Dahlgren Memorial Library

The Graduate Health & Life Sciences Research Library at Georgetown University Medical Center

Evidence-based medicine resource guide.

  • Defining EBM

Types of Clinical Questions

Formulating a well built clinical question, type of clinical question and study design.

  • Point-of-Care Tools
  • Databases for Clinical Research
  • Drug Information
  • Books & eBooks
  • EBM Journals
  • EBM Organizations & Centers
  • Health Sciences: The Research Process

Resources and Types of Clinical Question

Background questions are best answered by medical textbooks, point-of-care tools such as DynaMed Plus and Essential Evidence Plus, and narrative reviews.

Foreground questions are best answered by consulting medical databases such as MEDLINE (via PubMed or Ovid), Embase, Cochrane Database of Systematic Reviews and ACP Journal Club.

DML's Clinical Quick Reference page is a great place to locate EBM resources. Each resource has been labeled background and/or foreground, for you!

Clinical questions may be categorized as either background or foreground. Why is this important?

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 an illness, disease, condition, process or thing. These types of questions typically ask who, what, where, when, how & why about things like a disorder, test, or treatment, etc.

For example

  • How overweight is a woman to be considered slightly obese?
  • 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. Foreground questions tend to be more specific and complex compared to background questions. Quite often, foreground questions investigate comparisons, such as two drugs, two treatments, two diagnostic tests, etc. Foreground questions may be further categorized into one of 4 major types: treatment/therapy, diagnosis, prognosis, or etiology/harm.

  • Is Crixivan effective when compared with placebo in slowing the rate of functional impairment in a 45 year old male patient with Lou Gehrig's Disease?
  • In pediatric patients with Allergic Rhinitis, are Intranasal steroids more effective than antihistamines in the management of Allergic Rhinitis symptoms?

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 well-built clinical foreground question should have all four components. The PICO model is a helpful tool that assists you in organizing and focusing your foreground question into a searchable query. Dividing into the PICO elements helps identify search terms/concepts to use in your search of the literature.

P = Patient, Problem, Population (How would you describe a group of patients similar to you? What are the most important characteristics of the patient?)

I = Intervention, Prognostic Factor, Exposure (What main intervention are you considering? What do you want to do with this patient?)

C = Comparison (What are you hoping to compare with the intervention: another treatment, drug, placebo, a different diagnostic test, etc.? It's important to include this element and to be as specific as possible.)

O = Outcome (What are you trying to accomplish, measure, improve or affect? Outcomes may be disease-oriented or patient-oriented.)

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Two additional important elements of the well-built clinical question to consider are the type of foreground question and the type of study (methodology) . This information can be helpful in focusing the question and determining the most appropriate type of evidence.

Foreground questions can be further divided into questions that relate to therapy, diagnosis, prognosis, etiology/harm

  • Therapy: Questions of treatment in order to achieve some outcome. May include drugs, surgical intervention, change in diet, counseling, etc.
  • Diagnosis: Questions of identification of a disorder in a patient presenting with specific symptoms.
  • Prognosis: Questions of progression of a disease or likelihood of a disease occurring.
  • Etiology/Harm: Questions of negative impact from an intervention or other exposure.

EBM pyramid of evidence

Meta-analysis: A statistical technique that summarizes the results of several studies in a single weighted estimate, in which more weight is given to results of studies with more events and sometimes to studies of higher quality.

Systematic Review: a review in which specified and appropriate methods have been used to identify, appraise, and summarize studies addressing a defined question. (It can, but need not, involve meta-analysis). In Clinical Evidence, the term systematic review refers to a systematic review of RCTs unless specified otherwise.

Randomized Controlled Trial: a trial in which participants are randomly assigned to two or more groups: at least one (the experimental group) receiving an intervention that is being tested and another (the comparison or control group) receiving an alternative treatment or placebo. This design allows assessment of the relative effects of interventions.

Controlled Clinical Trial: a trial in which participants are assigned to two or more different treatment groups. In Clinical Evidence, we use the term to refer to controlled trials in which treatment is assigned by a method other than random allocation. When the method of allocation is by random selection, the study is referred to as a randomized controlled trial (RCT). Non-randomized controlled trials are more likely to suffer from bias than RCTs.

Cohort Study: a non-experimental study design that follows a group of people (a cohort), and then looks at how events differ among people within the group. A study that examines a cohort, which differs in respect to exposure to some suspected risk factor (e.g. smoking), is useful for trying to ascertain whether exposure is likely to cause specified events (e.g. lung cancer). Prospective cohort studies (which track participants forward in time) are more reliable than retrospective cohort studies.

Case control study: a study design that examines a group of people who have experienced an event (usually an adverse event) and a group of people who have not experienced the same event, and looks at how exposure to suspect (usually noxious) agents differed between the two groups. This type of study design is most useful for trying to ascertain the cause of rare events, such as rare cancers.

Case Series: analysis of series of people with the disease (there is no comparison group in case series).

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  • Last Updated: Sep 24, 2024 1:35 PM
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PICOT Question Examples for Nursing Research

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Are you looking for examples of nursing PICOT questions to inspire your creativity as you research for a perfect nursing topic for your paper? You came to the right place.

We have a comprehensive guide on how to write a good PICO Question for your case study, research paper, white paper, term paper, project, or capstone paper. Therefore, we will not go into the details in this post. 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.
  • Includes medical, clinical, and nursing terms where necessary.
  • It is not ambiguous.

For more information, read our comprehensive PICOT Question guide . You can use these questions to inspire your PICOT choice for your evidence-based papers , reports, or nursing research papers.

If you are stuck with assignments and want some help, we offer the best nursing research assignment help online. We have expert nursing writers who can formulate an excellent clinical, research, and PICOT question for you. They can also write dissertations, white papers, theses, reports, and capstones. Do not hesitate to place an order.

List of 180 Plus Best PICOT Questions to Get Inspiration From

Here is a list of nursing PICO questions to inspire you when developing yours. Some PICOT questions might be suitable for BSN and MSN but not DNP. If you are writing a change project for your DNP, try to focus on PICOT questions that align to process changes. 

