scholarly journals Controlling Confounding in a Study of Oral Anticoagulants: Comparing Disease Risk Scores Developed Using Different Follow-Up Approaches

2019 ◽  
Vol 7 (1) ◽  
pp. 27
Author(s):  
Justin Bohn ◽  
Sebastian Schneeweiss ◽  
Robert J. Glynn ◽  
Sengwee Toh ◽  
Richard Wyss ◽  
...  
Keyword(s):  
Disease Risk ◽  
Oral Anticoagulants ◽  
Risk Scores

scholarly journals GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e033283 ◽  
Author(s):  
Frederik Dalgaard ◽  
Karen Pieper ◽  
Freek Verheugt ◽  
A John Camm ◽  
Keith AA Fox ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Risk Model ◽  
Oral Anticoagulants ◽  
External Validation ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Secondary Outcome

ObjectivesTo externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular AF in a population-based cohort.DesignRetrospective cohort study.SettingDanish nationwide registries.Participants90 693 patients with newly diagnosed non-valvular AF were included between 2010 and 2016, with follow-up censored at 1 year.Primary and secondary outcome measuresExternal validation was performed using discrimination and calibration plots. C-statistics were compared with CHA2DS2VASc score for ischaemic stroke/systemic embolism (SE) and HAS-BLED score for major bleeding/haemorrhagic stroke outcomes.ResultsOf the 90 693 included, 51 180 patients received oral anticoagulants (OAC). Overall median age (Q1, Q3) were 75 (66–83) years and 48 486 (53.5%) were male. At 1-year follow-up, a total of 2094 (2.3%) strokes/SE, 2642 (2.9%) major bleedings and 10 915 (12.0%) deaths occurred. The GARFIELD-AF model was well calibrated with the predicted risk for stroke/SE and major bleeding. The discriminatory value of GARFIELD-AF risk model was superior to CHA2DS2VASc for predicting stroke in the overall cohort (C-index: 0.71, 95% CI: 0.70 to 0.72 vs C-index: 0.67, 95% CI: 0.66 to 0.68, p<0.001) as well as in low-risk patients (C-index: 0.64, 95% CI: 0.59 to 0.69 vs C-index: 0.57, 95% CI: 0.53 to 0.61, p=0.007). The GARFIELD-AF model was comparable to HAS-BLED in predicting the risk of major bleeding in patients on OAC therapy (C-index: 0.64, 95% CI: 0.63 to 0.66 vs C-index: 0.64, 95% CI: 0.63 to 0.65, p=0.60).ConclusionIn a nationwide Danish cohort with non-valvular AF, the GARFIELD-AF model adequately predicted the risk of ischaemic stroke/SE and major bleeding. Our external validation confirms that the GARFIELD-AF model was superior to CHA2DS2VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.

scholarly journals Real-Life Data and a Single Center Experience on the Efficacy and Toxicity Profile of Imatinib in the Treatment of Elderly Patients with Chronic Myeloid Leukemia

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1905-1905
Author(s):  
Ahmet Emre Eskazan ◽  
Mert Oztas ◽  
Fatih Bektas ◽  
Sevil Sadri ◽  
Dilek Keskin ◽  
...  
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Disease Risk ◽  
Disease Stage ◽  
Risk Scores ◽  
Study Patient ◽  
Molecular Responses ◽  
Group A ◽  
Group B

