Author Interviews, Heart Disease, JAMA, OBGYNE, Pediatrics / 21.10.2015

Nathalie Auger MD MSc FRCPC Crémazie Est Montréal, Québec MedicalResearch.com Interview with: Nathalie Auger MD MSc FRCPC Crémazie Est Montréal, Québec  Medical Research: What is the background for this study? What are the main findings? Dr. Auger: Congenital heart defects are the most common defects found in infants, but the causes are for the most part unknown. Only about 15-20% can be linked to a clear cause, such as a genetics or maternal infection.  Recently, certain imbalances of angiogenic signaling proteins that control blood vessel development have been identified in individuals with congenital heart defects. Similar imbalances in the same biomarkers have been observed in women with preeclampsia, a serious complication of pregnancy that occurs in 3-5% of pregnant women. Because of this similarity, we sought to determine the relationship that preeclampsia has with the presence of congenital heart defects in infants. What we found was that there was a significant association between preeclampsia and congenital heart defects. In particular, preeclampsia that was diagnosed before 34 weeks of pregnancy was significantly associated with critical and noncritical heart defects and seemed to be the driving factor. There was increased risk for defects involving all general structures of the heart, although the absolute risk of congenital heart defects was low (16.8 per 1,000 infants).
Author Interviews, Brain Injury, JAMA / 21.10.2015

Dr-Davinia-Fernandez-Espejo.jpgMedicalResearch.com Interview with: Dr Davinia Fernández-Espejo PhD School of Psychology University of Birmingham Birmingham  Medical Research: What is the background for this study? What are the main findings? Dr. Fernández-Espejo: We have previously shown that a number of patients who appear to be in a vegetative state are actually aware of themselves and their surroundings, and simply unable to show it with their external behavior. In a prior study we demonstrated that a patient who had been repeatedly diagnosed as vegetative state for 12 years was not only fully aware but able to create memories. Notably, this patient was capable to modulate their brain activity in a functional magnetic resonance imaging (fMRI) scanner to answer questions about their condition and preferences for care. In the present study we identified the reason for the dissociation between these patients’ retained awareness and their inability to respond with intentional movement. First, we used fMRI to demonstrate that a functional connection between the thalamus and the motor cortex is essential for a successful execution of voluntary movements. Second, we used diffusion tensor tractography, a technique that allows reconstructing and assessing white matter pathways in the brain, to identify damage to such connection (i.e. thalamus and motor cortex) in a paradigmatic patient who produced repeated evidence of covert awareness across multiple examinations, despite clinically appearing as being in a vegetative state.
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Health Care Systems, JAMA / 20.10.2015

MedicalResearch.com Interview with: Hannah Neprash PhD student Health Policy program Harvard University. Medical Research: What is the background for this study? Response: Hospitals are increasingly employing or purchasing physician practices. This trend started before the Affordable Care Act, as our study documents, but there is a concern that these trends may accelerate as providers reorganize to meet the challenges of new payment models that hold providers accountable for the entire spectrum of patient care, spanning inpatient and outpatient settings. It’s not clear how this change in provider market structure should affect spending. It could lead to lower spending, if care is better coordinated, reducing waste and unnecessary utilization. But, it could also lead to higher spending if larger provider groups have more market power and can negotiate higher prices with insurers. Medical Research: What are the main findings? Response: We used Medicare claims to quantify the share of physicians in major metropolitan markets that were owned or employed by a hospital. Most markets saw an increase in physician-hospital integration from 2008 to 2012. The average market saw a 3% increase in physician-hospital integration; the 75th percentile market saw a 5% increase; and the 95th percentile market saw a 15% increase. An increase in physician-hospital integration equivalent to the 75th percentile was associated with a $75 per person (or 3%) increase in annual outpatient spending among a non-elderly commercially insured population. This was driven by price increases – as we found no change in utilization. We did not find a similar association between physician-hospital integration and inpatient hospital spending. This is likely because hospital markets were already less competitive than physician markets at the beginning of our study period. When a hospital system buys a physician practice, the hospitals might not gain much bargaining power against an insurer in negotiating prices for inpatient care, but the hospital’s bargaining power could be used to negotiate higher fees for the outpatient physician practice.  That is, an insurer may not be persuaded by the threat of excluding the physician practice from its network, but the threat of excluding the entire hospital system from the insurer’s network is likely to carry more weight.
Author Interviews, Diabetes, JAMA, Surgical Research / 17.10.2015

