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Research Meeting 4.20.2023 with Dr. Steller and Dr ...
Research Meeting 4.20.2023 with Dr. Steller and Dr. Asima
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Aseema is having some difficulties, but we just want to welcome everyone. You know, just for the group, just make sure, Dr. Aseema, do you want to introduce yourself? Hi, I'm Dr. Aseema Mukhopadhyay. I'm a gynecologist and I'm an international mentor to Nepal and India site, but I'm co-chairing with Dr. Steller, this research publication committee. Great, and Dr. Steller? Good morning, I'm Michael Steller. I'm a retired gynecologic oncologist. I live near Boston in the US, and I'm happy to be working with Aseema and all of you on this effort for research and publication. Great, wonderful, thank you, everyone. So welcome, everyone. We will not go through everyone's introductions because there are going to be more people joining and we want to just stay on time. So feel free to put your name in the chat or where you're from, but I know all of you, but we'll get to, we'll have some time for questions and comments. So the first thing we want to discuss, and I think is there is a research protocol. We are working on getting a policy for that. And the main reason we want to make sure any, if you're using data from REDCap for research, there's a protocol that we want to make sure everyone's aware of. So I don't know if we will get more information for you later on, but I wanted Aseema and Dr. Stellar just to kind of touch on it, just so you're aware of this issue. So Aseema, do you want to start first and then Dr. Stellar? So thank you, everybody. And it's really great to see that the proposal is coming in. I just kind of want to say that, there are three things. And I, after just going through a couple of the proposals and I feel that, you know, the topic selection is great, but then there are, I feel that there needs to be a kind of a proper research protocol format, maybe that we could, we would need to guide you through in some of these cases. And it's always important to have three things in mind when you are devising a proposal. One end is to follow a grant application format, because it's really nice how they guide you to think about the gaps in the literature that you really want to address through your research protocol. And then, you know, side by side, then if you're developing a research protocol, then there are ways to do it. There are standard or some modifications, which, you know, maybe Dr. Stellar or I could guide you through some of them. And the third thing is to then side by side, think about an SLP, how are you going to do it? And I think if you have those absolute clarity, you know, those sections, then I, in my personal opinion, or my experience of protocol comes out quite nice. And it's also important to remember that because you have done all the reading and you have been thinking about it for quite some time, so it is an art to actually translate that into a protocol so that the other people who are reading them or evaluating your protocol or your grant, they may not know that topic that much, but it is let out sufficiently clearly and sometimes some lay terms so that it's very clear to understand what you want to do, why you want to do it, how you want to do it, and what are you going to get out of it? I think these are the four basic questions which should have real, real clarity when you develop a protocol or somebody reads a protocol. So that's all I want to say. Great, thank you. And Dr. Seller? Well, I think Asima has nicely outlined the aspects of the proposal. And I think that it's important for the group to understand that although we're trying to develop infrastructure and a resource for you to do research and to write papers, this is an educational process. So you're going to learn along the way, and hopefully we will have amassed a variety of tools for you to take advantage of that are available online through the IGCS research and the educational portal. We also emphasize the importance of having institutional review board approval to do your project. We can't provide the data or furnish you with data from REDCap, for example, without an IRB approval at your local institution. And we are kind of at a point where since we're going to be involving multiple investigators, fellows from various different institutions, we have to iron out the kinks of having so many different institutions involved. And probably you're going to need IRB approval from each of the participating institutions in order to go ahead and do the study. But these are all very doable milestones, but they're important because without having cleared these checkpoints, you really can't do any research. So again, Asima's ideas about your proposal and the principles of it, trying to have absolute clarity as often as possible really is a hallmark for success. And really, again, this is a process, an educational process. We're all going to learn along with you, having maybe a little bit more experience, but not experience doing something through Zoom and through global efforts is kind of cool. And also a challenge because we have to understand how to do it. And just to kind of add one word to what Dr. Stella has said, often that when you do these sort of multi-institutional studies, it is good to know your country requirements. For example, for the international data sharing, often only your local ethics approval is not need also a country approval for sharing your data internationally or get the international data to yours. So these are some of the nitty-gritties I think each country would have, but basically I understand it's similar or it should be similar everywhere. The data sharing guidelines or that it's beyond your local ethics, but you also need some sort of country clearance to share the data. I mean, is that what you find Dr. Stella or in every, because that's what my experience is with GCIG and when we participate in many multi-centric studies or data sharing. Yeah, I agree with everything you said. Great. I think, but the main thing is we're working on this, we're going to help you with it as you're working on papers and it has to do if there's patients involved is my understanding. If you have to make sure if you're using an international review board if patients are involved, that's been my basic understanding, but I've learned this too. So more to come on that, but we just kind of make sure everyone's aware of it. So I think one of the things that we've gotten a lot of questions about so I think one of the things that we've