Author Interviews, Gastrointestinal Disease, JAMA / 06.10.2015

Nynne Nyboe Andersen, MD Department of Epidemiology Research Statens Serum Institut Denmark MedicalResearch.com Interview with: Nynne Nyboe Andersen, MD Department of Epidemiology Research Statens Serum Institut Denmark Medical Research: What is the background for this study? Response: The use of TNF-α inhibitors, including infliximab, adalimumab and certolizumab pegol to treat people with inflammatory bowel disease is increasing worldwide and has improved the medical treatment modalities. However, in the post-marketing period, case-reports, data from retrospective cohort studies and spontaneous reporting systems have identified patients with inflammatory bowel disease treated with TNF-α inhibitors, developing a demyelinating event of the central nervous system. It remains unanswered whether this reflect a true association between TNF-α inhibitors and demyelinating diseases or whether these cases are a result of the well-established underlying association between demyelinating diseases and inflammatory bowel disease per se. The rarity of demyelinating diseases has stalled a thorough safety evaluation through analytical studies. Consequently, by use of the nationwide Danish registries, we conducted a large population-based cohort study, aiming to address the risk of demyelinating events of the central nervous system in patients with inflammatory bowel disease treated with TNF-α inhibitors compared to untreated patients. Medical Research: What are the main findings? Response: Using a matched study design, a 2-fold increased risk of demyelinating diseases was observed in patients with inflammatory bowel disease treated with TNF-α inhibitors compared to untreated. The absolute risk was low with less than four additional cases per 10000 person years in those treated compared to untreated. The rarity of demyelinating diseases limited the statistical power and capacity to adjust for or match on potential confounder variables, and therefore findings should be considered preliminary as they could be a result of chance or unmeasured confounding and need confirmation in other studies.
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA, Pediatrics / 06.10.2015

Susan Gray MD Division of Adolescent Medicine Boston Children's Hospital Boston, MAMedicalResearch.com Interview with: Susan Gray MD Division of Adolescent Medicine Boston Children's Hospital Boston, MA Medical Research: What is the background for this study? What are the main findings? Dr. Gray: This is a study of the health care costs of 13,000 privately insured adolescents (13 to 21 years old) cared for in an association of pediatric primary care practices. We found that a tiny fraction (1%) of adolescents accounted almost a quarter of the expenses of the whole cohort. Mental health disorders were the most common diagnosis among these high cost adolescents. The characteristics most strongly associated with high cost were complex chronic medical conditions, behavioral health disorders, and obesity, but many high cost adolescents had no chronic conditions. Pharmacy costs, especially orphan drug costs, were a surprisingly large contributor to high costs for these privately insured adolescents. Primary care costs were very small in high cost patients.
Author Interviews, Critical Care - Intensive Care - ICUs, NEJM / 05.10.2015

Dr. Paul Jeffrey Young MD Intensive Care Unit, Wellington Regional Hospital Wellington South, New ZealandMedicalResearch.com Interview with: Dr. Paul Jeffrey Young MD Intensive Care Unit, Wellington Regional Hospital Wellington South, New Zealand Medical Research: What is the background for this study? What are the main findings? Response: Fever is a response to infection that is broadly conserved across many animal species and it seems reasonable to presume that the components of the immune response have adapted to function optimally in the physiological febrile range.  We have previously shown that among patients with fever and infection, increasing degrees of fever in the first 24 hours in ICU are generally associated with reducing mortality risk after adjusting for illness severity.  Although acetaminophen (paracetamol) is commonly used to treat fever in the ICU, there are no previous data to demonstrate the safety and efficacy of this practice.  The HEAT trial was designed by a group of ICU clinicians to test the hypothesis that treating fever with acetaminophen in critically ill patients with infections would worsen outcomes, or more specifically that it would reduce the number of days patients spent alive and free from requiring intensive care. Medical Research: What are the main findings? Response: The primary finding was that early administration of acetaminophen to treat fever did not alter the number of ICU-free days in adult ICU patients with infections.  The mortality rates of acetaminophen and placebo patients were similar.  Patients who received acetaminophen had lower body temperature than patients who received placebo and did not have significantly more adverse events.  Acetaminophen use was associated with a shorter ICU stay than placebo among survivors and a longer ICU stay among patients who died.
Author Interviews, Heart Disease, NEJM, Surgical Research / 05.10.2015

Prof. Dr. med. Patrick Meybohm, MHBA Leitender Oberarzt Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum FrankfurtMedicalResearch.com Interview with: Prof. Dr. med. Patrick Meybohm, MHBAConsultant for Anesthesiology and Intensive Care Medicine University Hospital Frankfurt Dept. Of Anesthesiology, Intensive Care Medicine and Pain Therapy Frankfurt Germany Medical Research: What is the background for this study? What are the main findings? Prof. Meybohm: Remote ischemic preconditioning (RIPC) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery, but uncertainty about clinical outcomes remains. We conducted a prospective, double-blind, multicenter, randomized, controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass. The trial compared upper-limb RIPC with a sham intervention. The primary end point was a composite of death, myocardial infarction, stroke, or acute renal failure up to the time of hospital discharge. Secondary end points included the occurrence of any individual component of the primary end point by day 90. A total of 1403 patients underwent randomization. The full analysis set comprised 1385 patients (692 in the RIPC group and 693 in the sham-Remote ischemic preconditioning group). There was no significant between-group difference in the rate of the composite primary end point (99 patients [14.3%] in the RIPC group and 101 [14.6%] in the sham-RIPC group, P=0.89) or of any of the individual components: death (9 patients [1.3%] and 4 [0.6%], respectively; P=0.21), myocardial infarction (47 [6.8%] and 63 [9.1%], P=0.12), stroke (14 [2.0%] and 15 [2.2%], P=0.79), and acute renal failure (42 [6.1%] and 35 [5.1%], P=0.45). The results were similar in the per-protocol analysis. No treatment effect was found in any subgroup analysis.
Author Interviews, Cancer Research, Endocrinology, JAMA, Menopause / 05.10.2015

