Computer generated transcript

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

Right. Um Hi, everyone. Welcome to NMR A's second lecture in the lecture series of Systematic Reviews and meta analysis. Um With us today we have Doctor Rafi Sheriff, who's an incoming academic foundation doctor who's completed his PSE in biomedical science, M se in global health and conflict and got his medical degree at Saint George's University of London. Um He's also worked and completed projects in Kenya Morocco and Sierra Leone and worked with various organizations um such as the Ministry of Health and Sanitation at Sierra Leone. He's the founder and chair of Student Me London and the current chair of the Students for Global Health Board of Trustees. Um Doctor Sheriff of the floor is yours, I think. Um Thank you everyone for coming to this session. Um And M I are doing amazing work. These are essentially the building blocks and skills you guys are gonna use for the rest of your research careers. Um So I'm gonna start off by sharing my screen. Um Great. Once my screen is shared, I'm not gonna be able to see any of the comments, but please feel free to put comments or questions in the comments section. And the moderator will interrupt me and ask me questions. Um There are no stupid questions so feel free to just ask um about anything. But yes, mentioned, I'm an incoming academic foundation doctor. And most of my research experience in the past is related to more global health qualitative research, but also includes things like systematic reviews because um the, the bread a lot of research, especially for people who are still students or really early in their research careers. Um I'd be surprised if any of you are actively conducting random controller, right? Trials. All right, let's start. So what is a research protocol? Um So you can have them specifically to systematic reviews, but it's essentially useful for any kind of research you end up doing and it's essentially a detailed plan on the study you're going to conduct. If you've written dissertations or essays, you've probably been asked to write basic research proposals. And that's what kind of a research protocol is. It's a foundation that's gonna decide how you're going to conduct your study, what you're going to do, how you're going to analyze your data. And it's the second most important step after actually figuring out what your research question is. So what are you going to include in your research protocol? You're going to look at what your research question is and then the rationale behind the questions and the back related to that you're going to look at any type of methodology and research strategies you're gonna use for that project and also discuss what criteria you're gonna have s specifically for systematic reviews in terms of what papers to include and exclude. But you're also gonna talk about all other aspects of the study. So that's gonna include uh the quality assessments of your studies, how you're gonna extract and synthesize your data and also what your projected timetable is going to be. So it's gonna be an incredibly detailed plan of your whole study. And it's essentially gonna be the background of everything you're going to do that you can refer back to now, what are the benefits of a protocol? So your protocol is what allows you to have a more systematic approach rather than an ad hoc approach you would see in like a simple literature review or maybe even a coping review. It also makes sure that when you're working with a group of people, there's a level of consistency, there's a level of communication between you and the team you're working with and you don't have people just doing random things as part of the third strategy or as part of the collecting the data, you all have a very specific idea of what you're doing and everyone is essentially on the same boat and essentially on the same page in terms of what's going on. It also provides a public record of what your plan methods are. So it it reduces the risk of buyers you can't go into a study with a protocol written and halfway through just completely change your methodology to get the results you want. And in general, if you choose to register your protocol, which you can in places like Prospero, before you actually finish the study or the systematic review, it a raises awareness that your study exists. And in most cases, once you're then submitting a systematic review, you can then refer back to the protocol you originally submitted. And also even if you haven't finished your study and have just finished writing a protocol, in most cases, you can submit the protocol itself for conferences since essentially, it will include all aspects of your systematic review, even though at this stage, you probably don't have any results yet or haven't conducted any meta analysis. So I hope that kind of makes sense of why you would do a research protocol, what a research protocol is and what kind of the benefits are. So I'm assuming that most of you attended the first session last week and that's essentially the linchpin of everything else you will do going forward. It's essentially instrumental like a really good research questions will make things really easy even when it comes to writing your protocol. And I'm hoping uh last week, you must have learned about like basic structures like PCOS and spider. And you'll have an idea of a, the kind of studies you're looking at and the general structures of what they look like. Um But the research question is gonna determine what you do next. So what do you do next? What does the research protocol actually look like? So there are essentially three main sections. Section one usually includes information about personnel. So essentially the people involved in the study. Section two is gonna be your bread and butter. That's why you talk about the study design, the rationale the methodology and section three are any additional features. I will essentially spend 30 seconds in section one and section three. And then most of the talk is really going to be based on section two, which is where most of your research protocol work is gonna happen. So this is an example of what a section one looks like. So a section one is gonna include the title of your review, who the first reviewer are the other people involved in terms of the team of reviewers, the supervisors and just generally what other centers if this is a multicenter study and you have people across the world reviewing things, you