Author Interviews, Brigham & Women's - Harvard, JAMA, Prostate Cancer, Surgical Research, Testosterone / 04.01.2016

MedicalResearch.com Interview with: Quoc-Dien Trinh MD Assistant Professor, Harvard Medical School Brigham and Williams Hospital  Medical Research: What is the background for this study? What are the main findings? Dr. Trinh: Among elderly Medicare beneficiaries with metastatic prostate cancer, surgical castration is associated with lower risks of any fractures, peripheral arterial disease, and cardiac-related complications compared to medical castration using GnRH agonists. (more…)
Author Interviews, Duke, Heart Disease, Kidney Disease / 03.01.2016

MedicalResearch.com Interview with: Renato D. Lopes MD, MHS, PhD Duke University Medical Center Duke Clinical Research Institute Durham, NC 27705   John P. Vavalle, MD, MHS Assistant Professor of Medicine Division of Cardiology UNC Center for Heart & Vascular Care Medical Research: What is the background for this study? What are the main findings?  Dr. Lopes: Patients with varying degrees of underlying renal failure who presented for primary percutaneous coronary intervention (PCI) for the treatment of ST-segment elevation myocardial infarction (STEMI) were studied as part of the APEX-AMI trial. Baseline renal dysfunction portends a worse prognosis in patients undergoing PCI. However, the association between clinical outcomes and angiographic results with baseline renal function in this population of STEMI patients is not clearly defined.  We report the results of a trial population with a full spectrum of underlying renal function (normal to dialysis dependent) and developed a prediction model for the development of acute kidney injury following primary percutaneous coronary intervention. In summary, patients with worse underlying renal function had worse angiographic outcomes, higher mortality, and were less likely to be treated with evidence-based medications.  The rate of acute kidney injury (AKI) after PCI appears to increase with worsening underlying renal function, except for those with Class IV chronic kidney disease where the rate of AKI was lowest.  Our novel prediction model for the development of AKI found that the strongest predictors of AKI were age and presenting in Killip Class III or IV. (more…)
Author Interviews, OBGYNE, Surgical Research / 03.01.2016

MedicalResearch.com Interview with: Gabriele Saccone, MD Department of Neuroscience Reproductive Sciences and Dentistry School of Medicine University of Naples Federico II Naples, Italy Vincenzo Berghella, MD Department of Obstetrics and Gynecology Division of Maternal-Fetal Medicine Thomas Jefferson University Philadelphia, PA 19107, USA Medical Research: What is the background for this study? What are the main findings? Dr Saccone: Preterm birth (PTB) is the number one cause of perinatal mortality in many countries, including the US. The annual societal economic burden associated with Preterm birth in the US was at least $26.2 billion in 2006, or about $51,600 per infant born preterm. Defining risk factors for prediction of PTB is an important goal for several reasons.
  • First, identifying women at risk allows initiation of risk-specific treatment.
  • Second, it may define a population useful for studying particular interventions.
  • Finally, it may provide important insights into mechanisms leading to Preterm birth.Prior surgery on the cervix, such as cone biopsy and LEEP procedures, is associated with an increased risk of spontaneous PTB. History of uterine evacuation for abortion, by either induced termination of pregnancy (I-TOP) or treatment of spontaneous abortion (SAB) by suction dilation and curettage (D&C) or by dilation and evacuation (D&E), which may involve mechanical and/or osmotic dilatation of the cervix, has been associated with an increased risk of PTB in some studies, but not in others. Our systematic review and meta-analysis pooled data from 36 studies including 1,047,683 women with prior abortion. We found that history of surgical abortion is an independent risk factor for Preterm birth and also other obstetric complications including low birth weight and small for gestational age, while prior medical abortion with first-trimester mifepristone or mid-trimester misoprostol was not associated with an increased risk of PTB. The biological plausibility to explain our findings is not completely clear. However, three main hypotheses can be made.
  • The increased risk of Preterm birth could result from the overt or covert infection following surgically uterine evacuation,
  • as well as from mechanical trauma to the cervix leading to increased risk of cervical insufficiency.
  • Moreover, surgical procedures including curettage during D&E may result in scar tissue that may increase the probability of faulty placental implantation.
(more…)
Author Interviews, Breast Cancer, Immunotherapy, PLoS / 02.01.2016

MedicalResearch.com Interview with: David Gallego Ortega, PhD Group Leader, Tumour Development Group Cancer Division Garvan Institute of Medical Research Conjoint Lecturer, St Vincent’s Clinical School, Faculty of Medicine, UNSW, Australia National Breast Cancer Foundation and Cure Cancer Foundation Australia Fellow  Medical Research: What is the background for this study? What are the main findings? Dr. Ortega: We have identified a protein that 'goes rogue’ in breast cancer. The protein, called Elf5, ‘tricks' the immune system producing inflammation so that the immune cells now help the breast cancer cells to spread throughout the body. Cancer spread, or metastasis, is the ultimate cause of death of breast cancer patients, so we are very excited about our discovery because it opens the door to explore anti-inflammatory drugs that can be combined with existing therapies. We have found that luminal breast cancer patients that present high levels of Elf5 progress earlier in their disease. The Luminal subtype is the most common type of breast cancer, so these therapies will potentially benefit to 2/3 of all breast cancer patients. (more…)
Author Interviews, BMJ, Urinary Tract Infections / 02.01.2016