gotten at least four papers that we've had submitted. So we've kind of wanted to go through those and kind of work through those. So I think the first one is Eugene. I don't know, Eugene, I think you are on the call. Yes. Is Eugene on the call? I thought so. May, if not, let's go to is, I saw Kalima was on the call. I thought Eugene is on the call. Yes, I thought he was. Yeah, sorry, I'm having unstable internet. Maybe I couldn't catch everything that you have been talking, but it's of interest. So I shared my proposal. So today Donna told me that probably it's going to be discussed in this research and publication. So now hopefully I'm going to, I'm here, I'm around so that I can just get some inputs and also get some direction from the experts. Thank you. Great, okay. So I don't know, Donna, can you bring up Eugene's? So yeah, and then Dr. Sellers is gonna review it with you. For everyone's review. So, all right. So Eugene, if you want to just give everyone, if you have stable internet, if you want to just give everyone an idea, let them know what your idea is, and then Dr. Seller will kind of walk you through it. Yeah, yes. So my idea here is I want to, because this gynecology oncology is one of the, it's being now practiced in Rwanda and we're having so many patients who are now being cared by gynecology oncologists, but currently we don't know their nutritional status. There's no study done in Rwanda to evaluate these patients, their nutritional status. And we want to put like a protocol basing on the findings on this research. So that's where my title is, trying to assess the nutrition status of all the gynecological cancer patients that are coming into the cancer centers that we are caring for. So we basically want to know if the subjective assessment is important or as a biomarker is important in carrying out our nutrition assessment. So my... I think we lost him so I don't know if Dr. Stella if you want to kind of, I don't know if you've got a chance to review it and give some comments. Sure. When Eugene gets back online, or even if he doesn't, I want to send to him my edits because I made some, you know, some suggestions and questions on the document that was shared with me. But Eugene wants to investigate the role of nutritional status in and correlate it with patient outcome. It's a great idea, especially in a location like his where malnutrition occurs, far more commonly than it does in other parts of the world like the United States. So it does have great clinical utility. I think that his ideas is very sound. Eugene wants to inventory patients and assess their nutritional status using a pretty widely accepted measures of nutritional health, along with some routine lab studies, and then some arthropometric that means measurements of things like weight and height and circumference of maybe your forearm, your arm, some things like this. I think that understanding the nutritional health of someone prior to treatment will be useful in understanding what are likely to be toxicities and complications that they're going to encounter during and after their treatment. All together, though, he has a timeline in here, and you see, maybe you've already started to approve patients. I think you already have IRB approval, Eugene. If you can hear me, Eugene, please chime in to give us additional information about where things stand. Thank you for this. We have submitted this protocol for IRB. So I'm still waiting to get to go. And we usually go and ask us for more information and clarification if there's no harm to the patients, and if there's no other need to increase in the expenses for the patients. So all of this will be, I will present them to the IRB, and then after getting the IRB approval, that's when I will start conducting this study. Yeah, now, along the way, it's going to be important to figure out what you need as far as study size, sample size. At the moment, you're just taking all comers over a period of six months. I hope that you will accrue enough that you will have enough power to make some generalities when everything is said and done. So sample size is going to be an important component in developing your protocol. Do you mean that I can take only for six months? Well, didn't you say that six months was your interval? I forget. Yeah, yes. Before, we wanted to do one year, but they requested me to do it in all cancer centers. So the cancer centers here in Rwanda, we are having three. So that's why I thought that doing one year in these three cancer centers, then it will require some input that I cannot afford. So that's why we reduced it to at least six months, because we usually see new cancer patients per month in one center, like 40 to 50. So if we have this for six months, the sample size may be like 400 or 500. Okay. Well, then probably you will have sufficient numbers that six months will be sufficient. It just depends on how robust the accrual is. Yes. Good. Well, great. This is great. This is perfect. So I don't know if we want to share the results. Eugene, if you want to share the results with everyone or share your paper with everyone, we can. Or if it's just something you're working on, that's fine. But just to show everyone the detail he has worked on it. Anisa, you have your hand raised? I have a question. So this is a very good study, and it will impact quite a lot in terms of management of patients in LMICs. What I wonder is, for most of our patients, unfortunately, they do show up when they're in late stage. When you're picking up these patients at first point of contact, will we be able to know is the nutritional status because of the cancer or because of the general lifestyle, if living in poverty and things like that? And partly to answer, would it help to have like a control group from the general gynae clinic, perhaps, who are patients who do not have any malignancy? And then you compare them with a malignant group or the malignant cohort. I don't know what you think. Thanks. Yeah, you know, Anisa, that idea of comparison is good. I think that there's so many different directions that you can go in that it's going to be hard to design a perfect study. And I think Eugene should be given full credit for going this far to say nutrition and link it with clinical outcomes. So patients with cancer assess their nutritional status and watch how they do and compare people with good nutritional status as opposed to those with poor nutritional status. And we know what the result is going to be. And then the big thing is to try to figure out ways to improve people's nutrition before they begin therapy. Comparing it to a