Overview – POCT in general practice trialThe point-of-care testing in general practice trial (the trial) was an Australian Government funded multi-centre trial, to investigate and evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction of POCT in a general practice environment which included urban, rural and remote geographic regions.14
The trial was probably the most detailed and comprehensive of its type and provided an extensive set of data which has been well researched by members of the trial management committee. The accumulated data provides a strong evidence base in support of the conclusions which have been summarised under the headings: safety, clinical effectiveness, cost effectiveness, satisfaction, geographic difference, regulatory framework and estimated Medicare Benefit Schedule (MBS) costs. The executive summary of the trial report provides an excellent overview of procedures used and outcomes obtained. Chapter 14 of the report addresses the particular issues of regulation and quality management for POCT. The key findings from Chapter 14 are summarised by the statements “The trial model provides a framework that has been proven to work within the current regulatory environment and is acceptable to all stakeholders. The trial model could form the basis of a framework for the implementation of POCT in general practice more broadly.” … “For POCT to be implemented (in general practice), an effective quality management system is essential. Clinicians need reassurance that their decisions are based on reliable, accurate and precise results to ensure that patient safety is not compromised.”21
In addition to the trial report itself, members of the trial management committee have published supplementary assessments of the data and the associated quality management procedures, as evidence to support a number of important clinical outcomes in relation to POCT. A list of publications based on trial data or its associated management procedures is provided in appendix 4.
As outlined above, the trial was conducted using well defined quality standards which included training and competency assessment, clinical governance, quality control and the requirement for participation in an external proficiency program.13 This approach to quality management has been further described in various publications from members of the trial management committee as indicated in appendix 4 and provided by Shephard etal 22,23.
Transfer of information and conclusionsThe answers to questions provided as part of the trial and conclusions derived from trial data provide important information as to the applicability of POCT in general practice. However, extrapolation of clinical or analytical information to situations where less effective quality management procedures are employed is probably inappropriate. Conclusions derived from high quality data where consistent analytical performance can be demonstrated with quality control and external quality assessment, where desirable quality goals have been achieved by internationally recognised methods,23,24,25,26,27 can not be transferred to situations in which the analytical results are provided at an inferior level of testing. The authors of the trial report also make a similar statement in the text of their summary to Chapter 14: “If POCT were to be implemented in general practice more widely, it would be necessary for a similar system (of quality management) to be adopted to ensure that the success seen in the trial could be translated into practice.”
This concept is also supported by Price and St John in their discussion regarding transferability of clinical trial data “… in applying results to other situations, it is important to ensure that the new situation has similar characteristics to that in the study (that is, observational studies in secondary care cannot necessarily be applied directly to primary care settings).”28