Self-Management of oral Anticoagulation in nonvalvular Atrial Fibrillation (SMAAF study)

Völler, Heinz; Glatz, Johannes; Taborski, Uwe; Bernardo, Artur; Dovifat, C.; Heidinger, Kathrin

doi:10.1007/s00392-005-0199-0

Cited by 39 publications

(50 citation statements)

References 29 publications

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“…59 Similarly, one trial was discontinued before the end of the prespecified follow-up due to difficulties in the recruitment process. 60 Overall, only four trials were assessed to have adequate sequence generation, concealed allocation and blinded outcome assessment and, therefore, were judged at low risk of bias. …”

Section: Coaguchek Xs Versus Coaguchek Smentioning

confidence: 99%

“…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%

“…59,69,72,74,76,79 Seven trials relied on an intention-to-treat approach and all dropouts were fully accounted for in the statistical analyses, 55,61,[63][64][65]71,75 while the other four reported no missing data. 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%

“…55,58,[61][62][63]72,77 In six trials, neither the participants nor the personnel involved in delivering the interventions were blinded. 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.…”

Section: Performance and Detection Biasmentioning

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: Coaguchek Xs Versus Coaguchek Smentioning

confidence: 99%

Section: Selection Biasmentioning

confidence: 99%

Section: Selection Biasmentioning

confidence: 99%

Section: Performance and Detection Biasmentioning

confidence: 99%

See 2 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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“…4 Several published trials have compared self-management with physician management or management in an anticoagulation clinic. [4][5][6][7][8][9][10][11][12][13] It has been found that patients who self-manage check their INR more frequently and are able to maintain a greater proportion of INRs within the therapeutic range compared with those whose therapy is monitored by a physician or in an anticoagulation clinic. [11][12][13] The results of a recent meta-analysis showed a significant reduction in thromboembolic events (odds ratio [OR] 0.45), major hemorrhagic events (OR 0.65) and all-cause mortality (OR 0.61) for those using a self-management or self-test strategy.…”

mentioning

confidence: 99%

Cost-effectiveness of self-managed versus physician-managed oral anticoagulation therapy

Regier

Sunderji²,

Lynd³

et al. 2006

Canadian Medical Association Journal

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ResearchL ong-term oral anticoagulation therapy with vitamin K antagonists is prescribed as prophylaxis against strokes and other embolic events in patients with atrial fibrillation or a mechanical heart valve. 1,2 Warfarin therapy, however, is complicated by the variability of its biologic effect, its narrow therapeutic index, and the associated thrombotic or hemorrhagic events in the event of over-or underanticoagulation. 2 It has been shown that improved anticoagulant control can be achieved through frequent monitoring of the international normalized ratio (INR), resulting in improved health outcomes. 3 Monitoring the INR and managing warfarin dosing by a primary care physician is the current clinical standard of practice in Canada. 4 Physician management requires patients to visit a laboratory regularly for INR testing. The laboratory reports the INR to the physician, who subsequently contacts the patient with any required change in dosage. An alternative strategy is patient self-management. Self-management entails the measurement of the INR by the patient using a pointof-care device and, when necessary, self-adjustment of the warfarin dose using a nomogram. 4 Several published trials have compared self-management with physician management or management in an anticoagulation clinic. 4-13 It has been found that patients who self-manage check their INR more frequently and are able to maintain a greater proportion of INRs within the therapeutic range compared with those whose therapy is monitored by a physician or in an anticoagulation clinic. [11][12][13] The results of a recent meta-analysis showed a significant reduction in thromboembolic events (odds ratio [OR] 0.45), major hemorrhagic events (OR 0.65) and all-cause mortality (OR 0.61) for those using a self-management or self-test strategy. 14 The results also showed that self-management compared with self-testing alone reduces the occurrence of thromboembolic events (OR 0.27) and death (OR 0.37). 14 These results, together with the greater initial costs of educating patients to self-manage and of the pointof-care device itself, provide the impetus for a formal costeffectiveness analysis.The objective of this study was to evaluate the incremental cost and health benefits of self-managed versus physicianmanaged chronic oral anticoagulation therapy from the perspective of the Canadian health care payer. A Bayesian approach was adopted to facilitate the incorporation of prior knowledge of transition probabilities and for probabilistic sensitivity analysis. Cost-effectiveness of self-managed versus physician-managed oral anticoagulation therapy Background: Patient self-management of long-term oral anticoagulation therapy is an effective strategy in a number of clinical situations, but it is currently not a funded option in the Canadian health care system. We sought to compare the incremental cost and health benefits of self-management with those of physician management from the perspective of the Canadian health care payer over a 5-year period.

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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

112

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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Self-Management of oral Anticoagulation in nonvalvular Atrial Fibrillation (SMAAF study)

Abstract: Management of oral anticoagulation by INR self-management in patients with atrial fibrillation is not inferior to conventional care.

Cited by 39 publications

References 29 publications

Cost-effectiveness of self-managed versus physician-managed oral anticoagulation therapy

Self-monitoring and self-management of oral anticoagulation

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