TRial of an Educational intervention on patients' knowledge of Atrial fibrillation and anticoagulant therapy, INR control, and outcome of Treatment with warfarin (TREAT)

Background Atrial fibrillation (AF) patients with a high risk of stroke are recommended anticoagulation with warfarin. However, the benefit of warfarin is dependent upon time spent within the target therapeutic range (TTR) of their international normalised ratio (INR) (2.0 to 3.0). AF patients possess limited knowledge of their disease and warfarin treatment and this can impact on INR control. Education can improve patients' understanding of warfarin therapy and factors which affect INR control. Methods/Design Randomised controlled trial of an intensive educational intervention will consist of group sessions (between 2-8 patients) containing standardised information about the risks and benefits associated with OAC therapy, lifestyle interactions and the importance of monitoring and control of their International Normalised Ratio (INR). Information will be presented within an 'expert-patient' focussed DVD, revised educational booklet and patient worksheets. 200 warfarin-naïve patients who are eligible for warfarin will be randomised to either the intervention or usual care groups. All patients must have ECG-documented AF and be eligible for warfarin (according to the NICE AF guidelines). Exclusion criteria include: aged < 18 years old, contraindication(s) to warfarin, history of warfarin USE, valvular heart disease, cognitive impairment, are unable to speak/read English and disease likely to cause death within 12 months. Primary endpoint is time spent in TTR. Secondary endpoints include measures of quality of life (AF-QoL-18), anxiety and depression (HADS), knowledge of AF and anticoagulation, beliefs about medication (BMQ) and illness representations (IPQ-R). Clinical outcomes, including bleeding, stroke and interruption to anticoagulation will be recorded. All outcome measures will be assessed at baseline and 1, 2, 6 and 12 months post-intervention. Discussion More data is needed on the clinical benefit of educational intervention with AF patients receiving warfarin. Trial registration ISRCTN93952605

Patients’ and health professionals’ views and experiences of atrial fibrillation and oral-anticoagulant therapy:a qualitative meta-synthesis

Objective - Atrial fibrillation (AF) patients are prescribed oral-anticoagulant (OAC) therapy, often warfarin, to reduce stroke risk. We explored existing qualitative evidence about patients’ and health professionals’ experiences of OAC therapy. Methods - Systematic searches of eight bibliographic databases were conducted. Quality was appraised using the Critical Appraisal Skills Programme tool and data from ten studies were synthesised qualitatively. Results - Four third-order constructs, emerged from the final step in the analysis process: (1) diagnosing AF and the communication of information, (2) deciding on OAC therapy, (3) challenges revolving around patient issues, and (4) healthcare challenges. Synthesis uncovered perspectives that could not be achieved through individual studies. Conclusion - Physicians’ and patients’ experiences present a dichotomy of opinion on decision-making, which requires further exploration and changes in practice. Outcomes of workload pressure on both health professionals and patients should be investigated. The need for on-going support and education to patients and physicians is critical to achieve best practice and treatment adherence. Practice implications - Such research could encourage health professionals to understand and attend better to the needs and concerns of the patient. Additionally these findings can be used to inform researchers and healthcare providers in developing educational interventions with both patients and health professionals.

Development and trialling of a behavioural intervention for patients with atrial fibrillation initiating oral anticoagulation:the 'treat' study

