Objective: To compare the clinical effectiveness of point-of-care testing (PoCT) and that of pathology laboratory testing, as measured by therapeutic control in chronic conditions.
Design: Multicentre, cluster randomised controlled trial using non-inferiority analysis.
Setting: 53 Australian general practices in urban, rural and remote areas across three Australian states, September 2005 to February 2007.
Participants: 4968 patients with established type 1 or type 2 diabetes, established hyperlipidaemia, or taking anticoagulant therapy.
Intervention: The intervention group (3010 patients in 30 practices) had blood and urine samples tested by PoCT devices in their general practices, and the control group (1958 patients in 23 practices) had samples tested by their usual pathology laboratories.
Main outcome measures: The proportion of patients and of tests with results in the target range, and change in test results from baseline.
Results: For the proportion of patients with results in the target range, PoCT was found to be non-inferior to pathology laboratory testing for measuring glycated haemoglobin (HbA(1c)), urine albumin, albumin-creatinine ratio (ACR), total cholesterol and triglyceride levels but not for high-density lipoprotein (HDL) cholesterol level and international normalised ratio (INR). For the proportion of tests with results in the target range, PoCT was found to be non-inferior to pathology laboratory testing for measuring all variables except HDL cholesterol. For the proportion of patients showing an improvement in their test result from baseline, PoCT was non-inferior to pathology laboratory testing for HbA(1c), total cholesterol and triglyceride levels, but not for HDL cholesterol level.
Conclusions: This study provides important evidence for those considering the introduction of PoCT into general practice. For all tests except INR and HDL cholesterol, the PoCT approach demonstrated the same or better clinical effectiveness than pathology laboratory testing.
Trial registration: Australian Clinical Trials Registry ACTRN12612607000628448.