Abstract Background: Although it may vary between different registries, the median age of chronic myeloid leukemia (CML) at diagnosis is between 50-60 years, and approximately 40% of the patients (pts) are diagnosed after age 60 [Hoffmann et al. Leukemia. 2015;29(6):1336-43]. Tyrosinekinase inhibitors (TKIs) have revolutionized the treatment of CML and currently pts with CML may expect to live close to normal lifespan. So the number of elderly CML pts with various potentialcomorbidities started to increase, which then brings out the issues regarding TKI toxicities, medication adherence and responses to TKI treatment. Aim: The aim of this study was to evaluate the efficacy and safety ofimatinib treatment in the elderly population (pts equal to or older than 60 years) with CML and to compare these data with younger pts (pts < 60 years). Patients and Methods: Pts diagnosed and followed in our clinic with CML were enrolled in the study. Patient demographics, dose and duration ofimatinib therapy, disease risk scores, cytogenetic and molecular responses,comorbidities, adverse events (AEs), follow-up durations and outcomes were evaluated from files of the pts, retrospectively. TheCharlsoncomorbidity index (CCI) of each patient was calculated as stated before [Breccia et al.Haematologica. 2011;96(10):1457-61]. Results: The patient cohort was consisted of 158 pts with a median age of 44 years (range, 18 - 83 years). Group A consisted of thirty-three pts who were equal to or older than 60 years (Fig. 1), and there were 125 pts (Group B) who were < 60 years of age (Table 1). The two groups were balanced regarding gender, disease stage, treatments prior to TKI therapy, and the starting dose ofimatinib. There were more pts with intermediate and highSokal risk scores in Group A than that of Group B (p<0.001). Pts in Group A had significantly morecomorbidities (p<0.001) and higher CCI scores (p<0.001) than pts who were < 60 years of age (Table 1). Median time ofimatinib exposure (p=0.001) and follow-up durations (p<0.001) were significantly longer in Group B than those of Group A. There were significantly more hematologicAEs among pts in Group A than pts in Group B (24% vs. 7%, p=0.005). Although not statistically significant, non-hematologicAEs were more common in GroupA (18% vs. 7%, p=0.056), and the rates ofimatinib dose reduction due toAEs were significantly higher in Group A than Group B (33% vs. 9%, p<0.001). Cumulative complete cytogenetic (CCyR) and major molecular (MMR) response rates and the percentage of pts who switched to second-generationTKIs (2GTKIs) were similar in both groups (Table 1). Event-free survival (EFS) rates were comparable (Fig. 2A), however overall survival (OS) rate was significantly higher in Group B (Fig. 2B) (p<0.001). There were 7 pts in both groups who died during the follow-up, but five and 2 pts died due to non-CML related causes in Groups A and B, respectively. OS rates were similar in both groups when non-CML related deaths were excluded (Fig. 2C). Discussion: TKI therapy is relatively safe in elderly pts with CML, and cytogenetic and molecular responses are comparable with that observed in younger pts. In our institute, where pts are followed in a dedicated outpatient CML clinic, cytogenetic and molecular responses were similar in both elderly and younger pts leading to similar percentages of pts who were switched to 2GTKI therapy in both groups. Comorbidities can be problematic in elderly pts in whom CML and TKI relatedAEs are more common. However proper management of theseAEs including careful follow-up and timely TKI dose reductions may lead to successful outcomes. Inferior OS rates were observed in elderly pts with CML, but OS rates were similar in both groups when non-CML related deaths were excluded. Disclosures No relevant conflicts of interest to declare.

P019 OPTIMIZING NUTRITION RISK SCREENING AND FOLLOW-UP NUTRITION COUNSELING IN AN OUTPATIENT INFLAMMATORY BOWEL DISEASE POPULATION

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S54-S54
Author(s):  
Therezia AlChoufete ◽  
Siobhan Proksell ◽  
Marc Schwartz ◽  
Cassie Myers ◽  
Emily Weaver ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Screening Tool ◽  
Disease Risk ◽  
Nutrition Status ◽  
Risk Scores ◽  
Nutrition Screening ◽  
Nutrition Risk ◽  
Inflammatory Bowel

Abstract Background As management of Inflammatory Bowel Disease (IBD) advances, the outpatient (OP) population is shifting its fears from risks of malnutrition to those associated with over-nutrition and under-nutrition, lack of diet education, access to resources, mental health implications, and socioeconomic status. Failure to identify a patient at nutrition risk could lead to increased costs of care which can be avoided by proper nutrition screening and counseling with a Registered Dietitian (RD). The integration of nutrition counseling into the interdisciplinary care model for patients with IBD needs to be optimized to identify a broader range of risks to nutrition status in an efficient and objective format that can be applied universally in the OP IBD setting. Aims This study 1) explores a novel approach to nutrition risk screening within the OP IBD setting using an interdisciplinary team approach; and 2) evaluates correlations between an objective scoring method for biological and psychosocial risk with nutrition risk scores reported by an RD. Methods Two objective nutrition risk scoring methods were developed to capture biological (NUTR-OBJ) and lifestyle (NUTR-WELL) nutrition factors on a 0–6 scale (low-severe risk). Scores were determined using review of the electronic health record and a screening tool provided to patients. These scores were compared to the previously established IBD Biopsychosocial Complexity Grid, a tool which organizes this health information into biological and psychological domains and serves as the basis for algorithm-driven treatment plans within an IBD Medical Home. Results Data from 44 patients (mean age:35.2 years;47.7% female;56.8% Crohn’s Disease) were included in this study. BMI ranged from 18.08 to 37.92 kg/m2. BIO-C-PRO (mean=1.95,SD 1.86) and BIO-C-OBJ (mean 1.59, SD 1.76) indicate mild overall disease risk within our sample. NUTR-OBJ scores (mean=2.39, SD 1.28) showed no significant correlations with biological (BIO-C-PRO/OBJ) or psychosocial (PSY-C/H;SOC-SES;MI-C) scores. NUTR-WELL (mean=1.98,SD 1.36) showed strong positive correlations with PSY-C (r=.326, p&lt;.05), PSY-H (r=.386,p&lt;.01), SOC-SES (r=.306,p&lt;.05), and MI-C (r=.473,p&lt;.01). Discussion This study indicates a significant correlation between NUTR-WELL scores and psychosocial scores, suggesting validity for this nutrition screening tool to determine behaviors that may increase nutrition risk. Poor correlations between NUTR-OBJ and biological scores suggests that the need for nutrition intervention may not always be indicated by disease severity. This scoring system can potentially serve as a guide to maximize efficiency of follow-up appointments with an RD and avoid complications of care related to poor nutrition status that may be unidentified by disease risk alone. Further research is needed to confirm findings and extend to a larger sample.

