Outcomes of Warfarin Home INR Monitoring vs Office-Based Monitoring: a Retrospective Claims-Based Analysis.

BACKGROUND: Home INR testing (patient self-testing) is feasible and effective for warfarin patients but little is known about real-world differences in outcomes for patients using PST versus laboratory-based INR monitoring. OBJECTIVE: To compare the safety/efficacy of patient self-testing of real-world warfarin therapy versus office/lab-based monitoring of therapy. DESIGN/SETTING/PARTICIPANTS/EXPOSURE: A retrospective claims-based analysis of warfarin patients enrolled in the MarketScan® Commercial Claims and Encounters and Medicare databases between January 1, 2013, and March 30, 2020. Stratification was based on INR testing method: patient self-testing versus testing at physicians' offices/local laboratory. The probability of adverse events in each cohort was determined after adjusting for demographic and baseline clinical characteristics using a repeated measures analysis. MAIN MEASURES: Rates of all adverse events: deep venous thrombosis, pulmonary embolism, bleeding, and stroke. A secondary outcome of interest was emergency department visits. KEY RESULTS: A total of 37,837 patients were included in the analysis: 1592 patients in the patient self-testing group and 36,245 in the office-based therapy group. After adjusting for demographic and baseline clinical characteristics, patients in the office-based group had statistically significantly higher rates of all adverse events (incidence rate ratio [IRR]=2.07, 95% CI [1.82, 2.36]), and specific adverse events including thromboembolism (IRR=4.38, 95% CI [3.29, 5.84]), major bleed (IRR=1.45, 95% CI [1.28, 1.64]), and stroke (IRR=1.30, 95% CI [1.05, 1.61]) than patients in the patient self-testing group. Office-based patients also had a statistically significant higher rate of emergency department visits than patient self-testing patients (IRR = 1.65, 95% CI [1.47, 1.84]). CONCLUSIONS/RELEVANCE: This analysis of real-world claims data shows lower rates of stroke, thromboembolism, and major bleeding, as well as fewer emergency department visits, with patient self-testing compared to office-based/lab INR monitoring. Our finding that PST is safe and effective among current users suggests that more patients may benefit from its use.

Point-of-care testing, near-patient testing and patient self-testing: warning points.

Point-of-care testing (POCT), near-patient testing (NPT) and patient self-tests (PST) are diagnostic examinations performed at the time and place of patient care. While POCT and NPT are performed and analyzed by medical professionals, PST are based on samples and parameters directly collected and analyzed by lay users. These tests are spreading both in high income countries and in low to middle income countries as they are expected to improve healthcare efficiency and equity, by saving resources, releasing pressure from hospitals and reducing logistical barriers. However, accurate multidisciplinary assessment is mandatory to ensure that what they promise is real. We reviewed some important ethical aspects, international standards and regulations. The current risks associated with alternative ways of testing are explained by the principles of respect for patient autonomy and non-maleficence. Further evidence from multidisciplinary assessment is needed to evaluate pros and cons in light of the principles of beneficence and justice. Although POCT or NPT need common regulation and accurate provider training to ensure safe and appropriate interpretation of results, PST needs even more attention as they are subject to direct patient use. Randomized controlled trails including patient education should be conducted in order to provide reliable evidence on clinical outcomes, patient acceptance and cost-effectiveness. Mandatory regulation is needed to avoid harm and EU regulation should help different countries maintain a safe use of devices in a global population of producers and users.

Evaluation of the "safe multidisciplinary app-assisted remote patient-self-testing (SMART) model" for warfarin home management during the COVID-19 pandemic: study protocol of a multi-center randomized controlled trial.

BACKGROUND: Warfarin treatment requires frequent monitoring of INR (international normalized ratio) to adjust dosage in a therapeutic range. In China, patients living in small towns usually go to tertiary hospitals to get warfarin monitoring and dosing, resulting in low frequencies of follow-ups and high incidence of complications. Influenced by the COVID-19 pandemic, patients on warfarin have further reduced their visits to healthcare institutions. While patient self-testing (PST) via using a point-of-care testing device for INR measuring at home has been widely used in developed countries and demonstrated improved clinical outcomes compared to usual care in clinics, it is rarely applied in developing countries, including China. This proposed study will develop and assess the "Safe Multidisciplinary App-assisted Remote patient-self-Testing (SMART) model" for warfarin home management in China during the COVID-19 pandemic. METHODS: This is a multi-center randomized controlled trial. We will carry out the study in three county hospitals, three small tertiary hospitals and three large tertiary hospitals with anticoagulation clinics in Hunan province of China. Eligible patients will be randomly assigned to the SMART model group (n = 360) or the control group (usual care clinic group, n = 360; anticoagulation clinic group, n = 120). Patients in the SMART model group do PST at home once every two to 4 weeks. Controls receive usual care in the clinics. All the patients will be followed up through outpatient clinics, phone call or online interviews at the 3rd, 6th, 9th and 12th month. The percentage of time in therapeutic range (TTR), incidence of warfarin associated major bleeding and thromboembolic events and costs will be compared between the SMART model group and control groups. DISCUSSION: Patients in the SMART model group would show improved TTR, lower incidence of complications and better quality of life compared to the control groups. Our design, implementation and usage of the SMART model will provide experience and evidence in developing a novel model for chronic disease management to solve the problem of healthcare service maldistribution, an issue particularly obvious in developing countries during the COVID-19 pandemic. TRIAL REGISTRATION: ChiCTR, ChiCTR 2000038984 . Registered 11 October, 2020.

