Abbvie, ASCO, Author Interviews, Cancer Research, Leukemia / 03.06.2018

MedicalResearch.com Interview with: Dr. Danelle James, M.D., M.A.S. Head of Clinical Science Pharmacyclics, an AbbVie Company MedicalResearch.com: What is the background for this study? What are the main findings? Response: CAPTIVATE is a Phase 2 study investigating IMBRUVICA (ibrutinib) plus VENCLEXTA (venetoclax) for the treatment of Chronic Lymphocytic Leukemia (CLL) in the first-line setting. It was designed to evaluate if remission with undetectable minimal residual disease (MRD) can provide treatment-naïve CLL/SLL patients with treatment holidays (a period of time when a patient is able to stop therapy). The study enrolled 164 patients with previously untreated CLL or SLL. In preclinical and ongoing clinical studies, we’ve seen complementary activities with this combination. The combination has also previously shown potential for deeper remissions, as well as potential for lower risk of tumor lysis syndrome with ibrutinib as the lead-in therapy. Early data from CAPTIVATE show promising activity for the combination in this patient population, with 77 percent of the first 30 patients achieving responses with no detectable MRD in the blood after only six cycles of the combination therapy. Approximately nine out of 10 of the first patients achieved undetectable MRD after 12 cycles of combination therapy (which were preceded by three cycles of single agent ibrutinib, for a total of 15 cycles of therapy). Specifically, 86 percent of the first 14 patients achieved undetectable MRD in the marrow and 93 percent in the peripheral blood. (more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, JAMA / 02.06.2018

MedicalResearch.com Interview with: Jiang He, MD, PhD Joseph S. Copes Chair of Epidemiology, Professor School of Public Health and Tropical Medicine Tulane University MedicalResearch.com: What is the background for this study? What are the main findings?   Response: The 2017 American College of Cardiology and American Heart Association hypertension guideline recommended lower blood pressure cut points for initiating antihypertensive medication and treatment goals than the previous hypertension guideline. We estimated the prevalence of hypertension and the proportion of the US adult population recommended for antihypertensive treatment according to the 2017 hypertension guideline. More importantly, we estimated the risk reductions of cardiovascular disease and all-cause mortality, as well as increases in adverse events, assuming the entire US adult population achieved the 2017 guideline-recommended systolic blood pressure treatment goals of less than 130 mmHg. Our study indicated the prevalence of hypertension was 45.4%, representing 105 million US adults with hypertension, according to the 2017 hypertension guideline. In addition, the proportion of individuals recommended for antihypertensive treatment was 35.9% or 83 million US adults. Based on data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and US population-based cohort studies, we estimated 610 thousand cardiovascular disease events and 334 thousand total deaths could be prevented annually in the US population if the 2017 hypertension guideline systolic blood pressure treatment goals were achieved in the entire US population. Compared to full implementation of the previous hypertension guideline, we estimated the 2017 hypertension guideline recommendations would reduce an additional 340 thousand cardiovascular disease events and 156 thousand deaths per year in the US. Implementing the 2017 hypertension guideline was estimated to increase 62 thousand hypotension, 32 thousand syncope, 31 thousand electrolyte abnormality, and 79 thousand acute kidney injury or kidney failure events. These analyses indicated implementing the 2017 hypertension guideline would significantly increase the proportion of US adults recommended for antihypertensive treatment and further reduce cardiovascular disease events and all-cause mortality, but might increase the number of adverse events in the US population. (more…)
Author Interviews, Pharmaceutical Companies / 31.05.2018

MedicalResearch.com Interview with: “pills” by Dominique Godbout is licensed under CC BY 2.0George P. Ball PhD Operations and Decision Technologies Department Kelley School of Business, Indiana University Bloomington, IN 47405, MedicalResearch.com: What is the background for this study? What are the main findings? Response: We sought to examine how the intense pressure on firms to produce generic drugs more cheaply might influence product quality. We find that the greater proportion of generic drugs a firm manufactures, the more severe product recalls they experience, because of an apparent relaxation of manufacturing quality standards. Additionally, they experience fewer less severe recalls, which may also result from forces of competition. When the opportunity exists to not announce a recall that has high discretion, competition may lead firms to forgo the recall to avoid negative ramifications associated with recalls. (more…)
Author Interviews, JAMA / 30.05.2018

