Author Interviews, Hepatitis - Liver Disease, JAMA, University of Pittsburgh / 03.02.2015

Adeel A. Butt, MD, MS, FACP, FIDSA Adjunct Associate Professor of Medicine and Clinical and Translational Science University of Pittsburgh School of MedicineMedicalResearch.com Interview with: Adeel A. Butt, MD, MS, FACP, FIDSA Adjunct Associate Professor of Medicine and Clinical and Translational Science University of Pittsburgh School of Medicine   MedicalResearch: What is the background for this study? What are the main findings? Dr. Butt: Studying clinical consequences of hepatitis C virus (HCV) infection is often limited by the lack of knowledge of actual time of infection. We used the Electronically Retrieved Cohort of HCV-Infected Veterans (ERCHIVES), a well-established national cohort of HCV infected veterans and corresponding HCV-uninfected controls, to identify patients with a known time frame for HCV infection. Our primary aim was to determine the rate of liver fibrosis progression among HCV-infected persons over time, with and to determine factors associated with development of cirrhosis and hepatic decompensation among these persons. Among 1840 persons who were HCV+ and 1840 HCV− controls, we found that fibrosis progression started early after HCV infection tapered off after 5 years. After 10 years of follow-up, 18.4% of HCV+ and 6.1% of HCV- persons developed liver cirrhosis. Nine years after diagnosis of cirrhosis, only 1.8% of HCV+ and 0.3% of HCV- persons had developed hepatic decompensation. (more…)
Author Interviews, JAMA, Prostate Cancer, Radiology / 29.01.2015

MedicalResearch.com Interview with: Mohummad Minhaj Siddiqui, MD AssiMohummad Minhaj Siddiqui, MD Assistant Professor of Surgery - Urology Director of Urologic Robotic Surgery University of Maryland School of Medicine andstant Professor of Surgery - Urology Director of Urologic Robotic Surgery University of Maryland School of Medicine and Peter A. Pinto, M.D Head, Prostate Cancer Section Director, Fellowship Program Urologic Oncology Branch National Cancer Institute National Institutes of Health Bethesda, Maryland 20892-1210 Peter A. Pinto, M.D Head, Prostate Cancer Section  Director, Fellowship Program Urologic Oncology Branch National Cancer Institute  National Institutes of Health  Bethesda, Maryland Medical Research: What is the background for this study? What are the main findings? Response: For men suspected of having prostate cancer due to an elevated PSA or abnormal digital rectal exam, the next step in their diagnostic workup has traditionally been a standard 12-core biopsy to evenly sample the entire gland.  Unlike most other cancers, prostate cancer is one of the few solid tumors left which is diagnosed by randomly sampling the gland with the hope of biopsying the tumor, if it is present.  This paradigm has been largely due to the fact that imaging to date has been limited in its ability to identify prostate cancer.  Recent advancements in multiparametric MRI of the prostate however has significantly improved clinician's ability to identify regions in the prostate suspicious for cancer.  This has led to the emergence of MR/Ultrasound fusion technology which allows for targeted biopsy of the prostate into regions suspicious for cancer. Although conceptually, it makes sense that a targeted biopsy has the potential to perform better than the standard random sampling of the prostate in the diagnosis of prostate cancer, studies were needed to understand if this is true, and if so, if the improvement was substantial enough to justify the extra expense and effort needed to obtain a MRI guided biopsy.  This study performed at the National Cancer Institute's Clinical Center sought to address this clinical question of interest.  From 2007-2014, a total of 1003 men suspected to have prostate cancer underwent an MRI of the prostate.  If an area of suspicion was seen in the prostate, these men underwent both the targeted biopsy of the suspicious region in the prostate as well as the standard 12-core needle biopsy during the same session.  The results from the targeted biopsy were compared to the results of the standard biopsy. The key findings in this study was that targeted biopsy improved the rate at which high-risk clinically significant cancer was diagnosed by 30%.  Of interest, the study also found that low-risk, clinically insignificant disease (the type of prostate cancer that is unlikely to cause any harm to the patient over the course of his natural life) was decreased in diagnosis by 17%.  Decrease of diagnosis of such disease has the potential benefit that it could lead to less over-treatment of cancer that never needed to be treated.  In a subset of 170 men that ultimately underwent surgery to remove the prostate to treat their cancer, we were further able to examine how well the prostate biopsy reflected the actual cancer burden in the whole gland.   It is well known that standard biopsy can actually underestimate the total cancer grade in the whole prostate in upwards of 30-40% of cases.  We found that the targeted biopsy was significantly better at predicting whether the patient had intermediate to high-risk cancer compared to standard biopsy.  Through further analysis using a statistical method called decision curve analysis, we further found that for men who wish to undergo surgery for intermediate to high-risk cancer, but wish to go on active surveillance for low-risk cancer, targeted biopsy led to better decision making compared to standard biopsy, or even the two techniques combined. (more…)
Author Interviews, Geriatrics, Hearing Loss, JAMA / 28.01.2015

