Study protocol for a randomized, controlled trial using a novel, family-centered diet treatment to prevent nonalcoholic fatty liver disease in Hispanic children.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is the leading liver disorder among U.S. children and is most prevalent among Hispanic children with obesity. Previous research has shown that reducing the consumption of free sugars (added sugars + naturally occurring sugars in fruit juice) can reverse liver steatosis in adolescents with NAFLD. This study aims to determine if a low-free sugar diet (LFSD) can prevent liver fat accumulation and NAFLD in high-risk children. METHODS: In this randomized controlled trial, we will enroll 140 Hispanic children aged 6 to 9 years who are ≥50th percentile BMI and without a previous diagnosis of NAFLD. Participants will be randomly assigned to either an experimental (LFSD) or a control (usual diet + educational materials) group. The one-year intervention includes removal of foods high in free sugars from the home at baseline, provision of LFSD household groceries for the entire family (weeks 1-4, 12, 24, and 36), dietitian-guided family grocery shopping sessions (weeks 12, 24, and 36), and ongoing education and motivational interviewing to promote LFSD. Both groups complete assessment measures at baseline, 6, 12, 18, and 24 months. Primary study outcomes are percent hepatic fat at 12 months and incidence of clinically significant hepatic steatosis (>5%) + elevated liver enzymes at 24 months. Secondary outcomes include metabolic markers potentially mediating or moderating NAFLD pathogenesis. DISCUSSION: This protocol describes the rationale, eligibility criteria, recruitment strategies, analysis plan as well as a novel dietary intervention design. Study results will inform future dietary guidelines for pediatric NAFLD prevention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05292352.

Self-care research: How to grow the evidence base? (reprint).

BACKGROUND AND OBJECTIVE: The number of studies in the area of self-care is growing and international researchers are increasingly developing self-care interventions to improve outcomes of individual patients and communities. However, growth of the evidence is still slow due to challenges with designing and testing self-care interventions. In this article we address major methodological challenges with regard to the definition of self-care, use of theory, and research design, intended to provide guidance to researchers in this field. METHOD: During the inaugural conference of the International Center for Self-Care Research held in Rome, Italy in June 2019 we identified important issues in existing self-care research. Discussion and literature review lead to eight recommendation for future self-care research. RESULTS: In preparation, begin with a theoretically sound definition of self-care. In planning the intervention, build on and extend previous studies. Use theory to develop self-care interventions and consider translational models to guide development, evaluation and implementation of complex self-care interventions. Employ a study design that fits the current phase and objectives of the research and measure self-care and related factors carefully. In reporting, describe the sample and setting sufficiently so that others can draw conclusions about generalizability and applicability to their practice and patient population. In interpretation, describe how the intervention is assumed to work (causal assumptions) and its key components. CONCLUSION: Our review of existing self-care research clearly illustrates that the recommendations we provide are needed if we are to substantially grow the evidence base supporting self-care. Embracing a core set of principles will allow us to build on each other's work. Tweetable abstract: A core set of methodological principles is needed to substantially grow the evidence base supporting self-care.

Self-care research: How to grow the evidence base?

BACKGROUND AND OBJECTIVE: The number of studies in the area of self-care is growing and international researchers are increasingly developing self-care interventions to improve outcomes of individual patients and communities. However, growth of the evidence is still slow due to challenges with designing and testing self-care interventions. In this article we address major methodological challenges with regard to the definition of self-care, use of theory, and research design, intended to provide guidance to researchers in this field. METHOD: During the inaugural conference of the International Center for Self-Care Research held in Rome, Italy in June 2019 we identified important issues in existing self-care research. Discussion and literature review lead to eight recommendation for future self-care research. RESULTS: In preparation, begin with a theoretically sound definition of self-care. In planning the intervention, build on and extend previous studies. Use theory to develop self-care interventions and consider translational models to guide development, evaluation and implementation of complex self-care interventions. Employ a study design that fits the current phase and objectives of the research and measure self-care and related factors carefully. In reporting, describe the sample and setting sufficiently so that others can draw conclusions about generalizability and applicability to their practice and patient population. In interpretation, describe how the intervention is assumed to work (causal assumptions) and its key components. CONCLUSION: Our review of existing self-care research clearly illustrates that the recommendations we provide are needed if we are to substantially grow the evidence base supporting self-care. Embracing a core set of principles will allow us to build on each other's work. Tweetable abstract: A core set of methodological principles is needed to substantially grow the evidence base supporting self-care.

