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The significance of defining The Levels of Medical Evidence in Medico-legal practice

The significance of defining The Levels of Medical Evidence in Medico-legal practice. A. R. Markos FRCOG FRCP Consultant in Genito Urinary Medicine and Sexual Health Mid Staffordshire NHS Foundation Trust Stafford, UK. Medicine. “have been made a subject of investigations”…

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The significance of defining The Levels of Medical Evidence in Medico-legal practice

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  1. The significance of defining The Levels of Medical Evidence in Medico-legal practice A. R. Markos FRCOG FRCP Consultant in Genito Urinary Medicine and Sexual Health Mid Staffordshire NHS Foundation Trust Stafford, UK

  2. Medicine “have been made a subject of investigations”… “…open mindedness and the preparedness to seek observations through a process of questioning” “…to such a discovery and investigation, what more suitable name could one give than that of………………………………………….Medicine” Hippocrates: On Ancient Medicine; Part 3

  3. Galen: 129-200 AD • Rational Systemic study of Medicine • Roman Law prohibited Dissection # Greek Study of human body • Dissection of animals & observation of Gladiators’ wounds

  4. The Canon of Medicine: • 1025 BC • Quantification & Experimentation • Clinical Trials & Randomised Controlled Trials •  Efficacy Tests

  5. Effectiveness and Efficiency: Random reflections on Health Services Cochrane A, 1972 Canadian Researchers:  “Periodic Health Examination”: Levels of Evidence & Grades of Recommendations Canadian Task Force: The periodic health examinations. CMAJ, 1979;121:1193-1254 Medical Research workers: The use of antithrombotic agents Sackett DL. Rules of evidence and clinical recommendations on use of antithrombotic agents. Chest1986;89(2suppl.):2S-3S 

  6. US Preventative Services Task Force: 1984

  7. US Department of Health and Human Services (Public Health Services): Acute pain management: operative or medical procedures Acute pain managements: operative or a medical procedures. Rockville, MD: Agency for Health Care Policy and Research Publications (AHCPR Pub 92-0032), 1992.

  8. The Federal Rules of Evidence: Assessing the reliability of scientific expert testimony “Daubert-v-Merrell Dow Pharmaceuticals” • Whether the expert’s technique or theory can be or has been tested • Challenged in some objective sense or (Subjective conclusive approach that cannot be reasonably assessed for reliability) • Technique or theory has been subject to peer review and publication • Known or potential rate of error of the technique or theory • The existence and maintenance of standards and controls • Generally accepted in the scientific community Daubert-v-Merrell Dow Pharmaceuticals Inc (1993) 509 US 579

  9. The federal rules of evidence require expert witness to give an opinion or otherwise, if:- • The testimony is: based upon sufficient facts or data • Reliable principles and methods • The witness has applied the principle and methods reliably to the facts of the case Put to the test Test has been replicated by others Replications have been collectively analysed, studied, published, peer reviewed, critically appraised, retested and applied to the case under assessment

  10. The Health Insurance Industries: • The need of “Evidence Based Medicine” The integrity of medical “interventions” : to justify the duty of the insurers to pay for a prescribed course of management

  11. Politicians & Health Care Economists: • Escalating cost of Health Care Attempt on rationing “Evidence Based Medicine” NICE

  12. Clinical Applications of “Levels of Medical Evidence :- • RCOG Guidelines • Medical Societies’ Guidelines • Cochrane Reviews • Health Care Commission Reviews • Medical Textbooks • NICE Review/s • EBM Reviews (BMJ)

  13. Public Knowledge Levels of Medical Evidence: How much confidence exists in the Data • Case Report • An Observational Study • A Case-Control Study • Cohort Study • A Controlled Clinical Trial • A Double-blind, Randomised, Controlled Clinical Trial Washington Post 19 April 2005: HE06

  14. Oxford Centre for Evidence Based Medicine (EBM) Statement of evidence: To standardise the levels of evidence to 5 (instead of 4) Grades of Recommendations into 4 (instead of 3) To cover areas of diagnosis, prognosis and harm

  15. The Levels of Evidence

  16. Setting standards to improve women’s health Royal College ofObstetricians andGynaecologists Risk Management and Medico-Legal Issues In Women’s Health Joint RCOG/ENTER Meeting Please turn off all mobile phones and pagers

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