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Formulating Your PICOT Question and Searching the ...
Formulating Your PICOT Question and Then Searching ...
Formulating Your PICOT Question and Then Searching the Medical Literature
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Hi, this is Aileen Farrick. I'm a nurse practitioner for cardiac electrophysiology at White Plains Hospital, as well as the assistant director of research for cardiac at EP. And I have been involved with cardiac electrophysiology for, dare I say, the last 40 years. And I'm privileged today to talk to you about formulating your PICO question and then using that PICO question to do a search of the medical literature. This is actually the second part of a series called HRS Research 101. So the objectives of my talk today are going to teach you how to identify a clinical treatment concern or problem in your practice that may merit further study from your opinion, know the components of a PICO question, develop a research question based on that clinical concern that you deem should be further studied, and then learn to review the literature based on the PICO question that you develop, and then consider the next steps in the process for doing a research study. To illustrate this on a more personal level and to maybe drive the point home more clearly, I'm going to use some examples of my experience in research over the years. So what is a PICO question? It's a mnemonic derived from the elements of the research question. The PCOD format is a helpful approach to summarize your research questions, and it helps you explore the concepts that you may wish to study. So what is the clinical observation that you're going to identify? You may be in your practice and you are observing a particular treatment, concern, or problem, and it raises a clinical question in your mind. In order to illustrate my experience, I'm going to just give you some of the observations and musings I've experienced in my 40 years of practice. So one, which is really a clinical concern, was our EP service now allows same-day discharge for patients who are post atrial fibrillation ablations. And my thought or concern was, how satisfied are patients going to be with this practice? So that was one clinical observation. Another one is the post-cardiac implantable electronic device implants. Patients experience a lot of discomfort surrounding the implantation area. This is a clinical observation related to treatment. Would we improve patient outcomes if we treated the patient with an ice pack or with analgesics or a combination of both? The third example is more related to a problem, and that's looking at processing remote monitoring results. It really takes up a lot of EP clinic staff time. So I wanted to look to see, is there a difference in the time required to process in-office versus remote monitoring visits? And is there a difference in time required to process different types of devices? That can certainly impact our workflow in our device clinic. And then finally, my last example is in regard to a treatment. So patients with AF who undergo ablation procedures experience a lot of chest discomfort in the immediate post-procedure period related to inflammation from the application of the radiofrequency energy. So my thought was, would treating them paraprocedurally with an NSAID such as Colchicine, would that reduce their discomfort? One particular clinical observation that I actually did a full study on, and I will use it as an illustration throughout this lecture, is when subcutaneous implantable cardioverter defibrillators were first clinically introduced, we wanted to explore how patients would feel with a sub-Q ICD as compared to the conventional transvenous ICDs. And as you may recall, when they were first introduced, it was a whole shift in paradigm with where the device is located and differences, obviously, in the implantation procedure. So what I wanted to consider is, will it affect patient's quality of life, the subcutaneous ICD? Will it affect the patient's body image? Will it affect how they accept their device? And is there a difference in a fear of receiving device therapy between the two types of ICDs? So the first step in my process is to formulate my PICO question. And so what does PICO mean? P is patient population. I is the intervention that I want to study. C is the comparator, or if you will, a control group. O is the outcomes that I'm going to look at or measure. And T is the time frame of my study, my study period. And here's a little diagram that sort of gives you a sentence on how to specifically formulate that PICO question. And with my example of comparing the subcutaneous ICD with the transvenous ICD, here's how I formulated my PICO question. And patients who are eligible for primary prevention ICD implantation, so P, population, are those patients with a primary prevention indication for an ICD. How do subcutaneous ICDs, so my intervention that I'm looking at, or subcutaneous ICDs, compare to transvenous ICDs? Thus my comparator is the conventional transvenous ICD. And what I'm looking at is the effect that it has on quality of life, body image, acceptance of device, and fear of getting shocked. So those are the outcomes that I'm going to measure, and I wanted to do this within a two-year enrollment period. So once I formulated my PICO question, now I'm going to turn to do a review of the literature. Why is it important to search the medical literature? So some of the questions that I want to answer are, how has my treatment concern, my intervention, has it been previously studied? Will my particular study contribute to the body of knowledge on this particular intervention? So I'm looking, are there similar studies? Has it been done before? Maybe I want to reproduce a study that has already published its findings. Or maybe I want to look at the variables that they study and want to make a, you know, look at different variables, such as, with my example, maybe patients who have better knowledge of their disease have a better acceptance of one device over the other. Maybe