Why is inclusion so important? Why should we do our best to ensure appropriate inclusion?

Join Dr. Ana Quiñones, from Oregon Health & Science University, and Darina V. Petrovsky, PhD, RN from Rutgers University; Jane Jih, MD, MPH, MAS from UCSF; Elizabeth Eckstrom, MD, MPH from Oregon Health & Science University and Karen M. Goldstein, MD, MSPH from Durham VA Health Care System, to discuss why inclusion is so important in research and how inclusion will improve health equity overall. The group also discuss common barriers to participating in research studies by underrepresented groups and ways to strategize and approach these disparities.

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Transcript

Ana Quiñones, PhD: Thank you everyone. So my name is Anna Quiñones. I am an associate professor at Oregon Health and Science University, and I'm here today with Dr. Darina Petrosky. Darina is an assistant professor at Rutgers University School of Nursing. Also here with Karen Goldstein, who is an investigator with Durham VA Healthcare System in Durham, North Carolina. Jane Jih is an associate professor at UCSF, and Elizabeth Eckstrom is a professor at OHSU. 

So happy to have all of you here joining me. We're gonna be discussing the key points from the Inclusion Across the Lifespan module of the AGS AGING/ LEARNING Curriculum. And our topic today is why is inclusion so important in research and why should we do our best to ensure appropriate inclusion?

So, first of all, [00:01:00] I wanna start off and just talk about, you know, why is it so important to think about and to be attentive to issues of health equity and to the inclusions of study participants in our research studies of older adults? 

By inclusions, we're usually talking about groups that experience health disparities such as minoritized and racial/ ethnic underrepresented populations. Also sexual and gender minorities, low socioeconomic groups and rural residents. 

So the current state of the research and the statistics on participation in health related research studies and clinical trials in particular are pretty dismal, and they just result in really big evidence gaps for population groups that really are most often those that are most affected by the health conditions we're interested in studying and were interested in intervening upon. So these exclusions, not having sufficient numbers of participants [00:02:00] from these different backgrounds are at the heart or at the center of what we are trying to address, both with this curriculum and with the way that we each approach our work.

So I'll go around the room and I wanna ask each one of you about your perspectives. And I'll start with kind of this open-ended question of why is inclusion so important from your research vantage point. And more pointedly, how did we get here as a scientific community? How did we get to a situation with persistently low inclusions of people in our studies that we need to devise solutions for the most?

So I'll start with you, Dr. Petrosky. 

Darina Petrovsky, PhD, RN: Thank you for that question. I really like the point that you made earlier about perhaps why inclusion is important. And from my perspective, I believe inclusion is important because the therapies and interventions that we are developing, if we do not know how they are faring or how [00:03:00] individuals of certain groups are receiving those interventions and what effects those interventions have in those individuals, then how can we come up with evidence-based guidelines and really understand how these therapies work across different kinds of populations? So that for me is one of the sort of primary reasons I believe inclusion is absolutely necessary. 

And then in terms of your second part of your question, in my review of NIH and the National Institutes of Health policies on inclusion of research participants - which date not that far back, actually around the year that I was born in the eighties and since then - and I was just astounded by how little was there in terms of policies from the NIH in terms of inclusion of research participants, especially of older adults and other groups. And so [00:04:00] I think there is much work to be done. And historically there just hasn't been as much guidance and policies surrounding inclusion on a federal level. 

Ana Quiñones, PhD: Thank you so much. So I wanted to ping it over to Dr. Goldstein to see if you would like to add on to Dr. Petrovsky's points and, and specifically around your module your portion of the module that focuses on gender disparities and, and gender differences.

Karen Goldstein, MD, MSPH: Yeah, absolutely. Thank you. 

