Including an exposure to disease, a diagnostic test, a prognostic factor, a treatment, a patient perception, a risk factor, etc.
Is there an alternative treatment to compare?
Including no disease, placebo, a different prognostic factor, absence of risk factor, etc.
What is the clinical outcome, including a time horizon if relevant?
Fill in the blanks with information from your clinical scenario: THERAPY In_______________, what is the effect of ________________on _______________ compared with _________________?
PREVENTION For ___________ does the use of _________________ reduce the future risk of ____________ compared with ______________? DIAGNOSIS OR DIAGNOSTIC TEST Are (Is) ________________ more accurate in diagnosing _______________ compared with ____________? PROGNOSIS Does ____________ influence ______________ in patients who have _____________? ETIOLOGY Are ______________ who have _______________ at ______________ risk for/of ____________ compared with _____________ with/without______________? MEANING How do _______________ diagnosed with _______________ perceive __________________? Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-based practice in nursing & healthcare: A guide to best practice . Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins.
Now, let's expand on what pico stands for:.
How is PICO helpful?
Through forming a pico question, you will have an easier time:, focusing your topic - the four primary components of pico pushes you to think beyond the patient or problem. this is especially helpful when you are conducting a research study and must develop a topic yourself. in a clinical setting, many times, you have a patient with a distinct health concern, potential intervention and/or comparison, and a desired outcome. pico is formed with very little ease. however, when you are developing a research study of your own, you must consider all of the primary components that make up the "big picture." pico can help frame your scenario-building process, finding relevant search terms - finding search terms can be a process all on its own. pico's breakdown allows you to pull out your primary research concepts into a few simple terms. this puts you on the right path next, you will want to find alternative terms. check out the tab "additional libguides to know" to learn ways of finding term alternatives., retrieving the right amount of search results - ever conduct a search and feel overwhelmed by a huge number of results what about when you retrieve zero both happen. both scenarios are frustrating. you are not alone. pico will help you narrow your results to avoid those pages and pages of resources while, most times, remaining broad enough to still find a good handful or two of sources filled with relevant information. this is also where having those alternative search terms is of great importance knowing various ways to say the same thing will help you find more resources focused on your topic. .
Here are some resources for you to document and report your search process in a systematic review.
Except where otherwise noted, the content of this guide is licensed under a CC BY-NC 4.0 License .
A systematic review aims to answer a specific research (clinical) question. A well-formulated question will guide many aspects of the review process, including determining eligibility criteria, searching for studies, collecting data from included studies, and presenting findings ( Cochrane Handbook , Sec. 5.1.1).
To define a researchable question, the most commonly used structure is PICO , which specifies the type of P atient or P opulation, type of I nterventions (and C omparisons if there is any), and the type of O utcomes that are of interest.
The table below gives an example on how a research question is framed using the PICO structure. You may also use the PICO components to write the objective and title of your review, and later to structure your inclusion and exclusion criteria for study selection. This ensures that the whole review process is guided by your research question.
(Patient or Population or Problem) | (Intervention, prognostic factor, exposure) | (Comparison) | (Outcomes) | |
State the disease, age and gender, if appropriate, of the population. | State the intervention and specifics related to it. | A therapeutic question always has a comparator (even if it is standard care). | What is being looked for or measured? | |
(a therapeutic question) | Women who have experienced domestic violence | Advocacy programmes | General practice or routine treatment | Quality of Life (measured by the SF-36 scale) |
For women who have experienced domestic violence, how effective are advocacy programmes as compared with routine general practice treatment for improving women's quality of life (as measured by the SF-36 scale)? | ||||
The purpose of this review is to evaluate the effectiveness of advocacy programmes as compared with routine general practice on the quality of life of women who have experienced domestic violence. | ||||
The effectiveness of advocacy compared with routine general practice treatment for women who are or have previously experienced domestic violence: a systematic review of women's quality of life. | ||||
Reproduced from: Bettany-Saltikov, J, (2010). . Nursing Standard. 24(50), 47-55. |
While formulating your research question, it's also important to consider the type of question you are asking because this will affect the type of studies (or study design ) to be included in your review.
Each type of question defines its type of studies in order to provide the best evidence. For example, to answer a therapeutic question, you need to include as many Randomized Controlled Trials (RCTs) as possible, because RCTs are considered to have the highest level of evidence (least bias) for solving a therapeutic problem.
