Author Interviews, Biomarkers, JAMA, Prostate Cancer / 09.02.2016

MedicalResearch.com Interview with: Dr. Quoc-Dien Trinh MD Assistant Professor, Harvard Medical School Brigham and Williams Hospital  Medical Research:  Please briefly explain the potential benefits and harms of PSA testing, the rationale for screening all men, and the reason U.S. guidelines now recommend against routine screening.  Response: The goal of cancer screening is to detect the disease early, and consequently treat it before it becomes more aggressive and spread to other parts of the body (which ultimately leads to death). However, cancer screening may lead to overdiagnosis (detecting cancers that would not have been a problem for a while) and overtreatment. The latter is a problem for prostate cancer, because surgery and radiation therapy (the currently accepted first-line treatments for localized prostate cancer) have significant long-term adverse effects on sexual and urinary function. I wouldn't say that 'US' guidelines are against screening. Many professional societies continue to recommend some form of joint decision-making with regard to PSA screening. the USPSTF recommends against screening for all - they argue that the harms mentioned above outweigh the benefits. (more…)
Author Interviews, Diabetes, Exercise - Fitness, JAMA, Lifestyle & Health, Pediatrics / 08.02.2016

MedicalResearch.com Interview with: Mélanie Henderson, MD, FRCPC, PhD Pediatric Endocrinologist and Assistant Clinical Professor Division of Endocrinology and Diabetes University of Montreal/Centre Hospitalier Universitaire Ste-Justine Montréal, Québec Medical Research: What is the background for this study? What are the main findings? Dr. Henderson: Dysregulation in insulin sensitivity and insulin secretion are the basic elements in the pathophysiology of type 2 diabetes. There is extensive data suggesting that better lifestyle habits are associated with the prevention or the delay in onset of type 2 diabetes in adults, with improved lifestyle habits having been more effective than pharmacologic agents at diabetes prevention in one study. Little work however has been done to determine whether this holds true in children. Cross-sectional studies in youth have found conflicting results and no study has considered the combined effect of physical activity, fitness and sedentary behavior on insulin dynamics in children. Understanding the impact of lifestyle habits on insulin dynamics in childhood has become paramount, given that less than 7% of Canadian children are currently meeting physical activity guidelines and that 1/3 of school-aged Canadian children and 2/3 of Canadian teenagers are exceeding the current guidelines in terms of screen time, which advocate for a maximum of 2 hours daily. Our study shows that adiposity is the central predictor of insulin dynamics in children, and that physical activity and screen time play an important role, in part through their effect on adiposity. Thus, establishing and maintaining a highly physically active lifestyle early on in life, while minimizing sedentary behaviour (specifically screen time) appear to be important strategies to consider to prevent type 2 diabetes in youth. (more…)
Author Interviews, Cancer Research, Heart Disease, JAMA, Pharmacology / 06.02.2016

MedicalResearch.com Interview with: Jonathan Douxfils Pharm.D. - Ph.D. Research assistant Faculty of Medicine - Department of Pharmacy NAmur Research Institute for LIfe Sciences (NARILIS) Namur Thrombosis and Hemostasis Center (NTHC) Medical Research: What is the background for this study? What are the main findings? Dr. Douxfils: We decided to perform this study based on the release of the FDA regarding the risk of arterial occlusive events associated with ponatinib. We then hypothesize that the risk was not only restricted to ponatinib but also to other TKIs. This study shows that dasatinib, nilotinib and ponatinib increase the risk of vascular occlusive events compared to imatinib. Medical Research: What should clinicians and patients take away from your report? Dr. Douxfils: We suggest that patients treated with these molecules should be more frequently monitored, i.e. by an intensive support of associated comorbidities. In addition, even if they appear to have a better efficacy in terms of molecular response, new generation TKIs does not improve the overall survival at one year. As we have not access to individual data, it was impossible to clearly identify categories of patients for whom the risk of cardiovascular occlusive events is predominant. Therefore, the intensive monitoring proposed should be applied to all patients treated with these molecules. Regarding the choice of the therapy, the physician should certainly consider the goals of the treatment. For elderly patients, improving survival is the main objective and in this context, imatinib remains an excellent choice. For patients with a life expectancy greater than 10 years in whom we aim to achieve a deep molecular response to potentially reach a point of treatment cessation, dasatinib and nilotinib could be preferred. However, the choice of dasatinib or nilotinib as first-line treatments should involve a screening for potential risk factors such as diabetes, prior vascular occlusive events or any risk that could increase these adverse events. For second- and third-line treatments, the choice of the treatment has to be based on mutational analysis, previous adverse events, and the medical condition of the patient. Thus, in case of intolerance or resistance, the switch to one of the other TKIs approved for first-line therapy is an option. If treatment failure still occurs, a more potent TKI, i.e. bosutinib, is preferred. Importantly, ponatinib is reserved to patients with the T315I mutation and must be avoided in patients with good prognosis. (more…)
Author Interviews, Genetic Research, JAMA, Schizophrenia / 04.02.2016