MedicalResearch.com Interview with: Ildikó Gágyor MD Senior researcher in primary care Department of General Practice University Medical Center Göttingen Göttingen, Germany Medical Research: What is the background for this study? What are the main findings? Dr. Gágyor: Uncomplicated urinary tract infection is a common problem for women. Affected patients are usually treated with antibiotics to combat both unpleasant symptoms and to combat infection. However, prescription of antibiotics for a self-limiting condition, contributes to increased resistance rates posing a serious long-term threat to public health. In a double blind randomised controlled trial we examined whether symptomatic treatment of uncomplicated urinary tract infection with ibuprofen reduces the rate of antibiotic prescriptions without a significant increase in symptoms, recurrences, or complications. In all, 494 women were randomly assigned to receive: either ibuprofen for three days and antibiotics only if symptoms are persistent; or antibiotic treatment with fosfomycin. Results showed that antibiotic use could be reduced significantly: of the 248 women in the ibuprofen group two thirds recovered without antibiotics and one third received antibiotics subsequently. Women in the ibuprofen group had a higher symptom burden but in both groups, symptoms decreased within the first week (Figure 1). Six cases of pyelonephritis occurred, one in the fosfomycin group, five in the ibuprofen group. (more…)
Author Interviews, Autism, Pediatrics, Pharmacology / 02.01.2016

MedicalResearch.com Interview with: Diane C. Chugani, PhD Director, Nemours Neuroscience Research Nemours—AI DuPont Hospital for Children Wilmington, DE 19803  Medical Research: What is the background for this study? What are the main findings? Dr. Chugani: This clinical trial was performed at 5 sites throughout the country and was lead by our team at Wayne State University and Children’s Hospital of Michigan in Detroit.  The study was sponsored by the National Institutes of Health through an Autism Centers of Excellence Network grant.  Based upon our previous PET scanning studies showing low  serotonin synthesis  in the brains of young children with autism, we tested whether the serotonin-like drug buspirone would be beneficial in treating young children with Autism Spectrum Disorder.  We found that low doses of buspirone were effective in reducing repetitive behaviors with no significant side effects in this group of children. (more…)
Alcohol, Author Interviews, PLoS / 02.01.2016

MedicalResearch.com Interview with: Dr. Florian Naudet INSERM Centre d'Investigation Clinique 1414 Faculté de Médecine, Centre Hospitalier Universitaire de Rennes Laboratoire de Pharmacologie Expérimentale et Clinique Rennes, France Medical Research: What is the background for this study? What are the main findings? Dr. Naudet: To reduce harm, alcohol-dependent individuals are usually advised to abstain from drinking, but controlled (moderate) drinking may also be helpful. To help people reduce their alcohol consumption, the European Medicines Agency recently approved nalmefene for use in the treatment of alcohol dependence in adults who consume more than 60 g (for men) or 40 g (for women) of alcohol per day. However, several expert bodies have concluded that nalmefene shows no benefit over naltrexone, an older treatment for alcohol dependency, and do not recommend its use for this indication. This is problematic because randomised controlled trials (RCTs) should lead to objective conclusions concerning treatment efficacy and this was not the case concerning nalmefene's approval. We therefore performed a meta-analysis of aggregated data to enable an objective reappraisal of the efficacy of nalmefene for relevant health outcomes and on alcohol consumption endpoints at both 6 months (+/- 1 month) and 1 year (+/- 1 month). We identified five RCTs that met the criteria for inclusion in our study. All five RCTs (which involved 2,567 participants) compared the effects of nalmefene with a placebo; none was undertaken in the population specified by the European Medicines Agency approval. Among the health outcomes examined in the meta-analysis, there were no differences between participants taking nalmefene and those taking placebo in mortality (death) after six months or one year of treatment, in the quality of life at six months. The RCTs included in the meta-analysis did not report other health outcomes. Participants taking nalmefene had fewer heavy drinking days per month at six months and one year of treatment than participants taking placebo, and their total alcohol consumption was lower. These differences were small in terms of clinical significance. Additionally, more people withdrew from the nalmefene groups than from the placebo groups, often for safety reasons. Thus, attrition bias cannot be excluded. (more…)
Author Interviews, CT Scanning, JAMA, Lung Cancer / 02.01.2016

  MedicalResearch.com Interview with: Jan Marie Eberth, PhD Assistant Professor, Department of Epidemiology and Biostatistics Deputy Director, SC Rural Health Research Center Core Faculty, Statewide Cancer Prevention and Control Program Arnold School of Public Health University of South Carolina Columbia, SC 29208 Medical Research: What is the background for this study? Dr. Eberth: With the breakthrough findings of the National Lung Screening Trial released in 2011, professional organizations have largely embraced population-based screening guidelines for patients at high risk for lung cancer. The diffusion of screening into broad clinical practice has been slow to be adopted, given concerns about the efficacy of screening in community settings, lack of insurance reimbursement and unclear billing logistics, and difficulty weighing the pros of screening against the known cons (e.g., high rate of false positives). Medical Research: What are the main findings? Dr. Eberth: Provisions of the Patient Protection and Affordable Care Act mandate that US Preventive Services Task Force-recommended screening tests with an A or B rating receive full insurance coverage by private payers. The Centers for Medicare and Medicaid (CMS) soon thereafter approved full coverage for lung cancer screening in high-risk patients (i.e., those aged 55-77 years, asymptomatic for lung cancer, tobacco smoking history of 30+ pack-years, is a current smoker or has quit smoking within the past 15 years). Coding is rapidly evolving; as of November 2015, CMS released HCPCS codes G0296 (pre-screening counseling visit) and G0297 (screening visit). These codes will be accepted retroactively starting January 4, 2016 to the date of the final coverage determination (back to February 5, 2015). No coinsurance or deductibles shall be charged to the patient for either the pre-screening counseling visit, or the screening visit itself. Quality of screening  is an important, but understudied, area of research. Several publications have focused on aspects of quality programs, and how to achieve quality benchmarks, but data is still being collected to assess variation across programs. In the future, data from screening registries, such as the American College of Radiology Lung Cancer Screening Registry (LCSR), can be leveraged to examine these quality metrics and improve risk-prediction models for lung cancer. (more…)
Author Interviews, Education, Flu - Influenza, Vaccine Studies / 30.12.2015

