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 Many Players Roil The Research Waters

Although big business may be crowding independent research, providers still have the tools at hand to make a credible judgment.

 

 
There was a time when academic centers and not-for-profit organized institutions conducted the vast majority of the clinical research in the United States. Over the years, there has been a shift to more studies coming from for-profit organizations, resulting in drug and medical device companies having greater control over research.
 
As a result, practitioners, patients, and others must be savvier and more critical consumers of medical studies and articles they see in journals, magazines, and on the Internet.
 
Fear not. A health practitioner doesn’t have to be Indiana Jones or Sherlock Holmes to digest, assess, or use research studies. It just takes some analytical skills, a curious mind, and the willingness to do a little research of one’s own.

Pushing Past Privatization

In his book, “Overdosed America: The Broken Promise of American Medicine,” John Abramson, MD, a lecturer in health care policy at Harvard Medical School, addressed the privatization of medical research and its impact on medical practice and prescriber decision making. He told Provider, “Approximately 85 percent of clinical trials are commercially funded, as are 97 percent of the most frequently cited articles. Physicians need to understand that we have a moral responsibility to the patient to provide the best possible medical care and bring the best medical science.”

At the same time, pharmaceutical companies have fiduciary responsibilities to shareholders and incentives to promote data that support the use of their products. “Providers, health care systems, and practitioners must understand these diverse goals and be prepared to evaluate for themselves what is in patients’ best interests” and realize that they may not be getting the full picture from commercially funded studies, he says.

Why is there growing privatization? “One reason is that grant money for academia to conduct research has become more difficult to obtain,” says David Smith, MD, CMD, president of Geriatric Consultants in Brownwood, Texas. “At the same time, the old adage of ‘publish or perish’ has become unnecessarily weakened.”

Fallout For The Elderly

Why is this important? Consider the proliferation of second-generation antipsychotic use in the elderly, Abramson says. “We saw use of these medications rise rapidly between 1999 and 2006, mainly because physicians were led to believe that using these drugs was in the best interest of their patients.” Recently, national quality programs are rolling back the use of these medications. This is the consequence of the privatization of medical research and what happens when physicians don’t have real-time access to studies and to all of the data that are useful to them in their decision making, Abramson suggests.

Smith notes that “sometimes companies will get a bunch of data and mine it for any little part that shows a positive effect and highlight that. It’s called data mining. Chances are that if you look at enough data, you can find something positive.”

Another common practice is dropping sites that show negative results from a multi-site study. “Often, the truth comes out later,” Smith says, after health care providers and practitioners have made decisions using the flawed data.

Physicians and others need to realize that journal editors and peer reviewers rarely have access to all the data from clinical trials that are published and become accepted as scientific evidence, Abramson says.
“Patients face a great risk of harm from this research. But things won’t change until transparent access to the actual data from scientific studies allows real-time independent analysis. As things now stand, physicians have no alternative but to rely on the company’s version of the scientific evidence,” he says. “Until real data are available in real time, physicians can’t be sure they are bringing the true fruits of medical science to their patients.”

State Of Affairs

Regardless of the funding sources, there has always been a dearth of clinically specific research involving long term care facilities and patients. Concerns about involving frail individuals continue to be an issue.
In reality, there are several reasons that it is challenging to recruit and include elders—particularly those in long term care facilities—for research studies. In fact, there are many barriers, including cognitive impairment, presence of multiple comorbidities, cultural issues, language barriers, possibility of acute condition changes, and reluctance of family members.

Nothing has changed in the landscape of barriers to long term care and aging research, says Smith. “The long term care population is made up of a huge number of individuals with cognitive impairment of some degree. To help address this, advance directives should include prior determination that someone would like to be included in research.”

At the same time, researchers have to deal with the fact that nursing care centers sometimes are hesitant to allow researchers to conduct studies, even if the residents are willing to participate. “They often see nothing in it for them but a disruption of their work flow, increased burden on staff, and perceived liability,” says Smith.

“There remain gaps in every research topic, especially in aging and long term care,” says Milta Little, DO, CMD, assistant professor of geriatric medicine at Saint Louis University. Part of the challenge, she says, is that “there is not much financial support for studies in this setting.” As a result, studies are typically small and focus on one locality or region.

The good news is that as the elder population grows and more focus is placed on senior care, more practitioners are interested in studying these patients and more consumers are interested in participating in studies.

“I find no shortage of studies involving the older, frail population,” says Sheryl Zimmerman, PhD, distinguished professor of social work and co-director of the Program on Aging, Disability, and Long Term Care of the Sheps Center for Health Services, University of North Carolina at Chapel Hill. She says that there are, particularly, more studies on issues such as antipsychotic use, dementia care, and antibiotic stewardship that have come under national focus in recent years.

Research Partners Reach Out

Increasingly, there are opportunities for research partnerships and for providers to get involved in a variety of ways.