MedicalResearch.com Interview with: Jan Peter Yska, PharmD Medical Centre Leeuwarden Department of Clinical Pharmacy & Clinical Pharmacology Leeuwarden The Netherlands Medical Research: What is the background for this study? Dr. Yska: Many patients with morbid obesity have known type 2 diabetes mellitus. Bariatric surgery effectively prevents and treats type 2 diabetes. A growing number of studies suggests that surgical treatment for obese patients may be considered an additional treatment option for the management of type 2 diabetes. However, an observational study on the remission of type 2 diabetes, using strict criteria for remisson of diabetes, after different types of bariatric surgery, based on data from general practice has not been carried out yet. Medical Research: What are the main findings? Dr. Yska: Our study included 569 obese patients with type 2 diabetes who had different types of weight-loss surgery and 1,881 similar diabetic patients who didn’t have surgery. This study confirms that bariatric surgery is successful in treating diabetes mellitus type 2. Per 1,000 person years 94.5 diabetes remissions were found in patients who underwent bariatric surgery, compared to 4.9 diabetes remissions in matched controls. A strict definition of remission of diabetes was used, much stricter than in other studies: patients should have stopped all diabetic medications with an HbA1c < 6.0% after at least 6 months of follow-up. Diabetic patients who underwent bariatric surgery had an 18-fold increased chance of diabetes remission, compared to diabetic patients who did not undergo surgery, with the greatest effect size observed for gastric bypass (adj. RR 43.1), followed by sleeve gastrectomy (adj. RR 16.6), and gastric banding (adj. 6.9). The largest decrease in  HbA1c and blood glucose levels was observed in the first two years after bariatric surgery.
Author Interviews, JAMA, Social Issues / 16.10.2015

Joseph M. Unger, PhD MS Assistant Member Fred Hutchinson Cancer Research Center Seattle, WAMedicalResearch.com Interview with: Joseph M. Unger, PhD MS Assistant Member Fred Hutchinson Cancer Research Center Seattle, WA Medical Research: What is the background for this study? What are the main findings? Response: In a prior study, we identified patient-level income as an important predictor of clinical trial participation. Because this was one of many demographic and socioeconomic factors that we examined, we sought to confirm the finding in this new study using prospective data. Again, we found that patient-level income predicted clinical trial participation. Patients with household income <$50,000/year had a 32% lower odds of participating in clinical trials than patients with household income >$50,000/year. This confirmed our previous observation and provided strong evidence that the observation of income disparities in clinical trial enrollment is valid.
Author Interviews, CDC, JAMA, Opiods, Pharmacology / 16.10.2015

MedicalResearch.com Interview with: Beth Han, MD, PhD, MPH Substance Abuse and Mental Health Services Administration U.S. Department of Health and Human Services Rockville, Maryland Medical Research: What is the background for this study? What are the main findings? Dr. Han: Since 1999, the United States has experienced increases in negative consequences and deaths associated with nonmedical use of prescription opioids. During this period, emergency department visits and drug overdose deaths involving these drugs have increased rapidly. To fully understand the current status of this public health crisis and who is currently most affected, we conducted this study based on nationally representative U.S. surveillance data. Our main study findings include:
  • Among adults age 18 through 64 years, the prevalence of nonmedical use of prescription opioids decreased from 5.4 percent in 2003 to 4.9 percent in 2013, but the prevalence of prescription opioid use disorders increased from 0.6 percent in 2003 to 0.9 percent in 2013. The 12-month prevalence of high-frequency use (200 days or more) also increased from 0.3 percent in 2003 to 0.4 percent in 2013.
  • Mortality assessed by drug overdose death rates involving prescription opioids increased from 4.5 per 100,000 in 2003 to 7.8 per 100,000 in 2013. The average number of days of nonmedical use of prescription opioids increased from 2.1 in 2003 to 2.6 in 2013. The prevalence of having prescription opioid use disorders among nonmedical users increased to 15.7 percent in 2010, 16.1 percent in 2011, 17 percent in 2012, and 16.9 percent in 2013, from 12.7 percent in 2003.
Author Interviews, Cost of Health Care, JAMA, Surgical Research / 16.10.2015

