was only found in Recessive Dystrophic EB patients and not related to wound chronicity. Other less frequent bacterial species found included Pseudomonas aeruginosa, Streptococus spp. and Proteus spp. Infection was negatively associated with the healing status of wounds., (© 2022 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

This statement was written under the auspices of the World Gastroenterology Organization's Guidelines Committee. The authors are members of the Review Team of the WGO Endoscope Disinfection Guideline and have experience in endoscopy, endoscope reprocessing, and microbiology, including biofilms. During the preparation of the WGO Update on Endoscope Disinfection Guidelines, concerns about simethicone on endoscope channel surfaces compromising cleaning and disinfection were raised. Publications on simethicone, including modes of delivery, effectiveness, and risks, have been reviewed. The paper was written as a companion to the new guidelines with a focus on minimizing the risks of simethicone in endoscope reprocessing., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: This sequential, prospective meta-analysis sought to identify risk factors among pregnant and postpartum women with COVID-19 for adverse outcomes related to disease severity, maternal morbidities, neonatal mortality and morbidity, and adverse birth outcomes., Data Sources: We prospectively invited study investigators to join the sequential, prospective meta-analysis via professional research networks beginning in March 2020., Study Eligibility Criteria: Eligible studies included those recruiting at least 25 consecutive cases of COVID-19 in pregnancy within a defined catchment area., Methods: We included individual patient data from 21 participating studies. Data quality was assessed, and harmonized variables for risk factors and outcomes were constructed. Duplicate cases were removed. Pooled estimates for the absolute and relative risk of adverse outcomes comparing those with and without each risk factor were generated using a 2-stage meta-analysis., Results: We collected data from 33 countries and territories, including 21,977 cases of SARS-CoV-2 infection in pregnancy or postpartum. We found that women with comorbidities (preexisting diabetes mellitus, hypertension, cardiovascular disease) vs those without were at higher risk for COVID-19 severity and adverse pregnancy outcomes (fetal death, preterm birth, low birthweight). Participants with COVID-19 and HIV were 1.74 times (95% confidence interval, 1.12-2.71) more likely to be admitted to the intensive care unit. Pregnant women who were underweight before pregnancy were at higher risk of intensive care unit admission (relative risk, 5.53; 95% confidence interval, 2.27-13.44), ventilation (relative risk, 9.36; 95% confidence interval, 3.87-22.63), and pregnancy-related death (relative risk, 14.10; 95% confidence interval, 2.83-70.36). Prepregnancy obesity was also a risk factor for severe COVID-19 outcomes including intensive care unit admission (relative risk, 1.81; 95% confidence interval, 1.26-2.60), ventilation (relative risk, 2.05; 95% confidence interval, 1.20-3.51), any critical care (relative risk, 1.89; 95% confidence interval, 1.28-2.77), and pneumonia (relative risk, 1.66; 95% confidence interval, 1.18-2.33). Anemic pregnant women with COVID-19 also had increased risk of intensive care unit admission (relative risk, 1.63; 95% confidence interval, 1.25-2.11) and death (relative risk, 2.36; 95% confidence interval, 1.15-4.81)., Conclusion: We found that pregnant women with comorbidities including diabetes mellitus, hypertension, and cardiovascular disease were at increased risk for severe COVID-19-related outcomes, maternal morbidities, and adverse birth outcomes. We also identified several less commonly known risk factors, including HIV infection, prepregnancy underweight, and anemia. Although pregnant women are already considered a high-risk population, special priority for prevention and treatment should be given to pregnant women with these additional risk factors., (Copyright © 2022. Published by Elsevier Inc.)

Competing Interests: D.J.: No payment for work on these or any other guidelines; have participated in focus group meetings with several AFER manufacturers; have been a speaker at symposia/conferences supported by disinfectant and AFER manufacturers, all of which have been nonpaid; have shares in an Australian company involved in reprocessing technologies (not currently for endoscopy). M.A.: Consultant for 3M, Olympus, J&J ASP, Novaflux, Ofstead & Associates; royalties related to patent licenced to Healthmark through University of Manitoba; honoraria from Olympus and J&J ASP for invited presentations. H.G.: Speaker at education workshops sponsored by Cantel medical and Intercept medical. K.V.: Received no payment; have been a nonpaid, invited symposia speaker sponsored by Whiteley Corporation, a manufacturer of detergents and disinfectants. A.L.: Acting as guideline development consultant for WGO. R.S. declares no conflict of interest.

Organ transplantation is a lifesaving procedure for end-organ damage and remains up to today as the most cost-effective alternative to treat these conditions. However, the main limitation to performing organ transplants is the availability of donor organs suitable for transplantation. To increase the donor pool, expanding organ donation from the conventional neurologic determination of death (NDD) to include circulatory determination of death (DCD) has been a well-established method of increasing donors in other countries. In this article, we discuss the clinical and ethical considerations for introducing DCD in Chile. The concepts we have used could very well be translatable to other similar countries which have not implemented this donation system yet. The most relevant issue to date is that DCD needs to alter the care of dying patients to obtain quality donor organs. In some countries, including Chile, there are some cultural barriers regarding withdrawal-of-care. These barriers include confusing withdrawal of care with acceleration of death, which leads to many practitioners refusing to remove artificial life support, and in turn only minimize ventilatory support or switch to a T-tube (without extubation). This cultural barrier could be overcome with careful consideration of the opinions of healthcare workers, family members, community and policy-based stakeholders. We also identified ethical issues related to informed consent of both donor and recipients, among other relevant ethical considerations. In conclusion, DCD donation in Chile can increase organ donation numbers in one of Latin America's countries with the lowest effective donor rate. However, this opportunity must be taken with caution to avoid the opposite effect if this policy is not well implemented, respecting the sound ethical principles mentioned in this paper., (© 2021 John Wiley & Sons Ltd.)

Background: Clinical decisions are mainly driven by the ability of physicians to apply risk stratification to patients. However, this task is difficult as it requires complex integration of numerous parameters and is impacted by patient heterogeneity. We sought to evaluate the ability of transplant physicians to predict the risk of long-term allograft failure and compare them to a validated artificial intelligence (AI) prediction algorithm., Methods: We randomly selected 400 kidney transplant recipients from a qualified dataset of 4000 patients. For each patient, 44 features routinely collected during the first-year post-transplant were compiled in an electronic health record (EHR). We enrolled 9 transplant physicians at various career stages. At 1-year post-transplant, they blindly predicted the long-term graft survival with probabilities for each patient. Their predictions were compared with those of a validated prediction system (iBox). We assessed the determinants of each physician's prediction using a random forest survival model., Results: Among the 400 patients included, 84 graft failures occurred at 7 years post-evaluation. The iBox system demonstrates the best predictive performance with a discrimination of 0.79 and a median calibration error of 5.79%, while physicians tend to overestimate the risk of graft failure. Physicians' risk predictions show wide heterogeneity with a moderate intraclass correlation of 0.58. The determinants of physicians' prediction are disparate, with poor agreement regardless of their clinical experience., Conclusions: This study shows the overall limited performance and consistency of physicians to predict the risk of long-term graft failure, demonstrated by the superior performances of the iBox. This study supports the use of a companion tool to help physicians in their prognostic judgement and decision-making in clinical care., (© 2022. The Author(s).)