  • Among healthy newborn infants in low- and middle-income countries (P), does early skin-to-skin contact of the baby with the mother in the first hour of life (I) compared with drying and wrapping (C) have an impact on neonatal mortality, hypothermia or initiation/exclusivity/ duration of breastfeeding (O)?
  • Is it necessary to test blood glucose levels 4 times daily for a patient suffering from Type 1 diabetes?
  • Does raising the head of the bed of a mechanically ventilated patient reduce the chances of pneumonia?
  • Does music therapy is an effective mode of PACU pain management for patients who are slowly coming out from their anesthesia?
  • For all neonates (P), should vitamin K prophylaxis (I) be given for the prevention of vitamin K deficiency bleeding (O)?
  • For young infants (0-2 months) with suspected sepsis managed in health facilities (P), should third generation cephalosporin monotherapy (I) replace currently recommended ampicillin-gentamicin combination (C) as first line empiric treatment for preventing death and sequelae (O)?
  • In low-birth-weight/pre-term neonates in health facilities (P), is skin-to-skin contact immediately after birth (I) more effective than conventional care (C) in preventing hypothermia (O)?
  • In children aged 259 months (P), what is the most effective antibiotic therapy (I, C) for severe pneumonia (O)?
  • Is skin-to-skin contact of the infant with the mother a more assured way of ensuring neonatal mortality compared to drying and wrapping?
  • Are oral contraceptives effective in stopping pregnancy for women above 30 years?
  • Is spironolactone a better drug for reducing the blood pressure of teenagers when compared to clonidine?
  • What is the usefulness of an LP/spinal tap after the beginning of antivirals for a pediatric population suffering from fever?
  • In children aged 259 months in developing countries (P), which parenteral antibiotic or combination of antibiotics (I), at what dose and duration, is effective for the treatment of suspected bacterial meningitis in hospital in reducing mortality and sequelae (O)?
  • Does the habit of washing hands third-generation workers decrease the events of infections in hospitals?
  • Is the intake of zinc pills more effective than Vitamin C for preventing cold during winter for middle-aged women?
  • In children with acute severe malnutrition (P), are antibiotics (I) effective in preventing death and sequelae (O)?
  • Among, children with lower respiratory tract infection (P), what are the best cut off oxygen saturation levels (D), at different altitudes that will determine hypoxaemia requiring oxygen therapy (O)?
  • In infants and children in low-resource settings (P), what is the most appropriate method (D) of detecting hypoxaemia in hospitals (O)?
  • In children with shock (P), what is the most appropriate choice of intravenous fluid therapy (I) to prevent death and sequelae (O)?
  • In fully conscious children with hypoglycaemia (P) what is the effectiveness of administering sublingual sugar (I)?
  • Is using toys as distractions during giving needle vaccinations to toddlers an effective pain response management?
  • What is the result of a higher amount of potassium intake among children with low blood pressure?
  • Is cup feeding an infant better than feeding through tubes in a NICU setup?
  • Does the intervention of flushing the heroin via lines a more effective way of treating patients with CVLs/PICCs?
  • Is the use of intravenous fluid intervention a better remedy for infants under fatal conditions?
  • Do bedside shift reports help in the overall patient care for nurses?
  • Is home visitation a better way of dealing with teen pregnancy when compared to regular school visits in rural areas?
  • Is fentanyl more effective than morphine in dealing with the pain of adults over the age of 50 years?
  • What are the health outcomes of having a high amount of potassium for adults over the age of 21 years?
  • Does the use of continuous feed during emesis a more effective way of intervention when compared to the process of stopping the feed for a short period?
  • Does controlling the amount of sublingual sugar help completely conscious children suffering from hypoglycemia?
  • Is the lithotomy position an ideal position for giving birth to women in labor?
  • Does group therapy help patients with schizophrenia to help their conversational skills?
  • What are the probable after-effects, in the form of bruises and other injuries, of heparin injection therapy for COPD patients?
  • Would standardized discharge medication education improve home medication adherence in adults age 65 and older compared to-standardized discharge medication education?
  • In patients with psychiatric disorders is medication non-compliance a greater risk compared with adults experiencing chronic illness?
  • Is the use of beta-blockers for lowering blood pressure for adult men over the age of 70 years effective?
  • Nasal swab or nasal aspirate? Which one is more effective for children suffering from seasonal flu?
  • What are the effects of adding beta-blockers for lowering blood pressure for adult men over the age of 70 years?
  • Does the process of stopping lipids for 4 hours an effective measure of obtaining the desired TG level for patients who are about to receive TPN?
  • Is medical intervention a proper way of dealing with childhood obesity among school-going children?
  • Can nurse-led presentations of mental health associated with bullying help in combating such tendencies in public schools?
  • What are the impacts of managing Prevacid before a pH probe study for pediatric patients with GERD?
  • What are the measurable effects of extending ICU stays and antibiotic consumption amongst children with sepsis?
  • Does the use of infrared skin thermometers justified when compared to the tympanic thermometers for a pediatric population?
  • What are the roles of a pre-surgery cardiac nurse in order to prevent depression among patients awaiting cardiac operation?
  • Does the increase in the habit of smoking marijuana among Dutch students increase the chances of depression?
  • What is the direct connection between VAP and NGT?
  • Is psychological intervention for people suffering from dementia a more effective measure than giving them a placebo?
  • Are alarm sensors effective in preventing accidents in hospitals for patients over the age of 65 years?
  • Is the sudden change of temperature harmful for patients who are neurologically devastated?
  • Is it necessary to test blood glucose levels, 4 times a day, for a patient suffering from Type 1 diabetes?
  • Is the use of MDI derive better results, when compared to regular nebulizers, for pediatric patients suffering from asthma?
  • What are the effects of IVF bolus in controlling the amount of Magnesium Sulfate for patients who are suffering from asthma?
  • Is the process of stopping lipids for 4 hours an effective measure of obtaining the desired TG level for patients who are about to receive TPN?
  • What are the standards of vital signs for a pediatric population?
  • Is daily blood pressure monitoring help in addressing the triggers of hypertension among males over 65 years?
  • Does receiving phone tweets lower blood sugar levels for people suffering from Type 1 diabetes?
  • Are males over the age of 30 years who have smoked for more than 1 year exposed to a greater risk of esophageal cancer when compared to the same age group of men who have no history of smoking?
  • Does the increase in the use of mosquito nets in Uganda help in the reduction of malaria among the infants?
  • Does the increase in the intake of oral contraceptives increase the chances of breast cancer among 20-30 years old women in the UK?
  • In postpartum women with postnatal depression (P), does group therapy (I) compared to individual therapy (C) improve maternal-infant bonding (O) after eight weeks (T)?
  • In patients with chronic pain (P), does mindfulness-based cognitive therapy (I) compared to pharmacotherapy (C) improve quality of life (O) after 12 weeks (T)?
  • In patients with type 2 diabetes (P), does continuous glucose monitoring (I) compared to self-monitoring of blood glucose (C) improve glycemic control (O) over a period of three months (T)?
  • In patients with chronic kidney disease (P), does a vegetarian diet (I) compared to a regular diet (C) slow the decline in renal function (O) after one year (T)?
  • In pediatric patients with acute otitis media (P), does delayed antibiotic prescribing (I) compared to immediate antibiotic prescribing (C) reduce antibiotic use (O) within one week (T)?
  • In older adults with dementia (P), does pet therapy (I) compared to no pet therapy (C) decrease agitation (O) after three months (T)?
  • In patients with chronic heart failure (P), does telemonitoring of vital signs (I) compared to standard care (C) reduce hospital readmissions (O) within six months (T)?
  • In patients with anxiety disorders (P), does exposure therapy (I) compared to cognitive therapy (C) reduce anxiety symptoms (O) after 12 weeks (T)?
  • In postpartum women with breastfeeding difficulties (P), does lactation consultation (I) compared to standard care (C) increase breastfeeding rates (O) after four weeks (T)?
  • In patients with chronic obstructive pulmonary disease (P), does long-acting bronchodilator therapy (I) compared to short-acting bronchodilator therapy (C) improve lung function (O) after three months (T)?
  • In patients with major depressive disorder (P), does bright light therapy (I) compared to placebo (C) reduce depressive symptoms (O) after six weeks (T)?
  • In patients with diabetes (P), does telemedicine-based diabetes management (I) compared to standard care (C) improve glycemic control (O) over a period of six months (T)?
  • In patients with chronic kidney disease (P), does a low-phosphorus diet (I) compared to a regular diet (C) decrease serum phosphate levels (O) after one year (T)?
  • In pediatric patients with acute gastroenteritis (P), does probiotic supplementation (I) compared to placebo (C) reduce the duration of diarrhea (O) within 48 hours (T)?
  • In patients with chronic pain (P), does acupuncture (I) compared to sham acupuncture (C) reduce pain intensity (O) after eight weeks (T)?
  • In older adults at risk of falls (P), does a home modification program (I) compared to no intervention (C) reduce the incidence of falls (O) over a period of six months (T)?
  • In patients with schizophrenia (P), does cognitive remediation therapy (I) compared to standard therapy (C) improve cognitive function (O) after one year (T)?
  • In patients with chronic kidney disease (P), does angiotensin-converting enzyme inhibitors (I) compared to angiotensin receptor blockers (C) slow the progression of renal disease (O) over a period of two years (T)?
  • In postoperative patients (P), does chlorhexidine bathing (I) compared to regular bathing (C) reduce the risk of surgical site infections (O) within 30 days (T)?
  • In patients with type 2 diabetes (P), does a low-carbohydrate, high-fat diet (I) compared to a low-fat diet (C) improve glycemic control (O) over a period of six months (T)?
  • In patients with chronic obstructive pulmonary disease (P), does pulmonary rehabilitation combined with telemonitoring (I) compared to standard pulmonary rehabilitation (C) improve exercise capacity (O) after three months (T)?
  • In patients with heart failure (P), does a nurse-led heart failure clinic (I) compared to usual care (C) improve self-care behaviors (O) after six months (T)?
  • In postpartum women with postnatal depression (P), does telephone-based counseling (I) compared to face-to-face counseling (C) reduce depressive symptoms (O) after eight weeks (T)?
  • In patients with chronic migraine (P), does prophylactic treatment with topiramate (I) compared to amitriptyline (C) reduce the frequency of migraines (O) after three months (T)?
  • In pediatric patients with acute otitis media (P), does watchful waiting (I) compared to immediate antibiotic treatment (C) reduce the duration of symptoms (O) within seven days (T)?
  • In older adults with dementia (P), does reminiscence therapy (I) compared to usual care (C) improve cognitive function (O) after three months (T)?
  • In patients with chronic heart failure (P), does telemonitoring combined with a medication reminder system (I) compared to telemonitoring alone (C) reduce hospital readmissions (O) within six months (T)?
  • In patients with asthma (P), does self-management education (I) compared to standard care (C) reduce asthma exacerbations (O) over a period of one year (T)?
  • In postoperative patients (P), does the use of wound dressings with antimicrobial properties (I) compared to standard dressings (C) reduce the incidence of surgical site infections (O) within 30 days (T)?
  • In patients with chronic kidney disease (P), does mindfulness-based stress reduction (I) compared to usual care (C) improve psychological well-being (O) over a period of three months (T)?
  • In adult patients with chronic pain (P), does biofeedback therapy (I) compared to relaxation techniques (C) reduce pain intensity (O) after eight weeks (T)?
  • In patients with type 2 diabetes (P), does a low-glycemic index diet (I) compared to a high-glycemic-index diet (C) improve glycemic control (O) over a period of six months (T)?
  • In patients with chronic obstructive pulmonary disease (P), does regular physical activity (I) compared to no physical activity (C) improve health-related quality of life (O) after three months (T)?
  • In patients with major depressive disorder (P), does mindfulness-based cognitive therapy (I) compared to antidepressant medication (C) reduce depressive symptoms (O) after eight weeks (T)?
  • In postpartum women (P), does perineal warm compresses (I) compared to standard perineal care (C) reduce perineal pain (O) after vaginal delivery (T)?
