Engaging community residents to obtain their feedback in conducting clinical research, and including them as leaders in implementing applicable health advances is crucial for success and sustaining large center awards.
Engaging community residents to obtain their feedback in conducting clinical research, and including them as leaders in implementing applicable health advances is crucial for success and sustaining large center awards.
Forty-four adult men and women participated in one of four focus groups. Two groups each (one African American and one Caucasian) were conducted in Baton Rouge and in New Orleans.
In an effort to determine the knowledge, attitudes, and beliefs Louisiana residents have about the Louisiana Clinical and Translational Science (LA CaTS) Center concept, four main themes emerged from focus group participants concerning the state's research institutions, and what it means to have these institutions operating under one umbrella to improve the quality of health of its people: (1) academic/research institutions of the State are uniformly widely recognized and held in high regard; (2) increasing awareness of clinical research is a necessity; (3) establishing the LA CaTS Center is an excellent idea; and (4) effective communication including delivery style is crucial to partnerships and especially to the community.
Focus group discussions can provide insight into community residents’ perceptions, beliefs, motivations, and patterns of behavior for strategically planning for large center awards.
Since the doubling of the National Institutes of Health (NIH) budget in the new millennium, along with combined rapid acceleration in biomedical research discoveries, the urgency of translating laboratory results and proven medical advances into tangible health-related outcomes has increased. Currently, 60 funded academic health centers that competed successfully for Clinical and Translational Science Awards (CTSAs) agreed to work as a consortium and in cooperation with the NIH to improve the translation process by training the next generation of researchers to work in interdisciplinary teams, develop public–private partnerships in the movement of basic discovery to preclinical and clinical studies and trials, improve clinical research management, and engage with communities to ensure their involvement in shaping research questions and in implementing research results.
A traditional investigator-driven approach to research may fail to adequately engage community residents, clinicians, and other key stakeholders within academia and healthcare partnerships. However, a community-based participatory research (CBPR) model is a viable alternative to traditional research concepts because it emphasizes equitable partnerships with the community. In addition, CBPR promotes the sharing of power, knowledge, and resources between academic/research partners and community residents in all stages of research.[4, 5]
A key component activity of the recently funded Louisiana Clinical and Translational Science (LA CaTS) Center is engaging the community in the research process from inception. LA CaTS is built around four primary collaborating institutions—Pennington Biomedical Research Center (Lead), Louisiana State University (LSU) Health Science Center—New Orleans, Tulane Health Sciences Center, and LSU Health Care Services Division. Other strong collaborators include research partners: LSU Health Science Center—Shreveport, Xavier University of Louisiana, Research Institute for Children at Children's Hospital, and LSU A&M College. Together, and in keeping with the NIH mission, these institutions collaboratively sought to develop a unified research infrastructure with an overall theme of prevention, healthcare, and research of chronic diseases in underserved residents across the state of Louisiana. Therefore, the ability to engage community residents and include their feedback during the planning process is a critical component in strengthening the Center. The purpose of this qualitative study was to determine if typical residents of Louisiana are knowledgeable about the state's academic/research institutions; what their perceptions towards these institutions are; and what the concept of forming an overarching coalition of these institutions under the LA CaTS umbrella means to them.
The focus group methodology was used for this qualitative study. Focus groups are a qualitative research method that can be applied to health-related research to provide an in-depth understanding of social and behavioral attitudes of individuals. Focus group discussions are most useful when used with a homogeneous sample that contains 4–12 people. Focus groups also allow for a more in-depth exploration into participants’ experiences and explanation of certain beliefs and traditions. The focus group methodology has been used extensively in the literature to capture ideas about perceptions of specific illnesses, various aspects of lifestyle interventions, and participation in clinical research trials.[6-8]
African American and Caucasian men and women aged 25 years or older, willing to provide written informed consent, able to speak and read English, and a resident of Baton Rouge or New Orleans, Louisiana were eligible to participate in one of four focus groups. Individuals with a cognitive impairment that would interfere with participation in a group discussion, unable or unwilling to provide informed consent, and unwilling to be audio and videotaped were not eligible.
Participants were recruited by word of mouth, personal letters and telephone calls, and through various service organizations. Written informed consent was obtained when participants arrived and prior to the start of each focus group discussion. Light refreshments were provided to all participants, and each participant received a $30 Wal-Mart gift card. The study protocol, procedures, and consent form were reviewed and approved by the Pennington Biomedical Research Center's Institutional Review Board.
