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for that you can fall into once you develop your protocol. If you don't know exactly all of your outcomes up front have designed them. You can end up collecting unnecessary danger in your data collection forms. So trying to avoid that doing all this at the same time, if you can, I think it is a really good So, yeah, just in conclusion. Then there are a number of key resources for writing practical to look at online. Read about is definitely a team effort when it comes to clinical trials and you need input from lots of experts. No see compliant, separate key to achieving good, strong results. Thank you. What you've got online through your job. Now talk electric, removed your woman's health, and I'm just going to current for Adam left off. And I talked about this much of you particles. So you have objectives for this would be understand why we need to write a systematic What we need this political force system are to review who needs to write their their needs to contribute to it. I didn't like e elements. This is the magic of you protocol and then I'll just touch it common areas that I made and how we can avoid making. This is a very so first off. What is this? Too much of you? Protocol. So this is like the full review plan. It includes descriptions, off objectives and the methods off your system Metric of you, and it's often registered a published before completion of the review. So why do we need us to march of view protocol much give you pretty cool presents the y would on how so rational, objective methods of the review. It also helps the voice research way. So if we publishers two magical view protocol old and someone else who is impending on doing a similar research, concede that this already existed and saves them having to go through the same process off running this magical, it's already being planned on one is already being done. So your voice difficulty in a difference promotes accountability. So when you publish your findings at the end of your results, I'd end of your so much of you and it doesn't match up. What is you said you were going to do? Then you can you know. It allows the scientific community to query that So why did you change your recent metal? Continue on dialysis plan If you change your um so it helps for the council bility. The key elements of this is too much of you protocol. So the title needs to be clear. The title needs to be clear, focused on well defined, so good systematic of you Title is Know something like and, um, uterus is, um, in pregnant women like it's just too vague. You need Teo. Define your system. Are you that you're taking is to be clear for was the well defined and it's identify your protocol, a systematic of you and it should not be a question. So that's often something that gets done used to much of you. Title includes a quest to retract that included question the next care to make of a review. Product protocol is the background, so you stop by describing the condition was a burden off the condition in the population of interests. What current guidelines say, Oh, best practice on was a context under which you are based in this puts call for your for your readings. So what is your rash know what is already known and also what what the existing reviews currently say. If there any existing reviews on this most importantly, what is your systematic of you going to add? If it's just if it's not going to contribute and out of the literature, then did you think about what you need to do? Okay, so this please back to the throat to the to the title on. But it's good to have a name that you can define you because of your records. We such questions your population intervention or exposure comparison compared to outcomes on a type of studies that you can't including in your review and that should help inform you'll title the title of review. The next key element of critical is the methods and in methods way. Like I said, before you describe what it is you're going to exactly doing, most importantly, sets out the search quite so you start to stage it stop by setting your search quite terrier. So what sources I going to search? What strategy going to use, what the inclusion exclusion criteria for studies and you need to be explicit. Need to say this is what you're going to do, and I'll leave it with your open ended, you need to list your outcomes are kind of all comes I interested in capturing on what are the steps for study selection. So the most replacement is a two stage selections where you first came in, tight it out, abstracts and then you screen full text and how we resolve disagreements will use any software to do this. What data would be extracted? Will you pilot the data extraction form on how many independent reviews will that be? So everything about it in an education contacts not always possible to have two independent reviews on that is fine for doing this for a dissertation. Uh huh, Master's master's dissertation or on the ground in the station. You talking to say that you do this in your lap? Just another invitation in the fact that you're conducting this review on your own for your degree. Well, it's good to know. Address that even it open and the what quotes the assessment for risk of bars of studies. You. I do get how many views notice with. Typically it's my change in your ears. Are you doing this on your own military analysis, planting me to describe the method to be used to go into the narrative synthesis or what? And I said, using a fixed, we're under the six bottle on. How would you report to Geneti? We explore publication bias. What is your private dialysis going to be based on what you do subgroup Analysis of sensitivity. Nice is So you think you need to included in your protocol. Um, and then just off the back of that water, the common mistakes first of, like, high dose already pointed to find questions. Um, your question needs to be appropriately defining. It speaks their, um I cannot stress that it off. Um, if your rationale is all based on previous