I'm going to look to see what populations my concern or intervention has been addressed. I'm looking at primary prevention comparing subcutaneous ICDs to transvenous IDs. Maybe I should look at secondary prevention because there's already data out there on primary prevention. Other questions that I'm looking at when I'm searching the literature is, what tools or instruments did other studies use to measure, for example, quality of life? And what areas related to this concern or intervention need further exploration? So maybe a question has been raised out of another study that I hadn't even thought about, and maybe I want to gear my research question based on what I found in the literature review. So how do you access a medical library to do a review of the literature? Academic medical centers may offer access to their medical school library. Now I had the experience of working in one particular institution that would only allow physicians and students of the medical school to access the library, which was a very big frustration for me, but I was able to get a faculty appointment for the medical school and then had access to the medical school library. You should know that most academic medical libraries do employ research librarians who are available to help you with your search, or even on the other hand, if you give them the terms that you want to search, they will actually do the search for you. Other ways to access a medical library include perhaps where you work at your institutions. A lot of facilities in their intranet will give you access to certain databases, typically CINAHL, maybe PubMed. Another avenue for finding a medical library to search is your nursing college. I received my PhD from NYU, and now as an alum, I have lifetime access to the New York University library, which includes the medical library. So perhaps your nursing alma mater has the same privilege. Once you have access to the medical library, you want to select the databases for which you want to include in your search, and typically the most popular are Midline, PubMed, Enbase, CINAHL, and the Cochran Library. Now how do you begin your search within each database? So you need to choose your MeSH headings, and you'll see that on the database. It will actually have the word MeSH, and what that means is medical subject headings. These were developed over 40 years ago, and they were compiled by the National Library of Medicine, and they were topical subheadings used to catalog books and periodicals based on the Index Medicus. Now I'm old enough to remember the Index Medicus, which was a series of books that included all the publications. Now much more conveniently, we have this at our fingertips electronically. And what the MeSH terms are are labels assigned to the articles to describe the content of the article. They use specific vocabulary, and obviously it's usually more clinical terms. And just to give you an example, if you want to understand or do a search related to myocardial infarction, you wouldn't use the word heart attack. Most searches for a cancer topic would include neoplasm as opposed to cancer. Usually the MeSH terms are part of a tree with subtitles. An example of that is your MeSH heading may be diabetes mellitus, but it has a series of subtitles such as type 1 diabetes, type 2 diabetes, and gestational diabetes. And then under the subtitles are specific keywords that you may need to use. Once you get into your tree, you have the option of either exploding your MeSH term, which means you're going to include all the subtitles that are under that tree, or you're going to focus your MeSH term, and that will allow you to narrow your search and not include everything. So the first step I look at is that you try to think like a medical indexer who has just read an article from a study when you start to choose your MeSH terms. You may want to start with broad categories such as cardiovascular disease. If you ask for cardiovascular disease, some of the subheadings may be therapy, diagnosis, etiology. So you can start searching based on your PICO question, again, what you want to focus on. So what happens if you start to use those terms and nothing pertinent comes up with your search? It can be very frustrating. So some of the things you need to think about are you using the appropriate American spelling? You may try using an alternative name instead of cardiovascular disease, perhaps just cardiac disease. If you're using a non-disease term, you may want to combine a keyword associated with the disease. For example, if you're looking at injury or surgery, or more specifically, if you're looking at ice pack, like the example I used earlier for minimizing discomfort after a device implant, you may want to include ice pack, but then go to surgery or implantation procedure. The next step is you want to identify those additional keywords to sort of narrow down your search using that more general MeSH term. Some of the suggestions are to include the location of the disease or disorder. Is it right arm, left arm, causes of the disease, or diagnostic tests associated with the disease? Some examples that I'll give are if you're doing a study on pressure ulcers, you may want to include keywords of heel or sacrum if that's how you want to narrow or focus your search. You may also want to look at the MeSH headings in reference to diagnostic testing. So you may see under diabetes, creatinine slash urine, or insulin under therapy. Or you may want to look at, you know, for cause of disease, a keyword such as risk factors or other options, maybe adverse effects or complications. The next step is after you search several MeSH terms separately, you may now want to combine them. But again, you want to focus in on your PICO question and the factors that you're looking to search. So there is a term called Boolean operators that are functions to help you, again, narrow your search. And so when you take two MeSH terms, you can combine them with the word end, which means that you're going to combine those two terms and it's going to retrieve all articles containing both terms. Or