Abstract
Background
Underrepresentation of diverse populations in clinical trials poses challenges to equity and external validity in health care research. To successfully recruit underrepresented participants in pragmatic clinical trials, researchers must understand the perspectives and needs of individuals from diverse backgrounds who participate in research.
Objective
The purpose of this qualitative study was to gain an understanding of the needs and perspectives of participants of the OPTIMUM trial -- a pragmatic trial evaluating mindfulness-based stress reduction for chronic low back pain.
Methods
This qualitative study employed focus groups with participants from 3 clinical sites: Boston Medical Center, the University of North Carolina at Chapel Hill, and the University of Pittsburgh. Focus group discussions centered on participants’ experiences, barriers, and facilitators to engagement in the OPTIMUM trial. Data were analyzed using thematic content analysis and the rapid qualitative analysis method, Lightning Reports, for real-time feedback integration into the trial process.
Results
Six focus groups were conducted with 46 participants, of whom 39.1% were first-time research participants and 56.5% identified as Black or African American. Qualitative analysis identified five key themes:1) The importance of providers in the recruitment of cLBP patients, (2) Motivators to participate and stay engaged in clinical research, (3) Participant lack of understanding of randomized control trials (RCTs) and general research processes, (4) Desire for social connection and community-building among participants, and (5) the Positive impact of regular study staff interaction.
Conclusion
Equity in RCTs requires intentional strategies to address barriers to participation and engagement faced by historically underrepresented populations. Engaging health care providers in recruitment, fostering positive interactions with study staff, and creating opportunities for social connection can improve recruitment, retention, and engagement. Incorporating community-engaged research methods and real-time feedback mechanisms can further support inclusivity and equity in pragmatic clinical trials.
Keywords
Introduction
Health People 2030 defines health equity as valuing everyone equally with focused and ongoing societal efforts to address avoidable inequalities, historical and contemporary injustices, and the elimination of health and health care disparities. 1 Centering participant experiences in research is essential to advancing health equity. Qualitative studies have highlighted difficulty with recruitment and retention of research participants in clinical trials, particularly those living in rural, medically underserved areas, people who identify as men, and those from racially/ethnically minoritized groups.2-4 Issues of historical medical harm and racism, lack of adequate informed consent, and other unethical research practices, suggest that trust is a significant barrier to recruitment of underrepresented groups in clinical research.5-7 For example, historical events such as eugenics movements, acts of violence and experimentation by physicians for medical research, and discriminatory social policies have further marginalized those from historically underrepresented groups from engaging in clinical research.8-11 Challenges in recruitment, retention, and engagement of diverse populations in research have significant implications for generalizability and overall effectiveness of medical interventions and treatments. 12
Historically, there has been more emphasis on internal validity than external validity in clinical research, and thus less emphasis on recruitment of individuals that reflect the demographics of the overall population, and who have diverse perspectives and needs. 13 Pragmatic clinical trials prioritize external validity and seek to include participants who are representative of typical clinical populations. 14 To successfully recruit underrepresented participants in pragmatic clinical trials, researchers must understand the perspectives and needs of individuals from diverse backgrounds who participate in research. Further, although chronic pain is highly prevalent among rural, medically underserved and racially/ethnically minoritized patients, these groups have also been historically underrepresented in chronic pain resarch.15,16 Achieving health equity includes addressing and removing barriers to participating in pragmatic research. It is therefore imperative to understand what barriers underrepresented patients face to participate in pragmatic clinical trials. The purpose of this study was to gain a better understanding of the needs and perspectives of OPTIMUM trial participants to increase recruitment, retention, and engagement in clinical research studies for chronic pain.
