Clinical trials

Question 1

What is evidence based medicine?

Answer 1

-Application of the best available research to clinical care, integrated with clinical expertise and patient values
- Relevant, precise, internal + external validity + Magnitude

Question 2

What are the levels of evidence ?

Answer 2

Base to top:
- In vitro research
-Animal research
- Expert opinion, textbookd
- Case reports and series
- Case controlled studies
- Cohort studies
- RCT
- SR
- MA

Question 3

What are DOES?

Answer 3

Disease Orientated Evidence (DOEs)
- Outcomes that tend to be defined on the basis of the disease being studied (surrogate studies)
- i.e. reduction in cholesterol levels
- increased bone mineral density
- Increase in FEV1

Question 4

Why are surrogate outcoes used?

Answer 4

• can be measured in more patients, as trials are smaller and shorter

Question 5

Whar are POEMs?

Answer 5

Pateient Orientated Evidence that Matters
- matter to patients and their carers

• outcomes patient need to experience and care about
  E.g. fewer strokes and heart attacks
• reduced hip fractures
• Hospitalisation for COPD

Question 6

What is a limitation of the p value?

Answer 6

• only tells us stat significance and not clinical significance

Question 7

What is a confidence interval?

Answer 7

• a way of describing how much uncertainty is associated with the estimate of the intervention effect
• gives info on both stat significance and clinical significance

Question 8

What is a 95% CI?

Answer 8

• there is a 95% probability that the true value of the effect lies somewhere within this range

Question 9

How do we apply clinical trials to patient care?

Answer 9

• Do the study participants (Demographic) reflect your patient?
• • inclusion/exclusion criteria
• Have we considered all the important patient outcomes considered? - cost , other importannt patient-orientated outcome measures
• Do the potential treatment benefits outweigh the harm and cost?