OR
What is the problem of interest?
Karjalainen, T. V., Lusa, V., Page, M. J., O'Connor, D., Massy-Westropp, N., & Peters, S. E. (2023). Splinting for carpal tunnel syndrome . Cochrane Database of Systematic Reviews , (2).
PICO has variations and extensions to accommodate different question types, including qualitative questions. For example:
The PCC framework is useful for questions that are broad or reviewing qualitative research.
The PCC framework is recommended by the JBI Scoping Review guidelines ( 11.2.2 Developing the title and question ).
PCC stands for:
The government is funding a review into measuring the experiences of adults with atrial fibrillation. They're particularly interested in the impact atrial fibrillation has on quality of life. You want to apply for the grant and start planning your methodology.
What tools are available to measure quality of life (C) in adults with atrial fibrillation (P) in Australia (C)?
Element | Definiton | Scenario |
---|---|---|
P (population/problem) | Who is the population of interest? OR What is the problem of interest? | Adults with atrial fibrillation |
C (concept) | What is the concept of interest? | Quality of life measurement |
C (context) | What is the context? E.g. Geographic, Setting, etc. | Australia |
Risom, S. S., Nørgaard, M. W., & Streur, M. M. (2022). Quality of life and symptom experience measurement tools in adults with atrial fibrillation: a scoping review protocol . JBI evidence synthesis , 20 (5), 1376-1384.
The PEO framework is useful for epidemiological questions about exposure to an event or an illness.
PEO stands for:
Recently, there have been increasing cases of laryngeal cancer amongst people who work as stonemasons. The research team seeks to examine the literature to determine whether there is an association between exposure to dust through stonemasonry and developing silicosis.
Is there an association for people who work as stonemasons (P) between occupational exposure to silica dust (E) and laryngeal cancer (O)?
Element | Definiton | Scenario |
---|---|---|
P (population and their problem) | Who is the population of interest? AND What is the problem of interest? | People who work as stonemasons |
E (exposure) | What is the exposure event or exposure disease? | Silica dust |
O (outcomes or themes) | What is the result or outcome of interest? OR What themes are of interest? | Laryngeal cancer or silicosis |
Chen, M., & Tse, L. A. (2012). Laryngeal cancer and silica dust exposure: A systematic review and meta‐analysis . American journal of industrial medicine , 55 (8), 669-676.
The SPICE framework is useful for questions evaluating the results of a service, project, or intervention.
SPICE stands for:
You are wanting to design a new program to support the well-being of people living with spinal cord injury, but first, you want to know what other programs have been developed, and how they’ve been received by the program participants.
From the perspective of community-based (S) people living with spinal cord injury (P), what is the impact of well-being interventions (I) on their own quality of life (E)?
Element | Definiton | Scenario |
---|---|---|
S (setting) | What is the setting? | Community |
P (perspective) | Whose perspectives and experiences are of interest and what are they? | People living with a spinal cord injury |
I (intervention) | What is the intervention of interest? | Well-being |
C (comparison)* | What are you comparing the intervention to? | No comparison |
E (evaluation) | What is the result? | Impact of well-being interventions on people with a spinal cord injury |
*Note: There may not always be a comparison element.
Simpson, B., Villeneuve, M., & Clifton, S. (2022). The experience and perspective of people with spinal cord injury about well-being interventions: a systematic review of qualitative studies . Disability and rehabilitation , 44 (14), 3349-3363.
The SPIDER framework is useful to help frame qualitative questions or those involving mixed methods research.
SPIDER stands for:
You're beginning a research degree in which you want to investigate barriers to nurses offering cross-cultural care. You want to know whether any studies were undertaken from the perspectives of nurses before you start your research.
What are the perspectives (E) of nurses and nursing students (S) of their experiences in delivering transcultural care (PI)?
Element | Definiton | Scenario |
---|---|---|
S (sample) | Who is the group of interest? | Nurses or nursing students |
PI (phenomenon of interest) | What is the researcher interested in? (e.g. behaviours, experiences) | Experiences of transcultural care |
D (design) | What study designs will be included in the review? | Interview, survey, focus groups, questionnaires |
E (evaluation) | What are the outcomes of the research? (e.g. perspectives) | Themes in nurse perspectives |
R (research type) | What type of research will be included in the review? | Qualitative, mixed methods |
Shahzad, S., Ali, N., Younas, A., & Tayaben, J. L. (2021). Challenges and approaches to transcultural care: An integrative review of nurses' and nursing students' experiences . Journal of Professional Nursing , 37 (6), 1119-1131.
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It is important to be purposeful about creating a well-built clinical question so that you will be able to find the most relevant results possible. A well-built question will address four important items: P atient or Problem, I ntervention, C omparison, and O utcome. To help you remember this, you can use the mnemonic PICO. When you are designing your clinical question, here are some topics to take into consideration.
P= Patient or Problem:
How would you describe a group of patients similar to yours? What are the most important characteristics of the patient? This may include the primary problem, disease, or co-existing conditions. Sometimes the gender, age or race of a patient might be relevant to the diagnosis or treatment of a disease.
I= Intervention:
Which main intervention, prognostic factor, or exposure are you considering? What do you want to do for the patient? Prescribe a drug? Order a test? Order surgery? Or what factor may influence the prognosis of the patient - age, co-existing problems, or previous exposure?
C= Comparison:
What is the main alternative to compare with the intervention? Are you trying to decide between two drugs, a drug and no medication or placebo, or two diagnostic tests? Your clinical question may not always have a specific comparison.
O= Outcome:
What can you hope to accomplish, measure, improve or affect? What are you trying to do for the patient? Relieve or eliminate the symptoms? Reduce the number of adverse events? Improve function or test scores?
Using our clinical scenario, we will use PICO to develop a clinical question.
Question: In patients with type 2 diabetes and obesity, does bariatric surgery promote the management of diabetes and weight loss as compared to standard medical care?
Different types of clinical questions have certain kinds of studies that best answer them. The chart below lists the categories of clinical questions and the studies you should look for to answer them.
In our clinical scenario, we are want to determine whether or not bariatric surgery will benefit the patient, so this is a therapy question. As such, we will want to find randomized control trials to answer our question. If we found numerous RCTs on this topic, we might want to consider searching for a systematic review that synthesizes the results of these trials.
The strength of the evidence produced varies among the different types of studies. Filtered sources like systematic reviews and meta-analyses provide stronger evidence because they evaluate and compare a number of original studies. The image below demonstrates the relative strengths of the study types - generally, the higher up on the pyramid you go, the more rigorous the study design and the lesser likelihood of bias or systematic error.
Types of studies we are going to cover all fall under one of two categories - primary sources or secondary sources. Primary sources are those that report original research and secondary sources are those that compile and evaluate original studies.
Primary Sources
Randomized Controlled Trials are studies in which subjects are randomly assigned to two or more groups; one group receives a particular treatment while the other receives an alternative treatment (or placebo). Patients and investigators are "blinded", that is, they do not know which patient has received which treatment. This is done in order to reduce bias.
Cohort Studies are cause-and-effect observational studies in which two or more populations are compared, often over time. These studies are not randomized.
Case Control Studies study a population of patients with a particular condition and compare it with a population that does not have the condition. It looks the exposures that those with the condition might have had that those in the other group did not.
Cross-Sectional Studies look at diseases and other factors at a particular point in time, instead of longitudinally. These are studies are descriptive only, not relational or causal. A particular type of cross-sectional study, called a Prospective, Blind Comparison to a Gold Standard, is a controlled trial that allows a research to compare a new test to the "gold standard" test to determine whether or not the new test will be useful.
Case Studies are usually single patient cases.
Secondary Sources
Systematic Reviews are studies in which the authors ask a specific clinical question, perform a comprehensive literature search, eliminate poorly done studies, and attempt to make practice recommendations based on the well-done studies.
Meta-Analyses are systematic reviews that combine the results of select studies into a single statistical analysis of the results.
Practice Guidelines are systematically developed statements used to assist practitioners and patients in making healthcare decisions.
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Before beginning your search of the literature, it's important to understand the difference between background and foreground questions. This will guide you to the correct resource to aid you in answering your question.
Background question : Seek to answer foundational knowledge about a condition, illness, disease, etc.
Foreground question : Seek to answer specific knowledge regarding a clinical decision, usually concerning a specific patient, population, or intervention. According to Guyatt et al. there are 5 types of foreground questions: therapy, harm, differential diagnosis, diagnosis, and prognosis.
Guyatt, G, Rennie, D, Meade, MO, Cook, DJ. Users' Guide to the Medical Literature: Essentials of Evidence-based Clinical Practice . 3rd ed. New York, NY: McGraw Hill Education, 2015.
Before you can search the literature, it's important that you carefully break down your question into key search terms. Using PICO will guide you in thinking about your question.
Tips for Building | Who is your patient? What is the problem? | What are the management strategies we are interested in comparing or the potentially harmful exposures about which we are concerned? Diagnostic tests, foods, drugs, surgical procedures, time, or risk factors. | What do you wish to compare to your intervention? For issues of therapy, prevention, or harm, there will always be both an experimental intervention or putative harmful exposure and a control, alternative, or comparison intervention. | What are the patient-relevant consequences of the exposure in which we are interested? We may also be interested in the consequences to society, including cost or resource use. It may also be important to specify the period of interest. |
Guyatt, G, Rennie, D, Meade, MO, Cook, DJ. Users" Guide to the Medical Literature: Essentials of Evidence-based Clinical Practice. 3rd ed. New York, NY: McGraw Hill Education, 2015.