MedicalResearch.com Interview with: “Stop smoking!” by Emil_95 is licensed under CC BY 2.0Shahrokh F. Shariat, M.D. Professor and Chairman Department of Urology, Comprehensive Cancer Center Medical University Vienna Adjunct Professor of Urology and Medical Oncology Weill Medical College of Cornell University, New York, NY, USA Adjunct Professor of Urology UT Southwestern, Dallas, TX MedicalResearch.com: What is the background for this study? What are the main findings? Response: We know that tobacco smoking produces more than 70 carcinogens and is associated with worse prognosis in many solid cancers. Although the association between cigarette smoking and prostate cancer death has been demonstrated, such association regarding other end points is still unclear. We evaluated different disease endpoints, such as recurrence, occurrence of metastasis and cancer-specific mortality at an earlier stage of disease. We found that smokers who underwent primary treatment for localized prostate cancer - such as radical prostatectomy and radiotherapy - are at increased risk of recurrence, metastasis and cancer-specific mortality.  (more…)
Addiction, Author Interviews, Opiods, Pain Research / 23.05.2018

MedicalResearch.com Interview with: Dr. Stuart Lustig, M.D., M.P.H National Medical Executive for Behavioral Health Cigna Dr. Lustig discusses Cigna’s efforts to curb the opioid epidemic. MedicalResearch.com: What is the background for the Applying American Society of Addiction Medicine Performance Measures in Commercial Health Insurance and Services Data study? Response: In 2016 Cigna announced a collaboration with the American Society of Addiction Medicine (ASAM) to improve treatment for people suffering from substance use disorders and establish performance measures and best practices for addiction treatment. Mining anonymized data from Cigna’s administrative data, Brandeis University researchers have validated a new way to hone in on trouble spots where substance use disorder treatment for opioid, alcohol and other drug dependence is suboptimal, like the way police departments use computers to identify high crime areas in need of greater scrutiny and attention. The technique uses ASAM-defined performance measures to assess substance use disorder treatment patterns, giving researchers the ability to sort through administrative data and measure to the extent to which patients being treated for opioid or alcohol use disorder are receiving and using evidenced-based medications proven to be effective in improving outcomes and retention in treatment. It also measures whether those patients received support during substance withdrawal – a critical factor in the success of addiction treatment plans. The performance measures were first tested on the Veterans’ Health Administration in 2016 and now, on data from Cigna. (more…)
Author Interviews, JAMA, NIH / 23.05.2018

MedicalResearch.com Interview with: Jennifer Villani, PhD, MPH Office of Disease Prevention National Institutes of Health MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The US Preventive Services Task Force (USPSTF) develops recommendations for the delivery of clinical preventive services based on the highest quality scientific evidence available. We performed a comprehensive assessment of the sources of funding for the research studies in this evidence base. The results showed that government agencies supported the most articles (56%), with the remaining support coming from nonprofits or universities (32%), and industry (17%). The National Institutes of Health was the single largest funder of research articles underlying the USPSTF recommendations.  (more…)
Author Interviews, Gender Differences, JAMA, Surgical Research / 02.04.2018

MedicalResearch.com Interview with: Neel Mansukhani, MD Department of Surgery Northwestern University and Melina R. Kibbe, MD, FACS, FAHA Colin G. Thomas Jr. Distinguished Professor and Chair Department of Surgery Professor, Department of Biomedical Engineering The University of North Carolina at Chapel Hill Chapel Hill, NC 27599-7050 Editor in Chief, JAMA Surgery  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This study is a follow-up to our previous work that examined sex bias in surgical research. Previously, we examined sex bias in basic and translational science surgical research, as well as in clinical surgical research. We discovered previously that sex bias exists in basic and translational surgical research in the unequal inclusion of male and female research subjects. In clinical research, we found sex bias in the degree of sex matching of included subjects, and in the frequency of sex-based reporting, analysis, and discussion of the data. In this current work, we sought to understand the effect of author gender on sex bias in surgical research. In this work, we found that most authors are male, most authors work with other authors of the same gender, and sex bias is prevalent regardless of author gender. Most importantly, we found that sex inclusive research receives more citations after publication compared to sex-biased research.  (more…)
Author Interviews, Technology / 30.01.2018

