e-Health in Cardiovascular Medicine

Note: In lieu of an abstract, this is an excerpt from the first page.Cardiovascular disease (CVD), including coronary artery disease (CHD) and stroke, is the leading cause of death and disease burden globally [...

The Potential for mHealth Interventions to Support Women with Breast Cancer after Active Treatment

Breast cancer is the most commonly diagnosed cancer among women worldwide. Chances of living one-year after diagnosis are high (~98%), and health self-management is essential to reduce risks of recurrence. Mobile health (mHealth) has emerged as a wide-reaching and cost-effective way of providing health information and support. Therefore, we conducted a narrative review of the currently available mHealth literature and synthesised the literature according to the impacts of mHealth interventions on patient outcomes, the potential mechanism for behaviour change and innovative approaches to developing future mHealth interventions. Results found a small amount of evidence for the value of mHealth interventions (text message programs, smartphone applications and activity trackers) for supporting women after breast cancer treatment. However, accessibility, cost and gender inequities may pose barriers to implementation. Developing consumer-led mHealth interventions based on lived-experiences will be essential to improving user outcomes. In conclusion, mHealth interventions are widely available and have the potential to support women after breast cancer treatment and further robust research will determine effectiveness in specific subgroups and populations

A realist evaluation approach to explaining the role of context in the impact of a complex eHealth intervention for improving prevention of cardiovascular disease

BackgroundReduction of cardiovascular disease (CVD) is a worldwide health priority and innovative uses of technology-based interventions may assist patients with improving prevention behaviours. Targeting these interventions to recipients most likely to benefit requires understanding how contexts of use influence responsiveness to the intervention, and how this interaction favours or discourages health behaviour. Using a realist evaluation approach, the aim of this study was to examine the contextual factors influencing behaviour change within a multi-feature eHealth intervention with personalised data integration from the primary care electronic health record (EHR).MethodsRealist evaluation of qualitative data from the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) randomised trial (N = 934). Thirty-six participants from the intervention group (N = 486) who had completed 12 months of study follow-up were interviewed. Coding of transcripts was structured around configurations of contexts, mechanisms, and outcomes of intervention use. Contextual narratives were derived from thematic analysis of the interviews.ResultsMechanisms favouring positive health behaviour occurred when participants responded to four interactive features of the intervention. Facilitating mechanisms included greater cognitive engagement whereby participants perceived value and benefit, and felt motivated, confident and incentivised. Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention. Increased personalisation occurred when modifiable CVD risk factors became relatable to lifestyle behaviour; and experiences of feeling greater agency/self-efficacy emerged. Use and non-use of the intervention were influenced by four overarching narratives within the individual’s micro-level and meso-level environments: illness experiences; receptiveness to risk and prevention information; history of the doctor-patient relationship; and relationship with technology.ConclusionsIntervention-context interactions are central to understanding how change mechanisms activate within complex interventions to exert their impact on recipients. Intervention use and non-use were context-dependent, underscoring the need for further research to target eHealth innovations to those most likely to benefit

Utilisation of government-subsidised chronic disease management plans and cardiovascular care in Australian general practices

BACKGROUND: Government-subsidised general practice management plans (GPMPs) facilitate chronic disease management; however, impact on cardiovascular disease (CVD) is unknown. We aimed to determine utilisation and impact of GPMPs for people with or at elevated risk of CVD. METHODS: Secondary analysis of baseline data from the CONNECT randomised controlled trial linked to Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) claims. Multivariate regression examining the association of GPMP receipt and review with: (1) ≥ 1 MBS-subsidised allied health visit in the previous 24 months; (2) adherence to dual cardioprotective medication (≥ 80% of days covered with a dispensed PBS prescription); and (3) meeting recommended LDL-cholesterol and blood pressure (BP) targets concurrently. RESULTS: Overall, 905 trial participants from 24 primary health care services consented to data linkage. Participants with a GPMP (46.6%, 422/905) were older (69.4 vs 66.0 years), had lower education (32.3% vs 24.7% high school or lower), lower household income (27.5% vs 17.0% in lowest bracket), and more comorbidities, particularly diabetes (42.2% vs 17.6%) compared to those without a GPMP. After adjustment, a GPMP was strongly associated with allied health visits (odds ratio (OR) 14.80, 95% CI: 9.08–24.11) but not higher medication adherence rates (OR 0.82, 95% CI: 0.52–1.29) nor meeting combined LDL and BP targets (OR 1.31, 95% CI: 0.72–2.38). Minor differences in significant covariates were noted in models using GPMP review versus GPMP initiation. CONCLUSIONS: In people with or at elevated risk of CVD, GPMPs are under-utilised overall. They are targeting high-needs populations and facilitate allied health access, but are not associated with improved CVD risk management, which represents an opportunity for enhancing their value in supporting guideline-recommended care. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12875-022-01763-2

The CHOICE (Choice of Health Options In prevention of Cardiovascular Events) replication trial: study protocol