Margaret T. Dillon, AuD University of North Carolina School of MedicineMedicalResearch.com Interview with: Margaret T. Dillon, AuD University of North Carolina School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Dillon: The goal of this study was to evaluate whether age at revision cochlear implantation influences post-revision speech perception performance. A cochlear implant is an implantable auditory prosthesis that aims to provide sound to patients with certain degrees of hearing loss, by converting and transmitting the acoustic sound into electric stimulation. Research has shown cochlear implant recipients experience improved speech perception in quiet and noise as compared to preoperative performance with conventional amplification (ie, hearing aids). There is variability in postoperative performance. Understanding the cause or causes of this variability is the primary goal of a number of research studies. One suspected indicator for this variability is advanced age at the time of surgery. Though the incidence of revision cochlear implantation is low, it may be warranted when the internal device is no longer functional or not functioning optimally. We reviewed the pre-revision and post-revision speech perception performance of younger (< 65 years of age) and older (> 65 years of age) adult cochlear implant recipients. There was no difference between the post-revision speech perception performance between the two groups. (more…)
Author Interviews, Cognitive Issues, JAMA / 26.01.2015

Shelly L. Gray, PharmD, MS Professor of Pharmacy School of Pharmacy, University of Washington, SeattleMedicalResearch.com Interview with: Shelly L. Gray, PharmD, MS Professor of Pharmacy School of Pharmacy, University of Washington, Seattle Medical Research: What is the background for this study? What are the main findings? Dr. Gray: Many medications have anticholinergic effects such as those used to treat overactive bladder, seasonal allergies, and depression.  The general view is that anticholinergic-induced cognitive impairment is reversible, however, emerging evidence suggests that these medications may be associated with increased dementia risk.  We conducted a prospective population-based cohort study in 3434 older adults to examine whether cumulative anticholinergic medication use is associated with increased risk of incident dementia.  Using automated pharmacy data, we found that higher 10-year cumulative dose was associated with increased risk for dementia and Alzheimer disease over an average of 7.3 years of follow-up.  In particular, people with the highest use (e.g. taking the equivalent of oxybutynin 5 mg/day or chlorpheniramine 4 mg/day for longer than 3 years) were at greatest risk. (more…)
Author Interviews, JAMA, Ophthalmology / 26.01.2015

MedicalResearch.com Interview with: Simone L. Li, PhD Retina Foundation of the Southwest Dallas, Texas Medical Research: What is the background for this study? What are the main findings? Dr. Li: In a previous study, we found that binocular iPad game play significantly improved visual acuity in the amblyopic eye. The purpose of the current study was to determine the longevity of these effects and we found that the visual acuity improvements obtained with binocular iPad game play had been retained for at least 12 months after the treatment ended. (more…)
Author Interviews, JAMA, Mental Health Research / 23.01.2015

MedicalResearch.com Interview with: David P.G. van den Berg PhD student Clinical Psychologist Cognitive behavioural therapist Parnassia Psychiatric Institute Early Detection and Intervention Team (EDIT) Zoutkeetsingel, The Netherlands Medical Research: What is the background for this study? What are the main findings? Response: The last decade it has become clear that many people with psychotic disorders suffered severe childhood trauma. These experiences enhance chances of developing psychosis, but also result in comorbid posttraumatic stress disorder (PTSD). PTSD is highly prevalent in patients with psychotic disorders and negatively influences prognosis and wellbeing. Prolonged Exposure (PE) and Eye Movement Desensitization and Reprocessing (EMDR) are highly effective treatments and recommended as first choice treatments in PTSD guidelines worldwide. Although there is no evidence to support this, patients with psychosis are excluded from PTSD treatment due to fear of destabilization or psychotic decompensation. Moreover, psychosis is the most used exclusion criterion in PTSD trials. This is the first randomized clinical trial (RCT) of the efficacy of PTSD treatment in psychosis. In this RCT 155 patients with a psychotic disorder and comorbid PTSD were randomly assigned to PE, EMDR or Waiting List (WL). In the treatment conditions participants received 8 sessions of 90-minutes therapy. Standard protocols were used. Treatment was not preceded by stabilizing psychotherapeutic interventions or skills training. The first session comprised psycho-education about PTSD and target selection. In sessions 2 to 8 traumas were treated, starting with the most distressing experience. Baseline, post-treatment and 6-month follow-up assessments were made. Participants in both PE and EMDR showed greater reduction of PTSD symptoms than those in WL. Between group effect sizes were large. About sixty percent of the participants in the treatment groups achieved loss of diagnosis. Treatment effects were maintained at six-month follow-up for both PE and EMDR. Treatments did not result in serious adversities. (more…)
Author Interviews, Genetic Research, JAMA, Ophthalmology / 21.01.2015

Prof. David Mackey Centre for Ophthalmology and Vision Science/Lions Eye Institute Perth Managing Director/Chair of University of Western Australia, Perth, Australia Centre for Eye Research Australia, Melbourne UniversityMedicalResearch.com Interview with: Prof. David Mackey Centre for Ophthalmology and Vision Science/Lions Eye Institute Perth Managing Director/Chair of University of Western Australia, Perth, Australia Centre for Eye Research Australia, Melbourne University MedicalResearch: What is the background for this study? What are the main findings? Prof. Mackey: Too much or too little sun? Excessive sun exposure is associated with the eye disease pterygium, while lack of outdoor activity in childhood increases the risk of myopia (short sightedness). Measuring the amount of early sun damage to a person’s eyes would be of great use to researchers and potential use in clinical practice. Over the last few years we have developed a biomarker for sun exposure to the eye by photographing Conjunctival UV Auto-Fluorescence (CUVAF). The study published in JAMA Ophthalmology looked at the genetic and environmental factors that contribute to CUVAF levels in three Australian studies from Tasmania, Perth and Brisbane. People who live in sunnier environments closer to the equator have more evidence of sun damage using CUVAF.  However, genetic factors also play a role. (more…)
Author Interviews, Brigham & Women's - Harvard, Geriatrics, Hospital Readmissions, JAMA, Surgical Research / 21.01.2015