you can use the word or, which will retrieve articles that include at least one of those terms. Not excludes the terms, and so in articles that won't have those terms in them. And so you may, that may be a way to eliminate things that you don't want to search for. You can also use quotation marks, and that's used to search for a phrase exactly as it appears between the two quotes. Parentheses are a way to nest your terms together, and it will look within the parentheses. It'll read that first, and then the terms outside the parentheses are read next. And then finally, there are asterisks, which are used as wildcard symbols. And so if you're misspelling a word, or if there's a variation in a word, the asterisk will accommodate for that. I'm going to give you an example. So here is, within parentheses, heart rhythm or heart asterisk beat, and then within a larger parentheses or end disorder with an asterisk, followed by end, and within parentheses electrical asterisk or structural. So what is this going to focus on? This example will retrieve articles on heart rhythm or heartbeat or heartbeat combined and disorders, but again, it's going to look first at what's in the parentheses, and then it's going to look at electrical or structural disorders, and then it'll come up with a whole bunch of articles that have been focused based on your Boolean operators. And here's just an example of other ways to limit your search within a database. On the left here is PubMed, and as you can see, there is a little spectrum of dates. So if you want to just look at articles that are from maybe the last five years, you can pull this circle up and just go from 2018 to 2023. You can also decide that you just want English language articles only because there are publications that are written in other languages. You may want to define the species of the study. There are animal studies, but you may want to just restrict to human studies. You can choose the age of the study population. Perhaps you want to look at geriatric adults or pediatrics so you can focus in on the age, the publication years, as I just said, and the type of articles that you want to review. So if you look over here on PuttMed, it says abstract, free text, or full text. I'm sorry, I know this is very small, but I did want to give you, you know, an example again on Medline, where you can just look at abstracts, perhaps you want to just look at a female population. So these are ways of just filtering even more specifically to the search that you want to accomplish using your PICO question. And here's just an example I had to find before about what a MeSH term with a subheading looks like. And if you see here in my study, I did a MeSH term, this is just one, a body image, and you can see all the subtitles and keywords that are beneath that. And then over here on the right-hand side, you can see where you have the choice to either explore or focus on these terms that you're specifically picking for your search. So here's an example of search keywords that I use based on my PICO question. And again, it was inpatients are eligible for primary prevention ICDs, so the P, my population, these are the MeSH terms that I use, implantable cardioverter defibrillator, primary prevention, CIED, because some articles may be using the abbreviation. I wanted to look at guidelines, indications, cardiomyopathy, congenital arrhythmia disorders because they were more geared towards primary prevention devices. I wanted to prevent sudden cardiac death and sudden cardiac arrest. My intervention is the subcutaneous ICD. So I'm looking at subcutaneous extravascular. I could have also used extra thoracic in retrospect. I'm comparing it to the more conventional transvenous ICDs. So my C comparator, my keywords or my MeSH terms were transvenous, conventional, peptoral implants, right? And then the outcomes I'm looking at were the effect on quality of life, body image, acceptance of device, and fear of getting shot. So the MeSH terms and keywords I used were quality of life, body image, fear of shock, ICD acceptance, clinical outcomes, anxiety, and depression. And of course, my T is I wanted to do this within one year. I'm sorry, one year enrollment, actually two year total for the study. And I just wanted to show you, again, I apologize for this being small, but when I did my study, my first MeSH term search, I included subcutaneous, again, it was more with the intervention aspect of it. And then I did a separate one on quality of life. And you can see here the number of results that you can get, which are enormous numbers. And I'm trying to focus and narrow down, right? So then I can take the results of my first search and add it to my second search and get a separate search, which is search three, looking at the combination of these two concepts. And you can keep doing that. It's an iterative process. And as you see, just by comparing or searching one and two and three, I came down with four results from this particular search. And here's just an example of the article that I got. It's title is Quality of Life in Patients with Subcutaneous versus Transvenous Implantable Cardioverter Defibrillators. It's a Polish study, and I got it from Medline. So you can see the process that I took just to get one concept down to four different articles. The review of the literature, it is an iterative process. You really need to be creative with search keywords, as you can see. You need to combine and just keep trying combinations of keywords so that they're relevant to your concept. Again, that's why it's so helpful to use a research librarian when available. One thing that you should know is you can do an exhaustive search in one database. Say you do an exhaustive search in PubMed. You can then take that final search and apply it to Medline or CINAHL and see what the results are for that after having already done your whole iterative process. I totally recommend that you do review tutorials. I included two websites that are YouTube review of the literature tutorials that you might find interesting. And I just recommend that you practice. Go