International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients

Whereas multiple national, international, and trial registries for heart failure have been created, international standards for clinical assessment and outcome measurement do not currently exist. The working group's objective was to facilitate international comparison in heart failure care, using standardized parameters and meaningful patient-centered outcomes for research and quality of care assessments. The International Consortium for Health Outcomes Measurement recruited an international working group of clinical heart failure experts, researchers, and patient representatives to define a standard set of outcomes and risk-adjustment variables. This was designed to document, compare, and ultimately improve patient care outcomes in the heart failure population, with a focus on global feasibility and relevance. The working group employed a Delphi process, patient focus groups, online patient surveys, and multiple systematic publications searches. The process occurred over 10 months, employing 7 international teleconferences. A 17-item set has been established, addressing selected functional, psychosocial, burden of care, and survival outcome domains. These measures were designed to include all patients with heart failure, whether entered at first presentation or subsequent decompensation, excluding cardiogenic shock. Sources include clinician report, administrative data, and validated patient-reported outcome measurement tools: the Kansas City Cardiomyopathy Questionnaire; the Patient Health Questionnaire-2; and the Patient-Reported Outcomes Measurement Information System. Recommended data included those to support risk adjustment and benchmarking across providers and regions. The International Consortium for Health Outcomes Measurement developed a dataset designed to capture, compare, and improve care for heart failure, with feasibility and relevance for patients and clinicians worldwide

External validation of multidimensional prognostic indices (ADO, BODEx and DOSE) in a primary care international cohort (PROEPOC/COPD cohort)

Background: Due to the heterogeneous and systemic nature of the chronic obstructive pulmonary disease (COPD), the new guidelines are oriented toward individualized attention. Multidimensional scales could facilitate its proper clinical and prognostic assessment, but not all of them were validated in an international primary care cohort, different from the original ones used for model development. Therefore, our main aim is to assess the prognostic capacity of the ADO, BODEx and DOSE indices in primary care for predicting mortality in COPD patients and to validate the models obtained in subgroups of patients, classified by revised Global Initiative for Chronic Obstructive Lung Disease (2011) and updated Spanish Guideline (2014). Besides, we want to confirm that the prognostic capacity of all indices increases if the number of exacerbations is substituted by the interval between them and to assess the impact on health of the patient''s lifestyle, social network and adherence to treatment. Methods: Design: External validation of scales, open and prospective cohort study in primary care. Setting: 36 health centres in 6 European high, medium and low income countries. Subjects: 477 patients diagnosed with COPD, captured in clinical visit by their General Practitioner/Nurse. Predictors: Detailed patient history, exacerbations, lung function test and questionnaires at baseline. Outcomes: Exacerbations, all-cause mortality and specific mortality, within 5 years of recruitment. Analysis: Multivariate logistic regression and Cox regression will be used. Possible non-linear effect of the indices will be studied by using Structured Additive Regression models with penalised splines. Subsequently, we will assess different aspects of the regression models: discrimination, calibration and diagnostic precision. Clinical variables modulated in primary care and the interval between exacerbations will be considered and incorporated into the analysis. Discussion: The Research Agenda for General Practice/Family Medicine highlights that the evidence on predictive values of prognostic indices in primary care is scarce. A prospective cohort like that of PROEPOC/COPD provides good opportunities for research into COPD and make communication easier between family practitioners, nursing staff, pneumologists and other professionals, supporting a multi-disciplinary approach to the treatment of these patients. Trial registration:ISRCTN52402811. Date: 15/01/2015. Prospectively registered

Protein loop compaction and the origin of the effect of arginine and glutamic acid mixtures on solubility, stability and transient oligomerization of proteins

Addition of a 50 mM mixture of l-arginine and l-glutamic acid (RE) is extensively used to improve protein solubility and stability, although the origin of the effect is not well understood. We present Small Angle X-ray Scattering (SAXS) and Nuclear Magnetic Resonance (NMR) results showing that RE induces protein compaction by collapsing flexible loops on the protein core. This is suggested to be a general mechanism preventing aggregation and improving resistance to proteases and to originate from the polyelectrolyte nature of RE. Molecular polyelectrolyte mixtures are expected to display long range correlation effects according to dressed interaction site theory. We hypothesize that perturbation of the RE solution by dissolved proteins is proportional to the volume occupied by the protein. As a consequence, loop collapse, minimizing the effective protein volume, is favored in the presence of RE

Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes

BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to -0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95% CI, 0.83 to 1.20; P = 0.98). There were no significant between-group differences in rates of acute pancreatitis (P = 0.07) or pancreatic cancer (P = 0.32). CONCLUSIONS: Among patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalization for heart failure, or other adverse events

On the isotope effect in YBa/sub 2/Cu/sub 3/O/sub 7/: Measurements for two methods of synthesis

We prepared superconducting samples of YBa/sub 2/Cu/sub 3/(/sup 18/O)/sub 7-x/ and YBa/sub 2/Cu/sub 3/(/sup 16/O)/sub 7-x/ by two techniques: (a) burning powder of YBa/sub 2/Cu/sub 3/ in /sup 18/O/sub 2/ and /sup 16/O/sub 2/ and (b) crystallizing amorphous powder of YBa/sub 2/Cu/sub 3/(/sup 16/O)/sub 7.8/ in flowing /sup 18/O/sub 2/ and /sub 16/O/sub 2/. The percent of /sup 18/O in the YBa/sub 2/Cu/sub 3/(/sup 18/O)/sub 7-x/ samples was 96.5 at.% for method (a) and 92 at.% for method (b). The YBa/sub 2/Cu/sub 3/(/sup 16/O)/sub 7-x/ samples had 99.8 at.% /sup 16/O. Susceptibility measurements of the superconducting transition temperature show an oxygen isotope effect of 0.4 K for both methods

Inclusion of Beef Heart in Ground Beef Patties Alters Quality Characteristics and Consumer Acceptability as Assessed by the Application of Electronic Nose and Tongue Technology

Consumer purchasing of beef is often driven by the trinity of flavor, palatability, and convenience. Currently, beef patties in the United States are manufactured with fat and lean trimmings derived from skeletal muscles. A reduction in total beef supply may require the use of animal by-product utilization such as variety meats to achieve patty formulations. The current study aimed to assess textural, color, and flavor characteristics in addition to volatile compounds through electronic technology, e-nose and e-tongue, of ground beef patties formulated with beef heart. Ground beef patties were manufactured with 0%, 6%, 12%, or 18% beef heart, with the remainder of the meat block being shoulder clod-derived ground beef. Patties (n = 65/batch/treatment) within each batch (n = 3) with each treatment were randomly allocated to cooked color (n = 17/batch/treatment), Allo–Kramer shear force (AKSF; n = 17/batch/treatment), texture profile analysis (TPA; n = 6/batch/treatment), cooking loss (n = 17/batch/treatment), consumer panel (n = 3/batch/treatment), e-nose (n = 1/batch/treatment), and e-tongue (n = 1/batch/treatment) analysis groups. Patties containing beef heart did not require additional cooking time (p = 0.1325) nor exhibit greater cooking loss (p = 0.0803). Additionally, inclusion rates of beef heart increased hardness (p = 0.0030) and chewiness values (p = 0.0316) in TPA, were internally redder (p = 0.0001), and reduced overall liking by consumer panelists (p = 0.0367). Lastly, patties containing beef heart exhibited greater red-to-brown (p = 0.0003) and hue angle (p = 0.0001) values than control patties. The results suggest that beef heart inclusion does alter ground beef quality characteristics and consumer acceptability