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BackgroundTask force statements support the use of cognitive behavioral therapy (CBT) and motivational interviewing (MI) to promote self-care in chronic heart failure (CHF) patients. Digital counseling interventions have the potential to complement conventional programs. However, therapeutic components of digital programs associated with improved outcomes are not clearly established.ObjectiveIdentify therapeutic components of the Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) protocol that were associated with improved health-related quality of life (HRQL).Materials and methodsOrdinal logistic regression was used to identify therapeutic components of the CHF-CePPORT protocol. The primary outcome was the 12-month Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) tertile. Logistic regressions determined the association between 12-month KCCQ-OS tertile, using logon hours for key segments of the protocol, modality of content delivery, and clinical themes.ResultsA total of 117 patients were enrolled in the e-Counseling arm of the CHF-CePPORT trial. Median age was 60 years (IQR 52–69). Total logon hours in the initial 4-month segment of CHF-CePPORT (Sessions 1–16) was associated with increased 12-month KCCQ-OS tertile (Odds Ratio, OR = 1.31, 95% CI, 1.1–1.5, P = 0.001). Within sessions 1–16, improved KCCQ-OS was associated with logon hours for self-assessment tools/trackers (OR = 1.49, 95% CI, 1.1–2.0, P = 0.007), and videos (OR = 1.57, 95% CI, 1.03–2.4, P = 0.04), but not for CHF information pages.ConclusionThis study highlights the importance of using evidence-based guidelines from CBT and MI as core components of digital counseling, delivered through videos and interactive tools/trackers, to improve HRQL with CHF.

BackgroundMusic performance anxiety is a common experience among elite and professional musicians and impedes performers from achieving flow state, or a state of focused, sustained engagement that promotes optimal performance.ObjectiveThe aim of this study was to use heart rate variability (HRV) to determine the psychophysiological underpinnings of optimal music performance.MethodsWe assessed HRV to study how autonomic-cardiac modulation was associated with flow during piano performance. Twenty-two pianists (15–22 years) with at least a Grade 8 Royal Conservatory of Music certification prepared two standardized pieces and a self-selected piece. Performer heart rate data were measured with a Polar 800 watch in 5-min periods immediately before performances, during performances and post-performance. HRV was employed to assess autonomic modulation of cardiac intervals. HRV indices of sympathetic and parasympathetic modulation of the heart were analyzed in 2.5-min segments to monitor short-term autonomic adjustments using the Kubios HRV Software. Flow state was measured using the 36-item Flow State Scale (FSS). Relationships were analyzed using zero-order correlations and multiple linear regressions.ResultsOur sample consisted of 22 RCM Grade 8 certified pianists. Participants achieved the highest level of flow during performance of the Bach piece. Decreased HRV was observed during performance, as indicated by a significant drop in total power. Flow state was positively associated with High Frequency (HF) power during the pre-performance phase, and inversely associated with Low Frequency (LF) power during performance.ConclusionInverse association of flow with LF-HRV during performance affirms the importance of vagal-HR modulation for achievement of flow state. Increased HF-HRV and reduced LF-HRV immediately prior to performance suggests that flow state may be shaped as much by physiological preparation during pre-performance as it is by physiologic responses during performance. Further research is required to validate the correlation between autonomic modulation of the heart and flow state. Evidence of this correlation between autonomic modulation of the heart and achievement of flow state may pave the way for further research on enhancing musical performance and targeting MPA through HRV-based interventions.

Self-management has shown to improve the quality of life in patients with chronic kidney disease (CKD). Readily accessible self-management tools are essential in promoting adherence to self-care behaviors. In recognizing that digital health facilitates efficient access to self-management programs, we developed a digital counseling program, ODYSSEE Kidney Health, to promote self-care behaviors while supporting health-related quality of life.To present the design and development of ODYSSEE Kidney Health for digital counseling for patients with CKD.The study involved an iterative design process based on user-centered design principles to develop the digital counseling program, ODYSSEE Kidney Health.A sample of 10 to 15 participants were purposively sampled from nephrology clinics at the University Health Network, Toronto, Canada.Participants underwent 2 phases in the development process. In each phase, participants were presented with a component of the program, asked to perform goal-oriented tasks, and participate in the "think-aloud" process. Semi-structured interviews followed the first phase to identify feedback about the overall program. Thematic analysis of the interviews identified themes from the usability testing. Descriptive statistics were used to summarize patient demographic data.We enrolled 11 participants (n = 7 males, n = 4 females, ages 30-82). The main themes generated anchored on (1) impact on nephrology care, (2) technical features, and (3) CKD content. Overall, participants reported positive satisfaction toward the navigation, layout, and content of the program. They cited the value of the program in their daily CKD care.Study limitations included using a single center to recruit participants, most of the participants having prior technology use, and using one module as a representative of the entire digital platform.The acceptability of a digital counseling program for patients with CKD relies on taking the patients' perspective using a user-centered design process. It is vital in ensuring adoption and adherence to self-management interventions aimed at sustaining behavioral change.L’autogestion s’est avérée efficace pour améliorer la qualité de vie des patients atteints d’insuffisance rénale chronique (IRC). Des outils d’autogestion facilement accessibles sont essentiels pour favoriser l’adhésion aux comportements d’autogestion. Conscients que la santé numérique facilite l’accès efficace aux programmes d’autogestion, nous avons mis au point un programme de consultation numérique, ODYSSEE Kidney Health, afin de promouvoir les comportements d’autogestion tout en soutenant la qualité de vie liée à la santé.Présenter la conception et le développement du programme de consultation numérique ODYSSEE Kidney Health, destiné aux patients atteints d’IRC.L’étude a impliqué un processus de conception itératif fondé sur des principes de conception axés sur l’utilisateur pour développer le programme de consultation numérique, ODYSSEE Kidney Health.Un échantillon de 10 à 15 participants choisis à dessein dans des cliniques de néphrologie du University Health Network de Toronto (Canada).Les participants ont pris part à deux phases du processus de développement. À chaque phase, une composante du programme a été présentée aux participants et ceux-ci ont été invités à effectuer des tâches axées sur les objectifs et à participer à un processus de « réflexion à voix haute ». Des entretiens semi-structurés ont suivi la première phase pour fournir de la rétroaction sur le programme dans son ensemble. L’analyse thématique des entretiens a permis de dégager les thèmes des tests d’utilisabilité. Des statistiques descriptives ont servi à présenter les données démographiques des patients.Nous avons inclus 11 participants (7 hommes, 4 femmes; de 30 à 82 ans). Les principaux thèmes générés sont ancrés sur: 1) l’impact sur les soins de néphrologie, 2) les caractéristiques techniques et 3) le contenu sur l’IRC. Dans l’ensemble, les participants étaient satisfaits de leur expérience de navigation, de la disposition des contenus et du contenu du programme. Ils ont mentionné la valeur du programme dans leurs soins quotidiens d’IRC.Un seul centre a été utilisé pour recruter des participants, la majorité des participants avait déjà utilisé la technologie et un seul module a été utilisé pour représenter l’ensemble de la plateforme numérique.L’acceptabilité d’un programme de consultation numérique destiné aux patients atteints d’IRC repose sur la prise en compte du point de vue des patients par le biais d’un processus de conception axé sur l’utilisateur. Ceci est essentiel pour garantir l’adoption et l’adhésion aux interventions d’autogestion visant à pérenniser les changements de comportement.

