Association of patient-reported outcomes with hospitalization risk in atrial fibrillation.
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ABSTRACT: Background
Patient-reported outcomes in atrial fibrillation (AF) are increasingly used to evaluate treatment efficacy and as endpoints in clinical trials. Few studies have related patient-reported outcomes in AF to clinical events and outcomes. We examined the association between patient-reported outcomes and hospitalization risk in individuals with AF receiving care at a regional healthcare system.Methods and results
We related the AF Effect on QualiTy of Life (AFEQT), a validated measure (range 0-100) with higher scores indicating superior AF-specific patient-reported outcomes, to hospitalization events in a cohort with prevalent AF. We determined incidence rates for hospitalization events (all-cause, cardiac-, or AF-related) across quartiles of AFEQT scores. We used the Andersen-Gill method to account for multiple hospitalization events per individual and compared the risks of hospitalization across AFEQT quartiles in multivariable-adjusted models. In 339 individuals with AF (age 72.3 ± 10.1 years; 43% women) followed for median 2.6 years (range 0-3.4 years), we observed 417 total hospitalization events. We identified increased incidence rates of hospitalization with progressively decreased AFEQT quartile. Relative to those in the highest AFEQT quartile, individuals in the lowest AFEQT quartile had 3-fold greater risk of all-cause hospitalization (95% Confidence Interval [CI] 1.67-6.57, p < 0.001) and 5-fold greater risk of cardiac hospitalization (95% CI 1.66-13.80, p = 0.004).Conclusions
We identified a progressive association between patient-reported outcomes in AF and risk of hospitalization events. Our results underscore the relevance of patient-reported outcomes to clinical adversity and prognosis in AF.
SUBMITTER: Chen Y
PROVIDER: S-EPMC8211119 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:OBJECTIVES:Women report higher atrial fibrillation (AF) symptom severity and receive less AF therapies than their male counterparts. It is understudied if differences in AF therapies received explains sex differences in AF symptom severity. We investigate the impact of sex and AF therapies on patient-reported outcomes. METHODS:Participants were recruited (n=953) across four academic medical centres with an AF diagnosis and age ≥18 years. Patient-reported outcomes (AF symptom severity, AF-related quality of life, functional status and emotional status) were determined by biannual surveys. We performed multiple linear regressions on propensity-matched cohorts to determine the association of AF therapies and sex on patient-reported outcomes. RESULTS:Our study population (n=953) was 65% male (n=616), 93% white (n=890) and 72 (±10) years old. Individuals receiving rate control therapy reported comparatively lower AF-related quality of life (-7.22, 95% CI -11.51 to -2.92) and poorer functional status (-3.69, 95% CI -5.27 to -2.12). Individuals receiving rhythm control strategies did not report significantly different patient-reported outcomes. Women were more likely to report poorer functional status (-2.63, 95% CI -3.86 to -1.40) and poorer AF-related quality of life, higher anxiety (2.33, 95% CI 1.07 to 3.59), higher symptoms of depression (1.48, 95% CI 0.31 to 2.65) and AF symptom severity (0.29, 95% CI 0.07 to 0.52). CONCLUSIONS:Female sex was associated with comparatively poorer AF symptom severity and quality of life, and this association remained after accounting for AF therapies received. Receiving rate control medication alone was associated with comparatively poorer AF-related quality of life and functional status.
| S-EPMC7593897 | biostudies-literature
Project description:ObjectivesThis study sought to determine how frequently patient-reported outcomes (PROs) are collected in registered clinical studies of atrial fibrillation (AF).BackgroundImproving symptom burden and quality of life are important goals in the treatment of AF and are best measured with PROs.MethodsData from Clincaltrials.gov were studied to identify PROs in AF studies. All studies reporting AF as the disease condition were included, and PROs were identified by search terms within the outcome measures field. Generic and AF-specific PROs were identified and assessed by study type and year. Clinicaltrials.gov reporting was compared with published reports of linked studies in PubMed.ResultsFrom 1999 to 2018, 1,709 studies including AF patients were posted; 238 studies (14%) included PROs. Collection of PROs was reported in 22% of trials (n = 83 of 386) studying procedural interventions and 11% of all Phase 3 studies (n = 18 of 168). Among the 238 studies with PROs, most described "quality of life" (n = 194 [82%]), and most (n = 198 [83%]) included only generic (not AF-specific) PROs. Only 17% of studies (n = 40) reporting PROs specified a previously published AF-specific tool, most commonly the AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) form (n = 20 [8.4%]). Among the available PubMed citations of 391 studies, 74 studies (19%) described collecting a specific PRO tool (n = 29 [7.4%]) for an AF-specific PRO.ConclusionsDespite increased emphasis on the importance of PROs in AF, a minority of registered clinical trials reported collecting PROs, with very few using validated, AF-specific PROs. Improving outcomes that are most important to patients will necessitate increased emphasis on these PROs in pivotal clinical studies.