Richard S. Hoehn, MD Division of Transplant Surgery Department of Surgery, University of Cincinnati School of Medicine Cincinnati, OHMedicalResearch.com Interview with: Richard S. Hoehn, MD Division of Transplant Surgery Department of Surgery University of Cincinnati School of Medicine Cincinnati, OH Medical Research: What is the background for this study? What are the main findings? Dr. Hoehn: Safety-net hospitals are hospitals that either have a stated purpose of maintaining an “open door policy” to all patients, regardless of their ability to pay, or simply have a significantly high burden of patients with Medicaid or no insurance. As healthcare policy and reimbursement change to focus on both “quality” metrics as well as cost containment, these hospitals may find themselves in a precarious situation. Current literature suggests that increased safety-net burden corresponds to inferior surgical outcomes. If this is true, safety-net hospitals will have inferior outcomes and suffer more financial penalties than other centers. This decrease in resources may adversely affect patient care, leading to even worse outcomes and further financial penalties, potentially creating a downward spiral that exacerbates disparities in surgical care that already exist in our country. Medical Research: What are the main findings? Dr. Hoehn: Our study analyzed 9 major surgical operations using the University HealthSystem Consortium clinical database, which represents 95% of academic medical centers in the United States. We sought to determine the effect of patient and hospital characteristics on the inferior outcomes at safety-net hospitals. As expected, we found that safety-net hospitals had higher rates of patients who were of black race, of lowest socioeconomic status, had government insurance, had extreme severity of illness, and needed emergent operations. They also had the highest rates of post-operative mortality, 30-day readmissions, and highest costs associated with care. Next we performed a multivariate analysis controlling for patient age, race, socioeconomic status, and severity of illness, as well as hospital procedure-specific volume. Using this model, we found that the increased mortality and readmission rates at safety-net hospitals were somewhat reduced, but the increased costs were not affected. Safety-net hospitals still provided surgical care that was 23-35% more expensive, despite controlling for patient characteristics. This suggests that intrinsic hospital characteristics may be responsible for the increased costs at safety-net hospitals. To further investigate this finding, we analyzed Medicare Hospital Compare data and found that safety-net hospitals performed worse on Surgical Care Improvement Project (SCIP) measures, had higher rates of reported surgical complications, and also had much slower measures of emergency department throughput (time from arrival to evaluation, treatment, admission, etc). This corresponded with our finding that hospital characteristics may be driving increased costs at safety-net hospitals.
Author Interviews, JAMA, Melanoma, Technology / 15.10.2015

Ashley K. Day, Ph.D., M. Psych (Hlth) Post-Doctoral Associate Rutgers Cancer Institute of New JerseyMedicalResearch.com Interview with: Ashley K. Day, Ph.D., M. Psych (Hlth) Post-Doctoral Associate Rutgers Cancer Institute of New Jersey Medical Research: What is the background for this study? What are the main findings? Dr. Day: Skin cancer is one of the most common cancers in the US, and it is estimated that more than 9,000 Americans will die of melanoma this year. Melanoma patients have a 9-times greater risk for a diagnosis of another melanoma compared to the general population. Because of this, it is important that melanoma patients practice regular sun protection and skin self-examination behaviors. There is potential opportunity to use the Internet to deliver information and interventions to help melanoma patients engage in these behaviors. However, it is important to understand patients’ preferences. Our research explored factors associated with the receptivity of patients with melanoma to such Internet-delivered behavioral interventions. We found that, in a sample of 176 melanoma patients, the vast majority (84.1%) had Internet access and had previously sought melanoma information online (77.7%). More than two-thirds of patients (68.4%) reported being at least moderately interested in participating in an Internet-based intervention to promote engagement in sun protection and skin self-examination behaviors. Receptivity to such an intervention was higher among patients who were younger, had greater knowledge of the ABCDE signs of melanoma (looking at the asymmetry, border irregularity, color, diameter, and evolution of the mole or affected area), and were more comfortable using the Internet.
Author Interviews, JAMA, Mental Health Research, Pediatrics / 15.10.2015

