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Summary We report findings from a new survey of US public attitudes toward human-animal chimeric embryo (HACE) research, designed to compare with recently reported Japanese survey data. We find that 59% of the US public can personally accept the process of injecting human induced pluripotent stem cells into genetically modified swine embryos and having human tissues produced in a pig's body transplanted into a human. This is greater acceptance than in Japan, and there is even strong acceptance among those with strong religious affiliations and who self-identify as conservatives. We argue that strong public support for HACE research, as well as the emerging literature suggesting that humanization of research animals is very unlikely, should compel the NIH to lift its current moratorium on HACE research., Highlights • 430 US participants in a national survey on human-animal chimeric embryo research • 83% of respondents can personally accept research on human-animal chimeric embryos • Self-identified political conservatives accept human-animal chimera research • Individuals opposed to animal research also accept human-animal chimera research, In this report, Crane and colleagues report findings on US public attitudes toward human-animal chimeric embryo research. A majority of survey respondents personally accept the process of injecting human stem cells into genetically modified swine embryos and transplanting human tissues produced in a pig's body. Strong public support should compel the NIH to lift the moratorium on human-animal chimeric embryo research.

Alzheimer's disease (AD) begins with an asymptomatic "preclinical" phase, in which abnormal biomarkers indicate risk for developing cognitive impairment. Biomarker information is increasingly being disclosed in research settings, and is moving toward clinical settings with the development of cheaper and non-invasive testing. Limited research has focused on the safety and psychological effects of disclosing biomarker results to cognitively unimpaired adults. However, less is known about how to ensure equitable access and robust counseling for decision-making before testing, and how to effectively provide long-term follow-up and risk management after testing. Using the framework of Huntington's disease, which is based on extensive experience with disclosing and managing risk for a progressive neurodegenerative condition, this article proposes a conceptual model of pre-disclosure, disclosure, and post-disclosure phases for AD biomarker testing. Addressing research questions in each phase will facilitate the transition of biomarker testing into clinical practice.

The congenital heart care community faces a myriad of public health issues that act as barriers toward optimum patient outcomes. In this article, we attempt to define advocacy and policy initiatives meant to spotlight and potentially address these challenges. Issues are organized into the following 3 key facets of our community: patient population, health care delivery, and workforce. We discuss the social determinants of health and health care disparities that affect patients in the community that require the attention of policy makers. Furthermore, we highlight the many needs of the growing adults with congenital heart disease and those with comorbidities, highlighting concerns regarding the inequities in access to cardiac care and the need for multidisciplinary care. We also recognize the problems of transparency in outcomes reporting and the promising application of telehealth. Finally, we highlight the training of providers, measures of productivity, diversity in the workforce, and the importance of patient–family centered organizations in advocating for patients. Although all of these issues remain relevant to many subspecialties in medicine, this article attempts to illustrate the unique needs of this population and highlight ways in which to work together to address important opportunities for change in the cardiac care community and beyond. This article provides a framework for policy and advocacy efforts for the next decade.

BACKGROUND In January 2011, Centers for Medicare and Medicaid Services expanded the number of inpatient diagnosis codes from 9 to 25, which may influence comorbidity counts and risk‐adjusted outcome rates for studies spanning January 2011. This study examines the association between (1) limiting versus not limiting diagnosis codes after 2011, (2) using inpatient‐only versus inpatient and outpatient data, and (3) using logistic regression versus the Centers for Medicare and Medicaid Services risk‐standardized methodology and changes in risk‐adjusted outcomes. METHODS AND RESULTS Using 100% Medicare inpatient and outpatient files between January 2009 and December 2013, we created 2 cohorts of fee‐for‐service beneficiaries aged ≥65 years. The acute myocardial infarction cohort and the heart failure cohort had 578 728 and 1 595 069 hospitalizations, respectively. We calculate comorbidities using (1) inpatient‐only limited diagnoses, (2) inpatient‐only unlimited diagnoses, (3) inpatient and outpatient limited diagnoses, and (4) inpatient and outpatient unlimited diagnoses. Across both cohorts, International Classification of Diseases, Ninth Revision ( ICD‐9 ) diagnoses and hierarchical condition categories increased after 2011. When outpatient data were included, there were no significant differences in risk‐adjusted readmission rates using logistic regression or the Centers for Medicare and Medicaid Services risk standardization. A difference‐in‐differences analysis of risk‐adjusted readmission trends before versus after 2011 found that no significant differences between limited and unlimited models for either cohort. CONCLUSIONS For studies that span 2011, researchers should consider limiting the number of inpatient diagnosis codes to 9 and/or including outpatient data to minimize the impact of the code expansion on comorbidity counts. However, the 2011 code expansion does not appear to significantly affect risk‐adjusted readmission rate estimates using either logistic or risk‐standardization models or when using or excluding outpatient data.