evidence, you cannot want to do a systematic of you because you just feel like you're in there. You need to lay the foundation. Show what the correct insistent evidence. I leave it up to the point where you need to conduct us too much. So to move your post hole. Based on this, oftentimes, a lot of details on how the review of feeling sick current existent evidence and it just feels like it's old. Um no, the back of that. No teachers on what the review will add again. You know, having informational you said Structure will be so since you're going to search in thinking about students were doing this for, But it's a great degree or master's program where they have to write the station. A station with this much, uh, dad's company. Within three months, period, it's you can just If I search, it's just copper and think to basically just looking for under my country trials. And you can say I did this because I'll give you some time. But you need to be Clarence. See that this is what you've done this and then the included and right here games a way to express it in detail. What your conclusion, Um, and then the last two points here. You also find quality assessment being done using tools that, you know, match type of studies included. So you might know here we discussed a tower still or on the coq. A risk of bias assessment tools we need to do is the right tools for the right type of studies are being with this study. Don't just use any quote assistant to just because you've heard of it, it's too much at a Constitution cycle. Tito could have been your sentences so it wouldn't make sense to have a systematic of you. Say you include, um, case control case series or case studies and then wants to metanarratives on that little it Together. We called studies because those two types of studies designs do not fit in trying to in God since sized data. One key thing after like it so much the school is making it public. So how do you make pro school public? It's just some of the ways that I'm or come on, you know, a more popular in making your PSA prostrate is a registry in critical registry. Um, it's asks for 20 basic details in terms of what you need to have for your post course of those going to use. My keepers are saying right in. Reports call for publication in a journal or in the right of Cochran. You've you protocol. So you find that there is This is like this. Oh, in terms of how detailed getting to provide in writing a protocol, because from these two more detail that you go down this list, um, that the prostate, the hospital put possible databases quite used. You can send you so before you started under. Think your depo stop going to review your country review consist the take the base to see whether or not they are similar reviews already going on. Who is. This is not as use a friendly because you can register literally any kind of study. You know, it's if it doesn't have to just be it's too much of you for a scope. It's open source. It makes it quite good. And of course, you can search any off there. Uh, generally BMJ open BMC so much Refuse that except protocol. So not every journal be happy to publish a protocol was some girls are now the guys the rights of school days that Prisma pieces the prisoner. Very put in, I suppose, to much of your medicine possible so tonight and checklist. It's a guy to help you, right? You approach a couple so it's a guy to help you report. Report. Your system obviously is quite useful to be aware of, um, on, but that's you're not free. I I think I've just one more thing we'll do was take questions from the room does any any like that in issues around puts call designed for a systematic review or clinical trials. If you've got protocols trying to write right now, we'll get published and you stopped somewhere we could feel them is all. I think it's just like a yeah, questions in line question. Was it what? Please them? It it? Yes. So, um, you do a systematic review off Systematically, you said, is it goes back to the studies. Are all kind of stories. Are you including in your system? A trick of the few intention is to do. It's just a matter of you off systematically. Then you concludes too much as your your studies. But if you're interested in clinic primaries, probably studies. Then you wouldn't include Sister March something just did you have one? We kind of at the studies that this is the much review included. So it's It's too much, we found had included studies in the analysis. So if those if that's it's much these relevant for your sister much enamel. Is this the studies Within that system, much review might be relevant to you, so that's what you should consider it, including so you when you're doing your searches for your papers for inclusion. It's common practice to also screen existences to match reviews or previously conditions too much in seeking screen the past. You identify relevant articles that don't include that in your system, but you don't include the systematically that was conducted. Well, that should do it. This is the magic of you so much, I think. Also called brother Review. Yeah. So I think you didn't want to the next room. Thank you. Thank you. Gently, everyone. Yeah, never. You have a headache. Go back to the beginning for it's like around the whole day. Just did it. Yeah, time tension. So great. No, because it was an hour it started. It started, all right. Three months of twenties But I think it's It's obviously right. Thank you, everyone as Catherine to just don't say it's not. It's add, um, develop. Um, Elektra. Maternal Have a child who university, and I'm showing this session we've done our T wave in. This will be covering both our wisdom on day knowledge of both developing exotic travel to call in a systematic review protocol. So the way we're structure is we'll have some slides to present, and then afterwards we'll open the floor questions. If you have any burning about projects, working or anything general to ask. So what is a clinical trial protocol? So the the International Conference for harmonization