P6258Direct oral anticoagulants in non-valvular atrial fibrillation: accuracy of traditional bleeding scores in the elderly

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Novello ◽  
A Graceffa ◽  
C Ninivaggi ◽  
G I Greco ◽  
F Bonfante ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Roc Curves ◽  
Bleeding Risk ◽  
Discriminatory Power ◽  
Risk Scores

Abstract Background Due to the fear of increased risk of bleeding, anticoagulation treatment is underutilized in the prevention of stroke in elderly patients with non-valvular atrial fibrillation (NVAF). Although direct oral anticoagulants (DOAC) are safer than VKA, still little is known about the risk factors associated with bleeding in elderly patients treated with DOAC. Furthermore, it is still uncertain whether the risk scores that are currently used can serve to effectively identify higher bleeding risk in elderly subjects. Purpose The aim of this study was to identify predictors of bleeding in a cohort of elderly people affected by NVAF treated with DOAC, and to evaluate the accuracy of risk scores for bleeding used at present. Methods Data on outpatients aged ≥75 years, naïve for DOAC therapy, who started therapy with Dabigatran, Rivaroxaban, Apixaban or Edoxaban for the prevention of thromboembolism during FANV were analyzed. HASBLED, ATRIA, OBRI and ORBIT scores were calculated for each patient. Patients had follow-up for 12 months during which deaths, therapy discontinuation and adverse events such as thromboembolism and bleeding were reported. Potential predictors of bleeding and the predictive value of each bleeding score were tested using univariate Cox regression; testing accuracy was evaluated using ROC curves. Results A total of 291 patients (52.9% female, mean age 82.85±5.18 years) had a median follow-up time of 11 (10–12) months. The incidence rate of major bleeding was 4.7 per 100 patient-years, the rate of intracranial bleeding was 0.4 per 100 patient-years. Patients who had major bleeding were more often affected by heart failure (63.6% vs 25%; p=0.009) and thrombocytopenia (36.4% vs 7.4%; p=0,009). However in the multivariate analysis only heart failure remained statistically associated with major bleeding (HR 3.83, 95% CI 1.06–13.85; p=0.041). None of tested bleeding risk scores was able to predict major bleeding in our cohort. HASBLED and ORBIT scores were able to predict major and non-major clinically relevant bleeding (HR 1.32; 95% CI 1.01–1.71; p=0.042 and HR 1.20; 95% CI 1.00- 1.43; p=0.046); only the ORBIT score was found to be statistically significant, but with weak discriminatory power at ROC curves (AUC 0.59; 95% CI 0.51–0.68; p=0.041). Conclusions In our cohort of elderly patients aged 75 or older, anticoagulated for NVAF, heart failure history was the only effective predictor of major bleeding risk during DOAC treatment. None of the bleeding risk scores used currently have demonstrated a good discriminatory power in our cohort. As predictive factors of bleedings in DOAC-treated patients may not be the same as those for VKA-treated patients and those in elderly may also be differ in younger people, it calls for more investigation on the topic.

scholarly journals Cognitive dysfunction and adverse events during oral anticoagulant: a prospective cohort study