Methods
This qualitative study was completed as part of a stakeholder engagement supplement of the OPTIMUM trial, which aimed to improve the retention, engagement, and recruitment of chronic Low Back Pain (cLBP) patients. 17 OPTIMUM, which stands for (Optimizing Pain Treatment In Medical settings Using Mindfulness), is a pragmatic clinical trial that compares combined usual care plus mindfulness-based stress reduction (MBSR) delivered via telehealth to usual care alone for the treatment of chronic Low Back Pain. The study aimed to recruit and randomize 225 participants to the mindfulness group and 225 participants to the usual care, or control group, and collected data monthly over 12 months. At the end of the 12 months, individuals of the usual care group were offered free mindfulness sessions. Participants were recruited using flyers and digital advertisements in primary care clinics, and through provider referrals. OPTIMUM was conducted across 3 sites: Boston Medical Center, the largest safety net hospital in New England, federally qualified health centers in North Carolina, and a large academic health center in Pittsburgh, Pennsylvania. These sites serve large numbers of historically underrepresented patient populations. This study was conducted in accordance with the ethical standards of the University of Pittsburgh Institutional Review Board (Approval Number: 20110378).
Safety-net hospitals are comprised of hospitals and other providers that organize and deliver health care to patients with no insurance or with Medicaid. 18 Safety-net hospitals have historically provided services to medically and socially vulnerable populations, including those from racially/ethnically minoritized groups and those from low socio-economic backgrounds. 19 Federally Qualified Health Centers (FQHCs) were designed to serve medically underserved areas and populations and establish a set of health care services for Medicaid customers, offering core services or other ambulatory services. 20 OPTIMUM participants recruited from Boston Medical Center and the University of North Carolina at Chapel Hill demographically reflect the characteristics of individuals who utilize services at safety-net hospitals and FQHCs. Participants recruited from Pittsburgh included individuals from various racial and ethnic backgrounds, gender identities, and socioeconomic backgrounds.
Participants were eligible for OPTIMUM if they met the following criteria: (1) were at least 18 years of age, (2) had chronic low back pain, which is pain that persists for at least 3-month and has resulted in pain on at least half the days in the past 6 months, (3) had a score of greater than 3 on the PEG, (4) were willing and able to provide telephone informed consent, and (5) able to speak and read English as all materials and measures are in English. In addition to the main trial inclusion criteria, focus group participants had to be currently enrolled in the study at the time of the scheduled focus group.
A semi-structured interview guide was developed by the stakeholder engagement research team through a collaborative and iterative process and initially included questions that sought to understand participants’ general experience with research, experience participating in OPTIMUM, and feedback to improve the study and better engage study participants in real time. The stakeholder engagement team met several times over the course of a few weeks to collaborate as a group to develop questions. The team consisted of the lead virtual focus group facilitator, two clinicians, research coordinators from the Boston, and North Carolina sites, and the principal investigator of the main trial. The team developed a “menu” of questions that focused on topics related to participants’ experiences participating in research processes, their experience in OPTIMUM, and their feedback on keeping participants engaged in the study. As focus groups were conducted some interview questions were included a priori, focusing on understanding the needs and perspectives of participants regarding their recruitment, retention, and engagement during the OPTIMUM trial.
Across all sites, six focus groups were conducted via Zoom teleconference, 3 groups of OPTIMUM intervention participants and 3 groups of OPTIMUM control participants. All focus groups were conducted by an experienced focus group facilitator/qualitative researcher from the OPTIMUM team. The lead group facilitator had several years of experience conducting semi-structured interviews and focus groups and did not have previous contact with any of the participants prior to the focus groups. The co-facilitator had developed relationships with focus group participants from the North Carolina site but had not had previous contact with any participants from the Boston or Pittsburgh sites. Both group facilitators were from the North Carolina site, identified as women, had broader interests in the inclusion of historically underrepresented populations in clinical research, and were native English speakers with professional training in public health. Research team members from the other clinical sites were invited to assist with facilitating focus groups, but due to limited personnel and availability, were unable to participate. Focus group data was analyzed by research team members from Boston and North Carolina.
