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Sexual Activity and Health-Related Quality ofLlife in Heart Failure - An exploration of the patients’ and healthcare providers’ perspective
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Aims
Improving quality of life (QoL) in heart failure patients is a key management objective. Validated health‐related QoL (HR‐QoL) measurement tools have been incorporated into clinical trials but not routinely into daily practice. The aims of this study were to investigate the acceptability and feasibility of implementing validated HR‐QoL instruments into heart failure clinics and to examine the impact of patient characteristics on HR‐QoL.
Methods and results
One hundred and sixty‐three patients attending heart failure clinics at a UK tertiary centre were invited to complete three HR‐QoL assessments: the Minnesota Living with Heart Failure Questionnaire (MLHFQ); the EuroQoL 5D‐3L (EQ‐5D‐3L); and the Kansas City Cardiomyopathy Questionnaire (KCCQ) in that order. Data on patient demographics, co‐morbidities, New York Heart Association (NYHA) class, plasma B‐type natriuretic peptide (BNP), renal function, and left ventricular ejection fraction were recorded. 94% of patients attending clinic were willing to participate. The EQ‐5D‐3L had all questions answered by 92% of patients, compared with 86% and 51% for the MLHFQ and KCCQ, respectively. HR‐QoL significantly correlated with NYHA class using each tool (MLHFQ, r = 0.59; KCCQ, r = −0.61; EQ‐5D‐3L, r = −0.44, all P < 0.01). However, within each NYHA class, there was a widespread of HR‐QoL scores. There was no association between patient demographics, left ventricular ejection fraction, plasma B‐type natriuretic peptide, or renal function with HR‐QoL using any tool.
Conclusions
Health‐related QoL assessment by validated questionnaire was acceptable to patients and feasible to perform in routine practice. Although NYHA class correlated significantly with HR‐QoL scores, there was high variability in HR‐QoL within each NYHA class, highlighting its limitation as the sole assessment of HR‐QoL. Clinicians should encourage the assessment of HR‐QoL to facilitate patient‐centred care and make more specific use of HR‐QoL measurement tools.
Background:
Heart failure (HF) is a highly prevalent chronic disease, for which there is no cure available. Therefore, improving disease management is crucial, with mobile health (mHealth) being a promising technology. The aim of the HeartMan study is to evaluate the effect of a personal mHealth system on top of standard care on disease management and health-related quality of life (HRQoL) in HF.
Methods:
HeartMan is a randomized controlled 1:2 (control:intervention) proof-of-concept trial, which will enrol 120 stable ambulatory HF patients with reduced ejection fraction across two European countries. Participants in the intervention group are equipped with a multi-monitoring health platform with the HeartMan wristband sensor as the main component. HeartMan provides guidance through a decision support system on four domains of disease management (exercise, nutrition, medication adherence and mental support), adapted to the patient's medical and psychological profile. The primary endpoint of the study is improvement in self-care and HRQoL after a six-months intervention. Secondary endpoints are the effects of HeartMan on: behavioural outcomes, illness perception, clinical outcomes and mental state.
Discussion:
HeartMan is technologically the most innovative HF self-management support system to date. This trial will provide evidence whether modern mHealth technology, when used to its full extent, can improve HRQoL in HF.
Trial registration:
This trial has been registered on https://clinicaltrials.gov/ct2/show/NCT03497871 , on April 13 2018 with registration number NCT03497871.
This paper addresses patient-reported outcomes (PROs) and telemonitoring in congestive heart failure (CHF), both increasingly important topics. The interest in CHF trials is shifting from hard end-points such as hospitalization and mortality, to softer end-points such health-related quality of life. However, the relation of these softer end-points to objective parameters is not well studied. Telemonitoring is suitable for collecting both patient-reported outcomes and objective parameters. Most telemonitoring studies, however, do not take full advantage of the available sensor technology and intelligent data analysis. The Chiron clinical observational study was performed among 24 CHF patients (17 men and 7 women, age 62.9 ± 9.4 years, 15 NYHA class II and 9 class III, 10 of ishaemic, aetiology, 6 dilated, 2 valvular, and 6 of multiple aetiologies or cardiomyopathy) in Italy and UK. A large number of physiological and ambient parameters were collected by wearable and other devices, together with PROs describing how well the patients felt, over 1,086 days of observation. The resulting data were mined for relations between the objective parameters and the PROs. The objective parameters (humidity, ambient temperature, blood pressure, SpO2, and sweeting intensity) could predict the PROs with accuracies up to 86% and AUC up to 0.83, making this the first report providing evidence for ambient and physiological parameters to be objectively related to PROs in CHF patients. We also analyzed the relations in the predictive models, gaining some insights into what affects the feeling of health, which was also generally not attempted in previous investigations. The paper strongly points to the possibility of using PROs as primary end-points in future trials.
Patients with heart failure (HF) take many medications to manage their HF and comorbidities, and 20-50% experience depression. Depressed individuals with more complex medication regimens may be at greater risk for poor adherence. The aim of this study was to assess depressive symptoms as a moderator of the relationship between medication regimen complexity and medication adherence in an observational study of patients with HF. In hierarchical linear regression with the final sample of 299, the interaction of medication regimen complexity and depressive symptoms predicted medication adherence, p < .05. For individuals with higher levels of depressive symptoms [1 standard deviation (SD) above the mean], more regimen complexity was associated with lower adherence. For individuals with low (1 SD below the mean) or average levels of depressive symptoms, regimen complexity was unrelated to medication adherence. Care management strategies, including pillboxes and caregiver involvement, may be valuable in HF patients with depression.
