This is a pilot cluster randomized controlled trial to determine the feasibility and acceptability of training medical oncologists to use the Best Case/Worst Case-Geriatric Oncology communication tool in clinical practice with older adults with cancer (NCT05374304).
Influenza vaccines have been demonstrated to effectively reduce the incidence of influenza infection and potentially associated risks of cardiovascular events in patients with cardiovascular disease (CVD). Despite strong guideline and public health endorsements, global influenza vaccination rates in patients with…
Influenza vaccination rates remain suboptimal despite effectiveness in preventing influenza infection and related complications. We investigated whether behavioural nudges, delivered via a governmental electronic letter system, would increase influenza vaccination uptake among older adults in Denmark. We did a nationwide,…
This K23 career development project seeks to leverage electronic health record data from KPNC and 2 health system collaborators within the Mental Health Research Network to investigate population health management strategies to prevent diabetes and improve cardiovascular health among people…
The overarching goal of the KP NCORP Community Site is to bring the benefits of medical advances to our racially and ethnically diverse membership and to the community at large by increasing clinical trial access/accrual and by conducting cancer care…
This randomized controlled trial study is testing an intervention to reduce unsafe medication use in patients aged 75 years and older. The intervention uses collaborative drug therapy management between physicians and pharmacists, standard-of-care treatment protocols, shared decision-making, and the CEASE deprescribing protocol.…
This prospective, observational cohort study, an extension of clinical trial V503-069, will enroll and administer a second dose of 9vHPV to approximately 200 children/teens ages 10 to 15 who received their first 9vHPV vaccine at least 1 year prior. These…
This stepped-wedge cluster randomized trial will stagger implementation of a clinical decision support system (CDSS) across 13 KPNC emergency departments to assist emergency physicians and hospitalists in the comprehensive management of patients with atrial fibrillation/flutter. We will compare hospitalization rates,…
To evaluate the effect of inserting epidemiological information into lumbar spine imaging reports on subsequent nonsurgical and surgical procedures involving the thoracolumbosacral spine and sacroiliac joints. Analysis of secondary outcomes from the Lumbar Imaging with Reporting of Epidemiology (LIRE) pragmatic…
The MITIGATE study aims to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), compared with usual care, on laboratory-confirmed viral upper respiratory infection (URI)-related morbidity and mortality in adults with established atherosclerotic cardiovascular disease (ASCVD). IPE is…
This study is part of the Phase 3 pediatric clinical development program to evaluate the 20-Valent Pneumococcal Conjugate Vaccine for use in infants and children. This clinical trial will provide key safety and pivotal comparative immunogenicity data in infants to…
This clinical trial will evaluate treatment with IV administered remdesivir in an outpatient setting in patients with COVID-19 who are at risk for disease progression.
Most people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of…
A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for evidence synthesis and clinical guidelines. A core…
Mail order pharmacy (MOP) use has been linked to improved medication adherence and health outcomes among patients with diabetes. However, no large-scale intervention studies have assessed the effect of encouraging MOP use on medication adherence. To assess an intervention to…
A cluster-randomized trial of Addiction Medicine consultation (AMC) for primary care physicians (PCPs) and patients examining the effectiveness of a telehealth AMC intervention on initiation of alcohol use treatment, anti-craving medication and/or specialty addiction treatment initiation, and on patient alcohol…
The goal of this study is to apply the patient-centered advance care planning paradigm of values elicitation and decision-making and communication preparation to hypoglycemia-related adverse outcomes in vulnerable older patients with type 2 diabetes. This will involve a randomized clinical…
In-person clinic follow-up within 7 days after discharge from a heart failure hospitalization is associated with lower 30-day readmission. However, health systems and patients may find it difficult to complete an early postdischarge clinic visit, especially during the current pandemic.…
Assess the feasibility of conducting a cluster randomized trial (RCT) comparing technology-delivered mindfulness-based intervention (MBI) programs against a waitlist control arm targeting advanced cancer patients and their informal caregivers. Two-arm cluster RCT within Kaiser Permanente Northern California (KPNC). We recruited…
The COVID epidemic has exposed the fragility of the social network that supports our most complex and vulnerable members. We have established an interdisciplinary team of researchers, clinicians, and operational leaders at KPNC, KPCO, KPWA to study socially determined barriers…
This pragmatic randomized clinical trial funded through National and NCAL Community Health/Benefits is testing the impact of medically-tailored meals and enhanced nutritional counseling compared to usual care on clinical and patient-centered outcomes in hospitalized adults with targeted medical conditions being…
This multi-center, multi-country retrospective cohort study will assess the clinical course and outcome of adults with severe COVID-19 not treated with remdesivir using a 7-point ordinal scale for clinical outcomes on Day 14 and all-cause mortality at Day 28 after…
In a sample of people with HIV (PWH) enrolled in an alcohol intervention trial and followed for 12 months, we examined the association of changes in days (i.e., decrease, increase, no change [reference]) of unhealthy drinking (consuming ≥ 4/≥ 5 drinks for women/men) with…
This is a non-inferiority trial design comparing colorectal cancer incidence in trial participants with 1-2 non-advanced adenomas randomized to recommendation for a 5- and 10-year surveillance colonoscopy exam vs. a 10-year surveillance colonoscopy exam.
