Disease-specific Health Status Research Articles

Associations of Upper-Extremity Exercise Capacity and Grip Strength With Cognitive Domains in Patients With COPD.

Cognitive impairment (CI), which has been reported in COPD, has been related to physical performance. However, the association between CI and upper-extremity functions is unknown. We aimed to compare upper-extremity exercise capacity and grip strength between subjects with COPD with and without CI and to determine the relationship of upper-extremity functions with specific cognitive domains. In this cross-sectional study, 76 subjects with COPD (mean age 66.8 ± 7.5 y, FEV1% 47.12 ± 14.10) were classified as with and without CI according to the Montreal Cognitive Assessment. Clinical characteristics, upper-extremity exercise capacity (6-min pegboard ring test [6PBRT]), grip strength (hand dynamometer), dyspnea severity (modified Medical Research Council dyspnea scale), disease-specific health status (COPD Assessment Test), and disease-specific quality of life (St George Respiratory Questionnaire) were compared between groups, and the relationship of upper-extremity functions with cognitive subdomains was analyzed by multivariate regression analysis. The number of 6PBRT rings (P = .01) and the grip strength (P = .033) were lower in subjects with CI. Subjects with CI had lower FEV1% (P = .038), arterial oxygenation (P = .002), exercise habits (P = .033), health status (P = .01), quality of life (P = .042); and higher dyspnea (P < .001), smoking consumption (P = .032), emergency admission (P = .02), and hospitalization (P = .042). The adjusted model showed that executive functions and attention were related to upper-extremity capacity (β = 14.4 and β = 10.2, respectively) and hand-grip strength (β = 1.85 and β = 1.49, respectively). These findings suggest that upper-extremity functions might be decreased especially concerning executive functions and attention in subjects with COPD with CI.

Nurse and Social Worker Palliative Telecare Team and Quality of Life in Patients With COPD, Heart Failure, or Interstitial Lung Disease

Many patients with chronic obstructive pulmonary disease (COPD), heart failure (HF), and interstitial lung disease (ILD) endure poor quality of life despite conventional therapy. Palliative care approaches may benefit this population prior to end of life. Determine the effect of a nurse and social worker palliative telecare team on quality of life in outpatients with COPD, HF, or ILD compared with usual care. Single-blind, 2-group, multisite randomized clinical trial with accrual between October 27, 2016, and April 2, 2020, in 2 Veterans Administration health care systems (Colorado and Washington), and including community-based outpatient clinics. Outpatients with COPD, HF, or ILD at high risk of hospitalization or death who reported poor quality of life participated. The intervention involved 6 phone calls with a nurse to help with symptom management and 6 phone calls with a social worker to provide psychosocial care. The nurse and social worker met weekly with a study primary care and palliative care physician and as needed, a pulmonologist, and cardiologist. Usual care included an educational handout developed for the study that outlined self-care for COPD, ILD, or HF. Patients in both groups received care at the discretion of their clinicians, which could include care from nurses and social workers, and specialists in cardiology, pulmonology, palliative care, and mental health. The primary outcome was difference in change in quality of life from baseline to 6 months between the intervention and usual care groups (FACT-G score range, 0-100, with higher scores indicating better quality of life, clinically meaningful change ≥4 points). Secondary quality-of-life outcomes at 6 months included disease-specific health status (Clinical COPD Questionnaire; Kansas City Cardiomyopathy Questionnaire-12), depression (Patient Health Questionnaire-8) and anxiety (Generalized Anxiety Disorder-7) symptoms. Among 306 randomized patients (mean [SD] age, 68.9 [7.7] years; 276 male [90.2%], 30 female [9.8%]; 245 White [80.1%]), 177 (57.8%) had COPD, 67 (21.9%) HF, 49 (16%) both COPD and HF, and 13 (4.2%) ILD. Baseline FACT-G scores were similar (intervention, 52.9; usual care, 52.7). FACT-G completion was 76% (intervention, 117 of 154; usual care, 116 of 152) at 6 months for both groups. Mean (SD) length of intervention was 115.1 (33.4) days and included a mean of 10.4 (3.3) intervention calls per patient. In the intervention group, 112 of 154 (73%) patients received the intervention as randomized. At 6 months, mean FACT-G score improved 6.0 points in the intervention group and 1.4 points in the usual care group (difference, 4.6 points [95% CI, 1.8-7.4]; P = .001; standardized mean difference, 0.41). The intervention also improved COPD health status (standardized mean difference, 0.44; P = .04), HF health status (standardized mean difference, 0.41; P = .01), depression (standardized mean difference, -0.50; P < .001), and anxiety (standardized mean difference, -0.51; P < .001) at 6 months. For adults with COPD, HF, or ILD who were at high risk of death and had poor quality of life, a nurse and social worker palliative telecare team produced clinically meaningful improvements in quality of life at 6 months compared with usual care. ClinicalTrials.gov Identifier: NCT02713347.

