Heneghan, C; Ward, A; Perera, R; Bankhead, C; Fuller, A; Stevens, S; Bradford, K; ... The Self-Monitoring Trialist Collaboration; + view all Heneghan, C; Ward, A; Perera, R; Bankhead, C; Fuller, A; Stevens, S; Bradford, K; Tyndel, S; Alonso-Coello, P; Ansell, J; Beyth, R; Bernardo, A; Christensen, TD; Cromheecke, M; Edson, RG; Fitzmaurice, D; Gadisseur, APA; Garcia-Alamino, JM; Gardiner, C; Hasenkam, M; Jacobson, A; Kaatz, S; Kamali, F; Khan, TI; Knight, E; Körtke, H; Levi, M; Matchar, DB; Menéndez-Jándula, B; Rakovac, I; Schaefer, C; Siebenhofer, A; Souto, JC; Sunderji, R; Gin, K; Shalansky, K; Völler, H; Wagner, O; Zittermann, A; The Self-Monitoring Trialist Collaboration; - view fewer (2012) Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. The Lancet , 379 (9813) pp. 322-334. 10.1016/S0140-6736(11)61294-4.

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Abstract

Background: Uptake of self-testing and self-management of oral anticoagulation has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in the evidence, including an estimate of the effect on time to death, first major haemorrhage, and thromboembolism. / Methods: We searched Ovid versions of Embase (1980–2009) and Medline (1966–2009), limiting searches to randomised trials with a maximally sensitive strategy. We approached all authors of included trials and requested individual patient data: primary outcomes were time to death, first major haemorrhage, and first thromboembolic event. We did prespecified subgroup analyses according to age, type of control-group care (anticoagulation-clinic care vs primary care), self-testing alone versus self-management, and sex. We analysed patients with mechanical heart valves or atrial fibrillation separately. We used a random-effect model method to calculate pooled hazard ratios and did tests for interaction and heterogeneity, and calculated a time-specific number needed to treat. / Findings: Of 1357 abstracts, we included 11 trials with data for 6417 participants and 12 800 person-years of follow-up. We reported a significant reduction in thromboembolic events in the self-monitoring group (hazard ratio 0·51; 95% CI 0·31–0·85) but not for major haemorrhagic events (0·88, 0·74–1·06) or death (0·82, 0·62–1·09). Participants younger than 55 years showed a striking reduction in thrombotic events (hazard ratio 0·33, 95% CI 0·17–0·66), as did participants with mechanical heart valve (0·52, 0·35–0·77). Analysis of major outcomes in the very elderly (age ≥85 years, n=99) showed no significant adverse effects of the intervention for all outcomes. Interpretation: Our analysis showed that self-monitoring and self-management of oral anticoagulation is a safe option for suitable patients of all ages. Patients should also be offered the option to self-manage their disease with suitable health-care support as back-up. / Funding: UK National Institute for Health Research (NIHR) Technology Assessment Programme, UK NIHR National School for Primary Care Research.

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