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Clinical Research Methodology Day 2023 | Research Methodology | Mr Stephen McDonnell



This on-demand teaching session for medical professionals will provide an introduction to fundamental research methodology and research governance. Led by Mr. Stephen McDonald, attendees will gain an understanding of good medical practice and protocol when conducting research, such as how to get to a clinical trial, research tools, patient reported outcome measures, evaluations, health economics, evidence-based practice, critical appraisal of literature, qualitative and quantitative data, hypothesis formulation, and data management. Attendees will leave with the knowledge to succeed in their upcoming exams and be better equipped for future research including clinical trials.
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Orthopaedic Research Collaborative East Anglia (ORCA) is bringing you the 4th annual Clinical Research Methodology Day! This is a trainee-led East of England Orthopaedics (EoEOrtho) event focused on disseminating research methodologies, projects regionally and nationally.

The ORCA Clinical Research Day is a regional, national, and international educational opportunity to learn basic research principles, to showcase the orthopaedic research going on in the East of England Deanery in the United Kingdom and to have the opportunity to get involved yourself, and to hear from a diverse experienced faculty about their experiences in research and collaboration.

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Learning objectives

Learning Objectives: 1. Understand the GMC standard for research and scholarship and the GMP Six components. 2. Identify the different types of research and understand the importance of patient reported outcome measures. 3. Understand the difference between qualitative and quantitative research and the approaches to both. 4. Appreciate the research pathway and the importance of the research question and hypothesis. 5. Understand the concepts of validity and reliability and how to apply them in different scenarios.
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Computer generated transcript

The following transcript was generated automatically from the content and has not been checked or corrected manually.

And okay. So our next speaker is Mr Stephen mcdonald will be telling us more about research methodology. All right, you should be good to go. So have you got one hand just, just that? Uh okay. All right. Sure. Hopefully the market something did not help. Hopefully the Michael picking up. Um So welcome everyone uh research method methodology. So I'm going to go back to basics to give you an introduction of the foundations of all the pretty much all the other talks over the day. Um The cat has already given us a fantastic reviews, some clinical trials. Um But hopefully, we'll fill in the other gaps of how you get to a clinical trial in the first place. Well, you're all here, I suspect because you've got an exam coming up, that's what focuses the mine um Neil's here because he wants to learn, which is great. Uh But actually, there is a new curriculum which does have research in it published in 2021. And what and what does it say, who knows what it says in the curriculum. So trainees must provide evidence of having met the relevant requirements for research and scholarship that's pretty broad. Uh They understand that GM CSF uh GPC framework broadly in four areas, evidence based practice. So we can talk a lot about that today and actually, that should inform pretty much everything we do in clinic, which I can't go off on a women just decide that some with pain, the hip replacement. But actually, there is some evidence somewhere uh critically appraise literature, uh applying basic research principles, uh basic principles of principles of research governance uh that should guide or research activity. So all of that is very broad strokes and can be pretty much anything. So you go back to the old curriculum. Uh It was a little bit more detailed saying the knowledge of good medical practice is on the GMP six. So I'm not sure if it is a requirement that you're uh but it's definitely worth doing. Uh And uh you can do it online by the Nhrnihr portal for free. There are horses run here in Cambridge and around the region. But to recruit anyone into a clinic is first dipped your own uh knowledge. But actually to recruit anyone into a clinical trial or be involved in research, having that understanding of how to manage patient has managed consent. Uh The principles of clinical trials is pretty important. So I would try and have an afternoon of study lead. Uh get that done probably in your earlier years, particularly when you're here. We haven't department and recruiting problem uh is important thing to do by the registrars. Eventually it on your uh GMP certificate, research governance. We're gonna talk about methodology. What seems uh statistics uh who pays the research is expensive is expected. And the thing that is expensive, people, people, all of those people in that group that VIC have suggested sort of 10 people where their methodology, statisticians, uh clinical trials, nurses, recruitment study cost money. So someone's got to pay. So we'll talk a bit about that. Um Evidence bought it and then the research data bases and we're all judged the X research database. So I just had my appraisal and we submit RNJR data uh to be appraised to understand how they