MedicalResearch.com Interview with: Lieutenant Commander Matthew Doubrava Senior Medical Officer, Naval Medical Research Unit Dayton, Ohio  MedicalResearch.com: What is the background for this research? What types of problems will be investigated using the Osprey? Response: The U.S. Marine Corps V-22 Osprey tilt-rotor aircraft will be used to conduct static aerospace medical research in an effort to provide solutions toward preventing musculoskeletal injury to tilt-rotor aircraft crew and en route care training at Wright-Patterson Air Force Base. Naval Medical Research Unit – Dayton (NAMRU-Dayton) has been tasked as the lead agency for the Navy to investigate tilt-rotor aircrafts potential effects of flight and vibration on aircrews. NAMRU-Dayton scientists will be partnering with the U.S. Air Force School of Aerospace Medicine, who will be investigating en route care training to figure out the best way for the crew to use the aircraft for that purpose. (more…)
Author Interviews, Breast Cancer, Cancer Research, Yale / 28.01.2018

MedicalResearch.com Interview with: Lajos Pusztai, M.D, D.Phil. Professor of Medicine Director of Breast Cancer Translational Research Co-Director of the Yale Cancer Center Genetics, Genomics and Epigenetics Program Yale School of Medicine New Haven, CT  06511 MedicalResearch.com: What is the background for this study? Response: Overall, about 85% of newly diagnosed stage I-III breast cancer patients will not die of their disease, and this roughly equates to an 85% cure rate. Of course cure rates are higher for stage I cancers and lower for stage III cancers. An 85% overall cure rate is good but not good enough, we continuously try to develop new therapies hoping to push these rates to 90%...,95%...etc. However, it is not possible to cure a patient twice over. For example, if surgery plus endocrine therapy cures all patients, the addition of chemotherapy cannot improve on it no matter how effective it is. If surgery plus endocrine therapy cures 95%, adding the perfect chemo to this treatment can only bring about a 5% improvement, and very good chemo that would push cure from 95% to 97%, would require a very large trial including many thousands of patients. This is an increasingly common scenario in modern breast cancer adjuvant trials (where the goal is to improve survival and cure); the control arm that receives the current standard of care invariably does better than expected and the experimental arm only improves outcome by 1-3% that does not reach statistical significance.  The painful conclusion from these trials is that we do not know if the new drug actually works or not because there were not enough events to demonstrate an effect. Of course, a lot of patients in the study were also exposed to a new drug with all of its associated toxicities who could not possibly benefit from it. (more…)
Author Interviews, Emory, Genetic Research, JAMA, Ophthalmology / 24.01.2018

MedicalResearch.com Interview with: Eldon E. Geisert, PhD Professor of Ophthalmology Emory School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the late 1990s a group of doctors began a study of glaucoma patients to determine if there were phenotypes that are predictive for developing glaucoma. In this Ocular Hypertension Treatment Study (OHTS) one of the highly correlated ocular traits was central corneal thickness (CCT). The early clinical studies found that people with thinner corneas were at a higher risk of developing glaucoma. In two large studies, examining thousands of people a number of genes were identified that were risk factors for glaucoma or that controlled CCT in humans. In both cases the identified genes accounted for less than 10% of the genetic risk for glaucoma and less than for 10% of the genetic control for CCT. There was little data linking the genetic control of CCT to the glaucoma risk. Our group has taken an indirect approach to the question, using well-defined mouse genetic system to identify genes modulating CCT and then interrogating human glaucoma data to determine if these genes are associated with glaucoma risk.   (more…)
Author Interviews, JAMA / 24.01.2018

MedicalResearch.com Interview with: Stelios Serghiou PhD student Epidemiology and Clinical Research and John P.A. Ioannidis, MD, DSc Meta-Research Innovation Center Stanford (METRICS), Stanford University Stanford, California MedicalResearch.com: What is the background for this study? Response: Preprints refer to versions of a manuscript prior to the one published in a peer-reviewed journal. Even though preprints have been very popular in disciplines such as physics and computer science for many years now, their use in biomedicine had been very limited. However, this seems to be changing since the establishment of bioRxiv in 2013. As such, we became interested in exploring what happens to preprints uploaded on bioRxiv and what is the impact of bioRxiv to the peer-reviewed literature in terms of attention received. (more…)
AHA Journals, Author Interviews, Heart Disease, Thyroid, UCSF / 26.10.2017

