Author Interviews, Fertility, JAMA / 13.08.2015

Vitaly A Kushnir MD The Center for Human Reproduction New York, NY 10021MedicalResearch.com Interview with: Vitaly A Kushnir MD The Center for Human Reproduction New York, NY 10021 Medical Research: What is the background for this study? What are the main findings? Dr. Kushnir: In January 2013, the American Society for Reproductive Medicine declared the technique of oocyte cryopreservation no longer experimental, although they body did call for further study. Vitaly A. Kushnir, M.D., of the Center for Human Reproduction, and colleagues used 2013 data from 380 U.S fertility centers to compare live birth and cycle cancellation rates using either fresh or cryopreserved donor oocytes. The study found roughly 20 percent of donor cycles used cryopreserved oocytes and 80 percent fresh oocytes. Of those embryos transferred, 56 percent that started as fresh oocytes resulted in live births compared to just 47 percent of those that started as cryopreserved oocytes.
Author Interviews, Biomarkers, Dermatology, JAMA, Pulmonary Disease, University of Pennsylvania / 12.08.2015

Misha A. Rosenbach, MD Assistant Professor of Dermatology at the Hospital of the University of Pennsylvania Assistant Professor of Dermatology in MedicineMedicalResearch.com Interview with: Misha A. Rosenbach, MD Assistant Professor of Dermatology at the Hospital of the University of Pennsylvania Assistant Professor of Dermatology in Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Rosenbach: Sarcoidosis is an inflammatory disease of unknown etiology where genetically susceptible patients develop multi-organ granulomatous inflammation in response to an as-yet unidentified stimulus.  Patients with sarcoidosis typically have granulomatous inflammation in their lungs, but the second most commonly affected organ is the skin; the eyes, lymph nodes, liver, heart, brain, and other organs can be affected as well.  Patients with sarcoidosis can experience a few disease trajectories; some spontaneously recover, while others have persistent, active inflammation, whereas another group can experience inflammation which leads to scarring and fibrosis.  It can be challenging to distinguish these cohorts of patients based on their lungs alone. The skin is much easier to evaluate, as it is right there on the surface, and can be examined by physicians without resorting to invasive tests or radiography.  At Penn, we developed a novel cutaneous sarcoidosis assessment tool, called the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI), which is designed to accurately measure how inflamed skin sarcoid lesions are in a given patient, as well as describing which type of cutaneous lesion patients’ have.  The CSAMI has in previously studies been shown to be reliable when used by dermatologists, with excellent inter-rater and intra-rater reproducibility. In this study, we had a group of Pulmonologists, Rheumatologists, and Dermatologists (representing the groups of physicians who most commonly care for patients with sarcoidosis, especially if there is skin involvement) evaluate a group of patients with cutaneous sarcoidosis, using the CSAMI and another sarcoidosis activity instrument, the SASI, which has also previously been used to measure skin sarcoidosis activity in a number of settings.  We were able to demonstrate that these cutaneous scoring tools are reliable and reproducible and able to accurately measure cutaneous sarcoidosis disease activity in a variety of patients with a range of skin disease severity.  We also compared the physician scores to patients’ own evaluations of their disease, and showed that the CSAMI (physician impression of disease) correlated well with patients’ own perception of their disease activity and severity.
Author Interviews, Diabetes, Kidney Disease, Lancet / 12.08.2015

[caption id="attachment_16540" align="alignleft" width="238"]Prof. Der-Cherng Tarng, MD, PhD Division of Nephrology Taipei Veterans General Hospital, and National Yang-Ming University, Taiwan Prof. Der-Cherng Tarng[/caption] MedicalResearch.com Interview with: Prof. Der-Cherng Tarng, MD, PhD Division of Nephrology Taipei Veterans General Hospital, and National Yang-Ming University, Taiwan MedicalResearch: What is the background for this study? What are the main findings? Prof. Tarng: Metformin is generally recommended as a first-line therapy for type 2 diabetes mellitus, but the use of metformin has been limited in patients with impaired kidney function because of the perceived risk of lactic acidosis. More recently, available evidence supports the cautious expansion of metformin use in patients with mild to moderate chronic kidney disease (CKD). However, no studies have yet examined whether metformin can be prescribed more widely to patients with advanced CKD. We conducted a propensity score-matched cohort study using Taiwan’s National Health Insurance Research Database to assess the safety of metformin in patients with type 2 diabetes and serum creatinine levels >6 mg/dL, enrolled between January 1, 2000 and June 30, 2009 and followed-up until December 31, 2009, before Taiwan’s prescribing guidelines for metformin contraindicated its use in patients with CKD. From a consecutive sample of 12350 patients, 1005 (8.1%) were metformin users. Of these, 813 were successfully matched 1:3 to 2439 metformin nonusers. After multivariate adjustment, metformin use remained was an independent risk factor for mortality (hazard ratio 1.35, 95% confidence interval 1.20–1.45; p<0.0001). The increased risk was dose-dependent and was consistent across all subgroup analyses. However, metformin users compared with non-users were associated with a higher but insignificant risk of metabolic acidosis (hazard ratio 1.30, 95% confidence interval 0.88–1.93; p=0.188).
Author Interviews, Heart Disease, JACC, Nutrition / 12.08.2015