Example scenario : A 37-year-old female with Bipolar I Disorder is currently taking olanzapine with a mood stabilizer to manage manic or mixed episodes. The patient is experiencing suboptimal effects from the olanzapine including weight gain and poor satisfaction with the medication. Is it safe and effective to switch from olanzapine to ziprasidone in this patient?
37-year-old female, Bipolar 1 Disorder | olanzapine | ziprasidone | less weight gain |
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When searching for evidence-based practice studies in the Nursing and Medical databases, you must first develop a well-built clinical question . Below is a chart to guide you in formulating a question by breaking it down to its most important parts.
Students sometimes have difficulty incorporating classroom skills into the clinical setting. The PICO(T) Chart provides an easy framework for integrating clinical information into the development of a research question. Students can complete the following worksheet, incorporating detailed information into each response.
Decide what your research interest or topic is and then develop a research question to answer it.
PICO(T) | Your PICO(T) Elements ⇒ Search Terms | ||
---|---|---|---|
P | POPULATION / PATIENT / PROBLEM | ||
I | INTERVENTION | ||
C | COMPARISON / CONTROL | ||
O | OUTCOME | ||
T | TIME |
Design a question that incorporates the most salient piece of information from each of the above categories.
|
The PICO framework is ideal for building questions that focus on comparing treatments . Other types of questions—especially those focused on prognosis, etiology, or perceptions—can be more challenging. Just remember that the Intervention portion usually represents the piece of your research you're interested in comparing or controlling; if you were designing an experiment, it would be the piece that you manipulate to see what results you'd get.
Question Type | Patient/Problem | Intervention/Exposure | Comparison/Control | Outcome |
---|---|---|---|---|
Patient's disease or condition | Therapeutic measure (e.g., a medication, surgical intervention, lifestyle change) | Standard of care, another intervention, or placebo | Mortality rate, days absent from work, pain, disability | |
Patient's risk factors and general health condition | Preventive measure (e.g., a medication, lifestyle change) | May not be applicable | Disease incidence, mortality rate, days absent from work | |
Target disease or condition | Diagnostic test or procedure | Current "gold standard" test for the condition | Measures of the test utility (i.e., sensitivity, specificity, odds ratio) | |
Main prognostic factor or clinical problem, in terms of its severity and duration | Exposure of interest is usually time (sometimes expressed as "watchful waiting") | Usually not applicable; if your question is about "watchful waiting," identify standard treatment | Survival rates, mortality rates, rates of disease progression | |
Patient's risk factors, current health disorders, or general health condition | Intervention or exposure of interest, including some indication of the strength (dose) of risk factor and the duration of exposure | May not be applicable | Disease incidence, rates of disease progression, mortality rates |
You may find it helpful to use one of the following templates when creating your PICO question. Remember, the time (T) piece is usually optional and therefore can be omitted.
Treatment (therapy) — questions addressing the treatment of an illness or disability:
In _______(P), how does _______(I) compared with _______(C) affect _______(O) within _______(T)?
In _______(P), what is the effect of _______(I) on _______(O) compared with _______(C)?
Ex 1: In African American female adolescents with hepatitis B (P), how does acetaminophen (I) affect liver function (O) compared with ibuprofen (C)? Ex 2: In inpatient chronic schizophrenia patients (P), do social skills group training sessions (I) increase conversational skills (O) when compared with standard care (C)?
Prevention — questions addressing the prevention of a risk factor or problematic health condition:
In _______(P), does the use of _______(I) reduce the incidence [or future risk] of _______(O) compared with _______(C)?
Ex: In adult females (P), do daily vitamin C or zinc supplements (I) reduce the incidence of the common cold (O) compared with no intervention (C)?
Diagnosis — questions addressing the process of determining the nature and cause of a disease or injury through evaluation:
In _______(P) is/are _______(I) more accurate in diagnosing _______(O) compared with _______(C)?
Ex: In middle-aged males with suspected myocardial infarction (P), are serial 12-lead ECGs (I) more accurate in diagnosing an acute myocardial infarction (O) compared with one initial 12-lead ECG (C)?
Prognosis (natural history) — questions addressing the prediction of the course of a disease:
In _______(P) how does _______(I) compared with _______(C) influence _______(O) over/during _______(T)?
Does _______(I) influence _______(O) in patients who have _______(P) over _______(T)?
Ex 1: In patients 65 years and older (P), how does the use of an influenza vaccine (I) compared with not receiving the vaccine (C) influence the risk of developing pneumonia (O) during flu season (T)? Ex 2: In patients who have experienced an acute myocardial infarction (P), how does being a smoker (I) compared with being a non-smoker (C) influence death and infarction rates (O) during the first 5 years after the myocardial infarction (T)?
Etiology or harm (causation) — 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 of _______(O) compared with those who have/do not have _______(C) over/during _______(T)?
Ex: Are 30- to 50-year-old women (P) who have high blood pressure (I) at increased risk for an acute myocardial infarction (O) compared with those without high blood pressure (C) during the first year after hysterectomy (T)?
Meaning or quality of life — questions addressing how one experiences a phenomenon:
How do _______(P) diagnosed with _______(I) perceive _______(O) compared with _______(C) during/over _______(T)?
Ex 1: How do young males (P) diagnosed with below-the-waist paralysis (I) perceive their interactions with their romantic partners (O) during the first year after their diagnosis (T)? Ex 2: How do pregnant women (P) newly diagnosed with diabetes (I) perceive reporting their blood sugar levels to their healthcare providers (O) during their pregnancy and six weeks postpartum (T)?
Adapted from the PICOT Question Template, Ellen Fineout-Overholt, 2006. This form may be used for educational and research purposes without permission.
There are a variety of ways you can navigate this training. You can:
To use evidence-based practice, you need a clear idea of the question you would like to answer. PICO is an acronym to help you formulate a clinical question and guide your search for evidence. Using this formula can help you find the best evidence available in a quicker, more efficient manner. Click on each letter for a description.
P = patient or problem.
How would you describe the patient? What issue are they experiencing?
I = intervention.
What would you like to do to help the patient?
What would be the alternative to the intervention you selected?
By doing the intervention, what do you hope to accomplish?
Think about the following scenario and use PICO to create a clinical question:
Physicians in your office recommend exercise to patients age 65 and older who have high blood pressure. However, you overhear patients express doubts. One patient tells his spouse that he does not know how exercise will help. Will patients follow their physicians’ recommendations for exercise? You are considering whether creating handouts and holding a class on the benefits of physical activity might encourage patients to exercise.
Using PICO, we identify:
P = Patient or Problem - Patients age 65 and older with high blood pressure
I = Intervention - Patient education
C = Comparison - No patient education
O = Outcome - Patient participation in exercise
From this list, we develop the clinical question, “Are patient education programs effective (compared to no intervention) in increasing patient exercise in the population of patients age 65 and older with high blood pressure?”
(Image Source: iStock Photos, fstop123©)
Identify the PICO elements from the following scenario:
As a school nurse in a local high school, you notice an increase in teens that are vaping. You’d like to do some research into the possible negative health effects of vaping so that you can provide students with factual materials to help them stop or reduce their smoking.
P = Patient or Problem - High-school students (teenagers)
I = Intervention - Providing materials on negative health effects
C = Comparison - Not providing materials on negative health effects
O = Outcome - Help students stop or reduce smoking
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Clinical questions arise around the central issues involved in caring for patients. It is helpful to narrow down the type of clinical question you are asking. There are four main types of clinical questions:
1. Therapy : questions concerning the effectiveness of a treatment or preventative measure.
2. Harm/Etiology : questions concerning the likelihood of a therapeutic intervention to cause harm.
3. Diagnosis : questions concerning the ability of a test to predict the likelihood of a disease.
4. Prognosis : questions concerning the future course of a patient with a particular condition.
Well-formulated questions can help in many ways:
1. They help you focus on evidence that is directly relevant to patients’ clinical needs.
2. They help you focus on evidence that directly addresses clinicians' or learners' knowledge needs.
3. They can suggest high-yield search strategies.
4. They suggest the forms that useful answers might take.
5. They can help to communicate more clearly with clinicians and facilitate education and learning.
When well built, clinical questions usually have four components:
P : The patient situation, population, or problem of interest. I : The main intervention, defined very broadly, including an exposure, a diagnostic test, a prognostic factor, a treatment, a patient perception and so forth. C : A comparison intervention or exposure (also defined very broadly), if relevant. O : The clinical outcome(s) of interest, including a time horizon, if relevant.
In addition to the standard PICO components, the broader PICOTS framework is extremely useful and important for defining key clinical questions and assessing whether a given study is applicable or not. T refers to Timing and S refers to Setting or Study Design.
T : Timing, i.e. the time it takes to demonstrate an outcome OR the period in which patients are observed. S : Setting (e.g. ambulatory settings including primary, specialty care and inpatient settings), or sometimes Study Design (such as a randomized controlled trial).
