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Annals Internal Medicine, Author Interviews, Orthopedics / 11.02.2016

MedicalResearch.com Interview with: Teppo L N Järvinen MD PhD Sports Medicine, Orthopedic Surgery, Clinical Trials University of Helsinki, Helsinki MedicalResearch: What is the background for this study? What are the main findings? Dr. Järvinen: When the primary analysis of the FIDELITY trial was published in the New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa1305189), showing that arthroscopic partial meniscectomy (APM) is no better than sham/placebo surgery in relieving knee pain and improving knee function in patients with a degenerative meniscus tear and no knee OA, the study was met with unprecedented criticism, even hostility. The advocates of APM (which was at the time and probably still is the most common orthopedic procedure in the US and most other “western” countries) argued – despite the fact that our study only confirmed what several other high-quality RCTs had suggested – that  arthroscopic partial meniscectomy is a highly beneficial procedure in the “right” patients. Among the subgroups of patients allegedly having a favourable response to APM, those experiencing “mechanical symptoms” — sensations of knee catching or locking — represented the most obvious group who would benefit from  arthroscopic partial meniscectomy surgery. This assertion is plausible because knee catching or locking is believed to result from a mechanical blocking mechanism in the knee - a piece of the joint structure lodging between the articular surfaces. Because degenerative meniscal tears are very common pathologic alterations found by arthroscopy in the knee joints of patients with degenerative knee disease, trimming the torn meniscus should, in theory at least, improve the apparent mechanical derangement. Against this background, it is somewhat unusual that no study has yet specifically tested whether  arthroscopic partial meniscectomy is effective in alleviating these symptoms. Mechanical symptoms are usually thought to be a solid indication for arthroscopic knee surgery. This is what we set out to examine in our secondary analysis of our sham-surgery controlled FIDELITY trial.

Our key finding: arthroscopic partial meniscectomy (partial resection of a torn meniscus) does not reduce or alleviate mechanical symptoms any better than a sham surgical procedure.

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Annals Internal Medicine, Author Interviews, Kidney Disease, Weight Research / 09.02.2016

MedicalResearch.com Interview with: Yoosoo Chang MD PhD Kangbuk Samsung Hospital Sungkyunkwan University School of Medicine Seoul, Korea Medical Research: What is the background for this study? What are the main findings? Response: There is substantial controversy and a lot of interest on the health implications of metabolically healthy obesity, that is, subjects who are obese but do not have metabolic abnormalities in spite of their high body mass index. The risk for chronic kidney disease (CKD) among obese patients without metabolic abnormalities is unknown. In this cohort study of South Korean men and women, metabolically healthy overweight and obese participants had increased incidence of Chronic Kidney Disease (CKD) compared with normal-weight participants. (more…)
Annals Internal Medicine, Author Interviews, Biomarkers, Colon Cancer, Kaiser Permanente / 27.01.2016

MedicalResearch.com Interview with: Douglas A. Corley, MD, PhD Gastroenterologist and Research Scientist III Division of Research Kaiser Permanente Oakland, CA  Medical Research: What is the background for this study? What are the main findings? Dr. Corley: Colorectal cancer is a leading cause of cancer death in the United States, so understanding how cancer screening tests for this cancer are used and if they are effective is extremely important. There are two commonly used tests for colorectal cancer screening in the United States: colonoscopy and fecal immunochemical tests (also known as "FIT"). Colonoscopy requires a bowel preparation to clean you out and is invasive but, if normal, it is done infrequently (every ten years). FIT is simple to do at home but, to be most effective, needs to be done every year. This has the advantage of potentially picking up cancers that grow between tests. There are few studies that have looked at how well FIT picks up cancers when used year after year. If a test picks up most cancers, it is said to be very "sensitive" for picking up cancer. Most studies only looked at 1 or 2 years of use for how well FITdetected cancers. It is possible that the first year of use may "clear out" most of the easily detectable cancers and that FIT might not work as well in subsequent years. This very large study over several years at Kaisier Permanente, where we use both colonoscopy and FIT for colorectal cancer screening, looked at whether FIT worked as well at detecting cancer in years 3 and 4 as it did the first time someone used it. We found that the sensitivity was highest in the first year, likely from clearing out cancers that were there for a while and easily detected, but that in subsequent years the sensitivity, though 5-10% lower, remained high. Also, most people who started with FIT continued doing it, suggesting that it is both feasible and effective for colorectal cancer screening. (more…)
Annals Internal Medicine, Author Interviews, Menopause, Pain Research / 23.01.2016

MedicalResearch.com Interview with: Carolyn Ee, MBBS Department of General Practice University of Melbourne Carlton, Victoria, Australia Medical Research: What is the background for this study? What are the main findings? Response: Hot flushes affect up to 90% of women during the menopause and beyond, and women are turning to complementary therapies. Our randomised sham-controlled trial found no difference between real and sham acupuncture (given with a blunt needle) for hot flushes, with both groups improving by around 40% at the end of treatment. (more…)
Annals Internal Medicine, Author Interviews, Breast Cancer, Mammograms / 12.01.2016