MedicalResearch.com Interview with: Christine Baumgartner MD Inselspital Universitätsspital Bern Bern, Switzerland Research Fellow, Division of Hospital Medicine UCSF MedicalResearch.com: What is the background for this study? What are the main findings? Response: Overt and subclinical hyperthyroidism increase the risk of atrial fibrillation, but it is unclear whether subclinical hypothyroidism, which is known to increase cardiovascular events, or thyroid function in the normal range are also associated with incident atrial fibrillation. Given the high prevalence of atrial fibrillation and its associated morbidity and mortality, identifying potentially modifiable risk factors is important. Therefore, we aimed to assess the risk of atrial fibrillation in individuals with subclinical hypothyroidism or variations of thyroid function within the normal range. Our main findings are that higher free thyroxine levels are associated with an increased risk of atrial fibrillation in euthyroid individuals, but thyroid-stimulating hormone levels within the euthyroid or subclinical hypothyroid range was not related to atrial fibrillation risk. (more…)
Author Interviews, Heart Disease, JAMA / 25.10.2017

MedicalResearch.com Interview with: Hawkins C. Gay, MD, MPH Resident Physician, Internal Medicine Feinberg School of Medicine Northwestern University MedicalResearch.com: What is the background for this study? What are the main findings? Response: The National Academy of Medicine and other leading institutions have highlighted clinical trial data sharing as an important initiative for enhancing trust in the clinical research enterprise. More recently, the International Committee of Medical Journal Editors stipulated that manuscripts published in their journals must clearly state plans for data sharing in the trial’s registration, and the National Institutes of Health now requires a data sharing plan as part of new grant applications. Many clinical trialists rightly debate the costs and time required to curate their data into a format that is usable by third part data analysts. Similarly, there has been debate about the most efficient platforms from which to distribute this data, and different models exist, including governmental (NIH BioLINCC), commercial (ClinicalStudyDataRequest.com), and academic (Yale Open Access Data Project [YODA]) platforms. Our study sought to explore these questions by conducting a reproduction analysis of the Thermocool Smarttouch Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial (NCT01385202), which is the only cardiovascular clinical trial available through the YODA platform. Reproduction analyses represent a fundamental approach for and outcome from data sharing but are uncommonly performed even though results change more than one-quarter of the time in reproduction analyses. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011. The time from our initial proposal submission to YODA and the final analysis completion was 11 months. Freedom from atrial arrhythmias at 12 months post-procedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the two analyses. We could not reproduce all analyses that were conducted in the primary study report; specifically, the analyses relating to contact force range and regression models. The primary reason for non-reproducibility was missing or un-locatable data in the analyzable dataset. (more…)
Author Interviews, PLoS, Stem Cells / 23.10.2017

MedicalResearch.com Interview with: Serge Horbach MSc Institute for Science in Society Radboud University Nijmegen   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Since the late 60s, researchers have pointed to issues in biomedical research stemming from the misidentification of cells. Starting with controversy around HeLa cells, researchers became aware of cells invading other cell cultures. Currently, 488 cell lines have become mixed up with the wrong cells, still often HeLa cells. This leads to errors in reporting research. For example, some research papers have reported results for "lung cancer cells" that turned out to be liver cancer cells, or even mouse cells. We wanted to know what happened to past research and set out to estimate the number of scientific publications affected by misidentified cells. By tracing misidentified cells of the ICLAC database in Web of Science, we found 32.755 contaminated publications, or 0,8% of all literature in cell biology. These articles are cited by at least 500.000 other publications. More worryingly, it turned out that this problem is highly stubborn. Currently, still a few dozen new articles are published every month reporting on other cells than were actually used, leading to a total of 1200 each year. And this number is not decreasing, in spite of a database of misidentified cells, of genetic testing availability, requirements by some prominent journals, or attention for the problem in the literature. We were also able to establish that this is not just a problem for newly emergent countries in the international research community, but also for countries with well-establishments research traditions. In spite of great efforts, the problem of cell misidentification is not at all solved. (more…)
Author Interviews, Pharmacology / 12.06.2017