I think the point that Dr. Petrosky made, which is absolutely correct, is, you know, we strive in the clinic to provide patient-centered care that's really evidence-based. And if certain populations haven't been included in those studies, we just don't know if it's truly patient-centered because we don't know if the findings generalized the people we're sitting in front of. And that's something that comes up a lot when taking care of women because a lot of studies, historically and even now, have [00:05:00] not included women at equitable levels. And we know that there is, from a biologic basis, there's a number of differences in the way certain chronic conditions manifest and have a natural history and response to medications and things like that we know are different as well as gender-based differences.

So thinking about gender as a social construct and how people interact with the healthcare system. We know there's differences there too. So understanding that and making sure that women are represented in trials can help us generalize and increase the impact of the work that we're doing in research, but also help us really deliver that patient-centered care, which we're striving for.

And then for your second question about how we got here, I mean, I think there's probably a number of reasons. You know, when we're thinking about women in particular, historically, there have been policies around, primarily around reproductive age women and excluding them from research. Initially under the auspices of protecting the health of the, the woman and any child if she became pregnant. But I think also because [00:06:00] the hormones, as they shift over the lifespan can have impacts on the stability of an intervention or the outcomes. But, but again, that leaves women out, which can be problematic. 

Ana Quiñones, PhD: That's great. And I'm, I'm gonna come back and pick up on some of those points. I think you raised some really, really interesting points surrounding particular barriers that researchers might be facing or might be thinking about when they're devising their inclusion criteria for their studies. 

But I wanna keep going around the room and ask Dr. Jih. So your section of the module really focuses in on minoritized or racial/ ethnic underrepresented groups.

Can you talk a little bit about these two questions? Why is inclusion so important? How do we get to the situation? And specifically, I was really struck with your portion of the module in thinking about some of those failures of inclusion around rigor of science and misconceptions. 

Jane Jih, MD, MPH, MAS: Thank you. So, you know, like the other speakers have shared, you know, this is an historical issue that has not been resolved, in part because there hasn't been a [00:07:00] mandate or requirement or a lot of enforced guidance through funding mechanisms. Right?

In the NIH, we do have to provide, how are we gonna include minorities, women, or children. But I think when it comes to actually how those dollars are spent, there isn't a lot of directive. 

The one example that I would provide for this is that, you know, Asian Americans constitute about 6% of our society, right? And so NIH funds are taxpayer dollars, but there was a study done a few years ago that looked at all the NIH dollars that was solely dedicated to Asian Americans, and it was 0.16% for that time, in which 6% of Asian Americans. So there's a, there's, I think it goes to like the funding priorities, who's serving on the study sections, how we're evaluating science, and I think it needs to be a dramatic shift in how, you know, if we value health equity as a main core of what we're doing, then the science needs to reflect the people that we care of, that people have mentioned here. Right. 

It's very personal to me cuz there are a lot of times [00:08:00] where, you know, as an Asian American and having, you know, older adults in my family and close friends, when it comes time to really look at the data to offer guidance or to understand some of the medical problems that are having the decisions they have to make, they weren't included in those studies. Right? And so I think there's definitely some biological basis. Some bio, some of those components, right? And as well as the cultural attitudes, beliefs, preferences are not, they're not considered in, in that science, right? Because sometimes it's really a population that has diversity by a couple of racial ethnic groups, but may lack diversity with all the racial ethnic groups that are represented in our very, you know, diverse society.

And the other point I would want to make is that, you know, not all racial ethnic minorities speak English. And I think when we do not include them in our research, I think it loses some of the rigor. And so when we include everyone, I think it makes the science better. Right. It'll allow us to be able to offer more personalized counseling, [00:09:00] personalized treatment plans, and I think that that will advance equity more so. 

So I think it has become a priority for everyone at all stages of research. And to think about how we, as we contribute to the scientific, you know, system and how we contribute to, as, you know, reviewers and, and those that write grants, how we can better do that to advance health equity for everyone.

Ana Quiñones, PhD: Absolutely. That's fantastic. That's great points that you're raising here. 

And I especially liked in your slides that you, you really addressed some of these, maybe some potential misconceptions that researchers might have around, you know, particular groups being less likely to participate in research than other groups, and there being some, some fairly good evidence that that may not be the case.

