Author Interviews, JAMA, Opiods / 09.07.2018

MedicalResearch.com Interview with: Tyler Winkelman MD, MSc  Clinician-Investigator Division of General Internal Medicine, Hennepin Healthcare Center for Patient and Provider Experience, Hennepin Healthcare Research Institute Assistant Professor Departments of Medicine & Pediatrics University of Minnesota MedicalResearch.com: What is the background for this study? Response: Opioid overdose deaths continue to escalate, and there have been reports that jails and prisons are bearing the brunt of the opioid epidemic. However, it wasn’t known, nationally, how many people who use opioids were involved in the criminal justice system. We also didn’t have recent estimates of common physical and mental health conditions among people with different levels of opioid use. We used two years of national survey data to understand these associations, which are critical in developing a public health response to the opioid epidemic. (more…)
Author Interviews, Brigham & Women's - Harvard, Electronic Records, JAMA / 07.07.2018

MedicalResearch.com Interview with: Li Zhou, MD, PhD, FACMI Associate Professor of Medicine Division of General Internal Medicine and Primary Care Brigham and Women’s Hospital, Harvard Medical School Somerville, MA 02145 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Documentation is one of the most time-consuming and costly aspects of electronic health record (EHR) use. Speech recognition (SR) technology, the automatic translation of voice to text, has been increasingly adopted to help clinicians complete their documentation in an efficient and cost-effective manner. One way in which SR can assist this process is commonly known as “back-end” SR, in which the clinician dictates into the telephone, the recorded audio is automatically transcribed to text by an speech recognition engine, and the text is edited by a professional medical transcriptionist and sent back to the EHR for the clinician to review and sign. In this study, we analyzed errors at different processing stages of clinical documents collected from 2 health care institutions using the same back-end SR vendor. We defined a comprehensive schema to systematically classify and analyze these errors, focusing particularly on clinically significant errors (errors that could plausibly affect a patient’s future care). We found an average of 7 errors per 100 words in raw  speech recognition transcriptions, and about 6% of those errors were clinically significant. 96.3% of the raw speech recognition transcriptions evaluated contained at least one error, and 63.6% had at least one clinically significant error. However, the rate of errors fell significantly after review by a medical transcriptionist, and it fell further still after the clinician reviewed the edited transcript. (more…)
Author Interviews, Breast Cancer, Cancer Research, Cost of Health Care, JAMA / 06.07.2018

MedicalResearch.com Interview with:

Dr Nora Pashayan PhD

Clinical Reader in Applied Health Research

University College London

Dept of Applied Health Research

London 

MedicalResearch.com:  What is the background for this study?

Response: Not all women have the same risk of developing breast cancer and not all women have the same potential to benefit from screening.

 

If the screening programme takes into account the individual variation in risk, then evidence from different studies indicate that this could improve the efficiency of the screening programme. However, questions remain on what is the best risk-stratified screening strategy, does risk-stratified screening add value for money, and what are benefit and harm trade-offs.

(more…)
Author Interviews, JAMA, Mental Health Research, Nutrition, OBGYNE / 05.07.2018

MedicalResearch.com Interview with: Joshua L. Roffman, MD Department of Psychiatry Mass General Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Autism, schizophrenia, and other serious mental illness affecting young people are chronic, debilitating, and incurable at present.  Recent public health studies have associated prenatal exposure to folic acid, a B-vitamin, with reduced subsequent risk of these illnesses.  However, until this point, biological evidence supporting a causal relationship between prenatal folic acid exposure and reduced psychiatric risk has remained elusive. We leveraged the rollout of government-mandated folic acid fortification of grain products in the U.S. from 1996-98 as a "natural experiment" to determine whether increased prenatal folic acid exposure influenced subsequent brain development.  This intervention, implemented to reduce risk of spina bifida and other disabling neural tube defects in infants, rapidly doubled blood folate levels among women of childbearing age in surveillance studies. Across two large, independent cohorts of youths age 8 to 18 who received MRI scans, we observed increased cortical thickness, and a delay in age-related cortical thinning, in brain regions associated with schizophrenia risk among individuals who were born during or after the fortification rollout, compared to those born just before it.  Further, delayed cortical thinning also predicted reduced risk of psychosis spectrum symptoms, a finding that suggests biological plausibility in light of previous work demonstrating early and accelerated cortical thinning among school-aged individuals with autism or psychosis. (more…)
Accidents & Violence, Author Interviews, JAMA, Pediatrics, University of Pittsburgh / 05.07.2018