control group, though, is great. It's just that it might add another layer of complexity and most of all, expense. And money is in short supply all over the place. So sometimes a little bit less of a study is more feasible. Yeah, thank you. Thank you. May I ask a question, Dr. Seema? You know, it's a great idea. And I just had a question to Dr. Stella and you as well, that, you know, it's as he mentioned, it's always possibly better. I know you would get your ethics, but because you are learning how to do it, maybe, you know, it's better to follow what he said. Even if it's not in your ethics anymore, that, you know, think about how to do a sample size for this sort of study. Because, you know, it's fine that you are expecting that, you know, you would get sufficient numbers in six months time. But then suppose like a couple of years ago, Covid came. Right. So so many things happen. So six months is not six months. Right. So it's actually it's the number that you really need to show that you can correlate with some outcome. And I'm just kind of thinking that have you also stratified according to the type of gynecological malignancy? Because, again, if you have a gross imbalance between, say, only five versus something and the stages and all. So at least a basic structure of how you are and if it's a consecutive sampling or if it's an opportunistic sampling or how are you kind of. I think it could lay out a little bit clearer regarding early stage versus late stage or the different types of cancers, perhaps. Otherwise, analysis might be a bit tricky. I just thought, I mean, it's a great start that you're trying to see. And then from just looking at it, you could perhaps look into subsequent questions or the directions that you want to lay on further studies. But even at this stage, I just thought that if you could maybe have an idea of the different types of cancers that you want to look at early stage and late stage. Yeah. Now, the other aspect of this, Asima, is that we have such a disparate group of institutions. Some institutions don't have cancer registries. And so, you know, having a registry would be great because you could say in the last year, how many new cancers, gynecologic cancers and what were their stages? You'd have all that stuff. And several of these venues, that's not available. So, you know, this is going to be a challenge as we proceed through this, that some places will have more resource than others. That doesn't mean other places that have very limited resources can't do some good studies. And we're just going to have to improvise. Yeah, right. Eugene, do you have any other comments? Yeah, thank you for the comments. So I've got that I need to calculate the sample size. So I calculated from the prevalence, but the University of Rwanda rejected that. I shouldn't put the prevalence because they no longer want to do the prevalence studies in this stage. So I will try to calculate the sample size so that whenever I do this and I found that this sample size is not fulfilled, then that way I may add more mass to do the sample size during calculation. And I've got also that I may just need to use to try to find whenever the patient with malnutrition and those with not having malnutrition, and they may try to analyze which one do better during the treatment of gynecological cancers. Maybe if there's anyone that I couldn't catch up, maybe you can remind me and then I put it on this research. So I propose, Eugene, that between now and the next meeting, which will be in about a month, if you can make some headway into trying to figure out sample size and maybe you'll be able to do some power calculations, you don't have to do any of this. But having an endpoint of reaching an accrual target in a number of patients instead of in six months may be helpful as you embark on this. And let's get some more feedback in a month. Yes, yes, I would do it. Okay. Great. And then we have another proposal to review, at least I do. Yeah. And I don't know. Yeah, Kalima's on. Oh, Kalima's on. I just call her, I say Kalima. I think she's okay with that. Kalima, do you want to, are you available? Yes, I'm here, Suzanne. Okay, great. Kalima, why don't you go ahead and give us a brief overview of your proposal. Okay, thank you, Dr. Stella. So my proposal is we've been doing more surgery for women that have either vulva interepithelial lesions or invasive vulva cancer since the IGCS fellowship program started. But we do not have any information on the psychological, sexual, and like social challenges that these women go through. And so I was thinking of doing a study where I would sort of like try and find out what these issues are from the time that they get their diagnosis to the time that they've had surgery. And maybe if I have enough time to also see what short-term complications they experience after they've had the surgery and performed on them. So that's what I was thinking of doing. Okay. I have a couple, I reviewed your document and I have a bunch of edits that I made that I will send to you through either Susan or Donna will help to get the documents that I have reviewed back to you. I think your idea is a very good one. I think that you're going to need to get a little bit more specific about the types of surgery that these women are going to undergo. It's a lot more complicated than simply simple versus radical vulvectomy. Now, again, we work in an environment where there are extreme differences in access to resource. So many women who have vulvar intraepithelial neoplasia who get treated in the United States might get treated with Caldara with a miquimod, a cream, and they don't undergo surgery. And then there are some people who undergo laser vaporization of lesions and it spares them a more extensive surgery. Then some people are unfortunate and they have VIN that involves their clitoral butt and since your endpoint is psychological and sexual well-being, you need to include whether or not the clitoris is involved in the treatment because that will definitely impact their sexual function surgery. And then radical surgery, is it unilateral, is it bilateral, is it their nodes involved, is it an odd block or is it you know modified radicality, all of those variables I think will be important to catalog as you study. And then get back to something that we discussed earlier, has to do with sample size and trying to figure out how many subjects you'll need in order to be able to make some generalities, make some conclusions, so statistical power. So trying to figure out what your approval numbers need to be will be I think an important piece of this. Of