Profiles of patients’ self-reported health after acute stroke

Abstract Background We aimed to identify groups of patients with similar health status after stroke, assessed by patient reported outcome measures (PROMs), to improve initial risk stratification. Methods In a prospective study, inpatients were recruited during acute stroke treatment. Demographics, history, and cardio-vascular risk factors were assessed at baseline. Self-reported functional status, physical and mental health as well as anxiety and depressive symptoms were assessed 3 and 12 months after stroke and used to identify latent classes. The association of patient characteristics with latent class membership was investigated with multinomial logistic regression. Results Of the 650 patients included with a mean age of 75 years and 48% female, 70% had ischemic, 6% hemorrhagic strokes, and 24% transient ischemic attacks. Median NIHSS on admission was 2 (IQR:0,5). Values of PROMs remained comparable at 3 and 12 months. A three-class model was developed, differentiating between patients with mildly (75%), moderately (17%), and severely (8%) impaired self-reported health status. Adjusted for univariately significant baseline characteristics, initial NIHSS distinguished mild- from moderate-, and moderate- from severe-class-membership (p < 0.001). Length of inpatient stay (p < 0.001;OR = 1.1), diabetes (p = 0.021;OR = 1.91), and atrial fibrillation (p = 0.004;OR = 2.20) predicted allocation to the moderately vs. mildly affected class. Conclusions Grading stroke patients by a standard set of PROMs up to 1 year after stroke allows to distinguish the diverse impact of baseline characteristics on differently affected groups. In addition to initial stroke severity, longer inpatient stay, presence of diabetes and atrial fibrillation correlate with greater impairment of self-reported health in the less affected groups. Trial registration http://www.ClinicalTrials.gov; Unique identifier: NCT03795948.

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Effect of Inotropes on Patient-Reported Health Status in End-Stage Heart Failure

Circulation Heart Failure ◽

10.1161/circheartfailure.120.007759 ◽

2021 ◽

Vol 14 (2) ◽

Author(s):

John-Ross D. Clarke ◽

Ralph Riello ◽

Larry A. Allen ◽

Mitchell A. Psotka ◽

John R. Teerlink ◽

...

Keyword(s):

Health Status ◽

Health Related Quality ◽

Reduced Ejection Fraction ◽

Randomized Controlled ◽

Patient Reported ◽

Related Quality ◽

Health Related ◽

Reported Health ◽

End Stage

Background: A growing population of patients with end-stage heart failure (HF) with reduced ejection fraction has limited treatment options to improve their quality and quantity of life. Although positive inotropes have failed to show survival benefit, these agents may enhance patient-reported health status, that is, symptoms, functional status, and health-related quality of life. We sought to review the available clinical trial data on positive inotrope use in patients with end-stage HF and to summarize evidence supporting the use of these agents to improve health status of patients with end-stage HF. Methods: A literature review of randomized controlled trials examining the use of positive inotropy in HF with reduced ejection fraction was conducted. We searched MEDLINE, SCOPUS, and Web of Science between January 1980 to December 2018 for randomized controlled trials that used as their main outcome measures the effects of inotrope therapy on (1) morbidity/mortality, (2) symptoms, (3) functional status, or (4) health-related quality of life. Inotropes of interest included adrenergic agents, phosphodiesterase inhibitors, calcium sensitizers, myosin activators, and SERCA2a (sarcoplasmic reticulum Ca 2+ -ATPase) modulators. Results: Twenty-two out of 26 inotrope randomized controlled trials measured the effect of inotropes on at least one patient-reported health status domain. Among the 22 studies with patient-related health status outcomes, 11 (50%) gauged symptom response, 15 (68%) reported functional capacity changes, and 12 (54%) reported health-related quality of life measures. Fourteen (64%) of these trials noted positive outcomes in at least one health status domain measured; 11 (79%) of these positive studies used agents that worked through phosphodiesterase inhibition. Conclusions: There has been a lack of standardization surrounding measurement of patient-centered outcomes in studies of inotropes for end-stage HF with reduced ejection fraction. The degree to which positive inotropes can improve patient-reported health status and the adverse risk they pose remains unknown.

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Abstract TP233: Are Baseline Characteristics of Stroke Patients Included Into an Observational Study Similar to Patients Included Into a Randomised Controlled Trial?

Stroke ◽

10.1161/str.47.suppl_1.tp233 ◽

2016 ◽

Vol 47 (suppl_1) ◽

Author(s):

Anna Schulte ◽

Falko Jürries ◽

Anna Messerschmid ◽

Nico Behnke ◽

Jan Liman ◽

...