Jane Jih, MD, MPH, MAS: Definitely. 

So I, I think a very considerable myth is that individuals from racial, ethnic minorities do not want to participate in research. And I think that's really not true if there are a lot of studies where they dedicate adequate [00:10:00] resources in terms of language, cultural ethnic racial concordance, right? And where they're very successful in recruiting individuals from racial ethnic groups.

In most cases, they're no less likely and in some cases more likely. And so I think this is, comes from, you know, the study design that we, we come up with when we implement our studies. 

You know, are we assembling a team that reflects the populations we wanna engage? Are we engaging community, stakeholders, patient stakeholders, caregivers in all parts of the study cycle, right?

In terms of the design, implementation, and I think, you know, one point I really do make is that a one size fits all is not a very good solution. Especially when you're trying to study a lot of different, include a lot of different populations, and so there might need to be more tailoring, right? This might take more time. It might take reallocation of funds to really boost up or help support some of the different needs that might come up when you're trying to recruit a really racial, ethnically diverse population. 

Ana Quiñones, PhD: So, [00:11:00] Elizabeth, Dr. Eckstrom, I wanna ping it over to you. 

So in your slides, you, you made a lot of really, really important points. Specifically regarding some potential issues from resulting in a lack of, of appropriate inclusion that focus a little bit more around cultural competency and and cultural knowledge. 

Do you want to try to address these two questions that I'm, I'm starting us off with those barriers in mind.

Elizabeth Eckstrom, MD, MPH: Absolutely. Thank you. 

First of all, I, I've been spending time thinking about inclusion of rural, older adults and there's some really important reasons to include rural, older adults. First of all, they have poorer physical health and more chronic diseases, than urban older adults. So if we don't include them, we're gonna miss some of these disparities. They have more limited access to healthcare services, lower rates of insurance, poorer socioeconomic and educational levels, and all of these things contribute to those health disparities [00:12:00] and are really necessary to have those people in study so that we can understand how to best meet their needs. They're also more likely to perceive limited access to clinical trial sites and might lack awareness of possible available trials. And, you know, have trouble with transportation to research centers. They may perceive concern for privacy and confidentiality. 

So I think all of these things frame why we aren't including them as well, but also really set, set the stage for why it's so important to include these groups and to really think about how, how to reach out and how to change the context of research so that we can be more inclusive of rural, older adult populations.

Ana Quiñones, PhD: One of the reasons we wanted to ask all of you from these different vantage points from racial and ethnic underrepresented groups for women, thinking about rural residents, is because it really does span that gamut of what's been found in the literature around populations that [00:13:00] experience health disparities.

I think each of you are raising some really, really important points about why it's so important to include these different population point - populations. Think about what we might be excluding in our research and how generalizable is that gonna be? How , I think Darina you raised this, how then can we come up with those evidence-based guidelines that really do point us in the direction of reducing disparities and providing the best care that we can in the therapeutic interventions for populations that are affected. So if we're not including them, it does generate a, a huge blind spot a huge problem with that. 

So I wanna turn now and, and again, pick up on a point I believe that Dr. Goldstein made in asking the next question, my third question around strategies or approaches to ensure appropriate inclusion. So how can we, as researchers do better [00:14:00] in terms of the way that we approach our science in the most rigorous fashion and make sure that we are thinking about particular barriers to inclusion. 

Dr. Goldstein mentioned some, some reasons that we might be thinking about across the lifespan, so hormone changes, biophysical, biological changes. Dr. Eckstrom, you just mentioned maybe some logistical reasons. Things that we need to think about in terms of transportation, distance to the clinic. You know, are we imposing some of these artificial barriers that we probably could be addressing, maybe not easily, but it shouldn't be so difficult to think about these and to come up with some creative solutions so that we can make it as easy as possible for participants to, to participate in our work.

