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A Retrospective Study of Postoperative Outcomes in 98 Patients Diagnosed with Gastrointestinal Stromal Tumor (GIST) of the Upper, Middle, and Lower Gastrointestinal Tract Between 2009 and 2019 at a Single Center in Poland

Med Sci Monit. 2021 Oct 14;27:e932809. doi: 10.12659/MSM.932809.

ABSTRACT

BACKGROUND Gastrointestinal stromal tumors (GISTs) arise in the smooth muscle pacemaker interstitial cells of Cajal, or similar cells. The aim of this retrospective study between 2009 and 2019 from a single center in Poland was to assess the selected prognostic factors (location, tumor size, mitotic index, body mass index (BMI), length of hospital stay, age, sex, and coexistent neoplasm) and to investigate postoperative outcomes in 98 patients with GIST of the upper, middle, and lower gastrointestinal tract. MATERIAL AND METHODS Between 2009 and 2019, 98 patients (50 women and 48 men) with an average age of 63.8 years (range from 38 to 90 years) were operated on for GIST in the Department of Gastrointestinal Surgery in Katowice, Poland. Based on the intraoperative and postoperative investigations, the tumor size and mitotic index were determined in each case. RESULTS A statistically significant correlation between age and mitotic index (MI) was found (p=0.02). The higher the MI, the younger the age of the patients. However, regardless of sex, younger patients had a tendency to survive longer. A >60-year-old male patient’s probability of survival was around 65% after 40 months. Higher mitotic index was also associated with larger tumor size (p<0.0001). Female patients had a tendency to survive longer than males. CONCLUSIONS The findings from this small retrospective study support the importance of preoperative evaluation and frequent postoperative follow-up for patients with GIST of the gastrointestinal tract, particularly in older male patients, and patients with malignant comorbidities, which are associated with increased mortality.

PMID:34645778 | DOI:10.12659/MSM.932809

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Embotrap Extraction & Clot Evaluation & Lesion Evaluation for NeuroThrombectomy (EXCELLENT) Registry design and methods

J Neurointerv Surg. 2021 Oct 13:neurintsurg-2021-017671. doi: 10.1136/neurintsurg-2021-017671. Online ahead of print.

ABSTRACT

BACKGROUND: Relationships between occlusive clot histopathology, baseline characteristics, imaging findings, revascularization rates, and clinical outcomes of stroke patients with large vessel occlusion (LVO) are not well understood. This study will assess the real-world experience on the efficacy and safety of using the EmboTrap device as the first approach in LVO patients and explore the associations between clot histological characteristics, imaging and clinical findings, revascularization rates, and clinical outcomes.

METHODS: Prospective, global, multicenter, single-arm, imaging core laboratory, and clot analysis central laboratory observational registry. Adult patients (>18 years) with LVO, treated with EmboTrap as the first attempted device, will be eligible for study participation.

RESULTS: Up to 1000 subjects at 50 international sites may be enrolled. Occlusive clots will be collected from at least 500 subjects. Independent central and imaging core laboratories will perform clot analysis and image adjudication. Statistical analysis will assess the association between imaging and clinical findings, clot characteristics, subject comorbidities, revascularization, and clinical outcomes. Study endpoints are functional independence (modified Rankin Scale score ≤2 at 90 days), expanded Thrombolysis In Cerebral Infarction (eTICI) score ≥2b50 rate, first-pass effect, number of passes, embolization into new territory, symptomatic intracranial hemorrhage, and 90-day mortality.

CONCLUSIONS: The EXCELLENT registry will provide reproducible effectiveness and safety data of EmboTrap for its use for mechanical thrombectomy. Additionally, the study will characterize the blood clots retrieved during mechanical thrombectomy with respect to their composition and histopathological analysis and potential correlations with clinical and imaging findings.

TRIAL REGISTRATION NUMBER: NCT03685578.

PMID:34645704 | DOI:10.1136/neurintsurg-2021-017671

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Effectiveness and Safety of Direct Oral Anticoagulants vs. Warfarin and Recurrence After Discontinuation in Patients With Acute Venous Thromboembolism in the Real World

Circ J. 2021 Oct 12. doi: 10.1253/circj.CJ-21-0588. Online ahead of print.