Thomas C. Tsai, MD, MPH Departments of Surgery and Health Policy and Management Harvard School of Public Health, Boston, Massachusetts MedicalResearch.com Interview with: Thomas C. Tsai, MD, MPH Departments of Surgery and Health Policy and Management Harvard School of Public Health, Boston, Massachusetts Medical Research: What is the background for this study? What are the main findings? Dr. Tsai: Emerging evidence is suggesting that fragmented care is associated with higher costs and lower quality. For elderly patients undergoing major surgical procedures, fragmentation of care in the post-discharge period may be especially problematic. We therefore hypothesized that elderly patients receiving fragmented post-discharge care would have worse outcomes. We found that among Medicare patients who are readmitted after a major surgical operation, one in four are readmitted to a different hospital than the one where the original operation was performed. Even taking distance traveled into account, we find that this type of postsurgical care fragmentation is associated with a substantially higher risk of death. (more…)
Author Interviews, Baylor College of Medicine Houston, JAMA, Mental Health Research / 21.01.2015

M. Justin Coffey MD Associate Professor Menninger Department of Psychiatry & Behavioral Sciences Baylor College of MedicineMedicalResearch.com Interview with: M. Justin Coffey MD Associate Professor Menninger Department of Psychiatry & Behavioral Sciences Baylor College of Medicine MedicalResearch: What is the background for this study? What are the main findings? Dr. Coffey: Although both the US Surgeon General and the Institute of Medicine have called on health care systems to reduce suicide, the few assessments of suicide in such systems have examined only specific patient groups and not the entire population of health plan members. Our study reports the first information on suicide for the entire membership of a large health maintenance organization (HMO). The findings provide a previously unavailable baseline data for health care systems who are engaged in important efforts to measure and prevent suicide. We identified all suicides among the entire membership of our HMO network between 1999 and 2010, determining the date and cause of death using official state mortality records. In our sample, the annual suicide rate among all HMO members (including non-patient members) did not change over time, whereas the annual suicide rate in the general population of the state of Michigan increased significantly. Importantly, suicides actually decreased among HMO members who received specialty mental health services, whereas suicides increased among HMO members who accessed general medical services but not specialty mental health services.   (more…)
Author Interviews, Education, JAMA / 21.01.2015

Dr. Juliane Kämmer Postdoctoral Researcher on behalf of the authors Max Planck Institute for Human Development Center for Adaptive Rationality Berlin GermanyMedicalResearch.com Interview with: Dr. Juliane Kämmer  Postdoctoral Researcher on behalf of the authors Max Planck Institute for Human Development Center for Adaptive Rationality  Berlin Germany Medical Research: What is the background for this study? What are the main findings? Dr. Kämmer: Diagnostic errors contribute substantially to preventable medical error. Of the multiple reasons for diagnostic error (such as technical failures or poorly cooperating patients), cognitive error is among the most frequent. Although a vast amount of literature explores ways to reduce cognitive errors, for example, during data synthesis, the collaborative character of clinical decision making has been largely neglected so far. Thus, the aim of our study was to investigate the effect of working in teams as opposed to working alone on diagnostic accuracy and the diagnostic decision process as such (including the time to diagnosis, number of ordered diagnostic tests and calibration of diagnostic confidence to diagnostic accuracy). In our study, we asked senior medical students to imagine being at the emergency ward and having to diagnose six simulated patients with respiratory distress on a computer – either working individually or in pairs. We indeed found that working in pairs reduced diagnostic error without requiring more diagnostic data gathering. Interestingly, neither differences in knowledge nor in amount and relevance of acquired diagnostic information could explain the superior accuracy of the pairs; neither did the statistically increased likelihood of containing a knowledgeable member. We thus have shown that – similar to other studies outside medicine – collaboration may help correct errors, fill knowledge gaps and counteract reasoning flaws – and thus save lives. Moreover, we found that reflecting on their personal confidence may point members of teams towards an increased probability of a diagnostic error. (more…)
Author Interviews, CDC, JAMA, OBGYNE / 20.01.2015

Sheree L. Boulet, DrPH, MPH Division of Reproductive Health Centers for Disease Control and Prevention, Atlanta, GeorgiaMedicalResearch.com Interview with: Sheree L. Boulet, DrPH, MPH Division of Reproductive Health Centers for Disease Control and Prevention, Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Dr. Boulet:  Intracytoplasmic Sperm Injection is generally considered a safe and effective treatment for male factor infertility; however, some studies have shown that ICSI is increasingly used in patients without male factor infertility without clear evidence of a benefit over conventional in vitro fertilization (IVF). In addition to increasing the cost of an IVF cycle, use of  Intracytoplasmic Sperm Injection has been found to increase the risk for adverse infant outcomes such as birth defects, chromosomal abnormalities and autism. Using data from CDC’s National Assisted Reproductive Technology Surveillance System, we found that use of ICSI increased by fourfold from 1996 through 2012 (from 15.4% to 66.9%). Furthermore, we found that use of  Intracytoplasmic Sperm Injection did not improve reproductive outcomes such as rates of pregnancy, miscarriage and live birth, when compared with conventional IVF, regardless of whether male factor infertility was present. (more…)
Aging, Author Interviews, Heart Disease, JAMA, Salt-Sodium / 19.01.2015

