MedicalResearch.com Interview with:
Isabelle Bedrosian, M.D., F.A.C.S.
Associate Professor, Department of Surgical Oncology, Division of Surgery,
Medical Director, Nellie B. Connelly Breast Center
The University of Texas MD Anderson Cancer Center, Houston, TX
Medical Research: What is the background for this study? What are the main findings?
Dr. Bedrosian: There have been a number of reports on the rates of Breast Conserving Therapy (BCT) and mastectomy among women with early stage breast cancer. These reports have been discordant, with some suggesting that index mastectomy rates have increased and others suggestion Breast Conserving Therapy rates have actually increased. We hypothesized that these differences in reporting may be due to data source (ie tertiary referral centers vs population based studies) and turned to the NCDB, which captures 70% of cancer cases in the US and as such provides us with the most comprehensive overview on patient treatment patterns.
MedicalResearch.com Interview with:
Mr. Angus Turnbull
Imperial College School of Medicine,
London UK
Medical Research: What is the background for this study? What are the main findings?
Mr. Turnbull: Autopsy has been used to advance medical knowledge and understanding of pathological processes for millennia but increasing evidence indicates its decline in the UK and elsewhere. This study not only confirms that but suggests autopsy for learning purposes has almost disappeared.
In the United Kingdom autopsy is divided into medico-legal autopsy (that required by law under the jurisdiction of HM Coroner) and consented autopsy (performed with the consent of the bereaved or their family). Over the past half-century, small single site studies have noted a marked decline in consented autopsy rates, however there has been no study for over 20 years to determine the extent of the decline nationwide.
This study examined all acute NHS Trusts within England, NHS Boards in Scotland and Wales and Social Care Trusts in Northern Ireland. We found that the average autopsy rate (the percentage of adult inpatient deaths which under go consented autopsy) in the United Kingdom in 2013 was only 0.7%. The study showed that in nearly a quarter (23%) of all NHS Trusts in the United Kingdom, consented autopsy is now extinct.
These findings may have implications for training, for research and for learning from mortality – a key aspect of patient safety.
MedicalResearch.com Interview with:
Dr. Ken Uchino, MD
Cleveland Clinic Main Campus
Cleveland, OH 44195
Medical Research: What is the background for this study? What are the main findings?
Dr. Uchino: Stroke center designation started in 2003 and more hospitals have been certified as primary stroke centers over time. We asked the question how many are certified now? What are the characteristics of the hospitals that are certified?
In 2013, nearly a third (23%) of acute short-term adult general hospitals with emergency departments were certified as stroke centers. 74% of the stroke centers were certified by the Joint Commission, a non-profit organization that certifies health care facilities and programs. 20% were certified by state health departments. States varied in percentages of hospitals that were certified, ranging from 4% in Wyoming to 100% in Delaware.
Not unexpectedly larger hospitals and hospitals in urban locations were more likely to be certified as stroke centers.
But a hospital being located in a state with so-called “stroke legislation” more than tripled the chance of being a certified stroke centers, even accounting for other factors. These states passed legislation to promote stroke centers and mandated stroke patients to be preferentially transported to qualified hospitals.
MedicalResearch.com Interview with:
Daniel E. Freedberg, MD, MS
Assistant Professor of Medicine
Division of Digestive and Liver Diseases
Columbia University, New York
Medical Research: What is the background for this study?
Dr. Freedberg: Acid suppression medications are increasingly prescribed to relatively healthy children without clear indications, but the side effects of these medications are uncertain.
Medical Research: What are the main findings?
Dr. Freedberg: Acid suppression with (proton pump inhibitors ) PPIs or (histamine-2 receptor antagonists) H2RAs was associated with increased risk for C. diff infection in both infants and older children.
Medical Research: What should clinicians and patients take away from your report?
Dr. Freedberg: Increased risk for C. diff should be factored into the decision to use acid suppression medications in children. Our findings imply that acid suppression medications alter the bacterial composition of the lower gastrointestinal tract.