MMR II (M-M-R II [Merck & Co, Inc.]) is currently the only measles, mumps, and rubella (MMR) vaccine licensed in the United States. A second MMR vaccine would mitigate the potential risk of vaccine supply shortage or delay. In this…
The Menopause Strategies: Finding Lasting Answers for Symptoms and Health clinical trials network was funded by the National Institutes of Health to find new ways to alleviate the most common, bothersome menopausal symptoms by designing and conducting multiple concurrent clinical…
Frequent hemodialysis modifies serum phosphorus, blood pressure, and left ventricular mass (LVM). We ascertained whether frequent hemodialysis is associated with specific changes in biomarker profile among patients enrolled in the frequent hemodialysis network (FHN) trials. This was a post hoc…
In PIONEER-HF, among stabilized patients with acute decompensated heart failure (ADHF), the in-hospital initiation of sacubitril/valsartan was well tolerated and led to improved outcomes compared with enalapril. However, there are limited data comparing the strategies of in-hospital vs postdischarge initiation…
Cardiorespiratory fitness (CRF) is closely linked to health status and clinical outcomes in heart failure (HF) patients. We aimed to test whether biomarkers can reflect CRF and its change over time. This post hoc analysis used data from ambulatory cohorts…
The Mental Health Research Network (MHRN) is a consortium of 13 health system research centers, embedded in large and diverse healthcare systems, dedicated to improving patient mental health through research, practice, and policy; with expertise in mental health research as…
This intervention study will randomize 200 postpartum women at increased risk of postpartum depression to an eHealth physical activity intervention and assess the efficacy of the intervention on increasing physical activity and decreasing postpartum depressive symptoms. Additionally, this study will…
GlaxoSmithKline Vaccines is currently preparing for clinical trials that evaluate the safety/reactogenicity and immunogenicity of a respiratory syncytial virus maternal vaccine candidate in pregnant women. Robust epidemiological data is needed to support the interpretation of maternal and neonatal outcomes in…
Estimating hazard ratios (HR) presents challenges for propensity score (PS)-based analyses of cohorts with differential depletion of susceptibles. When the treatment effect is not null, cohorts that were balanced at baseline tend to become unbalanced on baseline characteristics over time…
Background Despite the success of current cardiovascular disease (CVD) management programs, many patients do not achieve optimal control of CVD-related risk factors. New strategies are needed to better activate and engage these patients. Methods and Results We conducted a parallel,…
Prospective enrollment of research subjects in the fast-paced emergency department (ED) is challenging. We sought to develop a software application to increase real-time clinical trial enrollment during an ED visit. The Prospective Intelligence System for Clinical Emergency Services (PISCES) scans…
Recent 15-year updates of sigmoidoscopy screening trials provide new evidence on the effectiveness of colorectal cancer screening. Prompted by the new evidence, we asked: "Does colorectal cancer screening make an important difference to health outcomes in individuals initiating screening at…
Concerns about reverse causality and selection bias complicate the interpretation of studies of body mass index (BMI, calculated as weight (kg)/height (m)2) and mortality in older adults. The objective of this study was to investigate methodological explanations for the apparent…
Unhealthy alcohol use has adverse effects on HIV treatment. Screening, brief intervention, and referral to treatment (SBIRT) has some evidence of efficacy but may not be sufficient for those with low motivation or comorbid substance use. To examine the effectiveness…
The MsFLASH (Menopause Strategies: Finding Lasting Answers for Symptoms and Health) Network recruited into five randomized clinical trials (n = 100-350) through mass mailings. The fifth trial tested two interventions for postmenopausal vulvovaginal symptoms (itching, pain, irritation, dryness, or pain with sex)…
Medicare-age patients with type 2 diabetes are projected to double in the next 25 years and have high rates of complications and adverse drug events. However, older patients are largely excluded from the major clinical trials of diabetes care. This…
This randomized trial will test whether the implementation of an mHealth tool in the health-plan setting increases the proportion of overweight and obese women with appropriate total gestational weight gain, according to Institute of Medicine (IOM) guidelines in comparison to…
This study aims to utilize data from the Kaiser Permanente Northern California Gestational Diabetes and Pregnancy Glucose Tolerance Registry for a cohort of 25,000 women diagnosed with gestational diabetes. The goal is to determine whether clinical and laboratory factors can…
A randomized, double-blind noninferiority trial of adductor canal catheters for postoperative pain management among patients undergoing elective, unilateral, total-knee arthroplasty.