  • In patients with chronic kidney disease (P), does a low-protein, low-phosphorus diet (I) compared to a low-protein diet alone (C) slow the progression of renal disease(O) after two years (T)?
  • In pediatric patients with attention-deficit/hyperactivity disorder (P), does mindfulness-based interventions (I) compared to medication alone (C) improve attention and behavior (O) after six months (T)?
  • In patients with chronic pain (P), does cognitive-behavioral therapy (I) compared to physical therapy (C) reduce pain interference (O) after 12 weeks (T)?
  • In elderly patients with osteoarthritis (P), does aquatic exercise (I) compared to land-based exercise (C) improve joint flexibility and reduce pain (O) after eight weeks (T)?
  • In patients with multiple sclerosis (P), does high-intensity interval training (I) compared to moderate-intensity continuous training (C) improve physical function (O) after three months (T)?
  • In postoperative patients (P), does preoperative carbohydrate loading (I) compared to fasting (C) reduce postoperative insulin resistance (O) within 24 hours (T)?
  • In patients with chronic obstructive pulmonary disease (P), does home-based tele-rehabilitation (I) compared to center-based rehabilitation (C) improve exercise capacity (O) after six months (T)?
  • In patients with rheumatoid arthritis (P), does tai chi (I) compared to pharmacological treatment (C) reduce joint pain and improve physical function (O) after six months (T)?
  • In postpartum women with postpartum hemorrhage (P), does early administration of tranexamic acid (I) compared to standard administration (C) reduce blood loss (O) within two hours (T)?
  • In patients with hypertension (P), does mindfulness meditation (I) compared to relaxation techniques (C) reduce blood pressure (O) after eight weeks (T)?
  • In elderly patients with hip fractures (P), does multidisciplinary geriatric care (I) compared to standard care (C) improve functional outcomes (O) after three months (T)?
  • In patients with chronic kidney disease (P), does aerobic exercise (I) compared to resistance exercise (C) improve renal function (O) after six months (T)?
  • In patients with major depressive disorder (P), does add-on treatment with omega-3 fatty acids (I) compared to placebo (C) reduce depressive symptoms (O) after 12 weeks (T)?
  • In postoperative patients (P), does preoperative education using multimedia materials (I) compared to standard education (C) improve patient satisfaction (O) after surgery (T)?
  • In patients with type 2 diabetes (P), does a plant-based diet (I) compared to a standard diet (C) improve glycemic control (O) after three months (T)?
  • In patients with chronic obstructive pulmonary disease (P), does high-flow oxygen therapy (I) compared to standard oxygen therapy (C) improve exercise tolerance (O) after three months (T)?
  • In patients with heart failure (P), does nurse-led telephone follow-up (I) compared to standard care (C) reduce hospital readmissions (O) within six months (T)?
  • In postpartum women with postnatal depression (P), does online cognitive-behavioral therapy (I) compared to face-to-face therapy (C) reduce depressive symptoms (O) after eight weeks (T)?
  • In patients with chronic migraine (P), does mindfulness-based stress reduction (I) compared to medication alone (C) reduce the frequency and severity of migraines (O) after three months (T)?
  • In older adults with delirium (P), does structured music intervention (I) compared to standard care (C) reduce the duration of delirium episodes (O) during hospitalization (T)?
  • In patients with chronic low back pain (P), does yoga (I) compared to physical therapy (C) reduce pain intensity (O) after six weeks (T)?
  • In pediatric patients with acute otitis media (P), does watchful waiting with pain management (I) compared to immediate antibiotic treatment (C) reduce the need for antibiotics (O) within one week (T)?
  • In patients with schizophrenia (P), does family psychoeducation (I) compared to standard treatment (C) improve medication adherence (O) over a period of six months (T)?
  • In patients with chronic kidney disease (P), does a low-phosphorus diet (I) compared to a regular diet (C) slow the progression of renal disease (O) after one year (T)?
  • In postoperative patients (P), does wound irrigation with saline solution (I) compared to povidone-iodine solution (C) reduce the incidence of surgical site infections (O) within 30 days (T)?
  • In patients with type 1 diabetes (P), does continuous subcutaneous insulin infusion (I) compared to multiple daily injections (C) improve glycemic control (O) over a period of six months (T)?
  • In postoperative patients (P), does the use of prophylactic antibiotics (I) compared to no antibiotics (C) reduce the incidence of surgical site infections (O) within 30 days (T)?
  • In patients with chronic obstructive pulmonary disease (P), does smoking cessation counseling (I) compared to no counseling (C) decrease the frequency of exacerbations (O) over a period of six months (T)?
  • In patients with diabetes (P), does a multidisciplinary team approach (I) compared to standard care (C) improve self-management behaviors (O) over a period of one year (T)?
  • In pregnant women with gestational hypertension (P), does bed rest (I) compared to regular activity (C) reduce the risk of developing preeclampsia (O) before delivery (T)?
  • In patients with chronic kidney disease (P), does angiotensin-converting enzyme inhibitors (I) compared to placebo (C) slow the progression of renal disease (O) over a period of two years (T)?
  • In older adults with hip fractures (P), does early surgical intervention (I) compared to delayed surgery (C) improve functional outcomes (O) after six months (T)?
  • In patients with major depressive disorder (P), does exercise (I) compared to antidepressant medication (C) reduce depressive symptoms (O) after eight weeks (T)?
  • In children with autism spectrum disorder (P), does applied behavior analysis (I) compared to standard therapy (C) improve social communication skills (O) over a period of one year (T)?
  • In postoperative patients (P), does the use of incentive spirometry (I) compared to no spirometry (C) decrease the incidence of postoperative pulmonary complications (O) within seven days (T)?
  • In patients with hypertension (P), does a combination of diet modification and exercise (I) compared to medication alone (C) lower blood pressure (O) after six months (T)?
  • In patients with chronic obstructive pulmonary disease (P), does home oxygen therapy (I) compared to no oxygen therapy (C) improve exercise capacity (O) after threemonths (T)?
  • In patients with heart failure (P), does a multidisciplinary heart failure management program (I) compared to standard care (C) reduce hospital readmissions (O) within six months (T)?
  • In postpartum women with postnatal depression (P), does mindfulness meditation (I) compared to relaxation techniques (C) reduce depressive symptoms (O) after eight weeks (T)?
  • In patients with chronic kidney disease (P), does a low-sodium diet (I) compared to a regular diet (C) lower blood pressure (O) after six months (T)?
  • In pediatric patients with attention-deficit/hyperactivity disorder (P), does neurofeedback training (I) compared to medication (C) improve attention and behavior (O) after six months (T)?
  • In patients with chronic pain (P), does transcranial direct current stimulation (I) compared to sham stimulation (C) reduce pain intensity (O) after eight weeks (T)?
  • In older adults with osteoporosis (P), does a structured exercise program (I) compared to no exercise (C) improve bone mineral density (O) after six months (T)?
  • In patients with type 2 diabetes (P), does a low-carbohydrate, high-protein diet (I) compared to a standard diet (C) improve glycemic control (O) over a period of six months (T)?
  • In patients with chronic obstructive pulmonary disease (P), does mindfulness-based stress reduction (I) compared to usual care (C) improve dyspnea symptoms (O) after three months (T)?
  • In postpartum women with postnatal depression (P), does online peer support (I) compared to individual therapy (C) reduce depressive symptoms (O) after eight weeks (T)?
  • In patients with chronic kidney disease (P), does resistance training (I) compared to aerobic training (C) improve muscle strength (O) after six months (T)?
  • In pediatric patients with asthma (P), does a written asthma action plan (I) compared to verbal instructions (C) reduce emergency department visits (O) within six months (T)?
  • In patients with chronic pain (P), does yoga (I) compared to pharmacological treatment (C) reduce pain interference (O) after eight weeks (T)?
  • In older adults at risk of falls (P), does a multifactorial falls prevention program (I) compared to no intervention (C) reduce the rate of falls (O) over a period of six months (T)?
  • In patients with schizophrenia (P), does cognitive-behavioral therapy (I) compared to medication alone (C) reduce positive symptom severity (O) after six months (T)?
  • In postpartum women with breastfeeding difficulties (P), does breast massage (I) compared to no massage (C) improve milk flow (O) after four weeks (T)?
  • In patients with chronic obstructive pulmonary disease (P), does long-term oxygen therapy (I) compared to short-term oxygen therapy (C) improve survival rates (O) after one year (T)?
  • In patients with major depressive disorder (P), does repetitive transcranial magnetic stimulation (I) compared to sham treatment (C) reduce depressive symptoms (O) after six weeks (T)?
  • In patients with diabetes (P), does a digital health app (I) compared to standard care (C) improve medication adherence (O) over a period of six months (T)?
  • In patients with chronic kidney disease (P), does a low-potassium diet (I) compared to a regular diet (C) lower serum potassium levels (O) after one year (T)?
  • In pediatric patients with acute gastroenteritis (P), does oral rehydration solution (I) compared to intravenous fluid therapy (C) reduce hospital admissions (O) within 48 hours (T)?
  • In patients with chronic pain (P), does hypnotherapy (I) compared to no hypnotherapy (C) reduce pain intensity (O) after eight weeks (T)?
  • In older adults at risk of falls (P), does a tai chi program (I) compared to no exercise program (C) improve balance and stability (O) after six months (T)?
  • In patients with chronic heart failure (P), does a home-based self-care intervention (I) compared to standard care (C) reduce hospital readmissions (O) within six months (T)?
  • In patients with anxiety disorders (P), does acceptance and commitment therapy (I) compared to cognitive-behavioral therapy (C) reduce anxiety symptoms (O) after 12 weeks (T)?
  • In postpartum women with breastfeeding difficulties (P), does the use of nipple shields (I) compared to no nipple shields (C) improve breastfeeding success (O) after four weeks (T)?
  • In patients with chronic obstructive pulmonary disease (P), does a comprehensive self-management program (I) compared to usual care (C) improve health-related quality of life (O) after three months (T)?
  • In patients with major depressive disorder (P), does internet-based cognitive-behavioral therapy (I) compared to face-to-face therapy (C) reduce depressive symptoms (O) after eight weeks (T)?
  • Does the increase in the habit of smoking marijuana among Dutch students increase the likelihood of depression?
  • Does the use of pain relief medication during surgery provide more effective pain reduction compared to the same medication given post-surgery?
  • Does the increase in the intake of oral contraceptives increase the risk of breast cancer among women aged 20-30 in the UK?
  • Does the habit of washing hands among healthcare workers decrease the rate of infections in hospitals?
  • Does the use of modern syringes help in reducing needle injuries among healthcare workers in America?
  • Does encouraging male work colleagues to talk about sexual harassment decrease the rate of depression in the workplace?
  • Does bullying in boarding schools in Scotland increase the likelihood of domestic violence within a 20-year timeframe?
  • Does breastfeeding among toddlers in urban United States decrease their chances of obesity as pre-schoolers?
  • Does the increase in the intake of antidepressants among urban women aged 30 years and older affect their maternal health?
  • Does forming work groups to discuss domestic violence among the rural population of the United States reduce stress and depression among women?
  • Does the increased use of mosquito nets in Uganda help in reducing malaria cases among infants?
  • Can colon cancer be more effectively detected when colonoscopy is supported by an occult blood test compared to colonoscopy alone?
  • Does regular usage of low-dose aspirin effectively reduce the risk of heart attacks and stroke for women above the age of 80 years?
  • Is yoga an effective medical therapy for reducing lymphedema in patients recovering from neck cancer?
  • Does daily blood pressure monitoring help in addressing the triggers of hypertension among males over 65 years?
  • Does a regular 30-minute exercise regimen effectively reduce the risk of heart disease in adults over 65 years?
  • Does prolonged exposure to chemotherapy increase the risk of cardiovascular diseases among teenagers suffering from cancer?
  • Does breastfeeding among toddlers in the urban United States decrease their chances of obesity as pre-schoolers?
  • Are first-time mothers giving birth to premature babies more prone to postpartum depression compared to second or third-time mothers in the same condition?
  • For women under the age of 50 years, is a yearly mammogram more effective in preventing breast cancer compared to a mammogram done every 3 years?
  • After being diagnosed with blood sugar levels, is a four-times-a-day blood glucose monitoring process more effective in controlling the onset of Type 1 diabetes?