Background Disparities in premature cardiac death (PCD) might stagnate the progress toward the reduction of PCD in the United States and worldwide. We estimated disparities across US counties in PCD rates and investigated county‐level factors related to the disparities. Methods and Results We used US mortality data for cause‐of‐death and demographic data from death certificates and county‐level characteristics data from multiple databases. PCD was defined as any death that occurred at an age between 35 and 74 years with an underlying cause of death caused by cardiac disease based on International Classification of Diseases, Tenth Revision (ICD‐10), codes. Of the 1 598 173 PCDs that occurred during 1999–2017, 60.9% were out of hospital. Although the PCD rates declined from 1999–2017, the proportion of out‐of‐hospital PCDs among all cardiac deaths increased from 58.3% to 61.5%. The geographic disparities in PCD rates across counties widened from 1999 (Theil index=0.10) to 2017 (Theil index=0.23), and within‐state differences accounted for the majority of disparities (57.4% in 2017). The disparities in out‐of‐hospital PCD rates (and in‐hospital PCD rates) associated with demographic composition were 36.51% (and 37.51%), socioeconomic features were 18.64% (and 18.36%), healthcare environment were 18.64% (and 13.90%), and population health status were 23.73% (and 30.23%). Conclusions Disparities in PCD rates exist across US counties, which may be related to the decelerated trend of decline in the rates among middle‐aged adults. The slower declines in out‐of‐hospital rates warrants more precision targeting and sustained efforts to ensure progress at better levels of health (with lower PCD rates) against PCD.

Atherosclerotic cardiovascular disease (ASCVD) has posed an increasing burden on Americans and the United States healthcare system for decades. In addition, ASCVD has had a substantial economic impact, with national expenditures for ASCVD projected to increase by over 2.5‐fold from 2015 to 2035. This rapid increase in costs associated with health care for ASCVD has consequences for payers, healthcare providers, and patients. The issues to patients are particularly relevant in recent years, with a growing trend of shifting costs of treatment expenses to patients in various forms, such as high deductibles, copays, and coinsurance. Therefore, the issue of“financial toxicity” of health care is gaining significant attention. The term encapsulates the deleterious impact of healthcare expenditures for patients. This includes the economic burden posed by healthcare costs, but also the unintended consequences it creates in form of barriers to necessary medical care, quality of life as well tradeoffs related to non‐health–related necessities. While the societal impact of rising costs related to ASCVD management have been actively studied and debated in policy circles, there is lack of a comprehensive assessment of the current literature on the financial impact of cost sharing for ASCVD patients and their families. In this review we systematically describe the scope and domains of financial toxicity, the instruments that measure various facets of healthcare‐related financial toxicity, and accentuating factors and consequences on patient health and well‐being. We further identify avenues and potential solutions for clinicians to apply in medical practice to mitigate the burden and consequences of out‐of‐pocket costs for ASCVD patients and their families.

Background The lack of diversity in the cardiovascular physician workforce is thought to be an important driver of racial and sex disparities in cardiac care. Cardiology fellowship program directors play a critical role in shaping the cardiology workforce. Methods and Results To assess program directors’ perceptions about diversity and barriers to enhancing diversity, the authors conducted a survey of 513 fellowship program directors or associate directors from 193 unique adult cardiology fellowship training programs. The response rate was 21% of all individuals (110/513) representing 57% of US general adult cardiology training programs (110/193). While 69% of respondents endorsed the belief that diversity is a driver of excellence in health care, only 26% could quote 1 to 2 references to support this statement. Sixty‐three percent of respondents agreed that “our program is diverse already so diversity does not need to be increased.” Only 6% of respondents listed diversity as a top 3 priority when creating the cardiovascular fellowship rank list. Conclusions These findings suggest that while program directors generally believe that diversity enhances quality, they are less familiar with the literature that supports that contention and they may not share a unified definition of "diversity." This may result in diversity enhancement having a low priority. The authors propose several strategies to engage fellowship training program directors in efforts to diversify cardiology fellowship training programs.

