Anti-Clot Treatment Scale Burdens Research Articles

Health Literacy and Treatment Satisfaction Among Patients with Venous Thromboembolism.

Venous thromboembolism (VTE) treatment requires complex management, and patients with limited health literacy (HL) may perceive higher burden and lower benefits associated with their treatment. To examine the association of HL with treatment satisfaction among patients with VTE. Retrospective cohort study PARTICIPANTS: Kaiser Permanente Southern and Northern California members who were taking oral anticoagulants (OAC) for incident VTE between 2015 and 2018 were surveyed. Main Measures HL was assessed using a 3-item HL assessment and dichotomized as having adequate or limited HL. High treatment burden and low treatment benefit were defined as Anti-Clot Treatment Scale (ACTS) scores below the 25th percentile of the distributions for ACTS Burdens and Benefits survey components, respectively. Using Poisson regression, multivariable adjusted risk ratios (RR) and 95% confidence intervals (CI) were calculated for the association of HL with high treatment burden and low treatment benefits. Among 2154 respondents, 397 (18.4%) had limited HL. Patients with limited vs adequate HL were older (47.9% vs 27.5% aged ≥ 75 years, p<0.001), more likely to use a non-English language when discussing their health (10.8% vs 1.7%, p<0.001), to have less than high school education (10.1% vs 1.7%, p<0.001), and to self-rate their health as fair or poor (47.6% vs 25.5%, p<0.001). After multivariable adjustment, patients with limited HL were more likely to have higher perceived treatment burden (RR 1.24, 95% CI 1.07, 1.45) and lower perceived treatment benefits (RR 1.21, 95% CI 1.08, 1.37). Limited HL was associated with lower OAC treatment satisfaction, though absolute differences in satisfaction scores were small. Further examination of the intersection of HL with VTE treatment satisfaction and compliance among older and non-English speaking patients is warranted.

Anticoagulant treatment satisfaction with warfarin and direct oral anticoagulants for venous thromboembolism

Treatment options for patients with venous thromboembolism (VTE) include warfarin and direct oral anticoagulants (DOACs). Although DOACs are easier to administer than warfarin and do not require routine laboratory monitoring, few studies have directly assessed whether patients are more satisfied with DOACs. We surveyed adults from two large integrated health systems taking DOACs or warfarin for incident VTE occurring between January 1, 2015 and June 30, 2018. Treatment satisfaction was assessed using the validated Anti-Clot Treatment Scale (ACTS), divided into the ACTS Burdens and ACTS Benefits scores; higher scores indicate greater satisfaction. Mean treatment satisfaction was compared using multivariable linear regression, adjusting for patient demographic and clinical characteristics. The effect size of the difference in means was calculated using a Cohen’s d (0.20 is considered a small effect and ≥ 0.80 is considered large). We surveyed 2217 patients, 969 taking DOACs and 1248 taking warfarin at the time of survey. Thirty-one point five percent of the cohort was aged ≥ 75 years and 43.1% were women. DOAC users were on average more satisfied with anticoagulant treatment, with higher adjusted mean ACTS Burdens (50.18 v. 48.01, p < 0.0001) and ACTS Benefits scores (10.21 v. 9.84, p = 0.046) for DOACs vs. warfarin, respectively. The magnitude of the difference was small (Cohen’s d of 0.29 for ACTS Burdens and 0.12 for ACTS Benefits). Patients taking DOACs for venous thromboembolism were on average more satisfied with anticoagulant treatment than were warfarin users, although the magnitude of the difference was small.

Translation, Pilot Psychometric Validation, and Comparative Performance of the Arabic Version of the Anti-Clot Treatment Scale (ACTS).

ABSTRACTBackground:Anticoagulation management is a complex process that is managed through careful monitoring, and patient satisfaction has a significant impact. Given the lack of a valid and reliable tool in Arabic to examine patient satisfaction, the present study aimed to translate and examine some of the psychometric properties of the Anti-Clot Treatment Scale (ACTS) among Saudi patients.Materials and Methods:This was a cross-sectional, methodological study conducted among patients receiving warfarin. The questionnaire was subjected to translation by using a multistep method. The final Arabic translated version of the ACTS underwent face and content validity assessments by independent experts to ensure its conceptual equivalence to the original English version. Subsequently, pilot testing of convergent, discriminant, and criterion validities were examined.Results:Overall, 136 patients participated in the study. All patients were asked to complete the generic Treatment Satisfaction Questionnaire for Medication (TSQM) alongside the ACTS tool. Convergent validity analyses revealed statistically significant positive correlations (p < 0.01) between the ACTS subscales and the four TSQM subdomains, as reflected by the Spearman correlation coefficient (r). Interestingly, the strongest correlations were observed between ACTS Burdens and the TSQM convenience domain (r = 0.61) and between ACTS Benefits and the TSQM effectiveness satisfaction score (r = 0.58). Similarly, discriminant validity was evidenced by moderate to high significant loading of all 12 items on each of their corresponding ACTS subscales.Conclusion:These findings of adequate validity support the use of the ACTS in Saudi patients receiving anticoagulant medications to measure their specific satisfaction levels with this type of therapy. However, future research addressing the clinical impact of ACTS scores in the Saudi population is needed.

