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A prediction rule for severe adverse events in all inpatients with community-acquired pneumonia: a multicenter observational study.
Sakakibara, T, Shindo, Y, Kobayashi, D, Sano, M, Okumura, J, Murakami, Y, Takahashi, K, Matsui, S, Yagi, T, Saka, H, et al
BMC pulmonary medicine. 2022;(1):34
Abstract
BACKGROUND Prediction of inpatients with community-acquired pneumonia (CAP) at high risk for severe adverse events (SAEs) requiring higher-intensity treatment is critical. However, evidence regarding prediction rules applicable to all patients with CAP including those with healthcare-associated pneumonia (HCAP) is limited. The objective of this study is to develop and validate a new prediction system for SAEs in inpatients with CAP. METHODS Logistic regression analysis was performed in 1334 inpatients of a prospective multicenter study to develop a multivariate model predicting SAEs (death, requirement of mechanical ventilation, and vasopressor support within 30 days after diagnosis). The developed ALL-COP-SCORE rule based on the multivariate model was validated in 643 inpatients in another prospective multicenter study. RESULTS The ALL-COP SCORE rule included albumin (< 2 g/dL, 2 points; 2-3 g/dL, 1 point), white blood cell (< 4000 cells/μL, 3 points), chronic lung disease (1 point), confusion (2 points), PaO2/FIO2 ratio (< 200 mmHg, 3 points; 200-300 mmHg, 1 point), potassium (≥ 5.0 mEq/L, 2 points), arterial pH (< 7.35, 2 points), systolic blood pressure (< 90 mmHg, 2 points), PaCO2 (> 45 mmHg, 2 points), HCO3- (< 20 mmol/L, 1 point), respiratory rate (≥ 30 breaths/min, 1 point), pleural effusion (1 point), and extent of chest radiographical infiltration in unilateral lung (> 2/3, 2 points; 1/2-2/3, 1 point). Patients with 4-5, 6-7, and ≥ 8 points had 17%, 35%, and 52% increase in the probability of SAEs, respectively, whereas the probability of SAEs was 3% in patients with ≤ 3 points. The ALL-COP SCORE rule exhibited a higher area under the receiver operating characteristic curve (0.85) compared with the other predictive models, and an ALL-COP SCORE threshold of ≥ 4 points exhibited 92% sensitivity and 60% specificity. CONCLUSIONS ALL-COP SCORE rule can be useful to predict SAEs and aid in decision-making on treatment intensity for all inpatients with CAP including those with HCAP. Higher-intensity treatment should be considered in patients with CAP and an ALL-COP SCORE threshold of ≥ 4 points. TRIAL REGISTRATION This study was registered with the University Medical Information Network in Japan, registration numbers UMIN000003306 and UMIN000009837.
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Risk Factors and Lifestyles in the Development of Atrial Fibrillation Among Individuals Aged 20-39 Years.
Itoh, H, Kaneko, H, Fujiu, K, Kiriyama, H, Morita, K, Kamon, T, Michihata, N, Jo, T, Takeda, N, Morita, H, et al
The American journal of cardiology. 2021;:40-44
Abstract
Epidemiological evidence on the relationship of modifiable risk factors and lifestyles with incident atrial fibrillation (AF) in young adults remains insufficient. We aimed to identify the determinants of AF among young adults using a nationwide epidemiological database. Medical records of 286,876 individuals (20-39 years) without prior history of cardiovascular disease were extracted from the JMDC Claims Database. We analyzed the association of modifiable risk factors with the incidence of AF. The median (interquartile range) age was 34 (29-37) years, and 54.4% were men. After a mean follow-up of 1,017 ± 836 days, 267 individuals (0.1%) developed AF. Multivariable Cox regression analysis demonstrated that high waist circumference, hypertension, cigarette smoking, and poor sleep quality as well as age and sex were associated with increased incidence of AF. Kaplan-Meier curves showed that number of modifiable components including high waist circumference, hypertension, cigarette smoking, and poor sleep quality clearly stratified the risk of AF development (Log rank test, p < 0.001). Age- and sex-adjusted Cox regression analyses showed individuals with one (hazard ratio [HR] 1.56, 95% confidence interval [CI] 1.13-2.18), two (HR 2.03, 95% CI 1.40-2.95), three (HR 3.48, 95% CI 2.19-5.54), and four (HR 10.78, 95% CI 5.26-22.11) components were associated with an increased incidence of AF compared with individuals with no components. In conclusion, high waist circumference, hypertension, cigarette smoking, and poor sleep quality were associated with the development of AF among young adults, suggesting the importance of maintaining these modifiable factors for the primordial prevention of AF in young adults.
