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Author Interviews, Cancer Research, Colon Cancer, Gastrointestinal Disease, JAMA / 03.02.2020

MedicalResearch.com Interview with: Jordan J. Karlitz, MD Staff Gastroenterologist Southeast Louisiana Veterans Health Care System Associate Professor, Division of Gastroenterology Director, GI Hereditary Cancer and Genetics Program, Tulane University School of Medicine MedicalResearch.com: What is the background for this study? Response: Currently, there is debate over whether average-risk colorectal cancer screening should begin at age 45 or 50. Given this controversy, we sought to conduct a colorectal cancer incidence rate analysis by yearly-age, as opposed to age range blocks (i.e. 30-39, 40-49 etc.) as has been done in the past. We believed that this type of "high definition" analysis would allow a better understanding of incidence rates of those approaching or at screening in age.  We were particularly interested in the transition from age 49 to 50 as this is when average risk screening has historically been recommended.  (more…)
Author Interviews, ENT, JAMA, Obstructive Sleep Apnea, Pediatrics / 03.02.2020

MedicalResearch.com Interview with: Dr. Jonathan R. Skirko, MD , MHPA, MPH Assistant professor Division of Pediatric Otolaryngology University of Utah Health  MedicalResearch.com: What is the background for this study? Response: Obstructive sleep apnea is a common problem that that impacts the lives of many people. Understanding treatment effectiveness is important and Health-State Utility is a standardized way of assessing quality of life.  Before this study, we didn't have a way of measuring quality of life in this population in this important way. You have to accurately measure something before you can improve it. (more…)
Author Interviews, Hip Fractures, JAMA, Orthopedics / 31.01.2020

MedicalResearch.com Interview with: Alison M. Cogan, PhD, OTR/L Polytrauma/TBI Advanced Fellow Washington DC VA Medical Center Washington DC MedicalResearch.com: What is the background for this study? Response: Medicare is shifting from a volume- to value-based payment for postacute care services, in which value is determined by patient characteristics and functional outcomes. Matching therapy time and length of stay (LOS) to patient needs is critical to optimize functional outcomes and manage costs. The objective of this study was to investigate the association among therapy time, LOS, and functional outcomes for patients following hip fracture surgery. This retrospective cohort study analyzed data on patients from 4 inpatient rehabilitation facilities and 7 skilled nursing facilities in the eastern and midwestern United States. Participants were patients aged 65 years or older who received inpatient rehabilitation services for hip fracture and had Medicare fee-for-service as their primary payer. We categorized patients into nine recovery groups based on low, medium, and high therapy minutes per day and low, medium, or high rate of functional gain per day. We measured the groups for functional mobility independence and self-care capabilities at the time each patient was discharged. (more…)
Author Interviews, Health Care Systems, JAMA / 30.01.2020

MedicalResearch.com Interview with: Coleman Drake, PhD Assistant Professor, Health Policy and Management Pitt Public Health Affiliate faculty member Medicaid Research Center and Center for Pharmaceutical Policy and Prescribing MedicalResearch.com: What is the background for this study? Response: The religious directives of Catholic hospitals prohibit the provision of many forms of contraception. To examine how Catholic hospitals restrict access to reproductive health services, we examined the market share of Catholic hospitals in every county in the continental US. We found that nearly 40% of women of reproductive-aged women live in counties with high or dominant Catholic hospital market share. We also examined whether the networks of Health Insurance Marketplace (i.e., Obamacare) plans direct their enrollees toward or away from Catholic hospitals, and thus reproductive health services.  (more…)
Abuse and Neglect, Author Interviews, JAMA, Pediatrics, Tobacco / 30.01.2020

MedicalResearch.com Interview with: Hongying (Daisy) Dai, PhD Associate Professor Department of Biostatistics | College of Public Health University of Nebraska Medical Center Omaha, NE MedicalResearch.com: What is the background for this study? Response: E-cigarette use increased dramatically from 11.7% to 27.5% for high school students and from 3.3% to 10.5% for middle school students during the periods of 2017 - 2019. In September 2018, the Food and Drug Administration (FDA) warned that youth e-cigarette use is reaching an epidemic proportion. Exposure to secondhand aerosol (SHA) from e-cigarettes is not harmless as e-cigarettes aerosol contains nicotine and potentially harmful substances, including carbonyl compounds, TSNAs, heavy metals, and glycols. This study analyzed the 2015-2018 National Youth Tobacco Survey (NYTS) and the main findings are:
  • The prevalence of secondhand aerosol exposure significantly increased from 25.6% in 2017 to 33.2% in 2018 (p<.001) after being stable during 2015 and 2017 (25.2% vs. 25.6%, p>0.05). The increase of SHA exposure from 2017 to 2018 was observed across socio-demographic groups.
  • Among never tobacco users in 2018 NYTS, students who reported secondhand aerosol exposure (vs. no) had higher odds of susceptibility to use e-cigarettes (38.8% vs. 21.0%) and cigarettes (30.7% vs. 21.2%) and higher odds of reporting exposure to e-cigarette marketing.
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Author Interviews, JAMA, Pediatrics, Weight Research / 29.01.2020