MedicalResearch.com Interview with: Mubdiul Ali Imtiaz, MD Department of Internal Medicine Rutgers University, New Jersey Medical School Newark, NJ 07103 Medical Research: What is the background for this study? Response: Resident physicians (RPs) were defined to be all individuals enrolled in a graduate medical education training program in a healthcare setting. There were 611 resident physicians enrolled in 47 post-graduate residency and fellowship programs at RU-NJMS during the 2013-2014 academic year. Influenza immunization was strongly recommended, but not mandatory for Resident physicians during 2013-2014. A link to the online survey using a standardized, anonymous, self-administered questionnaire was emailed by the program-chiefs to their respective RPs to collect demographic characteristics, influenza immunization status during the 2013-2014 and the previous season, and reasons for non-vaccination. Medical Research: What are the main findings? Response: The overall self-reported immunization rate of  Resident physicians in 2013-2014 was 76.7%. The immunization rate did not differ by the location of medical school attended (P= 0.55) or sex (P= 0.69). Among the respondents, 95.8% had influenza vaccination in the past and 83.1% received influenza vaccine during 2012-2013 flu season. History of influenza vaccination ever and in 2012-2013 were both significantly associated with receiving the vaccine during the 2013-2014 season (P<0.01 for both). The most common reason for not being vaccinated (38.6%) was “lack of time to get immunized” (see Figure 1). The most common cited motivating factors to be vaccinated during the next influenza season among the NVRPs were “making vaccinations in the workplace at convenient locations and times” (43.2%), “availability of mobile flu vaccination carts in hospital floors” (40.9%), and “establishing mandatory flu vaccination for employment” (36.4%). (more…)
Author Interviews, Hospital Acquired, Infections, OBGYNE, Outcomes & Safety / 30.12.2015

MedicalResearch.com Interview with: Muhammad A. Halwani, MSc, PhD Faculty of Medicine, Al Baha University Al Baha, Saudi Arabia.  Medical Research: What is the background for this study? What are the main findings? Response: The study idea was based on examining the current rate of post cesarean section infections that were detected in the hospital at the time. It was hypothesized that the detected infections were actually less than the real number identified. Therefore, we challenged the traditional surveillance method that was applied in the hospital with a new enhanced methodology which is telephone follow-ups for patients who under go C-section operations. Our main finding proved that this new applied method was able to detect more cases than the traditional one. Using phone calls as a gold standard, the sensitivity of the standard methodology to capture SSI after cesarean increased to 73.3% with the new methodology identifying an extra five cases. These patients represented 26.3% (5 of 19) of all the patients who developed SSI. In other words, for every 100 C-section procedures there were 2.6% missed cases which the new method was able to detect. The duration of the calls ranged from 1 to 5 minutes and were well received by the patients. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Heart Disease, JAMA, Kidney Disease, Surgical Research / 29.12.2015

MedicalResearch.com Interview with: Azra Bihorac, MD, MS and Department of Anesthesiology Charles Hobson, MD, MHA Department of Surgery, Malcolm Randall Veterans Affairs Medical Center, Department of Health Services Research, Management, and Policy University of Florida Gainesville Florida  Medical Research: What is the background for this study? What are the main findings? Response:   Background is that as ICU clinicians we see acute kidney injury (AKI) and chronic kidney disease (CKD) frequently and have to deal with the consequences, and as AKI researchers we have shown that even mild and moderate AKI – even if there is complete resolution of the AKI by the time of hospital discharge – result in significantly increased morbidity and mortality for the surgical patient. Furthermore we are aware of the existing relationship between CKD and cardiovascular mortality, and we wanted to explore any relationship between AKI and cardiovascular mortality in the vascular surgery patients that we care for on a daily basis. The most important finding was the strong association between AKI and cardiovascular mortality in these patients – equal to the well-known association between CKD and cardiovascular mortality. (more…)
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…)
Author Interviews, Johns Hopkins, Surgical Research, Vitamin D / 29.12.2015

MedicalResearch.com Interview with: Leigh A. Peterson, PhD, MHS Post-doctoral fellow Department of Surgery - Bayview Johns Hopkins School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Peterson: From our previous study published in Obesity Surgery earlier this year, we knew that vitamin D deficiency and insufficiency was very common in our bariatric surgery candidates (71.4% < 20 ng/ml and 92.9% < 30 ng/ml). We wanted to explore the effect of this deficiency on adverse outcomes after bariatric surgery such as wound healing, infection, and extended hospital stay. We turned to the Nationwide Inpatient Sample to answer this question, as it would contain enough surgeries to detect changes in even less frequent outcomes such as wound infection. But blood concentration of vitamin D is not available, so we used a traditional method to estimate group vitamin D status with season and geography. Vitamin D comes from the sun, so people have the most vitamin D in summer and in sunnier places. In 932,091 records of bariatric surgeries from 2001 to 2010, we saw that more adverse outcomes occurred during winter—January to March, the time of lowest vitamin D status—compared to summer or even spring or fall. Additionally, most adverse outcomes occurred in northern latitudes (≥ 37°N) compared to sunnier southern latitudes. (more…)
Author Interviews, Breast Cancer, Stem Cells / 29.12.2015

