Why So Many New HIV Infections in US, Despite PrEP Availability?

MedicalResearch.com Interview with:

Rogério M. Pinto, LCSW, Ph.D. Associate Professor Associate Dean for Research School of Social Work University of Michigan Ann Arbor, USA

Dr. Pinto

Rogério M. Pinto, LCSW, Ph.D.
Associate Professor
Associate Dean for Research
School of Social Work
University of Michigan
Ann Arbor, USA

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

Response: This integrative review, published in the journal AIDS and Behavior, includes content from 47 peer-reviewed scholarly articles reporting multiple barriers to high-risk individuals trying to access pre-exposure prophylaxis (PrEP), the HIV drugs that reduce subsequent risk of infection. We found 31 potential solutions to 30 barriers at the patient, provider and health-system levels. In synthesizing this research from a multi-level perspective, based upon a socioecological model, our report contributes much-needed analysis to the rapidly expanding field of PrEP implementation research.

At this stage in the scale-up of U.S. PrEP programs, it is important to systematically and comprehensively analyze and integrate knowledge about the successes of and the barriers to PrEP implementation. Our review provides a comprehensive analysis and informs the direction of PrEP implementation across a variety of settings.

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Venous Thromboembolism Prophylaxis Over & Underutilized in Some Hospitalized Patients

MedicalResearch.com Interview with:
Paul Grant, MD

Associate Professor of Medicine Associate Chief Medical Information Officer Director, Perioperative and Consultative Medicine Division of Hospital Medicine Department of Internal Medicine Michigan Medicine University of Michigan

Dr. Grant

Associate Professor of Medicine
Associate Chief Medical Information Officer
Director, Perioperative and Consultative Medicine
Division of Hospital Medicine
Department of Internal Medicine
Michigan Medicine
University of Michigan

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

Response: It is well known that hospitalized medical patients are at risk for venous thromboembolism VTE, but the severity of patient risk can vary significantly. National guidelines have consistently stated that low-risk patients should not receive VTE prophylaxis beyond early ambulation.

In this retrospective cohort study, we analyzed data from 52 hospitals participating in the Michigan Hospital Medicine Safety consortium. Trained medical record abstractors at each hospital collected data from 44,775 medical patients including VTE risk factors, type of VTE prophylaxis administered, and contraindications to pharmacologic prophylaxis. Individual patient risk of VTE was determined using the Padua risk assessment model.

Of the 32,549 low-risk patients, 77.9% received excess venous thromboembolism prophylaxis as either pharmacologic prophylaxis (30.6%), mechanical prophylaxis (20.8%), or both (26.5%). In the 12,226 high-risk patients, VTE prophylaxis was underused in 22% of patients. The rates of inappropriate prophylaxis varied considerably by hospital.  Continue reading

Can a Pill Plus Infrared Light Replace Mammograms?

MedicalResearch.com Interview with:

Greg Thurber, PhD Assistant Professor Department of Chemical Engineering Assistant Professor Department of Biomedical Engineering University of Michigan 

Dr. Thurber

Greg Thurber, PhD
Assistant Professor
Department of Chemical Engineering
Assistant Professor
Department of Biomedical Engineering
University of Michigan 

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

Response: Most current disease screening strategies rely on either blood tests, where the physician can obtain information on specific disease molecules but has no idea where they originated in the body, or anatomical imaging, where the physician can see changes in the structure of tissues but doesn’t have any molecular information. We wanted to develop a method that could provide both molecular information and an image of where these molecules were located. We know from decades of research in cancer that this is a molecular disease, so providing molecular information to the physician will help improve detection and diagnosis. Breast cancer screening provides an excellent opportunity to apply this approach to improve detection. Currently, estimates indicate that we are overspending $4 billion per year on the overdiagnosis and overtreatment of breast cancer because we cannot accurately determine which patients need treatment and which can be safely monitored with no intervention. Despite this problem with overdiagnosis, however, screening saves lives…we simply need a better way.