Each year, the American Heart Association (AHA), in conjunction with the Centers for Disease Control and Prevention, the National Institutes of Health, and other government agencies, brings together in a single document the most upto-date statistics related to heart disease, stroke, and the factors in the AHA's Life's Simple 7 (Figure1), which include core health behaviors (smoking, physical activity [PA], diet, and weight) and health factors (cholesterol, blood pressure [BP], and glucose control) that contribute to cardiovascular health. The Statistical Update represents a critical resource for the lay public, policy makers, media professionals, clinicians, healthcare administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions. Cardiovascular disease (CVD) and stroke produce immense health and economic burdens in the United States and globally. The Update also presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, congenital heart disease, rhythm disorders, subclinical atherosclerosis, coronary heart disease, heart failure (HF), valvular disease, venous disease, and peripheral arterial disease) and the associated outcomes (including quality of care, procedures, and economic costs). Since 2006, the annual versions of the Statistical Update have been cited >20000 times in the literature. In 2015 alone, the various Statistical Updates were cited '4000 times.
Demographic changes, progress in medicine technology and regional problems in providing healthcare to low density populations are posing great challenges to our healthcare systems. Rapid progress in computer sciences and information technologies have a great impact on the way healthcare will be delivered in the near future. This article describes opportunities and challenges of eHealth and telemedicine in the framework of our health systems and, in particular, in the context of today’s cardiology services. The most promising applications of eHealth and telemedicine include: (a) prevention and lifestyle interventions; (b) chronic disease management including hypertension, diabetes and heart failure; (c) arrhythmia detection including early detection of atrial fibrillation and telemonitoring of devices such as pacemaker, internal cardioverter defibrillators and implantable rhythm monitoring devices; (d) telerehabilitation. Major obstacles to the integration of eHealth and telemedicine into daily clinical practice include limited large-scale evidence, in particular, for cost-effectiveness, as well as lack of interoperability, inadequate or fragmented legal frameworks and lack of reimbursement. An important challenge for those involved in these new technologies will be to keep the main focus on patient’s individual needs and to carefully evaluate the evidence behind the practice.
Background
Decreased sexual activity and sexual problems are common among people with cardiovascular disease, negatively impacting relationship satisfaction and quality of life. International guidelines recommend routine delivery of sexual counselling to cardiac patients. The Cardiac Health and Relationship Management and Sexuality (CHARMS) baseline study in Ireland found, similar to international findings, limited implementation of sexual counselling guidelines in practice. The aim of the current study was to develop the CHARMS multi-level intervention to increase delivery of sexual counselling by healthcare professionals. We describe the methods used to develop the CHARMS intervention following the three phases of the Behaviour Change Wheel approach: understand the behaviour, identify intervention options, and identify content and implementation options. Survey (n = 60) and focus group (n = 14) data from two previous studies exploring why sexual counselling is not currently being delivered were coded by two members of the research team to understand staff’s capability, opportunity, and motivation to engage in the behaviour. All potentially relevant intervention functions to change behaviour were identified and the APEASE (affordability, practicability, effectiveness, acceptability, side effects and equity) criteria were used to select the most appropriate. The APEASE criteria were then used to choose between all behaviour change techniques (BCTs) potentially relevant to the identified functions, and these BCTs were translated into intervention content. The Template for Intervention Description and Replication (TIDieR) checklist was used to specify details of the intervention including the who, what, how and where of proposed intervention delivery. ResultsProviding sexual counselling group sessions by cardiac rehabilitation staff to patients during phase III cardiac rehabilitation was identified as the target behaviour. Education, enablement, modelling, persuasion and training were selected as appropriate intervention functions. Twelve BCTs, linked to intervention functions, were identified for inclusion and translated into CHARMS intervention content. Conclusions
This paper details the use of Behaviour Change Wheel approach to develop an implementation intervention in an under-researched area of healthcare provision. The systematic and transparent development of the CHARMS intervention will facilitate the evaluation of intervention effectiveness and future replication and contribute to the advancement of a cumulative science of implementation intervention design.
Background:
Studies in western populations have shown a positive association between depression and cardiovascular disease (CVD) and all-cause mortality. The association with depressive symptoms seems to be graded, rather than limited to the presence versus the absence of depression. Evidence from populations with potentially different patterns of confounders helps to address the consistency of these findings. The objective of the study was to investigate the association between depressive symptoms and all-cause and CVD mortality in populations of Central and Eastern Europe.
Study design:
This was a prospective cohort study.
Methods:
A total of 24,542 participants aged 45-69 years, randomly selected from populations of Novosibirsk (Russia), Krakow (Poland) and six Czech towns, were included. Depressive symptoms, assessed by the 20-item Center for Epidemiologic Studies Depression (CES-D) scale, were used as both continuous and categorical variables. Data on deaths were obtained from local or national death registers. Associations between depression and mortality were assessed using Cox proportional hazards models.
Results:
Over a median of 7 years, 2091 deaths from all causes and 850 CVD deaths occurred in the cohorts. There was a graded association between CES-D score and mortality; the hazard ratio (HR) of CVD mortality for a 1 SD increase in CES-D was 1.20 (95% confidence interval (CI): 1.16-1.24) in men and 1.23 (95% CI: 1.12-1.35) in women; for all-cause mortality, the HRs were 1.13 (95% CI: 1.09-1.18) and 1.17 (95% CI: 1.10-1.25), respectively. The results were similar across countries.
Conclusions:
Depressive symptoms predicted CVD and all-cause mortality independently of a wide range of potential confounders. The association followed a gradient and increased mortality risks were associated with scores below the cut-offs that are commonly used to define 'depression'.
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is one of the most widely used health-related quality of life questionnaires for patients with heart failure (HF). It provides scores for two dimensions, physical and emotional, and a total score. However, there are some concerns about its factor structure and alternatives have been proposed, some including a third factor representing a social dimension. The objectives of the present study were to analyze the internal structure of the MLHFQ and the unidimensionality of the total score, and to compare the different factor structures proposed.
The MLHFQ was given to 2565 patients with HF. The structural validity of the questionnaire was assessed by confirmatory factor analysis (CFA), and Rasch analysis. These two approaches were also applied to the alternative structures proposed.
The CFA results for the hypothesized model of two latent factors and the Rasch analysis confirmed the adequacy of the physical and emotional scales. Rasch analysis for the total score showed only two problematic items. The results of the CFA for other two-factor structures proposed were not better than the results for the original structure. The Rasch analyses applied to the different social factors yielded the best results for Munyombwe’s social dimension, composed of six items.