Rodrigo R. Munhoz, MD Hospital Sírio Libanês São Paulo, Brazil MedicalResearch.com Interview with: Rodrigo R. Munhoz, MD Hospital Sírio Libanês São Paulo, Brazil  Medical Research: What is the background for this study? What are the main findings? Dr. Munhoz:  Chemotherapy-induced early menopause and its impact on quality of life is clinically relevant issue that often arises during the treatment with curative intent of premenopausal patients with early breast cancer. The use of neo-/adjuvant chemotherapy is associated with risks of ovarian dysfunction, permanent or transient amenorrhea, infertility and symptoms of menopause with a premature onset. In addition to osteoporosis, loss of libido, increased cardiovascular risk and atrophic vaginitis, early ovarian dysfunction may adversely impact quality of life and result in significant psychosocial burden. Currently available guidelines addressing fertility preservation in young women undergoing treatment for early breast cancer recommend that patients at reproductive ages should be advised about the potential risks of fertility impairment and additional effects of adjuvant chemotherapy and that preservation techniques should be carefully considered. However, “evidence regarding the effectiveness of ovarian suppression” is quoted as “insufficient” and the use GnRH agonists as “experimental” . The current meta-analysis includes a large number of patients and also the results of recently presented clinical trials, and suggest that the use of GnRH agonists is associated a higher rate of recovery of regular menses in patients with breast cancer undergoing chemotherapy.These results summarize the findings of different clinical trials and has immediate clinical implications - this was not clear in the literature, since negative results had been reported across different clinical trials.
Author Interviews, Blood Pressure - Hypertension, Heart Disease, JAMA, Surgical Research / 05.10.2015

Mads Emil Jørgensen Copenhagen University Hospital..., MedicalResearch.com Interview with: Mads E. Jørgensen, MB Cardiovascular Research Center Gentofte Hospital University of Copenhagen, Denmark Medical Research: What is the background for this study? What are the main findings? Response: For many years there has been a wide use of beta blockers in the non-cardiac surgery setting with the intent to protect the heart. Within recent years, this field of research has opened up to new studies evaluating in detail which patient subgroups do benefit from this therapy and which may actually be at increased risk. The current study evaluated chronic beta blocker use and risks of perioperative complications in a rather low risk population of patients with hypertension, but without cardiac, kidney or liver disease. Among 55,000 patients receiving at least two antihypertensive drugs, we found that patients treated with a beta blocker were at increased risks of complications during surgery and 30-day after surgery, compared to patients treated with other antihypertensive drugs only. In various subgroup analyses (by age, gender, diabetes, surgery risk etc.) the findings were consistent although challenged in power.
Author Interviews, Flu - Influenza, JAMA, Vanderbilt / 05.10.2015

Carlos G. Grijalva, MD MPH Associate Professor Department of Health Policy Vanderbilt University Medical Center Nashville, TN 37212MedicalResearch.com Interview with: Carlos G. Grijalva, MD MPH Associate Professor Department of Health Policy Vanderbilt University Medical Center Nashville, TN 37212  Medical Research: What is the background for this study? Dr. Grijalva: Influenza is an important cause of disease. Every year influenza causes more than 200,000 hospitalizations in the US. The most effective strategy to prevent influenza infections is vaccination. Several studies have shown that influenza vaccines can prevent fever or respiratory symptoms caused by influenza. However, whether influenza vaccines can prevent more serious complications of influenza such as pneumonia, remains unclear This was a multicenter collaboration between academic institutions and the centers for disease control and prevention. We used data from the Etiology of Pneumonia in the community or EPIC study, a large prospective study of hospitalizations for pneumonia conducted between 2010 and 2012. The EPIC study enrolled patients from Chicago, IL, Salt Lake City, UT, and Memphis and Nashville, TN. The main goal of the EPIC study was to determine the causes of pneumonia in children and adults hospitalized with pneumonia. Medical Research:? What are the main findings? Dr. Grijalva: We conducted a case-control study using data from EPIC. Our study included more than 2700 patients hospitalized for pneumonia, including both children and adults. Approximately 6% of these patients had influenza pneumonia and were identified as cases. Other patients hospitalized for pneumonia that was not caused by influenza were the controls. We compared the history of influenza vaccination between cases and controls. We found that influenza vaccination was associated with a reduced risk of influenza pneumonia that required hospitalization. The estimated vaccine effectiveness was 57%. This means that about 57% of hospitalizations due to influenza-associated pneumonia could be prevented through influenza vaccination.
Author Interviews, Cancer Research, Colon Cancer, Genetic Research, JNCI, Mayo Clinic, Race/Ethnic Diversity / 05.10.2015

