Last March, the Obama administration announced that it would allocate $1.1 billion in American Recovery and Reinvestment Act of 2009 (ARRA) funding over a two-year period to expand comparative effectiveness research (CER) activities at federal health agencies. Specifically, $400 million has been allocated to the Office of the Secretary of Health and Human Services (HHS), $300 million to the Agency for Healthcare Research and Quality (AHRQ) and $400 million to the National Institutes of Health (NIH).
What exactly is comparative effectiveness research? According to the Henry J. Kaiser Family Foundation, "The aim of CER is to improve health outcomes by developing and disseminating evidence-based information to patients, providers and health care decision-makers about the effectiveness of treatments relative to other options. Traditional clinical research typically examines the effectiveness of one method, product or service at a time. Comparative effectiveness research compares two or more different methods for preventing, diagnosing and treating health conditions."
For example, in the case of diabetes, a disease that disproportionately affects racial and ethnic minorities, a CER study might compare and contrast the effectiveness of two different diabetes medications, insulin-delivery systems or diabetes self-management programs (such as group therapy versus home visits by nurses).
Admittedly, the goal of this aggressive federal focus on comparative effectiveness research is not specifically to close the gap of minority health disparities but to address the much broader issues of national health care reform and medical cost reduction. But as the ARRA-funded CER studies get underway, minority nursing leaders are optimistic that this large cash infusion will also help determine the effectiveness of interventions for vulnerable populations, add to the robustness and validity of evidence-based literature and help guide future health disparities research.
"The [government’s CER] agenda is pretty ambitious, but any agenda that draws attention to health disparities is hopeful," says Antonia M. Villarruel, PhD, RN, FAAN, associate dean of research and the Nola J. Pender Collegiate Chair in Health Promotion at the University of Michigan School of Nursing in Ann Arbor.
"What’s exciting about comparative effectiveness research is that it provides another piece of the puzzle," adds Nelda C. Martinez, PhD, RN, associate professor at the University of Texas at El Paso (UTEP) School of Nursing and a senior fellow at the University of Texas’ Hispanic Health Disparities Research Center. Not only will CER help improve the delivery of health care services to minority and underserved populations, she explains, it will also expand the body of minority health literature that will be taught in schools of nursing in the future.
To help coordinate CER initiatives across the federal government, ARRA established the Federal Coordinating Council for Comparative Effectiveness Research. The initial task of the 15-member council, which is comprised primarily of clinicians, was to recommend research priorities for the $400 million allocated to the Office of the HHS Secretary and create a strategic framework to guide research activities. At the same time, ARRA also mandated the Institute of Medicine (IOM) to create its own list of recommended research areas to be given priority funding.
For starters, the council defined CER as follows: "Comparative effectiveness research is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions. The purpose of this research is to inform patients, providers and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations. Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, behavioral change strategies and delivery system interventions. This research necessitates the development, expansion and use of a variety of data sources and methods to assess comparative effectiveness."
The council’s recommendations also grouped CER activities and capital investments into four major categories:
Many of the ARRA-funded CER initiatives are expected to encompass more than one category.
So where does improving minority health fit into all this? In a June 2009 report to the president and Congress, the council stressed the importance of addressing the needs of priority populations and subgroups that are often underrepresented in medical research, such as racial and ethnic minorities. The report notes that "CER will be an important tool to inform decisions for these populations and reduce health disparities."
"We need to better understand the causes of disparities, because this can lead to better treatment and better health outcomes for minorities," says Deborah Parham Hopson, PhD, RN, FAAN, associate administrator of the Health Resources and Services Administration (HRSA)’s HIV/AIDS Bureau, and the only nurse serving on the CER council. "Comparative effectiveness research will help identify treatments that work best for ethnic and racial minority populations in specific situations."
That same month, the IOM published its list of 100 recommended initial priority areas for CER. Nearly one-third of the primary research priorities address minority health disparities, such as "comparing the effectiveness of various strategies...to prevent obesity, hypertension, diabetes and heart disease in at-risk populations such as the urban poor and American Indians."
"There are several priority topics outlined in the IOM report that may not mention racial and ethnic health disparities [directly], but the topic relates to these populations," says Hopson. For example, one priority area is "to compare the effectiveness of dissemination and translation techniques" to facilitate the use of CER by patients and clinicians. "When you talk about translation techniques, [you’re usually talking about making health information linguistically accessible to patients] who speak a language other than English, [and many of those patients are from racial or ethnic minority populations]," she explains.
Although each federal agency has its own timeline for awarding its Recovery Act-funded comparative effectiveness research grants, all of the research is expected to begin in fiscal year 2010. Most of the grants are for a two-year period.
The NIH finished awarding its grants last September, as part of its new Challenge Grants in Health and Science Research initiative. Of the 69 CER studies funded by the grants, five directly address minority health disparities and many others focus on conditions that disproportionately affect Americans of color, including HIV/AIDS, cardiovascular disease, diabetes, cancer and asthma.
AHRQ is expected to award its Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) grants and Innovative Adaptation and Dissemination of AHRQ Comparative Effectiveness Research Products (iADAPT) grants in mid-April 2010, with the research studies expected to begin in August.