Keyword(s):

Atrial Fibrillation ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Stroke Severity ◽

Stroke Patients ◽

Exclusion Criteria ◽

Observational Trial ◽

Significant Difference ◽

Baseline Characteristics ◽

Randomised Controlled

Introduction: Undiagnosed atrial fibrillation (UAF) is a major burden in ischemic stroke. However, randomised trials have partly shown astonishingly low AF detection rates (e. g. in the CRYSTAL-AF study). This may be due to differences in baseline and stroke characteristics between studies. Hypothesis: We hypothesized that stroke patients in a randomised controlled trial have less severe strokes than patients in an observational trial with similar inclusion and exclusion criteria. Methods: We used data from the Find-AF observational (NCT 01855035) and the Find-AF randomised controlled trial (ISRCTN 46104198). We included only patients at study site Goettingen of the Find-AF randomised controlled trial (n=153) and only included patients from the Find-AF observational trial that fulfilled the inclusion/exclusion criteria of Find-AF randomised (n=90). We compared baseline characteristics of screened versus included patients in Find-AF randomised and baseline characteristics and stroke severity parameters between both studies. Data are shown as mean (Standard Deviation) or Median (25%; 75% percentile) and were compared by chi-square, t-test or Mann-Whitney U test. Results: Table 1 shows as comparison between baseline characteristics of both studies Comparing patients fulfilling the inclusion/exclusion criteria of Find-AF randomised, but unwilling to give informed consent to randomised patients showed a significant difference in age (77 ± 11 vs. 74 ± 8; p< 0.001), but no difference in gender (p=0.581). Conclusions: Both studies included patients similar in age, gender and many comorbidities. Major differences occurred in NIHSS and MRS. As NIHSS is a predictor of atrial fibrillation, randomized controlled trials investigating AF detection should include a minimum NIHSS to avoid a selection bias towards less severe strokes.

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Abstract 13: Patient-reported Health Status Changes are Associated With Subsequent Clinical Outcomes After Transcatheter Valve Therapies: Insights From the Sts/tvt Registry

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/hcq.13.suppl_1.13 ◽

2020 ◽

Vol 13 (Suppl_1) ◽

Author(s):

Vittal Hejjaji ◽

Zhuokai Li ◽

David J Cohen ◽

John Carroll ◽

Sreekanth Vemulapalli ◽

...

Keyword(s):

Health Status ◽

Clinical Outcomes ◽

Lower Risk ◽

Adverse Outcomes ◽

Short Term ◽

Patient Factors ◽

Risk Of Death ◽

Patient Reported ◽

Reported Health ◽

Procedure Type

Background: The goals of TAVR and transcatheter mitral valve repair (TMVr) are to prolong survival, reduce heart failure (HF) hospitalizations, and improve health status. Most patients report large improvements in health status within 30 days of these procedures. While this is an important patient-centered outcome on its own, if these changes were also associated with subsequent clinical outcomes, this would further support using short-term health status as a quality metric for valve procedures. Methods: Among patients who underwent transfemoral TAVR or TMVr, had KCCQ data at baseline and 30 days, and could be linked to CMS for 1-year outcomes; we constructed sequential models examining the association of KCCQ with death and HF hospitalization from 30 days to 1 year: 1) baseline KCCQ, 2) 30-day KCCQ, 3) baseline and 30-day KCCQ, 4) change in KCCQ from baseline to 30 days. In each model, we tested the interaction between procedure type and KCCQ, examined the linearity of the association of KCCQ with outcomes using restricted cubic splines, and adjusted for patient factors (Figure footnote). Results: Our cohort included 73,699 patients who underwent TAVR or TMVr from 2011-18 (median age 83 [IQR 77-87], 53% men, 92% TAVR). There were no significant interactions between procedure type and KCCQ, so all analyses used the combined cohort. Higher baseline KCCQ (model 1) and 30-day KCCQ (model 2) were both strongly associated with lower risk of death and HF hospitalization (Figure). When both were included in the model (model 3), each assessment was independently associated with subsequent outcomes, with the 30-day being most predictive. Change from baseline to 30 days was nonlinearly associated with outcomes (model 4), with increases up to 25 points associated with lower risk of death or HF hospitalization but no further risk reduction beyond 25 points. There were no meaningful changes in the associations after adjusting for patient factors. Conclusion: Short-term improvements in patient-reported health status after TAVR or TMVr were strongly associated with lower risk of death or HF hospitalization, with the 30-day assessment having a stronger association than baseline. These results support the routine use of 30-day KCCQ as a potential measure of quality after TVTs and to identify those at higher risk for adverse outcomes.

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Abstract 310: Variability in Patient-Reported Health Status by NYHA Classification: Implications for Clinical Trials

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/hcq.13.suppl_1.310 ◽

2020 ◽

Vol 13 (Suppl_1) ◽

Author(s):

Andy T Tran ◽

Paul S Chan ◽

Phillip G Jones ◽

John Spertus

Keyword(s):