MedicalResearch.com Interview with: Susan K. Boolbol, MD, FACS Chief, Division of Breast Surgery Chief, Appel-Venet Comprehensive Breast Service Co-Director, Breast Surgery Fellowship Mount Sinai Beth Israel Associate Professor of Surgery Icahn School of Medicine at Mount Sinai New York, NY 10003 Medical Research: What is the background for these new recommendations? Dr. Boolbol: To make this final recommendation, the Task Force conducted a comprehensive review of the science since its 2009 recommendation and considered the public comments it received on its 2015 draft recommendation statement. Based on all of this, the task force issued their recommendations. Medical Research: What are the main changes from current guidelines? Dr. Boolbol: Presently, there are several different guidelines and recommendations regarding screening mammography. Depending on the group issuing the guidelines, the recommendations vary from annual mammography beginning at 40 years old to biennial mammograms from 50 to 74 years old. The Task Force continues to find that the benefit of mammography increases with age, and recommends biennial screening in women ages 50 to 74. (more…)
Annals Internal Medicine, Author Interviews, Emergency Care, Opiods, Pain Research / 29.12.2015

MedicalResearch.com Interview with: Marc R. Larochelle, MD, MPH Assistant Professor of Medicine Boston Medical Center Boston, MA  Medical Research: What is the background for this study? What are the main findings? Dr. Larochelle: More than 16 thousand people in the United States die from prescription opioid overdose each year. However, morbidity extends well beyond fatal overdose - nearly half a million emergency department visits each year are related to prescription opioid-related harms. Emergency department visits for misuse of opioids represent an opportunity to identify and intervene on opioid use disorders, particularly for patients who receive prescriptions for opioids to treat pain. We examined a cohort of nearly 3000 commercially insured individuals prescribed opioids for chronic pain who were treated for a nonfatal opioid overdose in an emergency department or inpatient setting. We were interested in examining rates of continued prescribing after the overdose and the association of that prescribing with risk of repeated overdose. We found that 91% of individuals received another prescription for opioids after the overdose. Those continuing to receive opioids at high dosages were twice as likely as those whose opioids were discontinued to experience repeated overdose. (more…)
Annals Internal Medicine, Author Interviews, Diabetes, Pharmacology / 13.12.2015

MedicalResearch.com Interview with: Francesco Zaccardi, MD Diabetes Research Centre Leicester General Hospital, Leicester, United Kingdom Medical Research: What is the background for this study? Dr. Zaccardi: Nowadays there are different classes of drugs for the treatment of hyperglycaemia in patients with type 2 diabetes and, within the same class, multiple drugs are available.Glucagon-like peptide-1 receptors (GLP-1RAs) are a relatively new class of treatments that improve glucose control and reduce body weight, without an increased risk for hypoglycaemia. To date, however, no direct comparisons between once-weekly GLP-1RAs have been reported. In this view, the aim was to assess the comparative efficacy and safety profile of GLP-1RAs using a network meta-analysis, a methodology that allows the estimation of the comparative effectiveness of multiple treatments in the absence of direct evidence. Medical Research: What are the main findings? Dr. Zaccardi: There are several differences in the efficacy and safety profiles of once-weekly glucagon-like peptide-1 receptor agonists (GLP-1RAs). Some of these drugs evidenced a better glucose control or body weight reduction, while other had an increased risk of side effects, such as nausea. Compared to other once-weekly GLP-1RAs, dulaglutide 1.5mg, once weekly exenatide, and taspoglutide 20mg showed a greater reduction of HbA1c, fasting plasma glucose, and body weight. Marginal or no differences were found for blood pressure and blood lipid levels. While taspoglutide 20mg had the highest risk of nausea, the risk of hypoglycaemia among once-weekly GLP-1RAs was comparable. (more…)
Annals Internal Medicine, Author Interviews, Dermatology, Gastrointestinal Disease, Immunotherapy / 09.12.2015

