ALS, Alzheimer's - Dementia, Author Interviews, JAMA, Multiple Sclerosis, Neurological Disorders, Stem Cells / 12.01.2016

MedicalResearch.com Interview with: Prof. Dimitrios Karussis M.D., Ph.D. Professor of Neurology Head, Multiple Sclerosis Center Hadassah BrainLabs Medical Research: What is the background for this study? What are the main findings? Prof. Karussis: BrainStorm Cell Therapeutics is developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson’s Disease (PD).  Our technology, NurOwn™ is a first-of-its-kind approach that induces autologous bone marrow-derived Mesenchymal Stem Cells (MSCs) to secrete Neurotrophic Growth Factors (NTFs).  These MSC-NTF cells have been shown to be protective in several animal models of neurodegenerative diseases. Data from the clinical trials described in the recent issue of the Journal of American Medicine – Neurology (JAMA Neurology), suggest that NurOwn can help patients with ALS.  The two trials featured in the article, a phase 1/2 and a phase 2a, studied the transplantation NurOwn cells in ALS patients.  These trials confirmed the excellent safety profile of NurOwn and suggest a clinically meaningful effect. The investigators used two well established clinical endpoints that measure disease activity in ALS, the Revised ALS Functional Rating Scale and Forced Vital Capacity, and were able demonstrate a slowing of disease activity in the period following treatment. (more…)
Author Interviews, Depression, JAMA, Surgical Research, UCLA, Weight Research / 12.01.2016

MedicalResearch.com Interview with: Aaron J. Dawes, MD Fellow, VA/RWJF Clinical Scholars Program Division of Health Services Research University of California Los Angeles Los Angeles, CA 90024 Medical Research: What is the background for this study? What are the main findings? Dr. Dawes: We reviewed the published literature to answer three basic questions about bariatric surgery and mental health conditions. First, how common are mental health conditions among patients being referred for or undergoing bariatric surgery?
  • Second, do patients who carry a diagnosis of one of these conditions lose less weight after surgery than patients without these conditions?
  • And, third, what happens to the clinical course of mental health conditions after patients undergo surgery? Do they get better, worse, or stay the same?
We found that mental health conditions are surprisingly common among bariatric patients, especially depression and binge eating disorder, which occur at almost twice the rate among bariatric patients than in the general U.S. population. We also found no strong evidence to suggest that patients with depression lose less weight after surgery and some evidence that the condition may actually improve after surgery. Eleven of the twelve studies on the topic found either lower rates or fewer symptoms of depression, at least during the first 3 years post-operatively. (more…)
Accidents & Violence, Author Interviews, Autism, JAMA / 12.01.2016

MedicalResearch.com Interview with: Diana Schendel, Professor MSO Department of Public Health Institute of Epidemiology and Social Medicine and Department of Economics and Business                             National Centre for Register-based Research Aarhus University Denmark Medical Research: What is the background for this study? What are the main findings? Dr. Schende: Elevated mortality has been reported in persons with autism spectrum disorder (ASD), especially with comorbid epilepsy and intellectual disability. The effect of comorbidity on the risk for mortality in ASD, however, has not been rigorously examined in large, population-based studies. Our study aim was to investigate ASD mortality patterns overall and to assess the specific effects of comorbid mental, behavioral, and neurologic disorders on ASD mortality into young adulthood. Our study comprised a nation-wide Danish cohort of 1.9 million children of whom 20,492 were diagnosed with ASD. We observed 68 deaths in persons with ASD; 83% of the persons with ASD who died had comorbid mental/behavioral or neurologic disorders. The risk for mortality was two-fold higher in persons with autism spectrum disorder overall. An elevated risk for mortality was also seen in persons who had ASD only, or had both ASD and other neurologic or mental/behavioral disorders, compared to persons without these other morbidities and no ASD. However, the co-occurrence of ASD in persons with neurologic, or with mental/behavioral disorders, added no additional mortality risk compared to persons with these disorders and no autism spectrum disorder. These results suggest that the mechanisms underlying mortality risk in ASD in part may be shared with these other disorders, although what might be the specific shared mechanisms cannot be determined with these data. (more…)
Author Interviews, Clots - Coagulation, FDA, Heart Disease, JAMA, Johns Hopkins / 12.01.2016

MedicalResearch.com Interview with:
Victor Serebruany, MD, PhD
HeartDrug Research, Towson, Maryland
Department of Neurology Johns Hopkins University Baltimore, Maryland Medical Research: What is the background for this study? What are the main findings?

Dr. Serebruany: Missing data are common challenges to the validity of trial results, yet it is unclear how to characterize the extent of missing data.  We compared the published lost-to-follow-up rates to incomplete follow-up rates determined from subject records submitted to the FDA for major oral antithrombotic trials.  The 21 trials having both sets of rates included 270,089 patients followed for a median duration of 20 months.  The mean published lost-to-follow-up rates is 0.4% (median 0.3%, range 0.005% to 2%), consistently much lower than the FDA incomplete follow-up rates: mean 12% (median 13%, range 2% to 23%).  There is no correlation between the publication and FDA-calculated  rates (R 0.07, p = 0.76).   The FDA rates exceed greatly the endpoint rate differences: mean 1.3% (median 1,0%, range 0.2% to 3.0%). Medical Research: What should clinicians and patients take away from your report? Dr. Serebruany: That the FDA incomplete follow-up rates greatly exceed the endpoint rate differences raises questions of whether the endpoint differences may be due to differential follow-up rather than drug effect.  That they greatly exceed the measures routinely reported for trials, i.e., lost-to-follow-up rates, suggests that current trial reporting is inadequate.  Completeness of follow-up and other indicators of trial data quality should be considered when interpreting trial results. (more…)
Author Interviews, JAMA, OBGYNE, Pediatrics / 11.01.2016