Our results support the validity of using the MLHFQ physical, emotional and total scores in patients with HF, for clinical practice and research. In addition, they confirmed the existence of a third factor, and we recommend the use of Munyombwe’s social factor.
Importance
It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure (HF) after hospitalization.Objective
To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF.Design, Setting, and Participants
We randomized 1437 patients hospitalized for HF between October 12, 2011, and September 30, 2013, to the intervention arm (715 patients) or to the usual care arm (722 patients) of the Better Effectiveness After Transition–Heart Failure (BEAT-HF) study and observed them for 180 days. The dates of our study analysis were March 30, 2014, to October 1, 2015. The setting was 6 academic medical centers in California. Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF.Interventions
The intervention combined health coaching telephone calls and telemonitoring. Telemonitoring used electronic equipment that collected daily information about blood pressure, heart rate, symptoms, and weight. Centralized registered nurses conducted telemonitoring reviews, protocolized actions, and telephone calls.Main Outcomes and Measures
The primary outcome was readmission for any cause within 180 days after discharge. Secondary outcomes were all-cause readmission within 30 days, all-cause mortality at 30 and 180 days, and quality of life at 30 and 180 days.Results
Among 1437 participants, the median age was 73 years. Overall, 46.2% (664 of 1437) were female, and 22.0% (316 of 1437) were African American. The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge, which occurred in 50.8% (363 of 715) and 49.2% (355 of 722) of patients, respectively (adjusted hazard ratio, 1.03; 95% CI, 0.88-1.20; P = .74). In secondary analyses, there were no significant differences in 30-day readmission or 180-day mortality, but there was a significant difference in 180-day quality of life between the intervention and usual care groups. No adverse events were reported.Conclusions and Relevance
Among patients hospitalized for HF, combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions.Trial Registration
clinicaltrials.gov Identifier: NCT01360203
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Aim: The aim was to analyse the effect of antihypertensive therapy on incidence of sexual dysfunction in patients with arterial hypertension. Design: a review study. Methods: In the period from 2000 to 2015 we searched licensed and freely available electronic databases: CINAHL EBSCOhost, ProQuest, Pubmed and Medline for relevant recherches of Czech and foreign sources. We set the following criteria: a study of least 100 participants and a minimum six-month follow-up. We excluded experimental and vaguely defined studies. From a total of 123 searches, 45 articles met the criteria. A review includes a total of 15 studies, six studies with a control group of healthy individuals, two cohort studies, six randomized trials and one case study with a control group. Results: The study analysis showed that beta-blockers and thiazide diuretics are the most detrimental in terms of incidence of sexual dysfunction. Angiotensin II receptor antagonists and angiotensin-converting enzyme inhibitors have a neutral or beneficial effect. Conclusion: The review article deals with the issue of patients' sexuality, focusing on the potentially negative effect of antihypertensive therapy on sexual function. Current scientific findings suggest that antihypertensive therapy increases the risk of occurence of sexual dysfunction. Professional literature is more dedicated to the incidence of male sexual dysfunction, especially erectile dysfunction, than with female sexual dysfunction.
INTRODUCTION: Heart failure is a major public health issue and a growing concern in developing countries, including Saudi Arabia. Most related research was conducted in Western cultures and may have limited applicability for individuals in Saudi Arabia. Thus, this study assesses the quality of life of Saudi patients with heart failure. MATERIALS & METHODS: A cross-sectional correlational design was used on a convenient sample of 103 patients with heart failure. Data were collected using the Short Form-36 and the Medical Outcomes Study-Social Support Survey. RESULTS: Overall, the patients’ scores were low for all domains of Quality of Life. The Physical Component Summary and Mental Component Summary mean scores and SDs were (36.7±12.4, 48.8±6.5) respectively, indicating poor Quality of Life. Left ventricular ejection fraction was the strongest predictor of both physical and mental summaries. CONCLUSION: Identifying factors that impact quality of life for Saudi heart failure patients is important in identifying and meeting their physical and psychosocial needs.
An aging population has become a common structural problem for advanced countries worldwide. In the modern era of rapid IT (Information Technology) development, the adoption of technology products by senior citizens is an issue studied by many researchers. Demographic variables have been used as factors for investigating the individual differences in most of the research on IT acceptance; however, little research has actually examined the cognitive-oriented individual difference issues. Therefore, this study uses the Unified Theory of Acceptance and Use of Technology (UTAUT) model as the basis for its research and integrates the Technology Life Style (TLS) as the cognitive-oriented individual difference factor to propose an extended model for investigating senior citizens acceptance of new technological products. In a sequence of studies based on this extended model, we will prepare questionnaires and a survey on Taiwans senior citizens using a strict research design procedure. The results can provide the government with suggestions for planning IT education for senior citizens and offers reference indexes of different dimensions for the developers of technology products to evaluate the appropriateness of IT auxiliary products for senior citizens.
Aim:
To evaluate Quality of life (QoL) in chronic heart failure (CHF) in relation to Neuroticism personality trait and CHF severity.
Methods:
Thirty six consecutive, outpatients with Chronic Heart Failure (6 females and 30 males, mean age: 54 ± 12 years), with a left ventricular ejection fraction ≤ 45% at optimal medical treatment at the time of inclusion, were asked to answer the Kansas City Cardiomyopathy Questionnaire (KCCQ) for Quality of Life assessment and the NEO Five-Factor Personality Inventory for personality assessment. All patients underwent a symptom limited cardiopulmonary exercise testing on a cycle-ergometer, in order to access CHF severity. A multivariate linear regression analysis using simultaneous entry of predictors was performed to examine which of the CHF variables and of the personality variables were correlated independently to QoL scores in the two summary scales of the KCCQ, namely the Overall Summary Scale and the Clinical Summary Scale.
