Beyond Validation: Getting Wearable Activity Trackers into Cardiovascular Care - A Discussion Paper.

This paper addresses the challenge of integrating wearable activity trackers into cardiovascular disease care. Despite evidence supporting the use of trackers for monitoring and promoting physical activity, implementation challenges persist in clinical settings. The paper emphasises the lack of systematic, evidence-based implementation approaches for integrating trackers. It underscores the urgent need for stakeholder collaboration between clinicians, patients, implementation scientists, researchers, health and technology partners, and the use of proven implementation science methodologies. This is crucial for bridging the gap and ensuring effective translation of wearable activity trackers into cardiovascular disease care, meeting the increasing demand from patients and clinicians.

Strategies for improving diversity, equity, and inclusion in cardiovascular research: a primer.

This paper aims to empower cardiovascular (CV) researchers by promoting diversity, equity, and inclusion (DE&I) principles throughout the research cycle. It defines DE&I and introduces practical strategies for implementation in recruitment, retention, and team dynamics within CV research. Evidence-based approaches supporting underrepresented populations' participation are outlined for each research phase. Emphasizing the significance of inclusive research environments, the paper offers guidance and resources. We invite CV researchers to actively embrace DE&I principles, enhancing research relevance and addressing longstanding CV health disparities.

Accelerating knowledge translation to improve cardiovascular outcomes and health services: opportunities for bridging science and clinical practice.

Knowledge translation (KT) is the exchange between knowledge producers and users to understand, synthesize, share, and apply evidence to accelerate the benefits of research to improve health and health systems. Knowledge translation practice (activities/strategies to move evidence into practice) and KT science (study of the methodology and approaches to promote the uptake of research) benefit from the use of conceptual thinking, the meaningful inclusion of patients, and the application of intersectionality. In spite of multiple barriers, there are opportunities to develop strong partnerships and evidence to drive an impactful research agenda and increase the uptake of cardiovascular research.

Wearable Activity Trackers Objectively Measure Incidental Physical Activity in Older Adults Undergoing Aortic Valve Replacement.

BACKGROUND: For older adults with severe aortic stenosis (AS) undergoing aortic valve replacement (AVR), recovery of physical function is important, yet few studies objectively measure it in real-world environments. This exploratory study explored the acceptability and feasibility of using wearable trackers to measure incidental physical activity (PA) in AS patients before and after AVR. METHODS: Fifteen adults with severe AS wore an activity tracker at baseline, and ten at one month follow-up. Functional capacity (six-minute walk test, 6MWT) and HRQoL (SF 12) were also assessed. RESULTS: At baseline, AS participants (n = 15, 53.3% female, mean age 82.3 ± 7.0 years) wore the tracker for four consecutive days more than 85% of the total prescribed time, this improved at follow-up. Before AVR, participants demonstrated a wide range of incidental PA (step count median 3437 per day), and functional capacity (6MWT median 272 m). Post-AVR, participants with the lowest incidental PA, functional capacity, and HRQoL at baseline had the greatest improvements within each measure; however, improvements in one measure did not translate to improvements in another. CONCLUSION: The majority of older AS participants wore the activity trackers for the required time period before and after AVR, and the data attained were useful for understanding AS patients' physical function.

Development of the Consumer Involvement & Engagement Toolkit: a digital resource to build capacity for undertaking patient-centred clinical trials in Australia.

OBJECTIVE: This manuscript describes the novel approach to developing a toolkit to support meaningful consumer involvement in clinical trials in Australia to help guide others in considering the development of similar resources.The toolkit aims to support greater consumer involvement in shaping how clinical research is prioritised, designed and conducted. Type of program or service: A working group of researchers, research organisations and consumers was established to co-develop the Consumer Involvement and Engagement Toolkit (the 'Toolkit'), a digital resource to guide researchers and organisations regarding consumer involvement in clinical trials. FINDINGS: A literature review and international scan of best practice revealed numerous resources outlining best practice for consumer involvement in clinical research and clear evidence of its impact and value. Through a novel content-sharing process, we were able to utilise these resources to develop a comprehensive Toolkit for researchers and research organisations that provides world-class guidance. LESSONS LEARNT: There is a growing movement to ensure consumer involvement in healthcare, including in clinical research. We discovered its proponents were willing to share their tools and resources to promote international consumer involvement. Although these international tools and resources needed adaptation to suit the Australian research environment, this was achievable with far less effort than developing them from scratch.

Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial.