MedicalResearch.com Interview with:
Deborah S. Hasin, Ph.D.
Professor of Epidemiology
Columbia University
New York, New York 10032
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Hasin: The background for the study was the need to identify the causes of the marked increase in marijuana use among U.S. adolescents over the last several years, given that early adolescent marijuana use leads to a number of adverse health and psychosocial consequences, including cognitive decline, into adulthood.
We had two main findings from the study:
MedicalResearch.com Interview with:
William S. Yancy, Jr., MD, MHSc
Research Associate
Center for Health Services Research in Primary Care
Durham, NC 27705
Associate Professor Department of Medicine
Duke University Medical Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Yancy: A number of studies have compared different diet approaches for weight management with many of these finding that several different diets can result in significant weight loss. This has led many experts to advise that we should offer a choice among these diet options to our patients who are seeking to lose weight. We know that adherence is the best predictor of weight loss during dietary interventions, so the thought is that patients will adhere better to a diet that they prefer, resulting in more successful weight loss. In addition, allowing choice enhances patient autonomy, which is patient-centered and has been shown to increase treatment adherence. However, the previous studies of various diet approaches did not let people choose a diet, so we don’t actually know if letting them choose will lead to better weight loss. Our study specifically tested this assumption. We randomized participants to a condition where they were allowed to choose between 2 common weight loss diets or to a condition where they were randomly assigned to one of the diets. The 2 diets we used were a low-carbohydrate diet without calorie restriction and a low-fat diet combined with calorie restriction. Participants received counseling about the diets, and about behavioral strategies and physical activity, in 19 group sessions over the span of 12 months. They also received 6 phone calls with motivational counseling in the latter half of the program.
MedicalResearch.com Interview with:
Eric Jonasch, MD
Associate Professor Department of Genitourinary Medical Oncology
University of Texas MD Anderson Cancer Center
Houston, TX
and
Dr. Thai H. Ho, MD Ph.D.
Department of Oncology
Mayo Clinic Scottsdale Arizona
Medical Research: What is the background for this study? What are the main findings?
Response: The blueprints of a cell are encoded in DNA strands (its genome) which are highly compressed in order to fit into a tiny cell. The reading (called the epigenome) of these DNA ‘blueprints’ determines whether that cell will develop into a kidney cell or another type of cell. However, in cancer, errors occur either in the blueprints themselves or the cell makes mistakes in reading the blueprints. Cancers of the kidney affect more than 61,000 patients annually and over 13,000 patients die annually, making it one of the top 10 leading causes of cancer deaths. Studies have revealed that mutations occur in genes that regulate how our DNA ‘blueprints’ are compacted in greater than >50% of kidney cancers, making these genes as a group the most frequently mutated. In our study, we identified that these errors that initially arise in an early kidney cancer lead to propagation of these same errors in metastases, a phenomenon in which the cancer has spread to another organ and is a major cause of death. Furthermore, we generated a detailed map of these epigenomic changes in patient-derived tumors.
MedicalResearch.com Interview with:
Ron Postuma, MD, MSc
Associate Professor
Department of Neurology
Montreal General Hospital
Montreal, Quebec
Medical Research: What is the background for this study? What are the main findings?
Dr. Postuma: The background is that we often think about Parkinson’s Disease as a single disease. However, every clinician knows that there is a great deal of variability from patient to patient. If we can understand the main aspects that separate patients into groups, we can target therapy better.
The analysis used a semi-automated means to divide Parkinson’s patients into groups, using extensive information about motor and non-motor aspects of disease. We found that the non-motor symptoms, especially cognition, sleep disorders, and blood pressure changes were the most powerful predictors of which group a patient would be in. Based on these non-motor (and some motor aspects), the most accurate way to divide patients was into three groups - diffuse (many non-motor symptoms), pure motor, and intermediate (halfway between the other). We then followed patients over time. The diffuse group had, by far, the worse prognosis. This was not only for the non-motor aspects, but the motor as well.
