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Symptom Diary Use and Improved Survival for Patients With Heart Failure.

ABSTRACT: BACKGROUND:Attention to symptoms of weight gain and dyspnea are central tenets of patient education in heart failure (HF). However, it is not known whether diary use improves patient outcomes. The aims of this study were to compare mortality among rural patients with HF who completed versus did not complete a daily diary of weight and symptom self-assessment and to identify predictors of diary use. METHODS AND RESULTS:This is a secondary analysis of a 3-arm randomized controlled trial on HF education of self-care with 2 intervention groups versus control who were given diaries for 24 months to track daily weight, HF symptoms, and response to symptom changes. Mean age was 66±13, 58% were men, and 67% completed diaries (n=393). We formed 5 groups (no use, low, medium, high, and very high) based on the first 3 months of diary use and then analyzed time to event (cardiac mortality, all-cause mortality, and HF-related readmission) starting at 3 months. Compared with patients with no diary use, high and very high diary users were less likely to experience all-cause mortality (P=0.02 and P=0.01, respectively). Self-reported sedentary lifestyle was associated with less diary use in an adjusted model (odds ratio, 0.66; 95% confidence interval, 0.46-0.95; P=0.03). Depression and sex were not significant predictors of diary use in the adjusted model. CONCLUSIONS:In this study of 393 rural patients with HF, we found that greater diary use was associated with longer survival. These findings suggest that greater engagement in self-care behaviors is associated with better HF outcomes. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov. Unique Identifier: NCT00415545.

SUBMITTER: Park LG

PROVIDER: S-EPMC5705062 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Symptom Diary Use and Improved Survival for Patients With Heart Failure.

Park Linda G LG Dracup Kathleen K Whooley Mary A MA McCulloch Charles C Jin Chengshi C Moser Debra K DK Clark Robyn A RA Pelter Michele M MM Biddle Martha M Howie Esquivel Jill J

Circulation. Heart failure 20171101 11

<h4>Background</h4>Attention to symptoms of weight gain and dyspnea are central tenets of patient education in heart failure (HF). However, it is not known whether diary use improves patient outcomes. The aims of this study were to compare mortality among rural patients with HF who completed versus did not complete a daily diary of weight and symptom self-assessment and to identify predictors of diary use.<h4>Methods and results</h4>This is a secondary analysis of a 3-arm randomized controlled t ...[more]

PMID: 29158435

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Project description:BACKGROUND:Endometriosis is a common, chronic condition in women of reproductive age that is characterized by the presence of functional endometriotic lesions outside the uterus. The Endometriosis Symptom Diary (ESD) is an electronic patient-reported outcome (ePRO) instrument that assesses women's experience of endometriosis symptoms, with pain scored using a 0-10 numeric rating scale. This study investigated patterns of data missing from the ESD in the VALEPRO study. METHODS:Post hoc analyses of missing data were conducted. RESULTS:Of 272 participants using the ESD, 26.5% had no missing diary entries, 46.7% had >?0-5% of entries missing, 13.2% had >?5-10% of entries missing and 13.6% had >?10% of entries missing over the entire study period. The duration of missing episodes (defined as ?1 consecutive days with missing diary entries) was generally short; most (81.4%) were 1 day. The difference in mean worst pain scores between missing and complete episodes per participant was -?0.1, suggesting that missing episodes were not related to severity of pain. Entries were significantly more likely to be missing on Fridays (18.5%) and Saturdays (22.9%) compared with other days of the week (p?<?0.0001). Participants in the USA had significantly more long missing episodes than those in Germany (proportions of missing episodes longer than 1 day, 22.6 and 10.5%, respectively; p?<?0.0001). The proportions of women with ?1 missing entry were 50.0, 70.2 and 79.8% for women with elementary education, secondary education, and a college or university education, respectively. The proportions of women with ?1 missing entry were similar for those with and without children (72.2 and 74.3%, respectively). CONCLUSIONS:Most participants were highly compliant with entering data in the ESD and the amount of missing data was low. Entries were significantly more likely to be missing on Fridays and Saturdays compared with other days of the week, and participants in the USA had significantly more long missing episodes than participants in Germany. TRIAL REGISTRATION:Clinicaltrials.gov, NCT01643122 , registered 4 July 2012.