Background: although morbidity and mortality from coronary heart disease (CHD) are high, only a minority of acute coronary syndrome (ACS) survivors accesses an effective secondary prevention program. We aim to determine whether the previously proven CHOICE program can be replicated at multiple sites and whether ongoing reinforcement further improves risk factor modification.Methods/design: participants eligible for but not accessing standard cardiac rehabilitation will be randomly allocated to either a previously tested 3-month CHOICE program or a 30-month CHOICE program (CHOICE-plus). Both groups will participate in individualised risk factor modules of differing duration that involve choice, goal setting and telephone follow-up for three months. CHOICE-plus will also receive additional face-to-face and telephone reinforcement between three and 30 months. At one site we will recruit a randomised control group, receiving conventional care. Primary outcomes are lipid levels, blood pressure, physical activity levels and smoking rates. Secondary outcomes include readmission rates, death, the number of risk factors, other modifiable risk factors, quality of life and process evaluation measures over three years.Discussion: we present the rationale and design of a multi-centre, replication study testing a modular approach for the secondary prevention of CHD following an ACS

Effectiveness, acceptability and usefulness of mobile applications for cardiovascular disease self-management: Systematic review with meta-synthesis of quantitative and qualitative data

Background: Mobile technologies are innovative, scalable approaches to reducing risk of cardiovascular disease (CVD) but evidence related to effectiveness and acceptability remains limited. We aimed to explore the effectiveness, acceptability and usefulness of mobile applications (apps) for CVD self-management and risk factor control.Design: Systematic review with meta-synthesis of quantitative and qualitative data.Methods: Comprehensive search of multiple databases (Medline, Embase, CINAHL, SCOPUS, and Cochrane CENTRAL) and grey literature. Studies were included if the intervention was primarily an app aimed at improving at least two lifestyle behaviours in adults with CVD. Meta-synthesis of quantitative and qualitative data was performed to review and evaluate findings.Results: Ten studies of varying designs including 607 patients from 5 countries were included. Interventions targeted hypertension, heart failure, stroke and cardiac rehabilitation populations. Factors that improved among app users were rehospitalisation rates, disease-specific knowledge, quality of life, psychosocial well-being, blood pressure, body mass index, waist circumference, cholesterol, and exercise capacity. Improved physical activity, medication adherence, and smoking cessation were also characteristic of app users. Appealing app features included tracking healthy behaviours, self-monitoring, , disease education, and personalised, customisable content. Small samples, short duration, and selection bias were noted limitations across some studies, as was the relatively low overall scientific quality of evidence. Conclusions: Multiple behaviours and CVD risk factors appear modifiable in the shorter term with use of mobile apps. Evidence for effectiveness requires larger, controlled studies of longer duration, with emphasis on process evaluation data to better understand important system- and patient-level characteristics

Targeting DNA repair in Metastatic Castration-Resistant Prostate Cancer (mCRPC): Genomic Screening for a Clinical Trial of Rucaparib

Objectives: The high prevalence of men with mCRPC carrying pathogenic mutations in DNA damage repair (DDR) genes may have implications for clinical treatment, as poly(ADP-ribose) polymerase (PARP) inhibitors, such as rucaparib, have shown preliminary evidence of activity in these patients. The ongoing phase 2 TRITON2 study (NCT02952534) is evaluating rucaparib in mCRPC patients harboring a deleterious germline or somatic mutation in BRCA1, BRCA2, ATM, or other DDR gene. Here we present results from genomic screening of tissue and plasma samples from mCRPC patients. Methods: Comprehensive genomic profiling was performed by Foundation Medicine, Inc., using FFPE tumor tissue and plasma circulating cell-free DNA (cfDNA) samples. These next-generation sequencing (NGS) assays detect germline and somatic genomic alterations (GAs), but do not distinguish between them. Results: By Jan 15, 2019, prostate or metastatic tumor tissue samples from 1050 mCRPC patients were processed. Sequencing was successful for 68% of prostate samples, 82% of soft-tissue metastatic samples, and 57% of bone metastatic samples. In total, tissue sequencing results were obtained for 774 (74%) patients. GAs in BRCA1, BRCA2, or ATM were observed in 16.7% of patients’ tissue. In parallel, plasma from 654 mCRPC patients was collected and sequenced: 96% of plasma samples had sufficient cfDNA to obtain sequencing results, and sequencing success was independent of the location of metastases (visceral, nodal, or bone). GAs in BRCA1, BRCA2, or ATM were observed in 21.4% of patients’ plasma. There was high concordance between the alterations detected by the tissue and plasma assays. For example, in 86% of patients the plasma assay detected the same BRCA2 alteration present in tissue. Conclusions: Genomic profiling may help guide clinical decision-making for mCRPC patients. Tumor and plasma testing successfully identified patients with eligible somatic or germline GAs for enrollment into TRITON2. These data continue to support the utilization of plasma genomic testing, particularly in patients without a lesion that can be biopsied. Source of Funding: Clovis Oncology, Inc

Physicochemical equivalence of generic antihypertensive medicines (EQUIMEDS): protocol for a quality of medicines assessment.