Satisfaction of Patients with Nonvitamin K Anticoagulants Compared to Vitamin K Antagonists: a Systematic Review and Meta-analysis.

To undertake a systematic review and meta-analysis to assess the satisfaction of patients receiving nonvitamin K anticoagulants (NOACs), compared with vitamin K antagonists (VKAs). We searched CENTRAL, MEDLINE, Embase, and Clinicaltrials.gov for randomized controlled trials (RCTs) and observational studies. Two reviewers screened, extracted, and appraised data independently. We pooled data using a random-effects model. Outcome included treatment satisfaction, which was assessed by scores of Duke Anticoagulation Satisfaction Scale (DASS), Anticlot Treatment Scale (ACTS), Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2), or Treatment Satisfaction Questionnaire for Medication version II (TSQM-VII) and their domains reported with 95% confidence intervals (95% CIs). We followed MOOSE and PRISMA guidelines. We included four RCTs and 16 observational studies, enrolling 18,684 participants overall. Compared with VKAs, treatment with NOACs improved the ACTS Burdens score by 4.21 points (95% CI: 2.99-5.43, I 2 = 95%, combined n = 6,180), and ACTS Benefits by 0.49 points (95% CI: 0.18-0.81, I 2 = 85%, combined n = 6,171). Switching from VKAs to NOACs improved the ACTS Burdens score by 5.33 points (95% CI: 3.53-7.14, combined n = 3,097). Compared with VKAs, treatment with NOACs improved the TSQM-VII Global Satisfaction score by 6.86 points (95% CI: 3.00-10.73, combined n = 5,535). In patients with nonvalvular atrial fibrillation or venous thromboembolism, NOAC treatment is associated with greater satisfaction compared with VKAs. The switch from VKAs to NOACs was associated with improved patients' satisfaction. These effects were largely due to a lower degree of treatment burden with NOAC treatment.

The anti-clot treatment scale (ACTS): validation of the translated Arabic version among patients undergoing warfarin therapy in Saudi Arabia

BackgroundLong-term anticoagulation therapy, particularly with warfarin, is usually associated with poor adherence and low patient satisfaction. However, previous studies have highlighted the possibility that individual perceptions of warfarin differ according to cultural practices. This study validated the psychometric properties of the translated Arabic version of the Anti-Clot Treatment Scale (ACTS) for patients on warfarin therapy in Saudi Arabia.MethodsA cross-sectional multicenter study was conducted at the three main medical centers in Riyadh. Stratified sampling was employed to recruit Arabic-speaking patients who had been taking warfarin for a minimum of 3 months for any indication. The patients completed the specific ACTS along with the generic Treatment Satisfaction Questionnaire for Medication (TSQM 1.4) at two clinic visits. The psychometric performance of the ACTS was evaluated using well-established criteria: feasibility, reliability, and validity.ResultsOne hundred thirty-six patients participated in the study (mean age: 50.68 ± 14.6 years; range: 19–97). Overall, the patients reported moderate Burdens and Benefits scores (44 ± 9.9 and 11.92 ± 2.4, respectively) compared to the reference range for each subscale (12–60 and 3–15, respectively); however, they reported lower Burdens scores than other populations. Consistent with the original ACTS validation study, the criteria for acceptability (data targeting, floor/ceiling effects, and skewness) were satisfied; in fact, the Arabic version exhibited better item- and scale-level distributions of data than versions in other languages. The ACTS subscales also demonstrated satisfactory test-retest reliability with significant intraclass correlation coefficients ((ICC ≥ 0.5); p < 0.001) and good internal consistency (all Cronbach’s alpha values exceeded 0.7). Exploratory factor analysis supported the 2-factor loading model. Interestingly, the Arabic version exhibited greater convergent validity with the TSQM subdomains (r = 0.61).ConclusionsThis study provides convincing evidence that the Arabic versions of both the ACTS Burdens and ACTS Benefits scales are equivalent to other versions in terms of psychometric performance, as measured using reliability and validity criteria. These properties support the great potential of the Arabic ACTS to accurately reflect patient satisfaction, identify aspects of treatment that need improvement in clinical practice, and compare treatment satisfaction across different anticoagulant therapies or cultures in research.