Project description:BackgroundThis study aimed to develop and provide a psychometric and feasibility pilot evaluation of the Heart Failure (HF) Symptom Tracker (HFaST), a new patient-reported tool designed to facilitate communication between patients and health care providers (HCPs) in routine clinical care. The HFaST enables patients to identify worsening HF symptoms, with a long-term goal of preventing hospitalizations or emergency room visits.MethodsThe HFaST was developed drawing on evidence from the literature, qualitatively with cognitive interviews (12 patient/caregiver and 8 HCPs), and evaluated quantitatively (psychometric, feasibility assessment). The HFaST was administered for 7 consecutive days to 100 individuals diagnosed with HF during a multisite, non-interventional US pilot study. Health care providers then completed a survey assessing the feasibility and importance of the HFaST in clinical practice. Qualitative development included a literature review and cognitive interviews with patients, caregivers, and HCPs. The psychometric properties of the HFaST were evaluated using classical test theory methods. Descriptive statistics provided insight into HCPs' perceptions of the feasibility of using the HFaST in clinical practice.ResultsA preliminary set of 40 items was developed for the symptom tracker and iteratively reduced to 10 items based on the qualitative phase. Test-retest reliability (weighted kappa 0.71-0.97), discriminating validity, and construct validity of the HFaST were acceptable. HCPs rated the HFaST as a good (70%) or excellent (30%) means of tracking HF symptoms. Six HFaST items were ultimately retained, covering concepts of fatigue, shortness of breath (3 items), swelling, and rapid weight gain.ConclusionsThe 6-item HFaST is an easy-to-use tool designed to raise patients' awareness of HF symptoms and facilitate communication with HCPs. Future research should evaluate HFaST implementation in clinical practice and effectiveness as an intervention to potentially prevent hospitalizations and emergency room visits.

Project description:Background Resistant hypertension is a salt-retaining condition possibly attributable to inappropriate aldosterone secretion. Methods and Results This study was a secondary analysis of the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial. Patients with heart failure with preserved ejection fraction (HFpEF) with (n=1004) and without (n=2437) resistant hypertension were included. Resistant hypertension was defined as systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥80 mm Hg in a patient with hypertension, despite the concurrent use of a renin-angiotensin system blocker (angiotensin-converting enzyme inhibitor/angiotensin receptor blocker), a calcium channel blocker, and a diuretic; or as those patients using ≥4 classes of antihypertensive medication. The primary outcome was a composite of cardiovascular death, aborted cardiac arrest, or heart failure hospitalization. We analyzed hazard ratios (HRs) for outcomes with 95% CIs in the spironolactone group and compared them with the placebo group using Cox proportional hazard models. The risk of primary outcome events in patients with HFpEF with resistant hypertension was significantly lower in the spironolactone group than in the placebo group (HR, 0.70; 95% CI, 0.53-0.91; P=0.009), whereas the risk of primary outcome events in patients with HFpEF without resistant hypertension was not significantly different between the 2 groups (HR, 1.00; 95% CI, 0.83-1.20; P=0.97). There was a significant interaction between spironolactone use and resistant hypertension (P=0.03). Similar associations were also observed in patients with HFpEF from the Americas (United States, Canada, Brazil, and Argentina) only. Conclusions Spironolactone may be an effective add-on medication for patients with HFpEF with resistant hypertension taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, calcium channel blockers, and diuretics.

Project description:AimsPatients with heart failure (HF) may have variable unrecognized symptom burdens. We sought to investigate the details, determinants, and prognostic significance of symptom burden in hospitalized patients with HF.Methods and resultsWe prospectively evaluated consecutive hospitalized patients with HF as primary diagnosis at our institution using the Integrated Palliative care Outcome Scale (IPOS) both on admission and at discharge. The IPOS, which is a well-validated multi-dimensional symptom assessment scale among advanced illness, consists of 17 questions for enquiring about physical symptoms (10 items), emotional symptoms (4 items) and communication and practical issues (3 items) using a 5-point Likert scale (0 [best]-4 [worst] points). Clinically relevant symptoms were defined as ≥2 points for each IPOS item. Worsening symptom burden was defined as the total IPOS score at discharge being poorer than that on admission. Of 294 patients (mean age: 77.5 ± 12.0 years, male: 168 patients, New York Heart Association class IV: 96 patients, mean left ventricular ejection fraction [LVEF]: 44%, and median N-terminal pro B-type natriuretic peptide [NT-proBNP] level: 4418 ng/L), the median (IQR) total IPOS score on admission was 19 (12, 27) and they were widely distributed (minimum: 0 - maximum: 52). The total IPOS score on admission was not correlated with the HF severity, including LVEF (Spearman's ρ = -0.05, P = 0.43), NT-proBNP levels (Spearman's ρ = 0.08, P = 0.20) or in-hospital mortality prediction model (GWTG-HF risk score) (Spearman's ρ = 0.01, P = 0.90). Total IPOS scores significantly decreased during hospitalization as a whole (median [IQR]: 13 [6, 21] at discharge; P < 0.001 vs. those on admission). All of the four emotional symptoms (patient anxiety, depression, family anxiety and feeling at peace) remained in the top 5 of clinically relevant symptoms at discharge, whereas none of 10 physical symptoms were nominated. Worsening symptom burden was noted in 28% of the patients during hospitalization, and was independently associated with higher all-cause mortality after discharge (hazard ratio: 2.28, 95% confidence interval: 1.02-5.09; P = 0.044) even after adjustment by age and HF mortality prediction model (MAGGIC risk score).ConclusionsWe revealed that hospitalized patients with HF had multi-dimensional symptom burdens which varied among individuals and were not correlated with the disease severity. Emotional symptoms, such as anxiety and depression, were the main clinically relevant symptoms at discharge. A worsening IPOS score was noted in a quarter of patients with HF and was associated with a poor prognosis, suggesting the importance of holistic symptom assessment during the course of hospitalization for HF.