[caption id="attachment_18394" align="alignleft" width="214"]Christine Walrath, PhD Public Health Division, ICF International New York, New York Dr. Christine Walrath[/caption] MedicalResearch.com Interview with: Christine Walrath, PhD Public Health Division ICF International New York, New York Medical Research: What is the background for this study? What are the main findings? Dr. Walrath: The study is part of a legislatively mandated evaluation of programs funded by the Garrett Lee Smith Memorial Act, signed into law in 2004 in recognition of the major public health problem of suicide and suicidal behavior in the US. The legislation set aside funding for campuses, states, tribes and US territories to develop, evaluate, and improve early intervention and suicide prevention programs. This is the most widely implemented group of suicide prevention programs in the United States, and allowed a unique opportunity, as reflected in the findings of this study and the study in the American Journal of Public Health in the spring (Walrath, C., Godoy Garraza, L., Reid, H., Goldston, D. B., & McKeon, R. (2015) to demonstrate that comprehensive community based suicide prevention programs appear to be effective in reducing suicide and suicide attempts. As mentioned, this is the second article on the impact of GLS suicide prevention program on youth suicide behavior. The previous one, published in APHA earlier this year, focused on suicide deaths, while this one focuses on suicide attempts. They use different sources for the outcome measures: vital records in one case and a large national survey in the other. In both cases, the county is the unit of analysis. They both take advantage of the availability of a large amount of information for relatively small areas to select counties that are essentially comparable. Making sure that the counties being compared are similar except for the GLS implementation is very important when randomized trials to assess impact of the prevention program are not feasible. The study found a reduction in the rate of suicide attempts among youth 16 to 23 following the implementation of the GLS program in counties exposed to these prevention activities when compared with similar counties that were not exposed to such intervention. The difference is significant and substantial: 4.9 less attempts per thousand youths. There is no evidence of a simultaneous change in the suicide attempt rate among adults, a group that was not targeted by GLS. The findings are consistent with those from the previous study, which found a substantial reduction in suicide mortality among youths 10-24 following GLS implementation: 1.3 fewer deaths per one hundred thousand youths.
Author Interviews, JAMA, Pain Research / 13.10.2015

MedicalResearch.com Interview with: Julie M. Fritz, PT, PhD, FAPTA Professor, Department of Physical Therapy Associate Dean for Research, College of Health University of Utah Salt Lake City, UT  84106 Medical Research: What is the background for this study? What are the main findings? Dr. Fritz: Low back pain affects up to 80% of adults at some point in their lives and back pain is among the most common reasons why someone visits their primary care provider.  Despite how common back pain is, the health care system does a surprisingly poor job of managing patients with the condition. There are many things that can happen at the initial primary care visit for back pain that are unhelpful or may even delay recovery such as ordering an MRI or prescribing opioids. Most practice guidelines recommend that primary care providers avoid ordering an MRI or opioid pain medication, reassure the patient that they will begin to feel better quickly and then wait a few weeks before considering referral to physical therapy.  Others have suggested that earlier use of physical therapy may be more beneficial to patients.  We conducted this study to compare early physical therapy with a wait-and-see approach.
Author Interviews, Cleveland Clinic, JAMA, Multiple Sclerosis / 13.10.2015

Dr. Jeffrey Cohen MD Director Mellen Center for Multiple Sclerosis Treatment and Research Director of the Experimental Therapeutics Program Cleveland Clinic Main CampusMedicalResearch.com Interview with: Dr. Jeffrey Cohen MD Director Mellen Center for Multiple Sclerosis Treatment and Research Director of the Experimental Therapeutics Program Cleveland Clinic Main Campus MedicalResearch: What is the background for this study? What are the main findings? Dr. Cohen: Medications are a major contributor to the high cost of Multiple Sclerosis (MS) care.  As medications go off patent, there is the opportunity to develop generic versions with lower cost.  This trial was conducted after extensive in vitro and animal studies supported the equivalence of a generic glatiramer acetate to the brand drug Copaxone. The trial showed that generic and brand glatiramer acetate have equivalent efficacy as measured by MRI and clinical endpoints, safety, and tolerability.
Author Interviews, Cost of Health Care, Dermatology, JAMA / 12.10.2015

Pinar Karaca-Mandic, PhD on behalf of the authors Associate Professor Division of Health Policy and Management University of MinnesotaMedicalResearch.com Interview with: Pinar Karaca-Mandic, PhD on behalf of the authors Associate Professor Division of Health Policy and Management University of Minnesota  Medical Research: What is the background for this study? What are the main findings? Dr. Pinar Karaca-Mandic: Lymphedema is a common disease affecting several million people in the U.S, in particular cancer patients. The disease is associated with edema, recurrent cellulitis, loss of physical function, stress, and of course diminished quality of life. It is also associated with high health care costs. While there is no cure for lymphedema currently, it can be managed well with proper care. Pneumatic compression devices offer a valuable lymphedema self-management option. However, there is limited information on the effectiveness of these devices using data from real world settings.   In this paper, we used administrative and claims-based data from a major national insurer to examine the effectiveness of an advanced pneumatic compression device. We examined health economics costs as well as clinical health utilization outcomes associated with the use of the device. We found that the receipt of the device is associated with large declines in cellulitis rates. For example, among the cancer patients, cellulitis infection rates by 79% (from 21% to 4.5%). We saw similar reductions for patients without cancer (75%). We also observed large reductions in the use of manual therapy and in lymphedema related outpatient hospital visits. Finally, lymphedema related outpatient costs decreased substantially – for example for the cancer patients, they halved reducing from about $1,500 to $700 among cancer patients, and they declined by 65% from about $1,700 to $600 for patients without cancer. Among cancer patients, total lymphedema-related costs per patient, excluding medical equipment, declined by 37% and declined by 36% in patients without cancer.
Author Interviews, Dermatology, JAMA, Melanoma / 12.10.2015

