A 2-year-old boy presents in an outpatient clinic with fever and severe pain in his right ear. He has a history of recurrent ear infections, and his mother expresses a concern that he has been on the antibiotic amoxicillin for the past few weeks. She is worried about the consequences of the long-term antibiotic use. She is also concerned about the outcome associated with recurrent ear infections. She wants to know if the prescribed amoxicillin is effective, or it can be substituted with another antibiotic because of its side effects such as frequent diarrhea.
Several questions arise from this case which can be broadly classified into background and foreground questions. The general questions about a clinical problem or a disease are called “Background Questions.” These questions generally ask what, when, how, and where about the disease, disorder, or treatment for instance, “What is otitis media?” or “How does amoxicillin work?” etc. These types of questions can be answered by going through review articles or text books.
The patient-oriented questions involving interpretation of a therapy or disease and consideration of risk vs. benefit for a patient or a group of patient are called “Foreground Questions.” These types of complex clinical questions are best answered by primary or pre-assessed studies in the literature. These questions mostly compare the two, either two drugs or treatments or two diagnostic methods, etc.
The PICO (population, intervention, control, and outcomes) format [Table 1] is considered a widely known strategy for framing a “foreground” research question. Sackett et al. pointed out that breaking the question into four components will facilitate the identification of relevant information.
Considering PICO and FINER criteria for developing a research question[3,5]
Population or problem- addressing a specific population, its important characteristics and demographic information. From the above case, you can identify pediatric population with otitis media, the age range, sex, presenting complaint, and history.
Intervention or treatment of interest- the intervention can be a treatment, procedure, diagnostic test, and risk or prognostic factors. In this case, the intervention will be your plan to treat the patient which can be a new therapy, a diagnostic test, prognostic factor, or a procedure. For example, based on your observation in clinic, cefuroxime is another better treatment option as compared to amoxicillin in treating otitis media but you are not sure about its efficacy in pediatric population with otitis media.
Comparator or control-when a new therapy is compared with the existing one.
Outcome- is the effect of the intervention. For example, its effectiveness in controlling pain. Therefore, the outcome in the above case can be the relief of pain, the resolution of infection, or decreasing the risk of developing resistance. A good primary outcome should be easily quantifiable, specific, valid, reproducible, and appropriate to your research question.
In a typical clinical setting, a clinician needs to know about background and foreground questions depending upon the experience about a particular disease and therapy. Once background questions are answered, more complex questions are addressed. The clinical questions arise from the central issues in a clinical work. For example, identifying causes or risk factors (etiological questions), comparing diagnostic tests based on sensitivity and specificity (diagnostic query), identifying best treatment options (therapeutic question), and outcome of the treatment (prognostic question).
After determining a foreground question, the PICO approach is followed. Dissecting the question into parts makes it easy and searchable. As evident in this case, there are several relevant questions, for example: what are the outcomes associated with recurrent ear infection, what are the possible effects of long-term use of antibiotic, and what are the harms associated with current treatment? Now if you gather all the information from PICO approach, the following researchable questions can be formulated.
In children with acute otitis media (P), is cefuroxime (I) effective in reducing the duration of symptoms (O) as compared to amoxicillin (C)?
In children suffering from otitis media, will cefuroxime result in the improvement of symptoms and reduction in developing resistance?
Does treatment with amoxicillin increase the risk of developing resistance in children suffering from otitis media?
Does surgical procedure has better outcome for the treatment of otitis media in children after repeated antibiotic therapy?
From the above case, we have formulated multiple questions based on our patient’s illness and concerns. Now we can use the strategy of “selecting” the best question. For example, which question has more significance for the patient’s well-being, which question is relevant to our knowledge needs and which question might lead to interesting answers for our patients and clinical query? Further, we need to consider the feasibility of finding the evidence in a short period.
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