Effects of SGLT2 inhibitors on cardiac function and health status in chronic heart failure: a systematic review and meta-analysis

PurposeNumerous clinical studies have explored sodium–glucose cotransporter 2 inhibitor (SGLT2i) in patients with chronic heart failure (CHF), with or without type 2 diabetes mellitus (T2DM), and SGLT2i were proved to significantly reduce CHF hospitalization, cardiovascular death, cardiovascular mortality, all-cause mortality and myocardial infarction in patients with or without T2DM. However, only a limited few have investigated the effects of SGLT-2i on HF disease-specific health status and cardiac function. This meta-analysis aims to assess the effects of SGLT2i on disease-specific health status and cardiac function in CHF patients.MethodsA comprehensive search was conducted of trials by searching in PubMed, EMBASE, CENTRAL, Scopus, and Web of Science, and two Chinese databases (CNKI and Wanfang), Clinical Trials (http://www.clinicaltrials.gov) were also searched.ResultsA total of 18 randomized controlled trials (RCTs) involving 23,953 participants were included in the meta-analysis. The effects of SGLT2 inhibitors were compared with control or placebo groups in CHF with or without T2DM. The SGLT2 inhibitors group exhibited a significant reduction in pro b-type natriuretic peptide (NT-proBNP) levels by 136.03 pg/ml (95% confidence interval [CI]: −253.36, − 18.70; P = 0.02). Additionally, a greater proportion of patients in the SGLT2 inhibitors group showed a ≥ 20% decrease in NT-proBNP (RR = 1.45, 95% CI [0.92, 2.29], p = 0.072). However, no statistically significant difference was observed for the effects on B-type natriuretic peptide (BNP). The use of SGLT-2 inhibitors led to a noteworthy improvement in LVEF by 2.79% (95% CI [0.18, 5.39];P = 0.036). In terms of health status, as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6-minute walk distance, SGLT2 inhibitors led to a significant improvement in KCCQ clinical summary (KCCQ-CS) score (WMD = 1.7, 95% CI [1.67, 1.73], P < 0.00001), KCCQ overall summary (KCCQ-OS) score (WMD = 1.73, 95% CI [0.94, 2.52], P < 0.00001), and KCCQ total symptom (KCCQ-TS) score (WMD = 2.88, 95% CI [1.7, 4.06], P < 0.00001). Furthermore, the occurrence of KCCQ-CS and KCCQ-OS score increases ≥ 5 points had relative risks (RR) of 1.25 (95% CI [1.11, 1.42], P < 0.00001) and 1.15 (95% CI [1.09, 1.22], P < 0.00001), respectively. Overall, SGLT2 inhibitors increased the 6-minute walk distance by 23.98 m (95% CI [8.34, 39.62]; P = 0.003) compared to control/placebo from baseline.ConclusionsThe SGLT2 inhibitors treatment offers an effective strategy for improving NT-proBNP levels, Kansas City Cardiomyopathy Questionnaire scores and 6-minute walk distance in CHF with or without T2DM. These findings indicate that SGLT2i improve cardiac function and health status in CHF with or without T2DM, and provide valuable guidance for clinicians making treatment decisions for patients with CHF.

King's Sarcoidosis Questionnaire (KSQ) - Validation study in Serbian speaking population of sarcoidosis patients.

Sarcoidosis is a multiorgan, multisystem chronic disease of unknown etiology and unpredictable course. Health status is reduced in sarcoidosis and assessing it is a difficult multitask effort due to many faces this disease might have. Recently, a new questionnaire for assessing health status in sarcoidosis was developed by a group of authors from England-King's Sarcoidosis Questionnaire (KSQ). The benefit of KSQ is the ability to develop the best care plan for the patient, as well as to differentiate the efficacy of the administered treatment. The aim of this study was to validate the KSQ in Serbian speaking population of sarcoidosis patients. The test itself is a modular, multi-organ health status measure for patients with sarcoidosis for use in clinic and the evaluation of therapies. The correlation of KSQ with different clinical course of sarcoidosis (acute vs chronic disease) and with the clinical outcome status (COS) in sarcoidosis was also investigated. A total of 159 biopsy positive sarcoidosis patients participated in this study. The average age of the participants was 49.67, majority was female (67.3%) and majority had only pulmonary form of sarcoidosis (71.7%). KSQ - new disease-specific health status instrument, was compared with 5 other already existing instruments already used and validated in sarcoidosis (Saint George Respiratory Questionnaire- SGRQ, Daily Activity List -DAL, Fatigue Assessment Scale- FAS, Medical Research Council dyspnea scale-MRC, Borg Dyspnea Scale and 15D as general questionnaire. KSQ has significant correlation with other quality of life questionnaires already used in sarcoidosis. Translated version of KSQ shows significant internal reliability, similar to the original KSQ. Serbian version of KSQ has significant correlation with different clinical course of sarcoidosis and with COS as well. The translated version of KSQ is reliable sarcoidosis specific instrument for assessing health status in these patients.

