KINE 1020: Introduction to Fitness and Health - Evidence-Based Medicine

Evidence-Based Medicine (EBM)

Page 2: Evidence-Based Medicine Basics

  • EBM Definition: Systematically reviewing, appraising, and using clinical research findings and judgment for optimum patient care.

  • Importance: Enables informed decisions on disease risk, management, and treatment; provides accurate risk perceptions; encourages appropriate use of procedures.

Page 3: Therapeutic and Treatment Approaches

  • Conventional Medicine: Standard medical care provided by MDs/DOs (e.g., lifestyle, drugs, surgery). Also called biomedicine, Western medicine.

  • Complementary and Alternative Medicine (CAM): Medical products/practices not part of standard care (e.g., special diets instead of prescribed drugs). Generally, less research for most CAM types.

Page 4-5: Safe Sleep Example for Infants

  • Recommendation: Always place baby on their back to sleep, alone, in an empty crib.

  • Risk Reduction: Back sleeping reduces Sudden Infant Death Syndrome (SIDS) and other sleep-related deaths.

  • Dangers: Stomach sleeping (suffocation), co-sleeping, soft bedding, and bumpers are unsafe.

  • Information Sources: Emphasizes following research-backed advice over social media/unverified sources.

Page 7-8: Standard Medical Care & EBM Principles

  • Standard Medical Care: Accepted treatment by medical experts, widely used, based on "Scientific Evidence."

  • EBM Principles: Ensures medical decisions, guidelines, and policies are based on current best evidence on safety and efficacy of treatments.

Page 9-10: Levels of Evidence Pyramid

  • Hierarchy: Ranks evidence from strongest to weakest.

  • Level 1 (Strongest): Systematic Reviews & Meta-analysis of Randomized Controlled Trials (RCTs), Evidence-based Clinical Practice Guidelines.

  • Level 2: One or more RCTs.

  • Level 3: Controlled Trials (no randomization).

  • Level 4: Case-control or Cohort study.

  • Level 5: Systematic Review of Descriptive and Qualitative studies.

  • Level 6: Single Descriptive or Qualitative Study.

  • Level 7 (Weakest): Expert Opinion.

Page 11-15: Case Study: Tylenol (Acetaminophen) and Neurodevelopmental Disorders (NDDs)

  • Controversy: Public figures may make unsubstantiated claims.

  • Research Findings: Majority of 4646 identified studies reported positive associations between prenatal acetaminophen use and ADHD/ASD/NDDs; however, some showed null or negative associations.

  • Study Limitations: Most studies were retrospective, relying on maternal self-reports (high risk of bias).

  • Ahlqvist (2024) Study: Large study (nearly 2.52.5 million children) initially found a very small difference in ASD risk (exposed 1.42%1.42\% vs. unexposed 1.33%1.33\%).

  • Sibling-Controlled Analysis: Found no association between paracetamol and autism when comparing siblings, suggesting confounding factors in other studies.

  • Conclusion: Fetal exposure might alter development, but apparent risk difference is minimal, and rigorous studies show no direct association.

Page 16-17: Key EBM Concepts

  • "Best Evidence": EBM uses current best evidence from peer-reviewed original published manuscripts/journals.

  • RCTs for Tylenol/ASD: No RCTs have been conducted for Tylenol and ASD.

  • Association vs. Causation: Finding an association between two things does not mean one caused the other.

Page 18-19: Sources of Medical Advice

  • Caution: Do not confuse internet searches with professional medical degrees.

  • Reliable Evidence: Case reports (doctor), lab data (scientist), patient testimonials (friend) are insufficient. "Best evidence" comes from large studies with controls.

Page 20: Simplified EBM Evidence Types

  • Level I: At least one properly designed RCT (or meta-analysis of RCTs) (e.g., statins preventing heart attacks).

  • Level II: Well-designed controlled trials (no randomization) or cohort/case-control studies (e.g., stopping smoking reducing lung cancer risk).

  • Level III: Opinions of respected authorities, descriptive studies, or expert committees (e.g., exercise delaying senile dementia).

Page 21-22: EBM Integration & Steps to Level I

  • EBM Integration: Combines best research evidence, clinical expertise, and patient values.

  • Focus: Clinically effectiveness (efficacy) over cost-effectiveness.

  • Steps to Level I: Observational associations -> animal studies -> small proof-of-concept human studies (no randomization) -> large RCT.

  • Challenges for RCTs: Not always feasible (e.g., daily teeth brushing, diet and cancer).

Page 23-27: Estrogen Therapy Example (Level II vs. Level I)

  • Level II (Observational Studies): Initial studies (case-control, cohort) suggested women on estrogen therapy had less heart disease risk.

  • Level I (Randomized Controlled Trial - RCT): The Women's Health Initiative RCT showed that estrogen treatment increased heart attack, stroke, and breast cancer risk.

  • Conclusion: RCTs can yield different conclusions than observational studies, highlighting the importance of strongest evidence.

Page 28: Limitations of EBM

  • Ethical/Applicability: RCTs are not always ethical or possible.

  • Doctor-Patient Relationship: EBM does not replace clinical judgment or individual patient needs.

  • Individual Differences: Does not account for genetic or environmental variations.

  • Practical Issues: Doctor recommendations and insurance coverage can differ.

Page 30-35: Types of Evidence in Detail

  • Editorials and Expert Opinions: Weakest evidence, aiming to shape common practice.

  • Case-Series and Case-Reports: Descriptive studies following a small group or individual patient. Supplements to case reports.

  • Case-Control Studies: Observational, retrospective studies comparing patients with a disease to those without (e.g., lung cancer and smoking).

  • Cohort Studies: Prospective studies following a group with defined characteristics over time to determine health outcomes (e.g., Framingham Heart Study for cardiovascular disease risk factors).

  • Randomized Clinical Trial (RCT): Uses randomization to allocate participants to study arms, ensuring equal chance of selection. Often not feasible for certain studies (e.g., daily exercise and mortality).

  • Meta-analysis: A systematic, statistics-based review combining results from multiple related studies to identify patterns and disagreements. Provides stronger conclusions but may be prone to publication bias.