Focus group participants were selected by first evaluating the reported demographic factors of all potential participants. A random number generator was then used to select 10 individuals, followed by an assessment to ensure that the group reflected the diversity of the study population. Participants were assigned a number attached to their participant ID (eg, Participant 123 would be given the number “1”) and the generator would randomly select a number. The research team would then contact the participant to invite them to participate and if a selected participant was unavailable, another demographically similar participant was contacted to maintain group diversity. This participant was identified using the same random number generator method. This process continued until we reached our desired sample characteristics. Potential participants were not advised that the research team was seeking a demographically representative sample of focus group participants based on the demographic makeup of OPTIMUM main trial participants while being recruited for focus groups.
Focus Groups were audio recorded online using a HIPAA-compliant account on Zoom, a video conferencing platform, and then transcribed by an encrypted transcription service, Datagain. Focus group participants were also given a pseudonym (eg, “UNC Control 1”) to protect confidentiality and were compensated $100 for participation. Our team used a rapid qualitative analysis method, Lightning Reports, 21 to share feedback with the research team. With this method, real time synthesis of the focus groups was collected under classifications of “what works” (Plus), “what needs change” (Delta), and “insights, ideas or recommendations” (Insights). 21 Study procedures were modified based on feedback from focus group participants. In this process, two notetakers from the research team created brief, 1-2-page reports for each focus group and then consolidated their notes into a single report. Before conducting a content analysis of the focus group transcripts, our team read each of the transcripts and the Lightning Report associated with them to familiarize ourselves with the data.
Following distribution of Lightning Reports, we conducted in-depth thematic content analysis 22 of the focus group transcripts. A codebook was developed using an iterative, line-by-line coding process. Once the codebook was agreed upon by our team, coders met as a group to code one of the intervention and control group transcripts to ensure coding consistency. The remaining transcripts were divided between 3 coders and coded individually. Coders then met to review their analysis of remaining transcripts. When differences in coding occurred, the coding team examined quotes together and worked to reach a consensus on the code(s) to include. Following coding, quotes associated with various themes were reviewed using the constant comparative method to determine similarities and differences between the way focus group participants approached each topic that was coded. 23 All data analysis was conducted using ATLAS. ti (version 23.2.1) qualitative data management software.
Results
Focus Group Participants by Site.
Demographics of Focus Group Participants Compared to Total OPTIMUM Population.
*Participants could select more than one race.
Through content analysis, five central themes regarding increasing participant diversity, retention, and engagement were identified: (1) The importance of providers in the recruitment of cLBP patients, (2) Motivators to participate and stay engaged in clinical research, (3) Participant lack of understanding of randomized control trials (RCTs) and general research processes, (4) Desire for social connection and community-building among participants, and (5) the Positive impact of regular study staff interaction.
Theme #1: The Importance of Providers in Recruitment of cLBP Patients
Participants were asked to share their thoughts about recruitment methods and how they impacted their motivation to participate in OPTIMUM. Across both the intervention and control groups, providers were pivotal to the recruitment process and the likelihood that participants enrolled in the study. Specifically, participants reported feeling more comfortable with participating in a research study if they learned about it through their provider with whom they had previously established a positive relationship with and personally gave them information about the study. One participant (Control group 2 participant 1), shared how having a clinician involved in the recruitment process made them more likely to participate in research: “I feel like your doctors know what you go through. So, it becomes fun now -- we're more likely to participate or more likely be interested, because it's coming from somebody that is looking out for us, that knows us, that we go and see often, so I feel like, the doctors telling their patients about it -- will get more people to go on the study.”
In addition to seeing providers as people who tend to look out for their patients’ best interests, an Intervention group participant discussed how trust was a major component of whether or not they would participate in a study, and that hearing about a research study from their provider made them more likely to engage in research. “...Probably get a lot more participants wanting to be a part of studies if their doctor recommended it to them versus just seeing it necessarily out. I don't trust everything I see and like [focus group participant 1] and someone else who mentioned all the emails they get about wanting to participate in stuff, and knowing that it's a trusted source like [University] or my doctor who I trust, would make me a lot more likely to say, hey, I am interested in doing that. Yeah, the trust factor is a big thing.”