Introduction Heart failure (HF) symptoms improve through self-care, for which adherence remains low among patients despite the provision of education for these behaviours by clinical teams. Open Access Digital Community Promoting Self-Care, Peer Support and Health Literacy (ODYSSEE–vCHAT) combines automated digital counselling with social network support to improve mortality and morbidity, engagement with self–care materials, and health-related quality of life. Methods and analysis Use of ODYSSEE-vCHAT via Internet-connected personal computer by 162 HF patients will be compared with a control condition over 22 months. The primary outcome is a composite index score of all-cause mortality, all-cause emergency department visits, and HF-related hospitalisation at trial completion. Secondary outcomes include individual components of the composite index, engagement with self-care materials, and patient-reported measures of physical and psychosocial well-being, disease management, health literacy, and substance use. Patients are recruited from tertiary care hospitals in Toronto, Canada and randomised on a 1:1 ratio to both arms of the trial. Online assessments occur at baseline (t=0), months 4, 8 and 12, and trial completion. Ordinal logistic regression analyses and generalised linear models will evaluate primary and secondary outcomes. Ethics and dissemination The trial has been approved by the research ethics boards at the University Health Network (20-5960), Sunnybrook Hospital (5117), and Mount Sinai Hospital (21-022-E). Informed consent of eligible patients occurs in person or online. Findings will be shared with key stakeholders and the public. Results will allow for the preparation of a Canada-wide phase III trial to evaluate the efficacy of ODYSSEE-vCHAT in improving clinical outcomes and raising the standard of outpatient care. Trial registration number NCT04966104

Cardiovascular diseases, which include coronary heart diseases (CHD), remain the leading cause of death in Canada and other industrialized countries. This qualitative study used photo-elicitation, focus groups and in-depth interviews to understand health behaviour change from the perspectives of 38 people who were aware of their high risk for CHD and had received information about cardiovascular risk modification while participating in a larger intervention study. Participants were drawn from two selected regions: Sudbury and District (northern Ontario) and the Greater Toronto Area (southern Ontario). Analysis drew on concepts of place and space to capture the complex interplay between geographic location, sociodemographic position, and people‟s efforts to understand and modify their risk for CHD. Three major sites of difference and ambiguity emerged: 1) place and access to health resources, 2) time and food culture, and 3) itineraries or travels through multiple locations. All participants reported difficulties in learning and adhering to new lifestyle patterns, but access to supportive health resources was different in the two regions. Even within regions, subgroups experienced different patterns of constraint and advantage. In each region, “fast” food and traditional foods were entrenched within different temporal and social meanings. Finally, different and shifting strategies for risk modification were required at various points during daily and seasonal travels through neighbourhoods, to workplaces, or on vacation. Thus health education for CHD risk modification should be place-specific and tailored to the needs and resources of specific communities.

Background: International task force statements advocate telehealth programs to promote health-related quality of life for patients with chronic heart failure (CHF). To that end, we evaluated the efficacy and usability of an automated e-counseling program. Methods: This Canadian multi-site double-blind randomized trial assessed whether usual care plus either internet-based e-counseling (motivational and cognitive-behavioral tools for CHF self-care) or e-based conventional CHF self-care education (e-UC) improved 12-month Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS). Secondary outcomes included program engagement (total logon weeks, logons, and logon hours), total CHF self-care behaviors, diet (fruit and vegetable servings), 6-minute walk test, and 4-day step count. The association between program engagement and health-related quality of life was assessed using KCCQ-OS tertiles. Results: We enrolled 231 patients, median age =59.5 years, 22% female, and elevated median KCCQ-OS=83.0 (interquartile range, 68–93). KCCQ-OS increase ≥5 points was not more prevalent for e-counseling, n=29 (29.6%) versus e-UC, n=32 (34.0%), P =0.51. E-Counseling versus e-UC increased total logon weeks ( P =0.02), logon hours ( P =0.001), and logons ( P P =0.04) and logon hours ( P =0.004). E-Counseling increased CHF self-care behavior and diet but not 6-minute walk test or 4-day step count. Conclusions: The primary KCCQ-OS end point was negative for this trial. Only e-counseling showed a positive association between program engagement and 12-month KCCQ-OS tertile, and it improved CHF self-care behavior and diet. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01864369.

Background North American adults with congenital heart disease (CHD) are known to be at elevated risk of mood and anxiety disorders. This was the first trial of a group psychosocial intervention targeting this patient population. Methods Within this feasibility study, we conducted a 2-arm pilot randomized controlled trial (RCT) in which patients were randomized to Usual Care or an 8-session group psychosocial intervention ( A dult C ongenital H eart D isease- C oping a nd Re silience [ACHD-CARE]). Here, we report feasibility outcomes in accordance with published recommendations: (1) process, (2) resources, (3) management, (4) acceptability of the intervention, and (5) scientific outcomes (for which the primary outcome measures were anxiety and depression symptoms). Results Forty-two patients were randomized in the pilot RCT. The study was executable within a realistic timeline and revealed no significant human and data-management problems. The intervention was determined to be acceptable and highly valued by participants who participated in the ACHD-CARE program. The main challenges were practical barriers (eg, transportation, scheduling group sessions in-person given competing schedules) and retention. With regard to scientific outcomes, there were no adverse outcomes, and treatment fidelity was confirmed. Although not powered to test efficacy, there was a medium effect size (in favour of the intervention group) for depression symptoms. Conclusions We determined it would be feasible to conduct a full-scale trial of a psychosocial intervention targeting adults with CHD, although with modifications to address practical barriers to participation. Should this intervention prove effective, a manualized intervention could be made be available.

Introduction The effectiveness of self-guided Internet-based lifestyle counseling (e-counseling) varies, depending on treatment protocol. Two dominant procedures in e-counseling are expert- and user-driven. The influence of these procedures on hypertension management remains unclear. The objective was to assess whether blood pressure improved with expert-driven or user-driven e-counseling over control intervention in patients with hypertension over a 4-month period. Study design This study used a three-parallel group, double-blind randomized controlled design. Setting/participants In Toronto, Canada, 128 participants (aged 35–74 years) with hypertension were recruited. Participants were recruited using online and poster advertisements. Data collection took place between June 2012 and June 2014. Data were analyzed from October 2014 to December 2016. Intervention Controls received a weekly e-mail newsletter regarding hypertension management. The expert-driven group was prescribed a weekly exercise and diet plan (e.g., increase 1,000 steps/day this week). The user-driven group received weekly e-mail, which allowed participants to choose their intervention goals (e.g., [1] feel more confident to change my lifestyle, or [2] self-help tips for exercise or a heart healthy diet). Main outcome measures Primary outcome was systolic blood pressure measured at baseline and 4-month follow-up. Secondary outcomes included cholesterol, 10-year Framingham cardiovascular risk, daily steps, and dietary habits. Results Expert-driven groups showed a greater systolic blood pressure decrease than controls at follow-up (expert-driven versus control: −7.5 mmHg, 95% CI= −12.5, −2.6, p=0.01). Systolic blood pressure reduction did not significantly differ between user- and expert-driven. Expert-driven compared with controls also showed a significant improvement in pulse pressure, cholesterol, and Framingham risk score. The expert-driven intervention was significantly more effective than both user-driven and control groups in increasing daily steps and fruit intake. Conclusions It may be advisable to incorporate an expert-driven e-counseling protocol in order to accommodate participants with greater motivation to change their lifestyle behaviors, but more studies are needed. Trial registration This study is registered at www.clinicaltrials.gov NCT03111836.