Reference: Matchar DB. Introduction to the Methods Guide for Medical Test Reviews. AHRQ Publication No. 12-EHC073-EF. Chapter 1 of Methods Guide for Medical Test Reviews (AHRQ Publication No. 12-EHC017). Rockville, MD: Agency for Healthcare Research and Quality; June 2012.
You can use the Research Medical Library's PDF template linked above to help formulate a clinical question. Other resources for formulating clinical questions include:
PICO(T) Templates (McMaster University Health Sciences Library)
Example for Therapy question:
In ___ [ P ]___, do/does ___[ I ]___ result in ___[ O ]____ when compared with ___[ C ]___ over ___[ T ]____?
PICO Form (National Libra ry of Medicine)
The PICO form linked above can be used to search medical literature with your PICO terms.
Which type of question you're asking determines which type of study is most appropriate to consult.
Therapy | randomized controlled trial > cohort study |
Harm/Etiology | cohort study > case control > case series |
Diagnosis | prospective, blind comparison to a gold standard or cross-sectional |
Prognosis | cohort study > case control > case series |
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
In this guide.
Clinical questions arise from encounters with patients or problem in the clinical setting. While some clinical questions can be easily answered by consulting a reference guide, some questions are more complex and require you to search for research evidence.
Clarifying the key elements of the clinical question is an important step to frame the question and locate an answer to inform clinical decisions. To build a well-defined clinical question, you'll need to consider the type of foreground question and the most appropriate type of study or methodology that can address the question. It is important to look for the study design that will yield the highest level of evidence in the evidence pyramid.
Background questions:
Foreground questions:
The PICO is a mnemonic that captures the key elements to help develop focused clinical questions. It can also be used to formulate the search strategy by identifying key concepts.
For examples of well-defined PICO questions, visit the Cochrane Clinical Answers . The Cochrane Clinical Answers provides evidence-based answers to PICO clinical questions that come across in clinical practice. These answers have been created to inform decision-making at the point of care, and link to Cochrane Reviews that have been filtered to its clinically relevant aspects.
To develop a clinical question, it is important to think about the type of question you have. Here are some common types of clinical questions:
Different clinical questions are best answered by different types of research studies. The best available or highest level of evidence to answer your question may not always be available in a systematic review or meta-analysis.
All clinical questions | systematic review, meta-analysis |
Therapy | RCT |
Prognosis | cohort study, case control, case series |
Diagnosis | prospective, blind comparison to a gold standard or cross-sectional |
Etiology/Harm | RCT, cohort study, case control, case series |
Prevention | RCT, cohort study, case control, case series |
Cost | economic analysis |
Point of care tools are designed for rapid consultation and provide high level summaries of current evidence for diagnosis, tests, and interventions.
Drug information resources provide answers for drug information question, drug identifier tools, drug interaction tools, drug calculators, and more.
Drug information resource containing: American Hospital Formulary System (AHFS), drug formulary for Lucile Packard Children's Hospital (LPCH) and Stanford Hospital & Clinics (SHC), Lexi-Drugs (adverse reactions, dosage and administration, mechanism of action, storage, use, and administration information), Lexi-Calc, Lexi-ID, Lexi-I.V. Compatibility (King Guide), Lexi-Interact, and Lexi-PALS.
Differential diagnosis tools are used to help with diagnosis decision making by differentiating between diseases and conditions that present similar clinical features.
Clinical practice guidelines are systematically developed statements that provide recommendations and guide decisions about diagnosis, management, and treatment for specific areas of healthcare.
Clinical search engine designed to allow users to quickly and easily find and use high-quality research evidence to support their practice and/or care. Users are able to search across other content types including images, videos, patient information leaflets, educational courses and news.
A searchable database of 26 databases of hyperlinks from evidence-based medicine sites around the world.
Clinical questions generally fall into one of two categories: background questions and foreground questions .
Background questions are considered general knowledge questions and typically ask who , what , where , when or how and with regards to a disorder, test, treatment, etc.
Example: What causes migraines?
Foreground questions ask for specific knowledge to inform clinical decisions, and typically concern a specific patient or population. These questions tend to be more specific and complex compared to background questions and can include the type of study or methodology .
Example: Do Botox injections prevent migraines in adults who suffer from chronic migraines?
Foreground questions can be further divided into four major types:
Your next patient is a 72-year-old woman with osteoarthritis of the knees and moderate hypertension, accompanied by her daughter, a lab technician from the hospital. The daughter wants you to give her mother a prescription for one of the new COX-2 inhibitors because she has heard that they cause less GI bleeding. Her mother is concerned that the new drugs will mean more out-of-pocket costs each month.
Patient / Problem | Intervention | Comparison Intervention | Outcome(s) |
---|---|---|---|
72-year-old woman with osteoarthritis of the knee and moderate hypertension | COX-2 inhibitor | other NSAIDS | less GI bleeding; pain control |
In a 72-year-old woman with osteoarthritis of the knee, can COX-2 inhibitor use decrease the risk of GI bleeding compared to other NSAIDS?
You have been treating a 54-year-old woman for many years and despite the excellence of your fixed partial denture restorations, the intense routine maintenance by her periodontist, and good home care, she has been experiencing a continued deterioration of her periodontal tissues. Her attempts to quit smoking have been unsuccessful; otherwise she is in good health and taking no medications. Because you are her primary care dentist, she has questioned you about her current dilemma. The periodontist has suggested a 3-week course of doxycycline therapy to control her latest exacerbation of periodontal disease, but she is concerned about Food and Drug Administration (FDA) reports asking for prudent use of antibiotics. How do you advise this patient?
Patient / Problem | Intervention | Comparison Intervention | Outcome(s) |
---|---|---|---|
54-year-old woman with exacerbation of periodontal disease | doxycycline | no treatment | less gum bleeding; stop recession |
For a 54-year-old woman with periodontal disease, how effective is the therapeutic use of doxycycline decrease gum bleeding and recession compared to no treatment?
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Ravindra, Vijay M MD, MSPH; Kestle, John R W MD
Department of Neurosurgery, Division of Pediatric Neurosurgery, University of Utah School of Medicine, Salt Lake City, Utah
Correspondence: John R.W. Kestle, MD, Department of Neurosurgery, Division of Pediatric Neurosurgery, University of Utah, 100 N Mario Capecchi Drive, Salt Lake City, UT 84113. E-mail: [email protected]
Corresponding Article
The bar for clinical research in surgical subspecialties has been rising over the past 10 yr. It is now essential that neurosurgeons are familiar with the principles of evidence-based medicine to evaluate and conduct sound clinical research. In this review, we highlight the importance of formulating a good research question, which serves as the foundation for meaningful investigation.
Standards and methods for clinical research in surgery have become more accepted and expected in the last 10 yr than they were in the past. 1 Although neurosurgery has been responsible for some randomized, surgical trials with clearly defined outcome measures and clear clinical questions, 2-6 the surgical case series is still the most common clinical research method in the surgical literature. Fortunately, training in clinical research methods is now integrated into most residency training programs.
Since the enactment of the Affordable Care Act in 2010, healthcare payers and providers have shifted focus towards improving the quality of healthcare delivery. Surgeons strive to practice “evidence-based” medicine and decision-making, which look to clinical trials and clinical research for guidance. 1 With this in mind, it is the responsibility of the academic neurosurgery community to ask clinically relevant and important questions and attempt to answer them with sound study design with objective reporting of results.
One of the most fundamental aspects of performing impactful clinical research is formulating a sound, relevant research question. The development of the research question should set the investigator on a clear research pathway and will help generate evidence that has meaning for patients and surgeons. The current proliferation of large databases combined with easy access to statistical software has allowed anyone to “look around” the data and see what comes up. Without a clear study question, these quests are often pointless or lead to findings that can be unclear or misleading. In this review, we highlight the importance of a well-designed study question and offer advice for writing one.
Writing a clear primary question involves a series of steps to define all of the necessary details ( Figure ). The first step in writing a study question is to identify (precisely) the knowledge gap . This requires an intimate knowledge of the topic and the relevant literature. 7 A good study question should address an important gap in current knowledge, 8 and patients should be better off if that gap is filled. Haynes 7 suggests that delineating between current knowledge and ignorance is essential in formulating a sound study question.
A thorough assessment of the current state of knowledge can be done through a systematic review of the literature, interviews with focus groups and patients, and consultation with experts in the field of interest. Some granting institutions encourage applicants to perform a systematic review and conduct smaller pilot studies prior to applying for full clinical trial funding to ensure the fidelity of the research question. 1 In basic science and translational research, an exploratory analysis may be necessary prior to asking a specific study question. The formulation of an important research question requires understanding the biology, physiology, and epidemiology of the problem. 7 Current frustrations with the clinical management and/or clinical outcomes are often the driving force behind the question.
Ideally, a research plan should have ONE primary study question that includes the patients to be studied, the treatment given, the outcome to be assessed, and the plans for analysis. It should be written so that a simple “yes or no” conclusion can be stated at the end of the study. The primary question sets the investigator in the right direction and usually determines sample size, feasibility, and budget. In addition, it is usually scrutinized in the grant review and publication process. Additional “secondary” questions may be planned, but they should never compromise the primary question. 1 Secondary questions might look at subgroups of the study sample or evaluate less important secondary outcomes. Their purpose is to identify potential explanations for the primary study result and to generate new study questions, but usually the study will not be powered to answer them definitively. The study power should be adequate to answer the one primary study question.