This study explores the enduring impact of screening, brief intervention, and referral to treatment (SBIRT) delivered in pediatric primary care, on young adults. We will examine substance use, mental health and medical outcomes, and health services utilization and cost over…
To evaluate the efficacy of two common interventions for bothersome postmenopausal vaginal symptoms on improving sexual frequency and pain. This is a post-hoc analysis of data from a 12-week double-blind placebo-controlled trial that randomized postmenopausal women (ages 45-70 years) with…
This pilot study examined the ability to operationalize the collection of real-world data to explore the potential use of real-world end points extracted from data from diverse health care data organizations and to assess how these relate to similar end…
Primary care providers (PCPs) are often challenged to address multiple patient concerns during time-limited visits. The need for PCPs to limit the number of issues addressed may have a negative impact on discussion of patient-defined visit priorities. Using data from…
Most patients with diabetes do not meet all evidence-based goals of care, and many patients report poor communication and lack of involvement in decision-making during primary care visits. To test the hypothesis that a "Pre-Visit Prioritization" secure email message could…
The HealthyFood (HF) program offers members up to 25% cash back monthly on healthy food purchases. In this randomized controlled trial, we tested the efficacy of financial incentives combined with text messages in increasing healthy food purchases among HF members.…
Systolic blood pressure (SBP) and its association with clinical outcomes in atrial fibrillation (AF) patients in community practice are poorly characterized. In patients with AF, we sought to (1) examine the prevalence of baseline uncontrolled hypertension and the overall change…
Migraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects.…
Most studies on adolescent screening, brief intervention, and referral to treatment (SBIRT) have examined substance use outcomes. However, it may also impact service use and comorbidity-an understudied topic. We address this gap by examining effects of SBIRT on health care…
Excess gestational weight gain (GWG) is common among women with overweight or obesity, increasing their risks for pregnancy complications, delivering a large infant, and postpartum weight retention. To date, only intensive interventions have had success and few interventions have been…
Current World Health Organization guidelines for conducting anti-malarial drug efficacy clinical trials recommend genotyping Plasmodium falciparum genes msp1 and msp2 to distinguish recrudescence from reinfection. A more recently developed potential alternative to this method is a molecular genotyping assay based…
Time during primary care visits is limited. We tested the hypothesis that a waiting room health information technology (IT) tool to help patients identify and voice their top visit priorities would lead to better visit interactions and improved quality of…
I-scan is an electronic chromoendoscopy technology that improves resolution of epithelial and mucosal surfaces and vessels. We performed a randomized controlled trial to compare detection of adenomas by i-scan vs standard high-definition white-light (HDWL) colonoscopy. From February 1 through December…
A phase 3, randomized, double-blind trial will evaluate the safety and immunogenicity of 3 lots of 20-valent Pneumococcal conjugate vaccine in Pneumococcal vaccine–naive adults 18 through 49 years of age. The purpose of this study is to evaluate the safety…
This research will examine the relationship of alcohol use and depression over time using data based in the electronic health record (EHR), in the context of health care. We will conduct secondary analysis of depression and hazardous drinking patterns in…
Acute decompensated heart failure accounts for more than 1 million hospitalizations in the United States annually. Whether the initiation of sacubitril-valsartan therapy is safe and effective among patients who are hospitalized for acute decompensated heart failure is unknown. We enrolled…
Observational studies should have a core role in justifying and guiding the development of randomized controlled trials, but to date observational research and trials on Alzheimer’s disease prevention are not closely aligned. Observational and randomized studies nearly always answer different…
Obesity is associated with an increased risk of breast cancer, including the estrogen receptor (ER)-positive subtype in postmenopausal women. Whether excess adiposity is associated with increased risk in women with a normal body mass index (BMI; calculated as weight in…
Poor dietary quality, measured by the Healthy Eating Index 2010 (HEI-2010), is associated with risk of gestational diabetes mellitus (GDM) and type 2 diabetes. The aim was to investigate the association between dietary quality and glycemic control in women with…
The Northern California Regional Coordinating Stroke Center (NorCal-CSC) is a joint effort between U.C. San Francisco and selected medical center(s) within Kaiser Permanente as part of the National Institute of Neurological Disorders and Stroke (NINDS) Stroke Trials Network. This project…
