Category Archives: Clinical research
Roderic I. Pettigrew, PhD, MD, is director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH). He was a member of the inaugural class of the Robert Wood Johnson Foundation (RWJF) Harold Amos Medical Faculty Development Program.
On a fateful day in 2006, 20 year-old Rob Summers, a standout collegiate baseball pitcher at Portland State with aspirations to play in the big leagues, was a victim of a hit-and-run accident while standing in his own driveway. His injuries left him paralyzed below the chest, and his doctors informed him he would never move his legs again.
I first met Rob at NIBIB’s ten-year anniversary celebration. It had been just four years since his accident, and he had already broken new ground in spinal cord injury recovery. During the event, Rob shared his incredible story about the experimental procedure he had recently undergone as part of an NIBIB-funded research trial. In the trial, Rob became the first human to have an electrical stimulator implanted on his spinal cord with the goal of restoring some function to previously paralyzed muscles.
Rob spoke about how, in just weeks after implantation, the stimulation enabled him to hold himself in a standing position for the first time since his injury. In addition, he began to sense when he was uncomfortable in his wheelchair. Rob went on to describe how, seven months into the trial, he discovered he was able to move his toes, ankles, and legs on command, a feat that shocked the researchers, as they never expected Rob to regain voluntary movement.
A leading cause of preventable blindness in premature babies can be successfully identified by trained non-physician evaluators working remotely, according to a study published online by JAMA Ophthalmology. The number of ophthalmologists who conduct screenings for the condition, retinopathy of prematurity (ROP), has declined in the United States, while countries in parts of Latin America, Asia, and Eastern Europe have long-standing ophthalmologist shortages that contribute to high rates of childhood blindness caused by ROP.
“This study provides validation for a telemedicine approach to ROP screening and could help prevent thousands of kids from going blind,” lead investigator Graham E. Quinn, MD, MSCE, said in a news release from the Children’s Hospital of Philadelphia, where he is a pediatric ophthalmologist.
The study involved retinal images taken by neonatal intensive care unit nurses and transmitted to trained image readers at a central location. Ophthalmologists had also examined the infants, and the image readers identified 90 percent of the infants the ophthalmologists had flagged as needing further evaluation.
“Telemedicine potentially gives every hospital access to excellent ROP screening,” said Quinn.
This is part of the June 2014 issue of Sharing Nursing’s Knowledge.
Research Compares Nurse and Physician Prescription Practices
A newly published systematic review of more than four decades of research on nurse prescribing finds that in the U.S. states and foreign countries in which nurses are allowed to prescribe, their prescription practices are similar to those of physicians, but their patients report higher satisfaction with their care and are more likely to return for follow-up visits.
The review was conducted by a team of researchers in the Netherlands—one of several countries in which nurses may prescribe. The team screened all studies they could find on the subject dating back to 1974, finally identifying 35 studies that met their criteria, including 13 from the United States, 12 from the United Kingdom, five from the Netherlands, two from Canada, two from Norway, and one from Colombia. The studies’ methods and specific topics varied, but the team conducting the review identified a number of trends in the research. They wrote:
- “Our findings suggest that nurses prescribe for a wide range of patients and in comparable ways to physicians. Overall, nurses appear to prescribe for just as many patients as physicians do, nurses prescribe comparable numbers of medicines per patient visit and there appear to be few differences between nurses and physicians in the type and dose of medication prescribed and in clinical outcomes.
Michelle Mello, JD, PhD, is a professor of law and public health at the Harvard School of Public Health, and a fellow with the Edmond J. Safra Center for Ethics at Harvard University. She is a recipient of a Robert Wood Johnson Foundation Investigator Award in Health Policy Research.
For years, pharmaceutical companies have been lambasted in the media and government prosecutions for concealing information about the safety and efficacy of their products. In one particularly splashy example, GlaxoSmithKline (GSK) agreed to pay $3 billion in 2012 to settle criminal charges that it failed to report safety data concerning its antidepressant drug, Paxil, and its diabetes drug, Avandia, and engaged in unlawful marketing of these products and one other drug. One mechanism proposed for avoiding such problems is to establish a system through which participant-level data from clinical trials, stripped of identifying information about patients, would be available to the public.