Maternal mortality in the United States is the highest among all developed nations, partly because of the increased prevalence of cardiovascular disease in pregnancy and beyond. There is growing recognition that specialists involved in caring for obstetric patients with cardiovascular disease need training in the new discipline of cardio‐obstetrics. Training can include integrated formal cardio‐obstetrics curricula in general cardiovascular disease training programs, and developing and disseminating joint cardiac and obstetric societal guidelines. Other efforts to help strengthen the cardio‐obstetric field include increased collaborations and advocacy efforts between stakeholder organizations, development of US ‐based registries, and widespread establishment of multidisciplinary pregnancy heart teams. In this review, we present the current challenges in creating a cardio‐obstetrics community, present the growing need for education and training of cardiovascular disease practitioners skilled in the care of obstetric patients, and identify potential solutions and future efforts to improve cardiovascular care of this high‐risk patient population.

Introduction Between 0.02% and 0.04% of articles are retracted. We aim to: (a) describe the reasons for retraction of genetics articles and the time elapsed between the publication of an article and that of the retraction notice because of research misconduct (ie, fabrication, falsification, plagiarism); and (b) compare all these variables between retracted medical genetics (MG) and non-medical genetics (NMG) articles. Methods All retracted genetics articles published between 1970 and 2018 were retrieved from the Retraction Watch database. The reasons for retraction were fabrication/falsification, plagiarism, duplication, unreliability, and authorship issues. Articles subject to investigation by company/institution, journal, US Office for Research Integrity or third party were also retrieved. Results 1582 retracted genetics articles (MG, n=690; NMG, n=892) were identified . Research misconduct and duplication were involved in 33% and 24% of retracted papers, respectively; 37% were subject to investigation. Only 0.8% of articles involved both fabrication/falsification and plagiarism. In this century the incidence of both plagiarism and duplication increased statistically significantly in genetics retracted articles; conversely, fabrication/falsification was significantly reduced. Time to retraction due to scientific misconduct was statistically significantly shorter in the period 2006–2018 compared with 1970–2000. Fabrication/falsification was statistically significantly more common in NMG (28%) than in MG (19%) articles. MG articles were significantly more frequently investigated (45%) than NMG articles (31%). Time to retraction of articles due to fabrication/falsification was significantly shorter for MG (mean 4.7 years) than for NMG (mean 6.4 years) articles; no differences for plagiarism (mean 2.3 years) were found. The USA (mainly NMG articles) and China (mainly MG articles) accounted for the largest number of retracted articles. Conclusion Genetics is a discipline with a high article retraction rate (estimated retraction rate 0.15%). Fabrication/falsification and plagiarism were almost mutually exclusive reasons for article retraction. Retracted MG articles were more frequently subject to investigation than NMG articles. Retracted articles due to fabrication/falsification required 2.0–2.8 times longer to retract than when plagiarism was involved.

Since 1969, racial and ethnic preferences have existed throughout the American medical academy. The primary purpose has been to increase the number of blacks and Hispanics within the physician workforce as they were deemed to be “underrepresented in medicine.” To this day, the goal continues to be population parity or proportional representation. These affirmative action programs were traditionally voluntary, created and implemented at the state or institutional level, limited to the premedical and medical school stages, and intended to be temporary. Despite these efforts, numerical targets for underrepresented minorities set by the Association of American Medical Colleges have consistently fallen short. Failures have largely been attributable to the limited qualified applicant pool and legal challenges to the use of race and ethnicity in admissions to institutions of higher education. In response, programs under the appellation of diversity, inclusion, and equity have recently been created to increase the number of blacks and Hispanics as medical school students, internal medicine trainees, cardiovascular disease trainees, and cardiovascular disease faculty. These new diversity programs are mandatory, created and implemented at the national level, imposed throughout all stages of academic medicine and cardiology, and intended to be permanent. The purpose of this white paper is to provide an overview of policies that have been created to impact the racial and ethnic composition of the cardiology workforce, to consider the evolution of racial and ethnic preferences in legal and medical spheres, to critically assess current paradigms, and to consider potential solutions to anticipated challenges.