course IRB approval goes without saying, but all in all I think it's a very good idea in an area that's vastly under-researched, especially in developing areas and in places with limited resources. Thank you for those comments. I am looking forward to getting the document from either Susan or Donna so that I can read through and then readjust my proposal. I'm in the process of like polishing it up and trying to get that because we have a National Health Research Authority and everybody who's doing research before you can even think of getting IRB, you have to register with them. So I'm in the process of doing that and then once I've reviewed and adjusted the proposal then I can submit for the IRB. So I'm looking to maybe by the end of the third quarter of this year I should have that done and probably be ready to start collecting the data end of third quarter and certainly into the fourth quarter I should have started the data collection. Great. Asima? Yeah I have a comment. I mean I actually Donna sent me these two as well so I mean I have a you know it's a really great idea that you know this research proposal and I think I really liked this idea and I have just a question to Dr. Steller and maybe yourselves that you know like do you think that there is an opportunity that you know once you have your own ethics and you have started the work that you know the other sites or the other fellows if they wanted to do a similar kind of study with their own ethics and the pooling exercise that is an opportunity because I mean this is a great example I mean this is a I mean it's not only in Zambia but maybe you know in any other countries that you know we do these things there's a very valid question especially for women or in cultures which is socio-culturally it's quite a difficult disease to manage in many parts of the world especially if you've got younger women. I know when I practice in the UK it's 80-90 years old women most of the time but even then for them it is difficult because they come so late often from homes and things so there is definitely an area element around you know presenting and psychosexual or psychological factors even without surgery and after surgery but then in India especially when you are for poor socio-economic background or some areas which have got cultural taboos I think it's a brilliant question to be answered and or investigated and I think there is a scope for wider participation. Yeah I think that's an excellent point Asima and I think one of the things that we have to be very sensitive about is since there are so many venues involved in the IGCS training is that although they count as a part of the IGCS training each one culturally has its own nuance and sometimes the cultural differences are a world apart even though we're all zoomed in on this call each of us is working in a place with its own culture and when it comes to sexual candidacy that being open about it or closed it's very cultural and then you know you know some societies men and women are treated equally and then in some of the societies of the people that are in the audience right now it's not equal and so that will impact this particular area of investigation since it really deals directly with the consequences of surgery on the female genital area but I do think Asima you're right this could be something to open up to the greater IGCS training community and then as far as power and sample size you should have a bounty and that's the power of what absolutely this is this is amazing if we can corral this and harness it we can make some very very powerful statements very quickly because you guys have tons of disease and then the other thing that came up in the proposal was in Zambia vulvar disease of vulvar cancer I think is the third most common I know I know I was surprised which is pretty unusual but maybe there are other sites that we just then see it all depends on whether or not you have a registry if you can't catalog what you've done what you have you can't know how common the various diseases are did you did you say it's a second most commonest or something I mean I just I think it was the third you know everybody cervix right number one and then probably well it depends I think endometrial is probably number two but and just an aside we have a group that I've been trying to get some free education on vulvar cancer there's a group that does some great work and we're kind of going back and forth to see if they would offer education for our fellows but more to come on that so I keep going back and forth with them but so Kalima do you have any more we couldn't hear you yeah she says second most common malignancy according to global kind of which I was really surprised yes and we we it's surprising the first of course is the cervical cancer and then vulvar cancer is the second most common but when I looked at because we have a theater register so when I looked at our theater register from 2019 up to like middle last year we have done more vulva surgery than we've done cervical cancer surgery I suppose it's because one of the issues is because a lot of our cervical cancer patients come a bit late and we can't do any surgery for them but my numbers were I have far more cases of vulva surgery that we did and from the time we started the IDCS training for vulva I think it's first and then followed by cervical and then we have endometrial and ovarian coming in like third and fourth I mean this is amazing I'm going to send my fellows to you to learn vulva surgery because they get to do only four or five a year in India if they're lucky I actually we had two today are these primarily younger women or do you see yes and so young women because of HIV so most of our patients are HIV positive so they are younger than like you know statistic for the US for example they are much older patients but ours are like in their 30s 40s yeah because of most of them are HIV yeah no you know this but just to throw this out for younger people presenting with vulvar disease HPV is very commonly associated with that condition and then for the older women who are 80 and 90 years old HPV is less prevalent and you see a lot of p53 mutations and the outcomes for the older crowd are not so great and the outcomes for the younger crowd can be actually pretty good so then of course HIV figures prominently in the immune response to HPV so you have some opportunity to link that up to great wonderful okay the next one is Natalie morning how are you oh no okay I'm great I'm great I'm just I'm just listening to listening in today I don't have any other case to present but read this