| S-EPMC6540810 | biostudies-literature
Project description:Background The IMPACT-AF (Integrated Management Program Advancing Community Treatment of Atrial Fibrillation) trial is a prospective, randomized, cluster design trial comparing atrial fibrillation management with a computerized clinical decision support system with usual care (control) in the primary care setting of Nova Scotia, Canada. The objective of this analysis was to assess and compare patient-reported health-related quality of life and patient-reported experience with atrial fibrillation care between clinical decision support and control groups. Methods and Results Health-related quality of life was measured using the EuroQol 5-dimensional 5-level scale, whereas patient-reported experience was assessed using a self-administered satisfaction questionnaire, both assessed at baseline and 12 months. Health utilities were calculated using the Canadian EuroQol 5-dimensional 5-level value set. Descriptive statistics and generalized estimating equations were used to compare between groups. Among 1145 patients enrolled in the trial, 717 had complete EuroQol 5-dimensional 5-level data at baseline. The mean age of patients was 73.53 years, and 61.87% were men. Mean utilities at baseline were 0.809 (SD, 0.157) and 0.814 (SD, 0.157) for clinical decision support and control groups, respectively. At baseline, most patients in both groups reported being "very satisfied" with the care received for their atrial fibrillation. There were no statistically significant differences in utility scores or patient satisfaction between groups at 12 months. Conclusions Health-related quality of life of patients remained stable over 12 months, and there was no significant difference in patient satisfaction or utility scores between clinical decision support and control groups. Registration information clinicaltrials.gov. Identifier: NCT01927367.
| S-EPMC8475702 | biostudies-literature
Project description:IntroductionPatient-reported outcomes are routinely assessed in atrial fibrillation (AF) to evaluate efficacy of treatment and as clinical trial outcomes. The relation of depression to such measures has had limited study in AF.MethodsIn a cohort receiving treatment for AF, we assessed depression with the Patient Health Questionniare-9 (PHQ; 0-4, normal range; 5-9, mild depression; ?10 moderate depression). We related depression to disease-specific quality of life with the AF Effect on QualiTy of life (AFEQT, range 0-100) and the Global Perceived Stress Scale (GPPS, range 0-24) in multivariable-adjusted models.ResultsIn 260 individuals (age 71.7 ± 10.1, 44.6% women) with AF, 51 (26.1%) had PHQ scores ?5 and 17 (6.5%) ?10. AFEQT scores decreased progressively with depression severity (normal range PHQ, 81.4 ± 14.1; mild depression, 65.8 ± 17.1; moderate depression, 50.6 ± 19.3). Individuals without depression had lower GPPS scores (3.0 ± 2.6) than those with mild (4.9 ± 2.5) or moderate (8.9 ± 4.0) depression. In multivariable-adjusted models mild depression was associated with a 12.1-point (95% confidence interval [CI], -17.2 to -6.9) decrease in AFEQT and 1.9-point (95% CI, 1.1 to 2.7) increase in GPSS, while moderate depression a 27.7-point (95% CI, -35.5 to -19.8) decrease in AFEQT and 5.5-point (95% CI, 4.2 to 6.8) increase in GPSS, relative to normal range PHQ. Regression analyses confirmed significant correlations between depression and AFEQT and GPPS scores in multivariable-adjusted models.ConclusionsWe determined that depression is associated with a step-wise, progressively adverse change in patient-centered outcomes in individuals with AF. Our findings suggest the importance of assessing depression in the evaluation of AF. Subject term list: health services, atrial fibrillation, risk factors.
| S-EPMC7002250 | biostudies-literature
Project description:BackgroundAtrial fibrillation is a large and growing burden across all types of healthcare. Both incidence and prevalence are expected to double in the next 20 years, with huge impact on hospital admissions, costs and patient quality of life. Patient wellbeing determines the management strategy for atrial fibrillation, including the use of rhythm control therapy and the clinical success of heart rate control. Hence, evaluation of quality of life is an emerging and important part of the assessment of patients with atrial fibrillation. Although a number of questionnaires to assess quality of life in atrial fibrillation are available, a comprehensive overview of their measurement properties is lacking.Methods and resultsWe performed a systematic review of the measurement properties of atrial fibrillation-specific health-related quality of life questionnaires. Methodological quality was assessed using the Consensus based Standards for selection of health Measurement Instruments (COSMIN) checklist, with measurement properties rated for quality against optimal criteria and levels of evidence. We screened 2,216 articles, of which eight articles describing five questionnaires were eligible for inclusion: Atrial Fibrillation 6 (AF6), Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT), Atrial Fibrillation Quality of Life Questionnaire (AFQLQ), Atrial Fibrillation Quality of Life (AFQoL), and Quality of Life in Atrial Fibrillation (QLAF). Good reliability (internal consistency and test-retest reliability) was demonstrated for AF6, AFEQT, AFQLQ and AFQoL. Content, construct and criterion validity were positively rated only in AFEQT. Responsiveness was positively rated only in AFEQT, but with limited evidence. Overall, AFEQT showed strong positive evidence for 2 of 9 measurement properties, compared to one for AFQoL and none for the remaining questionnaires.InterpretationGiven the low ratings for many measurement properties, no single questionnaire can be recommended, although AFEQT performed strongest. Further studies to robustly assess reliability, validity and responsiveness of AF-specific quality of life questionnaires are required. This review consolidates the current evidence for quality of life assessment in patients with atrial fibrillation and identifies priority areas for future research.