Background Informed consent for acute myocardial infarction and stroke research is challenging. Time for enrollment decisions is limited, patients and family are usually stressed, and being asked to participate in research is often unexpected. Despite these barriers, patients and surrogates have reported a preference for prospective involvement in research decisions and generally positive views of the consent process. It is unknown what drives positive or negative consent experiences. These data are crucial to making consent processes more context appropriate. Methods and Results We conducted a qualitative interview study with 27 patients and surrogates enrolled in acute myocardial infarction and stroke trials in the past 5 years. Purposive sampling from the P‐CARE (Patient‐Centered Approaches to Research Enrollment) study was based on participant characteristics and responses to initial patient‐centered interviews. In‐depth interviews used open‐ended questions to explore factors influencing consent experiences. Qualitative descriptive analysis was performed utilizing a multilevel coding strategy. Participants identified specific researcher behaviors as important, including expressions of respect, professionalism, and nonpressuring communication. Participants preferred consent conversations focused on risks/benefits and the trial protocol. They had varying views of consent forms and communicated several reasons the form was valuable unrelated to informational content. Participants also valued postenrollment interactions as opportunities to ask questions and learn about the study. Conclusions Barriers to consent in acute myocardial infarction and stroke trials are unavoidable, but participants identified productive ways to demonstrate respect for patients during enrollment conversations. These include key researcher behaviors, concentrating consent discussions on what participants find most important, and structured postenrollment follow‐up.

Background Prior reports indicate that the effect of P2Y12 inhibitors may be different in East Asian patients (“East Asian paradox”); therefore, understanding the outcomes associated with potent P2Y12 inhibitors in different populations is clinically important. Methods and Results In this observational cohort study using administrative healthcare data sets, we compared safety and effectiveness of contemporary P2Y12 inhibitors in patients with acute coronary syndrome. The primary safety outcomes were major and any bleeding, and the primary effectiveness outcomes were major cardiovascular events (a composite of cardiovascular death, myocardial infarction, or stroke) and all‐cause mortality. Among 70 715 patients with acute coronary syndrome, 56 216 (79.5%) used clopidogrel, 11 402 (16.1%) used ticagrelor, and 3097 (4.4%) used prasugrel. The median follow‐up period was 18.0 months (interquartile range: 9.6–26.4 months). In a propensity‐matched cohort, compared with clopidogrel, ticagrelor was associated with a higher risk of any bleeding (hazard ratio: 1.23; 95% CI, 1.14–1.33) but a lower risk of mortality (hazard ratio: 0.76; 95% CI, 0.63–0.91). Prasugrel, compared with clopidogrel, was associated with higher risks of any bleeding (hazard ratio: 1.23; 95% CI, 1.06–1.43) and major bleeding (hazard ratio: 1.50; 95% CI, 1.01–2.21) but a similar risk of effectiveness outcomes. No significant difference was noted between ticagrelor and prasugrel with respect to key safety or effectiveness outcomes. Several sensitivity analyses showed similar results. Conclusions In East Asian patients with acute coronary syndrome, compared with clopidogrel, ticagrelor was associated with an increased risk of bleeding but a decreased risk of mortality. Prasugrel was associated with an increase of any bleeding without difference in effectiveness outcomes. The risks of bleeding and ischemic events were similar between ticagrelor and prasugrel.