Registration of clinical trials was introduced to mitigate the risk of publication and selective reporting bias in the realm of clinical research. The prevalence of publication and selective reporting bias in trial results has been evidenced through scientific research. This bias may compromise the ethical and methodological conduct in the design, implementation and dissemination of evidence-based healthcare interventions. Principal investigators of digital health trials may be overwhelmed with challenges that are unique to digital health research, such as the usability of the intervention under test, participant recruitment, and retention challenges that may contribute to non-publication rate and prospective trial registration. Our primary research objective was to examine the prevalence of prospective registration and publication rates in digital health trials. We included 417 trials that enrolled participants in 2012 and were registered in any of the seventeen WHO registries. The prospective registration and publication rates were at (38.4%) and (65.5%) respectively. We identified a statistically significant (PP=.003) between prospective registration and funding sources, with industry-funded trials having the lowest compliance with prospective registration at (14.3%). The lowest non-publication rates were in the Middle East (26.7%) and Europe (28%), and the highest were in Asia (56.5%) and the U.S. (42.5%). We found statistically significant differences (P

Background Behavioural counselling via internet- or mobile-based digital platforms is recommended for hypertension; however, outcome heterogeneity is problematic in trials of this digital intervention. Our objective was to assess how therapeutic outcome was optimized in digital trials for hypertension, according to key features of the intervention design and protocol. Methods We identified randomized controlled digital trials for systolic blood pressure (SBP) reduction in taskforce guideline and policy statements, systematic reviews, and meta-analyses published since 2010, by searching the EMBASE, Cochrane Library, psycINFO, and PubMed databases. This search was updated to January 2019. Trials included patients with elevated cardiovascular risk or cardiovascular disease. We classified digital trials by the number of components of the intervention, and whether the protocol was organized by an explicit model of behavioural change or counselling. The influence of these features was evaluated for treatment efficacy and heterogeneity of SBP outcomes. Results Seventeen trials met inclusion criteria: pooled n = 5780, 33% female, 93% taking antihypertensive medications. SBP reduction was −7.3 mm Hg for digital counselling (95% confidence interval: −7.0 to −7.5) vs −3.6 mm Hg for control (95% confidence interval: −3.4 to −3.9), P Conclusions Digital health interventions optimize the efficacy of medical therapy for SBP reduction. There is opportunity to promote a disruptive change in clinical science that accompanies technological developments in digital health promotion.

Objective 1) Evaluate the efficacy of e-Counseling vs. Control to promote lifestyle behaviors at 4 and 12-month follow-ups, 2) examine whether these behaviors changes were associated with lower blood pressure (BP), and Framingham Risk Index (FRI) at 12-month. Methods Hypertensive patients (n = 264) were randomized to the e-Counseling or the Control group. Primary trial outcome was BP and secondary outcomes included exercise and diet behaviors. This study presented the results of secondary outcomes. Linear mixed models evaluated treatment effects at 4 and 12-month. Treatment-by-sex exploratory analyses were conducted if no main treatment effect was observed. Results Daily steps significantly improved in e-Counseling vs. Controls at 12-month. Urinary sodium at 12-month did not significantly differ between the groups, but treatment-by-sex analysis showed that e-Counseling females lowered urinary sodium relative to Controls at 12 months. Improvements in steps and dietary sodium were significantly associated with improvements in BP and FRI at 12-month. Conclusion This hypertension e-Counseling protocol can promote long-term lifestyle behavior changes. Adherence to the lifestyle behavior change was associated with BP and FRI reduction at 12-month. Practice implications The hypertension e-counseling protocol has the potential to improve hypertension care and intervention reach.

Objectives To evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration. Design Cross sectional analysis. Data sources PubMed, the 17 World Health Organization’s trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports. Study selection criteria RCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018. Results This study included 10 500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P Conclusions This study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.

Background Persons identifying as Black, Chinese, or South Asian make up the largest minority groups in Canada. Individuals with chronic heart failure (CHF) from these groups experience a greater rate of re-hospitalization and poorer quality of life. Although experts agree that culture can shape the experience of CHF, little is known about how patients from these minority populations define a good quality of life with CHF and what barriers they experience when carrying out self-care behaviours. The aim of this qualitative study was to examine cultural and gender-based influences on quality of life in patients with CHF. Methods Purposive sampling included 30 patients (67% male), 18 to 75 years of age, who self-identified as Black (n = 8), Chinese (n = 9), or South Asian (n = 6). Caucasians (n = 7) were included as a comparison group. Semi-structured interviews (see the online appendix), lasting approximately 60 min, were conducted, which focused on personal understanding of CHF and living with the disease, including impact on lifestyle and quality of life. An inductive qualitative approach with thematic content analysis was used to develop key insights into individual experience of CHF, as well as cultural and gender-based influences on self-care and quality of life. Descriptive statistics were generated from questionnaire responses. Results Five key themes emerged from the narrative analysis of participant interviews: (i) CHF as an emergent reality, (ii) quality of life and disruption of lifecourse milestones, (iii) the challenge to accept CHF and re-evaluation of quality of life; (iv) impact on social activities essential to quality of life, and (v) life with CHF as a commitment to culturally tailored self-care. Participants described the unique impact of CHF on their quality of life, including life trajectory milestones such as dating, parenting, and retirement planning, as well as the importance of accepting their diagnosis, and the reframing goals for living well with heart failure. Positive and negative impacts on social relationships were noted, including sexual intimacy and interactions with spouses, other family members, and co-workers. Conclusions Study findings highlight important lifespan, cultural, and gender considerations that can inform the improvement of patient care and quality of life for patients and their families.

