Device-specific quality of life: Results from the ATLAS trial-Avoid Transvenous Leads in Appropriate Subjects.

AIM: Patient reported outcomes (PROs) provide important insights into patients' acceptance of their medical devices. ATLAS, a randomized, multi-center, open-label clinical trial, recently reported fewer perioperative complications in S-ICD compared to TV-ICD patients. This study reports PROs, including device-specific and generic quality of life (QOL) from the ATLAS trial. METHODS AND RESULTS: Device-specific QOL was the primary PRO using the Florida Patient Acceptance Survey (FPAS) at 1-and 6-months post-implantation. Secondary outcomes included generic QOL using the Medical Outcomes Survey (SF-36) pre-implant and 6-months post-implantation. FPAS and SF-36 were analyzed using ANCOVA. Pain measured using a Numeric Rating Scale, at 1-and 6-months, anesthetic, BMI and within/between differences were analyzed using descriptive statistics and mixed-effects linear models (MLM). Of the 503 patients randomized in ATLAS, 404 had complete FPAS data to include in this analysis. Participant characteristics were balanced. There were no significant differences between S-ICD and TV-ICD for FPAS or SF-36, across timepoints. Mean total FPAS scores increased from 73.73 (16.09) to 77.05 (16.13) and 74.43 (15.35) to 78.25 (15.88) for S-ICD and TV-ICD, respectively, (p <0.001). PROs suggested that both devices were associated with good QOL. CONCLUSION: Device-specific and generic QOL were similar between S-ICD and TV-ICD groups up to 6-months post-implantation indicating that regardless of device type, both groups reported good device specific QOL in ATLAS patients. S-ICD patients reported higher pain scores at implant, but pain decreased by 6 months. The findings offer evidence that can be included during shared decision-making. The inclusion of patient partners in ATLAS provided opportunity to measure PROs that were deemed important to patients.

Perceived self-efficacy and empowerment in patients at increased risk of sudden cardiac arrest.

Background: The role of multidisciplinary clinics for psychosocial care is increasingly recognized for those living with inherited cardiac conditions (ICC). In Canada, access to healthcare providers differ between clinics. Little is known about the relationship between access to specialty care and a patient's ability to cope with, and manage their condition. Methods: We leveraged the Hearts in Rhythm Organization (HiRO) to conduct a cross-sectional, community-based survey of individuals with ICC and their family members. We aimed to describe access to services, and explore the relationships between participants' characteristics, cardiac history and self-reported health status and self-efficacy (GSE: General Self-Efficacy Scale) and empowerment (GCOS-24: Genetic Counseling Outcome Scale). Results: We collected 235 responses from Canadian participants in 10 provinces and territories. Overall, 63% of participants reported involvement of a genetic counsellor in their care. Access to genetic testing was associated with greater empowerment [mean GCOS-24: 121.14 (SD = 20.53) vs. 105.68 (SD = 21.69); p = 0.004]. Uncertain genetic test results were associated with lower perceived self-efficacy (mean GSE: uncertain = 28.85 vs. positive = 33.16, negative = 34.13; p = 0.01). Low global mental health scores correlated with both lower perceived self-efficacy and empowerment scores, with only 11% of affected participants reporting involvement of psychology services in their care. Conclusion: Differences in resource accessibility, clinical history and self-reported health status impact the perceived self-efficacy and empowerment of patients with ICC. Future research evaluating interventions to improve patient outcomes is recommended.

Beyond Wellness Monitoring: Continuous Multiparameter Remote Automated Monitoring of Patients.

The pursuit of more efficient patient-friendly health systems and reductions in tertiary health services use has seen enormous growth in the application and study of remote patient monitoring systems for cardiovascular patient care. While there are many consumer-grade products available to monitor patient wellness, the regulation of these technologies varies considerably, with most products having little to no evaluation data. As the science and practice of virtual care continues to evolve, clinicians and researchers can benefit from an understanding of more comprehensive solutions capable of monitoring multiple biophysical parameters (eg, oxygen saturation, heart rate) continuously and simultaneously. These devices, herein referred to as continuous multiparameter remote automated monitoring (CM-RAM) devices, have the potential to revolutionise virtual patient care. Through seamless integration of multiple biophysical signals, CM-RAM technologies can allow for the acquisition of high-volume big data for the development of algorithms to facilitate early detection of negative changes in patient health status and timely clinician response. In this article, we review key principles, architecture, and components of CM-RAM technologies. Work to date in this field and related implications are also presented, including strategic priorities for advancing the science and practice of CM-RAM.

Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study.

BACKGROUND: Wearable continuous monitoring biosensor technologies have the potential to transform postoperative care with early detection of impending clinical deterioration. OBJECTIVE: Our aim was to validate the accuracy of Cloud DX Vitaliti continuous vital signs monitor (CVSM) continuous noninvasive blood pressure (cNIBP) measurements in postsurgical patients. A secondary aim was to examine user acceptance of the Vitaliti CVSM with respect to comfort, ease of application, sustainability of positioning, and aesthetics. METHODS: Included participants were ≥18 years old and recovering from surgery in a cardiac intensive care unit (ICU). We targeted a maximum recruitment of 80 participants for verification and acceptance testing. We also oversampled to minimize the effect of unforeseen interruptions and other challenges to the study. Validation procedures were according to the International Standards Organization (ISO) 81060-2:2018 standards for wearable, cuffless blood pressure (BP) measuring devices. Baseline BP was determined from the gold-standard ICU arterial catheter. The Vitaliti CVSM was calibrated against the reference arterial catheter. In static (seated in bed) and supine positions, 3 cNIBP measurements, each 30 seconds, were taken for each patient with the Vitaliti CVSM and an invasive arterial catheter. At the conclusion of each test session, captured cNIBP measurements were extracted using MediCollector BEDSIDE data extraction software, and Vitaliti CVSM measurements were extracted to a secure laptop through a cable connection. The errors of these determinations were calculated. Participants were interviewed about device acceptability. RESULTS: The validation analysis included data for 20 patients. The average times from calibration to first measurement in the static position and to first measurement in the supine position were 133.85 seconds (2 minutes 14 seconds) and 535.15 seconds (8 minutes 55 seconds), respectively. The overall mean errors of determination for the static position were -0.621 (SD 4.640) mm Hg for systolic blood pressure (SBP) and 0.457 (SD 1.675) mm Hg for diastolic blood pressure (DBP). Errors of determination were slightly higher for the supine position, at 2.722 (SD 5.207) mm Hg for SBP and 2.650 (SD 3.221) mm Hg for DBP. The majority rated the Vitaliti CVSM as comfortable. This study was limited to evaluation of the device during a very short validation period after calibration (ie, that commenced within 2 minutes after calibration and lasted for a short duration of time). CONCLUSIONS: We found that the Cloud DX's Vitaliti CVSM demonstrated cNIBP measurement in compliance with ISO 81060-2:2018 standards in the context of evaluation that commenced within 2 minutes of device calibration; this device was also well-received by patients in a postsurgical ICU setting. Future studies will examine the accuracy of the Vitaliti CVSM in ambulatory contexts, with attention to assessment over a longer duration and the impact of excessive patient motion on data artifacts and signal quality. TRIAL REGISTRATION: ClinicalTrials.gov NCT03493867; https://clinicaltrials.gov/ct2/show/NCT03493867.

Testing a nurse-led, pre-implantation educational intervention for primary prevention implantable cardioverter-defibrillator candidates: a randomized feasibility trial.