Background The angiotensin‐receptor/neprilysin inhibitor (ARNI) sacubitril/valsartan reduces hospitalization and mortality for patients with heart failure with reduced ejection fraction. However, adoption of ARNI into clinical practice has been slow. Factors influencing use of ARNI have not been fully elucidated. Using data from the Get With The Guidelines‐Heart Failure registry, Hospital Compare, Dartmouth Atlas, and the American Hospital Association Survey, we sought to identify hospital characteristics associated with patient‐level receipt of an ARNI prescription. Methods and Results We analyzed patients with heart failure with reduced ejection fraction who were eligible for ARNI prescription (ejection fraction≤40%, no contraindications) and hospitalized from October 1, 2015 through December 31, 2016. We used logistic regression to estimate the associations between hospital characteristics and patient ARNI prescription at hospital discharge, accounting for clustering of patients within hospitals using generalized estimating equation methods and adjusting for patient‐level covariates. Of 16 674 eligible hospitalizations from 210 hospitals, 1020 patients (6.1%) were prescribed ARNI at discharge. The median hospital‐level proportion of patients prescribed ARNI was 3.3% (Q1, Q3: 0%, 12.6%). After adjustment for patient‐level covariates, for‐profit hospitals had significantly higher odds of ARNI prescription compared with not‐for‐profit hospitals (odds ratio, 2.53; 95% CI, 1.05–6.10; P=0.04), and hospitals located in the Western United States had lower odds of ARNI prescription compared with those in the Northeast (odds ratio, 0.33; 95% CI, 0.13–0.84; P=0.02). Conclusions Relatively few hospital characteristics were associated with ARNI prescription at hospital discharge, in contrast to what has been observed in early adoption in other disease areas. Additional evaluation of barriers to implementing new evidence into heart failure practice is needed., See Editorial by Bergethon and Wasfy

Background “Financial toxicity” is a concern for patients, but little is known about how patients consider out‐of‐pocket cost in decisions. Sacubitril‐valsartan provides a contemporary scenario to understand financial toxicity. It is guideline recommended for heart failure with reduced ejection fraction, yet out‐of‐pocket costs can be considerable. Methods and Results Structured interviews were conducted with 49 patients with heart failure with reduced ejection fraction at heart failure clinics and inpatient services. Patient opinions of the drug and its value were solicited after description of benefits using graphical displays. Descriptive quantitative analysis of closed‐ended responses was conducted, and qualitative descriptive analysis of text data was performed. Of participants, 92% (45/49) said that they would definitely or probably switch to sacubitril‐valsartan if their physician recommended it and out‐of‐pocket cost was $5 more per month than their current medication. Only 43% (21/49) would do so if out‐of‐pocket cost was $100 more per month ( P Conclusions Out‐of‐pocket cost variation reflective of contemporary cost sharing substantially influenced stated willingness to take sacubitril‐valsartan, a guideline‐recommended therapy with mortality benefit. These findings suggest a need for cost transparency to promote shared decision making. They also demonstrate the complexity of cost discussion and need to study how to incorporate out‐of‐pocket cost into clinical decisions.

Background Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients’ and surrogates’ experiences. Methods and Results We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9 years (stroke) and 2.8 years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study. Conclusions Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context‐sensitive approaches to consent is important.

Children have historically been underrepresented or, indeed, omitted entirely, in drug trials, leading to a relative dearth of evidence in support of appropriate drug treatments for many pediatric diseases.[1][1], [2][2] Recent legislative initiatives in the United States and the European Union (EU

Background Patients with heart failure (HF) are admitted either under observation (OBS) or inpatient stays; however, there is little data on whether this designation reflects the clinical status of a patient, with significant logistical and financial implications. We sought to compare the outcomes of patients with HF admitted OBS versus inpatient stay (≤2 days; INPT). Methods and Results From January 1, 2008 to September 30, 2015, our multisite health system saw 21 339 unique patients totaling 52 493 hospital admissions with a primary diagnosis of HF. Patients were excluded if they underwent cardiac surgery (n=611), heart transplantation (n=187), or left ventricular assist device insertion (n=198), or if they died during hospitalization (n=1839). Of the remaining 50 654 discharges, 2 groups were identified: INPT group and OBS group. Outcomes were HF readmission, all‐cause readmission, and all‐cause mortality within 1 year of discharge. Hazard ratios were computed using the Andersen‐Gill method in the Cox proportional‐hazards model. A total of 8709 admissions (17%) occurred in the INPT group and 2648 admissions (5%) occurred in the OBS group. HF readmission rate at 1 year was 55.3% in INPT versus 66.5% in OBS (hazard ratio, 0.75; 95% confidence interval, 0.71–0.80; P