A potential benefit of sharing clinical trial data would be that independent scientists could re-analyze data to verify the accuracy of reports prepared by trial sponsors, which might deter sponsors from mischaracterizing or suppressing findings. Data sharing would also allow analysts both within and outside drug companies to pool data from multiple studies, creating a powerful database for exploring new questions that can’t be addressed within any given trial because the sample is too small to support such analyses.
The potential value of shared data in improving our understanding of the safety and efficacy of drugs, medical devices, and biologics has sparked considerable discussion about how to make data sharing happen. Earlier this year, the European Medicines Agency—the counterpart to the U.S. Food and Drug Administration (FDA) in the European Union—decided to start making data from trials of approved products available in 2014. This begs the question, should the FDA follow suit?
Lorenzo Lorenzo-Luaces graduated from the University of Puerto Rico–Rio Piedras, where he studied cross-cultural differences in suicidality. He is currently a graduate student in the University of Pennsylvania clinical psychology PhD program. Lorenzo-Luaces is an alumnus of Project L/EARN, a project of the Robert Wood Johnson Foundation, the Institute for Health, Health Care Policy and Aging Research, and Rutgers University.
The population of groups referred to as “minority” is growing at a faster rate in this country than Caucasians, with estimates suggesting that by 2060, 57 percent of the U.S. population will be non-White. This demographic shift could create a public health concern if racial/ethnic minorities remain underrepresented in mental health research. At present, these populations are less likely to receive mental health care than Whites. When they do receive care, it is usually of lesser quality.
Stereotypes among racial/ethnic minority communities regarding mental health are complex. Research suggests that they tend to have more negative beliefs about mental illnesses than White communities; for example, they are more likely to believe that mental illnesses occur due to factors outside of the individual’s control (e.g., spiritual or environmental reasons). However, despite generally holding more negative views about mental illnesses, research shows that racial/ethnic minorities tend to have less punitive attitudes about the mentally ill. Moreover, they tend to be more accepting about mental health treatments, although they express a clear preference for psychological services over medications.
Differences in access to care, rather than attitudes, likely explain the racial/ethnic gap in service use. Besides the obvious discrepancies in socioeconomic status (SES) between Caucasians and racial/ethnic minorities, the latter’s preference for psychological services may be one barrier to access. This is because, even among the insured, psychological services are more expensive in the short term and harder to access than psychotropic medications. There also are questions as to whether psychological interventions tested largely on White populations are effective for minorities.
CDC Study: Nurses, Physician Assistants More Likely to Provide Education in Chronic Disease Management than Doctors
Proper patient management of chronic diseases is increasingly important to the nation’s health care system, as the Baby Boom generation reaches the stage of life where such conditions are common. From diabetes, arthritis, and asthma to obesity, hypertension, and depression, the health care system is looking to train patients to take steps mapped out for them in discussions with their health care providers. A new study from the Centers for Disease Control and Prevention (CDC), however, finds that a minority of patients with chronic conditions receive education in managing their problems, and that some practitioners—nurses and physician assistants (PAs), in particular—are considerably more likely to provide such education than others.
“Disease self-management is an essential component of care for patients with most chronic conditions,” writes a team of researchers led by Tamara S. Ritsema, MPH, MMSc, PA-C. “Patients cannot perform daily self-management tasks if they have poor understanding of the disease process, medications used, or the practical tasks they need to accomplish to care for themselves. Health education is, therefore, a vital preventive element in the patient visit.”
The researchers examined five years of CDC data, accounting for more than 136,000 patients who had been diagnosed with asthma, chronic obstructive pulmonary disease (COPD), depression, diabetes, hyperlipidemia, hypertension, ischemic heart disease, or obesity. The records indicated whether the patients’ doctors, nurse practitioners (NPs), or PAs had provided education to the patients in the self-management of their conditions during each visit.
Ann H. Cary, PhD, MPH, RN, is dean and professor at the School of Nursing and Health Studies at the University of Missouri-Kansas City. She was a Robert Wood Johnson Foundation (RWJF) Executive Nurse Fellow from 2008 to 2011.
Human Capital Blog: Congratulations on the grant from the Centers for Disease Control and Prevention (CDC) to support the creation of a national resource center for HIV prevention at the School of Nursing and Health Studies at the University of Missouri-Kansas City! What will your role be at the center?
Ann H. Cary: My role is to ensure that the new center has the institutional resources it needs to succeed. This translates into procuring space reallocation and furnishings; supporting personnel hires; consulting with the CDC grant leadership team to remove organizational barriers; assisting in solving any challenges to the center’s rollout; and telling the story about this project through institutional messaging to our community, the discipline of nursing, and to other stakeholders and partners.