on Good Clinical Practice, which happened quite a number of years ago, now came over this definition are for a clinical trial protocol, which is a document that describes the objectives, design methodology, statistical considerations and the organization off a trial on the upshot of all this is that it's researchers. We have a distance. Great results, which is the spirit statement for the development off our clinical trial protocol. So what? This is a set of recommendations that you can easily follow to ensure that you are including all the relevant sections within your protocol to do it here to those international guidelines of what needs to be included in your in your protocol. So when you're developing, your protocol is, this should be the first place you go to to make sure that you have all of those sections within it. So why do we need a clinical trial practical. So first and foremost, it's to instruct the house care providers and study coordinator is exactly how to conduct execute the trial. Secondly, it is there to ensure the safety of the study participants on also to ensure the integrity of the data that is collected throughout the trial. One of the most important aspect is that we are documenting what our primary outcome is in the trial. So that is the measure that we're using to define the success of the trial. When you're comparing one intervention group to the other on, we also use this protocol to state what our sample sizes on opposite. Obviously also the subsequent statistical power that we're hoping to achieve. One essential thing that you need to do once after you developed your protocol is to also register it Perspectively s. So this is very important. Teo Transparency Teo Development process. Before you start the trial, you are stating up front and making it public that this is the trial that I'm doing. This is this is what we're trying to achieve. This is a sample size. This could be done it. So my like medical trials dot gov or the eye. It's our CT and registry, which is what we use quite a lot in the UK on. Certainly when you come to publish your findings from working, we'll try one of the first things that journals we do. Look at that registry to make sure you have registered before you started the Requip Mint. So who writes a clinical trial protocol? So the person who tends to leave this is the chief investigated. That's the person leading the trial. But you will also need input from a lot of other people. This will include statisticians who will help with determining the sample size based on what the literature says out there in terms of event rates. Other experts from the from your clinical area, they will help with some of the practicalities of making a pragmatic trial designed so that can be delivered on the ground at the hospitals or or wherever it is that you're conducting your trial and then also, court trial coordinators or managers can also be useful to input into your protocols because they're very experienced in the oversight and management of the trial on again, making sure that it is, it's feasible to deliver. It's another thing important thing to consider it reach clinical trial protocols so obviously the hospitals or other healthcare settings where the child's being conducted, they will be reading it only to understand that we have to follow it. If it is a drug trials control of the investigation of additional product, that competent authority in the countries where you're carrying out the trial world will be reviewing the protocol, it giving their approval and also the elephant research ethics committed that will need to give them a fruitful. So some of the examples here more focused around the case and Health Research authority another any chest management. But again, if it is a drug trial, been drug manufacturers may need to have him put into it. So this number of different people that will lead to have oversight of the protocol, certainly to make sure that you're following over all the guidelines to ensure each of these sections that over quiet, all of that ever written correctly, so obviously paramount importance in trials. It's pretty cool compliance, because adherence to me is is imperative to make sure not only maintain patient safety but also try quality on. Once you have been started trying to make sure that any deviations are documented so when it comes to the design, you want it again. Make sure that there isn't the ability to deviate too much from what you're what you're trying to do on. That's where I think having a good, pragmatic, designed trial in the first place that pragmatically designed protocol. It's very important, Um, so again you can doing the child make amendments the's office you need to plant, and then you need to go through the relevant approvals for any changes that you may. But they used to be really important consideration toe any, um, amendments that you make. There are sometimes need for urgent safety measures that come in cancer ound new information that comes out for a particular drug, for example, that you it's part of your trial. And again, amendments could be made in a rescue lated manner should those arise. So just gonna conclude with some of the top tips that I think hopefully I can pass them from my experience of working in clinical trials. First of all, it's very important to conduct a thorough literature research to understand event rates for the primary outcome that you want to want to look at your trial unequally. surveys of key stakeholders are really good. So you just participated in something similar. See, stay safe study down there. So this could help me to determine what is a clinically meaningful difference as well as what was the most appropriate program comes. So that's what How do you determine if you're looking? Want to be looking for a 5% or 10% difference in between the two groups that you wanted to compare? Um, nothing. I think he's a really good idea. If you cut the capacity to do so, it's actually think ahead to what your final A publication tunnel like in