1774P - Patient-reported outcomes associated with switching to rivaroxaban for the treatment of venous thromboembolism (VTE) in patients with active cancer

BackgroundLong-term anticoagulant treatment is important for the prevention of recurrent VTE in patients with cancer-associated thrombosis (CAT). Associated burdens of treatment include daily injections of low molecular weight heparin (LMWH) and challenges in maintaining safe and effective anticoagulation with vitamin K antagonists (VKAs), which may limit patient satisfaction and negatively impact on patient adherence and outcomes. Rivaroxaban may provide a more convenient option for these patients. MethodsCOSIMO (a multinational, prospective, non-interventional study) evaluated patient-reported outcomes in patients with active cancer scheduled to be switched to rivaroxaban following LMWH or VKA therapy for ≥4 weeks for the treatment of CAT. Treatment satisfaction was evaluated through the Anti-Clot Treatment Scale (ACTS), a 17-item measure of the negative and positive aspects of anticoagulation treatment, on subscales for ACTS Burdens (maximum score 60) and ACTS Benefits (maximum score 15), respectively. A higher score represents higher patient satisfaction. The primary outcome was a change in the ACTS Burdens score at week 4 compared with baseline. Analyses generally included all patients who received ≥1 dose of rivaroxaban, and who completed the ACTS questionnaire at the time point being assessed. p-values were generated through the Wilcoxon signed-rank test. ResultsOf 509 patients enrolled, 381 (74.9%) patients were valid for the ACTS analysis at week 4, 341 (67.0%) at month 3, and 253 (49.7%) at month 6. There was a significant increase in mean ACTS Burdens scores from baseline at week 4 (51.8 vs 55.6; mean difference = 3.9; p<0.0001), from baseline at month 3 (52.1 vs 56.2; mean difference = 4.2; p<0.0001), and from baseline at month 6 (51.7 vs 56.5; mean difference = 4.8; p<0.0001). There were also significant increases in ACTS Benefit scores from baseline at month 3 (p=0.04) and month 6 (p=0.01). ConclusionsPatients with CAT reported a durable improvement in anticoagulation-associated treatment satisfaction, specifically a reduction in the perceived burdens of therapy, following the switch from a LMWH or VKA to rivaroxaban. Clinical trial identificationNCT02742623, registered 19 April 2016. Editorial acknowledgementHayley Dawson of Chameleon Communications Int. Ltd. Legal entity responsible for the studyThe authors. FundingBayer AG and Janssen Scientific Affairs, LLC. DisclosureA.T. Cohen: Honoraria (self), Research grant / Funding (self): Bayer; Honoraria (self), Research grant / Funding (self): Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (self): Daiichi Sankyo Europe ; Honoraria (self), Research grant / Funding (self): Pfizer; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Johnson & Johnson; Honoraria (self): Portola; Honoraria (self): Sanofi; Honoraria (self): XO1; Honoraria (self): Janssen ; Honoraria (self): Ono Pharmaceuticals. A. Maraveyas: Honoraria (self): Bayer; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Pfizer. J. Beyer-Westendorf: Honoraria (self), Research grant / Funding (self): Bayer; Honoraria (self), Research grant / Funding (self): Boehringer Ingelheim; Honoraria (self), Research grant / Funding (self): Daiichi Sankyo; Honoraria (self), Research grant / Funding (self): Doasense; Honoraria (self), Research grant / Funding (self): Portola; Honoraria (self), Research grant / Funding (self): Pfizer. A.Y.Y. Lee: Honoraria (self): Bayer; Honoraria (self): LEO Pharma ; Honoraria (self): Pfizer; Research grant / Funding (self): Bristol-Myers Squibb. L.G. Mantovani: Honoraria (self): Bayer; Honoraria (self), Research grant / Funding (self): Boehringer Ingelheim; Honoraria (self): Pfizer; Research grant / Funding (self): Daiichi Sankyo. K. Folkerts: Full / Part-time employment: Bayer. M. Bach: Full / Part-time employment: Bayer. Y. De Sanctis: Full / Part-time employment: Bayer. K. Abdelgawad: Full / Part-time employment: Bayer.

Psychometric validation of anti-clot treatment scale and treatment satisfaction questionnaire for medication version II in Japanese patients with atrial fibrillation