The table below suggests the best designs for specific type of question. The Level of Evidence pyramid, which is widely adopted in the medical research area, shows a hierarchy of the quality of medical research evidence in different type of studies ( Level of Evidence (2011), Oxford Centre for Evidence-based Medicine, CEBM ).
Type of Question | Ideal Type of Study (or Study Design) | Level of Evidence |
Therapy / Intervention | > Cohort Study > Case Control Study > Case Series | |
Diagnosis | (with consistently applied reference standard and blinding) | |
Prognosis | > Case Control Study > Case Series | |
Etiology / Harm | RCT > Cohort Study > Case Control Study > Case Series |
Usually, the study design of a research work will be clearly indicated either in its title or abstract, especially for RCT. Some databases also allow to search or refine results to one or a few study designs, which helps you locate as many as possible the relevant studies. If you are not sure the study design of a research work, refer to this brief guide for spotting study designs (by CEBM).
Learn to build a good clinical question from this EBP Tutorial: Module 1: "Introduction to Evidence-Based Practice"
It is provided by Duke University and University of North Carolina at Chapel Hill, USA.
PICO Framework and the Question Statement The above named section in the Library guide: Evidence-Based Practice in Health , provided by the University of Canberra Library, explains the PICO framework with examples and in various question types.
Systematic review requires a detailed and structured reporting of the search strategy and selection criteria used in the review. Therefore we strongly advise you to document your search process from the very beginning. You may use this workbook to help you with the documentation.
The documentation should include:
and the whole search process, including:
Eventually, you will need to include the information above when you start writing your review. A highly recommended structure for reporting the search process is the PRISMA Flow Diagram . You may also use PRISMA Flow Diagram Generator to generate a diagram in a different format (based on your input).
A clinical question needs to be directly relevant to the patient or problem at hand and phrased in such a way as to facilitate the search for an answer. PICO makes this process easier. It is a mnemonic for the important parts of a well-built clinical question. It also helps formulate the search strategy by identifying the key concepts that need to be in the article that can answer the question.
PICO or PICOTT:
PATIENT OR PROBLEM How would you describe a group of patients similar to yours? What are the most important characteristics of the patient?
INTERVENTION, EXPOSURE, PROGNOSTIC FACTOR What main intervention, exposure, or prognostic factor are you considering? What do you want to do with this patient?
COMPARISON What is the main alternative being considered, if any?
OUTCOME What are you trying to accomplish, measure, improve or affect?
Type of Question Therapy / Diagnosis / Harm / Prognosis / Prevention
Type of Study Systematic review / RCT / cohort study / case-control
Primary Question Types
Other Question Types
From: Sackett, DL. Evidence-based medicine: how to practice and teach EBM .
The type of question will often dictate the best study design to address the question. In the absence of the best study design, move down the hierarchy of evidence:
Clinical Question Type | Study Design |
---|---|
Clinical Examination | Prospective, blind comparison to gold / reference standard |
Diagnostic Testing or Screening | Prospective, blind comparison to gold / reference standard |
Prognosis | Cohort Study > Case Control Study > Case Series |
Therapy | Randomized Controlled Trial (RCT) |
Prevention | RCT > Cohort Study > Case Control Study > Case Series |
Etiology / Harm | RCT* > Cohort Study > Case Control Study > Case Series |
Cost | Economic analysis |
*it is not always ethical to randomize people to a known harmful exposure. However, some RCTs do contain information on adverse events, side effects, etc. that could be helpful in answering certain clinical questions regarding harms.
You may need to find answers to background questions (i.e. about general knowledge) before seeking answers to foreground questions (i.e. about specific knowledge, such as information that might inform a clinical decision).
The research questions on this page are for foreground questions.
A well-formulated research question:
Question formats are helpful tools researchers can use to structure a question that will facilitate a focused search. Such formats include: PICO , PEO , SPIDER , and COSMIN . Other formats can be found here .
The PICO format is commonly used in evidence-based clinical practice. This format creates a "well-built" question that identifies four concepts: (1) the P atient problem or P opulation, (2) the I ntervention, (3) the C omparison (if there is one), and (4) the O utcome(s) .
Example : In adults with recurrent furunculosis (skin boils), do prophylactic antibiotics, compared to no treatment, reduce the recurrence rate? ( Cochrane Library Tutorial, 2005 )
adults with recurrent furunculosis | |
prophylactic antibiotics | |
no treatment | |
reduction in recurrence rate |
The PEO question format is useful for qualitative research questions. Questions based on this format identify three concepts: (1) P opulation, (2) E xposure, and (3) O utcome(s) .
