Atrial fibrillation increases the risks of stroke, heart failure, and death, and anticoagulation therapy increases the risk of gastrointestinal haemorrhage. However, the relative event rates for ...these outcomes are not well described. We sought to define the risks of major clinical events in older adults after a new diagnosis of atrial fibrillation.
We undertook a population-based, retrospective cohort study of a nationally representative sample of fee-for-service Medicare beneficiaries 65 years or older with incident atrial fibrillation diagnosed between 1999 and 2007. The main outcome measures were mortality and hospitalization or emergency department care for heart failure, myocardial infarction, stroke, or gastrointestinal haemorrhage. Among 186 461 patients with atrial fibrillation and no recent hospitalizations for heart failure, myocardial infarction, stroke, or gastrointestinal haemorrhage, mortality was the most frequent of these major clinical events (19.5% at 1 year; 48.8% at 5 years). By 5 years, 13.7% of patients were hospitalized for heart failure, 7.1% developed new-onset stroke, and 5.7% had gastrointestinal haemorrhage. Myocardial infarction was less frequent (3.9% at 5 years). Rates of mortality, heart failure, myocardial infarction, stroke, and gastrointestinal bleeding increased with older age and higher CHADS2 scores. Among 44 479 patients with previous events, the 5-year risk of death was greatest among patients with recent bleeding events (70.1%) and stroke (63.7%) and lowest among those with recent myocardial infarction (54.9%).
After the diagnosis of incident atrial fibrillation in older adults, mortality was the most frequent major outcome during the first 5 years. Among non-fatal cardiovascular events, heart failure was the most common event.
Background Timing of initial treatment for acute decompensated heart failure (ADHF) varies across hospitals and its impact on outcomes remains poorly defined. We examined the association between time ...to first intravenous (IV) heart failure (HF) therapy and patient outcomes. Methods Using the ADHERE-EM linked to Medicare claims data, we identified patients ≥65 years old who were hospitalized for ADHF and received IV HF therapy during index admission. Cox proportional hazard model was used to assess the association of time to treatment with a composite of 30-day all-cause mortality or re-admission. Generalized linear mixed models were used to examine the association of time to treatment with in-hospital all-cause mortality, index hospitalization length of stay, and total days alive and out-of-hospital at 30 days. Results Of 6,971 patients, the median time to first IV HF therapy was 2.3-hours (interquartile range 1.1, 4.4). The cumulative incidence of 30-day all-cause mortality or readmission was 27.4%. After adjusting for covariates, time to treatment was not associated with increased risk of composite 30-day all-cause mortality or re-admission (HR 1.00; 95% CI 1.00-1.00; P = .221). However, every hour delay in treatment was associated with a modest increased risk of in-hospital mortality (adjusted OR 1.01; 95% CI 1.00-1.02; P = .001) and an approximately 1.4-hour increase in index admission length of stay ( P < .001). Conclusion Among older patients presenting with ADHF, delay in initiating IV HF therapy was associated with modestly higher risk for in-hospital mortality and longer length of stay, but was not associated with 30-day outcomes.
CONTEXT Practice guidelines do not recommend use of an implantable cardioverter-defibrillator (ICD) for primary prevention in patients recovering from a myocardial infarction or coronary artery ...bypass graft surgery and those with severe heart failure symptoms or a recent diagnosis of heart failure. OBJECTIVE To determine the number, characteristics, and in-hospital outcomes of patients who receive a non–evidence-based ICD and examine the distribution of these implants by site, physician specialty, and year of procedure. DESIGN, SETTING, AND PATIENTS Retrospective cohort study of cases submitted to the National Cardiovascular Data Registry-ICD Registry between January 1, 2006, and June 30, 2009. MAIN OUTCOME MEASURE In-hospital outcomes. RESULTS Of 111 707 patients, 25 145 received non–evidence-based ICD implants (22.5%). Patients who received a non–evidence-based ICD compared with those who received an evidence-based ICD had a significantly higher risk of in-hospital death (0.57% 95% confidence interval {CI}, 0.48%-0.66% vs 0.18% 95% CI, 0.15%-0.20%; P <.001) and any postprocedure complication (3.23% 95% CI, 3.01%-3.45% vs 2.41% 95% CI, 2.31%-2.51%; P <.001). There was substantial variation in non–evidence-based ICDs by site. The rate of non–evidence-based ICD implants was significantly lower for electrophysiologists (20.8%; 95% CI, 20.5%-21.1%) than nonelectrophysiologists (24.8% 95% CI, 24.2%-25.3% for nonelectrophysiologist cardiologists; 36.1% 95% CI, 34.3%-38.0% for thoracic surgeons; and 24.9% 95% CI, 23.8%-25.9% for other specialties) (P<.001 for all comparisons). There was no clear decrease in the rate of non–evidence-based ICDs over time (24.5% 6908/28 233 in 2006, 21.8% 7395/33 965 in 2007, 22.0% 7245/32 960 in 2008, and 21.7% 3597/16 549 in 2009; P <.001 for trend from 2006-2009 and P = .94 for trend from 2007-2009). CONCLUSION Among patients with ICD implants in this registry, 22.5% did not meet evidence-based criteria for implantation.
