JAMA

22 Jan

Posted at 21:40h in Author Interviews, JAMA, Primary Care
MedicalResearch.com Interview with: [caption id="attachment_52904" align="alignleft" width="106"]Leah Marcotte, MD Clinical Assistant Professor, Medicine Associate Medical Director, Population Health Dr. Marcotte[/caption] Leah Marcotte, MD Clinical Assistant Professor, Medicine University of Washington
[caption id="attachment_52905" align="alignleft" width="107"]Joshua Liao, MD, MSc, FACP Assistant Professor, Department of Medicine Director, UW Medicine Value and Systems Science Lab Associate Medical Director, Contracting and Value-Based Care Dr. Liao[/caption] 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. 

22 Jan

Posted at 16:39h in Author Interviews, Dermatology, Environmental Risks, JAMA
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. 

22 Jan

Posted at 00:25h in Author Interviews, Brigham & Women's - Harvard, JAMA, Nutrition
MedicalResearch.com Interview with: [caption id="attachment_52849" align="alignleft" width="135"]Dr. Shan Dr. Shan[/caption] 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.

18 Jan

Posted at 22:30h in Author Interviews, Cancer Research, Cost of Health Care, JAMA
MedicalResearch.com Interview with: [caption id="attachment_52852" align="alignleft" width="142"]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 Dr. Graboyes[/caption] 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.

17 Jan

Posted at 14:51h in Author Interviews, Critical Care - Intensive Care - ICUs, Gastrointestinal Disease, JAMA
MedicalResearch.com Interview with: [caption id="attachment_52838" align="alignleft" width="100"]Dr. Paul Young Dr. Paul Young[/caption] 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.

15 Jan

Posted at 22:51h in Author Interviews, JAMA, Surgical Research, Weight Research
MedicalResearch.com Interview with: [caption id="attachment_52800" align="alignleft" width="200"]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 Dr. Courcoulas[/caption] 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.

15 Jan

Posted at 22:11h in Author Interviews, Heart Disease, JAMA
MedicalResearch.com Interview with: [caption id="attachment_47945" align="alignleft" width="200"]Mandeep R. Mehra, MD, MSc, FRCP (London)The William Harvey Distinguished Chair in Advanced Cardiovascular MedicineMedical Director, Heart and Vascular Center, Brigham and Women’s HospitalExecutive Director, Center for Advanced Heart DiseaseBrigham and Women’s HospitalProfessor of Medicine, Harvard Medical School Dr. Mehra[/caption] 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.

14 Jan

Posted at 18:51h in Author Interviews, Health Care Systems, JAMA, Social Issues
MedicalResearch.com Interview with: [caption id="attachment_52770" align="alignleft" width="175"]Elizabeth Tung MD MS Section of General Internal Medicine Instructor of Medicine University of Chicago Dr. Tung[/caption] 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.

13 Jan

Posted at 12:39h in Author Interviews, JAMA, Surgical Research, Technology, University of Michigan
MedicalResearch.com Interview with: [caption id="attachment_52750" align="alignleft" width="144"]Kyle Sheetz, MD Clinical Year 4 Resident, General Surgery Michigan Medicine Dr. Sheetz[/caption] 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.

09 Jan

Posted at 19:16h in Author Interviews, Breast Cancer, Cost of Health Care, JAMA, Race/Ethnic Diversity
MedicalResearch.com Interview with: [caption id="attachment_52714" align="alignleft" width="184"]Naomi Y Ko, MD Director, Inpatient Medical Operations Assistant Professor of Medicine, Department of Medicine Boston University School of Medicine Dr. Ko[/caption] 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.  

09 Jan

Posted at 16:07h in Author Interviews, Biomarkers, Heart Disease, JAMA, UCLA
MedicalResearch.com Interview with: [caption id="attachment_52737" align="alignleft" width="191"]Olujimi A. Ajijola, MD, PhD Neurocardiology Research Center of Excellence Cardiac Arrhythmia Center University of California, Los Angeles Olujimi A. Ajijola, MD, PhD[/caption] 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.

