TY - JOUR
T1 - Stakeholders' views on the routine use of n-of-1 trials to improve clinical care and to make resource allocation decisions for drug use
AU - Nikles, Jane
AU - Mitchell, Geoffrey K.
AU - Clavarino, Alexandra
AU - Yelland, Michael J.
AU - Del Mar, Christopher B.
PY - 2010
Y1 - 2010
N2 - N-of-1 trials are empirical formal tests using a within-patient randomised, double-blind, cross-over comparison of drug and placebo (or another drug), which we adapted to study individual patients' responses as a clinical tool to guide clinical management. We administered semi-structured interviews to gauge stakeholder perspectives on the possibility of using routine n-of-1 trials for this purpose. Stakeholders included government and non-government health care sector, and patient, clinician and consumer, organisations. Stakeholders supported more widespread implementation of n-of-1 trials, in a targeted fashion, with some caveats. Barriers to their widespread implementation included constraints on doctors' time, doctors' acceptance, drug company acceptance, patient willingness, and cost. Strategies for overcoming barriers included conditional Pharmaceutical Benefits Scheme listing if cost-effective. There was little consensus on which model of n-of-1 trial implementation would be most effective. We discuss different approaches to addressing the several concerns raised to enable widespread introduction of n-of-1 trials into routine clinical practice as a decision tool.
AB - N-of-1 trials are empirical formal tests using a within-patient randomised, double-blind, cross-over comparison of drug and placebo (or another drug), which we adapted to study individual patients' responses as a clinical tool to guide clinical management. We administered semi-structured interviews to gauge stakeholder perspectives on the possibility of using routine n-of-1 trials for this purpose. Stakeholders included government and non-government health care sector, and patient, clinician and consumer, organisations. Stakeholders supported more widespread implementation of n-of-1 trials, in a targeted fashion, with some caveats. Barriers to their widespread implementation included constraints on doctors' time, doctors' acceptance, drug company acceptance, patient willingness, and cost. Strategies for overcoming barriers included conditional Pharmaceutical Benefits Scheme listing if cost-effective. There was little consensus on which model of n-of-1 trial implementation would be most effective. We discuss different approaches to addressing the several concerns raised to enable widespread introduction of n-of-1 trials into routine clinical practice as a decision tool.
UR - http://www.scopus.com/inward/record.url?scp=77951918098&partnerID=8YFLogxK
U2 - 10.1071/AH09654
DO - 10.1071/AH09654
M3 - Article
C2 - 20334770
AN - SCOPUS:77951918098
SN - 0156-5788
VL - 34
SP - 131
EP - 136
JO - Australian Health Review
JF - Australian Health Review
IS - 1
ER -