MedicalResearch.com Interview with: Hannah J. Jones, PhD Centre for Academic Mental Health, School of Social and Community Medicine, Medical Research Council (MRC) Integrative Epidemiology Unit University of Bristol, Bristol, England MedicalResearch: What is the background for this study? What are the main findings? Dr. Jones: Schizophrenia is a highly heritable condition characterised by relatively diverse symptoms and frequent comorbid disorders. However, at present we don’t know how genetic risk for schizophrenia is expressed in children/adolescents in the general population. To investigate this, we studied data from individuals within the Avon Longitudinal Study of Parents and Children (ALSPAC) birth cohort which consists of approximately 14,000 children born to women living in the former Avon Health Authority area in England with an expected delivery date from April 1, 1991, to December 31, 1992. We used genetic data from approximately 5,000 ALSPAC children and measures from adolescence relating to psychopathology to determine whether genetic risk for schizophrenia is associated with variation in psychotic experiences (e.g. delusions, hallucinations), negative symptoms (e.g. apathy, withdrawal), depressive disorder and anxiety disorder during this developmental period. We derived a score of genetic risk for schizophrenia in each individual within our study. This score is normally distributed such that most people have some genetic risk and a few people have very high or very low genetic risk. We found very weak evidence of an association between genetic risk for schizophrenia and psychotic experiences in adolescence and no evidence of an association with depressive disorder. However, we found strong evidence of association between genetic risk for schizophrenia and negative symptoms and anxiety disorder.  (more…)
Allergies, Asthma, Author Interviews, JAMA / 04.02.2016

MedicalResearch.com Interview with: Prof Dr. Dr. h.c. Claus Bachert Head Upper Airways Research Laboratory (URL) Chief of Clinics ENT-Department University Hospital Ghent Ghent, Belgium Medical Research: What is the background for this study? What are the main findings? Prof. Bachert: Chronic sinusitis with nasal polyposis represents mucosal inflammation, and polyps in the nasal cavity and sinuses, which result in long-term symptoms of nasal obstruction and congestion, reduction in or loss of sense of smell, and loss of quality of life. Patients with nasal obstruction or congestion have a two-fold higher risk of sleep dysfunction, increased fatigue, and decreased work productivity. About 40 percent of chronic sinusitis with nasal polyps patients develop asthma, which often is non-allergic late-onset disease. Treatment options consist of nasal and systemic glucocorticosteroids; long-term or repeated treatment with oral GCS carries a great risk of side effects in these patients. Surgery of the sinuses is another option, but recurrence of polyps is frequent. Further treatment options are highly needed. About 85% of nasal polyps represent a type 2 inflammation, with increased eosinophils and IgE formation. Dupilumab is an investigational therapy that inhibits signaling of IL-4 and IL-13, two key cytokines required for type 2 (Th2) immune responses. Dupilumab has been successfully administered in patients with asthma and atopic dermatitis. The current randomized, double-blind, placebo-controlled group study enrolled 60 adult patients with chronic sinusitis with nasal polyposis refractory to intranasal corticosteroids at 13 sites in the United States and Europe. Following four weeks of mometasone furoate nasal spray (MFNS) run-in, patients in the study received 300 milligrams (mg) of dupilumab or placebo once per week subcutaneously for 16 weeks, after an initial loading dose of 600 mg. All patients in the study continued to receive daily MFNS. Eligible patients had bilateral nasal polyposis and showed chronic symptoms of sinusitis, despite treatment with an intranasal corticosteroid for at least two months. Fifty-eight percent of patients in the study had received prior nasal surgery for their condition.  ​ We found that dupilumab treatment was associated with significant improvements in endoscopic, clinical, radiographic, and pharmacodynamic end points after 16 weeks. Significant improvements in quality of life and in major symptoms, such as sense of smell, nasal congestion, and nocturnal awakenings,were reported. In those patients with asthma, also lung function and asthma control were significantly better with Dupilumab compared to placebo. Dupilumab was generally well tolerated, and no serious adverse events were considered to be related to dupilumab.​ (more…)
Author Interviews, Genetic Research, JAMA, Pediatrics, Surgical Research / 03.02.2016

MedicalResearch.com Interview with: Silje Steinsbekk PhD Associate Professor Dept. of Pschology Norwegian University of Science and Technology  Medical Research: What is the background for this study? Dr. Steinsbekk:  More than every third American child is overweight or obese. Childhood obesity is associated with multiple negative health outcomes such as metabolic syndrome and hypertension, as well as mental health problems, reduced self-esteem and impaired quality of life. Further, overweight and obesity tend to persist from childhood into adulthood, and the risk of adult overweight increases the longer a child has been overweight. Identifying modifiable factors contributing to the development and continuity of unhealthy weight is therefore needed. Genome-wide association studies (GWAS) have identified genetic risks for obesity and these genetic risks have shown to influence development of obesity partly by accelerating weight gain in childhood. Identification of mechanisms through which genetic risks for obesity accelerate weight gain in childhood can therefore provide insight into the developmental pathogenesis of obesity and thus inform intervention. Cross-sectional studies suggest appetite traits as a candidate mechanism. Appetite traits may therefore be targets of intervention to protect children against the effect of genetic predispositions to develop obesity. However, such a preventive approach presupposes that appetite traits indeed transmit the genetic effect upon later development of obesity. Notably, cross-sectional studies cannot establish whether appetite traits precede the development of obesity or are caused by it—a critical piece of information for clinicians seeking treatment targets to prevent childhood obesity. We therefore aimed to test whether genetic risk for obesity was associated with rapid childhood BMI growth and if this genetic effect was mediated by appetite traits, following a representative sample of Norwegian children from age 4 to 8. (more…)
Author Interviews, Genetic Research, JAMA, Pediatrics, Weight Research / 02.02.2016

