Building the Functional Medicine Evidence Base 


Michelle Beidelschies, PhD, is assistant professor of medicine in the Cleveland Clinic Lerner College of Medicine and staff in the Cleveland Clinic Center for Functional Medicine, where she is the research and education director. She is responsible for developing the evidence base for the functional medicine model of care and other innovative delivery models developed at the center. Dr. Beidelschies has coauthored numerous peer-reviewed research publications in various scientific journals, and in October 2019, Dr. Beidelschies and her team published the first-ever study on the functional medicine model of care in JAMA Network Open.

Nazleen Bharmal, MD, PhD, is the associate chief of Community Health & Partnerships for Cleveland Clinic Community Care and Population Health. In this role, she works with an interdisciplinary team to implement a community health strategy for Cleveland Clinic focused on health equity, social determinants of health, and partnerships with community stakeholders. Dr. Bharmal practices primary care internal medicine focused on disease prevention and health promotion. She has published in several scientific journals and received awards for her public health research and leadership activities. She received her MD from Harvard Medical School, PhD in health policy and management from the UCLA Fielding School of Public Health, and MPP from the John F. Kennedy School of Government.


Kalea Wattles, NDIFM’s Annual International Conference is coming up soon. Learn about the latest advancements in functional medicine research and what they mean for your practice. Join us June 4th and 5th for a reimagined online experience. I’ll see you there. Visit aic.ifm.org for more information.  

On this episode of Pathways to Well-Being, we’ll discuss the efforts undertaken by the research team at the Cleveland Clinic Center for Functional Medicine as they work to build a robust functional medicine evidence base. Drs. Michelle Beidelschies and Nazleen Bharmal join us to discuss not only their most recent study on the benefits of shared medical appointments in an under-resourced community but also to share how their studies aim to highlight the feasibility, value, and effectiveness of the functional medicine model of care. Drs. Beidelschies and Bharmal, thank you for being here today to discuss your research, and welcome to the show.  

Michelle Beidelschies, PhD: Oh, thank you very much for having us. We very much appreciate the invite. 

Nazleen Bharmal, MD, PhD: I would love to start out with just a little bit of background and context about the work that you’ve been doing. Can you give us an umbrella view of the research program at the Cleveland Clinic Center for Functional Medicine and maybe talk a little bit about how IFM has contributed to and supported that research? Michelle, I’ll hand it over to you to talk a little bit about that.

Michelle Beidelschies: All right, well, the Cleveland Clinic Center for Functional Medicine was introduced at Cleveland Clinic in 2014. It’s one of the first functional medicine practices to exist within an academic medical center. The main goal of this center was to transform health care. So we wanted to shift the traditional disease-centered focus of medical practice to a more patient-centered approach and in that demonstrate the value that this type of care delivers and this innovative model of care delivers. In terms of the research that we’re doing, we wanted to establish the evidence base for functional medicine care. And we have six research objectives that are really core to this mission.  

The first is to develop a functional medicine research program, which, you know, we’re building as we speak. The second is to study the functional medicine model of care as well as other innovative delivery models. So, our model of care here at the clinic is maybe similar to independent practices or maybe a little bit different, but when you come to the center, our model of care involves a provider, whether that’s an MD, a DO, a PA or an NP, a dietician, a health coach, and sometimes a behavioral health therapist. So we wanted to look at how that model of care is able to improve patient outcomes, and the innovative delivery models are designed around the ability for us to use that same multidisciplinary team approach in shared medical appointment or SMA settings.  

The third research objective is to develop a platform to extract and utilize electronic health data in order to expedite research and also to inform clinical and operational improvements. This is one of the biggest research objectives that we have, and it involved developing an IRB-approved registry, of which we have approximately 10,000 patients in that registry, where we have demographic data as well as laboratory data and patient-reported outcome data. So, the fact that we have all that data under one roof allows us to extract it and do research more efficiently.  

The fourth objective is to develop research collaborations. This has been the most fun, to do those external as well as with internal groups so that we can help improve chronic disease management and inform decision making. And so I’ve spent a lot of time working with other institutes here at the Cleveland Clinic, including Dr. Bharmal’s group, as well as external research collaborators.  