BACKGROUND: Prevention and optimal management of hypertension in the general population is paramount to the achievement of the World Heart Federation (WHF) goal of reducing premature cardiovascular disease (CVD) mortality by 25% by the year 2025 and widespread access to good quality antihypertensive medicines is a critical component for achieving the goal. Despite research and evidence relating to other medicines such as antimalarials and antibiotics, there is very little known about the quality of generic antihypertensive medicines in low-income and middle-income countries. The aim of this study was to determine the physicochemical equivalence (percentage of active pharmaceutical ingredient, API) of generic antihypertensive medicines available in the retail market of a developing country. METHODS: An observational design will be adopted, which includes literature search, landscape assessment, collection and analysis of medicine samples. To determine physicochemical equivalence, a multistage sampling process will be used, including (1) identification of the 2 most commonly prescribed classes of antihypertensive medicines prescribed in Nigeria; (2) identification of a random sample of 10 generics from within each of the 2 most commonly prescribed classes; (3) a geographical representative sampling process to identify a random sample of 24 retail outlets in Nigeria; (4) representative sample purchasing, processing to assess the quality of medicines, storage and transport; and (5) assessment of the physical and chemical equivalence of the collected samples compared to the API in the relevant class. In total, 20 samples from each of 24 pharmacies will be tested (total of 480 samples). DISCUSSION: Availability of and access to quality antihypertensive medicines globally is therefore a vital strategy needed to achieve the WHF 25×25 targets. However, there is currently a scarcity of knowledge about the quality of antihypertensive medicines available in developing countries. Such information is important for enforcing and for ensuring the quality of antihypertensive medicines

Persuasive design features within a consumer-focused eHealth intervention integrated with the electronic health record: a mixed methods study of effectiveness and acceptability

Introduction: eHealth strategies targeting health-related behaviour often incorporate persuasive software design. To further engage patients with their overall health management, consumer-facing web portals may be integrated with data from one or more care providers. This study aimed to explore effectiveness for healthier behaviour of persuasive design characteristics within a web application integrated with the primary health care electronic record; also patient and general practitioner (GP) preferences for future integrated records. Methods: Mixed methods study within the Consumer Navigation of Electronic Cardiovascular Tools randomised controlled trial. Participants were patients with moderate-high risk of cardiovascular disease, and their GPs. Survey and web analytic data were analysed with descriptive statistics. Interview and focus group transcripts were recorded, transcribed, coded and analysed for themes.Results: Surveys (n=397) received from patients indicated improved medication adherence (31.8%); improved mental health and well-being (40%); higher physical activity (47%); and healthier eating (61%). Users of the interactive features reported benefiting from personalised cardiovascular disease risk score (73%); goal tracking (69%); risk factor self-monitoring (52%) and receipt of motivational health tips (54%). Focus group and interview participants (n=55) described customisations that would increase portal appeal and relevance, including more provider interaction. Of the GP survey respondents (n=38), 74% reported increased patient attendance and engagement with their care. For future integrated portals, 94% of GPs were in favour and key themes among interviewees (n=17) related to design optimisation, impact on workflow and data security. Conclusion: Intervention features reflecting the persuasive design categories of Primary Task support, Dialogue support and System Credibility support facilitated healthier lifestyle behaviour. Patients valued customisable functions and greater patient-provider interactivity. GPs identified system challenges but saw advantages for patients and the health care relationship. Future studies could further elucidate the persuasive design principles that are at play and which may promote adoption of EHR-integrated consumer portals

What determines adherence to treatment in cardiovascular disease prevention? Protocol for a mixed methods preference study

Background: Significant gaps exist between guidelinesrecommended therapies for cardiovascular disease prevention and current practice. Fixed-dose combination pills ('polypills') potentially improve adherence to therapy. This study is a preference study undertaken in conjunction with a clinical trial of a polypill and seeks to examine the underlying reasons for variations in treatment adherence to recommended therapy. Methods/design: A preference study comprising: (1) Discrete Choice Experiment for patients; and (2) qualitative study of patients and providers. Both components will be conducted on participants in the trial. A joint model combining the observed adherence in the clinical trial (revealed preference) and the Discrete Choice Experiment data (stated preference) will be estimated. Estimates will be made of the marginal effect (importance) of each attribute on overall choice, the extent to which respondents are prepared to trade-off one attribute for another and predicted values of the level of adherence given a fixed set of attributes, and contextual and socio-demographic characteristics. For the qualitative study, a thematic analysis will be used as a means of exploring in depth the preferences and ultimately provide important narratives on the experiences and perspectives of individuals with regard to adherence behaviour. Ethics and dissemination: Primary ethics approval was received from Sydney South West Area Health Service Human Research Ethics Committee (Royal Prince Alfred Hospital zone). In addition to usual scientific forums, the findings will be reported back to the communities involved in the studies through sitespecific reports and oral presentations