Related: How to write an abstract poster presentation.

You can never go wrong with getting expertly written examples as a source for your inspiration. They factor in all the qualities of a good PICO question, which sets you miles ahead in your research process.

If you need a personalized approach to choosing a good PICOT question and writing a problem and purpose statement, our nursing paper acers can help you.

Nursing research specialists work with nursing students, professional nurses, and medical students to advance their academic and career goals. We offer private, reliable, confidential, and top-quality services.

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Capstone and PICO Project Toolkit

  • Starting a Project: Overview
  • Developing a Research Question
  • Selecting Databases
  • Expanding a Search
  • Refining/Narrowing a Search
  • Saving Searches
  • Critical Appraisal & Levels of Evidence
  • Citing & Managing References
  • Database Tutorials
  • Types of Literature Reviews
  • Finding Full Text
  • Term Glossary

Defining the Question: Foreground & Background Questions

In order to most appropriately choose an information resource and craft a search strategy, it is necessary to consider what  kind  of question you are asking: a specific, narrow "foreground" question, or a broader background question that will help give context to your research?

Foreground Questions

A "foreground" question in health research is one that is relatively specific, and is usually best addressed by locating primary research evidence. 

Using a structured question framework can help you clearly define the concepts or variables that make up the specific research question. 

 Across most frameworks, you’ll often be considering:

  • 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.

PICO (Problem/Population, Intervention, Comparison, Outcome)

Appropriate for : clinical questions, often addressing the effect of an intervention/therapy/treatment

Example : For adolescents with type II diabetes (P) does the use of telehealth consultations (I) compared to in-person consultations  (C) improve blood sugar control  (O)?

Description and example of PICO question framework.
Element Description Example
opulation / problem Who is the group of people being studied?  adolescents with T2D

ntervention

What is the intervention being investigated? (independent variable) telehealth consultations
omparison To what is the intervention being compared? in person consultations
utcome What are the desired outcomes of the intervention? (dependent variable) blood sugar control

Framing Different Types of Clinical Questions with PICO

Different types of clinical questions are suited to different syntaxes and phrasings, but all will clearly define the PICO elements.  The definitions and frames below may be helpful for organizing your question:

Intervention/Therapy

Questions addressing how a clinical issue, illness, or disability is treated.

"In__________________(P), how does__________________(I) compared to_________________(C) affect______________(O)?"

Questions that address the causes or origin of disease, the factors which produce or predispose toward a certain disease or disorder.

"Are_________________(P), who have_________________(I) compared with those without_________________(C) at_________________risk for/of_________________(O) over_________________(T)?" 

Questions addressing the act or process of identifying or determining the nature and cause of a disease or injury through evaluation.

In_________________(P) are/is_________________(I) compared with_________________(C) more accurate in diagnosing_________________(O)?

Prognosis/Prediction:

Questions addressing the prediction of the course of a disease.

In_________________(P), how does_________________(I) compared to_________________ (C) influence_________________(O)?

Questions addressing how one experiences a phenomenon or why we need to approach practice differently.

"How do_________________(P) with_________________(I) perceive_________________(O)?" 

Adapted from: Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-based practice in nursing & healthcare: A guide to best practice. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins.

Beyond PICO: Other Types of Question Frameworks

PICO is a useful framework for clinical research questions, but may not be appropriate for all kinds of reviews.  Also consider:

PEO (Population, Exposure, Outcome)

Appropriate for : describing association between particular exposures/risk factors and outcomes

Example : How do  preparation programs (E) influence the development of teaching competence  (O) among novice nurse educators  (P)?

Description and example of PEO question framework.
Element Description Example
opulation  Who is the group of people being studied?  novice nurse educators

xposure

What is the population being exposed to (independent variable)? preparation programs
utcome What is the outcome that may be affected by the exposure (dependent variable)? teaching competence

SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type)

Appropriate for : questions of experience or perspectives (questions that may be addressed by qualitative or mixed methods research)

Example : What are the experiences and perspectives (E) of  undergraduate nursing students  (S)  in clinical placements within prison healthcare settings (PI)?

Description and example of SPIDER question framework.
Element Description Example
ample  Who is the group of people being studied? undergraduate nursing students

henomenon of

nterest

What are the reasons for behavior and decisions? clinical placements in prison healthcare settings
esign How has the research been collected (e.g., interview, survey)? interview and surveys
valuation What is the outcome being impacted? attitudes, experiences and reflections on learning
esearch type What type of research? qualitative, quantitative or mixed methods

SPICE (Setting, Perspective, Intervention/phenomenon of Interest, Comparison, Evaluation)

Appropriate for : evaluating the outcomes of a service, project, or intervention

Example : What are the impacts and best practices for workplace (S) transition support programs (I) for the retention (E) of newly-hired, new graduate nurses (P)?

Description and example of SPICE question framework.
Element Description Example
etting What is the context for the question? (Where?) nursing workplaces (healthcare settings)

erspective

For whom is this intervention/program/service designed (users, potential users, stakeholders)? new graduate nurses
ntervention/Interest/Exposure What action is taken for the users, potential users, or stakeholders? long term transition support programs (residency/mentorship)
omparison What are the alternative interventions? no or limited transition support / orientation
valuation What is the results of the intervention or service/how is success measured? retention of newly hired nurses

PCC (Problem/population, Concept, Context)

Appropriate for : broader (scoping) questions

Example : How do nursing schools  (Context) teach, measure, and maintain nursing students ' (P)  technological literacy  (Concept))throughout their educational programs?

Description and example of SPIDER question framework.
Element Description Example
What are the important characteristics of the participants, or the problem of focus? nursing students

oncept

What is the core concept being examined by the review? technological literacy
ontext What is the context for the question? (Could include geographic location, or details about the setting of interest)? nursing schools

Background Questions

To craft a strong and reasonable foreground research question, it is important to have a firm understanding of the concepts of interest.  As such, it is often necessary to ask background questions, which ask for more general, foundational knowledge about a disorder, disease, patient population, policy issue, etc. 

For example, consider the PICO question outlined above:

"For adolescents with type II diabetes does the use of telehealth consultations compared to in-person consultations  improve blood sugar control ?

