is Jorge Hegel and I'm a gynecology oncologist from Caracas, Venezuela. And today we will discussion about answerable clinical questions. And today I have no conflict of interest for this lecture and it's a pleasure for me to do this for you. So, well, you know, in our daily clinical practice, there is a regular exchange of questions and answers with our patients and colleagues. And which in one way or another make us wonder how important these questions can be in our growth as researchers. And if these questions are really clinical and can have a positive impact on our patients and if we can answer them by doing clinical research. So this is the real reason for this presentation today based on this learning objective, you know, to understand the importance of formulating unanswerable questions and how to be able to formulate an answerable question. You know, well, this is very important thing related we make an adequate question, you know, and right now I'm gonna talking about how is important to do that. The core formulation of the research questions is perhaps the most important element for this development since it allows the researcher to focus on the problem, orient the methods and propose possible solutions among other things. And as we can see in this slide, you know, focus the problem, identify the study variables. However, in daily practice, it is common to find difficulties in identifying the elements of the question in achieving wording that matches the researcher's intention. You know, and on the other hand, we also eventually encountered two scenarios or two type of questions. And the first is the background questions. You know, background questions are related with ask for general knowledge of disease process or clinical context. And they ask who, where, when, how, why, about a single disease, drug intubation or concept. And secondary sources such as textbooks, nursing reference sources and review articles can provide relevant and reliable answers quickly. But we have two foreground questions and they ask for a specific knowledge one can apply to a specific patients or problem. And they often compare two things, you know, two things like two drugs or treatments, the prognosis of two groups, two diagnostic tests or the harms and benefits of two approaches. And they require primary sources that synthesize a wide range of knowledge and usually call for evidence-based answers. These types of more advanced or specific questions can only be answered using the results of clinical studies and that have been performed on groups of patients with the same characteristics and similar problems. You know, as we advance in clinical practice or clinical perception and the way we formulate questions could change in the time. Because in the beginning, more questions are very background and action questions whereas as experience knowledge are gained and more specific or action questions emerge. So let me show you now an example of questions. As you can see right now, there are two examples for background questions. And the first one is, are condoms effective in preventing HPV? And the other one question is, which interventions reduce health inequalities among people with cervical cancer and low middle income countries? So now you can see how we can formulate the same question but on a foreground question vision. You know, in sexually active woman, does condom use to reduce the risk of HPV infection? And the other one, in woman with cervical cancer in low middle income countries, do peer-based interventions reduce health inequalities? So here we can see example of questions where we clearly notice how the background questions are better elaborated questions with a well-defined objective to be evaluated. And that's what we're talking about right now here. So, although strategies have been developed that simplify the formulation of research questions, the diversity of clinical scenarios from which many researcher questions are derived may mean that the formulation may not always fit the strategy we want to develop. First, there is a very important thing here and is turning the clinical problem into a well-formulated question. And is the first, and as I say early, perhaps the most important step in evidence-based medicine. However, before we start looking for answers, it is advisable that our question is formulated in such a way that it allows us to highlight as far as possible the information needs and facilitates the development of an efficient search strategy. So, as you can see here in this slide, the real purpose is turn the clinical problem into a well-formulated question to perform a critical analysis of the evidence found. So, now, therefore, the correct elaboration of a well-formulated clinical question under the characteristics that can be observed. Here, you know, clearly define the problem to be solved and define the type of evidence will undoubtedly lead to a reasonable development of scientific research, thus reducing long searches and other related troubles. Now, that's really why we are here right now. You know, the PICO model or the PICO framework, the PICO model is a format that helps define or need for information in a well-defined searchable clinical question. As you can see in this slide, P represents patient, population, or problem. How would you describe this group of patients similar to yours? And what are the most important characteristics of the patients? What sort of participants from where and with? What features? Now, we have I that represents issue or intervention, which is the main prognosis factor, intervention, treatment, or exposure you are considering. What do you want to do for the patient and what other factors can influence in the prognosis of patient or in the group of patient? And C represents comparison. What is the main alternative to compare with intervention? Is this a placebo or a gold standard? And sometimes your question may not have a comparison and we all know the things related with the outcomes and what are you aiming to accomplish, make sure improve and make an impact on. Are you trying to eliminate or relieve the symptoms in this research or reduce the number of severity of adverse effects or imperfections? And sometimes we can add the T from time and this modification can provide something related of what is the duration or timeframe that you are looking to accent in those group. So basically research questions fall into three groups according to intentionality, purpose and clinical context. So we're gonna pay attention to clinical context because and the current strategy for answering these types of questions is evidence-based medicine. The clinical context is the most commonly used in evidence-based medicine and defines the universe of clinical activities in which the question is immersed. So clinical practice include four basic activities last as we can see here in this slide, identification of risk factors that are related with etiology, causality and detection of disease based on questioning and physical examination and proclinical data are related with diagnosis. And intervention are more related with prevention or treatment and prognosis are related with prediction of the consequences of that condition over the time. These questions in a clinical context can be the starting point. And I'm gonna make some specific here in a clinical context can be the starting point to identify a gap in knowledge which will transform it into a research question. Right? So let's elaborate the question right now. The question usually has many origins and the main ones are the experience of, you know, a senior researcher in a field of study and the in-depth study of the publisher literature on a given topic, the application of new technologies or most importantly, the careful observation of the patient and it's our job as researchers to know how to turn it into a subject that can be investigated, which is why several authors have defined a series of elements to be done in the best possible way using a finder criteria. And this is what finder, sorry, criteria represents. F or feasible pilot studies could test feasibility be less costly study and modify inclusion criteria among other things. And I for interesting, if attractive to partners and even potential founders for the project, novel, you have to be very familiar with the related literature and a mentor will be a great alternative. A mentor is a very important key in our growing as researchers and on our clinical practice. Always we have to be ethic with all related with clinical research and medicine and relevant. And we evaluate how important it is with respect to the health policies of a given region. No, so right now we have after see all of that, an example of our research question. As we can see here in this slide, we have foreground question in patients with cervical cancer stage 1A up to A equal or smaller than four centimeters. What is the rate of peritoneal carcinomatosis as a recurrence pattern in patients undergoing radical hysterectomy with minimal invasive surgery, robotic or laparoscopic compared to open surgery. So here you can see our research question. For example, today in this lecture, foreground question, and now you can see a PICO example. So we can see P represents patients with early stage cervical cancer. I represent radical hysterectomy in minimal invasive surgery approach. And the comparison is radical hysterectomy adult standard right now, open surgery. And we want to evaluate and take a look that very particular relapse pattern, not all relapse pattern related with early stage cervical cancer. Just one precise relapse pattern, peritoneal carcinomatosis. And we can define a type of study as, I don't know, maybe a systematic review and meta-analysis or a retrospective core studies or multicenter study that evaluate that relapse pattern. So for finish right now with this conclusion, please, please don't forget. It's important that the question is formulated before beginning the research. This is the most important things to take home right now. It is also important to have a mentor and a multidisciplinary team related to the research that allow us to exchange ideas and generate well elaborated questions in order to obtain the most suitable results as researchers and for our patients. And remember, make a very well-designed questions will lead to a successful research. So thank you so much for sharing this time with me right now. And I really appreciate your time. Thank you so much.

Dr. Jorge Hegel

gynecology oncologist

formulating answerable clinical questions

research

PICO model