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 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 million children) initially found a very small difference in ASD risk (exposed vs. unexposed ).
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.