James M. Shikany, DrPH Professor of Medicine Division of Preventive Medicine University of Alabama at Birmingham Birmingham, AL MedicalResearch.com Interview with: James M. Shikany, DrPH Professor of Medicine Division of Preventive Medicine University of Alabama at Birmingham Birmingham, AL   Medical Research: What is the background for this study? What are the main findings? Dr. Shikany: There is a growing interest in the field of nutritional epidemiology in relating overall dietary practices to various disease endpoints. For example, the assessment of dietary patterns in a population may be more meaningful than concentrating on isolated nutrients or foods because they more closely reflect how people eat in the real world. Previously, we looked at how the degree to which one adhered to 5 dietary patterns identified in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study was associated with the risk of stroke. In the current study, we investigated how the degree to which one adhered to these dietary patterns was related to the risk of incident acute coronary heart disease. The main finding was that a Southern dietary pattern (characterized by added fats, fried foods, eggs and egg dishes, organ meats, processed meats, and sugar-sweetened beverages) was associated with a significantly greater hazard of incident acute coronary heart disease in REGARDS participants. The association persisted following adjustment for sociodemographics, lifestyle factors, and energy intake. Specifically, following multivariable adjustment, participants in the highest quartile of consumption of the Southern pattern experienced a 56% greater hazard of incident coronary heart disease compared with those in the lowest quartile of consumption of this pattern. Another pattern we observed – the Plant-based pattern – characterized by vegetables, fruits, beans, yogurt, poultry, and fish was not associated with an increased risk of coronary heart disease.
Author Interviews, Hospital Readmissions, JAMA, Pediatrics / 11.08.2015

MedicalResearch.com Interview with: Alisa Khan, MD Pediatric hospitalist Boston Children's Hospital and Instructor of Pediatrics Harvard Medical School Medical Research: What is the background for this study? Dr. Khan: Patients can be readmitted to the same hospital they were discharged from or to a different hospital.  In adults, readmissions to different hospitals make up about 20% of all readmissions.  We don’t know a lot about how often different-hospital readmissions happen in children. Insurance companies know hospitals’ true readmission rates (which include when a hospital’s patients are readmitted to the same hospital and when they are readmitted to a different hospital).  However, hospitals don’t know their true readmission rates since they don’t have access to the full information that insurance companies have. If hospitals don’t know their true rates, they may think they are doing better at preventing readmissions than they really (for instance, if all their discharged patients are simply being readmitted to a different hospital).  Hospitals may also draw incorrect conclusions when they compare themselves to one another (like through benchmarking), and may not be able to predict whether they will be subject to penalties by insurers for having excessively high readmission rates. Medical Research: What are the main findings? Dr. Khan: We found that about 1 in 7 pediatric readmissions in New York over a 5-year period were to a different hospital than the hospital the patient was discharged from.   The percentage of different-hospital readmissions varied by hospital and patient characteristics.  Patients who were admitted to non-children’s hospitals, lower-volume hospitals, or urban hospitals had a higher chance of being readmitted to a different hospital, as did patients who were younger, white, privately insured, or who had certain chronic conditions (like mental health, neurologic, and circulatory conditions). We also found a lot of variability in how much individual hospitals would underestimate their true readmission rates if they only used this incomplete same-hospital readmission info.  Some hospitals would underestimate their true readmission rates by only 0.6 relative percentage points while others would underestimate them by 68 points.
Author Interviews, Fertility, JAMA, Pediatrics / 11.08.2015

Prof. Dr. med. Christian F. Poets Neonatologie, Univ.-Klinikum Tübingen Tübingen GermanyMedicalResearch.com Interview with: Prof. Dr. med. Christian F. Poets Neonatologie, Univ.-Klinikum Tübingen Tübingen Germany Medical Research: What is the background for this study? Prof. Poets: Episodes of intermittent hypoxemia (lack of oxygen) and bradycardia (slow heart rate) are common in very preterm infants and often a subject of considerable concern. However, up to now there has been a lack of knowledge as to how often or how long such episodes may occur without increasing an infant’s risk for impaired development or even death. In this study, we utilized long-term recordings (lasting 8-12 weeks) of oxygen saturation and heart rate obtained as part of the Canadian Oxygen Trial (COT), a large study performed in extremely immature infants and comparing a higher with a lower oxygen saturation target range (85-89 vs. 91-95% oxygen saturation measured by pulse oximetry). For this secondary analysis, we wanted to test the hypotheses that spending a high proportion of time at an oxygen saturation below 80% or a pulse rate <80 beats per minute increases the risk of the following adverse outcomes:
  1. Death after reaching a post-menstrual age of 36 weeks (i.e. 4 weeks before their due date) or disability, determined at 18-22 months corrected age and defined as motor impairment, cognitive or language delay, severe hearing loss, or bilateral blindness;
  2. Motor impairment (determined at 18-22 months corrected age);
  3. Cognitive or language delay (determined at 18-22 months corrected age);
  4. Severe retinopathy of prematurity.
Medical Research: What are the main findings? Prof. Poets: Analyzable recordings and outcome data were available for 1019 infants, of which the least affected 10% spent 0.4%, and the most affected infants 13.5% of the time at an oxygen saturation <80%. We found that the risk to develop all of the adverse outcomes mentioned above increased with the percentage of time spent at an oxygen saturation below 80%, but this was true only for hypoxemic events lasting for at least 1 minute. Episodes with a low heart rate (in the absence of concomitant hypoxemia) were not associated with an increased risk of an adverse outcome. Interestingly, hypoxemic events occurring in infants originally randomized to the higher oxygen group in the original COT study were associated with a stronger increase in the risk of death or disability than such episodes occurring infants randomized to the lower oxygen saturation target range. 
Author Interviews, JAMA, Neurological Disorders, Ophthalmology, Vanderbilt / 11.08.2015