Molecular imaging has the capability of providing both molecular information and the location within the body. However, most of these techniques are expensive and use ionizing radiation, meaning there is a small risk of actually causing cancer. This is not acceptable for screening large numbers of otherwise healthy patients. To avoid this risk and provide a safe, inexpensive, and relatively easy method for patients to undergo screening, we decided to develop near-infrared fluorescent imaging agents that can be taken as a pill. The goal is for the patient to simply take a pill a day or two before their visit, and then the physician shines near-infrared light on the breast tissue to detect tumors where they ‘light up’ by giving off a different color of light.

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Do Blacks Still Get More Opioid Prescriptions?

MedicalResearch.com Interview with:

Matthew A. Davis, MPH, PhD Assistant Professor Department of Systems, Populations and Leadership University of Michigan

Dr. Davis

Matthew A. Davis, MPH, PhD
Assistant Professor
Department of Systems, Populations and Leadership
University of Michigan

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

Response: The premise for the study was based on prior work that demonstrated that the likelihood of being prescribed an opioid differs according to a patient’s race and ethnicity.  Collectively this work has shown that Non-Hispanic Whites are more likely to receive opioids than other groups for pain.

We decided to look at trends in the prescribing of different pain medications over the last 16 years to see if we could detect any differences in prescribing patterns among racial and ethnic groups.  To do so we used national health data for a large sample of Americans who live with significant pain.

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Medicaid Expansion Improved Access to Cardiac Care Without Diminishing Outcomes

MedicalResearch.com Interview with:

Donald Likosky, Ph.D., M.S. Associate Professor Head of the Section of Health Services Research and Quality Department of Cardiac Surgery. University of Michigan

Dr. Likosky

Donald Likosky, Ph.D., M.S.
Associate Professor
Head of the Section of Health Services Research and Quality
Department of Cardiac Surgery.
University of Michigan

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

Response: Michigan was one of several states to expand Medicaid. Current evaluations of the Michigan Medicaid expansion program have noted increases in primary care services and health risk assessments, but less work has evaluated its role within a specialty service line. There has been concern among some that Medicaid patients, who have traditionally lacked access to preventive services, may be at high risk for poor clinical outcomes if provided increased access to cardiovascular interventions.

Using data from two physician-led quality collaboratives, we evaluated the volume and outcomes of percutaneous coronary interventions and coronary artery bypass grafting 24mos before and 24mos after expansion. We noted large-scale increased access to both percutaneous coronary interventions (44.5% increase) and coronary artery bypass grafting (103.8% increase) among patients with Medicaid insurance. There was a decrease in access for patients with private insurance in both cohorts. Nonetheless, outcomes (clinical and resource utilization) were not adversely impacted by expansion.  Continue reading

Ophthalmology Consultation for Emergency Care at a University Hospital

MedicalResearch.com Interview with:

Maria A. Woodward, MD, MSc Department of Ophthalmology and Visual Sciences W. K. Kellogg Eye Center Institute for Healthcare Policy and Innovation University of Michigan Ann Arbor, MI

Dr. Woodward

Maria A. Woodward, MD, MSc
Department of Ophthalmology and Visual Sciences
W. K. Kellogg Eye Center
Institute for Healthcare Policy and Innovation
University of Michigan
Ann Arbor, MI

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

Response: Many people go to emergency departments seeking care for their eye problems. We wished to investigate which factors are associated with the involvement of ophthalmologist consultants in the care of these patients and whether any disparities exist.  Continue reading

Combination Meropenem-Vaborbactam (Vabomere) Successfully Treats Complicated Urinary Tract Infections

MedicalResearch.com Interview with:

Keith S. Kaye, MD, MPH Professor of Medicine, Division of Infectious Diseases University of Michigan Medical School Ann Arbor MI 

