Development and Application of an Attribute-Based Taxonomy on the Benefits of Oral Anticoagulant Switching in Atrial Fibrillation: A Delphi Study.

INTRODUCTION: Patients with atrial fibrillation (AF) often switch between oral anticoagulants (OACs). It can be hard to know why a patient has switched outside of a clinical setting. Medication attribute comparisons can suggest benefits. Consensus on terms and definitions is required for inferring OAC switch benefits. The objectives of the study were to generate consensus on a taxonomy of the potential benefits of OAC switching in patients with AF and apply the taxonomy to real-world data. METHODS: Nine expert clinicians (seven clinical pharmacists, two cardiologists) with at least 3 years of clinical and research experience in AF participated in a Delphi process. The experts rated and commented on a proposed taxonomy on the potential benefits of OAC switching. After each Delphi round, ratings were analyzed with the RAND Corporation/University of California, Los Angeles (RAND/UCLA) appropriateness method. Median ratings, disagreement index, and comments were used to modify the taxonomy. The resulting taxonomy from the Delphi process was applied to a cohort of patients with AF who switched OACs in a population-based administrative health dataset from 1996 to 2019 in British Columbia, Canada. RESULTS: The taxonomy was finalized in two Delphi rounds, reaching consensus on five switch benefit categories: safety, effectiveness, convenience, economic considerations, and drug interactions. Safety benefit (a switch that could lower the risk of adverse drug events) had three subcategories: major bleeding, intracranial hemorrhage (ICH), and gastrointestinal (GI) bleeding. Effectiveness benefit had four subcategories: stroke and systemic embolism (SSE), ischemic stroke, myocardial infarction (MI), and all-cause mortality. Real-world OAC switches revealed that more OAC switches had convenience (72.6%) and drug interaction (63.0%) benefits compared to effectiveness (SSE 22.0%, ischemic stroke 11.1%, MI 3.1%, all-cause mortality 10.1%), safety (major bleeding 24.3%, GI bleeding 10.6%, ICH 48.5%), and economic benefits (12.1%). CONCLUSIONS: The Delphi-based taxonomy identified five criteria for the beneficial effects of OAC switching, aiding in characterizing real-world OAC switching.

Patterns of natural health product use at an outpatient heart function clinic.

Background: Natural health product (NHP) use is common among Canadians, but the NHPs used by outpatients with cardiovascular conditions such as atrial fibrillation and heart failure have not been identified. Objectives: Describe NHP use among outpatient cardiac patients, assess drug interactions and their potential implications and determine NHP documentation by health care providers. Methods: Telephone interviews were conducted by the main researcher with patients who attended the Cardiac Clinics at the Royal Columbian Hospital. Medication reconciliation was performed to elicit information regarding NHP use and clinic charts were used to supplement demographic information. Results: There were 119 successful interviews. Most patients were approximately 65 years old and male, were diagnosed with atrial fibrillation, had 2 to 3 queried comorbidities and took 2 cardiovascular medications. It was found that 62% of patients use NHPs, and 239 individual NHPs were identified. The most common NHPs used were vitamins and minerals (63%), especially vitamin D (13%), multivitamins (8%) and omega-3s (8%). Interactions between cardiac medications and NHPs occurred in 86% of patients. NHP use was completely documented by health care providers in 24% of patients. Conclusion: NHP use is common among patients who attend outpatient cardiac clinics. Interactions between NHPs and cardiovascular medications are prevalent and may carry specific individual patient risks. NHP documentation by health care providers is often incomplete.

Oral anticoagulant adherence and switching in patients with atrial fibrillation: A prospective observational study.

BACKGROUND: Adherence to oral anticoagulants (OACs) in patients with atrial fibrillation (AF) is important in preventing stroke. The dominance of retrospective studies using administrative data has led to a lack of data on psychosocial determinants of adherence and prevented comparison of adherence between OAC drug classes. OAC switching is another aspect of adherence that is unexplored. METHODS: A prospective design was utilized to measure AF patients' self-reported adherence and OAC switching, and to identify their clinical, demographic, and psychosocial determinants. Participants were recruited from specialized AF clinics in Canada and followed for up to 2 years. Data were collected via telephone every 3-4 months using a structured survey. Adherence was measured using the Morisky Medication Adherence scale (©MMAS-8). RESULTS: The included participants (N = 306) were followed for a median follow up time of 14.1 months and had an average of 3.2(SD 1.4) study visits. The mean self-reported adherence on the ©MMAS-8 was 7.28(SD 0.71) for patients receiving care at specialized AF clinics. Older age, experiencing a bleed, and higher satisfaction with the burden of medications were significantly associated with higher adherence. Drug class did not have any significant impact on adherence. 7.8% of the cohort experienced a switch with most of them being from warfarin to DOAC. Taking warfarin as the index medication, experiencing a bleed and older age were significantly associated with higher odds of switching. CONCLUSION: Patients with AF reported high adherence to their OAC therapy however being on DOAC may not translate to better adherence compared to VKA. Improving satisfaction with the burden of therapy is important in improving adherence.

