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

Heneghan, Carl; Ward, Alison; Perera, Rafael; Bankhead, Clare; Fuller, Alice; Stevens, Richard; Bradford, Kairen; Tyndel, S; Alonso‐Coello, Pablo; Ansell, Jack; Beyth, Rebecca J.; Bernardo, Artur; Christensen, Thomas; Cromheecke, Manon E.; Edson, Robert; Fitzmaurice, David; Gadisseur, Alain; García-Alamino, Josep M; Gardiner, Chris; Hasenkam, Michael; Jacobson, A.; Kaatz, Scott; Kamali, Farhad; Khan, Tayyaba; Knight, Eve; Körtke, Heinrich; Levi, Marcel; Matchar, David B.; Menéndez-Jándula, Bárbara; Rakovac, Ivo; Schaefer, Christian; Siebenhofer, Andrea; Souto, Juan Carlos; Sunderji, Rubina; Gin, Kenneth; Shalansky, Karen F.; Völler, Heinz; Wagner, Otto; Zittermann, Armin

doi:10.1016/s0140-6736(11)61294-4

Cited by 333 publications

(275 citation statements)

References 46 publications

(97 reference statements)

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“…This number was chosen to be consistent with the trials from which the relative effect estimates for self-monitoring were obtained. In a recent meta-analysis of patient-level data, 108 11 of the self-monitoring trials included in our review reported the mean increase in the number of tests performed with self-monitoring versus control. There was an average of 24 additional tests by 12 months for people with atrial fibrillation and 22 additional tests for people with an AHV.…”

Section: Costs Of Self-monitoringmentioning

confidence: 94%

“…108 Heneghan and colleagues 108 presented a subgroup analysis where they presented the estimated pooled hazard ratio and number needed to treat to prevent one major thromboembolic event (ischaemic stroke and systemic embolism) and one major haemorrhagic event by year of follow-up (up to 5 years) based on 2243 people with an AHV. The formula used by Heneghan and colleagues 108 to estimate the number needed to treat was:…”

Section: Assessment Of Cost-effectivenessmentioning

confidence: 99%

“…Furthermore, as data on minor bleeds were not available from Heneghan and colleagues 108 for people with an AHV, the same baseline risk applied for people with atrial fibrillation was adopted. This was justified on the grounds of the two groups of people facing similar risks of a major bleed (0.405 and 0.363).…”

Section: Assessment Of Cost-effectivenessmentioning

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: Costs Of Self-monitoringmentioning

confidence: 94%

Section: Assessment Of Cost-effectivenessmentioning

confidence: 99%

See 1 more Smart Citation

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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“…If PST actually does reduce major events, then the ICER would be even more attractive for PST, and possibly even dominant (i.e., offering better outcomes at lower costs). 9 .…”

Section: Discussionmentioning

confidence: 99%

“…Systematic reviews have supported frequent home monitoring via patient self-testing (PST) of INR as a safe and effective alternative to standard in-clinic testing. 6,[8][9][10] In 2012, the American College of Chest Physicians revised its clinical practice guidelines to incorporate the use of portable at-home INR testing devices. 11 The Home INR Study (THINRS), the largest randomized controlled trial of PST (n = 2922) to date, found negligible differences in clinical outcomes between weekly PST and once-monthly in-clinic testing via HQACM.…”

Section: Introductionmentioning

confidence: 99%

At-Home Versus In-Clinic INR Monitoring: A Cost–Utility Analysis from The Home INR Study (THINRS)

et al. 2016

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BACKGROUND: Effective management of patients using warfarin is resource-intensive, requiring frequent inclinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST. OBJECTIVE: To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency. PATIENTS/INTERVENTIONS: In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly inclinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up. RESULTS: PST and HQACM participants were similar with regard to gender, age, and CHADS 2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per qualityadjusted life year gained with PST once weekly was $5566 (95 % CI, −$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions. CONCLUSION: Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

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Long-term Clinical and Echocardiographic Outcomes in Young and Middle-aged Adults Undergoing the Ross Procedure

et al. 2021

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IMPORTANCEThere is no ideal valve substitute for young adults requiring aortic valve replacement. Multicenter data supporting use of the Ross procedure with respect to long-term postoperative valve-related mortality and reintervention, as well as function of the autograft and pulmonary homograft, are needed.OBJECTIVE To determine the long-term clinical and echocardiographic outcomes in young and middle-aged patients undergoing the Ross procedure. DESIGN, SETTING, AND PARTICIPANTSA retrospective multicenter international cohort study with a median follow-up period of 9.2 years was conducted in 5 experienced centers regularly performing the Ross procedure. Consecutive patients aged 18 to 65 years were included by each center between 1991 and 2018.MAIN OUTCOMES AND MEASURES Survival and autograft-related and homograft-related reintervention. Serial echocardiographic measurements of valve function were analyzed using mixed-effects modeling.RESULTS During the study period, 1431 patients (74.3% men; n = 1063) were operated on at a median age of 48.5 years (mean [SD], 47.7 [9.5]; range, 18.1-65; interquartile range, 42.7-54.0). Implantation techniques were root inclusion in 355 (24.9%), root replacement in 485 (34.0%), and subcoronary implantation in 587 (41.1%). Right ventricular outflow tract reconstruction was performed with homografts in 98.6% (n = 1189) and bioprostheses in 1.4% (n = 17). Ten patients (0.7%) died before discharge. Median follow-up was 9.2 years (13 015 total patient-years). Survival after 10 and 15 years was 95.1% (95% CI, 93.8%-96.5%) and 88.5% (95% CI, 85.9%-91.1%), respectively. Freedom from autograft and homograft reintervention after 15 years was 92.0% and 97.2%, respectively. Late events were autograft endocarditis in 14 patients (0.11% per patient-year), homograft endocarditis in 11 patients (0.08% per patient-year), and stroke in 37 patients (0.3% per patient-year).CONCLUSIONS AND RELEVANCE Given its excellent short-term and long-term outcome in young and middle-aged adults in this study, the Ross procedure should be considered in young and middle-aged adults who require aortic valve replacement. Patients should be referred to an experienced center with a program dedicated to the Ross procedure.

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

Cited by 333 publications

References 46 publications

At-Home Versus In-Clinic INR Monitoring: A Cost–Utility Analysis from The Home INR Study (THINRS)

Long-term Clinical and Echocardiographic Outcomes in Young and Middle-aged Adults Undergoing the Ross Procedure

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