Dataset Information

Development, psychometric evaluation, and initial feasibility assessment of a symptom tracker for use by patients with heart failure (HFaST).

ABSTRACT:

Background

This 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.

Methods

The 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.

Results

A 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.

Conclusions

The 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.

SUBMITTER: Lewis EF

PROVIDER: S-EPMC6497706 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

Development, psychometric evaluation, and initial feasibility assessment of a symptom tracker for use by patients with heart failure (HFaST).

Lewis Eldrin F EF Coles Theresa M TM Lewis Sandy S Nelson Lauren M LM Barrett Amy A Romano Carla DeMuro CD Stull Donald E DE Turner Stuart J SJ Chang Chunlan G CG

Journal of patient-reported outcomes 20190502 1

<h4>Background</h4>This 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.<h4>Methods</h4>The HFaST was developed drawing on evidence f ...[more]

PMID: 31049726

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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:BackgroundIndolent systemic mastocytosis (ISM) is a rare, clonal mast cell neoplasm characterized by severe, unpredictable symptoms. The Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) items compose a Total Symptom Score (TSS), Gastrointestinal Symptom Score (GSS), and Skin Symptom Score (SSS) to assess symptom severity. This study evaluated the psychometric performance of ISM-SAF among ISM patients.MethodsIn PIONEER, a Phase 2 trial evaluating safety and efficacy of selective kinase inhibitor avapritinib in patients with ISM, the 12-item ISM-SAF was administered daily. Psychometric evaluation of score reliability, validity, and clinical interpretation was conducted using the trial data.ResultsThirty-eight patients contributed to analyses (78.9% female; mean age = 49). Baseline internal consistency reliability (α) for bi-weekly TSS, GSS, and SSS was 0.86, 0.83, and 0.82, respectively. Test-retest reliability among patients exhibiting no change in Patient Global Impression of Symptom Severity (PGIS) between Baseline and Day 15 exceeded 0.74 universally. Construct validity and known-groups analysis showed moderate to strong ISM-SAF score correlation (r = 0.382-0.881) to supportive patient-reported questionnaires (e.g., PGIS and Mastocytosis Quality of Life Questionnaire) symptom and skin scores, and ability to distinguish among clinically unique groups. Correlations of ISM-SAF and other assessment change scores reflect evidence of score sensitivity. Clinically important difference and response estimates were 7-10 and 19, respectively.DiscussionISM-SAF produced reliable, construct-valid, sensitive scores when administered in PIONEER to patients in the target population. Results of this study support the use of the ISM-SAF as a reliable and valid measure to evaluate disease symptomology in ISM patients. Trial registration ClinicalTrials.gov, NCT03731260. Registered 10 October 2018, https://clinicaltrials.gov/ct2/show/study/NCT03731260 .

Project description:BackgroundPatient-reported outcome measures that facilitate self-report by children are needed to reduce the bias of proxy report. We previously developed an electronic Pediatric Asthma Symptom Diary (ePASD) to assess the severity of daily asthma symptoms and proximal impacts in children aged 6-11 years with mild to severe asthma. The ePASD, administered via a digital application with visuals, sounds, and text, is uniquely designed to minimize the importance of reading skills on children's ability to self-report accurately. Here, we describe the ePASD's psychometric properties.MethodsNinety-one children aged 6-11 years with mild to severe asthma and their caregivers participated in 2 study visits, which consisted of training on the provisioned device and completing asthma-specific clinical outcome assessment (COA) questionnaires. The children self-completed the ePASD at home twice daily for 8 consecutive days. The scoring of the ePASD was guided by factor analyses, inter-item correlations, and internal consistencies. Reliability, discriminating ability, construct validity, and responsiveness were evaluated for ePASD items and candidate scores.ResultsAll COAs included in the study-the ePASD, Asthma Control Questionnaire (ACQ), Childhood Asthma Control Test, Pediatric Asthma Quality of Life Questionnaire-Standardized (PAQLQ[S]), and global ratings-demonstrated that the children exhibited few asthma-related symptoms and impacts at all timepoints, and consequently, showed little change over time. Internal consistencies (all Cronbach's alphas ≥ 0.52) and test-retest reliabilities (all intraclass correlation coefficients ≥ 0.60) were largely satisfactory. Patterns of convergent and divergent correlations supported the construct validity of ePASD scores. The ePASD symptom scores correlated moderately to strongly with PAQLQ(S) Symptom scores (all correlations ≥ - 0.46) and with ACQ scores (all correlations ≥ 0.42), as predicted. Evidence of the discriminating ability of ePASD items and composite scores was demonstrated by known-groups analyses.ConclusionsThe ePASD is a reliable and valid measure of asthma symptoms and proximal impacts in children aged 6-11 years with mild, moderate, or severe asthma. These results lay the psychometric groundwork for use of the ePASD in future clinical trials for the management of pediatric asthma. An ongoing pediatric asthma treatment trial is anticipated to provide evidence of the ePASD's responsiveness to change.

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Dataset Information

Development, psychometric evaluation, and initial feasibility assessment of a symptom tracker for use by patients with heart failure (HFaST).

Background

Methods

Results

Conclusions

Publications

Development, psychometric evaluation, and initial feasibility assessment of a symptom tracker for use by patients with heart failure (HFaST).

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