Dr. Kaye

Keith SKayeMD, MPH
Professor of Medicine, Division of Infectious Diseases
University of Michigan Medical School
Ann Arbor MI 

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

Response: Complicated complicated urinary tract infections (cUTI), including acute pyelonephritis, are a major cause of hospital admissions, and are associated with significant morbidity and mortality and can be difficult to treat. While the most common pathogen is Escherichia coli, the more problematic pathogens are multidrug-resistant (MDR) gram-negative organisms including other Enterobacteriaceae species. The prevalence of cUTI due to MDR gram-negative bacteria has risen. In some instances, MDR gram-negative bacteria isolated from the urinary tract can cause bacteremia.

Vabomere was approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of adult patients with cUTI, including pyelonephritis, caused by designated susceptible Enterobacteriaceae: Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex.   Vabomere is a fixed-dose (2g/2g) combination product of a carbapenem and a β-lactamase inhibitor with potent in vitro activity against Klebsiella pneumoniae carbapenemase (KPC)-producing carbapenem-resistant Enterobacteriaceae (CRE), an important MDR organism associated with serious infections.

The Targeting Antibiotic Non-susceptible Gram-negative Organisms (TANGO I) trial was the pivotal Phase 3 study that compared the efficacy and safety of Vabomere to piperacillin-tazobactam in the treatment of patients with cUTI and acute pyelonephritis.

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Salt Content in Restaurant Food Remains High

MedicalResearch.com Interview with:

Julia Wolfson, PhD MPP Assistant Professor Department of Health Management and Policy Department of Nutritional Sciences University of Michigan School of Public Health Ann Arbor, MI 48109

Dr. Wolfson

Julia Wolfson, PhD MPP
Assistant Professor
Department of Health Management and Policy
Department of Nutritional Sciences
University of Michigan School of Public Health
Ann Arbor, MI 48109

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

Response: Over the past several years, Large chain restaurants in the United States have made some progress in introducing new lower calorie items on their menus. Since 2012, calories of items consistently on restaurant menus in all years have not significantly change. In this study, we examined the sodium content of restaurant menu items among 66 of the 100 largest restaurants in the US. We examined sodium content among items on the menu in all years (2012-2016) and among newly introduced items in 2013, 2014, 2015 and 2016 compared to items on the menu in 2012 only.

We found that sodium content of menu items on the menu in all years did not change, but that restaurants were introducing new, lower sodium menu items. However, sodium content of restaurant menu items remains high. This is important because diets high in sodium are associated with serious adverse health outcomes including hypertension, stroke and cardiovascular disease.

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FDgard® Study Demonstrates Rapid Relief of Functional Dyspepsia Symptoms

MedicalResearch.com Interview with:

William D. Chey

Dr. Chey

William D. Chey, M.D., F.A.C.G.
Timothy T. Nostrant Professor of Gastroenterology & Nutrition
Director, Digestive Disorders Nutrition & Lifestyle Program
Michigan Medicine
Ann Arbor, Michigan 

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

Response: Functional Dyspepsia (FD) has been characterized as recurring indigestion with no known organic cause and is an area of high unmet medical need. This medical condition, which is non-life threatening, can have a significant impact on an individual’s quality of life. It remains poorly recognized and presents a significant management challenge for providers and patients.

Gastrointestinal symptoms can include epigastric pain or discomfort, inability to finish a normal-sized meal, heaviness, pressure, nausea, bloating and belching.

Currently, there are no FDA-approved drugs for FD. Off-label medications are used to treat the condition and patient dissatisfaction remains high.[1]

In a real-world, observational study, called FDACT™ (Functional Dyspepsia Adherence and Compliance Trial), we analyzed information on the frequency of FD symptoms, daily consumption of capsules, onset of action, improvement in FD symptoms, quality of life and patient satisfaction among 600 patients who took FDgard®, a nonprescription medical food specially formulated for the dietary management of FD.