MedicalResearch.com Interview with: Alison J. Culyba, MD, PhD, MPH Assistant Professor of Pediatrics UPMC Children’s Hospital of Pittsburgh University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Homicide is the third leading cause of death among adolescents, and disproportionately affects minority youth in under-resourced urban communities. Most research on youth violence focuses on risk factors, such as weapon carrying and substance abuse. We know much less about factors that protect youth from violence. Future orientation, defined as hopes and plans for the future, is linked to many important positive outcomes for youth, including doing well in school and avoiding illicit substances. However, there has been very little research to examine whether future orientation may also protect youth from violence. To study links between future orientation and violence perpetration, we surveyed over 850 male youth in lower resource neighborhoods in Pittsburgh as part of a community-based sexual violence prevention study. We found that youth with positive future orientation were significantly less likely to report threatening someone with a weapon or injuring someone with a weapon in the past nine months. (more…)
Author Interviews, Cancer Research, JAMA, OBGYNE / 04.07.2018

MedicalResearch.com Interview with: Dr. Gina Ogilvie | MD MSc FCFP DrPH Professor | Faculty of Medicine | University of British Columbia Canada Research Chair | Global control of HPV related disease and cancer Senior Public Health Scientist | BC Centre for Disease Control Senior Research Advisor | BC Women's Hospital and Health Centre BC Women's Hospital and Health Centre Vancouver, BC MedicalResearch.com: What is the background for this study? What are the main findings? Response: HPV is known to be the cause of 99% of cervcial cancers. In this study, we compared the routine screening test for cervical cancer, Pap test, to HPV testing. We found that by using HPV testing, women were significantly more likely to have cervical pre-cancers detected earlier. In addition, women with negative HPV tests were significantly less likely to have pre-cancers 48 months later. (more…)
Author Interviews, Cancer Research, Endocrinology, JAMA, Pediatrics / 02.07.2018

MedicalResearch.com Interview with: “Cancer awareness” by Susan Roberts is licensed under CC BY 2.0Mette Vestergaard Jensen, MD Danish Cancer Society Research Center MedicalResearch.com: What is the background for this study? Response: Cancer survival rates have improved and it is necessary to explore the long-term consequences of cancer treatment. Adolescents and young adults with cancer are at risk for several therapy-related late effects; however, these have not been studied extensively. We investigatet the lifetime risks of endocrine late effects of cancer and cancer treatment in adolescent and young adult cancer s (more…)
Author Interviews, JAMA, OBGYNE, Surgical Research / 29.06.2018

MedicalResearch.com Interview with: Sarah CM Roberts, DrPH Associate Professor ObGyn&RS Zuckerberg San Francisco General UCSF MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thirteen states have laws that require abortions to be provided in Ambulatory Surgery Centers (ASCs); many of these laws apply only in the second trimester.  We examined outcomes from more than 50,000 abortions provided in two facility types:  Ambulatory Surgery Centers and office-based settings. We found that there was no significant difference in abortion-related complications across facility type; in both settings, about 3.3% had any complication and about 0.3% had a major complication.  There also was no significant difference in complications across facility types for second trimester and later abortions. (more…)
Aging, Alzheimer's - Dementia, Author Interviews, JAMA, Ophthalmology / 29.06.2018

MedicalResearch.com Interview with: “Old Eyeglasses” by Leyram Odacrem is licensed under CC BY 2.0Diane Zheng MS NEI F-31 Research Fellow and a Ph.D. candidate in Epidemiology Department of Public Health Sciences University of Miami MedicalResearch.com: What is the background for this study? Response: Worsening vision and declining cognitive function are common conditions among older people. Understanding the association between them could be beneficial to alleviate age related cognitive decline. (more…)
Author Interviews, JAMA, Osteoporosis / 28.06.2018