Background Hospitals are challenged to reduce length of stay (LOS), yet simultaneously reduce readmissions for patients with heart failure (HF). This study investigates whether 30-day ...rehospitalization or an alternative measure of total inpatient days over an episode of care (EOC) is the best indicator of resource use, HF quality, and outcomes. Methods Using data from the American Heart Association's Get With The Guidelines-Heart Failure Registry linked to Medicare claims, we ranked and compared hospitals by LOS, 30-day readmission rate, and overall EOC metric, defined as all hospital days for an HF admission and any subsequent admissions within 30 days. We divided hospitals into quartiles by 30-day EOC and 30-day readmission rates. We compared performance by EOC and readmission rate quartiles with respect to quality of care indicators and 30-day postdischarge mortality. Results The population had a mean age of 80 ± 7.95 years, 45% were male, and 82% were white. Hospital-level unadjusted median index LOS and overall EOC were 4.9 (4.2-5.6) and 6.2 (5.3-7.4) days, respectively. Median 30-day readmission rate was 23.2%. Hospital HF readmission rate was not associated with initial hospital LOS, only slightly associated with total EOC rank ( r = 0.26, P = .001), and inversely related to HF performance measures. After adjustment, there was no association between 30-day readmission and decreased 30-day mortality. In contrast, better performance on the EOC metric was associated with decreased odds of 30-day mortality. Conclusions Although hospital 30-day readmission rate was poorly correlated with LOS, quality measures, and 30-day mortality, better performance on the EOC metric was associated with better 30-day survival. Total inpatient days during a 30-day EOC may more accurately reflect overall resource use and better serve as a target for quality improvement efforts.
We sought to examine associations between initiation of beta-blocker therapy and outcomes among elderly patients hospitalized for heart failure.
Beta-blockers are guideline-recommended therapy for ...heart failure, but their clinical effectiveness is not well understood, especially in elderly patients.
We merged Medicare claims data with OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure) records to examine long-term outcomes of eligible patients newly initiated on beta-blocker therapy. We used inverse probability-weighted Cox proportional hazards models to determine the relationships among treatment and mortality, rehospitalization, and a combined mortality-rehospitalization end point.
Observed 1-year mortality was 33%, and all-cause rehospitalization was 64%. Among 7,154 patients hospitalized with heart failure and eligible for beta-blockers, 3,421 (49%) were newly initiated on beta-blocker therapy. Among patients with left ventricular systolic dysfunction (LVSD) (n = 3,001), beta-blockers were associated with adjusted hazard ratios of 0.77 (95% confidence interval CI: 0.68 to 0.87) for mortality, 0.89 (95% CI: 0.80 to 0.99) for rehospitalization, and 0.87 (95% CI: 0.79 to 0.96) for mortality-rehospitalization. Among patients with preserved systolic function (n = 4,153), beta-blockers were associated with adjusted hazard ratios of 0.94 (95% CI: 0.84 to 1.07) for mortality, 0.98 (95% CI: 0.90 to 1.06) for rehospitalization, and 0.98 (95% CI: 0.91 to 1.06) for mortality-rehospitalization.
In elderly patients hospitalized with heart failure and LVSD, incident beta-blocker use was clinically effective and independently associated with lower risks of death and rehospitalization. Patients with preserved systolic function had poor outcomes, and beta-blockers did not significantly influence the mortality and rehospitalization risks for these patients.
Purpose
Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling complication of many chemotherapies. We investigated the feasibility of using health plan claims and administrative data to ...identify CIPN occurrence by comparing patients who received neurotoxic and non-neurotoxic chemotherapies.
Methods
The sample included over 53,000,000 patients from two regional and one national insurer in the USA (> 400,000 exposed to chemotherapy). Peripheral neuropathy was identified using a broad definition (definition 1) and a specific definition (i.e., drug-induced polyneuropathy code) (definition 2).
Results
CIPN incidence as measured by definition 1 within 6 months of chemotherapy initiation was 18.1% and 6.2% for patients who received neurotoxic and non-neurotoxic chemotherapy, respectively (relative risk neurotoxic vs. non-neurotoxic (RR), 2.93 (95% CI, 2.87–2.98)). For definition 2, these incidences were 3.6% and 0.1% (RR, 25.2 (95% CI, 22.8–27.8)). The incidences of new analgesic prescriptions for neurotoxic and non-neurotoxic groups were as follows: gabapentin, 7.1%/1.7%; pregabalin, 0.69%/0.31%; and duloxetine, 0.78%/0.76%. The incidence of CIPN as defined by definitions 1 and 2 was low compared with that of published research studies, but the relative risk of CIPN among patients who received neurotoxic chemotherapies compared with those who received non-neurotoxic chemotherapies was high using definition 2.