terms of the tables you want to include. And this will help me to plan both the primary and the secondary outcomes on then. Also, if you I have any key secondary outcomes that you want to identify and you can state those within the protocol is, well, screw that kind of thought process and also this It's slightly aside from critical. But I think it's also really good idea is to develop your C. R s, which is your case. Report Form said that the tools he used to capture the data develop those at the same time is the protocol. Boys, your panic, all your outcomes, that way you avoid one of huge pitfalls in in clinical trials is, um, collecting a lot of data on forms that are actually are necessary. And don't end up being put into your and you'll find publication, which can sometimes compromised the data quality. Because if you've got very thick crx that researchers need to fill out that it does impact sometimes and you end up getting either feels not completed or data just not quality data that is entered, it isn't as good. So I think that again also helps to have a really tight protocol in data collection. So just a very brief conclusion. There are a lot of resources online to help with with protocol development. It's certainly a big team effort, and you need input from lots of people on your compliance is keep to achieving reliable results. Thank you. 100 which is gonna is gonna talk through Strattera particles. I think we just go to this much of your politicals and then afterwards we'll go to the questions. So you say I'm John Computer Club. It since for Global myself in permanent. And, um, this is going to just be a way. Teo highlight why we need. It's too much. It's cold. Um, identify what we should look for in it's too much of you political sort of kill a minutes and then maybe just point. I will couple mistakes people tend to make when development. It's too much of you put school nights, it's too much review, put school, and, um, I'm raising which we can avoid these common Paris. So what is this much of your protocol? So this is the the full research plans that is the review plan. It just it'll Descriptions of the objective methods off the systematic review on it is awful registered or publish before completion of the review on we Need is the magic view protocol because it presents why the words on the house or the rational objective on methods of the review it helps avoid recent weeks. We don't want to be doing what that something else is going to be doing only afford duplication of efforts. If we know that as a review that's already being conducted else. I know the group then saves. You know, there's no point in going to register you protocol to do to save you and also promote accountability. So it's it's a way of checking what was planned with you find out from a review, uh, was So what are the key elements office? Too much of you protocol. The first thing is a title. So we need to have a clear focused on world to find title, which needs to identify your protocol. Loss a system out and it should not be a question, just much. Your title should not be a question so moving on Teo the next element that's too much of the protocol background. So you stopped by describing the condition of interest. What's the burden? Burden off the condition of the population of interest or the current guidelines of what's best practice currently on? Then what is the context of existing cares? What's existent evidence say then what? You're wanting to do this too much of you in the first place of what is already known that it any existing reviews on the Stop it and what go your review? Add to the literature and evidence base. Next is the aimed eso the and that helps to develop your aims around your pickles in your records, or what's the population of interest? Intervention of exposure of interest here. What's a comparator? You're welcome on that study is that you plan on included on your methods. You might as like, I said, describes the whole entire it'll want to use you doing. So you stopped by detail in what your search quite here will be. What sources are you going to search for? Strategy Going to use on what will be your study Inclusion, exclusion criteria. So we need to be explicit at this point in detail and what is going. Teo, what the focus of still matter of you will be. You need to list outcomes you're interested in, um on then detail steps for study. Selections of this is usually a two stage two. The selection process where you first screen the title abstracts. All identified literature from your search. Certain Daniel screen the full text. How will disagreements be resolved? Will be somebody else to, um, it'll be end of the person who will help resulting in this group between the written multiple reviewers, if they don't agree about that is to be should be included on up and we'll use any software that quite a number of soft. And, uh, now that you can use to help this in this much with you. What type of data will be extracted? Will you be piloting a data extraction form? And how many independent reviews were doing this task on what kind of quality is system for risk of bison? Studies will be done on taking how many years were between. There's so next is the, uh, dialysis section. Eso in the analysis sexually, you want to describe the methods be used. Urinalysis. Are you going to be doing the narrative synthesis, or were you between himself? That analysis is in fixed or rundown effects model. And how would you report at your unity? If you do the math analysis, you explore publication bias on what is your height Marie Analysis of croup analysis or sensitive. Now this is going to be so. These are things you should consider, including in your system with the protocol. So some couple hours and mistakes that happened much protocol. Just first off is having a poorly defined question. Um, I said, you have a clear, focused question, and then where your rational is no based on previous evidence, So there's no detail on how your review of fit into existence evidence or don't get