Randomized clinical trial findings support decreased red blood cell (RBC) transfusion and short-term tolerance of in-hospital anemia. However, long-term outcomes related to changes in transfusion practice have not been described. To describe the prevalence of anemia at and after hospital…
The primary objective of this study is to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events. Secondary objectives are: 1) To evaluate the anti-pneumococcal polysaccharide serotype-specific Immunoglobulin Geometric Mean Concentrations at…
In Kaiser Permanente Northern California (KPNC), members had similar access to care and a very high overall rate of hypertension control. However, blacks had poorer blood pressure (BP) control than whites. The Shake Rattle & Roll (SRR) trial aimed to…
Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTaP-HBV-IPV/Hib) can further reduce the number of injections in pediatric immunization schedules of countries currently using pentavalent DTaP combination vaccines. This open-label, randomized, multicenter study (NCT02096263) conducted in…
Background Diminished peak lung function in young adulthood is a risk factor for future chronic obstructive pulmonary disease. The association between lung disease and cardiovascular disease later in life is well documented. Whether peak lung function measured in young adulthood…
Many low-risk patients with acute pulmonary embolism (PE) in the emergency department (ED) are eligible for outpatient care but are hospitalized nonetheless. One impediment to home discharge is the difficulty of identifying which patients can safely forgo hospitalization. To evaluate…
There is growing interest from the oncology community to understand how body composition measures can be used to improve the delivery of clinical care for the 18.1 million individuals diagnosed with cancer annually. Methods that distinguish muscle from subcutaneous and…
To determine the efficacy and safety of statins for primary prevention of atherosclerotic cardiovascular disease (ASCVD) events in older adults, especially those aged 80 and older and with multimorbidity. The National Institute on Aging and the National Heart, Lung and…
Background Current American College of Cardiology/American Heart Association guidelines suggest that for patients with atrial fibrillation who are at low risk for stroke (CHA2DS2VASc=1) (or women with CHA2DS2VASc=2) a variety of treatment strategies may be considered. However, in clinical practice,…
AIMS: Obesity is present in up to 45% of patients with heart failure (HF). Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor antagonist, facilitates weight loss in obese patients. The efficacy of liraglutide as a weight loss agent among patients with HF…
Patients with heart failure will be randomized 1:1 to either oral torsemide or oral furosemide prior to hospital discharge. The primary endpoint will be all-cause mortality over the follow-up period. Secondary endpoints are hospitalizations, quality of life, and depression.
In clinical trials of patients with type 2 diabetes, long-acting insulin analogs modestly reduced the risk of nocturnal hypoglycemia compared with human neutral protamine Hagedorn (NPH) insulin, but cost 2 to 10 times more. Outcomes in clinical practice may differ…
Evaluate whether a tailored letter improved gestational weight gain (GWG) and whether GWG mediated a multicomponent intervention's effect on postpartum weight retention among women with gestational diabetes mellitus (GDM). A cluster-randomized controlled trial of 44 medical facilities (n = 2,014…
Patients with chronic heart failure with reduced ejection fraction (HFrEF) benefit from medical and device therapies targeting sudden cardiac death (SCD). Contemporary estimates of SCD risk after hospitalization for heart failure are limited. We describe the incidence, timing, and clinical…
OBJECTIVES: As the largest acute heart failure (AHF) trial conducted to date, the global ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial database presented an opportunity to systematically describe the relationship among time of hospital…
Although traditional renin-angiotensin system antagonists including angiotensin-converting enzyme inhibitors and angiotensin receptor blockers have revolutionized the treatment of cardiovascular disease (CVD), the pivotal PARADIGM-HF trial demonstrated that sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), was superior to an angiotensin-converting enzyme inhibitor…
OBJECTIVE: The objective is to assess the safety, tolerability, and efficacy of sacubitril/valsartan compared with enalapril in patients with heart failure (HF) with a reduced ejection fraction (EF) stabilized during hospitalization for acute decompensated HF.BACKGROUND: Sacubitril/valsartan, a first-in-class angiotensin receptor-neprilysin…
This study is a phase 3, randomized, active-controlled, observer-blinded study to assess the immunogenicity, safety, and tolerability of bivalent rLP2086 when administered as a two-dose regimen in healthy subjects 10 to 26 years of age. The project also includes a…
AIMS: Patients hospitalized for heart failure (HF) are at high risk for 30-day readmission. This study sought to examine the timings and causes of readmission within 30 days of an HF hospitalization.METHODS AND RESULTS: Timing and cause of readmission in the…