MedicalResearch.com Interview with: Profa. Patrícia Pelufo Silveira, MD, PhD Universidade Federal do Rio Grande do Sul Brazil Medical Research: What is the background for this study? What are the main findings? Response: Previous studies have shown that women who carry a certain gene variant (namely the 7-repeat allele of the dopamine type 4 receptor) have increased risk for obesity, especially if they also suffer from eating disorders. We have also demonstrated that girls who have this gene variant prefer to eat more fat when allowed to choose. However, for some neuropsychiatric conditions, this gene was shown to function as a “plasticity gene”. That is to say that being a carrier makes the individual more or less vulnerable to the disease, depending if the environment in which the person lives is bad (more risk) or good (less risk for the disease). This is called the “differential susceptibility” model. Therefore, in this paper, we wondered if the above described higher fat intake already reported in 7-repeat girls could be modified by the social environment in which they are raised. We saw that if a girl has the gene variant and is raised in a poorer environment, she is more likely to prefer to eat fat in her diet as we knew. However, if she has the gene variant but is raised in a better socioeconomic environment, she actually eats less fat in her regular diet compared to her counterparts who do not carry the gene variant. This is important because we change the focus from the gene (previously "blamed" for increasing fat preference and obesity as the years pass by) to the environment, as the genetic association will increase or decrease the risk according to the conditions in which the child is raised. (more…)
Author Interviews, Depression, JAMA, NYU, Pediatrics / 01.02.2016

MedicalResearch.com Interview with: Briannon O'Connor PhD New York University Child Study Center Department of Child and Adolescent Psychiatry New York University School of Medicine New York Medical Research: What is the background for this study? What are the main findings? Dr. O'Connor: a.      As the health care system continues to emphasize accountability for providing high quality care, the development of meaningful quality standards is critical.  This study came from NCQA’s work to develop these quality measures for adolescent depression care.  Prior to this study, little was known about what routine care looked like for adolescents who showed up at their primary care visits with significant symptoms of depression. This study looked at follow up care documented in an electronic health record in the three months after an adolescent was first identified with significant symptoms of depression. Medical Research: What is the background for this study? What are the main findings? Dr. O'Connor:    Key findings from this study include:
  1. Most adolescents (nearly two-thirds) with newly prescribed depression symptoms received some treatment, usually including psychotherapy, within the first 3 months after depression symptoms were first identified.
  2. Among those adolescents who were prescribed antidepressant medications, 40% had no other follow up care in three months, which is quite concerning since current black box warnings highlight the risk for increased suicidality for youth prescribed antidepressants and clearly recommend close monitoring in the few months following initial prescription.
  3. There were low rates of other follow up care events in the three month follow up period:  19% of adolescents  did not receive any follow up care at all, 36% did not receive any treatment, and the majority (68%) lacked documentation that symptoms were monitored or re-assessed using a valid questionnaire
  4. The sites that participated in the study are highly regarded health care institutions, often looked to as leaders in cutting-edge care. Thus, results from this study, discouraging as they are, may overstate the quality of care in other settings.
(more…)
Aging, Author Interviews, Cognitive Issues, JAMA, Mayo Clinic, Weight Research / 01.02.2016

MedicalResearch.com Interview with: Rosebud O. Roberts, M.B., Ch.B. Mayo Clinic Rochester, Minn.  Medical Research: What is the background for this study? Dr. Roberts: Decline in weight has been observed 10-20 years prior to onset of dementia. We wanted to study whether this decline also occurs for mild cognitive impairment (an intermediate stage in the progression from normal cognition to dementia). Medical Research: What are the main findings? Dr. Roberts: The main finding was that there was indeed a decline in weight (from the maximum weight in midlife to weight assessed in late life) was associated with a increased risk of mild cognitive impairment. (more…)
Author Interviews, Compliance, JAMA, Technology / 01.02.2016

MedicalResearch.com Interview with: Dr. Clara Chow PhD Director of the Cardiovascular division The George Institute, Westmead Hospital Sydney, Australia Medical Research: What is the background for this study? What are the main findings? Dr. Chow: Text messaging has immense potential in healthcare. Not only for supporting medication adherence, but we have shown in the “TEXT ME” study its ability to simultaneously influence multiple lifestyle domains like increasing physical activity, embarking on healthier diets and reducing smoking rates. With increasing penetration of mobile phone use in developed as well as developing countries, there is a potential for wider reach, however there remains a need to evaluate the value of text messaging programs in various patient populations to establish the generalizability of these research findings. (more…)
Author Interviews, Autism, Genetic Research, JAMA, Schizophrenia / 30.01.2016

