Point of Care Testing Trial Report - Executive Summary

V. Overall Conclusions and Summary

Up to Point of Care Testing

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The following conclusions relate to the seven key research questions for the Trial:

1. Safety

It was safe to perform PoCT as assessed by the competency of Device Operators, quality assurance performance for HbA1c and ACR, analytical standards achieved for quality control (QC) testing (overall), agreement between PoCT and laboratory results, compliance with the Standards (accreditation), SAEs attributable to PoCT, SAEs per person year (overall) and the proportion of patients experiencing one or more SAEs (overall).

However, the results were less clear for some areas and may require further investigation. Quality control results did not meet the analytical goals for imprecision for one QC level for HDL-C. Quality assurance acceptable levels of accuracy were not clear for INR, total cholesterol (all geographic areas), HDL-C and triglyceride tests in remote locations. QA results did not meet the imprecision analytical goals for total cholesterol, HDL-C and triglycerides. Remote locations showed more imprecision and this requires further investigation. There were also some differences in SAEs by geographic location but all SAEs were deemed unlikely to be related to the Trial.

2. Clinical Effectiveness

The effectiveness of PoCT was the same or better (non-inferior) than pathology testing for the proportion of patients within target range for HbA1c, urine albumin, ACR, total cholesterol and triglycerides and the proportion of tests within target range for INR, HbA1c, urine albumin, ACR, total cholesterol and triglycerides. PoCT was non-inferior to pathology testing in relation to the proportion of MARS-5 responses indicating compliance with disease management. The number of GP visits for PoCT patients per person-year was different (greater) than control patients for all tests and PoCT GPs undertook a greater number of processes of care actions for INR and microalbumin compared to those carried out by control GPs. Top of Page

However, for some areas the results were less clear and may require further investigation. The proportion of PoCT patients who had results within target range was not the same or better for intervention patients who underwent INR and HDL-C testing when compared with control patients. Additionally, the proportion of tests within the target range in PoCT practices was not the same or better for intervention patients who underwent HDL-C testing when compared with control patients. Finally, the processes of care actions undertaken by PoCT GPs were similar to those carried out by control GPs for total cholesterol, HDL-C, triglycerides, and HbA1c.

3. Cost-Effectiveness

In terms of the incremental cost-effectiveness ratio for PoCT versus laboratory testing, ACR testing using a PoCT device appeared to dominate its comparator in a general practice setting. On the other hand, INR using PoCT was dominated. The other two tests (HbA1c and lipids) generated
health gains but at an extra cost.

4. Satisfaction

In terms of attitudes and satisfaction towards PoCT the Trial found an improvement in attitudes in most areas over the Trial period for patients, GPs and Device Operators. Patients, GPs and Device Operators were also more satisfied with PoCT in most areas. The only stakeholder where no change in the level of satisfaction with PoCT was found was with the Pathology Providers.

5. Geographic Differences

The Trial did not find any consistent and significant differences between urban, rural and remote geographic regions for any of the parameters measured. These included QC and QA, testing results, compliance with accreditation, incidences of SAEs, therapeutic control results, patient
compliance and general satisfaction.

6. Regulatory Framework

The regulatory environment used for the Trial was found to be acceptable and supported by all stakeholders (general practice, patients, pathology providers and government representatives) in the general practice setting.

7. Estimated MBS Test Cost

Unit Cost

The estimated unit costs of PoCT in general practice calculated from data collected during the Trial and updated to 2008 prices are:
INR $20.02 per test
HbA1c $75.88 per test
UrineACR $87.80 per test
Lipids $66.84 per test
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Possible MBS Fees

If the same formula used for other pathology tests is applied to the PoCT unit cost for each test, the MBS fees would be as follows:
INR $24.12 per test
HbA1c $91.42 per test
Urine ACR $105.78 per test
Lipids $80.53 per test

Existing MBS Fees

The existing MBS fees for these tests, if performed in a pathology laboratory, are as follows:
INR $14.05 per test
HbA1c $17.10 per test
Urine ACR $20.50 per test
Lipids $9.75 per test

It can be seen that the estimated costs based on calculations from the data collected from the
Trial are much higher than the equivalent tests provided by a pathology laboratory.

Summary

The PoCT Trial in a General Practice setting was formulated with the notion that PoCT could assist general practitioners and patients with the management of chronic illness. The Trial provides evidence that PoCT does have a role in assisting the primary health care team in the management of chronic disease, particularly in the areas of optimising therapy, engaging patients in their selfmanagement and providing regular follow-up.

For other aspects, such as GPs adhering to evidence-based guidelines, the results are less clear. The cost-effectiveness analysis showed that PoCT was not cost-effective for any of the tests examined during the Trial with the exception of urine ACR testing. However, the decision to fund PoCT in a general practice setting needs to consider the positive health benefits of the intervention and potential societal gain of maintaining a patient within target range. Top of Page

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