Evidence, guidelines and practice: the way forward in a digital age

1. - Evidence, warts and all - Evidence, guidelines and practice: the way forward in a digital age SYDNEY 11 April, 2013 Bill Runciman Professor – Patient Safety & Healthcare Human Factors – University of South Australia- Centre for Sleep Research Research Fellow, Australian Institute of Health Innovation, University of NSW Clinical Professor – Joanna Briggs Institute, Faculty Health Sciences – The University of Adelaide President, Australian Patient Safety Foundation Adam Dunn Senior Research Fellow, Australian Institute of Health Innovation

2. - Evidence - • Evidence is and includes everything that is used to reveal and determine the truth • Giving or procuring evidence is the process of using those things that are: • Presumed to be true or are • Proven by prior evidence (truth)

3. - Evidence - Eccles et al - Evidence from: Ia - meta-analysis of RCT’s Ib - at least one RCT II - at least one controlled study without randomisation III - comparative studies care-control studies correlation studies IV - consensus (expert reports/opinions)

4. - Consensus - “Experts”: self-selected, sometimes contaminated by vested interests • commercial • professional • personal • financial Guidelines that don’t guide

5. - Evidence issues and effects - Over claiming (efficacy, safety) Proclamations of “new standard of care” Over-diagnosis Over-testing Over-monitoring Over-treating Bias-dishonesty

6. - Evidence –Bias - dishonesty Design biases Publication biases Reporting biases Synthesis biases Marketing biases Media biases Denial/concealment biases

7. - Design biases - Little comparative effectiveness research Deliberate avoidance of unfavourable comparisons Unethical placebo studies Low doses of comparators for drugs

8. - Publication biases - Non-publication of negative results Refusal to allow scrutiny of data Duplicate publications Re-using subject data

9. - Reporting biases - Industry influence Shadow writers Results not those foreshadowed in trial registers Unwarranted conclusions which do not match the results Partial or biased reporting leading to distortions (safety, efficacy)

10. - Citation biases - Citation distortions can create unfounded authority Unfavourable studies can be ignored Supportive evidence can be over-cited

11. - Synthesis bias - Search and citation criteria Interpretation of articles found Selection of articles found Creation of presumptions “Low level” evidence ignored or discounted

12. - Other biases - • Marketing biases • off label prescribing • direct marketing • Media biases • Denial/concealment biases • Threats to “whistle-blowers”

13. - What should we do? - Review the whole area Develop further checklists Regulation ??? Transparency Penalties ??? Discount studies Publicity ??? Conflicts of interest ???