MedicalResearch.com Interview with: Andrea J. Gonzalez-Mantilla, M.D. Postdoctoral Fellow Andres Moreno-De-Luca, M.D. Investigator I Autism & Developmental Medicine Institute Department of Radiology Geisinger Health System Danville, PA 17822 Medical Research: What is the background for this study? What are the main findings? Response: Developmental brain disorders (DBD), such as autism, intellectual disability, and schizophrenia are a group of heterogeneous conditions characterized by deficits that affect multiple functional domains, such as cognition, behavior, communication, and motor skills. Previous studies provide strong evidence of common underlying molecular pathways and shared genetic causes among apparently different DBDs. Large-scale genomic studies of individuals with developmental brain disorders have found that identifying multiple, independent de novo pathogenic loss-of-function (pLOF) variants in the same gene among unrelated individuals is a powerful statistical approach to reliably identify disease-causing genes. However, genomic data from smaller cohorts and case reports are not routinely pooled with data from larger studies. Moreover, most previous studies have been restricted to cohorts of individuals ascertained based on a single diagnosis (e.g., a study will focus on only individuals with a diagnosis of autism and not consider other genomic data from individuals with a different diagnosis). Therefore, genomic data from individuals across DBD are not being jointly analyzed in search of pLOF variants in the same gene that may help build evidence for a causative role in developmental brain disorders. In this study, we carried out data mining of previously published data to identify genes related to the DBD phenotype. We expanded the aforementioned method and developed a multilevel data-integration approach, which capitalizes on three genotype-phenotype data sources: (1) genomic data from structural and sequence pLOF variants, (2) phenotype data from six apparently distinct DBD (autism, intellectual disability, epilepsy, schizophrenia, bipolar disorder and attention-deficit/hyperactivity disorder), and (3) data from large scale studies, smaller cohorts, and case reports. We identified 241 candidate genes for developmental brain disorders, including 17 genes that had not previously been associated with developmental brain disorders. (more…)
Abuse and Neglect, Accidents & Violence, Author Interviews, JAMA, Mental Health Research / 29.01.2016

MedicalResearch.com Interview with: Tracie O. Afifi, PhD Associate Professor of Epidemiology CIHR New Investigator (2013-2018) Departments of Community Health Sciences and Psychiatry College of Medicine, Faculty of Health Sciences University of Manitoba  Medical Research: What is the background for this study? Dr. Afifi: Recent studies in the US have examined predictors and correlates of suicide among solider, but none of these studies have investigated the potential role that child abuse exposure may play in suicide-related outcomes. In addition no representative military and civilian comparisons from any country have examined possible differences in the prevalence of child abuse exposure and the potential differences in the relationships between child abuse exposure and suicide-related outcomes in these populations. This study uses nationally representative military and civilian samples from Canada. Medical Research: What are the main findings? Dr. Afifi: Child abuse was more prevalent among Regular Forces personnel (47.7%) and Reserve Forces personnel (49.4%) compared to the Canadian general population (33.1%). Child abuse exposure was associated with an increased likelihood of suicidal thoughts, plans, and attempts in military and civilian populations, with associations weaker for many outcomes in military personnel relative to civilians. Deployment-related trauma was associated with past-year suicidal thoughts and suicide plans. However, relative to deployment-related trauma, child abuse exposure had a more robust association with suicide-related outcomes. (more…)
Author Interviews, JAMA, Smoking / 29.01.2016

MedicalResearch.com Interview with: John Cunningham, PhD Senior Scientist, Social & Epidemiological Research Centre for Addiction and Mental Health Toronto, Ontario  Medical Research: What is the background for this study? What are the main findings? Dr. Cunningham: Nicotine Replacement Therapy (NRT) has been found to improve tobacco cessation success rates in clinical trials where there is accompanying behavioral support. However, population survey data has indicated that people who purchase NRT as part of a quit attempt are no more successful at quitting smoking than people who don’t use NRT as part of their quit attempt. While causal statements about the effectiveness of NRT cannot be made based on the population survey findings, it does raise concerns about the effectiveness of NRT when there is no accompanying behavioral support. Our trial used an interesting design where participants were recruited for a longitudinal survey about their patterns of smoking. As part of this survey, participants were asked if they would be interested in nicotine patches to help them quit smoking, if they were offered for free. Of those participants who said they were interested, a randomized half were actually sent a five-week supply of nicotine patches. The other half of participants were not sent the nicotine patches and were, in fact, unaware that nicotine patches were sent to others in the trial. Participants were followed-up at 8 weeks and 6 months, with those participants receiving free-of-charge nicotine patches being more likely to report current abstinence compared to those participants not sent the free nicotine patches (30-day self-reported abstinence at 6-months was 7.6% versus 3.0% respectively; odds ratio (OR), 2.65; 95% CI, 1.44 - 4.89, p = .002). (more…)
Author Interviews, Brain Cancer - Brain Tumors, Dermatology, JAMA / 27.01.2016

MedicalResearch.com Interview with: Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital University of Copenhagen Hellerup, Denmark   Medical Research: What is the background for this study? What are the main findings? Dr. Egeberg: There appears to be an overlap in the pathogenesis of rosacea and glioma, focused around matrix metalloproteinases. Rosacea may be associated with an increased risk of glioma, however, it is important to note that the absolute risk is still low. Whether this is a causal link is not known. (more…)
Author Interviews, JAMA, Melanoma / 27.01.2016