MedicalResearch.com Interview with: Matthew Schrag MD Department of Neurology Yale University New Haven, Connecticut   Medical Research: What is the background for this study? What are the main findings? Dr. Schrag: Central retinal artery occlusion  (CRAO) is a relatively rare disorder that is caused by interruption of blood flow to the retina, usually by a clot or some other embolus.  Despite around 150 years of research, no compelling treatment has been found for this disease.  Treatment with fibrinolytics has been used experimentally for a long time and some of the results have been encouraging.  The point of the current study was to aggregate all of this observational data and compare how patients withCentral retinal artery occlusion do when treated with fibrinolytics versus when they are treated with other approaches or not treated at all. The biggest surprise in the data was the poor performance of conventional treatments at less than half the recovery rate of patients who were simply left alone.  The literature on treating central retinal artery occlusion with ocular massage, hemodilution or anterior chamber paracentesis has never been particularly compelling, but these treatments were thought to be harmless and are often practiced in the acute management of central retinal artery occlusion.  This new analysis strongly suggests that these interventions may be harmful.  While this data is not perfect (it is retrospective, non-randomized, acquired over long periods of time, etc), for me it raises enough doubt that I think ocular massage, anterior chamber paracentesis and hemodilution should be abandoned as treatments for acute CRAO.
Annals Thoracic Surgery, Author Interviews, Cancer Research, Lung Cancer, Outcomes & Safety / 11.08.2015

MedicalResearch.com Interview with: Raymond Osarogiagbon MD, FACP Thoracic Oncology Research Group Baptist Cancer Center Memphis, Tennessee MedicalResearch.com Interview with: Raymond Osarogiagbon MD, FACP Thoracic Oncology Research Group Baptist Cancer Center Memphis, Tennessee

Medical Research: What is the background for this study? What are the main findings? Dr. Osarogiagbon: Lung cancer care is complicated, but can be broken down into 5 steps: x-ray detection, biopsy, x-ray tests of cancer spread (the ‘stage’), biopsy of suspicious areas where cancer may have spread, and treatment. Looking only at patients who had surgery for a suspected lung cancer, we worked backwards to see how their care went through the key steps and how long it took. We found that patients often skip some of the crucial steps. For example, 22% did not have a staging PET/CT scan, 88% did not have an invasive staging test. Only 10% had the recommended combination of 3 staging tests leading up to surgery: a CT scan, PET/CT scan, and invasive staging test. It took a month and a half to more than 6 months for the middle half of patients to go from first abnormal x-ray sign of possible lung cancer to surgery.
Author Interviews, Emory, JAMA, Kidney Disease / 11.08.2015

Rachel Patzer, PhD, MPH Director of Health Services Research, Emory Transplant Center Assistant Professor Department of Surgery Division of Transplantation Emory University School of MedicineMedicalResearch.com Interview with: Rachel Patzer, PhD, MPH Director of Health Services Research, Emory Transplant Center Assistant Professor Department of Surgery Division of Transplantation Emory University School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Patzer: There are two main treatments for patients with end stage kidney disease: dialysis or kidney transplantation.  Kidney transplantation offers the best survival and quality of life compared to dialysis.  However, there is a limited supply of organs in the U.S., so not all patients with end stage organ failure get a kidney transplant. Certain regions of the country have lower access to kidney transplantation than other regions.  The Southeastern United States (GA, NC, and SC) has the lowest rates of kidney transplantation in the nation, and Georgia (GA) is the state that ranks at the very bottom. Our research team and collaborators from the Southeastern Kidney Transplant Coalition sought to examine some of the reasons for why Georgia had the lowest rates of kidney transplantation in the nation.  The transplant centers in our Coalition collaborated to share data on patient referrals from dialysis facilities, where the majority of end stage renal disease patients receive treatment, to transplant centers in Georgia. Referral from a dialysis facility to a transplant center is required for patients to undergo the extensive medical evaluation that is required for a patient to either be placed on the national deceased donor waiting list, or to receive a living donor kidney transplant (e.g. from a friend or family member). There were several major findings: 1)    That overall, referral of patients from a dialysis facility to a kidney transplant center is low (only about 28% of patients with kidney failure are referred to a transplant center within a year of starting dialysis). 2)    There was much variation in referral for transplantation across dialysis facilities in GA, where some facilities referred no patients within a year, and others referred up to 75% of their patient population.
Addiction, Author Interviews, HIV, Lancet / 10.08.2015

MedicalResearch.com Interview with: Dr. Keith Ahamad, a clinician scientist at the BC Centre for Excellence in HIV/AIDS and a Family Doctor trained and certified in Addiction Medicine. He is Division Lead for Addiction Medicine in the department of Family and Community Medicine at Providence Health Care, and is also an addiction physician at the St. Paul’s Addiction Medicine Consult Service, the Immunodeficiency Clinic and Vancouver Detox. He is also Lead Study Clinician for CHOICES, a US National Institutes of Drug Abuse (NIDA) funded clinical trial looking at an opioid receptor blocker (Vivitrol) to treat opioid or alcohol addiction in HIV positive patients.Dr. Keith Ahamad, a clinician scientist at the BC Centre for Excellence in HIV/AIDS and a Family Doctor trained and certified in Addiction Medicine. He is Division Lead for Addiction Medicine in the department of Family and Community Medicine at Providence Health Care, and is also an addiction physician at the St. Paul’s Addiction Medicine Consult Service, the Immunodeficiency Clinic and Vancouver Detox. He is also Lead Study Clinician for CHOICES, a US National Institutes of Drug Abuse (NIDA) funded clinical trial looking at an opioid receptor blocker (Vivitrol) to treat opioid or alcohol addiction in HIV positive patients. MedicalResearch: What is the background for this study? Dr. Ahamad: Previous methadone research has mostly been done in restrictive settings, such as the USA, where methadone can only be dispensed through restrictive methadone programs and cannot be prescribed through primary care physician’s offices. Since a systematic review in 2012, randomised controlled trials have compared methadone treatment provided at restrictive specialty clinics with primary care clinics, which have shown the benefits of primary care models of methadone delivery on heroin treatment outcomes, but not on HIV incidence. MedicalResearch: What are the main findings? Dr. Ahamad: After adjusting for factors commonly associated with HIV, methadone remained independently associated in protecting against HIV in this group of injection drug users. Those study participants who were not prescribed methadone at baseline were almost four times more likely to contract HIV during study follow up. MedicalResearch: What should clinicians and patients take away from your report? Dr. Ahamad: Methadone is an effective medication in treating opioid addiction. Through international randomized control trials, we already know that when prescribed though primary care offices, access to this life-saving medication is increased, effective, and increases patient satisfaction. Now, through our study, we have evidence that when delivered in this manner, it also decreases the spread of HIV.
Author Interviews, JAMA, Outcomes & Safety / 10.08.2015

