N of 1 trials. Practical tools for medication management.
BACKGROUND
In single patient (n of 1) trials, a patient acts as his or her own control in a study comparing the effectiveness of a drug with placebo or another drug. The aim of a single patient trial (SPT) is to identify the best treatment for the individual patient, formalising a 'trial of treatment' by using blinding and multiple crossover periods.


OBJECTIVE
We have successfully piloted SPTs for osteoarthritis and attention deficit hyperactivity disorder, and several others are currently being piloted. Barriers encountered include: obtaining identical placebos, ethical approval for individual SPTs, standardising doses, determining length of treatment periods, patient withdrawals and cost of the SPTs.


CONCLUSIONS
Only prescribing medications if an individual has been shown to be a responder can greatly benefit general practitioners, patients and the healthcare system. We have established the infrastructure necessary to offer a single patient trial service to GPs and patients anywhere in Australia. This has the potential to revolutionise prescribing for certain chronic conditions.
Nikles
C J
CJ
Centre for General Practice, University of Queensland, Herston Rd, Herston Qld 4006. j.nikles@spmed.uq.edu.au
Glasziou
P P
PP
Del Mar
C B
CB
Duggan
C M
CM
Mitchell
G
G
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D001315:Australia; D000697:Central Nervous System Stimulants / Q000008:administration & dosage*; D018849:Controlled Clinical Trials as Topic; D006801:Humans; D010003:Osteoarthritis / Q000188:drug therapy*; D018579:Patient Selection; D010865:Pilot Projects; D012680:Sensitivity and Specificity
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000697:Central Nervous System Stimulants