Janice Gill

A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics.

BackgroundPoint of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT.Design/MethodsThe Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting.The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location.DiscussionThe paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories.The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding provided. The PoCT Trial is regarded as a pragmatic RCT, evaluating the effectiveness of implementing PoCT in GP and every effort was made to ensure that, in these circumstances, internal and external validity was maintained.Trial Registration12612605000272695

An innovative australian point-of-care model for urine albumin : creatinine ratio testing that supports diabetes management in indigenous medical services and has international application

Background: Type 2 diabetes is the leading cause of end-stage renal failure in Australias indigenous people. The measurement of urine albumin:creatinine ratio (ACR) as a marker for early renal disease is an important component of the management of indigenous patients with diabetes. Methods: An innovative national program (Quality Assurance for Aboriginal Medical Services [QAAMS]) for point-of-care (POC) urine ACR testing on the DCA 2000 analyser (Bayer Diagnostics) was established to monitor microalbuminuria in indigenous people with diabetes in 30 Aboriginal and Torres Strait Islander medical services across Australia. Aboriginal health workers perform the ACR test. The QAAMS model provides ongoing education and training, an annual workshop, monthly quality assurance testing and a telephone help hotline. Quality assurance testing is conducted using paired, linearly related samples with a wide range of ACR concentrations (1-25 mg/mmol). Results: The average participation rate across four six-monthly QAAMS ACR testing cycles was 83%. In all, 94% of 1163 quality assurance tests performed were within the preset limits of acceptability. The median precision (coefficient of variation percent for ACR quality assurance testing averaged 5.4%, well within desirable performance specifications. Between-site accuracy was excellent. Conclusion: This unique POC model for supporting diabetes management is the first of its type to be developed for indigenous communities and has considerable potential to be adopted worldwide.

Vitamin B1 and B6 method harmonization: comparison of performance between laboratories enrolled in the RCPA Quality Assurance Program.

OBJECTIVES The RCPA Quality Assurance Program (RCPA QAP) offers monthly proficiency testing for vitamins A, B1, B6, β-carotene, C and E to laboratories worldwide. A review of the results submitted for the whole blood vitamin B1/B6 sub-program revealed a wide dispersion. Here we describe the results of a methodology survey for vitamins B1 and B6. DESIGN AND METHODS A questionnaire was sent to thirteen laboratories. Eleven laboratories were returning QAP results for vitamin B1 (thiamine diphosphate) and five were returning results for vitamin B6 (pyridoxal-5-phosphate). RESULTS All nine respondents provided a clinical service for vitamins B1 and B6. HPLC with fluorescence detection was the most common method principle. For vitamin B1, six respondents used a commercial assay whilst three used in-house methods; whole blood was the matrix for all. For vitamin B6, five respondents used commercial assays and four used in-house assays. The choice of matrix for vitamin B6 varied with three respondents using whole blood and five using plasma for analysis. Sample preparation incorporated protein precipitation and derivatization steps. An internal standard was employed in sample preparation by only one survey respondent. CONCLUSIONS The immediate result of this survey was the incorporation of plasma vitamin B6 into the RCPA QAP vitamin program. The absence of an internal standard in current vitamin B1 and B6 assays is a likely contributor to the wide dispersion of results seen in this program. We recommend kit manufacturers and laboratories investigate the inclusion of internal standards to correct the variability that may occur during processing.

Assessing agreement between point of care and laboratory results for lipid testing from a clinical perspective.

OBJECTIVES Investigate agreement between lipid pathology results from point-of-care testing (PoCT) devices and laboratories. DESIGN AND METHODS Agreement was assessed using the Bland-Altman method. RESULTS : Mean difference (limits of agreement) were: -0.28 mmol/L (-1.04, 0.48) for total cholesterol, -0.09 mmol/L, (-0.55, 0.36) for HDL-C. Median difference (nonparametric limits of agreement) were 0.07 mmol/L, (-0.40, 3.04) for triglycerides. CONCLUSIONS The clinical acceptability of the variation between lipid PoCT and laboratory test results is debatable but our work provides baseline data for further research.

Allowable limits of performance – statistical basis and implementation

In external quality assurance programs (EQA) the analytical goal is determined by the acceptable range about the central value. Some EQA programs around the world use a statistically determined range, such as two standard deviations from the mean value of returned results, to determine the acceptable range. This gives the laboratory information to compare their performance to the performance of other laboratories but does not relate the laboratory result to the clinical management of the patient. In the Royal College of Pathologists of Australasia (RCPA) Chemical Pathology Quality Assurance Programs (QAP) the acceptable range is determined by the allowable limits of performance (ALP). The ALP is related to clinical need. A result outside the acceptable range may compromise the clinical management of the patient. ALPs have been used by the QAP since its inception in 1982 and up until recently these have been determined by expert opinion. However there now exists an internationally agreed hierarchy of preferred methods for establishing performance goals and using biological inter- and intravariability is a higher order method to expert opinion. After much discussion the QAP has begun the process of revising the ALPs based on biological variability. The considerations that are taken into account and the implementation will be discussed in detail.

The point of care testing in general practice trial

Background Point of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). Pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater satisfaction for patients and general practitioners and savings in costs and time. Methods The Point of Care Testing in General Practice Trial was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting. It involved 53 urban, rural and remote practices, 221 GPs, 76 device operators and over 5000 patients. The Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. Results The results show PoCT is safe to perform in a GP setting. For most tests, the effectiveness of PoCT is non-inferior (exception of INR and HDL). PoCT is not cost effective except for ACR, but HbA1c and lipids are in the tradeoff area. Stakeholders are more satisfied with PoCT and there were no significant geographical differences. Conclusions The trial provides evidence that PoCT does have a role in the management of chronic disease.