[caption id="attachment_16466" align="alignleft" width="224"]Erika Newton MD, MPH Erika Newton MD, MPH[/caption] MedicalResearch.com Interview with: Erika Newton MD, MPH Department of Emergency Medicine Stony Brook University Medical Center Stony Brook, NY and Brenda Sirovich MD, MS Staff Physician Co-Director Outcomes Group VA Medical Center White River Junction, VT Associate Professor of Medicine and of Community and Family Medicine Geisel School of Medicine at Dartmouth, and The Dartmouth Institute for Health Policy and Clinical Practice Division of Trauma Surgery, Department of Surgery Stony Brook University Medical Center Stony Brook, New York Medical Research: What is the background for this study? Response: Clinical performance measures – quality indicators used to evaluate and motivate health care providers' performance – play a central role right now in efforts to improve quality in U.S. health care. But their potential to influence care on a wide scale has some worried about unintended effects. In particular, there’s been growing concern that if performance measures focus disproportionately on underuse of care – that is, measuring whether enough care is being provided – they risk leading to unexpected consequences.   Specifically, if incentives tend to reward clinicians for doing more without attention to whether they do too much – this could inadvertently contribute to the problem of excessive care, or overuse. Medical Research: What are the main findings? Response: We thought it was important to look at what that balance is – between measures of underuse and measures of overuse – in outpatient practice.   We looked at 16 major national collections of performance measures and essentially counted measures targeting underuse (‘Did the clinician do enough?’) versus overuse (‘Did the clinician do too much?’). We found that over 90 percent of 521 outpatient measures targeted underuse, while a mere 7 percent of outpatient measures addressed overuse – in fact nearly half of the collections contained no overuse measures at all.
AHA Journals, Author Interviews, Heart Disease, Outcomes & Safety / 10.08.2015

Helle Søholm, MD, PhDDepartment of Cardiology Copenhagen University Hospital Rigshospitalet Denmark MedicalResearch.com Interview with: Helle Søholm, MD, PhD Department of Cardiology Copenhagen University Hospital Rigshospitalet Denmark Medical Research: What is the background for this study? Dr. Søholm: The background of the current study is that previous studies have found higher survival rates after out-of-hospital cardiac arrest and admission to tertiary heart centres for post-resuscitaton care compared with nontertiary hospitals, however the reasons for this difference has only been speculative. The aim of the study was to examine the level-of post-resuscitation care at tertiary heart centers compared with nontertiary hospitals and to associate this with outcome. Only patients without ST-segment elevation myocardial infarction was examined to avoid referral bias. Medical Research: What are the main findings? Dr. Søholm: The main findings of the study of 1.078 patients was that the survival in patients admitted to tertiary heart centers was significantly higher compared with survival in patients admitted to nontertiary hospitals even after adjustment for known risk markers including pre-arrest co-morbidity. We found that the adjusted odds of predefined markers of level-of-care differed in both the acute phase after admission, during the intensive care admission and in the workup prior to hospital discharge. The odds of admission to an intensive care unit was 1.8 for patients admitted to a tertiary heart centre. During the intensive care admission the odds of a temporay pacemaker was 6.4, use of vasoactive agents 1.5, acute and late coronary angiography was 10 and 3.8 respectively, neurophysiological examination 1.8, brain computed tomography 1.9, whereas no difference in the odds of therapeutic hypothermia was found. Prior to hospital discharge the odds of a consultation by a cardiologist was 8.6, having an echocardiography was 2.9, and survivors more often had an implantable cardioverter defibrillator implanted (odds 2.1) as compared with patients admitted to nontertiary hospitals.
Author Interviews, Lancet, Nutrition, OBGYNE / 10.08.2015

Prof-Kate-JollyMedicalResearch.com Interview with: Prof. Kate Jolly Professor of Public Health and Primary Care Public Health Building School of Health & Population Sciences University of Birmingham Edgbaston Birmingham Medical Research: What is the background for this study? Response: The UK is amongst 32 countries worldwide with evidence of iodine deficiency. Severe iodine deficiency during pregnancy is associated with a lower intelligence quotient (IQ) and developmental abnormalities in the children; these are reversible by iodine supplementation during pregnancy. However, the effects of mild or moderate iodine deficiency during pregnancy are less clear as there are no high quality trials of supplementation that have reported the outcome of child IQ. However, in two studies in the UK and Australia, nine year old children of women who had a urinary iodine concentration suggestive of mild iodine deficiency during their pregnancy exhibited reduced educational outcomes and decreased IQ scores compared to children of iodine replete mothers. Recent research from the UK suggests that the country has become mildly iodine deficient. Many countries address their iodine deficiency by programmes of adding iodine to salt and some recommend that pregnant women take iodine supplements. Neither of these occur in the UK, although some commonly used pregnancy supplements already include iodine. Controversy about the need for supplementation in pregnancy, the ethics of undertaking a trial in which women would be randomly allocated to have iodine supplements, or not, and the high cost of following-up and assessing large numbers of children makes a trial unlikely.
Author Interviews, Heart Disease, Lancet / 09.08.2015

