Mark Douglas Shephard

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

Screening for chronic kidney disease in Australia: a pilot study in the community and workplace

The pilot program Kidney Evaluation for You (KEY) was conducted in Australia to screen for chronic kidney disease (CKD). Targeting people at high risk (those with diabetes, hypertension, a first-degree relative with kidney failure, or age >50 years), KEY aimed to establish community-based screening protocols, assess efficacy in promoting changes in risk-factor management, and explore participant CKD awareness. KEY offered free cardiovascular and kidney checks using point-of-care testing for on-site pathology measurements (estimated glomerular filtration rate, hemoglobin A1c, cholesterol, hemoglobin, albuminuria), lifestyle assessment, and exit interviews. Participants were telephoned at 3 months to ascertain whether KEY advice had been followed. Community and health professional support was strong; 99% of participants rated involvement as beneficial. Of 402 high-risk individuals recruited, findings were suggestive of CKD in 20.4%. Of these, 69% had hypertension, 30% diabetes, and 40% elevated total cholesterol. All participants with CKD stage 3b or higher were aged >61 years. Overall, 58% of participants were referred to their primary care providers for further action; of these, 82% saw their doctors in the next 3 months and 94% discussed KEY results. Follow-up telephone contact was successful for 82% of participants. A change in management occurred for 67%. Thus, the KEY approach to early detection of CKD and selected referral of participants was largely successful.

Assessment of the Nova StatSensor whole blood point-of-care creatinine analyzer for the measurement of kidney function in screening for chronic kidney disease

Abstract Background: Point-of-care testing for creatinine using a fingerprick sample and resultant estimated glomerular filtration rate has potential for screening for chronic kidney disease in community settings. This study assessed the applicability of the Nova StatSensor creatinine analyzer for this purpose. Methods: Fingerprick samples from 100 patients (63 renal, 37 healthy volunteers; range 46–962 μmol/L) were assayed using two StatSensor analyzers. Lithium heparin venous plasma samples collected simultaneously were assayed in duplicate using the isotope dilution mass spectrometry-aligned Roche Creatinine Plus enzymatic assay on a Hitachi Modular P unit. Method comparison statistics and the ability of the StatSensor to correctly categorise estimated glomerular filtration rate above or below 60 mL/min were calculated pre- and post-alignment with the laboratory method. Results: StatSensor 1 creatinine results (y) were much lower than the laboratory (y=0.75x+10.2, average bias –47.3, 95% limits of agreement –208 to +113 μmol/L). For estimated glomerular filtration rates above or below 60 mL/min, 100% and 87% of results respectively agreed with the laboratory estimated glomerular filtration rate (79% and 96% post-alignment). StatSensor 2 statistics were similar. The 95% limits of agreement between StatSensor creatinine results were –35 to +34 μmol/L. Conclusions: Isotope dilution mass spectrometry alignment of the StatSensor will identify most patients with estimated glomerular filtration rate <60 mL/min, but there will be many falsely low estimated glomerular filtration rate results that require laboratory validation. Creatinine results need improvement. Clin Chem Lab Med 2010;48:1113–9.

Design, implementation and results of the quality control program for the Australian government's point of care testing in general practice trial

Background From 2005 to 2007 the Australian Government funded a multicentre, clustered randomized controlled trial to determine the clinical effectiveness, cost-effectiveness, satisfaction and safety of point of care testing (PoCT) in general practice (GP). PoC tests measured (and devices used) in the trial were haemoglobin A1c and urine albumin:creatinine ratio (DCA 2000), lipids (Cholestech LDX) and international normalized ratio (CoaguChek S). Methods An internal quality control (QC) program was developed as part of a quality management framework for the trial. PoCT device operators were provided with a colour-coded QC Result Sheet and QC Action Sheet for on-site recording and interpreting of their results. Within-practice imprecision for QC testing was calculated and compared with the analytical goals for imprecision set prior to the trial. Results The average participation rate for QC testing was 91% or greater. Median within-practice imprecision met the analytical goals for all PoC tests, except for high-density lipoprotein-cholesterol (HDL-C) where observed performance was outside the minimum goal for one level and one lot number of QC. Most practices achieved the imprecision goals for all analytes, with the principal exception of HDL-C. Conclusions Results from QC testing indicate that PoCT in the GP trial met the analytical goals set for the trial, with the exception of HDL-C.

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.

Measurement of Plasma LDL Cholesterol in Patients with Diabetes

OBJECTIVE To assess the accuracy of plasma LDL cholesterol concentrations estimated by the Friedewald formula and a direct immunoseparation method by comparison with a reference ultracentrifugation procedure in patients with diabetes. RESEARCH DESIGN AND METHODS Fasting plasma samples with triglyceride concentrations < 4.5 mmol/l were collected from 100 patients with diabetes (28 type I and 72 type II) and LDL cholesterol concentrations were compared by the three methods. RESULTS LDL cholesterol values determined by the reference β-quantitation procedure were highly correlated with both the Friedewald formula (r = 0.96) and a direct immunoseparation method (r = 0.92). Calculated (Friedewald) LDL cholesterol coincided with the reference method with < 10% error in 74% of the total diabetic group (82% of type I and 68% of type II diabetic patients). However, agreement between the direct LDL cholesterol and reference methods was significantly less (P = 0.02), with only 44% of patients having an error of < 10% (52% of type I and 41% of type II diabetic patients). The direct immunoseparation method for LDL cholesterol showed a positive bias with increasing triglyceride concentrations, particularly for patients with type II diabetes. CONCLUSIONS In the group of diabetic patients studied with plasma triglyceride concentrations < 4.5 mmol/l, the Friedewald formula provided an accurate estimation of LDL cholesterol. The direct immunoseparation method significantly overestimated LDL cholesterol at triglyceride levels between 2 and 4.5 mmol/l.

