Self-monitoring of oral anticoagulation: does it work outside trial conditions?
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ABSTRACT:
SUBMITTER: Gardiner C
PROVIDER: S-EPMC2629005 | biostudies-other | 2009 Feb
REPOSITORIES: biostudies-other
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Project description:BackgroundThe 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.ObjectivesTo 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 methodsFor 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 criteriaOutcomes 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 analysisReview 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 resultsWe 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' conclusionsParticipants 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.
| S-EPMC8078378 | biostudies-literature
Project description:In this investigation, we hypothesize that quality of oral anticoagulation (OA) and long-term outcome after mechanical heart valve (MHV) replacement with self-management (Self-M) of OA is superior to conventional anticoagulation treatment (Conv-T), even in outside trial conditions. One hundred sixty patients (78.8% aortic valve replacements) were trained in international normalized ratio Self-M and 260 patients (86.2% aortic valve replacements) preferred Conv-T. Mean follow-up was 8.6 ± 2.1 years, representing 3612 patient-years. During follow-up, 37.2% bleedings and 10.6% thromboembolic events were recorded in the Self-M group versus 39.6% bleedings (P = 0.213) and 15.4% thromboembolic events (P = 0.064) in the Conv-T group. Serious adverse events were significantly lower in the Self-M group [grade III bleeding events causing disability or death: 0 versus 4.6% (P = 0.03); grade III thromboembolic events: 0.6 versus 5.0% (P = 0.011)]. Patients with Self-M were significantly more satisfied with their OA management and their quality of life (P < 0.001). Actuarial survival after 1, 5 and 10 years was 100, 99 and 97 with Self-M and 100, 95 and 81% with Conv-T, respectively (P < 0.001). Univariate risk factors for mortality were age (P = 0.008), type of operation (P = 0.021) and conventional OA (P < 0.001). In multivariate analysis, only conventional OA reached significance (P < 0.001). We conclude that in a routine setting under outside trial conditions Self-M of OA improves long-term outcome and treatment quality.
| S-EPMC3290375 | biostudies-literature
Project description:The role of dedicated anticoagulation management services (AMS) for patients receiving direct oral anticoagulant (DOAC) therapy is unclear. The objective of our study was to describe DOAC management in patients who were and were not managed by an AMS. We conducted a retrospective cohort study among patients with atrial fibrillation at the University of Utah Health (UUH) who received DOAC therapy between January 2013 and June 2016. Patients in the AMS group were managed by a pharmacist-led AMS whereas those in the non-AMS group were managed by other providers. The number and type of provider encounters and interventions related to DOAC therapy and a composite endpoint of thromboembolism, bleeding, and all-cause mortality were recorded. Overall, 90 and 370 patients were managed in the AMS and non-AMS groups, respectively. AMS group patients had greater chronic disease burden as measured by the Charlson comorbidity index. AMS group patients had more frequent DOAC-related encounters than non-AMS group patients but both groups had similar DOAC therapy intervention rates. Over half of patients in the AMS group received potentially duplicative interventions from their regular clinicians. The composite endpoint occurred in 18.9% and 13.5% of AMS and non-AMS group patients, respectively (p = 0.29). Patients managed by AMS providers were more complex and had more frequent encounters regarding their DOAC therapy than those managed by non-AMS providers. However, there was evidence of duplicative DOAC therapy management efforts. No difference between AMS and non-AMS groups in the composite clinical endpoint was detected.
| S-EPMC8744289 | biostudies-literature
Project description:BackgroundPatient 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.MethodsWe developed a Bayesian Markov model comparing the costs and quality-adjusted life years (QALYs) accrued to patients receiving oral anticoagulation therapy through self-management or physician management for atrial fibrillation or for a mechanical heart valve. Five health states were defined: no events, minor hemorrhagic events, major hemorrhagic events, thrombotic events and death. Data from published literature were used for transition probabilities. Canadian 2003 costs were used, and utility estimates were obtained from various published sources.ResultsSelf-management resulted in 3.50 fewer thrombotic events, 0.78 fewer major hemorrhagic events and 0.12 fewer deaths per 100 patients than physician management. The average discounted incremental cost of self-management over physician management was found to be 989 dollars (95% confidence interval [CI] 310 dollars-1655 dollars) per patient and the incremental QALYs gained was 0.07 (95% CI 0.06-0.08). The cost-effectiveness of self-management was 14,129 dollars per QALY gained. There was a 95% chance that self-management would be cost-effective at a willingness to pay of 23,800 dollars per QALY. Results were robust in probabilistic and deterministic sensitivity analyses.InterpretationThis model suggests that self-management is a cost-effective strategy for those receiving long-term oral anticoagulation therapy for atrial fibrillation or for a mechanical heart valve.