MedicalResearch.com Interview with: Chien-Wen Tseng, M.D., M.P.H., M.S.E.E. Hawaii Medical Service Association Endowed Chair in health services and quality research Associate professor, and the Associate research director Department of Family Medicine and Community Health University of Hawaii John A. Burns School of Medicine  MedicalResearch.com: What is the background for this recommendation statement? What are the main findings and recommendations? Response: Osteoporosis is a condition where bones become weak and can break or fracture more easily. These fractures can happen at the spine, hip, and other locations, and can have serious health consequences such as pain, limited mobility, or even death. By 2020, more than 12 million Americans over the age of 50 are expected to have osteoporosis and two million fractures occur yearly. Since people often may not know they have osteoporosis until they have a fracture, the U.S. Preventive Services Task Force looked at the evidence to see if screening for osteoporosis can help to prevent fractures. We found that screening for and treating osteoporosis can prevent fractures in women ages 65 and older and in younger women who have been through menopause and have additional factors that put them at increased risk for osteoporosis. In men, more research is needed to know if routine screening and treatment for osteoporosis can prevent fractures. (more…)
Author Interviews, Heart Disease, JAMA / 28.06.2018

MedicalResearch.com Interview with: Dan Blumenthal, MD, MBA Assistant in Medicine, Division of Cardiology Massachusetts General Hospital Instructor in Medicine Harvard Medical School  MedicalResearch.com: What is the background for this study? Response: Despite dramatic advances in the treatment of cardiovascular disease (CVD) over the past half-century, CVD remains a leading cause of death and health care spending in the United States (US) and worldwide. More than 2000 Americans die of CVD each day, and more than $200 billion dollars is spent on the treatment of CVD each year in the US By 2030, over 40% of the US population is projected to have some form of CVD, at a cost of $1 trillion to the US economy. The tremendous clinical and financial burden of cardiovascular illness has helped motivated policymakers to develop policy tools that have the potential to improve health care quality and curb spending.  Alternative payment models, and specifically bundled payments—lump sum payment for defined episodes of care which typically subsume an inpatient hospitalization and some amount of post-acute care—represent a promising tool for slowing health care spending and improving health care value. Despite broad interest in implementing bundled payments to achieve these aims, our collective understanding of the effects of bundled payments on .cardiovascular disease care quality and spending, and the factors associated with success under this payment model, are limited. Medicare’s Bundled Payments of Care Improvement (BPCI) is an ongoing voluntary, national pilot program evaluating bundled payments for 48 common conditions and procedures, including several common cardiovascular conditions and interventions.   In this study, we compared hospitals that voluntarily signed up for the four most commonly subscribed cardiac bundles—those for acute myocardial infarction, congestive heart failure, coronary artery bypass graft surgery, and percutaneous coronary intervention—with surrounding control hospitals in order to gain some insight into the factors driving participation, and to assess whether the hospitals participating in these bundles were broadly representative of a diverse set of U.S. acute care hospitals.  (more…)
Author Interviews, Dermatology, JAMA, Nutrition, UCLA / 27.06.2018

MedicalResearch.com Interview with: Adam Ford, BS Research fellow with Dr. April Armstrong Keck School of Medicine University of Southern California MedicalResearch.com: What is the background for this study? Response: Our psoriasis patients have long asked us about the role of diet on psoriasis. Previously, there was a lack of evidence synthesis on the relationship between psoriasis and diet. As such, providers were mostly unable to address their patients questions on the role of diet on psoriasis. This pivotal effort from the National Psoriasis Foundation has been a few years in the making. We looked at the role of diet on psoriasis and psoriatic arthritis based on a careful synthesis of the scientific studies available to us currently. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, JAMA / 26.06.2018

MedicalResearch.com Interview with: Bishal Gyawali, MD, PhD Department of Medicine Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: PD-1 inhibitors are an interesting class of cancer drugs with atypical response patterns in clinical trials. There is a lot of debate over cancer drugs that improve progression-free survival (PFS) – a surrogate measure of clinical benefit– without affecting patients’ overall survival (OS), but in some studies, PD-1 inhibitors appears to improve overall survival (OS) without affecting PFS. We therefore conducted a systematic review and meta-analysis of randomized trials of PD-1 inhibitors (nivolumab and pembrolizumab) to assess the effect of these drugs on OS versus PFS. We showed that PD-1 inhibitors do appear to improve OS more than PFS.  (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Health Care Systems, JAMA / 26.06.2018