MedicalResearch.com Interview with: DeAnn Lazovich, Ph.D. Associate Professor Division of Epidemiology and Community Health University of Minnesota Minneapolis, MN 55454 Medical Research: What is the background for this study? What are the main findings? Dr. Lazovich: In Minnesota, as well as nationally, melanoma rates have been increasing more steeply in women than men younger than age 50 years since about the mid-1990s.  Some have speculated that this could be due to women's indoor tanning use, as women use indoor tanning much more than men do.  We had data on indoor tanning for men and women according to their age from a case-control study on indoor tanning and melanoma that was published in 2010.  In that 2010 report, we examined the association for individuals regardless of sex, all ages combined.  In this analysis, we restricted the study to individuals under age 50 years, and looked at the association between indoor tanning and melanoma according to three age groups (less than 30 years, 30-39 years and 40-49 years) for men and women separately. (more…)
Author Interviews, JAMA, Smoking / 27.01.2016

MedicalResearch.com Interview with: Timothy Baker, PhD Professor of Medicine University of Wisconsin-Madison School of Medicine and Public Health Medical Research: What is the background for this study? What are the main findings? Dr. Baker: Previous research showed that combination nicotine replacement (the nicotine patch plus the nicotine lozenge or gum) and varenicline are the most effective smoking cessation treatments available, yet they had never been directly compared with one another. This study set out to do that, and compare them with the nicotine patch. The present study shows that three medications which were combined with coaching to quit smoking—a pill called varenicline (Chantix), the nicotine patch alone, and a combination of nicotine-replacement medications—all produced about the same abstinence rates among participants at 6- and 12-months after the quit attempt. We were surprised that the patch by itself produced about the same level of success as the other two more intensive medications. (more…)
Author Interviews, Brigham & Women's - Harvard, End of Life Care, JAMA / 27.01.2016

MedicalResearch.com Interview with: Joel Weissman, PhD, Deputy Director and Zara Cooper, MD, MSc Associate Surgeon Center for Surgery and Public Health Brigham and Women’s Hospital Boston, Massachusetts Medical Research: What is the background for this study? What are the main findings? Response: A major priority for providers of end-of-life care is balancing the intensity of a patient’s treatment with quality of life. Previous studies have looked at the intensity of end-of-life care for the general population, but not whether physicians, the group most familiar with end-of-life care, receive more or less intense end-of-life care compared to non-physicians. Research from the Center for Surgery and Public Health (CSPH) at Brigham and Women’s Hospital found that for 3 of 5 end-of-life care intensity measures, physicians received significantly less intensive end-of-life care than the general population.  The findings are published in the January 19, 2016 issue of JAMA, in a special themed issue focusing on end-of-life care. The analysis included non-health maintenance organization Medicare beneficiaries aged 65 years or older who died between 2004 and 2011 in Massachusetts, Michigan, Utah, and Vermont, and was based on availability of electronic death records and ability to link to Medicare. Researchers used data from these records to look at 5 validated measures of end-of-life care intensity during the last 6 months of life: surgery, hospice care, intensive care unit (ICU) admission, death in the hospital, and expenditures. They then compared these measures between physicians and the general population (excluding other health care workers and lawyers), physicians vs. lawyers, who are presumed to be socioeconomically and educationally similar, and lawyers vs. the general population. There were 2,396 deceased physicians, 2,081 lawyers, and 666,579 people included in the analysis. Overall, physicians were less likely to die in a hospital compared with the general population (27.9 percent vs. 32 percent, respectively), less likely to have surgery (25.1 percent vs. 27.4 percent), and less likely to be admitted to the ICU (25.8 percent vs. 27.6 percent). Physicians were less likely to die in a hospital compared to lawyers (27.9 percent vs. 32.7 percent, respectively), but did not differ significantly in other measures. (more…)
Asthma, Author Interviews, JAMA, OBGYNE, Vitamin D / 27.01.2016

More on Asthma on MedicalResearch.com MedicalResearch.com Interview with: Hans Bisgaard, MD, DMSc Professor of Pediatrics The Faculty of Health Sciences University of Copenhagen Head of the Copenhagen Prospective Studies on Asthma in Childhood University  of Copenhagen and Naestved Hospital MedicalResearch: What is the background for this study? What are the main findings? Dr. Bisgaard: Vitamin D deficiency has become a common health problem in westernized societies, possibly caused by a more sedentary indoor lifestyle and decreased intake of vitamin D containing foods. Vitamin D possesses a range of immune regulatory properties, and it has been speculated that vitamin D deficiency during pregnancy may affect fetal immune programming and contribute to asthma pathogenesis. Asthma often begins in early childhood and is the most common chronic childhood disorder. Observational studies have suggested that increased dietary vitamin D intake during pregnancy may protect against wheezing in the offspring, but the preventive effect of vitamin D supplementation to pregnant women is unknown. In our double-blind, single-center, randomized clinical trial conducted within the Copenhagen Prospective Studies on Asthma in Childhood 2010 cohort we supplemented 2800 IU/d of vitamin D3 during the third trimester of pregnancy compared with 400 IU/d in the control group. Although the maternal supplementation did not result in a statistically significant reduction of risk of persistent wheeze in the offspring through age 3 years, the interpretation of the study is limited by a wide confidence interval that includes a clinically important protective effect. (more…)
Asthma, Author Interviews, Brigham & Women's - Harvard, JAMA, Vitamin D / 26.01.2016