MedicalResearch.com Interview with:
Susan Schwab, PhD
Assistant professor at NYU Langone
Skirball Institute of Biomolecular Medicine
Medical Research: What is the background for this study? What are the main findings?
Dr. Schwab: T cell acute lymphoblastic leukemia (T-ALL) remains a devastating pediatric disease. Roughly 20% of children do not respond to current therapies. Furthermore, metastasis to the central nervous system is common in T-ALL, and intrathecal chemotherapy, even when successful at eradicating the cancer, causes serious long-term cognitive side-effects.
Here we report that the chemokine receptor CXCR4 is essential for T cell acute lymphoblastic leukemia progression in both mouse and human xenograft models of disease. Consistent with sustained disease remission in the absence of CXCR4, loss of CXCR4 signaling results in decreased levels of c-Myc, which is required for leukemia initiating cell activity. T-ALL cells reside near cells generating the CXCR4 ligand CXCL12 in the bone marrow, and our data suggest that vascular endothelial cells may be an important part of the T-ALL niche.
Raghavan Murugan MD, MS, FRCP, FCCP
Associate Professor of Critical Care Medicine and Clinical and Translational Science
Core Faculty, Center for Critical Care Nephrology, CRISMA Center,
John Kellum, MD
Professor and Vice Chair for Research
Director, Bioengineering and Organ Support Program, CRISMA Center
Director, Center for Assistance in Research using eRecord (CARe)
Department of Critical Care Medicine
University of Pittsburgh Pittsburgh, PA
Medical Research: What is the background for this study? What are the main findings?
Response: In our prior studies, we found that nearly one-half of critically ill patients in the intensive care unit who receive dialysis die by 2 months after acute illness and more than one-third of surviving patients are dialysis dependent. We sought to examine whether simple patient characteristics and inflammatory biomarkers predicted death and non-recovery of kidney function after severe acute kidney injury.
We found that a combination of four simple and readily available patient characteristics including older age, lower mean arterial pressure, need for mechanical ventilation, and higher serum bilirubin levels predicted death and dialysis dependence. Higher plasma concentration of interleukin (IL)-8 in combination with the clinical characteristics also increased risk prediction. To our knowledge, this study is the first large study to examine risk prediction for outcomes after severe acute kidney injury using a panel of biomarkers in a large cohort of critically ill patients receiving dialysis.
Dr. Ahmad Haidar Ph.D
Division of Experimental Medicine, Department of Medicine
McGill University, Montreal, QC, Canada
Medical Research: What is the background for this study? What are the main findings?
Dr. Haidar: This is the first head-to-head-to-head comparison in outpatient setting of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional pump therapy in children and adolescents with type 1 diabetes.
The main finding is that the dual-hormone artificial pancreas seems to outperform the other two systems in reducing nocturnal hypoglycemia in camp settings when the patients are very physically active during the day.
Medical Research: What should clinicians and patients take away from your report?
Dr. Haidar: Glucagon has the potential to reduce nocturnal hypoglycemia if added to the artificial pancreas. However, this needs to be confirmed in larger and longer studies as the single-hormone artificial pancreas might be sufficient in home settings (this study was conducted at a camp, which is an environment different that home).
MedicalResearch.com Interview with:
Aileen Gariepy, MD, MPH
Assistant Professor Section of Family Planning
Department of Obstetrics, Gynecology, and Reproductive Sciences
Yale School of Medicine
New Haven, CT
Medical Research: What is the background for this study? What are the main findings?
Dr. Gariepy: Women who have just given birth are often highly motivated to prevent a rapid, repeat pregnancy. For women who desire the contraceptive implant, a highly effective reversible form of contraception that is placed in the arm and can last for 3 years, new research shows that it is more cost-effective to place the implant while women are still in the hospital after giving birth, compared to delaying insertion to the postpartum visit 6-8 weeks later which is currently the most common practice.