MedicalResearch.com Interview with: A Jay Holmgren Doctoral Student, Health Policy and Management Harvard Business School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Post-acute care, care that is delivered following an acute care hospitalization, is one of the largest drivers of variation in US health care spending. To address this, Medicare has created several payment reform systems targeting post-acute care, including a voluntary bundled payment program known as the Model 3 of the Bundled Payment for Care Improvement (BPCI) Initiative for post-acute care providers such as skilled nursing facilities, long-term care hospitals, or inpatient rehabilitation facilities. Participants are given a target price for an episode of care which is then reconciled against actual spending; providers who spend under the target price retain some of the savings, while those who spend more must reimburse Medicare for some of the difference. Our study sought to evaluate the level of participation in this program and identify what providers were more likely to participate. We found that fewer than 4% of eligible post-acute care providers ever participated in the program, and over 40% of those who did participate dropped out. The providers more likely to remain in the program were skilled nursing facilities that were higher quality, for-profit, and were part of a multi-facility organization. (more…)
Author Interviews, JAMA, Opiods, University of Pittsburgh / 25.06.2018

MedicalResearch.com Interview with: Inmaculada Hernandez, PharmD, PhD Assistant Professor of Pharmacy and Therapeutics University of Pittsburgh School of Pharmacy Pittsburgh, PA 15261 MedicalResearch.com: What is the background for this study? Response: Prior research has found that taking opioids and benzodiazepines simultaneously increases the risk of overdose by 2 to 3 fold, when compared to opioid-use only. However, prior to our study, it was unclear how the risk of overdose changes over time with the concurrent use of opioids and benzodiazepines. (more…)
Alzheimer's - Dementia, Author Interviews, JAMA, Neurology / 25.06.2018

MedicalResearch.com Interview with: Paul Foster BMedSci(Hons) BMBS PhD FRCS(Ed) FRCOphth FRCS(Eng) Professor of Glaucoma Studies & Ophthalmic Epidemiology Research Theme Lead Integrative Epidemiology & Visual Function UCL Institute of Ophthalmology & Moorfields Eye Hospital London  MedicalResearch.com: What is the background for this study?  Response:  Dementia is the medical challenge of the moment – increasingly common, adversely impacting quality of life for millions, and a great worry for all. Efforts to identify treatments or interventions rely on being able to identify those people at greatest risk. Our motivation was to help identify those people, primarily to aid in the development of treatments through clinical trials. (more…)
Author Interviews, Heart Disease, JAMA / 25.06.2018

MedicalResearch.com Interview with: Dr. Michael Barry MD Director of the Informed Medical Decisions Program Health Decision Sciences Center at Massachusetts General Hospital Physician at Massachusetts General Hospit Professor of Medicine,Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cardiovascular disease (CVD), which can lead to heart attack and stroke, causes 1 in 3 deaths among adults in the United States. The Task Force reviewed the latest research on whether adding an electrocardiogram—or ECG, which is a test that records a person's heart activity—to the standard ways we measure CVD risk can help prevent heart attack and stroke in people who do not have symptoms and are generally healthy, as well as people who are already at risk for these conditions. The evidence shows that adding screening with ECG to the ways we already measure CVD risk is unlikely to help prevent heart attack or stroke in people at low risk. It can also cause harms—such as those from follow-on procedures like angiography and angioplasty, which can lead to heart attack, kidney failure, and even death. As a result, the Task Force recommends against screening with ECG for this group. For those who might benefit the most—people who are already at medium or high risk of CVD—there is not enough evidence to say whether or not adding screening with an ECG to standard care helps prevent heart attack and stroke. This is an area where we need more research.  (more…)
Author Interviews, Heart Disease, JAMA, Lipids / 21.06.2018

