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Objective: This study aimed to examine the factors associated with maternal mortality among women aged ≥35 years.Design: Unmatched population based case-control study.Setting: United Kingdom.Population: Between 2009 and 2012, 105 cases of maternal deaths aged ≥35 years were extracted from the surveillance database of the MBRRACE-UK confidential enquiries into maternal deaths in the UK. In addition, 766 controls aged ≥35 years were identified from the UK Obstetric Surveillance System (2005-2012).Methods: Risk factors known to be associated with maternal mortality and morbidity and for which data were available were examined for their association with maternal mortality among women ≥35 years using logistic regression analysis.Main Outcome Measures: Odds ratios and 95% confidence intervals associated with maternal death.Results: Five factors were found to be significantly associated with increased odds of death among women aged ≥35 years: smoking during pregnancy (adjusted odds ratio (aOR) 2.06, 95% CI 1.13-3.75), inadequate use of antenatal care (aOR 23.62, 95% CI 8.79-63.45), medical co-morbidities (aOR 5.92, 95% CI 3.56-9.86) and previous pregnancy problems (aOR 2.06, 95% CI 1.23-3.45). The odds associated with death increased by 12% per year increase in age (aOR 1.12, 95% CI 1.02-1.22).Conclusion: Age was associated with maternal mortality even after adjusting for other known risk factors. Importantly, this study showed an association between maternal mortality and smoking among women aged 35 years or older. It emphasises the importance of public health action to reduce smoking levels and address trends in rising maternal age.Tweetable Abstract: Smoking is a risk factor for maternal death for those aged over 35 years. [ABSTRACT FROM AUTHOR]

Quality and timely antenatal care is a vital component of pregnancy care for the well-being of mothers and babies. The aim of this study of to assess self-reported obstetricians' adherence to national and international antenatal care guidelines in Lebanon. This cross-sectional study approached all obstetricians registered with the Lebanese Society of Obstetrics and Gynecology and the Lebanese Order of Physicians to participate in an online and telephone-based survey. The study tool included all of the items from the World Health Organization and national guidelines for antenatal care. Obstetricians' self-reported adherence was assessed across five modules including dietary interventions, dietary supplements, antenatal care assessment, fetal growth assessment, and antenatal care preventive measures. A total of 134 obstetricians completed the survey. Overall, adherence was high for most antenatal care guidelines except for providing nutrition services to undernourished pregnant women, screening for intimate partner violence, and providing tetanus vaccines. The number of recommended antenatal care visits (≥8 vs. <8 visits) was higher among obstetricians in Mount Lebanon or Beirut compared to other areas in Lebanon (72.7%vs.48.6%; p-value <0.01). Provision of tetanus or diphtheria, tetanus, and pertussis (DTP) vaccination was lower for obstetricians who provide care for women who pay out-of-pocket compared to obstetricians who provide care to women who use other payment methods (25.3%vs.45.7%; p-value = 0.024). Group B streptococcus screening test and the provision of at least five ultrasounds were higher among obstetricians who provide care in private clinics or clinics in private hospitals compared to clinics in public hospitals or primary healthcare centers (88.8%vs.66.7%; p-value = 0.023) and (83.6%vs.55.6%; p-value = 0.011), respectively. Reinforcing the adherence to all antenatal care guidelines by continuous monitoring of health facilities is crucial for best practice. Subsidies for essential services may be required for those who are unable to afford components of antenatal care., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Khoury 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.)

Context.—: Biomedical research relies on available biomaterials and associated data, and the quality of this starting material can have a significant impact on the quality of the experimental results. In the 2000s, best-practice documents and guidelines for biorepositories were published, followed in the 2010s by standards documents used to support accreditation. The College of American Pathologists Biorepository Accreditation Program and the International Standards Organization's standard 20387 were launched in 2012 and 2018, respectively., Objective.—: To identify quantitative and qualitative differences between the two aforementioned biorepository accreditation standards for use by the larger biomedical research community; the results will empower biorepositories to select an accreditation program that best fits their goals., Design.—: Individual requirements of both accreditation standards were identified and a bidirectional crosswalk was performed to identify gaps. Requirements were assigned to one of several standardized categories to enable comparison of the relative emphasis of different categories between the standards., Results.—: Quantitatively, the College of American Pathologists program is comprehensive and stands alone, with 523 requirements, whereas the International Standards Organization program contains 167 requirements and is comprehensive through its incorporation and reference to numerous related standards documents. Qualitatively, both programs rely heavily on the implementation of an overarching quality management system and both programs can accommodate different types of biobanks (eg, human and animal)., Conclusions.—: The standards differ in number of requirements, distribution of requirements across categories, and amount of reliance on separate standard documents. This information may aid in selection of an appropriate accreditation standard., (© 2024 College of American Pathologists.)

Abstract: Pediatric hip pain can have orthopedic, infectious, inflammatory, neoplastic, or nonmusculoskeletal etiologies. Organizing the differential diagnosis by symptom chronicity and a determination of intraarticular versus extraarticular pain, as well as the age at pain onset, can be helpful to hone in on the cause. Clinicians should consider plain radiographs in cases of acute trauma, with concern for bony pathology, or in patients with unexplained limp or hip pain, with musculoskeletal ultrasound and magnetic resonance imaging used as advanced imaging when indicated. Relative rest with subsequent strengthening and stretching should be prescribed in nonoperative conditions, though several pediatric hip pain diagnoses require orthopedic or other specialty referral for definitive treatment. This article is a comprehensive review of hip pain etiologies in the pediatric population., (Copyright © 2024 Written work prepared by employees of the Federal Government as part of their official duties is, under the U.S. Copyright Act, a “work of the United States Government” for which copyright protection under Title 17 of the United States Code is not available. As such, copyright does not extend to the contributions of employees of the Federal Government.)

