N of 1 Trial

Question 1

When to conduct N of 1 trial?

Answer 1

Clinician uncertain if treatment will work for patient
Patient started medication but neither them or clinician are confident it is providing benefit
Neither are confident of optimal dose of medication
Patient has sx both suspect are caused by medication
Patient insists on taking treatment clinician feels may not work

Question 2

When is N of 1 feasible in a patient?

Answer 2

Patient eager to collaborate
Treatment has rapid onset and termination of action
Underlying condition must not be modified by treatment - only sx control
Optimal duration of treatment is feasible
Patient-important targets are amenable to measurement
Criteria of trial are identifiable
Pharmacist can help with blinding
Strategies to gather and interpret outcome

Question 3

Blinding in N of 1 trial

Answer 3

Both patient and clinician are blind
Pharmacist delivers control and active drug
Allocation in each cycle randomly determined by third party
Regular measurements

Question 4

When does N of 1 Trial stop?

Answer 4

If both patient and doctor agree to stop

When strong pattern emerged with respect to efficacy or lack thereof