study what I wanted to find out was this is a study that was presented before in the IADC so I actually started writing a protocol for a similar study I was just trying to find out if there was any questionnaire that was already validated and how we could access that tool to conduct it in Jamaica so I was briefly given this to read and I again I would go back to you that you just write something write a research question write a hypothesis and and it's very important that you know there is one thing I really immensely benefited when I was a training is there is a BMJ there is an article on authorship and it really tells you what to write in an introduction and methods and all but basically it is about clarifying three questions what is known what is unknown what is the gap and what are you going to do you know so basically is it like you are thinking of exactly copying what has been done because nothing is available in your country because as I understand self-sampling there are so many articles I mean I did my first self-sampling study 20 years back in India so it's kind of really there's been plethora of articles and even leading to WHO recommending self-sampling as a valid methodology so my question would be that what is it that as a fellow that you have in your mind that you really want to answer something new or is it not something you don't know in your population whether your subjects would be accepting it or your providers wouldn't be accepting it or you think that the barriers that they have identified in their providers it's only 18 focus group study right and that you think that the barriers identified by the providers in your country would be different so it is kind of really I think you need to put in a little bit more thought into that what is it that is going to be a research question and it does not necessarily need to be replicating but it could take a lead on that and be on your own study okay all right I understand but it's a similar thing because we don't have a lot of HPV testing done here in Jamaica and as you said WHO does recommend HPV testing whether it's self-collected or a clinician collected so in working towards getting that done in Jamaica HPV screening well that's a question just to throw it out to the healthcare workers you know nurses doctors to find out how they would feel about well HPV testing one overall do they know it's available and what are their thoughts on patients collecting it themselves because if they aren't aware of it being available and also the fact that patients can do it on their own they may not be as willing to facilitate or you know recommend it to patients or just to help to improve care overall so so that's really the rationale for it because it isn't being done here so it's really to just get an idea while informing persons about it somebody has got something I mean you're trying to assess the knowledge at issue practice in the provider community but then it is about the methodology that you're going to adopt because I have briefly read the paper they've got a very strong methodology of doing qualitative research you know through the focus group and things like that it's only 18 respondents but it's very in-depth and there and qualitative research is quite difficult as well it's not an easy thing because there is a strict methodology how to do it and then transcribing and things and also I would strongly suggest that you kind of think about whether you want to survey or whether you want to go to the depth of the qualitative methodological tools and then you have got somebody on board with you who is familiar how to do these things because at the end of it whatever you want to address it is dependent on how robust your methodology is and what method you used so I think if you would want to write a project or a proposal keeping these in mind and then we could review that perhaps all right okay I'll do that um I was thinking more of just getting the contacts for um through the medical associations for and sending like an email um survey but I'll give it some more thought to see if maybe focus groups or some type of qualitative aspect would be useful but the initial plan was to just use a like an email survey and send it out to the physicians and well to the healthcare workers yeah what I will be happy to write up something in more detail. I think if you write it, because again, just to email some random questions, you might not be able to analyse. Ultimately, whatever you are doing, you want a tangible outcome which results in a publication or to your next study or a protocol writing. So again, questions also need to be structured in a way that you really get relevant answers, whether it's yes, no, or whether it's a Likert scale. I mean, those are really some thoughts that you need to put in your mind, even when you send some questions out. Yeah, that's a very good point. All right, so I will go back and do some more work and present some methodology and then take it from there. But that makes sense. Great. Dali, you have your hand up. I was just going through some of the papers and the mentors would be able to kind of identify more. So if I can share my screen. So there is this knowledge attitude practice questionnaire that's already there and has been implemented in Northern Uganda. And it's like a structured questionnaire. And this study looked like a good one. So maybe you can have a look, but I'll send through Dr. Steller and Dr. Asima first before. And then perhaps you can have along with the idea of Dr. Asima and Dr. Steller. Because I was having a look at this paper and it kind of looked like similar to what you were planning to do. Just my thought. Oh, OK, thank you so much. I'll have a look at this. Great. Thank you. I don't see the next Dr. Asima. I have to jump off, but we'll keep the meeting open. But I have I want to kind of go over a few things before I have to jump off the call. There's two. One very exciting thing. The Mayo Clinic is going to be offering fellows and graduated fellows a discounted rate to take their their training. They do. And it's typically they're giving us a 90 percent discount. So it's a huge discount. So I'm working through the details and then we're going to figure out, does everyone want to take it? You know, if you sign up for it, we want to make sure you take it and how we get that paid for. So I have more details to come. But we've been working on other resources. We don't there's a lot of resources out there. So we want to try to make sure we're working with those resources so that we're not reinventing the wheel. So I will be working on getting that