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

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 Denmark DENMARK Email: tomghansen@dadlnet.dk. Tenets of evidence based- medicine.

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

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  1. 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 Denmark DENMARK Email: tomghansen@dadlnet.dk

  2. Tenets of evidence based- medicine

  3. Hierarchy of evidence Systematic review of RCTs A single RCT Observational studies Case series and reports

  4. Two caveats…….. Applicability of RCTs Quality of evidence: large observational study vs. a small RCT

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

  6. Slow implementation

  7. 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…………

  8. 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

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

  10. Guidelines - pros Facilitate EBM Variation in practice Discourage outdated practice Efficiency healthcare↑  Freeing resources? Awareness on subjects↑ Source of practical advice Standardize clinical management

  11. Guidelines - con Designed for ”average” patients Implementation difficult: - lack of expertise - disagreement - resources Professional judgement  Conflicts of interest Expensive Authority Duplication Lack of relevant research of high quality Legal consequences

  12. Types of knowledge →Explicit knowledge →”tacit knowledge”

  13. 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

  14. Who develops the guidelines? Local departments/hospitals Cluster of hospitals National International/continental

  15. A simple clinical question!

  16. Expensive new evidence

  17. The Fujii story

  18. Retracted articles by Fujii 1991-2011

  19. New metaanalysis withut Fujii’s studies

  20. 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…………...

  21. 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?

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

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