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. 2008 Aug 6:9:50.
doi: 10.1186/1745-6215-9-50.

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

Caroline Laurence  1 , Angela Gialamas, Lisa Yelland, Tanya Bubner, Philip Ryan, Kristyn Willson, Briony Glastonbury, Janice Gill, Mark Shephard, Justin Beilby; Members of the PoCT Trial Management Committee
Collaborators, Affiliations

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

Caroline Laurence et al. Trials. .

Erratum in

  • Trials. 2009;10:7

Abstract

Background: Point 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/methods: The 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.

Discussion: The 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 registration: 12612605000272695.

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Figures

Figure 1
Figure 1
CONSORT diagram showing flow of clusters and participants' progress through the Trial.
See this image and copyright information in PMC

References

    1. Price CP, St John A. Point-of-Care Testing in Primary Care. In: Price CP, St John A, Hicks JM, editor. Point-of-Care Testing. Second. AACC Press; 2004.
    1. Grieve R, Beech R, Vincent J, Mazurkiewicz J. Near patient testing in diabetes clinics: appraising the costs and outcomes. Health Technol Assess. 1999;3 - PubMed
    1. Hobbs FDR, Delaney BC, Fitzmaurice DA, Wilson S, Hyde CJ, Thrope GH, Earl-Slater ASM, Jowett S, Tobias RS. A review of near patient testing in primary care. Health Technol Assess. 1997;1 - PubMed
    1. Guibert R, Schattner P, Sikaris K, Churilov L, Leibowitz R, Matthews M. Review of the Role and Value of Near Patient Testing in General Practice: Report to the Pathology Section, Diagnostics and Technology Branch, Commonwealth Department of Health and Aged Care. Melbourne ; 2001.
    1. Price CP. Regular review: Point of care testing. Br Med J. 2001;322:1285–1288. doi: 10.1136/bmj.322.7297.1285. - DOI - PMC - PubMed

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