BACKGROUND Clinical trials are key to advancing evidence-based medical research. The medical research literature has identified the impact of publication bias in clinical trials. Selective publication for positive outcomes or nonpublication of negative results could misdirect subsequent research and result in literature reviews leaning toward positive outcomes. Digital health trials face specific challenges, including a high attrition rate, usability issues, and insufficient formative research. These challenges may contribute to nonpublication of the trial results. To our knowledge, no study has thus far reported the nonpublication rates of digital health trials. OBJECTIVE The primary research objective was to evaluate the nonpublication rate of digital health randomized clinical trials registered in ClinicalTrials.gov. Our secondary research objective was to determine whether industry funding contributes to nonpublication of digital health trials. METHODS To identify digital health trials, a list of 47 search terms was developed through an iterative process and applied to the “Title,” “Interventions,” and “Outcome Measures” fields of registered trials with completion dates between April 1, 2010, and April 1, 2013. The search was based on the full dataset exported from the ClinlicalTrials.gov database, with 265,657 trials entries downloaded on February 10, 2018, to allow publication of studies within 5 years of trial completion. We identified publications related to the results of the trials through a comprehensive approach that included an automated and manual publication-identification process. RESULTS In total, 6717 articles matched the a priori search terms, of which 803 trials matched our latest completion date criteria. After screening, 556 trials were included in this study. We found that 150 (27%) of all included trials remained unpublished 5 years after their completion date. In bivariate analyses, we observed statistically significant differences in trial characteristics between published and unpublished trials in terms of the intervention target condition, country, trial size, trial phases, recruitment, and prospective trial registration. In multivariate analyses, differences in trial characteristics between published and unpublished trials remained statistically significant for the intervention target condition, country, trial size, trial phases, and recruitment; the odds of publication for non-US–based trials were significant, and these trials were 3.3 (95% CI 1.845-5.964) times more likely to be published than US–based trials. We observed a trend of 1.5 times higher nonpublication rates for industry-funded trials. However, the trend was not statistically significant. CONCLUSIONS In the domain of digital health, 27% of registered clinical trials results are unpublished, which is lower than nonpublication rates in other fields. There are substantial differences in nonpublication rates between trials funded by industry and nonindustry sponsors. Further research is required to define the determinants and reasons for nonpublication and, more importantly, to articulate the impact and risk of publication bias in the field of digital health trials.

Background: The efficacy of internet-based interventions to improve hypertension management is not established. We evaluated the therapeutic benefit of e-counseling by adapting best evidence guidelines for behavioral counseling. Methods and Results: This multicenter double-blind randomized controlled trial included assessments at baseline, 4 months, and 12 months. Participants were 35 to 74 years of age and diagnosed with hypertension: systolic/diastolic blood pressure (BP) 130 to 180/85 to 110 mm Hg. BP was assessed by automated office measurement. E-Counseling used multimedia and interactive tools to increase motivation and skill for self-care (exercise, diet, medication adherence, and smoking cessation). Control used self-care education. Frequency of contact by our e-platform was equal for both trial arms. Primary end points were change at 4 and 12 months in systolic BP, diastolic BP, pulse pressure, total lipoprotein cholesterol, low-density lipoprotein cholesterol, total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio, non–high-density lipoprotein cholesterol, and Framingham 10-year cardiovascular risk index. Intention-to-treat analysis used generalized linear models adjusted for baseline measures, sex, and medications. Among 264 participants, mean age was 57.6 years (SE, 0.6), 58% were women, with 83% on antihypertensive medications. At 12 months, e-counseling versus control evoked greater reduction in systolic BP (−10.1 mm Hg [95% confidence interval (CI), −12.5, −7.6] versus −6.0 mm Hg [95% CI, −8.5, −3.5]; P =0.02); pulse pressure (−5.2 mm Hg [95% CI, −6.9, −3.5] versus −2.7 mm Hg [95% CI, −4.5, −0.9]; P =0.04), and Framingham risk index (−1.9% [95% CI, −3.3, −0.5] versus −0.02% [95% CI, −1.2, 1.7]; P =0.02), respectively. Among males in e-counseling versus control, 12-month end points included lower diastolic BP ( P =0.01), non–high-density lipoprotein cholesterol ( P =0.04), total lipoprotein cholesterol ( P =0.03), and a trend for total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio ( P =0.07). Conclusions: To our knowledge, this is the first double-blind randomized trial of e-counseling for hypertension. Added benefit for medical therapy was achieved by combining available technology with a clinically organized protocol of motivational and cognitive-behavioral counseling. Clinical Trial Registration: https://www.clinicaltrials.gov ; Unique identifier: NCT01541540

Purpose of review Lifestyle counseling that includes exercise training, diet modification, and medication adherence is critical to hypertension management. This article summarizes the efficacy of lifestyle counseling interventions in face-to-face, telehealth, and e-counseling settings. It also discusses the therapeutic potential of e-counseling as a preventive strategy for hypertension. Recent findings The recent proliferation of telehealth and e-counseling programs increases the reach of preventive counseling for patients with cardiovascular disorders. Blood pressure reduction following these interventions is comparable to face-to-face interventions. However, the effectiveness of e-counseling varies depending on the design features of the core protocol. An evidence-based guideline needs to be established that identifies e-counseling components which are independently associated with blood pressure reduction. As the Internet becomes more sophisticated, e-counseling is demonstrating a therapeutic advantage in comparison with other telehealth interventions. Summary Current evidence supports further development of preventive e-counseling programs for hypertension. A pressing challenge for investigators is to specify key evidence-based components of e-counseling that are essential to the core protocol. In order to achieve this goal, it will be necessary to ensure that e-counseling programs are also clinically organized, in order to guide patients through the process of initiating and sustaining therapeutic behavior change.

Chronically heightened physiological reactivity to or delayed recovery from stress may contribute to cardiovascular (CV) risk and mortality. Long-term stability of physiological stress responses has received little attention. Our objectives were to evaluate the 3-year stability of reactivity and recovery change scores across CV and autonomic parameters and assess whether sex and age moderate stability. A total of 134 healthy participants underwent two laboratory stress protocols, including four 5-min interpersonal stressors, each followed by a 5-min recovery period. Heart rate (HR), blood pressure (BP), and HR variability (high frequency, low frequency, very low frequency [VLF]) were obtained. Spearman rank correlations and linear regressions were performed. Significant correlations emerged for all physiological measures except diastolic BP and VLF recovery. No significant sex or age differences were found. Stress responses represent stable individual traits little affected by sex or age.