The development of a precise, answerable study question is a key early step in clinical research. Delving through large databases with statistical programs to find something “significant” without a predefined question or hypothesis only serves to “muddy” the waters and does not provide meaningful substance to the body of available literature. With the abundance of data available, the importance of a single, simple primary research question to answer is more important than ever. 8
Once a study question has been drafted, it should be widely circulated to coinvestigators, colleagues, and, if possible, patient representatives to assess whether it is clearly written, understandable, important, and answerable. Identifying an answerable question can be difficult for clinicians. We tend to want to answer too many questions at once. It is important to narrow the topic sufficiently to answer a single clear question. It may become apparent that there are multiple relevant questions to address for the clinical problem in question. The most important one with the greatest impact should be chosen if possible, although preliminary study questions that justify or help refine the main question may be necessary. In clinical research, the research question often stems from clinical scenarios that showcase a knowledge gap. It is important that asking a relevant research question and formulating and executing a study subsequently leads to translation of the results back to the clinical setting, which is the reason for formulating the research question in the first place.
Although a well-constructed research question can provide significant value when posed appropriately using the above-mentioned criteria, a poorly planned research question may heavily influence the study design and lead to significant limitations when analyzing the data. This undercuts the ability of the study to clearly answer the question. Adequate time should be given to formulating the research question. Although often overlooked, the use of appropriate thought, resources, and investigation during this stage is crucial. Spending an hour with a statistician or clinical epidemiologist to write a focused study question is time well spent.
Hulley and colleagues 9 have described the FINER criteria ( Table ) as a roadmap in developing a good research question. The FINER criteria assess whether the study is feasible (F), addresses an interesting topic (I), involves novel ideas (N), can be ethically studied and would be amenable to institutional review board approval (E), and is relevant to the scientific community (R). The FINER criteria serve as a starting point to help investigators choose a research topic, but do place value on novel ideas. Although novelty is very important, there is also a role for studies that are not novel and are designed to reproduce the findings of other researchers. Another approach, the PICOT format, may be more helpful for defining the specific components of the research question. 8 , 10 , 11 The PICOT format defines the population (P), the proposed therapeutic intervention (I), the comparison group or cohort (C), the outcome of interest (O), and timing of the study or investigation (T). 8 , 10 , 11 Using this method can help frame the study around the question being asked by defining the inclusion and exclusion criteria of the larger clinical population. Once the population, intervention, and outcome are identified, the study designer may determine the most appropriate assessment tool. 12
Criterion | Goal for study |
---|---|
Feasible | • Adequate number of subjects |
•Adequate technical expertise | |
•Affordable in time and money | |
•Manageable in scope | |
•Fundable | |
Interesting | •Getting the answer intrigues the investigator and her colleagues |
Novel | • Provides new findings |
•Confirms, refutes, or extends previous findings | |
•May lead to innovation in concepts of health and disease, medical practice, or methodologies for research | |
Ethical | •A study that the institutional review board will approve |
Relevant | •Likely to have significant impacts on scientific knowledge, clinical practice, or health policy |
•May influence directions of future research |
Studies on therapeutic interventions should ideally provide high-quality data for making recommendations to patients. In these situations, we are usually faced with a decision to recommend the best of 2 or more treatment options. The research will likely be based on a general idea, such as, “Are adjustable shunt valves better than fixed valves for patients with hydrocephalus?” Based on this idea, a succinct study question should be written that will lead to a Yes/No answer. As noted above, the components of the question should include: who will be studied, what are the interventions, what is the outcome, and how the results will be analyzed. Therefore, the general study question above could be formulated more precisely as the following question: In children aged birth to 18 yr with newly diagnosed hydrocephalus, do adjustable shunt valves improve the 1-yr shunt survival from 60% (the predicted value for differential pressure valves) to 70%? Written in this way, the reader immediately understands who is going to be studied: children aged birth to 18 yr with newly diagnosed hydrocephalus will be included. The intervention is shunt insertion with an adjustable valve or a differential pressure valve. The primary outcome is shunt survival, implying a time-to-failure analysis. The improvement in shunt survival from 60% to 70% at 1 yr indicates the difference that the investigators would like to detect.
The components of the question highlight the key aspects of the study proposal. These will be expanded in the detailed study protocol, but immediately upon reading the question, the reviewer understands the basic entry criteria, intervention, outcome, and analysis plans. The event rates in the question allow a sample size calculation that determines the study budget and feasibility.
The selection of a study sample has implications for internal and external validity of the project. External validity in the example stated above would be limited to children. The conclusions of this study question may not apply to elderly patients with normal pressure hydrocephalus. The effect of the sample selection on internal validity may be less obvious but relates to whether differences within the study population might affect the results. For example, it is possible that the study question above is too broad because it includes all forms of hydrocephalus. Perhaps adjustable valves are an advantage in older children with very large ventricles but they are not an advantage in infants with hydrocephalus. Inclusion of all ages therefore could result in a negative study and miss the positive effect in a subset of the study patients. The existing literature should be used to assess these issues and to further refine the study question if necessary. It may be appropriate to have a secondary question that asks whether adjustable valves improve shunt survival among the subgroup of older children with very large ventricles.
The choice of study intervention is important. For the results of the study to be useful, ideally the intervention should be available to practitioners. If the intervention is not widely available, however, the study results can also be used to justify expanded availability through policy change and training. In our example, it is unclear whether adjustable valves would be available to practitioners in some parts of the world. In addition, the intervention should be something that can be achieved by most surgeons. For example, if tumor removal is being studied and gross total resection is found to be important, then the study results only apply to surgeons who can achieve gross total resection.
Selection of the outcome measure is crucial. Ideally, only 1 measure should be chosen, and it should be the basis for the primary analysis. The primary outcome should be reliable and valid. A reliable measure provides a repeatable result if measured more than once. A valid measure accurately represents the finding of interest. If a measure is not reliable, it cannot be valid. Demonstrating reliability and validity require a lot of work, so investigators should look in the existing literature for outcome measures whose reliability and validity have already been demonstrated.
An outcome measure should be important to patients. Surrogate outcome measures may be considered when there is an extremely long time to a patient-centered outcome, but whenever possible, the study question should address outcomes that are patient focused. In our example above, shunt survival is likely to be important to patients since it results in hospital admission and repeat surgery. On the other hand, there is some evidence that patients will accept repeated procedures for hydrocephalus in order to achieve better cognitive function. In that case, a better outcome measure might be cognitive function at a specific age. In addition to being important to patients, the outcome should be measurable. Time to shunt failure is certainly measurable, and cognitive function in children can be assessed with the Bayley Scales of Infant and Toddler Development. 13 The use of a measurable outcome will enhance the reproducibility of the study results.
Finally, the selection of the primary outcome should consider observer bias. This is the phenomenon in which outcome assessment is influenced by the prior knowledge or bias of the assessor because of their awareness of the intervention. At first glance, shunt failure may appear to be quite objective. In fact, children can present with subtle symptoms and equivocal imaging so that a decision to revise the shunt can be difficult. In that situation, a surgeon assessing his own patient may choose to reoperate based on his or her knowledge of the valve in place. That is observer bias. To minimize observer bias, blinding is often used in clinical trials, but blinding is difficult to do in surgical interventions. In hydrocephalus clinical research, we have used an adjudication process 14 in which clinical records and imaging are presented to an adjudication committee after information about the intervention has been removed. The committee reviews the blinded data and determines, for each patient, whether they meet the definition of the primary outcome.
The study question should specify the magnitude of the difference in the outcome that investigators want to detect. The smaller the difference chosen, the larger the sample size that will be needed for the study. Ideally, investigators should choose the smallest difference that is clinically important. This is often referred to as the Minimal Clinically Important Difference (MCID). The MCID has been published for spine measures, 15 and this type of metric can be very useful in determining research questions. To determine MCID, input is required from patients and physicians. From the physician's perspective, the MCID is the smallest difference that would make the physician change his or her practice. It therefore incorporates complications and cost. Ideally, the MCID should also include patient input by assessing how much potential benefit a patient needs/expects to accept the risks, cost, pain, and inconvenience of the intervention. For most clinical outcomes, the MCID has not been formally determined, but the magnitude of difference that a study will be able to detect is very important and should be discussed and planned from the beginning.
Although study questions on therapeutic interventions help us the most, they are not always feasible. Other research designs may be necessary. One of the most common designs in surgical literature is the study of association. For example, an investigator may ask “What are the risk factors for recurrence after astrocytoma resection?” The same general principles for writing the study question should apply, but there are slight differences. Here, the study question should include the exposure of interest, the primary outcome, and the covariates that might impact the primary outcome, or the likelihood of receiving the intervention. This may result in the question being stated as follows: “When controlling for extent of resection, histology, and age, is BRAF status associated with tumor recurrence?” By writing the question in this way, the investigator demonstrates a priori knowledge of risk factors for recurrence and plans to account for them in the assessment of BRAF status. The question might be further improved by adding a definition of tumor recurrence and by specifying a time-dependent analysis plan.