Theme #2: Motivators to Participate and Stay Engaged in Clinical Research
The format of an intervention was identified as a deciding factor on whether or not a person was likely to engage in a research study. Among the study sample, the time needed to participate, and virtual offering of a study were frequently mentioned motivators for participating. One Control group participant discussed how the shift to telehealth formats in primary care settings during the COVID-19 pandemic made it easier for him to access health care as well as participate in research studies: “Basically, I think it depends on the study. And what they're – not what they're offering but how much time it would take because of, you know, daily schedules, busy life, whether I can commit to it or not. So, with COVID, it's been a lot easier because of my back issues, I don't have to travel in a lot to the office. It's done by Zoom or email, or by phone calls.”
Whether or not the format of the trial is convenient for the patient’s individual needs, especially considering the physical needs of patients dealing with chronic low back pain, was a key motivating factor for participants when deciding whether to participate in a study.
Participant responses also discussed education as a key motivating factor for participating in research. Another control group participant shared how their personal motivations to learn more about their health conditions motivated them to participate in research: “I wanted to get involved in the ones that were best suited for my conditions so I can get more education on it from clinical staff that know what they're talking about versus me googling on my own.”
Additionally, a desire to help others who may also benefit from study findings was noted as a motivator. Agreeing with the previous statement, one participant shared about their experience participating in another research study, and how wanting to help others motivated them to participate: “.... pretty much learn and according to my conditions and also to help out. Like I previously, it was long time ago they had a diabetes study, they need participants who didn't have diabetes to study to help further diabetes research. Because I have a lot of family members and friends that have diabetes. So, I just wanted to contribute and it's interesting to learn and something that's going to help in the future.”
Several other participants echoed these sentiments, sharing that some factors that steered them towards participating in OPTIMUM were education, wanting to learn more about themselves and how to manage chronic pain, and to help others.
Theme #3: Participant Lack of Understanding of Randomized Control Trials (RCTs) and General Research Processes
Another key theme involved participants’ general understanding of research processes and the significance of consistency within data collection. When asked by the focus group facilitator what could improve their experience of participating in OPTIMUM, another (Control group 1) participant shared how they felt that the questions being asked in surveys during the monthly data collection check in calls were repetitive: “It’s just a bit redundant sometimes though, a bit, you know, over and over. I think – I think it could be spiced up a little more with, you know, I don't know. Just – just the questions seem to be the same questions.”
In focus groups specific to the control group, the facilitator asked participants about their understanding of the purpose of a control group in a randomized control trial. The facilitator asked, “…do you feel like you know how much you're helping being in the control group or do you know kind of what it means to be part of the group that's not getting the mindfulness?” Participants responded with, “No.”
This response led the facilitator to briefly discuss with the participants the importance of control groups and clinical trials.
Theme #4: Desire for Social Connection and Community-Building Among Participants
Across all focus groups, participants expressed the desire for more connection and community-building with other study participants. Among intervention group participants, several participants expressed approval of the small group discussions during the intervention where participants were split into small groups to learn more about each other’s experiences with chronic pain and reflect on their practice of mindfulness. One participant shared that they would have liked more time to have small group sessions with other participants: I think the sessions where you ended up breaking out with another person were good. I understand why you break out each week with the doctor so that you can have a professional, but I think the sessions where you broke out with someone else for whatever it was three or five minutes, were actually good things. You learned about someone else and those were a nice interlude in there, because otherwise all you are is a little box on the screen, and you hear people's opinions but then you get more of a chance to know them. So that might make it better for it to continue on for a long period.
Control group participants similarly expressed their desire to develop a community and build connections with other study participants who could share their experiences of living with chronic pain. One participant shared: “I wish there was like a Facebook group or whatever where we could just talk to each other and monitor each other and talk to each other when we're hurting.”
Several other participants during this focus group expressed similar sentiments through verbal and non-verbal agreement.
