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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
N of 1 trials. Practical tools for medication management
C J Nikles1, P P Glasziou, C B Del Mar
1Centre for General Practice, University of Queensland, Herston Rd, Herston Qld 4006. j.nikles@spmed.uq.edu.au
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.
Discussion:
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.
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