When the costs associated with the implant insertion and the costs of unintended pregnancy are compared in women who receive immediate contraceptive implant insertion (while still in the hospital after giving birth) to women who are asked to come back in 6-8 weeks for the implant insertion (delayed insertion), immediate insertion is expected to save $1,263 per patient. Based on these estimates, for every 1,000 women using postpartum implant, immediate placement is expected to avert 191 unintended pregnancies and save $1,263,000 compared with delayed insertion in the first year. Cost savings would continue to increase for the second and third year after insertion.
In fact, over half of U.S. pregnancies are unintended. Maternal and infant care costs for unintended pregnancies amount to $11.1 billion annually for public insurance programs alone. The immediate postpartum period (after delivery but before discharge home) provides an ideal opportunity for initiating contraceptives as patients are motivated and timing is convenient.
However, the majority of insurance company policies do not provide coverage for insertion of the contraceptive implant when the new mother is still in the hospital. This lack of reimbursement is the most significant barrier to providing this highly effective contraceptive method for women who have just delivered a baby. Surprisingly, the reason most insurance companies do not offer reimbursement for immediate insertion is due to an outdated insurance protocol, “the global obstetric fee” which precludes separate reimbursement of individual procedures (like inserting the implant).
The main reason that immediate insertion results in cost savings is because more women will get the implant compared to a strategy of delayed insertion. Women can get pregnant again within 4 weeks of delivering a baby. Starting contraception as soon as possible after giving birth is important because most women will resume sexual activity before their postpartum office visit and therefore will be at risk of pregnancy. And approximately 35% of women do not return for a postpartum visit.
Even for women who want another pregnancy soon, the implant has benefits. When women conceive and deliver a baby within 2 years of last giving birth, there is a significantly higher risk of poor maternal and neonatal outcomes, including preterm birth, low birth weight, and even early neonatal and maternal death. Birth spacing is better for moms and babies.
MedicalResearch.com Interview with:
Joseph A. Ladapo, MD, PhD
Assistant Professor of Medicine
Section on Value and Effectiveness
Department of Population Health
NYU Langone School of Medicine
Medical Research: What is the background for this study? What are the main findings?
Dr. Ladapo: Routine tests before elective surgery are largely considered to be of low value, and they may also increase costs. In an attempt to discourage their use, two professional societies released guidance on use of routine preoperative testing in 2002. We sought to examine the long-term national effect of these guidelines from the American College of Cardiology/American Heart Association and the American Society of Anesthesiologists on physicians' use of routine preoperative testing. While we found that overall rates of routine testing declined across several categories over the 14-year study period, these changes were not significant after accounting for overall changes in physicians’ ordering practices. Our findings suggest that professional guidance aimed at improving quality and reducing waste has had little effect on physician or hospital practice.
MedicalResearch.com Interview with: Kristina H. Lewis, MD, MPH, SM Kaiser Permanente Georgia, Center for Clinical and Outcomes Research, Atlanta Department of Population Medicine Harvard Medical School/Harvard Pilgrim Health Care Institute, Boston, Massachusetts Medical Research: What is the background for this study? Dr. Lewis: The prevalence of severe obesity (BMI ≥40 kg/m2) in the U.S. is rising. This is...
MedicalResearch.com Interview with:
Nicholas Tatonetti, PhD
Department of Biomedical Informatics
Department of Systems Biology, Department of Medicine
Columbia University
New York, NY
Medical Research: What is the background for this study? What are the main findings?
Dr. Tatonetti: For decades, researchers have studied the link between disease incidence and the seasons. We’ve known, for example, that those born when the dust mite population is highest (summer) will have an increased chance of developing asthma. Traditionally, diseases have been studied one at a time to identify these seasonal trends. Because of the rapid adoption of electronic health records, it is now possible to study thousands of diseases, simultaneously. That is what we did in this study. We evaluated over 1,600 diseases and discovered 55 that showed this seasonal trend. Many of these had been studied previously, but several are new discoveries — most prominently, we found that the lifetime risk of developing cardiovascular disease is highest for those born in the spring.