Satisfaction With Oral Anticoagulants Among Patients With Atrial Fibrillation: A Prospective Observational Study.

BACKGROUND: Satisfaction with treatment has been identified as an important contributing factor to adherence with oral anticoagulant (OAC) therapy in patients with atrial fibrillation (AF). We aimed to evaluate the satisfaction level of patients with AF regarding OAC use over time, using validated patient-reported outcome instruments, and to identify associated patient characteristics. METHODS: Participants were recruited from specialized AF clinics in Canada. Eligible AF patients who were prescribed OACs were followed for up to 2 years. Participants were interviewed via telephone every 3-4 months using a structured survey. The Treatment Satisfaction Questionnaire for Medication (TSQM II) and the Anti-Clot Treatment Scale (ACTS) were used to measure satisfaction over time. RESULTS: Among the 306 participants, satisfaction scores on the TSQM II and ACTS instruments were high. Unadjusted analyses showed significantly greater satisfaction with the burden of therapy with direct OACs (DOACs) compared to that with warfarin (small-magnitude effect) and greater satisfaction with the convenience of rivaroxaban, compared with that of all other OACs (moderate-magnitude effect). After adjustment for all other variables, vitamin K antagonist therapy was associated with greater global satisfaction than was DOAC treatment. Satisfaction with benefit and burden as measured by the ACTS scale, and global satisfaction on the TSQM II scale, tended to increase over time. Patient factors that were somewhat consistently associated with greater satisfaction were female sex and younger age. CONCLUSIONS: Patients with AF were highly satisfied with their therapy, with few differences among OAC classes and individual OACs. Individual patients may or may not be more satisfied with DOAC than VKA therapy, and regardless of the OAC prescribed, the may require significant support to maintain therapy adherence.

CONTEXTE: La satisfaction à l'égard du traitement a été désignée comme un facteur important contribuant à l'adhésion au traitement par anticoagulants oraux (ACO) chez les patients atteints de fibrillation auriculaire (FA). Notre objectif était d'évaluer le degré de satisfaction des patients atteints de FA concernant l'utilisation des ACO au fil du temps, à l'aide d'instruments validés mesurant les résultats signalés par les patients, et de déterminer les caractéristiques connexes des patients. MÉTHODOLOGIE: Les participants ont été recrutés dans des cliniques spécialisées en FA au Canada. Les patients admissibles atteints de FA qui se sont fait prescrire des ACO ont été suivis pendant une période allant jusqu'à 2 ans. Les participants ont été interrogés par téléphone tous les 3 ou 4 mois à l'aide d'une enquête structurée. Le questionnaire Treatment Satisfaction Questionnaire for Medication ­ Version II (TSQM II) et l'échelle Anti-Clot Treatment Scale (ACTS) ont été utilisés pour mesurer la satisfaction au fil du temps. RÉSULTATS: Parmi les 306 participants, les taux de satisfaction indiqués par les instruments TSQM II et ACTS étaient élevés. Les analyses non corrigées ont montré une satisfaction liée au fardeau du traitement significativement plus élevée avec les ACO directs qu'avec la warfarine (effet de faible ampleur) et une plus grande satisfaction concernant la commodité du rivaroxaban par rapport à celle de tous les autres ACO (effet de moyenne ampleur). Après ajustement pour tenir compte de toutes les autres variables, le traitement par antivitamines K (AVK) était associé à une plus grande satisfaction globale que le traitement par ACO direct. La satisfaction à l'égard des avantages et du fardeau, mesurée par l'échelle ACTS, et la satisfaction globale sur l'échelle TSQM II, ont eu tendance à augmenter avec le temps. Les facteurs liés aux patients qui ont été associés de manière assez constante à une plus grande satisfaction étaient le sexe féminin et un âge plus jeune. CONCLUSIONS: Les patients atteints de FA étaient très satisfaits de leur traitement, et peu de différences existaient entre les classes d'ACO et les ACO individuels. Chaque patient peut être ou non plus satisfait du traitement par ACO direct que par AVK et, quel que soit l'ACO prescrit, il peut avoir besoin d'un soutien important pour maintenir l'adhésion au traitement.