AIMS: Implantable cardioverter-defibrillators (ICDs) deliver therapy for life-threatening arrhythmias. Evidence suggests that ICD candidates have misconceptions regarding ICD therapy and unmet information needs. We undertook a pilot feasibility trial comparing a nurse-led educational intervention plus standard care, vs. standard pre-ICD implantation care. Secondary aims included examination of anxiety, quality of life, and shock anxiety. METHODS AND RESULTS: Implantable cardioverter-defibrillator candidates were consented and randomized to standard pre-ICD implantation care vs. standard care plus a nurse-led educational intervention. The primary feasibility outcomes included: recruitment rate, consent rate, randomization rate, proportion of participants able to complete all questionnaires, time to deliver intervention, and intervention topics completion. At baseline, demographic and Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scores were collected. Four weeks post-ICD implantation, participants completed the PROMIS, Florida Patient Acceptance Survey (FPAS), and Florida Shock Anxiety Scale (FSAS). Twenty patients consented (10 per group). Feasibility targets were achieved for all but two outcomes: consent rate was 87% vs. 95% target, and completion of data collection measures was 85% vs. 90% target. Consent rate was lower than expected as one patient declined, and two could not be approached. Completion rate was lower than expected as two patients were lost to follow-up, and one did not receive an ICD during the study period, leading to incomplete post-implantation survey collections. CONCLUSION: The results demonstrate the feasibility of conducting a trial comparing a nurse-led pre-implantation educational intervention to standard care in an outpatient setting. Further study to evaluate the effectiveness of this intervention on patient-reported outcomes is warranted.

Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial.

BACKGROUND: Decision support can help patients facing implantable cardioverter-defibrillator (ICD) replacement understand their options and reach an informed decision reflective of their preferences. OBJECTIVE: The aim of this study was to evaluate the feasibility of a decision support intervention for patients faced with the decision to replace their ICD. METHODS: A pilot feasibility randomized trial was conducted. Patients approaching ICD battery depletion were randomized to decision support intervention or usual care. Feasibility outcomes included recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice. RESULTS: A total of 30 patients were randomized to intervention (n = 15) or usual care (n = 15). The intervention was used as intended, with 2% missing data. Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002). By 12 months, 8 of 13 (61.5%) in the intervention arm and 10 of 14 (71.4%) in the usual care arm accepted ICD replacement; 1 per arm declined (7.7% vs 7.1%, respectively). CONCLUSION: It was feasible to deliver the intervention, collect data, despite slow recruitment. The decision support intervention has the potential to improve ICD replacement decision quality.

Impact of nurse scientist-led digital health interventions on management of chronic conditions.

BACKGROUND: Chronic conditions are a major contributor to the burden of disease worldwide. Using innovative digital health technologies, nurse scientists are well-positioned to lead efforts to reduce the burden of chronic conditions on individuals, communities, and systems. PURPOSE: The purpose of this review was to summarize the outcomes commonly measured in nurse-led digital health interventions that target chronic conditions and pose recommendations for the education of future nurse scientists to lead these studies. METHODS: A rapid review of the literature was completed using CINAHL and Ovid Emcare. Studies were included if the research: a) was led by a nurse; b) described outcomes of a digital health intervention; and c) included any population with a prevalent chronic condition. FINDINGS: 26 studies were included in this review. Nurse-led digital health interventions are being used to support and manage a range of chronic conditions in varied settings. DISCUSSION: Digital health interventions are changing the delivery of healthcare for individuals living with chronic conditions. These interventions are bridging the gaps between the digital and physical worlds and are rapidly evolving. CONCLUSION: The recommendations posed in this review reiterate the importance of robust content and methods education for nurse scientists to address future research needs in a digital era.

Health-Related Quality of Life in Patients With Atrial Fibrillation Treated With Catheter Ablation or Antiarrhythmic Drug Therapy: A Systematic Review and Meta-analysis.

