title: Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation.
abstract: OBJECTIVE
  To investigate the clinical and cost-effectiveness of self-monitoring of coagulation status in people receiving long-term vitamin K antagonist therapy compared with standard clinic care.
  
  
  METHODS
  Systematic review of current evidence and economic modelling.
  
  
  METHODS
  Major electronic databases were searched up to May 2013. The economic model parameters were derived from the clinical effectiveness review, routine sources of cost data and advice from clinical experts.
  
  
  METHODS
  Randomised controlled trials (RCTs) comparing self-monitoring versus standard clinical care in people with different clinical conditions. Self-monitoring included both self-management (patients conducted the tests and adjusted their treatment according to an algorithm) and self-testing (patients conducted the tests, but received treatment recommendations from a clinician). Various point-of-care coagulometers were considered.
  
  
  RESULTS
  26 RCTs (8763 participants) were included. Both self-management and self-testing were as safe as standard care in terms of major bleeding events (RR 1.08, 95% CI 0.81 to 1.45, p=0.690, and RR 0.99, 95% CI 0.80 to 1.23, p=0.92, respectively). Self-management was associated with fewer thromboembolic events (RR 0.51, 95% CI 0.37 to 0.69, p ≤ 0.001) and with a borderline significant reduction in all-cause mortality (RR 0.68, 95% CI 0.46 to 1.01, p=0.06) than standard care. Self-testing resulted in a modest increase in time in therapeutic range compared with standard care (weighted mean difference, WMD 4.4%, 95% CI 1.71 to 7.18, p=0.02). Total health and social care costs over 10 years were £7324 with standard care and £7326 with self-monitoring (estimated quality adjusted life year, QALY gain was 0.028). Self-monitoring was found to have ∼ 80% probability of being cost-effective compared with standard care applying a ceiling willingness-to-pay threshold of £20,000 per QALY gained. Within the base case model, applying the pooled relative effect of thromboembolic events, self-management alone was highly cost-effective while self-testing was not.
  
  
  CONCLUSIONS
  Self-monitoring appears to be a safe and cost-effective option.
  
  
  BACKGROUND
  PROSPERO CRD42013004944.
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Pawana
authors.initials: P
authors.lastname: Sharma
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Graham
authors.initials: G
authors.lastname: Scotland
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Moira
authors.initials: M
authors.lastname: Cruickshank
authors.affiliation: Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Emma
authors.initials: E
authors.lastname: Tassie
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Fraser
authors.affiliation: Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Burton
authors.affiliation: Department of Clinical Biochemistry, University of Aberdeen, Aberdeen, UK.
authors.forename: Bernard
authors.initials: B
authors.lastname: Croal
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Ramsay
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Miriam
authors.initials: M
authors.lastname: Brazzelli
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D012648:Self Care / Q000191:economics*; D013923:Thromboembolism / Q000139:chemically induced; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D000925:Anticoagulants; D014812:Vitamin K
keywords: CARDIOLOGY; HEALTH ECONOMICS