Andreas Kalogeropoulos, MD MPH PhD Assistant Professor of Medicine (Cardiology) Emory University School of Medicine Emory Clinical Cardiovascular Research Institute Atlanta GA 30322MedicalResearch.com Interview with: Andreas Kalogeropoulos, MD MPH PhD Assistant Professor of Medicine (Cardiology) Emory University School of Medicine Emory Clinical Cardiovascular Research Institute Atlanta GA 30322 Medical Research: What is the background for this study? What are the main findings? Dr. Kalogeropoulos: There is ongoing debate on how low should we go when it comes to dietary sodium (salt) restriction recommendations. In this study, we examined the association between self-reported dietary sodium intake and 10-year risk for death, cardiovascular disease, and heart failure in approximately 2,600 adults 71-80 years old. The subjects (women: 51.2%; white: 61.7%; black: 38.3%) were participants of the community-based Health, Aging, and Body Composition Study, which is sponsored by NIH and focuses on aging processes, i.e. was not specifically designed to address the issue of dietary salt intake. Also, it is important to note that salt intake was self-reported (not objectively measured) using a food frequency questionnaire, which underestimates salt intake. Keeping these limitations in mind, we did not observe a significant association between self-reported sodium intake and 10-year mortality, cardiovascular disease, and heart failure. Ten-year mortality was lower in the group reporting 1500–2300 mg daily sodium intake (30.7%) compared to those reporting daily intake less than 1500 mg (33.8%) or over 2300 mg (35.2%); however, this difference was not statistically significant. The 10-year event rates for cardiovascular disease (28.5%, 28.2%, and 29.7%) and heart failure (15.7%, 14.3%, and 15.5%) were also comparable across the <1500-mg, 1500-2300-mg, and >2300-mg dietary sodium intake groups. (more…)
Author Interviews, Columbia, JAMA, Neurological Disorders / 19.01.2015

Jose Gutierrez MD, MPH Assistant Professor of Neurology Division of Stroke and Cerebrovascular Disease Columbia University Medical Center NY, NYMedicalResearch.com Interview with: Jose Gutierrez MD, MPH Assistant Professor of Neurology Division of Stroke and Cerebrovascular Disease Columbia University Medical Center NY, NY Medical Research: What is the background for this study? What are the main findings? Dr. Gutierrez: There is growing interest in the effects of vascular health in cognition. The prevailing thought is that vascular disease leads to worse cognition due to direct structural damage of the brain, as in the case of brain infarcts, microhemorrhages or white matter hyperintensities, which are themselves associated with traditional cardiovascular risk factors such as hypertension, diabetes, smoking etc. Arterial stiffness, particularly of the aorta, has gained interest among researchers as predictors of vascular disease and worse cognition, but it is not clear whether arterial stiffness in the absence of traditional definition of vascular disease may be associated with worse cognition. We investigated in a representative sample of the US among adults 60 years or older who underwent cognitive testing with the Digit Symbol Subtraction test and who also had other measures of vascular disease, including blood workup, blood pressure measurement and Pulse pressure. We hypothesized that indirect measures of arterial stiffness such as ABI > 1.3 or pulse pressure would be associated with worse cognition, even among those without any clinical vascular disease or traditional vascular risk factors. We Included 2573 US adults in the sample, segregated those with any self-reported vascular disease or vascular risk factors and we found that among those without vascular disease or risk factors, an ABI > 1.3 and increased intra-visit blood pressure variability were predictors of worse cognitive performance compared with those without these indicators. Among participants with both indirect markers of arterial stiffness, their cognitive performance was worse that having only one of them suggesting additive effects of these two variables. (more…)
Aging, Author Interviews, JAMA, Lifestyle & Health / 19.01.2015

Jane Wardle University College London MedicalResearch.com Interview with: Jane Wardle University College London Medical Research: What is the background for this study? What are the main findings? Dr. Wardle: Previous studies have shown that couples tend to have similar health behaviours to one another, but no studies had compared having a partner who takes up a healthy behaviour (e.g. quits smoking) with having one whose behaviour is consistently healthy (e.g. never smoked). Nor have there been other studies in the older age group – our participants were over 60 on average.  We used data from 3722 couples participating in the English Longitudinal Study of Ageing (ELSA) to explore this issue for three behaviours: smoking, physical activity, and weight loss. For each behaviour, we found that when one partner changed their behaviour, the other partner was more likely to make a positive change, and the effect was stronger than having a partner whose behaviour was consistently healthy (i.e. never smoked/always exercised). (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Surgical Research / 18.01.2015

Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s HospitalMedicalResearch.com Interview with: Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting (CAS) vs Carotid endarterectomy (CEA) in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population. Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting. Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians peforming stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated CAS proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse. We found that unadjusted mortality risks over study period of 5 years with a mean of 2 years of follow-up in our population was 32%.  Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA, Medicare, Mental Health Research, Pharmacology / 16.01.2015