Harry H. Yoon, MD Mayo Clinic Rochester, MN 55905MedicalResearch.com Interview with: Harry H. Yoon, MD Mayo Clinic Rochester, MN 55905 Medical Research: What is the background for this study? What are the main findings? Dr. Yoon: In the U.S., the survival of patients with colon cancer is known to differ by race, with individuals of black race having worse outcomes than those of white race. However, it has been difficult to tease apart why the differences in survival exist. It is generally believed that social or other non-biologic factors (eg, decreased access to care, suboptimal treatment) contribute to the discrepancy.  It’s also known that differences in the general medical condition of patients could affect how long a patient lives. However, it is unknown whether there are race-based differences in the biology of colon tumors themselves.  This biology can be reflected in the genetic composition of tumors, as well as by whether and how quickly the cancer returns after the patient has undergone surgery and chemotherapy. In addition, it is unknown whether race-based differences in biology may be related to the age of the patient at the time of diagnosis.  Blacks with colorectal cancer typically have an earlier age of onset than whites do. A major barrier to addressing these questions are that there are very few large populations of colon cancer patients where everyone had the same disease stage and received uniform treatment, and where patients were monitored for years afterward specifically to see whether the cancer returned.  It is much harder to measure whether cancer has returned (ie, cancer recurrence), as compared to simply knowing whether a patient is alive or dead.  This difference is important, because knowing about cancer recurrence sheds more light on cancer biology than only knowing about patient survival, since many factors unrelated to cancer biology (eg., heart disease) can affect whether a person is alive or dead. The most reliable data on cancer recurrence (not just patient survival) generally comes from patients who have enrolled in a clinical trial.  In the Alliance N0147 trial, all patients had the same cancer stage (ie, stage III), underwent surgery and received standard of care chemotherapy (ie, “FOLFOX”) after surgery.  Patients had uniform, periodic monitoring after chemotherapy to see if the cancer returned. In other words, examining racial outcomes in this cohort largely eliminates some of the key factors (eg, decreased access to care, suboptimal treatment) that are believed to contribute to racial discrepancies, and provides a unique opportunity to determine if differences in cancer biology between races may exist. This study was done to see if colon cancers are genetically different based on race, and whether race-based differences exist in cancer recurrence rates. The study found that tumors from whites, blacks, and Asians were different in terms of the frequency of mutations in two key cancer-related genes, BRAF and KRAS.  Tumors from whites were twice as likely to have mutated BRAF (14% in whites compared to 6% in Asians and 6% in blacks).  Tumors from blacks had the highest frequency of KRAS mutations (44% in blacks compared to 28% in Asians and 35% in whites).  Tumors from Asians were the mostly likely to have normal copies of both genes (67% in Asians compared to 50% in blacks and 51% in whites). Next, the study found that the colon cancers among blacks had more than double the risk of cancer recurrence, compared to whites.  However, this discrepancy was only evident among young patients (ie, aged less than 50 years).  Almost 50% of younger black patients experienced colon cancer recurrence within 5 years, compared to ~30% of black patients over age 50, or compared to white or Asian patients regardless of age. The worse outcome among young blacks remained evident even after adjusting for many potential confounding factors, such as tumor grade, the number of malignant nodes, or the presence of BRAF or KRASmutations.  Because this question was examined in a clinical trial cohort of uniform stage and treatment, the role of multiple important potential confounders was diminished. To our knowledge, this is the first report indicating that colon cancers from young black individuals have a higher chance of relapsing after surgery and chemotherapy, compared to those from white individuals.
Author Interviews, Depression, Genetic Research, JAMA / 03.10.2015

Dr. David Brent MD Department of Psychiatry Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center Pittsburgh, PennsylvaniaMedicalResearch.com Interview with: Dr. David Brent MD Department of Psychiatry Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Medical Research: What is the background for this study? Dr. Brent: Youth with a parent with a history of depression are at increased risk for having a depressive episode themselves. Medical Research: What are the main findings? Dr. Brent: Those who received a cognitive behavioral educational group program were less likely to have had a depressive episode, and were functioning better than those who did to receive the program 6 years later, especially if their parent was NOT depressed at the time that they received the program. If the parent was depressed then the program was no better than usual care.
Accidents & Violence, Author Interviews, JAMA, Surgical Research / 03.10.2015

Russ S. Kotwal, M.D., M.P.H. United States Army Institute of Surgical Research Joint Base San Antonio-Ft. Sam HoustonMedicalResearch.com Interview with: Russ S. Kotwal, M.D., M.P.H. United States Army Institute of Surgical Research Joint Base San Antonio-Ft. Sam Houston Medical Research: What is the background for this study? Dr. Kotwal: The term golden hour was coined to encourage urgency of trauma care. In 2009, Secretary of Defense Robert M. Gates mandated prehospital helicopter transport of critically injured combat casualties in 60 minutes or less. The objectives of the study were to compare morbidity and mortality outcomes for casualties before vs after the mandate and for those who underwent prehospital helicopter transport in 60 minutes or less vs more than 60 minutes. A retrospective descriptive analysis of battlefield data examined 21,089 US military casualties that occurred during the Afghanistan conflict from September 11, 2001, to March 31, 2014. Medical Research: What are the main findings? Dr. Kotwal: For the total casualty population, the percentage killed in action and the case fatality rate (CFR) were higher before vs after the mandate, while the percentage died of wounds remained unchanged. Decline in CFR after the mandate was associated with an increasing percentage of casualties transported in 60 minutes or less, with projected vs actual CFR equating to 359 lives saved. Among 4542 casualties with detailed data, there was a decrease in median transport time after the mandate and an increase in missions achieving prehospital helicopter transport in 60 minutes or less. When adjusted for injury severity score and time period, the percentage killed in action was lower for those critically injured who received a blood transfusion and were transported in 60 minutes or less, while the percentage died of wounds was lower among those critically injured initially treated by combat support hospitals. Acute morbidity was higher among those critically injured who were transported in 60 minutes or less, those severely and critically injured initially treated at combat support hospitals, and casualties who received a blood transfusion, emphasizing the need for timely advanced treatment.
Author Interviews, BMJ, Bone Density, Calcium, Mineral Metabolism, Orthopedics / 03.10.2015