MedicalResearch.com Interview with: Annie Gatewood Hoen, PhD  Assistant Professor of Epidemiology and of Biomedical Data Science and Juliette Madan, MD, MS Associate Professor of Pediatrics The Geisel School of Medicine at Dartmouth Dartmouth-Hitchcock Medical Center Lebanon, NH 03756 Medical Research: What is the background for this study? What are the main findings? Response: When newborns are delivered they begin the process of acquiring vast numbers of bacteria that are critical for healthy nutrition and for immune training for a lifetime of health. Diseases such as obesity, heart disease, colitis, autism, and even cancer risk is associated with particular patterns in the gut microbiota; interestingly breast milk exposure is associated with decreased risk of many of these diseases. The intestinal microbiome plays a critical role in development, and delivery mode (cesarean section versus vaginal delivery) and feeding method (breast milk vs. formula) are important determinants of microbiome patterns.  We observed the intestinal microbiome in 6 week old infants and how it relates to delivery type and feeding. We were particularly interested in examining patterns in the microbiome in infants who received combination feeding of both breast milk and formula, an area that has been understudied. We prospectively studied 102 infants and, with gene sequencing of bacteria, identified important patterns in microbiome composition that differed greatly based upon delivery method and between feeding groups.  Babies who were combination fed (formula and breast milk) had an intestinal microbiome that was more similar to babies who were exclusively formula fed than breast fed babies. We identified individual bacteria that were differentially abundant between delivery mode and feeding groups. (more…)
Author Interviews, Cancer Research, JAMA, Transplantation / 11.01.2016

MedicalResearch.com Interview with: Sergio A. Acuna, MD Graduate Student at St. Michael's Hospital and IHPME University of Toronto Medical Research: What is the background for this study? Dr. Acuna: Solid organ transplant recipients are known to be at greater risk of developing cancers compared to the general population; however, because they are also at high increased risk of mortality from non-cancer causes, the risk of cancer morality in this population is unclear. As previous studies on this topic have reported disparate findings, the cancer mortality risk in this population remained uncertain. Medical Research: What are the main findings? Dr. Acuna: Our study provides conclusive evidence that solid organ transplant recipients are at increased risk of cancer mortality. Our findings demonstrate that solid organ transplant recipients are at increased risk of cancer death compared to the general population regardless of age, transplanted organ, and year of transplantation, and indicate cancer is a substantial cause of death in this population. (more…)
Author Interviews, Exercise - Fitness, JAMA, Orthopedics, Pain Research / 11.01.2016

Daniel Steffens, Ph.D. The George Institute for Global Health The University of SydneyMedicalResearch.com Interview with: Daniel Steffens, Ph.D. The George Institute for Global Health The University of Sydney Medical Research: What is the background for this study? Dr. Steffens: Back pain is a leading cause of disease burden globally. At present, a variety of interventions, such as getting a mattress that can help with back pain, exercise, education, back belts and shoe insoles, are commonly prescribed to prevent an episode of low back pain. Guidelines lack clear recommendations for prevention of low back pain and the effectiveness of the range of possible prevention strategies for low back pain is not clear. Our study aimed to investigate the effectiveness of these interventions for prevention of low back pain. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 10.01.2016

MedicalResearch.com Interview with: Dr. Sigrid Bjerge Gribsholt MD, PhD Student Department of Endocrinology and Internal Medicine, Aarhus University Hospital 8000 Aarhus C Medical Research: What is the background for this study? What are the main findings? Response: Based on our clinical experiences we became aware that surgical, medical and nutritional symptoms were common in this group of patients. To enlighten the prevalence and severity we decided to undertake the study. Our main findings include that 88% of the patients felt better or much better than before surgery and 8% felt worse. Furthermore, we found that 68% of the patients had been in contact with the health care system. (more…)
Author Interviews, Cost of Health Care, JAMA, Stanford, Surgical Research / 08.01.2016

MedicalResearch.com Interview with: Sam P. Most, M.D., F.A.C.S. Professor, Departments of Otolaryngology-Head & Neck Surgery and Surgery (Division of Plastic Surgery, by courtesy) Chief, Division of Facial Plastic & Reconstructive Surgery Stanford University School of Medicine Stanford, CA  Medical Research: What is the background for this study? What are the main findings? Dr. Most: Insurance companies often require patients to try a 6 or more week treatment with nasal steroids prior to allowing nasal surgery to proceed. This is true even in cases of physician-documented severe or extreme anatomic nasal obstruction that we know will not respond to medical therapy. We sought to examine this from a cost and quality-of-life perspective. We found that while the up-front cost of surgery is obviously much higher than medical therapy, when viewed from an effect on improvement of quality of life (or lack thereof, in the case of medical therapy), the surgical therapy became more cost effective as years passed by. (more…)
Author Interviews, Dermatology, JAMA, Melanoma, Technology / 08.01.2016