BACKGROUND: Catheter ablation (CA) is performed in patients with atrial fibrillation (AF) to reduce symptoms and improve health-related quality of life (HRQL). METHODS: This systematic review and meta-analysis of randomized controlled trials (RCTs) evaluated CA of any energy modality compared with antiarrhythmic drugs (AADs) using inverse-variance random-effects models. We searched for RCTs reporting HRQL and AF-related symptoms at 3, 6, 12, 24, 48, and 60 months after treatment as well as the number of repeat ablations. RESULTS: Of 15,878 records, we included 13 RCTs of CA vs AADs for the analyses of HRQL, 7 RCTs for the analyses of AF-related symptoms, and 13 RCTs for the number of repeat ablations. For the HRQL analyses at 3 months, there were significant increases in both the Physical Component Summary score (3 months' standardized mean difference = 0.58 [0.39-0.78]; P < 0.00001, I 2 = 6%, 3 trials, n = 443) and the Mental Component Summary score (3 months' standardized mean difference = 0.57 [0.37-0.77]; P < 0.00001, I 2 = 0%, 3 trials, n = 443), favouring CA over AADs. These differences were sustained at 12 months but not >24 months after randomization. Similar results were seen for AF-related symptoms. The number of repeat ablations and success rates after procedure varied considerably across trials. CONCLUSIONS: Evidence from few trials suggests that CA improves physical and mental health and AF-related symptoms in the short term, but these benefits decrease with time. More trials, reporting both HRQL and AF-related symptoms, at consistent time points are needed to assess the effectiveness of CA for the treatment of AF.

CONTEXTE: L'ablation par cathéter (AC) est réalisée chez les patients atteints de fibrillation auriculaire (FA) afin d'atténuer les symptômes et d'améliorer la qualité de vie liée à la santé (QVLS). MÉTHODOLOGIE: Cette revue systématique et méta-analyse d'essais contrôlés à répartition aléatoire (ECRA) a permis d'évaluer l'AC, toutes modalités énergétiques confondues, comparativement aux agents antiarythmiques (AA) à l'aide de modèles à effets aléatoires à variance inverse. Nous avons recherché les ECRA qui faisaient état de la QVLS et des symptômes liés à la FA à 3, 6, 12, 24, 48 et 60 mois après le traitement et qui précisaient le nombre d'ablations répétées. RÉSULTATS: À partir de 15 878 entrées, nous avons retenu 13 ECRA comparant l'AC à des AA pour l'analyse de la QVLS, 7 autres pour l'analyse des symptômes liés à la FA et 13 de plus aux fins de calcul du nombre d'ablations répétées. L'analyse de la QVLS à 3 mois indique une augmentation significative du score sommaire de la composante physique (différence moyenne normalisée à 3 mois = 0,58 [0,39-0,78]; p < 0,00001, I 2 = 6 %, 3 essais, n = 443) et du score sommaire de la composante mentale (différence moyenne normalisée à 3 mois = 0,57 [0,37-0,77]; p < 0,00001, I 2 = 0 %, 3 essais, n = 443), faisant pencher la balance en faveur de l'AC plutôt que des AA. Ces différences persistaient à 12 mois après la répartition aléatoire, mais pas aux moments d'évaluation ultérieurs (24, 48 et 60 mois). Des résultats similaires ont été observés au chapitre des symptômes liés à la FA. Le nombre d'ablations répétées et le taux de réussite postopératoire variaient considérablement d'un essai à l'autre. CONCLUSIONS: Les données probantes de quelques essais donnent à penser que l'AC améliore la santé physique et mentale ainsi que les symptômes liés à la FA à court terme, mais que ces bienfaits s'atténuent avec le temps. D'autres essais faisant état de la QVLS et des symptômes liés à la FA, à des moments d'évaluation constants, devront être réalisés pour évaluer l'efficacité réelle de l'AC dans le traitement de la FA.

Preparing for patient partnership: A scoping review of patient partner engagement and evaluation in research.

BACKGROUND: Realizing patient partnership in research requires a shift from patient participation in ancillary roles to engagement as contributing members of research teams. While engaging patient partners is often discussed, impact is rarely measured. OBJECTIVE: Our primary aim was to conduct a scoping review of the impact of patient partnership on research outcomes. The secondary aim was to describe barriers and facilitators to realizing effective partnerships. SEARCH STRATEGY: A comprehensive bibliographic search was undertaken in EBSCO CINAHL, and Embase, MEDLINE and PsycINFO via Ovid. Reference lists of included articles were hand-searched. INCLUSION CRITERIA: Included studies were: (a) related to health care; (b) involved patients or proxies in the research process; and (c) reported results related to impact/evaluation of patient partnership on research outcomes. DATA EXTRACTION AND SYNTHESIS: Data were extracted from 14 studies meeting inclusion criteria using a narrative synthesis approach. MAIN RESULTS: Patient partners were involved in a range of research activities. Results highlight critical barriers and facilitators for researchers seeking to undertake patient partnerships to be aware of, such as power imbalances between patient partners and researchers, as well as valuing of patient partner roles. DISCUSSION: Addressing power dynamics in patient partner-researcher relationships and mitigating risks to patient partners through inclusive recruitment and training strategies may contribute towards effective engagement. Further guidance is needed to address evaluation strategies for patient partnerships across the continuum of patient partner involvement in research. CONCLUSIONS: Research teams can employ preparation strategies outlined in this review to support patient partnerships in their work.

