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AOSSM 2022 Annual Meeting Recordings - no CME
Multi-center Research Groups: Basics and How to Ge ...
Multi-center Research Groups: Basics and How to Get it Started
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Video Transcription
Thanks, Jim, and thanks, Rick, and everyone for involving me. I think this is going to be a great session, and hopefully we'll be able to share some good things. Here's some disclosures. I guess most pertinently is I've been involved with Moon Knee, Moon Shoulder, and Mars since their inceptions. Rob Brophy and I, about 10 years ago now, looked back at just to look at collaborative research in medicine. It was very interesting because it was relatively novel in orthopedics at the time, but when we compared orthopedic surgery to other disciplines, internal medicine and the other surgical specialties, we actually found that orthopedics was a bit behind in terms of doing collaborative, multi-centered type studies. Certainly, in the 90s, we had the LEAP study that came out in trauma. Moon started in the early 2000s in the sports world. We have Metric that started in the world of trauma in 2009, but unfortunately, a lot of our research 20 years ago was dominated by small case series. So why do teams research or multi-centered research? Well, the main thing is that data is powerful. More patients equals more variables that you can analyze. More surgeons that are involved, it's more generalizable. You can increase your production. Working as a team, you have more researchers to take on different questions, to write papers, to do different aspects of the research. You often will have people that are very good at one aspect of research and not very good at the other, and so working together, you can fill those gaps. And collaboration, quite honestly, can be fun. You create a network of research colleagues and that fosters ideas and studies. So getting started, the basics, you really need a question. You know, what is the question? What is your problem that you're trying to define? You know, we'll hear this from all the speakers here later today that define their question, but, you know, for example, what's the long-term outcome after ACL? 20 years ago, we really didn't know that, and we're still figuring it out today. So multi-centered research is really great for clinical problems or outcomes that are considered to be relatively uncommon or at least considered relatively uncommon at the time, and we can argue that re-tear after ACL or osteoarthritis after ACL or re-dislocation after shoulder instability we thought are relatively uncommon, but as we do more and more research with more and more patients, it's probably more common than we thought. Next thing of the basics with the group, you need a leader, and you need a leader with some strength and motivational capabilities. They have to be able to assemble the group, keep the group focused, steer the direction of the research, very importantly, get funding so that the research can be viable, and be good at herding cats with big egos. That's probably the most challenging part of team's research. As you assemble the groups, it's often researchers with common goals. You need members who can leave their ego at the door and put the group effort ahead of their own efforts and goals that they have for themselves personally. They have to be committed. So there should be rules about a group, you know, staying in the group, being active within the group. So attendance at meetings and on research calls. For instance, we had a 6 a.m. moon shoulder call today that Jed set up, you know, being available, participating, enrolling patients, filling out forms, writing, editing, reviewing, and then have some consequences if you're not able to participate in the team effort. Plan for regular research meetings. Just again, based on my experience, we've been having moon knee and shoulder meetings in person two or three times a year now for almost 20 years. We have monthly 6 a.m. calls to update the group, to talk about ideas, and to keep everybody in line. You have to determine how you're going to collect your data, and this can be anywhere from paper Scantron forms to red cap forms, and certainly in 2022, a lot of this is electronic, and there's a lot of mechanisms now that are a lot easier than they were back in 2003. You have to determine where the data will be stored and how you're going to pay for it, who's going to enter the data, and then who's going to make sure that that data is correct because inevitably there will be problems, mistakes, or things that need to be, quote, cleaned to make sure that your data is accurate and what it needs to be. IRBs, so multicenter research creates other problems. These days we have centralized IRBs, but that was not the case 10 to 15 years ago, and every site will have slightly different interpretations of the research plan, and someone has to be able to, capable and willing to manage all these different IRBs at multiple sites. You have to expect issues and problem solve. That always comes up no matter the research, but there just seems to be bigger problems with teams' research. After a trial run, modify things early. You can't do it later after you're into the study substantially, and err on the side of including more data than less because down the road you may think of something that you wish you would have included, so be more inclusive. The money. How is the research going to get paid for? You need a data hub or a data center, a primary research assistant that's kind of overseeing the study with the PI. Grants, determine the PI for those, industry support, society grants, and basically every participant's probably going to have to find a way to support the research with their local research assistants and so forth because obviously no matter the funding that you get, you probably are not going to have enough. Start small, aim big, figure out where that money's going to go, study coordinators, statisticians, money for patient follow-up. Researchers seem to be a lot more interested in following up if you give them $25 to $50 rather than doing it for free and then do things for your meetings. Here's all the different funding sources that we've been involved with with our Moon and Mars studies. Here's all the different staff that have been involved in the different Moon studies throughout the years for knee and shoulder. And as you get going, consider doing some validation, so defining things. You have different surgeons with different training backgrounds. You need to establish some group consensus on defining pathology. Evaluate how that group agrees on evaluating and treating that pathology. So listed are some of the studies that we've done in the knee and the shoulder. Just looking at how well our group agrees and defines things so that apples are apples and oranges are oranges when those papers come out. Define your rehabilitation. So part of it is surgery, but also part of it is a postoperative care if it's a surgical study. So make sure that your patients are being rehabbed a similar way and use some evidence to make sure that it's done appropriately or with the best evidence that you can provide at the time. And then once you get started, there will often be questions about how are things being done within the cohort. So in both Moon knee and both shoulder, we have done validation studies just to look at, for example, where are our tunnels? So we have patients that are getting trans-tibial versus medial portal versus independent drilling. Are those tunnels the same way? Are you doing the surgery the same way? So be able to validate what you're doing for an instance in the knee. And we did the same thing in the shoulder because we have beach chair and lateral decubitus patients. You know, are the anchors in the same place? Are we looking at the pathology the same? And are we able to validate that what we're doing is what we're stating in the research that's produced? So in summary, there's a lot of preparation that's needed. You have to be patient. It's a long haul. There's a lot of bumps along the road, but it can be really rewarding in terms of production. Your practice can alter. You can do practice altering research and some of the things that have been determined through these teams' research, allografts and ACLs, outcomes in 10 years and so forth. You can develop a lot of publications and presentations for the group as a whole, which is very rewarding. And then there's just a lot of friendships and collaboration that is very beneficial to everybody down the road. Thank you very much. Thank you.
Video Summary
In this video, the speaker discusses the importance of teams' research and collaboration in the field of medicine. They highlight the benefits of having more patients and surgeons involved, as it allows for more comprehensive data analysis and generalizability. The speaker emphasizes the need for a leader who can motivate and steer the direction of the research, as well as secure funding. They also discuss the importance of having committed team members who can put the group effort ahead of personal goals. The video touches on various aspects of conducting multi-centered research, including data collection, IRB management, problem-solving, and funding sources. The speaker concludes by emphasizing the rewards of team research, such as practice-altering findings, numerous publications, and the development of valuable collaborations. No credits were mentioned in the video.
Asset Caption
Brian Wolf, MD, MS
Keywords
teams' research
collaboration
medicine
comprehensive data analysis
generalizability
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