MedicalResearch.com Interview with: Dr. Carol Chelimo PhD Research Fellow Dept. of Paediatrics, School of Medicine University of Auckland MedicalResearch.com: What is the background for this study? Response: New Zealand has the third highest prevalence of obesity among Organisation for Economic Co-operation and Development countries. Pediatric obesity is associated with development of cardiovascular risk factors in later life, such as type 2 diabetes, hypertension, dyslipidemia, and metabolic syndrome. Antibiotic exposures in early life may affect weight by altering the gut microbiota, potentially increasing the risk of childhood obesity. The overall aim of this research was to examine whether repeated antibiotic exposure by age 48 months is associated with higher body mass index (BMI) at age 54 months. Specifically, it evaluates whether the number, timing (age), and type of antibiotic exposures are associated with a higher body mass and an increased likelihood of overweight and obesity. This work incorporates antibiotic exposure during pregnancy (more…)
Author Interviews, Dartmouth, JAMA, Pharmaceutical Companies, Primary Care / 27.01.2020

MedicalResearch.com Interview with: Steven Woloshin, MD, MS Professor of Medicine and Community and Family Medicine Professor, The Dartmouth Institute for Health Policy and Clinical Practice MedicalResearch.com: What is the background for this study? Response: Industry spends more on detailing visits and free samples than any other form of prescription drug marketing.  There is good evidence that these activities can lead to more use of expensive new drugs over equally effective cheaper options.  Given these concerns there have been efforts by some hospitalls and practices to restrict these forms of marketing. We asked physicians in group practices delivering primary care about how often pharmaceutical reps visit their practice and whether they have a free sample closet.  (more…)
Author Interviews, JAMA, Primary Care / 22.01.2020

MedicalResearch.com Interview with: Leah Marcotte, MD Clinical Assistant Professor, Medicine University of Washington
Joshua M. Liao, MD, MSc, FACP Assistant Professor, Department of Medicine Director, UW Medicine Value and Systems Science Lab Medical Director of Payment Strategy, UW Medicine University of Washington
  MedicalResearch.com: What is the background for this study? Response: In the last 7 years, Medicare has implemented payment reforms to encourage primary care and other ambulatory providers for dedicated care coordination activities. One such reform, Transitional Care Management (TCM) billing codes, was introduced in 2013 and emphasized coordination during care transitions from hospital to home – a particularly vulnerable period in which patients may be at risk for adverse outcomes. TCM services include patient contact (e.g., phone call) within two business days of discharge, a visit (e.g., office or home-based) within 14 days of discharge with at least moderate complexity medical decision making, and medication reconciliation. TCM services may be delivered after inpatient hospitalization, observation stay, skilled nursing facility admission or acute rehab admission. There have been few studies that have looked at early data in Transitional Care Management, and none that have described national use of and payment for these codes over an extended period of time. We analyzed a national Medicare dataset looking at 100% of submitted and paid TCM claims from 2013-2018.  (more…)
Author Interviews, Dermatology, Environmental Risks, JAMA / 22.01.2020

Comments from the FDA on this JAMA Dermatology study: Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial  Sunscreen CDC Phil imageMedicalResearch.com: What is the background for this study? Response: A prior pilot study published in JAMA in May 2019 demonstrated the systemic absorption of 4 sunscreen active ingredients; additional studies are needed to determine the systemic absorption of additional active ingredients, and how quickly absorption occurs.  This study assessed the systemic absorption of the 6 active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate and octinoxate) in 4 sunscreen products under single and maximal-use conditions.  (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Nutrition / 22.01.2020