Writing a clear primary question that specifies the key components of the research plan is an essential initial step in all clinical research projects. The main advantage is that it makes the investigator think about, and write down, the key factors that will define the study: who is being studied, what are they being exposed to (treatments or risk factors), and how are you going to measure the outcome? Getting these things right from the beginning requires identification of a specific gap in our knowledge, discussion and collaboration with colleagues, and consultation with experienced clinical researchers and statisticians. A well-written question will be the blueprint for a successful investigation and will be a reference point as the study protocol is developed in more detail.
The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article.
This article is of great value to anyone who reads the neurosurgical literature. It is not necessary to be planning a research study to benefit from the advice presented here. When considering whether or not to spend the time to read an article, the reader who understands what makes for a good research question will first determine if the authors have clearly presented a good research question as the foundation of their article. If they have not, the reader can move on, confident that nothing of great importance will be missed by consigning that article to the circular file.
The authors give sound advice for what should be the first step in beginning any research project: writing a clear, complete and concise research question. As they point out, good questions help define the data to be collected, the analytic techniques to be used, and the sample size, and guide the rest of the study design. Shared with colleagues, a good question can lead to advice on improving the research plan, finding existing publications on the topic that may have been missed or even learning that another research team has already embarked on a similar project. All of this can save time, resources, avoid embarrassment, and lead to better research outcomes.
The types of question asked differ depending on the circumstance. One may need to know how best to assess a patient, which requires evaluations of validity and reproducibility. The usefulness of a diagnostic test or procedure requires a comparison to a gold standard. The prognosis of a condition with or without treatment depends on objective observation of outcomes over time. Therapeutic efficacy questions revolve around unbiased comparisons of outcome. Questions of safety or harm assess the dependence of outcome on various factors. Choosing the right patient population, outcome measures, and type of analysis is a critical part of formulating a good research question.
Poorly conceived research questions can lead to confusing and inconclusive results. For example, composite outcomes, if not very carefully constructed, may defy clinical interpretation and, regardless of the quality of the conduct and analysis of the study, leave the reader confused as to the meaning of a “statistically significant” result. For example, the Management of Myelomeningocele Study (MOMS) had two predetermined composite outcomes. The first, “the rate of fetal or neonatal death or the need for a cerebrospinal fluid shunt” at 12 months of age is difficult to interpret. The apparent research question is “Do children with myeomeningocele diagnosed before birth have a lower rate of death or needing a CSF shunt within 12 months of birth if their myelomeningocele is repaired before or after birth?” 1
The forced equivalence of death or meeting the criteria for shunt placement does not make clinical sense. Clearly the impact on subsequent function and quality of life of being dead is different from that for having a CSF shunt. When contemplating the possible variations in the primary outcome results, irresolvable potential conflicts arise. The actual result of 68% of the prenatal group and 98% of the postnatal group meeting criteria for the primary outcome could, at the extremes, result from 68% of the prenatal group dying and 98% of the postnatal group requiring a shunt. It would be difficult for most people to accept this as a result favoring the prenatal group. A primary outcome measure that leads to confusing and controversial interpretations leads to a confusing and controversial study.
Therefore, both practitioners and researchers of neurosurgery are well advised to have a good understanding of what constitutes a good research question and to use that knowledge to advance their understanding of neurosurgical practice. The authors have provided an excellent guide to this topic.
Stephen J. Haines
Minneapolis, Minnesota
Randomized; Hypothesis; Quality of evidence
Commentary: Writing a Clinical Research Question
Walters, Beverly C
Neurosurgery. 84(1):17-18, January 2019.
Degenerative cervical myelopathy: a spectrum of related disorders affecting..., imaging surrogates of infiltration obtained via multiparametric imaging pattern ..., state of the art in degenerative cervical myelopathy: an update on current..., minimally invasive transforaminal lumbar interbody fusion: meta-analysis of the ..., national databases for neurosurgical outcomes research: options, strengths, and ....
Common clinical question types, background questions & foreground questions.
Recognising your clinical question's domain is an important part of the Evidence-Based Practice (EBP) process. Establishing the question type allows you to:
Identifying your question type will also assist you in critically appraising the evidence based on the appropriateness and rigor of the research methods described in a paper.
The table below explains the primary types of clinical questions and types of evidence to answer the question. 1
Therapy (Treatment) | Questions about the effectiveness of interventions in improving outcomes in sick patients / patients suffering from some condition. These are the most frequently asked. Among the many treatments offered by clinicians are medications, surgical procedures, excercise, and counseling about lifestyles changes. | Randomised Controlled Trial (RCT) |
Prevention | Questions about the effectiveness of an intervention or exposure in preventing morbidity and mortality. Similar to treatment questions. When assessing preventive measures, it is particularly important to evaluate potential harms as well as benefits. | RCT or Prospective Study |
Diagnosis | Questions about the ability of a test or procedure to differentiate between those with and without a condition or disease. | RCT or Cohort Study |
Prognosis (Forecast) | Questions about the probable cause of a patient's disease or the likelihood that he or she will develop an illness. | Cohort Study and/or Case-Control Series |
Etiology (Causation) | Questions about the harmful effect of an intervention or exposure on a patient. | Cohort Study |
Meaning | Questions about patients' experiences and concerns. | Qualitative Study |
Clinical questions can be categorised as either background or foreground. Determining the type of question will help you to select the best resource to consult for your answer. Background questions ask for general knowledge about a condition, test or treatment. These types of questions typically ask who, what, where, when, how & why about things like a disorder, test, or treatment, or other aspect of healthcare. For example:
What are the clinical manifestations of menopause?
What causes migraines?
Foreground questions ask for specific knowledge to inform clinical decisions. These questions typically concern a specific patient or particular population. They tend to be more specific and complex than background questions. Quite often, foreground questions investigate comparisons, such as two drugs, or two treatments. For example:
Is Crixivan effective in slowing the rate of functional impairment in a 45 year old male patient with Lou Gehrig's Disease?
In patients with osteoarthritis of the hip, is water therapy more effective than land-based exercise in restoring range-of-motion?
1. Fineout-Overholt, E. & Johnston, L. (2005), Teaching EBP: asking searchable, answerable clinical questions. Worldviews on Evidence-Based Nursing , 2, 157–160. doi: http://dx.doi.org/10.1111/j.1741-6787.2005.00032.x
Clinical question types, clinical question types & resources.
Information on how to build a Clinical PICO(TT) Question and recommended Resources for answering different types of Clinical Questions are available below.
Please select an option from the dropdown menu to see the recommended Resources for Question creation and Question type, or scroll down the page to see the various options.
Building a clinical question resources for pico(tt) question creation.
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Basic medical information resources for general medical knowledge (background questions).
Author: Bickley, Lynn S. Year: 2021
Epidemiology information resources for disease incidence, patterns, causes, and effects (background & foreground questions), medical research information resources for finding medical research and studies (foreground questions).
Treatment & therapy information resources for treatment & therapy options and comparisons (background & foreground questions), unusual presentations, unusual presentation information resources for unusual presentation of diseases, symptoms, etc. (foreground & background questions), resources as apps, resources as apps commonly used cqra resources available as mobile apps.
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Healing Through Knowledge
Pico(t) model & question types, example 1 - therapy, example 2 - diagnosis/diagnostic test, example 3 - etiology, example 4 - prognosis.
This model helps us create searchable clinical questions before we start looking at the literature.
P - Population
I - Intervention
C - Comparison or Control
O - Outcome (desired or of interest)
T- Time period (ie. "Over six month period.." or "In three years...")
Question: In POPULATION, does INTERVENTION as compared to COMPARISON/CONTROL GROUP result in OUTCOME?
Keep in mind, you may not have all the pieces depending on your type of question, but it's a great jumping off point.
Scenario: You have a female patient who has recently been diagnosed with SLE. Her rheumatologist suggested she start on Plaquenil for her joint pain, but she is interested in alternative therapies because she heard about success a neighbor had with turmeric tea.
P- patients with SLE
I- turmeric tea
C- Plaquenil (standard drug therapy)
O- reduction of joint pain
Question: In adult patients with SLE, is consuming turmeric tea more effective than Plaquenil at reducing joint pain?
This question could be more specific (Gender specific? What counts as a reduction in joint pain?), but is still a therapy question. We're comparing an alternative therapy (turmeric tea) with a more standard drug therapy (Plaquenil).
Scenario: Your patient has a history of blood clots and after they came in to your clinic with right calf discomfort and tightness, you're concerned about DVT. You remember reading about the limitations of duplex ultrasound and calfveins, and are wondering if a d-dimer assay can help you rule out DVT more accurately.
I- d-dimer assay
C- ultrasound
O- more accurate diagnosis of DVT
Question: Is d ‐ dimer assay more accurate at ruling out deep vein thrombosis compared to ultrasound?
Scenario: Your female patient is concerned about her risk of developing breast cancer. Her friend was recently diagnosed, and mentioned that her smoking might have been a factor. Your patient and her wife have lived together for 10 years, and while she doesn't smoke, her partner does. Is she at an increased risk over someone without daily exposure to second-hand smoke?
P- female non smokers w/ daily second hand smoke exposure
C- female non smokers w/o daily smoke exposure
O- develop breast cancer
T- over ten years
Question: Are female non-smokers with daily exposure to second-hand smoke over a period of ten years or greater more likely to develop breast cancer when compared with female non-smokers without daily exposure to second hand smoke?