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Despite Sleep Benefits To Teens, Only Half of Parents Support Later School Start Times

MedicalResearch.com Interview with:

Galit Dunietz, Ph.D., MPH Doctor of Philosophy Department of Neurology University of Michigan  Ann Arbor MI

Dr. Dunietz

Galit Dunietz, Ph.D., MPH
Epidemiologist, Sleep Disorders Center
Department of Neurology
University of Michigan
Ann Arbor MI

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

Response: Insufficient sleep has a negative impact on health, cognition and mood and is linked to motor vehicle accidents. However, sleep loss in adolescents has become an epidemic and arises in part from biological processes that delay sleep and wake timing at the onset of puberty. This biology does not fit well with early school start times (before 8:30 a.m.). Despite recommendations from the American Academy of Pediatrics and the American Academy of Sleep Medicine to delay school start times, most schools in the U.S. have current start times before 8:30 a.m.

In this nationally representative study of US parents of teens, we examined whether parents supported or opposed later school start times (after 8:30 a.m.). We also examined what may have influenced their opinions.

We found that only about half of surveyed parents of teens with early school start times supported later school start times. Opinions appeared to depend in part on what challenges and benefits were expected to result from the change.

For example, parents who expected an improvement in their teen’s academic performance or sleep quantity tended to support the change, whereas parents that expected negative impact on afterschool activities or transportation opposed delays in school start times.  We also found that parents had misconception about sleep needs of their adolescents, as the majority perceived 7-7.5 hours of sleep as sufficient, or possibly sufficient even at this young age when 8-10 hours are typically recommended.

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Volunteers Plus Free Hearing Aids Can Supply Adequate Auditory Care

MedicalResearch.com Interview with:
Aileen Wertz, MD

Otolaryngology – Head and Neck Surgery
University of Michigan 

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

Response: The key finding of this study is: free, comprehensive audiologic care, including hearing aids and fitting, is feasible within a well-established free clinic model.

We found that donated hearing aids and volunteer health care providers were able to run the clinic and that 20 patients have thus far been fit with hearing aids.

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IPF Patients Treated With Nintedanib (Ofev) More Likely To Have Stable Lung Function

MedicalResearch.com Interview with:

Kevin R. Flaherty

Dr. Flaherty

Kevin R. Flaherty, M.D., M.S.
Professor, Department of Internal Medicine
Associate Director, T32 Multidisciplinary Training Program in Lung Diseases
Chair, Pulmonary Fibrosis Foundation Clinical Care Network Steering Committee
University of Michigan Medicine 

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This is a new post-hoc analysis, recently presented at the 2017 American Thoracic Society (ATS) conference, which sought to further assess the efficacy of Ofev (nintedanib), an FDA-approved drug treatment for idiopathic pulmonary fibrosis (IPF), and its effect on lung function in those with this disease.

IPF is a rare and serious lung disease that causes permanent scarring of the lungs and affects as many as 132,000 Americans.

The analysis examined pooled data from the two placebo-controlled, global Phase III INPULSIS trials, which evaluated the efficacy and safety of 52 weeks’ treatment with nintedanib in people with IPF. In both trials, a higher proportion of people treated with placebo than nintedanib had disease progression from baseline to week 52, as defined by the proportions of patients with ≥5% or ≥10% declines in lung function, as measured by forced vital capacity (FVC) % predicted. Additionally, a lower proportion of patients treated with placebo than nintedanib had no decline or an improvement in FVC % predicted.

These data support the initial findings from the Phase III INPULSIS trials which found that more patients treated with nintedanib versus placebo had an absolute decline in FVC of less than 5%.

In this subgroup analysis, we assessed the proportions of patients from the two INPULSIS trials treated with nintedanib and placebo who had no decline or an improvement in lung function from baseline to week 52 using pooled data for this post-hoc analysis. In terms of those who participated, a total of 864 patients were included (519 treated with nintedanib, 345 treated with placebo). Baseline characteristics including age, gender and FVC were similar between the subgroups of patients who had no decline or an improvement in FVC and those whose FVC declined, and between the nintedanib and placebo groups within each subgroup.