Dr. Jeanne Madden PhD Instructor, Department of Population Medicine Harvard Medical SchoolMedicalResearch.com Interview with: Dr. Jeanne Madden PhD Instructor, Department of Population Medicine Harvard Medical School   Medical Research: What is the background for this study? What are the main findings? Dr. Madden: When Medicare Prescription Drug Coverage started in 2006, many experts voiced concerns about disabled patients with serious mental illness making the transition from state Medicaid coverage to Medicare.  Our study is one of the first to examine the impact of the transition in mentally ill populations.  People living with schizophrenia and bipolar disorder are at high risk of relapse and hospitalization and are especially vulnerable to disruptions in access to their treatments. We found that the effects of transitioning from Medicaid to Medicare Part D depended on where patients lived.  Transition to Part D in states that put limits on Medicaid drug coverage resulted in fewer patients going without treatment. By contrast, in states with more generous drug coverage, we saw reductions in use, of antipsychotics in particular, after patients shifted to Medicare Part D.  This may have been due to new cost controls used within many private Medicare drug plans.  Given that most states in the US are in this latter category, with the relatively generous Medicaid drug coverage, we also found reductions in antipsychotic use nation-wide. Although a very large group of people made that transition from Medicaid to Medicare in 2006, thousands more still transition every year because when disabled people qualify for Medicare, they must wait 2 years for their benefits kick in.  Also, many other disabled patients are on Medicaid only and don’t qualify for Medicare.  They are of course affected by restrictions on Medicaid coverage, which vary from state to state. (more…)
Author Interviews, CDC, Infections, JAMA, Pediatrics / 16.01.2015

MedicalResearch.com Interview with: Dr. Stefan Goldberg MD Medical Officer in CDC’s Division of Tuberculosis Elimination Clinical Research Branch Medical Research: What is the background for this study? What are the main findings? Dr. Goldberg: A shorter, simpler treatment regimen for children with latent TB infection can help prevent TB disease and reduce future transmission. The results from our study, a multinational, clinical trial, found that a once-weekly regimen of the anti-TB drugs rifapentine and isoniazid taken as directly observed therapy over a period of three months was safe and as effective for children (age 2-17) in preventing TB disease as the standard self-administered nine-month daily regimen of isoniazid alone. The study also showed that children are more likely to complete the shorter course of treatment, which is important given that treatment completion can be difficult. Specifically, we found that 88 percent of the trial participants on the combination regimen completed therapy while 81 percent completed the standard regimen. The CDC’s Tuberculosis Trials Consortium (TBTC), which conducted this study, works to include children in research when their inclusion is scientifically supportable and when children also might benefit from important new tools, such as alternative treatment regimens. This study is an extension of a large, international trial among persons age 12 and older, published by TBTC in 2011, which showed the shorter, simpler regimen to be as safe and effective as standard treatment. (more…)
Author Interviews, Breast Cancer, JAMA / 14.01.2015

Javaid Iqbal, MD, MSC (Candidate) Institute of Medical Sciences, and Women’s College Research Institute/Women’s College Hospital University of Toronto, Toronto CanadaMedicalResearch.com Interview with: Javaid Iqbal, MD, MSC (Candidate) Institute of Medical Sciences, and Women’s College Research Institute/Women’s College Hospital University of Toronto, Toronto Canada What is the background for this study? What are the main findings? Dr. Iqbal: A woman’s racial/ethnic background predicts her participation in breast cancer control program (i.e., awareness and screening). The ultimate objective of breast cancer control program is to detect cancer at an optimal stage, which is stage I, because women with stage I breast cancer survive longer. Given the racial/ethnic diversity of North America, this poses questions such as “what predicts stage I breast cancer in the multiethnic North American population?”, “what predicts its survival?”, and “does a woman’s ethnic background plays a role in predicting an early stage, and survival?” We studied 373,563 women diagnosed with invasive breast cancer in the United States between 2004 and 2011. We followed these women for 7 years and recorded whether or not they died of breast cancer, or whether they are still alive. We then divided all women into different ethnic groups, in particular white, black, Chinese, Japanese, and Indian/Pakistani (South Asian). For each racial/ethnic group, we estimated proportions of women who were diagnosed with stage I breast cancer, and risk of death at 7 years. Our aim was to determine if the racial/ethnic differences in early stage breast cancer, and its survival were better explained by intrinsic biological differences in tumor characteristics, or by differences in early-detection of breast cancer. We found that a woman’s racial/ethnic background predicted the diagnosis of stage I breast cancer, as well as her risk of dying at 7 years after breast cancer. A black woman was less likely than a white woman to be diagnosed with stage I breast cancer. A black woman was also more likely than a white woman to die of stage I breast cancer 7 years after her diagnosis. The Japanese and Chinese women were more likely than white women to be diagnosed with stage I breast cancer. The risk of death at 7 years was lowest for Indian or Pakistani (South Asian) women. Furthermore, even for small sized (2.0) breast cancers the risk of death at 7 years was higher for black women (9%), compared to white women (5%). Compared to white women, small sized breast cancers in black women were more aggressive at diagnosis, and had spread to lymph nodes and other organs. (more…)
Author Interviews, Hospital Acquired, JAMA / 13.01.2015

Teresa Waters PhD Professor and Chair, Preventive Medicine University of Tennessee Health Science Center Memphis TNMedicalResearch.com Interview with: Teresa Waters PhD Professor and Chair, Preventive Medicine University of Tennessee Health Science Center Memphis TN Medical Research: What is the background for this study? What are the main findings? Dr. Waters: On October 1, 2008, Medicare implemented the Hospital-Acquired Conditions (HACs) Initiative, a policy penalizing hospitals for eight complications of hospital care, also known as never events. Under the HACs Initiative, hospitals could no longer justify a higher level Medicare MS-DRG when caring for a patient who developed 1 of the 8 never events. This Initiative was one in a series of CMS payment reforms intended to increase emphasis on value-based purchasing. We found that Medicare's nonpayment policy was associated with significant improvements in the time trends for central line associated blood stream infections (CLABSIs) and catheter associated urinary tract infections(CAUTIs). For these outcomes, our data from the National Database of Nursing Quality Indicators showed that introduction of the Medicare policy was associated with an 11% reduction in the rate of change in central line associated blood stream infections and a 10% reduction in the rate of change in CAUTIs. We did not find any relationship between introduction of the policy and significant changes in injurious falls or hospital acquired pressure ulcers (two other important never events covered by the policy). We hypothesized that the Hospital-Acquired Conditions Initiative may have a great effect for conditions where there is strong evidence that better hospital processes yield better outcomes or where processes are more conducive to standardization. (more…)
Author Interviews, JAMA, Kidney Disease / 12.01.2015

