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Feasibility and safety of a 12-week INR follow-up protocol over 2 years in an anticoagulation clinic: a single-arm prospective cohort study.

ABSTRACT: The 2012 American College of Chest Physicians' guidelines recommended a 12-week INR follow-up interval may be appropriate for patients on stable warfarin doses. Limited evidence supports this recommendation. A single-arm, prospective cohort study over 24 months was completed in a Veterans Affairs anticoagulation clinic to determine the long-term feasibility and safety of implementing an extended INR follow-up interval in Veterans on stable doses of warfarin. Participants were required to have a stable warfarin dose for 6 months prior to enrollment. A prespecified protocol was used to titrate, extend, and manage the INR interval up to 12 weeks. Scheduling of extended INR intervals was a primary outcome. Safety outcomes included major and serious bleeding and thromboembolic events. A post-hoc comparison of baseline characteristics between individuals who were scheduled for at least 4 consecutive 12-week INR follow-up intervals and those who were not was completed. Of the 50 participants, 36 (72%) were scheduled for at least one 12-week interval and 15 (30%) were scheduled for 4 consecutive intervals. There were 2 thromboembolic events that occurred in 1 participant. There were 28 major and serious bleeding events in 19 participants; 8 occurred while on the extended INR interval. In the post-hoc analysis, no participants scheduled for 4 consecutive 12-week intervals had heart failure. Based on 2 years of monitoring, a 12-week INR follow-up interval using a detailed protocol with titration of INR interval extension appears feasible for a subset of patients. Patients with heart failure may not be suitable for this intervention.

SUBMITTER: Porter AL

PROVIDER: S-EPMC6398436 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Feasibility and safety of a 12-week INR follow-up protocol over 2 years in an anticoagulation clinic: a single-arm prospective cohort study.

Porter Andrea L AL Margolis Amanda R AR Staresinic Carla E CE Nagy Michael W MW Schoen Rebecca R RR Ray Cheryl A CA Fletcher Christopher D CD

Journal of thrombosis and thrombolysis 20190201 2

The 2012 American College of Chest Physicians' guidelines recommended a 12-week INR follow-up interval may be appropriate for patients on stable warfarin doses. Limited evidence supports this recommendation. A single-arm, prospective cohort study over 24 months was completed in a Veterans Affairs anticoagulation clinic to determine the long-term feasibility and safety of implementing an extended INR follow-up interval in Veterans on stable doses of warfarin. Participants were required to have a ...[more]

PMID: 30368762

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Project description:IntroductionThe Anticoagulation Forum and Centers for Disease Control and Prevention (CDC) recommend drive-up international normalized ratio (INR) testing to combat INR non-adherence and increase safety during the coronavirus disease 2019 (COVID-19) pandemic. Patient perceptions and impact on attendance have not been studied.ObjectiveTo assess appointment volume and patient perception after initiation of drive-up INR testing in a rural pharmacist-managed anticoagulation clinic.MethodsThis cross-sectional cohort survey study offered each patient attending the anticoagulation clinic via drive-up or in-office visit a survey between May 27 and July 2, 2020. Patients testing off-site were excluded. Study end points included monthly patient volume, visit type preference, testing barriers, desired drive-up duration, and overall clinic satisfaction. Clinic appointment volume from October 2019 to June 2020 was collected retrospectively through a schedule review.ResultsSixty-four (80%) of 80 surveys offered were completed: 46.6% of respondents preferred drive-up testing, 26.7% indifferent, and 26.7% preferred in-office visits; 38.7% of respondents indicated a greater likelihood of continuing routine INR monitoring via drive-up testing. Of the respondents completing the survey curbside, 46% and 27% of respondents identified reduced COVID-19 transmission risk and ease of transportation as benefits of drive-up INR testing, respectively. March and April clinic volumes were 19% and 22% below average, respectively, returning to baseline after drive-up testing was implemented. Clinic rating before and after drive-up testing remained high at 2.75 on a scale of 0-3. While infection risk was identified as the biggest barrier to care by 32.8% of respondents, 59.3% of all respondents wanted drive-up testing to continue indefinitely.ConclusionsDrive-up INR testing improves patient attendance during the COVID-19 pandemic. Patient perception of drive-up testing is positive. About 46% of respondents preferred drive-up INR testing with telehealth follow-up and 59.3% of respondents want drive-up testing to continue indefinitely, which suggests this approach to INR testing as a potential method to allay barriers to routine monitoring beyond the scope of the pandemic.

