Carolyn Miller Reilly

Recommended Patient-Reported Core Set of Symptoms to Measure in Adult Cancer Treatment Trials

BACKGROUND The National Cancer Institutes Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO). METHODS We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001-2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. RESULTS We recommend that a core set of 12 symptoms--specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea--be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients. CONCLUSIONS This core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies.

Effect of a Psychoeducational Intervention on Depression, Anxiety, and Health Resource Use in Implantable Cardioverter Defibrillator Patients

Background: Psychological responses have been reported for some patients after the insertion of an implantable cardioverter defibrillator (ICD). This study tested the effects of a psychoeducational intervention on anxiety, depressive symptoms, functional status, and health resource use during the first year after ICD implantation.

Dietary Sodium Intake in Heart Failure

Dietary sodium restriction is arguably the most frequent self-care behavior recommended to patients with heart failure (HF)1,2 and is endorsed by all HF guidelines.2–10 However, the data on which this recommendation is drawn are modest, and the limited trials conducted have produced inconsistent findings. Americans consume ≈3700 mg sodium daily,11 whereas the US Department of Agriculture and the Department of Health and Human Services recommend 2300 mg daily intake for the general population, with a stricter recommendation of 1500 mg/d for those >50 years of age, blacks, or individuals with hypertension, diabetes mellitus, or chronic kidney disease.12 According to a recent report from the National Health and Nutrition Examination Survey, although 47.6% of persons aged ≥2 years meet the criteria to limit daily sodium intake to 1500 mg, the usual intake for 98.6% of those persons was >1500 mg; in 88.2% of the remaining population, daily intake was greater than the recommended <2300 mg.13 The American Heart Association now recommends sodium intake of 1500 mg/d for all Americans,14 similar to the recommendation by the Institute of Medicine.15 Interestingly, and paradoxically, the suggested 1500 mg daily sodium intake for the general population is less than the limit proposed for HF patients by most guidelines, which appears as a contradiction. Whether this contradiction suggests inconsistent policy or a limited understanding of sodium homeostasis in the HF versus non-HF state is debatable. Sodium homeostasis physiology is altered in HF as opposed to healthy individuals and those with hypertension, and may partially explain these incongruous recommendations. This review summarizes the studies assessing the effects of sodium restriction in HF, highlighting knowledge gaps and future directions. Excessive sodium intake is associated with fluid retention. Therefore, all HF management guidelines recommend sodium restriction. In 2005, …

A Trial of Family Partnership and Education Interventions in Heart Failure

BACKGROUND Lowering dietary sodium and adhering to medication regimens are difficult for persons with heart failure (HF). Because these behaviors often occur within the family context, this study evaluated the effects of family education and partnership interventions on dietary sodium (Na) intake and medication adherence (MA). METHODS AND RESULTS HF patient and family member (FM) dyads (n = 117) were randomized to: usual care (UC), patient-FM education (PFE), or family partnership intervention (FPI). Dietary Na (3-day food record), urinary Na (24-hour urine), and MA (Medication Events Monitoring System) were measured at baseline (BL) before randomization, and at 4 and 8 months. FPI and PFE reduced urinary Na at 4 months, and FPI differed from UC at 8 months (P = .016). Dietary Na decreased from BL to 4 months, with both PFE (P = .04) and FPI (P = .018) lower than UC. The proportion of subjects adherent to Na intake (≤2,500 mg/d) was higher at 8 months in PFE and FPI than in UC (χ(2)(2) = 7.076; P = .029). MA did not differ among groups across time. Both FPI and PFE groups increased HF knowledge immediately after intervention. CONCLUSIONS Dietary Na intake, but not MA, was improved by PFE and FPI compared with UC. The UC group was less likely to be adherent with dietary Na. Greater efforts to study and incorporate family-focused education and support interventions into HF care are warranted.

Development, psychometric testing, and revision of the Atlanta Heart Failure Knowledge Test.