MedicalResearch.com Interview with: Dr. Mark J Bolland Associate professor of medicine Department of Medicine University of Auckland Auckland New Zealand Medical Research: What is the background for this study? Dr. Bolland: Many guidelines advise older people to take at least 1000-1200 mg/day of calcium to improve bone density and prevent fractures. The average calcium intake in most countries is a lot less than these recommendations, and so many people take calcium supplements to increase their calcium intake. However, recent concerns about the safety of calcium supplements have led experts to recommend increasing calcium intake through food rather than by taking supplements, even though the effect of increasing dietary calcium intake on bone health had not been clearly established. Our study was designed to fill this evidence gap. Medical Research: What are the main findings? Dr. Bolland: Firstly, we found that increasing calcium intake either from the diet or by taking calcium supplements led to similar, small, one-off increases in bone density of 1-2%. These increases do not build up over time and are too small to produce significant reductions in the chance of having a fracture. Secondly, the level of dietary calcium intake is not associated with the risk of having a fracture. Thirdly, in clinical trials, calcium supplements have only small, inconsistent benefits on preventing fractures, with no effect on fractures seen in the highest quality trials
Author Interviews, JAMA, Melanoma, Ophthalmology / 01.10.2015

Ann-Cathrine Larsen MD, PhD-student University of Copenhagen Faculty of Health Sciences Department of Neuroscience and Pharmacology, Eye Pathology Section CopenhagenMedicalResearch.com Interview with: Ann-Cathrine Larsen MD, PhD-student University of Copenhagen Faculty of Health Sciences Department of Neuroscience and Pharmacology, Eye Pathology Section Copenhagen Medical Research: What is the background for this study? Dr. Larsen: Conjunctival melanoma is an uncommon malignancy with a high mortality. Population-based studies evaluating prognostic features and treatment are rare. The clinicopathological and prognostic features associated with BRAF-mutations in conjunctival melanoma are unclear. Medical Research: What are the main findings? Dr. Larsen: Extrabulbar tumor location and invasion of adjacent tissue structures were poor prognostic features. Incisional biopsy and excision without adjuvant therapy were associated with metastatic disease. Younger age at diagnosis, bulbar or caruncular tumor location, T1 stage tumor, lack of clinical melanosis and mixed or non-pigmented tumor color were features associated with BRAF-mutated conjunctival melanoma. Furthermore, Patients with BRAF mutated tumors seem to have an increased risk of distant metastatic disease.
Author Interviews, BMJ, Weight Research / 01.10.2015

Dr Jonas Minet Kinge PhD Researcher, Department of Health Statistics, Norwegian Institute of Public Health Associate professor, Department of Health Management and Health Economics University of Oslo Norwegian Institute of Public Health Oslo, NorwayMedicalResearch.com Interview with: Dr Jonas Minet Kinge PhD Researcher, Department of Health Statistics, Norwegian Institute of Public Health Associate professor, Department of Health Management and Health Economics University of Oslo Norwegian Institute of Public Health Oslo, Norway Medical Research: What is the background for this study? What are the main findings? Response: Previous studies have shown that the number of people with obesity increases with the gross domestic product (GDP) of a country. Previous research has also indicated that education can be an important factor in this context. The aim of this new study was to explore the assumption from previous studies that obesity is linked to GDP and education, and to include new data from several different countries. The results from this study confirm that there is an association between obesity, education and GDP. The prevalence of obesity increases with rising GDP, but only among individuals with lower levels of education. There is no significant increase in obesity among those with higher education. This means that:
  • In countries with low GDP there is more obesity among those with high education.
  • In countries with high GDP there is more obesity among those with low education.
  • The study also found that the relationship was somewhat more marked among women than among men.
Author Interviews, BMJ, Cost of Health Care, Education, Health Care Systems, University of Pittsburgh / 30.09.2015

Timothy Anderson, M.D. Chief medical resident University of Pittsburgh’s Department of Internal MedicineMedicalResearch.com Interview with: Timothy Anderson, M.D. Chief medical resident Department of Internal Medicine University of Pittsburgh Medical Research: What is the background for this study? What are the main findings? Dr. Anderson: My coauthors and I analyzed the public disclosures of all publicly traded U.S. health care companies listed on the NASDAQ exchange and New York Stock Exchange in January 2014 that specialized in pharmaceuticals, biotechnology, medical equipment and providing health care services.  Of the 442 companies with publicly accessible disclosures on boards of directors, 180 – or 41 percent – had one or more academically affiliated directors in 2013. These individuals included chief executive officers, vice presidents, presidents, provosts, chancellors, medical school deans, professors and trustees from 85 non-profit academic research and health care institutions. These individuals received compensation and stock shares from companies which far exceeds payment for other relationships such as consulting. In some cases compensation approaches or exceeds average professor and physician salaries.
Author Interviews, BMJ, Heart Disease, Mediterranean Diet, Microbiome, Nutrition, Vegetarians / 29.09.2015