to you or finding out how people can sign up. They haven't told me when to start or anything, but hopefully the next couple weeks or months that we'll have that information. The other thing is we have been working on getting all the didactics and then the research. We have a research curriculum that a group from South Africa or South America has done for us. Let me share my screen real quick. I will send everyone after this call. I'll get people access sometime today. But if anyone if you all log into the IGCS, hopefully you've all logged into Education 360 IGCS. All of you should have access as a member of IGCS to get in here. And then you would look under catalog and you would just type in didactics. And then you. Oh, I have to log in first. There we go. That's why it's not looking right. OK, so I have to log in. Make sure you're logged in. And then you'll look at your course. You can do a search just for didactics. And then this course here didactics will show up. This will look a little bit different because I'm in a I'm looking at it from a administrative review. But all of these we have research and publications. We don't have all of them yet, but I still want to give you access while we have it. So evidence based medicine, answerable questions, literature search, literature search. So there's a lot of content in here already that this group from South America has done for our group. And then there is also I just want to make sure you're sure you're aware all the didactics that I've recorded over the years. I'm still populating some, but I've kind of broken them down by circle. Endometrial just GTD. This you'll have access to all these recordings. They were in Redcap, but I'm moving them all into this new learning management system for all fellows and graduated fellows. So I just want to make sure I will be getting to you by the end of the day today access to this. And if you don't get it, just feel free to email me. I'll make sure you have access. But just wanted to share that with you. OK. Any comments or questions about that? That's that's great. Susan, just to kind of make. Is it only for the fellows or for any members could log in and see this? This will be only for IGCS fellows at this point. Because a lot of these recordings were done. And they absolutely. Yeah. Yeah. Yeah. So but the goal is if the content is valuable and we think that we would just have to get permission from everyone that did didactics to say, can we put it for all members? But for right now, it's a benefit for all IGCS fellows and graduated fellows. Which is great. That's great. And actually probably local supervisors as well. So I'll make sure. Sure. Yeah. OK. All right. And then I know we still I don't know, Dr. Seema, if you want to go over. I don't think Dr. Inzam is on the call, but I think it would be OK for us to discuss his proposal and then we can send him the recording. Yeah, I think I just got an email, really. I can't remember seeing a proposal. Well, yeah, it's just he's just starting. This was like his this is very basic of what he was looking to do. So I think he would like any input to get started. Yeah. I mean, I think he kind of like I didn't understand quite what does he mean by the surgical checklist? Is it the checklist that you have in red cap already or is it something that you're looking to a WHO checklist or something? That's what or is it the operation record? So I was not sure exactly what. So I think it would be better that if he's around and he could explain it further, because this to me looks more like an audit rather than a research protocol. And I know that there are different types of research nowadays. You know, there is an implementation research. There is health services and operations research. So if we have to put anything like this into those categories, which is not an audit, but it becomes a research, then again, this for all of you, there are set methodologies and criterias how to do it. So, again, if the question he wants to address is a service implementation or service evaluation, and then that comes into a health operations research, then there is a set. There is a there is a validated methodology how to do it. If you want to construct the question that it falls under an implementation research type of project, then again, there is a validated like RE-AIM framework and others how to do it. So because he's put some barriers somewhere, I think. Is that right? He put some what? Some barriers and some challenges that the challenges that they're filling. Yes. So you see the barriers and challenges is a typical example of implementation research methodology, where there is a structured way of how to record a barrier challenge and do it. So what I'm I'm not sure, and that's why I can't comment on this, that doing an audit is different like a prospective audit. But if you want to do a research, then you have a hypothesis and a question and you want to either prove or disprove. And it's always important that you can use a validated method to do it. Otherwise, you cannot prove or disprove to your point. So that is what I really want to kind of make sure that you understand that the difference between an audit and research and then either is fine. But as long as you know what you are doing in terms of audit, if you want to do, there is a standard. And then you are trying to see whether you are meeting those standards. And then there is an audit tool or, you know, so basically if you're not meeting, then you are doing something and then you're seeing again, you are meeting the goal. There's a loop. Right. But then I was not sure really that whether he wants to do it as an audit framework or as a research framework. Research, you can be, of course, more exploratory. And even in finding these barriers, whether you use a survey or a qualitative research methodology or, you know, so I need more clarification. And I think, again, if it's a research proposal, if you write a protocol, put in your question what you want to do. Again, same framework. What is known? What is not known? Where is the gap? What is it that you want to address and how? I think it's just this basic questions and then come back with some more structure in it. OK, great. I think this is what's good to put out your ideas and then we kind of help you work through them. So I know he's not on the call, but I want to at least let other people see the ideas that are being thrown out there so people can kind of work through. How do you get from the idea to actually starting the research? So I will let you. I do have to jump off, but I know we'll leave time for comments and