MedicalResearch.com Interview with: Marc Haspeslagh, MD Dermpat, Ardooie, Belgium Department of Dermatology University Hospital, Ghent, Belgium Medical Research: What is the background for this study? Dr. Haspeslagh: In daily practice, most pathology laboratories process skin biopsy specimens without access to the clinical and /or dermoscopic images. In pigmented skin tumors, this information can be crucial to process and diagnose the lesion correctly. With increasingly smaller diameter lesions undergoing biopsy, these focal changes are only visible with dermoscopy; therefore, communication of this dermoscopic information to the pathologist is important. In many dermatopathology laboratories, this communication is often insufficient or totally absent, and one can presume that these suspicious areas are often missed with the standard random sectioning technique that examines less than 2% of the tissue. To overcome this diagnostic limitation we developed in 2013 a new method for processing skin biopsies, were we routinely take an ex vivo dermoscopic image of most tumoral skin lesions. In combination with marking specific and suspected areas seen on the ex vivo dermoscopy (EVD) with nail varnish, EVD with derm dotting is a simple and easy method that brings this crucial information to the pathologist and in the slides to be examined (Am J Dermatopathol 2013; 35(8),867-869). (more…)
Author Interviews, Depression, Hormone Therapy, JAMA, Menopause / 08.01.2016

MedicalResearch.com Interview with: Eleni Petridou, MD, MPH, PhD Marios K. Georgakis, MD Department of Hygiene, Epidemiology and Medical Statistics School of Medicine National and Kapodistrian University of Athens Athens, Greece Medical Research: What is the background for this study? Response: Previous epidemiologic studies have shown that women during their reproductive life are more vulnerable (by a factor of two) to depression than men; this has been particularly evident during peaks of intense fluctuations of ovarian hormones, like the premenstrual, perimenopausal and postpartum periods. Endogenous (natural) female sex hormones, however, have been shown in various experimental studies to possess neuroprotective and anti-depressive properties. Production of these hormones is diminished after menopause; therefore, age at menopause can be used as a proxy of the lifetime exposure to endogenous hormones. Our research hypothesis was whether longer exposure to endogenous sex hormones has a cumulative anti-depressive action, i.e., whether later age at menopause decreases the risk for postmenopausal depression. (more…)
Author Interviews, Exercise - Fitness, Heart Disease, JAMA, Nutrition / 08.01.2016

MedicalResearch.com Interview with: Dalane W. Kitzman, M.D. Professor, Cardiology Sticht Center on Aging Gerontology and Geriatric Medicine Translational Science Institute Wake-Forest Baptist Health Winston-Salem, NC Medical Research: What is the background of the research? Dr. Kitzman: Heart Failure With Preserved Ejection Fraction (HFPEF) is a relatively recently recognized disorder.  It used to be thought that it was rare.  However, we now realize that HFPEF is the dominant form of heart failure in America.  It is also the fastest growing cardiovascular disorder.  Interestingly, this disorder occurs almost exclusively among older persons, particularly women.  The need is great because outcomes in persons with HFPEF (death, rehospitalization, health care costs) are worsening.  This stands in contrast to most other cardiovascular disorders which are on the decline and / or are experiencing greatly improved outcomes.  Remarkably, all of the large studies that have used medications in HFPEF that seemed they should be ‘sure bets’ showed no benefit for their primary outcomes.  Thus, this is also the only major cardiovascular disorder where there is no proven medication treatment.  That means physicians take ‘educated guesses’ in choosing treatment for this large group of patients. The main symptom in patients with chronic HFPEF is shortness of breath and and fatigue with exertion.  We showed in 2002 in JAMA that when we objectively measured this symptom with expired gas analysis (Peak VO2), this was as severely decreased in HFPEF as in patients with HFREF (severely reduced EF), the classic, well accepted form of heart failure.  That and other studies helped lead to acceptance of HFPEF as a true Heart Failure disorder. We first showed 5 years ago that 4 months of exercise training improves peak VO2 and quality of life in patients with HFPEF.  In fact, exercise remains the only proven means to improve these patients’ chronic symptoms. The goal of our study was to determine if weight loss diet also improved peak VO2 and quality of life in HFPEF patients, alone and in combination with exercise training.  This was based on the under-recognized fact that over 80% of Heart Failure With Preserved Ejection Fraction patients are overweight or obese.  It was already known that weight loss diet in other groups of older persons improves peak VO2 and quality of life.  And small studies of weight loss surgery in the other form of HF (HFREF) suggested that weight loss can improves symptoms, peak VO2, and quality of life.  However, there had never been a study of weight loss, by diet or other means, in HFPEF.  In fact, it had been thought, based on observational data, that weight loss diet might be contraindicated in HFPEF. So we recruited 100 overweight / obese patients age 60 years and older with this disorder from our community; 80% were women.  The exercise was standard exercise training that we’d previously shown was effective.  The meals for the weight loss diet were prepared in our metabolic kitchen by a regisered dietition.  Patients made out menus selecting preferred foods.  Well balanced, healthy, nutritious, but very palatable.  The portions were controlled so that there was a 350 caloric deficit per day deficit, on average.  Pateints made their own breakfast with guidance, unlimited of certain fruits and vegetables, and occasional “free days”, such as for holidays.  Patients loved the meals and wanted to continue after the 5 month study. (more…)
Author Interviews, JAMA, Stroke / 07.01.2016