Forty-four adult men and women participated in one of four focus groups. Two groups each (one African American and one Caucasian) were conducted in Baton Rouge and in New Orleans. Two sessions were held in Baton Rouge over a 2-day period lasting for approximately 120 minutes during the early weekday evening hours or Saturday morning. Both New Orleans groups were held on Friday including a morning, and an afternoon session. Each participant attended only one focus group discussion held at the Pennington Biomedical Research Center, or health education facility in New Orleans, Louisiana. The Baton Rouge groups consisted of 6 men and 6 women in one group, and 5 men and 5 women in the other group; while the New Orleans groups consisted of 4 men and 5 women in one group, and 3 men and 10 women in the other group. All focus groups were moderated by BMK, and WPG served as the note keeper for each group.
After welcoming, discussing purpose, ground rules, and brief introductions, the moderator opened the focus groups by asking participants to comment on the state's research institutions using four broad categories: (1) knowledge, attitudes and beliefs about the partner institutions [Pennington Biomedical Research Center, Tulane University Health Sciences Center, LSU Health Sciences Center—New Orleans, and Xavier University of Louisiana], (2) knowledge, attitudes and beliefs about clinical research, (3) the institutions we told you about in Baton Rouge and New Orleans are developing a proposal to establish the LA CaTS, and (4) the LA CaTS center has planned to establish key functions to improve the quality of clinical research; each category with specific questions as outlined in (Table 1). At the conclusion of the focus group discussions, the moderator posed a final question—“Is there anything that we have not mentioned that you believe will help us improve health through collaboratively conducting research?”
|Knowledge, attitudes, and beliefs about LA CaTS institutions|
|Pennington Biomedical Research Center, Tulane University Health Sciences Center, LSU Health Sciences Center, and Xavier University are the LA CaTS institutions?|
|Have you heard of them?|
|What is your relationship with them?|
|What is your opinion about them?|
|Can you describe them in one word?|
|Knowledge, attitudes, and beliefs about clinical research|
|Have you ever volunteered for a clinical research study? Why or why not?|
|What is your opinion of clinical research?|
|How do you think the community feels about clinical research?|
|Are you aware of the benefits and risks of participating in clinical research?|
|How do you think your risks are minimized and your rights protected in clinical research?|
|The LA CaTS institutions goal is to improve health by conducting research in the best possible manner and to train young doctors in how to conduct excellent research|
|What is your response to this idea?|
|What do you think of the name LA CaTS, and the logo?|
|Do you think the computer (Internet/Website) approach is a good way to communicate with the public?|
|How do you feel about a community calendar that would inform you of what's going on in your area?|
|The LA CaTS Center has planned to establish key functions to improve the quality of clinical research. These key functions are the scientific priorities|
|What are your priorities for LA CaTS to accomplish?|
|What do you think of LA CaTS developing communication tools by an expert in targeting audiences of low health literacy to assist people who have a hard time understanding technical instructions, like medication doses and complicated treatment regimens?|
|What are your recommendations to make LA CaTS a success?|
|Can you think of any other ways LA CaTS can establish and maintain communication with the community?|
Demographic information was collected from the “Perceptions of Participation in Clinical Research” survey instrument and included age, ethnicity, gender, education, employment, annual household income, marital status, and health status. In addition to the standard audio recording used in most focus groups, all sessions were videotaped for accuracy and to allow review of non-verbal communications.[10, 11] Prior to conducting the focus group discussions; the investigative team articulated the questioning route. The questioning route was refined by conducting a pilot focus group composed of staff members at the Pennington Biomedical Research Center demographically similar to the targeted population to assure this process would capture the responses intended.
Audio and videotapes of the focus group sessions were transcribed and reviewed independently by the moderator and note keeper following a standardized methodology as established in previous qualitative research studies.[12, 13] Each reviewer identified comments that were perceived to represent specific perceptions conveyed by focus group participants pertaining to the LA CaTS Center. These comments were coded as knowledge, attitudes, and beliefs when agreed upon by at least one other participant in the group and repeated independently in another focus group session. Once the primary set of perceptions was agreed upon through an iterative process, they were grouped together based on unifying concepts and the responses were categorized into common observations. The moderator and medical investigator DHR reviewed the observational groupings to ensure consistency and relevance and proposed unifying themes for each grouping. All investigators reached a consensus on the final set of themes.