MedicalResearch.com Interview with: James Flory MD, MSCE Division of Endocrinology and Department of Healthcare Policy and Research Weill Cornell Medical College, NY NY Medical Research: What is the background for this study? What are the main findings? Dr. Flory: Metformin is the first-line drug for type 2 diabetes, with much better evidence for safety and improved clinical outcomes than any alternative. The one major safety concern about metformin is the fear that it can cause lactic acidosis, which led to a Food and Drug Administration black box warning against using metformin in patients with even a modest degree of renal impairment. These fears and warnings were based on serious problems with an older drug in the same class, not on experiences with metformin itself, and over the past 20 years it has become clear that the risk of lactic acidosis with metformin is extremely low, and that this warning against the use of the drug in mild renal failure is overly strict. (Dr. Lipska and colleagues published a superb review of this issue a few years back: Diabetes Care June 2011 vol. 34 no. 6 1431-1437) This is important from a public health perspective because so many patients with diabetes have mild to moderate kidney disease, and we were concerned that the FDA warning was preventing the use of metformin in these patients. Our study was intended to estimate how many patients who would benefit from metformin are not taking it because they have mild kidney disease. We found that rates of metformin use are much lower in patients with mild kidney disease – just the population where the FDA warning discourages use, but modern data show that metformin is safe. In all, at least 1 million patients with type 2 diabetes who would benefit from metformin appear not to be taking it because clinicians are following the FDA warning and being too conservative. (more…)
Author Interviews, Diabetes, Geriatrics, JAMA / 12.01.2015

Kasia Joanna Lipska MD, MHS Assistant Professor of Medicine (Endocrinology) Yale School of Medicine New Haven, CT 06520-8020MedicalResearch.com Interview with: Kasia Joanna Lipska MD, MHS Assistant Professor of Medicine (Endocrinology) Yale School of Medicine New Haven, CT 06520-8020 Medical Research: What is the background for this study? What are the main findings? Dr. Lipska: Diabetes is common and affects about 1 in 4 older adults (65 years or more). For younger adults with diabetes, most guidelines suggest lowering blood sugar levels to a hemoglobin A1c below 7%. However, in older patients, especially those with complex medical problems, the benefits of this strategy are unclear. What’s more, this strategy can cause harm. Aiming for a hemoglobin A1c below seven increases the risk for hypoglycemia. And older adults are especially susceptible to this risk. As a result, many guidelines suggest that treatment should be more cautious for these vulnerable elders and that aiming for “tight” blood sugar control may not be worth the risk. Medical Research: What are the main findings? Dr. Lipska: We looked at diabetes treatment of older adults using nationally representative data from 2001 to 2010. We found that 62% of older adults with diabetes had a hemoglobin A1c below 7%. But what’s really striking is that this proportion was similar for patients who were relatively healthy, for those with intermediate health, and for those with poor health. What’s more, the use of insulin or sulfonylureas (drugs that increase the risk for hypoglycemia) was common and similar across these groups. (more…)
Author Interviews, End of Life Care, JAMA / 12.01.2015

MedicalResearch.com Interview with: Younsuck Koh Professor of Medicine Professor of Medical Humanities and Social Sciences Chairman, the Organizing Committee of the 12th World Federation of Societies of Intensive and Critical Care Medicine Congress in Seoul Department of Pulmonary and Critical Care Medicine Asan Medical Center, Univ. of Ulsan College of Medicine Seoul, Korea and Jason Phua MBBS, FRCP National University Hospital, Singapore AVF Chairperson. Senior Consultant & Head Division of Respiratory & Critical Care Medicine Medical Research: What is the background for this study? What are the main findings? Response: Provision of humane end-of-life and palliative care for dying patients and their families must remain a focus in today’s intensive care units, which continue to see technological advancements in the forms of life-sustaining measures available. End-of-life care decisions are heavily dependent on the medical, ethical, social, and cultural context. Asia, which accounts for at least half of all patients with critical illness, mechanical ventilation, and intensive care unit deaths internationally, has diverse socioeconomic conditions, cultures, and religions. Therefore, it is likely that substantial difference in the way physicians approach end-of-life care exist between Asia and the West, and among Asian countries and regions themselves. However, prior to our study, little data existed on the end-of-life care practices in this region. We found that even as end-of-life care practices in intensive care units vary significantly across Asian countries and regions, physicians in Asia generally seem less likely to limit life-sustaining treatments than their Western counterparts. Implementation of do-not-resuscitate orders are affected by multiple factors related to country or region, including economic, cultural, religious, and legal differences, as well as personal attitudes. (more…)
Author Interviews, JAMA / 07.01.2015