MedicalResearch.com Interview with:
Jordan M. Cloyd, MD
Department of Surgery
Stanford University
Stanford, California
Medical Research: What is the background for this study? What are the main findings?
Dr. Cloyd: The motivation for the study was that, anecdotally, we had noticed that several of our patients who had been discharged on a weekend required readmission for potentially preventable reasons. We wanted to investigate whether the data supported the idea that weekend discharge was associated with a higher risk of hospital readmission.
MedicalResearch.com Interview with:
Michaela Dinan, Ph.D.
Duke Clinical Research Institute and Duke Cancer Institute
Department of Medicine
Duke University School of Medicine
Durham, North Carolina
Medical Research: What is the background for this study? What are the main findings?
Response: I think it will be critical to further explore the implications of Oncotype DX breast cancer assay (ODX testing) in women with breast cancer. The ODX test helps predict which cancers will be more aggressive as well as guide recommendations as to which patients would most likely benefit from chemotherapy. I think we should look to see what impact this test is really having on the use of chemotherapy and its associated costs and outcomes for real-world breast cancer patients.
MedicalResearch.com Interview with:
Jeffrey C. Schneider, M.D.
Medical Director, Trauma, Burn & Orthopedic Program
Assistant Professor, Dept. of Physical Medicine and Rehabilitation
Harvard Medical School
Spaulding Rehabilitation Hospital
Boston, MA 02129
Medical Research: What is the background for this study? What are the main findings?
Response: Hospitalizations account for the largest share of healthcare costs in the U.S., comprising nearly one-third of all healthcare expenditures. In 2011, readmissions within 30 days of hospital discharge represented more than $41 billion in hospital costs. Financial penalties for excess 30-day hospital readmissions were instituted by the Centers for Medicare and Medicaid Services in 20124; more than 2,200 hospitals were fined a total of $280 million in reduced Medicare payments in fiscal year 2013.
Most readmission risk prediction models have targeted specific medical diagnoses and have utilized comorbidities and demographic data as the central risk factors for hospital readmission. Yet, large U.S. administrative datasets have demonstrated poor discriminative ability (c-statistics: 0.55-0.65) in predicting readmissions. However, few studies have considered functional status as potential readmission risk factors.
There is increasing evidence that functional status is a good predictor of other health outcomes. To date, acute care hospital administrative databases do not routinely include functional status measures. Therefore, inpatient rehabilitation setting is an ideal population in which to examine the impact of functional status on readmission risk, because:
(1) inpatient rehabilitation patients often have complex care transitions after acute care discharge, and represent a significant proportion of total readmissions;
2) inpatient rehabilitation facilities routinely document functional status using a valid instrument—the FIM®; and
(3) a majority of U.S. IRFs participate in one of the only national datasets that contain standardized functional data—the Uniform Data System for Medical Rehabilitation.
Limitations of prior work include small and single-center study designs, narrowly defined patient populations, and defining readmissions beyond the 30-day period. Overall, there is a lack of literature on the utility of function as a readmission predictor in a large population of medical patients. Moreover, function is a modifiable risk factor with potential to impact readmission outcomes if function-based interventions are instituted early. Therefore, the objective of this study was to compare functional status with medical comorbidities as predictors of acute care readmissions in the medically complex rehabilitation population. We hypothesized that acute care readmission prediction models based on functional status would outperform models based on comorbidities,and that the addition of comorbidity variables to function-based models would not significantly enhance predictive performance.
MedicalResearch.com Interview with:
Yan S. Kim, MD PhD
Delivery Science Fellow Division of Research
Kaiser Permanente Northern California
Oakland, CA 94612
Medical Research: What is the background for this study? What are the main findings?