Baseline Health Status and its Association With Subsequent Cardiovascular Events in Patients With Atrial Fibrillation

BackgroundClinical practice guidelines recommend optimizing the health status of patients with atrial fibrillation (AF) as a primary treatment goal. Whether disease-specific health status is associated with subsequent clinical events is unknown. ObjectivesThe aim of this study was to investigate the association between health status and subsequent clinical events among patients with AF. MethodsUsing a prospective cohort study of patients with new-onset AF referred to 11 hospitals (n = 3,313, 68.4% men, mean age 67.8 ± 11.6 years), data were extracted from 3,296 patients (99.4%) who completed the disease-specific Atrial Fibrillation Effects on Quality-of-Life (AFEQT) questionnaire between 2012 and 2018. Factors associated with baseline AFEQT overall summary (OS) score and associations between major adverse cardiovascular or neurologic events (MACNE; a composite of all-cause death, stroke, or new-onset heart failure hospitalization) over 2 years were investigated. ResultsOverall, 517 participants (15.6%) had poor to fair health status (AFEQT OS <60), and 1,035 (31.2%) had fair to good health status (AFEQT OS 60 to <80) at baseline. Female sex, younger age, family history of AF, higher baseline heart rate, paroxysmal AF, initial visit to the emergency department, and history of heart failure were associated with lower AFEQT OS scores. Of those, 226 participants (6.8%) experienced MACNE; restricted cubic spline analysis with adjustment for factors associated with baseline AFEQT score showed a nonlinear increase in the risk for MACNE with AFEQT OS score <80. The strongest associations were observed for baseline AFEQT daily activity scores (for AFEQT daily activity score of <80 vs ≥80, HR: 1.65; 95% CI: 1.21-2.25). ConclusionsDiminished health status in patients with AF is common and is independently associated with subsequent adverse cardiovascular events.

The association between social determinants of health and patient-centred outcomes in adults with heart failure with reduced ejection fraction.

To explore the associations between social determinants of health and patient-centred outcomes among adults with chronic heart failure with reduced ejection fraction. Cross-sectional online self-report survey. A survey assessing social determinants of health (demographics, socio-economic position, affordability of care and social support) and patient-centred outcomes, including the Kansas City Cardiomyopathy Questionnaire-12 and validated measures of medication adherence, treatment satisfaction, treatment burden and mental health, was completed by 512 adults with chronic heart failure with a reduced ejection fraction between 06 March and 29 June 2020. Multivariable analyses included linear and logistic regression. Female gender, having a care partner, and being offered financial assistance with medications were associated with worse health status, while perceiving medication as affordable and being married were associated with better health status. Females and having Medicaid, dual Medicaid/Medicare or no medical insurance were associated with a higher likelihood of depression, and non-white race/ethnicity was associated with less depression. Medication adherence was lower in patients having a care partner and offered financial assistance. Patients being offered financial and medication management assistance were more likely to be overwhelmed by the treatment burden, whereas those having some college education were less so. Social determinants of health are associated with patients' disease-specific health status, mental health and treatment satisfaction and burden. These findings underscore the importance of assessing social determinants of health in clinical practice and the need for developing and testing novel strategies to determine whether they improve patients' health. The relationship between social determinants of health- and patient-centred outcomes was assessed; affordability of care and social support factors were most strongly associated with outcomes for patients with chronic heart failure and reduced ejection fraction, underscoring the importance of assessing social determinants of health in routine clinical care. Social determinants of health data could potentially inform care delivery for patients with heart failure and reduced ejection fraction by helping to identify those who require additional support to manage their symptoms, access care and adhere to treatment. Social support and affordability of treatment were associated with most patient-centred outcomes, suggesting these factors may provide clinicians with an indicator of a patient's level of general well-being that could be assessed during routine follow-up care. This research followed the STROBE checklist for cross-sectional studies. Adults who have heart failure with reduced ejection fraction that consented to participate in the study provided the data used for all analyses reported on in the manuscript. Service users, caregivers or members of the public had no involvement in the study.

The Role of Gender Regarding the Outcomes of Pulmonary Rehabilitation in Patients with COPD: A Retrospective Study

PURPOSE: Our aim is to compare the pulmonary rehabilitation outcomes of male and female patients diagnosed with COPD.&#x0D; METHODS: Outpatient PR program, consisting of 16 sessions, two times a week for two months was applied to the patients with COPD (41 males, 41 females). arterial blood gas (ABG) analyzes and pulmonary function tests (PFT), 6-minute walking test (6MWT), dyspnea scale (mMRC), health-related quality of life (QoL) questionnaire (SF-36), disease-specific health status (SGRQ) were applied to all participants before and after PR.&#x0D; RESULTS: There was no statistically significant differences between the two groups before PR in terms of age, BMI, PFT parameters, and ABG results. Cigarette consumption was higher in men(p=0.02). Quality of life survey results (SGRQ, SF36), HAD anxiety, mMRC were similar in both groups before PR(p&gt;0.05 for all).After PR, both clinical and statistically significant improvements were detected in 6mWD in both groups (p