MedicalResearch.com Interview with: Jenny C. Chang, M.D. Director, Houston Methodist Cancer Center Professor of Medicine, Weill Cornell Medical College Full Member, Houston Methodist Research Institute Houston, Texas  MedicalResearch: What is the background for this study? What are the main findings? Dr. Chang: The current treatment of triple negative breast cancer, which accounts for about 15% of all cases of breast cancer, is still based on surgery, radiotherapy, and classic chemotherapy because, unlike other types of breast cancer, it is not amenable to hormonal or targeted therapy. However, research findings suggest that cancer stem cells, which represent about 2% of all neoplastic cells, may play a role in disease relapses and the formation of distant metastases. As these cells may represent a therapeutic target, the aim of this study is to modify the micro-environment in which they reproduce by acting directly on the chemokines involved in inflammation because there is evidence indicating a possible mechanism of action of reparixin, a molecule developed by Dompé, an Italian biopharmaceutical company, in the targeted treatment of these cancers. (more…)
Author Interviews, Exercise - Fitness, Pediatrics, Weight Research / 28.12.2015

MedicalResearch.com Interview with: Michael Rebold, PhD, CSCS Assistant Professor Department of Exercise Science Bloomsburg University Bloomsburg, PA 17815 Medical Research: What is the background for this study? Dr. Rebold: The obesity epidemic seen in children.  If we can make children at a young age physically active then maybe they will be more likely to be physically active into their adult years.  Since parents are the primary role models for younger children we must find ways to get the parents involved in physical activity as well, because children will model their parent's behaviors. Medical Research: What are the main findings? Dr. Rebold: The main findings from this study are that when parents are actively participating in activities with their children, their children spend more time in physical activities and less time in sedentary activities. When parents are not present and children are alone, then they spend more time engaging in sedentary activities and less time in physical activities.  When parents are actively watching their children, children still engaged in a significant more amount of time in physical activities than sedentary activities when compared to the alone condition but still not as great as with parents participating. Children also liked and were motivated to engage in additional physical activity time when parents were participating with them. (more…)
Author Interviews, Brigham & Women's - Harvard, End of Life Care, JAMA, Leukemia / 28.12.2015

MedicalResearch.com Interview with: Oreofe O. Odejide, MD Instructor in Medicine, Harvard Medical School Dana-Farber Cancer Institute Medical Research: What is the background for this study? What are the main findings? Dr. Odejide: The care that patients with hematologic cancers receive near the end of life is distinct from patients with solid tumors. For instance, previous research has shown that patients with blood cancers are more likely to receive intensive care at the end of life such as chemotherapy within 14 days of death, intensive care unit admission within 30 days of death, and they are less likely to enroll in hospice. My colleagues and I hypothesized that timing of discussions regarding end-of-life preferences with patients may contribute to these findings, and we wanted to examine hematologic oncologists’ perspectives regarding end-of-life discussions with this patient population. We conducted a survey of a national sample of hematologic oncologists obtained from the publicly available clinical directory of the American Society of Hematology. We received responses from 349 hematologic oncologists, giving us a response rate of 57.3%. In our survey, we asked hematologic oncologists about the typical timing of EOL discussions in general, and also about the timing of the first discussion regarding resuscitation status, hospice care, and preferred site of death for patients. Three main findings emerged:
  • First, the majority of hematologic oncologists (56%) reported that typical EOL discussions occur “too late.”
  • Second, hematologic oncologists practicing primarily in tertiary care settings were more likely to report late discussions compared to those in community settings.
  • Third, a substantial proportion of respondents reported that they typically conduct the initial discussions regarding resuscitation status, hospice care, and preferred site of death at less optimal times.
(more…)
Abuse and Neglect, Accidents & Violence, Author Interviews, Sexual Health / 27.12.2015

MedicalResearch.com Interview with: Anna Austin, MPH PhD Student UNC Gillings School of Global Public Health MedicalResearch: What is the background for this study? What are the main findings? Response: Several studies have examined experiences of childhood abuse among individuals who identify as lesbian, gay, or bisexual (LGB), but there has been relatively little research exploring experiences of other types of childhood trauma, like witnessing domestic violence between parents or growing up with a parent who is an alcoholic, among LGB individuals. We know from the study on adverse childhood experiences (ACEs) conducted by Kaiser Permanente and the Centers for Disease Control and Prevention that the greater number of childhood traumas and adversities an individual experiences, the greater the risk for poor health later in life. There have also been a number of studies that have demonstrated health disparities by sexual orientation, with LGB adults typically having worse health than heterosexual adults. We were interested in the role that multiple types of adverse childhood experiences play in the development of poor adult health outcomes among LGB individuals. In this study, we captured 8 categories of ACEs. We captured 3 categories of childhood abuse (sexual, physical, and emotional abuse) and 5 categories of household dysfunction (adult mental illness, substance abuse, and domestic violence in the household; incarceration of a household member; and parental divorce or separation). LGB adults were more likely to report each of these 8 categories of ACEs than heterosexuals, with the largest differences found for sexual abuse, adult mental illness in the household, and incarceration of a household member. LGB adults were also more likely to report having experienced multiple ACEs. Forty-two percent of LGB adults compared to 24 percent of heterosexual adults reported having experienced between 3 to 8 ACEs. We also found that LGB adults were more likely to report poor adult health like smoking, HIV risk behaviors, 14 or more days of poor physical or mental health in the past 30 days, asthma, depression, and disability than heterosexuals. However, after we accounted for the number of ACEs each individual reported, LGB adults were no longer more likely to report smoking, binge drinking, and 14 or more days of poor physical health in the past 30 days. (more…)
Author Interviews, Pediatrics, Technology / 27.12.2015