MedicalResearch.com Interview with: Michael F. Waters, MD, PhD Department of Neurology Department of Neuroscience McKnight Brain Institute University of Florida College of Medicine Gainesville, Florida Medical Research: What is the background for this study? What are the main findings? Dr. Waters: This study was based on a subgroup of medically managed patients with severe, symptomatic, intracranial, atherosclerotic disease. Historically we know that these patients have a very high rate of additional strokes, and multiple studies have attempted to determine the best management for these patients. In SAMMPRIS, we were able to prove that aggressive medical management was superior to stenting in these patients. However, certain patients in the medically managed group still had a very high rate of repeat strokes, as much as 30% of those with certain risk factors. This study was an attempt to identify those risk factors to determine which patients were at the greatest risk for another stroke. (more…)
Author Interviews, Heart Disease, JAMA, Stanford, Surgical Research / 04.01.2016

MedicalResearch.com Interview with: Dr. Mary Hawn MD MPH Chair, Department of Surgery Stanford School of Medicine Stanford, California Medical Research: What is the background for this study? What are the main findings? Dr. Hawn: Patients with known coronary artery disease are at higher risk for adverse cardiac events in the peri-operative period.  Revascularization with coronary stents does not appear to mitigate this risk and in fact, may elevate the risk if surgery is in the early post-stent period.  Drug eluting stents pose a particular dilemma as these patients require 12 months of dual anti platelet therapy to prevent stent thrombosis, thus elective surgery is recommended to be delayed during this period.  In contrast, bare metal stents with early epithilialization are not at the same risk for stent thrombosis with anti platelet cessation.   In our retrospective cohort study, however, we observed that stent type was not a major driver of adverse events in the early post-stent period and that underlying cardiac disease and acuity of the surgery explained most of the risk.  We undertook this study to determine the influence of the underlying indication for the stent procedure on surgical outcomes over time following the stent. (more…)
Author Interviews, JAMA, Mental Health Research / 04.01.2016

MedicalResearch.com Interview with: Josephine Mollon MSc Department of Psychosis Studies Institute of Psychiatry, Psychology, and Neuroscience King’s College London London, England  Medical Research: What is the background for this study? What are the main findings? Dr. Mollon: Psychotic symptoms, such as hallucinations and delusions, are core features of psychotic disorders. A significant minority of the general population also reports subclinical psychotic experiences. Evidence suggests that these experiences may lie on a continuum with clinically significant psychotic symptoms. For example, cognitive deficits, which are a hallmark of psychotic disorders, are also seen in people with subclinical psychotic experiences. We used population-based survey data to characterize cognitive functioning in adults with psychotic experiences while adjusting for important sociodemographic characteristics and investigating the effect of age. The 171 (9.7%) adults with psychotic experiences showed significant memory and verbal deficits, but not IQ or processing speed deficits. Only participants 50 years and older with psychotic experiences showed medium to large impairments in general IQ, verbal knowledge, working memory and memory after adjusting for socioeconomic status, cannabis use, and common mental disorders. (more…)
Author Interviews, Beth Israel Deaconess, CT Scanning, JAMA, Neurological Disorders, Stroke / 04.01.2016

MedicalResearch.com Interview with: Sandeep Kumar, MD Assistant Professor of Neurology Harvard Medical School Director, Inpatient Stroke Service Department of Neurology, Stroke Division Beth Israel Deaconess Medical Center Boston, MA 02215 Medical Research: What is the background for this study? What are the main findings? Dr. Kumar: Transient deficits that start suddenly and typically last for a few minutes to a few hours are the hallmark of a transient ischemic attack (TIA) or a minor ischemic stroke. In this single-center observational study, we have reported similar clinical presentation in some patients with intracerebral hemorrhage (ICH) that are difficult to distinguish from cerebral ischemia based only on clinical signs and symptoms. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Prostate Cancer, Surgical Research, Testosterone / 04.01.2016

MedicalResearch.com Interview with: Quoc-Dien Trinh MD Assistant Professor, Harvard Medical School Brigham and Williams Hospital  Medical Research: What is the background for this study? What are the main findings? Dr. Trinh: Among elderly Medicare beneficiaries with metastatic prostate cancer, surgical castration is associated with lower risks of any fractures, peripheral arterial disease, and cardiac-related complications compared to medical castration using GnRH agonists. (more…)
Author Interviews, CT Scanning, JAMA, Lung Cancer / 02.01.2016

  MedicalResearch.com Interview with: Jan Marie Eberth, PhD Assistant Professor, Department of Epidemiology and Biostatistics Deputy Director, SC Rural Health Research Center Core Faculty, Statewide Cancer Prevention and Control Program Arnold School of Public Health University of South Carolina Columbia, SC 29208 Medical Research: What is the background for this study? Dr. Eberth: With the breakthrough findings of the National Lung Screening Trial released in 2011, professional organizations have largely embraced population-based screening guidelines for patients at high risk for lung cancer. The diffusion of screening into broad clinical practice has been slow to be adopted, given concerns about the efficacy of screening in community settings, lack of insurance reimbursement and unclear billing logistics, and difficulty weighing the pros of screening against the known cons (e.g., high rate of false positives). Medical Research: What are the main findings? Dr. Eberth: Provisions of the Patient Protection and Affordable Care Act mandate that US Preventive Services Task Force-recommended screening tests with an A or B rating receive full insurance coverage by private payers. The Centers for Medicare and Medicaid (CMS) soon thereafter approved full coverage for lung cancer screening in high-risk patients (i.e., those aged 55-77 years, asymptomatic for lung cancer, tobacco smoking history of 30+ pack-years, is a current smoker or has quit smoking within the past 15 years). Coding is rapidly evolving; as of November 2015, CMS released HCPCS codes G0296 (pre-screening counseling visit) and G0297 (screening visit). These codes will be accepted retroactively starting January 4, 2016 to the date of the final coverage determination (back to February 5, 2015). No coinsurance or deductibles shall be charged to the patient for either the pre-screening counseling visit, or the screening visit itself. Quality of screening  is an important, but understudied, area of research. Several publications have focused on aspects of quality programs, and how to achieve quality benchmarks, but data is still being collected to assess variation across programs. In the future, data from screening registries, such as the American College of Radiology Lung Cancer Screening Registry (LCSR), can be leveraged to examine these quality metrics and improve risk-prediction models for lung cancer. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Heart Disease, JAMA, Kidney Disease, Surgical Research / 29.12.2015