Prof. Danilo Ercolini, PhD Department of Agricultural Sciences University of Naples Federico II Portici - ItalyMedicalResearch.com Interview with: Prof. Danilo Ercolini, PhD Department of Agricultural Sciences University of Naples Federico II Portici - Italy Medical Research: What is the background for this study? What are the main findings? Prof. Ercolini: There is a thick body of literature showing that diet can significantly impact the gut microbiota and metabolome. In a recent study, negligible differences in gut microbiota and feca lshort-chain fatty acids (SCFA) were reported between habitual omnivores and vegans in the USA. In addition, Mediterranean diet is a recognized healthy dietary pattern but has not previously been related to the composition of the gut microbiota and related metabolome. That’s the background in short. Here we show how habitual vegetarian and vegan diets promote enrichment of fibre-degrading bacteria in the gut. Subjects who consume a Mediterranean diet rich in fruit, legumes and vegetables have higher levels of fecal short chain fatty acids, regardless of the diet type. Low adherence to the Mediterranean diet corresponds to an increase in urinary trimethylamine oxide levels, a potential risk factor for cardiovascular disease.
Author Interviews, Breast Cancer, Chemotherapy, Genetic Research, NEJM / 29.09.2015

Dr. Kathy D. Miller, MD Indiana University Melvin and Bren Simon Cancer CenterMedicalResearch.com Interview with: Dr. Kathy D. Miller, MD Indiana University Melvin and Bren Simon Cancer Center Medical Research: What is the background for this study? What are the main findings? Dr. Miller: Previous studies had found a small but real benefit with the addition of chemotherapy to anti-estrogen treatment in patients with hormone sensitive disease. The challenge for patients and clinicians has always been that the benefit of chemotherapy is quite small and the toxicity can be substantial. The Oncotype Dx recurrence score assay was developed to identify patients who could safely be treated with anti-estrogen therapy alone (and conversely those who truly need and would derive a much larger benefit from chemotherapy). When the Oncotype Dx RS was applied to samples stored from a previous randomized trial, patients with low risk scores didn't seem to benefit from chemotherapy. While those initial results had some impact on treatment, many were concerned about eliminating chemotherapy on the basis of one small retrospective trial. The overall trial enrolled 10,253 women. 1626 (15.9%) had a Recurrence Score of 0-10 and were assigned to receive antiestrogen therapy alone without chemotherapy. After five years 99.3% (98.7, 99.6%) for were free of distant relapse (that is to say, 99.3% of women had NOT had recurrence of breast cancer at distant sites in the body). Overall survival was 98%.
Author Interviews, Cancer Research, JAMA, Lung Cancer / 28.09.2015

[caption id="attachment_17881" align="alignleft" width="107"]Dr. Rebecca Prince Clinical Research Fellow and first author Dr. Rebecca Prince[/caption] MedicalResearch.com Interview with: Dr. Rebecca Prince MBBS Clinical Research Fellow and first author and [caption id="attachment_17883" align="alignleft" width="119"]Monika K. Krzyzanowska, MD MPH FRCPC Medical Oncologist, Princess Margaret Cancer Centre Associate Professor, Dept of Medicine and Institute of Health Policy, Management & Evaluation, University of Toronto Senior Adjunct Scientist, Institute for Clinical Evaluative Sciences Clinical Lead, Quality Care & Access, Systemic Treatment Program, Dr Monika Krzyzanowska[/caption] Monika K. Krzyzanowska, MD MPH FRCPC Medical Oncologist, Princess Margaret Cancer Centre, Associate Professor, Dept of Medicine and Institute of Health Policy, Management & Evaluation, University of Toronto Senior Adjunct Scientist, Institute for Clinical Evaluative Sciences Clinical Lead, Quality Care & Access, Systemic Treatment Program, Cancer Care Ontario Toronto, ON  Medical Research: What is the background for this study? What are the main findings? Response: This study was inspired by our previous work using administrative data in which we found that a large proportion of patients receiving chemotherapy in routine practice were visiting the emergency department and being admitted to hospital. Our perception was that the frequency of these events was higher than expected but when we went to look what was expected, ie. how often were people ending up in hospital during treatment in clinic trials, this data was not readily available. This led us to perform a systematic review of the literature including a comparison of hospitalization rates between patients treated in clinical trials and patients in similar clinical scenarios treated in routine practice. We ended up focusing on metastatic lung cancer as that was one of the clinical scenarios where we were able to identify published data from both clinical trials and routine practice. The main finding of our study is that hospitalizations are very common during chemotherapy. We compared patients with metastatic lung cancer being treated in routine practice and clinical trials and found that that approximately half (51%) of patients treated in routine practice were hospitalized during chemotherapy, compared to 16% of trial patients. We also found that very few clinical trials reported this information which is routinely collected during the trial.
Author Interviews, Depression, Heart Disease, JAMA / 28.09.2015

