Questions

1. Describe the key information about the trial:

   • State the intervention and control in the study – drug and regimen for each arm, duration, etc.
   • Describe the population studied – age, disease state, etc.
   • Describe the randomisation approach, assigning patient to treatments – the methods of randomisation, allocation sequence, etc.
   • Comment on the analysis of groups and if all participants accounted for its conclusion.

2. Describe two strengths of the trial:

   • State what the strength is and describe why it is a strength (5 marks for the description of each strength).

3. Describe two weaknesses of the trial:

   • State what the weakness is and describe why it is a weakness (5 marks for the description of each strength).

4. Explain what the result of the trial is:

   • State the primary outcome and the numbers for the primary outcome including the confidence interval (p-value if no confidence interval reported).
   • Describe in words what the numbers mean.
   • Comment on the clinical relevance and statistical significance.

5. Explain what the result of the trial means:

   • If the trial had a successful outcome:
     • What does that mean for the clinical management of patients?
     • Which patient groups might benefit from the intervention?
     • How might practice in your local context need to change assuming other trials also have the same outcome?
   • If the trial did not have a successful outcome:
     • Discuss the reasons for the unsuccessful outcome; e.g. if the trial was not sufficiently powered then it is still unknown whether or not there is an effect; if trial well conducted and sufficiently then the intervention does not work.