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
P Massoure ◽  
C Nguyen
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Cognitive Dysfunction ◽  
Oral Anticoagulants ◽  
Hospital Readmissions ◽  
Significant Risk ◽  
The Elderly ◽  
Risk Scores ◽  
Group 3

Abstract Background Oral anticoagulants (AC), represent the leading cause of iatrogenic morbimortality in France. AC are widely prescribed among the elderly. The assessment of the cognitive dysfunction (CD) is not included within the common thrombotic and bleeding risk scores. Purpose The objective of this study was to examine an association between CD and adverse events (AE) in patients receiving oral AC. Methods A prospective monocentric cohort study was conducted in patients (≥60 years-old) on oral AC. Death, hemorrhages, falls, hospital readmission, thromboembolic events were collected over 6 months follow-up. Patients were included during an hospitalization for any medical or surgical condition and divided in three groups, according to their Mini Mental State Examination (MMSE): Group 1 (absence of CD) MMSE ≥27, Group 2 (mild CD) 24&lt;mmse&lt;26, &gt;≤MMSE≤26, Group 3 (significant CD) MMSE ≤23. Results Among 120 patients (mean age: 82,2±8,8 years), the all-causes mortality (n=25) was significantly higher in the Group 3 (n=17, p=0,006); this also applies to the incidence of falls (n=34, p=0,009) or major hemorrhages (n=10, p=0,023). There was no thromboembolic event. Minor hemorrhages and hospital readmissions were not different in the 3 groups. Multivariate analysis shows a significant risk of mortality (OR 4.3, (p=0,025, IC [1,20–15,42]) in group 3. Conclusion After 6 months of follow up, the cognitive dysfunction was associated with mortality, major hemorrhages and falls among the elderly receiving oral AC. A systematic assessment of cognitive functions of these patients seems to be essential to analyze the global risk and the risks related to the AC treatment.&lt;/mmse&lt;26,&gt; FUNDunding Acknowledgement Type of funding sources: None.

SKIN MELANOMA INCIDENCE IN WORKERS OCUPATIONALLY EXPOSED TO IONIZING RADIATION OVER A PROLONGED PERIOD

2019 ◽  
Vol 65 (3) ◽  
pp. 441-446
Author(s):  
Valentina Rybkina ◽  
Tamara Azizova ◽  
Yevgeniya Grigoreva
Keyword(s):  
Ionizing Radiation ◽  
Gamma Rays ◽  
Disease Risk ◽  
Incidence Rates ◽  
Study Cohort ◽  
Calendar Period ◽  
Skin Melanoma ◽  
Melanoma Incidence ◽  
Occupationally Exposed

Purpose of the study. The study is aimed to investigate skin melanoma incidence in workers occupationally exposed to radiation over a prolonged period. Materials and methods. Skin melanoma incidence was studied in a cohort of workers first employed at nuclear facility Mayak Production Association (PA) between 1948 and 1982 who had been followed up till 31.12.2013 (22,377 individuals). Mean cumulative doses from external gamma-rays over the whole follow-up period were 0.54±0.001 Sv in males and 0.44±0.002 Sv in females. Incident rates for skin melanoma were analyzed by sex, attained age, calendar period of diagnostics and radiation dose using worldwide standard and the direct standardization technique. Results. 60 skin melanoma cases (37 in males and 23 in females) were registered in the study cohort over the whole follow-up period. The standardized skin melanoma incident rate was 8.51±1.46 in males and 8.78±2.27 in females per 100000 workers revealing statistically higher rates compared to corresponding rates for general populations of the Russian Federation, Urals Federal District and Chelyabinsk region. Skin melanoma incidence was significantly increased in the period of 1994 - 2013 as compared to the period of 1974 - 1993. Skin melanoma incidence excess in females was greater than that for males. Skin melanoma incidence increment in females was mostly driven by modifications of disease occurrence risk while in males it was driven by a combined effect of age pattern modifications in the study cohort and increase of disease risk. Conclusions. Skin melanoma incidence rates in the cohort of workers occupationally exposed to ionizing radiation over a prolonged period were associated with sex and attained age workers and the calendar period of diagnostics. No significant association of skin melanoma incidence with dose from external gamma-rays was observed. A significantly increasing trend was observed for skin melanoma incidence by the end of the follow-up in both males and females.

scholarly journals Quantitative disease risk scores from EHR with applications to clinical risk stratification and genetic studies