ABSTRACT

BACKGROUND: The efficacy of direct oral anticoagulants (DOACs) compared with warfarin for the treatment of venous thromboembolism (VTE), and the recurrence of VTE after discontinuation of anticoagulation therapy in research are limited.Methods and Results:This retrospective study enrolled 893 patients with acute VTE between 2011 and 2019. The cohort was divided into the transient risk, unprovoked, continued cancer treatment, and cancer remission groups. The following were compared between DOACs and warfarin: composite outcome of all-cause death, VTE recurrence, bleeding and composite outcome of VTE-related death, recurrence and bleeding. In the continued cancer treatment group, more bleeding was seen in warfarin-treated patients than in patients treated with DOACs (53.2% vs. 31.2%, [P=0.048]). In addition, composite outcome of VTE-related death and recurrence after discontinuation of anticoagulation therapy (n=369) was evaluated. The continued cancer treatment group (multivariate analysis: HR: 3.62, 95% CI: 1.84-7.12, P<0.005) and bleeding-related discontinuation of therapy (HR: 2.60, 95% CI: 1.32-5.13, P=0.006) were independent predictors of the event after discontinuation of anticoagulation therapy. VTE recurrence after discontinuation of anticoagulation therapy in the cancer remission group was 1.6% and a statistically similar occurrence was found in the transient risk group (12.4%) (P=0.754).

CONCLUSIONS: DOACs may decrease bleeding incidence in patients continuing to receive cancer treatment. In patients with bleeding-related discontinuation of anticoagulation therapy, VTE recurrence may increase. Discontinuation of anticoagulant therapy might be a treatment option in patients who have completed their cancer treatment.

PMID:34645732 | DOI:10.1253/circj.CJ-21-0588

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Integrating HIV, diabetes and hypertension services in Africa: study protocol for a cluster randomised trial in Tanzania and Uganda

BMJ Open. 2021 Oct 13;11(10):e047979. doi: 10.1136/bmjopen-2020-047979.

ABSTRACT

INTRODUCTION: HIV programmes in sub-Saharan Africa are well funded but programmes for diabetes and hypertension are weak with only a small proportion of patients in regular care. Healthcare provision is organised from stand-alone clinics. In this cluster randomised trial, we are evaluating a concept of integrated care for people with HIV infection, diabetes or hypertension from a single point of care.

METHODS AND ANALYSIS: 32 primary care health facilities in Dar es Salaam and Kampala regions were randomised to either integrated or standard vertical care. In the integrated care arm, services are organised from a single clinic where patients with either HIV infection, diabetes or hypertension are managed by the same clinical and counselling teams. They use the same pharmacy and laboratory and have the same style of patient records. Standard care involves separate pathways, that is, separate clinics, waiting and counselling areas, a separate pharmacy and separate medical records. The trial has two primary endpoints: retention in care of people with hypertension or diabetes and plasma viral load suppression. Recruitment is expected to take 6 months and follow-up is for 12 months. With 100 participants enrolled in each facility with diabetes or hypertension, the trial will provide 90% power to detect an absolute difference in retention of 15% between the study arms (at the 5% two-sided significance level). If 100 participants with HIV infection are also enrolled in each facility, we will have 90% power to show non-inferiority in virological suppression to a delta=10% margin (ie, that the upper limit of the one-sided 95% CI of the difference between the two arms will not exceed 10%). To allow for lost to follow-up, the trial will enrol over 220 persons per facility. This is the only trial of its kind evaluating the concept of a single integrated clinic for chronic conditions in Africa.

ETHICS AND DISSEMINATION: The protocol has been approved by ethics committee of The AIDS Support Organisation, National Institute of Medical Research and the Liverpool School of Tropical Medicine. Dissemination of findings will be done through journal publications and meetings involving study participants, healthcare providers and other stakeholders.

TRIAL REGISTRATION NUMBER: ISRCTN43896688.

PMID:34645657 | DOI:10.1136/bmjopen-2020-047979

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Helicobacter pylori infection disturbs the tumor immune microenvironment and is associated with a discrepant prognosis in gastric de novo diffuse large B-cell lymphoma

J Immunother Cancer. 2021 Oct;9(10):e002947. doi: 10.1136/jitc-2021-002947.

ABSTRACT

BACKGROUND: Gastric diffuse large B-cell lymphoma (gDLBCL) related to Helicobacter pylori infection exhibits a wide spectrum of prognosis, and the tumor immune microenvironment (TIME) affects tumor progression. However, there are few studies on the correlation between prognosis and changes of TIME induced by H. pylori infection in de novo gDLBCL.

METHODS: A retrospective study was performed to determine the prognostic value of TIME related to H. pylori infection in de novo gDLBCL. A total of 252 patients were included and have been treated with standard rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy or other similar regimens in addition to H. pylori eradication (HPE). All patients were stratified by H. pylori infection, HPE efficacy, and preliminary TIME evaluation using conventional criteria. Statistical analyses were conducted. To assess the mechanism, 30 subjects were assessed for H. pylori infection. The components and spatial distributions of TIME were analyzed.