Example: In infants, is there an association between exposure to soy milk and the subsequent development of peanut allergy ( Levine, Ioannidis, Haines, & Guyatt, 2014 )?
infants | |
exposure to soy milk | |
peanut allergy |
The SPIDER question format was adapted from the PICO tool to search for qualitative and mixed-methods research. Questions based on this format identify the following concepts: (1) S ample, (2) P henomenon of I nterest, (3) D esign, (4) E valuation, and (5) R esearch type .
Example: What are young parents’ experiences of attending antenatal education?
young parents | |
of | antenatal education |
questionnaire, survey, interview, focus group, case study, or observational study | |
experiences | |
qualitative or mixed method |
Search for ( S AND P of I AND ( D OR E ) AND R ) ( Cooke, Smith, & Booth, 2012 ).
The COSMIN ( CO nsensus-based S tandards for the selection of health status M easurement IN struments ) format is used for systematic review of measurement properties. Questions based on this format identify (1) the construct or the name(s) of the outcome measurement instrument(s) of interest, (2) the target population, (3) the type of measurement instrument of interest, and (4) the measurement properties on which the review focuses.
Visit the COSMIN website to view the COSMIN manual and checklist.
Table of Contents
When you’re beginning the clinical research process, one of your first decisions will be around framing your clinical question. That, in turn, will depend on if your research is quantitative, or based on numerical data, or qualitative research based on non-numerical data. A PICO clinical question is tied to quantitative data, whereas a PEO question relates to qualitative data.
Let’s take a look at both of these clinical question formats.
As mentioned above, a PICO research question is used when quantitative data is involved. PICO stands for:
So, essentially, your PICO question will answer the above aspects. This type of clinical question is most often used when the research is investigating evidence-based medicine or other interventions. However, the PICO question format can also be used for non-clinical settings, such as psychological interventions for school-age children, and how they relate to academic achievement.
It can sometimes be a challenge to write PICO Questions, as they can be very complex. Since we are looking at evidence-based conclusions, great thought has to be put into formulating a PICO research question. Once the question has been written and clarified, it can help the researcher determine what type of study model will work best to answer the question. So, in a very real way, asking the question properly helps you select what type of study you’ll be conducting.
Fortunately, once you are comfortable with the elements of a PICO question, it almost becomes a plug and play model. For example, if you are looking at questions around prognosis, you might structure your PICO question like this:
Would ________________ (I) affect or influence _________________________ (O) with patients or people who have ___________________________________________________ (P) compared to __________________________(C)?
Another example of a PICO research question might include an inquiry into prevention:
With ___________________ (P) does the practice or use of ________________________ (I) reduce or prevent risk of __________________________(O), compared with __________________________(C)?
A PEO research question focuses on non-numerical data, or qualitative research. Here, relationships and associations are explored. For example, a PEO question can try to explore whether there is a correlation between taking baby aspirin and a lowered risk of heart attacks.
PEO stands for:
Writing a PEO question isn’t generally as complex as writing a PICO question, since you’re only looking at what population, what they’re exposed to, and what your expected outcome is. For example, if you’re looking at food allergies in infants, your PEO question might look like this:
In infants between the age of 6 to 9 months (P), is there an association between exposure to micro-doses of common food allergens (E) and reduced childhood food allergies? (O)
Similar questions can be explored this way:
In or with ___________________ (P), will ________________________(E) result in _________________________ (O)?
Just as you might utilize PICO and PEO question formatting for designing your research, you can also tap into their formats when you’re looking for previous studies on your topic of interest. For example, if you are looking for information on dietary interventions and type 2 diabetes reversal, you can use keywords related to the formulation of a research question:
P: Individuals with type 2 diabetes E: Mediterranean Diet O: Reversal of type 2 diabetes
To find research related to the above question, you would pull out keywords, like:
“type 2 diabetes,” “reversal” and “Mediterranean Diet”
There are a wide variety of clinical question formats, in addition to PICO and PEO. These can include PICO(T), which adds a “time-frame” ingredient, and (P)PICO if your population is more complex, like white males, age 50-55.
The bottom line is that an effective clinical research question needs to be relevant to the patient or problem, and worded in a way that it’s easy for those looking for your research to find it. If you’re designing a research project, starting with an effective and well-written clinical research question is a critical first step.