Introduction: The COVID-19 pandemic has worsened pre-existing vulnerabilities among older Syrian refugees in Lebanon, potentially impacting their mental health. The study aims to describe the evolution of poor mental health over time and to develop and internally validate a prediction model for poor mental health among older Syrian refugees in Lebanon., Methods: This prognostic study used cross-sectional data from a multiwave telephone survey in Lebanon. It was conducted among all Syrian refugees aged 50 years or older from households that received assistance from a humanitarian organisation. Data were collected between 22 September 2020 and 20 January 2021. Poor mental health was defined as a Mental Health Inventory-5 score of 60 or less. The predictors were identified using backwards stepwise logistic regression. The model was internally validated using bootstrapping. The calibration of the model was presented using the calibration slope (C-slope), and the discrimination was presented using the optimised adjusted C-statistic., Results: There were 3229 participants (median age=56 years (IQR=53-62)) and 47.5% were female. The prevalence of poor mental health was 76.7%. Predictors for poor mental health were younger age, food insecurity, water insecurity, lack of legal residency documentation, irregular employment, higher intensity of bodily pain, having debt and having chronic illnesses. The final model demonstrated good discriminative ability (C-statistic: 0.69 (95% CI 0.67 to 0.72)) and calibration (C-slope 0.93 (95%CI 0.82 to 1.07))., Conclusion: Mental health predictors were related to basic needs, rights and financial barriers. These allow humanitarian organisations to identify high-risk individuals, organise interventions and address root causes to boost resilience and well-being among older Syrian refugees in Lebanon., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: There is currently limited literature assessing the real-world treatment patterns and clinical outcomes of patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) mutations., Methods: Medical charts were abstracted for mCRPC patients with ≥ 1 of 12 HRR somatic gene alterations treated at US oncology centers participating in the American Association for Cancer Research Project Genomics Evidence Neoplasia Information Exchange. Treatment patterns and clinical outcomes were assessed from the initiation of first-line or later (1L+) mCRPC therapy received on or after July 1, 2014., Results: Among 138 patients included in the study, the most common somatic HRR mutations were CDK12 (47.8%), BRCA2 (22.5%), and ATM (21.0%). Novel hormonal therapy and taxane chemotherapy were most commonly used in 1L; taxane use increased in later lines. Median overall survival (95% confidence interval [CI]) was 36.3 (30.7-47.8) months from initiation of 1L therapy and decreased for subsequent lines. Similarly, there was a trend of decreasing progression-free survival and prostate-specific antigen response from 1L to 4L+ therapy., Conclusions: Treatment patterns identified in this study were similar to those among patients with mCRPC regardless of tumor HRR mutation status in the literature., Competing Interests: Disclosure PJ Bobbili, M DerSarkissian, A Muthukumar, T Guo, M Mohan, A Zhang, and MS Duh are employees of Analysis Group, Inc.; a consulting company that has provided paid consulting services to Pfizer, Inc., which funded the development and conduct of this study and manuscript. J Ivanova, B Arondekar, J Chang, and A Niyazov are employees and shareholders of Pfizer, Inc. DB Solit is an employee of Memorial Sloan Kettering Cancer Center; has received payment or honoraria for participation in an advisory board for BridgeBio, Elsie Biotechnologies Inc, Fog Pharma, FORE Therapeutics, Function Oncology, PaigeAI, Pfizer Inc, Rain Therapeutics, Scorpion Therapeutics, and Vividion Therapeutics; has participated on a data safety monitoring board or advisory board for Rain Therapeutics; and is a shareholder in Elsie Biotechnologies Inc, FORE therapeutics, Function Oncology, and Scorpion Therapeutics. R Huq is an employee of Memorial Sloan Kettering Cancer Center. NB Mettu is an employee of Duke Cancer Institute; and has received research funding paid to their institution from Amgen, Amphivena Therapeutics, Aravive Inc, AstraZeneca, BioMed Valley Discoveries, Bristol-Myers Squibb Company, Erytech Pharma, Genentech-Roche, Incyte, Merck, Mereo Biopharma, Repare Therapeutics, and Syros. SJ McCall is an employee of Duke Cancer Institute; has received consulting fees from AstraZeneca; speaker fees from Takeda Pharmaceuticals; and is a part investor in Frameshift MRT software, owned by Duke University and licensed to SciMed Solutions. M Green is a former employee of Duke Cancer Institute and a current employee of Labcop. M Dhawan is an employee of Genentech. M Turski is an employee of UCSF Hellen Diller Cancer Center; and has received speaking fees from Bayer. P Lam is an employee of UCSF Hellen Diller Cancer Center. J Lee is an employee of the American Association for Cancer Research, and has received grants or contracts from AstraZeneca, Bayer Healthcare, Boehringer Ingelheim, BMS, Genentech, Janssen, Novartis, Merck, and Pfizer Inc. WK Oh is an employee of Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai; is the Chief Medical Officer of the Prostate Cancer Foundation; has received consulting fees from Genetic Chemistry Therapeutics and Pfizer Inc; has equity in Sema4/GeneDx, and is an author and editor for UpToDate., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: We designed a race-conscious study to assess the presence of Helicobacter pylori v irulence factor cagA in a retrospective cohort of patients with active H. pylori infection., Methods: We compared cagA status by race in gastric tissue samples from 473 patients diagnosed with active H. pylori infection from 2015 to 2019., Results: H. pylori + Black patients were 2 times more likely to be cagA + than H. pylori + White patients (82% vs 36%, P < .0001)., Discussion: Presence of cagA is common among endoscopy patients with active H. pylori infection; appropriate testing and treatment of H. pylori can both reduce gastric cancer risk and address health disparities., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

Acquired resistance remains a major challenge for therapies targeting oncogene activated pathways. KRAS is the most frequently mutated oncogene in human cancers, yet strategies targeting its downstream signaling kinases have failed to produce durable treatment responses. Here, we developed multiple models of acquired resistance to dual-mechanism ERK/MAPK inhibitors across KRAS-mutant pancreatic, colorectal, and lung cancers, and then probed the long-term events enabling survival against this class of drugs. These studies revealed that resistance emerges secondary to large-scale transcriptional adaptations that are diverse and cell line-specific. Transcriptional reprogramming extends beyond the well-established early response, and instead represents a dynamic, evolved process that is refined to attain a stably resistant phenotype. Mechanistic and translational studies reveal that resistance to dual-mechanism ERK/MAPK inhibition is broadly susceptible to manipulation of the epigenetic machinery, and that Mediator kinase, in particular, can be co-targeted at a bottleneck point to prevent diverse, cell line-specific resistance programs., (© 2024. The Author(s).)