questions. And then I was going to let Asim, I think you were going to talk a little bit about the upcoming submission of abstract. See if anyone has anything for the IGCSE annual meeting. But I will see you all later. Thank you. Thank you. Thanks, Susan. So any comments by anybody? And I think. It looks like a silence there. Anyone, any comments that you want to put in? I think this is a great, great platform. I don't know how much frequently are we going to do it, but I think it's good to see proposals coming in. I mean, you know, just some ideas that you want to do. And I think it's also important that you all of you who are there, you have heard about these four proposals. So you could also maybe think about a thing or two that you may want to add or if you wanted to do in your setting, what would you want to do it? So that is another way of putting more brains into it. Just one quick question. Morning, everyone. Is this a is this a forum also where we could explore possibly case studies for review for publication? Or is it strictly interventional research? There's no restriction. We're trying to facilitate and promote doing research and publishing papers. If you're doing a case report, that's every bit as legitimate as doing a multi-institutional trial with a thousand patients. Really put anything. Anything is fair game. Absolutely. And as you see that you put a case, I mean, maybe somebody has this equal, different, same kind of case. I mean, it would kind of be a really nice discussion. And then, you know, how to see whether we can even collaborate or pull out or, you know, those sort of exercises also could be possible. So, yes, case reports are also fine or discussions. If you want to publish that, that would be great. Yeah. And as if this forum catches on, it may be that what began as an interesting case report in your at your institution has also been experienced by other people in other member institutions. And then you can have a paper of maybe 10 patients instead of just one. So, but really, it all starts with something interesting that needs to be described. So in the future, we're also planning to do like groups, specific groups, maybe for cervix, maybe for ovaries, and then we can collaborate to work together. So that later on, if someone has an idea, and if you need more than one cases, then we can all come together and do breakout rooms, maybe Dr. Asim and Dr. Stella, then you can kind of liaise with the team, and we can proceed from there. I mean, the other thing I wanted to kind of, I thought about it this morning, that, you know, of course, this is a beginning, but if this platform flies on, maybe a few months later and all. You know, some of these ideas, you know, of course, you know, when you want to do some research, you know, application to grants and funding bodies, whatever small, even charities, they have, you know, a lot of charities have an application where you need to put in a structure to get some funding. So one of the things that could be useful later on is that, you know, we could perhaps help you in terms of maybe if you needed some guidance regarding how to put on an application to get a grant, because that's, again, any sort of research. I mean, you know, you are doing this case series and surveys, which is all your own effort and all, but sometimes even getting a small grant or some support to have somebody collecting the data systematically or something is going to be quite helpful. Dr. Asim, do you want to talk about the IGCS annual meeting and the abstract submissions? Yes, I mean, you know, Donna, when is the deadline? I have got, I just needed to kind of check on my thing, but I mean, I think, you know, you all of you know that the IGCS meeting is in Seoul, Korea this year, and I think the abstract submission deadline is pretty soon. So it would be really nice if, you know, you guys want to put up some ideas or you want to check your abstracts if you feel that's appropriate, and then before the abstract deadline, maybe we could review, make some comments or something if you felt that was necessary. But it would be really nice to see abstracts coming in from the fellows in whichever format. So it's May 8, right, for oral poster, and late breaking is different, but I think even, so 8th of May, so we got a couple of weeks left, I think, two weeks left, really. So if there is anything that you feel that you could want to write an abstract, and I don't know, Donna, maybe we could have another session before the, in a couple of weeks time, if we find that there are sufficient amount of abstracts, people think that, I mean, of course, your local supervisors should be the first port of call, because, you know, of course, it's your institutional thing, and then you want to directly go through them, but if any fellows felt that you want some more guidance, after you have asked your local supervisor, of course, then, I mean, that is something maybe we could help you with. I don't have anything more to add from what Asima just said. But please go to your local supervisor first because, you know, I think that would be the wrong thing to do to come to us first to submit an abstract rather than by, you know, bypassing your own team. So that would be my strong advice. Yeah, and I will take it a step further. Not only do you want to include your local mentor, but you should also include your international mentors. Yes, yes, absolutely. When you're on the Zoom conferences, they are a great resource. So start there. Yeah, and if there's anything else that you feel that you want to bring here, because it is your project, your idea, and you feel comfortable with this forum, we're there to help you out. But as I say that this is a very tricky thing, so don't try to bypass the mentors and come over here directly. Great. And just before our final words, maybe, last time Dr. Estella gave the presentation about the research and publication. So we have some information. We couldn't give possibly some information on GCIG and ENIGO and the other groups. So maybe, Dr. Essema, you could. Oh, yeah. So GCIG is called a Gynae Cancer Intergroup, right? So, I mean, I am quite new to this platform. I mean, you know, of course, it's only been five years, but then it was Dr. Ted Trimble who kind of introduced me to this concept. And then I was an observer in one of the platforms that GCIG has, which is called CCRN, which is Cervical Cancer Research Network. And basically, that allows many countries or centers from low middle income countries to actually participate in the multisensory clinical studies. Sometimes your center may not be ready