Project description:BackgroundCurrent guidance about the interval needed before retesting HbA1c when monitoring for glycaemic control is based on expert opinion rather than well-powered studies. The aim of our work was to explore how fast HbA1c changes after a change in glucose-lowering medication. This has implications for whether routine HbA1c testing intervals before 12 weeks could inform diabetes medication adjustments.MethodsThis 12-week cohort study recruited patients from 18 general practices in the United Kingdom with non-insulin treated diabetes who were initiating or changing dose of oral glucose-lowering medication. HbA1c was measured at baseline and 2, 4, 8 and 12 weeks after recruitment. HbA1c levels at earlier time intervals were correlated with 12-week HbA1c. A ROC curve analysis was used to identify the 8-week threshold above which medication adjustment may be clinically appropriate.ResultsNinety-three patients were recruited to the study. Seventy-nine patients with no change in medication and full 12-week follow-up had the following baseline characteristics: mean ± standard deviation age of 61.3 ± 10.8 years, 34% were female and diabetes duration of 6.0 ± 4.3 years. Mean HbA1c at baseline, 2, 4, 8 and 12 weeks was 8.7 ± 1.5%, (72.0 ± 16.8 mmol/mol) 8.6 ± 1.6% (70.7 ± 17.0 mmol/mol), 8.4 ± 1.5% (68.7 ± 15.9 mmol/mol), 8.2 ± 1.4% (66.3 ± 15.8 mmol/mol) and 8.1 ± 1.4% (64.8 ± 15.7 mmol/mol) respectively. At the end of the study 61% of patients had sub-optimal glycaemic control (HbA1c>7.5% or 59 mmol/mol). The 8-week change correlated significantly with the 12-week change in HbA1c and an HbA1c above 8.2% (66 mmol/mol) at 8 weeks correctly classified all 28 patients who had not achieved glycaemic control by 12 weeks.Conclusions/interpretationThis is the first study designed with sufficient power to examine short-term changes in HbA1c. The 12-week change in HbA1c can be predicted 8 weeks after a medication change. Many participants who had not achieved glycaemic control after 12 weeks may have benefitted from an earlier review of their HbA1c and medication.

Project description:BackgroundEffective management of patients using warfarin is resource-intensive, requiring frequent in-clinic 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.ObjectiveTo perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency.Patients/interventionsIn 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 in-clinic 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.ResultsPST and HQACM participants were similar with regard to gender, age, and CHADS2 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 quality-adjusted 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.ConclusionWeekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

Project description:IntroductionOlder adults with cancer suffer from the combined effects of ageing, cancer disease and treatment side effects. The main treatment for patients with haematological malignancies is chemotherapy, associated with significant toxicities. Chemotherapy can alter patients' physical function and quality of life which are often already diminished in older patients due to ageing and comorbidities. It therefore seems essential to develop and to evaluate interventions capable of preventing physical and psychosocial decline and its consequences. Promoting physical activity is a promising approach to improve physical function and quality of life in older adults with cancer, but there are limited data on the feasibility of such interventions among older patients with haematological malignancies, concomitant to chemotherapy.Methods and analysisOCAPI (OnCogeriatric and Individualized Physical Activity) is a single-arm, interdisciplinary, prospective, interventional, feasibility study. It is intended to include 40 patients (20 patients with acute myeloid leukaemia and 20 patients with non-Hodgkin's lymphoma) over 65 years in an individualised 6-month physical activity programme. The programme consists of individually supervised exercise sessions with an increasing volume of physical activity either at home and/or in a laminar airflow room (depending on the disease and treatment regimen) followed by unsupervised sessions and phone follow-ups. Patients will receive an activity tracker during the 6 months of the programme. Evaluations will take place at inclusion and at 3, 6 and 12 months to assess the feasibility of the programme and to explore potential changes in physical, psychosocial and clinical outcomes. The results will generate preliminary data to implement a larger randomised controlled trial.Ethics and disseminationThe study protocol was approved by the French ethics committee (Comité de protection des personnes Est I, N°ID-RCB 2019-A01231-56, 12 July 2019). All participants will have to sign and date an informed consent form. The findings will be disseminated in peer-reviewed journals and academic conferences.Trial registration numberNCT04052126.