Aims: The Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM-II) are validated treatment satisfaction patient-reported outcome (PRO) instruments. The ACTS includes two domains: Burdens and Benefits; the TSQM-II includes four: Effectiveness, Side Effects, Convenience, and Global Satisfaction. Japanese-language versions of the ACTS and TSQM-II have been developed and linguistically validated. This study aimed to assess their psychometric properties in Japanese patients with atrial fibrillation (AF). Materials and methods: ACTS and TSQM-II data from 534 patients with AF were collected in a Japanese post-marketing surveillance study of a direct oral-anticoagulant, rivaroxaban. Four key psychometric properties, in line with best practice guidelines from the US Food and Drug Administration, were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (i.e. internal consistency reliability, test-retest reliability), and construct validity (i.e. convergent validity and known groups). Results: ACTS Burdens and Benefits and TSQM-II Effectiveness, Convenience, and Global Satisfaction scales were found to be acceptable (e.g. item-level missing data at baseline <4%), with all scales having good internal consistency (Cronbach’s alpha > 0.80). test-retest reproducibility intraclass correlation coefficients for the ACTS Burdens and Benefits were 0.59 and 0.65, respectively, and between 0.54–0.61 for the TSQM-II scales. Known-groups validity for the ACTS and TSQM-II was supported by differences in scale scores by positive and negative impact (p < 0.05). Correlations between the ACTS and TSQM-II (convergent validity) were lower than expected (range r = 0.09–0.48), but in line with the original ACTS development study. Limitations: Evaluation of test-retest reproducibility was limited by assessment period, which was longer (3 months) than recommended guidelines (usually up to 2 weeks). Conclusions: Overall, Japanese versions of ACTS and TSQM-II scales satisfied internal consistency reliability and traditional validity criteria. Our study supports the ACTS and TSQM-II as appropriate PRO instruments to measure satisfaction with anticoagulant treatment in Japanese patients with AF. Trial registration: NCT01598051, clinicaltrials.gov; registered April 20, 2012.

Perception of Patients Regarding Burdens and Benefits of Vitamin K Antagonists Among Patients with Nonvalvular Atrial Fibrillation.

Achieving a good satisfaction with anticoagulant treatment should be a target in Atrial Fibrillation (AF) patients. To ascertain the perception of patients regarding burdens and benefits of anticoagulation with Vitamin K Antagonists (VKA). This was a multicenter cross-sectional/retrospective study conducted throughout Spain, in which AF patients taking VKA during the last year, attended at primary care setting were included. The Anti-Clot-Treatment Scale (ACTS) was used to determine perceived burdens and benefits with anticoagulation. Overall, 1,386 patients (mean age 77.4 ± 8.7 years; 48.6% women; 64.2% permanent AF; CHA2DS2-VASc 3.9 ± 1.5; HAS-BLED 1.6 ± 0.9) were analyzed. The adequate anticoagulation control was achieved by 56.9/60.6% of patients according to direct method/Rosendaal method, respectively. Overall, mean ACTS Burdens scale score was 49.4 ± 8.8 and mean ACTS Benefits scale score 11.2 ± 2.2. Active patients, polymedication, elderly and visits to the nurse were associated with higher scores in the ACTS Burdens scale (lower perceived burden), whereas visits to the emergency department and primary care physician were associated with lower scores in the ACTS Burdens scale (higher perceived burden). Active patients, number of INR determinations, visits to the nurse, and an adequate INR control were associated with higher scores in the ACTS Benefits scale (higher perceived benefit), whereas visits to the emergency department and to the primary care physician were associated with lower scores in the ACTS Benefits scale (lower perceived benefit). Satisfaction with treatment was high among patients with AF chronically anticoagulated with VKA, suggesting that quality of life is not impaired in this population.

Patient Satisfaction with Direct Oral Anticoagulants and Warfarin.

The burden of anticoagulation treatment affects patient satisfaction, which in turn affects adherence to treatment. Thus, we must thoroughly understand the advantages of direct oral anticoagulants (DOACs) over vitamin K antagonists (VKAs)/warfarin given for stroke prevention in patients with atrial fibrillation (AF). We compared satisfaction with anticoagulation therapy between 654 DOAC and 821 warfarin users enrolled in the SAKURA AF Registry. Satisfaction was assessed by means of the Anti-Clot Treatment Scale (ACTS), which includes 12-item burdens and 3-item benefits scales, and the treatment satisfaction questionnaire for medication II (TSQM II), which includes 2-item effectiveness, 3-item side effects, 3-item convenience, and 2-item global satisfaction domains. There were no significant between-group differences in TSQM II convenience (67.6 ± 14.5 versus 68.9 ± 14.5, P = 0.280), effectiveness (65.0 ± 13.3 versus 66.0 ± 15.0, P = 0.422), side effects (93.6 ± 13.7 versus 92.8 ± 14.4, P = 0.067), and global satisfaction (64.7 ± 14.9 versus 66.0 ± 14.6, P = 0.407) scores. In contrast, although there was no significant between-group difference in the ACTS benefits scores (9.8 ± 3.1 versus 10.1 ± 3.2, P = 0.051), the ACTS burdens scores (54.5 ± 6.3 versus 52.7 ± 6.9, P < 0.0001) were significantly higher in the DOAC users, independent of age, sex, and DOAC type. We can expect greater burden satisfaction with anticoagulation treatment in patients given a DOAC versus VKA/warfarin. The reduced burden of treatment will translate to greater patient adherence to their treatment plans and a positive effect on clinical outcomes.