Henning Kelbæk, MD Department of Cardiology Roskilde Hospital Roskilde, DenmarkMedicalResearch.com Interview with: Henning Kelbæk, MD Department of Cardiology Roskilde Hospital Roskilde, Denmark Medical Research: What is the background for this study? What are the main findings? Dr. Kelbæk: The background to conduct the DANAMI 3-Primulti trial is the uncertainty of which strategy is most favourable to the patient with ST-segment elevation myocardial infarction: to treat the culprit (resposible for the acute infarction) lesion only or to treat all visible lesions (complete revascularisation) The main findings of the PRIMULTI trial are that patients with ST-segment elevation myocardial infarction and multivessel disease, benefit from supplementary complete revascularisation of lesions in non-infarct related arteries when the second procedure is done during the index admission guided by measurement of the fractional flow reserve. This strategy results in a significant reduction in the combination of all-cause mortality, nonfatal reinfarction, and ischaemia-driven revascularisation.
Author Interviews, Clots - Coagulation, Duke, Heart Disease, JACC / 09.08.2015

Connie N. Hess, MD, MHS Duke Clinical Research Institute Duke University Durham, North CarolinaMedicalResearch.com Interview with: Connie N. Hess, MD, MHS Duke Clinical Research Institute Duke University Durham, North Carolina Medical Research: What is the background for this study? What are the main findings? Dr. Hess: Guidelines recommend the use of anticoagulation for thromboembolic prophylaxis in atrial fibrillation and also recommend use of dual antiplatelet therapy to reduce cardiovascular events after myocardial infarction and percutaneous coronary intervention.  The use of triple therapy in patients with indications for DAPT and anticoagulation is challenging due to the increased bleeding risk associated with this regimen.  The optimal antithrombotic regimen in this population has not yet been defined. This study specifically focused on older patients, a population that is at greater risk for Atrial Fibrillation-related stroke and recurrent events after MI but also higher risk for bleeding. Despite a growing population of older patients with indications for triple therapy, these patients have been underrepresented in clinical trials and are therefore understudied. We found that relative to DAPT, patients on triple therapy had a similar risk of 2-year major adverse cardiac events but a significantly increased risk of bleeding requiring hospitalization, including greater risk of intracranial hemorrhage.
Author Interviews, Cancer Research, JAMA, Radiation Therapy, University of Michigan / 08.08.2015

Dr. Reshma Jagsi MD, DPhil Associate Professor and Deputy Chair for Faculty and Financial Operations in the Department of Radiation Oncology at the University of Michigan Health System Research Investigator at the Center for Bioethics and Social Sciences in Medicine University of MichiganMedicalResearch.com Interview with: Reshma Jagsi, MD, DPhil Associate Professor and Deputy Chair Department of Radiation Oncology University of Michigan Medical Research: What is the background for this study? What are the main findings? Response: In recent years, there has been accumulating evidence from clinical trials that have supported the long-term safety and effectiveness of shorter courses of radiation therapy—“hypofractionated radiation therapy”—for patients with breast cancer.  However, little has been known about the experiences of patients during treatment, especially when this new approach is administered outside the setting of closely controlled clinical trials.  Our study examined the side effects and patient-reported experiences during radiation treatment of over 2000 breast cancer patients in the state of Michigan.  It found that women who received hypofractionated treatment were less likely to report side effects (including skin reaction and fatigue) than patients treated with more traditional courses of radiation treatment, delivered daily over 5-6 weeks or longer.
Author Interviews, BMJ, Brigham & Women's - Harvard, Fertility, Nursing, Occupational Health / 08.08.2015

Dr. Audrey J Gaskins Department of Nutrition Harvard T.H. Chan School of Public Health Boston, MAMedicalResearch.com Interview with: Dr. Audrey J Gaskins Department of Nutrition Harvard T.H. Chan School of Public Health Boston, MA Medical Research: What is the background for this study? What are the main findings? Dr. Gaskins: Previous studies have linked shift work, long working hours, and physical factors to an increased risk of menstrual cycle disturbances, spontaneous abortion, preterm birth, and low birth weight; however the association with fecundity is inconsistent. Several papers have also reviewed the occupational exposures of health care workers and concluded that reproductive health issues are a concern. Therefore we sought to determine the extent to which work schedules and physical factors were associated with fecundity in a large cohort of nurses. Women who work in an industry that requires them to work from a height or even lift heavy objects requires them to undertake training which guides them though the effective stages on how to work safely at heights. Without the right training, this sort of work can become very dangerous. Our main findings were that that working >40 hours per week and moving or lifting a heavy load >15 times per day (including repositioning or transferring patients) were associated with reduced fecundity in our cohort of female nurses planning pregnancy. However, all other factors such as frequency of night work, duration of rotating and non-rotating night shifts, and time spent walking or standing at work were not significantly associated with fecundity in this cohort.
Author Interviews, Genetic Research, NYU/NYMC, PLoS / 08.08.2015

