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Nevin Manimala Statistics

Association between circadian activity rhythms and mood episode relapse in bipolar disorder: a 12-month prospective cohort study

Transl Psychiatry. 2021 Oct 13;11(1):525. doi: 10.1038/s41398-021-01652-9.

ABSTRACT

A significant proportion of patients with bipolar disorder experience mood episode relapses. We examined whether circadian activity rhythms were associated with mood episode relapses in patients with bipolar disorder. This prospective cohort study included outpatients with bipolar disorder who participated in a study titled “Association between the Pathology of Bipolar Disorder and Light Exposure in Daily Life (APPLE) cohort study.” The participants’ physical activity was objectively assessed using a wrist-worn accelerometer over 7 consecutive days for the baseline assessment and then at the 12-month follow-up for mood episode relapses. The levels and timing of the circadian activity rhythms were estimated using a cosinor analysis and a nonparametric circadian rhythm analysis. Of the 189 participants, 88 (46%) experienced mood episodes during follow-up. The Cox proportional hazards model adjusting for potential confounders showed that a robust circadian activity rhythm, including midline-estimating statistic of rhythm (MESOR) and amplitude by cosinor analysis and 10 consecutive hours with the highest amplitude values (M10) by the nonparametric circadian rhythm analysis, was significantly associated with a decrease in mood episode relapses (per counts/min, hazard ratio [95% confidence interval]: MESOR, 0.993 [0.988-0.997]; amplitude, 0.994 [0.988-0.999]; and M10, 0.996 [0.993-0.999]). A later timing of the circadian activity rhythm (M10 onset time) was significantly associated with an increase in the depressive episode relapses (per hour; 1.109 [1.001-1.215]). We observed significant associations between circadian activity rhythms and mood episode relapses in bipolar disorder.

PMID:34645802 | DOI:10.1038/s41398-021-01652-9

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Nevin Manimala Statistics

Chagas disease and SARS-CoV-2 coinfection does not lead to worse in-hospital outcomes

Sci Rep. 2021 Oct 13;11(1):20289. doi: 10.1038/s41598-021-96825-3.

ABSTRACT

Chagas disease (CD) continues to be a major public health burden in Latina America. Information on the interplay between COVID-19 and CD is lacking. Our aim was to assess clinical characteristics and in-hospital outcomes of patients with CD and COVID-19, and to compare it to non-CD patients. Consecutive patients with confirmed COVID-19 were included from March to September 2020. Genetic matching for sex, age, hypertension, diabetes mellitus and hospital was performed in a 4:1 ratio. Of the 7018 patients who had confirmed COVID-19, 31 patients with CD and 124 matched controls were included (median age 72 (64-80) years-old, 44.5% were male). At baseline, heart failure (25.8% vs. 9.7%) and atrial fibrillation (29.0% vs. 5.6%) were more frequent in CD patients than in the controls (p < 0.05). C-reactive protein levels were lower in CD patients compared with the controls (55.5 [35.7, 85.0] vs. 94.3 [50.7, 167.5] mg/dL). In-hospital management, outcomes and complications were similar between the groups. In this large Brazilian COVID-19 Registry, CD patients had a higher prevalence of atrial fibrillation and chronic heart failure compared with non-CD controls, with no differences in-hospital outcomes. The lower C-reactive protein levels in CD patients require further investigation.

PMID:34645833 | DOI:10.1038/s41598-021-96825-3

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Nevin Manimala Statistics

A cross-sectional analysis of meteorological factors and SARS-CoV-2 transmission in 409 cities across 26 countries

Nat Commun. 2021 Oct 13;12(1):5968. doi: 10.1038/s41467-021-25914-8.

ABSTRACT

There is conflicting evidence on the influence of weather on COVID-19 transmission. Our aim is to estimate weather-dependent signatures in the early phase of the pandemic, while controlling for socio-economic factors and non-pharmaceutical interventions. We identify a modest non-linear association between mean temperature and the effective reproduction number (Re) in 409 cities in 26 countries, with a decrease of 0.087 (95% CI: 0.025; 0.148) for a 10 °C increase. Early interventions have a greater effect on Re with a decrease of 0.285 (95% CI 0.223; 0.347) for a 5th – 95th percentile increase in the government response index. The variation in the effective reproduction number explained by government interventions is 6 times greater than for mean temperature. We find little evidence of meteorological conditions having influenced the early stages of local epidemics and conclude that population behaviour and government interventions are more important drivers of transmission.

PMID:34645794 | DOI:10.1038/s41467-021-25914-8

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Association between workplace bullying and common mental disorders in civil servants from a middle-income country

Ind Health. 2021 Oct 12. doi: 10.2486/indhealth.2021-0049. Online ahead of print.

ABSTRACT

Workplace bullying (WB) is associated with Common mental disorders (CMD) in high-income countries, but there is a lack of evidence relating to this subject in low- and middle-income countries. Therefore, this study aimed to investigate the association between bullying and CMD in Brazil. A cross-sectional study with 907 judicial civil servants from Porto Alegre, southern Brazil, was carried out. WB was measured by the Negative Acts Questionnaire(NAQ-r) and CMD by the Self-Report Questionnaire(SRQ-20). Logistic regression was used to analyse data and test hypotheses. The overall prevalence of CMD was 32.8%, while the overall prevalence of bullying was 18.3%. WB was strongly associated with CMD, even after controlling for confounders. After adjustment for sociodemographic, personality and occupational confounders, weekly and daily exposures to negative acts increased 4.32 (95% CI: 2.00-9.33) and 6.80 (95% CI: 3.42-13.51) times the risk of CMD, respectively. Considering the operational definition, bullied workers had a 3.45 (95% CI: 2.26-5.25) higher risk of CMD. The results are consistent with studies from high-income countries. Different ways of categorising exposure to WB and testing association with CMD are suggested. Interventions to prevent bullying, focusing on work processes and psychosocial factors at work, could reduce the risk of mental health problems.

PMID:34645741 | DOI:10.2486/indhealth.2021-0049

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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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Nevin Manimala Statistics

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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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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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