COSIMO \u2013 patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study

BackgroundAround 20% of venous thromboembolism (VTE) cases occur in patients with cancer. Current guidelines recommend low molecular weight heparin (LMWH) as the preferred anticoagulant for VTE treatment. However, some guidelines state that vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) are acceptable alternatives for long-term therapy in some patients if LMWHs are not available. LMWHs and VKAs have a number of drawbacks that can increase the burden on patients. DOACs, such as rivaroxaban, can ameliorate some burdens and may offer an opportunity to increase patient satisfaction and health-related quality of life (HRQoL). The Cancer-associated thrOmboSIs – patient-reported outcoMes with rivarOxaban (COSIMO) study is designed to provide real-world information on treatment satisfaction in patients with active cancer who switch from LMWH or VKA to rivaroxaban for the treatment of acute VTE or to prevent recurrent VTE.MethodsCOSIMO is a prospective, non-interventional, single-arm cohort study that aims to recruit 500 patients in Europe, Canada and Australia. Adults with active cancer who are switching to rivaroxaban having received LMWH/VKA for the treatment and secondary prevention of recurrent VTE for at least the previous 4 weeks are eligible. Patients will be followed for 6 months. The primary outcome is treatment satisfaction assessed as change in the Anti-Clot Treatment Scale (ACTS) Burdens score at week 4 after enrolment compared with baseline. Secondary outcomes include treatment preferences, measured using a discrete choice experiment, change in ACTS Burdens score at months 3 and 6, and change in HRQoL (assessed using the Functional Assessment of Chronic Illness Therapy – Fatigue questionnaire). COSIMO will collect data on patients’ medical history, patterns of anticoagulant use and incidence of bleeding and thromboembolic events. Study recruitment started in autumn 2016.ConclusionsCOSIMO will provide information on outcomes associated with switching from LMWH or VKA therapy to rivaroxaban for the treatment or secondary prevention of cancer-associated thrombosis in a real-life setting. The key goal is to assess whether there is a change in patient-reported treatment satisfaction. In addition, COSIMO will facilitate the evaluation of the safety and effectiveness of rivaroxaban in preventing recurrent VTE in this patient population.Trial registrationNCT02742623. Registered 19 April 2016.

Patient-reported treatment satisfaction with rivaroxaban in Japanese non-valvular atrial fibrillation patients: an observational study

Objectives: Rivaroxaban has previously been shown to be as efficacious and safe as warfarin for the prevention of stroke in non-valvular atrial fibrillation (NVAF). Therefore, treatment satisfaction becomes an important consideration. Here we examine treatment satisfaction in Japanese NVAF patients who were switched from warfarin to rivaroxaban.Methods: Patient-reported outcome (PRO) data were collected as part of a prospective, multi-center, post-marketing surveillance (PMS) of a direct oral-anticoagulant, rivaroxaban, in Japan. The Anti-Clot Treatment Scale (ACTS) and the Treatment Satisfaction Questionnaire for Medication version II (TSQM-II) were collected at baseline, month 3, and month 6. Change in scores from baseline to month 3 and month 6 were assessed. Exploratory analyses included change in scores by patient characteristics. Safety and effectiveness of rivaroxaban were also assessed.Results: ACTS Burdens scores significantly improved at month 3 (54.5 ± 6.4) and month 6 (54.5 ± 6.5) compared to baseline (50.9 ± 7.6) (p < .001). ACTS Benefits score remained stable over time (baseline = 10.1 ± 2.8, month 3 = 10.2 ± 3.1, month 6 = 10.1 ± 3.1). Mean TSQM-II sub-scale scores significantly improved at month 3 and month 6 compared to baseline for all four domains (all p < .001).Conclusions: Findings suggest treatment satisfaction may improve in Japanese NVAF patients after a switch from warfarin to rivaroxaban. Higher treatment satisfaction may translate into improved treatment adherence, which is critical for the long-term prevention of stroke.

Satisfaction with oral anticoagulants in patients with atrial fibrillation.