MedicalResearch.com Interview with: Zhilei Shan PhD Postdoctoral fellow on Nutritional Epidemiology Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: Long-standing controversies have focused on the health consequences of dietary fat and carbohydrate. Previous evidence has shown that different types of carbohydrates and fats have varying effects on disease risk and health. For example, carbohydrates from refined grains and added sugars may contribute to insulin resistance and other metabolic problems while carbohydrates from whole grains and whole fruits appear to be beneficial. Likewise, replacing saturated fat with unsaturated fat was associated with lower risk of heart disease and mortality. Therefore, it is crucial to incorporate quality and types of carbohydrate and fat when investigating the associations of low-fat and low-carbohydrate diets with mortality. (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA / 18.01.2020

MedicalResearch.com Interview with: Evan M. Graboyes, MD Surveillance and Health Services Research American Cancer Society, Atlanta, Georgia Department of Otolaryngology–Head & Neck Surgery Medical University of South Carolina, Charleston  MedicalResearch.com: What is the background for this study? Response: Prior studies have shown that Medication Expansions under the Patient Protection and Affordable Care Act (ACA) are associated with a decrease in uninsured individuals and increases in the percentage of nonelderly patients diagnosed with localized (stage I-II) cancer, primarily for cancers for which effective screening tests exist. Because no screening test exists for head and neck squamous cell carcinoma (HNSCC), access to care for physical examination and tissue-based biopsy- and thus health insurance coverage- are critical for the timely recognition of symptoms, early disease stage at diagnosis, and treatment initiation. However, the downstream association of changes in health insurance coverage following Medicaid expansion under the ACA with stage at diagnosis and time to treatment initiation, key metrics for access to care for HNSCC, remain unknown. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Gastrointestinal Disease, JAMA / 17.01.2020

MedicalResearch.com Interview with: Dr. Paul Young MBChB, BSc (Hons), FCICM Medical Director of the Wakefield Hospital ICU Head of the Intensive Care Research Unit Wellington Hospital MedicalResearch.com: What is the background for this study? Response: Proton pump inhibitors (PPIs) are among the most widely prescribed drugs in the intensive care unit (ICU) in the world.   Many, if not most, prescriptions of PPIs in the ICU are for stress ulcer prophylaxis.  Although PPIs are used most widely for this indication, histamine-2 receptor blockers (H2RBs) are used in preference to PPIs in some ICUs.  This practice variation, which appears to be largely dependent on clinician preference rather than based on patient-specific factors, has continued for decades.  The PPIs vs. H2RBs for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) trial results raise the possibility that PPIs, the most commonly used medicines for stress ulcer prophylaxis, may be responsible for a clinically important increase in the risk of death that, in global health terms could equate to many tens of 1000s of deaths per year. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 15.01.2020

MedicalResearch.com Interview with: Anita P. Courcoulas MD, MPH, FACS Anthony M. Harrison MD Chair and Professor of Surgery Chief, MIS Bariatric & General Surgery University of Pittsburgh Medical Center  MedicalResearch.com: What is the background for this study? Response: Fewer published studies in bariatric surgery address long term adverse outcomes or problems that can occur after different operations.  In addition, a lack of standardized reporting of potential adverse events limits the understanding of these issues. This paper results from one of the largest studies of bariatric surgery ever undertaken and includes both gastric bypass and gastric sleeve, the 2 most common operations performed in the U.S. and worldwide at the current time.  This study leverages large data sets from the electronic health record linked to insurance claims and death indices.  This is real-world data coming from a population-based cohort of 33,560 adults at 10 sites in 4 clinical data research networks throughout the U.S., so it may be different from data that accrues from a longitudinal observational study or randomized trial.  Patients and other important stakeholders in bariatric surgery were critical to the design, conduct, and dissemination of results from this study. (more…)
Author Interviews, Heart Disease, JAMA / 15.01.2020

MedicalResearch.com Interview with: Mandeep R. Mehra, MD, MSc, FRCP The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine Medical Director, Heart and Vascular Center Brigham and Women’s Hospital Executive Director Center for Advanced Heart Disease Brigham and Women’s Hospital Professor of Medicine, Harvard Medical School    MedicalResearch.com: What is the background for this study? Response: Left Ventricular assist devices meaningfully prolong survival in patients with heart failure who are no longer responsive to guideline-directed medications. The MOMENTUM 3 trial tested a new generation device, the HeartMate 3 pump, to a more commonly used pump, the HeartMate II device. This trial showed the superiority of the new heart pump and found that survival free of a disabling stroke or need to place a second pump is improved considerably. In this prespecified analysis of the trial, we compared patients who were considered as eligible for transplantation to those considered ineligible for heart transplantation. We showed that these categories are associated with similar superiority of the HeartMate 3 pump compared to the control pump despite the categorization into these discrete buckets. (more…)
Author Interviews, Health Care Systems, JAMA, Social Issues / 14.01.2020

