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

C Heneghan; A Ward; R Perera; C Bankhead; A Fuller; R Stevens; K Bradford; S Tyndel; P Alonson-Coello; J Ansell; R Beyth; A Bernardo; TD Christensen; ME Cromheecke; RG Edson; David Fitzmaurice; AP Gadisseur; JM Garcia-Alamino; C Gardiner; JM Hasenkam; A Jacobson; S Kaatz; F Kamali; TI Khan; E Knight; H Kortke; M Levi; D Matchar; B Menendez-Jandula; I Rakovac; C Schaefer; A Siebenhofer; JC Souto; R Sunderji; K Gin; K Shalansky; H Voller; O Wagner; A Zitterman

doi:10.1016/S0140-6736(11)61294-4

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

C Heneghan, A Ward, R Perera, C Bankhead, A Fuller, R Stevens, K Bradford, S Tyndel, P Alonson-Coello, J Ansell, R Beyth, A Bernardo, TD Christensen, ME Cromheecke, RG Edson, David Fitzmaurice, AP Gadisseur, JM Garcia-Alamino, C Gardiner, JM HasenkamA Jacobson, S Kaatz, F Kamali, TI Khan, E Knight, H Kortke, M Levi, D Matchar, B Menendez-Jandula, I Rakovac, C Schaefer, A Siebenhofer, JC Souto, R Sunderji, K Gin, K Shalansky, H Voller, O Wagner, A Zitterman

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Abstract

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.

Original language	English
Pages (from-to)	322-34
Number of pages	13
Journal	Lancet
Volume	379
Issue number	9813
DOIs	https://doi.org/10.1016/S0140-6736(11)61294-4
Publication status	Published - 28 Jan 2012

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10.1016/S0140-6736(11)61294-4

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Heneghan, C., Ward, A., Perera, R., Bankhead, C., Fuller, A., Stevens, R., Bradford, K., Tyndel, S., Alonson-Coello, P., Ansell, J., Beyth, R., Bernardo, A., Christensen, TD., Cromheecke, ME., Edson, RG., Fitzmaurice, D., Gadisseur, AP., Garcia-Alamino, JM., Gardiner, C., ... Zitterman, A. (2012). Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet, 379(9813), 322-34. https://doi.org/10.1016/S0140-6736(11)61294-4

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title = "Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data",

abstract = "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.",

author = "C Heneghan and A Ward and R Perera and C Bankhead and A Fuller and R Stevens and K Bradford and S Tyndel and P Alonson-Coello and J Ansell and R Beyth and A Bernardo and TD Christensen and ME Cromheecke and RG Edson and David Fitzmaurice and AP Gadisseur and JM Garcia-Alamino and C Gardiner and JM Hasenkam and A Jacobson and S Kaatz and F Kamali and TI Khan and E Knight and H Kortke and M Levi and D Matchar and B Menendez-Jandula and I Rakovac and C Schaefer and A Siebenhofer and JC Souto and R Sunderji and K Gin and K Shalansky and H Voller and O Wagner and A Zitterman",

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doi = "10.1016/S0140-6736(11)61294-4",

language = "English",

volume = "379",

pages = "322--34",

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Heneghan, C, Ward, A, Perera, R, Bankhead, C, Fuller, A, Stevens, R, Bradford, K, Tyndel, S, Alonson-Coello, P, Ansell, J, Beyth, R, Bernardo, A, Christensen, TD, Cromheecke, ME, Edson, RG, Fitzmaurice, D, Gadisseur, AP, Garcia-Alamino, JM, Gardiner, C, Hasenkam, JM, Jacobson, A, Kaatz, S, Kamali, F, Khan, TI, Knight, E, Kortke, H, Levi, M, Matchar, D, Menendez-Jandula, B, Rakovac, I, Schaefer, C, Siebenhofer, A, Souto, JC, Sunderji, R, Gin, K, Shalansky, K, Voller, H, Wagner, O & Zitterman, A 2012, 'Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data', Lancet, vol. 379, no. 9813, pp. 322-34. https://doi.org/10.1016/S0140-6736(11)61294-4

TY - JOUR

T1 - Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data

AU - Heneghan, C

AU - Ward, A

AU - Perera, R

AU - Bankhead, C

AU - Fuller, A

AU - Stevens, R

AU - Bradford, K

AU - Tyndel, S

AU - Alonson-Coello, P

AU - Ansell, J

AU - Beyth, R

AU - Bernardo, A

AU - Christensen, TD

AU - Cromheecke, ME

AU - Edson, RG

AU - Fitzmaurice, David

AU - Gadisseur, AP

AU - Garcia-Alamino, JM

AU - Gardiner, C

AU - Hasenkam, JM

AU - Jacobson, A

AU - Kaatz, S

AU - Kamali, F

AU - Khan, TI

AU - Knight, E

AU - Kortke, H

AU - Levi, M

AU - Matchar, D

AU - Menendez-Jandula, B

AU - Rakovac, I

AU - Schaefer, C

AU - Siebenhofer, A

AU - Souto, JC

AU - Sunderji, R

AU - Gin, K

AU - Shalansky, K

AU - Voller, H

AU - Wagner, O

AU - Zitterman, A

PY - 2012/1/28

Y1 - 2012/1/28

N2 - 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.

AB - 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.

U2 - 10.1016/S0140-6736(11)61294-4

DO - 10.1016/S0140-6736(11)61294-4

M3 - Article

C2 - 22137798

SN - 1474-547X

VL - 379

SP - 322

EP - 334

JO - Lancet

JF - Lancet

IS - 9813

ER -

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

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