To best make sense of the literature that might address this PICO question, you would also need a deep understanding of background questions like:

  • What are the unique barriers or challenges related to blood sugar management in adolescents with TII diabetes?
  • What are the measures of effective blood sugar control?
  • What kinds of interventions would fall under the umbrella of 'telehealth'?
  • What are the qualitative differences in patient experience in telehealth versus in-person interactions with healthcare providers?
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example of clinical research questions

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Evidence-Based Practice: Asking a Clinical Question (PICO)

  • Asking a Clinical Question (PICO)
  • Levels of Evidence
  • Finding the Evidence
  • Practice Guidelines
  • Appraising the Evidence
  • Integrating the Evidence
  • Selected EBP Publications

What is PICO(T)

PICO(T) is a mnemonic that stands for:

PATIENT/PROBLEM/POPULATION

INTERVENTION

PICO Resources

  • Asking Focused Questions Tips and strategies for asking focused clinical questions more... less... OCEBM
  • Asking searchable, answerable clinical questions Fineout‐Overholt, Ellen, and Linda Johnston. "Teaching EBP: Asking searchable, answerable clinical questions." Worldviews on Evidence‐Based Nursing 2, no. 3 (2005): 157-160.
  • Evidence-based practice, step by step: asking the clinical question: a key step in evidence-based practice. Stillwell, S. B., Fineout-Overholt, E., Melnyk, B. M., & Williamson, K. M. (2010). Evidence-based practice, step by step: asking the clinical question: a key step in evidence-based practice. AJN The American Journal of Nursing, 110(3), 58-61.
  • The Well Built Clinical Question Clinical scenarios that walk you through how to turn them into clinical questions. more... less... WS Richardson, MC Wilson, J Nishikawa, RS Hayward. ACP Journal Club. Nov-Dec 1995;123;A12.
  • Formulating Answerable Questions Practice answering clinical questions with guided scenarios and step by step instructions.

PICO for MSK Nursing Projects

Are you working on a evidence based project or N-CARE project? Use the PICO(T) format to frame your question.

  • Population/ Patient Problem: Who is your patient? (Disease or Health status, age, race, sex) / What is the problem?
  • Intervention: What do you plan to do for the patient? (Specific tests, therapies, medications)
  • Comparison: What is the alternative to your plan? (ie. No treatment, different type of treatment, etc.)
  • Outcome: What outcome do you seek? (Less symptoms, no symptoms, full health, etc.)
  • Time:  What is the time frame? (This element is not always included.)

Your PICO(T) question will fall under one of these types:

  • Therapy/Prevention

Need Help?  Get assistance from the library -  Literature/PICO Search form !

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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Evidence Based Nursing Practice

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PICO Templates

For an intervention/therapy:

In _______(P), what is the effect of _______(I) on ______(O) compared with _______(C) within ________ (T)?

For etiology:

Are ____ (P) who have _______ (I) at ___ (increased/decreased) risk for/of_______ (O) compared with ______ (P) with/without ______ (C) over _____ (T)?

Diagnosis or diagnostic test:

Are (is) _________ (I) more accurate in diagnosing ________ (P) compared with ______ (C) for _______ (O)?

Prevention:

For ________ (P) does the use of ______ (I) reduce the future risk of ________ (O) compared with _________ (C)?

Prognosis/Predictions

Does __________ (I) influence ________ (O) in patients who have _______ (P) over ______ (T)?

How do ________ (P) diagnosed with _______ (I) perceive ______ (O) during _____ (T)?

Based on Melnyk B., & Fineout-Overholt E. (2010). Evidence-based practice in nursing & healthcare. New York: Lippincott Williams & Wilkins .

Using PICO to Formulate Clinical Questions

PICO  (alternately known as PICOT ) is a mnemonic used to describe the four elements of a good clinical question. It stands for:

P --Patient/Problem I --Intervention C --Comparison O --Outcome

Many people find that it helps them clarify their question, which in turn makes it easier to find an answer. 

Use PICO to generate terms - these you'll use in your literature search for the current best evidence.   Once you have your PICO terms, you can then use them to re-write your question.  (Note, you can do this in reverse order if that works for you.)

Often we start with a vague question such as, "How effective is CPR, really?"  But, what do we mean by CPR?  And how do we define effective?  PICO is a technique to help us - or force us - to answer these questions.   Note that you may not end up with a description for each element of PICO. 

P -  our question above doesn't address a specific problem other than the assumption of a person who is not breathing. So, ask yourself questions such as, am I interested in a specific age cohort? (Adults, children, aged); a specific population (hospitalized, community dwelling); health cohort (healthy, diabetic, etc.)   

I - our question above doesn't have a stated intervention, but we might have one in mind such as 'hands-only'

C - Is there another method of CPR that we want to compare the hands-only to?  Many research studies do not go head to head with a comparison.  In this example we might want to compare to the standard, hands plus breathing

O - Again, we need to ask, what do we mean by 'effective'?  Mortality is one option with the benefit that it's easily measured. 

Our PICO statement would look like:

From our PICO, we can write up a clearer and more specific question, such as:

 In community dwelling adults, how effective is hands-only CPR versus hands plus breathing CPR at preventing mortality?

More information on formulating PICO questions

Now that we've clarified what we want to know, it will be much easier to find an answer.

Breaking Down Your PICO into a Search Strategy

We can use our PICO statement to list terms to search on.  Under each letter, we'll list all the possible terms we might use in our search. 

P - Community Dwelling:  It is much easier to search on 'hospitalized' than non-hospitalized subjects.  So I would leave these terms for last. It might turn out that I don't need to use them as my other terms from the I, C, or O of PICO might be enough.

community dwelling  OR out-of-hospital

P - adults: I would use the limits in MEDLINE or CINAHL for All Adults.  Could also consider the following depending upon the population you need:

adult OR adults OR aged OR elderly OR young adult

CPR  -  cardiopulmonary resuscitation

I - Hands-only

 hands-only OR compression-only OR chest compression OR compression OR Heart Massage

C - Hands plus breathing Breathing is a tougher term to match.

breathing OR mouth to mouth OR conventional OR traditional

O - Mortality:  If your outcomes terms are general, they may not as useful in the literature search.  They will still be useful in your evaluation of the studies.

mortality OR death OR Survival

Putting it together - a search statement from the above might look like this:

cardiopulmonary resuscitation AND (hands-only OR compression-only OR chest compression OR compression OR Heart Massage) AND (breathing OR mouth to mouth OR conventional OR traditional)

Note that the above strategy is only using terms from the I and the C of PICO.  Depending upon the results, you may need to narrow your search by adding in terms from the P or the O.  

An easy way to keep track of your search strategy is to use a table. This keeps the different parts of your PICO question and their various keywords and subject terms together. This document shows you how to use the tables and provides a few options to organize your table. Use whichever works best for you!  Search Strategy Tables to Break your PICO into Concepts .

PICO and Qualitative Questions

A qualitative PICO question focuses on in-depth perspectives and experiences.  It does not try to solve a problem by analyzing numbers, but rather to enrich understanding through words.  Therefore, the emphasis in qualitative PICO questions is on fully representing the information gathered, rather than primarily emphasizing ways the information can be broken down and expressed through measurable units (though measurability can also play an important role). 

A strength of a qualitative PICO question is that it can investigate what patient satisfaction looks like, for example, instead of only reporting that 25% of patients who took a survey reported that they are satisfied. 

When working with qualitative questions, an alternative to using PICO in searching for sources is the SPIDER search tool.  SPIDER is an acronym that breaks down like this:

P=Phenomena of Interest

E=Evaluation

R=Research Type

Cooke, A., Smith, D., & Booth, A. (2012). Beyond PICO: The SPIDER tool for qualitative evidence synthesis . Qualitative Health Research, 22 (10), 1435-1443. doi:10.1177/1049732312452938

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Evidence Based Medicine

  • Levels of Evidence
  • Asking Clinical Questions
  • Searching PubMed
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  • Diagnosis Search Example
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Asking Clinical Questions: How to Develop an Answerable Question (8.5 minutes)

Background Vs. Foreground Questions

In the Evidence Based Medicine paradigm, questions can be categorized into two types to help you grow your knowledge and practice. By determining the type of question, it will guide you to the type of evidence to review for an answer.

1. Background questions concern general knowledge of a condition, disease, process, etc.  These types of questions generally have only two parts:

  • A question root (who, what, when, where, how, why) and
  • a disorder, test, treatment, or another aspect of health care.  

Often these questions can best be answered by using a health sciences textbook or consulting a clinical point-of-care tool like DynaMed or UpToDate.

  • What is a first line treatment for heart failure?
  • When should children receive the HPV vaccine?
  • What gene mutation causes polycystic kidney disease?

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 the primary medical literature in databases like PubMed or Embase.

  • In adults with heart failure, would adding warfarin to standard therapy reduce thromboembolism?
  • Are patient education YouTube videos effective at changing the preferences of vaccine-hesitant parents?
  • Does taking tolvaptan in adult patients with autosomal dominant polycystic kidney disease improve renal function and pain within six months of initiation of the medication?

Foreground questions may be further categorized into a type of clinical question such as treatment/therapy, diagnosis, prognosis, or etiology/harm that will also help in seeking out appropriate evidence types to address your inquiry. See more about question types on the CLINICAL FILTERS page.

What is the PICO Model?

The PICO Model is a format to help define your information need into a clinical question. By organizing a clinical question using PICO, the searcher can use the specific terms to aid in finding clinically relevant evidence in the literature. PubMed alone has over 34 million citations to search through so being able to reference a defined clinical question when reviewing title/abstracts will help filter the irrelevant materials out of the search results.