Background: Clinical trials are key to advancing evidence-based medical research. The medical research literature has identified the impact of publication bias in clinical trials. Selective publication for positive outcomes or nonpublication of negative results could misdirect subsequent research and result in literature reviews leaning toward positive outcomes. Digital health trials face specific challenges, including a high attrition rate, usability issues, and insufficient formative research. These challenges may contribute to nonpublication of the trial results. To our knowledge, no study has thus far reported the nonpublication rates of digital health trials. Objective: The primary research objective was to evaluate the nonpublication rate of digital health randomized clinical trials registered in ClinicalTrials.gov. Our secondary research objective was to determine whether industry funding contributes to nonpublication of digital health trials. Methods: To identify digital health trials, a list of 47 search terms was developed through an iterative process and applied to the “Title,” “Interventions,” and “Outcome Measures” fields of registered trials with completion dates between April 1, 2010, and April 1, 2013. The search was based on the full dataset exported from the ClinlicalTrials.gov database, with 265,657 trials entries downloaded on February 10, 2018, to allow publication of studies within 5 years of trial completion. We identified publications related to the results of the trials through a comprehensive approach that included an automated and manual publication-identification process. Results: In total, 6717 articles matched the a priori search terms, of which 803 trials matched our latest completion date criteria. After screening, 556 trials were included in this study. We found that 150 (27%) of all included trials remained unpublished 5 years after their completion date. In bivariate analyses, we observed statistically significant differences in trial characteristics between published and unpublished trials in terms of the intervention target condition, country, trial size, trial phases, recruitment, and prospective trial registration. In multivariate analyses, differences in trial characteristics between published and unpublished trials remained statistically significant for the intervention target condition, country, trial size, trial phases, and recruitment; the odds of publication for non-US–based trials were significant, and these trials were 3.3 (95% CI 1.845-5.964) times more likely to be published than US–based trials. We observed a trend of 1.5 times higher nonpublication rates for industry-funded trials. However, the trend was not statistically significant. Conclusions: In the domain of digital health, 27% of registered clinical trials results are unpublished, which is lower than nonpublication rates in other fields. There are substantial differences in nonpublication rates between trials funded by industry and nonindustry sponsors. Further research is required to define the determinants and reasons for nonpublication and, more importantly, to articulate the impact and risk of publication bias in the field of digital health trials.

Introduction The Survey on Living with Chronic Diseases in Canada—hypertension component (SLCDC-H) is a 20-minute cross-sectional telephone survey on hypertension diagnosis and management. Sampled from the 2008 Canadian Community Health Survey (CCHS), the SLCDC-H includes Canadians (aged ≥ 20 years) with self-reported hypertension from the ten provinces. Methods The questionnaire was developed by Delphi technique, externally reviewed and qualitatively tested. Statistics Canada performed sampling strategies, recruitment, data collection and processing. Proportions were weighted to represent the Canadian population, and 95% confidence intervals (CIs) were derived by bootstrap method. Results Compared with the CCHS population reporting hypertension, the SLCDC-H sample (n = 6142) is slightly younger (SLCDC-H mean age: 61.2 years, 95% CI: 60.8–61.6; CCHS mean age: 62.2 years, 95% CI: 61.8–62.5), has more post-secondary school graduates (SLCDC-H: 52.0%, 95% CI: 49.7%–54.2%; CCHS: 47.5%, 95% CI: 46.1%–48.9%) and has fewer respondents on hypertension medication (SLCDC-H: 82.5%, 95% CI: 80.9%–84.1%; CCHS: 88.6%, 95% CI: 87.7%-89.6%). Conclusion Overall, the 2009 SLCDC-H represents its source population and provides novel, comprehensive data on the diagnosis and management of hypertension. The survey has been adapted to other chronic conditions—diabetes, asthma/chronic obstructive pulmonary disease and neurological conditions. The questionnaire is available on the Statistics Canada website; descriptive results have been disseminated by the Public Health Agency of Canada.

Introduction L'Enquête sur les personnes ayant une maladie chronique au Canada – composante de l'hypertension (EPMCC-H) est une enquête téléphonique transversale de 20 minutes sur le diagnostic et la prise en charge de l'hypertension. L'échantillon de l'EPMCC-H, sélectionné à partir des répondants à l'Enquête sur la santé dans les collectivités canadiennes (ESCC) de 2008, était composé de Canadiens (de 20 ans et plus) des dix provinces ayant déclaré avoir reçu un diagnostic d'hypertension. Méthodologie Le questionnaire a été élaboré au moyen de la technique Delphi et a fait l'objet d'un examen externe ainsi que de tests qualitatifs. Statistique Canada s'est chargé des stratégies d'échantillonnage, du recrutement, de la collecte et du traitement des données. Les proportions ont été pondérées afin de représenter la population canadienne et les intervalles de confiance (IC) à 95 % ont été calculés au moyen de la méthode de rééchantillonnage bootstrap. Résultats Si on le compare à la population de l'ESCC ayant déclaré souffrir d'hypertension, l'échantillon de l'EPMCC-H (n = 6 142) est légèrement plus jeune (âge moyen des répondants à l'EPMCC-H : 61,2 ans, IC à 95 % : 60,8 à 61,6; âge moyen des répondants à l'ESCC : 62,2 ans, IC à 95 % : 61,8 à 62,5), comporte plus de détenteurs d'un diplôme d'études postsecondaires (EPMCC-H : 52,0 %, IC à 95 % : 49,7 % à 54,2 %; ESCC : 47,5 %, IC à 95 % : 46,1 % à 48,9 %) et moins de répondants prenant un médicament pour l'hypertension (EPMCC-H : 82,5 %, IC à 95 % : 80,9 % à 84,1 %; ESCC : 88,6 %, IC à 95 % : 87,7 % à 89,6 %). Conclusion Dans l'ensemble, l'EPMCC-H de 2009 est représentatif de sa population source et fournit des données nouvelles et exhaustives sur le diagnostic et la prise en charge de l'hypertension. L'enquête a été adaptée à d'autres maladies chroniques – diabète, asthme/maladie pulmonaire obstructive chronique et troubles neurologiques. Le questionnaire est accessible à partir du site Web de Statistique Canada; des résultats descriptifs ont été publiés par l'Agence de la santé publique du Canada.

Background: Elevated blood pressure is one of the main risk factors for death globally. Behavioral neurocardiac training (BNT) is a complementary approach to blood pressure and stress management that is intended to exercise the autonomic reflexes, improve stress recovery, and lower blood pressure. BNT involves cognitive-behavioral therapy with a paced breathing technique and heart rate variability biofeedback. BNT is limited to in-clinic delivery and faces an accessibility barrier because of the need for clinical oversight and the use of complex monitoring tools. Objective: The objective of this project was to design, develop, and evaluate a wearable electrocardiographic (ECG) sensor system for the delivery of BNT in a home setting. Methods: The wearable sensor system, Beat , consists of an ECG sensor and a mobile app. It was developed iteratively using the principles of test-driven Agile development and user-centered design. A usability study was conducted at Toronto General Hospital to evaluate feasibility and user experience and identify areas of improvement. Results: The Beat sensor was designed as a modular patch to be worn on the user’s chest and uses standard ECG electrodes. It streams a single-lead ECG wirelessly to a mobile phone using Bluetooth Low Energy. The use of small, low-power electronics, a low device profile, and a tapered enclosure allowed for a device that can be unobtrusively worn under clothing. The sensor was designed to operate with a mobile app that guides users through the BNT exercises to train them to a slow-paced breathing technique for stress recovery. The BNT app uses the ECG captured by the sensor to provide heart rate variability biofeedback in the form of a real-time heart rate waveform to complement and reinforce the impact of the training. Usability testing (n=6) indicated that the overall response to the design and user experience of the system was perceived positively. All participants indicated that the system had a positive effect on stress management and that they would use it at home. Areas of improvement were identified, which focused primarily on the delivery of training and education on BNT through the app. Conclusions: The outcome of this project was a wearable sensor system to deliver BNT at home. The system has the potential to offer a complementary approach to blood pressure and stress management at home and reduce current accessibility barriers. [JMIR Mhealth Uhealth 2016;4(2):e45]