MedicalResearch.com Interview with: Dr. Deirdre Murray Senior Lecturer/Consultant Paediatrician Dept of Paediatrics and Child Health University College Cork Clinical Investigations Unit Cork University Hospital Principal Investigator Irish Centre for Fetal and Neonatal Translational Research  Medical Research: What is the background for this study? What are the main findings? Dr. Murray: Everyday in clinic, and in waiting rooms and in restaurants we see parents are handing over their smart phones and iPads to occupy young children. The nature of childhood play is changing rapidly. The exact frequency and the effect of this change in unknown. We wanted to first measure how young children 12-36 months are using touchscreen devices. We asked parents who attended our paediatric unit, both outpatients and short stay inpatients to answer a study specific questionnaire. We found that of the 82 parents surveyed, 82% of parents owned a touchscreen device, and of these 87% gave their device to their toddler to play with. Thus 71% of toddlers had access to a touchscreen device. This rate was similar across the age range studied (12-36 months). By parental report, 24 months was the median age of ability to swipe (IQR: 19.5–30.5), unlock (IQR: 20.5–31.5) and active looking for touch-screen features (IQR: 22–30.5), while 25 months (IQR: 21–31.25) was the median age of ability to identify and use specific touch-screen features. Overall, 32.8% of toddlers could perform all four skills. Touchscreen usage was common at a very young age and from 2 years of age toddlers have the ability to interact purposefully with touch-screen technology.  (more…)
Author Interviews, Dermatology, Endocrinology, UCSF / 27.12.2015

MedicalResearch.com Interview with: Kanade Shinkai, MD PhD Associate Professor of Clinical Dermatology Director, Residency Program Endowed Chair in Dermatology Medical Student Education UCSF Department of Dermatology San Francisco, CA 94115  Medical Research: What is the background for this study? What are the main findings? Dr. Shinkai: Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder in the United States that has important skin manifestations including acne, hair loss, hirsutism, and acanthosis nigricans. We performed a retrospective cross-sectional study of women referred to a multidisciplinary PCOS clinic at UCSF to determine whether skin findings and systemic associations differ between women who meet diagnostic criteria for PCOS versus those suspected of having PCOS but do not meet diagnostic criteria. We found that women with PCOS commonly have skin findings, however, present across a broad spectrum of cutaneous manifestations. Comparing the skin findings in women who meet diagnostic criteria for PCOS with women who are suspected of having PCOS suggests that it can be very difficult to distinguish a patient with PCOS based on skin findings alone.  Hirsutism and acanthosis nigricans are the most helpful findings to suggest PCOS and require a comprehensive skin examination to diagnose; acne and androgenic alopecia are common findings but do not differentiate. The finding of hirsutism and acanthosis were associated with important systemic abnormalities including elevated free testosterone levels, insulin resistance, obesity, and dyslipidemia. This is the first study to perform systematic comprehensive skin exams on women with PCOS and link the skin findings to key systemic associations that have significant implications for the treatment and prognosis of women with the disease. (more…)
Author Interviews, Infections, JAMA, Microbiome / 24.12.2015

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

MedicalResearch.com Interview with: Filippo Montemurro, M.D. Director, Investigative Clinical Oncology (INCO) Fondazione del Piemonte per l'Oncologia Candiolo Cancer Institute (IRCCS) Torino, Italy Medical Research: What is the background for this study? Dr. Montemurro: The evaluation of treatment-related side effects is a critical step in cancer patient management. It is important in the clinical practice, where the decision to modify doses, omit administrations or establish supportive care measures is based on treatment tolerance and side effects severity and duration. It is also important in the context of clinical trials. In the latter setting, the mere information of the antitumor activity of a new drug or regimen under investigation is worth little if it not accompanied by an accurate reporting of the side effect profile. For this reason, over the years reference protocols to standardize the process of toxicity reporting in clinical trials have been established. The most recent and widespread is the Common Terminology Criteria for Adverse Events (CTCAE), that is issued and constantly updated by the National Cancer Institute. The CTCAE allows the description of the incidence and on the grade of severity on a scale ranging from 0 (no toxicity) to 5 (death due to that toxicity). Normally, the medical or nursing staff data collects information to fill in the CTCAE reports either by interviewing patients or extracting data from the clinical notes taken by physicians. The "indirectness" of this process has consequences that are becoming acknowledged for their potential implications. The incidence and severity of toxicities results often underestimated by doctors when their reports are compared with corresponding reports provided directly by patients without intermediaries (so called Patient reported outcomes-PRO). If this phenomenon is described in the context of clinical trials, it might occur to a greater extent also in the clinical practice, where the process of toxicity reporting is not mandated by a protocol and no reference standard is recommended. Based on these premises, we designed a study to pursue two aims;
  • the first was to assess whether a 10-item questionnaire derived by the CTCAE could be used by breast cancer patients receiving adjuvant chemotherapy after surgery in the daily clinical practice;
  • the second was to compare doctors and patients reports of toxicities at corresponding time-points.
Medical Research: What are the main findings? Dr. Montemurro: We administered the 10-item questionnaire after the first and third cycle of adjuvant chemotherapy to 601 women who had undergone surgery for breast cancer. To develop this questionnaire, CTCAE definitions of severity for each item (nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea) were translated into Italian and rephrased into statements. Patients were asked to choose the statement that best represented the worst experience with that side effect after the reference cycle of chemotherapy. At the same time-points, research nurses extracted information from the medical charts and reported them in paired doctor questionnaires. A total of 99% and 97% of the patient returned filled in questionnaires. Pairwise comparisons showed that doctors systematically underestimated both incidence and severity for all the side effects. Interestingly, comparison of the two patient questionnaires revealed temporal changes that were possibly related to the effect of prophylactic measures taken after the first cycle (i.e. reduction in vomiting, diarrhea and pain) or to cumulative toxicties (i.e. worsening dysgeusia and dyspnea). No such changes except for worsening dyspnea were observed comparing the two doctors questionnaires. Finally, we found a direct relationship between number of patients and magnitude of discrepancy in side effects reporting was observed, suggesting that the workload could be a factor influencing this phenomenon. (more…)
Author Interviews, Obstructive Sleep Apnea, Vitamin D / 24.12.2015