Results:
The Neuroticism personality trait score had a significant inverse correlation with the Clinical Summary Score and Overall Summary Score of the KCCQ (r = -0.621, P < 0.05 and r = -0.543, P < 0.001, respectively). KCCQ summary scales did not show significant correlations with the personality traits of Extraversion, Openness, Conscientiousness and Agreeableness. Multivariate linear regression analysis using simultaneous entry of predictors was also conducted to determine the best linear combination of statistically significant univariate predictors such as Neuroticism, VE/VCO2 slope and VO2 peak, for predicting KCCQ Clinical Summary Score. The results show Neuroticism (β = -0.37, P < 0.05), VE/VCO2 slope (β = -0.31, P < 0.05) and VO2 peak (β = 0.37, P < 0.05) to be independent predictors of QoL. In multivariate regression analysis Neuroticism (b = -0.37, P < 0.05), the slope of ventilatory equivalent for carbon dioxide output during exercise, (VE/VCO2 slope) (b = -0.31, P < 0.05) and peak oxygen uptake (VO2 peak), (b = 0.37, P < 0.05) were independent predictors of QoL (adjusted R2 = 0.64; F = 18.89, P < 0.001).
Conclusion:
Neuroticism is independently associated with QoL in CHF. QoL in CHF is not only determined by disease severity but also by the Neuroticism personality trait.
Patients with cardiovascular disease and their partners expect health care providers to provide sexual counseling to assist them in maintaining sexual quality of life. Evidence suggests however, that there is a gap in integrating evidence into practice and that relatively few cardiac patients receive sexual counseling. This can result in negative psychological, physical, and quality of life outcomes for couples who may needlessly decide sexual activity is too risky and cease all sexual activity. Two scientific statements now exist that provide ample guidance to health care providers in discussing this important topic. Using a team approach that includes physicians, nurses, physical therapists, rehabilitation staff, and others is important to ensure that sexual counseling occurs throughout recovery. In addition, several trials using interventional approaches for sexual counseling provide insight into successful approaches for sexual counseling in practice. This article provides practical strategies and evidence-based approaches for assessment and sexual counseling for all cardiac patients and their partners, and specific counseling for those with ischemic conditions, heart failure, and implanted devices.
After a cardiovascular event, patients and their families often cope with numerous changes in their lives, including dealing with consequences of the disease or its treatment on their daily lives and functioning. Coping poorly with both physical and psychological challenges may lead to impaired quality of life. Sexuality is one aspect of quality of life that is important for many patients and partners that may be adversely affected by a cardiac event. The World Health Organization defines sexual health as a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity. Sexual health requires a positive and respectful approach to sexuality and sexual relationships, as well as the possibility of having pleasurable and safe sexual experiences .(1(p4)) The safety and timing of return to sexual activity after a cardiac event have been well addressed in an American Heart Association scientific statement, and decreased sexual activity among cardiac patients is frequently reported.(2) Rates of erectile dysfunction (ED) among men with cardiovascular disease (CVD) are twice as high as those in the general population, with similar rates of sexual dysfunction in females with CVD.(3) ED and vaginal dryness may also be presenting signs of heart disease and may appear 13 years before the onset of angina pectoris. Estimates reflect that only a small percentage of those with sexual dysfunction seek medical care;(4) therefore, routine assessment of sexual problems and sexual counselling may be of benefit as part of effective management by physicians, nurses, and other healthcare providers.
Background
Heart failure (HF) patients experience impaired functional status, diminished quality of life, high utilization of healthcare resources, and poor survival. Yet, the identification of patient‐centered factors that influence prognosis is lacking.
Methods and Results
We determined the association of 2 measures of self‐rated health with healthcare utilization and skilled nursing facility (SNF) admission in a community cohort of 417 HF patients prospectively enrolled between October 2007 and December 2010 from Olmsted County, MN. Patients completed a 12‐item Short Form Health Survey (SF‐12). Low self‐reported physical functioning was defined as a score ≤25 on the SF‐12 physical component. The first question of the SF‐12 was used as a measure of self‐rated general health. After 2 years, 1033 hospitalizations, 1407 emergency department (ED) visits, and 19,780 outpatient office visits were observed; 87 patients were admitted to a SNF. After adjustment for confounding factors, an increased risk of hospitalizations (1.52 [1.17 to 1.99]) and ED visits (1.48 [1.04 to 2.11]) was observed for those with low versus moderate‐high self‐reported physical functioning. Patients with poor and fair self‐rated general health also experienced an increased risk of hospitalizations (poor: 1.73 [1.29 to 2.32]; fair: 1.46 [1.14 to 1.87]) and ED visits (poor: 1.73 [1.16 to 2.56]; fair: 1.48 [1.13 to 1.93]) compared with good‐excellent self‐rated general health. No association between self‐reported physical functioning or self‐rated general health with outpatient visits and SNF admission was observed.
Conclusion
In community HF patients, self‐reported measures of physical functioning predict hospitalizations and ED visits, indicating that these patient‐reported measures may be useful in risk stratification and management in HF.
Heart failure has a severe impact on different aspects of a patient's life, including sexual function. Sexual problems are common in heart failure (HF) patients, both in men and women, and are not always adequately addressed and treated in the current health care system. Several factors have been described to be related to sexual problems, such as activity intolerance, psychological factors, physiological factors, cardiac medications, recreational habits and co-morbidity. The current review summarizes knowledge that can help clinicians treat sexual dysfunction in HF patients. After a good assessment, several steps are advised, including improving HF and co-morbid conditions, discussing psychosocial problems, worries and misunderstandings, managing risk factors and considering PDE-5 inhibitors or other libido enhancing agents.
Heart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight, blood pressure, heart rate, and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure.
A multi-center, randomized controlled trial is being conducted at six academic health systems in California. A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure. Patients in the intervention group will receive intensive patient education using the 'teach-back' method and receive instruction in using the telemonitoring equipment. Following hospital discharge, they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a centralized call center. The nurses also will call patients and patients' physicians in response to alerts generated by the telemonitoring system, based on predetermined parameters. The primary outcome is readmission for any cause within 180 days. Secondary outcomes include 30-day readmission, mortality, hospital days, emergency department (ED) visits, hospital cost, and health-related quality of life.
BEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure, and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring. The study population also includes patients with a wide range of demographic and socioeconomic characteristics. Once completed, the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure.Trial registration: ClinicalTrials.gov # NCT01360203.
Purpose:
The Bonferroni correction adjusts probability (p) values because of the increased risk of a type I error when making multiple statistical tests. The routine use of this test has been criticised as deleterious to sound statistical judgment, testing the wrong hypothesis, and reducing the chance of a type I error but at the expense of a type II error; yet it remains popular in ophthalmic research. The purpose of this article was to survey the use of the Bonferroni correction in research articles published in three optometric journals, viz. Ophthalmic & Physiological Optics, Optometry & Vision Science, and Clinical & Experimental Optometry, and to provide advice to authors contemplating multiple testing.
Recent findings:
Some authors ignored the problem of multiple testing while others used the method uncritically with no rationale or discussion. A variety of methods of correcting p values were employed, the Bonferroni method being the single most popular. Bonferroni was used in a variety of circumstances, most commonly to correct the experiment-wise error rate when using multiple 't' tests or as a post-hoc procedure to correct the family-wise error rate following analysis of variance (anova). Some studies quoted adjusted p values incorrectly or gave an erroneous rationale.
Summary:
Whether or not to use the Bonferroni correction depends on the circumstances of the study. It should not be used routinely and should be considered if: (1) a single test of the 'universal null hypothesis' (Ho ) that all tests are not significant is required, (2) it is imperative to avoid a type I error, and (3) a large number of tests are carried out without preplanned hypotheses.
International disease management guidelines recommend the regular assessment of depression and anxiety in heart failure patients. Currently there is little data on the effect of screening for depression and anxiety on the quality of life and the prognosis of heart failure. We will investigate the association between the recognition of current depression/ anxiety by the general practitioner (GP) and the quality of life and the patients' prognosis.
In this multicenter, prospective, observational study 3,950 patients with HF are recruited by general practices in Germany. The patients fill out questionnaires at baseline and 12-month follow-up. At baseline the GPs are interviewed regarding the somatic and psychological comorbidities of their patients. During the follow-up assessment, data on hospitalization and mortality are provided by the general practice. Based on baseline data, the patients are allocated into three observation groups: HF patients with depression and/or anxiety recognized by their GP (P+/+), those with depression and/or anxiety not recognized (P+/-) and patients without depression and/or anxiety (P-/-). We will perform multivariate regression models to investigate the influence of the recognition of depression and/or anxiety on quality of life at 12 month follow-up, as well as its influences on the prognosis (hospital admission, mortality).
We will display the frequency of GP-acknowledged depression and anxiety and the frequency of installed therapeutic strategies. We will also describe the frequency of depression and anxiety missed by the GP and the resulting treatment gap. Effects of correctly acknowledged and missed depression/anxiety on outcome, also in comparison to the outcome of subjects without depression/anxiety will be addressed. In case results suggest a treatment gap of depression/anxiety in patients with HF, the results of this study will provide methodological advice for the efficient planning of further interventional research.
Exercise capacity and quality of life (QOL) are important outcome predictors in patients with systolic heart failure (HF), independent of left ventricular (LV) ejection fraction (LVEF). LV diastolic function has been shown to be a better predictor of aerobic exercise capacity in patients with systolic dysfunction and a New York Heart Association (NYHA) classification ≥II. We hypothesized that the currently used index of diastolic function E/e' is associated with exercise capacity and QOL, even in optimally treated HF patients with reduced LVEF. This prospective study included 44 consecutive patients aged 55±11 years (27 men and 17 women), with LVEF<0.50 and NYHA functional class I-III, receiving optimal pharmacological treatment and in a stable clinical condition, as shown by the absence of dyspnea exacerbation for at least 3 months. All patients had conventional transthoracic echocardiography and answered the Minnesota Living with HF Questionnaire, followed by the 6-min walk test (6MWT). In a multivariable model with 6MWT as the dependent variable, age and E/e' explained 27% of the walked distance in 6MWT (P=0.002; multivariate regression analysis). No association was found between walk distance and LVEF or mitral annulus systolic velocity. Only normalized left atrium volume, a sensitive index of diastolic function, was associated with decreased QOL. Despite the small number of patients included, this study offers evidence that diastolic function is associated with physical capacity and QOL and should be considered along with ejection fraction in patients with compensated systolic HF.
A meta-analysis of empirical studies ( N = 45) adopting Leventhal, Meyer and Nerenz's (1980) Common Sense Model (CSM) of illness representations is presented. The average corrected intercorrelation matrix for the sample of studies showed that the CSM illness cognition dimensions of consequences, control/cure, identity and timeline followed a logical pattern supporting their construct and discriminant validity across illness types. A content analysis classified coping strategies into seven distinctive categories and health outcomes into six categories. Examining the average corrected correlation coefficients across the studies revealed that perceptions of a strong illness identity were significantly and positively related to the use of coping strategies of avoidance and emotion expression. In addition, perceived controllability of the illness was significantly associated with cognitive reappraisal, expressing emotions and problem-focused coping strategies. Perceptions of the illness as highly symptomatic, having a chronic timeline and serious consequences was significantly correlated with avoidance and expressing emotions coping strategies. Further, perceptions that the illness was curable/controllable was significantly and positively related to the adaptive outcomes of psychological well-being, social functioning and vitality and negatively related to psychological distress and disease state. Conversely, illness consequences, timeline and identity exhibited significant, negative relationships with psychological well being, role and social functioning and vitality. The analyses provide evidence for theoretically predictable relations between illness cognitions, coping and outcomes across studies.