along. What? Your review. We'll add that again some more or human error is not having details on what your strategy will be or what type of sources you're going to say. What is it? What kind of databases are you going to search on? It haven't vague inclusion exclusion criteria. Oftentimes the quality of sessions having pan that, you know, fits review our study designed so you'd expect to use right? Quote a quote. This has been two has been designed to value quality off of randomized trials in a systematic view, but you wouldn't expect to use that seem to provide a court studies or, um, case control studies, for example. So you need to use the right Quentin assessment to the for your review for the particular type of studies included. And then finally, I'm often that come published a review protocol. Don't consider the type of data in relation to this into sense. So, for example, you can't you shouldn't really have, uh, this is the much could be that includes case series or case studies combined with court studies and then metamizole on that, um, one thing you should do is try to make a political public talked about every about avoiding recent racing. If your protocol is if you develop a research protocol or so much in your throat school board to publish it, we can register it in Prospero's. On. It's prosperous is that's image over data. It's online searchable, reports it. Terry forces too much reviews, um, on. But there's also always have, which is an open source database. You can register any kind of study on OSF what you could do it you can also use. This is the much of views on there. Prospero is good because you can search it. And it's easy to certain Prospero's to see whether or not that any existing reviews or plan reviews similar to what the age of planning on undertaking or said not as much, um, difficult to navigate yourself. You could also publish oh, protocol in journals. Oh, BMJ open BMC so much. Some general except protocols, of course. Call Crane Library publishes has protocols for Cochran, Cochran reviews on As You Go from Prospering Down Teo the cop in library. You've got an increase in an increasing amount of detail that you need to provide to the date of the registry or the journal in terms off what is needed in in the content of Europe. With this too much political and there are guidelines to help, you got the prisoner p the preferred reporting night and just a matter of your meta analysis particles. So it's a 79 to check list, which helps could help in the development of reports. Enough, sister, much for you. Protocols s. So that's always a good point. Teo, start off. If you want it start to develop in school because it's got all right. And just to make sure that your capture in these, in your view, possible what? Yeah, that's everything from for a couple of minutes Friday. I know laxity off the various levels off foods that so that could be. But the other thing that I want to mention your then if you have a study going on, please that market site training, you get a lot of comments of the revised and you end up having to submit bills several times a big stuff Thanks Kind of. Well, you back starting your child, I think from all those things they are, you know, they're really lately getting issues. That's a really good point because and it varies a lot between countries. There's some ethics committed. Well, if it's not, if it's not a patient facing case report form and they don't require it in UK that required to see them. But it is patient pacing in these by know in other places that every CRF rinse to be think it's it's important thing to consider I dearly factor in the time to be able to get you. I'm just query when it's only letting clinical travel do you? Sometimes putting made about 100 minutes. No. Well, certainly the child's gonna go get the bone. We didn't I guess we wish we get because of the challenges. Yeah, these things obviously can get thrown up, and it can be a problem in terms of theater play, ability of data that you collected pre pandemic and the post pandemic potentially because it may affect your patient population. But you hope to think that the effect may be the same in both of the groups that you're looking at. But maybe it's something in the future if we need to start factoring in quite often. It's the time implications. Well, thank you very much. It's last one. Yeah. Yeah, it was It was almost exactly might send you probably wait. Yes. Yeah, way. Haven't idea of what we wanted to. So way will that stuff, right? That's right. I think you got to be like, Wow way you have this checklist. 17 way that way. Yeah. Yeah, way. Uh, thank you, everyone. I think we'll get started. This is all of us for this last session. So as Catherine introduces downstairs, my name's Adam the Bottom A lecture of maternal health trials here. University of Moving. I'm showing this session with generality on between going to be covering first of all clinical trial protocols and then Jones going to talking about systematic review protocols. So we're both prepared some slides which will talk to another, and they'll be a chance to ask any burning questions if you have any. So start off with 10 controls. Practical. So what is a typical trial protocol? First of all, so I think the the meeting that happened back in the in the nineties. Now, which was a common ization on good clinical practice, came up with this definition for a clinical trial protocol, which is a document describes the objectives, design methodology, statistical considerations and organization off a trial on following on. From this, we thankfully have some really good tools for making sure that aloes elements are included in the trial protocol that we're designing. So the first thing you should do when you start thinking about putting together a topical is look at this spirit statements. It's available online by this you are on. This tells you each of the sections what needs to be included to make sure that you're adhering to those international standards for a clinical trials protocol. So