RESULTS: The median follow-up of the 252 patients was 66.6 months (range 0.7-119.2), and the 5-year overall survival (OS) was 78.0%. A total of 109 H. pylori-positive cases with pathological complete remission and high tumor-infiltrating T lymphocytes (cohort 1) had significantly higher 5-year progression-free survival (88.1% vs 70.5%, p<0.001) and OS (89.2% vs 76.6%, p<0.001) than the other 143 patients (cohort 2). Among 30 patients, 19 were cytotoxin-associated gene A-marked as the cohort 1 subset. Compared with cohort 2, cohort 1 exhibited increased inflammatory factors (tumor necrosis factor-α, interferon γ, etc) and decreased immunosuppressive components (PD-L1, PD-1, IL-10, etc). There was reduced NF-kB activation. Cancer-promoting immune cells (PD-1hiTim-3+ CTL, Tregs, M2-like macrophages, etc) occupied a minor spatial distribution, while the antitumor subtypes increased, corresponding to favorable survival.

CONCLUSION: H. pylori-evoked inflammatory responses disturb the TIME, causing a differential prognosis in de novo gDLBCL, which can be used to identify patients who could benefit from HPE and immunochemotherapy.

PMID:34645670 | DOI:10.1136/jitc-2021-002947

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Awareness of HPV-associated oropharyngeal cancers among GPs in the netherlands: cross-sectional study

BJGP Open. 2021 Oct 13:BJGPO.2021.0080. doi: 10.3399/BJGPO.2021.0080. Online ahead of print.

ABSTRACT

BACKGROUND: The incidence of human papillomavirus (HPV)-associated oropharyngeal cancer (OPC) is increasing in high-income countries. HPV-associated OPC generally presents as an invasive disease, often with lymph node involvement, in relatively young patients with minimal or no history of smoking and alcohol consumption. Knowledge on HPV-associated OPC among primary care professionals is essential for disease recognition and early start of treatment.

AIM: To examine the knowledge on HPV-associated OPC among general practitioners (GPs) in The Netherlands.

DESIGN AND SETTING: Cross-sectional postal survey among GPs in The Netherlands.

METHOD: twelve-item questionnaire was sent to 900 randomly selected general practices. Outcome measures included awareness of the link between HPV and OPC, epidemiological trends and patient characteristics. Data were statistically analyzed for gender, years after graduation, and self-rated knowledge of OPC.

RESULTS: 207 GPs participated in this study. 72% recognised HPV as a risk factor for OPC and 76.3% was aware of the increasing incidence rate of HPV-associated OPC. In contrast, 35.3% of participants knew that HPV-associated OPC patients are more often male, and just over half (53.6%) of the participants were aware of the younger age of these patients.

CONCLUSION: More than a quarter of GPs in The Netherlands is unaware of HPV as a causative factor for OPC. Furthermore, there is a gap in knowledge on HPV-associated OPC patient characteristics. Further training on these topics could improve disease recognition and ultimately patient survival.

PMID:34645653 | DOI:10.3399/BJGPO.2021.0080

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Broadband Dynamics Rather than Frequency-Specific Rhythms Underlie Prediction Error in the Primate Auditory Cortex

J Neurosci. 2021 Oct 12:JN-RM-0367-21. doi: 10.1523/JNEUROSCI.0367-21.2021. Online ahead of print.

ABSTRACT

Detection of statistical irregularities, measured as a prediction error response, is fundamental to the perceptual monitoring of the environment. We studied whether prediction error response is associated with neural oscillations or asynchronous broadband activity. Electrocorticography was conducted in three male monkeys, who passively listened to the auditory roving oddball stimuli. Local field potentials (LFPs) recorded over the auditory cortex underwent spectral principal component analysis, which decoupled broadband and rhythmic components of the LFP signal. We found that the broadband component captured the prediction error response, whereas none of the rhythmic components were associated with statistical irregularities of sounds. The broadband component displayed more stochastic, asymmetrical multifractal properties than the rhythmic components, which revealed more self-similar dynamics. We thus conclude that the prediction error response is captured by neuronal populations generating asynchronous broadband activity, defined by irregular dynamic states, which, unlike oscillatory rhythms, appear to enable the neural representation of auditory prediction error response.SIGNIFICANCE STATEMENTThis study aimed to examine the contribution of oscillatory and asynchronous components of auditory local field potentials in the generation of prediction error responses to sensory irregularities, as this has not been directly addressed in the previous studies. Here, we show that mismatch negativity-an auditory prediction error response-is driven by the asynchronous broadband component of potentials recorded in the auditory cortex. This finding highlights the importance of nonoscillatory neural processes in the predictive monitoring of the environment. At a more general level, the study demonstrates that stochastic neural processes, which are often disregarded as neural noise, do have a functional role in the processing of sensory information.