Acute heart failure (HF) is a global pandemic with more than one million admissions to hospital annually in the US and millions more worldwide. Post-discharge mortality and readmission rates remain unchanged and unacceptably high. Although recent drug development programmes have…
AIMS: Troponin levels are commonly elevated among patients hospitalized for heart failure (HF), but the prevalence and prognostic significance of early post-discharge troponin elevation are unclear. This study sought to describe the frequency and prognostic value of pre-discharge and post-discharge…
BACKGROUND: It is unclear how patients hospitalized for acute heart failure (HF) who are long-term chronic HF survivors differ from those with more recent HF diagnoses.OBJECTIVES: The goal of this study was to evaluate the influence of HF chronicity on…
Within the CVRN-HF Network, and in collaboration with NIA-sponsored PACTTE consortium investigators, we will examine the following among a large, multi-center cohort of elderly patients with heart failure with reduced or preserved left ventricular systolic function: 1) to characterize the…
OBJECTIVES: This study sought to examine the relationships between in-hospital and post-discharge body weight changes and outcomes among patients hospitalized for acute heart failure (AHF).BACKGROUND: Body weight changes during and after hospitalization for AHF and the relationships with outcomes have…
PURPOSE OF REVIEW: Heart failure is a global pandemic and there has been a growing effort to enroll patients from different geographical regions in randomized controlled trials. In this review, we examined regional variation in both patient characteristics and outcomes…
BACKGROUND: Although aerobic exercise improves quality of life as assessed by a disease-specific instrument in ambulatory HF patients with a reduced ejection fraction (EF), the impact of an exercise intervention on general health status has not been previously reported.METHODS: A…
Heart failure is a clinical syndrome that manifests from various cardiac and noncardiac abnormalities. Accordingly, rapid and readily accessible methods for diagnosis and risk stratification are invaluable for providing clinical care, deciding allocation of scare resources, and designing selection criteria…
BACKGROUND: Dyspnea is the most common symptom among hospitalized patients with heart failure and represents a therapeutic target. However, the association between short-term dyspnea relief and postdischarge clinical outcomes and health-related quality of life (HRQOL) remains uncertain.METHODS AND RESULTS: A…
Heart failure (HF) is a major and increasing global public health problem. In Asia, aging populations and recent increases in cardiovascular risk factors have contributed to a particularly high burden of HF, with outcomes that are poorer than those in…
BACKGROUND: Most international acute heart failure trials have failed to show benefit with respect to key end points. The impact of site enrollment and protocol execution on trial performance is unclear.METHODS AND RESULTS: We assessed the impact of varying site…
AIMS: Change in NT-proBNP level is a common surrogate endpoint in early phase heart failure (HF) trials, but whether this endpoint is influenced by atrial fibrillation/flutter (AFF) is unclear.METHODS AND RESULTS: This analysis included 1358 patients from the ASTRONAUT trial,…
Both quality improvement and clinical research efforts over the past few decades have focused on consensus definition of sepsis and acute respiratory distress syndrome (ARDS). Although clinical definitions based on readily available clinical data have advanced recognition and timely use…
Effective, practical, nonpharmacologic therapies are needed to treat menopause-related insomnia symptoms in primary and women's specialty care settings. To evaluate the efficacy of telephone-based cognitive behavioral therapy for insomnia (CBT-I) vs menopause education control (MEC). A single-site, randomized clinical trial…
The substantial nationwide investment in inpatient palliative care services stems from their great promise to improve patient-centered outcomes and reduce costs. However, robust experimental evidence of these benefits is lacking. The Randomized Evaluation of Default Access to Palliative Services (REDAPS)…
Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced…
OBJECTIVES: The aim of this study was to characterize the association between decongestion therapy and 30-day outcomes in patients hospitalized for heart failure (HF).BACKGROUND: Loop diuretic agents are commonly prescribed for the treatment of symptomatic congestion in patients hospitalized for…
Serum osmolality may fluctuate with neurohormonal activation and in response to certain therapeutics in patients with heart failure (HF). The clinical relevance of osmolality in patients with HF has not been defined. In this post hoc analysis of the Efficacy…
AIMS: A longitudinal and comprehensive analysis of health-related quality of life (HRQOL) was performed during hospitalization for heart failure (HF) or soon after discharge.METHODS AND RESULTS: A post-hoc analysis was performed of the ASCEND-HF trial. The EuroQOL five dimensions questionnaire…