MedicalResearch.com Interview with: Ken M. Kunisaki , MD Associate Professor of Medicine Pulmonary, Allergy, Critical Care and Sleep Medicine University of Minnesota  Medical Research: What is the background for this study? What are the main findings? Dr. Kunisaki : Obstructive sleep apnea (OSA) is a very common condition that is the result of recurrent complete or partial closure of the upper airway during sleep.  OSA leads to poor sleep quality and excessive daytime sleepiness. A previous study suggested that OSA is more common in the winter, but there were no vitamin D measurements in that study, which seemed potentially relevant since many people have lower vitamin D levels in the winter, due to less sunlight exposure in the winter.  Several studies have also shown that people with low vitamin D levels have worse muscle function.  Since muscles are partially responsible for keeping the upper airway open during sleep, we wondered whether people with low vitamin D levels might have weaker upper airway muscles and therefore be more prone to having OSA. In our study, we found that indeed, persons with OSA had lower vitamin D levels than those without OSA, but this was explained by obesity.  In other words, the low vitamin D levels seen in OSA patients is likely just a marker of obesity and not likely related to the presence or absence of OSA. (more…)
Author Interviews, CT Scanning, Heart Disease / 24.12.2015

MedicalResearch.com Interview with: Dr. Joan Pinto-Sietsma MD PhD Department of Clinical Epidemiology, Biostatistics and Bioinformatics Academic Medical Center Amsterdam, The Netherlands.  Medical Research: What is the background for this study? What are the main findings? Response: A positive family history for premature coronary artery disease is an important risk factor for coronary artery disease. Therefore, it is frequently proposed to be included in current risk assessment tools and clinical practice guidelines. On the other hand, a positive family history for coronary artery disease only identifies families at risk, whereas it fails to identify which specific individual within a family is at particular risk. Therefore, its applicability in clinical practice is limited. The detection of subclinical atherosclerosis as assessed by assessing coronary artery calcification, with CT scanning, has emerged as prognostic evaluation of coronary artery disease. Prospective follow-up studies have shown that coronary artery calcification predicts cardiovascular events, independent of risk factors. Therefore, assessing coronary artery calcifications in families with premature coronary artery disease might help in determining which individuals within such families are at particular risk and therefore help decide regarding treatment. We analysed the association between a positive family history for premature coronary artery disease and coronary artery calcifications in 704 asymptomatic individuals. Furthermore, we assessed the predictive value of coronary artery calcifications in individuals with a positive family history for premature coronary artery disease in a sub analysis in 834 individuals of the St. Francis Heart Study, in which subjects were followed for about 3.5 years. We observed, that individuals of high risk families (a positive family history of premature coronary artery disease) had a 2 time higher risk to have a calcium score > the 80th percentile as compared to individuals with a negative family history of premature coronary artery disease. Besides, individuals from high risk families with a high calcium score (> the 80th percentile) had a 2 time higher risk to get a cardiovascular event in 3,5 years, whereas individuals of high risk families without coronary calcifications did not have an increased risk at all. (more…)
Author Interviews, Cancer Research, Lymphoma, NEJM / 24.12.2015

