Interim Estimates of COVID-19 Vaccine Effectiveness in a Mass Vaccination Setting: Data from an Italian Province

This retrospective cohort study compared the rates of virologically-confirmed SARS-CoV-2 infections, symptomatic or lethal COVID-19 among the residents of the Italian province of Pescara who received one or two doses of COVID-19 vaccines, versus the unvaccinated. The official data of the National Health System were used, and a total of 69,539 vaccinated adults were compared with 175,687 unvaccinated. Among the subjects who received at least one vaccine dose, 85 infections (0.12%), 18 severe and 3 lethal COVID-19 cases were recorded after an average follow-up of 38 days. Among the unvaccinated, the numbers were 6948 (4.00%), 933 (0.53%) and 241 (0.14%), respectively. The serious adverse event reports—yet unconfirmed—were 24 out of 102,394 administered doses. In a Cox model, adjusting for age, gender, and selected comorbidities, the effectiveness of either BNT162b2, ChAdOx1 nCoV-19 or mRNA-1273 vaccines was higher than 95% in preventing infections (mostly due to B.1.1.7 variant), symptomatic or lethal COVID-19. No differences were observed across genders, and among the 691 subjects who received the second dose of vaccine later than the recommended date. Although preliminary, these findings support current immunization policies and may help reducing vaccine hesitancy.

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Epidemiology and resource use in Spanish type 2 diabetes patients without previous cardiorenal disease: CaReMe Spain study

10.21203/rs.3.rs-284316/v1 ◽

2021 ◽

Author(s):

Antoni Sicras-Mainar ◽

Aram Sicras-Navarro ◽

Beatriz Palacios ◽

Miren Sequera ◽

Julia Blanco ◽

...

Keyword(s):

Type 2 Diabetes ◽

Kidney Disease ◽

Resource Use ◽

Cox Model ◽

National Health System ◽

Secondary Data ◽

Baseline Characteristics ◽

Artery Disease

Abstract Background.To determine baseline characteristics, the first manifestation of cardiovascular or kidney disease (CVKD) and associated resource use in type 2 diabetes mellitus (T2DM) patients during 7 years of follow up. Methods.Observational-retrospective secondary data study using medical records of patients aged ≥18 years with T2DM and without prior CVKD during 2013-2019. The index date was 01/01/2013 (fixed date). The manifestation of CVKD was defined by the first diagnosis of heart failure (HF), chronic kidney disease (CKD), myocardial infarction (MI), stroke or peripheral artery disease (PAD). The main variables were baseline characteristics, manifestation of CVKD, mortality, resource use and costs (health, indirect related). Descriptive analyses and Cox model were applied to the data.Results.26,542 patients were selected (mean age: 66.6 years, women: 47.8%, mean duration of T2DM: 17.1 years). 18.7% (N=4974) developed a first CVKD manifestation during the 7 years [distribution: HF (22.4%), CKD (36.6%), MI (14.5%), stroke (15.3%) and PAD (11.3%)]. Overall mortality was 8.3% (N=2,214). The mortality risk of the group that developed HF or CKD as the first manifestation compared to the CVKD-free cohort was higher [HR: 2.5 (CI95%: 1.8-3.4) and 1.8 (95%CI: 1.4-2,3)], respectively. The cumulative costs per patient of HF (€50,942.8) and CKD (€48,979.2) were higher than MI (€47.343.2) and stroke (€47,070.3) and similar to PAD (€51,240,0) vs. €13,098.9 in patients who did not develop CVKD, p<0.001.Conclusions.In T2DM patients, HF and CKD were the first most common manifestations over the 7 years of follow up and had higher mortality and re-hospitalization rates. HF and CKD were associated with the highest resource use and costs for the Spanish National Health System.

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Analysis of loss to follow-up in 4099 multidrug-resistant pulmonary tuberculosis patients

European Respiratory Journal ◽

10.1183/13993003.00353-2018 ◽

2019 ◽

Vol 54 (1) ◽

pp. 1800353 ◽

Cited By ~ 1

Author(s):

Ian F. Walker ◽

Oumin Shi ◽

Joseph P. Hicks ◽

Helen Elsey ◽

Xiaolin Wei ◽

...

