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Effectiveness of point-of-care testing for therapeutic control of chronic conditions: results from the PoCT in General Practice Trial

Med J Aust 2009; 190 (11): 624-626.

Summary

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 (HbA1c), 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 HbA1c, 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.

  • Tanya K Bubner1
  • Caroline O Laurence1
  • Angela Gialamas1
  • Lisa N Yelland2
  • Philip Ryan2
  • Kristyn J Willson2
  • Philip Tideman3
  • Paul Worley4
  • Justin J Beilby5

  • 1 Discipline of General Practice, University of Adelaide, Adelaide, SA.
  • 2 Discipline of Public Health, University of Adelaide, Adelaide, SA.
  • 3 Integrated Cardiovascular Clinical Network SA, Flinders Medical Centre, Adelaide, SA.
  • 4 School of Medicine, Flinders University, Adelaide, SA.
  • 5 Faculty of Health Sciences, University of Adelaide, Adelaide, SA.


Acknowledgements: 

The trial was funded by the Australian Department of Health and Ageing through the Pathology Section, Diagnostics Services Branch.

The PoCT Trial Management Committee members include: Justin Beilby, Jan Gill, Briony Glastonbury, Caroline Laurence, Roger Killeen, Pamela McKittrick, Andrew St John, Debbie Stanford, David Thomas, Phil Tideman, Rosy Tirimacco and Paul Worley.

Competing interests:

None identified.

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