Theme #5: Positive Impact of Regular Study Staff Interaction
Participants emphasized the importance of positive study staff interactions in engaging and retaining study participants throughout randomized control trials. In the next quote, a control group participant recalls an experience they had with a research team member during a telephonic data collection interaction: “I just like the fact that they genuinely – the ones who do call each and every one of us genuinely do care. The empathy, you know, with us. So very empathetic and they really, like, help me out when – I felt so bad and kind of embarrassed the same as when – I was so embarrassed when I was doing the long questions that she asked me, and I felt so bad cause I was in so much pain that day and I had my meds, and I was on and off. And you know, I was like, “I'm sorry I dosed off.” Again, she's very genuinely nice and she took her time with me, so. That was a plus for me to keep going.”
Similarly, an intervention group participant expressed having a positive experience with research team members throughout the duration of the study, highlighting how this motivated them to continue participating in study activities: “I do want to give just positive news to the entire team. Like every single time [Research Assistant] would call me, it was just a nice conversation, and I really enjoyed that. And I think that everybody who is involved in the study, you know, [Mindfulness Instructor], [Clinician], absolutely everybody, you all have the patience of saints. And I just want to give you a shout out for that. You all did a fantastic job because you're dealing with groups of people that are coming from all walks of life, all technological levels and everything like that. So, I think you all did great.”
Participants emphasized the importance of study staff interactions in keeping them motivated to participate and complete data collection activities.
Discussion
This study examined the perspectives of both intervention and control group participants who were actively engaged in a pragmatic clinical trial. This facilitated real-time changes to the study protocol and identified strategies to increase retention and engagement during the ongoing clinical trial. This study revealed that some control group participants did not fully understand their role and its limitations, highlighted the significant role that clinical providers play in the recruitment process, the importance of participant interactions and social support, and the value of positive, clear communication with staff.
The study findings revealed the significance of the role of health care providers in building trust between the research community and potential study participants. Within both the intervention and control focus groups across each of the 3 sites, participants shared how their health care providers introduced them to the research study and encouraged them to participate if they were interested. They shared that this motivated them to participate and gave the study credibility. These perspectives suggest that providers and the relationships between them and their patients can facilitate successful recruitment of participants from underrepresented populations in pragmatic clinical trials. However, researchers must carefully consider when and how providers should be involved in the research process, given the power differentials between providers and patients, and the potential for coercion.
For clinical studies with a significant proportion of first-time research participants, researchers may need to be clearer about what changes can and cannot take place, particularly within randomized control trials. This finding is consistent with two previous studies that also highlighted lack of understanding of the importance and value of participating as a barrier to recruitment and retention of historically underrepresented groups in clinical trials.24,25 Ensuring research participants understand what can and cannot take place in a randomized control trial also includes addressing participants’ desire to develop connections and community with other participants in a randomized control trial. Specifically, our study findings highlight the need for clinical researchers to consider social support for participants engaging in clinical research, particularly among those living with chronic pain conditions, and be transparent that this may not be possible depending on the constraints of the trial. Therefore, in addition to main study procedures, researchers may need to spend more time helping participants get familiar with general research processes and to revisit these concepts throughout the trial, taking time to explain and repeat information as needed.
Findings from this study also suggest that consistent, positive interactions with study staff are key to patient retention and engagement in pragmatic randomized clinical trials. Previous studies have noted the importance of establishing trust and positive communication between researchers and research participants.26,27 Specific to the study sample, consistent, positive study staff interactions were particularly important for control group participants who were not immediately receiving the intervention that initially interested them in the trial. Therefore, positive communication between the participants and the research team may help improve retention and engagement of patients from historically underrepresented groups in pragmatic randomized clinical trials. Other motivations for focus group participants to participate and remain engaged in research included the desire for education on health-related topics and wanting to help others. 28 In summary, emphasizing the significance of the control group, educating participants of general research processes, and ensuring consistent communication between study staff and participants, as well as utilizing connections between clinical providers can improve recruitment, retention, and engagement of diverse, patient populations in pragmatic, randomized control trials.