| S-EPMC5089715 | biostudies-literature
Project description:CONTEXT:Although the heritability of atrial fibrillation (AF) is established, the contribution of familial AF to predicting new-onset AF remains unknown. OBJECTIVE:To determine whether familial occurrence of AF is associated with new-onset AF beyond established risk factors. DESIGN, SETTING, AND PARTICIPANTS:The Framingham Heart Study, a prospective community-based cohort study started in 1948. Original and Offspring Cohort participants were aged at least 30 years, were free of AF at the baseline examination, and had at least 1 parent or sibling enrolled in the study. The 4421 participants in this analysis (mean age, 54 [SD, 13] years; 54% women) were followed up through December 31, 2007. MAIN OUTCOME MEASURES:Incremental predictive value of incorporating different features of familial AF (any familial AF, premature familial AF [onset ?65 years old], number of affected relatives, and youngest age of onset in a relative) into a risk model for new-onset AF. RESULTS:Across 11,971 examinations during the period 1968-2007, 440 participants developed AF. Familial AF occurred among 1185 participants (26.8%) and premature familial AF occurred among 351 participants (7.9%). Atrial fibrillation occurred more frequently among participants with familial AF than without familial AF (unadjusted absolute event rates of 5.8% and 3.1%, respectively). The association was not attenuated by adjustment for AF risk factors (multivariable-adjusted hazard ratio, 1.40; 95% confidence interval [CI], 1.13-1.74) or reported AF-related genetic variants. Among the different features of familial AF examined, premature familial AF was associated with improved discrimination beyond traditional risk factors to the greatest extent (traditional risk factors, C statistic, 0.842 [95% CI, 0.826-0.858]; premature familial AF, C statistic, 0.846 [95% CI, 0.831-0.862]; P = .004). Modest changes in integrated discrimination improvement were observed with premature familial AF (2.1%). Net reclassification improvement (assessed using 8-year risk thresholds of <5%, 5%-10%, and >10%) did not change significantly with premature familial AF (index statistic, 0.011; 95% CI, -0.021 to 0.042; P = .51), although categoryless net reclassification was improved (index statistic, 0.127; 95% CI, 0.064-0.189; P = .009). CONCLUSIONS:In this cohort, familial AF was associated with an increased risk of AF that was not attenuated by adjustment for AF risk factors including genetic variants. Assessment of premature familial AF was associated with a very slight increase in predictive accuracy compared with traditional risk factors.
| S-EPMC3073054 | biostudies-literature
Project description:ObjectiveSocial determinants contribute to adverse outcomes in cardiovascular and non-cardiovascular conditions. However, their investigation in atrial fibrillation (AF) remains limited. We examined the associations between annual income and educational attainment with risk of hospitalization in individuals with AF receiving care in a regional health care system. We hypothesized that individuals with lower income and lower education would have an increased risk of hospitalization.MethodsWe enrolled a cohort of individuals with prevalent AF from an ambulatory setting. We related annual income (≤$19,999/year; $20,000-49,000/year; $50,000-99,999/year; ≥$100,000/year) and educational attainment (high school/vocational; some college; Bachelor's; graduate) to hospitalization events in multivariable-adjusted Cox proportional hazards models, using the Andersen-Gill model to account for the potential of participants to have multiple events.ResultsIn 339 individuals with AF (age 72.3 ± 10.1 years; 43% women) followed for median 2.6 years (range 0-3.4 years), we observed 417 hospitalization events. We identified an association between both income and educational attainment and hospitalization risk. In multivariable-adjusted analyses which included educational attainment individuals in the lowest annual income category (≤19,999/year) had 2.0-fold greater hospitalization risk than those in the highest (≥100,000/year; 95% Confidence Interval [CI] 1.08-4.09; p = 0.03). In multivariable-adjusted analyses without adjustment for income, those in the lowest educational attainment category (high school/vocational) had a 2-fold increased risk of hospitalization relative to the highest (graduate-level; 95% CI 1.12-3.54, p = 0.02). However, this association between education and events was attenuated with further adjustment for income (95% CI 0.97-3.15, p = 0.06).ConclusionsWe identified relationships between income and education and prospective risk of hospitalization risk in AF. Our findings support the consideration of social determinants in evaluating and treating socioeconomically disadvantaged individuals with AF to reduce hospitalization risk.