could include that information here. So it's just general information about who is doing the study, who is supervising, where is it happening? Who is involved? Section number three, again, this is template of what it might look like is any additional information that might be necessary? So is there any requirement for ethics and research governance for systematic reviews? Usually there aren't because you're looking at studies that already exist. Is there any finance or funding burden? Are you paying to get access to certain research paper? Are you being funded by anyone? Are there any conflicts of interest? Um And then also the uh issues with publication policy and intellectual property. So all the additional things that might doing the study or the systematic review will then go part into section three. I assume at your level, if you're involved in systematic review, section one or section three will be filled out by someone else or would be filled out by a lead investigator. Uh Sorry doctor. Would you be able to hide the message at the bottom of your screen just cause it's blocking out the slides? Oh, apologies. Um Yup. Thank you. Yes, perfect. Great. Now let's get to the bread and butter. So this is section two. So this is the section that you will focus on when you're writing a research protocol. And the first part of it is writing about the background and the rationale of your studies. If you've done the initial work of doing a research question, you hopefully at this point have thought about why you're doing the study, have done a bit of a literature review to get an idea of what other similar studies are out there and all of that feeds in your ability to write a background. So your background is now gonna be a very brief introduction as to why you're conducting this review and the information that's available on this review already. So in this part of the protocol, you will include references from previous literature that already exists and then the specific motivation you have behind the research question. Another part of your background and rationale is also gonna be your aims and objectives. Your aims are gonna be kind of general and essentially gonna be your research questions and how you're planning on achieving them. And then your objectives are gonna be very specific in terms of a, how you're actually getting from A to Z in terms of this um systematic review, you can have both primary and secondary research aims. Um And I'll talk a little bit about examples of each of those. So this is an example of what an aim would look like if you had a title along the lines of essentially a systematic review that's looking at the relationship of anxiety and depression and exacerbation of CO BT. So that's your general research question. You've thought about it, you've made it quite specific, you know exactly what you're looking for. Now, the aim that you would write for a research question like this would essentially be the research question and then adding what you're also doing. So in this case, it would be that you have an understanding that may allow potentially effective interventions for improving management and self management to be designed and later systematically evaluated in more in depth studies. So this is essentially the research question again and then explaining why as part of your background in a study like this, you would want to look at what literature is already available. You want to would want to look at the overlap of people who do have things like anxiety, depression or mental health issues and how that links to exasperation of CO PD in your background. You would also want to explain to a learn is what is CO PD, what causes exasperation of CO PD? Why does it cause hospital admissions? And why is it important that there might be a relationship between exasperation, co PD and anxiety and depression. So your background is essentially giving me the building blocks of why you are conducting this systematic review and why it kind of matters. So the next section of writing your background and your aims is writing your objectives. As I mentioned previously, you can have primary and secondary objectives again, using the same research question as an example. Your primary objective here is essentially looking at my research question, what am I trying to get out of it mostly? So, in this case, we will be just trying to find evidence and clarifying evidence between the relationship of anxiety and depression and C ot exasperation. So that would be the main purpose of your systematic review and that's what we'll be looking for in terms of like your A SA reviews. When you look at your third strategy, a secondary objective here would then be looking at all the other factors that may be involved in the admissions. So alongside anxiety and depression, any other comorbidities, they may have any other factors like self management or social factors that might affect that. So that wouldn't be your primary objective, but it's still something important to look at and it's additional data you'd want to see in a systematic review. So your primary objective would be incredibly important when you're done writing your inclusion exclusion criteria. Because that is specific. While when it comes to your secondary objective, some papers may include that information, some papers may not, but it wouldn't stop you from including them. Uh I hope that kind of makes sense of what should be included, kind of in the background and the rationale when you're writing your protocol. So the next section we we talked about briefly is the inclusion exclusion criteria. I think this is the part of the protocol that can sometimes confuse people and it's essentially really straightforward if bef during your research question or before you started writing your protocol, you've also already thought about things like pcos and spider, it's really useful here. So when you're thinking of your inclusion criteria, after having thought of the questions, you now need to decide what type of papers do I wanna include? Am I including cohort papers? Am I including randomized controlled trials? Am I more thinking? I'm just looking at qualitative data or gray literature or am I including absolutely everything in this section obviously, depending on how are you gonna analyze that data? For example, if you wanna do a meta analysis, you, you can't really choose all study types and you're more likely to look at RCT S. Then again, depending on the study you're looking at in