MedicalResearch.com Interview with: Augusto A. Litonjua, MD, MPH Associate Professor Channing Division of Network Medicine and Division of Pulmonary and Critical Care Medicine Department of Medicine Brigham and Women's Hospital Harvard Medical School Boston, MA 02115 USA  Medical Research: What is the background for this study? What are the main findings? Response: Vitamin D deficiency has been hypothesized to contribute to the asthma and allergy epidemic.  Vitamin D has been shown to affect lung development in utero. However, observational studies have shown mixed results when studying asthma development in young children. Since most asthma cases start out as wheezing illnesses in very young children, we hypothesized that vitamin D supplementation in pregnant mothers might prevent the development of asthma and wheezing illnesses in their offspring.  We randomly assigned 881 pregnant women at 10 to 18 weeks' gestation and at high risk of having children with asthma to receive daily 4,000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D (n = 440), or a placebo plus a prenatal vitamin containing 400 IU vitamin D (n = 436). Eight hundred ten infants were born during the study period, and 806 were included in the analyses for the 3-year outcomes. The children born to mothers in the 4,400 IU group had a 20% reduction in the development of asthma or recurrent wheeze compared to the children born to mothers in the 400 IU group (24% vs 30%, respectively; an absolute reduction of 6%).  However, this reduction did not reach statistical significance (p=0.051). (more…)
Author Interviews, Breast Cancer, Cancer Research, JAMA, Prostate Cancer / 23.01.2016

More on Cancer Research on MedicalResearch.com MedicalResearch.com Interview with: Firas Abdollah, M.D., F.E.B.U. (Fellow of European Board of Urology) Urology Fellow with the Center for Outcomes Research, Analytics and Evaluation Vattikuti Urology Institute at Henry Ford Hospital in Detroit  MedicalResearch: What is the background for this study? What are the main findings? Dr. Abdollah: Cancer screening aims to detect tumors early, before they become symptomatic. Evidence suggests that detection and treatment of early-stage tumors may reduce cancer mortality among screened individuals. Despite this potential benefit, screening programs may also cause harm. Notably, screening may identify low-risk indolent tumors that would never become clinically evident in the absence of screening (overdiagnosis), subjecting patients to the harms of unnecessary treatment. Such considerations are central to screening for prostate and breast cancers, the most prevalent solid tumors in men and women, respectively. These tumors are often slow growing, and guidelines recommend against screening (non-recommended screening) for these tumors in individuals with limited life expectancy, i.e. those with a life expectancy less than 10 years. Unfortunately, our study found that this practice is not uncommon in the US. Using a nationwide representative survey conducted in 2012, we found that among 149,514 individuals 65 years or older, 76,419 (51.1%) received any prostate/breast screening. Among these, 23,532 (30.8%) individuals had a life expectancy of less than 10 years. These numbers imply that among the screened population over 65 years old, almost one in three individuals received a non-recommended screening. This corresponds to an overall rate of non-recommended screening of 15.7% (23,532 of 149,514 individuals). Another important finding of our study was that there were important variations in the rate of non-recommended screening from state to state; i.e. the chance of an individual older than 65 to receive a non-recommended screening varies based on his/her geographical location in United States. Finally, on a state-by-state level, there was a correlation (40%) between non-recommended screening for prostate and breast cancer, i.e. states that are more likely to offer non-recommended screening for prostate cancer are also more likely to offer non-recommended screening for breast cancer, and vice versa. (more…)
Accidents & Violence, Author Interviews, JAMA, Surgical Research, UCSF / 22.01.2016

MedicalResearch.com Interview with: Dr. Rachael Callcut M.D., M.S.P.H Assistant Professor of Surgery Division of General Surgery UCSF Medical Research: What is the background for this study? What are the main findings? Dr. Callcut: San Francisco General Hospital (SFGH) responded on July 6, 2013 to one of the larger multiple casualty events in the history of our institution.  Asiana Airlines flight 214 crashed on approach to San Francisco International Airport with 307 people on board.  192 patients were injured and SFGH received the highest total of number of patients of area hospitals. The majority of data that is available on disaster response focuses on initial scene triage or initial hospital resources required to respond to these types of major events.  Our paper focuses on some additional considerations for optimizing disaster response not typically included in literature on these events including nursing resources, blood bank needs, and radiology studies. As an example, over 370 hours of nursing overtime were needed just in the first 18 hours following the disaster to care for patients.  This type of information in traditionally not been included in disaster planning, but clearly was a critical element of providing optimum care to our patients. (more…)
Author Interviews, HPV, JAMA / 22.01.2016