The aim of this study was to describe sexual well-being and sexual problems in the general population of Norway and, specifically, among people with heart disease. What is the relationship between sexual well-being, sexual problems and psychological, medical and relational factors? Data were collected from among 1664 persons with heart disease, aged 18 – 84 years (2004, LHL study), and from among a representative sample of 1093 adult Norwegians (1997, MMI study). Questionnaires were anonymous and self-administered. The response rate was 36% in the LHL study and 54% in the MMI study. Twenty-six percent in the LHL study and 11% in the MMI study reported ever having had sexual problems. Among those
Endpoint selection is a critically important step in clinical trial design. It poses major challenges for investigators, regulators, and study sponsors, and it also has important clinical and practical implications for physicians and patients. Clinical outcomes of interest in heart failure trials include all-cause mortality, cause-specific mortality, relevant non-fatal morbidity (e.g. all-cause and cause-specific hospitalization), composites capturing both morbidity and mortality, safety, symptoms, functional capacity, and patient-reported outcomes. Each of these endpoints has strengths and weaknesses that create controversies regarding which is most appropriate in terms of clinical importance, sensitivity, reliability, and consistency. Not surprisingly, a lack of consensus exists within the scientific community regarding the optimal endpoint(s) for both acute and chronic heart failure trials. In an effort to address these issues, the Heart Failure Association of the European Society of Cardiology (HFA-ESC) convened a group of expert heart failure clinical investigators, biostatisticians, regulators, and pharmaceutical industry scientists (Nice, France, 12-13 February 2012) to evaluate the challenges of defining heart failure endpoints in clinical trials and to develop a consensus framework. This report summarizes the group's recommendations for achieving common views on heart failure endpoints in clinical trials. © 2013 Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2013. For permissions please email: [email protected]
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Background:
Relationship satisfaction is generally positively correlated with sexual satisfaction, but this relation has been poorly examined in people with cardiovascular disease who are at increased risk of sexual problems compared with the general population.
Aim:
To document reported changes to sex after a diagnosis of cardiac disease and determine whether there is an association between sexual function and relationship satisfaction.
Methods:
Semistructured telephone interviews focused on relationship satisfaction and sexual problems were conducted with 201 people with cardiovascular disease who were currently in a sexual relationship with one main partner and were recruited from six hospital cardiac rehabilitation centers in Ireland. Comparisons between groups were conducted using t-tests and multivariate analysis of variance for continuous variables and χ(2) tests for categorical variables. Predictors of relationship satisfaction were assessed using multiple linear regression analysis.
Outcomes:
Data were gathered on demographic and clinical variables, sexual problems, and relationship satisfaction, including satisfaction with the physical, emotional, affection, and communication aspects of relationships.
Results:
Just less than one third of participants (n = 61, 30.3%) reported that sex had changed for the worse since their cardiac event or diagnosis, with approximately half of these stating that this was a serious problem for them. Satisfaction with relationships was high among patients surveyed; more than 70% of the sample reported being very or extremely satisfied with the physical and emotional aspects and showing affection during sex. Satisfaction with communication about sex was lower, with only 58% reporting being very or extremely satisfied. We did not find significant associations between reporting of sexual problems or deterioration of sex as a result of disease and relationship satisfaction.
Clinical implications:
Cardiac rehabilitation programs should address these sexual problems, potentially by enhancing communication within couples about sex.
Strengths and limitations:
The strength is that data are presented on the sexual experiences and relationship satisfaction of a relatively large sample of people diagnosed with cardiac disease, a relatively underexplored research area. Limitations include the possibility of selection bias of study participants and bias associated with self-report measurement.
Conclusions:
Sexual problems were significant in this population but were not related to relationship satisfaction in this cross-sectional survey. Byrne M, Murphy P, D'Eath M, et al. Association Between Sexual Problems and Relationship Satisfaction Among People With Cardiovascular Disease. J Sex Med 2017;14:666-674.
Context:
Problems with sexual function can have a detrimental effect on quality of life. Symptomatic heart failure has been associated with problems with sexual function, although the majority of reports are focused on men and erectile dysfunction. Understanding women's perception of and gender differences in problems with sexual function in heart failure could yield new insights.
Objectives:
To determine the gender differences in reporting and bothersomeness of problems with sexual function, defined as sexual interest or activity.
Methods:
Observational, cross-sectional study of adults with symptomatic heart failure from three health systems participating in a clinical trial. Eligible participants completed baseline surveys of symptom prevalence and bothersomeness. Logistic regression modeling was used to identify patient-level factors associated with problems with sexual interest or activity.
Results:
Among 314 patients with heart failure, we found large differences in reporting a problem with sexual function or interest in men (62.4%, n = 154/247) compared with women (37.9%, n = 25/66, p = 0.0004). When the symptom was reported, both men and women found it equally bothersome; 73.4% of men and 64.0% of women responded that this problem bothered them quite a bit or very much (p = 0.33). After adjusting for age, marital status, and income, men relative to women were still more likely to report problems with sexual function (OR 3.5, 95% CI 1.8-6.8).
Conclusion:
While men more commonly reported problems with sexual function, both genders were similarly highly bothered by this problem. These findings support the need for further research to assess and manage this symptom in both men and women with heart failure.
Purpose:
The assessment of the level of anxiety, depression and quality of life among patients with heart failure.
Methods:
It was an observational study. The populations were 231 patients with heart failure who were hospitalized in cardiology departments of 2 general hospitals in Athens, from September 1, 2010 through January 31, 2012. We used the "Minnesota Living with Heart Failure Questionnaire - MLHFQ" to evaluate patients' quality of life and the " State-Trait Anxiety Inventory - STAI" and the "Maastricht Questionnaire - MQ" to evaluate the level of stress and depression, respectively.
Results:
The mean age of patients was 66.1±10.1years. The quality of life was poor, since the average score in MLHFQ was 65.4±20.6. Also, patients revealed high levels of both trait and state anxiety (mean score in STAI was 54.5±9.4 and 52.8±8.5 respectively) and depression (mean score in MQ was 34.3±8.4). Factors associated with poor quality of life and high levels of anxiety and depression were older age, low level of education, unemployment, poor economic situation, multiple hospitalizations (> 4 times) and heart failure stages III and IV in NYHA (p<0.001 in all cases).