get that is important for your outcome, particularly the FRCS. And that's a pretty important question. I ask most years talk about hypothesis, ethical research and then design of other studies. So all of these a long list to review, what is your sex Georgia? Uh So it's a posing a new question. Uh scientific inquiry, end up learning new facts, um testing ideas and systematic collection of data. And we use that with the research tool kit. And the research tool kit is research methodology, understanding how we sample tech, sample things, understand what data we collect and how we can interact with that data, essentially statistics, making sure basically get any valid and reliable. Um And then someone else does the same study in the same patient So they have the same outcome because it's always disappointing when that happens when someone else tries to replicate. So we see this a lot of people going. So it's one critical trial enough, the same question where we would hope so, it's designed appropriately have the same answer. But there's lots of people that have conflicting out outcomes from exactly the same design type of study with different patient populations. So you need to make sure that it's valid and reliable and then ethics of research. So we've heard a lot I gave this sort of few years ago pre COVID and actually the nine o'clock or the 10 o'clock news for about two years, literally was a research overview every night, number of cases, clinical trials and comes mortality morbidity. Um And literally, there was a research dashboard on the BBC website for two years about the actions of research were and that sort of got a lot of the terminology into the public domain already, right? So basic research, so it starts at the, basically get closer to my friends or basic research starts at the fundamental level. And these are the blue sky thinkers in research, the chemists, the biologists, the physicists um understanding research principles. And that's not what we do in medical research. We do do that in some basic lab based research, but essentially a lot of the clinical research we define as applied research. And again, that's an industry, that's what we're looking at medical search, but it's the same thing applies to any industry. Um whether the agriculture education market that's using patient's uh as the question and, and trying to get the answer, medical research essentially comes into one of two or three areas, developing drugs, uh treatments for disease and the medical devices. And actually, most of the research that we do as clinicians falls into one of those three areas or with a functional outcome to improve patient care. Um and or reduce disease, life expectancy in mortality and morbidity mortality. Um And as like I said earlier, the the role of patient reported outcome measures is seen as the most valid tool uh to provide an outcome. Um and that can often be related to help. I haven't gone into this health economics um with quality of life years adjustment. And is it worth spending the money to improve that? Whether that be cancer drugs, whether it be an operation, whether that be an intervention and then it comes down to the data and understanding the data and managing the data and different data comes from different ways. Qualitatively, what's qualitative qualitative data? Thanks, essence, I can't quantify. So how do you, how do you get qualitative data? Uh So this this, this is this is a really soft type of data, however, really important because it's, it's stuff you can't put a number on. It's not an outcome score of an Oxford Ghi score 36 out of 48 it is um not in America, as you said, understanding, interpreting human experiences behaviors is often in an interview. And it's often looking at a transcript of how patient's feel about how uh their outcome, how they feel about the research process. And this has become much more um important in recent years. A lot of the NIH are now will want a number. I want to ensure that the patient factors are also interpreted because it's great if they, if they had to go through five operations, um take six pills and then their Oxford Ghi score is significantly better. Do they actually want to do that? Is that a better outcome for the patient? But two points on an Oxford knee score um or would it be better if they just had some physio? So you that you need to understand the qualitative inputs of both groups and then quantitative. I mean, this is pretty easy to understand. We spend a lot of time looking at numbers and trying to uh put an outcome to a number uh which is a numerical data describes infers and results problem using numbers on your. Uh is there an improvement? And a big ass is just given a brilliant example. Is there an improvement with your Oxford or your I hope 12 with the hip arthroscopy? So that's a, that's going to give you a number uh and that will give you some statistics and that will give you a significant or non significant difference with two trials. Uh We've worked through the sort of classical studies of a case study. Uh then, then surveys which could be either the cross sectional longitudinal or correlation all. And then we've talked about the strengths and weaknesses of uh different data sets. And what I probably say both are important. We used to swing a lot towards quantitative, that quantitative data. But actually, as time's gone on, um understanding the subtleties of an intervention and the subtleties of uh that study group um is really important. The patient's