HCB: What is your vision for the center?
Cary: That the National HIV Prevention Coordinating Resource Center grant results in a center that leads and coordinates products for providers and the communities they serve to ultimately improve the prevention and treatment of people living with, or at risk of, acquiring HIV.
HCB: The center will be housed at a school of nursing and health studies. Why is that important?
Brendan Carr, MD, MA, MS, directs the Emergency Care Coordination Center and is on the faculty of the Perelman School of Medicine at the University of Pennsylvania. He is an alumnus of the Robert Wood Johnson Foundation (RWJF) Clinical Scholars program (2008-2010).
Human Capital Blog: The Emergency Care Coordination Center (ECCC) was created in 2006 by presidential directive in response to pressing needs in the nation’s emergency medical care system. Can you describe those needs?
Brendan Carr: I’ll try my best. While the landmark Institute of Medicine (IOM) report on the future of emergency care really brought much of this into focus in 2006, the story of the emergency care system’s struggles extends back well before that. The IOM reports on the health care system’s response to injuries (Accidental Death and Disability in 1966 and Injury in America in 1985) really foreshadowed the shortcomings of acute care delivery. At the time, we understood that rapid intervention in trauma was lifesaving and that our delivery system wasn’t keeping pace with the science of emergency care.
Over the last few decades, we’ve really come face to face with this reality on a broader scale. Our growing appreciation for the importance of early diagnostics and intervention, combined with increased awareness about the importance of creating a patient-centered health care system, have highlighted the mismatch between the demand for care and the product that we deliver. The emergency care system’s crisis is really the health system’s crisis.
Angela Barron McBride, PhD, RN, is a distinguished professor and dean emerita at the Indiana University School of Nursing, a member of the Indiana University Health Board, and chair of the National Advisory Committee for the Robert Wood Johnson Foundation (RWJF) Nurse Faculty Scholars program.
As we celebrate National Nurses Week, which ends on Florence Nightingale’s birthday (tomorrow, May 12th), I have been thinking anew about why she is such a good role model for 21st-century nurse leadership. No insipid “Lady with a Lamp,” she pioneered the use of applied statistics to develop policy and other novel ways of displaying data to change minds. For example, she developed the coxcomb, a variation on today’s pie chart in which each wedge represents a month’s worth of mortality figures, and then made use of these graphic displays in arguing for how improved hygiene can dramatically result in decreased mortality.
The Robert Wood Johnson Foundation (RWJF) has been particularly encouraging of getting more nurses on boards, and Nightingale personified the skill set and abilities that we need on today’s hospital boards. While I wouldn’t presume to put myself in the same company as Ms. Nightingale, I do serve on the board of Indiana University Health, an 18-hospital network, and I have chaired the board’s committee on quality and patient safety for over nine years. That perspective has confirmed for me that the lens through which nurses look at health care, particularly as exemplified by Nightingale, is very much needed at the board level.
The American Hospital Association lists a number of capabilities needed for board governance—an understanding of health care, business acumen, achievement orientation, community-mindedness, organizational awareness, a sense of strategy, innovative thinking, and team leadership. These are the competencies Nightingale had and so do her 21st-century sisters and brothers.
In recent years, millions of Americans have had medical devices implanted in their bodies—artificial hips and knees; pins, rods and screws used to support fractured bones as they heal; stents that help carry blood from the heart; and more. The U.S. Food & Drug Administration is charged with regulating the devices for safety and effectiveness, but in the latest Robert Wood Johnson Foundation (RWJF) Clinical Scholars video podcast, Sharon-Lise Normand, PhD, explains that the United States lacks a device identifier system that would help track the specific devices implanted in patients. Such data would be invaluable in cases of product recalls, as well as to gauge effectiveness. In the podcast, David Grande, MD, MPA, Associate Director of the University of Pennsylvania's RWJF Clinical Scholars program, interviews Normand about her work with the FDA to build a tracking database.
Normand is a professor of health care policy (biostatistics) in the Department of Health Care Policy at Harvard Medical School and in the Department of Biostatistics at the Harvard School of Public Health. The video podcast is part of a series of RWJF Clinical Scholars Health Policy Podcasts, co-produced with Penn’s Leonard Davis Institute of Health Economics.
The video is republished with permission from the Leonard Davis Institute.