Project description:BackgroundCzech older adults have lower rates of physical activity than the average population and lag behind in the use of digital technologies, compared with their peers from other European countries.ObjectiveThis study aims to assess the feasibility of intensive behavior monitoring through technology in Czech adults aged ≥50 years.MethodsParticipants (N=30; mean age 61.2 years, SD 6.8 years, range 50-74 years; 16/30, 53% male; 7/30, 23% retired) were monitored for 12 weeks while wearing a Fitbit Charge 2 monitor and completed three 8-day bursts of intensive data collection through surveys presented on a custom-made mobile app. Web-based surveys were also completed before and at the end of the 12-week period (along with poststudy focus groups) to evaluate participants' perceptions of their experience in the study.ResultsAll 30 participants completed the study. Across the three 8-day bursts, participants completed 1454 out of 1744 (83% compliance rate) surveys administered 3 times per day on a pseudorandom schedule, 451 out of 559 (81% compliance rate) end-of-day surveys, and 736 episodes of self-reported planned physical activity (with 29/736, 3.9% of the reports initiated but returned without data). The overall rating of using the mobile app and Fitbit was above average (74.5 out of 100 on the System Usability Scale). The majority reported that the Fitbit (27/30, 90%) and mobile app (25/30, 83%) were easy to use and rated their experience positively (25/30, 83%). Focus groups revealed that some surveys were missed owing to notifications not being noticed or that participants needed a longer time window for survey completion. Some found wearing the monitor in hot weather or at night uncomfortable, but overall, participants were highly motivated to complete the surveys and be compliant with the study procedures.ConclusionsThe use of a mobile survey app coupled with a wearable device appears feasible for use among Czech older adults. Participants in this study tolerated the intensive assessment schedule well, but lower compliance may be expected in studies of more diverse groups of older adults. Some difficulties were noted with the pairing and synchronization of devices on some types of smartphones, posing challenges for large-scale studies.

Project description:PurposeTo assess longer-term patterns of glaucoma medication adherence and identify whether patterns established during the first year of medication use persist during 3 subsequent years of follow-up.DesignRetrospective, longitudinal cohort analysis.ParticipantsBeneficiaries aged ≥40 years who were enrolled in a United States (US)-managed care plan for ≥7 years between 2001 and 2012 and newly diagnosed and treated for open-angle glaucoma.MethodsFor each enrollee, we quantified medication adherence using the medication possession ratio. Group-based trajectory modeling (GBTM) was applied to identify patterns of adherence for 1 and 4 years of follow-up. The percent of beneficiaries who remained in the same trajectory group in the 1- and 4-year models was tabulated to evaluate group stability. Factors impacting adherence at 1 and 4 years were identified using regression analyses.Main outcome measuresPatterns of glaucoma medication adherence.ResultsOf the 1234 eligible beneficiaries, GBTM identified 5 distinct glaucoma medication adherence patterns in both the 1-year and 4-year follow-up periods. These groups were as follows: (1) never adherent after their index prescription fill (7.5% and 15.6% of persons in the 1- and 4-year models, respectively); (2) persistently very poor adherence (14.9% and 23.4% of persons in the 1- and 4-year models, respectively); (3) declining adherence (9.5% and 9.1% of persons in the 1- and 4-year models, respectively); (4) persistently moderate adherence (48.1% and 37.0% of persons in the 1- and 4-year models, respectively); and (5) persistently good adherence (20.0% and 15.0% of persons in the 1- and 4-year models, respectively). More than 90% of beneficiaries in the 4 groups with the worst and best adherence patterns (groups 1, 2, 3, 5) maintained their patterns from their first year throughout their 4 years of follow-up. Those with persistently moderate adherence (group 4), the largest group, were most likely to change groups from 1 to 4 years of follow-up. Persons with the best adherence over 4 years were more likely to be white, to be older, to earn >$60 000/year, and to have more eye care visits (P < 0.05 for all comparisons). Those with a higher initial copayment cost had lower adherence rates (β = -0.06/dollar, P = 0.03).ConclusionsFor most patients who were newly prescribed glaucoma medications, adherence patterns observed in the first year of treatment reflect adherence patterns over the subsequent 3 years. Investing resources in both identifying and helping patients with suboptimal adherence patterns over the first year may have a large impact on longer-term adherence.

Dataset Information

Feasibility and safety of a 12-week INR follow-up protocol over 2 years in an anticoagulation clinic: a single-arm prospective cohort study.

Publications

Feasibility and safety of a 12-week INR follow-up protocol over 2 years in an anticoagulation clinic: a single-arm prospective cohort study.

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