The PICO Model for Clinical Questions  

 

atient, opulation, or roblem

 

How would I describe a group of patients similar to mine?

 

ntervention, Prognostic Factor, or Exposure

 

Which main intervention, prognostic factor, or exposure am I considering?

 

omparison or Intervention (if appropriate)

 

What is the main alternative or gold standard to compare with the intervention?

 

utcome you would like to measure or achieve

 

What can I hope to accomplish, measure, improve, or affect for my patient or population?

Need to Refine your Search Further?  Try these additional elements in the PICOTTS Model.

 

What ype of clinical question are you asking?

 

Diagnosis, Etiology/Harm, Therapy, Prognosis, Prevention categories

 

Is ime important to your search?

 

Duration of data collection, duration of treatment, time to follow-up

 

What tudy type do you want to find?

 

What study design/methodology will address the clinical question according to the evidence hierarchy?

For more on searching by Type of Question, see CLINICAL FILTERS .

For more on searching by Study Design, see LEVELS OF EVIDENCE .

  • Educational Prescription Form -- The Centre for Evidence Based Medicine (CEBM)
  • PICO Linguist -- National Library of Medicine
  • TRIP - For UIC affiliates Click on the PICO tab over the search box. To access full text, look for the "Full Text: University of Illinois" link under each article summary.
  • TRIP - For non-UIC users Click on the PICO tab over the search box.

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Evidence-Based Practice: Step 1: Ask a clinical question

Evidence-based practice.

  • About this guide
  • The 5 As of evidence-based practice

Step 1: Ask a clinical question

  • Step 2: Access the information
  • Step 3: Appraise the information found
  • Step 4: Apply the information
  • Step 5: Audit
  • Further information

Email your Librarians

example of clinical research questions

The first step of Evidence Based Practice is to identify a clinical query. Then shape it into a focused and answerable clinical question.

Developing a clinical question can help to highlight key concepts from your clinical information need. These key concepts serve as the basis for searching relevant research evidence to address your clinical question. 

There are two main types of clinical questions: background questions and foreground questions . Knowing the type of clinical question you want to address can help when deciding where to search for research evidence.

What is a background question?

Background clinical questions are broad and general questions. They can usually be addressed with information found in textbooks, general clinical resources or by the patient themselves.  

For example:

  • How long have you had these symptoms?   
  • How do I set up a saline drip?

  

Addressing a background question can provide understanding around a clinical information need/problem. This can help you to develop a well-informed foreground question. 

What is a foreground question?

Foreground clinical questions are complex and specific questions. To be addressed these questions require the most up-to-date and highest quality research evidence.  

  • Does handwashing among healthcare workers reduce hospital-acquired infection?
  • In patients with osteoarthritis of the hip, is water therapy more effective than land-based exercise in restoring range-of-motion?

Addressing a foreground question can inform clinical decisions and determine the best course of action for patient care.

example of clinical research questions

To make it easier to find evidence to address your clinical question, time needs to be spent on structuring and refining your question.

Types of foreground questions

There are different types of foreground questions, each focusing on a different action in response to the clinical problem:  

Click on the plus (+) icons below to learn about the various types of foreground questions.

Therapy or Intervention

Definition .

Therapy or intervention questions explore potential interventions that could be used to treat or manage a patient's condition. They are used to evaluate medications, surgical procedures, exercise, alternative therapies or lifestyles changes. 

If you’re asking, 'What should I do to help my patient?' Then you’re asking a therapy or intervention question.

Example foreground question

What is the effectiveness of a particular intervention in improving outcomes in patients suffering from a particular health condition?

Definition  

Prevention questions explore ways to reduce the likelihood of particular condition or disease. They are used to reduce the chance of disease by identifying and modifying risk factors. 

If you are asking, 'How can I prevent a specific outcome for my patient?' Then you are asking a prevention question. 

Similar to treatment questions. When assessing preventive measures, it is particularly important to evaluate potential harms as well as benefits.

What is the effectiveness of an intervention or exposure in preventing morbidity (onset of disease) and mortality?

Diagnosis questions compare the accuracy and safety of diagnostic tests against the standard method. They are used to determine which test will be the most accurate in confirming or excluding a particular condition. 

If you are asking, 'How should I determine if my patient has a particular condition?' you are asking a diagnosis question.

What is the ability of a test or procedure to differentiate between those with and without a condition or disease?

Prognosis (Forecast)

Prognosis questions explore the likelihood of particular outcomes for patients with particular disorders. They are used to predict the patient's expected development and anticipate any future complications. 

If you are asking, 'What will happen to my patient in the future?' you are asking a prognosis question.

How will the disease progress or what is the likelihood that disease will develop?

Etiology (Causation/Harm)

Harm/etiology questions explore the causes and likelihood of a health care problem. They are used to find the origin of a patient's condition so that decisions about their care can be made. 

If you are asking, 'Why has this happened to my patient?' you are asking a harm or etiology question.

What is the negative impact of an intervention or exposure on a patient?

Meaning/Observational

Meaning/observational questions delve into understanding the lived experiences, perceptions, and meanings attributed to health conditions or interventions by patients. They aim to uncover the subjective aspects of illness, treatment, and recovery, focusing on qualitative insights rather than quantifiable outcomes. 

If you are asking, 'What are my patients' perceptions?' you are addressing a meaning/observational question.

What are the patient’s experiences of living with an illness?

Frequency questions are aimed at understanding the prevalence or occurrence of a phenomena within a population or group. They seek to quantify the frequency or distribution of specific conditions or behaviours. 

If you are asking, 'How many people experience this illness?' you are asking a frequency question.

How many individuals in the population have a particular condition?

Using question frameworks to shape foreground questions 

Question frameworks such as PICO, can be used to help to structure your foreground question, so that relevant evidence can be searched to address the question.

Question frameworks are tools that help to put together a foreground question. These tools identify the key elements of a foreground question, which can be used to formulate a search strategy to find relevant resources/studies that will help answer the foreground question. 

There are various types of question frameworks that can be applied to the different types of foreground questions. 

Click on the plus (+) icons below to explore the definition, purpose, and examples for each question framework type.

Definition and purpose

The PICO framework is useful for questions about the effectiveness of interventions.   

PICO stands for: 

  • P opulation or Patient or Problem 
  • I ntervention or Indicator  
  • C omparison or Control 
  • O utcome 

Wrist splints are commonly prescribed for people with carpal tunnel syndrome. You want to know what evidence there is for their effectiveness in reducing pain and increasing wrist function.

Research question

What is the effectiveness of wrist splints (I) compared with corticosteroid injections (C) for reducing pain and increasing function (O) in for carpal tunnel syndrome (P)?  

Framework and scenario matching

Element Definiton Scenario
P (patient/population/problem) Who is the population of interest? 
OR
What is the problem of interest?
People with carpal tunnel syndrome
I (intervention/indicator) What is the intervention or indicator of interest? Wrist splits
C (comparison/control) What are you comparing the intervention to? Corticosteroid injections
O (outcome) What is the outcome of interest? Improvement of pain and wrist function

Example research paper

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).  

Variant PICO Frameworks 

PICO has variations and extensions to accommodate different question types, including qualitative questions. For example: 

  • PICOS stands for PICO plus Study design 
  • PICOT stands for PICO plus Time 
  • PECO stands for Population/Problem, Exposure, Comparison, Outcome 
  • PECOS stands for Population/Problem, Exposure, Comparison, Outcome, Study design 
  • PICo stands for Problem, phenomenon of Interest, Context (used on qualitative questions)

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:

  • P opulation or P roblem

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: 

  • P opulation and their problems 
  • E xposure 
  • O utcomes or themes

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: 

  • S etting 
  • P erspective 
  • I ntervention 
  • C omparison 
  • E valuation

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: 

  • S ample 
  • P henomenon of I nterest 
  • D esign 
  • E valuation 
  • R esearch type

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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Evidence-Based Practice Tutorial: Asking Clinical Questions

  • Asking Clinical Questions
  • Acquiring the Evidence
  • Appraising the Evidence
  • Applying the Results
  • Assessing the Outcome
  • Practicing Evidence-Based Medicine
  • Additional Resources

Using PICO to Create a Well-Built Clinical Question

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?

PICO Example

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?

Categories of Clinical Questions

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.

example of clinical research questions

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.

Hierarchy of Evidence

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

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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Evidence-Based Practice: Clinical Questions & PICO

  • Clinical Questions & PICO
  • Evidence, Study Designs, and Clinical Tools
  • Tips for Searching the Literature
  • Critical Appraisal and More

Types of Questions

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.

  • Therapy : determining the effect of interventions on patient-important outcomes ( symptoms , function, morbidity, mortality, and costs)
  • Harm : ascertaining the effects of potentially harmful agents (including therapies from the first type of question) on patient-important outcomes
  • Differential diagnosis : in patients with a particular clinical presentation, establishing the frequency of the underlying disorders
  • Diagnosis : establishing the power of a test to differentiate between those with and without a target condition or disease
  • Prognosis : estimating a patient's future course

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.