Background and Research Objective:Several heart failure (HF) knowledge tools have been developed and tested over the past decade; however, they vary in content, format, psychometric properties, and availability. This article details the development, psychometric testing, and revision of the Atlanta Heart Failure Knowledge Test (A-HFKT) as a standardized instrument for both the research and clinical settings. Participants and Methods:Development and psychometric testing of the A-HFKT were undertaken with 116 New York Heart Association (NYHA) class II and III community-dwelling HF patients and their family members (FMs) participating in a family intervention study. Internal consistency, reliability, and content validity were examined. Construct validity was assessed by correlating education level, literacy, dietary sodium ingestion, medication adherence, and healthcare utilization with knowledge. Results:Content validity ratings on relevance and clarity ranged from 0.55 to 1.0, with 81% of the items rated from 0.88 to 1.0. Cronbach α values were .84 for patients, .75 for FMs, and .73 for combined results. Construct validity testing revealed a small but significant correlation between higher patient and FM knowledge on sodium restriction questions and lower ingested sodium, r = −0.17, P = .05 and r = −0.19, P = .04, respectively, and between patient knowledge and number of days that medications were taken correctly (diuretics: r = 0.173, P < .05, and angiotensin-converting enzyme: r = 0.223, P = .01). Finally, patients seeking emergency care or requiring hospitalization in the 4 months before study entry were found to have significantly lower FM knowledge using both t test and logistic regression modeling. Conclusions:The A-HFKT was revised using the content and construct validity data and is available for use with HF patients and FMs. The construct validity testing indicates that patient knowledge has a significant relationship to aspects of self-care. Furthermore, family knowledge may influence patient adherence with sodium restriction and healthcare utilization behavior.

Family partner intervention influences self-care confidence and treatment self-regulation in patients with heart failure:

Background: Heart failure self-care requires confidence in one’s ability and motivation to perform a recommended behavior. Most self-care occurs within a family context, yet little is known about the influence of family on heart failure self-care or motivating factors. Aims: To examine the association of family functioning and the self-care antecedents of confidence and motivation among heart failure participants and determine if a family partnership intervention would promote higher levels of perceived confidence and treatment self-regulation (motivation) at four and eight months compared to patient–family education or usual care groups. Methods: Heart failure patients (N=117) and a family member were randomized to a family partnership intervention, patient–family education or usual care groups. Measures of patient’s perceived family functioning, confidence, motivation for medications and following a low-sodium diet were analyzed. Data were collected at baseline, four and eight months. Results: Family functioning was related to self-care confidence for diet (p=0.02) and autonomous motivation for adhering to their medications (p=0.05) and diet (p=0.2). The family partnership intervention group significantly improved confidence (p=0.05) and motivation (medications (p=0.004; diet p=0.012) at four months, whereas patient–family education group and usual care did not change. Conclusion: Perceived confidence and motivation for self-care was enhanced by family partnership intervention, regardless of family functioning. Poor family functioning at baseline contributed to lower confidence. Family functioning should be assessed to guide tailored family–patient interventions for better outcomes.

Quality and adequacy of dietary intake in a southern urban heart failure population.

Background:Few studies have examined the quality and adequacy of dietary intake in patients attempting to limit sodium. Objective:The aim of this study was to provide a comprehensive analysis of the dietary intake of persons with heart failure (HF) in the Southern United States who have been advised to limit their sodium intake. Methods:Three-day food diaries were completed by 114 New York Heart Association class II and III persons with HF enrolled in a family partnership intervention study, which were reviewed by a dietitian and analyzed using validated nutritional software. The Harris-Benedict equation for sedentary adults was used to determine macronutrient intake adequacy. Demographic information and clinical data were obtained through patient report and medical record review. Results:Dietary sodium ingestion ranged from 522 to 9251 mg/d (mean [SD], 2671 [1432] mg/d), with 38 (33.3%) individuals consuming the recommended 2000 mg/d or less in this sample (age, 28–78 years; 64.0% men; 57.0% African American). Mean (SD) caloric intake for the total sample was 1674 (636) kcal/d, with participants eating 99% of the recommended daily allowance (RDA) of protein, 63% of the RDA of carbohydrates, and 89% of the RDA of fat. Participants eating 2000 mg or less of sodium consumed significantly less calories (P < .001), protein (P < .001), carbohydrates (P = .008), and fat (P < .001), but not fiber (P = .103), compared with those consuming more than 2000 mg of sodium after adjusting for body mass index. When analyzed by amount of sodium consumption, persons ingesting 2000 mg or less of sodium per day ate significantly less grains (P = .001) and meat and beans (P = .004) and had less intake of the micronutrients calcium (P < .001), zinc (P = .002), and thiamine (P = .05). Conclusion:Only one-third of participants with HF who have been instructed on a low-sodium diet reported consuming the RDA of 2000 mg or less, indicating the need for further dietary instruction with a particular focus on modifying the Southern US diet.