BackgroundAlthough, by itself, atrial fibrillation is associated with an impairment of quality of life antithrombotic therapy may play a role.ObjectiveTo evaluate the satisfaction with anticoagulant treatment in patients with nonvalvular atrial fibrillation who attended internal medicine departments in Spain.MethodsPatients from two different cross-sectional studies were combined. To measure the satisfaction with anticoagulant treatment, the Anti-Clot-Treatment Scale (ACTS) questionnaire was completed by every patient. A multivariate analysis was performed to determine the variables associated with satisfaction of patients receiving oral anticoagulants.ResultsA total of 1,309 patients (mean age 78.5±8.4 years; 49.3% men; CHA2DS2VASC 4.9±1.5; HAS-BLED 2.0±0.9) were included in the study, of whom 902 (68.9%) were taking vitamin K antagonists (VKA) and 407 (31.1%) direct oral anticoagulants (DOACs). Overall, satisfaction with oral anticoagulation was high (ACTS Burdens scale 49.69±9.45; ACTS Benefits scale 11.35±2.61). The perceived burdens with anticoagulant treatment were lower in men, as well as in patients with no dependency, normal renal function, who were not polymedicated, or who had moderate bleeding risk. Among patients taking VKA, those subjects with a lower number of International Normalized Ratio (INR) determinations in the last 6 months or with an optimal time in the therapeutic range exhibited a lower perceived burden. Patients taking DOACs (vs VKA) showed a lower perceived burden with anticoagulation. Benefits with anti-coagulation were higher in men, younger patients, those with no dependency, or low bleeding risk. Perceived benefits were higher in patients taking DOACs (vs VKA).ConclusionSatisfaction with oral anticoagulation was high in patients with nonvalvular atrial fibrillation, who were attending internal medicine departments daily in Spain. Among patients taking VKA, those subjects with a lower number of INR determinations in the last 6 months or with an optimal time in the therapeutic range exhibited a lower perceived burden with anticoagulant therapy. Patients taking DOACs (vs VKA) showed lower perceived burdens and higher perceived benefits with anticoagulation.

Satisfaction, quality of life and perception of patients regarding burdens and benefits of vitamin K antagonists compared with direct oral anticoagulants in patients with nonvalvular atrial fibrillation

To compare the satisfaction of patients treated with vitamin K antagonists (VKA) with that of patients treated with direct oral anticoagulants (DOACs) and to determine the impact on quality of life of both treatments in patients with nonvalvular atrial fibrillation (NVAF). Cross-sectional multicenter study in which outpatients with NVAF completed the ACTS (Anti-Clot Treatment Scale), SAT-Q (Satisfaction Questionnaire) and EQ-5D-3L (EuroQol 5 dimensions questionnaire, 3 level version) questionnaires. The study population comprised 1337 patients, of whom 587 were taking DOACs and 750 VKAs. Compared with VKAs, DOACs were more commonly prescribed in patients with a history of stroke and in patients with a higher thromboembolic risk. The study scores were as follows: SAT-Q: 63.8 ± 17.8; EQ-5D-3L total score: 75.6 ± 20.9; visual analog scale: 63.1 ± 20.6; ACTS Burdens: 51.8 ± 8.4 and ACTS Benefits: 11.9 ± 2.4. The ACTS Burdens score and ACTS Benefits score were higher with DOACs than with VKAs (54.83 ± 6.11 vs 49.50 ± 9.15; p < 0.001 and 12.36 ± 2.34 vs 11.48 ± 2.46; p < 0.001 respectively). NVAF patients treated with oral anticoagulants had many comorbidities and a high thromboembolic risk. Satisfaction and quality of life with oral anticoagulants were high, although they were both better with DOACs than with VKAs.

Abstract 078: Implications of Patient-Reported Treatment Satisfaction for Discontinuation of Rivaroxaban versus Warfarin in ROCKET-AF

Background: Patient-reported outcomes and satisfaction are important in both trials and clinical practice and may be associated with treatment adherence. Methods: ROCKET-AF was a randomized, double-blind trial of rivaroxaban versus warfarin for prevention of thromboembolism in patients with atrial fibrillation. In a substudy, we compared treatment satisfaction scores: Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM II). Patient-driven discontinuation included stopping study drugs due to withdrawal of consent, non-compliance, or loss to follow-up. Rates of discontinuation were calculated for participants above and below the median scores for each scale. Results: Of 14,264 patients in ROCKET AF, 1,181 (8.3%; median age 75 years; 34% women) patients completed both the ACTS and TSQM II questionnaires 4 weeks after starting the study drug. Over a median follow-up of 1.6 years, 450 premature study drug discontinuations occurred, 116 (26%) patient-driven. Patients less satisfied with treatment by the ACTS Benefits and Burdens and TSQM II scales had higher rates of study drug discontinuation ( Table ). Conclusions: Patient-reported satisfaction was lower in patients with study drug discontinuation, suggesting that collecting patient-reported outcomes early in clinical trials may guide interventions that improve adherence and clinical outcomes.

Patient-Reported Treatment Satisfaction with Rivaroxaban for Stroke Prevention in Atrial Fibrillation. A French Observational Study, the SAFARI Study.