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Picot example.
PICO is an acronym that can help you create a well-built clinical question by identifying the key aspects of a complex patient presentation.
Patient or Problem = hypertension
KEYWORDS: hypertension, high blood pressure, hypertensive
Intervention = telemonitoring blood pressure
KEYWORDS: telemonitor, telemedicine, MeSH term is “Blood Pressure Monitoring, Ambulatory”
Comparison = n/a
Outcome = improve blood pressure
MeSH term is “Blood Pressure” (but if you are using terms for “telemonitoring blood pressure ,” this is unnecessary).
Timeframe = within one year
one year, twelve months (searching for timeframes can be tricky -- this won't find studies that were less than 12 months! If your results are too limited, you can try removing this from your search).
or if you search everything in a single line:
Want to see an example in action? Check out the video below.
PICOT example begins at the 3:00 mark.
"Table 1" is from:
Gallagher Ford, L., & Melnyk, B. M. (2019). The Underappreciated and Misunderstood PICOT Question: A Critical Step in the EBP Process. Worldviews on Evidence-Based Nursing, 16(6), 422–423. https://doi.org/10.1111/wvn.12408
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Practitioners of evidence-based practice (EBP) often use a special framework called PICO to form clinical questions and facilitate the literature search (evidence). The PICO Process or Framework makes defining a clinical question and seeking a solution easier, and .
A clinical question needs to be directly relevant to the patient or problem at hand. It needs to be phrased in a way that facilitates the search for an answer. Without a well-focused question, it can be difficult and time-consuming to identify appropriate resources and search for relevant evidence.
PICO is a mnemonic (a memory tool) for the important parts of a well-built clinical question. PICO stands for:
This table shows a basic outline of how the PICO Process can help you define an evidence-based care plan.
atient Problem (or Population) | What are the patient's demographics such as age, gender and ethnicity? Or what is the or problem type? | Work-related neck muscle pain |
ntervention | What type of theraputic intervention is being considered? For example, is the intervention medication, exercise or rest, surgery? | Strength training of the painful muscle |
omparison or Control | Is there a comparable treatment to be considered? The comparison may be with another medication, another form of treatment such as exercise, surgery, or no treatment at all. | Rest |
utcome | What would be the desired effect you would like to see? What effects are not wanted? Are there any side effects involved with this form of testing or treatment? | Pain relief |
When forming your question using PICO , keep the following points in mind:
This guide about the PICO framework has been adapted from the original at the website of the University of Canberra Library.
Once you have clearly identified the main elements of your question using the PICO framework, it is easy to write your question statement. The following table provides some examples.
Therapy | In patients with osteoarthritis of the knee | is hydrotherapy more effective than | traditional physiotherapy | in relieving pain? |
Prevention | For obese children | does the use of community recreation activities | compared to educational programs on lifestyle changes | reduce the risk of diabetes mellitus? |
Diagnosis | For deep vein thrombosis | is D-dimer testing or | ultrasound | more accurate for diagnosis? |
Prognosis | In healthy older women that suffer hip fractures | within the year after injury | what is the relative risk of death? | |
Etiology | Do adults | who binge drink | compared to those who do not binge drink | have higher mortality rates? |
Here are a basic and a more advanced document about how to use the PICO framework or formula. The first one has some excellent examples of fully formed PICO questions. The PDF link is a template for working your way through forming the elements of your question.
When forming your question using the PICO framework, it is useful to think about what type of question it is you are asking, (therapy, prevention, diagnosis, prognosis, etiology ). The table below illustrates ways in which P roblems, I nterventions, C omparisons and O utcomes vary according to the type or domain of your question.
Therapy (Treatment) | Patient's disease or condition. | A therapeutic measure, eg., medication, surgical intervention, or life style change. | Standard care, another intervention, or a placebo. | Mortality rate, number of days off work, pain, disability. |
Prevention | Patient's risk factors and general health condition. | A preventive measure, e.g., A lifestyle change or medication. | Another preventative measure OR maybe not applicable. | Mortality rate, number of days off work, disease incidence. |
Diagnosis | Specific disease or condition. | A diagnostic test or procedure. | Current "reference standard" or "gold standard" test for that disease or condition. | Measures of the test utility, i.e. sensitivity, specificity, odds ratio. |
Prognosis (Forecast) | Duration and severity of main prognostic factor or clinical problem. | Usually time or "watchful waiting". | Usually not applicable. | Survival rates, mortality rates, rates of disease progression. |
Etiology (Causation) | Patient's risk factors, current health disorders, or general health condition. | The intervention or exposure of interest. Includes an indication of the strength/dose of the risk factor and the duration of the exposure. | Usually not applicable. | Survival rates, mortality rates, rates of disease progression. |
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University of Kansas Medical Center
Nursing research guide.