MedicalResearch.com Interview with: Isabelle Cleynen  PhD University of Leuven  Medical Research: What is the background for this study? What are the main findings? Dr. Cleynen : Ulcerative colitis and Crohn’s disease, together inflammatory bowel disease (IBD), are characterized by chronic inflammation of the gastrointestinal tract. Treatment for IBD usually involves drug therapy including anti-inflammatory drugs and immune system repressors, amongst which biologics as the anti-TNF antibodies used for patients with moderate to severe IBD. Although these TNF-blocking drugs are effective in many patients with immune-mediated disorders like psoriasis, rheumatoid arthritis and spondylarthropathies, and IBD, several case reports and series showed that some patients developed troubling skin problems (including psoriasis and eczema), causing them to stop the anti-TNF treatment. It is however not clear how often these skin problems develop in IBD patients treated with anti-TNF, and what could be the predisposing factors. In a retrospective cohort of 917 IBD patients initiated on anti-TNF therapy in a single center, we have studied which patients did and did not develop skin problems, what type of skin problems, how they were treated, and whether the lesions resolved upon treatment. We found that about one third of the patients developed skin problems while being treated with anti-TNF drugs. The most common type was psoriasiform eczema, often occurring in flexural regions, the scalp, and genitalia. The time between starting the TNF-blocking drug and the appearance of the skin problem varied from less than half a year to more than 4 years. Quite surprisingly, we found that the cumulative dose of the treatment, or drug serum levels were not different in skin and non-skin lesion patients. Skin lesion patients however seemed to be younger when diagnosed with IBD and when started on anti-TNF agents, more often had anti-nuclear and dsDNA antibodies (both auto-immune factors), and a higher number of skin-disease related genetic risk variants. Most patients had a good response to treatment of their skin problem. About 10% of the patients who developed skin problems, however, stopped the TNF-blocking treatment because of this issue. (more…)
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease / 24.11.2015

MedicalResearch.com Interview with: Dr. Tianhua He MD Beijing China, 100005 Medical Research: What is the background for this study? What are the main findings? Response: The prevalence of Hepatitis C (HCV) infection is high (17%) in US prisons. And about 30% of all HCV-infected persons in US spend part of the year in correctional facilities. However, most state prisons offer no routine screening for Hepatitis C. Undiagnosed and untreated inmates, after releasing, will contribute to the spread of the disease in society. HCV infection is now the leading cause of liver cancer, and the most common indication for liver transplant. With the recently launched highlyy effective antiviral drugs, previous studies have shown that treating infected prisoners was cost-effective. However, no studies yet have evaluated the effect of interventions including screening and treatment among prisoners on prevention of Hepatitis C transmission and reduction of disease burden, neither the cost effectiveness of such interventions. (more…)
Annals Internal Medicine, Author Interviews, Critical Care - Intensive Care - ICUs, Technology / 18.11.2015

MedicalResearch.com Interview with: Daniel Niven MD, MSc, FRCPC Department of Critical Care Medicine Department of Community Health Sciences O'Brien Institute for Public Health Cumming School of Medicine, University of Calgary  Medical Research: What is the background for this study? Dr. Niven: Fever (temperature 38.0 degrees Celsius or higher) and hypothermia (temperature less than 36.0 degrees Celsius) are commonly included in diagnostic criteria for certain disorders, influence clinical decision making, and are associated with an increased risk for death in select patient populations. Therefore, accurately measuring body temperature is important. Unfortunately, the accuracy of many commonly employed thermometers is not well defined.  Medical Research: What are the main findings? Dr. Niven: This systematic review and meta-analysis examined the accuracy of thermometers measuring temperature from peripheral sites (for example, forehead measurement devices) relative to central sites (for example, the bladder) in adults and children. From 75 studies and 8,682 patients, this meta-analysis found that the majority of commonly used peripheral thermometers do not have clinically acceptable accuracy among adults and children. This was especially the case for patients with fever and hypothermia, where peripheral temperature measurements may be as much as 1 to 2 degrees higher or lower than actual body temperature. Sensitivity for detection of fever was low (64%), whereas specificity was high (96%). (more…)
Annals Internal Medicine, Asthma, Author Interviews, Pharmacology / 16.11.2015

MedicalResearch.com Interview with: Michael Miligkos, MD, MS Laboratory of Biomathematics, University of Thessaly School of Medicine Larissa, Greece Medical Research: What is the background for this study? What are the main findings? Dr. Miligkos: Asthma is one of the most common chronic diseases with and has considerable social and economic burdens. Although inhaled corticosteroids constitute the current gold standard of maintenance treatment, leukotriene-receptor antagonists (LTRAs) have the advantages of oral once- or twice- daily dosing and, apparent avoidance of the adverse effects associated with long-term corticosteroid therapy. In addition, their mechanisms of action theoretically predicts a good response in patients with specific asthma “phenotypes”. This systematic review investigated the use of all marketed LTRAs in usual licensed doses as asthma controller medications compared with placebo and found that administration of a LTRA to adults and adolescents with asthma significantly reduced the risk for an exacerbation. In trials of LTRA monotherapy, LTRAs significantly improved asthma control compared with placebo, whereas only some measures of asthma control were significantly improved in trials of LTRAs used as add-on use therapy to ICSs. (more…)
Annals Internal Medicine, Author Interviews, Heart Disease, Surgical Research / 11.11.2015

