OBJECTIVE: To compare portable coagulometer devices and conventional coagulometers. The clinical validity will be estimated via anticoagulation control (maintenance of therapeutic range), patient satisfaction, thrombotic or haemorrhagic events and mortality. Analytical validity will be studied in quality control terms. DESIGN: Systematic review. DATA SOURCES: MEDLINE and EMBASE databases, CRD, Cochrane, EMEA, FDA, EuroScan and the ClinicalTrials.gov. METHODS: Inclusion criteria were studied in patients on anticoagulation therapy who used portable coagulometer devices. In an additional undertaking, the comparison with lab references was looked for, in order to evaluate the effectiveness. The quality of selected studies was assessed according to CASPe check-list. As meta-analysis was not possible, a qualitative synthesis was made. RESULTS: Four evaluation reports and 7 systematic reviews were selected (two of them with meta-analysis). After these, 22 original articles were included for this review and they had high or very high score for CASPe check-list (≥7/10). Almost all of the studies found very high correlations between portable coagulometer devices and conventional coagulometers (r>90), and clinical advantages such as lower incidence of thromboembolism events. Three systematic reviews showed a lower mortality index. CONCLUSIONS: The analytical-validity related articles show that portable coagulometers have an equivalent effectiveness to conventional coagulometers. Studies that include patient-reported outcomes show that self-monitoring patients, by means of portable coagulometers, have better analytical measurement results and fewer rates of thromboembolic events. Survival was analysed in very few studies; nevertheless, all of these show lower mortality. Similarly, the minority of selected articles includes economic evaluations, although they suggest a better cost-effectiveness of portable coagulometers compared to the conventional mode.
OBJECTIVE: To compare portable coagulometer devices and conventional coagulometers. The clinical validity will be estimated via anticoagulation control (maintenance of therapeutic range), patient satisfaction, thrombotic or haemorrhagic events and mortality. Analytical validity will be studied in quality control terms. DESIGN: Systematic review. DATA SOURCES: MEDLINE and EMBASE databases, CRD, Cochrane, EMEA, FDA, EuroScan and the ClinicalTrials.gov. METHODS: Inclusion criteria were studied in patients on anticoagulation therapy who used portable coagulometer devices. In an additional undertaking, the comparison with lab references was looked for, in order to evaluate the effectiveness. The quality of selected studies was assessed according to CASPe check-list. As meta-analysis was not possible, a qualitative synthesis was made. RESULTS: Four evaluation reports and 7 systematic reviews were selected (two of them with meta-analysis). After these, 22 original articles were included for this review and they had high or very high score for CASPe check-list (≥7/10). Almost all of the studies found very high correlations between portable coagulometer devices and conventional coagulometers (r>90), and clinical advantages such as lower incidence of thromboembolism events. Three systematic reviews showed a lower mortality index. CONCLUSIONS: The analytical-validity related articles show that portable coagulometers have an equivalent effectiveness to conventional coagulometers. Studies that include patient-reported outcomes show that self-monitoring patients, by means of portable coagulometers, have better analytical measurement results and fewer rates of thromboembolic events. Survival was analysed in very few studies; nevertheless, all of these show lower mortality. Similarly, the minority of selected articles includes economic evaluations, although they suggest a better cost-effectiveness of portable coagulometers compared to the conventional mode.
Authors: Ingrid Leichsenring; Winfried Plesch; Volker Unkrig; Steve Kitchen; Dianne P Kitchen; Rhona Maclean; Bert Dikkeschei; Anton M H P van den Besselaar Journal: Thromb Haemost Date: 2007-05 Impact factor: 5.249
Authors: Robert W Hoel; Robert C Albright; Lisa K Beyer; Paula J Santrach; Donna L Magtibay; Stephanie L Everson; Robert D McBane Journal: Clin J Am Soc Nephrol Date: 2008-11-05 Impact factor: 8.237
Authors: Chris Gardiner; Ian Longair; Jennifer Hills; Hannah Cohen; Ian J Mackie; Samuel J Machin Journal: Am J Clin Pathol Date: 2008-03 Impact factor: 2.493
Authors: W Plesch; T Wolf; N Breitenbeck; L D Dikkeschei; A Cervero; P L Perez; A M H P van den Besselaar Journal: Thromb Res Date: 2008-06-27 Impact factor: 3.944
Authors: Mary E Bauman; Karina L Black; Mary P Massicotte; Michelle L Bauman; Stefan Kuhle; Susan Howlett-Clyne; George S Cembrowski; Laszlo Bajzar Journal: Thromb Haemost Date: 2008-06 Impact factor: 5.249
Authors: Misericòrdia Carles; Max Brosa; Juan Carlos Souto; Josep Maria Garcia-Alamino; Gordon Guyatt; Pablo Alonso-Coello Journal: BMC Health Serv Res Date: 2015-07-28 Impact factor: 2.655