PMID:34645605 | DOI:10.1523/JNEUROSCI.0367-21.2021

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Biomarkers of response and resistance to palbociclib plus letrozole in patients with ER+/HER2- breast cancer

Clin Cancer Res. 2021 Oct 13:clincanres.1628.2021. doi: 10.1158/1078-0432.CCR-21-1628. Online ahead of print.

ABSTRACT

Purpose: To determine (i) the relationship between candidate biomarkers of the antiproliferative (Ki67) response to letrozole and palbociclib alone and combined in ER+/HER2- breast cancer; (ii) the pharmacodynamic effect of the agents on the biomarkers. Experimental design: 307 postmenopausal women with ER+/HER2- primary breast cancer were randomly assigned to neoadjuvant treatment with letrozole for 14 weeks; letrozole for 2 weeks, then letrozole+palbociclib to 14 weeks; palbociclib for 2 weeks, then letrozole+palbociclib to 14 weeks; or letrozole+palbociclib for 14 weeks. Biopsies were taken at baseline, 2 and 14 weeks and surgery at varying times after stopping palbociclib. Immunohistochemical analyses were conducted for Ki67, c-PARP, ER, PgR, RB1, CCNE1 and CCND1. Results: Higher baseline ER and PgR were significantly associated with a greater chance of Complete Cell Cycle Arrest (CCCA: Ki67 <2.7%) at 14 weeks and higher baseline Ki67, c-PARP and CCNE1 with a lower chance. The interaction with treatment was significant only for c-PARP. CCND1 levels were decreased c.20% by letrozole at 2 and 14 weeks but showed a tendency to increase with palbociclib. CCNE1 levels fell 82% (median) in tumours showing CCCA but were unchanged in those with no CCCA. Only 2/9 tumours showed CCCA 3-9 days after stopping palbociclib. ESR1 mutations were found in 2/4 tumours for which surgery took place {greater than or equal to}6 months after starting treatment. Conclusion: High CCNE1 levels were confirmed as a biomarker of resistance to letrozole+palbociclib. Ki67 recovery within 3-9 days of discontinuing palbociclib indicates incomplete suppression of proliferation during the “off” week of its schedule.

PMID:34645649 | DOI:10.1158/1078-0432.CCR-21-1628

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COVID-19 Vaccine and Fitness to Fly

Aerosp Med Hum Perform. 2021 Sep 1;92(9):698-701. doi: 10.3357/AMHP.5882.2021.

ABSTRACT

INTRODUCTION: On December 2020 the U.S. Food and Drug Administration (FDA) authorized the emergency use of Pfizer-BioNTech COVID-19 vaccine. This new vaccine has several side effects that can potentially impair function, which warrants special attention regarding aircrews fitness to fly following vaccination.METHODS: A survey was conducted in the Israeli Air Force (IAF) Aeromedical Center in order to characterize the side effects and their duration following Pfizer-BioNTech COVID-19 vaccine administration to aviators.RESULTS: The most common side effect was injection site pain. Headache, chills, myalgia, fatigue, and weakness were more common following the second dose administration. The difference is statistically significant. Following the second vaccine, duration of side effects was longer compared to the first vaccine (P-value 0.002).CONCLUSION: The IAF Aeromedical center policy for Pfizer-BioNTech COVID-19 vaccine recipients among aircrew members, based on side effects duration and severity, is to temporarily ground from flight duties for 24 and 48 h following the first and the second dose, respectively.Gabbai D, Ekshtein A, Tehori O, Ben-Ari O, Shapira S. COVID-19 vaccine and fitness to fly. Aerosp Med Hum Perform. 2021; 92(9):698701.

PMID:34645549 | DOI:10.3357/AMHP.5882.2021

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Evaluation of an online learning module to improve nurses

Aust J Prim Health. 2021 Oct 14. doi: 10.1071/PY21026. Online ahead of print.

ABSTRACT

Optimal parental preconception health improves the likelihood of a successful pregnancy and a healthy child. Although primary healthcare professionals believe that it is within their role to promote preconception health to people of reproductive age, few do this routinely, in part because they lack knowledge on the topic and confidence to discuss it with their patients. The aim of this study was to evaluate the efficacy and acceptability of a free online learning module to assist nurses and midwives in primary health care to promote preconception health in their practice. A repeat online survey was administered before and after completion of the online learning module. The survey included questions gauging knowledge about and attitudes towards promoting preconception health. In all, 121 nurses/midwives completed the two surveys and the learning module. There were statistically significant improvements in the knowledge scores (from 6.42 to 8.31; P < 0.001) and in the proportion of participants who reported feeling confident in their knowledge about preconception health (from 15% to 53%). Almost all (95%) were satisfied with the duration and content of the learning module. The findings of this study suggest that the learning module is acceptable and improves nurses’ and midwives’ capacity to promote preconception health in their practice.

PMID:34645562 | DOI:10.1071/PY21026