And around this entire module, we're all here because we're interested in multiple chronic conditions because we think about that we're all gerontologists or geriatricians, and we certainly are all aware of the huge omissions in that evidence base, especially at the later stages of the [00:15:00] lifespan around older adults who often have multiple chronic conditions and who are often excluded from research. 

So how can we think about strategies for ensuring that appropriate inclusion that addresses some of these problems that you have all identified, that exclude participants that stand to benefit most from our research? 

I'll start with Dr. Jih. 

Jane Jih, MD, MPH, MAS: Okay, thanks. I think when there are certain very, like RCTs have very very strict eligibility criteria that might often exclude older adults. Right. Especially those with a lot of, and especially patients with multiple chronic conditions cuz they have. Different combinations of different things that are controlled or uncontrolled. 

So I think more flexible study designs, more pragmatic or hybrid sort of study designs may allow us to, you know, really look at effectiveness, but also the implementation and allow broader eligibility [00:16:00] criteria that include more patients of different, you know, have different types of medical conditions.

I think the other way to help bolster involvement of different types of populations that are currently underrepresented in research would really be stakeholder engagement. Not only with patients and, and their caregivers and families, but also with community-based organizations that, that serve the populations that you're hoping to include in your research.

Cuz I think, you know, we often- I think in partnering that you might learn, you learn a lot of different ways and things about how, you know, things that we never thought of. And I think it really enriches the science. It helps with recruitment, it helps with, you know, making some of our research questions more relevant to the actual things that are happening to our patients and their families.

So I think those are two potential ways to sort of help address underrepresentation in, in the groups that we're talking about today. 

Ana Quiñones, PhD: That's fantastic. Those are two really fantastic answers. Thank you, Dr. Jih. 

Dr. [00:17:00] Eckstrom, I'm gonna ping it back to you. 

What strategies for ensuring appropriate inclusion have you thought about or have you encountered in your research?

Elizabeth Eckstrom, MD, MPH: So I think, you know, when we go go back to a rural, older adult population there are a couple things that are really important. Context, adaptability, accessibility, inclusion of care partners, translation and compensation are some key areas. And I'll just go into each of those in a tiny more detail.

So many rural populations have had trauma in their past or present, and care should be paid attention to that context. It's- you can't just walk into a community and expect that they're going to be immediately receptive. You wanna include some local cultural leaders, such as tribal elders and community health workers, those types of groups, because they can help with study development, they can help with recruitment and retention. They can just be a part of helping you as a researcher understand the context of that particular community. 

It's always valuable to identify a guardian, a caregiver, [00:18:00] or a research partner who can help navigate the research study. And of course, many of our rural populations, as has been mentioned already are not, don't have English as their first language. So you wanna make sure that you're able to translate materials and utilize interpreter services when needed. 

And then really this is a population that is, it could take a lot of expense to get to the study site if you're not going out to the communities yourself. So providing participant compensation, including time and travel if rural elders are being asked to travel to remote site is very important for this group.

Ana Quiñones, PhD: That's great. Those are all really practical and thoughtful ways to point researchers in different directions and, and making sure that we're thinking about all of these things both from the larger, you know, do we have good and, and adequate partners in the research area and both in the content and also in in the geographic location that can help, you know, give us greater understanding and awareness of what some of those context- [00:19:00] specific factors might be that we need to think about that could really pose some problems in our research designs. That's really helpful. 

Dr. Goldstein, so you mentioned earlier specifically thinking about some of these processes that occur over the lifespan, biological processes that occur that may inadvertently create these pitfalls where women have been excluded from research.

So what are some of the strategies that you're thinking about or that you've encountered that can really help guide investigators in appropriate inclusion. 

Karen Goldstein, MD, MSPH: Yeah. Thanks. And, and I just, I wanted to say I love this conversation. I think all of the examples given so far can really help across all of these populations. So many of the things that were mentioned or being sensitive to trauma history and stakeholder engagement really apply for women as well. 