For example, the Center for Long-Term Care Quality & Innovation, an independent research center formed by the American Health Care Association/National Center for Assisted Living at Brown University, links researchers with providers to test and disseminate interventions to improve care for post-acute and long term care residents.

Rosa Baier, MPH, the center’s associate director, says, “We are a resource for practitioners who have innovations that they want to test rigorously and interventions they want to evaluate. We also help them find funding for studies they want to pursue, existing studies in which they can participate, and opportunities to implement tested successes.”

Elsewhere, a growing number of Geriatric Research Education and Clinical Centers (GRECCs) have popped up across the country.

Established by the Veterans Health Administration to handle the complexities of a growing elder population, these are designed to attract scientists and students to the field of geriatrics and to conduct and disseminate research on how care is delivered to elders and the effects of rehabilitation.
Each GRECC contains educational and clinical components, as well as the research component. They publish numerous peer-reviewed articles on a variety of geriatrics-related topics.
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Get Out The Magnifying Glass

Viewing research studies with a critical eye takes a little time, but it is worth the effort. Generally, there are four main aspects of research methodology: design, sampling, data collection, and data analysis. If researchers use inappropriate or poor methodology, study results can be misleading.

There are several types of research studies, including:
  • Case series and reports. These involve collections of reports on the treatment of individual patients with a common condition or a report on a single patient.
  • Case control studies. This involves comparing patients who already have a particular condition with people who, for example, don’t have it. These are generally designed to estimate the odds of someone developing the illness or condition.
  • Cohort studies (including longitudinal studies). These involve following a case-defined population who are receiving a specific treatment over time and comparing them with a group of people who aren’t receiving that treatment.
  • Randomized controlled studies. These involve two groups—a treatment group and a control group. The treatment group receives the treatment/intervention being investigated, while the control group receives either a placebo or treatment. Patients are randomly assigned to one group or the other. These studies are considered the gold standard of medical research.
  • Double-blind study. This is a type of randomized controlled trial in which neither staff/practitioners nor the patient knows which of various possible treatments participants are receiving.
  • Meta analysis. This study is a systematic, objective means of combining data from several studies and determining a pooled estimate of treatment effectiveness and statistical significance.
  • Systematic reviews. These comprehensive reviews take all relevant studies on a topic and analyze them to reach a balanced and impartial summary of all findings. Similar to literature reviews, they are more rigorous.

How To Assess A Study

To begin assessing research findings, says Smith, look at who the authors are and if they have an “axe to grind;” that is, if they have a financial interest or other bias. He says that a potential bias doesn’t mean that the study should be summarily dismissed; instead, take the results with a grain of salt. Look at other studies on the topic before making any decisions or reaching conclusions. Smith also suggests looking at the study construction and research design.

“There needs to be a proper sample that is representative and adequate,” he says. A sample can be biased by slanted recruitment of volunteers or selective attrition, which is the likelihood that some people are more likely to drop out of a study than others.

When it comes to assessing research, practice makes perfect—or close to it. Little says, “Journals can be a goldmine. Look at the references and review those articles. Contact the authors—most are extremely willing to share information and answer questions.” She also suggests brushing up on skills such as statistical analysis. “Don’t forget the simple statistics you learned in school.”
Smith adds, “One trick of statistics is to use risk-reduction data that can make small things look like big things.”

For example, if an event happens once in a million times and you give it treatment that changes it to one in 2 million, you’ve reduced risk by 50 percent. That number looks meaningful and huge, but it’s not particularly relevant.
“To understand risk reduction data, it’s valuable to also know the number needed to treat to get a benefit and the number needed to harm,” he says.
There are hundreds of sources of information, studies, and findings. A person could spend 24 hours a day online or in a library and still not read everything. Zimmerman suggests starting with some reliable sources.
“Look for refereed journals with a robust editorial board that reviews papers for their content and level of evidence, as well as relevance to the field and declines to publish articles that fail to cut the mustard,” she says. “The rate of citation also tells you if a journal is successful in finding and publishing credible, important studies.”

From Small Acorns Can Come Big Trees

A study doesn’t have to be huge and involve hundreds of patients, dozens of facilities, and complex research protocols, experts say. Increasingly, individual facilities and practitioners are conducting small quality improvement studies to address specific problems and target solutions. For example, Zachary Palace, MD, CMD, a medical director in Bronx, N.Y., conducted a quality improvement (QI) project on “Development of an Outpatient Transfusion Program to Reduce Avoidable Hospitalizations,” which received a Quality Improvement (QI) Award from AMDA—The Society for Post-Acute and Long Term Care Medicine Foundation.

The project started out as a tiny seed but grew tall rapidly. Not only did Palace present his study’s impressive results at the 2015 AMDA Annual Conference, he also was interviewed by national media, including The New York Times. He since has been asked to speak about his study at various meetings, and he has been contacted by practitioners across the country who want to hear more about his efforts.
It all started with an issue that troubled Palace. His facility would send residents with anemia and requiring blood transfusions to the emergency room (ER), and the physicians there would admit them to the hospital based on a diagnosis of anemia. The residents had a 5.3-day mean length of stay in the hospital and a mean cost to Medicare of $10,339.