08 Jan

Posted at 21:33h in Author Interviews, Bipolar Disorder, Depression, JAMA, Schizophrenia, Weight Research
MedicalResearch.com Interview with: [caption id="attachment_52731" align="alignleft" width="150"]Shahram Bahrami, PhD NORMENT Centre, Institute of Clinical Medicine Division of Mental Health and Addiction Oslo University Hospital Oslo, Norway Dr. Bahrami[/caption] 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. 

08 Jan

Posted at 20:41h in Author Interviews, Dermatology, Education, Gender Differences, JAMA, Race/Ethnic Diversity
MedicalResearch.com Interview with: [caption id="attachment_52697" align="alignleft" width="70"]Imam Xierali, PhD Associate Professor / UT Southwestern Medical Center Dallas, Texas Dr. Xierali[/caption] 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.

08 Jan

Posted at 20:37h in Author Interviews, Genetic Research, Heart Disease, JAMA, Weight Research
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.

08 Jan

Posted at 20:32h in Author Interviews, Breast Cancer, Brigham & Women's - Harvard, JAMA, Surgical Research
MedicalResearch.com Interview with: [caption id="attachment_52688" align="alignleft" width="200"]Mehra Golshan, MD, MBA Dr. Abdul Mohsen & Sultana Al-Tuwaijri Distinguished Chair Surgical OncologyDirector of Breast Surgical Oncology Fellowship Associate Professor, Harvard Medical School Dr. Golshan[/caption] 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.

08 Jan

Posted at 20:16h in Author Interviews, Dermatology, HPV, Infections, JAMA, OBGYNE
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.

08 Jan

Posted at 20:03h in Accidents & Violence, Author Interviews, Brain Injury, JAMA, Pediatrics, UCSF
MedicalResearch.com Interview with: [caption id="attachment_52671" align="alignleft" width="179"]Benjamin N. Breyer MD, MAS, FACS Associate Professor Departments of Urology and Epidemiology and Biostatistics University of California, San Francisco Dr. Breyer[/caption] 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.

06 Jan

Posted at 17:17h in Author Interviews, JAMA, Opiods, Pediatrics
MedicalResearch.com Interview with: [caption id="attachment_52629" align="alignleft" width="133"]Rachel H. Alinsky, MD, MPH Adolescent Medicine and Addiction Medicine Fellow Division of General Pediatrics and Adolescent Medicine Johns Hopkins University School of Medicine Dr. Alinsky[/caption] 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.

06 Jan

Posted at 15:11h in Addiction, Alcohol, Author Interviews, JAMA, Methamphetamine
MedicalResearch.com Interview with: [caption id="attachment_52664" align="alignleft" width="200"]Eric Dawson, PharmD Vice President, Clinical Affairs Millennium Health Dr. Dawson[/caption] 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.

05 Jan

Posted at 16:54h in Author Interviews, Gender Differences, JAMA, Occupational Health, Surgical Research
[caption id="attachment_52648" align="alignleft" width="200"]Matilda Anderson MBBS MBS General Surgery Trainee/Public Health/Researcher Footscray, Victoria, Australia Dr. Anderson[/caption] 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.

02 Jan

Posted at 22:20h in Author Interviews, Brigham & Women's - Harvard, JAMA, OBGYNE, Pediatrics, Weight Research
MedicalResearch.com Interview with: [caption id="attachment_52619" align="alignleft" width="200"]Elvira Isganaitis, M.D., M.P.H. Pediatric Endocrinologist, Joslin Diabetes Center Assistant Professor of Pediatrics, Harvard Medical School Boston, MA 02215 Dr. Isganaitis[/caption] 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).

30 Dec

Posted at 19:34h in Author Interviews, Health Care Systems, JAMA
MedicalResearch.com Interview with: [caption id="attachment_52591" align="alignleft" width="160"]Maryam Guiahi MD, MSc Associate Professor of Obstetrics and Gynecology University of Colorado Denver School of Medicine Dr. Guiahi[/caption] 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. 