BACKGROUND: For decades, the research community has called for participant information sheets/consent forms (PICFs) to be improved. Recommendations include simplifying content, reducing length, presenting information in layers and using multimedia. However, there are relatively few studies that have evaluated health consumers' (patients/carers) perspectives on the type and organisation of information, and the level of detail to be included in a PICF to optimise an informed decision to enter a trial. We aimed to elicit consumers' views on a layered approach to consent that provides the key information for decision-making in a short PICF (layer 1) with additional optional information that is accessed separately (layer 2). We also elicited consumers' views on the optimal content and layout of the layered consent materials for a large and complex Bayesian adaptive platform trial (the SNAP trial). METHODS: We conducted a qualitative multicentre study (4 focus groups and 2 semi-structured interviews) involving adolescent and adult survivors of Staphylococcus aureus bloodstream infection (22) and their carers (2). Interview transcripts were examined using inductive thematic analysis. RESULTS: Consumers supported a layered approach to consent. The primary theme that emerged was the value of agency; the ability to exert some control over the amount of information read before the consent form is signed. Three other themes emerged; the need to prioritise participants' information needs; the importance of health literacy; the importance of information about a trial's benefits (over its risks) for decision-making and the interplay between the two. CONCLUSIONS: Our findings suggest that consumers may challenge the one-size-fits-all approach currently applied to the development of PICFs in countries like Australia. Consumers supported a layered approach to consent that offers choice in the amount of information to be read before deciding whether to enter a trial. A 3-page PICF was considered sufficient for decision-making for the SNAP trial, provided that further information was available and accessible.

Including ethnic minorities in dementia research: Recommendations from a scoping review.

Introduction: Ethnicity influences dementia etiology, prognosis, and treatment, while culture shapes help-seeking and care. Despite increasing population diversity in high-income settlement countries, ethnic minorities remain underrepresented in dementia research. We investigated approaches to enhance the recruitment, and consistent collection and analysis of variables relevant to, ethnic minorities in dementia studies to make recommendations for consistent practice in dementia research. Methods: We did a scoping review, searching Embase, PsycINFO, Medline, CENTRAL, and CINAHL between January 1, 2010 and January 7, 2020. Dementia clinical and cohort studies that actively recruited ethnic minorities in high-income countries were included. A steering group of experts developed criteria through which high-quality studies were identified. Results: Sixty-six articles were retrieved (51 observational; 15 experimental). Use of interpreters and translators (n = 17) was the most common method to facilitate participant recruitment. Race and ethnicity (n = 59) were the most common variables collected, followed by information on native language (n = 14), country of birth (n = 9), and length of time in country of settlement (n = 8). Thirty-three studies translated or used a culturally validated instrument. Twenty-three articles conducted subgroup analyses based on ethnicity. Six high-quality studies facilitated inclusion through community engagement, collected information on multiple aspects of ethnic diversity, and adjusted/substratified to analyze the impact of ethnicity on dementia. Discussion: We make recommendations for consistent recruitment, collection, and reporting of variables relating to ethnic and cultural diversity in dementia research.

Who's included? The role of the Clinical Research Nurse in enabling research participation for under-represented and under-served groups.

Background: There is a global call for more inclusive clinical research that is representative of all populations, particularly those historically under-represented or under-served. A lack of broad representation results in disproportionate health outcomes and limits the applicability and translation of research findings. Aim: Identify and describe barriers to participation across the research lifecycle and consider the role of the Clinical Research Nurse (CRN) in promoting inclusivity, including for Aboriginal and Torres Strait Islander Peoples within Australia. Discussion: Review of recent literature and best practice identified barriers to research participation across the research process; at system, participant and practitioner levels. This discussion paper explores the role of the CRN; acting as enablers, facilitators and navigators, to mitigate participation barriers. Conclusion: With their comprehensive understanding of the research process, clinical care pathways, reflective practices and participant-centred approaches, CRNs are uniquely positioned to advocate for greater equity in access to clinical research and to motivate stakeholders across the research enterprise to embed inclusive approaches in the design, conduct and dissemination of research. Implications for Practice: An in-depth understanding of the research process, self, and cultural norms of the populations they serve is essential for CRNs to effectively advocate for equity in access to research.

A snapshot of consumer engagement in clinical trials in Australia: results of a national survey of clinical trial networks and research organisations.