Point-of-Care Testing for Chlamydia and Gonorrhoea: Implications for Clinical Practice

Objectives Point-of-care (POC) testing for chlamydia (CT) and gonorrhoea (NG) offers a new approach to the diagnosis and management of these sexually transmitted infections (STIs) in remote Australian communities and other similar settings. Diagnosis of STIs in remote communities is typically symptom driven, and for those who are asymptomatic, treatment is generally delayed until specimens can be transported to the reference laboratory, results returned and the patient recalled. The objective of this study was to explore the clinical implications of using CT/NG POC tests in routine clinical care in remote settings. Methods In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with a range of sexual health and laboratory expertise. Results Participants highlighted the potential impact POC testing would have on different stages of the current STI management pathway in remote Aboriginal communities and how the pathway would change. They identified implications for offering a POC test, specimen collection, conducting the POC test, syndromic management of STIs, pelvic inflammatory disease diagnosis and management, interpretation and delivery of POC results, provision of treatment, contact tracing, management of client flow and wait time, and re-testing at 3 months after infection. Conclusions The introduction of POC testing to improve STI service delivery requires careful consideration of both its advantages and limitations. The findings of this study will inform protocols for the implementation of CT/NG POC testing, and also STI testing and management guidelines.

Design, implementation and initial assessment of the Northern Territory Point-of-Care Testing Program.

OBJECTIVE The objective of the study was to improve pathology services in selected remote health centres from the Northern Territory (NT) through the implementation of a quality managed point-of-care pathology testing (POCT) service. DESIGN Study of the efficacy of the POCT service after 1 year and qualitative survey of POCT device operators. SETTING The study was set in thirty-three remote health centres in the NT administered by the NT Department of Health. PARTICIPANTS Remote health centre staff at participating remote health centres participated in the study. INTERVENTIONS The introduction of the i-STAT device to perform on-site POCT. MAIN OUTCOME MEASURES The main outcome measures used in the study were the number of remote staff trained, volume of testing performed and satisfaction of POCT device operators. RESULTS One hundred and sixty-four health professional staff were trained to perform i-STAT POCT during the first year of the program. A total of 2290 POCT tests were performed on the i-STAT. The volume of testing consistently increased across the year. Tests for international normalised ratio were the most frequently performed (averaging 70 tests per month). Stakeholder satisfaction with the i-STAT device was high, with a statistically significant improvement in satisfaction levels with pathology service provision being reported after the introduction of POCT. Greater than 80% of respondents stated POCT was more convenient than the laboratory service and assisted in the stabilisation of acutely ill patients. CONCLUSIONS The NT POCT Program has been operationally effective and well received by staff working as i-STAT POCT operators in remote health centres. Retention of remote health centre staff is the most significant challenge to ensuring the programs long-term viability.

Assessment of the practicability and analytical performance of a point-of-care affinity chromatography haemoglobin A1c analyser for use in the non-laboratory setting

Background: Haemoglobin A1c (HbA1c) is a pivotal pathology test used around the world for the long-term management of patients with diabetes. Point-of-care testing (POCT) provides a convenient means for conducting HbA1c testing outside the laboratory. Methods: The practicability and analytical performance of the Micromat II POCT HbA1c analyser (Bio-Rad Laboratories, USA), which has affinity chromatography as its methods principle, was evaluated in Australia and compared with the DCA 2000 POCT device (Bayer Australia) and a laboratory-based high-performance liquid chromatography (HPLC) method. Results: Overall between-day imprecision over 10 days was 1.9% for the laboratory HPLC method, 2.2% for the DCA 2000 and 7.0% for the Micromat II. In a second study over the same time period, the Micromat IIs imprecision was 6.4%. The mean difference between the Micromat II and the laboratory method in a patient comparison (n = 100) was -0.25% (lower and upper limits of agreement -1.79 to 1.30). Conclusions: The imprecision obtained with the Micromat II was inferior to both the DCA 2000 and laboratory methods and did not meet current internationally accepted precision goals for this analyte. The Micromat IIs poor imprecision can be explained by the high degree of technical expertise needed to perform the test; its use by non-laboratory health professionals such as nurses and Aboriginal health workers in rural and remote Australia cannot be recommended.

The total apolipoprotein B/LDL-cholesterol ratio does not predict LDL particle size

Abstract Small dense low density lipoprotein (LDL Pattern B) particles are associated with low plasma concentrations of high density lipoprotein (HDL)-cholesterol and high concentrations of triglyceride and also with occurrence of coronary heart disease. Because LDL size is not measured easily, the ability of plasma total apolipoprotein (apo) B and a calculated LDL-apo B combined as a ratio with LDL-cholesterol (Friedewald) to predict LDL Pattern B (peak LDL size LDL-apo B total apo B with triglyceride and was correlated strongly (r = 0.94) with measured LDL-apo B. There was no difference in either ratio between plasma samples with LDL Pattern A (peak LDL size ≥ 25.5 nm) or Pattern B for samples with triglyceride > 2.0 mmol/l. An apo B cholesterol ratio was measured for LDL separated by ultracentrifugation and was higher in plasma with LDL Pattern B than Pattern A (P = 0.018). Nevertheless, in combination with LDL-cholesterol, neither total apo B nor a calculated LDL-apo B was useful in predicting LDL particle size.