Point of Care Testing Trial Report - Executive Summary
5. Are there differences between urban, rural and remote geographic regions in any of the parameters measured?
Analyses were undertaken to determine whether there were differences between urban, rural and remote geographic regions in any of the outcomes measured.
To test for evidence of effect modification by geographic location, analyses for clinical effectiveness and stakeholder satisfaction were repeated with a geographic location effect, as well as an interaction between treatment group and geographic location. Post hoc tests were performed to examine the effect of treatment separately within each geographic region. Descriptive analyses to determine the influence of geographic location were completed for QA test results, standards and accreditation, PoCT versus laboratory test results and SAEs and incidents. A Kruskall Wallis analysis was completed for QC results by geographic location.
Key Findings
- analysis of the analytical imprecision observed for QC testing found, in general, no difference across geographic locations. There was no pattern for unacceptable results for QA testing by geographic location for all tests
- some variation was observed between geographic location and the level of agreement between the PoCT and laboratory testing. Remote practices had the widest limits of agreement
- the proportion of dual INR test results that satisfied the narrow (89.7% urban, 88.6% rural, 87.6% remote) and expanded (91.6% urban, 91.6% rural, 90.7% remote) criteria was similar across geographic location
- the proportion of dual readings within 0.5 units for INR by geographic location was similar for results <4.0. For results >4.0 there were lower levels of agreement across all geographic locations, particularly so for remote areas (58.8% compared to 82.3% rural and 68.1% urban)
- evaluation of the (Interim) Standards for PoCT found that urban GPs were more unsure about their applicability than rural and remote GPs, while Device Operator responses did not vary by geographic location
- all urban practices complied fully at the first accreditation visit, while 90% of rural practices and 70% of remote practices complied, the latter requiring review before achieving accreditation. All practices in all regions complied fully at the second accreditation visit
- while some differences in SAEs by geographic location were found, all SAEs were deemed unlikely to be related to the Trial
- the percentage of operator, patient and Trial related incidents was similar across all geographic regions
- there was no evidence of effect modification by geographic area for any of the hypotheses related to therapeutic control
- patients in the intervention group from rural and remote areas had a higher number of GP visits per person-year compared with the control group (p<0.05), whereas patients in both treatment groups from urban areas had similar numbers of GP visits
- there was no evidence of effect modification by geographic area for the hypothesis related to patient compliance with disease management (use of medicines)
- there was evidence of effect modification by geographic area for hypotheses relating to the average change in patient attitudes (p<0.05)
- there was no evidence of effect modification by geographic area for hypotheses relating to the average change in attitudes for GPs and Device Operators
- there was no evidence of effect modification by geographic area for hypotheses relating to satisfaction for patients and GPs.