Background: Lebanon has a high caesarean section use and consequently, placenta accreta spectrum (PAS) is becoming more common., Objectives: To compare maternal characteristics, management, and outcomes of women with PAS by planned or urgent delivery at a major public referral hospital in Lebanon., Design: Secondary data analysis of prospectively collected data., Setting: Rafik Hariri University Hospital (public referral hospital), Beirut, Lebanon., Participants: 159 pregnant and postpartum women with confirmed PAS between 2007-2020., Main Outcome Measures: Maternal characteristics, management, and maternal and neonatal outcomes., Results: Out of the 159 women with PAS included, 107 (67.3%) underwent planned caesarean delivery and 52 (32.7%) had urgent delivery. Women who underwent urgent delivery for PAS management were more likely to experience antenatal vaginal bleeding compared to those in the planned group (55.8% vs 28.0%, p<0.001). Median gestational age at delivery was significantly lower for the urgent group compared to the planned (34 vs. 36 weeks, p<0.001). There were no significant differences in terms of blood transfusion rates and major maternal morbidity between the two groups; however, median estimated blood loss was significantly higher for women with urgent delivery (1500ml vs. 1200ml, p = 0.011). Furthermore, the urgent delivery group had a significantly lower birth weight (2177.5g vs. 2560g, p<0.001) with higher rates of neonatal intensive care unit (NICU) admission (53.7% vs 23.8%, p<0.001) and perinatal mortality (18.5% vs 3.8%, p = 0.005)., Conclusion: Urgent delivery among women with PAS is associated with worse maternal and neonatal outcomes compared to the planned approach. Therefore, early referral of women with known or suspected PAS to specialized centres is highly desirable to maximise optimal outcomes for both women and infants., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 McCall 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.)

Background: COVID-19 vaccine acceptance among refugees in the Arab region remains low. This study aimed to examine the prevalence, reasons and predictors of intention to refuse the COVID-19 vaccine among older Syrian refugees in Lebanon., Methods: A nested cross-sectional study within a longitudinal study among older Syrian refugees in Lebanon. The sampling frame was a complete listing of beneficiary households of a humanitarian organization with at least one adult aged 50 years or older. Telephone surveys were completed at months 1 starting September 2020 (wave 1), months 2 (wave 2), months 5 (wave 3), months 6 (wave 4) and months 17 (wave 5) in March 2022. Logistic regression models were used to identify predictors of intention to refuse the COVID-19 vaccine. Models were internally validated using bootstrap methods and the models' calibration and discrimination were presented., Findings: Of 3167 Syrian refugees, 61.3% intended to receive the COVID-19 vaccine, 31.3% refused, and 7.4% were undecided. Reasons for vaccine refusal were: preference to follow preventive measures (27.4%) and belief that the vaccine is not essential (20.7%). Furthermore, 57.1% of participants registered to take the COVID-19 vaccine in wave 5. Irrespective of vaccination intention, reasons for not registering included: not wanting to receive the vaccine, and being unsure whether to take it. Predictors of intention to refuse the COVID-19 vaccine included: being a female, older age, having elementary education or above, living outside informal tented settlements, perceiving COVID-19 as not severe and vaccines as not safe or effective, and using social media for information on COVID-19. After adjusting for optimization, the final model showed moderate discrimination (C-statistic: 0.651 (95% CI:0.630-0.672)) and good calibration (C-slope: 0.93 (95% CI: 0.823-1.065))., Conclusions: This study developed a predictive model for vaccination intention with a moderate discriminative ability and good calibration. Prediction models in humanitarian settings can help identify refugees at higher risk of not intending to receive the COVID-19 vaccine for public health targeting., 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 Ltd. All rights reserved.)

Background: Magnetic resonance imaging (MRI) studies have identified brain changes associated with anxiety disorders (ADs), but the results remain mixed, particularly at a younger age. One key predictor of ADs is behavioral inhibition (BI), a childhood tendency for high avoidance of novel stimuli. This study aimed to evaluate the relationships between candidate brain regions, BI, and ADs among children using baseline data from the Adolescent Brain Cognitive Development (ABCD) study., Methods: We analyzed global and regional brain volumes of 9,353 children (9-10 years old) in relation to BI and current ADs, using linear mixed models accounting for family clustering and important demographic and socioeconomic covariates. We further investigated whether and how past anxiety was related to brain volumes., Results: Among included participants, 249 (2.66%) had a current AD. Larger total white matter (Beta = -0.152; 95% CI [-0.281, -0.023]), thalamus (Beta = -0.168; 95% CI [-0.291, -0.044]), and smaller hippocampus volumes (Beta = 0.094; 95% CI [-0.008, 0.196]) were associated with lower BI scores. Amygdala volume was not related to BI. Larger total cortical (OR = 0.751; 95% CI [0.580;0.970]), amygdala (OR = 0.798; 95%CI [0.666;0.956]), and precentral gyrus (OR = 0.802; 95% CI [0.661;0.973]) volumes were associated with lower odds of currently having ADs. Children with past ADs had smaller total white matter and amygdala volumes., Conclusions: The results show associations between brain volumes and both BI and ADs at an early age. Importantly, results suggest that ADs and BI have different neurobiological correlates and that earlier occurrences of ADs may influence brain structures related to BI and ADs, motivating research that can better delineate the similarities and divergence in the neurobiological underpinnings and building blocks of BI and ADs across their development in early life., (© 2024. The Author(s).)

Patient-Derived Organoids (PDO) and Xenografts (PDX) are the current gold standards for patient-derived models of cancer (PDMC). Nevertheless, how patient tumor cells evolve in these models and the impact on drug response remains unclear. Herein, the transcriptomic and chromatin accessibility landscapes of matched colorectal cancer (CRC) PDO, PDX, PDO-derived PDX (PDOX), and original patient tumors (PT) are compared. Two major remodeling axes are discovered. The first axis delineates PDMC from PT, and the second axis distinguishes PDX and PDO. PDOX are more similar to PDX than PDO, indicating the growth environment is a driving force for chromatin adaptation. Transcription factors (TF) that differentially bind to open chromatins between matched PDO and PDOX are identified. Among them, KLF14 and EGR2 footprints are enriched in PDOX relative to matched PDO, and silencing of KLF14 or EGR2 promoted tumor growth. Furthermore, EPHA4, a shared downstream target gene of KLF14 and EGR2, altered tumor sensitivity to MEK inhibitor treatment. Altogether, patient-derived CRC cells undergo both common and distinct chromatin remodeling in PDO and PDX/PDOX, driven largely by their respective microenvironments, which results in differences in growth and drug sensitivity and needs to be taken into consideration when interpreting their ability to predict clinical outcome., (© 2024 The Authors. Advanced Science published by Wiley‐VCH GmbH.)