For the CHOICE grants, the agency will award a total of $100 million to fund an anticipated 10 studies. While AHRQ is using the council’s definition of CER, it has added that the medical interventions under consideration can be prognostic, preventive, diagnostic, therapeutic or palliative. The agency is especially interested in studies that include underrepresented and AHRQ priority populations—e.g., minorities, women, and rural, inner city and low-income populations—as well as projects that focus on the 14 priority conditions previously identified by Medicare, Medicaid and the federal Children’s Health Insurance Program (CHIP).
AHRQ is asking researchers to propose novel or alternative study designs that emphasize prospective data collection, as appropriate, says Lia Hotchkiss, MPH, director of the agency’s CER Portfolio. This is especially important for studies in which randomized controlled trials may not be feasible or timely, or would raise ethical concerns that are difficult to address.
Martinez applauds AHRQ’s interest in innovative approaches to research, such as community-based participatory research (CBPR). "We have to actively engage [people] in the community, not just health professionals," she says. "I am seeing a growing number of participatory types of projects."
AHRQ is also expected to award a total of $29.5 million in iADAPT grants to support an anticipated 20 to 25 projects. Unlike the clinically focused CHOICE grants, the iADAPT grants focus more on the dissemination of information gained from CER studies. Their purpose is to help increase the use, implementation and impact of CER by customizing or adapting the content and/or delivery mechanism(s) of AHRQ’s already published CER reviews and patient guides (available from the agency’s Effective Health Care Program Web site) for difficult-to-reach populations. This includes underserved racial and ethnic minority populations, immigrants, patients with limited English proficiency, patients with limited education and/or low health literacy, uninsured or underinsured patients, and other populations that may have limited contact with the health care system and with traditional sources of health information.
Basically, AHRQ wants to determine where and how these populations get their health care information and target those delivery models, Hotchkiss explains. For example, do they use resources such as neighborhood, community or faith-based organizations?
Comparative effectiveness research has the potential to reduce racial and ethnic health disparities in a variety of ways. For one thing, it will improve inclusion criteria in clinical studies by targeting minority populations for participation, says Christina Esperat, PhD, RN, FAAN, professor and associate dean for research and clinical services at Texas Tech University Health Sciences Center’s Anita Thigpen Perry School of Nursing in Lubbock.
"You will see a lot more recruiting and retention of minorities in clinical trials, making data derived from such research projects more credible," she notes.
CER studies can also help determine which treatment options work best for patients from specific populations and subpopulations. And because patients of color are more likely than whites to have multiple chronic illnesses, CER can examine how one intervention for a certain chronic condition can affect patients who have additional illnesses.
"The CER agenda that is being put forward looks beyond what works for the masses to look at what works for those who are most affected by [particular] conditions," says Villarruel, who is also president of the National Coalition of Ethnic Minority Nurse Associations (NCEMNA).
In addition to evaluating the effectiveness of medical treatments, such as drugs and surgical procedures, CER studies can also compare behavioral change interventions and health care delivery systems. All three of these areas play an important role in improving minority health outcomes.
"Simply knowing that a medication works effectively in elderly African American diabetic patients is not enough," Hopson explains. "We will only succeed in improving outcomes if we understand how to deliver this medication reliably and consistently to patients in the communities. What works and how to deliver the care most effectively are the two questions we need to figure out for specific populations."
Improving the quality of health care in communities of color is extremely complex because it is affected by numerous biological, physiological, social and cultural variables, Esperat says. All of these factors must be taken into consideration when determining the effectiveness of interventions.
For example, Martinez has submitted a grant proposal to the NIH for a CBPR study that would compare three diabetes self-management education programs targeting Mexican Americans in El Paso County. All three programs offer similar services, but there is a key difference in how, and by whom, those services are provided.
"Is the hospital-based program more effective because it uses certified diabetes educators or are the two community-based programs that use promotoros (lay health care workers from within the community) more effective because the Hispanic population is more comfortable seeking services from them?" That’s the question Martinez hopes her research will answer. "Comparative effectiveness research will be able to look at the range of issues and key factors that influence minority populations to access and use these types of services," she says. "And that will help determine the most effective interventions."
While many minority nurse researchers are encouraged by the fact that the government is not just talking about using CER to improve minority health outcomes but putting real money behind it, others are more skeptical. Josefina Lujan, PhD, RN, regional dean at the Anita Thigpen Perry School of Nursing, acknowledges that a significant amount of federal CER money is being invested in health disparities research and it is well-intentioned—but she feels it’s not enough.
"The reality is that we have been asked to do this for the past ten years and little progress has been made," she argues. "If you look at the total number of grants that were awarded, the amount of money that was actually awarded to [health disparities] projects is very small."
Lujan also contends that there has not been enough patient-outcome-driven research that is community participative in nature. "Comparative effectiveness research assumes that all the interventions are on the table. I submit to you that we still need to develop more interventions."
Creating and mentoring a cadre of minority nurse scientists who can conduct participatory research in communities of color would make CER more valuable, she says. "We have to nurture and grow our own diversity researchers who have grassroots knowledge of the community and can engage the community more in participative research so that we can identify behavioral [change] delivery models that will work. Then and only then will we be able to truly have a fair opportunity to do comparative effectiveness research."
Esperat, on the other hand, is optimistic that CER will help researchers make headway in the fight against health disparities. "It will lead us not just to quality, cost-effective care, but care that is individualized, based on a person’s culture and other physiological and social factors," she says.
Adds Villarruel, "Nurse researchers, clinicians and community mentors all have a role in leading this agenda—not only in terms of what is studied but how it is studied, and eventually in [making sure patients receive the treatments that best meet their needs]."