Comparative Study of a Portable Prothrombin Time Monitor Employing Three Different Systems in Oral Anticoagulant Units

Vacas, Marta; Fernández, María; Martínez-Brotóns, F; Lafuente, P.J.; Ripoll, Francisco; Álvarez, Carolina Rodríguez; Iriarte, J.A.

doi:10.1159/000048040

Cited by 6 publications

(4 citation statements)

References 14 publications

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“…(1998) concluded from the results of their study that the CoaguChek monitor ‘achieved a clinically acceptable level of accuracy when compared with the traditional laboratory method and provides a suitable alternative method of monitoring the INR in patients receiving warfarin’. Vacas et al. (2001) also confirmed in a study involving capillary, plasma and whole blood samples, that the CoaguChek could be used as a new method for oral anticoagulant monitoring and is in best agreement with the capillary blood prothrombin time (PT) system.…”

Section: Discussionmentioning

confidence: 76%

Accuracy, reproducibility and clinical utility of the CoaguChek S portable international normalized ratio monitor in an outpatient anticoagulation clinic

et al. 2004

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The accuracy and reproducibility of the CoaguChek S, and its clinical agreement with conventional laboratory international normalized ratio (INR) determination, were evaluated in an outpatient anticoagulation clinic setting. Forty-three patients provided 248 paired INR measurements for analysis. The paired results were highly correlated (r = 0.90). The mean coefficient of variation for the CoaguChek S for a random sample of 21 patients with three repeated tests each, was 4%. Clinical applicability was also measured by discrepant INR values, as defined in the literature by expanded and narrow agreement, and by INR values resulting in a different clinical decision by a blinded haematology registrar. Expanded agreement and narrow agreement between the two INR values occurred 90 and 88% of the time, respectively. The stricter criteria set down by the clinician resulted in 73% of paired results producing the same dosage decision. The CoaguChek S displayed good correlation with laboratory determination of INR and compared relatively well with expanded and narrow clinical agreement criteria.

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Section: Discussionmentioning

confidence: 76%

Accuracy, reproducibility and clinical utility of the CoaguChek S portable international normalized ratio monitor in an outpatient anticoagulation clinic

et al. 2004

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“…The European Concerted Action on Anticoagulation (ECAA) among others have recommended an external calibration of the ISI value [46,50,74,76,[110][111][112]. It is possible to calibrate the CoaguChek R coagulometer using fresh, citrated plasma [75] and even lyophlized plasma [112].…”

Section: Calibrationmentioning

confidence: 99%

Self-Management of Oral Anticoagulant Therapy: A Review

Christensen

2004

J Thromb Thrombolysis

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Patient self-management of oral anticoagulant therapy has over the last years gained increasing attention and widespread use. The method implies self-testing using a coagulometer (point-of-care device) and self-dosaging of coumarin. The method entails advantages for selected patients, who do not need to go to the hospital or family doctor for blood specimen and drug dosage adjustment. In contrast to patients on conventional management, patients performing self-managing have a reduced binding to the health care system, and it allows these patients unhindered to travel and manage their job or school. Therefore, the patients have a high degree of compliance because they are highly motivated. This has been the main justification for patient self-management. Furthermore, the conducted trials have also indicated a better quality of treatment compared to conventional management. In this paper the different aspects of this new treatment modality are critically reviewed, with special focus on the published clinical studies and the evaluation of the used coagulometers.

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“…Such monitors need to be accurate over the full therapeutic range of the INR, between 2·0–4·5, and require an acceptable independent evaluation (Fitzmaurice & Machin, 2001). A number of studies have proved comparability between POC testing and conventional laboratory techniques based on POC testing by healthcare professionals (Bachour et al , 2001; Vacas et al , 2001; Havrda et al , 2002; Shiach et al , 2002; Loebstein et al , 2003; Jackson et al , 2004), whereas others have questioned the reliability of POC test INR results (Poller et al , 2003; Vacas et al , 2003). Of note, INR results obtained by technically skilled healthcare professionals using POC testing devices have been reported to be more reliable than those achieved by non‐technical trained individuals (Delaney et al , 1999).…”

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confidence: 99%

Patient self‐testing is a reliable and acceptable alternative to laboratory INR monitoring

et al. 2004

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SummaryAn ageing population and the continuing expansion of clinical indications for coumadin therapy have increased pressure on hospital anticoagulant clinics. One solution is patient self-testing (PST) of the international normalized ratio (INR) using capillary blood samples on point-of-care coagulation monitors at home. We conducted a prospective study to determine whether patients can achieve accurate INR values through PST, using the CoaguChek S (Roche Diagnostics, Lewes, UK). The main outcome measurements were: comparability of INR values obtained by PST and the hospital laboratory, patient acceptability as assessed by a questionnaire and anticoagulant control. Eighty-four patients [53 men, 31 women; median age 59 years (range 26-83)], receiving long-term oral anticoagulation (warfarin), were recruited from our Anticoagulation Clinic. Patients were randomized to weekly self-testing or continuing 4-weekly hospital laboratory monitoring of INR. Comparison of INRs (n ¼ 234) showed no significant differences between the CoaguChek (median INR 3AE02) and laboratory testing (median INR 3AE07). There was excellent correlation between the two methods (r ¼ 0AE95), with 85% of CoaguChek results within 0AE5 INR units of the laboratory method. On four occasions, differences of >1 unit INR were obtained, but in each case the patient's anticoagulation was unstable (INR >4AE5 by both methods) and the differences in INR would not have altered patient management. 87% of patients found self-testing straightforward, 87% were confident in the result they obtained and 77% preferred self-testing. We conclude that PST is a reliable alternative to hospital clinic attendance and is acceptable to the majority of suitably trained patients.

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Comparative Study of a Portable Prothrombin Time Monitor Employing Three Different Systems in Oral Anticoagulant Units

Cited by 6 publications

References 14 publications

Accuracy, reproducibility and clinical utility of the CoaguChek S portable international normalized ratio monitor in an outpatient anticoagulation clinic

Accuracy, reproducibility and clinical utility of the CoaguChek S portable international normalized ratio monitor in an outpatient anticoagulation clinic

Self-Management of Oral Anticoagulant Therapy: A Review

Patient self‐testing is a reliable and acceptable alternative to laboratory INR monitoring

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