BACKGROUND: Little is known about the extent, perceptions or experiences of consumers involved in clinical trials across Australia. The purpose of this National study was to better understand the activity and perceptions of clinical trial networks (CTNs), research co-ordinating centres and their consumers, around consumer involvement in clinical trials. METHODS: CTNs and research co-ordinating centres who were members of the Australian Clinical Trials Alliance (ACTA), and consumers involved in the activities of these organisations, were invited to participate in online surveys. Surveys were completed between April and September 2018. RESULTS: 80 respondents completed the surveys in full: 25 of 34 CTNs, 5 from 15 research co-ordinating centres, and included research investigators of 13 active trials, 10 completed trials. There were 27 consumer respondents. Consumers were involved in clinical trial activities across 19/25 (76%) of CTNs and 3/5 (60%) of research co-ordinating centres. Consumers were involved at all stages of the trial cycle. Despite this, only 8/30 (27%) of research organisations provided specific training to their employees or members on consumer involvement in research, and most did not have a specific policy or process relating to conducting consumer involvement in clinical trials. At the organisation level, barriers to consumer involvement in clinical trials included being unsure how to involve consumers effectively and systematically, difficulty in accessing consumers or lack of infrastructure and resources. At the consumer level, barriers included limited understanding of their roles, a lack of resources and training. Enablers included education, training and funding for both the research sector and for consumers. Almost all consumer respondents (25/27; 92%) would recommend the consumer role to other potential consumers, stating it was a valuable experience that led to knowledge exchange and learning about the research process. CONCLUSIONS: Over the last few years, consumer involvement in clinical trials has increased in Australia, but the scope of involvement varies across different research organisations, and therapeutic areas. Consumer involvement in clinical trials is valued by most that do it, however, there are opportunities to further foster and strengthen ongoing partnerships, for example by providing practical advice for researchers on how to best engage and involve consumers.

Consumer involvement in clinical research (including clinical trials) is considered best practice in Australia, yet it is not yet standard practice. Before doing this research, we did not know the involvement, perceptions and experiences of researchers and consumers within research networks or organisations. Surveys were used to ask Australian Clinical Trials Alliance (ACTA) member organisations including their consumers, about how consumers are being involved in clinical trials. The surveys found that consumers are involved across many clinical trials conducted in Australia, and that their input is valued by researchers and research organisations. Sometimes researchers were uncertain on how to best involve consumers in the different aspects of clinical trials so their contribution was effective and added value. Consumers also expressed at times they were uncertain as to what was expected of them, and in some instances training would have been useful to help them engage more effectively. Support and training also needs to be more appropriate for people from different populations, ethnic backgrounds and cultures, including First Nations peoples. All agreed more resources, training and funding would be needed to support consumer involvement in clinical trials.

Normalising comparative effectiveness trials as clinical practice.

There is a lack of high-quality evidence underpinning many contemporary clinical practice guidelines embedded in the healthcare systems, leading to treatment uncertainty and practice variation in most medical disciplines. Comparative effectiveness trials (CETs) represent a diverse range of research that focuses on optimising health outcomes by comparing currently approved interventions to generate high-quality evidence to inform decision makers. Yet, despite their ability to produce real-world evidence that addresses the key priorities of patients and health systems, many implementation challenges exist within the healthcare environment.This manuscript aims to highlight common barriers to conducting CETs and describes potential solutions to normalise their conduct as part of a learning healthcare system.

Data management and wearables in older adults: A systematic review.

BACKGROUND: Wearable trackers as research or clinical tools are increasingly used to support the care of older adults, due to their practicality in self-monitoring and potential to promote healthy lifestyle behaviours. However, there is limited understanding of appropriate data collection and analysis methods in different contexts. AIM: To summarise evidence on wearable data generation and management in older adults, focusing on physical activity (PA), electrocardiogram (ECG), and vital signs monitoring. In addition to examine the accuracy and utility of wearable trackers in the care of older people. METHODS: A systematic search of CINAHL, MEDLINE, PubMed and a manual search were conducted. Twenty studies on the use of wearable trackers by older adults met the inclusion criteria. RESULTS: Methodological designs for data collection and analysis were heterogeneous, with diverse definitions of wear and no-wear time, the number and type of valid days, and proprietary algorithms. Wearable trackers had adequate accuracy for measuring step counts, moderate to vigorous physical activity (MVPA), ECG and heart rate (HR), but not for respiratory rate. Participants reported ease of use and had high-level adherence over daily long-term use. Moreover, wearable trackers encouraged users to increase their daily level of physical activity and decrease waist circumference, facilitating atrial fibrillation (AF) diagnoses and predicting length of stay. CONCLUSION: Wearable trackers are multi-dimensional technologies offering a viable and promising approach for sustained and scaled monitoring of older people's health. Frameworks and/or guidelines, including standards for the design, data management and application of use specifically for older adults, are required to enhance validity and reliability.

The validity and reliability of consumer-grade activity trackers in older, community-dwelling adults: A systematic review.