Health-related results that are discovered in the process of genomic research should only be returned to research participants after being clinically validated and then delivered and followed up within a health service. Returning such results may be difficult for genomic researchers who are limited by resources or unable to access appropriate clinicians. Raw sequence data could, in theory, be returned instead. This might appear nonsensical as, on its own, it is a meaningless code with no clinical value. Yet, as and when direct to consumer genomics services become more widely available (and can be endorsed by independent health professionals and genomic researchers alike), the return of such data could become a realistic proposition. We explore attitudes from

Background Concern regarding overutilization of cardiac imaging has led to the development of appropriate use criteria ( AUC ). Myocardial perfusion imaging ( MPI ) is one of the most commonly used cardiac imaging modalities worldwide. Despite multiple iterations of AUC, there is currently no evidence regarding their real‐world impact on population‐based utilization rates of MPI . Our goal was to assess the impact of the AUC on rates of MPI in Ontario, Canada. We hypothesized that publication of the AUC would be associated with a significant reduction in MPI rates. Methods and Results We conducted a retrospective cohort study of the adult population of Ontario from January 1, 2000, to December 31, 2015. Age‐ and sex‐standardized rates were compared from 4 different periods intersected by 3 published iterations of the AUC. Overall, 3 072 611 MPI scans were performed in Ontario during our study period. The mean monthly rate increased from 14.1/10 000 in the period from January 2000 to October 2005 to 18.2/10 000 between November 2005 and June 2009. After this point in time, there was a reduction in rates, falling to a mean monthly rate of 17.1/10 000 between March 2014 and December 2015. Time series analysis revealed that publication of the 2009 AUC was associated with a significant reduction in MPI rates ( P MPI scans at a cost savings of ≈72 million Canadian dollars. Conclusions Our results reflect a potential real‐world impact of the 2009 MPI AUC by demonstrating evidence of a significant effect on population‐based rates of MPI .

Background It is not clear whether Magnet recognition by the American Nurses Credentialing Center (nursing excellence program) is associated with improved patient outcomes. We investigated whether hospitalization in a Magnet hospital is associated with improved outcomes for patients with ischemic stroke. Methods and Results We performed a cohort study of patients with ischemic stroke from 2009 to 2013, who were registered in the New York Statewide Planning and Research Cooperative System database. Propensity‐score‐adjusted multivariable regression models were used to adjust for known confounders, with mixed effects methods to control for clustering at the facility level. An instrumental variable analysis was used to control for unmeasured confounding and simulate the effect of a randomized trial. During the study period, 176 557 patients were admitted for ischemic stroke, and met the inclusion criteria. Of these, 32 092 (18.2%) were hospitalized in Magnet hospitals, and 144 465 (81.8%) in non‐Magnet institutions. Instrumental variable analysis demonstrated that hospitalization in Magnet hospitals was associated with lower case‐fatality (adjusted difference, −23.9%; 95% CI , −29.0% to −18.7%), length of stay (adjusted difference, −0.4; 95% CI , −0.8 to −0.1), and rate of discharge to a facility (adjusted difference, −16.5%; 95% CI , −20.0% to −13.0%) in comparison to non‐Magnet hospitals. The same associations were present in propensity‐score‐adjusted mixed effects models. Conclusions Using a comprehensive all‐payer cohort of patients with ischemic stroke in New York State, we identified an association of treatment in Magnet hospitals with lower case‐fatality, discharge to a facility, and length of stay. Further research into the factors contributing to the superiority of Magnet hospitals in stroke care is warranted.