With respect to eligibility criteria, I think just taking a close look at what you have chosen to make sure that, you know, they're truly needed. Women may be developing some chronic illnesses even later in life.

So just making sure that any age limits are [00:20:00] really truly necessary. I think that really is relevant to all of this conversation obviously. I think one big thing especially when we think about older women is messaging and making sure that they know that they're truly being sought after and valued as participants. I think sometimes because of the historical sort of exclusion of women. I think they may not realize that they're a valued part of a research program. So tailoring some of the recruitment messaging can be helpful. And that can be important to have them feel a valuable part, especially if it's a condition that women may not be as aware of as affecting them.

So heart disease is the area that I do a lot of work in and across the board nationally, women are less likely to be aware of their diagnosis or being at risk for heart disease compared to men. So again, thinking about the messaging and how it may land with the population. 

And then the other thing I think is again, probably universally helpful is just thinking about the burden of the study process. As a population, women often have a lot of competing demands. Even if they're not of [00:21:00] reproductive years, they may well be taking care of other individuals, whether they're, you know, grandchildren or family members or anybody. And that may get in the way of their ability to participate even if they really want to.

So thinking very critically about, you know, what is the burden of the consent process? What's the burden of the evaluation and outcomes measurement in addition to any sort of intervention work? And how can we create opportunities to let people balancing the competing demands in their life, but still participate?

Ana Quiñones, PhD: That's really fantastic and that's a great call out. I think there's a little bit of an artificial distinction that I made here around these different populations that experience disparities, but agree completely. I think a lot of what we're talking about here today really should almost be part of the routine process that we all use to query our own, our own research processes. And thinking about, you know, what are/ might be some of these unintended barriers that I may be embedding in my research design and that that could really apply to, to multiple populations and [00:22:00] multiple groups of people that have historically been excluded from our research processes. 

So, Dr. Petrovsky last but very much not least, can you comment on some strategies that you have found to be particularly helpful and insightful in ensuring appropriate inclusion?

Darina Petrovsky, PhD, RN: Sure. So in the module for the course, I focused a bit of my time thinking about the ongoing longitudinal studies that have been successful in using sort of, you know, different approaches such as, you know, multi-prong community based approaches, which includes, you know, building trust and relationship with older adults.

And I think this underscores the importance of community-based participatory methods. And instead of reinventing the wheel, I think it is very important to learn from researchers and teams who have been doing this work for [00:23:00] quite some time. Obviously this is an ongoing issue. In terms of myself, you know, I want to learn from others and how they have been successful.

So I definitely agree with everything that's been said so far and, and myself, you know, I'm learning a lot about sort of the art and the science of recruitment and all of the strategies that have been mentioned before I found to be quite helpful for my own research as well. 

I also want to point out, I think Dr. Jih has mentioned the importance of the research staff and the diversity of the research staff. And that's not something that I, myself, or at least from my colleagues, we had learned as we, you know, grew up to be principal investigators, and then that is a very hard thing to do when you're in earlier in your career. 

But I'm definitely starting to think about, you know, who I'm hiring to be [00:24:00] on my research team, how I'm helping them grow. You know, where are they from? Do they have the skills and have, for example, the language of individuals I'm hoping to recruit for my study? 

So it is not just, you know, What is the most immediate goal of the research project, but how am I cultivating a practice of inclusivity as well as professional growth?

And I think once, in my experience, once research participants see that there's sort of a bigger vision, that there's this sense of purpose in being inclusive, then I think they're more likely to enroll in your studies and more likely to stick with you and work with you to really be a, a partner rather than just you know, a research subject.

Ana Quiñones, PhD: Well, this has been a really fantastic conversation. Thank you all for your really thoughtful comments, your insights, your advice, your cautionary tales. [00:25:00] I think this is gonna be a, a, a really wonderful resource for people listening and, and a companion resource for those who are able to look through the curriculum that you put together, the, the course, and the module that you put together.

So thank you so much. Very much appreciated talking with all of you.