| S-EPMC1475919 | biostudies-literature
Project description:ObjectivesAlthough psychological stress is a risk factor for oral diseases, there seems to be no review on work stress. This study aimed to review the evidence on the association between work stress and oral conditions, including dental caries, periodontal status and tooth loss.DesignA systematic review of published observational studies.Data sourcesA systematic literature search was conducted in PubMed and Scopus databases on 12 August 2020.Study selectionArticles were screened based on the following inclusion criteria: published after 1966; in English only; epidemiological studies on humans (except case studies, reviews, letters, commentaries and editorials); and examined the association of work stress with dental caries, periodontal status and tooth loss.Data extractionData were extracted from eligible studies. A quality assessment was conducted using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies.ResultsOf 402 articles identified, 11 met the inclusion criteria, and 1 study assessed the association of work stress with dental caries and periodontal status. Of 11 studies, 1 reported a non-significant association between work stress and dental caries; 8 of 9 studies reported a significant association between work stress and worse periodontal status; and 1 of 2 studies reported a significant association between work stress and tooth loss. Nine of 11 studies were cross-sectional, while the remaining 2 studies had unclear methodology. Only two studies were sufficiently adjusted for potential confounders. Eight studies assessed work stress but did not use the current major measures. Three studies were rated as fair, while eight studies had poor quality.ConclusionsThere is a lack of evidence on the association of work stress with dental caries and tooth loss. Eight studies suggested potential associations between periodontal status and work stress. Cohort studies using the major work stress measures and adjusting for the potential confounders are needed.
| S-EPMC8166606 | biostudies-literature
Project description:High levels of stress at work may have serious consequences for employee functioning and mental health. By providing employees with an easily accessible instrument to regularly evaluate stressors and resources, employee self-monitoring and guidance to support can be accommodated. We evaluated an online self-monitoring tool Brief Assessment of Stress and Energy (BASE). Through their organization, 139 railway emergency services employees were invited to complete BASE and six wellbeing measures. We assessed BASE in two ways: using multiple regression analysis (N = 102, 73.4%), as well as by telephone follow-up interviews during which experts and respondents evaluated the BASE outcome (N = 67, 65.7%). Explained variances of BASE on the six wellbeing measures ranged between 26.6% and 49.9%. Telephone interviews confirmed the BASE outcome. The results indicate that BASE is associated with several measures of wellbeing and accurately refers respondents to counseling. This study shows that BASE is a promising instrument to encourage employees to self-monitor stressors and resources and identify those who need counseling.
| S-EPMC9292705 | biostudies-literature
Project description:Self-management may be an option to monitor oral anticoagulant therapy in health systems, but before recommending it, we need to assess patients' ability to take on this task. The purpose of the study was to describe patients' ability to self-manage and associated factors.This was a 3-year prospective quasi-experimental study with a control group. Overall, 333 patients on anticoagulant therapy from seven primary care health centres of the Basque Health Service were included in the intervention group and followed up for 6 months after the intervention, assessing their ability to self-test and self-manage. The intervention consisted of a patient training programme, providing detailed information on their condition and its treatment, and practical training in how to use a portable blood coagulation monitor and adjust their anticoagulant dose. Comparisons were made with a control group (333 patients receiving OAT under usual care from the same seven health centres). Outcome variables were ability to self-manage, quality of the outcome (in terms of time in therapeutic range), and quality of life in the intervention group, and general patient characteristics (age and sex), clinical variables (reason for OAT, INR range), and quality of the outcome (in terms of percentage of INR measurements in range and complications) in both groups.Overall, 26.13 % of patients invited to participate in the intervention agreed. Of these, 99 % successfully learned to self-manage their OAT. Just 4.2 % did not complete the follow-up, in all cases for reasons unrelated to self-management, and 4.5 % required additional learning support. Outcomes were better than under usual care in terms of percentage of INR measurements in range (12 %), rate of complications (4 %) and quality of life (9.2 %).Patients were only followed-up period for 6 months and the study was conducted in a single health organization. Though patients eligible to participate were selected randomly, they were not randomly allocated to the groups. This is a potential source of selection bias. Data needed to calculate in-range time were not collected from controls; rather the results for the self-management group were compared with external data from other studies.Almost all participants achieved competency in self-management, with no differences by age, sex, concurrent illnesses, polypharmacy or educational level. The greatest barrier to self-management was the attitude of patients themselves and those around them. Self-management in primary care is a good alternative to usual care, patients having longer times in therapeutic range and fewer complications, and improving their quality of life. Remote management is a good support tool.ClinicalTrials.gov Identifier: NCT01878539.