MedicalResearch.com Interview with: Elizabeth Tung MD MS Section of General Internal Medicine Instructor of Medicine University of Chicago MedicalResearch.com: What is the background for this study? Response: Medicare provides hospital ratings for all Medicare-certified hospitals in the U.S. based on quality metrics, including mortality, patient experience, hospital readmissions, and others. While ratings are important for comparing hospitals, there's been some concern that some of these quality metrics are outside a hospital's control, especially for hospitals taking care of vulnerable or socially complex patient populations. Take "timeliness of care" as a quality metric, for instance--this measure includes emergency room wait times. But in places that are medically underserved and have very few emergency rooms, these wait times will inevitably be much higher. What this means is that hospitals taking care of medically underserved populations end up getting lower quality ratings, even though they're addressing health disparities by filling an access gap. (more…)
Author Interviews, JAMA, Surgical Research, Technology, University of Michigan / 13.01.2020

MedicalResearch.com Interview with: Kyle Sheetz, MD Clinical Year 4 Resident, General Surgery Michigan Medicine MedicalResearch.com: What is the background for this study? Response: There are concerns that robotic surgery is increasing for common surgical procedures with limited evidence and unclear clinical benefit. Prior studies describing the use of robotic surgery relied upon claims or billing data to identify robotic operations from laparoscopic or open ones. This may lead to inaccuracies as claims data may not provide specific codes for robotic operations. (more…)
Author Interviews, Breast Cancer, Cost of Health Care, JAMA, Race/Ethnic Diversity / 09.01.2020

MedicalResearch.com Interview with: Naomi Y Ko, MD Director, Inpatient Medical Operations Assistant Professor of Medicine, Department of Medicine Boston University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study is to help understand the association between risk of more advanced cancer in racial minorities and insurance.   (more…)
Author Interviews, Biomarkers, Heart Disease, JAMA, UCLA / 09.01.2020

MedicalResearch.com Interview with: Olujimi A. Ajijola, MD, PhD Neurocardiology Research Center of Excellence Cardiac Arrhythmia Center University of California, Los Angeles MedicalResearch.com: What is the background for this study? Response: It hadn’t been understood why some people with basic heart failure might live longer than others despite receiving the same medications and medical device therapy. Through this research we set out to determine whether a biomarker of the nervous system could help explain the difference. This study revealed a biomarker that can specifically predict which patients with “stable” heart failure have a higher risk of dying within one to three years. (more…)
Author Interviews, Bipolar Disorder, Depression, JAMA, Schizophrenia, Weight Research / 08.01.2020

MedicalResearch.com Interview with: Shahram Bahrami, PhD NORMENT Centre, Institute of Clinical Medicine Division of Mental Health and Addiction Oslo University Hospital Oslo, Norway  MedicalResearch.com: What is the background for this study? Response: We know that patients with severe mental disorders such as schizophrenia, bipolar disorder and major depression have shorter life span than the rest of the population, largely due to comorbid cardiovascular diseases. The increased risk seems related to lifestyle including diet and physical activity and medicines, while the mechanisms are not fully understood. Different studies have shown increased weight (high body mass index) in many people with mental disorders. Yet very little is known about genetic variants jointly in influencing major psychiatric disorders and body mass index. Thus, we investigated if there are overlapping genetic risk variants between body mass index and the mental disorders schizophrenia, bipolar disorders and major depression.  (more…)
Author Interviews, Dermatology, Education, Gender Differences, JAMA, Race/Ethnic Diversity / 08.01.2020

MedicalResearch.com Interview with: Imam Xierali, PhD Associate Professor / UT Southwestern Medical Center Dallas, Texas MedicalResearch.com: What is the background for this study? Response: Despite the continued efforts in academic medicine to increase the representation of women and minorities underrepresented in medicine (URM), there is a lack of information on trends in dermatology department faculty diversity and how they compare with those in other clinical departments. (more…)
Author Interviews, Genetic Research, Heart Disease, JAMA, Weight Research / 08.01.2020