to participate in a clinical trial. But if you start engaging yourself, then maybe in five years time, you really know what is it required to even put one or two patients in a trial. And I always think it's exactly like what Neil Armstrong said when he landed on the moon. It's a small step, but a huge leap for the mankind. And it's exactly how it felt when after four or five years of hard work, when I could put one patient from India into an international clinical trial. So this is, again, a learning exercise. And if you want more information as a part of GCIG, I'll be very happy to maybe arrange a lecture or something or the other to let you know more about GCIG and CCRN, especially the Cervical Cancer Research Network. They also have a young investigator program. And I always encourage a lot of the IGCS fellows. We had a brilliant lecture yesterday by Elise Kohn. And then tomorrow we have a couple of lectures, which I have submitted the link to your group. These are really nice tools to learn from the experts how to even think about a question and do some studies. And the young investigator platform is something which I think there is a talk between GCIG and IGCS collaboration, which can work with you guys. GCIG is trying to lay down a curriculum for trainees. And that is kind of going them through to the basics of clinical trials and how to do it. And one of the major mandate is for everybody, even for FDA and EMA, that they need participation from low middle income countries in the trials. So it is an opportunity actually to learn. And those curriculum materials, I am trying to make it available to IGCS as well, if it is available. So in any way, it's trying to join a larger community who are doing things. And it may take five years or 10 years, but if you start today, you will get there someday. So that is about GCIG. And Enigo is again a platform from ESCO. It's a young investigator and researchers from the European platform. I'm sure in the US you would have a similar platform, Dr. Stella, for young researchers. So they do a lot of activities, but it's possibly similar to what you have in your IGCS early career network. I know Artie is there. So all of them, they're doing the same thing, but different names, I think. But it's good to learn from others who are doing things and more active in research publications, committees and things like that. That's all I had to say. But GCIG and CCRN, especially with the cervical cancer, it is a brilliant platform because they are really looking in an academic trial setting to sort out or even to think about questions which are relevant to low middle income countries. Great. So I will be sending out again another meeting survey link for people, which one will be feasible and the one with the highest number of votes will be the next meeting date. So we will be planning to meet before the deadline. And yeah, as both Dr. Stella and Dr. Asima said, so this is a group where you all will be coming and we will be having discussions. But always keep your local supervisors and your international mentors in the loop as well so that they also get to know and help you out in everything. Any final words, Dr. Stella? No, I just want to say that I think that this forum has the potential to really catapult all these fellows into the realm of publication and research, we hope. And it takes a village and this is your village. Great. Dr. Asima, any last words? No, I think, you know, I think it's a great feeling. I'm really so happy to be part of this. It really feels humbling that I've been privileged that I've been able to do this and learn from all of you. I mean, I am learning about, you know, how different, different challenges everybody has. And I'm kind of thinking so. So thank you, everybody. And also be having the courage to put up your ideas in an open forum is not an easy job. So great. Well done, guys. So well done, everybody. So if you have any other research ideas for our next meeting, do send that to me and Susan and we'll discuss that. Thank you, everyone, for joining. Thank you. Thank you. Bye bye. Bye bye. Bye. Thank you. Bye bye. Bye bye.
Video Summary
In this video summary, Dr. Aseema Mukhopadhyay and Dr. Michael Steller co-chair a research publication committee meeting. They introduce themselves and welcome attendees. Dr. Aseema discusses the importance of having a proper research protocol format and clarifies the three main components: grant application format, research protocol development, and understanding the study's aims. She emphasizes the importance of clarity in these sections. Dr. Steller emphasizes the educational process of the committee and the need for institutional review board approvals for any project involving patient data. They also discuss the need to understand country-specific requirements for international data sharing. They then review a proposal from Eugene, who wants to assess the nutritional status of gynecological cancer patients in Rwanda. Dr. Steller provides feedback on sample size calculations and the need to understand the types of surgeries performed. Dr. Aseema suggests stratifying according to cancer type and stage and obtaining country clearances for international data sharing. They also review a proposal from Kalima, who wants to study the psychosocial and sexual challenges experienced by vulva cancer patients in her region. Dr. Steller suggests expanding on surgical procedures and including clitoral involvement. They discuss the importance of sample size calculations and the potential for collaboration among participants. The group also briefly discusses Natalie's proposal to assess healthcare workers' knowledge and attitudes towards HPV testing in Jamaica. Dr. Aseema suggests exploring validated questionnaires and focusing on qualitative research methods. The video concludes with a discussion on future plans for the group, including access to educational materials and collaboration with international organizations like the GCIG and ENIGO. The group also mentions upcoming deadlines for abstract submissions to the IGCS annual meeting. Overall, the meeting provides valuable feedback and guidance for participants seeking to develop their research projects.
Keywords
research publication committee meeting
grant application format
research protocol development
institutional review board approvals
international data sharing
sample size calculations
stratifying
surgical procedures
collaboration
validated questionnaires
qualitative research methods
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education@igcs.org
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