Budget Impact of Increasing Market Share of Patient Self-Testing and Patient Self-Management in Anticoagulation.

BACKGROUND: Patient self-testing (PST) and/or patient self-management (PSM) might provide better coagulation care than monitoring at specialized anticoagulation centers. Yet, it remains an underused strategy in the Netherlands. METHODS: Budget-impact analyses of current and new market-share scenarios of PST and/or PSM compared with monitoring at specialized centers were performed for a national cohort of 260,338 patients requiring long-term anticoagulation testing. A health care payer perspective and 1- to 5-year time horizons were applied. The occurrence of thromboembolic and hemorrhagic complications in the aforementioned patient population was assessed in a Markov model. Dutch-specific costs were applied, next to effectiveness data derived from a meta-analysis on PST and/or PSM. Sensitivity and scenario analyses were performed to assess uncertainty on budget-impact analysis results. RESULTS: Increasing PST and/or PSM usage in the national cohort from the current 15.4% to 50% resulted in savings ranging from €8 million after the first year to €184 million after 5 years. Further increases in the use of PST and/or PSM produced greater savings. Sensitivity analyses revealed budget-impact model sensitivity to the baseline and relative risks of thromboembolic complications. Unfavorable budget impact was found in scenarios exploring an increase in the use of PST alone as well as an increase in the market share of PST and PSM in patients with atrial fibrillation. CONCLUSIONS: Overall study findings indicated that PST and PSM are more favorable alternatives to monitoring at specialized centers in patients without atrial fibrillation.

System Accuracy and Interference Evaluation of a New Glucose Dehydrogenase-Based Blood Glucose Meter for Patient Self-Testing.

New European medical device regulations require the performance of postmarketing surveillance evaluations for blood glucose meters (BGMs). We conducted an ISO15197:2015-conform system performance evaluation with the approved glucose dehydrogenase (GDH)-based Wellion NEWTON BGM. One hundred subjects were enrolled into the study (44 female, 56 male, 43 healthy subjects, 23 type 1 diabetes, 34 type 2 diabetes, age: 53.7 ± 15.8 years). In addition, manipulated heparinized whole blood was used for a laboratory interference test with ten selected substances (interference definition: substance-induced bias > 10%). The mean absolute relative difference (MARD) was 4.7%, and 100% of the values were in zones A (99.7%) and B (0.3%), respectively, of the consensus error grid. Interference was observed with xylose only, which is a known interfering substance for GDH-based BGMs.

In-home Compared With In-Clinic Warfarin Therapy Monitoring in Mechanical Heart Valves: A Population-Based Study.

OBJECTIVE: To evaluate differences in time in therapeutic range (TTR), major bleeding, thromboembolism, and survival comparing in-home and in-clinic international normalized ratio monitoring for patients with mechanical heart valves receiving warfarin anticoagulation. PATIENTS AND METHODS: An observational population-based study of 383 patients (mean ± SD age, 61.5±14.1 years; 38.6% female) with mechanical heart valves (aortic, 77.8%; mitral, 31.1%; tricuspid, 1%; pulmonic 0.2%; and multiple, 9.7%) was performed from January 1, 2012, through December 31, 2017. The target international normalized ratio was 2.5 for 199 patients (52.0%) and 3.0 for 184 (48.0). Of these patients, 37.9% (n=145) were managed by in-home monitoring (cases) and 62.1% (n=238) were monitored in the clinic (controls). RESULTS: During median follow-up of 3.1 years, mean ± SD TTR was similar between in-home (66.6%±19.2%) and in-clinic (67.2%±19.8%) monitoring (P=.76). There were no differences between the in-home and in-clinic groups regarding survival to major bleeding (5.7% per person-year vs 6.7% per person-year; P=.66) or thrombotic complications (2.3% vs 1.8%; P=.56). In-home monitoring was associated with reduced all-cause mortality (hazard ratio, 0.40; 95% CI, 0.19 to 0.83; P=.01) on univariate analysis; however, this was no longer apparent when controlling for age and baseline left ventricular ejection fraction. CONCLUSION: In this real-world population-based study of patients with mechanical heart valves, in-home monitoring was equivalent to in-clinic monitoring regarding TTR and important clinical outcomes.

Cost-benefit analysis of VKA versus NOAC treatment in German patients with atrial fibrillation utilizing patient self-testing.