Eleni Linos, MD DrPH, MPH Assistant Professor UCSF School of MedicineMedicalResearch.com Interview with: Eleni Linos, MD DrPH, MPH Assistant Professor UCSF School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Linos: Google offers a remarkable service for non-profit organizations-in our case we used AdWords, Google’s keyword-specific advertising service, to disseminate skin cancer prevention messages to people searching for tanning. Our question was simple: can we send a skin cancer prevention message to someone who is searching for information about tanning beds online? From this preliminary data we found that it is possible to use online advertising to reach a large, targeted audience with specific health messages. Or Online advertising for prevention is a brand new concept. It builds on the knowledge of online advertisers and marketers-and uses this knowledge for good. We hope other social media and technology companies will join this effort to provide precise, tailored health messages to those who need them the most. Marketing is a powerful tool when it comes to getting the message out to a larger audience. As we are thinking of using Google Ads for our services, we were recommended to compare Adwords software and tools, as it would make the decision of finding the right software a lot easier. As technology becomes apparent within businesses, it makes sense for us and other companies to use this to their advantage.
Author Interviews, JAMA, Ophthalmology / 08.10.2015

Prof-Jeremy-A-GuggenheimMedicalResearch.com Interview with: Professor Jeremy A. Guggenheim School of Optometry & Vision Sciences Cardiff University Cardiff, UK Medical Research: What is the background for this study? Dr. Guggenheim: An increased risk of myopia (nearsightedness) in first-born vs. non-first-born individuals was noticed in a 2013 study, which focused on 4 cohorts of children and young adults. We wanted to know whether the link between birth order and myopia was present in an earlier generation – before the invention of mobile phones and other gadgets. Also, first-born children tend to get slightly higher exam grades than do non-first-born children, an effect that has been attributed to slightly greater investment of time and energy by parents in the education of their first-born child. A high level of education is a well-known risk factor for myopia, therefore we were interested to find out whether the association between birth order and myopia was attributable to the slightly greater educational exposure of first-born individuals 
Author Interviews, JAMA, PTSD / 08.10.2015

Kathryn Magruder, Ph.D., M.P.H. Johnson Veterans Affairs Medical Center Charleston, S.C.MedicalResearch.com Interview with: Kathryn Magruder, Ph.D., M.P.H. Johnson Veterans Affairs Medical Center Charleston, S.C. Medical Research: What is the background for this study? What are the main findings? Dr. Magruder: There has been lots of attention and concern over PTSD in your younger veterans — both male and female -- and in male Vietnam veterans.  Too often the women who served during the Vietnam Era have been largely overlooked.  We felt like we owed it to them to understand better their responses to their wartime experiences — even if 40 years later.  It’s never too late to do the right thing! Our main finding is that the women who served in Vietnam had high prevalence of PTSD (20% lifetime, 16% current) and this was not attributable to cases that had developed prior to entering the military.  This was higher than the women who served near Vietnam or in the United States.  When we looked at their reported experiences during the Vietnam Era, the women who were in Vietnam reported higher levels of exposure to all of the items on our scale.  It was these experiences — especially sexual harassment, performance pressures, and experiences with triage and death — that explained their higher levels of PTSD.
Author Interviews, JAMA, Mental Health Research, Surgical Research / 08.10.2015