MedicalResearch.com Interview with:Dr-Ken-Freedland Kenneth E. Freedland, PhD Professor of Psychiatry and Psychology Washington University School of Medicine St. Louis, Missouri Medical Research: What is the background for this study? What are the main findings? Dr. Freedland: Major depression is a common problem in patients with heart failure, and it makes heart failure self-care tasks such as daily weight checks and compliance with dietary restrictions more difficult for these them.  Unfortunately, recent clinical trials have shown that both depression and inadequate self-care can be hard to treat in patients with heart failure. Cognitive behavior therapy (CBT) is often used to treat depression in otherwise healthy individuals, but it hasn’t been tested in patients with heart failure. We added a self-care component to the standard CBT treatment protocol and conducted a clinical trial to determine whether it is effective both for depression and for self-care.  We randomized 158 heart failure patients to  cognitive behavior therapy or to usual care, and both groups received heart failure education.  About 1/3 of the patients in both groups were also taking antidepressant medications. The intervention was effective for depression, with remission rates of 51% in the cognitive behavior therapy group compared to only 20% in the usual care group.  However, it was not effective for heart failure self-care.
Author Interviews, Cognitive Issues, Pediatrics, PLoS / 27.09.2015

Sophie von Stumm BSc MSc PhD Department of Psychology Goldsmiths University of London London, United KingdomMedicalResearch.com Interview with: Sophie von Stumm BSc MSc PhD Department of Psychology Goldsmiths University of London London, United Kingdom Medical Research: What is the background for this study? Dr. von Stumm: At the Hungry Mind Lab (www.hungrymindlab.com), which I direct, we study individual differences in lifespan cognitive development. In particular, I am interested in factors that influence change in cognitive ability and knowledge. One such factor is breastfeeding, which some previous studies suggested to be associated children's intelligence and IQ gains while others failed to find a relationship. Medical Research: What are the main findings? Dr. von Stumm: For this study, which was published last week in PloS One (link:http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0138676), data were analyzed from more than 11,000 children born in the UK between 1994 and 1996. The children had been repeatedly assessed on IQ: the first time they were tested on intelligence at age 2, and then again repeatedly throughout childhood, overall 9 times, until the age of 16 years. We found that having been breastfed versus not having been breastfed was not meaningfully associated with children's IQ differences at age 2 and also not with differences in children's IQ gains until age 16. That is not to say that breastfeeding may not have other benefits for children's development but our study strongly suggests that breastfeeding is not important for children's IQ.  
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA, Prostate Cancer, Testosterone / 27.09.2015

Anthony V. D'Amico, MD, PhD Chief, Division of Genitourinary Radiation Oncology Professor of Radiation Oncology, Harvard Medical SchoolMedicalResearch.com Interview with: Anthony V. D'Amico, MD, PhD Chief, Division of Genitourinary Radiation Oncology Professor of Radiation Oncology, Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. D'Amico: Controversy exists as to whether androgen deprivation therapy (ADT) used to treat prostate cancer can cause fatal cardiac events. We found that in men with moderate to severe comorbidity based most often on a history of a heart attack that the use of 6 months of androgen deprivation therapy to treat non metastatic but clinically significant prostate cancer was associated with both an increased risk of a fatal heart attack and shortened survival.
Author Interviews, Blood Pressure - Hypertension, Diabetes, Diabetologia / 25.09.2015

Ramon C. Hermida Dominguez, Ph.D. Director, Bioengineering & Chronobiology Labs. Campus Universitario Vigo, PontevedraMedicalResearch.com Interview with: Ramon C. Hermida Dominguez, Ph.D. Director, Bioengineering & Chronobiology Labs. Campus Universitario Vigo, Pontevedra Medical Research: What is the background for this study? What are the main findings? Dr. Hermida Dominguez: Independent studies have shown that the asleep blood pressure (BP) mean is abetter predictor of cardiovascular risk than clinic BP or the awake blood pressure mean derived from ambulatory BP monitoring. Moreover, sleep-time hypertension is highly prevalent among patients with type 2 diabetes. In the first manuscript we tested two novel hypotheses: (i) whether sleep-time BP is a prognostic marker for future development of diabetes; and (ii) whether progressive reduction of sleep-time blood pressure actually reduces the risk of developing diabetes. The main findings indicate that sleep-time blood pressure is indeed a highly significant prognostic marker for new-onset diabetes, while clinic blood pressure measurements are not. Most important from the therapeutic point of view, the results from our prospective study also indicate lowering asleep blood pressure could indeed be a significant method for reducing the risk of developing diabetes. On the other hand, multiple clinical trials have shown that bedtime ingestion of hypertension medications of several classes is associated with improved blood pressure measurements control and increased efficacy in lowering asleep BP. In the second manuscript we investigated whether therapy with the entire daily dose of one or more antihypertensive medications at bedtime exerts better reduction in the risk of developing diabetes than ingesting all medications in the morning upon awakening. The results from this randomized clinical trial indicate a significant 57% decrease in the risk of developing diabetes in the bedtime compared to the awakening treatment regimen.
Author Interviews, Geriatrics, Hearing Loss, JAMA / 25.09.2015

Kevin J. Contrera, MPH MD Candidate Johns Hopkins School of MedicineMedicalResearch.com Interview with: Kevin J. Contrera, MPH MD Candidate Johns Hopkins School of Medicine Medical Research: What is the background for this study? What are the main findings? Response: Hearing impairment is common in older adults. The prevalence of clinically significant hearing loss doubles with every decade of life, affecting two-thirds of adults 70 years of age or older. Hearing loss has been shown to be associated with various negative cognitive, mental, and physical health outcomes. In a nationally representative sample of 1,666 adults aged 70 years or older, moderate or greater hearing impairment was associated with a 54% increased risk of mortality. This was after we statistically took into account factors that could influence this association. Essentially, the worse the patient's hearing loss, the greater the risk of death.
Author Interviews, HIV, PLoS / 25.09.2015