Dr. Giuseppe Andò University of Messina, Messina, ItalyMedicalResearch.com Interview with: Dr. Giuseppe Andò University of Messina, Messina, Italy Medical Research: What is the background for this study? Dr. Andò: Patients’ preference for radial access for coronary angiography and percutaneous intervention is paralleled by an almost complete abolition of access-site bleeding. Given the deleterious impact of any clinically relevant bleeding event on short- and long-term outcomes, the use of radial access should translate into a reduction in net adverse events, especially in patients with high risk of bleeding such as those with an acute coronary syndrome. Nonetheless, studies conducted over the past decade by pioneers of radial access were relatively small and not sufficiently compelling to affect guidelines and endorse a change in current practice. Medical Research: What are the main findings? Dr. Andò: We have pooled in the present study 4 well-conducted, large, multicenter studies with data from centers with different expertise in radial procedures across America, Europe, Asia and Oceania. We demonstrate that the use of radial access can reduce mortality in patients with acute coronary syndromes undergoing invasive management by a consistent reduction in major bleeding. (more…)
Annals Internal Medicine, Author Interviews, Diabetes, Heart Disease / 30.10.2015

MedicalResearch.com Interview with: Dr. Yung-Tai Chen MD Division of Nephrology Department of Medicine Taipei City Hospital Heping Fuyou Branch Taipei, Taiwan Medical Research: What is the background for this study? What are the main findings? Dr. Chen: Recent studies concluded that dipeptidyl peptidase-4 (DPP-4) inhibitors can provide glycemic control but also raised concerns about the risk of heart failure in patients with Type 2 Diabetes Mellitus (T2DM). However, large-scale studies of the effects of DPP-4 inhibitors versus sulfonylureas (SUs) on cardiovascular outcomes when used as add-ons to metformin therapy remain scarce. Our study showed that compared to SUs, DPP-4 inhibitors were associated with a lower risk of all-cause mortality, stroke and hypoglycemia as an add-on to metformin. Besides, dipeptidyl peptidase-4 inhibitors had comparable risks of hospitalization for heart failure to sulfonylureas as add-ons to metformin. (more…)
Annals Internal Medicine, Author Interviews, Cognitive Issues, Cost of Health Care, End of Life Care / 28.10.2015

MedicalResearch.com Interview with: Amy S. Kelley, MD, MSHS Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai New York, NY Medical Research: Why is it so important to understand the financial burdens families may face in providing end-of-life care for a loved one and why do you think the burdens may be greater for dementia than for other medical conditions? Dr. Kelley: Understanding the financial risks that older adults face in the last years of life is important for individuals and families, in order to plan and save, if possible. It is also important for our policy makers, in particular, to know about these costs so that this information can help shape health and social policy that will best serve our society. Households of those with dementia face the greatest burden of costs, on average, particularly with regard to out-of-pocket expenses and the costs of caregiving.  Many costs related to daily care for patients with dementia are not covered by health insurance, and these care needs, including everything from supervision, to bathing and feeding, may span several years. (more…)
Annals Internal Medicine, Author Interviews, Diabetes, Heart Disease, Nutrition / 13.10.2015

Iris Shai MD PhD Professor of Nutrition and Epidemiology of Chronic Diseases Dep. of Public Health Faculty of Health SciencesMedicalResearch.com Interview with: Iris Shai MD PhD Professor of Nutrition and Epidemiology of Chronic Diseases Dep. of Public Health Faculty of Health Sciences Medical Research: What is the background for this study? What are the main findings? Dr. Shai: Despite enormous contribution of observational studies, clinical recommendations for moderate alcohol consumption remain controversial, particularly for people with diabetes, due to lack of long-term, randomized controlled trials, which are needed for evidence-based medicine. People with diabetes are more susceptible to developing cardiovascular diseases than the general population and have lower levels of HDL-c. Also, it is uncertain if red wine confers any advantage over white wine or whether the ethanol is the primary mediator of alcoholic beverages related beneficial associations.  The two-year CArdiovaSCulAr Diabetes and Ethanol (CASCADE) RCT was performed among 224 controlled diabetes patients (aged 45 to 75), who generally abstained from alcohol. Red wine was found to be superior in improving overall metabolic profiles, mainly by modestly improving the lipid profile. As for glycemic control and blood pressure, the effect of both, red or white wine, was dependent on ADH enzyme polymorphism, suggesting personalized approach. Overall, wine of either type did not effect change in liver function tests, adiposity, or adverse events/symptoms. However, sleep quality was significantly improved in both wine groups, compared with the water control group. All comparisons were adjusted for changes in clinical, medical and drug therapy parameters occurring among patients during the years of the study. The trial completed with adherence rate of 87 percent after 2 years. (more…)
Annals Internal Medicine, Author Interviews, Colon Cancer / 25.08.2015