Dr. Arthur Caplan Ph.D. Drs. William F and Virginia Connolly Mitty Professor Head of the Division of Medical Ethics New York University, Langone Medical Center, NYMedicalResearch.com Interview with: Dr. Arthur Caplan Ph.D. Drs. William F and Virginia Connolly Mitty Professor Head of the Division of Medical Ethics New York University, Langone Medical Center, NY Medical Research: What is the background of the Down Syndrome Prenatal Education Act? Dr. Caplan: For many years women who  receive a positive prenatal test for Down syndrome have been aborting their pregnancies.  Rates of pregnancy termination, while somewhat disputed, are very high.  In the USA, UK and Denmark they have consistently been over 80% for many years.   This has led some parents of children with Down to wonder if the counseling that women receive is biased negatively against a life with Down. They working with pro life legislators in many states have promoted legislation to insure that mothers carrying an infant with a diagnosis of Down Syndrome have access to positive information and helpful resources about life with a child with Down.  This legislation has been enacted in many states and there is a Federal law as well. Medical Research: How does Chloe's Law impact genetic testing? Dr. Caplan: These laws represent a seismic shift in counseling about genetic disorders and diseases.  Historically counselors aspired to be value-free—simply trying to provide objective information to their patients/clients.  With laws like Chloe’s the public is saying they do not trust the neutrality of counselors and counseling and want more positive messages sent about Down.  This is quite simply an ethical revolution in how counseling for Down will be done in the future.  It is also a direct Challenge to the legitimacy of value-neutrality as a counseling norm that certainly will be extended to other conditions and disabilities where abortion rates are high and where there is the belief that there is unjustified prejudice or bias against disabilities among those working in clinical genetics.
Author Interviews, Hospital Readmissions, JAMA, Johns Hopkins / 08.08.2015

Timothy M. Pawlik, MD, MPH, MTS, PhD, FACS, FRACS (Hon.)Professor of Surgery and Oncology John L. Cameron M.D. Professor of Alimentary Tract Diseases Chief, Division of Surgical Oncology Program Director, Surgical Oncology Fellowship Director, Johns Hopkins Medicine Liver Tumor Center Multi-Disciplinary Clinic Johns Hopkins Hospital Baltimore, MD 21287MedicalResearch.com Interview with: Timothy M. Pawlik, MD, MPH, MTS, PhD, FACS, FRACS (Hon.) Professor of Surgery and Oncology John L. Cameron M.D. Professor of Alimentary Tract Diseases Chief, Division of Surgical Oncology Program Director, Surgical Oncology Fellowship Director, Johns Hopkins Medicine Liver Tumor Center Multi-Disciplinary Clinic Johns Hopkins Hospital Baltimore, MD 21287 MedicalResearch: What is the background for this study? What are the main findings? Dr. Pawlik: In 2012, the Centers for Medicare and Medicaid Services (CMS) introduced the Hospital Readmission Reduction Program (HRRP) whereby hospitals with higher than expected 30-day readmission incur financial penalties. Initially proposed to target readmissions following acute myocardial infarction, pneumonia and congestive heart failure, the program has since expanded to encompass knee and hip replacement surgery with the inclusion of additional surgical procedures anticipated in the near future. Although initial results from the Hospital Readmission Reduction Program have been promising, several concerns have been raised regarding potential limitations in methodological approach; specifically in the ability to adequately risk-adjust and account for variations in patient, provider and disease. As a consequence, many fear that the Hospital Readmission Reduction Program may disproportionately penalize safety-net hospitals as well as hospitals caring for “sicker” and more vulnerable populations. In the current study we sought to investigate factors associated with the variability in 30-day readmission among a cohort of 22,559 patients discharged following a major surgical procedure at the Johns Hopkins Hospital between 2009 and 2013. Overall, 30-day readmission was noted to be 13.2% varying from 2.1% to 24.8% by surgical specialty / procedure and from 2.1% to 32.9% by surgeon. Non-modifiable patient specific factors such as preoperative comorbidity, insurance status and race / ethnicity, were found to be most predictive of 30-day readmission as well as postoperative factors such as complications and length of stay both of which may also be influenced by preoperative comorbidity. Overall, we noted that 2.8% of the variation in 30-day readmission was attributed to provider-specific factors, 14.5% of the variability was due differences in surgical specialty / procedure while over 84% of the variability in 30-day readmission remained unaccounted for due to non-modifiable patient-specific factors.
Author Interviews, Dermatology, JAMA, NIH, Pain Research / 07.08.2015

Edward W. Cowen, MD, MHSc Dermatology Branch, Center for Cancer Research National Cancer Institute Bethesda, MarylandMedicalResearch.com Interview with: Edward W. Cowen, MD, MHSc Dermatology Branch, Center for Cancer Research National Cancer Institute Bethesda, Maryland Medical Research: What is the background for this study? Dr. Cowen: Cutaneous leiomyomas are benign smooth muscle proliferations that are associated with pain that is typically not well-controlled by topical remedies or systemic pain medication. Hereditary leiomyomatosis and renal cell cancer is a rare syndrome in which patients may have dozens or even hundreds of these painful tumors. We sought to determine if botulinum toxin injected directly into leiomyomas may ameliorate discomfort and improve quality of life in patients who experience significant pain from cutaneous leiomyomas. Medical Research: What are the main findings? Dr. Cowen: In a double-blinded placebo-controlled study, we found that injection of botulinum toxin was associated with improved skin-related quality of life (p = 0.007) and decreased skin-specific pain (p = 0.048) on the Dermatology Life Quality Index. A trend for decreased pain (p = 0.06) by visual analog score was reported in the botulinum toxin treated group compared to the placebo group.
Author Interviews, Hand Washing, Infections, Lancet / 07.08.2015