MedicalResearch.com Interview with: Christine Bourgeois Unité UMR 1184 / Centre IMVA CR1 INSERM, Coordinatrice site Bicêtre Le Kremlin-Bicêtre Cedex Medical Research: What is the background for this study? What are the main findings? Response: Antiretroviral therapy (ART)  treatment in HIV infected patients had successfully reduced the development of AIDS (acquired immune deficiency syndrome). However, chronic HIV infection in ART treated patients exhibit rapid uprising of viral load following ART interruption indicating that the virus is not eradicated and persist in some cellular or anatomical sites that are called “reservoir”. Secondly, ART controlled HIV-infected patients exhibit low grade inflammation developing despite efficient viral control. This low grade inflammation has been associated with non AIDS related pathologies. The aim of our work was to identify site that may combine viral persistence and inflammatory potential. We believed that adipose tissue was a very promising candidate because it included the major targets of HIV infection (CD4 T cells, and macrophages) and exhibited a highly pro-inflammatory potential. Although adipose tissue has been extensively studied as a target of antiretroviral toxicity, we readdress the role of adipose tissue as a reservoir and a site of inflammation. We demonstrated that indeed, adipose tissue from  Antiretroviral therapy controlled HIV-infected patients contained infected CD4 T cells that upon in vitro reactivation were able to produce HIV RNA. These results are extremely important because adipose tissue represents 15%-20% of body weight and is diffusely located. We thus identify a large new reservoir.
Author Interviews, Cancer Research, CT Scanning, JAMA, Melanoma, Radiology, University of Michigan / 25.09.2015

MedicalResearch.com Interview with: Benjamin Y. Scheier, MD Division of Hematology/Oncology Department of Internal Medicine University of Michigan, Ann Arbor Medical Research: What is the background for this study? What are the main findings? Dr. Scheier: Existing data suggests that PET/CT has use in the detection of metastases from multiple primary tumor types. However, PET/CT lacks data supporting its use in staging asymptomatic patients with early-stage melanoma, may inconsistently impact treatment decisions, and carries a false-positive finding risk that may detract from its use. To evaluate an evolving practice, this study aims to assess the use of PET/CT in detecting occult metastases in SLN-positive melanoma prior to resection. In this retrospective evaluation of patients with melanoma and clinically silent regional lymph nodes treated at the University of Michigan, only 7% had PET/CT findings that ultimately identified metastatic melanoma and precluded LND. Of the 46 patients who underwent a preoperative PET/CT, 15 (33%) had intense uptake distant from the primary tumor and local lymph node basin. Nine of those 15 patients (60%) had abnormalities biopsied prior to LND. Three of the 9 biopsies yielded metastatic melanoma, a false-positive rate of 67% for PET/CT in identifying distant metastases in asymptomatic patients.
JAMA, Vanderbilt / 24.09.2015

Michael A. Vella, M.D. Veterans Affairs Medical Center Vanderbilt University, NashvilleMedicalResearch.com Interview with: Michael A. Vella, M.D. Veterans Affairs Medical Center Vanderbilt University, Nashville Medical Research: What is the background for this study? What are the main findings? Dr. Vella: We are fortunate to take care of Veterans from all over Middle TN at the Tennnessee Valley Healthcare System Nashville Campus.  A significant number of Veterans travel long distances and invest time and money in order to visit with us.  We noticed that many patients undergoing "low complexity" operations like removal of gallbladders and repair of groin hernia spend a significant amount of time, energy, and, in some cases, money to travel to our facility for post operative visits relative to the amount of time they spend in their evaluations.  We wanted to look at the quality of and Veteran preference for telehealth visits (phone and video) with the idea that, if feasible, we could implement a telehealth program at our facility. In our small pilot study, 23 Veterans underwent sequential phone, video, and in-person visits.  The Veterans were evaluated on four domains at each visit type: general recovery, follow-up needs, wound care needs, and complications.  We then determined the agreement among the three visit types.  There was 100% agreement across the three visit types in the domains of general recovery and follow-up needs.  Percent agreement for wound needs and complications was 96%, reflecting a possible infection on a phone encounter that was not present on clinic or video assessment.  One Veteran in the sample had a wound infection that was detected by both phone and video and confirmed during the in-person visit.  Importantly, there were no instances in which we failed to detect a wound issue or postoperative complication by phone or video.  We also found an association between preference for telehealth visits and distance traveled, although the majority of Veterans in our study preferred telehealth visitation over traditional face-to-face encounters. We found that over the phone and video visits were not only high quality, but were preferred by our Veterans, especially those living far from our facility.  We have implemented a telehealth program for general surgery post operative follow up at our institution and currently evaluate 3-5 patients a week using telehealth modalities with plans to continue to expand.
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA / 24.09.2015