Søren Friis, Senior Scientist, Associate Professor, MD Danish Cancer Society Research Center Danish Cancer Society Department of Public Health University of Copenhagen Faculty of Health Institute of Clinical Medicine Department of Clinical Epidemiology Aarhus University DenmarkMedicalResearch.com Interview with: Søren Friis, Senior Scientist, Associate Professor, MD Danish Cancer Society Research Center Danish Cancer Society Department of Public Health University of Copenhagen Faculty of Health Institute of Clinical Medicine Department of Clinical Epidemiology Aarhus University Denmark Medical Research: What is the background for this study? Dr. Friis: Although laboratory, clinical, and epidemiological studies have all provided strong evidence for protection against colorectal cancer from regular use of aspirin, the optimal dose and duration of use for cancer prevention remain to be established. Medical Research: What are the main findings? Dr. Friis: Continuous use of low-dose aspirin for five or more years was associated with a reduced risk of colorectal cancer, but overall long-term use (continuous or non-continuous) was not. Long-term, high-intensity use (average of ≥0.3 daily doses) of non-aspirin NSAIDs was associated with a substantially reduced risk of colorectal cancer, particularly for NSAIDs with the highest COX-2 selectivity. The results for long-term continuous users of low-dose aspirin should be interpreted cautiously, since these patients comprised only a small proportion of the low-dose aspirin users and might have a risk profile different from that of the general population. (more…)
Annals Internal Medicine, Author Interviews, Infections, Respiratory / 16.08.2015

Reed A.C. Siemieniuk, MD Department of Clinical Epidemiology & Biostatistics Ontario CanadaMedicalResearch.com Interview with: Reed A.C. Siemieniuk, MD Department of Clinical Epidemiology & Biostatistics Ontario Canada Medical Research: What is the background for this study? What are the main findings? Dr. Siemieniuk: Local and cytokine-mediated systematic inflammatory responses help clear bacterial pathogens in community-acquired pneumonia (CAP), but often they can also cause harm. Pneumonia is the most common cause of the acute respiratory distress syndrome (ARDS), an often fatal inflammatory complication. Two randomized trials were published earlier this year, each of which suggested the possibility of  benefit from adjunctive corticosteroid therapy. We decided to perform a systematic review and meta-analysis, taking all available data into consideration. Corticosteroids may be effective for reducing the incidence of ARDS by 6%, the need for mechanical ventilation by 5%, and mortality by 3% (all moderate confidence). They also reduce time to clinical stability and time to discharge by approximately 1 day (high confidence). For an interactive summary of findings table that shows the study's findings, please see: http://isof2.epistemonikos.org/#/finding/550bc6acf30d0c43083e63a0. (more…)
Annals Internal Medicine, Author Interviews, Cancer Research / 14.08.2015

Thomas F. Imperiale, MD Indiana University Medical Center Regenstrief Institute Indianapolis, IN 46202 MedicalResearch.com Interview with: Thomas F. Imperiale, MD Indiana University Medical Center Regenstrief Institute Indianapolis, IN 46202   Medical Research: What is the background for this study? Dr. Imperiale: The background is that colorectal cancer (CRC) screening is effective and cost-effective, but it is underutilized (35% of eligible persons in the U.S. are not current with screening; 28% have never been screened) and inefficient (persons at low risk have colonoscopy; persons at high risk have stool blood testing or nothing). We know about several risk factors for colorectal cancer and advanced, precancerous polyps. We wanted to see how those factors perform together in stratifying (or separating) risk among the 85% of the U.S. population that is considered to be “average-risk”. Medical Research: What are the main findings? Dr. Imperiale: We found that age, sex, whether a first-degree relative has or had colorectal cancer, cigarette smoking, and waist circumference do a good job in separating risk into the 4 categories described in the paper.  When tested in the validation subgroup, the risk estimates reproduced themselves fairly well.  (more…)
Annals Internal Medicine, Author Interviews, Pain Research, Rheumatology / 30.07.2015

MedicalResearch.com Interview with: Raveendhara R Bannuru MD, PhD, FAGE Director, Center for Treatment Comparison and Integrative Analysis (CTCIA) Asst Professor of Medicine, Tufts University School of Medicine Special & Scientific Staff, Center for Arthritis and Rheumatic Diseases Tufts Medical Center Boston, MA Medical Research: What is the background for this study? Dr. Bannuru: Placebos are used to determine the efficacy of a wide variety of treatments for medical conditions such as osteoarthritis. A sound understanding of potential differences among placebos is essential for determining the relative efficacy of such treatments. Medical Research: What are the main findings? Dr. Bannuru: Our results indicate that different types of placebos do in fact differ in efficacy. Placebo injections and topical placebos were both found to be more effective than orally administered placebos for reducing knee osteoarthritis pain. (more…)
Accidents & Violence, Annals Internal Medicine, Author Interviews, Brigham & Women's - Harvard, Pediatrics / 24.06.2015