don't, won't know what the, well, the patient will know what may or may not know what they've had um depending on their blinding situation. Uh But in cohort studies, if it's surgery versus no surgery, then you can't blind, uh not having an operation. Well, you can, if you give them a placebo based trial and that's one of the reasons to do that. But that ethical considerations, the research pathway. So you have your question and we'll get there in a second for the PICO. Uh how do you get it to happen? And this is what I and Vic Ass and George and uh people and Hamza have done on a, on a sort of a monthly, yearly basis is you've got to come up with your proposal. What is the idea? What is the question? Then you got to find some funding. Uh You got to write protocol. Patient information sheet and consent form gets ethically reviewed by an ethical the Iris research panel. Uh Then you've got to do the study and you got to publish the study uh to lose the output and then go around the cycle again. All of it starts with the research question the hypothesis. So we, we um and that's how we reference stuff or reference the question uh to be able to either prove or disprove the hypothesis. We often work with the null hypothesis uh where there's no significant difference between two treatments. So uh we'll go back to Vikas is um physiotherapy versus uh hip arthroscopy for tanase to arthritis. So your patient group and then we can do the PK for that. Um And then using statistics which right in the correct statistics for the group you've got uh you can then see if there, if there really is a significant difference between the two groups because it's already touched on validity. But if you do, if you do construct a study, um then you need to make sure that you know what you're measuring. Uh and that and that um it is appropriate. Uh You're testing what you're thinking of testing and understanding validity. It's, it's not easy to go over it today, but make sure you go home and have a fairly strong definition of two words, validity and reliability because that's a really uh I've seen it asked, what do you understand by the validity as an FRCS or by the question, um It's one that you really need to sort of work on to try and understand and actually if you can apply that to different scenarios, um and, and different questions, reliability is the accuracy of measurement is your ruler 10 millimeters long when you're measuring leg length? And are you accurately, if you, if you measure, if 10 people measure the same patient 10 times, do they get the same leg length difference? So uh is your tool accurate? Um We know that there are lots of ways to uh and that can be whether it be uh measurement of, of sorts or whether it is the uh the prom you're using appropriate pick up. So if you give the same patient the same prom on a number of different days, uh will they give or repeatedly? Will they give, will it be reliable? So that's test retest repeatability. Um If the same person is measuring this inter inter rater reliability is if two people are measuring the same thing, do they get the same result? Um And then is it valued between the two Pekoe? So we study that you think of and the NIH are make you submit a basic PICO has an expression of interest. When you come up with your idea, it really helps you formulate your thoughts in what is your research question. And if you don't take home many things from this today, um take home a PICO as one of those really big take home message is because you've got to really think about any question, any patient group in clinic. Uh There's uh I'm a knee surgeon, knee lots of a CLS. So uh the patient population to get the ACL snap study done last year or published last year, patient's with unstable needs of an ACL injury. The intervention is uh surgery versus physio. Uh the outcome is going to be a patient reported outcome. So, uh they're going to fill in a questionnaire about how they're getting on and that can be a knee score of sorts that happened to be the cu score. Um and then evaluation uh various time points after that, uh six months, 12 months and two years. So the primary outcome comes with two year outcome and that study showed the patient's with unstable. These and then 80 an injury are significantly better uh on who's for two years after uh or 18 months after their uh intervention, which is surgery. So, but I think take that home and once you get the question right, as like I said, if you're asking the right question, then you get a really good study, good. Uh Anything else will fly from there? You ask the wrong question, the whole thing becomes difficult. So the process review, the available literature go and do your literature reviews go and do your systematic reviews can do you're escaping reviews and do Adelphi to find out what, what people think formulate a question come up with an appropriate study design which you can work out from the PICO. But, and the other thing to say about the study design is, are you going for a non inferiority study? This is this intervention is uh not superior, however, is equivocal to the current standard of care or are you saying to study this intervention is better than the current standard of care, which is your control room, collect the data. And actually, I haven't said much about this but collecting data is key lost to follow up gaps in data trash studies. Um Even with that questionnaire is trying to get patients to do their, their promise school. Um And we, we saw this in uh