MedicalResearch.com Interview with: Dr. Michael van Leeuwen PhD Department of Epidemiology Netherlands Cancer Institute Amsterdam, the Netherlands Medical Research: What is the background for this study? What are the main findings? Response: Over the last decades cure rates for Hodgkin’s lymphoma patients have increased dramatically. Cure and long-term survival may, however, come at a price, in the form of an increased risk of second cancers and other late effects. Since the late 1980’s treatment of Hodgkin’s lymphoma has been changed towards smaller radiation target volumes and more effective, generally less toxic chemotherapy. In a study which included 3905 Hodgkin’s lymphoma patients treated between 1965 and 2000 in the Netherlands, the impact of these treatment changes on second malignancy risk was evaluated. Hodgkin’s lymphoma patients were between the ages of 15 and 50 years and had survived at least 5 years after treatment. During follow-up, 1055 second cancers were diagnosed in 908 survivors, corresponding to a risk of 4.6 times as high as the occurrence of cancer in the general population. Up to at least 40 years after treatment for Hodgkin’s lymphoma, survivors remained at increased risk for second cancers. The cumulative incidence of a second cancer was 33.2% at 30 years, compared with 9.6% in the general population, and 48.5% at 40 years, compared with 19.0% in the general population. Breast cancer was the most common second cancer reported followed by lung and gastrointestinal cancers. Thirty-year cumulative incidence was 16.6% for breast cancer, 7.1% for lower respiratory tract cancers, 7.0% for gastrointestinal cancers, and 3.7% for non-Hodgkin’s lymphomas. The risk of solid cancer after treatment for Hodgkin’s lymphoma was not lower among more recently treated patients (patients treated between 1989 and 2000) than among those who were treated in earlier time periods, despite changes in treatment. Nonetheless, patients treated with smaller radiation fields (e.g., a supradiaphragmatic field radiotherapy not including the axilla) were at a 63% lower relative risk of breast cancer as a second malignancy than if they received complete mantle-field radiotherapy. The lack of change in the cumulative incidence of solid cancers could be due to an incomplete adoption of the more modern radiotherapy concepts but may also be explained on the basis of a change in the chemotherapy regimens used in the 1990s. Because in the 1970’s many women exposed to high doses of alkylating agents were experiencing premature menopause, doses of alkylating agents were lowered over time to preserve fertility. However, early menopause introduced with the alkylating regimens was likely responsible for decreasing the breast cancer incidence. With the lower doses of the alkylating agents, this protection was taken away. The cumulative incidence of non-Hodgkin’s lymphoma and of leukemia (and the myelodysplastic syndrome) was, however, much lower among patients who were treated in the period from 1989 through 2000 than among those who were treated in the period from 1965 through 1976. For leukemia, the decrease in cumulative incidence is likely due to the much lower doses of alkylating agents used in Hodgkin’s lymphoma treatment in the 1990’s compared to earlier decades. It is important to realize that current common practice in radiation oncology, including involved-node or involved-site radiotherapy, three-dimensional conformal radiation treatment planning, and radiation doses of less than 36 Gy, was not applied in our study population. It is hoped that these changes may reduce the risk of solid cancer among patients treated after 2000. (more…)
Author Interviews, Immunotherapy, NEJM, Rheumatology / 24.12.2015

MedicalResearch.com Interview with: Prof. dr. D.L.P. Baeten MD Clinical Immunology and Rheumatology Academic Medical Center University of Amsterdam Amsterdam, The Netherlands Medical Research: What is the background for this study? What are the main findings? Prof. Baeten: Ankylosing spondylitis is a debilitating rheumatic condition which affects young adults and with NSAIDS and TNF inhibitors as only therapeutic option. Over the last years, we generated evidence that IL-17 is an important inflammatory mediator in this condition. In the two studies reported here in the NEJM, we demonstrate that IL-17 inhibition with secukinumab has a very profound and long-lasting effect on signs and symptoms as well as inflammation in ankylosing spondylitis patients, even in those patients that failed a TNF blocker before. (more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, Lancet / 24.12.2015

MedicalResearch.com Interview with: Kazem Rahimi | FRCP DM MSc FESC Associate Professor of Cardiovascular Medicine, University of Oxford Deputy Director, The George Institute for Global Health James Martin Fellow in Healthcare Innovation, Oxford Martin School Honorary Consultant Cardiologist, Oxford University Hospitals NHS Trust Medical Research: What is the background for this study? What are the main findings? Prof. Rahimi: Although the benefits of blood pressure lowering treatment for prevention of cardiovascular disease are well established, the extent to which these effects differ by baseline blood pressure, presence of co-morbidities (such as stroke or diabetes), or drug class is less clear. Medical Research: What should clinicians and patients take away from your report? Prof. Rahimi: Our study has several implications for clinical practice. Our findings suggest that blood pressure lowering to levels below those recommended in current guidelines (ie, systolic blood pressure of less than 140 mm Hg) will reduce the risk of cardiovascular disease. By showing no evidence for a threshold below which blood pressure lowering ceases to work, the findings call for blood pressure lowering based on an individual’s potential net benefit from treatment rather than treatment of the risk factor to a specific target. Furthermore, the differences we identified between classes of drugs support more targeted drug use for individuals at high risk of specific outcomes (eg, calcium channel blocker therapy for individuals at high risk of stroke or and diuretics are more eff ective for prevention of heart failure). Overall, our findings clearly show that treating blood pressure to a lower level than currently recommended could greatly reduce the incidence of cardiovascular disease and potentially save millions of lives if the treatment was widely implemented. The results provide strong support for reducing systolic blood pressure to less than 130 mmHg, and blood pressure-lowering drugs should be offered to all patients at high risk of having a heart attack or stroke, whatever their reason for being at risk.  (more…)
Author Interviews, Frailty, Mayo Clinic, Pulmonary Disease, Transplantation / 23.12.2015