Purpose: Atrial fibrillation (AF) is the most common heart arrhythmia and is associated with an increased risk of stroke. Stroke risk is commonly treated with oral anticoagulation (OAC) with a narrow therapeutic range (INR 2.0 to 3.0); which is poorly controlled in practice. Barriers to adherence include poor knowledge, and inaccurate perceptions surrounding illness and medications. Trial registration: ISRCTN93952605. Systematic review: Seven trials of educational, self-monitoring and decision aid interventions were included in a systematic review. Pooled analysis suggested education OR, 95% CI 7.89 (5.54-10.24) and self monitoring OR (95% CI) 5.47(2.55-8.39) significantly improve TTR; whereas decision aids are no more effective in reducing decision conflict than usual care, OR (95% CI) -0.10 (-0.17 to -0.02). Intervention development: The intervention was theoretically-driven (utilising the common sense and beliefs about medication models) and developed with expert patient feedback. Described using behavioural change techniques, the one-off group session included an educational booklet, ‘expert-patient’ focussed DVD, and worksheet. Methods: Ninety seven warfarin-naïve AF patients were randomised to receive the intervention (n=43), or usual care (n=54). The primary endpoint was time within therapeutic range (TTR), secondary endpoints included knowledge, quality of life (AF-QoL-18), beliefs about medication (BMQ), illness perceptions (IPQ-B), and anxiety and depression (HADS). Results: Intervention group had significantly higher TTR than usual care (78.5% vs. 66.7%; p=0.01). Knowledge changed significantly across time (F (3, 47) = 6.4; p<0.01), but not between groups (F (1, 47) = 3.3; p = 0.07). At six months knowledge predicted TTR (r=0.245; p=0.04). Illness concern negatively correlated with TTR (r= - 0.199; p=0.05). General Harm scores at one month predicted TTR (F (1, 72) = 4.08; p=0.048). There were significant differences in emotional representations (F (3, 49) = 3.3 (3, 49); p= 0.03), anxiety (F (3, 46) = 25.2; p<0.01) and depression (F (3, 46) = 37.7; p<0.01) across time. Conclusion: A theory-driven educational intervention can improve TTR in AF patients and potentially reduce the risk of adverse clinical outcomes. Improving education provision for AF patients is essential to ensure efficacious treatment.

Patients’ and physicians’ experiences of atrial fibrillation and anticoagulation therapy:a qualitative journey

Background: Oral anticoagulation (OAC) reduces stroke risk in patients with atrial fibrillation (AF) however it is often underutilized and sometimes refused by patients. This programme of work included a meta-synthesis and two inter-linking studies aiming to explore patients’ and physicians’ experiences of AF and OAC. Methods: A meta-synthesis of qualitative evidence was conducted which informed the empirical work. Semi-structured individual interviews were utilised. Study 1: Three AF patient sub-groups were interviewed; accepted (n=4), refused (n=4), or discontinued (n=3) warfarin. Study 2: Four physician sub-groups (n=4 each group) prescribing OAC to AF patients were interviewed: consultant cardiologists, consultant general physicians, general practitioners and cardiology registrars. Data was analysed using interpretative phenomenological analysis. Results: Study 1: Three over-arching themes comprised patients’ experiences: (1) the initial consultation, (2) life after the consultation, and (3) patients’ reflections. Patients commented on the relief and reassurance experienced during the consultation but they perceived the decision making process mostly led by the physician. Lack of education and take-home materials distributed during the initial consultation was highlighted. Patients who had experienced stroke themselves or were caregivers, were more receptive to education aimed towards stroke risk reduction rather than bleeding risk. Warfarin monitoring was challenging for patients, however some patients perceived it as beneficial as it served to enhance patient-physician relationship. Study 2: Two over-arching themes emerged from physicians’ experiences: (1) communicating information and (2) challenges with OAC prescription for AF. Physicians’ approach to the consultation style shifted through a continuum of compliance-adherence-concordance during the consultation. They aimed for concordance, however challenges such as time and the perceived patient trust in them as the expert, led to physicians adopting a paternalistic approach. Physicians also pointed out challenges associated with guideline adherence and the need to adopt a multi-disciplinary approach, where other health professionals could provide on-going education. Conclusion: This programme of work has illustrated the benefit of taking an in depth phenomenological approach to understanding the lived experience of the physician-patient consultation. Together with the meta-synthesis, this work has strengthened the evidence base and demonstrated that there is a need to target patients' and physicians' ability to communicate with each other in a comprehensible way.

Educational intervention improves anticoagulation control in atrial fibrillation patients:the TREAT randomised trial

Background: Stroke prevention in atrial fibrillation (AF), most commonly with warfarin, requires maintenance of a narrow therapeutic target (INR 2.0 to 3.0) and is often poorly controlled in practice. Poor patient-understanding surrounding AF and its’ treatment may contribute to patient’s willingness to adhere to recommendations. Method: A theory-driven intervention, developed using patient interviews and focus groups, consisting of a one-off group session (1-6 patients) utilising an ‘expert-patient’ focussed DVD, educational booklet, self-monitoring diary and worksheet, was compared in a randomised controlled trial (ISRCTN93952605) against usual care, with patient postal follow-ups at 1, 2, 6, and 12-months. Ninety-seven warfarin-naïve AF patients were randomised to intervention (n=46, mean age (SD) 72.0 (8.2), 67.4% men), or usual care (n=51, mean age (SD) 73.7 (8.1), 62.7% men), stratified by age, sex, and recruitment centre. Primary endpoint was time within therapeutic range (TTR); secondary endpoints included knowledge, quality of life, anxiety/depression, beliefs about medication, and illness perceptions. Main findings: Intervention patients had significantly higher TTR than usual care at 6-months (76.2% vs. 71.3%; p=0.035); at 12-months these differences were not significant (76.0% vs. 70.0%; p=0.44). Knowledge increased significantly across time (F (3, 47) = 6.4; p<0.01), but there were no differences between groups (F (1, 47) = 3.3; p = 0.07). At 6-months, knowledge scores predicted TTR (r=0.245; p=0.04). Patients’ scores on subscales representing their perception of the general harm and overuse of medication, as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months. Conclusions: A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months. Adverse clinical outcomes may potentially be reduced by improving patients’ understanding of the necessity of warfarin and reducing their perception of treatment harm. Improving education provision for AF patients is essential to ensure efficacious and safe treatment.