The fifth objective is also quite important, as they all are, is to build the reputation of the Center for Functional Medicine as being credible, collaborative, and evidence-based. This requires a lot of, again, conversations with others about what it is that we’re trying to do with our model of care and how it may complement other specialties that are out there.   

And then lastly, number six, is to provide education and mentorship to caregivers in the center. We just started doing this about a year ago. We do deliver a lot of research education, helping them understand what that looks like, to go from having an idea to a protocol and the submission through the IRB, and then what it looks like to collect the data and analyze it. 

Kalea Wattles: So, Michelle, will you tell us a little bit about how IFM has contributed to and supported this research? 

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Michelle Beidelschies: Yeah, so IFM is obviously an important partner for the work that’s being done in research as well as education in our center. You know, they’ve provided opportunities through functional medicine education and training for the providers who are in fact on the ground, carrying out the much needed research. So obviously, they need to understand the model and the protocols that we’re implementing. And so without that education, you’re pretty much stuck. They also provide opportunity to access all the patient and practitioner resources that we need to educate the patients on nutrition and lifestyle and other interventions. You know, there’s also providing ongoing support for research activities that originate at the center. And so I actually meet frequently with IFM’s senior research advisor, Chris D’Adamo, who’s out of the University of Maryland, to discuss potential research and collaborations we are working on together. And so that’s been very beneficial to have someone to talk to about stuff that we’re doing and get their input. And IFM has just supported our initiatives to develop and study not only the functional medicine model but also the innovative care delivery models that we deliver for patients with chronic diseases. 


Kalea Wattles: This is such a thoughtful approach to evidence collection. And I think it’s so important to all of us that we continue to build that really robust functional medicine evidence base. Will you give us a little bit of insight into strategic areas that you might focus on in order to establish that really strong foundation of evidence?  

Michelle Beidelschies: Yeah. So you could look at strategic areas from disease perspectives. Those are important. We can talk a little bit about the studies we’ve had previously, where we look at the whole model versus particular conditions, but in terms of strategic areas of focus for what we’re doing on a more operational level with research, you know, we’re very focused on optimizing data collection for patient care, whether that’s in an in-person setting or a virtual setting or an individual appointment setting versus a shared medical appointment setting. And the optimization of this data collection is, again, going to inform clinical as well as research operations. And it also allows us to perform cost-effective research. When we do community programs, it’s quite labor intensive to make sure we get the outcomes and the data that we need to demonstrate the value of what we’re doing. But as any researcher would say, you don’t know unless you’re collecting the data. So it is very important to optimize the data collection. We’ve done a lot of focus more recently on retrospective studies that are obviously more cost effective than large randomized controlled trials. They require less resources, but they’re able to inform larger, more rigorous trials. And so we’ve done a lot with our registry data to help lay down the foundation for potential larger future feasibility or pilot studies.  

The last area is really the focus on the collection of, and I submitted a paper regarding this just recently, the focus on the collection of not only just biomedical outcomes but patient-reported outcomes. We in our center collect PROMIS global health, which we use on all of our patients. We have very good completion rates for this. It’s embedded in a lot of the research that we do, but we like to pair PROMIS, that patient-reported outcome measure, with biomedical data, the biomarkers, and then we’ve actually advanced beyond that to examine symptom burden and functional status, nutrition literacy, and nutrition and lifestyle adherence. So all together, all of those domains allow us to take a more broad look at the patient’s overall health.  

Kalea Wattles: Well, it sounds like you’ve learned so much about what works best in terms of optimizing that data collection. In light of these strategic areas you just talked to us about, could you elaborate a little bit about how your research approach has evolved over time as you’re utilizing all of these tools? 

Michelle Beidelschies: Yeah, so, you know, our research has evolved to really align with our care strategies here in the center. We do deliver care at Cleveland Clinic Main Campus, as well as a family health center within the Cleveland Clinic. In both settings, we’ve delivered care and individual appointments as well as shared medical appointments. We’ve done those in person as well as virtual. So, as our model of care has evolved and our care strategies have evolved, the research has followed suit. So we went from looking at what’s happening in individual appointments to what’s happening in shared medical appointments. This shared medical appointment setting has really enabled us to have a closer look at what the patients are actually doing to get better, what they’re not doing to get better, and making sure we get that data that we need. 