your inclusion criteria. Are you looking for specific demographics? Are you looking for people above the age of 45 who have heart failure? Are you looking for people who specifically have CO PD? Are you looking for studies that have been published with people specifically in Sub Saharan Africa? Then again, you're looking at the types of interventions that are maybe mentioned abstract. Are you looking at hospitalization and the rates of those, are you looking at the effects of a specific pharmacological drugs? Are you looking at other types of interventions? Let's say education physio and then that links in with the comparator because there's no point looking for studies which are, let's say RCT S with a specific demographic where the main intervention you're looking at is hospitalization. If the comparator to that study is exactly the same. So you need to think about what is your control group, you need to compare it to your intervention in terms of what you wanna put in your inclusion criteria. And then other things that might be relevant to put in your inclusion criteria is like what are the outcomes of the studies you're looking for? What are the following up times? When was the settings? Are you looking for papers published after 2015? Are you looking at studies specifically in the last 23 years? So essentially all of these examples of things you would put in your inclusion criteria. But that again, is gonna be based on your original research question and what you're hoping to get out of it in terms of your analysis and then eventual results. But again, you don't need to include all of these. But most commonly, you'd probably talk about the type of studies you wanna include the demographic of the participants and what intervention and control groups are gonna be. The more specific your inclusion criteria, the smaller the pool of papers you potentially have access to and then some people do really well in writing the inclusion criteria, come to the exclusion criteria and get stuck. Um And your exclusion criteria is actually a lot simpler. Once you have sat down and actually thought about your inclusion criteria, what you're gonna include your exclusion criteria is essentially everything you did mention your inclusion criteria. So if you don't have a specific population, your inclusion criteria, for example, only people between the ages of 18 to 45 with asthma. At this point, you would mention populations that aren't including, that aren't like included. So they would be part of the exclusion criteria if you're only including papers that are written in English and French. Then your exclusion criteria would be any papers that weren't written in English and French. But most of your like deciding about what papers to include or not include in your study are gonna come from your inclusion criteria and your exclusion criteria is just clearing up by essentially mentioning anything that happens or not in your inclusion criteria. An example of what this might look like is this Um I think this study is from actually I think a survey and qualitative interview. So not specifically a systematic review, but it gives you an idea of what the difference between inclusion and exclusion criteria should look like. In this case, the inclusion criteria talks about specific stakeholders and age groups. In terms of demographic, it excludes when the world this should be and it has two types of inclusion criteria because it has essentially two population groups. And as you can see the exclusion criteria really straightforward. For group one, it's just that they don't match the inclusion criteria. And for group two, it's the fact that have access to healthcare services outside of this specific region or again, they don't match the inclusion criteria. But yeah, the type of things you should think about are populations type of studies, languages. And then also you can also think about setting dates et cetera, but it's usually really straightforward. Yeah, we have one question, sorry. Um So our secondary objectives obligatory to be present in section two. Sorry. So yes, you need to include if you have secondary objectives and you're writing a protocol, they need to be written as part of your protocol, but you can make it clear that they're secondary. You don't need to be actively searching for secondary objectives in your inclusion exclusion criteria. For example, if your primary objective, I was looking at the relationship of anxiety and depression to co PD exasperations that lead to hospital admission as part of your inclusion criteria. You want papers that are looking at the population that has had AC O PD exasperation and also issues with anxiety and depression that has to be part of your inclusion criteria. Cos that's your primary objective and that's what you're looking for, which means a paper that talks about co PD exasperation that doesn't mention anxiety and depression isn't useful to you. But when it comes to your secondary objectives, you don't then need to actively look for papers that are talking about your ability to cope or self manage and social factors that doesn't have to be part of your inclusion criteria. It's just some of your papers may have this information and that achieves your secondary objective if that kind of makes sense. So your primary objective has to be part of your inclusion criteria because that's specifically the information you're trying to find out the objectives you have to achieve. But for secondary objectives, they don't have to be part of an inclusion criteria because otherwise you're limiting the papers you have access to cause you could have a paper that talks about COPD exasperation that talks about anxiety and depression. But then that doesn't talk about your ability to cope and self manage because it doesn't fit the secondary objectives. And then somehow you now don't have access to this paper. I hope that kind of makes sense of the difference between primary and secondary objectives and how that links to your inclusion and exclusion criteria. I great. Where was high next? So when you're writing your research protocol, as I mentioned, there are obviously several sections. So it one of them being your background, then you will discuss your inclusion exclusion criteria, but then you also need to discuss your search strategy. There's a session next week that I'm giving that will talk about this in detail. So I'll just talk about briefly. So when you're writing your research protocol, you obviously haven't done