MedicalResearch.com Interview with: Paul Little MBBS, BA, MD, DLSHTM, MRCP, FRCGP, FMedSci Professor of Primary Care Research University of Southampton

Medical Research: What is the background for this study? What are the main findings? Prof. Little: Hand washing has been recommended to help prevent respiratory infections (coughs, colds flu, sore throats) - this can be important in normal winters but might be especially important in pandemic flu years. However, there has been little evidence from randomised trials to date to show that handwashing works. [caption id="attachment_16369" align="alignleft" width="350"]A simple internet based intervention to support increasing handwashing behaviour reduced the numbers of infections caught and the number of infections given to family members, A simple internet based intervention to support increasing hand washing behavior reduced the numbers of infections caught and the number of infections given to family members,[/caption]
Author Interviews, Herpes Viruses, HIV, NEJM / 06.08.2015

Dr. Salim Abdool Karim at CAPRISA Doris Duke Medical Research Institute South AfricaMedicalResearch.com Interview with: Dr. Salim Abdool Karim at CAPRISA Doris Duke Medical Research Institute South Africa Medical Research: What is the background for this study? What are the main findings? Response: Globally, Herpes simplex virus type-2 (HSV-2) is among the most common sexually transmitted infections and is the leading cause of genital ulcers. Available global estimates indicate that approximately 417 million sexually active adults between the ages of 15 and 49 years had an existing prevalent HSV-2 infection in 2012. Current interventions to prevent HSV-2 infection, including condoms, circumcision, and antiviral treatment among heterosexual, HSV-2-discordant couples, have demonstrated protection levels ranging from 6% to 48%. This study showed that peri-coital tenofovir gel reduced HSV-2 acquisition in women by 51%, rising to 71% in high gel-users.
Author Interviews, Hip Fractures, JAMA, Menopause, Osteoporosis, Vitamin D / 05.08.2015

MedicalResearch.com Interview with: Karen E. Hansen, M.D., M.S. Associate Professor of Medicine University of Wisconsin School of Medicine and Public Health Madison, WI 53705-2281 Medical Research: What is the background for this study? Dr. Hansen: The USPTF says to older community dwelling adults, "don't bother taking vitamin D", the Endocrine Society says "take 2,000-4,000 IU daily" and the Institute of Medicine gave an RDA of 600-800 IU daily. The Endocrine Society argues that optimal vitamin D levels are 30 ng/mL and higher, while the Institute of Medicine concludes that 20 ng/mL and higher indicates optimal vitamin D status. The disagreement between experts prompted my study. Medical Research: What are the main findings? Dr. Hansen: Among postmenopausal women whose vitamin D level was ~21 ng/mL at baseline, there was no benefit of high-dose or low-dose vitamin D, compared to placebo, on spine/hip/total body bone mineral density, muscle fitness by 5 sit to stand test or Timed Up and Go, or falls. We did see a small 1% increase in calcium absorption in the high-dose vitamin arm, but this small increase did not translate into clinically meaningful changes in bone density or muscle tests.
Aging, Author Interviews, BMJ, Exercise - Fitness / 05.08.2015

Dr David Hupin CHU Saint-Etienne, Hôpital Nord Service de Physiologie Clinique et de l'Exercice, Centre VISAS Cedex 2, FranceMedicalResearch.com Interview with: Dr David Hupin CHU Saint-Etienne, Hôpital Nord Service de Physiologie Clinique et de l'Exercice, Centre VISAS Cedex 2, France Medical Research: What is the background for this study? Dr. Hupin: Today, over 95% of the world’s population has health problems, according to the Global Burden of Disease Study published recently in The Lancet. The proportion of healthy years lost due to disease rapidly increased with age. There is no medical treatment that can influence as many diseases in a positive manner as can physical activity. It is well established that regular physical activity is an efficient strategy for successful aging. The 2008 Physical Activity guidelines for Americans recommend a minimum of 150 min of moderate-intensity (>3 MET) or 75 min of vigorous-intensity (≥6 MET) physical activity per week or an equivalent combination of moderate and vigorous physical activity (MVPA). A Metabolic Equivalent or MET is a unit useful for describing the energy expenditure of a specific physical activity. However, less than 50% of older adults are able to achieve the current recommendations of physical activity. Thus, the prescription of physical activity for older adults needs to be clarified, i.e., what "dose" of physical activity is required. Medical Research: What is the design of your study? Dr. Hupin: Within the dynamic Department of Clinical and Exercise Physiology of University Hospital of St-Etienne, we conducted a systematic review and meta-analysis. Out of at total of 835 relevant studies, nine were suitable for analysis. These involved a total of 122, 417 participants, monitored for an average of around 10 years, during which time 18,122 died.
Author Interviews, JAMA, PTSD / 05.08.2015

