Review: Policies, procedures and guidelines for point-of-care testing

Appendix 6. Summary of the objectives and conclusions for the clinical trials involving

Page last updated: 14 May 2013

POCT as discussed under the heading “POCT, clinical trials and evidence-based practice”.

  • Australian Government point-of-care testing in general practice trial (refer to item 5.0 above), reference 7.
    Overall summary – executive 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 self- management and providing regular follow-up. For other aspects, such as general practitioners 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 (albumin creatinine ratio) 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.”
  • Point-of-care testing: randomised controlled trial of clinical outcomes.
    Kendall etal, reference 124.
    Objectives:

    “To describe the proportion of patients attending an accident and emergency department for whom blood analysis at the point of care brought about a change in management; to measure the extent to which point of care testing resulted in differences in clinical outcome for these patients when compared with patients whose samples were tested by the hospital laboratory.”
    Conclusion:
    “Point of care testing reduced the time taken to make decisions on patient management that were dependent on the results of blood tests. It also brought about faster changes in treatment for which timing was considered to be critical in about 7% of patients. These changes did not affect clinical outcome or the amount of time patients spent in the department.”
  • Changes in clinical practice and patient disposition following the introduction of point-of-care testing in a rural hospital. Blattner etal, reference 125.
    Objectives:

    “To determine whether the practical impact of point-of-care (POC) laboratory testing justifies its use in a remote rural hospital (Rawene hospital New Zealand).”
    Conclusions:
    “POC testing helps address inequity in acute health care provision for a disadvantaged rural community by allowing rural clinicians access to necessary and critical investigations in a clinically relevant turn-around time.”
  • A review of near patient testing in primary care. Hobbs etal, reference 126.
    Objectives:
    "
    “To identify publications relating to near patient testing (NPT), the use of alternative delivery systems between laboratory and general practice, including electronic data interchange (EDI), and computerised diagnostic decision support (CDDS), in the primary care setting to answer the following questions:
    • what is the availability of NPT for primary care
    • what evidence is available to support the clinical effectiveness of NPT
    • what evidence is available on the accuracy and reliability of NPT within primary care
    • what evidence is available on the cost effectiveness of different NPTs
    • how may CDDS improve the effectiveness of NPT
    • what evidence is available that compares NPT and existing laboratory services
    • what evidence is available on the cost-effectiveness of EDI or alternative delivery systems ?”
    Conclusions:
    “There is little evidence to support the general introduction of NPT in general practice in preference to existing laboratory services, other than as part of a rigorous, controlled evaluation. There may be specific clinical areas where NPT may provide additional value to patients, particularly in the areas of early diagnosis, screening, and monitoring of chronic disease. The provision of additional diagnostic information during a consultation may enable primary care physicians to improve the quality and accuracy of their diagnoses, with potential benefit to patients. Such selective introduction of NPT should only take place after evaluation. Even if there is a substantial increase in NPT in primary care, the laboratory service will continue to provide its existing service, and may need to expand its role in support of quality control and training of practice staff. Although unevaluated, one potential means of introducing NPT into primary care is through laboratory outreach. Specific practice protocols that give details of the clinical indications for testing, staff training and the necessary quality control procedures may be required to support the introduction of NPT.”
  • Near patient testing in diabetes clinics: appraising the costs and outcomes. Grieve etal, reference 127.
    Objectives:

    “To compare the costs and consequences of providing test results by near patient testing (NPT) compared with conventional testing. The effect of the testing method on the process of care, the accuracy of testing, patient satisfaction, clinical attitudes, and health service and patient costs were investigated. A secondary aim was to generate hypotheses concerning the effect of the testing method on clinical outcome.”
    Conclusions:
    “A controlled trial compared the effect of the testing method on the process of care. A total of 599 patients were alternately allocated to either nurse NPT or conventional testing. The number of management changes to the patients’ diet, insulin or tablet therapy was recorded for all the patients. Results showed that patients were more likely to have a change in management related to their glycaemic control if they had been in the NPT rather than the conventional testing group (odds ratio 1.52; 95% confidence interval (CI) 1.02–2.26). Subgroup analysis showed that patients with poor glycaemic control were more likely to have management changes in the NPT than in the conventional group (odds ratio 1.75; 95% CI 1.12–2.76). For patients with good control the number of management changes did not differ according to the testing method employed (odds ratio 0.92, 95% CI 0.35–2.44). This suggested that the process of care may be improved if results related to glycaemic control (HbA 1C) are provided by NPT. There did not seem to be any improvement in the process of care from providing lipid or creatinine results immediately, which suggests that the merits of NPT are likely to vary according to the test in question.”
  • A prospective randomised controlled trial of point-of-care testing on the coronary care unit. Collinson etal, reference 128
    Objectives:

    Perform “a prospective randomized controlled trial to compare measurement of the cardiac biomarker cTnT (cardiac Troponin T) by central laboratory testing (CLT) with point-of-care testing (POCT) performed in the coronary care unit (CCU).
    The staff involved in routine patient care performed the analyses. The objective was to assess the impact of POCT on patient management overall and in low risk (rapid rule-out) patients.”
    Conclusion:
    “A combination of rapid biochemical diagnosis and structured decision making reduces length of hospital stay.”
  • A multicenter randomised controlled trial comparing central laboratory testing and POCT cardiac marker testing strategies: the disposition impacted by serial POCT markers in acute coronary syndromes. Ryan etal, reference 129.
    Objectives:

    “Point-of-care testing reduces time to cardiac marker results in patients evaluated for acute coronary syndromes, yet evidence this translates to a decreased length of stay is lacking. We hypothesized that point-of-care testing decreases length of stay in patients being evaluated for acute coronary syndromes in the emergency department (ED).”
    Conclusion:
    “The effect of point-of-care testing on length of stay in the ED varies between settings. At one site, point-of-care testing decreased time to admission, whereas at another, point-of-care testing increased time to discharge. Potential effects of point-of-care testing on patient throughput should be considered in the full context of ED operations.”
  • A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management. Fitzmaurice etal, reference 130.
    Objectives:

    “To test whether patient self management is as safe, in terms of clinical effectiveness, as primary care management within the UK, as assessed by therapeutic international normalised ratio (INR) control.”
    Conclusion:
    “These are the first UK data to demonstrate that patient self management is as safe as primary care management for a selected population. Further studies are needed to elucidate whether this model of care is suitable for a larger population.”
  • Self management of oral anticoagulation: Randomised trial. Fitzmaurice etal, reference 131.
    Objectives:

    “To determine the clinical effectiveness of self management compared with routine care in patients on long term oral anticoagulants.”
    Conclusion:
    “With appropriate training, self management is safe and reliable for a sizeable proportion of patients receiving oral anticoagulation treatment. It may improve the time spent within the therapeutic range for patients with initially poor control.”
  • Anticoagulation management in primary care: a trial-based economic evaluation. Parry etal, reference 132.
    Objectives:

    “To determine the cost and cost-effectiveness of primary care based anticoagulation management in comparison with ‘traditional’ hospital care-based provision by means of a cost-effectiveness analysis using data from a Birmingham based multicentre randomized controlled trial.”
    Conclusion:
    “The costs per patient per year in primary care were 170 [95% confidence interval (CI) 149190] vs. 69 (95% CI 5781). Sensitivity analysis demonstrated that the cost in primary care could be reduced to under 100 per patient per year under plausible changes in the variables. Primary care provides similar levels of control to secondary care for patients on anticoagulation therapy. There is an increased cost of managing patients in primary care and at no point did primary care become a lower cost option than secondary care. Local decision- makers need to assess the increased cost of primary care anticoagulation management in terms of the potential reductions in high-cost serious adverse events.
  • Comparing the quality of oral anticoagulant management by anticoagulation clinics and by family physicians: a randomised controlled trial. Wilson etal, reference 133.
    Objectives:

    To assess whether “better outcomes are achieved when anticoagulation is managed by anticoagulation clinics rather that family physicians.” A randomised controlled trial was performed “to evaluate these two models of anticoagulant care.”
    Conclusion:
    “Anticoagulation clinics provide better oral anticoagulant management than family physicians, but the differences were relatively modest.”
  • Randomised controlled trial of near-patient testing for glycated haemoglobin in people with type 2 diabetes mellitus. Khunti etal, reference 134.
    Objectives:

    “To assess the effect and costs of rapid testing for glycated haemoglobin (HbA1c) in people with type 2 diabetes.” A pragmatic open randomised controlled trial.
    Conclusion:
    “Near-patient testing for HbA1c alone does not lead to outcome or cost benefits in managing people with type 2 diabetes in primary care. Further research is required into the use of rapid testing as part of an optimized patient management model including arrangements for patient review and testing.
  • Point-of-care testing for HbA1c in the management of diabetes: A systematic review and metaanalysis. AL-Ansay etal, reference 77.
    Objectives:

    “To perform a systematic review of current trials to determine whether POCT for HbA1c, compared with conventional laboratory testing, improves outcomes for patients with diabetes.”
    Conclusions:
    “There is an absence of evidence in clinical trials data to date for the effectiveness of POCT for HbA1c in the management of diabetes. In future studies attention to trial design is needed to ensure appropriate selection and stratification of patients, collection of outcome measures, and action taken upon HbA1c results when produced.”