OBJECTIVE: To understand the validity and reliability of consumer-grade activity trackers (consumer wearables) in older, community-dwelling adults. METHODS: A systematic review of studies involving adults aged over 65 years who underwent physical activity monitoring with consumer wearables. A total of 7 observational studies qualified, identified from electronic databases: MEDLINE, EMBASE, Cochrane Library and others (2014-2018). Validity was interpreted using correlation coefficients (CC) and percentage error for agreement between reference devices or gold-standard validation methods Reliability was compared using mean differences or ranges (under- or overestimation) of step count and activity time. RESULTS: Total sample size was 290 adults, mean age of 70.2 ±â€¯4.8 years and females constituting 46.7 ±â€¯26.1%. The studies evaluated eight different consumer wearables used by community-dwelling adults with a range of co-morbidities. Daily step count for all consumer wearables correlated highly with validation criterion, especially the ActiGraph device: intraclass correlation coefficients (ICC) were 0.94 for Fitbit One, 0.94 for Zip, 0.86 for Charge HR and 0.96 for Misfit Shine. Slower walking pace and impaired ambulation reduced the levels of agreement. Daily step count captured by Fitbit Zip was on average 7117 (±5,880.6), which was overestimated by five of the eight consumer wearables compared with reference devices (range 167.6-2,690.3 steps/day). Measurement of activity duration was accurate compared with reference devices, yet less so than step count. CONCLUSION: In older, community-dwelling adults, consumer wearables accurately measure step count and activity duration, as confirmed by reference devices and validation methods Further research is required to understand how co-morbidities, gait and activity levels interact with monitoring in free-living environments.

Functional capacity and health-related quality of life outcomes post transcatheter aortic valve replacement: a systematic review and meta-analysis.

Background: transcatheter aortic valve replacement (TAVR) provides prognostic benefit for high surgical-risk patients with severe aortic stenosis (AS), yet the impact to patient outcomes is far less understood. Method: we performed a systematic review and meta-analysis to evaluate functional capacity and health-related quality of life (HRQoL) outcomes for patients up to 12 months post TAVR. A total of 20 eligible publications, comprising randomised-controlled trials, observational studies and a registry study were identified from electronic databases, including MEDLINE, EMBASE, Cochrane Library and others (inception to February 2017). Results: the total sample was 2,775 with a mean age of 81.8 ± 2.1 years, more than half (52%) were female and high surgical risk 9.6 ± 4.3% mean STS (Society of Thoracic Surgeons risk model). Post TAVR, patients had significant improvement in functional capacity of >40 m in the 6-minute walk test (6MWT) (95% confidence interval (CI) 9.69-73.28) and a clinically meaningful increase in ability to perform daily physical-based tasks (Duke Activity Status Index (DASI), mean difference (MD) increase 5.42 points, 95% CI 3.16-7.68). HRQoL improved consistently following TAVR regardless of measure used. Significant increases occurred in the physical component summary scores (PCS) of the short form (SF) health surveys (MD increase 10.45 (SF36) and 10.14 (SF12) points). Conclusion: functional capacity and HRQoL improved substantially following TAVR, despite evolving patient selection criteria, thus TAVR continues to provide a directly beneficial option for severe AS patients.

Harnessing the Potential of Wearable Activity Trackers for Heart Failure Self-Care.

PURPOSE OF REVIEW: The purpose of this study was to explore the potential of wearable activity trackers to promote self-care management for physical activity in heart failure (HF). RECENT FINDINGS: Exercise participation decreases hospital admissions and improves quality of life in HF, and activity tracking devices provide more precise means to assess free-living physical activity and thus enable tailored exercise instruction. Use of activity trackers by cardiac patients for self-monitoring and motivational purposes is associated with increased levels of physical activity and is predictive of disease severity. However, more research is required to establish the feasibility and validity of these devices in HF patients. It is also critical that the devices can be easily used to collect, process and utilise relevant data. Activity trackers have the potential to promote HF self-care because they provide monitoring of physical activity behaviours and the potential to generate habit formation and goal reinforcement, all of which foster physical activity.

Transcatheter aortic valve implantation: current trends and future directions.

Transcatheter aortic valve implantation (TAVI) has been increasingly utilized for the treatment of severe symptomatic aortic stenosis in inoperable and high surgical risk patients. Recent advances in valve technology include repositionable scaffolds and smaller delivery systems, as well as improvement in periprocedural imaging. These advances have resulted in reduction of vascular complications, rates of paravalvular aortic regurgitation and periprocedural stroke and improved overall outcomes. Increasingly, TAVI is the preferred treatment for high-risk surgical patients with severe aortic stenosis. Consequently, there is growing interest for the use of TAVI in lower surgical risk patients. Furthermore, the role of TAVI has expanded to include valve-in-valve procedures for the treatment of degenerative bioprosthetic valves and bicuspid aortic valves. Questions remain in regard to the optimal management of concurrent coronary artery disease, strategies to minimize valve leaflet restriction and treatment of conduction abnormalities as well as identifying newer indications for its use.