this study, you don't know where the papers that you're looking for exist, you don't know what your results are gonna be and you won't have analyzed the data, but you will need to essentially make a basic prediction based on your literature review of where you think the information may be. So when you're writing a search strategy for your research protocol, the things you might include are examples of electronic databases that you might look at. So you might be looking at MEDLINE Ovid PUBMED depending on the type of literature review you're doing, you might also be looking at gray literature. So this might be policy papers, it might be newspapers and you'll also probably in your protocol want to include that you're probably gonna be doing reference checkings. So essentially what that involves is whenever you include a paper or read a paper that fits your inclusion and exclusion criteria, you will then look at the references of those papers to potentially generate more papers that might fit your inclusion exclusion criteria and your general systematic review. But we'll talk about this in more detail in your session tomorrow. Another session, uh Another section which needs to be included in your research protocol. What I believe you have a session about in the future is how are you actually gonna review your data and how you're gonna extract it. So in the protocol, you will need to talk about the number of reviews you're gonna have who your primary view is going to be and how they're going to decide what is going to be included and your systematic review, there needs to be some form of system of where you say something along the lines in your protocol. Uh All abstracts are going to be reviewed uh by two individuals. If there are disagreements between them, there will be a third reviewer who will check this will be done independently to reduce bias. But you need to make it clear in your research protocol. How many people are gonna review this, what their process is in deciding what's included and what's not included? And how are these agreements dealt with? You also probably wanna talk about what information you are actually collecting from the papers you're looking at, since it's unlikely you're gonna collect all of the information in the papers. And you also need to discuss where is this information going? Do you have a database you're using? Do you have an alternate system? Are you gonna include it on Excel on a worksheet? And you also then need to talk about what are you doing to check for quality assessment and risk of buyers? But again, I think you guys have a specific session on this later that tells you how to do that, but this needs to be included in your research protocol. The next as part of your research protocol. Yes, you don't have any results yet, but you also need to write about how you're planning on analyzing that data and how you're planning on presenting it. If your systematic review involved looking at RCT S, you are probably going to try to do a meta meta analysis. If it's slightly more qualitative, you might possibly do a narrative synthesis, but you can also do that for RCT S. But you need to have an idea before you start your study. Once you've uh written your protocol, once you've selected your papers based on your inclusion exclusion criteria. Once you have put all of this information and extracted it and put in an Excel sheet or a system or use something like in vivo, how are you gonna actually analyze that data? And then you need to essentially write, what are you planning on doing with it? Are you gonna plan on doing some tables flow charts? What are you planning on your outcomes to be? Are you planning on writing a paper for a specific journal? Is it gonna be a report? Is it gonna be like a conference presentation? So your research protocol also outside of just how you're going to conduct a study needs to include how you're planning on analyzing the data and where or how you're planning on presenting that data. And then lastly as part of your research protocol, it's important to include a timeline. So I personally like using gun charts. That's what I did on my first degree book in 2017. But yeah, cause I think a gun chart is like visually pleasing, it's really straightforward and it essentially gives an idea of what you're doing as part of the systematic review when you're doing it and what the general timeline is. So all of these different sections will then be included in your research protocol. Now, things I haven't mentioned yet, if you're planning on doing a systematic review and writing a protocol, things that are really, really useful are the Prisma checklist there used to be a 2009 version, but they updated it a few um years ago to the rema 2020 checklist. And this is an overall checklist, not just for your protocol, but essentially for your whole systematic review. It's essentially a checklist of. Have you identified a title and abstract? Do you have a rational objective? Have you considered your search strategy or eligibility criteria? Essentially, you will have sessions across the next eight weeks unlike every element of this. But it's also useful to look at when you're writing your research protocol because your research protocol should also be mentioning all of these section. Your research protocol should be mentioning what your inclusion exclusion criteria are, what your plans are analyzing your data, how you're planning on presenting that data if you're planning, I registering your research protocol on Prospero. But this is just it's like easily available online if you just Google prima checklist. Uh They have got really good guidance for systematic reviews in general and that brings me to the end of my sessions on how to write a research pro protocol, what to include and specifically what your inclusion exclusion criteria look like. I usually also ask for a personal feedback on teaching sessions. I do it's just part of my own personal professional learning. So I'd appreciate it if you guys took a screenshot of the QR code. Just to be clear, this isn't a feedback session. You guys have to fill out to get certificates at the end of the sessions. This is just for me, um personally. So I'll leave it up for a few more seconds and then send a link um in the chat function. And if you guys have any questions, please let me know. And essentially next week, we are going to have another session, which is gonna be specifically about how to write a certain strategy for your literature review. Um We