Limitations
This study has potential limitations. While the research team chose the clinical sites intentionally to recruit a diverse sample, the study was only offered in English due to limited time and financial resources. Offering the intervention in Spanish may have increased ethnic diversity among participants. The recruitment approach, which involved outreach by research staff with prior relationships to participants, alongside the $100 incentive for participation, raises concerns about potential coercion. These factors may have influenced participants’ decisions to participate or shaped their responses during focus groups, which could lead to a risk of bias, impacting the trustworthiness of study findings. This highlights a broader challenge in research: while building trust and rapport is essential for participant engagement, it is equally important to ensure that participants feel comfortable declining participation without fear of disappointing the research team. To navigate this, researchers should implement clear consent processes that emphasize voluntariness, provide neutral points of contact for recruitment of focus groups if possible, and reinforce that declining participation will not affect participants’ relationships with the research team or access to any study-related resources.
Our sample demographics were comparable to the main trial, but African Americans were overrepresented compared to the general population of the U.S. (∼14%). 29 Therefore, our study results may not be generalizable for the chronic pain population. However, a large portion of our sample being African American was not surprising, given our recruitment sites including FQHC’s, where 63% of people served are people of color, and people who identify as Black or African American make up 22% of the FQHC people of color patient population. 30 This suggests that other historically underrepresented groups make up the majority of FQHC patients of color. Utilizing strategies such as a community advisory board (CAB) while developing the study design may have helped improve strategies to recruit more individuals from historically underrepresented groups. However, funding for the stakeholder engagement supplement was only made available after the trial began. Our findings illustrate the need for mechanisms that fund stakeholder engagement earlier in trial design development. Lastly, this study was conducted during the COVID-19 pandemic, so the desire for participant connection and community-building may have been more pronounced for participants during this time. More in-depth research is needed to better understand how researchers can attempt to improve the experience of diverse groups engaging in pragmatic clinical research.
Conclusion
To improve engagement and retention of research participants from historically underrepresented and medically underserved areas in pragmatic randomized control trials, it is important that the research team take time to build trust and rapport with study participants. This can be achieved by being intentional about helping participants get familiar with general research processes, including revisiting knowledge about research processes several times throughout the study and keeping dialogue open between participants and research staff. When designing pragmatic clinical trials, researchers may consider having a process evaluation or incorporating focus groups or other qualitative data components that allow for study participants to share their feedback regarding participating in clinical research. Further, for studies that include randomization to a control condition that involves no active treatment beyond usual care, it is particularly important for study staff to emphasize the purpose and significance of the control group, as participants may not understand the value of participation. Increased understanding among participants could improve participant experience and therefore increase study retention and engagement.
By prioritizing active inclusivity of historically underrepresented populations in pragmatic clinical trials, we may work towards more equitable and representative health research that translates into improved health outcomes for all. This can be achieved by creating space for participants and research staff to engage in bidirectional communication regarding study processes and study updates, checking in on participants more regularly, and allowing space for participants to share their perspectives regarding the patient experience of being involved in research. Research staff should remain actively engaged with participants and acknowledge their role and significance in making participants comfortable with research processes. Study staff should also take time to reflect on patient feedback and use suggestions to continually improve study engagement. Ultimately, building and retaining a research team that engages with participants in a supportive manner improves participant retention, satisfaction, and the overall quality of clinical research.
Footnotes
Acknowledgements
We gratefully acknowledge the participants who made this research possible. We would also like to express our sincere gratitude to the members of the OPTIMUM Community Advisory Board for their invaluable contributions throughout this study. Their insights, guidance, and support were instrumental in ensuring cultural relevancy and appropriateness of focus group questions for our study population and fostering meaningful participant engagement. Their dedication to improving the health and well-being of those living with chronic low back pain and their collaboration with our research team has made this work more impactful. We appreciate their commitment to enhancing the quality and equity of this study, and we are deeply grateful for their collaboration.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported within the National Center for Complementary and Integrative Health; 4UH3AT010621-02.
