II. Trial Preparation

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a) Selection of devices for the Trial and training of Device Operators

Flinders Consulting Pty Ltd (Flinders Consulting) was contracted by the Department of Health and Ageing to supply and distribute the testing devices and provide training and ongoing support for Device Operators. In conjunction with researchers at Flinders University Rural Clinical School, Flinders Consulting selected the devices and suppliers to be used for the Trial. Based on best available evidence in 2004, the following devices were selected:

DCA 2000+ as the point of care analyser for HbA1c and urine ACR, supplied by Bayer Australia (now Siemens);
Cholestech LDX as the point of care analyser for lipids (total cholesterol, HDL-C and triglyceride) supplied by Point of Care Diagnostics; and
CoaguChek S as the point of care analyser for INR supplied by Roche Diagnostics Australia.

Flinders Consulting provided initial training and ongoing support for operators of the devices during
the trial.
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The key conclusion is:

the devices selected for the trial were satisfactory# and the training and ongoing support was appropriate

# In October 2006 Roche Diagnostics Australia advised of an international recall of testing strips for the CoaguChek S INR testing device. The Product Safety Notice identified that the testing strips might occasionally lead to an abnormally high INR test result due to a manufacturing fault. An urgent notice was issued by Flinders Consulting providing instructions on the duplicate testing procedure to be followed when using testing strips from a different batch to ensure the integrity of testing and the subsequent data analysis.

b) Recruitment of participants

Practices were recruited through the support of local Node Support Officers and Divisions of General Practice. Randomisation and allocation to treatment group occurred prior to the initial training on use of PoCT devices, the Trial protocols and data collection processes.

Interest from all stakeholders in participating in the Trial was high and the Trial achieved excellent retention rates.

c) Participant baseline description

Baseline characteristics of the four participant groups involved in the PoCT Trial – patients, GPs, Device Operators and Pathology Providers – were collected through baseline questionnaires. A high response rate was obtained for all groups except Pathology Providers.

The key findings were:

the practices based in rural and remote locations tended to be solo (48%), bulk billed (100%), had smaller patient numbers and an older patient profile
a higher percentage of urban practices used their computer systems for disease register (82%) and recall systems (100%)
the characteristics of the GPs in the Trial were similar to those found across the GP workforce. The majority were vocationally registered (89%), with a median number of years in general practice of 16 years, worked between five and nine sessions per week and were male (63%)
Device Operators were mainly female (93%), with a median age of 45 years and were qualified as nurses
patients recruited to the Trial tended to be older (75%), male (53%), married (72%), born in Australia (77%) and many had retired (54%)
the most common co-morbidities for patients (other than the conditions in the Trial) were previous heart attack (15%), coronary heart disease (15%), and depression or anxiety (14%)
atrial fibrillation was the most common reason for patients being on anticoagulant therapy (38%)
the Pathology Providers recruited for the Trial had similar characteristics. They serviced a mixture of private and public patients, provided laboratory and collection services, with technicians and scientists forming the majority of staff.

The key conclusions are:

on the whole, participants in each treatment group had similar characteristics, although when analysed by geographic location, a number of rural/urban differences were found
the characteristics and patterns found in the baseline descriptions reflect the general practice workforce profile and the practice structure. The characteristics of patients reflect the conditions being evaluated.Top of Page

d) Systematic review of PoCT in general practice literature

A systematic review of the literature on PoCT was conducted to assess whether the available evidence relating to the safety, clinical effectiveness, cost and patient and health professional satisfaction supported the introduction of PoCT for diabetes, hyperlipidaemia and patients requiring anticoagulant therapy on a population-wide basis in Australian general practice.

Studies of adults 18 years and older treated for diabetes, hyperlipidaemia and anticoagulant therapy in a GP setting in either an urban, rural or remote geographic location were included. The studies included in the review were aimed at determining the safety, clinical effectiveness, cost and satisfaction of patients and health professionals with PoCT compared to usual care (pathology laboratory testing). All study designs were included in the search.

All titles and abstracts were independently assessed by two review authors. All randomised controlled trials were assessed independently by two review authors and all other study designs were assessed individually.

Twenty-nine studies were included in the review which included six RCTs of which three produced two papers.

The key findings were:

in terms of clinical effectiveness, only one study found a significant difference between PoCT and usual care (pathology laboratory testing)
studies relating to the safety or quality of PoCT by comparing agreement of PoCT results to pathology laboratory results were limited, with variable analytical methods used to show the agreement between the methods, making conclusions difficult to draw
conclusions about the costs of PoCT were also difficult to draw because of limited studies with variable analyses and findings
patient and health professional satisfaction towards PoCT was generally positive. However, small participant numbers and no comparative analyses completed in most of the studies were limitations that needed to be considered.

The key conclusion is:

the systematic review of the PoCT literature in GP does not provide good evidence that PoCT improves patient health outcomes, that it has comparable analytical quality to pathology laboratory testing or that it is cost-effective compared to usual care. Most studies found that patients and health professionals were satisfied and found PoCT to be acceptable.

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