“Our residents would come back to us with decubiti and all sorts of infections that they didn’t have when we sent them out,” Palace says.

Finding A New Way

Palace did a little research and discovered that hematologists in the area were sending community-based patients to a blood center for transfusions. He and his team decided that a similar model would work for them if they enhanced communication with the hospital physician and got him or her to take responsibility for the patient if the person required special care during the transfusion or needed to be hospitalized afterward.

To address these issues, Palace and his team implemented a transfusion transfer form that is completed by the nursing care center physician or nurse practitioner and faxed to the hospital-based geriatrician. This form contains relevant patient demographic and clinical data, including diagnoses, medications, allergies, recent lab values, and previous transfusion history.

Using this information, the hospital-based physician coordinates with the blood center for an outpatient transfusion. Then, instead of going to the ER and then being admitted to the hospital, the patient is transported to the blood center for the transfusion and returned to the nursing center later that same day.
From July 2009 through December 2014, the facility experienced a 74 percent reduction in patients transferred to the hospital for a diagnosis of anemia. The cost savings to Medicare per patient was $9,772.
During 2014 alone, 71 patients were able to get outpatient transfusions, at a total savings of nearly $700,000. As a side benefit, Palace says, “We have improved relationships with the local hospital.”
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Identify The Issue

To conduct a successful QI study, Palace says, “You have to recognize that there is something that needs to be addressed, something that isn’t happening efficiently or effectively.” Once the issue is identified, he says, “You need to get leaders and key stakeholders to understand the value of your study and its potential to improve quality of care.” Keep the study manageable, he says. “People often think of QI as overhauling the entire process, but you actually need to find something focused, doable, and not too broad. Don’t bite off more than you can chew.”

As the project moves forward, he stresses the importance of sharing results. “We would come back and report on cases to enable people to see our successes and how the process worked.” Ultimately, Palace would like his project to be an inspiration. “I hope it will give others ideas to start thinking about ways they can identify specific issues that they can address and devise simple ideas that can have a significant impact,” he says.

Others agree about the value of these small studies. QI projects “give you the latitude to look at what you need to change in your organization, to determine what to change and make it happen. These studies are a really good starting point,” says Chapel Hill’s Zimmerman. Looking at QI studies in the literature, as well as at conference poster sessions and other venues, also can be helpful.

“You may be able to adapt what others are doing to address your issues. You may have to inflate or deflate it a little, but you won’t have to reinvent the wheel, and that is always a good thing,” she says.

The Practical Side Of Research

Michael Yao, MD, CMD, chief medical officer at Golden Living, comes from a background as a medical educator and is a voracious reader. He stays on top of the literature and doesn’t hesitate to share interesting and important studies with his staff and colleagues. However, he does so cautiously and selectively.

“We pride ourselves on being an organization that practices evidence-based medicine. We pay attention to new developments in research. However, we are careful about new things that have not yet become proven standards,” he says.

“We have to be careful how we apply research findings to our population, which is significantly complex. At the same time, we are patient-centered, so we value patient and family preferences and wishes on how to manage care and their goals for health and independence.”

Nonetheless, it is more important than ever for Yao to know what is happening in the research world.
“It is our responsibility to communicate to patients what the prevailing opinion and state of affairs is and give them a professional perspective so that they have a basic understanding and can weigh risks and benefits of various interventions,” Yao says. “It is our responsibility to identify resources that they can utilize and point them to reliable, credible sources of information.”

What Makes The Grade

For example, he says, “Tools like the lists from the Choosing Wisely campaign provide good guidance and help us steer both patients and practitioners away from interventions and treatments that no longer are supported by clinical evidence and best practices.”

Before he’ll pass a study or article on to his team or colleagues, Yao says, “it has to be information that is well-studied, applicable, and important … such as the new Beers criteria.” (The Beers Criteria for Potentially Inappropriate Medication Use in Older Adults is a guideline for health professionals to improve safety when prescribing for elders.)

The study “has to have a significant impact on what we’re doing now,” Yao says. “For example, a prospective randomized controlled trial is the gold standard, but a sizable proportion of study participants should reflect our population.”

For facility-wide policies and procedures, Yao and his team tend to depend on evidence-based consensus documents such as AMDA and the Infectious Disease Society of America guidelines.

“These represent opinions that have been filtered through and tempered by the experiences of experts in the field and the strongest clinical evidence,” he says.

Research will always be an important part of health care, and it will continue to play a role in guiding care, standards, trends, and payment. However, it is up to facility leaders to become savvy research consumers and take the time and effort to assess studies before making decisions or declarations about their value or viability.

This is part of providers’ responsibility: to protect their patients’ safety and best interests.
 
Joanne Kaldy is a freelance writer and communications consultant.
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