L 7 Pico

PICO Evidence-Based Medicine

  • Introduction to Evidence-Based Medicine (EBM)

    • EBM was first coined by the Evidence-Based Medicine Working Group in 1992.

    • Definition by Dr. David Sackett, McMaster University:

    • “Evidence-based medicine (EBM) is the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients.”

    • Core Principle: Utilizes the best quality information to provide quality care to patients.

Components of Evidence-Based Medicine

  • Three Integral Components:

    1. The best available research evidence.

    2. The clinician's expertise.

    3. The patient's values, desires, and circumstances.

  • Formula for Best Outcomes:
    extData/Evidence+extClinicalExpertise+extPatientValues=extBestOutcomesext{Data/Evidence} + ext{Clinical Expertise} + ext{Patient Values} = ext{Best Outcomes}

  • Function of EBM:

    • Apply research and clinical outcomes to improve patient care.

    • Meant to work alongside clinician judgment and the socially, culturally, and personally accepted care standards.

    • Streamlines the process of sorting through the vast literature for accurate and applicable information.

  • Data Visualization:

    • Image depicted the exponential growth of medical literature from 1946 to 2015.

Steps of Evidence-Based Medicine in Practice

  1. Create a clinical, answerable question.

  2. Search for the best evidence to the question.

  3. Critically evaluate the validity, applicability, and impact of the evidence.

  4. Apply the evidence along with clinician expertise and patient preferences.

  5. Evaluate the effectiveness of the EBM process and outcomes; consider improvements.

Step 1: Ask a Clinical, Focused, Answerable Question

  • Types of Questions:

    • Background Questions: Simple questions addressing one issue, typically formatted to ask: who, what, where, when, why, or how.

    • Examples:

      • Who should be screened for colon cancer?

      • What is the test for iron-deficiency anemia?

      • Where do sulfonylureas act in the body?

      • When can patients stop having Pap smears?

      • Why do statins reduce myocardial infarctions?

      • How does excess bilirubin cause jaundice?

      • Why do you experience brain freeze when consuming ice cream?

    • Foreground Questions:

    • These questions contrast two or more variables such as treatments or diagnostic tests.

    • Requires foundational background knowledge.

    • Used to develop PICO questions.

PICO – Four Components

  • Definition of PICO:

    • P: Patient, Population, or Problem

    • I: Intervention (what is administered or tried)

    • C: Comparison (what has been done previously, the Gold Standard)

    • O: Outcome

  • PICO Question Format:

    • For a given P, will I vs C result in a better O?

    • P: Patient, Population, or Problem

    • I: Intervention (drug, therapy, test, lifestyle change)

    • C: Comparison (standard treatment)

    • O: Outcome (result metrics such as recovery, pain relief, cost efficacy)

P: Patient, Population, or Problem

  • Clinical Characteristics to Consider:

    • Age

    • Gender

    • Race

    • Condition

    • Body habitus

  • Patient Preferences and Values:

    • Be specific without being too narrow.

    • Examples of Appropriate vs. Inappropriate Scope:

    • Too Broad: “Patients with hypertension.”

    • Too Narrow: “50-year-old obese hypertensive African-American males using enalapril for 3 years with BP over 140/95.”

    • Just Right: “Adult patients with hypertension on ACE inhibitors not achieving BP goal.”

  • Clinical Scenario Examples:

    • A 52-year-old Caucasian woman inquiries about GLP-1 medication for weight loss.

    • Identified P: Adult women who are overweight.

    • A 25-year-old overweight Asian male smoker seeks advice on quitting.

    • Identified P: Adult smoker.

I: Intervention

  • Key Considerations for Intervention:

    • What is going to change?

    • What alternative is being considered?

    • What new options are being evaluated?

    • Possible focus areas include medication, lifestyle changes, diagnostic tests, or risk factors.

    • Should be clinically relevant and feasible, ensuring it's important and applicable to patient(s).

    • Consider patient willingness to accept the intervention.

  • Clinical Scenario Examples:

    • 58-year-old male with prior adenomatous polyp prefers CT colonography over colonoscopy.

    • Identified I: CT colonography vs. conventional colonoscopy.

    • 16-year-old female with moderate acne not fully treated with topical retinoid questions treatment options.

    • Identified I: Comparison of retinoid vs. retinoid + antibiotic.

C: Comparison

  • Identifying Comparison in EBM:

    • To what is the intervention being compared?

    • Options include medications (placebo, standard dose), lifestyle (standard approaches), diagnostic tests (gold standard), or risk factors.

    • Typically, the current treatment or gold standard.

  • Clinical Scenario Examples:

    • For fatty liver disease evaluation, comparing traditional liver biopsy to new MRI non-invasive testing options.

    • Identified C: Traditional test: liver biopsy; new option: MRI.

    • Direct comparison in IBD treatment: mesalamine vs. biologics.

    • Identified C: Biologics.

  • Type of Questions to Gather Best Evidence:

    • Therapy: Randomized controlled trials

    • Prevention: RCT > Cohort > Case-control

    • Diagnosis: Prospective blinded trials

    • Prognosis: Cohort studies

    • Etiology/Harm: RCT or observational studies

    • Cost: Economic evaluations

    • Quality of life: Qualitative studies

O: Outcome

  • Defining Outcomes:

    • What results are being measured?

    • Outcomes must be well-defined, measurable, reliable, and clinically relevant.

    • Different types of outcomes include composite endpoints, soft vs hard outcomes, and surrogate outcomes:

    • Examples of Surrogate Outcomes:

      • HbA1c measurements vs. mortality rates.

      • Pain levels vs. need for procedure.

      • Bone density vs. fracture risk.

  • Clinical Scenario Examples:

    • Type 2 diabetics on Metformin with good HbA1c but adverse side effects look for alternatives.

    • Identified O: Need for alternative medication with fewer adverse effects.

    • Patients with dense breasts, looking into screening mammography options—digital mammography vs other imaging.

    • Identified O: Earlier detection of potential issues.

PICO in Practice

  • Applied Clinical Scenarios:

    • GERD and Fracture Risk with Long-term PPI Use:

    • P: Adult with GERD, I: Long-term PPI, C: No PPI, O: Fracture risk assessment.

    • Obscure GI Bleeding Diagnostics:

    • P: Adult obscure GI bleeder, I: Push enteroscopy, C: Capsule endoscopy, O: Accurate diagnosis.

    • IBS-C Treatment:

    • P: Adult patient with IBS-C, I: Psychological therapy, C: Lubiprostone, O: Pain relief.

    • Celiac Disease Diet:

    • P: Adult with documented celiac disease, I: Gluten diet, C: Gluten-free diet, O: Greater lifespan.

    • Eosinophilic Esophagitis Treatment:

    • P: Adults with EE, I: Aerosolized steroid, C: Elimination diet, O: Symptom control.

  • Benefits of the PICO Model:

    • Clarifies the question types.

    • Simplifies the literature search process.

    • Helps determine appropriate study types.

    • Encourages systematic reviews and guideline usage.

    • Emphasizes clinician judgment and patient preferences for treatment decisions.