Kalea Wattles: Well, as your approach to research has evolved, I know that the type of evidence that you’re publishing has also evolved. I think there’s some papers that we could highlight here. Would you be willing to walk us through some of that published evidence from the center? 

Michelle Beidelschies: Yeah, our first manuscript was published in 2019 in JAMA Network Open. That was looking at the overall model of care, the functional medicine model of care, as it relates to improvement in patients’ global health, again, PROMIS global physical health as well as global mental health. And we had a control in that, it was another family health center. And what we demonstrated is that we showed an improvement in global physical health, and that was sustained long term, but it wasn’t significant compared to the control. And so we were very pleased about that.

I was reflecting on that first manuscript, and I recall talking to Amy Mack on the phone, and I was quite nervous about literally hitting the send button on the manuscript, cause it felt like I wanted to do right by functional medicine and make sure that what we’re talking about were the important key points that we wanted to get across. And yeah, there was the weight of the world, it felt like, when it finally came out. That was, you know, it seems like a very short time ago but was in fact long ago and led us to our second publication which came out. That was with Dr. Elaine Husni in the Rheumatological Institute and Nicole Droz. And that paper was looking at rheumatological care versus rheumatological care plus functional medicine, again demonstrating an improvement in patient-reported outcomes for the functional medicine group. And so that was going from the model to being a little bit more disease-specific, really teasing out if we can have improvements in a particular condition.

And then from there we moved to the SMA paper that was published in BMJ Open. And that one we really compared to ourselves, because we already knew we did well in individual appointment settings, but what we wanted to see is if we did even better in shared medical appointment settings. And you know, what it demonstrated is that we did, but the other things that we wanted to include in there was the improvement in those biometric outcomes, the blood pressure, weight. And then we decided, well, while we’re doing that, we might as well show cost as well. So we did a demonstration of how the shared medical appointment setting, especially for functional medicine, is more cost effective than doing the individual setting. 

Kalea Wattles: Well, wonderful work that you’ve all been doing. And Nazleen, I’ll loop you into this conversation now because you have this shared medical visit study that was recently published, but rather than being performed in the clinic, you actually took your shared medical appointment model to the community, to an underserved community, actually. Could you walk us through this program and the goal of your research? 

Nazleen Bharmal: Yeah, thank you so much for the opportunity to talk about it. So what we did was we adapted the shared medical appointment to a population that is traditionally underserved, mainly African American population who also happen to live in a disadvantaged neighborhood in a community setting that’s right near the main campus where we provide clinical care. And the reason is that we know that patients who live in more disadvantaged neighborhoods or who are minorities have greater health disparities and a greater burden of chronic disease: high blood pressure, diabetes, whatnot. And there’s a great interest in health equity and in reducing those disparities and thinking about innovative interventions that also provide patient empowerment.  

So, you know, the hard part is that we knew that part of the shared medical appointment was focused on lifestyle behaviors. And in this community setting, there were really few outlets for affordable and nutritious foods, very limited spaces for physical activity. We knew that there was the stress from living in these neighborhoods, plus any microaggressions that racial and ethnic minorities face, and that causes increased inflammation, lowers immunity, can lead to chronic disease. But we wanted to see if this was feasible, and love the model, love that approach that was happening in the clinical setting, and seeing if we could adapt it to a different patient population in a different location. And really our objective was to see just that, whether this shared medical appointment would be acceptable to community residents who may not often feel comfortable coming to a large integrated hospital, which is where ours was currently delivered closest to them.  

Kalea Wattles: Really important work that you’re doing, and I’d love to hear some of the key results and conclusions that came away from that work.  

Nazleen Bharmal: Yeah, I will just take a second to talk a little bit about the background and some methods so that we can talk about the results. We adapted the shared medical appointment in several ways. So I’ve already talked about the location. We had it in a community space where the residents already were frequenting and felt comfortable. It also included engaging with a community engagement staff that had already built trust with the residents. So the center was working with a community engagement staff. This was sort of a clinical community collaboration. We offered things that were important for this particular population. They wanted a customized shopping list, they wanted menu options that were important for their culture. They asked for a cooking demonstration, which we were able to provide. And I think one of the biggest things was we provided in-kind donations for supplementation, as well as food delivery for every member of the household. That was part of the study. It was mixed methods, so it included both quantitative things like surveys and biomarkers as well as qualitative, where we asked in focus groups and the stakeholders who were involved in making this program possible, you know, how did that go and how was it for them? What were the barriers and facilitators to implementing this program? And could we make this sustainable?  

