BACKGROUND: The efficacy of self-managed oral anticoagulant therapy has been addressed in few randomized, controlled trials, which have provided inconsistent results. The aim of this study was to compare the quality of self-managed oral anticoagulant therapy with conventional management. METHODS: This was a pragmatic, open-label, randomized, controlled trial where 100 patients receiving long-term oral anticoagulant therapy referred to a Danish clinic for self-management was randomized to either self-management of oral anticoagulant therapy (including a teaching program of self-management followed by 6 months of self-management) or 6 months of conventional management. The primary endpoint was an intention-to-treat analysis of a composite score combining the variance (median square of the standard deviation) of the International Normalized Ratio (INR) value (using a blinded control sample analyzed monthly by a reference laboratory), death, major complications, or discontinuation from the study. Secondary endpoints - assessed in per-protocol analyses - were the variance of the INR value (using the blinded control sample) and time within therapeutic INR target range using the standard INR values from the coagulometer and laboratory measurement. RESULTS: There was no significant difference in the primary endpoint between the self-management and conventional management groups (composite score 0.16 vs. 0.24, respectively, p=0.09). Self-management was significantly better (0.16 vs. 0.24, p=0.003) with regard to the variance in a per-protocol analysis. The difference in time within therapeutic INR target range was not significantly better (78.7% vs. 68.9%, p=0.14) using self-management. CONCLUSION: The quality of self-management of oral anticoagulant therapy is at least as good as that provided by conventional management.
RCT Entities:
BACKGROUND: The efficacy of self-managed oral anticoagulant therapy has been addressed in few randomized, controlled trials, which have provided inconsistent results. The aim of this study was to compare the quality of self-managed oral anticoagulant therapy with conventional management. METHODS: This was a pragmatic, open-label, randomized, controlled trial where 100 patients receiving long-term oral anticoagulant therapy referred to a Danish clinic for self-management was randomized to either self-management of oral anticoagulant therapy (including a teaching program of self-management followed by 6 months of self-management) or 6 months of conventional management. The primary endpoint was an intention-to-treat analysis of a composite score combining the variance (median square of the standard deviation) of the International Normalized Ratio (INR) value (using a blinded control sample analyzed monthly by a reference laboratory), death, major complications, or discontinuation from the study. Secondary endpoints - assessed in per-protocol analyses - were the variance of the INR value (using the blinded control sample) and time within therapeutic INR target range using the standard INR values from the coagulometer and laboratory measurement. RESULTS: There was no significant difference in the primary endpoint between the self-management and conventional management groups (composite score 0.16 vs. 0.24, respectively, p=0.09). Self-management was significantly better (0.16 vs. 0.24, p=0.003) with regard to the variance in a per-protocol analysis. The difference in time within therapeutic INR target range was not significantly better (78.7% vs. 68.9%, p=0.14) using self-management. CONCLUSION: The quality of self-management of oral anticoagulant therapy is at least as good as that provided by conventional management.
Authors: Rowena J Dolor; R Lynne Ruybalid; Lauren Uyeda; Robert G Edson; Ciaran Phibbs; Julia E Vertrees; Mei-Chiung Shih; Alan K Jacobson; David B Matchar Journal: J Thromb Thrombolysis Date: 2010-10 Impact factor: 2.300
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Authors: Carl J Heneghan; Josep M Garcia-Alamino; Elizabeth A Spencer; Alison M Ward; Rafael Perera; Clare Bankhead; Pablo Alonso-Coello; David Fitzmaurice; Kamal R Mahtani; Igho J Onakpoya Journal: Cochrane Database Syst Rev Date: 2016-07-05
Authors: Andrea Siebenhofer; Klaus Jeitler; Karl Horvath; Wolfgang Habacher; Louise Schmidt; Thomas Semlitsch Journal: Dtsch Arztebl Int Date: 2014-02-07 Impact factor: 5.594
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