Example Sources:
PICO is a formula used to develop a researchable clinical question.
The purpose of a PICO question is to help breakdown a research question into smaller parts, making the evaluation of evidence more straightforward.
P: Population, patient, or problem
I: Intervention or indicator
C: Comparison or control
O: Outcome
Note: Not every question will have a time frame or a comparison. Outcomes should be a measure of clinical well-being/quality of life.
P: Population, patient, or problem
Who is the patient or population? (Think demographics: age, sex, gender, race).
What problem or disease or situation are you facing?
I: Intervention or indicator
What do you plan to do for your patient? (medications, diagnostic tests, therapies, procedures)
What intervention is implemented to help make a difference to your patient/population?
C: Comparison or control
What other interventions should be considered? What can we compare our research too?
Is there a control group you would like to compare your intervention with?
O: Outcome
What is the desired or effective outcome of the intervention compared to the control?
Case: patient education.
Your full PICO question is:
"Among hospitalized chronic smokers, does a brief educational nursing intervention lead to long term smoking cessation [when compared with no intervention]?"
Patients on coronary artery bypass graft (CABG) waiting lists often experience anxiety and depression and your nurse manager wants to know if it would be a good idea to reach out to these patients with presurgical home visits and follow-up calls from a specialist cardiac nurse.
P: patients on CABG waiting lists I: program consisting of presurgical home visit and follow-up calls form a specialist cardiac nurse C: no intervention O: decreased patient anxiety and depression
For patients on CABG waiting lists, does an intervention program consisting of presurgical home visits and follow-up calls from a specialist cardiac nurse lead to decreased patient anxiety and depression [when compared with no intervention]?
You work in the Big City Hospital ICU. Your mechanically ventilated patients sometimes contract nosocomial pneumonia, which leads to costly complications. You want to know if raising the head of the bed lowers the chance of the patient contracting pneumonia compared to letting the patient lie flat on their back.
P: mechanically ventilated ICU patients I: semi-fowlers position C: supine position O: lower incidence of nosocomial pneumonia In mechanically ventilated ICU patients, does positioning the patient in semi-fowlers result in a lower incidence of nosocomial pneumonia when compared to the supine position?
In the past few years, your hospital has installed antibacterial foam dispensers on all the nursing units. You’ve had nurses asking you if the foam is just as effective as washing their hands with water and soap.
P: hospital nurses I: using antibacterial foam C: hand washing with soap and water O: decreased bacteria count In hospital nurses, does antibacterial foam decrease bacteria count on hands as much as hand washing with soap and water?
You’re a new nurse on a labor and delivery unit. You’ve noticed that most women give birth in the lithotomy position at the encouragement of their doctors. However, you’re sure you heard in nursing school that other positions are less likely to lead to deliveries with forceps or a vacuum...or did you? You want to find some literature to back up your claim.
P: laboring women delivering in a hospital I: positions other than the lithotomy position C: lithotomy position O: decreased incidence of assisted deliveries In laboring women delivering in the hospital, do positions other than lithotomy position lead to a decreased incidence of assisted deliveries?
You’re the nurse manager of a NICU unit. One concern of parents of infants receiving tube feedings is being able to successfully breastfeed their child upon discharge. One of your staff nurses asks if it would be helpful to give the infants cup feedings instead of tube feedings during their NICU stay.
P: Infants in the NICU I: cup feeding throughout the hospital stay C: tube feedings throughout the hospital stay O: greater reported success with breastfeeding post-discharge In infants in the NICU, will cup feeding throughout the hospital stay lead to greater success with breastfeeding post-discharge when compared to tube feedings?
You work with patients with advanced cancer and have been taught to suggest pain diaries for your patients as a form of pain management. You’ve been wondering for a while now if these diaries actually improve pain control or make pain worse by making patients more aware of their pain.
P: patients with advanced cancer I: keeping a pain journal C: no intervention O: lower reported pain scores In patients with advanced cancer, does keeping a pain journal result in lower reported pain scores when compared to no intervention?
