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Meta-Analysis
. 2016 Jul 5;7(7):CD003839.
doi: 10.1002/14651858.CD003839.pub3.

Self-monitoring and self-management of oral anticoagulation

Carl J Heneghan  1 , 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
Affiliations
Meta-Analysis

Self-monitoring and self-management of oral anticoagulation

Carl J Heneghan et al. Cochrane Database Syst Rev. .

Abstract

Background: The introduction of point-of-care devices for the management of patients on oral anticoagulation allows self-testing by the patient at home. Patients who self-test can either adjust their medication according to a pre-determined dose-INR (international normalized ratio) schedule (self-management), or they can call a clinic to be told the appropriate dose adjustment (self-monitoring). Increasing evidence suggests self-testing of oral anticoagulant therapy is equal to or better than standard monitoring. This is an updated version of the original review published in 2010.

Objectives: To evaluate the effects on thrombotic events, major haemorrhages, and all-cause mortality of self-monitoring or self-management of oral anticoagulant therapy compared to standard monitoring.

Search methods: For this review update, we re-ran the searches of the Cochrane Central Register of Controlled Trials (CENTRAL), 2015, Issue 6, the Cochrane Library, MEDLINE (Ovid, 1946 to June week 4 2015), Embase (Ovid, 1980 to 2015 week 27) on 1 July 2015. We checked bibliographies and contacted manufacturers and authors of relevant studies. We did not apply any language restrictions .

Selection criteria: Outcomes analysed were thromboembolic events, mortality, major haemorrhage, minor haemorrhage, tests in therapeutic range, frequency of testing, and feasibility of self-monitoring and self-management.

Data collection and analysis: Review authors independently extracted data and we used a fixed-effect model with the Mantzel-Haenzel method to calculate the pooled risk ratio (RR) and Peto's method to verify the results for uncommon outcomes. We examined heterogeneity amongst studies with the Chi(2) and I(2) statistics and used GRADE methodology to assess the quality of evidence.

Main results: We identified 28 randomised trials including 8950 participants (newly incorporated in this update: 10 trials including 4227 participants). The overall quality of the evidence was generally low to moderate. Pooled estimates showed a reduction in thromboembolic events (RR 0.58, 95% CI 0.45 to 0.75; participants = 7594; studies = 18; moderate quality of evidence). Both, trials of self-management or self-monitoring showed reductions in thromboembolic events (RR 0.47, 95% CI 0.31 to 0.70; participants = 3497; studies = 11) and (RR 0.69, 95% CI 0.49 to 0.97; participants = 4097; studies = 7), respectively; the quality of evidence for both interventions was moderate. No reduction in all-cause mortality was found (RR 0.85, 95% CI 0.71 to 1.01; participants = 6358; studies = 11; moderate quality of evidence). While self-management caused a reduction in all-cause mortality (RR 0.55, 95% CI 0.36 to 0.84; participants = 3058; studies = 8); self-monitoring did not (RR 0.94, 95% CI 0.78 to 1.15; participants = 3300; studies = 3); the quality of evidence for both interventions was moderate. In 20 trials (8018 participants) self-monitoring or self-management did not reduce major haemorrhage (RR 0.95, 95% CI, 0.80 to 1.12; moderate quality of evidence). There was no significant difference found for minor haemorrhage (RR 0.97, 95% CI 0.67 to 1.41; participants = 5365; studies = 13). The quality of evidence was graded as low because of serious risk of bias and substantial heterogeneity (I(2) = 82%).

Authors' conclusions: Participants who self-monitor or self-manage can improve the quality of their oral anticoagulation therapy. Thromboembolic events were reduced, for both those self-monitoring or self-managing oral anticoagulation therapy. A reduction in all-cause mortality was observed in trials of self-management but not in self-monitoring, with no effects on major haemorrhage.

PubMed Disclaimer

Conflict of interest statement

CJH: CH has received financial support from the National Institute of Health Research (NIHR) School of Primary Care Research in the UK for this update and is also part funded by the NIHR Oxford Diagnostic Evidence Co‐operative (NIHR DEC). The opinions are those of the authors and not the Department of Health.

JMGA: None known.

EAS: None known.

AMW: None known.

RP: I am an investigator in the cohort study looking at estimating how successful self‐monitoring is (in terms of control levels) in individuals that attempt self‐monitoring (non‐RCT setting). The results of this study would not be included in this Cochrane SR but could inform its discussion.

CB: None known.

PAC: None known.

DF: The institution I work for, The Univeristy of Birmingham, has received educational grants from Roche Diagnsotics UK to deliver on‐going educational activities in the area of oral anticoagulation management.

KRM: None known.

IJO: None known.

Figures

1
1
Flowchart showing the results of combined searches
2
2
Funnel plot of comparison: 1 Major haemorrhage, outcome
3
3
Funnel plot of comparison: 2 Thromboembolic events
4
4
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
5
5
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Thromboembolic events, Outcome 1: Self‐monitoring and self‐management
1.2
1.2. Analysis
Comparison 1: Thromboembolic events, Outcome 2: Events by Clinical Condition
1.3
1.3. Analysis
Comparison 1: Thromboembolic events, Outcome 3: Events by Self‐management (sensitivity)
1.4
1.4. Analysis
Comparison 1: Thromboembolic events, Outcome 4: Events by specialty
2.1
2.1. Analysis
Comparison 2: All‐cause mortality, Outcome 1: Events by Self‐management
2.2
2.2. Analysis
Comparison 2: All‐cause mortality, Outcome 2: Events by Clinical Condition
2.3
2.3. Analysis
Comparison 2: All‐cause mortality, Outcome 3: Events by Self‐management (sensitivity)
2.4
2.4. Analysis
Comparison 2: All‐cause mortality, Outcome 4: Events by specialty
3.1
3.1. Analysis
Comparison 3: Major haemorrhage, Outcome 1: Events by Self‐management
3.2
3.2. Analysis
Comparison 3: Major haemorrhage, Outcome 2: Events by Clinical Condition
3.3
3.3. Analysis
Comparison 3: Major haemorrhage, Outcome 3: Events by Self‐management (sensitivity)
3.4
3.4. Analysis
Comparison 3: Major haemorrhage, Outcome 4: Events by specialty
4.1
4.1. Analysis
Comparison 4: Minor haemorrhage, Outcome 1: Events by Self‐management
See this image and copyright information in PMC

Update of

Comment in

References

References to studies included in this review

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