why do we need a clinical trial particle? So first up instructs the healthcare providers on also, instead of coordinated on how to execute the trial. This is obviously very important to make sure that there is a standardization in terms of in terms of each healthcare setting with running the trial. Secondly, ensuring the safety of study participants see if we're doing something like a drug trials of chemical trial of an investigational medicine product we would we want to be controlling. There are methods in place and processes for safety reporting the only adverse outcomes. Thirdly, the integrity of the data collected throughout the child's obviously very important to make sure we're getting her bust. Findings on D also documents the primary outcome and also any other secondary outcomes. Along with the study sample size and power of the primary outcome is whatever you're gonna be measuring in your trial of, that is the basis for your for your study to determine whether think one group compared with the other group is it is better. Once you've done all of this and you got a critical in place, it's also very important that you register your protocol in advance of you starting recruitment. This's essential for transparency. So you're very clear front. This is what we're sitting out to do in this trial. This is the primary outcome. This is the study sample size. That's the power cetera, and nearly all journals now will go online. As soon as you submitted the findings from the trouble. We've actually completed it. They will go and check the registries before you before we do anything else. to make sure that it has been registered up from. And certainly now, when it comes to the systematic reviews there are. Certainly Cochran Group are now starting to look at these trustworthiness checks. Four studies on this is one of the things they look at. What's it registered? Perspectively. So it's a very important thing to make sure you do won't see what's actually devote your practical before you start. So who writes a clinical trial for it to go? So this is certainly a collaborative process. So the chief investigates. That's a cousin who's leading the trial will be the one that probably drives the drives, the protocol writing forward. But there is also input from lots of others. So this one statisticians. So once you know what your primary outcome is and you've got understanding from the literature of what the event rates are, you can then be planning what your sample size and power will be. Other experts that this could be other conditions who work in that area they can give feedback on what they think is is the most important outcomes. Also, they can input on what they think is a clinically meaningful difference So what the difference is is are between the two the two interventions, the intervention group of the Comparator groups. So all of these things can help input into it. Also, it's also, I think, important to have people who are experienced intro coordination and management because they can help with the pragmatic planning off the trial, making sure that it is feasible to run that it could work from the kind of from a local management. So you need input from lots of people. It's definitely a good thing. So who reads your clinical trial protocol? There are quite a few people that will have site of it and need to be able to understand and follow it. First of all, the the healthcare settings that sites where you actually running the trial will need to obviously be able to understand it and follow it, so it needs to be appropriate for them if it is a drug trial. So seating trial, the competent authority in the country where you are really get warm eater have been sent in and give them their approval. So again, it used to make sure it complies with all of their requirements. Obviously, the Research Ethics Committee is a swell, which we need to give their approvals. We'll we'll be reading it as well. The next two listed here are kind of very UK focus of health research authority and other NHS institutions. We'll we'll want to be looking at it. And also, if it is a drug trial, drug manufacturers may May may have certain requirements for to get their approval. So again, all of these different people need to be satisfied with. The protocol is fit for purpose protocol. Compliance is a hugely important thing in clinical trials. So once you have your protocol is important that across all the settings where you're running in, the protocol is being in here. It's This is not only important for patients safety, but also try quality and recorded the date you're getting out and very important. Once you started, any deviations from the protocol are documented. I guess when it comes to design, you want, ideally have a protocol that is well designed so that it's pragmatic and you don't end up with lots of deviations. But there can be amendments made during the trial once you have actually started. But actually these need to be well planned on all the necessary approvals need to be obtained before you make those. There are occasions where they are religion, safety measures that need to be put in place and those could be again Don't in, um, or escalated on expediting manner. But the ability to change is there, but ideally, cleanest. The most desirable outcome is that you have your trial of that stuff, that you designed it while it starts. You don't have to do anything with the protocol once you've got going. So I just got finished with my top tips from kind of experience of being involved with running, designing trials. So conducting a thorough literature search is very important. So you can understand event rates for what your primary outcome is for your trial on that. Well, then, obviously help statisticians with determining the sample size and achieving the necessary statistical power. Surveys are also very important, so we like picking part in the sea safe one earlier, which again it's a great opportunity to get key stakeholders to input on what they think Not only are important