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Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis.
Goette, A, Eckardt, L, Valgimigli, M, Lewalter, T, Laeis, P, Reimitz, PE, Smolnik, R, Zierhut, W, Tijssen, JG, Vranckx, P
Clinical research in cardiology : official journal of the German Cardiac Society. 2021;(6):831-840
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Abstract
AIMS: This subgroup analysis of the ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; Date of registration: August 2016) evaluated type of AF, and CHA2DS2-VASc score parameters as predictors for clinical outcome. METHODS Patients were randomly assigned after percutaneous coronary intervention (PCI) to either edoxaban (60 mg/30 mg once daily [OD]; n = 751) plus a P2Y12 inhibitor for 12 months or a vitamin K antagonist [VKA] (n = 755) plus a P2Y12 inhibitor and aspirin (100 mg OD, for 1-12 months). The primary outcome was a composite of major/clinically relevant non-major bleeding (CRNM) within 12 months. The composite efficacy endpoint consisted of cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis. RESULTS Major/CRNM bleeding event rates were 20.7%/year and 25.6%/year with edoxaban and warfarin, respectively (HR [95% CI]: 0.83 [0.654-1.047]). The event rates of composite outcome were 7.26%/year and 6.86%/year, respectively (HR [95% CI]): 1.06 [0.711-1.587]), and of overall net clinical benefit were 12.48%/year and 12.80%/year, respectively (HR [(95% CI]: 0.99 [(0.730; 1.343]). Increasing CHA2DS2-VASc score was associated with increased rates of all outcomes. CHA2DS2-VASc score ≥ 5 was a marker for stent thrombosis. Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024). CONCLUSION After PCI in AF patients, increasing CHA2DS2-VASc score was associated with increased bleeding rates and CHA2DS2-VASc score (≥ 5) predicted the occurrence of stent thrombosis. Paroxysmal AF was associated with MI. These findings may have important clinical implications in AF patients.
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Ten-year incidence and assessment of safe screening intervals for diabetic retinopathy: the OPHDIAT study.
Chamard, C, Daien, V, Erginay, A, Gautier, JF, Villain, M, Tadayoni, R, Carriere, I, Massin, P
The British journal of ophthalmology. 2021;(3):432-439
Abstract
BACKGROUND To estimate the 10-year incidence of referable diabetic retinopathy (DR) in a French population with type 1 and 2 diabetes mellitus (DM). A secondary objective was the assessment of safe screening intervals in patients with diabetes without retinopathy. METHODS Observational, prospective and multicentric study between June 2004 and September 2017 based on a regional screening programme for DR in the Paris region. The incidence of referable DR in patients without retinopathy at baseline was calculated by the Turnbull survival estimator. A safe screening interval was defined as a 95% probability of remaining without referable DR. RESULTS Among the 25 745 participants with type 1 (n=6086) or type 2 (n=19 659) DM, the 10-year cumulative incidence of referable DR was 19.10% (95% CI 17.21% to 21.14%) and 17.03% (15.78% to 18.35%), median (IQR) follow-up=3.33 (4.24) years. The safe screening interval for patients without DR at the first examination for type 1 and 2 DM was 2.2 (95% CI 2.0 to 2.4) and 3.0 (2.9 to 3.1) years, respectively. In a subgroup of low-risk patients with type 2 DM, the safe screening interval was 4.2 (3.8 to 4.6) years. CONCLUSIONS These data suggest that in Paris area, a 2-year, 3-year and 4-year screening interval was considered safe for type 1 DM, type 2 DM and for low-risk patients with type 2 DM, respectively, without DR at the first examination. While these data might be used to support the consideration of extending screening intervals, a randomised clinical trial would be suitable to confirm the safety for patients with DM.
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Biomarker-Based Risk Prediction of Alzheimer's Disease Dementia in Mild Cognitive Impairment: Psychosocial, Ethical, and Legal Aspects.