Dr. Kim: Long-term care hospitals first emerged in the 1980s as an alternative to lengthy acute-care hospital stays for patients with complex medical problems who need prolonged hospital-level care. In 2002, Medicare changed its payment method for these facilities from cost-based to a lump sum per admission based on the diagnosis. Under this system, which is still in place, Medicare pays these hospitals a higher rate for patients who stay a minimum number of days based on the patient's condition. Shorter stays are paid much less and longer stays do not necessary generate higher reimbursements.
Using Medicare data, we analyzed a national sample of patients who required prolonged mechanical ventilation – the most common, and among the most costly, conditions for patients in long-term care hospitals – to examine whether this payment policy has created incentives to base discharge decisions on payments. We found that in the years after the policy’s implementation there was a substantial spike in the percentage of discharges on and immediately after the minimum-stay threshold was met, while very few patients were discharged before the threshold. By contrast, prior to 2002, discharges were evenly distributed around the day that later became the short-stay threshold. These findings confirm that the current payment policy has created unintended incentives for long-term care hospitals to base the timing of patient discharges on payments and highlight how responsive these hospitals are to payment incentives.
Qihong Huang, M.D., Ph.D.
Associate professor in the Tumor Microenvironment and Metastasis Program
The Wistar Institute
Medical Research: What is the background for this study? What are the main findings?
Dr. Huang: Lung cancer is the leading cause of cancer deaths in both men and women in the United States and results in more deaths globally than breast, prostate and colon cancers combined. While the five year survival rate for early stage non-small cell lung cancer (NSCLC) is above 50%, it is less than 5% in patients with metastatic disease. Clearly, early detection can save lives, but accurate screening tests for high-risk individuals are still lacking. Although low dose computed tomography (LDCT) has been successfully used for screening in high-risk populations, multiple negative factors are associated with recurrent LDCT screening, including false-positives and false-negatives, unnecessary invasive procedures, radiation exposure, global availability of the technology and cost. Although several non-invasive tests for lung cancer using body fluids such as blood, urine or sputum are under investigation, none are currently available.
When low dose computed tomography is used for screening, patients who are 50 years old or older are frequently diagnosed with pulmonary nodules. However, only a small fraction of the nodules detected are subsequently diagnosed as lung cancer. In cases where it is difficult to differentiate malignant from benign nodules, it is recommended that patients with these indeterminate nodules be followed with serial LDCT, which increases radiation exposure and financial cost. A simple, inexpensive blood test that differentiates malignant from benign nodules would fill an important clinical need.
In this study, we validated AKAP4 as a highly accurate biomarker in a cohort of 264 blood samples from patients with known non-small cell lung cance and 135 controls samples from two different sites including a subset of controls with high risk lung nodules. When all 264 lung cancers were compared with all 135 controls, the area under the ROC curve (AUC) was 0.9714. When 136 stage I NSCLC lung cancers were compared with all controls, the AUC is 0.9795, and when all lung cancer patients were compared to 27 controls with histologically confirmed benign lung nodules – a comparison of significant clinical importance – the AUC was 0.9825. AKAP4 expression increases significantly with tumor stage but independently of age, gender, smoking history or cancer subtype. Follow-up studies in a small number of resected NSCLC patients revealed a decrease of AKAP4 expression post-surgical resection that remained low in patients in remission and increased with tumor recurrence. AKAP4 is a highly accurate biomarker for the detection of early stage lung cancer, lung cancer recurrence, and distinguishing malignant from benign lung nodules.
MedicalResearch.com Interview with:
Jacob Hollenberg M.D., Ph.D.
Assistant Professor, Cardiologist
Head of Research, Centre for Resuscitation Science
Karolinska Institutet, Stockholm, Sweden
Editor’s note: Dr. Hollenberg and colleagues published two articles in the NEJM this week discussing CPR performed by bystanders in out-of-hospital cardiac arrests.
MedicalResearch: What is the background for the first study?