Keyword(s):

Risk Factors ◽

Adverse Event ◽

Treatment Success ◽

Multidrug Resistant ◽

Cox Proportional Hazards Model ◽

Serious Adverse Event ◽

Loss To Follow Up ◽

Factors Associated ◽

Mdr Tb

Loss to follow-up (LFU) of ≥2 consecutive months contributes to the poor levels of treatment success in multidrug-resistant tuberculosis (MDR-TB) reported by TB programmes. We explored the timing of when LFU occurs by month of MDR-TB treatment and identified patient-level risk factors associated with LFU.We analysed a dataset of individual MDR-TB patient data (4099 patients from 22 countries). We used Kaplan–Meier survival curves to plot time to LFU and a Cox proportional hazards model to explore the association of potential risk factors with LFU.Around one-sixth (n=702) of patients were recorded as LFU. Median (interquartile range) time to LFU was 7 (3–11) months. The majority of LFU occurred in the initial phase of treatment (75% in the first 11 months). Major risk factors associated with LFU were: age 36–50 years (HR 1.3, 95% CI 1.0–1.6; p=0.04) compared with age 0–25 years, being HIV positive (HR 1.8, 95% CI 1.2–2.7; p<0.01) compared with HIV negative, on an individualised treatment regimen (HR 0.7, 95% CI 0.6–1.0; p=0.03) compared with a standardised regimen and a recorded serious adverse event (HR 0.5, 95% CI 0.4–0.6; p<0.01) compared with no serious adverse event.Both patient- and regimen-related factors were associated with LFU, which may guide interventions to improve treatment adherence, particularly in the first 11 months.

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Growth Hormone Treatment and Risk of Second Neoplasms in the Childhood Cancer Survivor

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2006-0656 ◽

2006 ◽

Vol 91 (9) ◽

pp. 3494-3498 ◽

Cited By ~ 185

Author(s):

Berrin Ergun-Longmire ◽

Ann C. Mertens ◽

Pauline Mitby ◽

Jing Qin ◽

Glenn Heller ◽

...

Keyword(s):

Cancer Survivors ◽

Childhood Cancer ◽

Cancer Survivor ◽

Retrospective Cohort ◽

Rate Ratio ◽

Cox Model ◽

Childhood Cancer Survivor ◽

Second Neoplasms ◽

Increased Risk

Abstract Context: GH deficiency is common in childhood cancer survivors. In a previous report, although we did not find an increase in the risk of disease recurrence in survivors treated with GH, GH-treated survivors did have an increased risk of developing a second neoplasm (SN) (rate ratio, 3.21). Objective: In this analysis, we have reassessed the risk of GH-treated survivors developing an SN after an additional 32 months of follow-up. Design and Setting: We conducted a retrospective cohort multicenter study. Patients: Among a total of 14,108 survivors who were enrolled in the Childhood Cancer Survivor Study, a retrospective cohort of 5-yr survivors of childhood cancer, we identified 361 who were treated with GH. Main Outcome: We assessed the risk of developing an SN. Results: During the extended follow-up, five new SN developed in survivors treated with GH, for a total of 20 SN, all solid tumors. Using a time-dependent Cox model, the rate ratio of GH-treated survivors developing an SN, compared with non-GH-treated survivors, was 2.15 (95% confidence interval, 1.3–3.5; P < 0.002). Meningiomas were the most common SN (n = 9) among the GH-treated group. Conclusion: Although cancer survivors treated with GH appear to have an increased risk of developing SN compared with survivors not so treated, the elevation of risk due to GH use appears to diminish with increasing length of follow-up. Continued surveillance is essential.

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Associated Factories and Time to Occurrence of Tuberculosis Among Children on HIV/AIDS Care in Assosa and Pawe General Hospitals North West Ethiopia: A Retrospective Cohort Study 2020

10.21203/rs.3.rs-118270/v1 ◽

2020 ◽

Author(s):

Fassikaw kebede Bizuneh ◽

Tadese Tollosa Daba ◽

Belayneh Mengist Mitike ◽

Tamrat sheawno Fikretsion ◽

Belete Negese Negese

Keyword(s):