LIU, S., J. GOODMAN, R. NOLAN, S. LACOMBE, and S. G. THOMAS. Blood Pressure Responses to Acute and Chronic Exercise Are Related in Prehypertension. Med. Sci. Sports Exerc., Vol. 44, No. 9, pp. 1644–1652, 2012. Purpose: Aerobic exercise is recommended as a way to prevent hypertension. However, about 25% of individuals receive minimal antihypertensive benefits associated with chronic exercise training. Thus, we attempt to identify those ‘‘nonresponders’’ to chronic exercise on the basis of their blood pressure (BP) responses to acute exercise (single session). Our primary objective was to correlate the magnitude of BP decrease after acute exercise to the magnitude of BP reduction after chronic exercise. Our secondary objective was to examine the correlates of BP reduction after acute and chronic exercise. Methods: Seventeen prehypertensive (120 to 139/80 to 89 mm Hg) males and females (45–60 yr old) underwent acute exercise assessments before an 8-wk walking/jogging program (four times per week, 30 min per session, 65% maximum oxygen consumption). BP, hemodynamics, HR variability, and baroreflex sensitivity were assessed before and after acute exercise and chronic training. Results: BP was significantly reduced j7.2 T 1.2/j4.2 T 1.0 and j7.0 T 1.4/j5.2 T 1.2 mm Hg relative to baseline after acute (30 min at 65% maximum oxygen consumption) and chronic exercise, respectively (P G 0.01). The magnitude of change in systolic BP after acute exercise was strongly correlated with change in resting systolic BP after chronic training, r = 0.89, P G 0.01. A similar correlation was observed with diastolic BP, r = 0.75, P G 0.01. After acute exercise, significant reductions in total power (ms 2 ) and baroreflex sensitivity were observed in both sexes (P G 0.01). However, after chronic exercise, only men demonstrated a significant reduction in the low-frequency-to-high-frequency ratio (j36%), P G 0.01. Conclusions: The magnitude of the acute BPlowering with exercise may predict the extent of BP lowering after chronic training interventions in prehypertensive individuals.

Background Preventive electronic (e)-counselling has been shown to reduce cardiovascular risk factors. However, heterogeneity in outcomes is commonly reported due to differences in e-protocols. We incorporated key features of an established behavioural therapy, motivational interviewing, to help standardize e-counselling in order to reduce blood pressure in patients with hypertension. Methods Subjects (n = 387, mean age=56 years, 59% female, 72% taking ≥ 1 antihypertensive drug) were diagnosed with stage 1 or 2 hypertension. Subjects were randomized to a 4-month protocol of e-counselling (beta version of the "Blood Pressure Action Plan", Heart and Stroke Foundation of Canada) vs waitlist control (general e-information on heart-healthy living). Outcomes were systolic, diastolic, and pulse pressures, and total lipoprotein cholesterol after treatment. Results Intention to treat analysis did not find a significant group difference in outcomes due to contamination across the 2 arms of this trial. However, per protocol analysis indicated that subjects receiving ≥ 8 e-counselling messages (a priori therapeutic dose) vs 0 e-counselling messages (control) demonstrated greater reduction in systolic blood pressure (mean, −8.9 mm Hg; 95% confidence interval [CI], −11.5 to −6.4 vs −5.0 mm Hg; 95% CI, −6.7 to −3.3, P = 0.03), pulse pressure (−6.1 mm Hg; 95% CI, −8.1 to −4.1 vs −3.1 mm Hg; 95% CI, −4.3 to −1.8, P = 0.02) and total cholesterol (−0.24 mmol/L; 95% CI, −0.43 to −0.06 vs 0.05 mmol/L; 95% CI, −0.06 to 0.16, P = 0.03), but not diastolic blood pressure. Conclusions These findings support the merit of evaluating whether e-counselling can improve blood pressure control and reduce cardiovascular risk over the long-term.

Nolan RP, Floras JS, Ahmed L, Harvey PJ, Hiscock N, Hendrickx H, Talbot D (University Health Network and University of Toronto; Women’s College Hospital, University of Toronto, Toronto, ON, Canada; and Unilever Discover, Colworth Science Park, Sharnbrook, UK). Behavioural modification of the cholinergic anti-inflammatory response to C-reactive protein in patients with hypertension. J Intern Med 2012; 272: 161–169. Objectives. A central hypothesis of the cholinergic anti-inflammatory reflex model is that innate immune activity is inhibited by the efferent vagus. We evaluated whether changes in markers of tonic or reflex vagal heart rate modulation following behavioural intervention were associated inversely with changes in high-sensitivity C-reactive protein (hsCRP) or interleukin-6 (IL-6). Design. Subjects diagnosed with hypertension (n = 45, age 35–64 years, 53% women) were randomized to an 8-week protocol of behavioural neurocardiac training (with heart rate variability biofeedback) or autogenic relaxation. Assessments before and after intervention included pro-inflammatory factors (hsCRP, IL-6), markers of vagal heart rate modulation [RR high-frequency (HF) power within 0.15–0.40 Hz, baroreflex sensitivity and RR interval], conventional measures of lipoprotein cholesterol and 24-h ambulatory systolic and diastolic blood pressure. Results. Changes in hsCRP and IL-6 were not associated with changes in lipoprotein cholesterol or blood pressure. After adjusting for anti-inflammatory drugs and confounding factors, changes in hsCRP related inversely to changes in HF power (β =−0.25±0.1, P = 0.02), baroreflex sensitivity (β = −0.33±0.7, P = 0.04) and RR interval (β = −0.001 ± 0.0004, P = 0.02). Statistically significant relationships were not observed for IL-6. Conclusions. Changes in hsCRP were consistent with the inhibitory effect of increased vagal efferent activity on pro-inflammatory factors predicted by the cholinergic anti-inflammatory reflex model. Clinical trials for patients with cardiovascular dysfunction are warranted to assess whether behavioural interventions can contribute independently to the chronic regulation of inflammatory activity and to improved clinical outcomes.

Patients with hypertension are advised to lower their blood pressure to

Background: This study examined whether mild-to-moderate depressive symptoms are associated with increased high-sensitivity C-reactive protein (hsCRP) and interleukin 6 (IL-6) levels in apparently healthy individuals at high risk for coronary artery disease. We investigated in individuals whether: (1) current depressive symptoms were associated with increased hsCRP and IL-6 levels; (2) persistent depressive symptoms at two time points 6 months apart were associated with hsCRP and IL-6; and (3), sex-based differences in inflammation were a function of depressive symptoms. Methods: We measured depressive symptoms (twice), hsCRP, and IL-6 (follow-up time point) in 84 apparently healthy individuals (52% women) at high cardiac risk. Results: Patients with persistent depressive symptoms had higher hsCRP, compared to participants without persistent symptoms (5.55 vs. 1.70 mg/l, p Conclusions: Before a first ischaemic coronary event, persistent mild-to-moderate depressive symptoms were associated with increased hsCRP. Women with depressive symptoms had higher hsCRP than men with symptoms.