More on HPV on MedicalResearch.com  MedicalResearch.com Interview with: Ilir Agalliu, M.D., Sc.D. Assistant Professor, Department of Epidemiology & Population Health and Department of Urology Albert Einstein College of Medicine Jack and Pearl Resnick Campus Bronx, NY Medical Research: What is the background for this study? Dr. Burk: We performed this study since we had previously detected an unusually high prevalence of HPV types found on the skin and skin cancers in the oral cavity in addition to HPV16 and other high-risk (HR) types (as defined by their association with cervix cancer) (see Journal of Infectious Diseases 204:787, 2011). We wished to determine if these types were associated with risk of head and neck cancers (HNSCCs). In addition, we wished to determine if HPV detection preceded the diagnosis of HNSCCs and might serve as a biomarker. Currently there are no good screening tests for HNSCC. Dr. AgalliuTo-date, there have been no prospective studies examining the temporal relationship between oral HPV detection and risk of head and neck squamous cell carcinoma (HNSCC). In this manuscript we examined prospectively associations between detection of a wide spectrum of oral HPVs (alpha, beta and gamma) with incident HNSCC in a nested case-control study among ~100,000 participants who provided mouthwash samples in the American Cancer Society-CPS II cohort and the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Dr. Agalliu: Oral HPV16 detection, which preceded cancer development on average for 4 years, was associated with a 22-fold increased risk for incident oropharyngeal cancer. Detection of other oral HPVs (beta1 HPV5, and gamma11 and 12 species) were associated with a 3.3 to 5.5-fold higher risk of  head and neck squamous cell carcinoma after adjustment for smoking, alcohol and HPV16. Associations of beta and gamma HPVs, which have been identified in the skin, with risk of HNSCC suggest a broader role for HPVs in HNSCC etiology. (more…)
Author Interviews, JAMA, Nursing, Outcomes & Safety, Surgical Research, University of Pennsylvania / 20.01.2016

More on Nursing Research on MedicalResearch.com MedicalResearch.com Interview with: Jeffrey H. Silber, M.D., Ph.D. The Nancy Abramson Wolfson Professor of Health Services Research Professor of Pediatrics and Anesthesiology & Critical Care,  The University of Pennsylvania Perelman School of Medicine Professor of Health Care Management The Wharton School Director, Center for Outcomes Research The Children's Hospital of Philadelphia Philadelphia, PA 19104  Medical Research: What is the background for this study? Response: We wanted to test whether hospitals with better nursing work environments displayed better outcomes and value than those with worse nursing environments, and to determine whether these results depended on how sick patients were when first admitted to the hospital. Medical Research: What are the main findings? Response: Hospitals with better nursing work environments (defined by Magnet status), and staffing that was above average (a nurse-to-bed ratio greater than or equal to 1), had lower mortality than those hospitals with worse nursing environments and below average staffing levels. The mortality rate in Medicare patients undergoing general surgery was 4.8% in the hospitals with the better nursing environments versus 5.8% in those hospitals with worse nursing environments. Furthermore, cost per patient was similar. We found that better nursing environments were also associated with lower need to use the Intensive Care Unit. The greatest mortality benefit occurred in patients in the highest risk groups. (more…)
Anesthesiology, Author Interviews, Frailty, JAMA, Surgical Research / 20.01.2016

More on Frailty on MedicalResearch.com MedicalResearch.com Interview with: Dr. Daniel I McIsaac, MD, MPH, FRCPC Assistant Professor of Anesthesiology Department of Anesthesiology The Ottawa Hospital, Civic Campus Ottawa, ON Medical Research: What is the background for this study? Dr. McIsaac: Older age is a well-known risk factor for adverse outcomes after surgery, however, many older patients have positive surgical outcomes. Frailty is a syndrome that encompasses the negative health attributes and comorbidities that accumulate across the lifespan, and is a strong discriminating factor between high- and low-risk older surgical patients.  By definition, frail patients are “sicker” than non-frail patients, so their higher rates of morbidity and mortality after surgery aren’t surprising. However, frailty increases in prevalence with increasing age, so as our population ages we expect to see more frail people presenting for surgery.  Our goal was to evaluate the impact of frailty on postoperative mortality at a population-level, and over the first year after surgery to provide insights that aren’t available in the current literature, which largely consists of single center studies limited to in-hospital and 30-day outcome windows. (more…)
Author Interviews, JAMA, Neurological Disorders, Parkinson's / 20.01.2016

More Interviews on Neurological Disorders on MedicalResearch.com MedicalResearch.com Interview with: Professor Carl E Clarke Professor of Clinical Neurology and Honorary Consultant Neurologist Department of Neurology City Hospital Sandwell and West Birmingham Hospitals NHS Trust Birmingham UK Medical Research: What is the background for this study? Dr. Clarke: Parkinson's disease causes problems with activities of daily living that are only partially treated by medication and occasionally surgery. Physiotherapy and occupational therapy services like Ck Physio are traditionally used later in the disease, but it is unclear whether they are clinically and cost-effective in Parkinson's disease. Medical Research: What are the main findings? Dr. Clarke: We performed a large pragmatic randomised trial to evaluate the clinical and cost-effectiveness of individualized physiotherapy and occupational therapy in Parkinson's disease. The PD REHAB trial was a multicenter, open label, parallel group, controlled efficacy trial. 762 patients with mild-moderate Parkinson’s disease were recruited from 38 sites across the United Kingdom. For patients with mild to moderate Parkinson disease, there were no clinically meaningful benefits in activities of daily living or quality of life associated with physiotherapy and occupational therapy. (more…)
Author Interviews, Diabetes, JAMA, Mental Health Research, Pediatrics, Pharmacology / 20.01.2016