MedicalResearch.com Interview with: Dr. Stephen Burgess PhD Programme Leader at the Medical Research Council Biostatistics Unit University of Cambridge MedicalResearch.com: What is the background for this study? What are the main findings? Response: Lipoprotein(a) is a lipoprotein subclass, and an important biomarker for coronary heart disease. As a clinical biomarker, it has a similar story to LDL-cholesterol (“bad” cholesterol), in that it is thought to be a causal risk factor for coronary heart disease, and so is a potential target for drug development. However, while drugs that lower LDL-cholesterol, such as statins, have been successful in reducing coronary heart disease risk, drugs that lower lipoprotein(a) have not as yet been successful. New drugs are currently in development that specifically target lipoprotein(a) and can lower lipoprotein(a) concentrations by 80-90%. We performed this study to investigate whether these drugs are likely to be successful in reducing coronary heart disease risk. We compared individuals with naturally-occurring genetic variants that predispose them to a higher or lower lifetime concentration of lipoprotein(a) as a way of mimicking a randomized controlled trial. This approach has previously been undertaken for other biomarkers, including LDL-cholesterol. We found that having 10mg/dL lower genetically-predicted concentration of lipoprotein(a) was associated with a 5.8% reduction in coronary heart disease risk. However, associations between genetically-predicted LDL-cholesterol and coronary heart disease risk are quantitatively much stronger than the proportional effect of LDL-cholesterol lowering on coronary heart disease risk as estimated by statin trials. This is because differences in genetic variants reflect lifelong changes in LDL-cholesterol, whereas statin trials only lower LDL-cholesterol for a few years. Hence, using the ratio between the genetic and trial estimates for LDL-cholesterol, we estimate that lowering lipoprotein(a) by 10mg/dL in a short-term clinical trial would only reduce coronary heart disease risk by 2.7%. To obtain the same reduction in coronary heart disease risk of around 20% as observed in statin trials, lipoprotein(a) would have to be lowered by around 100mg/dL. This explains why previous trials of less specific and less potent lipoprotein(a)-lowering drugs have failed to demonstrate benefit. (more…)
Author Interviews, JAMA, Karolinski Institute, Mental Health Research, PTSD, Rheumatology / 21.06.2018

MedicalResearch.com Interview with: Huan Song Associated Department of Medical Epidemiology and Biostatistics Karolinska Institutet MedicalResearch.com: What is the background for this study? Response: Earlier findings from our group (e.g. Fang et al., NEJM 2012; Arnberg et al., Lancet Psychiatry 2015; Lu et al., JAMA Oncol 2016; Shen et al., BMJ 2016; Zhu et al., Ann Oncol 2017) have identified pathways through which stressful events contribute to deterioration in human health. With strong animal models and human data supporting a role of stress in immune dysregulation, the hypothesis linking mental distress with autoimmune is indeed plausible. However, the evidence is as yet limited to clinical observations and a few larger observational studies on US veterans, most of them on men only, and some of which have cross-sectional designs and various other methodological shortcomings. (more…)
Author Interviews, CDC, JAMA, NIH, Weight Research / 20.06.2018

MedicalResearch.com Interview with: Cynthia L. Ogden, PhD, MRP Chief, NHANES Analysis Branch Epidemiologist, NCHS/CDC Hyattsville, MD 20782 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: 40% of adults and over 18% of youth in the US have obesity. Disparities in obesity have been reported by demographics and urbanization. We looked at the prevalence of obesity and severe obesity by demographics and by level of urbanization – rural, small/medium metro and large urban. We also looked at trends over time in urban and rural areas. Obesity and severe obesity rates were higher in rural areas than large urban areas among adults. Among youth, severe obesity rates were higher in rural areas compared to large urban areas. Differences in age, smoking, education or race/ethnicity between urban and rural areas did not explain the differences we found between urban and rural areas. Between 2001-2004 and 2013-2016 severe obesity among men in rural areas more than tripled and among women more than doubled. Increases in severe obesity also occurred in urban areas in men and women but they were not nearly as large. (more…)
AHA Journals, Allergies, Author Interviews, Infections, JAMA / 17.06.2018