MedicalResearch.com Interview with: Huseyin Naci, PhD Assistant Professor of Health Policy LSE Health Department of Social Policy London School of Economics and Political Science London, United Kingdom  MedicalResearch.com: What is the background for this study? What are the main findings? Response: An increasing proportion of novel therapeutic agents are entering the market on the basis of expedited development and approval programs. The Food and Drug Administration's (FDA) Accelerated Approval pathway is one such expedited approval program. In our study, we examined the dynamics of research on drugs receiving accelerated approvals. We were particularly interested in the timing and characteristics of research studies including drugs with accelerated approvals. Our primary findings are the following:
  • First, there is an abundance of research on drugs receiving accelerated approvals. Yet, the majority of this research (about 70%) is of poor quality. Ideally, these drugs are evaluated in so-called randomised controlled trials to establish their efficacy and safety. However, only about a third of all existing studies are randomised controlled trials.
  • Second, a substantial share (about 30%) of the existing research on these drugs is in areas not approved by the FDA. This may be indicative of industry research practices in trying to prioritise identification of new uses for drugs receiving accelerated approvals instead of strengthening their evidence base.
  • Third, when focusing on well-designed studies, only about a half actually evaluate the effectiveness of the accelerated approval drugs. The rest appears to use the accelerated approval drug as background therapy. Interestingly, these two types of studies are conducted concurrently. In other words, while one research group is trying to find out if an accelerated approval drug is effective, other research groups are already using it as part of a background regimen when testing the effectiveness of another, potentially newer drug
(more…)
Author Interviews, Outcomes & Safety / 11.06.2017

MedicalResearch.com Interview with: Antonio García-Romero IE University – IE Business School Madrid, SpainAntonio García-Romero IE University – IE Business School Madrid, Spain MedicalResearch.com: What is the background for this study? Response: There is an increasing need for new approaches capable of measuring the “real” effects of research on society. People are interested in knowing what benefits are obtained from scientific research. Our aim in this project was to develop a valid methodology capable of measuring the effects from scientific research on some healthcare outcomes such as the average length of stay in a hospital. Our central hypothesis is that the more research is carried out in hospitals, the more efficient the hospitals are regarding the length of stay (LOS). (more…)
Author Interviews, BMJ / 25.04.2017

MedicalResearch.com Interview with: Gary Evoniuk, PhD Director of Publication Practices, Medical Communications Quality & Practices GlaxoSmithKline Research and Development, Research Triangle Park, NC 27709 MedicalResearch.com: What is the background for this study? Response: In recent years, industry, and to a lesser extent academia, have been criticised for failing to submit clinical trial data for publication, especially when the data are perceived to be “negative”, (i.e. unfavourable to the drug under study) leading to publication bias. We felt it was important to determine whether this criticism is based on perception or reality and so we conducted what is, to our knowledge the only study to systematically address the issue of submission and publication bias based on study outcome. (more…)
Author Interviews, BMJ / 19.01.2017

MedicalResearch.com Interview with: Salomeh Keyhani MD Associate professor of general internal medicine San Francisco VA Medical Center and University of California San Francisco, CA 94121, USA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Randomized controlled trials are the foundation of the evidence base. We examined the prevalence of financial ties in randomized controlled trials and also examined the relationship of financial ties of principal investigators (PI) with trial outcome. We defined a financial tie as the direct compensation (e.g., consulting fees) of a PI by the drug manufacturer of interest. Although there have been past studies that have examined this relationship, many did not separate financial ties from funding source for the trial and many were focused on one specialty, journal, or type of drug. This study identified a random sample of RCTs published in 2013 that were focused on assessing drug efficacy. Both the disclosure section of the paper and several online databases (Medline, Google, Propublica’s Dollars for Doctors, and the US Patent Office) were searched for evidence of financial ties. Principal investigators financial ties with industry were independently associated with positive study outcomes. (more…)
Author Interviews, Autism, Genetic Research, Kidney Disease, Nature / 28.09.2016

MedicalResearch.com Interview with: Prof Adrian S. Woolf Chair, Professor of Paediatric Science University of Manchester, UK MedicalResearch.com: What is the background for this study? Response: Several years ago, Laurent Fasano discovered that the Drosophila teashirt gene was needed to pattern the body of embryonic flies. He then found that this transcription factor had three similar genes in mammals. Working with Adrian Woolf in the UK, they found that Teashirt-3 (Tshz3) was needed in mice to make muscle form in the ureter When the gene was mutated, mice were born with ureters that were 'blown-up' and they failed to milk urine from the kidney with the bladder. (more…)
Author Interviews, JAMA / 28.09.2016