A pilot test of an integrated self-care intervention for persons with heart failure and concomitant diabetes.

Studies show 30% to 47% of people with heart failure (HF) have concomitant diabetes mellitus (DM). Self-care for persons with both of these chronic conditions is conflicting, complex, and often inadequate. This pilot study tested an integrated self-care program for its effects on HF and DM knowledge, self-care efficacy, self-care behaviors, and quality of life (QOL). Hospitalized HF-DM participants (N = 71) were randomized to usual care or intervention using a 1:2 allocation and followed at 30 and 90 days after intervention. Intervention was an integrated education and counseling program focused on HF-DM self-care. Variables included demographic and clinical data, knowledge about HF and DM, HF- and DM-specific self-efficacy, standard HF and DM QOL scales, and HF and DM self-care behaviors. Analysis included descriptive statistics, multilevel longitudinal models for group and time effects, post hoc testing, and effect size calculations. Sidak adjustments were used to control for type 1 error inflation. The integrated HF-DM self-care intervention conferred effects on improved HF knowledge (30 days, p = .05), HF self-care maintenance (30 and 90 days, p < .001), HF self-care management (90 days, p = .05), DM self-efficacy (30 days, p = .03; 90 days, p = .004), general diet (30 days, p = .05), HF physical QOL (p = .04), and emotional QOL scores (p = .05) at 90 days within the intervention group. The participants in the usual care group also reported increased total and physical QOL. Greater percentages of participants in the intervention group improved self reported exercise between 0 and 30 days (p = .005 and moderate effect size ES = .47) and foot care between 0 and 90 days (p = .03, small ES = .36). No group differences or improvements in DM-specific QOL were observed. An integrated HF-DM self-care intervention was effective in improving essential components of self-care and had sustained (90 day) effects on selected self-care behaviors. Future studies testing HF-DM integrated self-care interventions in larger samples with longer follow-up and on other outcomes such as hospitalization and clinical markers are warranted.

Length of Residence in the United States is Associated With a Higher Prevalence of Cardiometabolic Risk Factors in Immigrants: A Contemporary Analysis of the National Health Interview Survey

Background Cardiometabolic risk (CMR) factors including hypertension, overweight/obesity, diabetes mellitus, and hyperlipidemia are high among United States ethnic minorities, and the immigrant population continues to burgeon. Methods and Results Hypothesizing that acculturation (length of residence) would be associated with a higher prevalence of CMR factors, the authors analyzed data on 54, 984 US immigrants in the 2010–2014 National Health Interview Surveys. The main predictor was length of residence. The outcomes were hypertension, overweight/obesity, diabetes mellitus, and hyperlipidemia. The authors used multivariable logistic regression to examine the association between length of US residence and these CMR factors. The mean (SE) age of the patients was 43 (0.12) years and half were women. Participants residing in the United States for ≥10 years were more likely to have health insurance than those with <10 years of residence (70% versus 54%, P<0.001). After adjusting for region of birth, poverty income ratio, age, and sex, immigrants residing in the United States for ≥10 years were more likely to be overweight/obese (odds ratio [OR], 1.19; 95% CI, 1.10–1.29), diabetic (OR, 1.43; 95% CI, 1.17–1.73), and hypertensive (OR, 1.18; 95% CI, 1.05–1.32) than those residing in the United States for <10 years. Conclusions In an ethnically diverse sample of US immigrants, acculturation was associated with CMR factors. Culturally tailored public health strategies should be developed in US immigrant populations to reduce CMR.

Psychosocial factors associated with diet quality in a working adult population

The associations between specific intra- and inter-personal psychosocial factors and dietary patterns were explored in a healthy, working adult sample of university and health center employees (N = 640) who were enrolled in a prospective predictive health study. Participants had a mean age of 48 (SD = 11) years and were 67% women and 30% minority. Baseline psychosocial measures of perceived stress, depressive symptoms, social support, and family functioning were examined for their relationships with three diet quality indices-AHEI, DASH, and the Mediterranean. Dietary intake was of moderate quality in this high-income, well-educated, psychosocially healthy population. Social support was positively associated with better diet quality for all three indices (p < .01). Further research should focus on socio-environmental factors associated with diet quality.