Transition Experiences of Caregivers of Older Adults With Dementia and Multiple Chronic Conditions: An Interpretive Description Study.

INTRODUCTION: Family caregivers provide most of the care for older persons living with dementia (PLWD) and multiple chronic conditions (MCCs) in the community. Caregivers experience transitions, such as changes to their health, roles, and responsibilities, during the process of caring. Transitions encompass a time when caregivers undergo stressful responses to change. However, we know little about the transition experiences of caregivers of persons living with both dementia and MCCs. OBJECTIVE: This qualitative study explored the transition experiences of caregivers of PLWD within the context of MCCs, from the perspective of both caregivers and practitioners. The research question was the following: What are the transition experiences of family caregivers in providing care to older PLWD and MCCs living in the community? METHODS: This study was conducted using an interpretive description approach. Semistructured interviews were conducted with 19 caregivers of older community-dwelling PLWD and MCCs and 7 health-care providers working with caregivers in Ontario, Canada. Concurrent data collection and inductive data analysis were used. RESULTS: Caregivers of older PLWD and MCCs experienced four key transitions: (a) taking on responsibility for managing multiple complex conditions, (b) my health is getting worse, (c) caregiving now defines my social life, and (d) expecting that things will change. Findings highlight how the coexistence of MCCs with dementia complicates caregiver transitions and the importance of social networks for facilitating transitions. CONCLUSION: The study provided insight on the transition experiences of caregivers of older PLWD and MCCs. MCCs increased the care load and further complicated caregivers' transition experiences. Health-care providers, such as nurses, can play important roles in supporting caregivers during these transitions and engage them as partners in care.

Examination of psychological risk factors for chronic pain following cardiac surgery: protocol for a prospective observational study.

INTRODUCTION: Approximately 400 000 Americans and 36 000 Canadians undergo cardiac surgery annually, and up to 56% will develop chronic postsurgical pain (CPSP). The primary aim of this study is to explore the association of pain-related beliefs and gender-based pain expectations on the development of CPSP. Secondary goals are to: (A) explore risk factors for poor functional status and patient-level cost of illness from a societal perspective up to 12 months following cardiac surgery; and (B) determine the impact of CPSP on quality-adjusted life years (QALYs) borne by cardiac surgery, in addition to the incremental cost for one additional QALY gained, among those who develop CPSP compared with those who do not. METHODS AND ANALYSES: In this prospective cohort study, 1250 adults undergoing cardiac surgery, including coronary artery bypass grafting and open-heart procedures, will be recruited over a 3-year period. Putative risk factors for CPSP will be captured prior to surgery, at postoperative day 3 (in hospital) and day 30 (at home). Outcome data will be collected via telephone interview at 6-month and 12-month follow-up. We will employ generalised estimating equations to model the primary (CPSP) and secondary outcomes (function and cost) while adjusting for prespecified model covariates. QALYs will be estimated by converting data from the Short Form-12 (version 2) to a utility score. ETHICS AND DISSEMINATION: This protocol has been approved by the responsible bodies at each of the hospital sites, and study enrolment began May 2015. We will disseminate our results through CardiacPain.Net, a web-based knowledge dissemination platform, presentation at international conferences and publications in scientific journals. TRIAL REGISTRATION NUMBER: NCT01842568.

"I don't know exactly what you're referring to": the challenge of values elicitation in decision making for implantable cardioverter-defibrillators.