| S-EPMC8387303 | biostudies-literature
Project description:BackgroundAtrial fibrillation (AF) significantly reduces health-related quality of life (HRQoL), previously measured in clinical trials using patient-reported outcomes (PROs). We examined AF PROs in clinical practice and their association with subsequent clinical management.MethodsThe Utah My Evaluation (mEVAL) program collects the Toronto AF Symptom Severity Scale (AFSS) in AF outpatients at the University of Utah. Baseline factors associated with worse AF symptom score (range 0-35, higher is worse) were identified in univariate and multivariable analyses. Secondary outcomes included AF burden and AF healthcare utilization. We also compared subsequent clinical management at 6 months between patients with better versus worse AF HRQoL.ResultsOverall, 1338 patients completed the AFSS symptom score, which varied by sex (mean 7.26 for males vs. 10.27 for females; p < .001), age (<65, 9.73; 65-74, 7.66; ≥75, 7.58; p < .001), heart failure (9.39 with HF vs. 7.67 without; p < .001), and prior ablation (7.28 with prior ablation vs. 8.84; p < .001). In multivariable analysis, younger age (mean difference 2.92 for <65 vs. ≥75; p < .001), female sex (mean difference 2.57; p < .001), pulmonary disease (mean difference 1.88; p < .001), and depression (mean difference 2.46; p < .001) were associated with higher scores. At 6-months, worse baseline symptom score was associated with the use of rhythm control (37.1% vs. 24.5%; p < .001). Similar cofactors and results were associated with increased AF burden and health care utilization scores.ConclusionsAF PROs in clinical practice identify highly-symptomatic patients, corroborating findings in more controlled, clinical trials. Increased AFSS score correlates with more aggressive clinical management, supporting the utility of disease-specific PROs guiding clinical practice.
| S-EPMC7749047 | biostudies-literature
Project description:BackgroundEvidence is sparse on the association between alcohol intakes in the lower range and risk of atrial fibrillation (AF). We aimed to investigate self-reported low and moderate alcohol intakes and subsequent risk of incident AF among current drinkers.MethodsNorwegian population-based health examination surveys assessing self-reported daily alcohol intake (mean grams per day) were linked to health and population registers. Hazard ratios (HR) (95% confidence interval) for time to incident (first) hospitalization with AF by alcohol intake level were assessed by Cox regression, with adjustment for educational level and cardiovascular risk factors except blood pressure.ResultsThe study population included 234,392 participants (49% men). Incident hospitalization with AF was identified in 5043 (2.2%) persons during a mean follow-up of 9 years. Compared to a very low alcohol intake of <1 unit weekly, a moderate consumption in the range of 1 to <2 units daily increased the risk of incident AF by 18% (HR 1.18 [1.06-1.32]). The average risk of incident AF increased by 9% per daily alcohol unit of 12 g (HR 1.09 [1.03, 1.14]). In sex-stratified analyses significant associations were found in men only.ConclusionsWe found that less than two alcohol units/day significantly increased the risk of incident AF, however, in men only. Reduction of even a moderate alcohol intake may thus reduce the risk of AF at the population level.
| S-EPMC8164130 | biostudies-literature
Project description:AimsTo determine the extent of shared decision-making (SDM), during selection of oral anticoagulant (OAC) and rhythm control treatments, in patients with newly diagnosed atrial fibrillation (AF).Methods and resultsWe evaluated survey data from 1006 patients with new-onset AF enrolled at 56 US sites participating in the SATELLITE substudy of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT II). Patients completed surveys at enrolment and at 6-month follow-up. Patients were asked about who made their AF treatment decisions. Shared decision-making was classified as one that the patient felt was an autonomous decision or a shared decision with their healthcare provider (HCP). Approximately half of patients reported that their OAC treatment decisions were made entirely by their HCP. Compared with those reporting no SDM, patients reporting SDM for OAC were more often female (47.2% vs. 38.4%), while patients reporting SDM for rhythm control were more often male (62.2% vs. 57.6%). The most important factors cited by patients during decision-making for OAC were reducing stroke and bleeding risk, and their HCP's recommendations. After adjustment, patients with self-reported understanding of OAC, and rhythm control options, had higher odds of having participated in SDM [odds ratio (OR) 2.54, confidence interval (CI): 1.75-3.68 and OR 2.36, CI: 1.50-3.71, both P ≤ 0.001, respectively].ConclusionShared decision-making is not widely implemented in contemporary AF practice. Patient understanding about available therapeutic options is associated with a more than a two-fold higher likelihood of SDM, and may be a potential target for future interventions.
| S-EPMC7778449 | biostudies-literature