Patient Intervention Comparator Outcome (PICO) Framework Tutorials

Framing the Clinical Question using PICO

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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Evidence-Based Practice (EBP)

  • The EBP Process
  • Forming a Clinical Question
  • Inclusion & Exclusion Criteria
  • Acquiring Evidence
  • Appraising the Quality of the Evidence
  • Writing a Literature Review
  • Finding Psychological Tests & Assessment Instruments

The PICO(T) Chart

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
Consider:

                                                                                                                                                                                                                 
I

INTERVENTION
Consider:

 
C

COMPARISON / CONTROL 
Consider:

 
O

OUTCOME 
Consider:

 
T

TIME 
Consider:

 

Design a question that incorporates the most salient piece of information from each of the above categories.

                                                                                                                                                             


 

PICO Template Questions

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.

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  • Course Home
  • What is Evidence-Based Practice?
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Using PICO to Frame Clinical Questions

  • Using PICO to Identify Search Terms
  • Perform a PubMed Search
  • Connect Search Terms to MeSH Terms
  • Filter PubMed Search Results
  • Perform a Clinical Queries Search and Filter Results
  • Use the Systematic Review Filter
  • Scenario Practice
  • Additional Resources

How to Navigate This Course

There are a variety of ways you can navigate this training. You can:

  • Click the Back and Next buttons at the bottom of each page to move through the material
  • Use the main navigation with dropdown subsections featured on all pages
  • Use a combination of the above methods to explore the course contents

Develop a Clinical Question

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.

Image of the letter P

Patient or Problem

P = patient or problem.

How would you describe the patient? What issue are they experiencing?

Image of the letter I

Intervention

I = intervention.

What would you like to do to help the patient?

Image of the letter C

C = Comparison

What would be the alternative to the intervention you selected?

Image of the letter O

O = Outcome

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?”

Doctor with older patient and nurse watching on.

(Image Source: iStock Photos, fstop123©)

Try-It Exercise

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.

Exercise - P

P = Patient or Problem - High-school students (teenagers)

Exercise - I

I = Intervention - Providing materials on negative health effects

Exercise - C

C = Comparison - Not providing materials on negative health effects

Exercise - O

O = Outcome - Help students stop or reduce smoking

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Evidence-Based Medicine: Ask a Clinical Question

  • What is EBM?
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Type of Questions

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.

Why Spend Time Formulating Questions?

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.

PICOTS Framework for Clinical Questions

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.

  • Research Medical Library Evidence-Based Prescription

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.

Find Studies

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

example of clinical research questions

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Evidence-Based Practice

  • Introduction to EBP
  • PICO(T) for Clinical Questions

Creating a Clinical Question: PICO / PICOTS

Picot example.

  • Qualitative Questions This link opens in a new window
  • 3. Appraise
  • Study Design
  • Resources about EBP

PICO  is an acronym that can help you create a well-built clinical question by identifying the key aspects of a complex patient presentation. 

example of clinical research questions

  • Patient or Population or Problem  The disease or condition you are investigating, and the particular demographic you are wanting to learn about (if applicable)
  • I ntervention or Indicator  Primary treatment option
  • Comparison or Control  Comparison treatment (if applicable)
  • Outcome What you you expect to see?
  • Timeline**:  Time it takes to demonstrate a clinical outcome or how long patients are observed.
  • Study Type:  What kind of study would best answer this question (i.e., RCT, Case Series, etc.). Rather than using keywords in your search strategy, you can often use filters to limit to specific study types / designs. ** Note that the timeframe does not always show up in the abstract. If you aren't getting enough results, you may need to remove this from your search, and just eliminate results that don't fit your preferred timeframe in the Prisma screening section.

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).

Potential search strategy:

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.

example of clinical research questions

"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

  • PICO Tutorial from University of Washington
  • Johns Hopkins EBP Question Development Tool Worksheet to help EBP teams develop an question that will answer a clinical, administrative, or knowledge problem.
  • PICOT Worksheet This worksheet will help you build a PICOT question and identify keywords for your searchable question.
  • Pubmed Clinical Queries This tool uses predefined filters to help you quickly refine PubMed searches on clinical or disease-specific topics.
  • The Underappreciated and Misunderstood PICOT Question: A Critical Step in the EBP Process
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MD/MSPA Students

In this guide.

  • Access Key Resources
  • Practicing Evidence-Based Medicine

Asking a Clinical Question

  • Searching the Literature
  • Appraising the Evidence
  • Library Resources
  • Pre-clerkship Supplemental Ebooks & Practice Questions
  • Clerkship Supplemental Ebooks & Practice Questions
  • License Exam Preparation
  • Research & Scholarship
  • Keep Current on Journal Articles

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:

  • general knowledge and foundational information on an illness, disease, diagnostics, procedures, and etc. What? Why? Where? Who? How?

Foreground questions:

  • specific knowledge to inform clinical decisions for a particular patient, population, or research topic

example of clinical research 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.

  • P atient/problem/population: who the relevant individuals are for the problem being addressed
  • I ntervention: what main intervention is being considered
  • C omparison: what is the main alternative or comparator to the intervention that is being assessed
  • O utcomes: what is being measured, improved, or affected

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.

Types of Clinical Questions

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:

  • Diagnosis : questions concerning the ability of a test to predict the likelihood of a disease in order to confirm or exclude a diagnosis
  • Therapy : questions concerning the effectiveness of a treatment or preventative measure to offer a patient that is work the effort and cost
  • Prognosis : questions concerning an estimate of the clinical course of a condition over time and anticipate likely complications of the disease
  • Harm/etiology : questions concerning the causes of the disease including iatrogenic forms
  • Prevention : questions concerning differential diagnosis and symptom prevalence
  • Cost : questions concerning the cost effectiveness of interventions

Clinical Questions and Suggested Research Design

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

Clinical Resources Available at Lane Library

  • Point of Care Tools
  • Drug Information
  • Differential Diagnosis Tools
  • Clinical Practice Guidelines

Point of care tools are designed for rapid consultation and provide high level summaries of current evidence for diagnosis, tests, and interventions.

  • UpToDate Point-of-care clinical information resource containing succinct and aggressively updated clinical topic reviews. Offers free DME/CE/CPD. Access Instructions. . . less... Mobile app download instructions
  • DynaMed Provides synthesized evidence and objective analysis to answer clinical questions. Features overviews and recommendations, expert reviews, mobile access, and links to Micromedex drug content. Access Instructions. . . less... Instructions for mobile app access
  • BMJ Best Practice Evidence-based decision trees and a step-by-step approach, covering prevention, diagnosis, treatment and prognosis. Incorporates multiple platforms, systematic reviews from BMJ Clinical Evidence, and content from Cochrane Clinical Answers and AHFS Drug Information Essentials.

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.

  • Micromedex Premier pharmaceutical information source containing multiple databases and drug reference tools. Easy-to-interpret Levels of Evidence help clinicians rapidly determine the quality of the available evidence. Access Instructions. . . less... There are five distinct mobile apps available for Micromedex: Drug Ref., Drug Int., IV Comp., NeoFax, and Pediatrics. To download them, select the “Download Mobile Apps” button in the bottom right of the page. Alternatively, select the “Mobile Application Access” link in the upper right of the page. Each app has a specific password for authentication. The passwords change on an annual basis.

Differential diagnosis tools are used to help with diagnosis decision making by differentiating between diseases and conditions that present similar clinical features.

  • VisualDx Decision support system that allows clinicians to build a patient-specific differential, search by diagnosis, or review medication-related events.
  • GIDEON (Global Infectious Disease & Epidemiology Network) Web-based, decision support system for infectious diseases, epidemiology, microbiology, and antimicrobial chemotherapy. Access Instructions. . . less... Limited to 4 simultaneous users
  • DXplain Enter clinical findings to produce a ranked list of diagnoses with justifications or access a description of over 2400 different diseases
  • Diagnosaurus Tool for Differential Diagnoses (DDx) of symptoms, signs, and diseases that are searchable alphabetically, by symptom, disease, and organ system.

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.

  • ECRI Guidelines Trust Comprehensive database of evidence-based clinical practice guidelines and related documents. Features concise summaries of guidelines based on systematic reviews of evidence; current, evidence-based guidance from key medical societies and organizations; and new scorecards showing guideline quality in terms of IOM standards. Access Instructions. . . less... Register for a free account to access content
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Evidence-Based Medicine: Clinical Questions & PICO

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What is PICOT?

patient or problem

  • What are the characteristics of the patient or population?
  • What is the condition or disease you are interested in?

intervention

  • What do you want to do with this patient (e.g. treat, diagnose, observe)?

comparison

  • What is the alternative to the intervention (e.g. placebo, different drug, surgery)?

outcome

  • What are you trying to accomplish, measure, improve or affect (e.g. relieving or eliminating specific symptoms, improving or maintaining function)?
  • Outcomes should be measurable.

type of study / time

  • Do you need a systematic review or a case study?
  • What type of foreground question are you trying to answer (e.g., therapy, diagnosis, harm, prognosis, prevention)?
  • What is your timeframe, or the period over which an outcome is to be measured?

How to Use the PICO Method to Form a Clinical Question

  • Types of Clinical Questions

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:

  • Therapy:   Questions of treatment in order to achieve a specific outcome.  These questions may include drugs, surgical intervention, change in diet, counseling, etc.
  • Diagnosis:   Questions of identification of a disorder in a patient presenting with specific symptoms.
  • Prognosis:   Questions of progression of a disease or likelihood of a disease occurring.
  • Etiology/Harm:   Questions of negative impact from an intervention or other exposure.

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

A well-written, clinical question would be:

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?

example of clinical research questions

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Writing a Clinical Research Question

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.

KEY CONCEPTS

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.

fig1

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.

Published Criteria for Developing Research Questions

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

A Study Question for Assessment of a Therapeutic Intervention

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.

A Study Question for Assessment of Association

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.

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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.

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Evidence-Based Practice in Health

  • Introduction
  • PICO Framework and the Question Statement

Types of Clinical Question

Common clinical question types, background questions & foreground questions.

  • Hierarchy of Evidence
  • Selecting a Resource
  • Searching PubMed
  • Module 3: Appraise
  • Module 4: Apply
  • Module 5: Audit
  • Reference Shelf

Recognising your clinical question's domain is an important part of the Evidence-Based Practice (EBP) process. Establishing the question type allows you to:

  • Identify the research methodology that provides the best evidence to answer the question.  Note that the hierarchy of evidence ( covered in 1.3 Hierarchy of Evidence ) will differ according to question type.
  • Select the best EBP Tools to search for the evidence. The Cochrane Database of Systematic Reviews, for example, only addresses treatment and prevention questions.  Other databases address questions of treatment and prevention, diagnosis, prognosis, etiology, quality improvement, and health economics, among others.
  • Select evidence filters in PubMed / CINAHL and other databases that will help narrow your search to papers using appropriate research methods.

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

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Clinical Questions & Resources Activity: CQRA

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

Building a clinical question resources for pico(tt) question creation.

Database

  • Provides Tools for understanding & applying Medical Literature and making Clinical Diagnosis.
  • Includes: The User's Guide to Medical Literature , and The Rational Clinical Examination .

E-Book

  • JAMAevidence Education Guide PowerPoint on creating Clinical (PICO) Questions.
  • Copyright: Slides can be shared for educational purposes only.

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Basic Medical Information

Basic medical information resources for general medical knowledge (background questions).

Author: Bickley, Lynn S. Year: 2021

  • Now in its Fifth Edition and featuring completely reshot content and new clinical skills videos, Bates’ Visual Guide delivers head-to-toe and systems-based physical examination techniques for the (Advanced) Assessment or Introduction to Clinical Medicine course.
  • The site features more than 8 hours of video content.

Diagnostic Information Resources for Diagnostic Tools, Diagnosis, and Differential Diagnosis (Background & Foreground questions)

  • An Evidence-Based, Clinical Decision Support tool which provides evidence-based recommendations on 3,000+ topics.
  • Evidence is evaluated using two systems: Levels of Evidence & GRADE.
  • Includes: Point-of-Care tools, ICD-9 codes, & Patient Information.
  • Available as a mobile App.

Off-Campus Access limited to College of Medicine Users. Access for non-College of Medicine users available on-site at the College of Medicine Campus.

  • An Evidence-Based, Clinical Decision Support Resource.
  • Authored by Physicians to help Healthcare Practitioners make the best decisions at the Point-of-Care.
  • Available as an app.
  • A Clinical Decision Support System: Recognition & Diagnosis of Conditions by Visual Symptoms.
  • Disease Presentation by: Age, Skin Type, Location, and Severity.
  • Registration is required for the app.
  • Available as an app for Apple & Android.

Drug Information Resources for Drugs, Drug Interactions, and Drug Comparison (Background & Foreground questions)

  • Epocrates provides drug information, interaction check, pill ID, clinical practice guidelines, formulary, athenaText, tables, and calculators.
  • Epocrates Plus provides access to all the free content plus disease information, alternative medicine, ICD-10 and CPT codes, infectious disease treatment, and labs.
  • Epocrates Plus is available to medical students. Follow these directions to get Epocrates Plus. You will need a medical education number. Click here to find/get your ME number or call the AMA Member Service Center at 800-262-3211. It is available Monday through Friday from 8:00 AM until 5:00 PM CST.
  • Authoritative Drug Information.
  • Includes: A-Z Drug Facts, Drug Identification Tool, Herbal Interaction Facts, MedFacts Patient Information, 5-Minute Consult Series, and More.
  • A Comprehensive, Point-of-Care, Drug Information Database.
  • provides drug, disease, and toxicology information, as well as patient education documents and pediatric and neonatal evidence for patient safety.

Epidemiology

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).

  • comprises more than 30 million citations for biomedical literature from MEDLINE, life science journals, and online books.
  • Includes Links to Full-Text Articles where available.

Treatment & Therapy

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.

App

  • This app is for the Access suite of products. The Health Sciences Library subscribes to AccessMedicine, JAMAevidence, Case Files Collection, and Pharmacotherapy Principles & Practice.
  • A My Access account is required for the mobile app; Click here to create an account.
  • Mobile access to DynaMed content
  • Features Offline content access, Topic bookmarking, and Topic notations
  • For installation instructions please see the M1 Technology Guide
  • Epocrates Plus is available to medical students. Follow these directions to get Epocrates Plus. You will need a medical education number. Click here to find/get your ME number or call the AMA Member Service Center at 800-262-3211. It's available Monday through Friday from 8:00 AM until 5:00 PM CST.
  • An Evidence-Based, Clinical Decision Support Resource App.
  • The mobile version of the UpToDate database.
  • App installation instructions available at Health Sciences Library: Apps .
  • Last Updated: Sep 23, 2024 12:27 PM
  • URL: https://guides.med.ucf.edu/CQRA

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Evidence Based Practice

Pico(t) model & question types, example 1 - therapy, example 2 - diagnosis/diagnostic test, example 3 - etiology, example 4 - prognosis.

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PICO(T): Definitions and Examples

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.

example of clinical research questions

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)?

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  • Last Updated: Aug 5, 2024 4:10 PM
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Medical Research Guide

  • Introduction
  • Your Clinical Question
  • Get Ready to Document Your Research
  • Finding Resources for Your Research
  • If your project includes human subjects
  • Managing Your Project
  • Writing Your Paper
  • PowerPoint Presentation Guide
  • Creating a Quality Poster Presentation
  • "Where can I submit my research for publication consideration?"

What is a Clinical (Or Research) Question?

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.).

Examples of Clinical Questions

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.

Translating Your Clinical Question into Searchable Terms

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.)

  • Your Clinical Question & Defining a Search Strategy
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About YSERE

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:

  • College transcript
  • Resume or curriculum vitae (including extra-curricular activities)
  • FAFSA report of Estimated Family Contribution (EFC) - OPTIONAL but inclusion of FAFSA may help determine your eligibility for the program
  • Personal statement (2-page max): Please describe how your participation in the program aligns with the program’s goal of advancing diversity in biomedical research. Please describe your future goals and how this program may help you achieve such goals. Please share an example (if any) of a major life obstacle you overcame to pursue your education/training. Please feel free to include additional information that you wish to share with us (e.g. your interest, prior research experience etc.).
  • Two letters of recommendation (one from a science faculty member).

Meet Our 2024 YSERE Interns

2024 Yale Summer Enrichment Research Experience Intern

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Questions about the program or the application process?

Yale Summer Enrichment Research Experience Brochure

Redirect Notice

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

  • in competing applications for all types of grant programs,
  • in progress reports when new senior/key personnel or other significant contributors are identified, and
  • to support prior approval requests for changes in senior/key personnel status and changes of recipient organization.

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 (Fellowship): Biographical Sketch Format Page - FORMS-H

Biosketch (non-fellowship): biographical sketch format page - forms-h.

  • How to Apply — Application Guide
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  • Create your biosketch here!

Model site agreements (model contracts, standard research agreements)

  • Published: 24 May 2019
  • Version: V 1.0

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.

Access the suite of model agreements

For more information and to access the latest versions of model agreement templates, visit the IRAS website .

model Industry Collaborative Research Agreement (mICRA)

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.

  • mICRA Template contract (MS word)
  • mICRA Guidance 2011

Feedback on the use of the mICRA is welcomed to help inform its future development. Email comments to  [email protected]

Explore our full range of support

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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British Journal of General Practice

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Trends in clinical workload in UK primary care 2005–2019: a retrospective cohort study

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  • ORCID record for Lyvia de Dumast
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  • Figures & Data

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.

  • consultation
  • primary care
  • staff workload
  • electronic health records
  • retrospective study
  • Introduction

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.

Study design

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.

Multimorbidity status

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 ).

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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).

GP face-to-face/telephone consulting rates

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

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.

Clinical workload

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 ).

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Mean age-standardised workload per person–year by staff role. F2F = face to face.

GP workload

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 ).

Practice nurse workload

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

Multimorbidity levels

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.

Strengths and limitations

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.

Comparison with existing literature

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

Implications for research and practice

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.

  • Acknowledgments

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.

Ethical approval

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.

Competing interests

The authors have declared no competing interests.

Discuss this article:

bjgp.org/letters

  • Received November 14, 2023.
  • Revision requested February 29, 2024.
  • Accepted March 27, 2024.
  • © The Authors

This article is Open Access: CC BY 4.0 licence ( http://creativecommons.org/licences/by/4.0/ ).

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