PURPOSE: Patients' values are a key component of patient-centered care and shared decision making in health care organizations. There is limited understanding on how patients' values guide their health related decision making or how patients understand the concept of values during these processes. This study investigated patients' understanding of their values in the context of considering the risks/benefits of receiving an implantable cardioverter-defibrillator (ICD). PATIENTS AND METHODS: A qualitative substudy was conducted within a feasibility trial with first-time ICD candidates randomized to receive a patient decision aid or usual care prior to specialist consultation. Semi-structured interviews were conducted with participants post-implantation or post-specialist consultation. RESULTS: Sixteen patients (ten male) aged 47-87 years participated. Of these, ten (62.5%) received the patient decision aid prior to specialist consultation. Findings revealed patients were confused by the word "values" and had difficulty expressing values related to risks/benefits during ICD decision making. When probed, values were conceptualized broadly capturing other factors such as desire to live, good quality of life, family's views, ICD information, control over decision, and medical authority. CONCLUSION: This study revealed the difficulty patients considering an ICD had with articulating their values in the context of an ICD health decision and highlighted the challenge to effectively elicit patients' values within health decisions overall. It is suggested that there should be a shift away from the use of the word "values" when speaking directly to patients toward language such as "what matters to you the most" or "what is most important to you".

Postoperative Remote Automated Monitoring: Need for and State of the Science.

Worldwide, more than 230 million adults have major noncardiac surgery each year. Although surgery can improve quality and duration of life, it can also precipitate major complications. Moreover, a substantial proportion of deaths occur after discharge. Current systems for monitoring patients postoperatively, on surgical wards and after transition to home, are inadequate. On the surgical ward, vital signs evaluation usually occurs only every 4-8 hours. Reduced in-hospital ward monitoring, followed by no vital signs monitoring at home, leads to thousands of cases of undetected/delayed detection of hemodynamic compromise. In this article we review work to date on postoperative remote automated monitoring on surgical wards and strategy for advancing this field. Key considerations for overcoming current barriers to implementing remote automated monitoring in Canada are also presented.

User-centered Development of a Decision Aid for Patients Facing Implantable Cardioverter-Defibrillator Replacement: A Mixed-Methods Study.

BACKGROUND: Because of battery depletion, an implantable cardioverter-defibrillator (ICD) generator requires surgical replacement every 5 to 7 years. Routine replacement is the norm without discussion with patients about whether or not to proceed. OBJECTIVE: The aim of this study was to develop a patient decision aid (PDA) for patients facing ICD replacement and plan for its implementation. METHODS: An embedded mixed-methods study was conducted using questionnaires and semistructured interviews focused on current ICD replacement practices; PDA acceptability, usability, and content; and PDA implementation. Transcripts were analyzed using constant comparative analysis. RESULTS: Eighteen PDA end users in 16 interviews characterized the current ICD replacement approach as automatic without consideration for patient preferences. The PDA was positively received, and the content was iteratively revised 4 times during the interviews. Changes were related to missing and excess information, language, and wording. The PDA was identified as a means to support a shared decision-making (SDM) process, not to be used as a standalone instrument. To shift current practices to an SDM process, participants identified that an invitation to discuss the option of ICD replacement is required-whether initiated by the patient or the clinician. CONCLUSION: Currently, the option of ICD replacement is rarely offered, and patient preferences are seldom elicited. Participants believed the PDA to be a useful intervention that could help facilitate an SDM process for patients facing ICD replacement. Preparing for implementation during the development phase will allow us to strategize effectively to overcome perceived barriers and capitalize on perceived facilitators during actual implementation.

Incorporating patients' preference diagnosis in implantable cardioverter defibrillator decision-making: a review of recent literature.