Conclusion:
Patients with heart failure present severe symptoms of anxiety and depression and poor quality of life. Assessing those patients for these symptoms and providing holistic health care by a multidisciplinary team, will lead to the prevention and early treatment not only of physical but also of the psychosocial manifestations of the disease.
The reactions of 153 college students to incidents of sexuality were measured using a series of scenarios. Age of target was manipulated with three levels (30-35, 50-55, and 70-75) to test reactions to the sexuality of different age groups. Gender of target was also manipulated with three levels (female, male, and couple). For sexual scenarios, age of target was found statistically significant for all reactions, with responses less favorable toward older targets. No gender differences were found for sexual scenarios. Results were evidence for a strong bias against the sexuality of older people.
Patients with heart failure (HF) often worry about resuming sexual activity and may need information. Nurses have a role in helping patients to live with the consequences of HF and can be expected to discuss patients' sexual concerns.
The aims of this study were to identify whether nurses discuss consequences of HF on sexuality with patients and to explore their perceived role and barriers regarding this topic.
A cross-sectional research design with a convergent parallel mixed method approach was used combining qualitative and quantitative data collected with a self-reported questionnaire.
Nurses in this study rarely addressed sexual issues with their patients. The nurses did not feel that discussing sexual concerns with their patients was their responsibility, and only 8% of the nurses expressed confidence to do so. The main phenomenon in discussing sexual concerns seems to be "one of silence": Neither patients nor nurses talk about sexual concerns. Factors influencing this include structural barriers, lack of knowledge and communication skills, as well as relevance of the topic and relationship to patients.
Cardiac nurses in Germany rarely practice sexual counseling. It is a phenomenon that is silent. Education and skill-based training might hold potential to "break the silence."
AimsSexual dysfunction is common among patients with heart failure (HF) and considered an important hamper to quality of life. While implantation of left ventricular assist device (LVAD) may prolong and improve life in advanced HF, limited data are available on its impact on sexual function. The aim of this study is to evaluate sexual function in LVAD patients and compare this with patients after heart transplantation (HTx).Methods and resultsSexual activity and satisfaction of stable patients with durable LVAD or after HTx were evaluated using a validated questionnaire and visual analogue scale from 0 to 10. Data were collected from 31 patients (mean age 59 ± 12 years, 87% male), 17 after HTx and 14 with LVAD. Pleasure or satisfaction with sex was significantly higher in HTx patients (P = 0.0005). In total, 29% LVAD patients and 71% HTx patients reported content with sexual activity. Recalled satisfaction with sex life pre-operation was comparable between the groups. During support, satisfaction with sex life using visual analogue scale was 7.6 ± 3.1 for HTx versus 3.9 ± 4.0 for LVAD patients (P = 0.017). In total, 11 LVAD patients (79%) reported specific problems in sexual function including erectile dysfunction or vaginal dryness (8, 57%); problems with the LVAD, cable, or batteries (5, 36%); problems with orgasm (4,29%); and other problems such as fear of injury, feeling depressed, partner issues, self-image, and pain (1, 7% each).Conclusion
Sexual dysfunction occurs in patients with LVAD support and may be more prominent than after HTx. Problems limiting sexual function related to physiological, psychological, and equipment merit consideration during follow-up.
Objectives
This study sought to review the literature for risk prediction models in patients with heart failure and to identify the most consistently reported independent predictors of risk across models.
Background
Risk assessment provides information about patient prognosis, guides decision making about the type and intensity of care, and enables better understanding of provider performance.
Methods
MEDLINE and EMBASE were searched from January 1995 to March 2013, followed by hand searches of the retrieved reference lists. Studies were eligible if they reported at least 1 multivariable model for risk prediction of death, hospitalization, or both in patients with heart failure and reported model performance. We ranked reported individual risk predictors by their strength of association with the outcome and assessed the association of model performance with study characteristics.
Results
Sixty-four main models and 50 modifications from 48 studies met the inclusion criteria. Of the 64 main models, 43 models predicted death, 10 hospitalization, and 11 death or hospitalization. The discriminatory ability of the models for prediction of death appeared to be higher than that for prediction of death or hospitalization or prediction of hospitalization alone (p = 0.0003). A wide variation between studies in clinical settings, population characteristics, sample size, and variables used for model development was observed, but these features were not significantly associated with the discriminatory performance of the models. A few strong predictors emerged for prediction of death; the most consistently reported predictors were age, renal function, blood pressure, blood sodium level, left ventricular ejection fraction, sex, brain natriuretic peptide level, New York Heart Association functional class, diabetes, weight or body mass index, and exercise capacity.
Conclusions
There are several clinically useful and well-validated death prediction models in patients with heart failure. Although the studies differed in many respects, the models largely included a few common markers of risk.
The present paper systematically reviews and compares existing prediction models in order to establish the strongest variables, models, and model characteristics in patients with heart failure predicting outcome. To improve decision making accurately predicting mortality and heart-failure hospitalization in patients with heart failure can be important for selecting patients with a poorer prognosis or nonresponders to current therapy, to improve decision making. MEDLINE/PubMed was searched for papers dealing with heart failure prediction models. To identify similar models on the basis of their variables hierarchical cluster analysis was performed. Meta-analysis was used to estimate the mean predictive value of the variables and models; meta-regression was used to find characteristics that explain variation in discriminating values between models. We identified 117 models in 55 papers. These models used 249 different variables. The strongest predictors were blood urea nitrogen and sodium. Four subgroups of models were identified. Mortality was most accurately predicted by prospective registry-type studies using a large number of clinical predictor variables. Mean C-statistic of all models was 0.66 ± 0.0005, with 0.71 ± 0.001, 0.68 ± 0.001 and 0.63 ± 0.001 for models predicting mortality, heart failure hospitalization, or both, respectively. There was no significant difference in discriminating value of models between patients with chronic and acute heart failure. Prediction of mortality and in particular heart failure hospitalization in patients with heart failure remains only moderately successful. The strongest predictors were blood urea nitrogen and sodium. The highest C-statistic values were achieved in a clinical setting, predicting short-term mortality with the use of models derived from prospective cohort/registry studies with a large number of predictor variables.