Background and Research Purpose: Coronary heart disease (CHD) continues to be a major cause of death and disability across the globe. Regional differences in CHD exist throughout Canada, including Ontario. It is important to explore the complex interplay between geographical regions and individuals’ efforts at reducing their cardiovascular risk. This study explored barriers and supports to heart healthy lifestyles and associated meanings within various regions of Ontario. The focus of this paper is on the northern context to better understand the issues these individuals face when making heart healthy lifestyle changes. Sample and Method: The study used an ethnographic approach and photo-elicitation interviews. Participants took photographs of places that represented the barriers and supports to lifestyle changes for cardiovascular risk modification. These photographs were used as the basis for interview dialogue. Twelve informants from a larger study comprised the northern sub-sample considered in this paper. Results and Conclusions: When the data were analyzed, health care access and access concerns related to heart healthy lifestyles for people in northern Ontario emerged as key findings. Findings suggest that the concept of place is pivotal to recognizing issues related to health care access, which should be incorporated as part of our understanding of health and cardiovascular risk modification.

We evaluated whether telehealth counseling augments lifestyle change and risk factor decrease in subjects at high risk for primary or secondary cardiovascular events compared to a recommended guideline for brief preventive counseling. Subjects at high risk or with coronary heart disease (35 to 74 years of age, n = 680) were randomized to active control (risk factor feedback, brief advice, handouts) or telehealth lifestyle counseling (active control plus 6 weekly 1-hour teleconferenced sessions to groups of 4 to 8 subjects). Primary outcome was questionnaire assessment of adherence to daily exercise/physical activity and diet (daily vegetable and fruit intake and restriction of fat and salt) after treatment and at 6-month follow-up. Secondary outcomes were systolic and diastolic blood pressures, ratio of total to high-density lipoprotein cholesterol, and 10-year absolute risk for coronary disease. After treatment and at 6-month follow-up, adherence increased for telehealth versus control in exercise (29.3% and 18.4% vs 2.5% and 9.3%, respectively, odds ratio 1.60, 95% confidence interval 1.2 to 2.1) and diet (37.1% and 38.1% vs 16.7% and 33.3%, respectively, odds ratio 1.41, 95% confidence interval 1.1 to 1.9). Telehealth versus control had greater 6-month decreases in blood pressure (mean ± SE, systolic -4.8 ± 0.8 vs -2.8 ± 0.9 mm Hg, p = 0.04; diastolic -2.7 ± 0.5 vs -1.5 ± 0.6 mm Hg, p = 0.04). Decreases in cholesterol ratio and 10-year absolute risk were significant for the 2 groups. In conclusion, telehealth counseling augments therapeutic lifestyle change in subjects at high risk for cardiovascular events compared to a recommended guideline for brief preventive counseling.

The care of adult patients with congenital heart disease (CHD) is challenging from a mental health perspective, as these patients continue to face a variety of biopsychosocial issues that may impact emotional functioning. Despite these issues, there are limited data on the psychosocial functioning of adults with CHD, and there are no data on the impact of parental overprotection on heart-focused anxiety in this patient population. The aim of this study was to examine the relationships between patient recollections of parental overprotection and current heart-focused anxiety in adults with CHD. A cross-sectional sample of 190 adult patients with CHD (51% male; mean age = 32.28, SD = 11.86 years) completed validated measures of perceived parental overprotection (Parental Bonding Instrument) and heart-focused anxiety (Cardiac Anxiety Questionnaire). The results indicated that perceived parental overprotection (β = 0.19, p = 0.02) and heart defect complexity (β = 0.17, p = 0.03) were significantly related to heart-focused anxiety. Contrary to hypotheses, perceived parental overprotection did not vary as a function of heart defect complexity (F (2, 169) = 0.02, p = 0.98). Perceived parental overprotection and heart defect complexity are associated with heart-focused anxiety in adults with congenital heart disease. These results can inform the development of clinical interventions aimed at improving the psychosocial adjustment of this patient population.

Background: Practice guidelines advocate combining pharmacotherapy with lifestyle counseling for patients with hypertension. To allow for appropriate tailoring of interventions to meet individual patient needs, a comprehensive understanding of baseline patient characteristics is essential. However, few studies have empirically assessed behavioral profiles of hypertensive patients in Web-based lifestyle counseling programs. Objective: The objectives of this study were to (1) specify baseline psychobehavioral profiles of patients with hypertension who were enrolled in a Web-based lifestyle counseling trial, and (2) examine mean differences among the identified profile groups in demographics, psychological distress, self-reported self-care behaviors, physiological outcomes, and program engagement to determine prognostic implications. Methods: Participants (N=264; mean age 57.5 years; 154/264, 58.3% female; 193/264, 73.1% white) were recruited into a longitudinal, double-blind, randomized controlled trial, designed to evaluate an online lifestyle intervention for hypertensive patients. A series of latent profile analyses identified psychobehavioral profiles, indicated by baseline measures of mood, motivation, and health behaviors. Mean differences between profile groups were then explored. Results: A 2-class solution provided the best model fit (the Bayesian information criterion (BIC) is 10,133.11; sample-size adjusted BIC is 10,006.54; Lo-Mendell-Rubin likelihood ratio test is 65.56, P=.001). The 2 profile groups were (1) adaptive adjustment, marked by low distress, high motivation, and somewhat satisfactory engagement in health behaviors and (2) affectively distressed, marked by clinically significant distress. At baseline, on average, affectively distressed patients had lower income, higher body mass index, and endorsed higher stress compared with their adaptive adjustment counterparts. At 12-months post intervention, treatment effects were sustained for systolic blood pressure and Framingham risk index in the adaptive adjustment group, and those in the adaptive adjustment group were 2.4 times more likely to complete the 12-month intervention study, compared with their affectively distressed counterparts. Conclusions: Interventions for patients who are adaptively adjusted may differ in focus from those designed for the affectively distressed patients. As such, this study underscores the importance of identifying psychobehavioral profiles, as they allow for evidence-based tailoring of lifestyle counseling programs for patients with hypertension. Trial Registration: ClinicalTrials.gov NCT01541540; https://clinicaltrials.gov/ct2/show/NCT01541540 (Archived by WebCite at http://www.webcitation.org/6yzZYZcWF)

It is not established whether behavioral interventions add benefit to pharmacological therapy for hypertension. We hypothesized that behavioral neurocardiac training (BNT) with heart rate variability biofeedback would reduce blood pressure further by modifying vagal heart rate modulation during reactivity and recovery from standardized cognitive tasks (“mental stress”). This randomized, controlled trial enrolled 65 patients with uncomplicated hypertension to BNT or active control (autogenic relaxation), with six 1-hour sessions over 2 months with home practice. Outcomes were analyzed with linear mixed models that adjusted for antihypertensive drugs. BNT reduced daytime and 24-hour systolic blood pressures (−2.4±0.9 mm Hg, P =0.009, and −2.1±0.9 mm Hg, P =0.03, respectively) and pulse pressures (−1.7±0.6 mm Hg, P =0.004, and −1.4±0.6 mm Hg, P =0.02, respectively). No effect was observed for controls ( P >0.10 for all indices). BNT also increased RR-high-frequency power (0.15 to 0.40 Hz; P =0.01) and RR interval ( P P =0.29), and RR interval decreased ( P =0.03). Neither intervention altered spontaneous baroreflex sensitivity ( P >0.10). In contrast to relaxation therapy, BNT with heart rate variability biofeedback modestly lowers ambulatory blood pressure during wakefulness, and it augments tonic vagal heart rate modulation. It is unknown whether efficacy of this treatment can be improved with biofeedback of baroreflex gain. BNT, alone or as an adjunct to drug therapy, may represent a promising new intervention for hypertension.