MedicalResearch.com Interview with: Lois K. Lee, MD, MPH Division of Emergency Medicine Boston Children's Hospital Boston, MA 02115 Medical Research: What is the background for this study? What are the main findings? Response: Motor vehicle crashes remain a leading cause of death for children and adults in the U.S. Seat belts are the single most effective protective device to decreased death and mitigate injuries in the event of a motor vehicle crash. Our study found that states with primary seat belt laws, where a motorist can be ticketed only for not wearing a seat belt, demonstrated a 17% decreased fatality rate, compared to states with secondary seat belt laws, where a motorist must be cited for another violation first before also getting ticketed for not wearing a seat belt. We found this difference was robust even after controlling for other motor vehicle safety legislation and state demographic factors. We found that although seatbelts prevent deaths, they don't completely stop injury so if you have been in an accident that wasn't your fault then you might want to look for a place like the Parnall Law Firm to see if they can help you get compensation for your injuries. (more…)
Annals Internal Medicine, Author Interviews, Duke, Weight Research / 18.06.2015

William S. Yancy, Jr., MD, MHSc Research Associate Center for Health Services Research in Primary Care Durham, NC 27705 Associate Professor Department of Medicine Duke University Medical CenterMedicalResearch.com Interview with: William S. Yancy, Jr., MD, MHSc Research Associate Center for Health Services Research in Primary Care Durham, NC  27705 Associate Professor Department of Medicine Duke University Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. Yancy: A number of studies have compared different diet approaches for weight management with many of these finding that several different diets can result in significant weight loss. This has led many experts to advise that we should offer a choice among these diet options to our patients who are seeking to lose weight. We know that adherence is the best predictor of weight loss during dietary interventions, so the thought is that patients will adhere better to a diet that they prefer, resulting in more successful weight loss. In addition, allowing choice enhances patient autonomy, which is patient-centered and has been shown to increase treatment adherence. However, the previous studies of various diet approaches did not let people choose a diet, so we don’t actually know if letting them choose will lead to better weight loss. Our study specifically tested this assumption. We randomized participants to a condition where they were allowed to choose between 2 common weight loss diets or to a condition where they were randomly assigned to one of the diets. The 2 diets we used were a low-carbohydrate diet without calorie restriction and a low-fat diet combined with calorie restriction. Participants received counseling about the diets, and about behavioral strategies and physical activity, in 19 group sessions over the span of 12 months. They also received 6 phone calls with motivational counseling in the latter half of the program. (more…)
Annals Internal Medicine, Author Interviews, Infections / 11.06.2015

MedicalResearch.com Interview with: Dr. Philip Molloy, MD Imugen Medical Director Medical Research: What is the background for this study? What are the main findings? Response: There is a newly described tick-borne infection in the US, first case published in NEJM Man 2013 (from Imugen researchers).  We then developed and validated both PCR and serologic blood tests.  Physicians  started ordering these tests, and many additional cases were uncovered, 51 of which are described in this paper. Medical Research: What should clinicians and patients take away from your report? Response: Be aware of yet another pathogen transmitted to humans from ticks, and don't assume it's Lyme.  Tests are available to help sort it out.  Imugen has been offering these tests commercially since 2013. (more…)
Annals Internal Medicine, Author Interviews, Insomnia, Psychological Science / 10.06.2015

MedicalResearch.com Interview with: Dr David Cunnington Sleep Physician & Director Melbourne Sleep Disorders Centre East Melbourne Australia Medical Research: What is the background for this study? What are the main findings? Response: Insomnia is a very common problem with 15-20% of adults having chronic insomnia, that is, trouble getting to sleep or staying asleep most days for  3 months or more. The most commonly used treatment is sleeping pills or hypnotics, however, they don’t address the underlying disorder, and come with potential side effects. Also, sleeping tablets just mask the symptoms, and as soon as tablets are stopped, symptoms recur. People with chronic insomnia think and behave differently around sleep, which perpetuates their symptoms. The key to improving symptoms in the long run is addressing thoughts and behaviours around sleep, which is what cognitive behaviour therapy does. Our study showed that cognitive behaviour therapy reduced the time taken to get to sleep by 20 minutes and reduced the amount of time spent awake after falling asleep by nearly 30 minutes. These effects were maintained out to 12 months after treatment. These reductions in time taken to get to sleep and time spent awake are similar to those reported in clinical trials of hypnotics.  (more…)
Annals Internal Medicine, Author Interviews, Beth Israel Deaconess, Hospital Readmissions / 04.06.2015

MedicalResearch.com Interview with: Kelly L. Graham, MD, MPH Instructor in Medicine Harvard Medical School Division of General Medicine and Primary Care Beth Israel Deaconess Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. Graham: 30-day readmissions have become a standard quality metric used to represent inpatient quality of care and unnecessary healthcare utilization.  Effective 10/1/2009, hospitals with excess 30-day readmissions have been faced with financial penalties.  Experts have questioned the validity of this metric, and have raised concerns about the potential unintended consequence of creating health disparities, as critical access hospitals caring for the most socioeconomically burdened patients have faced the highest penalties. We were interested to see if factors associated with readmissions in the early part of the 30 day window (0-7 days post-discharge) differed from those associated with the later window (8-30 days post-discharge), ultimately attempting to better understand the "pathophysiology" of a readmission. Our findings suggest that early readmissions are associated with many factors, including those related to the index admission (acute illness burden and suboptimal discharge timing), and factors that are not related to the index hospitalization, such as chronic illness burden and social determinants of health.  In contrast, late readmissions were only associated with chronic illness burden and social determinants of health. (more…)
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease / 26.04.2015

