Comparison of the Quality of Oral Anticoagulant Therapy Through Patient Self-management and Management by Specialized Anticoagulation Clinics in the Netherlands

Gadisseur, Alain; Breukink-Engbers, W. G. M.; Meer, F. J. M. Van Der; Besselaar, A. M. H. van den; Sturk, Augueste; Rosendaal, Frits R.

doi:10.1001/archinte.163.21.2639

Cited by 114 publications

(164 citation statements)

References 32 publications

(31 reference statements)

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“…55,57,[61][62][63][64][65] In 11 trials, the randomisation process proved to be adequate but no information was provided on the way in which participants were allocated to the study interventions. 58,60,[66][67][68][69][70][71][72][73][74] One trial 75 reported adequate details about the generation of the random sequence but failed to conceal the allocation of participants to study interventions. In contrast, another trial 76 reported adequate information on allocation concealment but failed to provide details on the randomisation process.…”

Section: Selection Biasmentioning

confidence: 99%

“…58,60,62,78 Eight of the 26 included trials were at high risk of attrition bias, with more than 5% dropout rate and with missing data not appropriately tackled. 45,56,57,[66][67][68]73,77 In the Early Self-Controlled Anticoagulation Trial, 70 the problem of incomplete outcome data was addressed for the first 600 participants but not for all included participants. …”

Section: Selection Biasmentioning

confidence: 99%

“…60,65,66,71,74,75 One trial 70 was described as 'double blinded' but no further information was given. Another trial 68 reported that one of the two standard care groups studied (the untrained routine group) was blinded. In addition, this trial revealed that the nurses involved in transferring data on dosing as well as the dosing physicians were blinded.…”

Section: Performance and Detection Biasmentioning

confidence: 99%

“…The majority of included trials were conducted in Europe: six trials were conducted in Germany, 57,59,60,70,72,78 six in the UK, 45,56,64,67,69,73 three in Denmark, 58,66,75 three in the Netherlands, 68,76,79 one in Ireland, 62 one in Austria, 63 one in France 77 and one in Spain. 61 Three trials were conducted in Canada 55, 65,74 and one in the USA.…”

Section: Study Detailsmentioning

confidence: 99%

“…61 Three trials were conducted in Canada 55, 65,74 and one in the USA. 71 Of the 26 included trials, seven were multicentred, 60,63,64,67,68,71,72 while the remaining 19 were conducted in a single centre.…”

Section: Study Detailsmentioning

confidence: 99%

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The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy, compared with standard UK practice: systematic review and economic evaluation

Sharma

Scotland

Cruickshank

et al. 2015

Health Technol Assess

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This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/).Editorial contact: nihredit@southampton.ac.ukThe full HTA archive is freely available to view online at www.journalslibrary.nihr.ac.uk/hta. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Health Technology Assessment journalReports are published in Health Technology Assessment (HTA) if (1) they have resulted from work for the HTA programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors.Reviews in Health Technology Assessment are termed 'systematic' when the account of the search appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others. HTA programmeThe HTA programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.The journal is indexed in NHS Evidence via its abstracts included in MEDLINE and its Technology Assessment Reports inform National Institute for Health and Care Excellence (NICE) guidance. HTA research is also an important source of evidence for National Screening Committee (NSC) policy decisions.For more information about the HTA programme please visit the website: http://www.nets.nihr.ac.uk/programmes/hta This reportThe research reported in this issue of the journal was commissioned and funded by the HTA programme on behalf of NICE as project number 13/06/01. The protocol was agreed in June 2013. The assessment report began editorial review in December 2013 and was accepted for publication in March 2014. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Departm...

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Section: Selection Biasmentioning

confidence: 99%

Section: Selection Biasmentioning

confidence: 99%

Section: Performance and Detection Biasmentioning

confidence: 99%

Section: Study Detailsmentioning

confidence: 99%

Section: Study Detailsmentioning

confidence: 99%

See 3 more Smart Citations

The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy, compared with standard UK practice: systematic review and economic evaluation

Sharma

Scotland

Cruickshank

et al. 2015

Health Technol Assess

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Ximelagatran vs Warfarin for Stroke Prevention in Patients With Nonvalvular Atrial Fibrillation

2005

JAMA

596

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ONVALVULAR ATRIAL FIBRILlation is implicated in nearly 15% of strokes. 1 By metaanalysis of 6 randomized trials, dose-adjusted warfarin decreases stroke risk by 62%. 2,3 In practice, the risk of bleeding limits treatment with warfarin, particularly among the elderly. Variability of anticoagulation intensity from interactions with foods and medication 4 necessitates frequent monitoring and dose adjustments yet leaves patients outside the therapeutic range almost half the time. 5,6 Underuse of warfarin in patients with atrial fibrillation at high risk of bleeding 5,6 calls for safer, more dependable alternatives. 7,8 The direct thrombin inhibitor ximelagatran offers fixed oral dosing without need for coagulation monitoring, rapid onset and offset of action, stable pharmacokinetics with little potential for drug interactions, and no known food interactions. 9-12 The SPORTIF (Stroke Prevention using an Oral Thrombin Inhibitor in Atrial Fibrillation) program included 2 longterm trials comparing ximelagatran to warfarin for prevention of thromboembolism in patients with atrial fibrillation. The open-label SPORTIF III study See also pp 681, 699, and 736. *Authors/SPORTIF Executive Steering Committee and the SPORTIF V investigators are listed at the end of this article.

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Self-monitoring and self-management of oral anticoagulation

García-Alamino

Ward

Alonso‐Coello³

et al. 2010

Cochrane Database of Systematic Reviews

110

128

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BACKGROUND: The introduction of portable monitors (pointof-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 predetermined dose-INR schedule (self-management) or they can call a clinic to be told the appropriate dose adjustment (self-monitoring). Several trials of selfmonitoring of oral anticoagulant therapy suggest this may be equal to or better than standard monitoring. OBJECTIVES: To evaluate the effects of self-monitoring or self-management of oral anticoagulant therapy compared to standard monitoring. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 4), MEDLINE, EMBASE and CINAHL (to November 2007). We checked bibliographies and contacted manufacturers and authors of relevant studies. No language restrictions were applied. 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: The review authors independently extracted data. 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. MAIN RESULTS: We identified 18 randomized trials (4723 participants). Pooled estimates showed significant reductions in both thromboembolic events (RR 0.50, 95% CI 0.36 to 0.69) and all-cause mortality (RR 0.64, 95% CI 0.46 to 0.89). This reduction in mortality remained significant after the removal of low-quality studies (RR 0.65, 95% CI 0.46 to 0.90). Trials of self-management alone showed significant reductions in thromboembolic events (RR 0.47, 95% CI 0.31 to 0.70) and all-cause mortality (RR 0.55, 95% CI 0.36 to 0.84); self-monitoring did not (thrombotic events RR 0.57, 95% CI 0.32 to 1.00; mortality RR 0.84, 95% CI 0.50 to 1.41). Self-monitoring significantly reduced major haemorrhages (RR 0.56, 95% CI 0.35 to 0.91) whilst self-management did not (RR 1.12, 95% CI 0.78 to 1.61). Twelve trials reported improvements in the percentage of mean INR measurements in the therapeutic range. No heterogeneity was identified in any of these comparisons.

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Comparison of the Quality of Oral Anticoagulant Therapy Through Patient Self-management and Management by Specialized Anticoagulation Clinics in the Netherlands

Cited by 114 publications

References 32 publications

Ximelagatran vs Warfarin for Stroke Prevention in Patients With Nonvalvular Atrial Fibrillation

Self-monitoring and self-management of oral anticoagulation

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