MedicalResearch.com Interview with: “Lone Star Tick” by Katja Schulz is licensed under CC BY 2.0Jeffrey Wilson, MD, PhD Research Fellow, Allergy & Immunology University of Virginia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Galactose-α-1,3-galactose (α-Gal) represents an oligosaccharide that is present in mammalian products and is the causal allergen in a syndrome of delayed red meat allergy (commonly called α-Gal syndrome). Sensitization to this allergen has been linked to tick bites, specifically the lone star tick in the United States. Thus, sensitization to α-Gal (and the prevalence of subjects with symptomatic red meat allergy) is relatively common where the lone star tick is common, i.e- the southeast. For a variety of reasons we hypothesized that specific immune sensitization (which relates to IgE antibody production) to α-Gal would be a risk factor for coronary artery disease. To address this possibility we measured IgE specific to α-Gal in 118 adults subjects from central Virginia who had undergone advanced cardiac imaging with a technique called intravascular ultrasound. Out of the cohort 26% of the subjects in the study had the sensitivity to α-Gal. The main finding was that subjects with the IgE sensitization to α-Gal had greater amounts of atherosclerosis, as well as atherosclerotic plaques with more unstable characteristics. This association was significant when controlled for traditional cardiovascular risk factors such as hypertension, diabetes and lipids levels. (more…)
Author Interviews, Biomarkers, Cancer Research, JAMA, UCSD / 15.06.2018

MedicalResearch.com Interview with Aaron Goodman, MD Hematologist/Medical Oncologist Assistant Professor of Medicine UC San Diego Health  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Response rates to PD-1/PD-L1 blockade in solid tumors are reported at 10-20%.  Remarkably, response rates of 65% to 87% have been reported in patients with refractory classical Hodgkin lymphoma treated with checkpoint inhibitors. In nodular sclerosing Hodgkin lymphoma, amplification of the chromosomal region 9p24.1, which contains the genes PD-L1 (CD274), PDCD1LG2 (PD-L2)and JAK2, is directly correlated with increased expression of these proteins on Reed–Sternberg cells. Overall, 105 of 108 (97%) biopsies from patients with newly diagnosed classical Hodgkin lymphoma have increased PD-L1 and PDCD1LG2 copy numbers.  The prevalence and utility of PD-L1amplification as a response biomarker to PD-1/PD-L1 blockade is unknown in other tumors. We sought to determine the prevalence and utility of PD-L1 amplification as a response biomarker to PD-1/PD-L1 blockade in solid tumors.  (more…)
Author Interviews, Duke, Heart Disease, JAMA, Lipids, Race/Ethnic Diversity, Statins / 14.06.2018

MedicalResearch.com Interview with: Michael G. Nanna, MD Fellow, Division of Cardiology Duke University Medical Center Durham, NC MedicalResearch.com: What is the background for this study? Response: We know that African Americans are at higher risk for cardiovascular disease than white patients. We also know that African American individuals have been less likely to receive statin therapy compared to white individuals in the past. However, the reasons underlying these racial differences in statin treatment are poorly understood. We set out to determine if African American individuals in contemporary practice are treated less aggressively than whites and, if so, we wanted to investigate potential reasons why this might be the case. (more…)
Author Interviews, Health Care Systems, Infections, JAMA, Outcomes & Safety / 13.06.2018

MedicalResearch.com Interview with: Sarah L. Krein, PhD, RN Research Career Scientist VA Ann Arbor Healthcare System Ann Arbor, MI  Sarah L. Krein, PhD, RN Research Career Scientist VA Ann Arbor Healthcare System Ann Arbor, MI MedicalResearch.com: What is the background for this study? Response: We conducted this study to better understand the challenges faced by health care personnel when trying to follow transmission based precaution practices while providing care for hospitalized patients.  We already know from other studies that there are breaches in practice but our team was interested in better understanding why and how those breaches (or failures) occur so we can develop better strategies to ensure the safety of patients and health care personnel. (more…)
Author Interviews, JAMA, OBGYNE / 12.06.2018

MedicalResearch.com Interview with: Björn Pasternak, MD, PhD Associate Professor,Clinical Epidemiology Division Department of Medicine Solna Karolinska Institutet Stockholm, Sweden MedicalResearch.com: What is the background for this study? Response: To summarize the background for this study, there have been animal studies suggesting that oral fluconazole may give rise to fetal death. Given this background and the paucity of controlled human studies, we previously conducted a nationwide register-based study in Denmark, which was published in JAMA in 2016. In that study, we observed an increased risk of spontaneous abortion associated with fluconazole use in pregnancy. This prompted the European Medicines Agency to update the European label of fluconazole, warning about this potential adverse event. Further, findings in that study indicated that there could be an increased risk of stillbirth. We wanted to investigate this outcome further, in an independent data material, and also to investigate the outcome of neonatal death. Here, we report the results of a bi-national study conducted on the basis of nationwide health care registers in Sweden and Norway. From a background cohort of close to 1.5 million deliveries, we identified more than 10,000 pregnancies exposed to oral fluconazole and matched these to more than 100,000 unexposed pregnancies. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, OBGYNE / 12.06.2018