New biomarkers and risk stratification in atrial fibrillation:simplicity and practicality matter

Advances in our understanding of pathological mechanisms can inform the identification of various biomarkers for risk stratification, monitoring drug efficacy and toxicity; and enabling careful monitoring of polypharmacy. Biomarkers in the broadest sense refer to 'biological markers' and this can be blood-based (eg. fibrin D-dimer, von Willebrand factor, etc) urine-based (eg. thromboxane), or even related to cardiac or cerebral imaging(1). Most biomarkers offer improvements over clinical risk scores in predicting high risk patients - at least statistically - but usually at the loss of simplicity and practicality for easy application in everyday clinical practice. Given the various biomarkers can be informed by different aspects of pathophysiology (e.g. inflammation, clotting, collagen turnover) they can nevertheless contribute to a better understanding of underlying disease processes(2). Indeed, many age-related diseases share common modifiable underpinning mechanisms e.g. inflammation, oxidative stress and visceral adiposity.

Patients' and physicians' experiences of atrial fibrillation consultations and anticoagulation decision-making:a multi-perspective IPA design

OBJECTIVE: To explore patients' and physicians' experiences of atrial fibrillation consultations and oral anticoagulation decision-making. DESIGN: Multi-perspective interpretative phenomenological analyses. METHODS: Participants included small homogeneous subgroups: AF patients who accepted (n=4), refused (n=4), or discontinued (n=3) warfarin, and four physician subgroups (n=4 each group): consultant cardiologists, consultant general physicians, general practitioners and cardiology registrars. Semi-structured interviews were conducted. Transcripts were analysed using multi-perspective IPA analyses to attend to individuals within subgroups and making comparisons within and between groups. RESULTS: Three themes represented patients' experiences: Positioning within the physician-patient dyad, Health-life balance, and Drug myths and fear of stroke. Physicians' accounts generated three themes: Mechanised metaphors and probabilities, Navigating toward the 'right' decision, and Negotiating systemic factors. CONCLUSIONS: This multi-perspective IPA design facilitated an understanding of the diagnostic consultation and treatment decision-making which foregrounded patients' and physicians' experiences. We drew on Habermas' theory of communicative action to recommend broadening the content within consultations and shifting the focus to patients' life contexts. Interventions including specialist multidisciplinary teams, flexible management in primary care, and multifaceted interventions for information provision may enable the creation of an environment that supports genuine patient involvement and participatory decision-making.

Psychological influence of the media on patients commencing oral anticoagulation in atrial fibrillation:a qualitative analysis

Background: Oral anticoagulation (OAC) reduces stroke risk in patients with atrial fibrillation (AF); however it is still underutilized and sometimes refused by patients. Two inter-related studies were undertaken to understand the experiences and what influences this un- derutilisation of warfarin treatment in AF patients. These studies explored physician and patient experiences of AF and OAC treatment. The paper focuses on specific sub-themes from the study that explored patients’ experiences will be discussed. Aim: The study in question aimed to explore the experiences which influence patients’ decisions to accept, decline or discontinue OAC. Methods: Semi-structured individual interviews with patients were con- ducted. Three sub-groups of patients (n = 11) diagnosed with AF were interviewed; those who accepted, refused, and who discontinued war- farin. Interpretative phenomenological analysis (IPA) was used to examine the data. IPA is a qualitative method that focuses on how participants make sense of an experiences phenomenon Results: Three over-arching themes comprised patients’ experiences: (i)the initial consultation, (ii) life after the consultation, and (iii) patients’reflections. In the last theme, patients reflected on their perceptions ofaspirin and warfarin. Aspirin was perceived as a natural wonder-drugwhile warfarin was perceived as a dangerous drug usually given to peo-ple at the end of their life. Interestingly they perceive both drugs as‘old’. However, for aspirin it had a positive association, old meaningtried and tested. While for warfarin, old meant ‘has been around fortoo long’.Conclusion: Media had an important role in how patients’ perceptionsof these two drugs were influenced. Literature shows that framingtechniques, i.e. using certain words or phrases such as ‘rat poison’, areprocesses adopted by media to alter medical knowledge into lay per-son’s language. Patients in turn form negative cognitive schemas,between the word ‘poison’ and warfarin, leading to the negative per-ception of warfarin which could influence non-adherence to treatment.This qualitative research highlighted the potential influences of themedia on AF patient perceptions commencing OAC treatment. Theassociation between media stimuli and patient perceptions on OACshould be further explored. The influential power of lay-media couldalso be instrumental in disseminating appropriate educational materialto the public