Sakthivel Sadayappan, PhD, MBA Associate Professor Department of Cell and Molecular Physiology Loyola University Chicago Health Sciences Division Maywood, IL 60153-5500, USA.MedicalResearch.com Interview with: Sakthivel Sadayappan, PhD, MBA Associate Professor Department of Cell and Molecular Physiology Loyola University Chicago Health Sciences Division Maywood, IL  60153-5500, USA. MedicalResearch: What is the background for this study? What are the main findings? Dr. Sadayappan: Hypertrophic cardiomyopathy (HCM) is the most common form of genetic heart defect, affecting 1 in 500 people in the general population. HCM results in excessive thickening of heart muscle without an obvious cause, such as hypertension or exercise stress. Often, HCM results in sudden cardiac arrest as a result of cardiac arrhythmia. Electrocardiogram, echocardiogram and cardiac magnetic resonance imaging are commonly used to diagnose HCM. However, genetic defects in more than 10 genes could also cause HCM, and standard screening for these genes is readily available. Notwithstanding our ability to diagnose the disease, a major challenge arises from its heterogeneity. That is, individuals with the same genetic defect often present with different symptoms, ranging from no symptoms at all to severe heart enlargement. Therefore, treatment options vary from person to person, and, at present, no permanent cure is available for HCM. Beta-blockers, calcium antagonists and anti-arrhythmic drugs are currently being used to manage the disease. However, scientists must discover the reasons that explain why some people experience more severe symptoms than others. In today’s modern world, people are afflicted with stresses including, for example, diabetes, hypertension, hyperlipidemia (high cholesterol), and alcoholism. Therefore, we have hypothesized that additional cardiac stresses can aggravate the onset of Hypertrophic cardiomyopathy. To prove our hypothesis, we used a mouse model having a genetic defect known to affect cardiac muscle contractility. We subjected these mice to severe cardiac stress over a period of 12 weeks. Compared with normal mice, we found that the mutant mice showed significant cardiac abnormalities, including those associated with HCM. Thus, this demonstrated, for the first time, that additional cardiac stress applied in the presence of known genetic defects exacerbates the onset of HCM. (more…)
Author Interviews, Heart Disease, JAMA, University of Pittsburgh / 07.01.2015

Inmaculada Hernandez, PharmD PhD Student, Health Services Research and Policy Deparment of Health Policy and Management Graduate School of Public Health University of Pittsburgh Pittsburgh, PA 15261MedicalResearch.com Interview with: Inmaculada Hernandez, PharmD PhD Student, Health Services Research and Policy Deparment of Health Policy and Management Graduate School of Public Health University of Pittsburgh Pittsburgh, PA 15261 Medical Research: What is the background for this study? What are the main findings? Response: The approval of dabigatran was considered a major contribution to the therapeutic arsenal of anticoagulants since warfarin, whose therapeutic management is complicated, was the only oral anticoagulant approved before 2011. Clinicians therefore considered dabigatran a very promising drug; however, the safety warnings released by the regulatory agencies and the reports of bleeding published in 2011 raised concerns about the safety profile of dabigatran. By the time we initiated our study, the FDA had concluded that dabigatran was associated with similar rates of bleeding than warfarin. However, the results of this observational study were not adjusted by patient characteristics. We therefore compared the risks of bleeding with dabigatran and warfarin adjusting for patient characteristics and using propensity score methods to mitigate selection biases, which observational studies are sensitive to. We found that dabigatran was associated with a higher risk of major bleeding and gastrointestinal bleeding than warfarin. However, the risk of intracranial bleeding was lower with dabigatran. In addition, we found that the increased risk of bleeding with dabigatran was specially higher for African Americans and for patients with chronic kidney disease. (more…)
Author Interviews, JAMA, Mental Health Research, University of Pittsburgh / 06.01.2015

Dr. Brent David MD Academic Chief, Child and Adolescent Psychiatry at Western Psychiatric Institute and Clinic Professor of Psychiatry, Pediatrics & Epidemiology University of Pittsburgh School of Medicine MedicalResearch.com Interview with: Dr. Brent David MD Academic Chief, Child and Adolescent Psychiatry at Western Psychiatric Institute and Clinic Professor of Psychiatry, Pediatrics & Epidemiology University of Pittsburgh School of Medicine Medical Research: What is the background for this study? Dr. David: There are now many studies that show that suicide and suicidal behavior run in families. A family history of suicide increases the risk for suicide attempt and vice versa, so that we believe that the trait that is being passed from parent to child is a tendency to act on suicidal thoughts, resulting in either an attempt or an actual suicide. However, what was not not known was the mechanism by which parents transmitted the risk of suicidal behavior to their children, and what the precursors of suicidal behavior looked like in individuals who were at risk for suicidal behavior, but had not yet engaged in a suicide attempt. Therefore, we conducted a high-risk family study, in which studied the children of parents with mood disorders, about half of whom also had a history of a suicide attempt. Medical Research: What are the main findings? Dr. David: We followed 701 offspring for an average of 5.6 years, and found that those offspring whose parents had made a suicide attempt were almost 5 times more likely to make a suicide attempt themselves, even after accounting for mood disorder in parent and child and past suicidal behavior in the offspring. We found three main pathways by which suicidal behavior was passed from parent to child:
  • Parental mood disorder was transmitted to children, and that was a precursor of a suicide attempt.
  • Parent attempt was related to offspring impulsive aggression, which in turn increased the risk for mood disorder, which then increased the likelihood of a suicide attempt. (We define impulsive aggression as a tendency to response with hostility or aggression to provocation or frustration.
  • Finally, there is a direct path from parent attempt to child attempt, with no precursors or intervening variables.
Implications for clinicians and patients:
  • First, these findings highlight that a parental history of a suicide attempt increases the risk of an attempt in the parent's children. Clinicians who take care of adults who have attempted suicide should make sure that children are assessed as they are at increased risk and that parents know what to look for in the future in order to get their children into needed treatment.
  • Second, the transmission of suicidal behavior from parent to child can be attenuated by preventing the transmission of mood disorder, and of impulsive aggression. There are now evidence based interventions that reduce the likelihood of a child of a depressed parent from developing depression; these treatment involve cognitive behavioral principles and may also involve family interventions. There are now good family-based interventions for impulsive aggression that can attenuate the risk that the child or adolescent will go on to develop a mood disorder, which in turn greatly increases the risk for suicidal behavior.
(more…)
Author Interviews, JAMA, Schizophrenia / 06.01.2015