MedicalResearch.com Interview with: Sheryl L. Rifas-Shiman, MPH Lead Research Analyst Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Landmark Center Boston, MA 02215  MedicalResearch.com: What is the background for this study? Response: Caesarean delivery rates remain high and variable across hospitals, regions, and countries. Caesarean delivery may be a risk factor for childhood obesity, possibly because delivery route can influence the intestinal microbiomes, which may influence energy regulation. Previously reported associations of caesarean delivery with childhood obesity may be confounded by maternal BMI and sociocultural factors. To address this possibility, we studied sibling pairs from the Linked CENTURY Study, a longitudinal clinical database of well-child visits in Massachusetts linked to each child’s birth certificate, to isolate the effect of caesarean delivery from most other factors. (more…)
Alzheimer's - Dementia, Author Interviews, JAMA, Medical Imaging, Memory / 12.06.2018

MedicalResearch.com Interview with: Arno de Wilde, MD / PhD candidate Department of Neurology & Alzheimer Center Amsterdam Neuroscience VU University Medical Center Amsterdam, the Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous studies assessing the clinical utility of amyloid imaging used very selected research populations, limiting the translatability to clinical practice. In contrast, we used an unselected memory clinic cohort, offering amyloid PET to ALL patients visiting our memory clinic, and for the purpose of this study, we implemented amyloid PET in our routine diagnostic work-up. Our results demonstrate that amyloid PET has important consequences, in terms of diagnosis and treatment changes, for a significant number of patients within a situation that closely resembles clinical practice. I think that these results are an important step in 'bridging the gap' between using amyloid PET in a research setting versus daily clinical practice. (more…)
Author Interviews, JAMA, MRI, Prostate Cancer / 11.06.2018

MedicalResearch.com Interview with: Dr. Lars Boesen MD PhD Department of Urology Herlev Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The current standard of care in prostate cancer diagnosis includes untargeted transrectal ultrasound-guided biopsies for all biopsy-naïve men with clinically suspicion of prostate cancer. However, this strategy that practically has remained unchanged for decades has limited diagnostic accuracy as significant cancers are missed or under-graded and insignificant cancers are unintendedly detected by the random sampling leading to possible overtreatment. Multiparametric MRI in the diagnosis of prostate cancer has been studied extensively in recent years and has improved detection, localization, staging and risk stratification. It has been suggested that if multiparametric MRIs were used as a triage test prior to biopsies, a significant proportion of men might safely avoid prostate biopsies and the diagnostic ratio of significant vs. insignificant cancer could be improved compared to performing standard biopsies in all men. However, multiparametric MRIs are generally time-consuming (~40 min scan time), expensive and include intravenous contrast media. This reduces its feasibility for widespread clinical implementation in larger patient populations in the western community with its high PCa prevalence. The development of a simpler and faster (~15 min) biparametric MRI protocol using less scan sequences and circumvents intravenous contrast-media seems to preserve adequate diagnostic accuracy in a detection setting and could facilitate dissemination of prostate MRI as a triage test before any biopsy. Here we present a large prospective study that assesses the diagnostic accuracy of a novel biparametric MRI to rule out significant prostate cancer in N=1020 biopsy-naive men with clinically suspicion of prostate cancer. We found that a low suspicion biparametric MRI had a very high negative predictive value (97%) for ruling out significant cancer on confirmatory biopsies. Furthermore, bpMRI suspicion scores were strongly associated with prostate cancer detection rates and restricting biopsies (targeted plus standard) to men with suspicious biparametric MRIs meant 30% could avoid prostate biopsies, improved significant prostate cancer diagnosis by 11%, and reduced insignificant prostate cancer diagnosis by 40% compared to our current diagnostic approach – standard biopsies for all men with clinically suspicion of prostate cancer.  (more…)