Rostamzadeh, A, Schwegler, C, Gil-Navarro, S, Rosende-Roca, M, Romotzky, V, Ortega, G, Canabate, P, Moreno, M, Schmitz-Luhn, B, Boada, M, et al
Journal of Alzheimer's disease : JAD. 2021;(2):601-617
Abstract
BACKGROUND Today, a growing number of individuals with mild cognitive impairment (MCI) wish to assess their risk of developing Alzheimer's disease (AD) dementia. The expectations as well as the effects on quality of life (QoL) in MCI patients and their close others through biomarker-based dementia risk estimation are not well studied. OBJECTIVE The PreDADQoL project aims at providing empirical data on effects of such prediction on QoL and at developing an ethical and legal framework of biomarker-based dementia risk estimation in MCI. METHODS In the empirical study, 100 MCI-patients and their close others will be recruited from two sites (Germany and Spain). They receive standardized counselling on cerebrospinal fluid (CSF) biomarker-based prediction of AD dementia and a risk disclosure based on their AD biomarker status. A mixed methods approach will be applied to assess outcomes. RESULTS The pilot-study yielded a specification of the research topics and newly developed questionnaires for the main assessment. Within this binational quantitative and qualitative study, data on attitudes and expectations toward AD risk prediction, QoL, risk communication, coping strategies, mental health, lifestyle changes, and healthcare resource utilization will be obtained. Together with the normative part of the project, an empirically informed ethical and legal framework for biomarker-based dementia risk estimation will be developed. CONCLUSION The empirical research of the PreDADQoL study together with the ethical and legal considerations and implications will help to improve the process of counselling and risk disclosure and thereby positively affect QoL and health of MCI-patients and their close others in the context of biomarker-based dementia risk estimation.
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Effect of the Million Hearts Cardiovascular Disease Risk Reduction Model on Initiating and Intensifying Medications: A Prespecified Secondary Analysis of a Randomized Clinical Trial.
Peterson, GG, Pu, J, Magid, DJ, Barterian, L, Kranker, K, Barna, M, Conwell, L, Rose, A, Blue, L, Markovitz, A, et al
JAMA cardiology. 2021;(9):1050-1059
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IMPORTANCE The Million Hearts Cardiovascular Disease (CVD) Risk Reduction Model pays provider organizations for measuring and reducing Medicare patients' cardiovascular risk. OBJECTIVE To assess whether the model increases the initiation or intensification of antihypertensive medications or statins among patients with blood pressure or low-density lipoprotein (LDL) cholesterol levels above guideline thresholds for treatment intensification. DESIGN, SETTING, AND PARTICIPANTS This prespecified secondary analysis of a cluster-randomized, pragmatic trial included primary care and cardiology practices, health care centers, and hospital-based outpatient departments across the US. Participants included Medicare patients who were enrolled into the model in 2017 by participating organizations and who were at high risk and at medium risk of a myocardial infarction or stroke in 10 years. Patient outcomes were analyzed for 1 year postenrollment (through December 2018) using an intent-to-treat design. Analysis began November 2019. INTERVENTIONS US Centers for Medicare & Medicaid Services paid organizations for risk stratifying Medicare patients and reducing CVD risk among high-risk patients through discussing risk scores, developing individualized risk reduction plans, and following up with patients twice yearly. MAIN OUTCOMES AND MEASURES Initiating or intensifying statin or antihypertensive therapy within 1 year of enrollment, measured in Medicare Part D claims, and LDL cholesterol and systolic blood pressure levels approximately 1 year after enrollment, measured in usual care and reported to Centers for Medicare & Medicaid Services via a data registry (data complete for 51% of high-risk enrollees). The study's primary outcome (incidence of first-time myocardial infarction and stroke) is not reported because the trial is ongoing. RESULTS A total of 330 primary care and cardiology practices, health care centers, and hospital-based outpatient departments and 125 436 Medicare patients were included in this analysis. High-risk patients in the intervention group had a mean (SD) age of 74 (4.1), 15 213 (63%) were male, 21 657 (90%) were receiving antihypertensive medication at baseline, and 16 558 (69%) were receiving statins. Almost all (21 791 [91%]) high-risk intervention group patients had above-threshold systolic blood pressure level (>130 mm Hg), LDL cholesterol level (>70 mg/dL), or both. Patients in the intervention group with these risk factors were more likely than control patients (8127 [37.3%] vs 4753 [32.4%]; adjusted difference in percentage points, 4.8; 95% CI, 2.9-6.7; P < .001) to initiate or intensify statins or antihypertensive medication. Centers for Medicare & Medicaid Services did not pay for CVD risk reduction for medium-risk enrollees, but initiation or intensification rates for these enrollees were also higher in the intervention vs control groups (12 668 [27.9%] vs 7544 [24.8%]; adjusted difference in percentage points, 3.1; 95% CI, 1.9-4.3; P < .001). Among high-risk enrollees with clinical data approximately 1 year after enrollment, LDL cholesterol level was slightly lower in the intervention vs control groups (mean [SD], 89 [31.8] vs 91 [32.1] mg/dL; adjusted difference in percentage points, -1.8; 95% CI, -2.9 to -0.6; P = .002), as was systolic blood pressure (mean [SD], 133 [15.7] vs 135 [16.4] mm Hg; adjusted difference in percentage points, -1.7; 95% CI, -2.8 to -0.6; P = .003). CONCLUSIONS AND RELEVANCE In this study, a pay-for-performance model led to modest increases in the use of CVD medications in a range of organizations, despite high medication use at baseline.