Patient-reported outcomes (PROs), such as symptoms, health-related quality of life (HRQOL), or patient perceived health status, are reported directly by the patient and are powerful tools to inform patients, clinicians, and policy-makers about morbidity and 'patient suffering', especially in chronic diseases. Patient-reported outcomes provide information on the patient experience and can be the target of therapeutic intervention. Patient-reported outcomes can improve the quality of patient care by creating a holistic approach to clinical decision-making; however, PROs are not routinely used as key outcome measures in major cardiovascular clinical trials. Thus, limited information is available on the impact of cardiovascular therapeutics on PROs to guide patient-level clinical decision-making or policy-level decision-making. Cardiovascular clinical research should shift its focus to include PROs when evaluating the efficacy of therapeutic interventions, and PRO assessments should be scientifically rigorous. The European Society of Cardiology and other professional societies can take action to influence the uptake of PRO data in the research and clinical communities. This process of integrating PRO data into comprehensive efficacy evaluations will ultimately improve the quality of care for patients across the spectrum of cardiovascular disease.
Patients with heart failure experience adverse physical symptoms that affect quality of life. The number of patients with heart failure in Taiwan has been growing in recent years.
This article examines correlations among illness knowledge, self-care behaviors, and quality of life in elderly patients with heart failure.
A cross-sectional research design using three questionnaires was adopted. The study was undertaken in an outpatient department of a teaching hospital in Taiwan from January to June 2008. Potential participants aged 65 years or older were selected by a physician based on several diagnostic findings of heart failure that included an International Classification of Diseases' code 4280 or 4289. Patients who were bedridden or had a prognosis of less than 6 months were excluded from consideration.
One hundred forty-one patients with heart failure were recruited. Most participants were men (51.8%), older adults (49.6% older than 71 years old), and either educated to an elementary school level or illiterate (69.5%) and have New York Heart Association class II (61.0%). Participants had an average left ventricular ejection fraction of 41.1%. The illness knowledge of participants was poor (accuracy rate: 29.3%), and most were unaware of the significance of self-care. Illness knowledge correlated with both self-care behaviors (r = -.42, p < .01) and quality of life (r = -.22, p < .01). Illness knowledge and age were identified as significant correlated factors of self-care behaviors (R = .22); and functional class, living independently, and age were identified as significant correlated factors of quality of life (R = .41).
Participants in this study with higher self-reported self-care behaviors and quality of life were younger in age and had better illness knowledge. Furthermore, physical function and independence in daily living significantly affected quality of life. Care for patients with heart failure, particularly older adults, should focus on teaching these patients about heart failure illness and symptom management. Assisting elderly patients with heart failure to promote and maintain physical functions to handle activities of daily living independently is critical to improving patient quality of life.
Context A predictive model of mortality in heart failure may be useful for clinicians to improve communication with and care of hospitalized patients. Objectives To identify predictors of mortality and to develop and to validate a model using information available at hospital presentation. Design, Setting, and Participants Retrospective study of 4031 communitybased patients presenting with heart failure at multiple hospitals in Ontario, Canada (2624 patients in the derivation cohort from 1999-2001 and 1407 patients in the validation cohort from 1997-1999), who had been identitifed as part of the Enhanced Feedback for Effective Cardiac Treatment (EFFECT) study. Main Outcome Measures All-cause 30-day and 1-year mortality. Results The mortality rates for the derivation cohort and validation cohort, respectively, were 8.9% and 8.2% in hospital, 10.7% and 10.4% at 30 days, and 32.9% and 30.5% at 1 year. Multivariable predictors of mortality at both 30 days and 1 year included older age, lower systolic blood pressure, higher respiratory rate, higher urea nitrogen level (all P.001), and hyponatremia (P.01). Comorbid conditions associated with mortality included cerebrovascular disease (30-day mortality odds ratio [OR], 1.43; 95% confidence interval [CI], 1.03-1.98; P=.03), chronic obstructive pulmonary disease (OR, 1.66; 95% CI, 1.22-2.27; P=.002), hepatic cirrhosis (OR, 3.22; 95% CI, 1.08-9.65; P=.04), dementia (OR, 2.54; 95% CI, 1.77-3.65; P.001), and cancer (OR, 1.86; 95% CI, 1.28-2.70; P=.001). A risk index stratified the risk of death and identified low- and high-risk individuals. Patients with very low-risk scores (60) had a mortality rate of 0.4% at 30 days and 7.8% at 1 year. Patients with very high-risk scores (150) had a mortality rate of 59.0% at 30 days and 78.8% at 1 year. Patients with higher 1-year risk scores had reduced survival at all times up to 1 year (log-rank, P.001). For the derivation cohort, the area under the receiver operating characteristic curve for the model was 0.80 for 30-day mortality and 0.77 for 1-year mortality. Predicted mortality rates in the validation cohort closely matched observed rates across the entire spectrum of risk. Conclusions Amongcommunity-basedheartfailurepatients,factorsidentifiablewithin hours of hospital presentation predicted mortality risk at 30 days and 1 year. The externally validated predictive index may assist clinicians in estimating heart failure mortality risk and in providing quantitative guidance for decision making in heart failure care.
For a non-empty class of groups ℱ, two subgroups A and B of a finite group G are said to be ℱ-connected if 〈a, b〉 ∈ ℱ for all a ∈ A and b ∈ B. This paper is a study of ℱ-connection for saturated formations ℱ ⊆ (where denotes the class of all finite groups with nilpotent commutator subgroup). The class of all finite supersoluble groups constitutes an example of such a saturated formation. It is shown for example that in a finite soluble group G = AB the subgroups A and B are -connected if and only if [A, B] ⩽ F(G), where F(G) denotes the Fitting subgroup of G. Also ℱ-connected finite soluble products for any saturated formation ℱ with ℱ ⊆ are characterized.