outcomes, which is a good thing, but also you can ask them What is a clinically meaningful difference between the two groups you're comparing. So is 5% improvement of them. And that can help with your justification off the difference that you're looking at between your two trial groups. So it's something that we've Certainly when we've been some trials has been really useful to be able to plan that, Um, if you got the time, I think this is a really good one in the stink. So what, you want your final publication to look like you could draw out the table to have your baseline characteristics table. You have the outcomes take. This could really help with thinking about the primary on also the secondary outcomes you're going to include. And you also may think a severely important subgroup that we want to include. So again, you can incorporate that in there. Um, it can also consider identifying what it's called a key secondary outcome so you can have your primary outcome, which is what the trial is, just, um but you are also able to declare key secondary outcome, which you could then potentially report on a swell within the publication. But declaring that up front is again really important as well as any subgroup analyses. And if possible, developing the CRX at the same time of the protocol is another really good habit to get into quite often trials. If they don't happen in parallel, people will design the CRF, where you got a telephone tree almost crx, and you collect a lot of data, which at the time you think is important. But the trouble with that is it can compromise the quality of the data that you get. So if you can try and hold it down to the really important things, I think that's a that's a really good tip. So just to conclude then yet there are a number of the resources on line for for writing trial protocols, which I think everyone should be making yourself definitely a team effort on the compliance is very keto thing of to achieve reliable results from your trials. Thank you for having me to John. Now he's gonna talk you through, so just, um, clean out from then presentation. So it's too much of you particles. I'm going to just talk about why we need this dimension, people, because I understand need first much few protocol identify key elements of us too much of your protocol, and it also point out common areas and, um, suggestions on how to avoid these common mistakes made. So a smartview protocol is the full review planet. It's, uh, it's a detailed description off the objectives and methods of what you plan on doing this to metric of you, some from registered and published before completion of the review on We need a stomach review to present the Why how on the words off most much of you. So what is your rational conclusion, this much vee or the objectives? And what's the meth meth charge of the review going to be? It's important because it helps avoid research wastes. It was duplication off efforts. You have got this great genes idea or connections review chances research question. And it's always what, while going to check much view protocol databases, even a general obligation to see what their notes, an existing review has really been conducted or one is being indeed planned. Um oh is in progress, and it helped from promotes accountability. So you've got the intention. This is what you plan on doing on. Then you've collected reviewing your publisher, alkums and necessarily much what the CT set out to do. So you could be held to account by the scientific community repairs and saying, Well, you know, it doesn't match up. Can you explain why? Um on. But it was on to the key element of you put score. So first off is, um, the title. So the title needs to be clear focused on well defined. See, you're you're much of you. Title has to also identify to put called Titus. See, I didn't feel your throat cause this is the much of you, and it should not be a question. Um, the background comes next on in the background. You want to describe the condition that you are investigating? What's the burden off this? Um, what is the population of interests? What? Our current guidelines The best practice? Uh, what's the contest of existing evidence? And then what is your rationale for wanting to undertake systematic review on what is already known at any other existing reviews on what will yours add to the review? And this leads to the next section, which is? The aim is really means it's helps to define your aims is in the Pecos of the Pecos. So you could define your population of the interventional exposure comparison outcomes and then type of studies that you including your review. So really, just to the methods in the method section you want to detail you're such criteria. So what sources are you going to search? What database sources. What is a sample? So strategy you're going to use? What kind of studies would you include on what the exclusion criteria. So you need to be expressing because us, a recent method in his old Reiter systematic of you needs to be replaced about also need you to take up your protocol and run with it as well. So what? I'll comes alkums Are you interested in exploring? What steps are you going to take for study selection? So this is usually two stage a study selection process way screening title, abstract first, and then the full text screening. And then you need to also detail how you just resolve disagreement on do you use any software so the variety or software now available that makes systematic of you conducts the magic of, you know easier. So you know that free open access wants that grand on. Do you got more like once you've got to pay for covered in so much time to the confidence my health makes the magic of you process easier In your method section you wanted the detail kind of data will be extracted. Will you use the data extraction form the husband piloted? And how many independent reviews have you doing this data extraction task. So So it's also good to, uh I don't know what kind are quality assessment of a risk of bias of