into a database and think about maybe some clinical concern that you are thinking about studying and see what you can come up with with an attempt at a review of the literature. Now once you choose the articles and the studies that you now have narrowed in your search, you really wanted to critically appraise those studies. Are these studies relative, or I'm sorry, relevant to your research question? And are these studies good studies? So what do I mean by that? You're going to need to do a critical appraisal of the studies that you've chosen. And what is that? It's the process of carefully and systematically examining research to judge its trustworthiness, its value, and its relevance to your particular context. The process allows the nurse or any researcher, really, to identify evidence that comes from, is it rigorous, is it reliable, is it unbiased, and is it methodologically appropriate research? So that you know that if you're using this as your review of the literature for your study that these are good studies that you are reviewing. So some of the questions that I ask myself when I'm doing a critical appraisal of a study is like, who wrote the article, when and where was it published? So is it relevant to current times? What is their PICO question, right? So what is their population intervention comparative outcome and timeframe? Was that clearly defined in their study or at least laid out? Is the study ethical? And how do we know it's ethical? Was it reviewed by an institutional review board or some sort of a process to deem that it is ethical? Is the study design valid and appropriate to the question that they're asking? What are the results? How did they come to those results? What is the statistical analysis? What are the implications for the finding for clinical practice? And is it relevant to my research question? Critical appraisal, you really need to rate the strength of each study. You're going to determine the level of evidence and the methodological quality. And there is a hierarchy of strength or quality of evidence. And as you can see here in this cartoon pyramid, the least quality of evidence is something that is of expert opinion. And then you go up to case-controlled studies, cohort studies. Randomized controlled studies are a stronger level of evidence, but the highest level of evidence are those systematic reviews that use randomized controlled trials. And there are tools for you to develop the practice of appraising studies. The Cochran Library, you can just go on to their website. They have a very good tool, and the tool is specific to the type of study that you are appraising. So there's one for a cohort study, there's one for a case-controlled study, there's one for a systematic review, and there's a separate one for randomized controlled trials. So what I also recommend is as you're choosing your research and you are appraising them critically, you want to keep track of them. And we had to do this when I was working on my PhD. You maintain an evidence table. It just helps you organize and keep track of the evidence that you've found. And so you're going to author in the year it was published. Maybe it's easiest to use the PubMed ID number because that's easy then to relocate the study. You're going to just keep a record of the aim of the study, the size of the population that was studied, what was the population, what were the inclusion and exclusion criteria, what were the results, were there other relevant findings or adverse events that came from the study, and what were the limitations and conclusions of the study. And you can just keep, even some people keep a evidence table based on their PICOT or PICO variables and separate them out accordingly. And I recommend once you do identify your relevant studies that you use software such as EndNote or RefWorks so that you have them listed. That will really help you when you go to publish your findings because it will develop a reference table for you. Okay, so what's the next step in the research process? You thought about your clinical observation, you did a PICOT question so that you formulated a research question that then helped guide you through your review of the literature. You've now come up with relevant studies that you've critically appraised. So what's the next process in research? So the next thing would be to write your study proposal. You may want to consider applying for a grant. There are many different organizations that offer grants, including nursing organizations, I'm sure that physician's assistant organizations, many, American Heart Association, Heart Rhythm Society, there are many different organizations that you can apply for a grant, including industry, they also have grants. As I spoke about the ethics of a study before, all study proposals should be submitted to the institutional that you work at or where you're performing the research study, the approval committee. Typically, it's the institutional review board. If it's a quality improvement study, a lot of institutions have a quality improvement committee, and it may be that they're the ones that approve your study. But there is a process and you need to learn from your institution where you're going to perform your study what their process is. Then once you get approval, you can conduct your study within your timeframe, prepare an abstract for the presentation at the Heart Rhythm Society or any other organization that you feel is pertinent, and then you want to follow through by publishing your results. Now, each of these steps that I'm talking about merit a lesson or a lecture through Research 101, which is something that I think we will be doing in the future. So stay tuned. And just to give you a brief summary, I said, oh, write a study proposal. So what does that encompass? Typically, these are the parts of a study proposal. You're going to develop an abstract, which is really just a one or two-paragraph summary of your study proposal. You're going to write an introduction, and that's going to include the review of the literature. You want to give background information. What