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Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data.

Publication ,  Journal Article
Heneghan, C; Ward, A; Perera, R; Self-Monitoring Trialist Collaboration; Bankhead, C; Fuller, A; Stevens, R; Bradford, K; Tyndel, S; Ansell, J ...
Published in: Lancet
January 28, 2012

BACKGROUND: Uptake of self-testing and self-management of oral anticoagulation [corrected] 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 coagulation 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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Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

January 28, 2012

Volume

379

Issue

9813

Start / End Page

322 / 334

Location

England

Related Subject Headings

  • Vitamin K
  • Thromboembolism
  • Self Care
  • International Normalized Ratio
  • Humans
  • Hemorrhage
  • General & Internal Medicine
  • Drug Monitoring
  • Anticoagulants
  • Administration, Oral
 

Citation

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Heneghan, C., Ward, A., Perera, R., Self-Monitoring Trialist Collaboration, Bankhead, C., Fuller, A., … Zittermann, A. (2012). Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet, 379(9813), 322–334. https://doi.org/10.1016/S0140-6736(11)61294-4
Heneghan, Carl, Alison Ward, Rafael Perera, Self-Monitoring Trialist Collaboration, Clare Bankhead, Alice Fuller, Richard Stevens, et al. “Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data.Lancet 379, no. 9813 (January 28, 2012): 322–34. https://doi.org/10.1016/S0140-6736(11)61294-4.
Heneghan C, Ward A, Perera R, Self-Monitoring Trialist Collaboration, Bankhead C, Fuller A, et al. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet. 2012 Jan 28;379(9813):322–34.
Heneghan, Carl, et al. “Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data.Lancet, vol. 379, no. 9813, Jan. 2012, pp. 322–34. Pubmed, doi:10.1016/S0140-6736(11)61294-4.
Heneghan C, Ward A, Perera R, Self-Monitoring Trialist Collaboration, Bankhead C, Fuller A, Stevens R, Bradford K, Tyndel S, Alonso-Coello P, Ansell J, Beyth R, Bernardo A, Christensen TD, Cromheecke ME, Edson RG, Fitzmaurice D, Gadisseur APA, Garcia-Alamino JM, Gardiner C, Hasenkam JM, Jacobson A, Kaatz S, Kamali F, Khan TI, Knight E, Körtke H, Levi M, Matchar D, Menéndez-Jándula B, Rakovac I, Schaefer C, Siebenhofer A, Souto JC, Sunderji R, Gin K, Shalansky K, Völler H, Wagner O, Zittermann A. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet. 2012 Jan 28;379(9813):322–334.
Journal cover image

Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

January 28, 2012

Volume

379

Issue

9813

Start / End Page

322 / 334

Location

England

Related Subject Headings

  • Vitamin K
  • Thromboembolism
  • Self Care
  • International Normalized Ratio
  • Humans
  • Hemorrhage
  • General & Internal Medicine
  • Drug Monitoring
  • Anticoagulants
  • Administration, Oral