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

A. R. Markos FRCOG FRCPConsultant in Genito Urinary Medicine and Sexual Health

Mid Staffordshire NHS Foundation TrustStafford, UK

Mid StaffordshireNHS Foundation Trust

NHS

““have been made a subject of have been made a subject of investigations”…investigations”…

“…“…open mindedness and the preparedness open mindedness and the preparedness

to seek observations through a process of to seek observations through a process of questioning”questioning”

“…“…to such a discovery and investigation, to such a discovery and investigation,

what more suitable name could one give what more suitable name could one give than that than that of………………………………………….Medicine”of………………………………………….Medicine”Hippocrates: On Ancient Medicine; Part 3


NHS

Rational Systemic study of MedicineRational Systemic study of Medicine

Roman Law prohibited Dissection # Roman Law prohibited Dissection #

Greek Study of human bodyGreek Study of human body

Dissection of animals & Dissection of animals &

observation of Gladiators’ woundsobservation of Gladiators’ wounds


NHS

1025 BC 1025 BC

Quantification & ExperimentationQuantification & Experimentation

Clinical Trials & Randomised Controlled Clinical Trials & Randomised Controlled TrialsTrials

Efficacy TestsEfficacy Tests


NHS

Effectiveness and Efficiency:Effectiveness and Efficiency: Random reflections on Health ServicesRandom reflections on Health Services

Cochrane A, 1972Cochrane A, 1972

Canadian Researchers: Canadian Researchers: “ “Periodic Health Examination”: Levels of Periodic Health Examination”: Levels of

Evidence & Grades of Recommendations Evidence & Grades of Recommendations Canadian Task Force: Canadian Task Force:

The periodic health The periodic health examinations. examinations.

CMAJ, 1979;121:1193-1254CMAJ, 1979;121:1193-1254

Medical Research workers:Medical Research workers: The use of antithrombotic agentsThe use of antithrombotic agents

Sackett DL.Sackett DL.

Rules of evidence and clinical recommendations Rules of evidence and clinical recommendations

on use of antithrombotic on use of antithrombotic agents.agents.

Chest1986;89(2suppl.):2S-3S Chest1986;89(2suppl.):2S-3S


NHS

Level

IEvidence obtained from at least one properly designed randomised controlled trial.

II-1Evidence obtained from well-designed controlled trials without randomisation.

II-2Evidence 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.

IIIOpinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.


NHS

Acute pain management: Acute pain management: operative or medical operative or medical proceduresprocedures

Acute pain managements: Acute pain managements:

operative or a medical procedures. operative or a medical procedures.

Rockville, MD: Rockville, MD:

Agency for Health Care Policy and Research Publications Agency for Health Care Policy and Research Publications

(AHCPR Pub 92-0032), 1992.(AHCPR Pub 92-0032), 1992.


NHS

Assessing the reliability of scientific expert testimonyAssessing the reliability of scientific expert testimony

“ “Daubert-v-Merrell Dow Pharmaceuticals”Daubert-v-Merrell Dow Pharmaceuticals”

1.1. Whether the expert’s technique or theory can be or has been Whether the expert’s technique or theory can be or has been testedtested

2.2. Challenged in some Challenged in some objective objective sense or (Subjective conclusive approach sense or (Subjective conclusive approach

that cannot be reasonably assessed for reliability)that cannot be reasonably assessed for reliability)

3.3. Technique or theory has been subject to Technique or theory has been subject to peer review and publicationpeer review and publication

4.4. Known or potential Known or potential rate of errorrate of error of the technique or theory of the technique or theory

5.5. The existence and maintenance of The existence and maintenance of standards and controlsstandards and controls

6.6. Generally accepted in the Generally accepted in the scientific communityscientific community

Daubert-v-Merrell Dow Pharmaceuticals IncDaubert-v-Merrell Dow Pharmaceuticals Inc

(1993) 509 US 579(1993) 509 US 579


NHS

require expert witness to give an opinion or otherwise, if:-require expert witness to give an opinion or otherwise, if:-

1.1. The testimony is: based upon sufficient The testimony is: based upon sufficient facts or datafacts or data

2.2. Reliable Reliable principles and methodsprinciples and methods

3.3. The witness has The witness has appliedapplied the principle and methods reliably to the principle and methods reliably to the facts of the casethe facts of the case

Put to the testPut to the test

Test has been replicated by othersTest has been replicated by others

Replications have been collectively analysed, studied, published, Replications have been collectively analysed, studied, published, peer reviewed, critically appraised, retested and applied to peer reviewed, critically appraised, retested and applied to the case under assessmentthe case under assessment


NHS

The need of “Evidence Based Medicine” 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 managementfor a prescribed course of management


NHS

Escalating cost of Health CareEscalating cost of Health Care

Attempt on rationingAttempt on rationing

“ “Evidence Based Medicine”Evidence Based Medicine”

NICENICE


NHS

1.1. RCOG GuidelinesRCOG Guidelines

2.2. Medical Societies’ GuidelinesMedical Societies’ Guidelines

3.3. Cochrane ReviewsCochrane Reviews

4.4. Health Care Commission ReviewsHealth Care Commission Reviews

5.5. Medical TextbooksMedical Textbooks

6.6. NICE Review/sNICE Review/s

7.7. EBM Reviews (BMJ)EBM Reviews (BMJ)


NHS

Levels of Medical Evidence: Levels of Medical Evidence:

How much confidence exists in the DataHow much confidence exists in the Data

Case ReportCase Report

An Observational StudyAn Observational Study

A Case-Control StudyA Case-Control Study

Cohort StudyCohort Study

A Controlled Clinical TrialA Controlled Clinical Trial

A Double-blind, Randomised, Controlled Clinical TrialA Double-blind, Randomised, Controlled Clinical Trial

Washington Post 19 April 2005: HE06Washington Post 19 April 2005: HE06


NHS

Statement of evidence:Statement of evidence:

To standardise the levels of evidence to To standardise the levels of evidence to 5 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 harmdiagnosis, prognosis and harm


NHS

Level Definition

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.

Royal College ofObstetricians andGynaecologists

Setting standards to improve women’s health

Risk Management and Medico-Legal Issues In Women’s HealthJoint RCOG/ENTER Meeting

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Documents

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