Project description:Background: Interleukin-11 (IL11) was initially identified as a fibroblast secreted factor that supports haematopoietic cell function. This led to its development as a drug to increase platelet counts in patients with thrombocytopenia. However, IL11 was later found redundant for hematopoiesis and its use in humans causes severe and unexplained cardiac side effects. Here we identify and dissect mechanisms underlying previously unappreciated cardiac toxicities associated with IL11 therapy. Methods: We injected recombinant mouse lL11 (rmIl11) at clinically relevant doses to study its effects on myocardial signalling using immunoblotting and genomic variation using qRT-PCR, RNA-seq and ATAC-seq. The physiological impact of Il11 was assessed by echocardiography in vivo and cardiomyocyte contractility assays in vitro. To determine the specific activity of IL11 in cardiomyocytes we generated two distinct cardiomyocyte-specific IL11 receptor knockout (CMKO) mouse models using either AAV9-mediated, Tnnt2-restricted (vCMKO) or mhy6 (m6CMKO) Cre expression in an Il11ra1 floxed mouse strain. In pharmacologic studies, we studied the effects of JAK/STAT inhibition following rmIl11 injection to mice.Results: Injection of rmIl11 to mice caused dose-dependent impairment of left ventricular ejection fraction (LVEF: saline, 64.2%±1.62; rmIl11 (50 mg/kg), 31.6±2.0; p<0.0001). RNA-seq of hearts one and three hours following rmIl11 injection revealed strong upregulation of the TNF, NFkB and JAK/STAT pathways as well as increased Nppa and Rrad levels. vCMKO mice were protected from rmIl11-induced STAT3 activation, Rrad upregulation and LV impairment. Similarly, m6CMKO mice of both sexes, were protected from the molecular, cellular and whole organ cardiac toxicities associated with Il11. Administration of JAK inhibitors prevented rmIl11-induced STAT3 activation and preserved cardiac function. Conclusions: Here we show that Il11 injection to mice is strongly proinflammatory in the heart. Furthermore, Il11 has profound negative inotropic effects that are mediated via its on-target activation of JAK/STAT3 signalling in cardiomyocytes. Our data explain the cardiac side effects associated with IL11 therapy and question its continued use in patients.

Project description:BackgroundPatient-reported outcome (PRO) measures are important to consider when evaluating treatments, yet there are no PRO measures for patients with acromegaly that have been developed in accordance with US Food and Drug Administration guidance. Acromegaly is a rare, chronic condition caused by hypersecretion of growth hormone. Disease activity is monitored by measurement in serum of growth hormone and insulin-like growth factor-I. The objectives of this research were to develop the Acromegaly Symptom Diary (ASD), establish a scoring algorithm, and evaluate the psychometric measurement properties of the ASD.MethodsSemistructured interviews consisting of concept elicitation and cognitive debriefing components were conducted with 16 adult participants with acromegaly. The concept elicitation component identified symptoms important to individuals with acromegaly. The cognitive debriefing component gathered information about the participants' experience with each proposed item of the ASD, their thought process for answering each question, and their interpretation of the items. The psychometric properties of the draft ASD were then evaluated using data from the ACROBAT Evolve (NCT03792555; n = 13) and ACROBAT Edge (NCT03789656; n = 47) clinical trials.ResultsThe 16 participants from the interviews described ongoing symptoms, with the most frequently reported being joint pain (n = 13) and fatigue (n = 12), followed by swelling (n = 8), headache (n = 7), and mood swings (n = 6), and were able to interpret and understand the ASD items and had no issues with the 24-hour recall period. From data collected in the clinical studies, the psychometric properties of internal consistency (0.91 - 0.80), test-retest reliability with item-level and total ASD scores (> 0.70), baseline construct validity (r ≥ |0.38|) across scales, and responsiveness to change (r = 0.52-0.56) were supported for the ASD. The proposed preliminary threshold range to characterize a meaningful change from the patients' perspective for the ASD total is a 4- to 6-point change for improvement or worsening out of a total score of 70.ConclusionThese findings provide qualitative and quantitative evidence to support the ASD as fit for the purpose of evaluating the symptom experience of patients with acromegaly in clinical trials.

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Symptom Diary Use and Improved Survival for Patients With Heart Failure.

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Symptom Diary Use and Improved Survival for Patients With Heart Failure.

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