MedicalResearch.com Interview with: Ravi V. Shah, MD Cardiology Division, Department of Medicine Massachusetts General Hospital Boston, MA Venkatesh L. Murthy MD, PhD Division of Cardiovascular Medicine Department of Medicine and Frankel Cardiovascular Center University of Michigan Ann Arbor, MI MedicalResearch.com: What is the background for this study? Response: We were interested in evaluating how added information like fitness assessed on a treadmill exercise test, physical activity questionnaires and genetic risk scores could inform patients and doctors’ understanding of how an individuals BMI might change over time. We used one of the latest and broadest polygenic risk scores. We investigated the CARDIA cohort, a study sponsored by the National Heart, Lung, and Blood Institute, who were young adults aged 18 to 30 and have been followed serially for 25 years. (more…)
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, JAMA, Surgical Research / 08.01.2020

MedicalResearch.com Interview with: Mehra Golshan, MD, MBA Dr. Abdul Mohsen & Sultana Al-Tuwaijri Distinguished Chair Surgical OncologyDirector of Breast Surgical Oncology Fellowship Associate Professor, Harvard Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Triple negative breast cancer is an aggressive form of breast cancer that often requires chemotherapy. In this study we provided neoadjuvant chemotherapy with or without a PARP inhibitor and showed that many women who were originally ineligible for breast conservation (lumpectomy) became eligible after treatment. If lumpectomy was tried it was usually successful.  Many more women in the US compared to Europe and Asia chose mastectomy when lumpectomy was an option even when genetics is negative. (more…)
Author Interviews, Dermatology, HPV, Infections, JAMA, OBGYNE / 08.01.2020

MedicalResearch.com Interview with: Niklas Worm Andersson, MD Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen NV, Denmark MedicalResearch.com: What is the background for this study? What is Podophyllotoxin used for? Response: Podophyllotoxin is an antimitotic agent primarily used in the local treatment of anogenital warts, which are among the most prevalent sexually transmitted diseases worldwide. Most women affected by anogenital warts are of childbearing age and during pregnancy, they may become symptomatic, enlarge, or multiply. While podophyllotoxin is part of first-line treatment of anogenital warts for the non-pregnant population, it is contraindicated during pregnancy. Fetal safety data are limited and to our knowledge, no previous human data exist to help inform on this issue. (more…)
Accidents & Violence, Author Interviews, Brain Injury, JAMA, Pediatrics, UCSF / 08.01.2020

MedicalResearch.com Interview with: Benjamin N. Breyer MD, MAS, FACS Associate Professor Departments of Urology and Epidemiology and Biostatistics University of California, San Francisco Vice-Chair of Urology Chief of Urology, Zuckerberg San Francisco General Hospital and Trauma Center Director, UCSF Male Genitourinary Reconstruction and Trauma Surgery Fellowship MedicalResearch.com: What is the background for this study? Response: There has been a large increase in upright scooter usage among adults as a mode of transportation. It's convenient for commuters and may encourage greater use of public transit leading to less car traffic in cities. (more…)
Author Interviews, JAMA, Opiods, Pediatrics / 06.01.2020

MedicalResearch.com Interview with: Rachel H. Alinsky, MD, MPH Adolescent Medicine and Addiction Medicine Fellow Division of General Pediatrics and Adolescent Medicine Johns Hopkins University School of Medicine MedicalResearch.com: What is the background for this study? Response: We know that over 4,000 adolescents and young adults between the ages of 15-24 are dying from an opioid overdose every year. Nonfatal opioid overdose has been identified as a potential touchpoint with the healthcare system when individuals can be drawn into treatment, yet very little is known about health care use following opioid overdose in youth. We were interested in figuring out the extent to which adolescents and young adults are receiving evidence-based treatment after an opioid overdose. (more…)
Addiction, Alcohol, Author Interviews, JAMA, Methamphetamine / 06.01.2020

MedicalResearch.com Interview with: Dr. Eric Dawson, PharmD Vice President, Clinical Affairs Millennium Health MedicalResearch.com: What is the background for this study? Response: The US Centers for Disease Control and Prevention has projected a drop in the number of overdose deaths for 2018; the first reported decline since 1990. They cite a decrease in prescription opioid deaths as the leading contributor to the overall reduction, but caution that deaths associated with synthetic opioids, primarily fentanyl, as well as stimulants appear to be increasing. In 2019, we reported a 798% increase in urine drug test positivity rates for nonprescribed fentanyl among results positive for methamphetamine and an 1850% increase among results positive for cocaine. In an effort to conduct ongoing surveillance of the polysubstance use landscape and help characterize these evolving trends in a more timely manner, we examined our UDT data as close to real-time as possible to observe trends in positivity for methamphetamine, cocaine, and heroin, with and without illicit fentanyl. (more…)
Author Interviews, Gender Differences, JAMA, Occupational Health, Surgical Research / 05.01.2020