saw this in snap. We know that most people's most patient spent about 90 seconds doing their follow up and when the patient's they'd like doing on their phone and depending on when they did it often, they did it first thing in the morning when Sichuan uh their outcome measures to, to have their needs for it. So trying to make sure that your data collection matches the patient population and that you can get them. You have to be able to get through your questionnaires in 90 seconds. Going tap, tap, tap, tap, tap uh means that you will collect your data. If you've only got 50% of your data collected, then actually you only know 50% of the answer to the question which won't get you, you need 75% and above to make sure that you've got a valid how it comes. It's over the findings and then publish and then you do it all again. And as, like I said, in his talk, they did the whole fake one study just to find out and they haven't really answer the question. They wanted to know which was what happens to the patient's that got a bit of arthritis or thomas to arthritis. So they've got to go around the whole process again to get an answer. The question. That should have an answer in the first place. You don't know that until you've done the study. This is review life, life is easy. So pub med who has access to the med? Everyone, yeah, who has access to the papers that come from public. So don't just read the abstract because abstracts make everything sound wonderful and fantastic and a great output who has access to a library which can give you the outputs. Uh um uh So the answer to that is you all, do you all pretty much either get it through the Royal College of Surgeons, the University library here. University orange, the university library to the UE A or the NHS pay for pretty much all papers. It's pretty rare, not be able to get e mails from people saying can you possibly send me that paper with a pub meddling because it takes two clicks because we're on the university system, which is fine. But actually you can all have access and don't just rely, don't believe what is written in the abstract. Uh pull the paper uh because once you do start doing systematic reviews and start going through stuff in a little bit more detail, you find it all that's great in the abstract that they have mentioned all the biases, the exclusions or the other things which are within the rest of the paper. Google scholar, Google works pretty well. Can find a lot of stuff again, hyperlinked to the, to the appropriate papers and a lot of stuff is now open access. Uh You don't have to pay for it. Uh As you did historically, it's funny come from, comes up, we just wanna come from with people and problems with peer organizations or any problems such as uh yeah, and we'll see about the process. You're straight hospital, charitable trusts, hospital, charitable trusts, a charity, big sort of uh disease based charities, big sort of funding versus arthritis, big funder uh Royal College of Surgeons. Actually, they're the conduit to other charities, um industry or MRC big research councils. So there's, there's all sorts of places. Um and it actually doesn't matter. We've got eu there that you, it used to be hopefully said, well, we'll see where we are in that way. But when I used to give this talk, we weren't sick on to begin you grants. Uh We're not seeing require as many but um uh the UK NIH AARP find a huge amount of research. They have 1.6 billion a year to put into medical research, uh which actually all they need is is pretty underrepresented despite um the patient population, patient needs. Um but MRC Research councils, the colleges, so there is funding out there. It is hard. It's uh yeah. So um we are currently opinion a grant application uh for and it's uh hrht A and meals uh grants in the past and even if you can answer that question. Uh and it is for ACL reconstruction versus repair. So that the two, they're the two groups for a two year study. Um With all those people mentioned in the uh there is actually not many patient costs because the actual standard of care, the MRI is that the patient follow up, the surgery is all picked up by the NHS which because it is a standard of care. Uh We are just looking under a microscope of those two patient groups. Uh It's 286 patient's probably 10 clinical trial center or 10 centers across the UK. And the funding is about 1.8 million um with match funding by the Australian Research Council, with another 1.8 million to do the study in Australia as well. So that's a 3.6 million talked to that question, which is a lot of money. However, if you take a step back and think about it's a lot of money to do those operations if they don't work. Um, and we need to ask these questions because industry isn't regulated. They can say you shiny device which is going to make everything better. They don't have to prove it's better or not. They can just provide that to you and the director to come and tell you to use their new widgets is going to solve all your problems and be fantastic. And we love that in a minute. We all have patience to do wonderfully with them who have patients that don't do quite as well. But that's probably just because we put it in my or do. But actually as a, as a group, you either take the registry to answer that question if you have a robust registry or you've got to do a unbiased clinical trial. But the patient's don't open that hand because the patient's can be influenced by the I have this new super duper widget operation. The