Stefan Zeuzem, MDProfessor of Medicine Chief Department of Medicine Goethe University Hospital FrankfurtMedicalResearch.com Interview with: Stefan Zeuzem, MD Professor of Medicine Chief Department of Medicine Goethe University Hospital Frankfurt Medical Research: What is the background for this study? What are the main findings? Dr. Zeuzem: Interferon- and ribavirin-free regimens are needed to treat HCV infection. The objective of the study was to evaluate the safety and efficacy of grazoprevir (NS3/4A-protease-inhibitor) and elbasvir (NS5A-inhibitor) in previously untreated patients with chronic hepatitis C (without and with liver cirrhosis). Among 421 participants, 194 (46%) were women, 157 (37%) were non-white, 382 (91%) had genotype-1 infection, and 92 (22%) had cirrhosis. Of 316 patients receiving immediate treatment, 299/316 achieved SVR12 (undetectable HCV 12 weeks after treatment), including 144/157  with genotype-1a, 129/131  with genotype-1b, 18/18  with genotype-4, 8/10 with genotype-6, 68/70 with cirrhosis, and 231/246 without cirrhosis. Virologic failure occurred in 13 patients including 1 breakthrough and 12 relapses, and was associated with baseline NS5A-polymorphisms and emergent NS3- and/or NS5A-variants. Serious adverse events occurred in 9 (2.8%) and 3 (2.9%) patients in the active and placebo arms, respectively; none were considered drug-related. (more…)
Annals Internal Medicine, Author Interviews, Johns Hopkins, Weight Research / 06.04.2015

Kimberly Gudzune, MD, MPH Assistant Professor; The Johns Hopkins University School of Medicine Core Faculty; Welch Center for Prevention, Epidemiology, and Clinical Research The Johns Hopkins Digestive Weight Loss CenterMedicalResearch.com Interview with: Kimberly Gudzune, MD, MPH Assistant Professor; The Johns Hopkins University School of Medicine Core Faculty; Welch Center for Prevention, Epidemiology, and Clinical Research The Johns Hopkins Digestive Weight Loss Center Medical Research: What is the background for this study? What are the main findings? Dr.Gudzune: Changes in healthcare policy may encourage healthcare providers to screen their patients for obesity, so it is critical to then have a weight management plan if obesity is identified. Recent guidelines recommend that clinicians consider referring patients to high intensity weight loss programs. Commercial weight loss programs may be one of the options available, so providers need to know which programs help people lose weight and keep it off. We found that only 11 out of 32 programs that we looked at had rigorous studies reporting on weight loss, which means that we do not know whether most programs work. Several well-known commercial programs have been scientifically tested and two programs, Weight Watchers and Jenny Craig, achieved significant weight loss that was sustained 12 months later. (more…)
Annals Internal Medicine, Author Interviews, Surgical Research, University of Pittsburgh / 06.04.2015

Anthony Delitto, PT, Ph.D, FAPTA Professor and Chair Department of Physical Therapy Associate Dean for Research, SHRS School of Health and Rehabilitation Sciences Pittsburgh,MedicalResearch.com Interview with: Anthony Delitto, PT, Ph.D, FAPTA Professor and Chair Department of Physical Therapy Associate Dean for Research, SHRS School of Health and Rehabilitation Sciences University of Pittsburgh Medical Research: What is the background for this study? What are the main findings? Dr. Delitto: I work with a team, many of whom were authors on the paper, and we see a lot of patients with lumbar spinal stenosis. Some of them did very well with Physical Therapy and avoided surgery. Some people didn’t do well and we ended up having surgery. We really wanted to do a study that compared, in a randomized format, doing surgery vs. a non-surgical approach to lumbar spinal stenosis. The idea we had was to really put the two approaches head to head – a randomized trial of surgery vs. physical therapy for people with lumbar spinal stenosis. We decided only to recruit patients after they had consented to surgery in order to avoid the pitfalls of previous studies where people crossed over after being assigned to a group, for example, being assigned to surgery and then deciding against having surgery. Medical Research: What should clinicians and patients take away from your report? Dr. Delitto: Probably the biggest point to put across to physicians, patients and practitioners, one of the things we realized was: patients don’t exhaust all of their non-surgical options before they consent to surgery. And physical therapy is one of the non-surgical options. The obvious finding is, when you compare the two groups, they seem to do the same. The results were equivalent at two years. Now, embedded in that, there are patients who did well in surgery, and patients who failed in surgery. There are patients who did well in Physical Therapy, and there are patients who failed with PT. But when we looked across the board at all of those groups, their success and failure rates were about the same. So it tells us that for the most part there were equivalent outcomes at two years. (more…)
Annals Internal Medicine, Author Interviews, CDC, Infections / 17.03.2015

