This interview is the fifth in a series between CFAH President and Founder Jessie Gruman and patient and consumer group leaders about their experiences with and attitudes toward comparative effectiveness research (CER).
Gruman: Tell me about yourself and your organization.
Venus Ginés: I founded Dia de la Mujer Latina (DML), translated as Day of the Latin American Woman, to raise awareness of risks and preventive care of breast and cervical cancer 15 years ago. We created a health fiesta, a cultural intervention, in response to the disparities of care I experienced after my diagnosis with breast cancer in 1992 and my stepsister's untimely death to cervical cancer in 1994. We represent the Latino community in the U.S. and Latin America. Much of our work involves training Promotores, community health workers and patient navigators.
We educate Latinos about health services but also help them navigate post cancer diagnoses. DML is a full-circle MINE program: We Motivate the community for screening, Inform them about available resources, Navigate with them throughout their follow up care, and Empower families and communities to think about disease prevention and health.
Gruman: From your perspective, what constitutes comparative effectiveness research (CER)?
Venus Ginés: CER is when you have two different therapies and you look at both and evaluate which is the best for a particular patient, depending on the current research. You hope that with enough research you would fine-tune the best drug therapy or treatment so at the end of the research the doctor would have the best information about what are the best treatment options for their patients. Question is, do doctors have enough time to read the CER results?
Gruman: Where does CER fit in the effort to improve the effectiveness of health care?
Venus Ginés: As a patient advocate, it's always good to know what the best treatment options are for our patients. As we continue to see so much fraud in research, there is mistrust about validity of data and the research itself relative to particular at-risk communities. Unfortunately, patients don't have access to the research, and some are getting misleading information on treatment options. Many doctors don't have much time to talk with their patients and some tend to follow their peers' recommendations rather than read the latest research. Moreover, there are critical points ' ethical standards, sample size, inclusion of races and ethnicities ' which are often overlooked.
Gruman: Tell me how Dia de la Mujer Latina views the relationship between CER and patient-centered outcomes research (PCOR).
Venus Ginés: The only difference I see is that PCOR incorporates patient perspectives into research design. We conducted some focus groups with a project called EDICT (Eliminating Disparities in Clinical Trials) with African American patients in Harlem Hospital NYC, the American Indian in Arizona, the Latino/Hispanics in Texas and Puerto Rico, the Native Hawaiians in Hawaii, the rural community in West Virginia and the Asian American/Pacific Islanders in San Francisco. ' Many minority groups around the country are underrepresented in clinical trials because of the lack of information and communication. At the end of the project, we found that mistrust is a huge concern for all groups.
We believe that patient navigators/Promotores/Community Health Workers need to be trained and included in protocol design, because including the patient perspective is important.
We don't have a clue as to how these research projects are currently being conducted. It seems to be that white patients have more time to participate in research studies, but PCOR needs to set a standard that includes locating and incorporating representatives of minority groups to get their views and input as part of the research application.
Gruman: Can you give me an example of how your constituents have been affected by CER?
Venus Ginés: Folks like me rarely find out about results of research studies. That is why I believe that many of our Latinos are mistrustful of CER. There is really no accountability once the funding has been provided. As advocates, we need to know what works with patients like us ' people in our communities at risk. We are clueless. Research results are not disseminated to us.
Gruman: How do you see the increased attention to CER affecting the care your constituents will receive in the future?'
Venus Ginés: I don't know if this is just a phase or not, but CER is fashionable now. I'm not sure whether it will be long-term. I haven't felt a commitment to conduct research on Latinos or other racial or ethnical minorities, so it is something I don't have a lot of faith in either. Another issue is that the funding mostly goes to academic institutions that rarely establish a relationship with the affected community at risk. So these folks will be marginalized once again or misrepresented, which is something that many of us advocates fear ' the research that comes up with numbers that are not inclusive of our vulnerable and underrepresented populations. I don't really know if PCOR will be different, but I'm more hopeful with PCOR than CER, especially because of the patient inclusion part.
When I look at my own life, I had two different serious diagnoses, so I'm concerned about the validity of the comparative research. If it is not reflective of my community, then the mistrust will always be present.
Gruman: Some professionals believe that patients are opposed to comparative effectiveness research. Do you think this is accurate?
Venus Ginés: Many underrepresented communities and advocates don't know a whole lot about CER so it is difficult to assume that the statement is accurate. Many patients don't understand the full definition and purpose of comparative effectiveness research because it hasn't been promoted as well as it should be. Doctors don't talk about it in the 8 minutes they spend with you. It all goes back to mistrust, how is CER presented, what's and who's behind the research? We don't know how applicable the research is if it does not include all people.
Gruman: What are your fears and hopes for CER?
Venus Ginés: One size doesn't fit all. Therapies are developed on white middle class people for white middle class folks who don't have barriers and issues, such as lack of access to care, dangerous neighborhoods, history of medical abuse, no transportation, treatments limited by ability to pay or by Medicaid and other issues that affect the effectiveness of a treatment for people facing different health threats. My hope is that CER will include Promotores/Community Health Workers as Clinical Trial Navigators who will work with patients of all races and ethnicities and build trust.
Research has to be based more on our experience so therapies will be effective for us.