Background Surrogate endpoint trials test strategies more efficiently but are accompanied by uncertainty about the relationship between changes in surrogate markers and clinical outcomes. Methods and Results We identified cardiovascular trials with primary surrogate endpoints published in the New England Journal of Medicine , Lancet , and JAMA: Journal of the American Medical Association from 1990 to 2011 and determined the trends in publication of surrogate endpoint trials and the success of the trials in meeting their primary endpoints. We tracked for publication of clinical outcome trials on the interventions tested in surrogate trials. We screened 3016 articles and identified 220 surrogate endpoint trials. From the total of 220 surrogate trials, 157 (71.4%) were positive for their primary endpoint. Only 59 (26.8%) surrogate trials had a subsequent clinical outcomes trial. Among these 59 trials, 24 outcomes trial results validated the positive surrogates, whereas 20 subsequent outcome trials were negative following positive results on a surrogate. We identified only 3 examples in which the surrogate trial was negative but a subsequent outcomes trial was conducted and showed benefit. Findings were consistent in a sample cohort of 383 screened articles inclusive of 37 surrogate endpoint trials from 6 other high‐impact journals. Conclusions Although cardiovascular surrogate outcomes trials frequently show superiority of the tested intervention, they are infrequently followed by a prominent outcomes trial. When there was a high‐profile clinical outcomes study, nearly half of the positive surrogate trials were not validated. Cardiovascular surrogate outcome trials may be more appropriate for excluding benefit from the patient perspective than for identifying it.

Background Cost sharing is widely used to encourage therapeutic substitution. This study aimed to examine the impact of increases in patient cost‐sharing differentials for brand name and generic drugs on statin utilization on entry into the Medicare Part D coverage gap. Method and Results Using 5% Medicare Chronic Condition Warehouse files from 2006, this quasi‐experimental study examined patients with hyperlipidemia who filled prescriptions for atorvastatin or rosuvastatin between January and March 2006. Propensity score matching and difference‐in‐difference regressions were used to compare changes in statin utilization for the study group (patients who were not eligible for low‐income subsidies [non– LIS ] and had generic‐only gap coverage) to those of a control group ( LIS patients who faced the same cost sharing before and during the Part D coverage gap). In the final sample, 801 patients in the study group were matched to 801 patients in the control group. We found that, compared to the control group, the study group had a larger decline in any monthly brand‐name statin use (−0.24 30‐day fills, P P P OR 0.81, P OR 1.62, P Conclusions Increases in cost‐sharing differentials for brand name and generic drugs on coverage gap entry were associated with discontinuation of statins in Medicare Part D patients with hyperlipidemia.

Background Cardiovascular clinical trials depend on patient enrollment. Enrollment rates appear inadequate, but little is known about how frequently patients accept or decline offers of enrollment. The objective of this study was to assess trends and predictors of patient acceptance of offers to enroll in clinical trials for cardiovascular disease. Methods and Results We utilized an established database containing all randomized, controlled trials (n=1224) in cardiovascular disease published between 2001 and 2012 in the 8 highest‐impact general medical and cardiology journals. Studies were eligible if the number of patients approached and number of patients declining enrollment could be ascertained from published materials. All studies were screened for eligibility. Each eligible study was reviewed by 3 co‐authors. All discrepancies were resolved by the group. The main outcome was acceptance rate, defined as the number of patients enrolled divided by the number patients who were eligible and approached. Only 21.7% (n=266) of studies provided information sufficient to assess patient enrollment and refusals. The median acceptance rate across trials was 83.2%. Significant predictors of higher enrollment included: enrollment in the acute setting ( P =0.031); geographical region ( P P =0.006 for group). Conclusions Rates of reporting data sufficient to calculate acceptance rates are low. This compromises the ability to identify drivers of low enrollment and assess trial generalizability. However, the high rates of acceptance observed suggest that factors other than patients’ decisions may be the primary drivers of declining rates of trial enrollment.

Background Industry‐sponsored clinical trials produce high‐quality data sets that can be used by researchers to generate new knowledge. We assessed the availability of individual participant‐level data (IPD) from large cardiovascular trials conducted by major pharmaceutical companies and compiled a list of available trials. Methods and Results We identified all randomized cardiovascular interventional trials registered on ClinicalTrials.gov with >5000 enrollment, sponsored by 1 of the top 20 pharmaceutical companies by 2014 global sales. Availability of IPD for each trial was ascertained by searching each company's website/data‐sharing portal. If availability could not be determined, each company was contacted electronically. Of 60 included trials, IPD are available for 15 trials (25%) consisting of 204 452 patients. IPD are unavailable for 15 trials (25%). Reasons for unavailability were: cosponsor did not agree to make IPD available (4 trials) and trials were not conducted within a specific time (5 trials); for the remaining 6 trials, no specific reason was provided. For 30 trials (50%), availability of IPD could not be definitively determined either because of no response or requirements for a full proposal (23 trials). Conclusions IPD from 1 in 4 large cardiovascular trials conducted by major pharmaceutical companies are confirmed available to researchers for secondary research, a valuable opportunity to enhance science. However, IPD from 1 in 4 trials are not available, and data availability could not be definitively determined for half of our sample. For several of these trials, companies require a full proposal to determine availability, making use of the IPD by researchers less certain.