Processing the Intracardiac Electrogram for Atrial Fibrillation Ablation

Atrial fibrillation (AF) is a major global health issue as it is the most prevalent sustained supraventricular arrhythmia. Catheter-based ablation of some parts of the atria is considered an effective treatment of AF. The main objective of this research is to analyze atrial intracardiac electrograms (IEGMs) and extract insightful information for the ablation therapy. Throughout this thesis we propose several computationally efficient algorithms that take streams of IEGMs from different atrial sites as the input signals, sequentially analyze them in various domains (e.g., time and frequency), and create color-coded three-dimensional map of the atria to be used in the ablation therapy.

Contact Force in Atrial Fibrillation: Role of Atrial Rhythm and Ventricular Contractions: Co-Force Atrial Fibrillation Study

In an experimental model, variable and intermittent contact force (CF) resulted in a significant decrease in lesion volume. In humans, variability of CF during pulmonary vein isolation has not been characterized. Methods and Results-In 20 consecutive patients undergoing CF-guided circumferential pulmonary vein isolation, 914 radiofrequency applications (530 in sinus rhythm and 384 in atrial fibrillation) were analyzed. The variability of the 60% CF range (CF60%) was 17 ± 9.6 g. Hundred seventy-one (19%) applications were delivered with constant, 717 (78%) with variable, and 26 (3%) with intermittent CF. The mean CF and force-time integral were significantly higher during applications with variable than with intermittent or constant CF. There was no significant difference in CF variability, CF60% variability, and force-time integral between applications delivered in sinus rhythm and atrial fibrillation. The main reasons for CF variability were systolo-diastolic heart movement (29%) and respiration (27%). In 10 additional patients, during adenosine-induced atrioventricular block, the minimum CF significantly increased at 19 sites (5.3 ± 4.4 versus 13.4 ± 5.9 g; P < 0.001) and at 16 sites intermittent or variable CF became constant. At only 1 site systolo-diastolic movement remained the main reason for variable CF. Conclusions-CF during pulmonary vein isolation remains highly variable despite efforts to optimize contact. CF and CF parameters were similar during sinus rhythm and atrial fibrillation. The main reasons for CF variability are systolodiastolic heart movement and respiration. The systolo-diastolic peaks and nadirs of CF are because of ventricular contractions at the large majority of pulmonary vein isolation sites.

Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation: A Single Technology Appraisal. Evidence Review Group Report to NICE

1.1 Edoxaban is recommended, within its marketing authorisation, as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more risk factors, including: congestive heart failure hypertension diabetes prior stroke or transient ischaemic attack age 75 years or older

Oral anticoagulation in atrial fibrillation, the patients and physicians experiences of the consultation:a qualitative study