Aaron L. Schwartz, PhD Department of Health Care Policy Harvard Medical School Boston, Massachusetts MedicalResearch.com Interview with: Aaron L. Schwartz, PhD Department of Health Care Policy Harvard Medical School Boston, Massachusetts   Medical Research: What is the background for this study? What are the main findings? Dr. Schwartz: It is widely believed that much health care spending is devoted to services that provide little or no health benefit to patients. In previous work, we demonstrated that low-value services were commonly delivered to the Medicare population. In this study, we examined whether a new form of paying physicians and hospitals was effective in discouraging the use of low-value services. The payment reform we studied was the Medicare Pioneer Accountable Care Organization (ACO)  Program, a feature of the Affordable Care Act. This program financially rewards health care provider groups who keep spending under a specified budget and achieve high performance on measures of quality of care. This voluntary program employs a similar ACO payment model that some private insurers have adopted.  The hope is that such models can encourage providers to be more efficient by allowing them to share in the savings generated by lower health care spending. In previous work, we demonstrated that the Pioneer ACO Program was associated with lower overall health care spending and steady or improved performance on health care quality measures. However, it was unclear whether providers were focusing on low-value services in their attempts to reduce spending. We examined  2009-2012 Medicare claims data and measured the use of, and spending on, 31 services often provided to patients that are known to provide minimal clinical benefit. We found that patients cared for in the ACO model experienced a greater reduction in the use of low-value services when compared to patients who were not served by ACOs. We attributed a 4.5 percent reduction in low-value service spending to the ACO program. Interestingly, this was a greater reduction than the 1.2 percent reduction in overall spending attributed to the program, which suggests that providers were targeting low-value services in their efforts to reduce spending. In addition, we found that providers with the greatest rate of low-value services prior to the ACO program showed the greatest reduction in these services. We also found similar reductions in service use between services that are more likely to be requested by patients (i.e. early imaging for lower-back pain) and other services.
Author Interviews, Lancet, Mental Health Research / 24.09.2015

Professor Jane Pirkis PhD Centre for Mental Health Melbourne School of Population and Global Health University of Melbourne, AustraliaMedicalResearch.com Interview with: Professor Jane Pirkis PhD Centre for Mental Health Melbourne School of Population and Global Health University of Melbourne, Australia Medical Research: What is the background for this study? What are the main findings? Professor Pirkis:  Public sites that gain a reputation as places where people might go to seek to end their lives are a particular problem in suicide prevention.  Any suicide is tragic, but suicides at these sites have an extra level of complexity because they can lead to copycat acts and can have a major impact on people who work at or live near these sites, or visit them for other reasons.  Our meta-analysis, which pooled data from 18 individual studies from around the world,  found that three interventions work really well in reducing suicides at these sites.
  • Restricting access to means (e.g., installing barriers) can reduce suicides at these sites by 90% or more, and
  • encouraging help-seeking (e.g., installing phones that link directly to crisis services) and
  • increasing the likelihood of someone intervening (e.g., installing CCTV cameras, training staff who work at these sites) can each reduce them by around 50%, or more in some cases.  The interventions seem to work well together and complement each other too.  
Author Interviews, Critical Care - Intensive Care - ICUs, JAMA, Pulmonary Disease, University of Michigan / 23.09.2015

Thomas Valley, MD Fellow, Division of Pulmonary and Critical Care University of Michigan Ann Arbor, MIMedicalResearch.com Interview with: Thomas Valley, MD Fellow, Division of Pulmonary and Critical Care University of Michigan Ann Arbor, MI Medical Research: What is the background for this study? What are the main findings? Dr. Valley: There has been dramatic growth in intensive care unit (ICU) use over the past 30 years. As the reasons for this growth are not entirely clear, some have suggested that the ICU is a meaningful source of low-value care. The value of the ICU, however, depends on the net benefit that ICUs provide patients. Prior observational studies assessing the effectiveness of the ICU were limited because patients admitted to the ICU are inherently sicker and more likely to die than patients admitted to the general ward. Given the substantial number of patients with pneumonia who are admitted to an ICU, it is vital to understand whether admission to the ICU is beneficial. In our study of 1.1 million Medicare beneficiaries with pneumonia between 2010 and 2012, we used an instrumental variable, a statistical technique to pseudo-randomize patients based on their proximity to a hospital that uses the ICU frequently for pneumonia, in order to determine whether ICU admission saved lives and at what financial cost. An estimated 13 percent of patients were admitted to the ICU solely because they lived closest to a hospital that used the ICU frequently for pneumonia. Among these patients, ICU admission was associated with a nearly six percent reduction in 30-day mortality compared to general ward admission. In addition, there were no significant differences in hospital costs or Medicare reimbursement between patients admitted to the ICU and to the general ward.
Alzheimer's - Dementia, Author Interviews, Cleveland Clinic, JAMA / 22.09.2015

Jeffrey L. Cummings, M.D., Sc.D. Director, Lou Ruvo Center for Brain Health Camille and Larry Ruvo Chair for Brain Health Cleveland Clinic Las Vegas, NV 89106MedicalResearch.com Interview with: Jeffrey L. Cummings, M.D., Sc.D. Director, Lou Ruvo Center for Brain Health Camille and Larry Ruvo Chair for Brain Health Cleveland Clinic  Las Vegas, NV 89106  Medical Research: What is the background for this study? What are the main findings? Dr. Cummings: Agitation is a common problem in Alzheimer’s disease (AD); approximately 70% of patients with AD will experience periods of agitation.  This difficult behavior challenges patients and caregivers, adversely affects quality of life, and may precipitate institutionalization.  There are not drugs approved for treatment of agitation in Alzheimer’s disease. The study reported in JAMA showed that a drug based on a combination of dextromethorphan and quinidine (DM/Q) produced statistically significant and clinically meaningful reduction in agitation in Alzheimer’s disease patients.  The study met its primary outcome (decline in the Neuropsychiatric Inventory agitation scale in drug compared to placebo) and many of its secondary outcomes (e.g, decreases in caregiver stress).  The agent was safe and well tolerated.