Abstract 9234: Evaluating the Association Between Perceived Discrimination and Health Status Outcomes Among Young Adults Hospitalized for Acute Myocardial Infarction

Background: Perceived discrimination is associated with several risk factors for acute myocardial infarction (AMI), but little is known about the association between discrimination and health status outcomes post-AMI. Methods: We analyzed the 1- and 12-month health status of 2,670 young (≤ 55 years) adults recovering from an AMI enrolled in the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients). Perceived discrimination was assessed using the Everyday Discrimination Scale (EDS). General health status was measured using the Short Form 12 Physical and Mental Component Scores (PCS and MCS). Disease-specific health status was measured using the following domains of the Seattle Angina Questionnaire (SAQ): treatment satisfaction (TS), quality of life (QL) and dichotomous forms of the physical limitation and angina frequency domain scores (score &lt; 100). Lower scores indicate worse health status. Multivariable linear regression of the PCS, MCS, TS, and QL scores and multivariable logistic regression of the dichotomous forms of physical limitation and angina frequency were used to assess their adjusted associations with perceived discrimination. Results: Nearly 35.0% of the cohort reported discrimination (EDS &gt; 0). At 1-month post-AMI, increased EDS score was significantly associated with lower MCS, TS, and QL scores and higher odds of physical limitation and angina after adjustment (Figure) . At 12-months post-AMI, increased EDS score retained its significant associations with lower MCS and QL scores and higher odds of physical limitation and angina, but not its association with TS (Figure) . The EDS score was not associated with PCS at either 1- or 12-months post-AMI. Conclusions: Perceived discrimination was associated with worse mental health and disease-specific health status one year after AMI after adjusting important confounders. Further work to understand the source and how to mitigate perceived discrimination is needed.

Abstract 14944: Comorbid Obesity in Symptomatic Peripheral Artery Disease: A Modifiable Factor Associated With Health Status

Introduction: Obesity is a modifiable risk factor for peripheral artery disease (PAD). While highly prevalent, the association between obesity and health status outcomes in PAD has not been studied. We aim to summarize obesity management and its association with health status in patients with PAD. Methods: We conducted a longitudinal cohort study of patients with symptomatic PAD from the international multicenter PORTRAIT registry. Body mass index (BMI) was analyzed continuously (per 10kg/m2) and categorically as underweight (BMI &lt; 18.5 kg/m 2 ), normal weight (BMI 18.5 - 24.9 kg/m 2 ), overweight (BMI 25 - 29.9 kg/m 2 ) and obesity (BMI &gt; 30 kg/m 2 ). Obesity management strategies included diet or weight counseling and anti-obesity medications. Disease-specific health status was assessed with the Peripheral Artery Questionnaire (PAQ) (range=0-100, higher scores indicate better health status). Linear regression models examined the association between obesity and both baseline and 12-month PAQ summary scores. Results: Obesity was present in 37% (370/989) of patients (mean age 68.0 + 9.1 years, 40.1% female). No patients received anti-obesity medications. Weight and/or diet counseling were prescribed in only 12% of overweight and in 21% of patients with obesity. BMI (per 10 kg/m 2 ) was associated with worse PAQ summary scores at baseline (-5.7, 95% CI -8.0 to -3.5, p &lt;0.01) and 12 months (-7.8, 95% CI -12.3 to -3.4, p &lt;0.01) in unadjusted and models adjusting for medical comorbidities and PAD-associated factors. This was consistent when obesity was compared categorically to normal/overweight at baseline (mean difference = -7.2, 95% CI -10.4 to -4.1, p&lt; 0.01) and at 12 months (-7.4, 95% CI -11.4 to -3.5, p&lt; 0.01). Conclusions: Obesity is a potentially modifiable comorbidity in PAD that is currently under addressed and a strong correlate of PAD-specific health status following PAD diagnosis and treatment.

Abstract 13672: Quality of Life Impact of Transcatheter Edge to Edge Repair of Mitral Valve With the Mitraclip System in Patients With Mitral Regurgitation and Cardiogenic Shock