Introduction: Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes., Objective: To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts., Design: Scoping review., Data Sources: Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews-Cochrane Methodology Registry (Final issue, third Quarter 2012)., Eligibility Criteria: Reports published between January 2007 and December 2021 of (a) cohorts used or planned to be used, to conduct RCTs, or (b) RCTs which use cohorts to recruit participants and/or collect trial outcomes, or (c) methodological studies discussing the use of cohorts for RCTs., Data Extraction and Synthesis: Data were extracted on the condition being studied, age group, setting, country/continent, intervention(s) and comparators planned or received, unit of randomisation, timing of randomisation, approach to informed consent, study design and terminology., Results: A total of 175 full-text articles were assessed for eligibility. We identified 61 protocols, 9 descriptions of stand-alone cohorts intended to be used for future RCTs, 39 RCTs using cohorts and 34 methodological papers.The use and scope of this approach is growing. The thematics of study are far-ranging, including population health, oncology, mental and behavioural disorders, and musculoskeletal conditions.Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers., Conclusion: This review outlines the development of cohorts to conduct RCTs including the range of use and innovative changes and adaptations. Inconsistencies in the use of terminology and concepts are highlighted. Guidance now needs to be developed to support the design and reporting of RCTs conducted using cohorts., Competing Interests: Competing interests: Publication costs for this article have been met by Queen Mary University of London and the University of Western Ontario under the BMJ Open Access publication agreement., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: Gastric cancer (GC) accounts for the greatest disparity in cancer mortality between Black and White Americans. Although clinical trials have shown that Helicobacter pylori (Hp) treatment reduces risk of GC, Hp testing and treatment is not consistently performed in the US, and may offer an opportunity to improve survival., Methods: In a diverse retrospective cohort of 99 GC cases diagnosed at Duke University from 2002-2020 (57% Black; 43% white), we examined the association of Hp testing and treatment prior to or at cancer diagnosis with overall survival using Cox regression analyses to calculate adjusted hazards ratios (HRs) and 95% confidence intervals (CIs)., Results: Overall, 62% of patients were tested for Hp prior to or at GC diagnosis. Of those, 25% tested positive and were treated < 1 year prior to or at diagnosis, 15% tested positive and were treated ≥ 1 year prior to diagnosis, 6% tested positive without evidence of treatment, and 54% tested negative. Compared to never tested, Hp testing and treatment < 1 year prior to or at diagnosis was associated with a significantly reduced likelihood of death (HR 0.21, 95% CI 0.08-0.58). The benefit of any Hp test and treat prior to or at GC diagnosis was significant even among stage IV patients only (HR, 0.22; 95% CI 0.05-0.96)., Conclusions: These findings support Hp testing and treatment for patients at risk of or diagnosed with GC, and suggest Hp treatment may provide an opportunity to reduce GC mortality disparities in the US., (© 2023. The Author(s) under exclusive licence to The International Gastric Cancer Association and The Japanese Gastric Cancer Association.)

The Cooperative Human Tissue Network was created by the NCI in 1987 to support a coordinated national effort to collect and distribute high quality, pathologist-validated human tissues for cancer research. Since then, the network has expanded to provide different types of tissue samples, blood and body fluid samples, immunohistologic and molecular sample preparations, tissue microarrays, and clinical datasets inclusive of biomarkers and molecular testing. From inception through the end of 2021, the network has distributed 1,375,041 biospecimens. It served 889 active investigators in 2021. The network has also taken steps to begin to optimize the representation of diverse communities among the distributed biospecimens. In this article, the authors review the 35-year history of this network, describe changes to the program over the last 15 years, and provide operational and scientific highlights from each of the divisions. Readers will learn how to engage with the network and about the continued evolution of the program for the future., (©2023 American Association for Cancer Research.)

Objective: To identify the lessons learned from women who died during pregnancy or childbirth in Lebanon between 2018 and 2020., Method: This is a case series and synthesis of maternal deaths between 2018 and 2020 that were reported by healthcare facilities to the Ministry of Public Health in Lebanon. The notes recorded from the maternal mortality review reports were analyzed using the "Three Delays" model to identify preventable causes and lessons learned., Results: A total of 49 women died before, during, or after childbirth, with hemorrhage being the most frequent cause (n = 16). The possible factors that would have prevented maternal deaths included a prompt recognition of clinical severity, availability of blood for transfusion and magnesium sulfate for eclampsia, adequate transfer to tertiary care hospitals comprising specialist care, and involvement of skilled medical staff in obstetric emergencies., Conclusion: Many maternal deaths in Lebanon are preventable. Better risk assessment, use of an obstetric warning system, access to adequately skilled human resources and medications, and improved communication and transfer mechanisms between private and tertiary care hospitals may avoid future maternal deaths., (© 2023 International Federation of Gynecology and Obstetrics.)

Introduction: Lebanon has battled the COVID-19 pandemic in the midst of an economic crisis. The evolution of the pandemic and a fragile health system have meant that public health policy has had to rely heavily on non-pharmaceutical interventions for disease control. However, changes in disease dynamics, an unraveling economy, and pandemic fatigue have meant that disease control policies need to be updated., Methods: Using recent and timely data on older (50 years and above) Syrian refugees in Lebanon, this paper uses multivariate linear probability models to explore the determinants of adherence to two non-pharmaceutical COVID-19 prevention measures (wearing a mask and avoiding social gatherings) among this high-risk subgroup in a vulnerable population. Among respondents who report adhering to these measures, the paper also investigates the determinants of sustained adherence over a period of 6 months., Results: The findings suggest that no individual-level characteristics were robustly associated with mask wearing. For avoiding social gatherings, education was inversely associated with adherence to this preventive measure. Avoiding social gatherings was also significantly lower for residents of informal tented settlements (ITSs). Among initial adherents, and for both preventive practices, ITS dwellers were also significantly less likely to maintain adherence., Conclusion: Identifying variables associated with adherence to non-pharmaceutical preventive practices, particularly for vulnerable groups, can help inform and refine interventions in the face of changing conditions. The material, physical, administrative and socio-economic constraints of life in an ITS suggest that avoiding social gatherings is hardly feasible. Yet despite the challenging conditions of ITSs, the indication to wear a mask is initially complied with, suggesting that tailoring policies to the limits and constrains of context can lead to successful outcomes even in very adverse settings., Competing Interests: The authors declared that no competing interests exist., (Copyright: © 2023 Salti 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.)

