COVID-19 vaccine effectiveness against laboratory confirmed symptomatic SARS-CoV-2 infection, COVID-19 related hospitalizations and deaths, among individuals aged 65 years or more in Portugal: a cohort study based on data-linkage of national registries February-September 2021

Background: Using data from electronic health registries, this study intended to estimate the COVID-19 vaccine effectiveness in the population aged 65 years and more, against symptomatic infection, COVID-19 related hospitalizations and deaths, overall and by time since complete vaccination. Methods: We stablished a cohort of individuals aged 65 and more years old, resident in Portugal mainland, using the National Health Service unique identifier User number to link eight electronic health registries. Outcomes included were symptomatic SARS-CoV-2 infections, COVID-19 related hospitalizations or deaths. The exposures of interest were the mRNA vaccines (Cominarty or Spikevax) and the viral vector Vaxzevria vaccine. Complete scheme vaccine effectiveness (VE) was estimated as one minus the confounder adjusted hazard ratio, for each outcome, estimated by time-dependent Cox regression with time dependent vaccine exposure. Results: For the cohort of individuals aged 65-79 years, complete scheme VE against symptomatic infection varied between 43% (Vaxzevria) and 65% (mRNA vaccines). This estimate was slightly lower in the ≥80 year cohort (53% for mRNA vaccines. VE against COVID-19 hospitalization varied between 89% (95%CI: 52-94) for Vaxzevria and 95% (95%CI: 93-97) for mRNA vaccines for the cohort aged 65-79 years and was 76% (95%CI: 67-83) for mRNA vaccines in the ≥80 year cohort. High VE against COVID-19 related deaths were estimated, for both vaccine types, 95% and 81% for the 65-79 years and the ≥80 year cohort, respectively. We observed a significant waning of VE against symptomatic infection, with VE estimates reaching approximately 34% for both vaccine types and cohorts. Significant waning was observed for the COVID-19 hospitalizations in the ≥80 year cohort (decay from 83% 14-41 days to 63% 124 days after mRNA second dose). No significant waning effect was observed for COVID-19 related deaths in the period of follow-up of either cohorts. Conclusions: In a population with a high risk of SARS-CoV-2 complications, we observed higher overall VE estimates against more severe outcomes for both age cohorts when compared to symptomatic infections. Considering the analysis of VE according to time since complete vaccination, the results showed a waning effect for both age cohorts in symptomatic infection and COVID-19 hospitalization for the 80 and more yo cohort.

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The impact of statin therapy after surgical or endovascular treatment of cerebral aneurysms

Journal of Neurosurgery ◽

10.3171/2019.3.jns183500 ◽

2020 ◽

Vol 133 (1) ◽

pp. 182-189

Author(s):

Tae-Jin Song ◽

Seung-Hun Oh ◽

Jinkwon Kim

Keyword(s):

Statin Therapy ◽

Coil Embolization ◽

Primary Outcome ◽

Cox Regression ◽

Cerebral Aneurysms ◽

Time Dependent ◽

Lipid Lowering ◽

Surgical Clipping ◽

The Impact

OBJECTIVECerebral aneurysms represent the most common cause of spontaneous subarachnoid hemorrhage. Statins are lipid-lowering agents that may expert multiple pleiotropic vascular protective effects. The authors hypothesized that statin therapy after coil embolization or surgical clipping of cerebral aneurysms might improve clinical outcomes.METHODSThis was a retrospective cohort study using the National Health Insurance Service–National Sample Cohort Database in Korea. Patients who underwent coil embolization or surgical clipping for cerebral aneurysm between 2002 and 2013 were included. Based on prescription claims, the authors calculated the proportion of days covered (PDC) by statins during follow-up as a marker of statin therapy. The primary outcome was a composite of the development of stroke, myocardial infarction, and all-cause death. Multivariate time-dependent Cox regression analyses were performed.RESULTSA total of 1381 patients who underwent coil embolization (n = 542) or surgical clipping (n = 839) of cerebral aneurysms were included in this study. During the mean (± SD) follow-up period of 3.83 ± 3.35 years, 335 (24.3%) patients experienced the primary outcome. Adjustments were performed for sex, age (as a continuous variable), treatment modality, aneurysm rupture status (ruptured or unruptured aneurysm), hypertension, diabetes mellitus, household income level, and prior history of ischemic stroke or intracerebral hemorrhage as time-independent variables and statin therapy during follow-up as a time-dependent variable. Consistent statin therapy (PDC > 80%) was significantly associated with a lower risk of the primary outcome (adjusted hazard ratio 0.34, 95% CI 0.14–0.85).CONCLUSIONSConsistent statin therapy was significantly associated with better prognosis after coil embolization or surgical clipping of cerebral aneurysms.