Dr. Hollenberg: There are 10,000 cases of cardiac arrest annually in Sweden. Cardiopulmonary Resuscitation (CPR) has been taught to almost a third of Sweden’s population of 9.7 million. In recent years the value of bystander CPR has been debated, largely due to a lack of a randomized trial demonstrating that bystander CPR is lifesaving.
In this study, which included all cases of emergency medical services (EMS) treated and bystander-witnessed out-of-hospital cardiac arrests recorded in the Swedish Cardiac Arrest Registry from January 1, 1990, through December 31, 2011, our primary aim was to assess whether CPR initiated before the arrival of EMS was associated with an increase in the 30-day survival rate.
MedicalResearch: What were the main findings?
Dr. Hollenberg: Early CPR prior to arrival of an ambulance more than doubled the chance of survival. (30-day survival rate was 10.5% among patients who underwent CPR before EMS arrival, as compared with 4.0% among those who did not (P<0.001).)
This association held up in all subgroups regardless of sex, age, cause of cardiac arrest, place of arrest, EKG findings or time period (year analyzed).
MedicalResearch: How did the patients who survived cardiac arrest do from a disability standpoint?
Dr. Hollenberg: We had cerebral performance scores from 474 patients who survived for 30 days after cardiac arrest. (higher scores indicate greater disability).
At the time of discharge from the hospital, 81% of these patients had a score of category of 1. Less than 2% had category scores of 4 or 5.
MedicalResearch: What should patients and providers take away from this report?
Dr. Hollenberg:
MedicalResearch.com Interview with:
James V. Freeman MD, MPH, MS
Yale University School of Medicine
New Haven, CT
Medical Research: What is the background for this study? What are the main findings?
Dr. Freeman: Atrial fibrillation (AF) substantially increases the risk of major adverse clinical outcomes such as stroke and death, but it can also cause frequent symptoms, affect patient’s functional status, and impair their quality of life. While prior studies have reported the range of AF-related symptoms in patient populations, these studies were generally from highly selected patients and referral based practices, and may not reflect results in community practice or results with contemporary AF management. Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), a large, contemporary, prospective, community-based outpatient cohort, we evaluated the type and frequency of symptoms in patients with Atrial fibrillation. In addition, we measured the degree to which physician assessed symptom severity (using the European Heart Rhythm Association [EHRA] classification system) was correlated with patient reported quality of life (assessed by the Atrial Fibrillation Effect on QualiTy-of-life [AFEQT] questionnaire). Finally, we association between symptoms or quality of life with clinical outcomes, including death, hospitalization, stroke and major bleeding.
In our community-based study, the majority of AF patients (61.8%) were symptomatic (EHRA >2) and 16.5% had severe or disabling symptoms (EHRA 3-4). EHRA symptom class was well correlated with the AFEQT quality of life score (Spearman correlation coefficient -0.39). Over 1.8 years of follow-up, Atrial fibrillation symptoms were associated with a higher risk of hospitalization (adjusted HR for EHRA ≥2 vs EHRA 1 1.23, 95% CI 1.15-1.31) and a borderline higher risk of major bleeding. Lower quality of life was associated with a higher risk of hospitalization (adjusted HR for lowest quartile of AFEQT vs highest 1.49, 95% CI 1.2-1.84), but not other major adverse events including death.
MedicalResearch.com Interview with:
Emmanuel S. Antonarakis, M.B.B.CH
Department of Urology and Oncology
Johns Hopkins University School of Medicine
Baltimore, Maryland
Medical Research: What is the background for this study? What are the main findings?
Dr. Antonarakis: In a previous publication, we reported that detection of the androgen receptor splice variant 7 (AR-V7; an abnormal version of the androgen receptor) in circulating tumor cells from patients with advanced prostate cancer was associated with resistance to hormonal therapies such as abiraterone and enzalutamide. Here, we aimed to explore the role of AR-V7 in the context of chemotherapy treatment. We showed that detection of AR-V7 was not associated with resistance to the chemotherapy drugs docetaxel or cabazitaxel, and that AR-V7-positive patients could still derive benefit from these chemotherapies.