MedicalResearch.com Interview with: Cassie Kennedy, M.D. Pulmonology and Critical Care Medicine Mayo Clinic  Medical Research: What is the background for this study? Dr. Kennedy: Lung transplant is a surgical procedure that can offer extended life expectancy and improved quality of life to selected patients with end-stage lung disease. However there are about 1700 patients awaiting lung transplant at any given time in the United States because transplant recipients far exceed potential donors.  In addition, even with carefully chosen candidates, lung transplant recipients live on average about 5.5 years.  It is therefore very important for transplant physicians to choose patients who will receive the most benefit from their lung transplant. Frailty (defined as an increased vulnerability to adverse health outcomes) has typically been a subjective consideration by transplant physicians when choosing lung transplant candidates.  The emergence of more objective and reproducible frailty measures from the geriatric literature present an opportunity to study the prevalence of frailty in lung transplant (despite that subjective screening) and to determine whether the presence of frailty has any impact on patient outcomes. Medical Research: What are the main findings? Dr. Kennedy: Frailty is quite common --46 percent of our patient cohort was frail by the Frailty Deficit Index. We also saw a significant association between frailty and worsened survival following lung transplantation: one-year survival rate for frail patients was 71.7 percent, compared to 92.9 percent for patients who were not frail. At three years this difference in survival persisted--the survival rate for frail patients was 41.3 percent, compared to 66.1 percent for patients who were not frail. (more…)
Author Interviews, Cancer Research, Prostate Cancer, Surgical Research, Transplantation / 23.12.2015

MedicalResearch.com Interview with: Gerardo Vitiello, MD Emory University School of Medicine Emory Transplant Center NYU Langone Medical Center Department of Surgery  Medical Research: What is the background for this study? What are the main findings? Dr. Vitiello:   Screening for prostate cancer with prostate specific antigen (PSA) levels is highly controversial, as it is a non-specific marker for prostate cancer. A PSA level may be elevated in a variety of disease processes (not only prostate cancer), and even in the general population, the benefit of early intervention for prostate cancer is unclear. In contrast, end stage renal disease (ESRD), where patients no longer have renal function and require dialysis, is a major health problem with a huge impact on a patient’s quality of life. The only cure for ESRD is kidney transplantation, which has been shown to have an enormous health and quality of life benefit for transplant recipients. Transplant centers have rigorously screened candidates for potential malignancy prior to transplantation to ensure that there are no contraindications to receiving a transplant. For the first time, we demonstrate that screening for prostate cancer in kidney transplant candidates is not beneficial, and may actually be harmful, since it delays time to transplant and reduces a patient’s chance of receiving a transplant without an apparent benefit on patient survival. (more…)
AHA Journals, Author Interviews, Education, Heart Disease, Stroke / 23.12.2015

MedicalResearch.com Interview with: Carole Decker, RN, PhD, CPHQ, FAHA Director, Cardiovascular Outcomes Research Saint Luke's Mid America Heart Institute Kansas City, MO 64111 Medical Research: What is the background for this study? What are the main findings? Dr. Decker: Stroke is the leading cause of disability and the fifth leading cause of death. The utilization of thrombolytic therapy is the national standard of care for acute ischemic stroke (AIS) treatment resulting in improved outcomes at 90 days and yet only 7% of patients with AIS receive a thrombolytic. The American College of Emergency Physicians emphasizes the importance of using a shared medical decision-making model with AIS patients and their caregivers to discuss benefits and risks of treatment. The recommended door-to-needle (emergency door to thrombolytic administration) is 60 minutes to achieve the optimal patient outcomes which can be problematic in that conversation on benefits and risks occurs in a hurried emergency setting. Multiple risk models to identify individualized benefits and risks of thrombolytic therapy have been developed but few are used prospectively and are not used at the point of care. Our team created ePRISM (Personalized Risk Information Services Manager), a Web-based tool, to generate personalized documents with patient-specific outcomes based on validated risks models. To support knowledge transfer and creation of a shared decision-making tool, our multidisciplinary team conducted qualitative interviews to define the information needs and preferred presentation format for stroke survivors, caregivers, and clinicians considering thrombolytic treatment. (more…)
Author Interviews, HPV, Infections, Pediatrics, Sexual Health / 23.12.2015

MedicalResearch.com Interview with: Seo Yoon Lee, RN Department of Health Policy and Management Graduate School of Public Health Eun-Cheol Park MD, PhD Institute of Health Services Research Department of Preventive Medicine Yonsei University, Seoul, South Korea  Medical Research: What is the background for this study? What are the main findings? Response: Sexually Transmitted Infections (STIs) are a major public health issue which causes acute illness, infertility, long-term disability or other serious medical and psychological consequences, around the world. Adolescence is a key developmental period with rapid cognitive growth. In recent decades, substantial change in the sexual behaviors and attitudes of adolescents has occurred and this would lead them greater risk of STIs than other. Our study looked at the relationship between adolescents’ first sexual intercourse age and their STI experience, as well as to identify vulnerable time table of their sexual activity by considering the time gap between their secondary sex characteristic occurrence age and first sexual intercourse age. The findings from our study show that earlier initiation of sexual intercourse increases the odds of experiencing STIs. Also as the age gap gets shorter, the odds of experiencing STIs increase. Approximately 7.4% of boys and 7.5% of girls reported had STI. For both boys and girls, the chance of experiencing STIs increased as the age of first sexual intercourse decreased [boys: before elementary school (age 7 or under) OR=10.81, first grade (age 7or 8) OR=4.44, second grade (age 8 or 9) OR=8.90, fourth grade (age 10 or 11) OR=7.20, ninth grade (age 15 or 16) OR=2.31; girls: before elementary school OR=18.09, first grade OR=7.26, second grade OR=7.12, fourth grade OR=8.93, ninth grade OR=2.74]. The association between the absolute age gap (AAG: defined as absolute value of “Age gap” = [Age at first sexual intercourse] - [age of secondary sexual manifest]) and STI experience was examined additionally which the result showed, students who had sexual intercourse after their secondary sexual manifestation, as the AAG increases, the odds of STI experience were decreased (boys OR=0.93, girls OR=0.87). (more…)