28 Dec

Posted at 13:49h in Author Interviews, JAMA, Sleep Disorders
MedicalResearch.com Interview with: [caption id="attachment_52595" align="alignleft" width="200"]Margaret Moline, PhD Lemborexant International Program Lead and Global Medical Lead Executive Director, Neurology Business Group Eisai, Inc. Dr. Moline[/caption] 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.

26 Dec

Posted at 12:48h in Author Interviews, JAMA, Orthopedics, Vitamin D
MedicalResearch.com Interview with: [caption id="attachment_52550" align="alignleft" width="200"]Robert Clarke MD, FRCP, FFPH, FFPHI, MSc, DCH Professor of Epidemiology and Public Health Medicine Clinical Trial Service Unit (CTSU) Nuffield Department of Population Health University of Oxford Dr. Clarke[/caption] Robert Clarke MD, FRCP, FFPH, FFPHI, MSc, DCH Professor of Epidemiology and Public Health Medicine Clinical Trial Service Unit (CTSU) Nuffield Department of Population Health University of Oxford MedicalResearch.com: What is the background for this study? Response: Approximately 1 in 2 women and 1 in 5 men aged 50 years or older will suffer from an osteoporotic fracture in their remaining lifetime. Hip fracture is the most serious type of osteoporotic fracture with an approximately 30% risk of death in the year following a hip fracture. Vitamin D is essential for optimal musculoskeletal health by promotion of calcium absorption, and mineralisation of osteoid tissue formation in bone and maintenance of muscle function. Low vitamin D status causes secondary hyperparathyroidism, bone loss and muscle weakness. Observational studies have reported that lower blood concentrations of vitamin D are associated with higher risks of falls and fractures. Combined supplementation with 800 IU/day vitamin D and 1200 mg/day calcium has been recommended for prevention of fractures in older adults living in institutions and in those with low vitamin D status. However, previous trials and meta-analyses of vitamin D alone, or in combination with calcium for prevention of fracture in either community-dwelling or general population settings reported conflicting results, with some reporting protective effects against fractures, but others demonstrated no beneficial effects. However, most of the previous trials had only limited power to detect differences in risk of fracture predicted by the observational studies, largely because of a combination of small sample size, relatively low equivalent daily doses of vitamin D, intermittent dosing regimens (>1 month), and short duration of follow-up. In addition, interpretation of the results of previous meta-analyses of such trials is complicated by use of variable inclusion criteria, inappropriate statistical methods, inclusion of multiple small trials with very few fracture events, in addition to failure to report achieved differences in blood 25(OH)D concentrations. We summarised the available evidence to guide clinical practice and future research, by conducting parallel meta-analyses of:
  • (i) observational studies of risks of fracture associated with prolonged differences in blood concentrations of 25(OH)D;
  • (ii) randomised trials of vitamin D alone versus placebo or no treatment for prevention of fracture; and
  • (iii) randomised trials of calcium and vitamin D versus placebo or no treatment for prevention of fracture.In addition, we reviewed the design of the ongoing randomised trials assessing the effects of higher doses of vitamin D alone or in combination with calcium for prevention of fracture.

20 Dec

Posted at 20:19h in Author Interviews, Cannabis, JAMA, Pediatrics
MedicalResearch.com Interview with: [caption id="attachment_51463" align="alignleft" width="165"]Hongying (Daisy) Dai, PhD Associate Professor Department of Biostatistics | College of Public Health University of Nebraska Medical Center Omaha Dr. Hongying (Daisy) Dai[/caption] Hongying (Daisy) Dai, PhD Associate Professor Department of Biostatistics | College of Public Health University of Nebraska Medical Center  MedicalResearch.com: What is the background for this study? Response: E-cigarette use increased significantly from 2017 to 2019 among U.S. adolescents, and marijuana and other substances besides can be used in e-cigarettes. Meanwhile, restrictions on marijuana use have been relaxing and social acceptability of marijuana use is shifting among youth. This study analyzed 38,061 middle and high school students from the 2017 and 2018 National Youth Tobacco Survey. 