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Better Communication Linked To Reduced Racial Disparities in Breast Reconstruction Surgery

MedicalResearch.com Interview with:

Elham Mahmoudi, PhD, MS Section of Plastic Surgery, University of Michigan Medical School Ann Arbor, Michigan

Dr. Mahmoudi

Elham Mahmoudi, PhD, MS
Section of Plastic Surgery, University of Michigan Medical School
Ann Arbor, Michigan

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

Response: About one-third of all women diagnosed with breast cancer undergo mastectomy. In recent years, owing to advancements in screening and treatment, life expectancy after being diagnosed with breast cancer has increased. Research has shown that for patients who undergo mastectomy, breast reconstruction offers many psychological benefits such as improved self-esteem, reduced sexual dysfunction, decreased anxiety, and overall improvement in quality of life. After the passage of the Women’s Health and Cancer Rights Act in 1998, the coverage of post-mastectomy breast reconstruction (PBR) by any type of health insurance became mandatory. However, there are large and widening racial and ethnic disparities in PBR, with White women having a higher rate of PBR than women from other racial and ethnic groups.

In 2011, the State of New York enacted a law mandating that surgeons advise their patients undergoing mastectomy about available breast reconstruction options, insurance coverage, and referral to a plastic surgeon. We evaluated the effect of this law on racial/ethnic disparities in immediate PBR.

Our results did not show any effect on the overall rate of immediate  post-mastectomy breast reconstruction or on disparities between white and African-American women; however, we found that White-Hispanic and White-other racial/ethnic group disparities in immediate PBR were reduced by 9 and 13 percentage points, respectively. This is a substantial reduction in disparity within only a year after the passage of the law, which demonstrates the importance of physician-patient communication.

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Risks of Surgery For Thyroid Cancer Higher Than Expected

MedicalResearch.com Interview with:

Megan Rist Haymart MD Assistant Professor University of Michigan

Dr. Haymart

Megan Rist Haymart MD
Assistant Professor
University of Michigan

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

Response: Thyroid cancer is typically treated with thyroid surgery. It is common practice for physicians to inform patients that the risk of vocal cord paralysis or hypoparathyroidism with thyroid surgery is 1-3%.

However, most of these estimates are based on single institution studies with high volume surgeons. In our study we evaluated surgical risks in a population-based cohort. Using the Surveillance, Epidemiology, and End Results-Medicare database, we found that 6.5% of thyroid cancer patients developed general post-operative complications (fever, infection, hematoma, cardiopulmonary and thromboembolic events) and 12.3% developed thyroid surgery specific complications (hypoparathyroidism/hypocalcemia, vocal cord/fold paralysis).

Older patient age, presence of comorbidities, and advanced stage disease were associated with the greatest risks of surgical complications.

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Millions of Americans Become Chronic Opioid Users After Surgery

MedicalResearch.com Interview with:

Chad M. Brummett, MD Division of Pain Medicine, Department of Anesthesiology University of Michigan Medical School Ann Arbor, MI 48109

Dr. Brummett

Chad M. Brummett, MD
Division of Pain Medicine, Department of Anesthesiology
University of Michigan Medical School
Ann Arbor, MI 48109 

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

Response: The opioid epidemic has received considerable attention, but most of the focus has been on chronic pain and primary care. However, surgeons prescribe ~40% of the opioids in the US, and little attention has been given to the importance of prescribing after surgery.

In this study, we found that among patients not using opioids in the year prior to surgery, ~6% of patients continued to use opioids long after what would be considered normal surgical recovery. Furthermore, there was no difference between patients undergoing minor and major surgeries, thereby suggesting that some patients continue to use opioids for reasons other than pain related to surgery.

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