PURPOSE OF REVIEW: Strong recommendations exist for implantable cardioverter defibrillators (ICD) in appropriately selected patients. Yet, patient preferences are not often incorporated when decisions about ICD therapy are made. Literature published since 2016 was reviewed aiming to discuss current advances and ongoing challenges with ICD decision-making in adults, discuss shared decision-making (SDM) as a strategy to incorporate preference diagnoses, summarize current evidence on effective interventions to facilitate SDM, and identify opportunities for research and practice. RECENT FINDINGS: Advances in risk stratification can identify patients who will most and least likely benefit from the ICD. Interventions to support SDM are emerging. These interventions present options, the risks, and the benefits of each option, and elicit patients' values and preferences regarding possible outcomes. SUMMARY: Appropriate patient selection for initial or continued ICD therapy is multifactorial. It requires accurate clinical diagnosis using careful risk stratification and accurate preference diagnosis based upon the patient's preferences. SDM aims to unite the elements that constitute these two equally important diagnoses. High-quality decision-making will be difficult to achieve if patients lack or misunderstand information, and if evolving patient preferences are not incorporated when making decisions.

Evaluating the feasibility of conducting a trial using a patient decision aid in implantable cardioverter defibrillator candidates: a randomized controlled feasibility trial.

BACKGROUND: Patient decision aids (PtDA) support quality decision-making. The aim of this research was to evaluate the feasibility of conducting a randomized controlled trial delivering an implantable cardioverter defibrillator (ICD)-specific PtDA to new ICD candidates and examining preliminary estimates of differences in outcomes. METHODS: Prior to recruitment, ICD candidacy was determined. Consented patients were randomized to (1) usual care or (2) PtDA intervention. Feasibility outcomes included referral and recruitment rates, successful PtDA delivery, and completion of measures. The PtDA intervention was administered prior to specialist consultation and baseline demographics, and measures of decision quality including decisional conflict (DCS), SURE test (Sure of myself, Understand information, Risk-benefit ratio, Encouragement), patient's ICD specific values, ICD knowledge, and health-related quality of life were recorded. Post-consultation, participant's DCS was repeated and decisions to proceed, decline, or defer ICD implantation were collected. Feasibility data was determined using descriptive statistics (continuous and categorical). Preliminary estimates of differences in outcomes were assessed using mean differences. Concordance between values and decision choice was assessed using logistic regression of the intervention group. RESULTS: We identified 135 eligible patients. Eighty-two consented to the trial randomizing patients to usual care (n = 41) or PtDA intervention (n = 41). Feasibility outcome results were (1) referral rate at approximately 20/month, (2) recruitment rate 61%, and (3) successful delivery of PtDA and study management. Pre-consultation, PtDA patients scored lower on the DCS scale (mean, standard deviation [SD] 27.3 (18.4) compared to usual care, 49.4 (18.6); the between-group difference in means [95% confidence interval (CI)] was - 22.1[- 30.23, - 13.97]. A difference remained post-implantation 21.2 (11.7), PtDA intervention 29.9 (13.3), and usual care - 8.7 [- 14.61, - 2.86]. SURE test results supported DCS differences. The PtDA group scored higher on the ICD-related knowledge questions, with 47.50% scoring greater than 3/5 of the knowledge questions correct, compared to 23.09% receiving usual care. The mean [SD] number of correct knowledge responses out of 5 was 3.33(1.19) in the PtDA group and 2.62 (1.16) in usual care pre-implant. Concordance between values and decision choice found a strong association between predicted and actual ICD implant status in the intervention group. CONCLUSION: Our results suggest that a future definitive trial is feasible. The ICD-specific PtDA shows promise with respect to preliminary estimates of differences in outcomes. TRIAL REGISTRATION: NCT01876173.

Questioning patient engagement: research scientists' perceptions of the challenges of patient engagement in a cardiovascular research network.