MedicalResearch.com Interview with: Azra Bihorac, MD, MS and Department of Anesthesiology Charles Hobson, MD, MHA Department of Surgery, Malcolm Randall Veterans Affairs Medical Center, Department of Health Services Research, Management, and Policy University of Florida Gainesville Florida  Medical Research: What is the background for this study? What are the main findings? Response:   Background is that as ICU clinicians we see acute kidney injury (AKI) and chronic kidney disease (CKD) frequently and have to deal with the consequences, and as AKI researchers we have shown that even mild and moderate AKI – even if there is complete resolution of the AKI by the time of hospital discharge – result in significantly increased morbidity and mortality for the surgical patient. Furthermore we are aware of the existing relationship between CKD and cardiovascular mortality, and we wanted to explore any relationship between AKI and cardiovascular mortality in the vascular surgery patients that we care for on a daily basis. The most important finding was the strong association between AKI and cardiovascular mortality in these patients – equal to the well-known association between CKD and cardiovascular mortality. (more…)
Author Interviews, Brigham & Women's - Harvard, End of Life Care, JAMA, Leukemia / 28.12.2015

MedicalResearch.com Interview with: Oreofe O. Odejide, MD Instructor in Medicine, Harvard Medical School Dana-Farber Cancer Institute Medical Research: What is the background for this study? What are the main findings? Dr. Odejide: The care that patients with hematologic cancers receive near the end of life is distinct from patients with solid tumors. For instance, previous research has shown that patients with blood cancers are more likely to receive intensive care at the end of life such as chemotherapy within 14 days of death, intensive care unit admission within 30 days of death, and they are less likely to enroll in hospice. My colleagues and I hypothesized that timing of discussions regarding end-of-life preferences with patients may contribute to these findings, and we wanted to examine hematologic oncologists’ perspectives regarding end-of-life discussions with this patient population. We conducted a survey of a national sample of hematologic oncologists obtained from the publicly available clinical directory of the American Society of Hematology. We received responses from 349 hematologic oncologists, giving us a response rate of 57.3%. In our survey, we asked hematologic oncologists about the typical timing of EOL discussions in general, and also about the timing of the first discussion regarding resuscitation status, hospice care, and preferred site of death for patients. Three main findings emerged:
  • First, the majority of hematologic oncologists (56%) reported that typical EOL discussions occur “too late.”
  • Second, hematologic oncologists practicing primarily in tertiary care settings were more likely to report late discussions compared to those in community settings.
  • Third, a substantial proportion of respondents reported that they typically conduct the initial discussions regarding resuscitation status, hospice care, and preferred site of death at less optimal times.
(more…)
Author Interviews, Infections, JAMA, Microbiome / 24.12.2015

MedicalResearch.com Interview with: Tara F Carr, MD Assistant Professor, Medicine and Otolaryngology Allergy and Immunology Fellowship Training Program Director Director, Adult Allergy Division of Pulmonary, Allergy, Critical Care and Sleep Medicine University of Arizona Tucson, AZ 85724 Medical Research: What is the background for this study? What are the main findings? Dr. Carr: Some patients with chronic rhinosinusitis continue to suffer from symptoms despite aggressive medical and surgical treatments. For these individuals, therapy is generally chosen based on bacterial culture results, and often includes the use of topical antibacterial rinses with a medication called mupirocin.  We found that if patients are still having problems after this treatment, the bacteria identified from repeated sinus cultures are very different than those usually expected, and in general more difficult to treat. (more…)
Author Interviews, Breast Cancer, Cancer Research, Chemotherapy, JAMA / 24.12.2015