Although the prognosis of ambulatory heart failure (HF) has improved dramatically there have been few advances in the management of acute HF (AHF). Despite regional differences in patient characteristics, background therapy, and event rates, AHF clinical trial enrollment has transitioned…
Hospitalized heart failure (HHF) patients carry a prognosis comparable to many cancers and constitute more than 1 million hospital admissions annually in the United States. To date, North Americans have comprised a minority of those included in prior hospitalized HF…
More than two-thirds of US women are overweight or obese, placing them at increased risk for postmenopausal breast cancer. To investigate in this secondary analysis the associations of overweight and obesity with risk of postmenopausal invasive breast cancer after extended…
To describe the effects of six interventions for menopausal vasomotor symptoms relative to control in a pooled analysis, facilitating translation of the results for clinicians and symptomatic women. The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network tested…
This study aims to evaluate the effects of low-dose estradiol (E2) or venlafaxine on menopause-related quality of life and associated symptoms in healthy perimenopausal and postmenopausal women with hot flashes. A double-blind, placebo-controlled, randomized trial of low-dose oral 17?-E2 0.5…
AIMS: Previous reports have provided conflicting data regarding the relationship between length of stay (LOS) and subsequent readmission risk among patients hospitalized for heart failure (HF).METHODS AND RESULTS: We performed a post-hoc analysis of the Efficacy of Vasopressin Antagonism in…
To determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice. We performed a multicenter, randomized, nonmasked clinical trial in newborns with neonatal encephalopathy cooled during transport to 9 neonatal intensive…
Heart failure (HF) is a public health problem of global proportions afflicting more than 25 million patients worldwide. Despite stable or declining per capita hospitalization rates in the USA and several European countries, there are over one million hospitalizations for…
We investigated the clinical profiles associated with serum uric acid (sUA) levels in a large cohort of patients hospitalized for worsening chronic heart failure with ejection fraction (EF) ≤40%, with specific focus on gender, race, and renal function based interactions.…
Recent international phase III clinical trials of novel therapies for hospitalized heart failure (HHF) have failed to improve the unacceptably high postdischarge event rate. These large studies have demonstrated notable geographic and site-specific variation in patient profiles and enrollment. Possible…
BACKGROUND: Anemia has been associated with worse outcomes in patients with chronic heart failure (HF). We aimed to characterize the clinical profile and postdischarge outcomes of hospitalized HF patients with anemia at admission or discharge.METHODS AND RESULTS: An analysis was…
This study aims to determine the efficacy of exercise training for alleviating vasomotor and other menopausal symptoms. Late perimenopausal and postmenopausal sedentary women with frequent vasomotor symptoms (VMS) participated in a randomized controlled trial conducted in three sites: 106 women…
Lower serum lipid levels are paradoxically predictive of poor clinical outcomes in hospitalized and ambulatory patients with heart failure (HF). In large randomized controlled trials, statins did not demonstrate an overall mortality benefit in chronic HF patients. We currently lack…
The purpose of this study was to determine the efficacy of 3 nonhormonal therapies for the improvement of menopause-related quality of life in women with vasomotor symptoms. We conducted a 12-week 3 × 2 randomized, controlled, factorial design trial. Peri-…
AIMS: Haemoconcentration has been studied as a marker of decongestion in patients with hospitalization for heart failure (HHF). We describe the relationship between haemoconcentration, worsening renal function, post-discharge outcomes, and clinical and laboratory markers of congestion in a large multinational…
Hospitalization for heart failure (HF) is a clinical entity associated with high postdischarge morbidity and mortality, yet few therapies are available to improve outcomes in patients with this condition. In the past decade, large phase III studies of HF treatments…
AIMS: Signs and symptoms of congestion are the most common cause for hospitalization for heart failure (HHF). The clinical course and prognostic value of congestion during HHF has not been systemically characterized.METHODS AND RESULTS: A post hoc analysis was performed…
BACKGROUND: In metastatic colorectal cancer (mCRC), mutations in the KRAS gene predict poor response to EGF receptor (EGFR) inhibitors. Clinical treatment guidelines now recommend KRAS testing if EGFR inhibitors are considered. Our study investigates the clinical uptake and utilization of…
BACKGROUND: Systolic blood pressure (SBP) is related to the pathophysiologic development and progression of heart failure (HF) and is inversely associated with adverse outcomes during hospitalization for HF (HHF). The prognostic value of SBP after initiating inhospital therapy and the…
BACKGROUND: Arginine vasopressin (AVP) levels are elevated in proportion to heart failure severity and are associated with higher cardiovascular mortality in ambulatory patients. However, the relationship between baseline and trends in AVP with outcomes in patients hospitalized for worsening heart…