You work in a pediatrician’s office and give patients their routine vaccinations. The younger children are often fearful of needles, and some of the RNs use toys to distract the patients. You want to know if this technique actually has an effect on the children's pain response.
P: young children I: distraction techniques during immunization C: no intervention O: lower pain scores rated by the Faces pain scale In young children, do distraction techniques during immunization administration using toys result in lower pain scores when compared to no intervention?
You work on an inpatient psychiatric unit. One of your patients with chronic schizophrenia, Joe, normally mumbles to himself, but will occasionally speak to others when residents play games together. Noticing this, you say to a coworker that maybe social skills group training sessions would bring out Joe’s conversational skills. Your coworker shakes her head and says "I don’t think so. Joe is in and out of this hospital, he’s a lost cause."
P: Inpatient chronic schizophrenia patients I: social skills group training sessions C: standard care O: increased conversational skills as evidenced by greater number of interactions with peers In inpatient chronic schizophrenia patients, do social skills group training sessions increase conversational skills when compared to standard care?
A diabetic patient from a nursing home has recently been admitted with a stage III pressure ulcers on his heels. The unit nurses have called you in for a wound consult. You have to choose between standard moist wound therapy and using a wound vac.
P: elderly diabetic with stage III foot ulcers I: negative pressure wound therapy C: standard moist wound therapy O: improved wound healing as measured by pressure ulcer grading system guidelines In elderly diabetic patients with stage III foot ulcers, does negative pressure wound therapy lead to improved wound healing when compared to standard moist wound therapy?
The main concern for most of your patients coming out of anesthesia in your PACU is pain. You want to explore nursing interventions you can use on top of medication administration to decrease pain. One coworker mentions trying to make the PACU feel less clinical by playing soft music to relax patients.
P: PACU patients I: soft music as an adjunct to standard care C: standard care alone O: lower reported pain scores In PACU patients, will playing soft music in the PACU as an adjunct to standard care result in lower reported pain scores when compared to standard care alone?
How do I Break Down a PICO Question?
You first need to come up with a question that includes all of the PICO components and break those down for searching the database.
For example: In non-ambulatory patients, (P) does turning the patient (I) compared to pressure mattresses (C ) reduce the risk of pressure ulcers? (O)
To search for evidence-based articles related to your PICO question, identify the keywords for each PICO element.
Turn these keywords into subject descriptors or MeSH/CINAHL subject headings to use in your database searches.
Ask background questions and foreground questions.
Think about inclusion and exclusion criteria to help you select and set boundaries for your searching.
EBP Learning Module
Formulating a question using pico.
Often our need for information is not formulated as a question to begin with - but if you don't ask a question, it is probably fair to say you will not get an answer! Asking the right question is an important start to finding the information needed to inform clinical practice.
Structuring the question is the first step. Vague, broad, poorly framed questions will most likely result in lost time and an inability to locate useful evidence. In comparison, asking a specific and focused question enables the development of relevant keywords and an effective search strategy.
Most questions can be broken down into three or four components that describe the population, the intervention or treatment (and sometimes an alternative treatment), and the outcome you want to investigate. This is known as the PICO method, and it is widely used by health researchers, healthcare professionals, and related collaborations such as those in The Cochrane Library, to construct searchable questions that give relevant and precise results.
The table below shows how the PICO method is used.
Population or problem | Describe the patient or the relevant group of people |
---|---|
Intervention or treatment | Identify the intervention such as a test, drug, or factor that might affect a health outcome |
Comparison | Identify an alternative strategy if you want to compare one intervention to another |
Outcome | State the clinical outcome - usually what you and the patient are most concerned about |
The acronym is sometimes given as PICOT where T stands for time, type of study, or test; or PECOT where E stands for the exposure group, C for the control group and T for time, type of study, or test.
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Use the PICOT format to break down your question into smaller parts and identify keywords:
atient / opulation | ntervention / ndicator | ompare / ontrol | utcome | ime / ype of Study or Question |
Who are the relevant patients? Think about age, sex, geographic location, or specific characteristics that would be important to your question. | What is the management strategy, diagnostic test, or exposure that you are interested in? | Is there a control or alternative management strategy you would like to compare to the intervention or indicator? | What are the patient-relevant consequences of the intervention? | What time periods should be considered? What study types are most likely to have the information you seek? What clinical domain does your question fall under? |
It can be helpful to classify your question based on the clinical domain(s) it falls under.