 And so some of our key results were that we had, it was a small group, 15 participants, which is similar to what we see as shared medical appointments in the clinic setting. There were 10 weekly sessions; they attended all 10 weekly sessions. Most of them were older adults, African American, and they had chronic conditions, such as like high blood pressure and diabetes or obesity. And they were really there for our lifestyle changes. And what we found were a few key findings. One is that in over about a three-month time period, so 10 weeks plus a few weeks later, we saw that there was actually an aggregate, a pre and post-improvement in the systolic and diastolic blood pressure that was significant from baseline. We also saw a significant decrease in weight as an aggregate at three months. We also followed them for three additional months once the program was completely over, and we continued to see that trend toward blood pressure improvement and weight improvement but not significant from baseline.   

We also saw that a number of things improved for the individuals who participated in this program. So they reported increased health status, increase in daily fruit and vegetable intake, increase in sleep than they had previously. And they also talked about just a greater understanding of the positive changes that were a result of the education they received through the shared medical appointments. So greater understanding of food as medicine, greater understanding of water, gut function, mindful eating, and energy. They loved the format. The biggest, I think, thing that we heard was that they love the time. In a shared medical, you have one to two hours in a multi-disciplinary group as opposed to like maybe 30 minutes to 60 minutes with a provider. And they loved the group setting, but they also loved how things were explained to them, which is sort of the functional medicine way. So those were some of our results that we found overall in the study. 

Kalea Wattles: Really wonderful results. And I love that you highlighted the fact that, you know, in functional medicine, we talk about our personal modifiable lifestyle factors and relationships, and community is one of them, and that’s really at the foundation of our health. And so I think it’s really beautiful that the community aspect of a shared medical appointment is actually, I think, part of the healing process. And I’d love to hear, you answered this, I think already, but let’s kind of summarize. From your research experience, how do you think these community-based shared medical appointments can really help to facilitate the nutrition piece and the lifestyle interventions that are really important for everyone? But I think the community aspect in these communities is so crucial.  

Nazleen Bharmal: Yeah, I would say that we have become in our community group, in collaboration with the center, we have real—Center for Functional Medicine—we have really become believers of the shared medical appointment approach to talking with patients about lifestyle changes and factors and thinking about their community and what could be assets and leveraging partnerships, quite frankly, with a whole host of groups and organizations, individuals. So, for example, I mentioned that, you know, participants had in-kind food delivery, and that was because of a relationship and an in-kind donation by Freshly to deliver weekly meals to the participants. So leveraging those kinds of opportunities so that all individuals have an opportunity, a fair and just opportunity to be healthy. I think what our biggest thing was, which we found, was that everybody showed up, and everyone found that it was acceptable, and they loved it.  

And I have to say kudos to the staff, because there were challenges. They had to—it took time. They had to adapt to a population that might have had lower health literacy as a group than, you know, what you see in the clinical setting, who might not have actually had any understanding of some of these factors. We were talking about nutrition, functional medicine, gut health, and explaining that, but such an open group that was ready to implement it in their lifestyle. I think another thing that was really important for us is that we partnered with a trusted community partner. And that made all the difference because they already had, once the community partners staff said, “Hey, we like these guys, we trust them,” it was very easy to get the participants to also engage and have that built-in trust, which sometimes can be challenging in sort of that clinic setting.  

Michelle Beidelschies: I would add that, that was a great summary, but I also want to point out that, I could read all the papers I want about doing research in the community. And Nazleen knows that, you know, I’ve pulled up, oh, look at this article, look at this article, and it’s great to just know of it. But until you’ve had an experience of it, going there, talking to them, even sitting in the back of the room and listening to them have conversations with each other, it was eye opening. And so I think Nazleen is right when she says, you know, having that partner to sort of open the door for you, a trusted partner with that particular population, is quite important. We did measure, I think, Nazleen, about trust in the research that we’re doing, because we appreciate that there may be less likely for them to trust what it is that we’re doing from a research perspective based on history. And we did help to improve that over the course of the program. They started to trust us more. And I think that’s really come down to, and if you look at some of the feedback in the article, we really focus on education, trying to help them understand why we’re doing something, why they should eat something, why they might be able to, why it might be beneficial for them to take a supplement, how the exercise is important, how the sleep is important, how the relationships are important, everything all together. So once we started giving more education and explaining things, that was, I feel as though that was the real core to developing the trust with the population. 