Background: Vaccination is important to prevent morbidity and mortality due to COVID-19 among older Syrian refugees. We aimed to elucidate the predictors of COVID-19 vaccine uptake among Syrian refugees aged 50 years or older in Lebanon and to understand their main reasons for not receiving the vaccine., Methods: This was a cross-sectional analysis of a five-wave longitudinal study, conducted through telephone interviews between Sept 22, 2020, and March 14, 2022, in Lebanon. For this analysis, data were extracted from wave 3 (Jan 21-April 23, 2021), which included a question on vaccine safety and on whether participants intended to receive the COVID-19 vaccine, and wave 5 (Jan 14-March 14, 2022), which included questions on actual vaccine uptake. Syrian refugees aged 50 years or older were invited to participate from a list of households that received assistance from the Norwegian Refugee Council, a humanitarian non-governmental organisation. The outcome was self-reported COVID-19 vaccination status. Multivariable logistic regression was used to identify predictors of vaccination uptake. Validation was completed internally with bootstrapping methods., Findings: 2906 participants completed both wave 3 and 5; the median age was 58 (IQR 55-64) years and 1538 (52·9%) were male. 1235 (42·5%) of 2906 participants had received at least one dose of the COVID-19 vaccine. The main reasons for not receiving the first dose included being afraid of its side-effects (670 [40·1%] of 1671) or not wanting the vaccine (637 [38·1%] of 1671). 806 (27·7%) of 2906 participants received the second dose of the vaccine and 26 (0·9%) of 2906 received the third dose. The main reason for not receiving the second (288 [67·1%] of 429) or third dose (573 [73·5%] of 780) was waiting for a text message for an appointment. Predictors of receiving at least one dose of the COVID-19 vaccine included younger age (odds ratio 0·97; 95% CI 0·96-0·98), being male (1·39; 1·19-1·62), living inside informal tented settlements (1·44; 1·24-1·66), having elementary (1·23; 1·03-1·48) and preparatory education or above (1·15; 0·95-1·40), and having a pre-existing intention to receive the vaccine (1·29; 1·10-1·50). After adjusting for optimisation, the final model, which includes these five predictors of receiving at least one dose of the COVID-19 vaccine, showed moderate discrimination (C-statistic 0·605; 95% CI 0·584-0·624) and good calibration (c-slope 0·912; 95% CI 0·758-1·079)., Interpretation: There is an ongoing need to address COVID-19 vaccine uptake among older Syrian refugees by improving deployment planning and raising awareness about the importance of vaccination., Funding: ELRHA's Research for Health in Humanitarian Crisis Programme., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Objectives: This study aims to assess whether the characteristics, management and outcomes of women varied between Syrian and Palestinian refugees, migrant women of other nationalities and Lebanese women giving birth at a public tertiary centre in Beirut, Lebanon., Methods: This was a secondary data analysis of routinely collected data from the public Rafik Hariri University Hospital (RHUH) between January 2011 and July 2018. Data were extracted from medical notes using text mining machine learning methods. Nationality was categorised into Lebanese, Syrian, Palestinian and migrant women of other nationalities. The main outcomes were diabetes, pre-eclampsia, placenta accreta spectrum, hysterectomy, uterine rupture, blood transfusion, preterm birth and intrauterine fetal death. Logistic regression models estimated the association between nationality and maternal and infant outcomes, and these were presented using ORs and 95% CIs., Results: 17 624 women gave birth at RHUH of whom 54.3% were Syrian, 39% Lebanese, 2.5% Palestinian and 4.2% migrant women of other nationalities. The majority of women had a caesarean section (73%) and 11% had a serious obstetric complication. Between 2011 and 2018, there was a decline in the use of primary caesarean section (caesarean section performed for the first time) from 7% to 4% of births (p<0.001). The odds of preeclampsia, placenta abruption and serious complications were significantly higher for Palestinian and migrant women of other nationalities compared to Lebanese women, but not for Syrian women. Very preterm birth was higher for Syrians (OR: 1.23, 95% CI: 1.08 to 1.40) and migrant women of other nationalities (OR: 1.51, 95% CI: 1.13 to 2.03) compared to Lebanese women., Conclusion: Syrian refugees in Lebanon had similar obstetric outcomes compared to the host population, except for very preterm birth. However, Palestinian women and migrant women of other nationalities appeared to have worse pregnancy complications than the Lebanese women. There should be better healthcare access and support for migrant populations to avoid severe complications of pregnancy., 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: Identifying what prompts or hinders women's help-seeking behaviour is essential to ensure timely diagnosis and management of gynaecological cancers., Aim: To understand the factors that influence the help- seeking behaviour of women diagnosed with gynaecological cancer., Design and Setting: Systematic review and narrative synthesis of studies from high-income settings worldwide., Method: Five databases were searched for studies, of any design, that presented factors related to the help-seeking behaviour of women diagnosed with a gynaecological cancer. Data from the articles were extracted and presented using narrative synthesis, which was both inductive and deductive. The COM-B (capability, opportunity, motivation, behaviour) model of behaviour change was used as a framework., Results: In total, 21 studies were included in the review. Inductive synthesis presented three main themes of factors related to the help-seeking behaviour of women diagnosed with gynaecological cancer: patient factors, such as knowledge of symptoms; emotional factors, including previous healthcare experience, embarrassment, and trust; and practical factors, including time and resources. Deductive synthesis demonstrated that capability (namely, symptom knowledge), opportunity (having the required time and overcoming the cultural taboos surrounding gynaecological symptoms), and motivation (believing that seeking help is beneficial) are all required to initiate help-seeking behaviour., Conclusion: Although it is a journey of defined steps, the help- seeking behaviour of women with symptoms diagnosed with gynaecological cancer is influenced by personal and societal factors. Interventions to improve help seeking will need to address the specific identified factors, as well as capability, opportunity, and motivation., (© The Authors.)

Intrahepatic cholangiocarcinoma (ICC) remains a deadly malignancy lacking systemic therapies for advanced disease. Recent advancements include selective FGFR1-3 inhibitors for the 15% of ICC patients harboring fusions, although survival is limited by poor response and resistance. Herein we report generation of a patient-derived FGFR2 fusion-positive ICC model system consisting of a cell line, organoid, and xenograft, which have undergone complete histologic, genomic, and phenotypic characterization, including testing standard-of-care systemic therapies. Using these FGFR2 fusion-positive ICC models, we conducted an unbiased high-throughput small molecule screen to prioritize combination strategies with FGFR inhibition, from which HDAC inhibition together with pemigatinib was validated in vitro and in vivo as a synergistic therapy for ICC. Additionally, we demonstrate broad utility of the FGFR/HDAC combination for other FGFR fusion-positive solid tumors. These data are directly translatable and justify early phase trials to establish dosing, safety, and therapeutic efficacy of this synergistic combination., (© 2022. The Author(s).)