Introduction: Transcatheter Edge to Edge Repair (TEER) of the mitral valve is a viable option for patients with moderate to severe mitral regurgitation (MR) who are at high surgical risk. TEER has been shown to improve quality of life (QOL) in patients with MR. Data is limited regarding QOL in patients with MR and cardiogenic shock (CS) who undergo TEER. Methods: A single-center, retrospective cohort study including adult patients with moderate to severe MR and CS who underwent TEER between January 2012 and December 2021. CS was defined as a sustained systolic blood pressure &lt;90mmHg for at least 1 hour, use of inotropes, vasopressors, or mechanical circulatory support, and clinical and lab findings of end-organ damage. The primary outcome was change in disease-specific health status (Kansas City Cardiomyopathy Questionnaire-Overall Summary score [KCCQ-OS] at 30 days. Statistical analysis was done using Wilcoxon signed-rank test and t-test. Results: Thirty-three patients with mod-severe MR and CS had undergone TEER (See table 1 for baseline characteristics) . KCCQ data were available on 30% survivors at 30 days. KCCQ increased from 17.19 (11.88) before TEER to 53.85 (30.89) in 30 days (mean change 36.67; 95% CI 14.24-59.09; P&lt;0.05, see table2). There was an improvement in 2 out of 4 KCCQ domains; symptoms frequency (mean change 49.17; 95% CI 18.17-80.16; P&lt;0.05) and social limitation (mean change 49.54; 95% CI 22.25-76.83); P&lt;0.05). Conclusion: TEER of the mitral valve improves QOL at 30 days in patients with moderate to severe MR and CS.

Effects of Pulmonary Rehabilitation Including Inspiratory Muscle Training in Patients with Chronic Obstructive Pulmonary Disease after Stratification by the Degree of Static Hyperinflation

Inspiratory muscle training (IMT) improves inspiratory muscle strength, exercise capacity and health status in patients with chronic obstructive pulmonary disease (COPD). However, there is no additional effect on top of comprehensive pulmonary rehabilitation (PR). It is unclear whether patients with different baseline degrees of static hyperinflation respond differentially to IMT as part of a PR program. Therefore, the aim was to study the effects of IMT as an add-on on PR after stratification for baseline degrees of static hyperinflation. In this single center retrospective study data were extracted between June 2013 and October 2020 of COPD patients who participated in a comprehensive PR program including IMT. IMT was performed twice daily, one session consisted of 3 series of 10 breaths and training intensity was set initially at a load of approximately 50% of patients' maximal static inspiratory mouth pressure (MIP). The primary outcome measure was MIP. Secondary outcomes were the distance achieved on the 6-min walk test (6MWD), endurance cycling exercise capacity at 75% of the peak work rate (CWRT) and disease-specific health status using the COPD assessment test. 754 patients with COPD were screened for eligibility and 328 were excluded because of repeated PR programs, missing data or baseline residual volume (RV) > 350%. In total, 426 COPD patients were categorized into RV categories 50-130% (n = 84), 131-165% (n = 86), 166-197% (n = 86), 198-234% (n = 85) and 235-349% (n = 85). In the whole sample, MIP, endurance exercise capacity and health status improved significantly. The change in 6MWD was higher in the lowest baseline degree of static hyperinflation [+ 39 (9-92) m] compared with the baseline highest degree of static hyperinflation [+ 11 (- 18-54) m] (p < 0.05). IMT as part of a PR program in patients with COPD with different baseline degrees improved MIP irrespective of the degree of static lung hyperinflation. Improvement in functional exercise capacity was significantly higher in the group with the lowest degree of static hyperinflation compared with the patients with the highest degree of static hyperinflation.

Health literacy and physical and mental health status in octogenarian patients with coronary artery disease - a prospective cohort multicentre study

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): MTG Holding AS Introduction The number of octogenarians (≥80 years of age) receiving percutaneous coronary intervention (PCI) is rising. Evidence supports that PCI improves quality of life and functional status in this group. Optimal health-promoting behaviour is strongly influenced by health literacy. However, there is limited knowledge about the association between health literacy, physical and mental health status in octogenarians. Purpose To determine if octogenarians health literacy is associated with generic and disease-specific physical and mental health status after PCI. Methods A prospective cohort study recruited 3417 participants from seven Danish and Norwegian PCI centres, and was conducted from June 2017 until May 2019. Multiple linear regression analysis was used. Health literacy was assessed by four of the nine scales from the Health Literacy Questionnaire (HLQ) (were higher score are better); "Social support for health" (scale range 1-4) "Appraisal of health information", (scale range 1-4) "Ability to find good health information" (scale range 1-5) and "Understand health information well enough to know what to do" (scale range 1-5). Generic physical and mental health status was assessed with RAND-12 at baseline (scale range 0-100, were higher score are better). After two months, disease-specific physical and mental health status was assessed with Myocardial Infarction Dimensional Assessment Scale (scale range 0-100, were lower score are better). Socio-demographic (age, gender, cohabitation status, education) and clinical variables (number of comorbidities) were included as covariates. Results In all, 318 octogenarians with mean age 83.4 years (range 80-96) participated, of which 69% were males. Three aspects of health literacy, "Social support for health", "Ability to find good health information" and "Understand health information well enough to know what to do", were significantly associated with health status. Specifically, for a unit increase of "Social support for health", the generic mental health status increased by 3 units (B: 3.0 [0.2 to 5.8] P=0.034). Further, a unit increase of "Ability to find good health information" was associated with a significant 4.2 higher disease-specific physical health and significant 5.3 higher disease-specific mental health (B:-4.2 [-8.0 to -0.4] P=0.029, B:-5.3 [-9.0 to -1.6] P=0.005, respectively). Finally, for a unit increase of "Understand health information well enough to know what to do" the disease-specific physical health improved by 5.1 units (B:-5.1 [-9.7 to -0.5] P=0.029) and disease-specific mental health improved by 5.2 units (B:-5.2 [-9.7 to -0.7] P=0.025). Conclusion In this study, we found that elements of health literacy were associated with both physical and mental health status in octogenerians. These findings highlight the importance of adequate health literacy and the need to support those with lower health literacy following PCI.