Scenario: Your patient, who owns a bakery, recently participated in their employer's wellness program. Their BMI is within a normal range, but they have a family history of obesity, and are concerned about the impact carbs may have on maintaining a healthy weight.
P- pts w/ family history of obesity
I- carb intake; specific diet?
O- keeping BMI below 25; healthy weight management
Question: Does dietary carbohydrate intake influence healthy weight maintenance (BMI <25) in patients who have family history of obesity (BMI >30)?
A clinical question is the foundation of a quality article or paper. Good clinical questions are both detailed and succinct and frame the question in such a way that it can be answered effectively. Clinical questions are patient-focused. The PICO acronym describes the components of an effective clinical question.
P Patient (Who is the patient? For example, "a middle aged female with hypertension")
I Intervention (What is the treatment being considered?)
C Comparison (To what is the treatment or course of action being compared?)
O Outcome (What is the desired result? For example "improved quality of life" or "pain reduction."
Sometimes you will see the acronym variation PICOTS. T stands for timing, such as does the dosage timing or interval make a difference. S stands for setting, which refers to the location in which the intervention takes place (for example, outpatient clinic, workplace, hospital, etc.).
Would you like to see examples of a good clinical question? Take a look at these POEMS (Essential Evidence that Matters) in Essential Evidence Plus. To get started, click a year or click the link to the archive at the bottom left of the Essential Evidence Plus POEMS page.
Some resources have filters that make it easy to search with PICO. To see one, visit TRIP (Turning Research Into Practice) . PubMed4Hh (PubMed for Handhelds) also offers PICO searching--you can find it in your app store and download it to your phone or mobile device.
Once you have decided upon a clinical question, take a moment to consider
1. Possible synonyms for terms used in the question.
2. What type of literature do you want?
3. How recent should the information be?
4. Are there terms you want to exclude?
5. Are you looking for a particular time frame? (5 years back, last two years only, etc.)
6. Do you want to limit your search to a particular type of patient? (male/female, age, ethnicity, etc.)
7. I s timing or setting or geographic location important? (Giving patients medication in morning vs evening, assisted living facilities, North Carolina, etc.)
INFORMATION FOR
The Yale Summer Enrichment Research Experience (YSERE) is a free 6-week summer program for undergraduate students who are currently enrolled in an accredited degree-granting institution other than Yale and considering a future career in biomedical research. YSERE seeks applicants who are 1) interested in advancing the goals of increasing diversity in biomedical research and 2) committed and determined to work through difficult challenges. Students from educationally or economically disadvantaged backgrounds are particularly encouraged to apply.
The YSERE 2024 program runs from July 8, 2024 – August 16, 2024. Students will participate in an intensive research program designed to expose them to the process of scientific discovery and the path to a PhD or MD/PhD degree. Each student will be matched with a research laboratory at Yale and work on a primary research project within their assigned laboratory for 6 weeks. In addition to conducting a primary research project, students will participate in weekly seminars, career discussions, and related social activities. The program aims to develop students’ skills on critical thinking, analysis of scientific literature, and effective scientific communication.
There is no fee to attend, and each student will receive a stipend. Students are required to make a full-time commitment, Monday-Friday, for the 6-week duration.
The YSERE 2024 is made possible by generous support from Yale Center for Clinical Investigation (YCCI), Yale Cooperative Center for Excellence in Hematology (YCCEH) and Yale Department of Genetics. YSERE 2024 is co-organized by YCCI, YCCEH, Yale Department of Genetics and Yale Stem Cell Center.
You will need:
2024 Yale Summer Enrichment Research Experience Intern
2023 Yale Summer Enrichment Research Experience Intern
2022 YSERE Intern
Biosketch format pages, instructions, and samples.
A biographical sketch (also referred to as biosketch) documents an individual's qualifications and experience for a specific role in a project. NIH requires submission of a biosketch for each proposed senior/key personnel and other significant contributor on a grant application. Some funding opportunities or programs may also request biosketches for additional personnel (e.g., Participating Faculty Biosketch attachment for institutional training awards). Applicants and recipients are required to submit biosketches
NIH staff and peer reviewers utilize the biosketch to ensure that individuals included on the applications are equipped with the skills, knowledge, and resources necessary to carry out the proposed research. NIH biosketches must conform to a specific format. Applicants and recipients can use the provided format pages to prepare their biosketch attachments or can use SciENcv , a tool used to develop and automatically format biosketches according to NIH requirements.
Biosketch (non-fellowship): biographical sketch format page - forms-h.
Model agreements, often called model Clinical Trial Agreements (mCTAs), of one of two UK-wide tools you will need to use to complete National Contract Value Review (NCVR) - the UK’s standardised, national approach to costing and contracting for commercial contract research.
If you are not familiar with NCVR, visit our Costing and contracting using National Contract Value Review (NCVR) web page . This helpful overview explains what NCVR is, why it has been implemented, and how it is helping to speed up the costing and contracting activities for commercial clinical research in the UK.
Unmodified use of the appropriate model agreement helps to speed up the contracting process for studies carried out in the NHS, by removing site-by-site review and negotiation. Unmodified use is a general expectation and, in most cases, an obligation for the NHS - as set out in the National Directive on Commercial Contract Research Studies . This standardised approach protects all parties, enables studies to start earlier and gives NHS patients faster access to innovative treatments in high quality research. The suite of model site agreements are supported by guidance which sets out the aims and provides details on how the agreement should be used in the development of contracts for clinical research sponsored by pharmaceutical, biopharmaceutical or medical technology companies.
For more information and to access the latest versions of model agreement templates, visit the IRAS website .
The model Industry Collaborative Research Agreement (mICRA) launched in February 2011 aims to support clinical research collaborations involving the pharmaceutical and biotechnology industries, academia and NHS organisations across the UK.
A Decision Tree is available to guide users in identifying when studies are collaborative and whether mICRA is applicable.
Feedback on the use of the mICRA is welcomed to help inform its future development. Email comments to [email protected] .
National Contract Value Review (NCVR) is just one of the ways we work in partnership with life science organisations to help you to plan, place and perform commercial clinical research in the UK. Visit our offer to the life Sciences Industry page to discover our full range of support and request a meeting with our dedicated industry team:
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Background Substantial increases in UK consulting rates, mean consultation duration, and clinical workload were observed between 2007 and 2014. To the authors’ knowledge, no analysis of more recent trends in clinical workload has been published to date. This study updates and builds on previous research, identifying underlying changes in population morbidity levels affecting demand for primary health care.
Aim To describe the changes in clinical workload in UK primary care since 2005.
Design and setting Retrospective cohort study using GP primary care electronic health records data from 824 UK general practices.
Method Over 500 million anonymised electronic health records were obtained from IQVIA Medical Research Data to examine consulting rates with GPs and practice nurses together with the duration of these consultations to determine total patient-level workload per person–year.
Results Age-standardised mean GP direct (face-to-face and telephone) consulting rates fell steadily by 2.0% a year from 2014 to 2019. Between 2005 and 2019 mean GP direct consulting rates fell by 5.8% overall whereas mean workload per person–year increased by 25.8%, owing in part to a 36.9% increase in mean consultation duration. Indirect GP workload almost tripled over the 15 years, contributing to a 48.3% increase in overall clinical workload per person–year. The proportion of the study population with ≥3 serious chronic conditions increased from 9.7% to 16.1%, accounting for over a third of total clinical workload in 2019.
Conclusion Findings show sustained increases in consulting rates, consultation duration, and clinical workload until 2014. From 2015, however, rising demand for health care and a larger administrative workload have led to capacity constraints as the system nears saturation.
Strong primary care is associated with better population health, lower healthcare expenditure, and a more equitable distribution of health resources. 1 In the UK, primary care plays an essential role in the provision of health care, accounting for approximately 90% of all NHS contacts. 2 Although NHS activity data indicate that general practices delivered a record 356 million appointments in 2023, demand continues to outstrip capacity. 3 A recent survey reported that 71% of GPs in the UK found their job to be very or extremely stressful, with the highest proportion among the 10 high-income countries surveyed. 4
Fears that primary care in the UK is in crisis or nearing breaking point are nothing new. 5 Although pressures on general practice were undeniably exacerbated by the COVID-19 pandemic, the current situation is the outcome of many years of underinvestment, a shrinking of the GP workforce, an ageing and growing population, and national strategic objectives that sought to shift care out of hospitals and into the community. Analysis of 2023 workforce data showed an 11.8% fall in the number of full-time equivalent (FTE) GPs (excluding locums, trainees, and retainers) and a 41% increase in the number of patients per FTE GP since 2014. 1 , 6 The proportion of NHS funding directed to general practices declined from 10.6% in 2005/2006 to 6.8% in 2020/2021 as secondary care services secured a greater share of increases in healthcare spending. 7 The UK population increased by 11.4% over the same period and its median age rose from 38.7 to 40.7 years. 8
Analysis of a large database of electronic health records described a 10.5% increase in annual consultation rates per person between 2007 and 2014, mainly accounted for by an increase in GP consultations. 9 The same period also saw an increase in consultation duration. In cross-sectional analysis, consultation rates were higher in older patients, females, and those living in more deprived regions. 10 A similar analysis of duration found GP consultations were longer in older patients and females, although the differences were small. 11 The focus of much of the literature on GP workload is on direct patient care, an activity that typically accounts for 75% of patient-related clinical workload. 12 Time spent on indirect patient care (for example, referral letters or repeat prescriptions) was not included, implying that primary care workload data may under-represent total patient-related clinical activity by a third.