Melissa A. Polusny, PhD, LP Staff Psychologist/Clinician Investigator Core Investigator, Center for Chronic Disease Outcomes Research Associate Professor, University of Minnesota Medical School Minneapolis VA Health Care System (B68-2) One Veterans Drive Minneapolis, MN 5541MedicalResearch.com Interview with: Melissa A. Polusny, PhD, LP Staff Psychologist/Clinician Investigator Core Investigator, Center for Chronic Disease Outcomes Research Associate Professor, University of Minnesota Medical School Minneapolis VA Health Care System One Veterans Drive Minneapolis, MN 5541 Medical Research: What is the background for this study? What are the main findings? Dr. Polusny: VA has invested heavily in the dissemination of prolonged exposure therapy and cognitive processing therapy as first-line treatments for PTSD; however, 30% to 50% of Veterans do not show clinically significant improvements and dropout rates are high. Evidence suggests that mindfulness-based stress reduction – an intervention that teaches individuals to attend to the present moment in a non-judgmental, accepting manner – can reduce symptoms of anxiety and depression. This randomized clinical trial compared mindfulness-based stress reduction with present-centered group therapy – sessions focused on current life problems. We randomly assigned 116 Veterans with PTSD to receive nine sessions of mindfulness-based stress reduction therapy (n=58) or nine sessions of present-centered group therapy (n=58). Outcomes were assessed before, during and after treatment, and at two-month follow-up. Exclusion criteria included: substance dependence (except nicotine), psychotic disorder, suicidal or homicidal ideation, and/or cognitive impairment or medical illness that could interfere with treatment. The primary outcome was a change in self-reported PTSD symptom severity over time. Secondary outcomes included interview-rated PTSD severity scores, self-reported depression symptoms, quality of life, and mindfulness skills. Mindfulness-based stress reduction therapy – compared with present-centered group therapy – resulted in a greater decrease in self-reported PTSD symptom severity. Veterans in the mindfulness-based stress reduction group were more likely to show clinically significant improvement in self-reported PTSD symptom severity (49% vs. 28%) at two-month follow-up, but they were no more likely to have loss of PTSD diagnosis (53% vs. 47%). Veterans participating in mindfulness-based stress reduction therapy reported greater improvement in quality of life and depressive symptoms than those in present-centered group therapy; however improvement in depressive symptoms scores did not reach the level of significance. Improvements in quality of life made during treatment were maintained at 2-month follow-up for Veterans in the mindfulness-based stress reduction group, but reports of quality of life returned to baseline levels for those in present-centered group therapy. The dropout rate observed for mindfulness-based stress reduction therapy (22%) in this study was lower than dropout rates reported in previous studies for PE (28.1% to 44%) and CPT (26.8% to 35%).
Accidents & Violence, Author Interviews, CDC, JAMA, Primary Care / 05.08.2015

Joanne Klevens, MD, PhD Division of Violence Prevention US Centers for Disease Control and Prevention Atlanta, GeorgiaMedicalResearch.com Interview with: Joanne Klevens, MD, PhD Division of Violence Prevention US Centers for Disease Control and Prevention Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Dr. Klevens: The United States Preventive Services Task Force recommends women of reproductive age be screened for partner violence but others, such as the World Health Organization and the Cochrane Collaborative conclude there is insufficient evidence for this recommendation. Our randomized clinical trial allocated 2700 women seeking care in outpatient clinics to 1 of 3 study groups: computerized partner violence screening and provision of local resource list, universal provision of partner violence resource list without screening, or a no-screen/no resource list control group.  No differences were found in women’s quality of life, days lost from work or housework, use of health care and partner violence services, or the recurrence of partner violence after 1 year. In this three-year follow-up, no differences were found in the average number of hospitalizations, emergency room visits or ambulatory care visits.
Author Interviews, Cancer Research, End of Life Care, Lancet, Leukemia / 01.08.2015

Prof David C Currow Discipline of Palliative and Supportive Services Flinders University Adelaide, SA, AustraliaMedicalResearch.com Interview with: Prof David C Currow Discipline of Palliative and Supportive Services Flinders University Adelaide, SA, Australia Medical Research: What is the background for this study? Prof. Currow: This study grew out of a desire to better understand the symptom burden experienced by people with hematological malignancies at the end of life. This has been very poorly documented and although there are lots of strong opinions, there are very few data at a population level. Medical Research: What are the main findings? Prof. Currow: The main finding is that community-dwelling people with hematological malignancies at the end of life have a burden of symptoms that looked almost identical to people with solid tumours. Given much lower rates of access to the hospice and palliative care, this suggests that these people and their family caregivers are missing out on opportunities for better symptom control and better support.
Author Interviews, HIV, PLoS, UC Davis / 31.07.2015

Dr. Satya Dandekar PhD Professor and Chair Department of Medical Microbiology and Immunology UC DavisMedicalResearch.com Interview with: Dr. Satya Dandekar PhD Professor and Chair Department of Medical Microbiology and Immunology UC Davis Medical Research: What is the background for this study? What are the main findings? Dr. Dandekar: Current anti-retroviral therapy is effective in suppressing HIV replication and enhancing immune functions in HIV infected individuals. However, it fails to eradicate the latent HIV reservoirs. Therapy interruption leads to a rapid viral rebound in these patients.  Eradication of latent HIV reservoirs is essential to achieve HIV cure. A “shock and kill” strategy for HIV cure has been proposed that involves reactivation of latent viral reservoirs using latency reversal agents (LRA) and eradication by the immune response. This highlights the need to identify potent LRAs to optimally activate latent HIV reservoirs so that immune surveillance and clearance mechanisms can be effectively engaged in the process of viral eradication. We have found that ingenol-3-angelate (PEP005), an anti-cancer drug can effectively reactivate latent HIV. It is a protein kinase C agonist that activates NF-kB and stimulates HIV expression. In combination with another compound, JQ1, a previously known p-TEFb agonist, the efficacy of PEP005 for HIV reactivation is markedly increased. In addition, ingenol-3-angelate decreases the expression of HIV co-receptors on immune cells, which potentially will help preventing further spread of the virus. The use of ingenol-3-angelate in combination with other latency reversal agents provides an excellent opportunity to optimally activate latent HIV reservoirs and target them for eradication.