BACKGROUND: Clinical complications of long-term anticoagulation in patients with atrial fibrillation cause significant morbidity and have a substantial economic impact on the healthcare system. OBJECTIVE: To assess the cost-benefit by implementing patient self-testing (PST) in German patients anticoagulated with vitamin K antagonists (VKA) compared to treatment with the new oral anticoagulant drugs (NOAC) apixaban, dabigatran, edoxaban, and rivaroxaban. METHODS: A deterministic decision-analytic model was developed simulating the number of major bleedings, ischemic strokes, and hemorrhagic strokes and their associated costs by utilizing PST compared to those of treatment with NOAC. Data on the rates of these adverse events in both groups during the 1st year of treatment was taken from the NOAC approval studies. Direct costs were evaluated from the perspective of the Statutory Health Insurance (SHI) considering the use of resources directly related to PST testing and costs incurred by hospital treatment of the adverse events. Univariate sensitivity analysis was performed to examine the extent to which our calculations were affected by varying the parameters considered in our model within plausible extremes. To capture the interactions between multiple inputs, we also provided a probabilistic sensitivity analysis (PSA). RESULTS: When achieving an average time in therapeutic range (TTR) of 78%, implementing PST in VKA patients reduces cost per patient compared to NOAC treatment between €603.38 [USD 681.52] (edoxaban) and €762.64 [USD 861.40] (rivaroxaban) during the 1-year observation period. In line with the TTR increase, the initially higher number of adverse events per VKA patient compared to NOACtreated patients in the approval studies becomes largely aligned; the difference in associated hospital costs per patient in the NOAC groups is then only €1.03 [USD 1.16] (in favor of dabigatran), €23.41 [USD 26.44] (in favor of apixaban), €0.53 [USD 0.60] (in favor of edoxaban) and €52.62 [USD 59.43] (in favor of VKA anticoagulation in the rivaroxaban group).In PSA, implementation of self-management results on average in a cost saving between €619.20 [USD 699.39] and €785.24 [USD 886.93] per VKA patient in favor of the SHI. Under all reasonable assumptions, PST remains constantly less expensive irrespective of which NOAC is administered. CONCLUSION: Implementing PST in German VKA patients may significantly reduce SHI expenditures compared to utilizing NOAC.

Clinical and Financial Outcomes Evaluation of Multimodal Pharmacist Warfarin Management of a Statewide Urban and Rural Population.

PURPOSE: To evaluate the efficacy, safety, and indirect financial outcomes of pharmacist face-to-face warfarin management with telephone-based distance management utilizing local laboratories or patient self-testing (PST). METHODS: A retrospective analysis of a clinic population of 336 patients on established warfarin therapy distributed statewide in rural and urban settings over a 6-month period was conducted. Participants were stratified into face-to-face management, telephone-based management utilizing local laboratory testing, and telephone-based management utilizing PST. RESULTS: The primary outcome of international normalized ratio (INR) time in therapeutic range (TTR) for face-to-face management was significantly greater than distance management utilizing local laboratory testing (69.0% vs 60.5%, P = .0032). No difference was observed between face-to-face management and PST (69.0% vs 68.0%, P = .25). No significant difference in bleeding or thromboses was observed. Although increased clinician time was utilized during face-to-face encounters compared to telephone encounters (8.7-minute face-to-face, 5.5-minute local laboratory, and 5.4-minute PST), face-to-face encounters tended to be billable at lower levels, whereas telephone-based encounters were billable at higher levels. CONCLUSION: A multimodal approach to pharmacist warfarin management of a patient population distributed statewide in rural and urban locations is effective despite TTR differences associated with INR testing used in distance management. PST may improve warfarin treatment outcomes and adherence in distance management, particularly when the use of alternative oral anticoagulants is inappropriate. Although time and billing differences between face-to-face and distance management exist, clinical and safety outcomes remain acceptable despite encounter complexity and support reimbursement of pharmacist anticoagulation management in all settings.

Implementation and evaluation of a pharmacist-led electronic visit program for diabetes and anticoagulation care in a patient-centered medical home.

PURPOSE: Results of a study evaluating quality-of-care, financial, and patient satisfaction outcomes of pharmacist-conducted telehealth visits for diabetes management and warfarin monitoring are reported. METHODS: A retrospective pre-post study was conducted to determine the impact of an electronic visit (e-visit) program targeting 2 groups of outpatients: adults with uncontrolled diabetes and warfarin-treated adults performing patient self-testing (PST) for monitoring of International Normalized Ratio (INR) values. RESULTS: A total of 36 patients participated in the e-visit program during the 2-year study period. Among warfarin-treated patients, the percentage of INR values in the desired range increased relative to preenrollment values (from 62.5% to 72.7%, p = 0.07), and the frequency of extreme INR values (values of <1.5 or >5.0) decreased (from 4.8% to 0.01%, p = 0.01); the margin per patient was $300 during the first year and $191 annually thereafter. In the diabetes group, a decrease from baseline in glycosylated hemoglobin values of 3.4 percentage points was observed at 5.7 months after enrollment (p < 0.001), with significant improvements in frequencies of statin use, aspirin use, and blood pressure control; the margin was $100 per patient. The overall median patient satisfaction survey score was 39 of 40. CONCLUSION: An online e-visit model for warfarin monitoring was an efficient, safe, and cost-effective method for implementing PST. Pharmacist-led management of diabetes through e-visits, often in combination with in-person visits, generated revenue while significantly improving clinical outcomes.