BackgroundFor antithrombotic treatments, Patient Reported Outcomes (PRO) and patient satisfaction with treatment are essential data for physicians because of the strong relationship between patient satisfaction and adherence to treatment. The impact of rivaroxaban on patient satisfaction and quality of life was not sufficiently documented in phase III studies. There is a need for further data in this field especially in real life conditions.MethodsThe SAFARI study is composed of patients with non-valvular atrial fibrillation (AF), previously treated with vitamin K antagonist (VKA) and switched to rivaroxaban. Patient satisfaction with anticoagulant therapy was measured by the Anti-Clot Treatment Scale (ACTS), a validated 15-item patient-reported scale including a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Satisfaction of medication was compared between baseline and 1, 3 and 6 months.ResultsStudy population was composed of 405 patients. Mean age was 74.8 (standard deviation = 9.0) years and 63.0% were male. Mean CHA2DS2-VASc score was 3.4 (1.5) and mean HAS-BLED score was 2.9 (1.0). After 3 months of treatment with rivaroxaban, patient satisfaction improved compared with VKA: mean ACTS burdens scores significantly increased by 8.3 (8.9) points (p<0.0001) and ACTS benefits scale by 0.4 (2.9) (p<0.001). Compared with baseline, the improvement in ACTS burdens and benefits became apparent at 1 month (46.5 vs. 53.6 p<0.001 and 10.4 vs. 10.7, p<0.05 respectively) and persisted at 6 months (46.5 vs. 54.76 p<0.001 and 10.4 vs. 10.8 p = 0.02 respectively). Rivaroxaban persistence was 88.7% at 6 months.ConclusionsSAFARI data support a good risk-benefit balance for rivaroxaban, with a good safety profile and encourage PRO design studies. The switch from VKA to rivaroxaban improved patient satisfaction at 1, 3 and 6 months after rivaroxaban initiation among patients with AF, particularly in reducing patient-reported anticoagulation burden.

Abstract 12462: Improved Treatment Satisfaction Independent of Stroke and Bleeding Risk Among Patients Transitioned From a Vitamin K Antagonist to Rivaroxaban: A XANTUS-ACTS Analysis

Introduction: The effectiveness, safety and ease of use of rivaroxaban may reduce anticoagulation treatment burden and improve nonvalvular atrial fibrillation (NVAF) patient satisfaction compared to vitamin K antagonists (VKAs). Objective: To assess consistency in changes in treatment satisfaction among patients transitioned from a VKA to rivaroxaban in routine practice across stroke and bleeding risk subgroups. Methods: Xarelto on Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation (XANTUS) was a prospective, non-interventional study in patients prescribed rivaroxaban for prevention of stroke in routine practice within 7 European countries and Canada. Patients receiving a VKA 4-weeks prior to the initial XANTUS study visit and switched to rivaroxaban were asked to complete the Anti-Clot Treatment Scale (ACTS). Changes in scores, as recorded during the initial and first follow-up visit at ~3-months (corresponding to a comparison of rivaroxaban vs. prior VKA) for the ACTS Burdens and Benefits scores, were calculated and reported as least squares (LS)-mean differences with standard errors. Results: After ~3-months’ rivaroxaban treatment, both Burdens and Benefits scores were significantly improved in NVAF patients with prior VKA treatment ( Table ). Improvements in Burden scores across subgroups were generally consistent (LS-mean difference range, 2.68 to 3.46) with the overall cohort findings. The Benefit score improved in the overall cohort, but was not found to significantly differ in any subgroup (LS-mean difference range, -0.26 to 0.58). Conclusions: In XANTUS, patients switching from a VKA to rivaroxaban for stroke prevention reported significant improvements in treatment satisfaction. Independent of stroke or bleeding risk, switching to rivaroxaban appears to improve patient treatment satisfaction; mainly due to a perceived lower treatment burden

Validation of satisfaction questionnaire ACTS in outpatients with atrial fibrillation treated with oral anticoagulants in Spain. ALADIN Study

Background and objectiveTo validate the satisfaction questionnaire Anti-Clot-Treatment Scale (ACTS) in outpatients with nonvalvular atrial fibrillation (NVAF) treated with oral anticoagulants attended in Internal Medicine and Neurology departments in Spain. MethodsIn this cross-sectional and multicentrer study, 1337 outpatients aged ≥18 years, with NVAF, treated with oral anticoagulants ≥3 months, attended in Internal Medicine and Neurology departments in Spain were analysed. The patients completed ACTS, Self-Assessment of Treatment Questionnaire (SAT-Q) and EuroQol-5 dimensions (EQ-5D) questionnaires. ACTS is a satisfaction tool that specifically analyzes burdens (higher score, lesser burden) and benefits (higher score, higher benefit) with anticoagulant treatment. The psychometric properties of the questionnaire were evaluated according to the classical test theory. ResultsThe average time to complete the questionnaire was 8.99±6.06min and 63.70% of patients needed assistance to complete it. There was a high concordance between test and retest scores. Total reliability (Cronbach's alpha) was 0.95 in the ACTS Burdens scale and 0.82 in the ACTS Benefits scale. The factorial model was pertinent. All correlations with the SAT-Q questionnaire were positive, moderate and statistically significant. With regard to the EQ-5D-3L questionnaire, correlations were positive, low and statistically significant. Patient satisfaction was higher in the individuals being treated with new direct oral anticoagulants. ConclusionsIn patients with NVAF treated with oral anticoagulants, the Spanish version of ACTS questionnaire was reliable, valid and feasible.