Atrial fibrillation patients' experiences and perspectives of anticoagulation therapy changes.

BACKGROUND: Atrial fibrillation (AF) patients' experiences with changes in their oral anticoagulant (OAC) therapy are understudied. OBJECTIVE: The objective of this study was to qualitatively describe AF patients' experiences and perspectives of changes made to their OAC therapy (switches or discontinuations). METHODS: A thematic analysis was performed on systematically-collected qualitative data from AF patients who experienced a therapy change (switching or discontinuing an OAC) as part of their participation in a large 2-year prospective observational study. RESULTS: A total of 56 participants met the inclusion criteria. Six themes emerged from the data: 1. reasons for switch or discontinuation of therapy, 2. attitudes towards changes in therapy attributes, 3. challenges with taking medications after therapy change, 4. relief from perceived burden of medication after discontinuation, 5. patients' limited involvement in decision-making, and 6. inadequate education and follow up. Patients were found to request changes in therapy based on their subjective experience with it (rather than clinically justified reasons). They were found to have limited knowledge about their medications, differing reactions to changes in their therapy attributes after a switch, an overall negative attitude towards taking medications, adherence challenges after switching from once daily to twice daily medication, feelings of being excluded from the decision-making process about their therapy changes and feelings of being unsupported after these changes. CONCLUSIONS: There are clear opportunities to improve patients' experiences with OAC therapy changes through improved shared decision-making and patient education/counselling.

Evaluating the Effect of a Patient Decision Aid for Atrial Fibrillation Stroke Prevention Therapy.

BACKGROUND: Stroke prevention therapy decisions for patients with atrial fibrillation (AF) are complex and require trade-offs, but few validated patient decision aids (PDAs) are available to facilitate shared decision making. OBJECTIVE: To evaluate the effects of a novel PDA on decision-making parameters for AF patients choosing stroke prevention therapy. METHODS: We developed an evidence-based individualized online AF PDA for stroke prevention therapy and evaluated it in a prospective observational pilot study. The primary outcome was decisional conflict. Secondary outcomes were knowledge, usability/acceptability, patient preferences, effects on therapy choices, and participant feedback. RESULTS: 37 participants completed the PDA. The PDA could be completed independently and was well accepted. It significantly decreased the mean decisional conflict score ( P < 0.001) and all its subscales and increased participant AF knowledge ( P = 0.02). 76% of participants indicated that their individualized therapy attribute ranking was congruent with their values. The PDA-generated best-match therapy was chosen by 70% of participants in decision 1 (no therapy, aspirin, or oral anticoagulant), and 17% for decision 2 (choice of anticoagulant). Among AF patients, 60% chose a different drug than that currently prescribed to them. Conclusion and Relevance: Our PDA was effective for reducing decisional conflict, increasing patient knowledge, eliciting patients' values, and presenting therapy options that aligned with patients' values and preferences. Using the PDA revealed that many patients have therapy preferences different from their currently prescribed treatment. The PDA is a practical and potentially valuable tool to facilitate decision making about stroke prevention therapy for AF.

Assessment of atrial fibrillation patients' education needs from patient and clinician perspectives: A qualitative descriptive study.

INTRODUCTION: Patients' lack of knowledge is a key barrier to therapy adherence. We aimed to gather insights into atrial fibrillation (AF) patients' education needs from patient and clinician viewpoints. METHODS: We conducted a qualitative descriptive study using purposive sampling and semi-structured interviews with AF patients and clinicians recruited from AF clinics. Data from patients and clinicians were analyzed independently and iteratively through inductive qualitative thematic analysis. RESULTS: Eleven clinicians and 10 patients were interviewed. Three themes emerged from analysis of clinician data: (1) patients' knowledge gaps and misconceptions, (2) clinicians' experiences teaching AF patients, and (3) clinicians' suggestions for AF education programs. Four themes emerged from the patient data: (1) emotional appraisal of the disease, (2) information seeking behavior, (3) knowledge gaps, and (4) education preferences. A key finding was identification of the need for education that addresses patients' unjustified anxieties by emphasizing that AF is not fatal, and that many patients with AF live a normal life. Risk communication was identified as the most challenging aspect of AF education. In synthesizing our findings, we developed evidence-based recommendations for educational strategies for AF. CONCLUSION: We found that AF patients have many knowledge gaps and misconceptions, significant emotional education needs, and a positive attitude towards online and classroom education. In synthesizing our findings, we developed evidence-based recommendations which can inform the design of AF patient education programs and initiatives.