See below for definitions, PICO templates, and example questions from the primary clinical domains: intervention , diagnosis , etiology , prevention , prognosis/prediction , quality of life/meaning , and therapy .
Questions addressing the treatment of an illness or disability.
In _________ (P), how does _________ (I) compared to _________(C) affect _______(O) within _______ (T)? In _______(P), what is the effect of _______(I) on ______(O) compared with _______(C) within ________ (T)?
Questions addressing the act or process of identifying or determining the nature and cause of a disease or injury through evaluation.
Are (is) _________ (I) more accurate in diagnosing ________ (P) compared with ______ (C) for _______ (O)? In ________ (P) are/is ________(I) compared with ________(C) more accurate in diagnosing ________(O)?
Questions addressing the causes or origin of disease, the factors that produce or predispose toward a certain disease or disorder.
Are ____ (P) who have _______ (I) at ___ (Increased/decreased) risk for/of_______ (O) compared with ______ (P) with/without ______ (C) over _____ (T)?
Are ______(P) who have ______(I) compared with those without _______(C) at ________ risk for/of _______ (O) over ________(T)?
Questions on how to reduce the chance of disease by identifying and modifying risk factors and how to diagnose disease early by screening.
For ________ (P) does the use of ______ (I) reduce the future risk of ________ (O) compared with _________ (C)?
Questions addressing the prediction of the course of a disease.
Does __________ (I) influence ________ (O) in patients who have _______ (P) over ______ (T)? In _______ (P), how does ________ (I) compared to ________ (C) influence _________ (O) over _________ (T)?
Questions addressing how one experiences a phenomenon.
How do ________ (P) diagnosed with _______ (I) perceive ______ (O) during _____ (T)?
Questions around how to select treatments to offer our patients that do more good than harm and that are worth the efforts and costs of using them.
In _______(P), what is the effect of _______(I) on ______(O) compared with _______(C) within ________ (T)?
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WHO guideline on preventive chemotherapy for public health control of strongyloidiasis [Internet]. Geneva: World Health Organization; 2024.
Annex 4 pico questions and grade summary tables, a4.1. efficacy of ivermectin against strongyloides stercoralis infection, pico question.
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Individuals infected with | |
Periodic single dose ivermectin | |
Placebo, co-interventions or no treatment | |
Infection with |
Outcome Timeframe | Study results and measurements | Absolute effect estimates | Certainty of the evidence (Quality of evidence) | |
---|---|---|---|---|
Reference | Ivermectin | |||
Cure (ivermectin with albendazole comparator) Mean 5 weeks | Relative risk: 1.79 (CI 95% 1.55–2.08) Based on data from 478 participants in four studies | per 1000 | per 1000 |
Downgraded due to very serious risk of bias; upgraded due to large effect |
Difference: (CI 95% 261 more–513 more) | ||||
Cure (ivermectin with thiabendazole comparator) Mean 11 weeks | Relative risk: 1.07 (CI 95% 0.96–1.2) Based on data from 467 participants in three studies | per 1000 | per 1000 |
Downgraded due to very serious risk of bias and serious imprecision |
Difference: (CI 95% 31 fewer–157 more) | ||||
Cure (two-dose ivermectin vs one-dose) | Relative risk: 1.02 (CI 95% 0.94–1.11) Based on data from 94 participants in two studies | per 1000 | per 1000 |
Downgraded due to very serious risk of bias |
Difference: (CI 95% 58 fewer–106 more) | ||||
Cure (four-dose ivermectin vs one-dose) | Risk difference: 15.0 (CI 95% −76.0–105.0) Based on data from 231 participants in one study | NA | NA |
Downgraded due to serious imprecision |
NA |
CI: confidence interval; GRADE: Grading of Recommendations, Assessment, Development and Evaluation NA: not applicable.
A relative risk greater than one is a higher cure rate against the comparator, while a relative risk less than one is a lower cure rate. The absolute effect estimates refer to the number of persons with infection that are cured.
The GRADE ratings are based on guideline member and methodologist judgements using pre-defined criteria specific to the guideline. Thus, ratings may differ from those in published literature.