Cohort Study ◽

Retrospective Cohort Study ◽

Retrospective Cohort ◽

Cox Regression ◽

Cox Model ◽

Incidence Density ◽

Human Immune Deficiency Virus ◽

Cox Regression Analysis ◽

Hiv Aids

Abstract Background: Tuberculosis (TB) incidence in peadtrics and children living with human immune-deficiency virus (HIV) is an emerging global concern. Although, the incidence of TB among adult HIV patients is exhaustively studied in Ethiopia, but among children on HIV/AIDS care is overlooked. Knowledge of the time when TB develops during successive follow up could be helpful for time relevant intervention strategies.Methods: health institution based retrospective cohort study conducted among 421 children on HIV/AIDS from 2009-2018. Time to develop TB was defined as time from enrollment for ART care until development of TB among children on ART. Proportional hazard assumption was checked for each variable and no variable was found with Schoenfeld test <0.05. Variables with P-value <0.25 at bivariate Cox regression analysis were entered into multivariable Cox model. Multivariable Cox regression model with 95%CI and AHR was used to identify significant predictor variables to develop TB at P< 0.05.Result: Totally 421 children were followed for a total of 662.5 Person Years of observation (PYO). The maximum and minimum follow up time on ART was 0.37 and 4.49 years, respectively. The median age of the children on ART at enrollment was 8 years (IQR=2-15). The Overall incidence density of tuberculosis in HIV infected children was 9.6/ 100 PYOs 95%CI (8.06-10.3). Tuberculosis occurrence among HIV infected children was significantly associated within TB history of contact AHR=3.7, 95%CI (2.89-7.2), not started on cotrimoxazole(CPT) AHR=2.4: 95%CI (1.84-4.74), incomplete vaccination AHR=2.4, 95%CI (1.32-4.5), sever stunting AHR =2.99:95%CI (1.2-7.81), having hemoglobin (Hgb) ≤10 mg/dl AHR = 4.02, 95%CI (2.01-8.1).Conclusion: More than 80% of TB incidences occurred during two years of follow up after ART started. So intensified screening of CPT& therapeutic feeding is highly recommended for all children.

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Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies

Frontiers in Pharmacology ◽

10.3389/fphar.2021.747416 ◽

2021 ◽

Vol 12 ◽

Author(s):

Hui Tian ◽

Xuan Wang ◽

Bin Lian ◽

Xieqiao Yan ◽

Lu Si ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Event ◽

Treatment Duration ◽

Retrospective Cohort ◽

Regression Models ◽

Antiangiogenic Therapy ◽

Risk Models ◽

Clinical Trial Registration ◽

Logistic Regression Models

Objective: To describe the frequency and spectrum of treatment-related adverse events (TRAEs) of immunotherapy combined with antiangiogenic therapy in patients with melanoma.Methods: This retrospective cohort study included three clinical trials on patients with stage III/IV melanoma treated with anti–PD 1 and antiangiogenic therapy.Results: We analyzed data from 72 patients with a median follow-up time of 25.9 months (95% CI, 9.1–42.7 m). The median treatment duration was 7.5 months (range, 0.7–42.8 m), and the median of treatment cycles was 11.0 (range, 1–90). Most patients (70 of 72 or 97.2%) experienced TRAEs (mostly grades 1 or 2). No drug-related deaths were reported. Most TRAEs were hepatic (75%), endocrine (72.2%), skin (65.3%), and gastrointestinal tract (59.7%) manifestations, followed by myelosuppression (55.6%), renal dysfunction (55.6%), and dyslipidaemia (54.2%). The adverse event (AE) spectra were similar between regimens. Using multivariate Cox proportional risk models showed that hypertension was associated with a long PFS. According to our multivariable logistic regression models, TRAEs were not associated with ORR.Conclusion: We found that the prevalence of AEs was higher than that of anti–PD-1 monotherapy. Most of the AEs were mild. The AE spectra were similar to those seen after anti–PD-1 or antiangiogenic therapy monotherapy, without unexpected AEs. Immunotherapy combined with antiangiogenic therapy was well tolerated.Clinical Trial Registration: ClinicalTrials.gov, identifier NCT03955354.

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Time to develop tuberculosis and predictors of incidence among anti-retroviral therapy children on two selected hospitals at benishangule Gumuz region, North West Ethiopia: A retrospective cohort study

10.21203/rs.3.rs-18481/v1 ◽

2020 ◽

Author(s):

Fassikaw kebede Bizuneh ◽

Tadese Tolossa Daba ◽

Belayneh Mengist Mitiku ◽

Tamrat shewano Fikretsion

Keyword(s):

Cohort Study ◽

Retrospective Cohort Study ◽

Retrospective Cohort ◽

Cox Regression ◽

Cox Model ◽

Incidence Density ◽

Human Immune Deficiency Virus ◽

Cox Regression Analysis ◽

North West

Abstract Background: Currently, tuberculosis (TB) incidence in peadtrics and children living with human immune-deficiency virus (HIV) is an emerging global concern. Although, the incidence of TB among adult HIV patients is exhaustively studied; the incidence of TB among children on ART is overlooked. Knowledge of the time when TB develops among children on ART could be helpful to develop time relevant intervention strategies.Methods: This was a hospital based retrospective cohort study conducted among 429 children on ART from 2009-2018. Time to develop TB was defined as time from enrollment for ART care until development of TB among children on ART. Proportional hazard assumption was checked for each variable and no variable was found with Schoenfeld test <0.05. Variables with P-value <0.25 at bivariate Cox regression analysis were entered into multivariable Cox model. Multivariable Cox regression model with 95%CI and AHR was used to identify significant predictor variables to develop TB at P< 0.05Result: 421 children were followed for a total of 662.5 Person Years of observation (PYO). The maximum and minimum follow up time on ART was 0.37 and 4.49 years, respectively. The median age of the children on ART at enrollment was 9 years (SD=3.36). The Overall incidence density of tuberculosis in HIV infected children was 9.6/ 100 PYOs 95%CI (8.06-10.3). Tuberculosis occurrence among HIV infected children was significantly associated within TB history of contact AHR=3.7, 95%CI (2.89-7.2), not started on cotrimoxazole(CPT) AHR=2.4: 95%CI (1.84-4.74), incomplete vaccination AHR=2.4, 95%CI (1.32-4.5), sever stunting AHR =2.99:95%CI (1.2-7.81), having hemoglobin (Hgb) ≤10 mg/dl AHR = 4.02, 95%CI (2.01-8.1)Conclusion: More than 80% of TB incidences occurred during two years of follow up after ART started. So intensified screening of CPT& therapeutic feeding is highly recommended for all children

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Emergency Department Admission and Mortality Rate for Suicidal Behavior

Crisis ◽

10.1027/0227-5910/a000282 ◽

2014 ◽

Vol 35 (6) ◽

pp. 406-414 ◽

Cited By ~ 10

Author(s):

Raimondo Maria Pavarin ◽

Angelo Fioritti ◽

Francesca Fontana ◽

Silvia Marani ◽

Alessandra Paparelli ◽

...

Keyword(s):

Emergency Department ◽

Metropolitan Area ◽

Suicidal Behavior ◽

Mortality Risk ◽

Illicit Drugs ◽

Attempted Suicide ◽

Cox Model ◽

Emergency Department Admission ◽

Completed Suicide

Background: The international literature reports that for every completed suicide there are between 8 and 22 visits to an Emergency Department (ED) for attempted suicide/suicidal behavior. Aims: To describe the characteristics of admission to emergency departments (EDs) for suicide-related presenting complaints in the metropolitan area of Bologna; to estimate the risk for all-cause mortality and for suicide; to identify the profiles of subjects most at risk. Method: Follow-up of patients admitted to the EDs of the metropolitan area of Bologna between January 2004 and December 2010 for attempted suicide. A Cox model was used to evaluate the association between sociodemographic variables and the general mortality risk. Results: We identified 505 cases of attempted suicide, which were more frequent for female subjects, over the weekend, and at night (8:00 p.m./8:00 a.m.). The most used suicide methods were psychotropic drugs, sharp or blunt objects, and jumping from high places. In this cohort, 3.6% of subjects completed suicide (4.5% of males vs. 2.9% of females), 2.3% within 1 year of the start of follow-up. The most common causes of death were drug use and hanging. In the multivariate analysis, those who used illicit drugs 24 hr prior to admission to the ED (hazard ratio [HR] = 3.46, 95% CI = 1.23–9.73) and patients who refused the treatment (HR = 6.74, 95% CI = 1.86–24.40) showed an increased mortality risk for suicide. Conclusion: Deliberate self-harm patients presenting to the ED who refuse treatment represent a specific target group for setting up dedicated prevention schemes.

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