Conclusions
These data suggest that as used currently by clinicians, administrative codes likely underestimate CIPN incidence. Thus, studies using administrative data to estimate CIPN incidence are not currently feasible. However, the drug-induced polyneuropathy code is a specific indicator of CIPN in administrative data and may be useful for investigating predictors or potentially preventive therapies of CIPN.
The learning healthcare system uses health information technology and the health data infrastructure to apply scientific evidence at the point of clinical care while simultaneously collecting ...insights from that care to promote innovation in optimal healthcare delivery and to fuel new scientific discovery. To achieve these goals, the learning healthcare system requires systematic redesign of the current healthcare system, focusing on 4 major domainsscience and informatics, patient-clinician partnerships, incentives, and development of a continuous learning culture. This scientific statement provides an overview of how these learning healthcare system domains can be realized in cardiovascular disease care. Current cardiovascular disease care innovations in informatics, data uses, patient engagement, continuous learning culture, and incentives are profiled. In addition, recommendations for next steps for the development of a learning healthcare system in cardiovascular care are presented.
Purpose To examine the use of anti–vascular endothelial growth factor (VEGF) therapy in clinical practice among patients with neovascular age-related macular degeneration (AMD). Design Retrospective ...cohort study. Methods Among 459 237 Medicare beneficiaries, we identified anti-VEGF treatment using claims for intravitreal injections of anti-VEGF medications with a supporting diagnosis of neovascular AMD. We used the cumulative incidence function to calculate the frequency of anti-VEGF treatments and treatment visits for neovascular AMD per treated eye in the first and second year after the initial anti-VEGF injection. We calculated the mean number of treatments and treatment visits per eye using the mean frequency function. Rates of discontinuation were estimated using Kaplan-Meier methods. Results The mean number of injections was 4.3 in the first year, with 58% of patients receiving 1–4 injections, 20% receiving 5–6 injections, and 22% receiving 7 or more injections. Among patients who received 7 or more injections during the first year, 31% received a comparable number during the second year, and 12% received no injections. Of patients who received 1–4 injections during the first year, 70% received no injections and 24% received 1–4 injections during the second year. Rates of anti-VEGF discontinuation were 57% within 12 months and 71% within 24 months. Conclusions The frequency of anti-VEGF injections for neovascular AMD was lower than that recommended by large-scale clinical trials, and rates of discontinuation were high. National practice patterns in anti-VEGF therapy for patients with neovascular AMD do not reflect optimal treatment strategies suggested by recent clinical trial evidence.
Data from randomized controlled trials and observational studies on older adults who take statins for primary prevention of atherosclerotic cardiovascular disease are limited. To determine the ...incidence of statin use in older adults with and without cardiovascular disease (CVD) and/or diabetes (DM), we conducted a descriptive observational study.
The cohort consisted of health plan members in the NIH Collaboratory Distributed Research Network aged >75 years who had continuous drug and medical benefits for ≥183 days during the study period, January 1, 2008- March 31, 2018. We defined DM and CVD using diagnosis codes, and identified statins using dispensing data. Statin use was considered incident if a member had no evidence of statin exposure in the claims during the previous 183 days, and the use was considered long-term if statins were supplied for ≥180 days. Incidence rates were reported among members with and without CVD and/or diabetes, and stratified by year, sex, and age group.
Among 757,569 eligible members, 109,306 older adults initiated statins and 54,624 became long-term users. Health plan members with CVD had the highest incidence of statin use (143.9 initiators per 1,000 member-years for CVD & DM; 114.5 initiators per 1,000 member-years for CVD & No DM). Among health plan members without CVD, those with DM had rates of statin use that were over two times higher than members without DM (76.1 versus 34.5 initiators per 1,000 member-years, respectively). Statin initiation remained steady throughout 2008-2016, was slightly higher in males, and declined with increasing age.
Incidence of statin use varied by CVD and DM comorbidity, and was lowest among those without CVD. These results highlight the potential clinical equipoise to conduct large pragmatic clinical trials to generate evidence that could be used to inform future blood cholesterol guidelines.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Improving diversity in clinical trials is essential in order to produce generalizable results. Although the importance of representation has become increasingly recognized, identifying strategies to ...approach this work remains elusive. This article reviews the proceedings of a multi-stakeholder conference about the current state of diversity in clinical trials and outlines actionable steps for improvement.
Conference attendees included representatives from the United States Food and Drug Administration (FDA), National Institutes of Health (NIH), practicing clinical investigators, pharmaceutical and device companies, community-based organizations, data analytics companies, and patient advocacy groups. At this virtual event, attendees were asked to consider key questions around best practices for engagement of underrepresented populations.
Community engagement is an integral part of recruitment and retention of underrepresented groups. Decentralization of sites and use of digital tools can enhance the accessibility of clinical research. Finally, improving representation among investigators and clinical research staff may translate to diverse clinical trial participants.
Improving diversity in clinical trials is an ethical and scientific imperative, which requires a multifaceted approach.
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