Previous literature on GP and practice nurse face-to-face or telephone consultations showed an increase in direct patient workload between 2007 and 2014. This study examines all aspects of patient workload, both direct contacts and patient-related administrative work, in terms of consulting rates per person–year and the duration of these consultations from 2005 to 2019. Health and social care system changes, rising levels of morbidity, and increased demand from patients have all combined to place additional pressures on UK general practice. |
How this fits in
Many questions remain unanswered. There is limited understanding of the factors driving long-term trends in consultation rates. The aim of this analysis of the volume and nature of GP and practice nurse consultations was to obtain objective data on changes in clinical workload between 2005 and 2019. Overall clinical workload over time, workload by clinical role, and by multimorbidity level are examined.
A retrospective cohort study was carried out using data obtained from IQVIA Medical Research Data UK (IMRD) incorporating data from The Health Improvement Network, a Cegedim database. IMRD includes anonymised electronic primary health care records from approximately 6% of the UK population in over 800 UK general practices. General practices are largely representative of UK primary care practices in size, age, and the sex of patients, and prevalence of chronic conditions. 13
Data were extracted for all patients registered with practices contributing to IMRD, covering the period 1 January 2005 to 31 December 2019. Data extraction was facilitated using the Data Extraction for Epidemiological Research (DExtER) tool. 14
The primary outcome is individual patient clinical workload, defined as the total number of contact minutes per year that the patient has with their general practice, coded by staff role and by type of contact. A GP contact is defined as any file opening by a GP and includes face-to-face consultations, telephone calls to or from a patient, results recording, or issuance of a repeat prescription. Similarly, a nurse contact is defined as any file opening recorded as being made by a practice nurse. Patient consultations with nurses are mainly separate from those with doctors. In the UK, primary care nurses’ responsibilities include immunisation, cervical screening, health promotion, and chronic disease management. 15 All non-clinical work by a GP or practice nurse was excluded from the workload calculations, as was any work done by other clerical or administrative staff or other providers of direct care such as physiotherapists or dieticians.
File openings of 0 min have been rounded up to 30 s. File openings of ≥30 min were truncated at 30 min as long openings were considered unlikely to reflect patient work. Consultation rates are defined as the number of times a patient’s file is opened per person–year, by a nurse or a GP. Consultation rates for direct patient contacts (face-to-face surgery consultations and telephone consultations) are also reported. Clinical workload per person–year is defined as the sum of all GP and nurse contact minutes for a given patient in a given year.
Information about patients’ long-term conditions was obtained from IMRD with medical diagnoses of these conditions recorded using the Read code clinical classification system. Read codes are a hierarchical clinical terminology system used within both primary and secondary care to record a wide range of information relating to a patient’s demography, symptoms, tests, results, and diagnoses.
Previous work by Barnett et al identified 40 long-term conditions that had a significant impact on a patient’s quality of life, risk of mortality, and need for health care. 16 In the current study the code lists associated with each of these conditions as determined by a multimorbidity research joint project between the Universities of Cambridge and Birmingham was used. 17
Consulting patterns from 2015 until 2019 were examined, comparing individual workload at 1-year pre-diagnosis to workload 1 year, 3 years, and 5 years post-diagnosis for each condition to determine the length of time that conditions should be shown as present following diagnosis.
Person–years for each age group were calculated for each year. Workload per person–year and consultation rates were age standardised to the population of the 2005 IMRD dataset to allow comparison over time. Mean annual clinical consulting rates and mean duration of file openings were calculated for all types of consultations with a GP, face-to-face and telephone consultations with a GP, and consultations with a practice nurse. Patients were grouped according to how many chronic conditions they had (0, 1, 2, and ≥3 conditions) and average workload per person–year calculated for each group over the period. Summary statistics are presented in the following section, either graphically or in tables.
Overall, data for over 550 million file openings for 10 098 454 patients from 824 practices were examined in this study, representing over 69 million person–years of observation. Descriptive statistics are given for 2005 and 2019 ( Table 1 ).
Descriptive statistics of dataset
A comparison of the population by age group for the dataset and for the UK population as a whole in 2005 and 2019 shows that the sample is broadly similar to UK national data obtained from the World Bank databank. 18 For example, in 2005, 59.7% of the UK population was aged <45 years compared with 55.5% for the sample ( n = 2 861 740/5 159 933). In 2019, 55.7% of the UK population was aged <45 years compared with 50.2% for the sample ( n = 1 399 167/2 785 796) (see Supplementary Table S1).
After an initial drop in the age-standardised mean consulting rate, rates climbed to a high of 3.84 (95% confidence interval [CI] = 3.84 to 3.85) direct consultations per year in 2014. From 2014 mean consulting rates fell steadily by 2.0% a year to 3.47 (95% CI = 3.46 to 3.47) consultations per year by 2019. Between 2005 and 2019 mean consulting rates fell by 5.8% overall (see Supplementary Figure S1).
Duration of file openings by practice nurses increased at a relatively constant rate over the period from a mean of 6.83 (95% CI = 6.82 to 6.83) min in 2005 to 8.99 (95% CI = 8.98 to 9.00) min in 2019, a rise of 31.7% overall (see Supplementary Figure S2).
For GP face-to-face or telephone consultations, mean duration increased by 36.0% between 2005 and 2011. From 2011 onwards, the rate of increase in mean duration of GP face-to-face consultations plateaued, remaining between 8.21 (95% CI = 8.21 to 8.21) min and 8.46 (95% CI = 8.45 to 8.46) min until 2019. The biggest change was in all GP file openings where mean duration increased by 68.4% from 4.57 (95% CI = 4.57 to 4.57) min in 2005 to 7.69 (95% CI = 7.69 to 7.70) min by 2019 (see Supplementary Figure S2). From 2005 to 2019, mean duration of GP direct consultations increased by 36.9% overall.
Age-standardised mean clinical workload per person–year increased by over 48% from 39.06 (95% CI = 39.03 to 39.10) min in 2005 to 57.61 (95% CI = 57.55 to 57.66) min in 2014. From 2014 to 2019 it remained relatively stable, fluctuating between 56.98 (95% CI = 56.93 to 57.03) and 57.98 (95% CI = 57.93 to 58.03) min ( Figure 1 ).
Mean age-standardised workload per person–year by staff role. F2F = face to face.
In the study, GP workload was separated into two parts: patient-facing workload (GP F2F: all face-to-face consultations and telephone consultations) and patient-related administrative work (GP admin). Mean GP F2F workload per person–year increased every year between 2005 and 2012 to a maximum of just under 33 min. From 2012 to 2019 it fell by 10.6% to just below 30 min. Mean GP admin workload stood at 4.60 (95% CI = 4.60 to 4.60) min per person–year in 2005 rising to 12.53 (95% CI = 12.52 to 12.55) min by 2019, an increase of 172.4%. Administrative workload as a proportion of total GP workload nearly doubled from 16.3% in 2005 to 29.6% in 2019 ( Figure 1 ).
Age-standardised mean practice nurse workload per person–year rose consistently over the period from 10.75 (95% CI = 10.74 to 10.76) min in 2005 to 15.58 (95% CI = 15.56 to 15.59) min in 2019, an increase of 44.9% overall ( Figure 1 ).
Changes over the period in age-standardised mean workload by staff role and type of consultation are shown in Table 2 .
Age-standardised mean workload (in minutes per person–year) by staff role
Analysis of the impact of a diagnosis on workload found that for most conditions clinical consultation time increased considerably in the year of diagnosis compared with the year before diagnosis, however, consultation time returned to below pre-diagnosis levels within 5 years. For 11 conditions, consultation time increased considerably in the year of diagnosis and remained at a higher level even after 5 years. These conditions were coded to show as present indefinitely, whereas all the other conditions were coded to show as present for 5 years only following diagnosis (see Supplementary Information S1 for details).
Multimorbidity increased across all older age groups between 2005 and 2019 ( Figure 2 ). Overall, 51.5% of the study population had no serious chronic conditions recorded in 2005 and accounted for 27.9% of total clinical workload. Patients with multimorbidity with ≥3 serious chronic conditions represented just 9.7% of the study population but 24.2% of the workload ( n = 499 998/5 159 933). By 2019 the share of the population without any serious chronic conditions had fallen to 43.6% whereas that for patients with multimorbidity with ≥3 conditions had increased to 16.0% ( n = 447 060/2 785 796). The share of total clinical workload accounted for by these patients was 34.5%.
Prevalence of chronic conditions by age group. a) 2005; and b) 2019.
The mean clinical workload associated with patients with no chronic conditions was 21.71 (95% CI = 21.67 to 21.75) min in 2005. Clinical workload increased linearly with the number of chronic diseases: mean workload was 41.13 (95% CI = 41.04 to 41.22) min for patients with one condition, 62.54 (95% CI = 62.37 to 62.71) min for two conditions, and 97.14 (95% CI = 96.86 to 97.42) min for ≥3 conditions. In 2019, mean workload was 31.08 (95% CI = 30.99 to 31.16) min, 54.83 (95% CI = 54.67 to 54.99) min, 79.73 (95% CI = 79.45 to 80.00) min, and 131.03 (95% CI = 130.63 to 131.42) min for 0, 1, 2, and ≥3 conditions, respectively ( Figure 3 ).