Importance: Older Syrian refugees have a high burden of noncommunicable diseases (NCDs) and economic vulnerability., Objectives: To develop and internally validate a predictive model to estimate inability to manage NCDs in older Syrian refugees, and to describe barriers to NCD medication adherence., Design, Setting, and Participants: This nested prognostic cross-sectional study was conducted through telephone surveys between September 2020 and January 2021. All households in Lebanon with Syrian refugees aged 50 years or older and who received humanitarian assistance from a nongovernmental organization were invited to participate. Refugees who self-reported having chronic respiratory disease (CRD), diabetes, history of cardiovascular disease (CVD), or hypertension were included in the analysis. Data were analyzed from November 2021 to March 2022., Main Outcomes and Measures: The main outcome was self-reported inability to manage any NCD (including CRD, CVD, diabetes, or hypertension). Predictors of inability to manage any NCD were assessed using logistic regression models. The model was internally validated using bootstrapping techniques, which gave an estimate of optimism. The optimism-adjusted discrimination is presented using the C statistic, and calibration of the model is presented using calibration slope (C slope)., Results: Of 3322 older Syrian refugees, 1893 individuals (median [IQR] age, 59 [54-65] years; 1089 [57.5%] women) reported having at least 1 NCD, among whom 351 (10.6% overall; 18.6% of those with ≥1 NCD) had CRD, 781 (23.7% overall; 41.4% of those with ≥1 NCD) had diabetes, 794 (24.1% overall; 42.2% of those with ≥1 NCD) had history of CVD, and 1388 (42.3% overall; 73.6% of those with ≥1 NCD) had hypertension. Among individuals with NCDs, 387 participants (20.4%) were unable to manage at least 1 of their NCDs. Predictors for inability to manage NCDs were age, nonreceipt of cash assistance, household water insecurity, household food insecurity, and having multiple chronic diseases, with an adjusted C statistic of 0.650 (95% CI, 0.620-0.676) and C slope of 0.871 (95% CI, 0.729-1.023). The prevalence of nonadherence to medication was 9.2%, and the main reasons for nonadherence were unaffordability of medication (40.8%; 95% CI, 33.4%-48.5%) and the belief that they no longer required the medication after feeling better (22.4%; 95% CI, 16.4%-29.3%)., Conclusions and Relevance: In this cross-sectional study, the predictors of inability to manage NCDs among older Syrian refugees in Lebanon were mainly related to financial barriers. Context-appropriate assistance is required to overcome financial barriers and enable equitable access to medication and health care.

Background: Prostate cancer is a clinically and molecularly heterogeneous disease, with highest incidence and mortality among men of African ancestry. To date, prostate cancer patient-derived xenograft (PCPDX) models to study this disease have been difficult to establish because of limited specimen availability and poor uptake rates in immunodeficient mice. Ancestrally diverse PCPDXs are even more rare, and only six PCPDXs from self-identified African American patients from one institution were recently made available., Methods: In the present study, we established a PCPDX from prostate cancer tissue from a patient of estimated 90% West African ancestry with metastatic castration resistant disease, and characterized this model's pathology, karyotype, hotspot mutations, copy number, gene fusions, gene expression, growth rate in normal and castrated mice, therapeutic response, and experimental metastasis., Results: This PCPDX has a mutation in TP53 and loss of PTEN and RB1. We have documented a 100% take rate in mice after thawing the PCPDX tumor from frozen stock. The PCPDX is castrate- and docetaxel-resistant and cisplatin-sensitive, and has gene expression patterns associated with such drug responses. After tail vein injection, the PCPDX tumor cells can colonize the lungs of mice., Conclusion: This PCPDX, along with others that are established and characterized, will be useful pre-clinically for studying the heterogeneity of prostate cancer biology and testing new therapeutics in models expected to be reflective of the clinical setting., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

Background: Female genital mutilation/cutting (FGM/C) is a nonmedical procedure entailing the modification of the external female genitalia. A description of the prevalence and distribution of FGM/C allows the tracking of progress toward ending FGM/C by 2030 (Sustainable Development Goal (SDG): target 5.3). This systematic review aimed to examine FGM/C prevalence and types, by World Health Organization (WHO) region and country., Methods and Findings: A systematic search using Medical Subject Headings (MeSH) and keywords from 2009 to March 24, 2022 was undertaken in MEDLINE, PubMED, PsycINFO, Web of Science, and Embase to identify studies presenting FGM/C prevalence. Abstract and full-text screening, quality assessment, and data extraction were undertaken by 2 reviewers. Only nationally representative studies were included in the meta-analysis. Pooled FGM/C prevalence was estimated by random-effects meta-analysis using generalized linear mixed models (GLMMs). FGM/C prevalence with 95% confidence intervals (CIs), prediction intervals (PIs), and FGM/C type were presented separately by women aged 15 to 49 years and girls aged 0 to 14 years. A total of 163 studies met the inclusion criteria and 30 were included in the meta-analysis, of which 23 were from the WHO African Region (AFR), 6 from the Eastern Mediterranean Region (EMR), and 1 from the South East Asian Region (SEAR). These studies included data from 406,068 women across 30 countries and 296,267 girls across 25 countries; the pooled prevalence estimate of FGM/C among women aged 15 to 49 years was 36.9% (95% CI: 19.6% to 58.3%; PI: 0.4% to 99.0%), and 8.27% (95% CI: 3.7% to 17.3%; PI: 0.1% to 89.3%) among girls aged 0 to 14 years. Among included countries, this gave a total estimated prevalence of 84,650,032 women (95% CI: 45,009,041 to 133,834,224) and 13,734,845 girls with FGM/C (95% CI: 6,211,405 to 28,731,901). Somalia had the highest FGM/C prevalence among women (99.2%), and Mali had the highest among girls (72.7%). The most common type of FGM/C among women was "flesh removed" (Type I or II) in 19 countries. Among girls, "not sewn closed" (Type I, II, or IV) and "flesh removed" (Type I or II) were the most common types in 8 countries, respectively. Among repeated nationally representative studies, FGM/C decreased for both women and girls in 26 countries. The main limitation of the study methodology is that estimates were based on available published data, which may not reflect the actual global prevalence of FGM/C., Conclusions: In this study, we observed large variation in FGM/C prevalence between countries, and the prevalence appears to be declining in many countries, which is encouraging as it minimizes physical and physiological harm for a future generation of women. This prevalence estimate is lower than the actual global prevalence of FGM/C due to data gaps, noncomparable denominators, and unavailable surveys. Yet, considerable policy and community-level interventions are required in many countries to meet the SDG target 5.3., Trial Registration: Registration: CRD42020186937., Competing Interests: The authors have declared that no competing interests exist.