| S-EPMC5022157 | biostudies-literature
Project description:Background:Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with an increased risk of stroke and thromboembolism. Anticoagulation with Vitamin K antagonists (VKAs) or with novel oral anti-coagulants (NOACs) represents the cornerstone of the pharmacological treatment to reduce the risk of thromboembolism. This study aims to provide real-world data from a whole large European country about NOAC use in "non-valvular atrial fibrillation" (NVAF). Methods:We analysed the Italian Medicines Agency (AIFA) monitoring registries collecting data of a nationwide cohort of patients with "NVAF" treated with NOACs. Using logistic regression analysis, baseline characteristics and treatment discontinuation information were compared among initiators of the 4 NOACs. Results:In the reference period, the NOAC database collected data for 683,172 patients. The median age was 78?years with 19.5% aged 85 or older. Overall, the treatments were in accordance with guidelines. About 1/3 of patients switched from a prior VKA treatment; in the 72.3% of cases, these patients had a labile International Normalized Ratio (INR) at first prescription. The most prescribed NOAC was rivaroxaban, followed by apixaban, dabigatran and edoxaban. Conclusions:This study is the largest European real-world study ever published on NOACs. It includes all Italian patients treated with NOACs since 2013 accounting for about 1/3 of subjects with AF. The enrolled population consisted of very elderly patients, at high risk of ischemic adverse events. The AIFA registries are consolidated tools that guarantee the appropriateness of prescription and provide important information for the governance of National Health System by collecting real-world data.
| S-EPMC6994529 | biostudies-literature
Project description:The skills of patients on oral anticoagulants are critical for achieving good outcomes with this treatment. Self-management, or the capacity of patients to control their INR level and adjust their treatment, is an effective strategy of treatment. Capacity of patients to self manage is determined by a range of factors. The identification of these factors would improve the design of self management programmes and in turn increase the number of patients able to self-manage. The objective of our study is to identify those factors that determine the ability of patients on oral anticoagulant therapy to achieve self-management of their treatment.This will be a three year quasi- experimental prospective study with a control group. 333 patients on anticoagulant therapy from five health centres of the Basque Health Service are to be followed up for a period of six months each after the intervention, to assess their ability to self-test and self-manage. The intervention will consist of a patient training programme involving the provision of information and practical training concerning their condition and its treatment, as well as how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose.The ease-of-use of this technique lead us to believe that self-management is feasible and will represent an innovative advance that should have a substantial impact on the quality of life of this patients and their families as well as on the health care provision systems.Osakidetza Protocol Record ISCIII-11/02285, Oral anticoagulation and self-management, ClinicalTrials.gov Identifier: NCT01878539.
| S-EPMC3765739 | biostudies-literature
Project description:Anticoagulation therapy is administered to patients to prevent or stop thrombin generation in vivo. Although plasma tests of in vivo thrombin generation have been available for more than 2 decades, they are not routinely used in clinical trials or practice to monitor anticoagulation therapy. We observed a fall in one such marker, the D-dimer antigen, in patients receiving anticoagulation therapy. We therefore conducted a systematic review of the medical literature to document the change in serum biomarkers of thrombin generation following the initiation of anticoagulation therapy. Using a defined search strategy, we screened PubMed and Embase citations and identified full-length articles published in English. Eighteen articles containing serial changes in 1 of 3 markers of thrombin generation (D-dimer antigen, thrombin-antithrombin complexes, and prothrombin fragment 1+2 antigen levels) in the 14 days following the initiation of anticoagulation were identified. Even though the assays used varied considerably, each of the 3 markers of thrombin generation declined in the initial period of anticoagulation therapy, with changes evident as early as 1 day after beginning therapy. These observations provide a rationale for further exploration of these markers as measures of the adequacy of anticoagulation using classic as well as novel anticoagulants. Particular patient groups that would benefit from additional means of monitoring anticoagulation therapy are discussed.
| S-EPMC6714868 | biostudies-literature