Abstract
To validate and analyze the accuracy of the Simonetti adherence score among patients on chronic use of vitamin K antagonists and their time in therapeutic range (TTR) of the international normalized ratio as a measure of quality of anticoagulation. A prospective cohort study with a nonrandomized intervention in patients from an anticoagulation center of a public hospital. Baseline data were collected from May to September 2017, and follow-up data were obtained eight months after a nurse-led educational intervention, which was given to all patients after consent form and after applying the adherence score (N=205). The intervention was undertaken through 30-40 min conversation about relevant factors that had been previously identified in the score derivation study, which comprised drug-drug interactions, inadequate OAC use, comorbidities, effects of food on vitamin K absorption, and invasive procedures. A receiver operating characteristic (ROC) curve was applied to validate the adherence score in terms of prediction of INR out of recommended therapeutic range. At baseline, mean adherence score was 44.69 and standard deviation (SD) was 18.37, and mean TTR was 41.07 (SD 15.40). Patients were reassessed after 8 months. At follow-up, there were significant improvements in mean adherence score 54.28 (SD 13.13), and in mean TTR 50.99 (SD 26.10). The Simonetti adherence score yielded high performance and accuracy in clinical practice among patients on chronic use of vitamin K antagonists. Our data indicate that nurse led educational intervention yielded favorable impact in terms of adherence score and TTR improvements.
Highlights
The guidelines of the European (2016), American (2014), and Brazilian (2016) Cardiology Societies recommend the use of oral anticoagulants (OACs) for patients with atrial fibrillation (AF) and with a CHA2DS2-VASc score ≥1 in men and ≥2 in women regarding new OACs (January CT et al, 2014; Kirchhof P et al, 2016; Magalhães LP et al., 2016)
We found that the area under the receiver operating characteristic (ROC) (AUROC) was 0.84 compared to the AUROC in Simonetti's adherence score (Simonetti, Faro & Bianchi, 2018)
Our results demonstrate that Simonetti’s adherence score is a valid tool with adequate performance and accuracy in measuring patient adherence to Vitamin K antagonists (VKA) and good correlation with international normalized ratio (INR) and therapeutic range (TTR), especially when used by nurses in the setting of anticoagulation clinics
Summary
The guidelines of the European (2016), American (2014), and Brazilian (2016) Cardiology Societies recommend the use of oral anticoagulants (OACs) for patients with atrial fibrillation (AF) and with a CHA2DS2-VASc score ≥1 in men and ≥2 in women (level 1A evidence) regarding new OACs (January CT et al, 2014; Kirchhof P et al, 2016; Magalhães LP et al., 2016). We hypothesized that a nurse-led specific educational intervention delivered to VKA users, identified by the Simonetti score as having low level of adherence/poorer INR and TTR values would improve these measures of OAC quality. Validation of a new instrument that allows for the INR to be maintained within the recommended range and improves therapeutic adherence to OAC is likely to generate positive patient perspectives concerning clinical management, with higher safety and optimized quality control of the anticoagulation level (Neto Almeida et al, 2016). To validate and analyze the accuracy of an adherence score among patients on chronic use of VKA and their TTR of the INR as a measure of quality of anticoagulation
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