Nazleen Bharmal: I couldn’t agree more with you, Michelle. And I think it was also the opportunity to see like a multidisciplinary team. It wasn’t just a provider, it was also the dietician. It was also the health coach. And I don’t think that they had ever, or what the feedback we had received, is they had health care delivered in such a way, with the multidisciplinary team. And I think that’s the advantage of shared medical appointments. 

Michelle Beidelschies: Yeah. You know, some of them even mentioned that, you know, I never had anyone explain why this was important. You know, we walk through lab results even, and supplementation that I believe was through Pure Encapsulations as well. But, you know, for them to understand actually why there’s something, you know, is one thing, but that also improves adherence. And oh, now I know, and I can do better. And this study is, I shouldn’t say this study, this program as well as study, actually, led to us focusing on measuring nutrition literacy even more in our community-based programs, because it really is the crux of ensuring we’re saying the same thing. You know, in the surveys, they felt as though they’re eating healthy, you know, already, but what does that mean to them? Like, do they know how to eat healthy? It might look different for one person versus another person. So for us to measure that in a more formal way is very important.  

Kalea Wattles: That’s actually a great lead in to my next question. I’m sure you learned so much from this program and this study. What did you all learn from this study that will really help support other studies that you might have planned or are currently underway? 

Nazleen Bharmal: Yeah, I mean, I think there were a few things that we recognized from the study overall, which is that, like, there are challenges to implementing this as well as sort of facilitators. So, I mean, the challenges were, you know, that you really had to have an extended amount of time for your providers to spend in a patient population that, again, might not have the same health literacy. You also had to think about what resources sort of existed at their fingertips and adapt accordingly.  

But the opportunities, we’ve already started thinking about opportunities to vary this, and I know Michelle will touch on this more, one is likely very quickly after this. The place where we held the study actually started becoming from a community education center to being a place where they started delivering primary care. And that allowed us to start thinking about, okay, could we identify patients who would then benefit from a shared medical appointment or partner with particular groups? So, for example, partnering with the Cleveland Police Department, as an example, and thinking about them, for them, for having an opportunity to think about how they could benefit from this shared medical appointment for, again, lifestyle, weight management, whatnot, reduction of chronic disease, and having it be done in a community setting as opposed to a clinical setting. Michelle, do you wanna talk a little bit about some of the other opportunities we’ve touched on? 

Michelle Beidelschies: Yeah, for sure. In addition to doing that shared medical appointment with the Cleveland Police Department, which showed very similar outcomes to this particular manuscript, as well as other outcomes that we have, we also started work—and it’s taking us a long time to launch it—we started the work early last year, a program for the Hispanic population, which we call Buena Vida. And we worked very closely again with Nazleen’s group on the development of this program, really trying to implement the key learnings from this, you know, Functioning for Life, community-based SMA cohort. One of the first things we did with the Hispanic population was we delivered a quite extensive survey to over 4,000 people who are Hispanic, asking them various questions related to social determinants of health. We looked at their PROMIS global health, PHQ-9 for depression, sleep, other attempts to lose weight. Who’s living in their homes, how long they’ve been living there, have they come from other countries recently to live here in Ohio? Just really trying to understand the demographics of the population and perhaps what may be contributing to some disparities in their care, in their current health status.   

Again, we didn’t do this alone, we partnered. And one of the particular people who really helped facilitate this survey and the rest of the program is someone that Nazleen knows well, Marilyn Alejandro-Rodriguez. She was a research coordinator in our department, and she has been integral to really developing relationships with this particular community. And following that survey, what we did with that data was we used it to help build a culturally tailored SMA program for this particular population. We also went into the communities, as I said before, it’s one thing to read about it, see it on the news. It’s another thing to actually go there. So we went into the communities with a lot of other individuals from the Cleveland Clinic, and we went to the places they’re actually shopping. We went to large grocery stores, we went to small grocery stores. We talked to people who knew about what they were eating consistently. We looked at the backs of the containers, looking at the ingredients, trying to understand how we could adapt what it is that we think would be beneficial for their health, for something that they’re looking to eat. And then, you know, we developed a 10-week shared medical appointment off of that, and we just finished two cohorts for that.   