OBJECTIVES: The study investigated whether the number of participants enrolled per site in an acute heart failure trial is associated with participant characteristics and outcomes.BACKGROUND: Whether and how site enrollment volume affects clinical trials is not known.METHODS: A total of…
Lower cholesterol levels are associated with worse outcomes in patients with chronic heart failure (HF) and have been shown to predict in-hospital mortality. The relation between lipid profile and postdischarge outcomes in patients hospitalized for worsening HF is less clear.…
OBJECTIVE: Nutrition plays an important role in metabolic syndrome etiology. We examined whether the Women's Health Initiative (WHI) Dietary Modification Trial influenced metabolic syndrome risk. MATERIALS/METHODS: 48,835 postmenopausal women aged 50-79 years were randomized to a low-fat (20% energy from…
Despite the large burden of chronic kidney disease (CKD) in Hispanics, this population has been underrepresented in research studies. We describe the recruitment strategies employed by the Hispanic Chronic Renal Insufficiency Cohort Study, which led to the successful enrollment of…
BACKGROUND: Heart failure (HF) complicated by atrial fibrillation/flutter (AF/AFL) is associated with worse outcomes. However, the clinical profile and outcomes of patients following hospitalization for HF with AF/AFL on initial electrocardiogram (ECG) has not been well studied.METHODS: EVEREST was a…
BACKGROUND: Low lymphocyte count has been shown to be an independent prognostic marker in heart failure (HF) in the outpatient setting. Limited data exist regarding whether relative lymphocyte count correlates with postdischarge outcomes in patients hospitalized for HF.METHODS AND RESULTS:…
AIMS: Data on the prognosis of heart failure (HF) patients with coronary artery disease (CAD) have been conflicting. We describe the clinical characteristics and mode-specific outcomes of HF patients with reduced ejection fraction (EF) and documented CAD in a large…
OBJECTIVE: The aim of this study was to determine the effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes. METHODS: A randomized, blinded, multicenter, placebo-controlled parallel-group 8-week trial with 205…
Heart failure (HF) patients are a medically complex and heterogeneous population with multiple cardiac and non-cardiac comorbidities. Although there are a multitude of etiologic substrates and initiating and amplifying mechanisms contributing to disease progression, these pathophysiologic processes ultimately all lead…
Hospitalization for worsening chronic heart failure results in high post-discharge mortality, morbidity, and cost. However, thorough characterization, soon after discharge of patients with early post-discharge events has not been previously performed. The objectives of this study were to describe the…
AIMS: Abnormal liver function tests (LFTs) are common in ambulatory heart failure (HF). The aim of this study was to characterize abnormal LFTs during index hospitalization.METHODS AND RESULTS: A post-hoc analysis was carried out of the placebo group of the…
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is prevalent in heart failure (HF) patients, yet these patients are poorly characterized. We aimed to describe the characteristics and outcomes of patients with systolic dysfunction and COPD in a contemporary HF randomized trial.METHODS…
AKI is an important clinical problem that has become increasingly more common. Mortality rates associated with AKI remain high despite advances in supportive care. Patients surviving AKI have increased long-term mortality and appear to be at increased risk of developing…
AKI remains an important clinical problem, with a high mortality rate, increasing incidence, and no Food and Drug Administration-approved therapeutics. Advances in addressing this clinical need require approaches for rapid diagnosis and stratification of injury, development of therapeutic agents based…
Acute kidney injury (AKI) remains a complex clinical problem associated with significant short-term morbidity and mortality and lacking effective pharmacologic interventions. Patients with AKI experience longer-term risks for progressive chronic ESRD, which diminish patients' health-related quality of life and create…
AIM: To provide an in-depth clinical characterization and analysis of outcomes of the patients hospitalized for heart failure (HF) who subsequently develop worsening renal function (WRF) during hospitalization or soon after discharge.METHODS AND RESULTS: Of the 4133 patients hospitalized with…
BACKGROUND: There is a paucity of literature comparing Bayesian analytic techniques with traditional approaches for analyzing clinical trials using real trial data. METHODS: We compared Bayesian and frequentist group sequential methods using data from two published clinical trials. We chose…
AIMS: The objective of the RO-AHFS registry was to evaluate the epidemiology, clinical presentation, inpatient management, and hospital course in a population hospitalized for acute heart failure syndromes.METHODS: During a 12-month period, 13 Romanian medical centers enrolled all consecutive patients…