talked about some of the ways and some of the places you can look for information in this one, but this one will be slightly more in depth this session so far. I have tried to keep it relatively brief. Great. Uh How do I stop sharing my screen? All right. Thank you very much. Um Would you be comfortable sharing your slides with everyone just asking for them? Oh, yes, of course. Happy to. OK. That's great. Thank you. Sorry. Let me just find my um the link to my form. But yeah, I haven't seen the comments section yet. Are there any other questions? Yeah. So we just have another question. Um So by the time we published the protocol, we have already gone through the literature screen them. Is that correct? No, actually, that's the interesting thing about the protocol. So the only thing that you will have done before writing your protocol is decided on your research question, which means when you're writing your protocol, you're deciding what type of literature, you're going to look at how you're going to screen them and how you're gonna analyze that data. All of that has to happen before you've done your literature review and you screened them because otherwise if you work in a team of people, what's deciding how you're screening it compared to how someone else is screening it. Your protocol is essentially your template. It's the guide on how you're going to conduct your whole study, which means you write it before you actually do those sections. I hope that kind of made sense. Alexandra. Yeah. And then just one last question, what's Gray Literature? So Gray Literature is any information out there that isn't already a part of like a peer reviewed, like published journal and papers. So you might have really in depth newspapers, article on the situation, you might have policy briefs and papers, you essentially have other sources of information that might also be accurate and useful but aren't technically published in a journal. So essentially all of those things are called Gray Literature. So for example, in the example, questions I used about COPD exasperations and anxiety and depression and how those two things like a piece of Gray literature would be an NHS report. That's letting you the number of people who were admitted with CO PD. So maybe that's not a publication that was written, it's not a research paper, it's a report, but it would be an important part. An important piece of gray literature that might feed into your background or that you might want to include as part of your systematic review. And one more question is the protocol published or submitted somewhere or is it just to help guide you through the research? So the protocol itself, since the protocol is like a really in depth document, you have a few choices. One choice is you can register your protocol itself on what does Prospero stand for. There's essentially a website, an organization called Prospero where all systematic reviews, not all all systematic reviews that are essentially health related. If you have written a protocol for that, you will register that on Prospero. And right now you could go on Prospero and essentially find systematic reviews that have currently been registered there. It doesn't mean they've been done, but it means there will be done and it's essentially saves you time from repeating work that someone else is doing. So your protocol a you can register on Prospero. So essentially be like I'm planning on doing this systematic review. This is what it's gonna look like. Thank you, Adela B. You can take the protocol itself and submit it as an abstract for a conference cause your research protocol already, you've done a bit of a literature review already. You've done the background and you're going into detail of what your plans are in terms of inclusion exclusion criteria, how you're planning on analyzing that data. It may be a vague suggestion of what your results might be. So in most cases, there are people who will present a literature review at the conference will then present the whole protocol at a conference and then can present a whole systematic review before. But you don't have to publish um or register your research protocol. It's just really useful to do so. All right, thank you. And we have one more. How much can we change from our objectives? After publishing the protocol? If the literature goes in another direction and how do you feel about negative publications? Um I'm not sure what you mean by negative publications, but I'll answer the first part of the questions in terms of it'd be very difficult for you to need to change your objectives after your literature review. Since if you can't fit your objectives, that's a whole different literature review that you're not answering your initial question. And therefore it's not about changing your objectives. It's about changing your question itself because there isn't enough data to essentially like answer your questions. But in most cases, if you have written an appropriate protocol and you've differentiated primary from secondary and additional like objectives, it w you won't have to change them. There might be a case of like you are, there isn't enough literature so like fit your objectives, but that's something you will then o talk about when you're writing your literature review. But it's unlike cause your objectives aren't saying one thing that your objectives aren't going to say there is a link between CO PD and Depression or there's not a link between CO PD and uh Depression. What your objectives are going to be is I'm going to look at if there's a link between this or this or I'm going to review if the data that currently exists, support this or doesn't support this. So if your literature says it doesn't support this, it's still fitting your objectives. If that kind of makes sense. And sorry, I wasn't sure what you meant by a negative publication. So if you could clarify that later, great. Any other questions? All right. I think that's all the questions for now. Thank you very much. Thank you very much for your time. I think it was a really useful session. No worries. And I guess I will see some of you next week for those of you who haven't had a chance to fill out my feedback form. Let me make it clear again. You don't have to fill it out. It's just for my own personal and professional learning and it's not linked to your certificate, but I would really appreciate it if you did. So I'm just gonna share it again and thank you guys for attending the session. Oh, wait, sorry.