BACKGROUND: Patient engagement in research is a dominant discourse in clinical research settings as it is seen as a move toward sustainable and equitable health care systems. In Canada, a key driver is the Strategy for Patient-Oriented Research of the Canadian Institutes of Health Research, which asserts that meaningful patient engagement can only be fostered when stakeholders understand its value. This study assessed researchers' perceptions of the meaning and value of patient engagement in research within a Canadian cardiovascular research network. In doing so, the secondary aim was to inform the development of a structured patient engagement initiative by identifying potential challenges and related mitigation strategies. METHODS: We employed a multi-method strategy involving electronic surveys and semi-structured telephone interviews with network research scientists across Canada. Interview data were analyzed using thematic and content analysis. Survey data were analyzed using descriptive statistics. RESULTS: Thirty-eight electronic surveys (response rate =33%) and 16 interviews were completed with network members. Some participants were uncertain about the meaning and value of patient engagement. While voicing guarded support, four challenges relating to patient engagement were identified from the interviews: 1) identification of representative and appropriate patients, 2) uncertainty about the scope of patients' roles given concerns about knowledge discrepancies, 3) a perceived lack of evidence of the impact of patient engagement, and 4) the need for education and culture change as a prerequisite for patient engagement. Research scientists were largely concerned that patients untrained in science and tasked with conveying an authentic patient experience and being a conduit for the voices of others might unsettle a traditional model of conducting research. CONCLUSION: Concerns about patient involvement in research were related to a lack of clarity about the meaning, process, and impact of involvement. This study highlights the need for education on the meaning of patient engagement, evidence of its impact, and guidance on practical aspects of implementation within this research community.

The Caregiver Contribution to Heart Failure Self-Care (CACHS): Further Psychometric Testing of a Novel Instrument.

Caregivers (CGs) contribute important assistance with heart failure (HF) self-care, including daily maintenance, symptom monitoring, and management. Until CGs' contributions to self-care can be quantified, it is impossible to characterize it, account for its impact on patient outcomes, or perform meaningful cost analyses. The purpose of this study was to conduct psychometric testing and item reduction on the recently developed 34-item Caregiver Contribution to Heart Failure Self-care (CACHS) instrument using classical and item response theory methods. Fifty CGs (mean age 63 years ±12.84; 70% female) recruited from a HF clinic completed the CACHS in 2014 and results evaluated using classical test theory and item response theory. Items would be deleted for low (<.05) or high (>.95) endorsement, low (<.3) or high (>.7) corrected item-total correlations, significant pairwise correlation coefficients, floor or ceiling effects, relatively low latent trait and item information function levels (<1.5 and p > .5), and differential item functioning. After analysis, 14 items were excluded, resulting in a 20-item instrument (self-care maintenance eight items; monitoring seven items; and management five items). Most items demonstrated moderate to high discrimination (median 2.13, minimum .77, maximum 5.05), and appropriate item difficulty (-2.7 to 1.4). Internal consistency reliability was excellent (Cronbach α = .94, average inter-item correlation = .41) with no ceiling effects. The newly developed 20-item version of the CACHS is supported by rigorous instrument development and represents a novel instrument to measure CGs' contribution to HF self-care. © 2016 Wiley Periodicals, Inc.

The Canadian Arrhythmogenic Right Ventricular Cardiomyopathy Registry: Rationale, Design, and Preliminary Recruitment.

BACKGROUND: Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a complex and clinically heterogeneous arrhythmic condition. Incomplete penetrance and variable expressivity are particularly evident in ARVC, making clinical decision-making challenging. METHODS: Pediatric and adult cardiologists, geneticists, genetic counsellors, ethicists, nurses, and qualitative researchers are collaborating to create the Canadian ARVC registry using a web-based clinical database. Biological samples will be banked and systematic analysis will be performed to examine potentially causative mutations, variants, and biomarkers. Outcomes will include syncope, ventricular arrhythmias, defibrillator therapies, heart failure, and mortality. RESULTS: Preliminary recruitment has enrolled 365 participants (aged 42.7 ± 17.1 years; 50% women), including 129 probands and 236 family members. Previous cardiac arrest occurred in 28 (8%) participants, syncope occurred in 43 (12%) participants, and 46% of probands had a family history of sudden death. Overall yield of genetic testing was 36% for a disease-causing mutation and 20% for a variant of unknown significance. Target enrollment is 1000 affected patients and 500 unaffected family member controls over 7 years. The cross-sectional and longitudinal data collected in this manner will allow a robust assessment of the natural history and clinical course of genetic subtypes. CONCLUSIONS: The Canadian ARVC Registry will create a population-based cohort of patients and their families to inform clinical decisions regarding patients with ARVC.