Patients with heart failure (HF) fall into two categories—those who are stable and ambulatory with a relatively low event rate, and patients requiring hospitalization who are characterized by high post-discharge mortality and rates of rehospitalization. HF trials in 2010 contributed…
INTRODUCTION: It has been > 25 years since it was first discovered that arginine vasopressin levels are elevated in heart failure and this elevation is proportional to the severity of heart failure. Tolvaptan is an oral nonpeptide V₂-selective antagonist and…
CONTEXT: Concerns regarding the risks associated with estrogen and progesterone to manage menopausal symptoms have resulted in its declining use and increased interest in nonhormonal treatments with demonstrated efficacy for hot flashes. OBJECTIVE: To determine the efficacy and tolerability of…
BACKGROUND: A provocative finding from several double-blind clinical trials has been the association between greater adherence to placebo study medication and better health outcomes. We used data from the Studies of Left Ventricular Dysfunction (SOLVD) Treatment Trial (SOLVD-TT) and the…
BACKGROUND: Inguinal hernia repair, hydrocelectomy, and orchidopexy are commonly performed surgical procedures in children. Postoperative pain control is usually provided with a single-shot caudal block. Blockade of the ilioinguinal nerve may lead to additional analgesia. The aim of this double-blind,…
This clinical trial compared two brief alcohol use interventions in prenatal clinics: Early Start (ES), a substance-abuse screening and treatment program integrated with prenatal care focused on abstention (n=298), and Early Start Plus (ESP), adding a computerized drink-size assessment tool…
BACKGROUND: The objective of our study was to examine cardiologists' and organizational leaders' interest in clinical trial participation and perceived barriers and facilitators to participation within ten diverse non-profit healthcare delivery systems. Trials play a pivotal role in advancing knowledge…
BACKGROUND: Obesity in the United States has increased significantly during the past several decades. The role of calcium in the maintenance of a healthy body weight remains controversial. METHODS: A randomized, double-blinded, placebo-controlled trial was performed with 36 282 postmenopausal…
BACKGROUND: Estradiol reduced progression of ultrasonographic carotid disease in a randomized trial. No trials of unopposed estrogen for prevention of lower extremity arterial disease or aortic aneurysm have been conducted. METHODS: The Estrogen Alone trial randomized 10739 postmenopausal women with…
CONTEXT: Despite decades of use and considerable research, the role of estrogen alone in preventing chronic diseases in postmenopausal women remains uncertain. OBJECTIVE: To assess the effects on major disease incidence rates of the most commonly used postmenopausal hormone therapy…
OBJECTIVE: To determine the sensitivity and positive predictive value (PPV) of computerized diagnostic data from health maintenance organizations (HMOs) in identifying incident breast cancer cases. STUDY DESIGN: An HMO without a cancer registry developed an algorithm identifying incident breast cancer…
CONTEXT: Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have increased interest in other therapies for menopausal symptoms. Dietary supplements containing isoflavones are widely used as alternatives to hormonal therapies…
OBJECTIVE: To assess whether, in children, oral magnesium oxide reduces migrainous headache frequency, severity, and associated features compared to placebo. BACKGROUND: There is no single, safe, widely well-tolerated, and effective prophylactic treatment for all children and adolescents with frequent migrainous…
OBJECTIVE: To evaluate changes in food sources of dietary fat made by participants in the Women's Health Initiative Low-Fat Dietary Modification Trial. DESIGN: This study compares sources of dietary fat intake, estimated by a food frequency questionnaire, between intervention and…
The Women's Healthy Eating and Living (WHEL) Study is a multisite randomized controlled trial of the effectiveness of a high-vegetable, low-fat diet, aimed at markedly raising circulating carotenoid concentrations from food sources, in reducing additional breast cancer events and early…
CONTEXT: Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain. OBJECTIVE: To assess the major health benefits and risks of the most commonly used combined hormone preparation in…
OBJECTIVE: Short postpartum stays are common. Current guidelines provide scant guidance on how routine follow-up of newly discharged mother-infant pairs should be performed. We aimed to compare 2 short-term (within 72 hours of discharge) follow-up strategies for low-risk mother-infant pairs…
CONTEXT: Raloxifene hydrochloride, a selective estrogen receptor modulator, prevents bone loss in postmenopausal women, but whether it reduces fracture risk in these women is not known. OBJECTIVE: To determine the effect of raloxifene therapy on risk of vertebral and nonvertebral…
The Women's Health Initiative (WHI) is a large and complex clinical investigation of strategies for the prevention and control of some of the most common causes of morbidity and mortality among postmenopausal women, including cancer, cardiovascular disease, and osteoporotic fractures.…
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