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As Clinical Markers, Hand-Foot-Skin Reaction and Diarrhea Can Predict Better Outcomes for Hepatocellular Carcinoma Patients Receiving Transarterial Chemoembolization plus Sorafenib

Canadian Journal of Gastroenterology and Hepatology ◽

10.1155/2019/2576349 ◽

2019 ◽

Vol 2019 ◽

pp. 1-7

Author(s):

Lei Liu ◽

Enxin Wang ◽

Lin Li ◽

Dongyu Chen ◽

Kun Peng ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Combination Therapy ◽

Skin Reaction ◽

Transarterial Chemoembolization ◽

Cox Regression ◽

Time Dependent ◽

Clinical Markers ◽

Study Population ◽

Hand Foot Skin Reaction

Background. Combination therapy of transarterial chemoembolization plus sorafenib (TACE-S) has been proven to be safe and effective for hepatocellular carcinoma (HCC); however, this combination therapy is associated with a high incidence of adverse events (AEs). Our study focused on the relationships between AEs and treatment outcomes and aimed to discover AE-based clinical markers that can predict the survival benefits of combination treatment. Methods. From January 2010 to June 2014, a total of 235 HCC patients treated with TACE-S were retrospectively enrolled. Major sorafenib-related AEs were prospectively recorded, and their correlations with overall survival (OS) were analysed using time-dependent covariate Cox regression analyses. Results. The majority of the patients (200, 85.1%) were male, and the median age was 51 years old. After two years of follow-up, the median OS of the study population reached 12.4 months. In all, 218 patients (92.8%) presented at least one AE, and 174 (74.0%) suffered AEs ≥2 grade. Based on time-dependent multivariate analyses, the development of hand-foot skin reaction (HFSR) ≥2 grade (HR = 0.43, 95% CI: 0.32–0.58, P<0.001) and diarrhoea ≥1 grade (HR = 0.72, 95% CI: 0.53–0.97, P=0.029) were identified as independent predictors of prolonged OS. Moreover, patients who developed both HFSR ≥2 grade and diarrhoea ≥1 grade achieved better outcomes than those patients who developed either or neither of these AEs (HR = 1.51, 95% CI: 1.11–2.06, P=0.009). Conclusions. The development of HFSR ≥2 grade or diarrhoea ≥1 grade during TACE-S treatment indicated prolonged OS, and these AEs should be considered important clinical markers for predicting patient prognoses.

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Development of a Multivariable Prediction Model to Identify Patients Unlikely to Complete a Colonoscopy Following an Abnormal FIT Test in Community Clinics

10.21203/rs.3.rs-23641/v2 ◽

2020 ◽

Author(s):

Amanda Petrik ◽

Erin Keast ◽

Eric Johnson ◽

David H. Smith ◽

Gloria D. Coronado

Keyword(s):