And what’s really unique about this program is it wasn’t just the 10 weeks. We had what we called an induction phase and a maintenance phase. Excuse me. So the induction phase is the 10-week Shared Medical Appointment Program, where we’re doing very similar things to what Nazleen discussed in the community-based setting. The maintenance phase is a partnership we developed with the Endocrinology and Metabolic Institute here at the Cleveland Clinic. So what they’re doing is they’re taking the patients from that really intense educational, functional medicine–based SMA, and they’re holding their hands for the rest of the year. So we had them for three months; they’re spending the rest of the time with them, one time a month, checking in, making sure they’re maintaining the improvements that they’ve had, because what we’re interested in, is this, you know, something people can do long term. As Nazleen said, in that community setting, we measured, you know, outcomes at three months, and then we went back at six months, and we saw a little bit of a drop off. I think one of the things that we need to start thinking about as a community is how do we make what we’re recommending for people sustainable, so that they’re not only implementing it themselves, but they’re also taking it back to their families and communities and implementing it there and talking about it?  

Nazleen Bharmal: I love that, Michelle, because that, I think, was one of our greatest findings was that we wanted, when you work with a partner, thinking about what that bridge might be, after sort of the intensive program, how can you have that bridge? And you said it so nicely, you partnered with them, the Endocrine and Metabolic Institute, to think about what that would be. I think we have also in the community setting, they thought about what could our community partner offer as a bridge. And for us, we are very fortunate. We feel like we have a lot of opportunities for future research in community settings with sort of this community-based Functioning for Life shared medical appointment. There is a grocery store that’s being built in that same area now, in the food desert, a lot of opportunities to do exactly what they’re doing with Buena Vida, which is taking patients and having that experience. A teaching kitchen is being built, and it’s having a community advisory board that will talk about, let’s have that experience of making food instead of having food just delivered to you and what that might look like also in social settings. So many opportunities to think beyond and support.  

Michelle Beidelschies: Yeah, also, because Dr. Bharmal mentioned the fact that the culinary medicine is becoming more important in the community setting with this Buena Vida Program, we actually did try to get at least three sessions following our dietician sessions that we have with culinary medicine. And they had just rave reviews about how wonderful it was to learn knife skills, how certain knives work, how to make, you know, or how to use different spices to help improve health, various things that they just otherwise would perhaps not have exposure to. So we’re really, at the Cleveland Clinic, trying to work on how we introduce culinary medicine, you know, into our programs.  

Kalea Wattles: Well, I have to say this all is very exciting, and I’m so delighted to see the rise of culinary medicine as important in our community. Nazleen, you’ve been talking a little bit about the implementation and how we reinforce these lifestyle changes long-term. And I know that one of your goals in doing this study was really to demonstrate the feasibility and efficacy of implementing functional medicine–type interventions across varied settings and populations. Will you give us a summary of how this type of research is really doing that, is really demonstrating this feasibility and efficacy?  

Nazleen Bharmal: Yeah, I think that there should just be an understanding that no population is unable to be reached by these types of interventions, and we should never sort of say, “Oh, there are too many barriers,” whether it be community barriers or patient social need barriers or chronic condition or health literacy barriers. I think that’s what we were trying to prove with this particular intervention, which is that, and looking at the research behind it, which is to show that regardless of the patient population and whatever they’re dealing with, these can be successful. They’re acceptable, they’re feasible, and they can be efficacious. So, and we hope to build on sort of that groundwork with other work that we are doing. It’s also just meeting people where they’re at, right? So, if coming to a particular setting is challenging, then let’s go out and meet them in a space that’s comfortable with them. Let’s work with partners who can sustain the program potentially over time. Let’s leverage our partnerships. I think all of that leads to sort of healthier patients, families, communities. 

Kalea Wattles: Well said. And as we look toward the future, Michelle, you mentioned a little bit about the Buena Vida Program, but, I mean, what’s next for you? It sounds like you have some more condition-focused or disease-based studies coming up. Anything you can say about that exciting work on the horizon? 