MedicalResearch.com Interview with: Toshiaki A. Furukawa, MD, PhD Professor and Chair, Department of Health Promotion and Human Behavior Professor, Department of Clinical Epidemiology Kyoto University Graduate School of Medicine / School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto Japan Medical Research: What is the background for this study? What are the main findings? Dr. Furukawa: The efficacy of antidepressants in the treatment of depressive disorders has recently been called into question as some studies suggested they may have less efficacy for the milder spectrum of the disorder. It is not known if the same would apply to antipsychotics, which constitute the mainstay in the treatment of schizophrenia. We found that, in patients with schizophrenia with acute treatment as well as with predominant negative symptoms, the severer the baseline severity, the greater the magnitude of the benefit from the active treatment in comparison with placebo. (more…)
Author Interviews, JAMA, OBGYNE / 06.01.2015

Dr. Jennifer Kawwass MD Assistant Professor Emory UniversityMedicalResearch.com Interview with: Dr. Jennifer Kawwass MD Assistant Professor Emory University Medical Research: What should clinicians and patients take away from your report? Dr. Kawwass: This study affirms that Assisted Reproductive Technology treatment is relatively safe and that reported complications remain rare.  In the US from 2000-2011, autologous and donor ART procedures were associated with low reported stimulation and surgical complication risks; no concerning trends or patterns were identified. Ovarian hyperstimulation syndrome (OHSS) was the most frequently reported complication among autologous and donor cycles, though less frequent in donor cycles.  Obstetric mortality which may or may not be related to Assisted Reproductive Technology was rare. (more…)
Author Interviews, JAMA, Pediatrics, UCSF / 06.01.2015

Yvonne Wu MD Professor of Clinical Neurology and Pediatrics UCSF School of MedicineMedicalResearch.com Interview with: Yvonne Wu MD Professor of Clinical Neurology and Pediatrics UCSF School of Medicine   Medical Research: What is the background for this study? What are the main findings? Dr. Wu: Newborn infants commonly have elevated bilirubin levels, manifested as jaundice, because the body's mechanisms for breaking down bilirubin have not yet fully matured.  Although high bilirubin levels are almost always well tolerated, extremely high bilirubin levels may lead to brain injury, or kernicterus, which in turn can cause a very severe form of cerebral palsy.  When bilirubin levels are extremely high, or when bilirubin levels remain high despite phototherapy, it is recommended that an exchange transfusion be performed to prevent brain injury and cerebral palsy.  The American Academy of Pediatrics (AAP) has published recommendations on when an exchange transfusion should be performed, based on bilirubin level, age of infant and other clinical factors.  However, no previous study had examined the actual risk of cerebral palsy in infants whose bilirubin levels exceeded the exchange transfusion thresholds. Among 500,000 newborns born at Kaiser Permanente Northern California over a 17-year period, we found 1833 who had at least one bilirubin level above the AAP exchange transfusion level.  There were only 3 cases of cerebral palsy due to kernicterus in this group, even though only 42 (2.3%) of them had received exchange transfusions.  All 3 infants had bilirubin levels at least 5 mg/dL above the AAP exchange transfusion threshold and all 3 infants had 2 or more other risk factors for brain damage, including prematurity, sepsis, hypoxia and the hereditary blood disorder G6PD deficiency.  We did not identify any cases of kernicterus among otherwise well term babies, even at bilirubin levels that exceeded the AAP exchange transfusion threshold. (more…)
Author Interviews, JAMA, Mental Health Research, UCSF / 06.01.2015

Dr. Georges Naasan MD Neurologist, Clinical Instructor UCSF Memory and Aging CenterMedicalResearch.com Interview with: Dr. Georges Naasan MD Neurologist, Clinical Instructor UCSF Memory and Aging Center Medical Research: What is the background for this study? What are the main findings? Dr. Naasan: Degenerative diseases of the brain can lead to dysfunction in judgment, emotional processing, social decorum and self-awareness. In turn, such dysfunctions may result in criminal behavior that appears for the first time in middle-aged adults or even later in life. We studied 2397 patients from the Memory and Aging Center at UCSF and found 204 (8.5%) that had a criminal behavior as part of their illness. The large majority of these patients were patients with a specific type of neurodegenerative disease called behavioral variant of frontotemporal dementia, followed by a group of people with a disease called semantic variant of primary progressive aphasia. People with Alzheimer's disease, a disease that does not usually interrupt the functions mentioned above, were the least likely to exhibit criminal behavior. The common manifestation of criminal behaviors in people with the behavioral variant frontotemporal dementia included theft, sexual advances trespassing and public urination in contrast to people with Alzheimer's disease who, when such behaviors were present, primarily committed traffic violations often secondary to cognitive impairment. (more…)