Objective: To compare the management and outcomes of women with placenta accreta spectrum (PAS) in France and the UK., Design: Two population-based cohorts., Setting: All obstetrician-led hospitals in the UK and maternity hospitals in eight French regions., Population: A cohort of 219 women with PAS in France and a cohort of 154 women with PAS in the UK., Methods: The management and outcomes of women with PAS were compared between the UK and France., Main Outcome Measures: Median blood loss, severe postpartum haemorrhage (≥3 l), postpartum infection and damage to surrounding organs., Results: The management of PAS differed between the two countries: a larger proportion of women with PAS in the UK had a caesarean hysterectomy compared with France (43% vs 26%, p < 0.001), whereas in France a larger proportion of women with PAS received a uterus-preserving approach compared with the UK (36% vs 19%, p < 0.001). The total median blood loss in the UK was 3 l (IQR 1.7-6.5 l), compared with 1 l (IQR 0.5-2.5 l) in France; more women with PAS had a severe postpartum haemorrhage (PPH) in the UK compared with women with PAS in France (58% vs 21%, p < 0.001) [Correction added on 06 May 2022, after first online publication: '24 hour' has been changed to 'total' in the preceding sentence]. There was no difference between the UK and French populations for postpartum infection or organ damage., Conclusions: The UK and France have very different approaches to managing PAS, with more women in France receiving a uterine-conserving approach and more women in the UK undergoing caesarean hysterectomy. A life-threatening haemorrhage was more common in the UK than in France, which may be the result of differential management and/or the organisation of the healthcare systems. In women with placenta accreta spectrum, severe haemorrhage was more common in the UK than in France., Tweetable Abstract: In women with placenta accreta spectrum, severe haemorrhage was more common in the UK than in France., (© 2022 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Background: This systematic review aimed to identify and describe the factors that influence female genital mutilation/cutting (FGM/C)., Methods: Searches were conducted in Medline, PsycInfo, Web of Science, Embase and the grey literature from 2009 to March 2020 with no language restrictions, using related MESH terms and keywords. Studies were included if they were quantitative and examined factors associated with FGM/C. Two researchers independently screened studies for inclusion, extracted data and assessed study quality. The direction, strength and consistency of the association were evaluated for determinants, presented as a descriptive summary, and were disaggregated by age and region., Results: Of 2230 studies identified, 54 published articles were included. The majority of studies were from the African Region (n=29) followed by the Eastern Mediterranean Region (n=18). A lower level of maternal education, family history of FGM/C, or belonging to the Muslim religion (in certain contexts) increased the likelihood of FGM/C. The majority of studies that examined higher paternal education (for girls only) and living in an urban region showed a reduced likelihood of FGM/C, while conflicting evidence remained for wealth. Several studies reported that FGM/C literacy, and low community FGM/C prevalence were associated with a reduced likelihood of FGM/C., Conclusions: There were several characteristics that appear to be associated with FGM/C, and these will better enable the targeting of policies and interventions. Importantly, parental education may be instrumental in enabling communities and countries to meet the Sustainable Development Goals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The lack of validated, distributed comprehensive genomic profiling assays for patients with cancer inhibits access to precision oncology treatment. To address this, we describe elio tissue complete, which has been FDA-cleared for examination of 505 cancer-related genes. Independent analyses of clinically and biologically relevant sequence changes across 170 clinical tumor samples using MSK-IMPACT, FoundationOne, and PCR-based methods reveals a positive percent agreement of >97%. We observe high concordance with whole-exome sequencing for evaluation of tumor mutational burden for 307 solid tumors (Pearson r = 0.95) and comparison of the elio tissue complete microsatellite instability detection approach with an independent PCR assay for 223 samples displays a positive percent agreement of 99%. Finally, evaluation of amplifications and translocations against DNA- and RNA-based approaches exhibits >98% negative percent agreement and positive percent agreement of 86% and 82%, respectively. These methods provide an approach for pan-solid tumor comprehensive genomic profiling with high analytical performance., (© 2022. The Author(s).)

Background: Hormonal therapy targeting the androgen receptor inhibits prostate cancer (PCa), but the tumor eventually recurs as castration-resistant prostate cancer (CRPC)., Objective: To understand the mechanisms by which subclones within early PCa develop into CRPC., Design, Setting, and Participants: We isolated epithelial cells from fresh human PCa cases, including primary adenocarcinoma, locally recurrent CRPC, and metastatic CRPC, and utilized single-cell RNA sequencing to identify subpopulations destined to become either CRPC-adeno or small cell neuroendocrine carcinoma (SCNC)., Outcome Measurements and Statistical Analysis: We revealed dynamic transcriptional reprogramming that promotes disease progression among 23226 epithelial cells using single-cell RNA sequencing, and validated subset-specific progression using immunohistochemistry and large cohorts of publically available genomic data., Results and Limitations: We identified a small fraction of highly plastic CRPC-like cells in hormone-naïve early PCa and demonstrated its correlation with biochemical recurrence and distant metastasis, independent of clinical characteristics. We show that progression toward castration resistance was initiated from subtype-specific lineage plasticity and clonal expansion of pre-existing neuroendocrine and CRPC-like cells in early PCa., Conclusions: CRPC-like cells are present early in the development of PCa and are not exclusively the result of acquired evolutionary selection during androgen deprivation therapy. The lethal CRPC and SCNC phenotypes should be targeted earlier in the disease course of patients with PCa., Patient Summary: Here, we report the presence of pre-existing castration-resistant prostate cancer (CRPC)-like cells in primary prostate cancer, which represents a novel castration-resistant mechanism different from the adaptation mechanism after androgen deprivation therapy (ADT). Patients whose tumors harbor increased pre-existing neuroendocrine and CRPC-like cells may become rapidly resistant to ADT and may require aggressive early intervention., (Copyright © 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objective: To describe characteristics of randomized controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria., Study Design: MEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011-2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form., Results: Of the 183 RCT publications identified, 122 (67%) used EHRs to identify eligible participants, 139 (76%) used the EHR as part of the intervention and 137 (75%) to ascertain outcomes. When 60 publications were evaluated against the CONSORT 2010 item and the corresponding extension for the 8 modified items, four items were 'adequately reported' for most trials. Five new reporting items were identified for the CONSORT-ROUTINE extension; when evaluated, one was 'adequately reported', three were reported 'inadequately or not at all', the other 'partially'. There were, however, some encouraging signs with adequate and partial reporting of many important items, including descriptions of trial design, the consent process, outcome ascertainment and interpretation., Conclusion: Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting., (Copyright © 2021. Published by Elsevier Inc.)