is the point of your study? What is the aim of your study? What are you adding to the body of knowledge on the concept that you've decided to explore or study? The next section would be what are your methods? What is your design and methodology? Is this a cohort study? Is this a randomized controlled trial study? Who are you including in your population? What are the inclusion? You have to write out specific inclusion, exclusion criteria, and how you're going to recruit those patients. What is the process? You're going to define your instrumentation. What tools are you going to do to measure quality of life or body image? You're going to define your data analysis. So what statistical tests are you using? Do you have a budget? And then, as I said before, you need to enlist your references, and that's why using a software such as EndNote or RefWorks helps you keep that organized in a convenient manner so that you're not trying to put together a whole reference list when you're preparing your study proposal. You've done it as you've done the reviews of literature. So back to my SICD versus transvenous ICD study, just so you know, what did I accomplish after I hatched my idea? So I did a review of the literature based on my PICO question, as I showed you. I prepared a study research proposal. I actually applied and won a grant. It was a $20,000 grant through the investigator-initiated study grant from Boston Scientific. I decided I was going to use a multi-center design to ensure enrollment in both arms. As you may recall, subcutaneous ICDs, when they were first clinically approved, were not necessarily the first choice for ICD implantation. So I was worried about recruiting and enrolling the number of patients that I wanted to enroll, which was originally 100. So I got IRB approval. I did go through the IRB process through New York Medical College, from Westchester Medical Center, Montefiore Medical Center, Albert Einstein College of Medicine, and NYU's IRB. We were over the period of a one-year enrollment. We enrolled 55 patients, which was much less than we anticipated. We continued follow-up for an additional year. We did our statistical analysis, and we found that there was no significant difference in IRB variables of body image, quality of life, acceptance of the device, and fear of shock, except there was better acceptance of a transvenous ICD at the one-year follow-up series of questionnaires. I did present my results at HRS a number of years ago, and since then, we've submitted it to five different journals and were rejected. And I just bring this up, not to discourage you by any stretch of the imagination, but to give you an illustration of why my study was not quickly published. One, negative studies are usually less publishable than studies that have shown a significant difference between the intervention and the comparator. Our sample size was just too small. We wanted to have 100 patients, 50 in each group, but we were not able to recruit that despite having three institutions, although NYU did drop out on us. The other problem was our sample was unbalanced. There were many more sub-q ICDs than there were transvenous, interestingly enough. And it was also biased because there were more subcutaneous ICD implants at Montefiore as compared to Westchester Medical Center. It wasn't an evenly distributed group. Here is just an example of my poster that we did present, just so you can see how we put it all together. Here is our quality of life results, our Florida patient acceptance scale, and our Florida shock acceptance scale, our introduction, our objectives, how we conducted the study, our results, and our conclusions with our references. So this was our presentation at HRS several years ago. And that's it. Thank you for participating in this lecture. I am always happy to be available if anybody has any questions, if they're thinking about trying to put together a PICO question after finding something clinically relevant in their practice that they would like to further pursue.
Video Summary
In this video, Aileen Farrick, a nurse practitioner and assistant director of research for cardiac electrophysiology, discusses the process of formulating a PICO question and conducting a literature search. A PICO question is a mnemonic that helps to summarize the components of a research question, including the patient population, intervention, comparison, and outcomes. Farrick provides examples of clinical concerns and observations from her own experience in cardiac electrophysiology and explains how to formulate a PICO question based on these observations. She then discusses the importance of conducting a literature search to explore existing studies and identify gaps in knowledge or areas for further study. Farrick provides practical tips for accessing medical libraries and databases, selecting appropriate search terms, and using Boolean operators to refine searches. She also emphasizes the critical appraisal of articles and discusses the hierarchy of evidence and the importance of rating the strength and quality of studies. Farrick concludes by discussing the next steps in the research process, such as writing a study proposal, seeking ethical approval, conducting the study, and publishing the results. She uses her own study comparing subcutaneous implantable cardioverter-defibrillators with conventional transvenous ICDs as an example throughout the video. However, she notes that the study had limitations and was not easily publishable due to a smaller sample size and unbalanced participant numbers.
Asset Caption
Learning Objectives:
1. Identify a problem in clinical practice that you may want to explore through research.
2. Develop a research question based on the identified clinical problem.
3. Know how to develop a PICOT question for generating your research study.
4. Know how to complete a review of the literature based on your PICOT question.
Keywords
PICO question
literature search
clinical concerns
cardiac electrophysiology
medical libraries
Boolean operators
hierarchy of evidence
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