Heart Failure ◽

Clinical Trials ◽

Health Status ◽

Ejection Fraction ◽

Nyha Class ◽

Class I ◽

Nyha Classification ◽

Patient Reported ◽

Patients With Heart Failure ◽

Reported Health

Background: A foundation of current clinical trials is to categorize the severity of heart failure (HF) by New York Heart Association (NYHA) classification to ensure that enrolled patients have similar disease severity. Because the NYHA represents a clinician’s assessment of patients’ health status, it may vary from patients’ perspectives and can lead to more or less symptomatic patients being enrolled in clinical trials. We sought to directly compare the ranges of patient-reported health status, as assessed by the well-validated and reliable Kansas City Cardiomyopathy Questionnaire (KCCQ), with NYHA class in recent clinical studies. Methods: We used data from 2 contemporary HF clinical trials, HF-ACTION in patients with Heart Failure with Reduced Ejection Fraction (HFrEF) and TOPCAT in patients with Heart Failure with Preserved Ejection Fraction (HFpEF), and 1 prospective cohort study, the KCCQ Interpretability study (KCCQINT) in patients with HFrEF, where both NYHA and the KCCQ were contemporaneously collected. The distributions of KCCQ Overall Summary (KCCQ-os) scores by NYHA and the variation in assigned NYHA classes among patients with KCCQ scores ≥80 (congruent with NYHA Class I) were then described. Results: A total of 6,072 patients (mean age 64±12 years, 41% female) were included across the 3 studies. Figure 1 shows marked overlap in KCCQ scores across NYHA classes. In KCCQINT, 148 (27%) out of 545 patients reported a KCCQ-os score ≥80, of whom 39 (26%), 81 (55%) and 28 (19%) were coded as NYHA Class I, II and III. None were classified as NYHA Class IV. In HF-ACTION, 677 (32%) of 2129 patients reported a KCCQ-os score ≥80, of whom 548 (81%), 128 (19%) and 1 (<1%) were coded as NYHA Class II, III and IV, respectively. In TOPCAT, 484 (14%) out of 3398 patients reported a KCCQ-os score ≥80, of whom 410 (85%) and 74 (15%) were considered NYHA Class I-II and III-IV, respectively. Conclusions: Although the NYHA is used to identify similarly ill patients for enrollment in clinical trials, there is marked variability within and across studies in patients’ self-reported health status. Future trials should consider patient-reported outcome measures as the basis for defining patient eligibility to enroll a more homogenous cohort of disease severity.

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FEASIBILITY AND VALIDITY OF MEASURING PATIENT-REPORTED HEALTH STATUS AT TIME OF PCI: RESULTS FROM A SINGLE-CENTER QUALITY IMPROVEMENT INITIATIVE

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(18)30637-5 ◽

2018 ◽

Vol 71 (11) ◽

pp. A96

Author(s):

Usman Baber ◽

Serdar Farhan ◽

Nitin Barman ◽

Joseph Sweeny ◽

Jason Kovacic ◽

...

Keyword(s):

Quality Improvement ◽

Health Status ◽

Quality Improvement Initiative ◽

Single Center ◽

Patient Reported ◽

Reported Health

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Multimorbidity, physical frailty, and self-rated health in older patients with atrial fibrillation

BMC Geriatrics ◽

10.1186/s12877-020-01755-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Hawa O. Abu ◽

Jane Saczynski ◽

Jordy Mehawej ◽

Tenes Paul ◽

Hamza Awad ◽

...

Keyword(s):

Atrial Fibrillation ◽

Health Status ◽

Older Patients ◽

Logistic Models ◽

Health Study ◽

Cardiovascular Health Study ◽

Physical Frailty ◽

Self Rated Health ◽

Patient Reported ◽

Fair Poor

Abstract Background Holistic care models emphasize management of comorbid conditions to improve patient-reported outcomes in treatment of atrial fibrillation (AF). We investigated relations between multimorbidity, physical frailty, and self-rated health (SRH) among older adults with AF. Methods Patients (n = 1235) with AF aged 65 years and older were recruited from five medical centers in Massachusetts and Georgia between 2015 and 2018. Ten previously diagnosed cardiometabolic and 8 non-cardiometabolic conditions were assessed from medical records. Physical Frailty was assessed with the Cardiovascular Health Study frailty scale. SRH was categorized as either “excellent/very good”, “good”, and “fair/poor”. Separate multivariable ordinal logistic models were used to examine the associations between multimorbidity and SRH, physical frailty and SRH, and multimorbidity and physical frailty. Results Overall, 16% of participants rated their health as fair/poor and 14% were frail. Hypertension (90%), dyslipidemia (80%), and heart failure (37%) were the most prevalent cardiometabolic conditions. Arthritis (51%), anemia (31%), and cancer (30%), the most common non-cardiometabolic diseases. After multivariable adjustment, patients with higher multimorbidity were more likely to report poorer health status (Odds Ratio (OR): 2.15 [95% CI: 1.53–3.03], ≥ 8 vs 1–4; OR: 1.37 [95% CI: 1.02–1.83], 5–7 vs 1–4), as did those with more prevalent cardiometabolic and non-cardiometabolic conditions. Patients who were pre-frail (OR: 1.73 [95% CI: 1.30–2.30]) or frail (OR: 6.81 [95% CI: 4.34–10.68]) reported poorer health status. Higher multimorbidity was associated with worse frailty status. Conclusions Multimorbidity and physical frailty were common and related to SRH. Our findings suggest that holistic management approaches may influence SRH among older patients with AF.

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