One-Year Health Status Outcomes Following Early Invasive and Noninvasive Treatment in Symptomatic Peripheral Artery Disease.

Lifestyle changes and medications are recommended as the first line of treatment for claudication, with revascularization considered for treatment-resistant symptoms, based on patients' preferences. Real-world evidence comparing health status outcomes of early invasive with noninvasive management strategies is lacking. In the international multicenter prospective observational PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry, disease-specific health status was assessed by the Peripheral Artery Questionnaire in patients with new-onset or worsening claudication at presentation and 3, 6, and 12 months later. One-year health status trajectories were compared by early revascularization versus noninvasive management on a propensity-matched sample using hierarchical generalized linear models for repeated measures adjusted for baseline health status. In a propensity-matched sample of 1000 patients (67.4±9.3 years, 62.8% male, and 82.4% White), 297 (29.7%) underwent early revascularization and 703 (70.3%) were managed noninvasively. Over 1 year of follow-up, patients who underwent early invasive management reported significantly higher health status than patients managed noninvasively (interaction term for time and treatment strategy; P<0.001 for all Peripheral Artery Questionnaire domains). The average 1-year change in Peripheral Artery Questionnaire summary scores was 30.8±25.2 in those undergoing early invasive, compared with 16.7±23.4 in those treated noninvasively (P<0.001). Patients with claudication undergoing early invasive treatment had greater health status improvements over the course of 1 year than those treated noninvasively. These data can be used to support shared decision-making with patients. URL: https://www. gov; Unique identifier: NCT01419080.

Association of Disease-Specific Health Status With Long-Term Survival in Peripheral Artery Disease.

BackgroundWhile peripheral artery disease (PAD) is associated with increased cardiovascular morbidity with mortality remaining high and challenging to predict, accurate understanding of serial PAD‐specific health status around the time of diagnosis may prognosticate long‐term mortality risk.Methods and ResultsPatients with new or worsening PAD symptoms enrolled in the PORTRAIT Registry across 10 US sites from 2011 to 2015 were included. Health status was assessed by the Peripheral Artery Questionnaire (PAQ) Summary score at baseline, 3‐month, and change from baseline to 3‐month follow‐up. Kaplan‐Meier using 3‐month landmark and hierarchical Cox regression models were constructed to assess the association of the PAQ with 5‐year all‐cause mortality. Of the 711 patients (mean age 68.8±9.6 years, 40.9% female, 72.7% white; mean PAQ 47.5±22.0 and 65.9±25.0 at baseline and 3‐month, respectively), 141 (19.8%) died over a median follow‐up of 4.1 years. In unadjusted models, baseline (HR, 0.90 per‐10‐point increment; 95% CI, 0.84–0.97; P=0.008), 3‐month (HR [95% CI], 0.87 [0.82–0.93]; P<0.001) and change in PAQ (HR [95% CI], 0.92 [0.85–0.99]; P=0.021) were each associated with mortality. In fully adjusted models including combination of scores, 3‐month PAQ was more strongly associated with mortality than either baseline (3‐month HR [95% CI], 0.85 [0.78–0.92]; P<0.001; C‐statistic, 0.77) or change (3‐month HR [95% CI], 0.79 [0.72–0.87]; P<0.001).ConclusionsPAD‐specific health status is independently associated with 5‐year survival in patients with new or worsening PAD symptoms, with the most recent assessment being most prognostic. Future work is needed to better understand how this information can be used proactively to optimize care.

Relationship between thoracic kyphosis angle, dyspnea perception, and disease-specific health status in patients with COPD

Purpose: This study was carried out to examine the relationship between thoracic kyphosis angle, dyspnea perception, and disease-specific health status in patients with COPD and thus to reveal the postural effect.Methods: A total of 105 patients (68.10±8.59 years, FEV1:47.59±21.50%) diagnosed with COPD were included in the study. The thoracic kyphosis angle was evaluated using the Spinal Mouse® device and the dyspnea perception with the Modified Medical Research Council (MMRC) Dyspnea Scale. For the disease-specific health status, the COPD Assessment Test (CAT) and the Clinical COPD Questionnaire (CCQ) were used. The patients were separated into three groups according to the thoracic kyphosis angle as Group 1: 20°-50°, Group 2: 51°-60°, and Group 3: 61°-90° and groups were compared.Results: While a significant positive relationship at a low level was observed between the thoracic kyphosis angle and the dyspnea perception (rho=0.23, p=0.02), no relationship was determined with the disease-specific health status (rho&amp;lt;0.20, p&amp;gt;0.05). CAT and CCQ scores were similar between groups (p&amp;gt;0.05). In group 3 with thoracic kyphosis angle&amp;gt;60°, the dyspnea perception was significantly higher (p=0.03).Conclusion: As the thoracic kyphosis angle increase in patients with COPD, the dyspnea perception increases, but the disease-specific health status remains stable. The postures of patients with COPD should be evaluated in detail in physiotherapy and rehabilitation practices due to increased dyspnea caused by thoracic kyphosis. Also, preventive measures such as exercise and ergonomic arrangements should be taken for thoracic kyphosis in the early period.

