Case study of published trial

Question 1

describe the structure of a published clinical trial

Answer 1

1. abstract
2. methods
3. results
4. discussion

Question 2

what should be included in the methods section

Answer 2

1. why the trial was done
2. inclusion and exclusion criteria
3. consent
4. principles for conducting the trial, ethics approval
5. randomisation
6. procedures and recording of outcomes
7. statistical analysis

Question 3

what are the outcome measures in the methods section

Answer 3

1. primary outcome
2. secondary outcomes
   - eg. time until discharge
   - additional treatments needed

Question 4

what should be calculated in statistical analysis in the methods

Answer 4

1. estimate number of patients needed in order to achieve power of 90% and P value= 0.1

Question 5

what should be included in the results section

Answer 5

1. primary outcome
2. secondary outcomes

Question 6

what should be included in the discussion section

Answer 6

1. was the intervention useful
2. does the data provide compelling evidence for treatment
3. would you recommend it
4. summary statistics- risk reduction and NNT

Question 7

how do you calculate absolute risk reduction

Answer 7

ARR= absolute risk in control group (ARC)- absolute risk in treatment group (ART)

Question 8

how do you calculate the relative risk reduction

Answer 8

RRR= absolute risk reduction/absolute risk in control group

Question 9

how do you calculate NNT

Answer 9

1/ARR