Prediction Model ◽

Cox Regression ◽

Outreach Program ◽

Risk Levels ◽

C Statistic ◽

Clinic Site ◽

Flu Vaccine ◽

Using Data ◽

Priority Populations

Abstract Background: Colorectal cancer (CRC) is the 2nd leading cancer killer in the US. The Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) project aimed to increase CRC screening among patients in Federally Qualified Health Centers (FQHCs) through a mailed fecal immunochemical test (FIT) outreach program. However, rates of completion of the follow-up colonoscopy following an abnormal FIT remain low. We developed a multivariable prediction model using data available in the electronic health record to assess the probability of patients obtaining a colonoscopy following an abnormal FIT test. Methods: To assess the probability of obtaining a colonoscopy, we used Cox regression to develop a risk prediction model among a retrospective cohort of patients with an abnormal FIT result and a year of follow-up data. Results: Of 1596 patients with an abnormal FIT result, 556 (34.8%) had a recorded colonoscopy within 6 months. The model shows adequate separation of patients across risk levels for non-adherence to follow-up colonoscopy (bootstrap-corrected C-statistic > 0.63). The refined model included 8 variables: age, race, insurance, GINI income inequality, long term anticoagulant use, receipt of a flu vaccine in the past year, frequency of missed clinic appointments, and clinic site. Probability of obtaining a follow-up colonoscopy within 6 months varied across quintiles; patients in the lowest quintile had an estimated 18% chance, whereas patients in the top quintile had a greater than 55% chance of obtaining a follow-up colonoscopy. Conclusions: Knowing who is unlikely to follow-up on an abnormal FIT test could help identify patients who need an early intervention aimed at complete a follow-up colonoscopy. Trial registry: This trial was registered at ClinicalTrials.gov (NCT01742065) on December 5, 2012. The protocol is available.

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COVID-19 vaccine effectiveness among healthcare workers in Portugal: results from a hospital-based cohort study, December 2020 to November 2021

10.1101/2022.01.07.22268889 ◽

2022 ◽

Author(s):

Vânia Gaio ◽

Adriana Silva ◽

Palmira Amaral ◽

João Faro Viana ◽

Pedro Pinto Leite ◽

...

Keyword(s):

Cohort Study ◽

Healthcare Workers ◽

Vaccine Effectiveness ◽

Symptomatic Infection ◽

Cox Models ◽

Mainland Portugal ◽

Hazard Ratios ◽

Group Sex ◽

Tagus Valley

Introduction: Healthcare workers (HCW) were amongst the first prioritized for COVID-19 vaccination but data on COVID–19 vaccine effectiveness among HCW is still limited. This study aims to estimate the COVID–19 vaccine effectiveness (VE) against SARS–CoV–2 symptomatic infection among HCW from Portuguese hospitals. Methods: In this prospective cohort study, we analysed data from HCW (all professional categories) from two central hospitals in the Lisbon and Tagus Valley and Centre regions of mainland Portugal between December 2020 and November 2021. VE against symptomatic SARS–CoV–2 infection was estimated as one minus the confounder adjusted hazard ratios by Cox models considering age group, sex, presence of chronic disease and occupational exposure to patients diagnosed with COVID–19 as adjustment variables. Results: During the 11 months of follow up, the 2213 HCW contributed a total of 1950 person-years at risk and 171 SARS–CoV–2 events occurred. The COVID–19 incidence rate for unvaccinated HCW was 348.7 per 1000 person-years while for fully vaccinated HCW was 43.0 per 1000 person-years. We observed a VE against symptomatic SARS–CoV–2 infection of 73.9% (95% CI: 26.2–90.8%) for complete vaccination status. Conclusion: This cohort study found a high COVID-19 VE against symptomatic SARS–CoV–2 infection in Portuguese HCW, which is in concordance with previous studies from other countries. Monitoring of VE in this HCW cohort continues during the winter 2021/2022 to evaluate potential VE decay and booster vaccine effect. Keywords: Vaccine effectiveness, SARS–CoV–2 , COVID–19, symptomatic infection, healthcare workers.

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Vaccine effectiveness when combining the ChAdOx1 vaccine as the first dose with an mRNA COVID-19 vaccine as the second dose

10.1101/2021.07.26.21261130 ◽

2021 ◽

Author(s):

Mie Agermose Gram ◽

Hanne-Dorthe Emborg ◽

Ida Rask Moustsen-Helms ◽

Jens Nielsen ◽

Anne Katrine Bj&oslashrkholt S&oslashrensen ◽

...