Clustering based on comorbidities in patients with chronic heart failure: an illustration of clinical diversity.

AimsIt is increasingly recognized that the presence of comorbidities substantially contributes to the disease burden in patients with heart failure (HF). Several reports have suggested that clustering of comorbidities can lead to improved characterization of the disease phenotypes, which may influence management of the individual patient. Therefore, we aimed to cluster patients with HF based on medical comorbidities and their treatment and, subsequently, compare the clinical characteristics between these clusters.Methods and resultsA total of 603 patients with HF entering an outpatient HF rehabilitation programme were included [median age 65 years (interquartile range 56–71), 57% ischaemic origin of cardiomyopathy, and left ventricular ejection fraction 35% (26–45)]. Exercise performance, daily life activities, disease‐specific health status, coping styles, and personality traits were assessed. In addition, the presence of 12 clinically relevant comorbidities was recorded, based on targeted diagnostics combined with applicable pharmacotherapies. Self‐organizing maps (SOMs; www.viscovery.net) were used to visualize clusters, generated by using a hybrid algorithm that applies the classical hierarchical cluster method of Ward on top of the SOM topology. Five clusters were identified: (1) a least comorbidities cluster; (2) a cachectic/implosive cluster; (3) a metabolic diabetes cluster; (4) a metabolic renal cluster; and (5) a psychologic cluster. Exercise performance, daily life activities, disease‐specific health status, coping styles, personality traits, and number of comorbidities were significantly different between these clusters.ConclusionsDistinct combinations of comorbidities could be identified in patients with HF. Therapy may be tailored based on these clusters as next step towards precision medicine. The effect of such an approach needs to be prospectively tested.

Abstract 12934: The Association of Health Literacy With Health Status Outcomes in Heart Failure Patients

Background: Low health literacy (HL) is a known barrier to care and is associated with worse overall health status. The association of HL with disease-specific health status in heart failure (HF) patients is unknown. To address this gap we used data from Hopeful Heart , a randomized trial examining the impact of two 12-month treatment strategies in patients with HF and depression vs usual care. Methods: Health literacy was assessed at baseline via a brief screening tool previously validated in patients with HFrEF, classifying patients into adequate vs. low literacy. HF-specific health status was quantified with the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at baseline, 3, 6, and 12 months. Using linear regression, we estimated the association of low HL with 12-month KCCQ-12 Summary Score, adjusting for treatment group, age, gender and LVEF. We also assessed the association of low HL with 12-month change in KCCQ-12, additionally adjusting for baseline score. Finally, we analyzed depression severity as a moderator in the interaction between HL and PROMIS-D depression score. Results: Among 756 patients, those with low HL (N=235, 31%) were similar in demographics (65±13 vs 64±13 years; 43% vs. 44% female; 24% vs. 28% non-White), but had less education (36% vs. 61% high school) and employment (10% vs. 19%) compared to those with adequate HL. Mean KCCQ-12 scores were consistently lower in participants with low HL at all time points (Figure). After adjusting for treatment group, age, sex, and LVEF, low HL was strongly associated with lower 12-month KCCQ-12 score (-9.5 points, CI [-13.7,-5.3]). After adjustment for baseline score, low HL remained associated with less improvement in KCCQ-12 (-5.9 points, CI [-9.7, -2.2]). Depressive symptoms did not moderate this association (interaction p=0.72). Conclusion: In patients with HF, low HL is associated with worse disease-specific health status and with poorer recovery in health status at 12-month follow up.

Abstract 13154: Association of Serial Health Status Measurements With Clinical Events: Insights From the ISCHEMIA Trial