Clinical workload by number of chronic conditions.
The rate of increase in clinical workload per person–year over the study period was highest for patients with no chronic conditions at +43.2%, compared with a +33.3% increase in workload for those with one condition, +27.5% for two conditions, and +34.9% for ≥3 conditions ( Figure 3 ).
This study examined trends in consulting rates and duration of consultations for GPs and practice nurses from 2005 to 2019. To capture the full scope of patient-level activity, all aspects of GP workload were studied: both time spent in face-to-face and telephone consultations as well as patient-related administrative work, such as results recording or third-party consultations. Direct patient workload has considerably increased over the period for both GPs and practice nurses by roughly the same amount. However, the amount of time spent by GPs doing patient-related administrative work has increased enormously.
Many factors are likely to have contributed to the increased admin workload of GPs observed over the study period, including the increased ability of GPs to access diagnostic services directly, the transfer of work from secondary to primary care, as well as the introduction of the Quality and Outcomes Framework (QOF) in 2004. 19 , 20 The QOF is a pay- for-performance scheme intended to reward primary care providers for improvements in the management of long-term conditions, representing over 8% of total practice income on average in 2019/2020. 21 Little existing literature on the QOF examines its impact on administrative work undertaken by GPs. There is evidence to suggest, however, that its introduction led to a substantial increase in non-consultation GP workload, in particular that associated with tests. A study of changes in diagnostic testing in UK primary care reported a 3.3-fold increase in test use between 2000/2001 and 2015/2016, and estimated that the average GP spent 1.5 to 2 h each day reviewing test results. 22
The current study recorded a plateauing of the rate of increase in clinical workload from 2014 onwards, with the higher levels of GP admin workload making up for the decline in the GP face-to-face or telephone consulting rate.
The main strength of this study is that it is the first, to the authors’ knowledge, to report on trends in overall clinical workload, examining duration and frequency of clinical consultations, for both patient-facing and administrative activity related to a direct patient contact, such as a repeat prescription or recording of test results. Its findings are based on nearly 70 million person–years of observation covering a 15-year period for practices throughout the UK, making it, to the authors’ knowledge, the largest analysis of clinical workload to date.
This study has several limitations. The most important limitation is that it was not possible to include data from 2020 onwards in the analysis. However, it was felt that the considerable disruption in primary care use during the COVID-19 pandemic was unlikely to be permanent and consequently that the use of data from that period and shortly after would not be representative of any underlying trend. Although the IMRD database is one of the most comprehensive data sources worldwide, as is the case for many observational studies using electronic health records, the accuracy of the recording of consultation durations and types is variable. Short file openings for face-to-face consultations may not accurately reflect the actual work associated with a particular patient if the practitioner does not open the file at the beginning of a consultation, underestimating workload. Similarly, workload will be overestimated if a practitioner forgets to close a patient’s file at the end of the session (all consultations were truncated at 30 min to mitigate this problem).
The list of chronic conditions selected to determine morbidity levels is based on highly regarded previous work: the Read codes used to define these conditions for the present study closely mirror those used by Barnett et al and Cassell et al but may differ slightly. 16 , 23 Using a different set of conditions may have given different results in terms of prevalence and workload associated with the different levels of multimorbidity.
This study supports previous literature that showed an increase in face-to-face and telephone GP and practice nurse workload between 2007 and 2014 in English general practices, observing both a rise in the mean number of consultations per year and a 4.9% increase in consultation duration. 9 Research by Kontopantelis et al described an increase in the number of GP consultations per year from a median of 5.3 to 8.3 between 2000 and 2019, whereas the number of face-to-face GP consultations per year per patient fell from 3.7 to 3.1. 24 Analysis of the use of primary care by children in England reported a fall in general practice consulting rates of 1% per year in all age bands (except for infants) between 2007 and 2017 while observing a corresponding rise in urgent care use. 25
Whereas literature examining overall trends in clinical workload is scarce, considerable research has examined the association between primary care use and multimorbidity. The crude prevalence rate of multimorbidity (defined as the presence of ≥2 long-term conditions) was 31.6% in the present study in 2019 compared with 22.5% in 2005, rates that are broadly consistent with previous studies of similar populations in the UK. 16 , 23 Multimorbid patients consulted a GP 2.6 times more frequently 23 and each consultation lasted 0.2 min longer on average than for patients without multimorbidity. 26 Using a different definition of multimorbidity (≥2 chronic conditions of the 17 conditions included in the QOF), the first comprehensive study published on the prevalence of morbidity in England identified 16% of patients as being multimorbid in 2008 and these patients accounted for almost a third of all primary care consultations. Patients with multimorbidity had on average 9.4 consultations per annum compared with 3.8 for those without multimorbidity. 27
Primary care practices have had to adjust to consistent increases in the duration of nurse and GP contacts since 2005 in the face of higher numbers of patients with multimorbidity with complex care needs and a greater administrative load per patient. With fewer FTE GPs per head of population, many practices have been unable to keep pace with these changes, leading to a drop in consulting rates since 2015.
The implications of this for practice funding and access to care are important. Approximately half of practice revenue is from the global sum payment, with the amount allocated based on an estimate of a practice’s patient-level workload using demographic data that is over 20 years old. The statistical model used is commonly known as the Carr-Hill formula and it includes factors relating to patient age and gender, morbidity and mortality measures, the number of newly registered patients, staff expenses, practice rurality, and the number of patients living in nursing and residential homes. It is widely recognised that the Carr-Hill formula does not adequately reflect population healthcare needs, particularly need associated with socioeconomic deprivation. 28 , 29 Previous research reported that practices in areas of greater deprivation received 7% less funding per need-adjusted patient than those in more affluent areas. 30 An analysis of primary care funding in England for 2015–2016 found only a modest association between practice funding and morbidity burden at the regional level, with the North East and North West regions appearing to be particularly under-resourced. 28
Repeated calls on the government to replace the Carr-Hill formula with a more equitable formula that better reflects the greater workload associated with deprivation and morbidity have resulted in little progress. Acknowledging in 2015 that the current formula is ‘out of date and needs to be revised’, NHS England and the British Medical Association committed to review the Carr-Hill formula, anticipating that the work would be completed by the summer of 2016. 31 The timeline for reporting findings has since been extended several times but no details of any proposed changes to the formula have been reported to date.
Thank you to the DExtER team at the Institute of Applied Health Research, University of Birmingham, for their assistance in extracting the data from IMRD.
This article is based on independent research carried out as part of Lyvia de Dumast’s PhD thesis. Analysis of IQVIA Medical Research Data (IMRD) was approved by London — South East Research Ethics Committee pm 5 Jul 2018 (reference: 18/LO/0441), subject to independent scientific review of the analysis. Scientific Review Committee approval for this analysis of the IMRD-UK data was received in January 2021 (reference: 20SRC076).
The IMRD-UK dataset cannot be shared under the data-sharing agreement with the University of Birmingham on behalf of IQVIA.
Freely submitted; externally peer reviewed.
The authors have declared no competing interests.
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According to the Centre for Evidence Based Medicine (CEBM), "one of the fundamental skills required for practising EBM is the asking of well-built clinical questions. To benefit patients and clinicians, such questions need to be both directly relevant to patients' problems and phrased in ways that direct your search to relevant and precise answers."
A good PICOT question possesses the following qualities: A clinical-based question addresses the nursing research areas or topics. It is specific, concise, and clear. Patient, problem, or population. Intervention. Comparison. Outcome. Includes medical, clinical, and nursing terms where necessary. It is not ambiguous.
a who (who was studied - a population or sample) a what (what was done or examined - an intervention, an exposure, a policy, a program, a phenomenon) a how ([how] did the [what] affect the [who] - an outcome, an effect). PICO is the most common framework for developing a clinical research question, but multiple question frameworks exist.
Before developing a specific question, it is important to think about the type of question you have. Clinical questions can be narrowed down to four types: therapy, prognosis, diagnosis and economic/decision analysis. For example, if you are comparing two treatments such as amputation and reconstructive surgery, this is a therapy question.
This easy-to-follow tutorial from the Librarians at the Bodleian Library at Oxford University, in partnership with the Centre for Evidence Based Medicine (CEBM), walks you through an example of turning a clinical research question into PICO format and using that to create search terms. <<
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2. Foreground questions are specific knowledge questions . that affect clinical decisions and ; include a broad range of biological, psychological, and sociological issues. Foreground questions are best suited to the PICO model as it captures the essential elements of your information need to help translate that question into a search query. To obtain answers, generally it requires a search of ...
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Foreground question: Seek to answer specific knowledge regarding a clinical decision, usually concerning a specific patient, population, or intervention. According to Guyatt et al. there are 5 types of foreground questions: therapy, harm, differential diagnosis, diagnosis, and prognosis.
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The PICO(T) Chart provides an easy framework for integrating clinical information into the development of a research question. Students can complete the following worksheet, incorporating detailed information into each response. Decide what your research interest or topic is and then develop a research question to answer it.
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