Keyword(s):

Cohort Study ◽

Confidence Interval ◽

Cox Regression ◽

Population Based ◽

Vaccine Effectiveness ◽

Danish Population ◽

Calendar Time ◽

High Quality ◽

New Knowledge

Background: The recommendations in several countries to stop using the ChAdOx1 vaccine has led to vaccine programs combining different vaccine types, which necessitates new knowledge on vaccine effectiveness (VE). In this study, we aimed to estimate the VE when combining the ChAdOx1 vaccine as the first dose and an mRNA vaccine as the second dose. Methods: This nationwide population-based cohort study estimated VE against SARS-CoV-2 infection, all-cause and COVID-19 related hospitalization and death after receiving the ChAdOx1 vaccine as the first dose followed by an mRNA vaccine as the second dose. VE estimates were obtained using a Cox regression with calendar time as underlying time and adjusted for sex, age, comorbidity, heritage and hospital admission. Information on all individuals was extracted and linked from high-quality national registries. Results: A total of 5,542,079 individuals were included in the analyses (97.6% of the total Danish population). A total of 144,360 were vaccinated with the ChAdOx1 vaccine as the first dose and of these 136,551 individuals received an mRNA vaccine as the second dose. A total of 1,691,464 person-years and 83,034 cases of SARS-CoV-2 infection were included. The VE against SARS-CoV-2 infection when combining the ChAdOx1 and an mRNA vaccine was 88% (95% confidence interval (CI): 83; 92) 14 days after the second dose and onwards. There were no COVID-19 related hospitalizations and deaths among the individuals vaccinated with the combination of the ChAdOx1 and an mRNA vaccine during the study period. Conclusion: In conclusion, this study found a reduction in the risk of SARS-CoV-2 infection when combining the ChAdOx1 and an mRNA vaccine, compared with unvaccinated individuals. This is similar to the VE of two doses of an mRNA vaccine. Longer follow-up time is needed to confirm vaccine induced protection against severe events, such as COVID-19 related hospitalization and death.

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mRNA vaccines effectiveness against COVID-19 hospitalizations and deaths in older adults: a cohort study based on data-linkage of national health registries in Portugal

10.1101/2021.08.27.21262731 ◽

2021 ◽

Author(s):

Baltazar Nunes ◽

Ana Rodrigues ◽

Irina Kislaya ◽

Camila Cruz ◽

Andre Peralta-Santos ◽

...

Keyword(s):

Older Adults ◽

Cohort Study ◽

National Health ◽

Data Linkage ◽

Cox Regression ◽

Vaccine Effectiveness ◽

Hazard Ratio ◽

Time Dependent ◽

Age Group ◽

Vaccination Scheme

Background: We used electronic health registries to estimate the mRNA vaccine effectiveness (VE) against COVID-19 hospitalizations and deaths in older adults. Methods: We established a cohort of individuals aged 65 and more years, resident in Portugal mainland through data linkage of eight national health registries. For each outcome, VE was computed as one minus the confounder-adjusted hazard ratio, estimated by time-dependent Cox regression. Results: VE against COVID-19 hospitalization ≥14 days after the second dose was 94% (95%CI 88 to 97) for age-group 65-79 years old (yo) and 82% (95%CI 72 to 89) for ≥80 yo. VE against COVID-19 related deaths ≥ 14 days after second dose was 96% (95%CI 92 to 98) for age-group 65-79 yo and 81% (95%CI 74 to 87), for ≥80 yo individuals. No evidence of VE waning was observed after 98 days of second dose uptake. Conclusions: mRNA vaccine effectiveness was high for the prevention of hospitalizations and deaths in age-group 65-79 yo and ≥80 yo with a complete vaccination scheme, even after 98 days of second dose uptake.

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751Investigation of the obesity paradox in kidney cancer: mystifying association or myth?

International Journal of Epidemiology ◽

10.1093/ije/dyab168.274 ◽

2021 ◽

Vol 50 (Supplement_1) ◽

Author(s):

Alicia Heath ◽

Joanna Clasen ◽

Elio Riboli ◽

Ghislaine Scelo ◽

David Muller

Keyword(s):