MedicalResearch.com Interview with: Filippo Montemurro, M.D. Director, Investigative Clinical Oncology (INCO) Fondazione del Piemonte per l'Oncologia Candiolo Cancer Institute (IRCCS) Torino, Italy Medical Research: What is the background for this study? Dr. Montemurro: The evaluation of treatment-related side effects is a critical step in cancer patient management. It is important in the clinical practice, where the decision to modify doses, omit administrations or establish supportive care measures is based on treatment tolerance and side effects severity and duration. It is also important in the context of clinical trials. In the latter setting, the mere information of the antitumor activity of a new drug or regimen under investigation is worth little if it not accompanied by an accurate reporting of the side effect profile. For this reason, over the years reference protocols to standardize the process of toxicity reporting in clinical trials have been established. The most recent and widespread is the Common Terminology Criteria for Adverse Events (CTCAE), that is issued and constantly updated by the National Cancer Institute. The CTCAE allows the description of the incidence and on the grade of severity on a scale ranging from 0 (no toxicity) to 5 (death due to that toxicity). Normally, the medical or nursing staff data collects information to fill in the CTCAE reports either by interviewing patients or extracting data from the clinical notes taken by physicians. The "indirectness" of this process has consequences that are becoming acknowledged for their potential implications. The incidence and severity of toxicities results often underestimated by doctors when their reports are compared with corresponding reports provided directly by patients without intermediaries (so called Patient reported outcomes-PRO). If this phenomenon is described in the context of clinical trials, it might occur to a greater extent also in the clinical practice, where the process of toxicity reporting is not mandated by a protocol and no reference standard is recommended. Based on these premises, we designed a study to pursue two aims;
  • the first was to assess whether a 10-item questionnaire derived by the CTCAE could be used by breast cancer patients receiving adjuvant chemotherapy after surgery in the daily clinical practice;
  • the second was to compare doctors and patients reports of toxicities at corresponding time-points.
Medical Research: What are the main findings? Dr. Montemurro: We administered the 10-item questionnaire after the first and third cycle of adjuvant chemotherapy to 601 women who had undergone surgery for breast cancer. To develop this questionnaire, CTCAE definitions of severity for each item (nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea) were translated into Italian and rephrased into statements. Patients were asked to choose the statement that best represented the worst experience with that side effect after the reference cycle of chemotherapy. At the same time-points, research nurses extracted information from the medical charts and reported them in paired doctor questionnaires. A total of 99% and 97% of the patient returned filled in questionnaires. Pairwise comparisons showed that doctors systematically underestimated both incidence and severity for all the side effects. Interestingly, comparison of the two patient questionnaires revealed temporal changes that were possibly related to the effect of prophylactic measures taken after the first cycle (i.e. reduction in vomiting, diarrhea and pain) or to cumulative toxicties (i.e. worsening dysgeusia and dyspnea). No such changes except for worsening dyspnea were observed comparing the two doctors questionnaires. Finally, we found a direct relationship between number of patients and magnitude of discrepancy in side effects reporting was observed, suggesting that the workload could be a factor influencing this phenomenon. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, JAMA, Nutrition / 23.12.2015

MedicalResearch.com Interview with: Philipp Schuetz, MD, MPH University Department of Medicine Clinic for Endocrinology/Metabolism/Clinical Nutrition, Kantonsspital Aarau, Aarau, Switzerland Medical Faculty of the University of Basel Basel, Switzerland Medical Research: What is the background for this study? What are the main findings? Dr. Schuetz: Malnutrition is common in hospitalised patients and associated with detrimental metabolic consequences. The current clinical approach is to provide at risk patients nutritional support as a strategy to tackle malnutrition and its associated adverse outcomes. Yet, whether this strategy is effective and improves clinical outcomes in the medical inpatient population is unclear. In addition, recent trials from critical care have shown adverse outcomes when nutritional therapy was used too aggressively. Herein, our metaanalysis is the first to systematically investigate effects of nutritional support in medical inpatients. Our analysis shows that nutritional support is highly effective in increasing energy and protein intake and helps to stabilize weight loss. Also, risk for unplanned readmission after discharge from the hospital was reduced and length of stay was shorter in the patient population with established malnutrition. Yet, for other important clinical outcomes such as mortality and functional outcomes effects of nutritional support remained uncertain. Also, the quality of evidence was found to be moderate to low. (more…)
Author Interviews, Diabetes, JAMA, Ophthalmology, Telemedicine / 23.12.2015

MedicalResearch.com Interview with: Christina Y. Weng, MD, MBA Assistant Professor-Vitreoretinal Diseases & Surgery Baylor College of Medicine-Cullen Eye Institute  Medical Research: What is the background for this study? What are the main findings? Dr. Weng: Telemedicine has been around for a long time, but only recently have technological advances solidified its utility as a reliable, effective, and cost-efficient method of healthcare provision.  The application of telemedicine in the field of ophthalmology has been propelled by the development of high-quality non-mydriatic cameras, HIPAA-compliant servers for the storage and transfer of patient data, and the growing demand for ophthalmological care despite the relatively stagnant supply of eye care specialists.  The global epidemic of diabetes mellitus has contributed significantly to this growing demand, as the majority of patients with diabetes will develop diabetic retinopathy in their lifetime. Today, there are over 29 million Americans with diabetes, and diabetic retinopathy is the leading cause of blindness in working age adults in the United States.  The American Academy of Ophthalmology’s and American Diabetes Association’s formal screening guidelines recommend that all diabetic patients receive an annual dilated funduscopic examination.  Unfortunately, the compliance rate with this recommendation is quite dismal at an estimated 50-65%.  It is even lower amongst minority populations which comprise the demographic majority of those served by the Harris Health System in Harris County, Texas, the third most populous county in the United States. In 2013, the Harris Health System initiated a teleretinal screening program housed by eight of the district’s primary care clinics.  In this system, patients with diabetes are identified by their primary care provider (PCP) during their appointments, immediately directed to receive funduscopic photographs by trained on-site personnel operating non-mydriatic cameras, and provided a follow-up recommendation (e.g., referral for in-clinic examination versus repeat imaging in 1 year) depending on the interpretation of their images.  The images included in our study were interpreted via two different ways—once by the IRISTM (Intelligent Retinal Imaging Systems) proprietary auto-reader and then again by a trained ophthalmic specialist from the IRISTM reading center.  The primary aim of this study was to evaluate the utility of the auto-reader by comparing its results to those of the reading center. Data for 15,015 screened diabetic patients (30,030 eyes) were included.  The sensitivity of the auto-reader in detecting severe non-proliferative diabetic retinopathy or worse, deemed sight threatening diabetic eye disease (STDED), compared to the reading center interpretation of the same images was 66.4% (95% confidence interval [CI] 62.8% - 69.9%) with a false negative rate of 2%.  In a population where 15.8% of diabetics have STDED, the negative predictive value of the auto-reader was 97.8% (CI 96.8% - 98.6%). (more…)
Author Interviews, Cancer Research, Colon Cancer, Cost of Health Care, JAMA, Social Issues, University of Michigan / 23.12.2015