Association between obesity and heart failure symptoms in male and female patients.

In patients with heart failure (HF), higher body mass index (BMI) has been associated with lower rates of hospitalization and mortality (obesity paradox). Symptoms are antecedents of hospitalizations, but little is known about the relationship between BMI and symptoms and gender differences. To examine the association of BMI with symptoms in male and female patients with HF, controlling for covariates (sample characteristics, depressive symptoms and sodium intake). In this cross-sectional correlational study, patients (N = 247) provided data on BMI, symptoms and covariates. BMI was categorized into four groups: normal/underweight (<25 kg/m2 ), overweight (25-29.9 kg/m2 ), obese I (30-34.9 kg/m2 ) and obese II/III (≥35 kg/m2 ). General linear regression was used to analyse the data. The Obese II/III group had more severe HF symptoms than other groups only in male patients. In male patients, older age, Caucasian race, more comorbidities and more severe depressive symptoms were also associated with more severe symptoms. In female patients, more severe depressive symptoms, more comorbidities and higher sodium intake were associated with more severe symptoms. The obesity paradox does not fully extend to symptoms, and gender has a role in the relationship between obesity and symptoms.

Cardiac instrument development in a low-literacy population: the revised Chest Discomfort Diary.

OBJECTIVE: The purpose of this study was to pilot test a self-administered chest pain questionnaire, a revised version of the Chest Discomfort Diary (CDD-R), in a sample of patients with chronic angina selected from a population known to have low literacy. DESIGN: The study design was descriptive and correlational. SAMPLE: The study used a convenience sample of 27 subjects with documented history of coronary artery disease and angina. Characteristics of the sample included a mean age of 56.3 years (SD, 12.4 years), 88.9% African-American, and 56.3% male, and 59.3% had a history of acute myocardial infarction. Approximately 28% had achieved a 9th-grade education or less, and reading levels ranged from 4th grade to 12th grade. Subjects completed the CDD-R, a 36-item instrument reflecting multiple dimensions of anginal chest pain. RESULTS: Descriptions of the location (left chest, 66.6%), character (pressure, 59.2%), and precipitants of chest pain (walking, 51.8%) were consistent with clinical descriptions of "typical angina." Other physical symptoms such as shortness of breath (88.8%) and fatigue (85.1%) were reported. Walking (55.5%) was the activity most frequently described as difficult to perform because of chest pain, with sublingual nitroglycerin (77.7%) the most frequently used and most effective chest pain relief strategy. CONCLUSION: The CDD-R adequately measured multiple characteristics of anginal chest pain. Further research is needed to establish construct validity of the CDD-R and to determine the feasibility of using the instrument to monitor changes over time in patients' chronic angina.

Psychological reactions among family members of patients with implantable defibrillators.

OBJECTIVE: To describe psychological reactions among family members of patients receiving an implantable cardioverter/defibrillator (ICD) during the first 9 months after implantation. METHODS: Eighty-two family members (age 56+/-12 years, 74 percent female, 79 percent married, 88 percent Caucasian) of ICD patients completed questionnaires regarding their mood (Profile of Mood State), cognitive illness appraisals (Meaning of Illness Questionnaire) and coping strategies (Jalowiec Coping Scale) prior to ICD implantation, and as well as 1 and 9 months postoperatively. RESULTS: Total mood disturbance score (TMD), threat appraisal, and emotion- and problem-focused coping were highest prior to ICD implantation, and decreased during the first postoperative month showing stable values thereafter. There was no change in challenge appraisal. Multiple regression analysis found that the use of psychotropic drugs (anxiolytics, sedatives; Beta = .25), emotion-focused coping (Beta = .37), and challenge appraisal (Beta =-.21) at 1 month accounted for 26 percent of variance in TMD at 9 mon ths. CONCLUSION: A spouse's ICD implantation is a major stressful event for family members leading to a diminished mood state prior ICD implantation. Reduction in emotion-focused coping and the use of challenge appraisal may improve mood state in family members of ICD patients during early follow-up.