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Inflammation-based assessment for the risk stratification of mortality in patients with heart failure.
Itagaki, T, Motoki, H, Otagiri, K, Machida, K, Takeuchi, T, Kanai, M, Kimura, K, Higuchi, S, Minamisawa, M, Kitabayashi, H, et al
Scientific reports. 2021;(1):14989
Abstract
The Glasgow Prognostic Score (GPS) has been established as a useful resource to evaluate inflammation and malnutrition and predict prognosis in several cancers. However, its prognostic significance in patients with heart failure (HF) is not well established. To investigate the association between the GPS and mortality in patients with HF, we assessed 870 patients who were 20 years old and more and had been admitted for acute decompensated HF. The GPS ranged from 0 to 2 points as previously reported. Over the 18-month follow-up (follow-up rate, 83.9%), 143 patients died. Increasing GPS was associated with higher HF severity assessed by New York Heart Association functional class and B-type natriuretic peptide (BNP) levels. Kaplan-Meier analysis showed significant associations for mortality and increased GPS. In multivariate analysis, compared to the GPS 0 group, the GPS 2 group was associated with high mortality (hazard ratio 2.92, 95% confidence interval 1.77-4.81, p < 0.001) after adjustment for age, sex, blood pressure, HF history, HF severity, hemoglobin, renal function, sodium, BNP, left ventricular ejection fraction, and anti-HF medications. In conclusion, high GPS was significantly associated with worse prognosis in patients with HF. Inflammation-based assessment by the GPS may enable simple evaluation of HF severity and prognosis.
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Derivation of a Coronary Age Calculator Using Traditional Risk Factors and Coronary Artery Calcium: The Multi-Ethnic Study of Atherosclerosis.
Blaha, MJ, Naazie, IN, Cainzos-Achirica, M, Dardari, ZA, DeFilippis, AP, McClelland, RL, Mirbolouk, M, Orimoloye, OA, Dzaye, O, Nasir, K, et al
Journal of the American Heart Association. 2021;(6):e019351
Abstract
Background The optimal method for communicating coronary heart disease (CHD) risk to individual patients is not yet clear. Recent research supports the concept of "coronary age" for more effective risk communication. We defined an individual's coronary age as the age at which an average healthy individual would have an equivalent estimated CHD risk as that calculated for the index individual, building on our previously validated MESA (Multi-Ethnic Study of Atherosclerosis) 10-year CHD Risk Score equations with and without coronary artery calcium (CAC). Methods and Results We derived a coronary age by (1) calculating the MESA 10-year CHD risk; (2) mathematically setting this equal to an equation describing risk of an average healthy MESA participant, as a function of age; and (3) solving for age. The risk discrimination of the resultant coronary age was compared with that of chronological age, the MESA CHD Risk Score, and CAC alone. Approximately 95% of coronary age values ranged from 30 years less to 30 years higher than chronological age. Although the mean chronological age of individuals experiencing CHD events compared with those free of events was 67.4 versus 61.8 years, the difference in coronary age including CAC was larger (80.6 versus 62.8 years). Coronary age with CAC had identical predictive ability to that of MESA CHD Risk Score and outperformed chronological age and CAC alone. Conclusions The newly derived coronary age is a convenient transformation of MESA CHD Risk, retaining very good risk discrimination. This easy-to-communicate tool will be available for patients and clinicians, potentially facilitating risk communication in routine care.
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Malnutrition at diagnosis in amyotrophic lateral sclerosis (als) and its influence on survival: Using glim criteria.
