MPP3 Lecture 6

Dr A Kostzrewski

What is evidence?  The hierarchy of evidence  What is evidence-based medicine?  Role of NICE, SIGN, PRODIGY, NSF, Cochrane Library  Implications of national guidance for practice

What is evidence?
A

patient tells you that the atenolol really helps to reduce her angina attacks.
group of specialists from the local area have decided by consensus that beta-blockers should be used as first-line treatment for angina. RCT of 10,000 people shows lower incidence of MI‟s and of premature death in those treated with beta-blockers compared with amlodipine.

A

A

net . case series V Consensus/expert opinion www.nice.cebm. case reports.The Hierarchy of evidence for effectiveness I Systematic reviews of RCTs.org.uk www. or RCTs II Cohort studies III Case-control studies IV Cross-sectional studies.

The Hierarchy of evidence for effectiveness Systematic reviews of RCTs. case reports. case series  Consensus/expert opinion  Increasing bias . or RCTs  Cohort studies  Case-control studies  Cross-sectional studies.

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org/index.Systematic reviews   Synthesis of studies Available studies are systematically gathered and reviewed according to pre-defined methods  i. methods are explicit and reproducible   Meta-analysis (pooling of data) undertaken if same outcomes used across studies Example – Cochrane library of systematic reviews (http://www.cochrane.e.htm) .

Systematic Review Study 1 Study 2 Study 3 Study 4 Combined results  Meta-analysis .

343: d4488 No randomised trials  6 cohort studies  One cross sectional study. BMJ.   Highest levels of chocolate consumption associated with 37% reduction in CVD 29% reduction in stroke compared with lowest levels . Buitrago-Lopez A et al (2011).CHOCOLATE CONSUMPTION AND CARDIOVASCULAR DISORDERS: SYSTEMATIC REVIEW AND META-ANALYSIS.

?generalisability . timeconsuming.Randomised Controlled Trial  Allocate intervention and comparator(s) randomly to selected population Follow-up and compare groups in terms of pre-defined outcomes Best design for evaluating interventions    Disadvantages .expensive.

RCT Treatment group Follow-up Selected population Random assignment Compare groups Control group (different treatment or none) Follow-up .

selected on basis of presence or absence of risk factor (e.Cohort  Comparison of groups.g. loss to follow-up  HRT    example – different results for RCT vs cohort studies . exposure or intervention) Follow-up from „exposure‟ (event or intervention) to outcome (predefined) Best design for prognostic studies Potential selection bias.

Cohort Group of interest e. women who are incontinent Follow over time Compare outcomes (predefined) Follow over time Comparison group e.g.g. women who are not incontinent .

Case-control  Compare a group that has an „outcome‟ with matched controls  Controls differ only in exposure to possible causal agent  Retrospective  i.e. and looks back to identify whether there is an association between exposure and outcome by identifying „non-cases‟  Useful when examining risk factors for disease (rare conditions)  Potential recall bias . starts with outcome.

Case-control Take histories Group of interest (with „outcome‟) Compare histories Draw conclusion Take histories Comparison group (no outcome. „matched‟ with group of interest) .

g.Cross-sectional  Survey  Examine exposure and outcome in a population at single time period Useful in epidemiology and public health e. prevalence  Can  identify associations but not explain them .

Cross-sectional Population Population with exposure and outcome Population surveyed at one point in time .

Case-series      Based on medical histories No comparison group New treatments or tests described in a study with no control group also fall into this category Descriptive only – can suggest trends but do not provide explanations or show associations between cause and effect Open to selection bias .

Case-series Patients Records Report .

or RCTs  Cohort studies  Case-control studies  Cross-sectional studies. case reports. case series  Consensus/expert opinion  Increasing bias .The Hierarchy of evidence for effectiveness Systematic reviews of RCTs.

Answer our question of what is evidence…. . A A RCT of 10.000 people shows lower incidence of MI‟s and of premature death in those treated with beta-blockers compared with amlodipine. group of specialists from the local area has decided by consensus that beta-blockers should be used as first-line treatment for angina. A patient tells you that the atenolol really helps to reduce her angina attacks.

What is evidence-based medicine?  Various definitions Involves “judicious” use of evidence in managing patients   Hierarchy of evidence is used to grade recommendations in guidelines („strength of evidence‟) .

Herceptin. drugs or groups of similar drugs e.National Institute for Health and Clinical Excellence (NICE) Four programmes of work  Clinical guidelines Technology appraisals   Single technologies e.g. workplace smoking  . proton pump inhibitors  Interventional procedures Public health guidance e.g.g.

NICE and evidence based practice  NICE guidance is based on best available evidence  e.g. if there is systematic review that considers the question no need to go further  also includes consideration of cost-effectiveness  Best available clinical/cost evidence + clinical interpretation/ input = NICE guidance . for a question about effectiveness.

uk .ac.sign.Scottish Intercollegiate Guidelines Network (SIGN) NICE guidance applies to both England and Wales  SIGN covers Scotland  Similar methodology   www.

g.uk   .co.prodigy. other best available evidence http://www.clarity.PRODIGY (CKS NHS Clinical Knowledge Summaries – NHS Evidence)  “A source of clinical knowledge for the NHS about the common conditions managed in primary and first contact care” Assimilates guidance from other sources e. NICE.

National Service Frameworks  Department of Health Set standards for service delivery  Examples  coronary heart disease. long-term conditions  Relationship between NICE and NSF‟s . older people.

Implications of national guidance for practice   Follow as „best practice‟ NICE Technology Appraisals  The NHS must demonstrate funding is available .

..implications for pharmacy practice  Know what the current national guidance is (and why) .beware. things change – new evidence  Ask  yourselves how old the guidance is  Where also would you go? ..

com/your-day-to-day-practice/essential-websites-for-pharmacists. PRODIGY.asp .rpharms. Cochrane Library  Implications of national guidance for practice  http://www. SIGN. NSF.Conclusions What is evidence?  The hierarchy of evidence  What is evidence-based medicine?  Role of NICE.

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