Michelle Beidelschies: Yeah, sure. You know, again, the first manuscript that we put out was about, you know, the model as a whole in patient-reported outcomes, particularly PROMIS. Then we moved from, you know, an individual appointment setting to a shared medical appointment setting and doing very similar outcomes, adding to them the biomedical outcomes. What we’re really trying to do now is, because we are opening a lot of collaboration with other areas within the clinic and outside, is really focusing on particular chronic conditions. And one of the areas that I’m working on currently is pre-diabetes as well as diabetes. We do have an RCT for diabetes that’s not going to be done for about another year, but I wanted to look at some retrospective data that we do have available for pre-diabetic patients and compare them to control patients with pre-diabetes and examine changes in patient-reported outcomes, weight, blood pressure, maybe even medication use. So our hope is to get that out sometime this year.   

We also, you know, because we do a lot of shared medical appointments, also did an appropriate for the time of post-COVID syndrome shared medical appointment. What we demonstrate as part of that particular shared medical appointment program is that we’re able to, you know, improve symptom burden, functional status of patients, we’re able to show that they’re adhering to the nutrition and lifestyle recommendations. But what we had a, you know, somewhat of a challenge in doing was moving the patient-reported outcomes, the PROMIS scores for those patients, because they’re so sick. An average PROMIS score in our center is around 43 to 45, which is, you know, the general US population’s about 50. The patients with post-COVID syndrome are coming in in the low thirties. They’re quite sick, as everyone is learning about now.  

So we have a great task on our hands in trying to improve them through nutrition and lifestyle. And we’re hoping to get some of that work out and demonstrate what we’ve shown. So we had two cohorts for that. And again, I was speaking to our preliminary evidence, but we have more patients to add to that, so those outcomes might change as we go along. So I’ve partnered with Dr. Joe Pizzorno and Chris D’Adamo, who is one of IFM’s senior research advisors, on a study using NHANES data where we’re looking at toxicant exposure and prevalence of rheumatoid arthritis. And we’re writing that up currently for submission. We’re very excited about that data.  

And we also recently launched, I believe earlier this year, if not in late 2021, I think it was early this year, a wound study that we’re looking at in women who have undergone autologous breast reconstruction. And so we’re delivering perioperative nutrition and lifestyle-based interventions. Right now, we’re just trying to see if it’s feasible, if they’ll follow it. But long term, we want to understand if, following surgery, those interventions are able to improve outcomes related to wound healing, surgical site infection, the need for resurgery, et cetera. So those are some of the things that are coming up in the future. 

Kalea Wattles: Well, the evidence base is certainly building and building. I think you’re getting so skilled in getting to know your community and partnering with the right community members. As we look big picture now, what do you see as the center’s role as widespread functional medicine–specific research continues to move forward and build? I know that’s a loaded question, but the initial insights, it’s really exciting to see. 

Michelle Beidelschies: You know, I think what it comes back to is just really focusing on doing quality work, engaging with the functional medicine community and others interested in studying the model of care, whether in functional medicine or not, understanding if it can improve health status, biomedical, or patient-reported outcomes. But I think it needs to be done, and we need to aim high with our aspirations for research, publishing quality work, well controlled, written well, and take a chance on submitting it to top-tier journals, because you may be surprised sometimes and, you know, if anything, you’re getting wonderful feedback if it doesn’t work. I’ve had many conversations with people in the community about work that they’re doing. And, you know, research is hard. As Nazleen knows, you just have to keep pushing forward, you know, do a few iterations, keep going, keep going, and you’ll get there. So I think, you know, in terms of what the center is really interested in doing, it’s more collaboration, helping guide other people interested in research. That’s something that, you know, I very much enjoy doing, so I always encourage people, yeah, call me, you know, email’s probably not the best, but call me, let me know if you’re interested, and we’ll talk. 

Nazleen Bharmal: I want to say that I couldn’t agree more. I think that there’s such a place here for rigor and rigor around these things that, and it’s okay to publish a negative study. There’s still much learning to be done from it. Our study that we published in the community was small, but it can lead to something larger. We did not have a control group; we should next time. So I think there’s many, many opportunities to learn and build on previous findings and iterate. And that’s what I think the center really allows in big things is allows real rigor around some of these topics that are challenging but so critically important when it comes to the health of our populations. 