Resumen:El presente estudio pretende realizar una ruptura con la matriz lineal clásica de la pedagogía, replanteándola así en interconexión de diferentes perspectivas o saberes de lo real, para ello propone a la pedagogía como una disciplina indisciplinada, que trasciende las fronteras segmentacioncitas y colonizadoras que se le adhieren. Se propone, pues, la indisciplina como una alternativa de resistencia, un acto de pensar-sentir-hacer otra pedagogía. Abstract:The present study aims to develop a rupture of the classical linear matrix about the concept of pedagogy. The proposal restates the idea of pedagogy within an interconnection of different perspectives and knowledge about reality as well. In order to reach that, the vision of pedagogy as a rebellious discipline is proposed. The colonialist and separatist boundaries that characterize pedagogy are discussed. Therefore, the concept of indiscipline as an alternative which resists the educational system is presented, and the new idea of pedagogy as an act of thinking-feeling-doing is analyzed.

Non-communicable diseases have been somewhat neglected as a public health issue in the past, but there is now growing international consensus that they present a significant obstacle to economic development for both high- and low-income countries. Cardiovascular disease accounts for more than half of all non-communicable disease deaths, and presents a promising target for curbing the non-communicable disease epidemic. This article explains the pressing need for non-communicable disease prevention, focusing on strategies that can be employed to decrease cardiovascular disease risk at an individual and population level, and outlines the UK’s approaches to cardiovascular disease prevention in particular. Given the mounting burden of non-communicable diseases, responsible health governance and a balanced economic policy could consider the use of low cardiovascular disease rates as a measure of positive and sustainable economic development.

El proposito de este articulo es mostrar al hombre en las redes de las nuevas tecnologias en un sentido filosofico, en el que hombre cubre tambien al ser, a su ser y no solamente desde una perspectiva antropologica. En la actualidad se requiere de una nueva concepcion de mundo bajo las redes tecnologicas, igualmente este nuevo develar del hombre-en-el-mundo nos lleva a otras cuestiones eticas, politicas y culturales. Se recurrira al pensador aleman Martin Heidegger, pues su propuesta puede aportar a la explicacion de la cuestion hombre-tecnologia en la actualidad, puesto que el pregunta por la esencia de la tecnica yendo a la techne y nos da dos nuevos conceptos para abordar el estaren-este-mundo de las nuevas tecnologias: lo Gestell y la Kehre. DOI: http://dx.doi.org/10.22518/16578953.786

Objective To document the ethical issues regarding the systematic inclusion of relatives as clients in the post-stroke rehabilitation process. Methods A two-phase qualitative design consisting of in-depth interviews with relatives and stroke-clients (Phase 1) and three focus groups with relatives, stroke-clients and health professionals (Phase 2). Data was audio recorded. Transcribed interviews and focus groups content were rigorously analyzed by two team members. Results The interview sample was composed of 25 relatives and of 16 individuals with a first stroke whereas the three focus group sample size varied from 5 to 7 participants. Four main themes emerged: (1) overemphasis of caregiving role with an unclear legitimacy of relative to also be a client; (2) communication as a key issue to foster respect and a family-centered approach; (3) availability and attitudes of health professionals as a facilitator or a barrier to a family-centered approach; and (4) constant presence of relatives as a protective factor or creating a perverse effect. Conclusion/practice implications The needs of relatives are well known. The next step is to legitimize their right to receive services and to acknowledge the combined clinical and ethical value of including them post-stroke. Interdisciplinary health care approaches and communication skills should be addressed.