1. A. R. Markos FRCOG FRCP Consultant in Genito Urinary Medicine and Sexual Health Mid Staffordshire NHS Foundation Trust Stafford, UK

2. Mid Staffordshire NHS Foundation Trust NHS “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. Mid Staffordshire NHS Foundation Trust NHS  Rational Systemic study of Medicine  Roman Law prohibited Dissection # Greek Study of human body Greek Study of human body  Dissection of animals & observation of Gladiators’ wounds observation of Gladiators’ wounds

4. Mid Staffordshire NHS Foundation Trust NHS  1025 BC  Quantification & Experimentation  Clinical Trials & Randomised Controlled Trials  Efficacy Tests

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

6. Mid Staffordshire NHS Foundation Trust NHS Level I Evidence obtained from at least one properly designed randomised controlled trial. II-1 Evidence obtained from well-designed controlled trials without randomisation. II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one centre or research group. II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence. III Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

7. Mid Staffordshire NHS Foundation Trust NHS Acute pain management: operative or medical procedures operative or medical procedures Acute pain managements: operative or a medical procedures. Rockville, MD: Agency for Health Care Policy and Research Publications Agency for Health Care Policy and Research Publications (AHCPR Pub 92-0032), 1992.

8. Mid Staffordshire NHS Foundation Trust NHS Assessing the reliability of scientific expert testimony “Daubert-v-Merrell Dow Pharmaceuticals” “Daubert-v-Merrell Dow Pharmaceuticals” 1. Whether the expert’s technique or theory can be or has been tested 2. Challenged in some objective sense or (Subjective conclusive approach that cannot be reasonably assessed for reliability) 3. Technique or theory has been subject to peer review and publication 4. Known or potential rate of error of the technique or theory 5. The existence and maintenance of standards and controls 6. Generally accepted in the scientific community Daubert-v-Merrell Dow Pharmaceuticals Inc (1993) 509 US 579

9. Mid Staffordshire NHS Foundation Trust NHS require expert witness to give an opinion or otherwise, if:- 1. The testimony is: based upon sufficient facts or data 2. Reliable principles and methods 3. 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. Mid Staffordshire NHS Foundation Trust NHS  The need of “Evidence Based Medicine” The integrity of medical “interventions” : The integrity of medical “interventions” : to justify the duty of the insurers to pay to justify the duty of the insurers to pay for a prescribed course of management for a prescribed course of management

11. Mid Staffordshire NHS Foundation Trust NHS  Escalating cost of Health Care Attempt on rationing Attempt on rationing “Evidence Based Medicine” “Evidence Based Medicine” NICE NICE

12. Mid Staffordshire NHS Foundation Trust NHS 1. RCOG Guidelines 2. Medical Societies’ Guidelines 3. Cochrane Reviews 4. Health Care Commission Reviews 5. Medical Textbooks 6. NICE Review/s 7. EBM Reviews (BMJ)

13. Mid Staffordshire NHS Foundation Trust NHS Levels of Medical Evidence: How much confidence exists in the Data 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. Mid Staffordshire NHS Foundation Trust NHS Statement of evidence: To standardise the levels of evidence to 5 To standardise the levels of evidence to 5 (instead of 4) (instead of 4) Grades of Recommendations into 4 Grades of Recommendations into 4 (instead of 3) (instead of 3) To cover areas of To cover areas of diagnosis, prognosis and harm diagnosis, prognosis and harm

15. Mid Staffordshire NHS Foundation Trust NHS LevelDefinition Ia Evidence obtained from meta-analysis of randomised controlled trails Ib Evidence obtained form at least one randomised controlled trial. IIa Evidence obtained from at least one well-designed controlled study without randomisation. IIb Evidence obtained from at least one other type of well- designed quasi-experimental study. III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies. IV Evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities.

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