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 MIs and of premature death in those treated with beta-blockers compared with amlodipine.

The Hierarchy of evidence for effectiveness

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

The Hierarchy of evidence for effectiveness

Systematic reviews of RCTs, or RCTs Cohort studies Case-control studies Cross-sectional studies, case reports, case series Consensus/expert opinion

Increasing bias

Systematic reviews

Synthesis of studies Available studies are systematically gathered and reviewed according to pre-defined methods
i.e.

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.org/index.htm)

Systematic Review
Study 1 Study 2 Study 3 Study 4

Combined results Meta-analysis

CHOCOLATE CONSUMPTION AND CARDIOVASCULAR DISORDERS: SYSTEMATIC REVIEW AND META-ANALYSIS. Buitrago-Lopez A et al (2011); BMJ. 343: d4488

No randomised trials 6 cohort studies One cross sectional study.

Highest levels of chocolate consumption associated with 37% reduction in CVD 29% reduction in stroke compared with lowest levels

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, timeconsuming, ?generalisability

RCT
Treatment group Follow-up Selected population

Random assignment

Compare groups

Control group (different treatment or none)

Follow-up

Cohort

Comparison of groups, selected on basis of presence or absence of risk factor (e.g. exposure or intervention) Follow-up from exposure (event or intervention) to outcome (predefined) Best design for prognostic studies Potential selection bias, loss to follow-up
HRT

example different results for RCT vs cohort studies

Cohort
Group of interest e.g. women who are incontinent Follow over time

Compare outcomes (predefined)

Follow over time Comparison group e.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. starts with outcome, 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

Case-control
Take histories Group of interest (with outcome)

Compare histories

Draw conclusion

Take histories

Comparison group (no outcome, matched with group of interest)

Cross-sectional

Survey

Examine exposure and outcome in a population at single time period Useful in epidemiology and public health e.g. 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

The Hierarchy of evidence for effectiveness

Systematic reviews of RCTs, or RCTs Cohort studies Case-control studies Cross-sectional studies, case reports, case series Consensus/expert opinion

Increasing bias

Answer our question of what is evidence.

A

patient tells you that the atenolol really helps to reduce her angina attacks.
group of specialists from the local area has decided by consensus that beta-blockers should be used as first-line treatment for angina.

RCT of 10,000 people shows lower incidence of MIs and of premature death in those treated with beta-blockers compared with amlodipine.

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)

National Institute for Health and Clinical Excellence (NICE)

Four programmes of work

Clinical guidelines
Technology appraisals

Single technologies e.g. drugs or groups of similar drugs e.g. Herceptin, proton pump inhibitors

Interventional procedures Public health guidance e.g. workplace smoking

NICE and evidence based practice

NICE guidance is based on best available evidence

e.g. for a question about effectiveness, 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

Scottish Intercollegiate Guidelines Network (SIGN)

NICE guidance applies to both England and Wales SIGN covers Scotland Similar methodology

www.sign.ac.uk

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.g. NICE, other best available evidence
http://www.prodigy.clarity.co.uk

National Service Frameworks

Department of Health
Set standards for service delivery
Examples

coronary heart disease, older people, long-term conditions

Relationship between NICE and NSFs

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?

Conclusions
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

http://www.rpharms.com/your-day-to-day-practice/essential-websites-for-pharmacists.asp