The perceptions of menopause of African-American and white women and affect on willingness to participate in a HRT clinical trial.

Menopause is a normal developmental process for women; however, few studies of healthy menopausal women and African-American women have been reported. While hormone replacement therapy (HRT) has been touted as a treatment for menopausal women, clinical trials of HRT still need to be conducted to determine its potential positive and negative effects. This is a focus group study of 21 women of menopausal age (11 African-Americans and 10 White women) to determine their experiences with menopause and their willingness to participate in a HRT clinical trial. Results indicated generally positive attitudes toward menopause and a variety of symptoms of varying degrees of severity in African-American and White women. Limited knowledge about menopause and HRT were apparent; however, White women were more likely to be receiving HRT and were more informed about HRT than African-American women. White women also were more positive about participating in a HRT clinical trial than African-American women who feared cancer as a potential side effect.

Factors associated with outcomes 3 months after implantable cardioverter defibrillator insertion.

BACKGROUND: Adjustment to living with an implantable cardioverter defibrillator (ICD) is a dynamic process that varies among individuals. The purpose of this study was to describe patterns of recovery and to examine the relationships among demographic and clinical factors, illness appraisal and coping behaviors, and outcomes of physical and emotional function in the early recovery period of the first 3 months after initial ICD insertion. METHODS: Data were collected in the acute care setting and again at 1 and 3 months after ICD insertion. Subjects were 213 patients (83% men), ages 24-85 (mean 59.6) years. Demographic and clinical variables representing personal and situational factors, illness appraisal, and coping variables were examined using hierarchical multiple-regression analyses to predict outcomes of mood disturbance and functional status. RESULTS: The data revealed that symptoms, illness appraisal, and coping behaviors significantly explained additional variance in both functional status and mood disturbance above that accounted for by the less modifiable demographic and clinical variables. CONCLUSIONS: Symptoms, illness appraisal, and coping behaviors were predictors of outcomes in ICD patients. These factors are modifiable aspects of the recovery process, and interventions aimed at symptom management, appraisal reframing, and coping training should be tested to improve mood and functional outcomes for ICD patients.

Association of mood disturbance and arrhythmia events in patients after cardioverter defibrillator implantation.

BACKGROUND: Life stresses and negative emotions, such as anxiety and depression, are associated with adverse cardiac events, including arrhythmia. Patients undergoing implantation of an automatic internal cardioverter defibrillator provide a unique opportunity to characterize these relationships since all tachyarrhythmia episodes are recorded by the device. OBJECTIVES: The purpose of this study was to examine the association of emotional status after internal cardioverter defibrillator (ICD) implantation and subsequent arrhythmia events. METHODS: An analysis of data obtained in a prospective longitudinal study of responses to the ICD measured mood disturbance (Profile of Mood States; POMS) before implant and at 1, 3, 6, and 9 months postoperatively. Subjects included 144 men and 32 women with a mean age of 60 +/- 13 years and a mean left ventricular ejection fraction (LVEF) of 33 +/- 12%. Arrhythmia events were measured by self-report of shocks and by ICD device interrogation to obtain the number and type (defibrillation, cardioversion, and antitachycardia pacing) of therapies delivered by the ICD. For each time point, POMS scores of subjects who had arrhythmia events were compared with those who did not. For subjects who had ICD shocks, pre-event and post-event POMS scores were also compared. Multiple logistic regression was used at each time point to determine if clinical, demographic and psychological data could predict arrhythmia events. RESULTS: Patients with arrhythmia events had higher POMS scores throughout the 9 months of follow-up. Higher level of mood disturbance (specifically anxiety, fatigue, and confusion) at 1 and 3 months were independent predictors of subsequent arrhythmia events at 3 and 6 months after controlling for LVEF, the presence of coronary artery disease, pre-implant arrhythmia history, and the use of amiodarone and beta-blocking agents. There were no differences in POMS scores before and after ICD shocks, reinforcing the notion that negative emotions were a cause, rather than a consequence, of arrhythmia events. CONCLUSIONS: Mood disturbances, such as anxiety, may increase the risk for arrhythmia events after ICD insertion.