MedicalResearch.com Interview with: Christine Veenstra MD Clinical Lecturer, Internal Medicine Medical Oncology University of Michigan Ann Arbor, MI  48109-5343 MedicalResearch: What is the background for this study? What are the main findings? Dr. Veenstra: Patients with cancer face many costs and incur financial burden as they go through diagnosis and treatment. For working patients, cancer diagnosis and treatment may come with the additional burden of time away from work, lost income, and even long-term job loss. Although 40% of US workers do not have access to paid sick leave, we hypothesized that availability of paid sick leave could reduce the need to take unpaid time away from work during cancer treatment and might therefore be associated with job retention and reduced personal financial burden. In a survey of over 1300 patients with Stage III colorectal cancer, we found that only 55% of those who were employed at the time of their cancer diagnosis retained their jobs. Working patients with paid sick leave were nearly twice as likely to retain their jobs compared with working patients who did not have paid sick leave. This held true even when controlling for income, education and health insurance. Furthermore, working patients without paid sick reported significantly higher personal financial burden than those who had paid sick leave available. (more…)
Author Interviews, Cancer Research, JAMA, Lung Cancer, Surgical Research / 23.12.2015

MedicalResearch.com Interview with: Dr Najib Rahman D Phil MSc MRCP Consultant and Senior Lecturer Lead for Pleural Diseases Oxford Centre for Respiratory Medicine Clinical Director, Oxford Respiratory Trials Unit Tutor in Clinical Medicine University College, Oxford Medical Research: What is the background for this study? Dr. Rahman : Up to TIME1, the evidence base behind optimal pleurodesis for malignant pleural effusion in terms of tube size and analgesia was poor. Optimal pleurodesis in this context is one which is successful (i.e. the patient needs no further pleural interventions for that malignant effusion), but occurs with the minimum discomfort. This is particularly important as the treatment intent in malignant effusion pleurodesis is palliative. This is the first adequately powered randomized trial to address two important issues in pleurodesis for malignant pleural effusion - that of whether NSAIDs reduce pleurodesis efficacy, and if smaller chest tubes (12F) are "as good as" larger chest tubes (24F) for pleurodesis success and in terms of pain. Medical Research: What are the main findings? Dr. Rahman : The main and somewhat surprising findings are that:
  1. NSAIDs given short term but at high dose do not impair pleurodesis - they are no better than morphine for pain control (in fact, they needed modestly more rescue medication), but can be freely used during malignant effusion pleurodesis with no fear of reducing pleurodesis success.
  1. Smaller tubes were marginally less painful than larger tubes - but this difference was not clinically very relevant
  1. Smaller tubes cannot now be said to be "as good as" larger tubes for malignant effusion pleurodesis. Our data shows that they failed in non-inferiority to larger tubes for pleurodesis success at 3 months. 
  1. Smaller tubes resulted in higher fall our rates, a higher incidence of not being able to administer talc and were associated with more complications during insertion .
(more…)
Author Interviews, JAMA, MRI, Stroke / 22.12.2015

MedicalResearch.com Interview with: Sepideh Amin-Hanjani, MD FAANS FACS FAHA Professor & Program Director Co-Director, Neurovascular Surgery Department of Neurosurgery University of Illinois at Chicago Past Chair, AANS/CNS Cerebrovascular Section  Medical Research: What is the background for this study? What are the main findings? Dr. Amin-Hanjani: Posterior circulation strokes account for up to 30% of all ischemic strokes, and atherosclerotic occlusive disease of the vertebrobasilar (VB) is responsible for approximately one third of these cases. Symptomatic atherosclerotic VB occlusive disease is associated with a high risk of recurrent stroke despite medical therapy, in the range of 10-15% within 2 years. There have been advances in treatment options, particularly endovascular angioplasty and stenting, aimed at reverting the blockage; however these procedures themselves carry risks, and are likely to benefit only selected patients who are at highest risk without intervention. Our study, VERiTAS, aimed to determine if measurement of blood flow in the posterior circulation vessels could identify the high risk patients. Flow measurements were performed using the technique of quantitative magnetic resonance angiography (QMRA) relying on standard MR sequences and  the commercial software NOVA. These flow measurements were used to designate patients presenting with symptomatic vertebrobasilar disease as flow compromised or not, and patients were then followed for a median of 23 months in a blinded fashion to determine the risk of subsequent strokes. We found that among 72 such patients, only one quarter (18 patients) demonstrated flow compromise on QMRA, but that this group had a significantly higher risk of subsequent stroke at one year, 22% vs only 4% in the other group. The hazard ratio for subsequent stroke was markedly elevated at 11.5 even after adjusting for age and other stroke risk factors. (more…)
Author Interviews, Cost of Health Care, Education, JAMA / 16.12.2015