MedicalResearch.com Interview with: Kanu Okike MD MPH Department of Orthopaedic Surgery, Kaiser Moanalua Medical Center Honolulu, Hawaii MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many journals in the social sciences practice double-blind review, in which reviewers and authors are both blinded to each others' identities. In medicine, on the other hand, most journals practice single-blind review, in which authors' identities are known to reviewers. Concerns have been raised that this could lead to biased reviews, however, especially in the case of well-known authors. In our study, we composed a fabricated test manuscript and randomized reviewers for an orthopaedic journal to receive single-blind (prestigious authors listed) or double-blind (no authors listed) versions. In our study, the reviewers who were under the impression that the manuscript was written by prestigious authors (single-blind review) awarded higher marks and also recommended acceptance more often, in spite of the fact that the manuscripts were otherwise identical. (more…)
Author Interviews, Outcomes & Safety, PLoS / 21.09.2016

MedicalResearch.com Interview with: Dr Su Golder PhD Research Fellow Department of Health Sciences University of York MedicalResearch.com: What is the background for this study? What are the main findings? Response: Serious concerns have emerged regarding publication bias or selective omission of outcomes data, whereby negative results are less likely to be published than positive results. There remains considerable uncertainty about the extent of unpublished data on adverse events beyond that reported in the published literature. We aimed to estimate the potential impact of additional data sources and the extent of unpublished information when conducting syntheses of adverse events. We found that less published papers contain adverse events information. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies. We also found even when adverse events are reported in the published and unpublished versions of the same study that the numbers of adverse events do not always match The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Lastly we found that inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals) in three-quarters of pooled analyses, but did not markedly change the direction or statistical significance of the risk in most cases. (more…)
Author Interviews, Gender Differences, Heart Disease, JAMA, Menopause / 15.09.2016

MedicalResearch.com Interview with: Taulant Muka, MD, MPH, PhD Postdoctoral Researcher Erasmus University, Rotterdam MedicalResearch.com: What is the background for this study? What are the main findings? Response: Menopause marks a major life transition for women, resulting in the loss of ovarian follicle development. Although menopause is a universal phenomenon among women, the timing of the final menstrual period differ greatly between women, and is considered a marker of aging. By quantifying data of nearly 310,329 non-overlapping women, we found that women who experienced an early menopause (i.e. younger than 45 years) have an excess risk of CHD, CVD-mortality and all-cause mortality. Furthermore, being 45-49 years at menopause compared to ≥50 years was associated with increased risk of carotid atherosclerosis. (more…)
Author Interviews, Breast Cancer, JAMA / 15.09.2016

MedicalResearch.com Interview with: Tehillah S. Menes, MD Department of Surgery Tel Aviv-Sourasky Medical Center Tel Aviv, Israel MedicalResearch.com: What is the background for this study? Response: Atypical ductal hyperplasia (ADH) is a known risk factor for breast cancer. The diagnosis is made by a biopsy showing a uniform proliferation of cells lining the ducts of the breast. These cells have monomorphic round nuclei and characteristically fill only part of the involved duct. Women diagnosed with ADH are recommended to undergo increased surveillance and offered chemoprevention (i.e. Tamoxifen) for risk reduction. Most studies reporting on the risk of subsequent breast cancer in women with ADH were done prior to the wide use of screening mammography and percutaneous needle biopsy. Our study examined 10-year risk of invasive breast cancer in women diagnosed with ADH (by needle biopsy or excisional biopsy), using data collected by the Breast Cancer Surveillance Consortium (BCSC). (more…)
Author Interviews, NEJM, Prostate Cancer / 15.09.2016

MedicalResearch.com Interview with: Professor Jenny Donovan  PhD OBE FMedSci NIHR-SI AcSS FFPHM Director, NIHR CLAHRC West (National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West) at University Hospitals Bristol NHS Trust Bristol, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: PSA testing identifies many men with prostate cancer, but they do not all benefit from treatment. Surgery, radiation therapy and various programs of active monitoring/surveillance can be given as treatments for fit men with clinically localized prostate cancer. Previous studies have not compared the most commonly used treatments in terms of mortality, disease progression and patient-reported outcomes. In the ProtecT study, we used a comprehensive set of validated measures, completed by the men at baseline (before diagnosis), at six and 12 months and then annually for six years. The main finding is that each treatment has a particular pattern of side-effects and recovery which needs to be balanced against the findings from the paper reporting the clinical outcomes (Hamdy et al). (more…)
Author Interviews, Psychological Science / 14.09.2016