López-Gómez, JJ, Ballesteros-Pomar, MD, Torres-Torres, B, De la Maza, BP, Penacho-Lázaro, MÁ, Palacio-Mures, JM, Abreu-Padín, C, López-Guzmán, A, De Luis-Román, DA
Clinical nutrition (Edinburgh, Scotland). 2021;(1):237-244
Abstract
BACKGROUND Malnutrition is a prognostic factor in Amyotrophic Lateral Sclerosis (ALS). Sometimes, this condition is underdiagnosed, and it might influence on disease progression. AIMS To evaluate a) nutritional status at the beginning of specialized nutritional treatment and b) the influence of initial nutritional status on disease evolution and survival in a group of patients with amyotrophic lateral sclerosis (ALS). METHODS An interhospital registry of patients with motor neuron disease treated at the Clinical Nutrition Clinics of six hospitals in the region of Castilla y León in Spain was created. The study was developed from January 2015 to December 2017. An anamnesis, affiliation data, past medical history, disease evolution, nutritional history and an anthropometry and bioelectrical impedance analysis were performed at baseline. The mortality rate was compared among those patients with worse nutritional status at the beginning of the follow-up against those with a better nutritional situation using two tools: The Subjective Global Assessment (SGA) and the criteria of the Global Leadership Initiative for Malnutrition (GLIM). RESULTS A total of 93 patients were analysed. The median age of the patients was 67 (57.5-75.5) years. The median Body Mass Index was 24.4 (21.7-25.9) kg/m2 and the median percentage of weight loss was 9.32 (2.7-17.6)% without differences between the onset type. According to the SGA, 27 (29%) patients were in grade A; 43 (46.3%) patients were in grade B and 23 (24.7%) were in grade C. According to the new GLIM malnutrition criteria, 45 patients (48.4%) had malnutrition. Patients with worse nutritional status had a lower survival median with both SGA (SGA A 20.5 (10.2-35) months vs SGA B-C: 12 (5.2-23.7) months (p = 0.03)) or the new GLIM criteria according to severity (severe malnutrition: 18 (5-24) months vs. no severe malnutrition: 20 (12-33) months (p = 0.01)). In the multivariate analysis, malnutrition measured by SGA was an independent risk factor (HR: 4.6 (1.5-13.9) p = 0.007) for survival over 15 months when adjusted for age, sex and type of onset of ALS. CONCLUSIONS Patients with ALS have a severe deterioration in nutritional status when analysed using a classical malnutrition test (SGA) or a new one (GLIM criteria). Patients with a better nutritional situation according to SGA and GLIM severity classification were associated with a longer survival time.
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Hypertensive Retinopathy and the Risk of Stroke Among Hypertensive Adults in China.
Chen, X, Liu, L, Liu, M, Huang, X, Meng, Y, She, H, Zhao, L, Zhang, J, Zhang, Y, Gu, X, et al
Investigative ophthalmology & visual science. 2021;(9):28
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PURPOSE This study aimed to investigate the association between hypertensive retinopathy and the risk of first stroke, examine possible effect modifiers in hypertensive patients, and test the appropriateness of the Keith-Wagener-Barker (KWB) classification for predicting stroke risk. METHODS In total, 9793 hypertensive participants (3727 males and 6066 females) without stroke history from the China Stroke Primary Prevention Trial were included in this study. The primary outcome was first stroke. RESULTS Over a median follow-up of 4.4 years, 592 participants experienced their first stroke (509 ischemic, 77 hemorrhagic, and six unclassifiable strokes). In total, 5590 participants were diagnosed with grade 1 retinopathy (57.08%), 1466 with grade 2 retinopathy (14.97%), 231 with grade 3 retinopathy (2.36%), and three with grade 4 retinopathy (0.03%). Grades 1 and 2 were merged and classified as mild retinopathy, and grades 3 and 4 were merged and classified as severe retinopathy. There was a significant positive association between hypertensive retinopathy and the risk of first stroke and first ischemic stroke, and no effect modifiers were found. The hazard ratios (HRs) for first stroke were as follows: mild versus no retinopathy, 1.26 (95% confidence interval [CI], 1.01-1.58, P = 0.040), and severe versus no retinopathy, 2.40 (95% CI, 1.49-3.84, P < 0.001). The HRs for ischemic stroke were as follows: severe versus no retinopathy, 2.35 (95% CI, 1.41-3.90, P = 0.001), and nonsignificantly increased HRs for mild versus no retinopathy, 1.26 (95% CI, 0.99-1.60, P = 0.057). CONCLUSIONS There was a significant positive association between hypertensive retinopathy and the risk of first stroke in patients with hypertension, indicating that hypertensive retinopathy may be a predictor of the risk of stroke. A simplified two-grade classification system based on the KWB classification is recommended for predicting stroke risk.