Objective: We evaluated reporting completeness and transparency in randomized controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria., Study Design and Setting: MEDLINE and the Cochrane Methodology Register were searched (2011 and 2018). Eligible RCTs used administrative databases for identifying eligible participants or collecting outcomes. We evaluated reporting based on CONSORT-ROUTINE, which modified eight items from CONSORT 2010 and added five new items., Results: Of 33 included trials (76% used administrative databases for outcomes, 3% for identifying participants, 21% both), most were conducted in the United States (55%), Canada (18%), or the United Kingdom (12%). Of eight items modified in the extension; six were adequately reported in a majority (>50%) of trials. For the CONSORT-ROUTINE modification portion of those items, three items were reported adequately in >50% of trials, two in <50%, two only applied to some trials, and one only had wording modifications and was not evaluated. For five new items, four that address use of routine data in trials were reported inadequately in most trials., Conclusion: How administrative data are used in trials is often sub-optimally reported. CONSORT-ROUTINE uptake may improve reporting., Competing Interests: Declaration of Competing Interests All authors have completed the ICJME uniform disclosure form and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, (Copyright © 2021. Published by Elsevier Inc.)

Objective: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries., Study Design and Setting: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed., Results: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate)., Conclusion: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

This study assesses COVID-19 vaccine intentions among a sample of older Syrian refugee beneficiaries of a humanitarian organization in Lebanon, and explores factors associated with vaccine refusal. The findings are part of an ongoing rotating 4-wave panel study. The sample was limited to participants from the first panel who completed a phone interview between January-February 2021. Out of 1,037 beneficiaries, almost a third (29%) reported no intention to vaccinate. Reasons for refusal were: newness of the vaccine (35%); preference to maintain precaution measures (21%); belief that the COVID-19 vaccine is not essential (21%); and other (23%). COVID-19 vaccine refusal was significantly associated with perceptions regarding vaccine safety (OR: 5.97; 95%CI: 4.03-8.84) and effectiveness (OR: 6.80; 95%CI:4.44-10.42) but did not differ by age, presence of chronic conditions, self-reported adherence to COVID-19 measures, and perceptions of susceptibility to and severity of COVID-19. Addressing vaccine hesitancy among Syrian refugees in Lebanon necessitates disseminating accurate, accessible, and culturally appropriate information about vaccine safety and effectiveness., Competing Interests: 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., (© 2021 The Authors.)

Objective: To examine trends and variations of caesarean section by economic status and type of healthcare facility in Arab countries in the Middle East and North Africa (MENA)., Methods: Secondary data analysis of nationally representative household surveys conducted between 2008-2020 across nine Arab countries in the MENA region. The study population was women aged 15-49 years with a live birth in the two years preceding the survey. Temporal changes in the proportion of deliveries by caesarean section in each country were calculated using generalised linear models and presented as risk differences (RD) with 95% confidence intervals (95%CI). Caesarean section was disaggregated by household wealth index and type of healthcare facility., Results: Use of caesarean section ranged from 57.3% (95%CI:55.6-59.1%) in Egypt to 5.7% of births (95%CI:4.9-6.6%) in Yemen. Overall, the use of caesarean section has increased across the MENA region, except in Jordan, where there was no evidence of change (RD -2.3 (95%CI: -6.0 ‒1.4)). Across most countries, caesarean section use was highest in the richest quintile compared to the poorest quintile, for example, 42.8% (95%CI:38.0-47.6%) vs. 22.6% (95%CI:19.6-25.9%) in Iraq, respectively. Proportion of caesarean section was higher in private sector facilities compared to public sector: 21.8% (95%CI:18.2-25.9%) vs. 15.7% (95%CI:13.3-18.4%) in Yemen, respectively., Conclusion: Variations in caesarean section exist within and between Arab countries, and it was more commonly used amongst the richest quintiles and in private healthcare facilities. The private sector has a prominent role in observed trends. Urgent policies and interventions are required to address non-medically indicated intervention., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Professor Abdel-Fattah’s full declaration is on his webpage [URL: https://www.abdn.ac.uk/iahs/research/obsgynae/profiles/m.abdelfattah]. All other authors have no conflicts of interest to report.

Genomic tumor profiling by next-generation sequencing (NGS) allows for large-scale tumor testing to inform targeted cancer therapies and immunotherapies, and to identify patients for clinical trials. These tests are often underutilized in patients with late-stage solid tumors and are typically performed in centralized specialty laboratories, thereby limiting access to these complex tests. Personal Genome Diagnostics Inc., elio tissue complete NGS solution is a comprehensive DNA-to-report kitted assay and bioinformatics solution. Comparison of 147 unique specimens from >20 tumor types was performed using the elio tissue complete solution and Foundation Medicine's FoundationOne test, which is of similar size and gene content. The analytical performance of all genomic variant types was evaluated. In general, the overall mutational profile is highly concordant between the two assays, with agreement in sequence variants reported between panels demonstrating >95% positive percentage agreement for single-nucleotide variants and insertions/deletions in clinically actionable genes. Both copy number alterations and gene translocations showed 80% to 83% positive percentage agreement, whereas tumor mutation burden and microsatellite status showed a high level of concordance across a range of mutation loads and tumor types. The Personal Genome Diagnostics Inc., elio tissue complete assay is comparable to the FoundationOne test and will allow more laboratories to offer a diagnostic NGS assay in house, which will ultimately reduce time to result and increase the number of patients receiving molecular genomic profiling and personalized treatment., (Copyright © 2021 Association for Molecular Pathology and American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.)

Comprehensive genomic profiling to inform targeted therapy selection is a central part of oncology care. However, the volume and complexity of alterations uncovered through genomic profiling make it difficult for oncologists to choose the most appropriate therapy for their patients. Here, we present a solution to this problem, The Molecular Registry of Tumors (MRT) and our Molecular Tumor Board (MTB)., Patients and Methods: MRT is an internally developed system that aggregates and normalizes genomic profiling results from multiple sources. MRT serves as the foundation for our MTB, a team that reviews genomic results for all Duke University Health System cancer patients, provides notifications for targeted therapies, matches patients to biomarker-driven trials, and monitors the molecular landscape of tumors at our institution., Results: Among 215 patients reviewed by our MTB over a 6-month period, we identified 176 alterations associated with therapeutic sensitivity, 15 resistance alterations, and 51 alterations with potential germline implications. Of reviewed patients, 17% were subsequently treated with a targeted therapy. For 12 molecular therapies approved during the course of this work, we identified between two and 71 patients who could qualify for treatment based on retrospective MRT data. An analysis of 14 biomarker-driven clinical trials found that MRT successfully identified 42% of patients who ultimately enrolled. Finally, an analysis of 4,130 comprehensive genomic profiles from 3,771 patients revealed that the frequency of clinically significant therapeutic alterations varied from approximately 20% to 70% depending on the tumor type and sequencing test used., Conclusion: With robust informatics tools, such as MRT, and the right MTB structure, a precision cancer medicine program can be developed, which provides great benefit to providers and patients with cancer., (© 2021 by American Society of Clinical Oncology.)