Implementing a new drug or technique (APA Cambridge 21. June 2013)

Tom G. Hansen, MD, PhD, Department of Anaesthesia & Intensive Care Odense University Hospital & University of Southern DenmarkDENMARKEmail: tomghansen@dadlnet.dk

Tenets of evidence based- medicine

Hierarchy of evidence

1. Systematic review of RCTs2. A single RCT3. Observational studies4. Case series and reports

Two caveats……..

• Applicability of RCTs• Quality of evidence:

large observational study vs. a small RCT

Gap between need from public health perspective and what can be afforded

Slow implementation

Clinical guidelines

The WHO definition:……systematically developed evidence

based statements which asisst providers, recipients and other stakeholders to make informed decisions about appropriate health interventions…………

Clinical guidelines: - Aims• Appropriate care• Best available evidence • Multidisciplinary groups• Systematic and transparent concensus

processes• End-user involvement• Adaptations should be re-edited• Guidance of doctors• Do not replace knowledge and skills

AGREE-II (www.agreetrust.org)23-point checklist: ….scope and purpose ….stakeholder involvement ….rigour of development ….clarity ….presentation ….applicability ….editorial independence

Guidelines - prosFacilitate EBMVariation in practiceDiscourage outdated practiceEfficiency healthcare↑ Freeing resources?Awareness on subjects↑Source of practical adviceStandardize clinical management

Guidelines - conDesigned for ”average” patients Implementation difficult:

- lack of expertise- disagreement- resources

Professional judgement Conflicts of interestExpensiveAuthorityDuplicationLack of relevant research of high qualityLegal consequences

Types of knowledge

→Explicit knowledge

→”tacit knowledge”

Requirements to guidelines• Support not constraint• Address practical questions• Short and concise• Standardized (e.g. AGREE-II)• New→ Why? Add? Divergence?• Evidense ↔ Expert opinion• Conflicts of interest• Reviewing• Revision

Who develops the guidelines?

• Local departments/hospitals• Cluster of hospitals• National• International/continental

A simple clinical question!

Expensive new evidence

The Fujii story

Retracted articles by Fujii 1991-2011

New metaanalysis withut Fujii’s studies

Carlisle’s Conclusions

……………. if data with unusual distributions

are removed from meta-analysis and articles

by Fujii et al. excluded, then the antiemetic

effects of granisetron and ramosetron are

greatly reduced; further, there is no evidence

of synergism between antiemetics and

indeed, some evidence of antagonism

between antiemetic agents…………...

Conclusions• Transfer of research possible but success

varies• Gap between recommended and received

healthcare• Causes of knowing-doing gaps unknown• Complex and context dependent process• Need for assessment of interventions• Best implementation strategy unknown• Economics?

Aesop

After all is said and done.……..more is said than done…..