19 Dec

Posted at 02:33h in Author Interviews, JAMA, Opiods, Pediatrics, University of Michigan
MedicalResearch.com Interview with: [caption id="attachment_52464" align="alignleft" width="200"]Kao-Ping Chua, MD PhD Assistant Professor, Department of Pediatrics Susan B. Meister Child Health Evaluation and Research Center University of Michigan Dr. Kao-Ping Chua[/caption] Kao-Ping Chua, MD PhD Assistant Professor, Department of Pediatrics Susan B. Meister Child Health Evaluation and Research Center University of Michigan MedicalResearch.com: What is the background for this study? Response: Opioids are frequently prescribed to adolescents and young adults aged 12-21 years – in a recent study, 1 in 8 patients in this population were prescribed opioids during the year. At the same time, almost 30% of the 3000 opioid-related overdose deaths in 2016 among adolescents and young adults involved prescription opioids. Given the frequency of opioid prescribing and the risk of overdose, it is important to understand how to prescribe opioids safely to adolescents and young adults. However, there have been few studies that examine which opioid prescribing patterns are associated with prescription opioid overdose in adolescents and young adults. Prior studies examining these patterns have focused on older adults, particularly U.S. Veterans, so the generalizability of these findings to younger populations is unclear.

18 Dec

Posted at 20:04h in Author Interviews, Brain Injury, Exercise - Fitness, JAMA
MedicalResearch.com Interview with: [caption id="attachment_52509" align="alignleft" width="133"]John Breck, DO,  CAQSM Medical Services at University of Colorado, Boulder Dr. Breck[/caption] John Breck, DO,  CAQSM Medical Services at University of Colorado, Boulder MedicalResearch.com: What is the background for this study? Response: To date, most concussion research has focused on sport-related concussion, though it is known that a substantial number of concussions occur outside of participating in sport. Focusing solely on sport-related concussion may result in an underestimation of the underlying incidence and prevalence of concussion in the general population and leads to the widely held perception that most concussions are sport-related. An understudied population at risk for concussion are United States undergraduate college students. 

18 Dec

Posted at 18:46h in Author Interviews, JAMA, USPSTF
MedicalResearch.com Interview with: [caption id="attachment_42708" align="alignleft" width="143"]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 Dr. Barry[/caption] 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? Response: An abdominal aortic aneurysm (AAA) is a bulge in the wall of the main artery that carries blood from the heart to the lower part of the body. While AAA often has no signs or symptoms, the aneurysms can grow silently and burst without warning, which can be deadly. 

18 Dec

Posted at 17:00h in Author Interviews, Diabetes, JAMA, Nutrition
MedicalResearch.com Interview with: Dr Mathilde Touvier, MPH, PhD Head of the Nutritional Epidemiology Research Team Dr Bernard Srour, PharmD, PhD Inserm, Inrae, University of Paris MedicalResearch.com: What is the background for this study? Response: We found that for an increase of 10 in the percentage of ultra-processed food quantity in the diet, we had a significant 15% increase in Type 2 diabetes risk. We have already shown, in the NutriNet-Santé cohort, associations between the consumption of ultra-processed foods and overall cancer, breast cancer, cardiovascular, coronary heart diseases risk, mortality and depressive symptoms. However, no prior study had studies the associations between ultra-processed food and Type 2 diabetes risk. We suspected that we would find these associations since some components of ultra-processed foods light have metabolic interactions with human health (some food additives for instance).

16 Dec

Posted at 00:56h in Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, JAMA, Supplements
MedicalResearch.com Interview with: [caption id="attachment_52478" align="alignleft" width="160"]Pieter A. Cohen, MD Department of Medicine, Cambridge Health Alliance Somerville, Massachusetts Harvard Medical School Boston, Massachusetts Dr. Cohen[/caption] Pieter A. Cohen, MD Department of Medicine, Cambridge Health Alliance Somerville, Massachusetts Harvard Medical School Boston, Massachusetts MedicalResearch.com: What is the background for this study? Response: There has been increasing interest in the use of over-the-counter supplements to help improve memory and cognitive function.  However, prior studies have suggested that these types of supplements might contain unapproved investigational drugs.