Individual patient meta-analysis of self-monitoring of an oral anticoagulation protocol.

摘要: Background and aim of the study: Oral anticoagulation with vitamin K antagonists is effective for prevention treatment thromboembolic events. Recent systematic reviews have shown that self-monitoring improved quality oral therapy (OAT), patients spending more time in therapeutic range than traditionally monitored patients, a concomitant decrease incidence adverse effects. However, methodological reporting heterogeneity has limited strength reviews' conclusions. Differences were noted terms assessment outcome measures analysis methods used. For instance, not all used an intention-to-treat analysis, which may over-inflated results. Interpretation was by missing data: example, it possible to combine mean tests range, or determine level deviant values. Time-to-event data (e.g., death, events) reported as numbers events, prevented adequate analysis. In order overcome these limitations allow further investigation data, study undertake Individual Patient Data (IPD) meta-analysis. Methods design: The IPD will include from randomized trials compared (self-testing self-management) OAT versus control group, measured events defined major hemorrhage, thromboembolism, death. be requested each trial include: outcomes, demographic psychosocial life) data. primary outcomes interest secondary minor percentage within patient satisfaction. intention treat, multilevel models two levels, explored investigate effects on various outcomes. Patient-level covariates incorporated into attempt account statistical heterogeneity, well interactions effect. Conclusion: Predictive should lead identification those most likely benefit anticoagulation, potentially also targeted cost-effective use intervention. © Copyright ICR Publishers 2008.