devices, uh devices are different than the threshold for medicines is much higher. Um but I mps, but the device is pretty much you can do what you like as long as Scott Ce Mark. Um whether they work, whether they don't work, this has caused problems in the past past with implants, which is the, the hips and you're going to hear later, I think about all of the, the, the detailed microscope registry stuff that goes on with, with joint replacements now with Odette to understand how they, how that we now are much more careful about introducing uh implant into the, into hospitals and patient's because, uh they didn't have to have a trial proving that was better. They could just say here's an you shining knee replacement is going to work wonderfully, um, accepted six years that were falling out. But there's only one falling out in Peterborough. There's one falling out in Cambridge was one falling out of knowledge and that will be falling out together. You wouldn't know ethics. So you might think it's a good idea and not a problem to the patient and it wouldn't it be wonderful. But you've actually got to convince some others that it's safe for the patient. Uh The ethical uh ethical review, the RS for uh is the patient's advocate. They are there to be lay and to make sure that what you're doing is reasonable and safe for the patient. We've talked about doing your GCP. Have a look on the NH our website, do that, make sure that you have to have done that to be involved in research. And actually, it's a good thing to do for everyone. It is compulsory, it is compulsory. Uh You can't see CT without it and you will have it on your way from Checkers. You JC hang on. So um researchers reviewed by the HR A uh to get hr a approval. Um and then you have your local research officers and you pretty much have to go through 33 checks before you can get what we call a research green light. You get your R as application which is making sure this is safe and sensible and is appropriate for the patient's. They will review all of your patient, patient documents such as the consent form, such as the patient information sheep. And that means means that they make sure that things are balanced and fair. Also, if there's a reason for complaint and patient safety, um they make sure that you've got insurance in case patients come to harm and they make sure it's a totally funded by a sponsor hr A review. Um And then local R and DHR A means that you're not using hospital resources uh to run a research study which are appropriately funded. So what's in the protocol? And actually, it's a pretty easy thing to write once you understand the headers because you just fill in the gaps. So who's doing it? What is your hypothesis? What is the background? What do you want to get is your objectives, your design, your primary and secondary out which patient's are doing and this is like a peek. Uh And you just transfer this from your PICO to fill in the gaps who are the study participants and where you're going to get them from where, where you're, where you're identifying them and recruiting them from who's in and who's act with the exclusion criteria. And that could be age bm I gender language. Um However, there is a big push to try and include non uh represented groups and research. And so if you do have a reason for excluding people, then it has to be a valid reason. You can't just say uh we don't want to, everyone has to speak English because we don't want to have to produce the different uh patient information sheet. The NIH are will throw that back to you. So you need to produce uh an appropriate uh population sheet for the population we're looking at. Yeah. So and actually part of the PPI and Ed I inclusion is making sure that underrepresented groups are who do not have direct access to healthcare and research are included in research. And so that's a big push. So we're spending a lot of time trying to work out how to include people that, that may not be that interested in research. Uh We talked about outcomes interventions, safety reporting and then trial steering committee and data Safety Monitoring committee. So if you do set up this trial, you might think it's the greatest thing and safest thing in the world and be running it and have some problems along the way. But actually having wise words and wise advice is helpful and there's two groups there that, that's making sure that the data is safe. You don't, you don't know that, that what's going on within the study because you're blinded as the investigator, you don't see the raw data coming in. You don't know if they have the intervention or not had the intervention but the data Safety Monitoring Committee or see both groups of data, uh un blinded and be able to give you an early warning and actually give, give the the safety uh an early warning if there is a problem in one of those groups. And a number of studies have been stopped early either because there is because they're causing harm in one of the groups. Uh And then the trial steering committee tries to help the, the study uh improve their recruitment, improve their safety and get the, get the study over the line because as we said earlier, there's a lot of money invested in studies and studies are pulled that just pulled uh the cold weather. I mean, the, the meniscal, it wasn't, wasn't meniscal needles going on. It just pulled the, the Kandra guide study which is Condra guide for uh osteochondral defects. And actually recruitment is very slow. People's practices