MedicalResearch.com Interview with: Dr.Yecai Liu Division of Global Migration and Quarantine Centers for Disease Control and Prevention, Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Response: Since the early 1900s, immigrants and refugees applying for a visa to come to the United States undergo a medical examination that includes tuberculosis (TB) screening. In 2007, CDC began implementing the new screening guidelines, which require people suspected of having TB to receive a much more sensitive sputum culture test to confirm TB to ensure that those individuals who do have TB receive treatment before they arrive in the United States. These requirements have now been completely rolled out to all countries with U.S.-bound immigrants and refugees. From 2007 through 2012, half of the 3.2 million arrivals of immigrants and refugees to the United States were screened for TB by the new screening guidelines. Out of more than 4,000 TB cases diagnosed by the new screening guidelines during this period, nearly 2,200 were smear-negative and culture positive. These cases would likely have been missed under the previous screening requirements. The results of this study showed that the updated overseas screening guidelines led to a roughly one-third decrease in the annual number of TB cases among foreign-born persons within their first year in the United States. (more…)
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease, MD Anderson / 17.03.2015

Jagpreet Chhatwal Ph.D. Assistant Professor, Department of Health Services Research Division of Cancer Prevention and Population Sciences The University of Texas MD Anderson Center Houston, TXMedicalResearch.com Interview with: Jagpreet Chhatwal Ph.D. Assistant Professor, Department of Health Services Research Division of Cancer Prevention and Population Sciences The University of Texas MD Anderson Center Houston, TX Medical Research: What is the background for this study? What are the main findings? Dr. Chhatwal: More than two million people in the U.S. are infected with Hepatitis C (HCV), a virus found in the liver. In 2012, the Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force both recommended a one-time hepatitis C screening for baby boomers – people born between the years 1946 and 1964. Last year, the Food and Drug Administration approved the medications sofosbuvir and ledipasvir for Hepatitis C treatment. The newly approved oral regimen comes at a staggering price to payers – as much as $1,125 per day. As a result, several payers have questioned if the price is justified. The study results show that using new therapies is cost-effective in the majority of patients. However, the budget required to treat all eligible patients would be $136 billion over the next five years. Compared with the old drugs, new therapies would cost an additional $65 billion, whereas the cost offsets would be only $16 billion. (more…)
Annals Internal Medicine, Author Interviews, Heart Disease, Outcomes & Safety / 11.03.2015

MedicalResearch.com Interview with: Harindra C. Wijeysundera MD PhD FRCPC Interventional Cardiology, Schulich Heart Centre, Sunnybrook Health Sciences Centre Scientist, Sunnybrook Research Institute (SRI) Assistant Professor, Dept. of Medicine & Institute of Health Policy, Management and Evaluation University of Toronto Adjunct Scientist, Institute for Clinical Evaluative Sciences (ICES) Toronto, ON, Canada Medical Research: What is the background for this study? What are the main findings? Dr. Wijeysundera: Given the rapid increase in health care costs, there has been growing emphasis on the more rational use of resources.  One such effort is the development of appropriate use  criteria.  Such criteria have been developed in many areas of medicine, including in cardiology for diagnostic angiography.  The underlying rationale for a test to be appropriate is that its anticipated benefit outweighs its anticipated harms.  However, there is a paucity of empirical evidence validating this conceptual framework. Our goal was to validate the 2012 appropriate use criteria for diagnostic coronary angiography, by examining the relationship between the appropriateness of a coronary angiography in patients with suspected stable ischemic heart disease and the proportion of patients who were found to have obstructive coronary artery disease.  We used data obtained from the Cardiac Care Network registry of Ontario, Canada.  This is a population based registry of all cardiac procedures in the province of Ontario.  We examined 48,336 patients and found that 58.2% of angiographic studies were classified as appropriate, 10.8% were classified as inappropriate, and 31.0% were classified as uncertain. Overall, 45.5% of patients had obstructive CAD. In patients with appropriate indications for angiography, 52.9% had obstructive CAD, with 40.0% undergoing revascularization. In those with inappropriate indications, 30.9% had obstructive CAD and 18.9% underwent revascularization; in those with uncertain indications, 36.7% had obstructive CAD and 25.9% had revascularization. Although more patients with appropriate indications had obstructive CAD and underwent revascularization (P < 0.001), a substantial proportion of those with inappropriate or uncertain indications had important coronary disease.  Our conclusion was that despite the association between appropriateness category and obstructive CAD, this study raises concerns about the ability of the appropriate use  criteria to guide clinical decision making. (more…)