Dr. Junaid A. Bhatti MBBS PhD Sunnybrook Health Sciences Centre Toronto, ONMedicalResearch.com Interview with: Dr. Junaid A. Bhatti MBBS PhD Sunnybrook Health Sciences Centre Toronto, ON Medical Research: What is the background for this study? What are the main findings? Dr. Bhatti:  Bariatric surgery remains an important option for morbidly obese patients where other obesity management options fail. It is a safe procedure with mortality risk not higher than any other major procedure of this type. Some studies report that some patients may experience psychological stress following surgery. Studies on the long-term outcomes noted that there was a higher suicide risk in bariatric patients as compared to the general population. It was not clear whether these risks increased following surgery. In this study, we used the data of bariatric patients from Ontario who underwent surgery between 2006 and 2011. We assessed their emergency room visits three years before and three years following surgery. We looked into whether these patients had significantly more visits related to suicide attempts before compared to post surgery period. Overall, about 111 patients (1%) of the cohort had suicide attempts during follow-up. What we saw is that suicide risk increased by 50% following surgery than before surgery period. The risks were higher, but not significantly higher than others, if they were 35 years or older or from low-income or rural settings. The emergency services utilization of suicide attempts following surgery was more intense for the visits before surgery.
Author Interviews, JAMA, Surgical Research / 08.10.2015

Dr-Isam-Atroshi.pngMedicalResearch.com Interview with: Isam Atroshi, MD, PhD Department of Orthopedics Hässleholm-Kristianstad Lund University Lund, Sweden Medical Research: What is the background for this study? Dr. Atroshi: Although carpal tunnel release surgery is a very common operation and we know that, in the short term, the results in most patients are very good, we do not know that much about long-term outcomes. In fact, before our study there have been no reliable data about outcomes beyond 5 years and whether or not the results differ depending on type of surgery. Medical Research: What are the main findings? Dr. Atroshi: In our study patients with carpal tunnel syndrome who had participated in a randomized clinical trial of open versus endoscopic release were evaluated 11 to 16 years after they had the surgery. We were able to follow 124 of the 128 patients (3 had died and only 1 declined); this almost complete follow-up is unique in clinical research and a major strength of the study. Our main findings are that the good short-term results of surgery are durable in the majority of the patients irrespective of the type of surgery whether open or endoscopic. Two-thirds of the patients can expect to continue being completely free of symptoms more than 10 years after surgery. About a third of the patients still experience some numbness or tingling in the fingers but in most of these the symptoms are only mild and do not cause functional difficulties. More than 85% are very satisfied with the results of the surgery after more than 10 years. However, up to 6% of patients who have surgery could need further surgery because of symptom recurrence.
Author Interviews, JAMA, Orthopedics / 07.10.2015

Dr. Anne Moseley Senior Research Fellow, Musculoskeletal Division The George Institute for Global Health Sydney Australia MedicalResearch.com Interview with: Dr. Anne Moseley Senior Research Fellow, Musculoskeletal Division The George Institute for Global Health Sydney Australia  Medical Research: What is the background for this study? What are the main findings? Dr. Moseley: Ankle fracture is a common injury and is treated with reduction (realignment), sometimes with surgical fixation, followed by a period of immobilization while the fracture heals. Rehabilitation addresses the detrimental effects of the ankle fracture and the subsequent immobilization. Supervised exercise programmes are a common form of rehabilitation traditionally offered to some patients. The benefits of supervised exercise after immobilization for ankle fracture has been unclear. We conducted a clinical trial to determine the effectiveness and cost-effectiveness of a supervised exercise programme and advice about self-management ("rehabilitation" group) compared to advice about self-management alone. Contrary to accepted wisdom, we found that a supervised exercise programme did not offer advantages over physical therapist-prescribed self-management.
Author Interviews, JAMA, Surgical Research / 07.10.2015

[caption id="attachment_18193" align="alignleft" width="250"] Prof. Tom Øresland and Johannes Schultz Prof. Tom Øresland and
Dr. Johannes Schultz[/caption] MedicalResearch.com Interview with: Johannes Kurt Schultz, MD Department of Gastrointestinal Surgery Akershus University Hospital, Lørenskog, Norway Faculty of Medicine, University of Oslo, Oslo, Norway  Medical Research: What is the background for this study? What are the main findings? Dr. Schultz: Acute perforated diverticulitis is a serious condition requiring urgent surgical attention. Laparoscopic peritoneal lavage has been described as a tempting option in treatment of these patients instead of today’s standard management with resection of the diseased bowel segment. Previous non-randomized studies have suggested that this novel mini-invasive approach is superior to traditional surgery. Our randomized trial is the largest study conducted to investigate these two treatment options. We demonstrate that the new treatment is not superior to the established surgical management. In fact, the reoperation rate in the laparoscopic lavage group was higher and some sigmoid cancers were not identified in the lavage group and thus left in-situ.
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, 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, 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, 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, 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.
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