Michelle Beidelschies: I should also add, because I just, you know, we deal with this all the time, you know, step into the uncomfortable conversations with people who may be skeptics of what it is that you’re doing. You know, don’t be defensive, listen to what they have to say, understand where there’s an issue. Maybe it becomes a potential collaboration of some sort to demonstrate efficacy of the model. And that’s how we’re gonna get to where we need to go, is through the work and the conversations. And so, you know, lean into those uncomfortable situations, because good comes out of them.  

Kalea Wattles: Well, I know there’s so many clinicians among us who’d like to do some research. Will you give us some advice about what can functional medicine primary care clinicians who might be working as part of a health system or they’re in a solo practice, what can we do to help move this research on functional medicine forward? How can we participate in a meaningful way?  

Michelle Beidelschies: Yeah, that’s a great question. You know, I always encourage people to start with case reports. You know, they’re closer to the bottom of the evidence pyramid, but don’t underestimate their value of demonstrating efficacy for a particular intervention. So I always encourage people to start there, because as you start digging into your data, you may see that you have one book end, which is the baseline measurement, but you don’t have the follow up book end. You don’t know what happened to the patient. They didn’t come back, they didn’t get their lab test. You didn’t get a measure that you really care about. And then you understand the issue, right? You need the data. Data, data, data is so important. So start with the case report, and see what it’s telling you, follow those patients.  

And then, you know, open up the door for collaborations in terms of, once you do write up the case report, send it to someone that, you know, maybe someone at IFM knows someone who’s willing to review, or me or Nazleen or whomever, people are willing to review what you’re writing and take that feedback, incorporate it, and then bring it back. I think the feedback is very important because, again, you’re trying to publish in journals where people have very different points of view, if that’s what you’re trying to do. And so you want a lot of different perspectives with the research or case report that you’re trying to publish. 

Nazleen Bharmal: Yeah, I’d say that, there’s also just, I think what’s wonderful about the primary care functional medicine physician is that you actually are seeing what questions there might be, or you’re hearing anecdotally from patients. And we can, as Michelle mentioned the case report, but then also to bring some of those ideas back, what are you hearing about patients’ experiences? And can we quantify that in a measurable way as opposed to one or two anecdotes?  

Kalea Wattles: I think we’re all feeling very excited about the work that you’re doing and empowered to participate in whatever way we can. I wanted to thank you both so much for sharing these insights. It’s clear how much you care about this work, and it’s so fun to see that passion come through. Thank you both for spending time with us today.  

Michelle Beidelschies: Thank you. 

Nazleen Bharmal: Thank you. 

Kalea Wattles: IFM’s Annual International Conference is coming up soon. Learn about the latest advancements in functional medicine research and what they mean for your practice. Join us June 4th and 5th for a reimagined online experience. I’ll see you there. Visit aic.ifm.org for more information. 

Show Notes

Below are links to the Cleveland Clinic Center for Functional Medicine studies referenced in this episode: 

  • Bharmal N, Beidelschies M, Alejandro-Rodriguez M, et al. A nutrition and lifestyle-focused shared medical appointment in a resource-challenged community setting: a mixed-methods study. BMC Public Health. 2022;22(1):447. doi:10.1186/s12889-022-12833-6  
  • Beidelschies M, Alejandro-Rodriguez M, Ji X, Lapin B, Hanaway P, Rothberg MB. Association of the functional medicine model of care with patient-reported health-related quality-of-life outcomes. JAMA Netw Open. 2019;2(10):e1914017. doi:10.1001/jamanetworkopen.2019.14017 
  • Droz N, Hanaway P, Hyman M, Jin Y, Beidelschies M, Husni ME. The impact of functional medicine on patient-reported outcomes in inflammatory arthritis: a retrospective study. PLoS One. 2020;15(10):e0240416. doi:10.1371/journal.pone.0240416  
  • Beidelschies M, Alejandro-Rodriguez M, Guo N, et al. Patient outcomes and costs associated with functional medicine-based care in a shared versus individual setting for patients with chronic conditions: a retrospective cohort study. BMJ Open. 2021;11(4):e048294. doi:10.1136/bmjopen-2020-048294