A child's occupational performance: considerations of sensory processing and family context.

Sensory processing problems can be serious enough to affect a child's performance in school and home environments but often go undetected or are misunderstood. Poor sensory processing can affect a child's ability to successfully perform daily activities because of its effect on cognitive, sensory, and motor development. The relationship of sensory processing to children's occupational performance in their daily lives is an important consideration.

Heart failure: strategies to enhance patient self-management.

Successful management of heart failure requires an active partnership between the patient and health care providers. This can be facilitated through a focused patient education plan that begins in acute care and has continuity into the community. Elements of the education plan involve both teaching content areas and self-management behaviors. Clinical pathways for heart failure incorporate teaching and educational strategies to guide the work of the multidisciplinary team, and the advanced practice nurse has tremendous potential in facilitating improved patient outcomes.

Discoverer, teacher, friend: a tribute to Marguerite Kinney.

This tribute to Dr Marguerite Kinney, a transformational leader in cardiovascular nursing, highlights her influence on the lives and careers of previous students and those she has mentored. Examples of Dr Kinney's excellence in teaching, leadership, scholarship and research, and creative thinking within the discipline of nursing are provided.

Cognitive therapy for ventricular dysrhythmia patients.

Living with a serious ventricular dysrhythmia and its treatment poses certain psychological stressors including anxiety, depression, fear, and a sense of loss of control. Additional stressors related to side effects and technology issues may be present depending on whether the patient is treated with antidysrhythmic medications, an internal cardioverter defibrillator, or both. Cognitive therapy has been used with some success to reduce patient fear and improve psychological outcomes in some patient populations with illnesses characterized by loss of control including cancer and epilepsy. This article outlines a cognitive therapy approach for use with patients who have a serious ventricular dysrhythmia.

Mood disturbance in patients with recurrent ventricular dysrhythmia before insertion of implantable cardioverter defibrillator.

OBJECTIVE: To examine the relationships among personal factors (demographic variables and trait optimism); situational factors (ejection fraction, functional status, history of sudden cardiac arrest); coping and appraisal processes; and mood disturbance in patients hospitalized for recurrent ventricular dysrhythmia before the insertion of an implantable cardioverter defibrillator (ICD). DESIGN: Descriptive and correlational. SETTING: Five community and tertiary care hospitals in the southeast and midwest. PATIENTS: Eighty-four men and 17 women (aged 24 through 79) scheduled to receive an initial implant of an ICD. VARIABLES AND MEASURES: Trait optimism measured by the Life Orientation Tool; coping measured by the Jalowiec Coping Scale; threat-and-challenge appraisal measured by the Meaning in Illness Questionnaire; functional status measured by the Heart Failure Functional Status Inventory; and total mood disturbance measured by the Profile of Mood States. RESULTS: Hierarchical regression analysis revealed that factors of age, sex, optimism, functional status, and history of sudden cardiac arrest accounted for 47% of the variance in the total mood disturbance score (F = 7.44, df = 11.68, p = 0.00) with female sex, and less trait optimism, higher threat appraisal, and more use of evasive coping behavior as significant predictors. CONCLUSIONS: These findings can be used to identify patients with recurrent ventricular dysrhythmia who are potentially at risk for mood disturbance in the acute care setting before ICD insertion. Nursing interventions to address these factors can be developed and tested. Longitudinal studies on the response to ICDs should include assessment of preinsertion affective state.

Temporal patterns of heart rate and blood pressure in elders.