studies, including review be done. And I get how many How many reviews will be doing this. So the next section key imagine, Could is your analysis. So in your notices section you want to describe that method to be used, What kind of analysis will be done? It's going be narrative or things or that analysis, fixed or random effects model in your much analysis on it. So we could be report how you report today. Um, would you explode publication bias? What is your primary now? This is going to be a going to be taking subgroup analysis or the sensitivity analysis. So some coven mistakes there is a mistakes. First off is having a poorly defined questions. So question that's too vague, too broad. What is, um, that what is how many women with endometriosis and gotta or exploring and the mattress is in South America is like toujeo. You need to have a focused question. Your Russian is to be based on previous evidence. When I write in your protocol, oftentimes get review protocols that have no detail on how the reviews were fitting to exist in evidence. And it's cause this, this further highlighted by their know being any details on what your reviews going to add. So it's just I want to do this and it just starts on its own. Um, that is how the haven't did a search strategy or what sources are going to search again. It's perfectly fine, especially a student who is doing the systematically you for your dissertation project to say Okay, you're kind of study, including interested, including a randomized trials on. You've got three months to conduct the review because of your dissertation for your project, and so you're going to set a queen database. That is fine, but your detail about you don't have to then go on to say it's a compartment and then based on all of that as well. But it's reporting to see what sorts of going to search on what you said prompted You will be. And you need to be clear on what your inclusion exclusion criteria is. Oftentimes, that very, very inclusion exclusion criteria, which it's no good. Um, on my last point is having a quiet. It's just, um, it's lactated to the kind of study designed that you including use like some if you if you including run the mice control trials and just a much of you expect to use acquits assistance is like the cooker was good bias to you, too. You wouldn't ordinarily use, um, a risk of bias to like Newcastle, a tire scale or something else that's being given up for court studies. Okay, so control. So you need to use the right quote. The assessment tool for the right kind of study designed You can think quitting review, and it lasts, you know, constant during the type of data that will be included in your review in terms of sentences. So began it. It's don't advice advisable to combine studies. That aspect designs off like a series in case study with cohort studies and then do a medicine. Aris's in that. So those two kinds of sentences senses of those two different type of study design invalidates your research you tried to synthesize. So how can you make your personal public eso that various Havanese in which you can make it possible? Probably you can register your protocol on Prospero's, which is free, Um, like a searchable. So it makes it easy. See, what are these existent yourself is an open, sore state made? You can register any kind of study on there and increasing this is too much of using study our registered on there as well. You could also publish it puts Coal journals will be in job being some journals except protocols. And, of course, call Crane reviews a publishing in Cochran Library on as you go from prospering down, see the cover All right, you've got There's an increase in the amount of detail you need to provide So with prosperity, ask for to have it registered and have it publicly available. It's your basic information on what your review question will be. What kind of studies you could design, and he gets, um, evaluated by the team responsible for gets in a proven the protocol. You can go back and update this. Ask your protocol. Your review progresses, and it's it it it's a little bitty. It is a trac. In each time you're going to make a change on down to, say, like a general publication, which is pair reviewed. So you need to have a lot more detail. What kind of study do, including type of strategy to be considered so there are guidelines to help in developing. It's too much you protocol. The prisoner Pee Preferred report tonight since March previews for protocols. It's 70 19. Check this, and this is really helpful in developing on actual report. It's just a matter of you protocol. So you've got this checklist that you can match to the work that you're developing in terms of different your systematic You brought school. That's, um, yeah, that's everything from maybe we'll take any questions or come in looking at the room. They're expensive system much of view designs and clinical trials. But yeah, question about mentioned that was a software that helps with so I think the most time consuming pollicis Too much of you is screening of articles of the title. After two units, you go Covance, which helps from the very beginning. Did you run? Enticed much of you on Cobra and see you to the searches on the database. Important about the articles on take over this and you're tight in the lab check screen in and 40 experience on the anchoring data extraction and quality. Ryan is a free C is a free access one. You can do the same thing on there, and regimen is is just It's associated with Cochran. You can run non Cochran reviews on Reverend is Well, you kind of do the types of options cream on Redmond, but it will. We can help with data extraction analysis so you can use a combination of these Softwares to run your review. What's the second, right? Uh, a a y n hard to be closing up now as well. I mean, it's quiet. Well, thank you, everyone. More questions you can buy downstairs for the summary of the day. Okay. Okay. Okay. Okay. Yeah, yeah. How many times? Sorry. 20. I mean, we had seven people at some point, so right here