Selected demographic characteristics of the 44 focus group participants (22 each in Baton Rouge and New Orleans) are shown in Table 2. Overall, 50% of participants were in the 46–65 year age range, and 57% were African Americans. Men and women were evenly distributed in Baton Rouge, and overall men constituted 41% of the groups. Education varied widely with 34% of all participants having postgraduate degrees, and those having high school and college degrees were evenly distributed across Baton Rouge and New Orleans. More than half of all participants were employed full-time. Thirty-four percent of all participants’ annual household incomes were $70,000 or more; while those in the $30–$39,999 range were comparable in both groups and overall. Fifty percent or more of all participants were married, and 45% in Baton Rouge and in New Orleans reported being in very good or good health, respectively.
|Demographic||Baton Rouge (n = 22)||New Orleans (n = 22)||Total (n = 44)|
|1–3 years college||13||36||25|
|Annual incomea (%)|
|Marital status (%)|
|Health status (%)|
Utilizing the principle CBPR is built upon, the community was engaged from the very beginning of the research planning process ultimately to determine the knowledge, attitudes, and beliefs Louisiana residents have about the LA CaTS Center concept. As a result, four main themes emerged from focus group participants concerning the perceptions they have about Louisiana's academic/research institutions, and what it means to have these institutions operating under one umbrella to improve the quality of health of its people. The four themes listed in Table 3 are: (1) academic/research institutions of the State are uniformly widely recognized and held in high regard, (2) increasing awareness of clinical research is a necessity, (3) establishing the LA CaTS Center is an excellent idea, and (4) effective communication including delivery style is crucial within the partnerships and especially within the community. These themes are further expounded below to include focus group participant's perception on each.
Academic/Research institutions of the State are uniformly widely recognized and held in high regard
The majority of focus group participants in both Baton Rouge and New Orleans were familiar with or at least had heard about the research institutions in the state. Some participants had graduated from the institutions or had relatives who graduated, while others participated in clinical research trials, and some were previously employed at these institutions. Some participants described the institutions as “very kind and caring; very professional and trust what they put together; all are very reputable.” When asked to describe the institutions in one word; participants stated; “positive, excellent, outstanding, awesome, and simply marvelous.” Ultimately, the consensus of focus group participants was that no one institution should dominate another, but rather they should act together in unity. Therefore, collaboration among partner institutions was seen not only as desirable, but should be expanded.
Increasing awareness of clinical research is a necessity
Lack of education and understanding about the importance of clinical research to possibly offset many chronic diseases faced by community residents was seen as a barrier to participation in clinical trials. For example, both Baton Rouge and New Orleans participants repeatedly stated; “most people hear negative things about clinical trials but not the positive things; clinical trial is scary and too broad and has negative connotation; study is clear, simple, and practical; it's confusing when participants are not sure if they are taking a placebo or medication; and African Americans are apprehensive about research due to past abusive clinical research (Tuskegee study).” It was generally agreed by a substantial number of focus group participants that the community is not always aware of clinical research trials being conducted; and especially of how a trial progresses. Equally as important for those who had completed a trial, were having the results readily available to the public and written in lay terminology.
Establishing the LA CaTS is an excellent idea
Participants across all focus groups were perceived as being eager and excited about the excellence in research that could result from the partnership of academic/research institutions collaborating under one umbrella. Ultimately, these partnerships may allow the State of Louisiana to become well known and fully recognized across the nation thus, serving as a beacon in the community for the health of its residents. Participants cited “there's a fundamental misunderstanding of the institutions and clinical research such that Louisiana is considered not healthy.” Some participants further stated “North Carolina research center is named “Research Triangle,” everyone knows about it; everyone knows about MD Anderson.” The general consensus of all focus group participants was that LA CaTS should represent who Louisiana really is, and a larger health and well-being focus was preferred by a large number of participants in both Baton Rouge and New Orleans over a more basic clinical translational site. The concept of collaborating partnerships was additionally perceived by participants as a means to create more jobs and training opportunities for Louisiana physicians, nurses, medical staff, and residents. Furthermore, the integration of both private and public research institutions was perceived as valuable, especially if the LA CaTS center was housed on neutral ground and the institutions were showcased as one entity.
Effective communication including delivery style is crucial within the partnerships and especially within the community
Generally, Caucasian focus group participants responded similarly to African Americans for most discussion topics. In fact, for some questions, there were no differences in responses. For example, the majority of focus group participants stated that “although the Internet is widely used and available, the poor and underserved populations may not have access to it for various reasons, including cost and transportation.” Participants across all focus groups expressed concern for the quality and level of communication: “Staff (experts) must be compassionate; respectful, and not talk down to patients because disease has no boundaries; and should use people from the community who talk the same language and on the same level.” To establish and maintain communications within the community, participants responded “it depends on the targeted population's culture for example, black radio is one way of reaching African Americans as well as their pastors in church, TV, word of mouth; Caucasians and others may respond more to advertisements in newspaper ads, newsletters; and for the general population, hold community health fairs to share research findings on an ongoing basis; text messages to children and adolescents to educate them about LA CaTS so they can educate parents, provide public service announcements, flyers, and advertise on buses and park benches.” Effective communication as well as having an effective communicator was viewed as being very important to focus group participants.