Kidney Cancer ◽

Cox Regression ◽

Obesity Paradox ◽

Hazard Ratios ◽

Increased Risk ◽

Incidence And Mortality ◽

All Cause Mortality ◽

Using Data ◽

Restricted Cubic Splines

Abstract Background An “obesity paradox” has been reported in kidney cancer, whereby obesity is a risk factor, yet appears to be associated with better survival. To evaluate this paradox, we investigated the association between pre-diagnostic adiposity and renal cell carcinoma (RCC) incidence and mortality. Methods Using data from 363,521 men and women in the European Prospective Investigation into Cancer and Nutrition (EPIC), Cox regression models yielded confounder-adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for RCC incidence and mortality in relation to BMI modelled continuously and using restricted cubic splines. RCC-specific and all-cause mortality were evaluated among cases. Results During a mean follow-up of 14.9 years, 936 incident RCC cases were identified, 383 of whom died (278 due to RCC). Each 5 kg/m2 increment in BMI was associated with 27% and 46% higher RCC incidence and mortality (HRs=1.27, 95% CI 1.18-1.37 and 1.46, 95% CI 1.28-1.66, respectively). Comparing a BMI of 35 with 22 kg/m2, HRs for RCC incidence and mortality were 1.88 (95% CI 1.54-2.30) and 2.37 (95% CI 1.68-3.35), respectively. Among RCC cases, HRs per 5 kg/m2 increment in BMI were 1.22 (95% CI 1.07-1.41) for RCC-specific mortality and 1.18 (95% CI 1.04-1.34) for all-cause mortality. Similar, positive linear associations were evident for waist circumference and waist-to-hip ratio. Conclusions Obesity was associated with increased RCC incidence and mortality, and worse prognosis among cases. Key messages The kidney cancer-obesity paradox does not appear to be real. Higher adiposity is associated with an increased risk of incident and fatal RCC.

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Development of a Multivariable Prediction Model to Identify Patients Unlikely to Complete a Colonoscopy Following an Abnormal FIT Test in Community Clinics

10.21203/rs.3.rs-23641/v1 ◽

2020 ◽

Author(s):

Amanda Petrik ◽

Erin Keast ◽

Eric Johnson ◽

David H. Smith ◽

Gloria D. Coronado

Keyword(s):

Prediction Model ◽

Cox Regression ◽

Outreach Program ◽

Risk Levels ◽

C Statistic ◽

Clinic Site ◽

Flu Vaccine ◽

Using Data ◽

Priority Populations

Abstract Background Colorectal cancer (CRC) is the 2nd leading cancer killer in the US. The Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) project aimed to increase CRC screening among patients in Federally Qualified Health Centers (FQHCs) through a mailed fecal immunochemical test (FIT) outreach program. However, rates of completion of the follow-up colonoscopy following an abnormal FIT remain low. We developed a multivariable prediction model using data available in the electronic health record to assess the probability of patients obtaining a colonoscopy following an abnormal FIT test.Methods We used Cox regression to develop a risk prediction model among a retrospective cohort of patients with an abnormal FIT result and a year of follow-up data.Results Of 1723 patients with an abnormal FIT result, 699 (40.6%) had a colonoscopy within 1 year and 597 (34.6%) had a recorded colonoscopy within 6 months. The model shows adequate separation of patients across risk levels for non-adherence to follow-up colonoscopy (bootstrap-corrected C-statistic > 0.63). The refined model included 8 variables: age, race, insurance, GINI income inequality, long term anticoagulant use, receipt of a flu vaccine in the past year, frequency of missed clinic appointments, and clinic site. Probability of obtaining a follow-up colonoscopy within 6 months varied across quintiles; patients in the lowest quintile had an estimated 18% chance, whereas patients in the top quintile had a greater than 55% chance of obtaining a follow-up colonoscopy.Conclusions Knowing who may be at risk for failing to follow-up on an abnormal FIT test could help identify patients in need of early interventions aimed at completing a colonoscopy.Trial registry This trial was registered at ClinicalTrials.gov (NCT01742065) on December 5, 2012.