MedicalResearch.com Interview with: Matilda Anderson MBBS MBS General Surgery Trainee/Public Health/Researcher Footscray, Victoria, Australia MedicalResearch.com: What is the background for this study? Response: Female representation in the surgical workforce is increasing.  Previous studies have shown higher infertility rates and adverse pregnancy outcomes in this population.  We aimed to accurately define the available research in this area and provide some basic recommendations about how workplaces can support their female surgical residents and surgeons. On a more personal note- Dr Anderson is a female surgical resident and have seen countless pregnant colleagues remove themselves from operating rooms with the concern about how the conditions may affect their pregnancies.  Dr. Anderson met Associate Professor Goldman at Harvard University (a leading expert on occupational reproductive hazards) and collaborated to explore this area further. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, OBGYNE, Pediatrics, Weight Research / 02.01.2020

MedicalResearch.com Interview with: Elvira Isganaitis, M.D., M.P.H. Pediatric Endocrinologist, Joslin Diabetes Center Assistant Professor of Pediatrics, Harvard Medical School Boston, MA 02215 MedicalResearch.com: What is the background for this study? Response: The concept that a mother's nutrition prior to and during pregnancy is important for health outcomes in the offspring is now well accepted. For example, women intending to get pregnant must take prenatal vitamins, and are encouraged to attain a healthy weight before conception. However, much less is known about how a father's nutritional status may influence childhood health outcomes.  Based on studies in animals, exposure to undernutrition, high-fat diet, or stressful experiences in fathers can result in increased risk of obesity and diabetes in the offspring. These effects are mediated in part by epigenetic mechanisms (i.e. changes in gene expression due to differences in DNA methylation, histones, or other non-genetic mechanisms). (more…)
Author Interviews, Health Care Systems, JAMA / 30.12.2019

MedicalResearch.com Interview with: Maryam Guiahi MD, MSc Associate Professor of Obstetrics and Gynecology University of Colorado Denver School of Medicine MedicalResearch.com: What is the background for this study? Response: The composition of the U.S health care system is shifting; between 2001 to 2016 the number of Catholic-owned or affiliated health facilities grew by 22% in contrast to the overall number of acute care hospitals that decreased by 6% and the number of other nonprofit religious hospitals that decreased by 38%. This is relevant as Catholic health care systems enforce religious directives that restrict many aspects of reproductive care and certain aspects of end-of-life care.  Yet little is known about the extent to which U.S. patients consider religious affiliation when selecting a health care facility.  (more…)
Author Interviews, JAMA, Sleep Disorders / 28.12.2019

MedicalResearch.com Interview with: Margaret Moline, PhD Lemborexant International Program Lead and Global Medical Lead Executive Director, Neurology Business Group Eisai, Inc.  MedicalResearch.com: What is the background for this study? This study, called SUNRISE 1, is one of two pivotal Phase 3 studies in the lemborexant clinical development program that supported the recent FDA approval of DAYVIGO (lemborexant).
  • On December 20, the U.S. Food and Drug Administration (FDA) approved DAYVIGO (lemborexant) 5 mg and 10 mg, an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, which is characterized by difficulties with sleep onset and/or sleep maintenance.1
  • DAYVIGO will be commercially available following scheduling by the DEA, which is expected to occur within 90 days.
  • SUNRISE 1 was a one-month, randomized, double-blind, placebo- and active-controlled, multi-center, parallel-group clinical trial in adult female patients age 55 and older and male patients 65 years and older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=208), lemborexant 5 mg (n=266) or 10 mg (n=269), or active comparator (n=263) once nightly.1
  • The primary efficacy endpoint was the mean change in log-transformed latency to persistent sleep (LPS; defined as the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness) from baseline to end of treatment (Days 29/30), as measured by overnight polysomnography (PSG) monitoring.1
  • The pre-specified secondary efficacy endpoints in Study 2 were the mean change from baseline to end of treatment (Days 29/30) in sleep efficiency (SEF) and wake after sleep onset (WASO) measured by PSG.1
  • SUNRISE 1, lemborexant 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, LPS, compared to placebo. lemborexant 5 mg and 10 mg demonstrated statistically significant improvement in SEF and WASO compared to placebo.1
  • The effects of lemborexant at the beginning of treatment were generally consistent with later timepoints.
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