|1.||Academic/Research institutions of the State are uniformly widely recognized and held in high regard.|
|2.||Increasing awareness of clinical research is a necessity.|
|3.||Establishing the Louisiana Clinical and Translational Science Center (LA CaTS) is an excellent idea.|
|4.||Effective communication including delivery style is crucial within the partnerships and especially within the community.|
Overall, Louisiana residents taking part in this qualitative study were knowledgeable about the academic/research institutions in the state and expressed that the LACaTS center should be one of excellence and something Louisiana can be proud of. The perceived sentiment of focus group participants was that excellence and professionalism must be exemplified in every way such that all staff and affiliates of the LACaTS center must have a great attitude and cannot talk down to educated or uneducated people especially when emotions are aroused. Researchers must seek to combine a dynamic team of people with talents and ethnic experiences who can inform research design and operations to benefit diverse populations. The key is image, and the overarching perceptions of the majority of these focus group participants.
Increasing awareness of clinical trials was perceived by focus group participants as a necessity, and an issue that CTSAs and similar research infrastructure projects are required to address. Research has shown generally that people are primarily interested in being educated about research and lack of information was a primary reason for not participating in clinical trials.[16, 17] Those that are aware of clinical research trials are skeptical, and whether or not participants were African American or Caucasian, the Tuskegee study was yet a hot topic and fresh on their minds due to past abusive clinical research, leaving many still fearful. Additionally, a perceived concern of most focus group participants was that once a clinical research study is completed, the community must see results with the findings written in lay terminology and copies placed in outlets frequented by community residents of the State.
Establishing the LACaTS center was perceived by focus group participants as an excellent idea and something to be proud of for the state of Louisiana, especially since the academic/research institutions are widely recognized and held in high regard. One major concern shared by many focus group participants was the location of the LA CaTS center. The consensus by some focus group participants in New Orleans and alluded to by others in Baton Rouge was that a new center should be built on neutral ground with community involvement and with the community as partners, because bridging the regional divides separating these institutions is crucial. Together, the academic/research partners can make a difference through their collaborative efforts, which is far reaching for the communities locally, statewide, and for national exposure.
Acting independently or as regional consortia, several CTSA sites have developed new or improved partnerships with their communities predicated on the development of trust, ongoing involvement, and bidirectional control of the agenda for establishment of priorities, clinical investigation, and communication about research findings and best practices. The ultimate aim is to mobilize communities to identify their own health needs and the role of academic/research partners in framing a response to those needs; work with academic/research partners on the design of clinical trials to develop evidence-based practices; act as leaders in communicating about health research and the implementation of new methods of managing health issues; and work with academic/research partners to evaluate existing practices.
Effective communication including delivery style within the partnerships and especially within the community was viewed as crucial to these focus group participants. It was perceived that communication should be based on the culture of a group such that, African Americans listen to black radio, TV, word of mouth, and their pastors at church to obtain information, whereas Caucasians may be more prone to use printed materials such as newspapers and newsletters. Ultimately, the consensus of focus group participants was that people of the community should be sought based on their cultural perspective. Research has shown that a perceived lack of cultural understanding among providers, and a lack of interpretation limit access to healthcare services.
The limitations of this study are based primarily on the population of the focus groups. The focus group discussions were designed to be influenced by group dynamics and facilitation and it is possible that shyer participants may have been inhibited by the more vocal participants and consequently did not share their thoughts or opinions. Focus group discussions also rely on participant ability to accurately report their experiences and may be subject to human error or perspective. Because qualitative data collection can be subjective, they may be subject to human error and perception. Nevertheless, this qualitative study provided background information for strategically planning for the LA CaTS center and this mechanism may be useful on an ongoing basis for evaluating key component activities. More importantly, inclusion of qualitative data specifically from focus group discussions can provide insight into individual and community perceptions, beliefs, motivations and patterns of behavior as a prelude for center awards of this magnitude.
The authors would like to thank Dr. Leonard Jack and Ms. Patrice Rose for participating in early discussions about this qualitative work. Special thanks to all focus group participants in Baton Rouge and in New Orleans for completing this study.
Supported in part by 1 U54 GM104940 from the National Institute of General Medical Sciences of the National Institutes of Health, which funds the LA CaTS.