More on Mental Health on MedicalResearch.com MedicalResearch.com Interview with: Christoph U. Correll, MD Professor of Psychiatry and Molecular Medicine Hofstra Northwell School of Medicine Hempstead, New York, USA Investigator, Center for Psychiatric Neuroscience Feinstein Institute for Medical Research Manhasset, New York, Medical Director, Recognition and Prevention The Zucker Hillside Hospital, Department of Psychiatry  Medical Research: What is the background for this study? Dr. Correll: Antipsychotics have been used increasingly for psychotic, but also for many non-psychotic conditions, including for disorders and conditions for which they have not received regulatory approval. Moreover, antipsychotics have been associated with weight gain and abnormalities in blood fat and blood glucose levels. Although data in youth have been less available than in children and adolescents, youth appear to be more sensitive to the cardiometabolic adverse effects of antipsychotics than adults in whom significant weight gain might have already occurred due to long-term prior antipsychotic treatment. Nevertheless, type 2 diabetes, which is related to weight gain, overweight and obesity, seemed to be more common in adults than youth, likely due to the fact that it takes a long time for the body to develop diabetes. Recently, several individual epidemiologic or database studies with sufficient long-term follow-up durations suggested that the type 2 diabetes risk was higher in youth exposed to antipsychotics than healthy control youth and, possibly, even compared to psychiatrically ill patients treated with non-antipsychotic medications. However, a meta-analytic pooling of all available data has not been available to estimate the absolute and relative risk of type 2 diabetes in youth receiving antipsychotic treatment.  Medical Research: What are the main findings? Dr. Correll: The main findings of the study that meta-analyzed data from 13 studies with 185,105 youth exposed to antipsychotics (average age 14.1 and 59.5 percent male) are that the absolute rates of type 2 diabetes are fortunately still relatively low, i.e. a cumulative type 2 diabetes  risk of 5.7/1,000 patients and an exposure adjusted incidence rate of 3.1/1,000 patient-years. Nevertheless, the cumulative risk of type 2 diabetes and its exposure adjusted incidence rate per patient were 2.6 times and three times higher compared with 298,803 healthy controls. Furthermore, the cumulative risk of type 2 diabetes and its exposure adjusted incidence rate per patient were 2.1 times and 1.8 times higher compared with 1,342,121 psychiatric patients not exposed to antipsychotics. Main modifiable risk factors for type 2 diabetes development in antipsychotic-treated youth were treatment with the antipsychotic olanzapine and longer antipsychotic exposure time. (more…)
Author Interviews, Brigham & Women's - Harvard, Dermatology, JAMA, Melanoma, Transplantation / 20.01.2016

More on Dermatology from MedicalResearch.com  MedicalResearch.com Interview with: Pritesh S. Karia, MPH Manager-Dermatologic Oncology Research Program Mohs and Dermatologic Surgery Center Brigham and Women's Hospital Boston, MA 02130  Medical Research: What is the background for this study? Response: Several recent studies have shown a reduced incidence of skin cancer in organ transplant recipients (OTR) treated with sirolimus as first-time therapy and those converted from calcineurin inhibitors to sirolimus. Although cancer formation is one of the main reasons for conversion to sirolimus, studies examining the effect of sirolimus on the risk of subsequent cancer formation in organ transplant recipients who have already been diagnosed with a post-transplant cancer are limited. (more…)
Author Interviews, JAMA, NYU, Pediatrics, Weight Research / 20.01.2016

More on Obesity from MedicalResearch.com MedicalResearch.com Interview with: Brian Elbel, PhD, MPH, Associate Professor, Department of Population Health, NYU Langone Medical Center Amy Schwartz, PhD, Director, New York University Institute for Education and Social Policy, and the Daniel Patrick Moynihan Chair in Public Affairs, Syracuse University Michele Leardo, MA, Assistant Director New York University Institute for Education and Social Policy Medical Research: What is the background for this study? What are the main findings? Response: New York City, as well as other school districts, is making tap water available to students during lunch by placing water dispensers, called water jets, in schools. Surprisingly, drinking water was not always readily available in the lunchroom. Water jets are part of a larger effort to combat child obesity. We find small, but statistically significant, decreases in weight for students in schools with water jets compared to students in schools without water jets. We see a .025 reduction in standardized body mass index for boys and .022 for girls. We also see a .9 percentage point reduction in the likelihood of being overweight for boys and a .6 percentage point reduction for girls. In other words, the intervention is working. (more…)
Author Interviews, Heart Disease, JAMA, Wake Forest / 20.01.2016

More on Heart Disease on MedicalResearch.com MedicalResearch.com Interview with: Ajay Dharod, M.D. Coordinator of Medical Informatics Department of Internal Medicine Wake Forest School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Dharod: There is a relative paucity of data regarding asymptomatic bradycardia in adults free of clinical cardiovascular disease. Are individuals with low heart rates simply healthy individuals with a non-clinically significant finding or is there a subclinical disease process? That was the question that generated this study. Until now, there had not been any research to determine if a slow heart rate contributed to the development of cardiovascular disease. We found that a heart rate (HR) of less than 50 was not associated with an elevated risk of cardiovascular disease in participants regardless of whether they were taking Heart Rate-modifying drugs, such as beta blockers and calcium channel blockers. However, we did find a potential association between bradycardia and higher mortality rates in individuals taking HR-modifying drugs. (more…)