Dan Keller 0:08
Welcome to this episode of Substantial Matters: Life and Science of Parkinson's. I'm your host, Dan Keller. At the Parkinson's Foundation, we want all people with Parkinson's and their families to get the care and support they need. Better care starts with better research and leads to better lives. In this podcast series, we highlight the fruits of that research, the treatments and techniques that can help you live a better life now, as well as research that can bring a better tomorrow. An overriding goal of the Parkinson's Foundation is to improve the lives of people with PD and to ensure that every person with Parkinson's receives the best possible care. To do so, researchers need to evaluate a wide range of Parkinson's factors to determine a comprehensive view of the disease and its overall impact, including treatment plans, therapy benefits, the best candidates for each treatment, and lifestyle modifications. So, the Parkinson's Foundation initiated the Parkinson's Outcomes Project, the largest ever clinical study involving thousands of people with PD across several countries. The foundation's Centers of Excellence track and monitor the care of people with PD, from the newly diagnosed to people who have been living with PD for decades. The goal is to develop a comprehensive view of the disease and its treatments and other interventions and to determine who can best benefit from them. This knowledge can then be spread among healthcare professionals to optimize care. Fernando Cubillos, the Director of Research Programs for the Parkinson's Foundation, leads the operations of the Parkinson's Outcomes Project. When we spoke, he told me about the study's progress and explained its key elements. Since then, the Parkinson's study has already exceeded its goal of enrolling 10,000 people with Parkinson's and now includes over 11,000 participants.
Fernando Cubillos 2:17
The Parkinson's Outcomes Project started in 2009, and the purpose of the study is to identify all those factors that affect the life of people with Parkinson's. We have 20 participating centers. By the report from the data coordinator centers and the latest report, we have more than 8,500 patients already included in the study. We're covering different areas in the study: demographics, aspects about the disease, time of diagnosis, comorbidities, all those diseases related or not related to Parkinson's, different medications, therapies, including referrals to therapies like PT, OT, and speech therapies. We are also collecting data using a questionnaire for caregiver burden. In the Parkinson's Foundation, we have 40 Centers of Excellence, and to be part of the Parkinson's Project, the centers must be part of the network. So, 20 of those 40 are currently participating, and we plan to expand the study to 25 by the end of the year, and the goal is to have each one of the Centers of Excellence participating in the study. And one of the goals also was to collect data from 10,000 patients, but I think we plan to get a little bit more patients to collect additional data from the previous findings. During all these years analyzing data, we've seen that the more answers we get, the more questions we have. One of the examples is the exercise question, because now we know that regular exercise can slow the progression of the disease, but people came back to us with more questions like, "Hey, what type of exercise?" So, based on these findings, including hospitalizations, use of medications, referrals to therapies, and visits to specialized neurologists, movement disorder specialists, we, with the steering committee of the Parkinson's Health Conference, noticed the need to redesign the form and include more questions in the data collection form that we are using currently. So, we started working with the steering committee a couple of years ago, trying to include variables that we were missing in the past. So now, we recently submitted the amendment to the centers, including those questions that we were missing, and now we'll be collecting dosing for medications. We are going to include those questions about exercise. We included a validated questionnaire about other comorbidities that we were missing in the previous form, and also how the patient is being related to the center, including the management involving a PD nurse or a nurse at the center, and also referrals to support groups. These questions came from the centers, because this is data that we're missing. They want to follow up. Okay, we know the patient needs to follow these therapies. We know the patient needs to go see these other specialists. But what about support groups? What about alternative therapies? What about other professionals getting involved in the treatment? It's in the mission of the Parkinson's Foundation. And also, we're working with the Centers of Excellence that we want to make sure that the Centers of Excellence understand the concept of the multidisciplinary teams involved in the treatment of patients with Parkinson's, but we want to see if that's happening and how it's really affecting and changing the lives of these patients.
Dan Keller 5:51
So, it sounds like there's going to be practical outcome from all this data gathering. It sounds like you're pulling in a whole lot of data with patient protections. It sounds like a very rigorous study that's gone through institutional review boards and all that, and probably respects HIPAA. But what are you going to do? How are you going to disseminate the results? What's the ultimate goal?
Fernando Cubillos 6:10
That's a very good question. What we want to do is to improve care. So, by getting all these results, we want to design guidelines or recommendations in the management of patients based on the results from these outcomes. We want to start with our Centers of Excellence. We are getting results from these centers. We want to implement all these results with our participating centers, and if the results are positive, the idea is to disseminate all the results and all these guidelines to the Centers of Excellence network and through the community.
Dan Keller 6:43
Doctors certainly have to individualize therapy, and doctors have their own mind. But it sounds like this is kind of a lead by example.
Fernando Cubillos 6:50
Correct, correct.
Dan Keller 6:53
Will you be so bold as to tell each center how they're doing in relation to other centers?
Fernando Cubillos 6:59
Oh, it's interesting. We are analyzing key outcomes, and those key outcomes are hospitalizations, falls, caregiver burden, quality of life. We use a questionnaire, the PDQ-39, to analyze quality of life. And it's interesting when we see that those Centers of Excellence—they are good in care—but some of them are better in some of those outcomes. So, the idea is learning from those centers that are doing well in these specific outcomes, to learn from them and disseminate to put everybody on the same line. So, one example is we have a center that is very good with falls, and they have a specific program for patients for fall prevention. So, what we want to do is to replicate what they're doing well, so we can disseminate this information with the other centers and put everybody—all those centers that are not doing that well—up to, you know, the same level with the center that is doing really well, and the same thing for the other outcomes.
Dan Keller 8:05
Does this project have a finite end? Things change in the field—you could go on forever.
Fernando Cubillos 8:10
It's a question that everybody's been asking about. The answer is no, we don't have an end date yet. But as you mentioned, this has been changing. We'll see in the future. We're working with the steering committee and with the centers, with the medical directors and principal investigators, and see how much we need. We have a large amount of data. Some of this data needs to be refreshed, let's put it that way, but it's something that could develop and take us to another level of data analysis and what we can get out of what we already have. But also, there are some questions that probably we're missing and we don't know yet that we haven't explored, but in the future, we probably get there. So yes, it's a transformation of the study. It is a transformation of a big, big project, but not having an end date, from our perspective, could be a good thing.
Dan Keller 9:06
Anything important to add or interesting that we missed?
Fernando Cubillos 9:09
I think that we have to give recognition to the centers and to the patients and to the caregivers. With their collaboration, we're learning more about the disease, and that's what we want. We need to understand Parkinson's better, and the only way to do it is by collecting data and using these types of projects.
Dan Keller 9:30
Very good. I appreciate it. To find out if a center near you is enrolling people with PD in the Parkinson's Outcomes Project, visit clinicaltrials.gov or call our toll-free helpline to speak with our PD Information Specialists. They can answer questions and provide information about this topic or anything else having to do with Parkinson's. You can reach them toll-free at 1-800-4PD-INFO. If you have any questions about the topics discussed today, or if you want to leave feedback on this podcast or any other subject, you can do it at parkinson.org/feedback. At the Parkinson's Foundation, our mission is to help every person diagnosed with Parkinson's live the best possible life today. To that end, we'll be bringing you a new episode in this podcast series every other week. Till then, for more information and resources, visit parkinson.org or call our toll-free helpline at 1-800-4PD-INFO—that's 1-800-473-4636. Thank you for listening.