have changed. They had a comparative microfracture of people weren't really doing micro fractures. Uh So this started in the underground despite, and it's, it's much harder to stop a study when it's going uh than before it gets funded. So we talked about the Data management committee. So what about, uh, one of these things you read in the New England Journal, stem cells for knee osteoarthritis who's ever heard of stem cells from Nielsen arthritis usually get some daily mail. So, is there any evidence? And so this is a study were involved in, uh, which, which hasn't published yet, but we can talk about the design of how you, how would you prove that stem cells for osteoarthritis? Were this is out of power to a face to be prospective multi center, double blinded, triple, um, randomized versus placebo trial. So, what the heck is going on there? That's uh injecting either two times 10 to the sixth autologous adipose derived mesenchymal stromal cells in the treatment of multi moderate oh A in the need active unresponsive to conservative release 12 months. Wow, that's a mouthful. So that's the sort of title that gets written at the beginning. But what does that actually mean? So, to be, um, so we'll look at that prospective means that you're going to pick up the population and move forward multi center. Yeah, we can get that lots of places. And this is a Pan European study, double blinded. So, um, everybody doesn't know what's going, what, what's in the tube. So you as the surgeon don't know if you put themselves in and the patient doesn't know if they're getting cells triple arm. So that's three different groups of patient's uh versus placebo. So to be, you're going to hear about this later and you should have heard about this on vic asses trial about what are the different phases of clinical trials. So phase one is the safety studies. So if we're going to inject into a sense and these are the ones that are done with patients that are monitored very closely in a hospital environment to make sure that they're not having outcomes. Uh who's, who's ever heard of Norfolk Park? Yeah, they gave, they gave experimental treatment and they're all lined up in a row. I think next to each other in about five or seven m. So that massively changed, that massively changed the way. So look at, look up the north work part. It's probably the early two thousands when this happened and we have a, we have a phase one clinical unit here. Um And essentially it, it changed a lot of things in this phase one research. So this is a safety study where and it can be monaco an anti political. The medicine can be an imp for a stem cell is an interventional medical product that is given to a patient. And then they're watched very closely for a period of time to see how they get on. Um what happened? There was as you say, they, they, they didn't have a staggered enough approach to giving it, they gave it and then they gave all of the seven patient's lined up in quick succession when had a coffee and as the first patient was crashing, the second patient had 24 minutes before they crashed. The next one was uh 20 minutes and literally was um all of the phase one studies are connected now, uh you and have research facilities and um the regulation amongst those has changed a lot. So this isn't this, this isn't that study, but phase two is working the effectiveness doting. So this is what this study was about when you give, I think it was uh about 3 million or uh 6 million stem cells to try and have an efficacious as a response. So this is an efficacy dating. And then you go into the phase three studies which are hundreds and hundreds of people to sort of get population response to see if that treatment is effectiveness. So this is uh to be means that deciding progress into a phase three study. Once you've got a, once you got the uh safe, once you've got the um at the dose, right. Again, 150 patient's three groups, first groups, control group. So they had a harmonic acid injection into their need or they also had because they control with the Shan liposuction. So they went to theater, had an incision on there. After then, they had the uh the trope are inserted into their abdomen for the for the liposuction they had, but they didn't have the machine turned on. So they had a, they didn't collect anything and then they had a package which essentially was nothing, scent wasn't sent. But, uh, everyone thought that they were having a procedure so they had a surgical procedure. So that takes quite a lot of ethical, uh, persuasion. And the funny thing was the ethical panel. We're completely fine with it because that's the only way we can prove there's so much hype around send themselves and whether they work and whether there there's gonna be a good output um that they were, it was clear to the ethics and clear to the patient's would have to believe that they had a product um in order for them to be able to truly test the, the hypothesis. And then we came to the to other groups and this was not thinking 10 sites across Europe and €8 million or €9 million uh standard inclusion exclusion criteria and a primary outcome of pain and physical function at six months after injection. So, I mean, it seems like a very blunt tool to be able to put €8 million on whether the pain and outcome is uh a secondary questionnaires. Uh Up to a year, we were collecting detail MRI data um as a quantitative value uh from the structural of the joint, but a lot of money spent on pain and physical function. Again, serious