Validación del cuestionario de satisfacción ACTS en pacientes con fibrilación auricular tratados con anticoagulantes orales en España. Estudio ALADIN

Background and objectiveTo validate the satisfaction questionnaire Anti-Clot-Treatment Scale (ACTS) in outpatients with nonvalvular atrial fibrillation (NVAF) treated with oral anticoagulants attended in Internal Medicine and Neurology departments in Spain. MethodsIn this cross-sectional and multicentrer study, 1,337 outpatients aged≥18 years, with NVAF, treated with oral anticoagulants≥3 months, attended in Internal Medicine and Neurology departments in Spain were analyzed. The patients completed ACTS, Self-Assessment of Treatment Questionnaire (SAT-Q) and EuroQol-5 dimensions (EQ-5D) questionnaires. ACTS is a satisfaction tool that specifically analyzes burdens (higher score, lesser burden) and benefits (higher score, higher benefit) with anticoagulant treatment. The psychometric properties of the questionnaire were evaluated according to the classical test theory. ResultsThe average time to complete the questionnaire was 8.99±6.06min and 63.70% of patients needed assistance to complete it. There was a high concordance between test and retest scores. Total reliability (Cronbach's alpha) was 0.95 in the ACTS Burdens scale and 0.82 in the ACTS Benefits scale. The factorial model was pertinent. All correlations with the SAT-Q questionnaire were positive, moderate and statistically significant. With regard to the EQ-5D-3L questionnaire, correlations were positive, low and statistically significant. Patient satisfaction was higher in the individuals being treated with new direct oral anticoagulants. ConclusionsIn patients with NVAF treated with oral anticoagulants, the Spanish version of ACTS questionnaire was reliable, valid and feasible.

Psychological effects of treatment with new oral anticoagulants in elderly patients with atrial fibrillation: a preliminary report.

Background and aimsAtrial fibrillation (AF) is the most common arrhythmia in elderly people, yet oral anticoagulation is underused in the aged. We tried to determine whether new oral anticoagulants (NOA) have greater psychological tolerability than warfarin.MethodsAge-, gender-matched groups of AF patients receiving NOA (N = 15) or warfarin (N = 15) were assessed with the Anti-Clot Treatment Scale (ACTS) and the Perceived Stress Scale (PSS).ResultsPatients were old (81 ± 9 years). NOA group showed greater psychological satisfaction, with lower therapy-related burden (ACTS burdens: 16.3 ± 4.5 vs. 32.9 ± 10.2, p < 0.001) and higher awareness of benefits (ACTS benefits: 13.0 ± 1.3 vs. 10.8 ± 1.9, p = 0.001). Even stress was lower (PSS: 13.1 ± 4.0 vs. 17.1 ± 4.2, p = 0.013). The multivariate analysis confirmed these findings, showing that higher levels of anxiety and depression could justify more stress in warfarin patients.ConclusionsThe results of this preliminary study show that NOA have an improved psychological impact compared with warfarin in elderly patients.

Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis

Rivaroxaban, an oral, direct factor Xa inhibitor, has been approved for the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE as a fixed-dose, single-drug regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. This study evaluated patient-reported treatment satisfaction in EINSTEIN DVT--a large, open-label, randomised study that compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy in patients with acute symptomatic DVT without PE. As part of EINSTEIN DVT, a total of 1,472 patients in seven countries were asked to complete a new, validated measure of treatment satisfaction--the Anti-Clot Treatment Scale (ACTS)--at scheduled visits throughout 12 months of treatment. ACTS scores were compared between study groups in the intention-to-treat population. Patients reported greater satisfaction in the rivaroxaban group compared with the enoxaparin/VKA group, with higher mean ACTS scores across visits. Mean ACTS Burdens scores were 55.2 vs 52.6 (p<0.0001) in favour of rivaroxaban, equivalent to a moderate effect size of 0.42. The treatment effect was consistent over time, with the mean score difference ranging from 2.18 (month 2) to 3.18 (month 12). Overall mean ACTS Benefits scores were 11.7 vs 11.5 in favour of rivaroxaban (p=0.006). This was associated with a small overall effect size of 0.12. The improvement in ACTS Benefits for rivaroxaban became apparent at month 2 and subsequent visits. Rivaroxaban results in improved treatment satisfaction compared with enoxaparin/VKA among patients with DVT, particularly in reducing patient-reported anticoagulation burden.