Preliminary experiences with a single-patient trials service in general practice.
OBJECTIVE
To pilot a single-patient trials (SPTs) service in general practice, designed to improve decision-making about long-term medications for chronic conditions.


METHODS
12-week within-patient, randomised, double-blind, placebo-controlled, crossover comparison of ibuprofen with paracetamol for osteoarthritis, involving three pairs of two-week treatment periods for each participating patient.


METHODS
Patients attending an academic general practice with a clinical diagnosis of osteoarthritis, with pain of at least a month's duration severe enough to warrant consideration of long-term non-steroidal anti-inflammatory drug (NSAID) use.


METHODS
Pain and stiffness; measures of overall arthritis compared with previous fortnight; preference for NSAID at the end of each two-week treatment period; use of escape analgesia; side effects; and management changes as a result of the SPTs.


RESULTS
Eight of 14 patients completed SPTs. One was a clear responder to NSAIDs, five were non-responders, and two were indefinite. Of the five who were using NSAIDs' before the SPT, two continued and three ceased using them. Clinically useful information assisted decision-making for all eight participants. Medication management changed for six.


CONCLUSIONS
Single-patient trials can be successfully implemented in general practice and might be a valuable method for GPs to identify patients who respond to medication for chronic stable conditions such as osteoarthritis, in which individual response to medication is variable.
Nikles
C J
CJ
Centre for General Practice, University of Queensland, Herston. j.nikles@spmed.uq.edu.au
Glasziou
P P
PP
Del Mar
C B
CB
Duggan
C M
CM
Clavarino
A
A
Yelland
M J
MJ
D000082:Acetaminophen / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D002908:Chronic Disease / Q000188:drug therapy*; D018592:Cross-Over Studies; D003657:Decision Making; D004311:Double-Blind Method; D005194:Family Practice; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D018401:Sample Size
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; D007052:Ibuprofen