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Danqing Xu ◽  
Chen Wang ◽  
Atlas Khan ◽  
Ning Shang ◽  
Zihuai He ◽  
...  
Keyword(s):  
Risk Stratification ◽  
Disease Risk ◽  
Association Studies ◽  
Large Datasets ◽  
Risk Scores ◽  
Sequencing Data ◽  
Case Definitions ◽  
Phenotypic Data ◽  
Clinical Risk ◽  
Phenotypic Features

AbstractLabeling clinical data from electronic health records (EHR) in health systems requires extensive knowledge of human expert, and painstaking review by clinicians. Furthermore, existing phenotyping algorithms are not uniformly applied across large datasets and can suffer from inconsistencies in case definitions across different algorithms. We describe here quantitative disease risk scores based on almost unsupervised methods that require minimal input from clinicians, can be applied to large datasets, and alleviate some of the main weaknesses of existing phenotyping algorithms. We show applications to phenotypic data on approximately 100,000 individuals in eMERGE, and focus on several complex diseases, including Chronic Kidney Disease, Coronary Artery Disease, Type 2 Diabetes, Heart Failure, and a few others. We demonstrate that relative to existing approaches, the proposed methods have higher prediction accuracy, can better identify phenotypic features relevant to the disease under consideration, can perform better at clinical risk stratification, and can identify undiagnosed cases based on phenotypic features available in the EHR. Using genetic data from the eMERGE-seq panel that includes sequencing data for 109 genes on 21,363 individuals from multiple ethnicities, we also show how the new quantitative disease risk scores help improve the power of genetic association studies relative to the standard use of disease phenotypes. The results demonstrate the effectiveness of quantitative disease risk scores derived from rich phenotypic EHR databases to provide a more meaningful characterization of clinical risk for diseases of interest beyond the prevalent binary (case-control) classification.

scholarly journals Metabolic Syndrome Features and Excess Weight Were Inversely Associated with Nut Consumption after 1-Year Follow-Up in the PREDIMED-Plus Study

2020 ◽  
Vol 150 (12) ◽  
pp. 3161-3170
Author(s):  
Alicia Julibert ◽  
Maria del Mar Bibiloni ◽  
Laura Gallardo-Alfaro ◽  
Manuela Abbate ◽  
Miguel Á Martínez-González ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Metabolic Syndrome ◽  
Energy Intake ◽  
Disease Risk ◽  
Cardiovascular Disease Risk ◽  
Virgin Olive Oil ◽  
Hdl Cholesterol ◽  
Excess Weight ◽  
Study Cohort

ABSTRACT Background High nut consumption has been previously associated with decreased prevalence of metabolic syndrome (MetS) regardless of race and dietary patterns. Objectives The aim of this study was to assess whether changes in nut consumption over a 1-y follow-up are associated with changes in features of MetS in a middle-aged and older Spanish population at high cardiovascular disease risk. Methods This prospective 1-y follow-up cohort study, conducted in the framework of the PREvención con DIeta MEDiterránea (PREDIMED)-Plus randomized trial, included 5800 men and women (55–75 y old) with overweight/obesity [BMI (in kg/m2) ≥27 and &lt;40] and MetS. Nut consumption (almonds, pistachios, walnuts, and other nuts) was assessed using data from a validated FFQ. The primary outcome was the change from baseline to 1 y in features of MetS [waist circumference (WC), glycemia, HDL cholesterol, triglyceride (TG), and systolic and diastolic blood pressure] and excess weight (body weight and BMI) according to tertiles of change in nut consumption. Secondary outcomes included changes in dietary and lifestyle characteristics. A generalized linear model was used to compare 1-y changes in features of MetS, weight, dietary intakes, and lifestyle characteristics across tertiles of change in nut consumption. Results As nut consumption increased, between each tertile there was a significant decrease in WC, TG, systolic blood pressure, weight, and BMI (P &lt; 0.05), and a significant increase in HDL cholesterol (only in women, P = 0.044). The interaction effect between time and group was significant for total energy intake (P &lt; 0.001), adherence to the Mediterranean diet (MedDiet) (P &lt; 0.001), and nut consumption (P &lt; 0.001). Across tertiles of increasing nut consumption there was a significant increase in extra virgin olive oil intake and adherence to the MedDiet; change in energy intake, on the other hand, was inversely related to consumption of nuts. Conclusions Features of MetS and excess weight were inversely associated with nut consumption after a 1-y follow-up in the PREDIMED-Plus study cohort. This trial was registered at isrctn.com as ISRCTN89898870.

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