adverse events collected. Um And there were a few and then you've got to understand recruitment. So where do these things get published? Who's published in any of these journals that Neil has? What are you publishing now? Um published? That's in my view. D studying uh general, general. Uh BJJ. Fine. What's the impact factor? Uh 5.3 now, probably we'll get that okay. Any pain when I was population? Because my publication definitely we'll, we'll talk about how they get there. So you can either be a general specific open or and then thinking about the impact factor who reads it. So it's all about the citations, these, these get referenced on citation index, other other journals, referencing, other journals, get your publication up. So the BJJ has worked pretty hard publishing systematic reviews and uh has driven its impact factor up uh primary research. So nature had an impact score of 41 in 2014 which probably when I wrote this talk. So BJJ Impact Factor. Now this is, did you say uh you were listening good uh JB Jazz America, right? It's about, it's about six, I think a JSN American General Schools nights in seven. I don't know, actually lanced uh a very good, very good. This is the whole time I looked this up this week. Actually, there's a whole table that I can make 22 different lots of journals, lancet oncology, lancets, Genetics, like Microbiology, lancet Global Health. Uh So there you go. 202 is the lancet current relation. Uh BJJ five is actually for, for, for quite a niche job specialty is pretty good. 96 BMJ. 96. So I always got, I don't know what the impact back to the Christmas BMJ, but I'm sure it must be higher in that one journal. Uh Anyone want to write Christmas BMJ are. So we didn't, we didn't try with a big uh big, big uh we didn't quite get quality of obligation. Good. Any questions? Okay. So, so hopefully that is, that is an overview uh today, essentially, there's gonna be more detail on things like statistics and clinical trials and levels of evidence. But that should give you uh an idea where the pigeon holed these things. Um For the day. Brilliant, I'll see if there's any questions on the chat or is iggy moderating any questions on the chat or smoke? Thanks. Thank you very much. I contribute that, you know, hoping after all before, right, any questions and guys, if anyone does want to, I know you're gonna have some talks later about sort of research plans. And uh if so, I have to say after once you've done a 500 the replacement, they also incredibly boring in the same uh having a portfolio career and having other things to do in your week uh makes life interested, not just for the first five years if, but the next 25 years as a consultant. So having sort of research uh direction is a good thing to do. So definitely carried anyone also haven't had a chat. Uh Andrew, it has to operate uh about some research products. Uh Sometimes uh there is no rush to finish. Uh You will be fine in your clinical data. Uh having other stuff in your, in your uh very good. Uh uh So uh non academic uh clinicians, I mean, Neil runs a whole bunch of studies here. Uh Multi center, national collaborator uh gets you to know, able to be confessed another uh societies. So, uh yeah, they've got, will, will, will you hold the associate the Ice Tea for Meteor, which is a municipal Trump believing, say all these national trials that take especially the trauma trials phase. So she get GI scheme nowadays. So you have to have a GCP for that and then that sets it apart from just recruiting five patient's all the uh the CT, it actually also gives you that kind of understanding of research technology before you go. It's absolutely uh actually, uh I need your secret. Uh it's not discriminated uh having all these other things on your CV. Uh it's a much more useful discriminator. Uh Okay. So it depends on the study. So it ha your hospital. So you, you could be the confidence. So if there is a national study again, so let's make proper to uh hush that are going on control. Now, you know, they're going to uh get your hospital. Uh one of the consultants leave. Uh And you say I'll be uh but the A piuse it was uh six. you need to have the uh we want to create. But yes, lots of reasons uh range, unfortunately not empty hospital. Eight point you are migrant recruitment trials don't work. And Steve mentioned the travel uh because it, it decreases uh two or three reasons not be it. Uh Just before. Yeah. So all these happened. So I just mentioned to massive trials proper, too hush across the country. Trauma humor, sharp practice, proximal humerus practice. Really coming up that yet we're not able to group with, it's really tight and uh studies that come to their clothes anyway. Uh Just about the same probably to mayor can get 95% of its uh you're getting 218 patient's. Yes, recruitment is the lifeblood of any study and all that you need to have dedicated time. So I think you said t money and time are the three things that I would say take away. I'm going to summarize that. I'm going to summarize that for the benefits of everyone who's signed in remotely. We'll talk about team money in time has been crucial for studies. We talked about portfolio careers as being a massive advantage and about checking out the associate P I scheme as well. Um I think you need to be in situ for about six months to register as associate P I. Um And we've just been discussing that you need to be um you need to register your. Yeah perfect. Ok think he's gonna cover that later right.