MedicalResearch.com Interview with: Mr Liam Satchell Research Associate Department of Psychology University of Portsmouth, UK MedicalResearch.com: What is the background for this study? Response: Most people in general are really interested in trying to understand "body language", how a person behaves may give clues to their psychology. However, psychology has rarely engaged in an empirical investigation of what information about personality may be available in largely automatic movements, such as walking. We brought together techniques from psychology research and sports and exercise science to investigate what features of personality may be available in gait. (more…)
Author Interviews, Cost of Health Care, Health Care Systems, JAMA / 14.09.2016

MedicalResearch.com Interview with: Gillian D. Sanders-Schmidler Ph.D. Professor of Medicine Duke Evidence Synthesis Group, Director Duke Evidence-based Practice Center, Director Duke Clinical Research Institute Duke University MedicalResearch.com: What is the background for this study? Response: In 1996, the original panel on cost effectiveness in health and medicine published recommendations for the use of cost effectiveness analysis. During the 20 years since the original panel’s report, the field of cost-effectiveness analysis has advanced in important ways and the need to deliver health care efficiently has only grown. In 2012 the Second Panel on Cost Effectiveness in health and Medicine was formed with a goal of reviewing and updating the recommendations. This paper summarizes those recommendations. This process provided an opportunity for the Panel to reflect on the evolution of cost-effectiveness analysis and to provide guidance for the next generation of practitioners and consumers. (more…)
ASCO, Author Interviews, Journal Clinical Oncology, MD Anderson, Ovarian Cancer / 14.09.2016

MedicalResearch.com Interview with: Larissa A. Meyer, MD MPH F.A.C.O.G. Assistant Professor Dept of Gynecologic Oncology and Reproductive Medicine Houston, TX 77030-1362 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Despite the completion of two randomized controlled trials, controversy regarding the optimal approach for the treatment of advanced ovarian cancer remains. Our observational study highlights the importance of thoughtful selection of individuals for primary cytoreductive surgery for advanced ovarian cancer. Our results suggest that primary cytoreductive surgery may improve survival for patients with stage IIIC ovarian cancer who are likely to achieve an optimal cytoreduction, while neoadjuvant chemotherapy may be the preferred option for many women with stage IV ovarian cancer. (more…)
Author Interviews, Heart Disease, Infections, Surgical Research / 14.09.2016

MedicalResearch.com Interview with: Josep Rodés-Cabau, MD Director, Catheterization and Interventional Laboratories Quebec Heart and Lung Institute Professor, Faculty of Medicine, Laval University Quebec City, Quebec, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: Infectious endocarditis (IE) is one of the most serious complications after surgical prosthetic valve replacement. There are however scarce data regarding the incidence, predictive factors, treatment, and outcomes of IE post-TAVR. To date, the present study represents the largest series of IE post-TAVR, and the main findings can be summarized as follows: (1) the incidence of infective endocarditis (IE) post-TAVR is similar to that reported for IE after surgical prosthetic valve replacement; (2) among patients undergoing TAVR, younger age, male sex, a history of diabetes mellitus, and moderate-to-severe residual aortic regurgitation were associated with a higher risk of IE, (3) Enterococci species was the most frequently isolated pathogen, (4) IE post-TAVR was associated with a very high rate of in-hospital complications and mortality during index hospitalization and at follow-up. (more…)
Author Interviews, Cancer, Cancer Research, OBGYNE, Pediatrics / 14.09.2016

MedicalResearch.com Interview with: Pooja Rao, MD, MSCE Assistant Professor Division of Pediatric Hematology/Oncology Milton S. Hershey Medical Center Penn State College of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although many chemotherapy drugs can cause birth defects, no standardized guidelines exist for pregnancy screening in adolescent female patients with cancer. Additionally, little is known about how often they are screened prior to receiving treatment. Our study found that adolescent girls are not adequately screened for pregnancy prior to receiving chemotherapy or CT scans that could potentially harm a developing fetus. Adolescents with acute lymphoblastic leukemia, the most common childhood cancer, had the lowest pregnancy screening rates of the patients studied. (more…)
Annals Internal Medicine, Author Interviews, Heart Disease, Transplantation / 14.09.2016

MedicalResearch.com Interview with: Prof. Xavier Jouven Service de Cardiologie Hôpital Européen Georges Pompidou Paris MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are many cardiac arrests (around 300 000 per year in United States). The possibility to collect organs from a certain proportion of those cardiac arrests represents an important opportunity to fill the gap of the organ shortage. It is absolutely mandatory to identify patients with no chance of survival. This study showed 3 criteria which allow this early identification. Several thousands of patients die every year waiting for organ transplantation. (more…)