Children aged 5–17 years and/or adults 18 years or older living in a region endemic for | |
Periodic preventive chemotherapy with ivermectin at intervals of up to 12 months | |
Placebo, co-interventions or no treatment | |
Mortality and/or morbidity risk from strongyloidiasis |
Outcome Timeframe | Study results and measurements | Absolute effect estimates | Certainty of the evidence (Quality of evidence) | |
---|---|---|---|---|
Pre PC ivermectin | Post PC ivermectin | |||
Prevalence (faecal test) | Relative risk: 0.18 (CI 95% 0.14–0.23) Based on data from 5262 participants in six studies | per 1000 | per 1000 |
Downgraded due to non-randomized data and very serious risk of bias; upgraded due to very large effect |
Difference: (CI 95% 120 fewer–107 fewer) | ||||
Prevalence (serology) | Relative risk: 0.35 (CI 95% 0.26–0.48) Based on data from 1763 participants in three studies | per 1000 | per 1000 |
Downgraded due to non-randomized data; upgraded due to large effect |
Difference: (CI 95% 158 fewer–111 fewer) | ||||
Prevalence (post 1 round) | Relative risk: 0.22 (CI 95% 0.02 – 2.25) Based on data from 2083 participants in two studies | per 1000 | per 1000 |
Downgraded due to non-randomized data, very serious inconsistency and serious imprecision |
Difference: (CI 95% 60 fewer–76 more) | ||||
Prevalence (post 2+ rounds) | Relative risk: 0.18 (CI 95% 0.14 – 0.23) Based on data from 3179 participants in four studies | per 1000 | per 1000 |
Downgraded due to non-randomized data and very serious risk of bias; upgraded due to large effect |
Difference: (CI 95% 222 fewer–199 fewer) |
CI: confidence interval; PC: preventive chemotherapy.
Infected or non-infected individuals | |
Ivermectin treatment | |
Placebo, co-interventions or no treatment | |
Adverse effects |
Outcome Timeframe | Study results and measurements | Absolute effect estimates | Certainty of the evidence (Quality of evidence) | |
---|---|---|---|---|
Lower-dose ivermectin | Higher-dose ivermectin | |||
Adverse effects (comparator = 400 ug/kg) | Odds ratio: 1.06 (CI 95% 0.67–1.69) Based on data from 1426 participants in five studies | per 1000 | per 1000 |
Downgraded due to serious imprecision |
Difference: (CI 95% 64 fewer–106 more) | ||||
Adverse effects (comparator = 200 ug/kg) | Odds ratio: 1.16 (CI 95% 0.89–1.52) Based on data from 1427 participants in four studies | per 1000 | per 1000 |
Downgraded due to serious imprecision |
Difference: (CI 95% 16 fewer–68 more) |
We followed recent GRADE guidance to evaluate certainty of evidence for modelling studies with a qualitative appraisal of the modelling evidence in this study ( 1 , 2 ).
We assessed the risk of bias of model outputs by considering the credibility of the model itself (e.g. structure, performance on calibration and validation) and the certainty of evidence for each model input (e.g. infection incidence, disseminated disease incidence; for economic model outputs, resource use, utility values and baseline risks of outcomes). In our evaluation, there is some risk of bias for the key model inputs of incidence of disseminated strongyloidiasis and disability weight for chronic infection. Given the lack of longitudinal data, model validation was not formally undertaken, but the findings broadly align with observational studies.
We assessed consistency in the model inputs ascertained from the literature. Overall model inputs were consistent. Further, the model consistently demonstrated the cost–effectiveness of mass drug administration (MDA) with ivermectin across a range of epidemiological settings and sensitivity analyses. This increased confidence in the modelled reductions in infection prevalence and disability-adjusted life years (DALYs) post-MDA with ivermectin.
We considered the point estimates and the variability from the results of the modelling study. The modelling study did include information about the output variability and the key findings on cost–effectiveness were precise overall.
We evaluated the indirectness of the modelling evidence, based on whether the modelling input data were discrepant with the ideal target model’s input or the modelling outputs were discrepant with the intended population, intervention(s), time horizon, analytic perspective and/or outcome(s), and/or did not accurately reflect the decision question at hand. Overall, the Guideline Development Group did not identify issues with indirectness.
Risk of publication bias was not relevant when assessing this modelling evidence because this is a single model that was constructed de novo. Publication bias may be possible for model inputs.
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PICO question. Population: Children aged 5-17 years and/or adults 18 years or older living in a region endemic for S. stercoralis: Intervention: Periodic preventive chemotherapy with ivermectin at intervals of up to 12 months: Comparator: Placebo, co-interventions or no treatment: