Your protocol states your rationale, hypothesis and planned methodology.
P = Patient or Problem
I = Intervention or Exposure
C = Comparison or Control
O = Outcome
T = Timing
S = Setting
Use frameworks to help structure your question
Select a framework according to the research domain and type of question
Describe each element of the question so it can be clearly understood by team members and future readers
The PICO format is an example of a common framework used for clinical topics
- Patient Intervention Comparator Outcome (PICO) Framework [Cochrane UK: Video; 3 minutes]
Example: In patients with systemic lupus erythematosus [population], is consuming turmeric tea [intervention] more effective than Plaquenil [comparison] for reducing joint pain [outcome]?
PCC works well for scoping reviews
Population Concept Context (PCC)
For patients with systemic lupus erythematosus [population], what patient-reported outcome measures [concept] are used in trials of pain relief [context]?
For a more in-depth look at research frameworks, refer to the University of Maryland's research guide: https://lib.guides.umd.edu/SR/research_question
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?”