Introduction: The Seattle Angina Questionnaire (SAQ), a disease-specific health status measure, has been shown to predict future clinical outcomes in patients with chronic coronary disease (CCD) at a single point in time. The prognostic value of serial SAQ scores in patients with CCD is unknown. Methods: Serial assessments of the 7-item SAQ were obtained in the ISCHEMIA trial of patients with CCD and moderate/severe ischemia. Using Cox regression, we examined the association of baseline and 3-month SAQ-7 Summary Scores (SAQ7-SS) with CV death, MI or unstable angina hospitalization over a 12 month period (between 3 and 15 months after randomization) in patients randomized to conservative treatment. We fit several models including: (a) baseline score only; (b) 3-month score only; (c) 3-month change only; (d) baseline and 3-month score; (e) 3-month change and score. Results: The mean age was 64.3 years in 2095 patients randomized to conservative care with SAQ scores at 1 and 3 months; 78% were men. Twelve-month event rates were 3.3% overall; 2.9% with a 3-month SAQ7-SS ≥75, and 6.9% in those with 3-month scores &lt;50. In unadjusted analyses, higher scores at baseline, 3 months, and greater 3-month improvement were associated with fewer clinical events (Figure 1a). In landmark analyses combining serial scores, neither baseline nor change were significant after adjustment for 3-month score (Figures 1b and 1c). Conclusions: We found that the most recent SAQ score was more predictive of subsequent clinical events than prior scores or changes. Following patients’ health status not only provides an assessment of their current angina control, but also a continuously updatable insight into their risk for subsequent cardiac events.

Patient representativeness of a peripheral artery disease cohort in a randomized control trial versus a real-world cohort: The CLEVER trial versus the PORTRAIT registry

IntroductionPeripheral artery disease (PAD) is a burdensome disease. It is unclear whether PAD cohorts enrolled in contemporary randomized control trials (RCT) are representative of the real-world PAD populations in terms of their patient characteristics. MethodsWe compared baseline patient characteristics and health status (as measured by the Peripheral Artery Questionnaire [PAQ]) between the randomized CLEVER study, and the real-world PORTRAIT registry. CLEVER was an RCT of PAD patients enrolled from 29 centers across the US and Canada comparing revascularization with stenting versus optimal medical therapy (OMT) and supervised exercise therapy (SET) plus OMT. PORTRAIT was a multicenter, prospective study of patients with new or worsening PAD symptoms across ten sites in the US. ResultsThe final cohort consisted of 879 patients (n = 119 from CLEVER, n = 760 from PORTRAIT (24.5% black, 41.4% women). While CLEVER enrolled patients with aortoiliac disease, only 16.0% of the PORTRAIT cohort had isolated aortoiliac disease. Compared with CLEVER, patients from PORTRAIT were older (64.0 ± 9.5 versus 68.9 ± 9.5 yrs., p ≤0.001), had more severe disease as measured by the ankle brachial index (0.7 ± 0.2 versus 0.9 ± 0.2, p ≤0.001) and a higher prevalence of cardiovascular risk factors including hyperlipidemia and diabetes (all p values<0.05). Both cohorts had similar disease-specific health status as measured by the PAQ summary score (47.4 ± 21.9 versus 43.6 ± 18.4, p = 0.07). ConclusionIn this comparative study, real-world patients with PAD were older and sicker when compared to an RCT with similar indications. This gap may be bridged by improving enrollment of underrepresented high-risk patients in PAD trials testing strategies for PAD symptom relief. Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT01419080?term=portrait&rank=1NCT01419080.

Advanced Dental Cleaning is Associated with Reduced Risk of COPD Exacerbations - A Randomized Controlled Trial.

PurposeInfections from the oral microbiome may lead to exacerbations of chronic obstructive pulmonary disease (COPD). We investigated whether advanced dental cleaning could reduce exacerbation frequency. Secondary outcomes were disease-specific health status, lung function, and whether the bacterial load and composition of plaque microbiome at baseline were associated with a difference in outcomes.Patients and MethodsOne-hundred-one primary and secondary care patients with COPD were randomized to intervention with advanced dental cleaning or to dental examination only, repeated after six months. At baseline and at 12 months, data of exacerbations, lung function, COPD Assessment Test (CAT) score, and periodontal status were collected from questionnaires, record review, and periodontal examination. Student’s t-test and Mann–Whitney-U (MWU) test compared changes in outcomes. The primary outcome variable was also assessed using multivariable linear regression with adjustment for potential confounders. Microbiome analyses of plaque samples taken at baseline were performed using Wilcoxon signed ranks tests for calculation of alpha diversity, per mutational multivariate analysis of variance for beta diversity, and receiver operating characteristic curves for prediction of outcomes based on machine learning models.ResultsIn the MWU test, the annual exacerbation frequency was significantly reduced in patients previously experiencing frequent exacerbations (p = 0.020) and in those with repeated advanced dental cleaning (p = 0.039) compared with the non-treated control group, but not in the total population including both patients with a single and repeated visits (p = 0.207). The result was confirmed in multivariable linear regression, where the risk of new exacerbations was significantly lower in patients both in the intention to treat analysis (regression coefficient 0.36 (95% CI 0.25–0.52), p < 0.0001) and in the population with repeated dental cleaning (0.16 (0.10–0.27), p < 0.0001). The composition of microbiome at baseline was moderately predictive of an increased risk of worsened health status at 12 months (AUC = 0.723).ConclusionAdvanced dental cleaning is associated with a reduced frequency of COPD exacerbations. Regular periodontal examination and dental cleaning may be of clinical importance to prevent COPD exacerbations.