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The association between patterns of atrial fibrillation, anticoagulation, and cardiovascular events

EP Europace ◽

10.1093/europace/euz292 ◽

2019 ◽

Vol 22 (2) ◽

pp. 195-204 ◽

Cited By ~ 4

Author(s):

Dan Atar ◽

Eivind Berge ◽

Jean-Yves Le Heuzey ◽

Saverio Virdone ◽

A John Camm ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cardiovascular Events ◽

Cox Regression ◽

Risk Calculator ◽

Systemic Embolism ◽

Unique Identifier ◽

Clinical Trial Registration ◽

Risk Of Death ◽

Anticoagulated Patients

Abstract Aims Guidelines do not recommend to take pattern of atrial fibrillation (AF) into account for the indication of anticoagulation (AC). We assessed AF pattern and the risk of cardiovascular events during 2-years of follow-up. Methods and results We categorized AF as paroxysmal, persistent, or permanent in 29 181 patients enrolled (2010–15) in the Global Anticoagulant Registry In the FIELD of AF (GARFIELD-AF). We used multivariable Cox regression to assess the risks of stroke/systemic embolism (SE) and death across patterns of AF, and whether this changed with AC on outcomes. Atrial fibrillation pattern was paroxysmal in 14 344 (49.2%), persistent in 8064 (27.6%), and permanent 6773 (23.2%) patients. Median CHA2DS2-VASc, GARFIELD-AF, and HAS-BLED scores assessing the risk of stroke/SE and/or bleeding were similar across AF patterns, but the risk of death, as assessed by the GARFIELD-AF risk calculator, was higher in non-paroxysmal than in paroxysmal AF patterns. During 2-year follow-up, after adjustment, non-paroxysmal AF patterns were associated with significantly higher rates of all-cause death, stroke/SE, and new/worsening congestive heart failure (CHF) than paroxysmal AF in non-anticoagulated patients only. In anticoagulated patients, a significantly higher risk of death but not of stroke/SE and new/worsening CHF persisted in non-paroxysmal compared with paroxysmal AF patterns. Conclusion In non-anticoagulated patients, non-paroxysmal AF patterns were associated with higher risks of stroke/SE, new/worsening HF and death than paroxysmal AF. In anticoagulated patients, the risk of stroke/SE and new/worsening HF was similar across all AF patterns. Thus AF pattern is no longer prognostic for stroke/SE when patients are treated with anticoagulants. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362.

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Development of a multivariable prediction model to identify patients unlikely to complete a colonoscopy following an abnormal FIT test in community clinics

BMC Health Services Research ◽

10.1186/s12913-020-05883-2 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Amanda F. Petrik ◽

Erin Keast ◽

Eric S. Johnson ◽

David H. Smith ◽

Gloria D. Coronado

Keyword(s):

Prediction Model ◽

Cox Regression ◽

Outreach Program ◽

Risk Levels ◽

C Statistic ◽

Clinic Site ◽

Flu Vaccine ◽

Using Data ◽

Priority Populations

Abstract Background Colorectal cancer (CRC) is the 3rd leading cancer killer among men and women in the US. The Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) project aimed to increase CRC screening among patients in Federally Qualified Health Centers (FQHCs) through a mailed fecal immunochemical test (FIT) outreach program. However, rates of completion of the follow-up colonoscopy following an abnormal FIT remain low. We developed a multivariable prediction model using data available in the electronic health record to assess the probability of patients obtaining a colonoscopy following an abnormal FIT test. Methods To assess the probability of obtaining a colonoscopy, we used Cox regression to develop a risk prediction model among a retrospective cohort of patients with an abnormal FIT result. Results Of 1596 patients with an abnormal FIT result, 556 (34.8%) had a recorded colonoscopy within 6 months. The model shows an adequate separation of patients across risk levels for non-adherence to follow-up colonoscopy (bootstrap-corrected C-statistic > 0.63). The refined model included 8 variables: age, race, insurance, GINI income inequality, long-term anticoagulant use, receipt of a flu vaccine in the past year, frequency of missed clinic appointments, and clinic site. The probability of obtaining a follow-up colonoscopy within 6 months varied across quintiles; patients in the lowest quintile had an estimated 18% chance, whereas patients in the top quintile had a greater than 55% chance of obtaining a follow-up colonoscopy. Conclusions Knowing who is unlikely to follow-up on an abnormal FIT test could help identify patients who need an early intervention aimed at completing a follow-up colonoscopy. Trial registration This trial was registered at ClinicalTrials.gov (NCT01742065) on December 5, 2012. The protocol is available.

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