Background: Oral anticoagulation (OAC) reduces stroke risk in patients with atrial fibrillation (AF), however it is still underutilized and sometimes refused by patients. This project was divided in two inter-related studies. Study 1 explored the experiences that influence prescription of OAC by physicians. Study 2 explored the experiences which influence patients' decisions to accept, decline or discontinue OAC. Methods: Semi-structured individual interviews were conducted in both studies. In Study 1four sub-groups of physicians (n = 16) experienced with OAC in AF were interviewed: consultant cardiologists, consultant general physicians, general practitioners and cardiology registrars. In Study 2 three sub-groups of patients (n = 11) diagnosed with AF were interviewed; those who accepted, refused, and who discontinued warfarin. Results: Study 1: Two over-arching themes emerged from doctors' experiences: (1) communicating information and (2) challenges with OAC prescription for AF. Physicians still adopt a paternalistic approach to decision-making. They should instead motivate patients to take part in treatment discussions and choices should reflect the patient's needs and concerns. Physician education should focus more on communication skills, individualised care and time-management as these are critical for patient adherence. Continuous OAC education for AF should adopt a multi-disciplinary approach. Further, interpreters should also be educated on medical communication skills. Study 2: Three over-arching themes comprised patients' experiences: (1) the initial consultation, (2) life after the consultation, and (3) patients' reflections. Patient education during the initial consultation was critical in increasing patient's knowledge of OAC. On-going patient education is imperative to maintain adherence. Patients valued physicians' concern for their needs during decision-making. Patients who had experience of stroke were more receptive to education aimed towards stroke risk reduction rather than bleeding risk. Patients' perceptions of warfarin are also influenced by the media. Comment: Qualitative research is crucial in exploring barriers to treatment as it provides an excellent insight into patients' experiences of healthcare. A patient-centred approach should be adopted and incorporated into physicians' education. Education and patient involvement in the decision-making process is essential to promote treatment acceptance and long-term adherence

Partner relationship in couples living with atrial fibrillation

The aim of this thesis was to describe and explore how the partner relationship of patient–partner dyads isaffected following cardiac disease and, in particular, atrial fibrillation (AF) in one of the spouses. The thesis is based on four individual studies with different designs: descriptive (I), explorative (II, IV), and cross-sectional (III). Applied methods comprised a systematic review (I) and qualitative (II, IV) and quantitative methods (III). Participants in the studies were couples in which one of the spouses was afflicted with AF. Coherent with a systemic perspective, the research focused on the dyad as the unit of analysis. To identify and describe the current research position and knowledge base, the data for the systematic review were analyzed using an integrative approach. To explore couples’ main concern, interview data (n=12 couples) in study II were analyzed using classical grounded theory. Associations between patients and partners (n=91 couples) where analyzed through the Actor–Partner Interdependence Model using structural equation modelling (III). To explore couples’ illness beliefs, interview data (n=9 couples) in study IV were analyzed using Gadamerian hermeneutics. Study I revealed five themes of how the partner relationship is affected following cardiac disease: overprotection, communication deficiency, sexual concerns, changes in domestic roles, and adjustment to illness. Study II showed that couples living with AF experienced uncertainty as the common main concern, rooted in causation of AF and apprehension about AF episodes. The theory of Managing Uncertainty revealed the strategies of explicit sharing (mutual collaboration and finding resemblance) and implicit sharing (keeping distance and tacit understanding). Patients and spouses showed significant differences in terms of self-reported physical and mental health where patients rated themselves lower than spouses did (III). Several actor effects were identified, suggesting that emotional distress affects and is associated with perceived health. Patient partner effects and spouse partner effects were observed for vitality, indicating that higher levels of symptoms of depression in patients and spouses were associated with lower vitality in their partners. In study IV, couples’ core and secondary illness beliefs were revealed. From the core illness belief that “the heart is a representation of life,” two secondary illness beliefs were derived: AF is a threat to life, and AF can and must be explained. From the core illness belief that “change is an integral part of life,” two secondary illness beliefs were derived: AF is a disruption in our lives, and AF will not interfere with our lives. Finally, from the core illness belief that “adaptation is fundamental in life,” two secondary illness beliefs were derived: AF entails adjustment in daily life, and AF entails confidence in and adherence to professional care. In conclusion, the thesis result suggests that illness, in terms of cardiac disease and AF, affected and influenced the couple on aspects such as making sense of AF, responding to AF, and mutually incorporating and dealing with AF in their daily lives. In the light of this, the thesis results suggest that clinicians working with persons with AF and their partners should employ a systemic view with consideration of couple’s reciprocity and interdependence, but also have knowledge regarding AF, in terms of pathophysiology, the nature of AF (i.e., cause, consequences, and trajectory), and treatments. A possible approach to achieve this is a clinical utilization of an FSN based framework, such as the FamHC. Even if a formalized FSN framework is not utilized, partners should not be neglected but, rather, be considered a resource and be a part of clinical caring activities. This could be met by inviting partners to take part in rounds, treatment decisions, discharge calls or follow-up visits or other clinical caring activities. Likewise, interventional studies should include the couple as a unit of analysis as well as the target of interventions.