Adult congenital heart disease (ACHD) patients face unique medical and social challenges that may contribute to psychological difficulties. The goals of this study were to identify predictors of symptoms of depression and anxiety and evaluate the prevalence of mood and anxiety disorders among North American ACHD patients.In this cross-sectional study, consecutive patients were recruited from two ACHD outpatient clinics. All patients completed self-report psychosocial measures and a subset was randomly selected to participate in structured clinical interviews. Linear regression models were used to predict symptoms of depression and anxiety.A total of 280 patients (mean age=32 years; 52% female) completed self-report measures. Sixty percent had defects of moderate complexity and 31% had defects of great complexity. Significant predictors of depressive symptoms were loneliness (p0.001), perceived health status (p0.001), and fear of negative evaluation (p=0.02). Predictors of anxiety symptoms were loneliness (p0.001) and fear of negative evaluation (p0.001). Disease severity and functional class did not predict mood or anxiety symptoms. Fifty percent of interviewed patients (29/58) met diagnostic criteria for at least one lifetime mood or anxiety disorder, of whom 39% had never received any mental health treatment.The results confirm an increased risk and under-treatment of mood and anxiety disorders in ACHD patients. Social adjustment and patient-perceived health status were more predictive of depression and anxiety than medical variables. These factors are modifiable and therefore a potential focus of intervention.

We examined the association between heart rate variability (HRV) and duration of type 2 diabetes among 155 female and 106 male subjects: mean±SD for duration=49.6±65.6 and 57.3±77.1 months, respectively, p=0.38. Among males, duration of diabetes was independently and inversely associated with vagal-heart rate modulation (high frequency (HF) power, 0.15—0.40 Hz, standardised ß = -0.32, p=0.001; root mean square of successive differences between R-R intervals, ß = -0.26, p=0.006) and total R-R variability (standard deviation of normal R-R intervals, ß = -0.36, p=0.001); but not among females (p≥0.80 for each HRV index). In contrast, HF was inversely associated with age of diabetes diagnosis (ß = -0.16, p=0.04) and 10-year absolute risk for coronary heart disease (ß = -0.16, p=0.04) among female subjects. Longitudinal research is needed to establish whether risk factors for early cardiac autonomic impairment differ among men and women with type 2 diabetes.

To study patients with coronary artery disease (CAD) scheduled for coronary angioplasty and to examine platelet activation in response to mental stress as a potential mechanism involved in the association between psychosocial factors and cardiac outcomes. Psychosocial factors have been identified as risk factors for CAD and adverse cardiac outcomes, although the underlying mechanisms are poorly understood.Markers of platelet activation and platelet reactivity in response to experimentally induced mental stress (mental arithmetic and anger recall) were examined, using flow cytometry analysis and beta-thromboglobulin (BTG) assays among 249 CAD patients (age = 60.3 +/- 9.0 years, 15% women) who were scheduled to undergo elective percutaneous coronary intervention.Mental stress-induced increases in platelet activation (CD41 (GP IIb/IIIa), p = .002; percent of mononuclear cells positive for CD41, p = .01; CD62P (P-selectin) expression, p = .005; and percent platelets positive for CD62P, p.001). The degree of platelet reactivity was not related to demographic, clinical, or psychological variables, or cardiovascular hemodynamic changes.Experimentally induced mental stress induced platelet activation in patients with CAD. This mechanism may partially explain the link between psychosocial variables and the development of adverse cardiac outcomes in patients with CAD.

The dynamics of blood supply to a vascular bed depend on lumped mechanical properties of that bed, namely the compliance (C), resistance (R), viscoelasticity (K), and inertance (L). While the study of regulatory mechanisms has so far placed the emphasis largely on R, it is not known how the remaining properties contribute collectively to the play of dynamics in vasomotor control. To examine this question and to establish some benchmark values of these properties, simultaneous measurements of pressure and flow waveforms in the vascular bed of the forearm were obtained from three groups: young healthy individuals, older hypertensives with controlled blood pressure, and older hypertensives with uncontrolled blood pressure. The values of R and C were found to vary within a wide range in each of the three groups to the extent that neither R nor C could be used independently as an indicator of health or age of the subjects tested. However, higher level dynamic properties of the bed, such as the time constants and damping index, which depend on combinations of C,K, and L, and which may reflect measures of the dynamic responsiveness or “sluggishness” of the system, were found to be maintained over a wide range of pulse pressures. These findings support a hypothesis that the pulsatile dynamics of blood supply to a vascular bed are adapted to the individual baseline values of R and C in different subjects with the effect of optimizing the level of dynamic responsiveness to changes in pressure or flow, and that this dynamic property of the vascular bed may be a protected and/or regulated property.

Fibrous minerals are common in nature but asbestiform minerals are rare. The unique mineralogical characteristic common to all the asbestos minerals is their morphologic form (or habit of crystallization) as polyfilamentous fiber bundles. The individual fibrils within the bundles have a tendency to be very long with a narrow range of diameters and grow with their long fiber axis in parallel orientation to the bundle length. The asbestiform habit imparts to the asbestos minerals sufficient flexibility and tensile strength so that most can be woven into cloth. In the past application has focused on their ability to insulate against the transfer of heat. However, these minerals possess other properties which make them useful in many industrial applications.

The incidence of coronary heart disease (CHD) and the distribution of contributory risk factors are closely linked with social patterns of advantage and disadvantage. The authors conducted eight focus groups in urban, northern, and rural sites in Ontario, Canada. Participants were all at high absolute risk for or had been diagnosed with CHD. Analysis centered on habitus, which forms the pivotal link between the person and “place.” The authors focused on participants' dialogue about stress because it dealt with the impingements of the social world and resultant constraints on health-related activities in everyday places. Participants described four types of places or social positions in their “stress talk”: work-places, transitional spaces, gendered situations, and exclusions. Places can support or constrain health related activities in many ways. Habits and practices linked with stress by participants were enduringly associated with these contexts, suggesting that place, body, and health are inseparable and coconstituted.