Circadian patterns of heart rate, systolic and diastolic blood pressure, and rate-pressure product were compared in elders with heart disease (N = 22, mean age 86 years) and a comparison group (N = 18, mean age 80 years) who did not have a cardiac diagnosis. For 4 consecutive days, automated measures of heart rate, diastolic and systolic blood pressure, and rate-pressure product were taken every 2 hours while subjects were awake. Activity-rest patterns were recorded by an observer, and demographic and medication profiles were obtained. Data were subjected to cosinor analysis, and the groups were compared on rhythmic parameters. Although the cardiac subjects were older, in poorer health, less active, and more prone to daytime napping, they exhibited more rhythms in rate-pressure product than did the comparison subjects. The cardiac group also had more synchronized oscillation of overt heart rate and systolic blood pressure rhythms. These results can be attributed to standardized times of cardiac medication administration. Attention to patterns of heart rate and systolic blood pressure in elders may suggest more appropriate times of day for conducting individual cardiac assessments.

Supraventricular tachycardia after coronary artery bypass grafting surgery and fluid and electrolyte variables.

OBJECTIVE: To explore the relationship between fluid and electrolyte variables and the development of supraventricular tachycardia (SVT) after coronary artery bypass grafting (CABG) surgery. DESIGN: Retrospective chart review. Random selection from a list obtained from the medical records department and with use of the International Classification of Diseases code to identify patients undergoing their initial CABG. SETTING: Medical records department of a southeastern 600-bed urban referral hospital with a large cardiovascular surgical program. PATIENTS: Forty patients experiencing SVT and 40 patients not experiencing SVT during their stay in an intensive care unit after CABG. OUTCOME MEASURES: Fluid and electrolyte variables and the development of SVT in the intensive care unit after CABG. VARIABLES: Data collected included preoperative demographic variables such as age and gender; previous history of SVT, congestive heart failure, cardiac arrest, previous surgery, diabetes, hypertension, valve disease, tobacco use, obesity; preoperative and postoperative medications; postoperative laboratory values of potassium, calcium, and magnesium; intravenous intake; hourly urine output; and chest tube drainage. RESULTS: Demographic variables revealed that patients with SVT were older (p = 0.001) and had a higher incidence of preoperative SVT (p = 0.04). Although groups did not differ by numbers of patients with high or low potassium, calcium, or magnesium, patients receiving additional intravenous potassium by bolus after surgery had a higher incidence of SVT (p = 0.02). Patients who lost blood via the chest tube at a rate greater than 100 ml per hour for at least 1 hour after surgery had a higher incidence of SVT (p = 0.02). Patients with a urine output greater than 300 ml per hour for longer than 9 hours had an increased incidence of SVT (p = 0.02). In the patients experiencing SVT, 62% had it occur 24 to 48 hours after surgery. CONCLUSIONS: These data suggest that shifts in fluid and electrolytes may be important characteristics of patients in whom SVT will develop, which could lead to better identification and nursing management of SVT and improve hemodynamic status, patient recovery, and cost after CABG.

Agency for health care policy and research: Clinical practice guidelines for heart failure.

The Agency for Health Care Policy and Research (AHCPR) and Rand Corporation convened a panel of experts to review published studies on care of the patient with heart failure. The outcome was the Clinical Practice Guideline for the evaluation and care of patients with left ventricular systolic dysfunction, published in June 1994. This article reviews key points in the clinical practice guideline and summarizes important areas for future research to improve patient outcomes.

Drug profiles: maximizing therapeutic effectiveness.

Major cardiac events are inevitably followed with a pharmacologic plan of therapy for cardiac patients. Careful assessment of the patient's drug regimen is an important aspect of cardiovascular nursing practice. Such assessment will reveal implications for education, compliance counseling, and side effect evaluation. A thorough drug history should include information about both prescription and nonprescription drug use. Assessment for adherence is improved by using supportive, open-ended questions. Assessment for side effects that affect quality of life is important, particularly in the area of sexual dysfunction. Sexual function should be assessed before beginning cardiovascular drug therapy and monitored for changes during treatment. Using principles of chronopharmacology, or therapy based on the time-dependent effects of drugs, nurses can schedule cardiovascular medications and evaluate patient responses in relation to circadian variability in vulnerability and symptoms. Assessment for ease of self-management of the drug regimen should be a particular focus with non-English-speaking patients and those with complex or costly drug regimens.