MedicalResearch.com Interview with: Lorette A. Stammen, MD Department of Educational Development and Research Faculty of Health, Medicine, and Life Sciences Maastricht University, Maastricht The Netherlands Medical Research: What is the background for this study? What are the main findings? Dr. Stammen: Research indicated that we can improve the quality of care and reduce the health care costs by eliminating health care waste. Health care waste are health care services that are not beneficial to patients. There are many ways to reduce health care waste, like through insurance and government policies modification,  but we were especially interested in how the medical expertise of physicians could improve high-value, cost-conscious care. We conducted a systematic review with the aim of understanding how training programs cause learning among physicians, residents and medical students. We analyzed 79 articles using realist review method and found three important factors that facilitate the learning of physicians (in training).
  • First, educational programs should focus on knowledge transmission. Knowledge that is essential entails knowledge regarding prices and general health economics, scientific evidence, and patient preferences.
  • Besides knowledge, the second factor of training for high-value, cost-conscious care is reflective practice. Reflective practice for example using feedback and asking reflective questions, by peers, colleagues and supervisors to reflect on decisions made in daily practice.
  • The third element of training programs should address an supportive environment in which physicians, residents and medical students learn. A supportive environment is important to cultivate the importance of high-value, cost-conscious care on multiple levels in the health care system. Since physicians are a part of a health care team their training programs should incorporate the training of health care professionals.
  • Furthermore, it is important that role models demonstrate high-value cost-conscious care.
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Author Interviews, JAMA, Pediatrics, Surgical Research / 16.12.2015

MedicalResearch.com Interview with: Dr. Peter C. Minneci, M.D., MHSc Center for Innovation in Pediatric Practice Assistant Professor, Pediatric Surgery The Ohio State's Wexner Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. Minneci: Non-operative management of uncomplicated appendicitis has been shown to safe and effective studied in several international adult trials. To be a reasonable treatment alternative to urgent appendectomy, non-operative management of appendicitis in children must have a clinically acceptable success rate with minimal harm in patients that fail and subsequently undergo appendectomy. We performed a prospective single-institution patient choice trial allowing the families of children with acute uncomplicated appendicitis to choose between urgent appendectomy or non-operative management with antibiotics alone. We enrolled 102 patients, with 65 choosing surgery and 37 choosing non-operative management with antibiotics alone. Non-operative management had an in-hospital success rate of 94%, a 30-day success rate of 89%, and a 1-year success rate of 76%. Compared to the surgery group, patients managed non-operatively reported higher quality of life scores at 30 days and had significantly fewer disability days and lower costs, with no differences in the rates of complicated appendicitis or treatment-related complications at 1 year of follow-up. With this being said, there are some cases that I have read about where doctors have failed to diagnose patients for Appendicitis even after they have complained about having a number of the symptoms associated with it. Following this, some patients have even contacted companies like Negligence Claimline to get back what they deserve. You go to doctors as they are the ones who can help you get your health back in order, but when something like this happens, it is understandable as to why some people lose faith in this system. (more…)
Author Interviews, Gastrointestinal Disease, JAMA, Stem Cells / 16.12.2015

MedicalResearch.com Interview with: Dr. Chris J. Hawkey, DM, FRCP, FMedSci. University of Nottingham and Nottingham University Hospital England Medical Research: What is the background for this study?  Dr. Hawkey: ASTIC (The Autologous Stem Cell Transplantation International Crohn's Disease) systematically investigated the effect of immunoablation and autologous haemopoietic stem cell transplantation (HSCT) on objective signs of disease, symptoms and need for treatment and is the only controlled trial to have done so. The body’s immune system normally protects us from infections but in Crohn’s disease it turns on itself.  The treatment involves wiping out the body’s immune system (immunoablation) and replacing it with the patient’s own (autologous haemopoietic stem cell transplantation) innocent stem cells, a sort of immunological spring clean. Patients were randomly assigned to undergo transplantation (n=23) or just continue on best conventional treatment (n=22). ASTIC was stimulated by reports which suggested that long-term regression of disease amounting to potential cure could be achieved. But the treatment is hazardous with major potentially lethal risks, so recruitment to the trial was cautious and only the most resistant cases were studied. And we used the most stringent criteria ever developed for the trial’s primary endpoint. Medical Research: What are the main findings?  Dr. Hawkey: In fact the criteria we used for success were so stringent (no symptoms, no signs of disease on total bowel examination and no need for treatment) that few patients achieved them. Nevertheless, there were improvements in the individual measures underlying this composite endpoint. Objective signs of disease disappeared so that the gut looked normal from mouth to anus in about a quarter of actively treated patients vs no controls. Eight vs two patients were adjudicated free of active disease on endoscopy and radiology at final assessment (p=0.054). Patients were able to come off drug treatments: by the end of a year 61% of HSCT patients off immunosuppressive drugs for >3 months vs 23% of controls (p=0.012). Ten vs two patients had lost symptoms of active disease, eight vs two for of them for > 3 months (p=0.052). But treatment was challenging: there were 76 serious adverse events in HSCT patients (particularly infections) vs 38 in controls. One HSCT patient died. (more…)