Association of patient-reported outcomes and heart rate trends in heart failure: a report from the Chiron project.
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SUBMITTER: Monzo L
PROVIDER: S-EPMC6969136 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
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Association of patient-reported outcomes and heart rate trends in heart failure: a report from the Chiron project.
Monzo Luca L Schiariti Michele M Calvisi Pietro Fedele PF Bonfiglio Silvio S Luštrek Mitja M Puddu Paolo E PE
Scientific reports 20200117 1
Patient-reported outcomes (PROs) have been previously considered "soft" end-points because of the lack of association of the reported outcome to measurable biological parameters. The present study aimed to assess whether electrocardiographic measures are associated to PROs changes. We evaluated the association between heart rate (HR), QRS and QT/QTc durations and PROs, classified as "good" or "bad" according to the patients' overall feeling of health, in patients from the Chiron project. Twenty- ...[more]
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Project description:Background Heart failure (HF) is the leading cause of mortality and associated with significant morbidity in adults with congenital heart disease. We sought to assess the association between HF and patient-report outcomes in adults with congenital heart disease. Methods and Results As part of the APPROACH-IS (Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease-International Study), we collected data on HF status and patient-reported outcomes in 3959 patients from 15 countries across 5 continents. Patient-report outcomes were: perceived health status (12-item Short Form Health Survey), quality of life (Linear Analogue Scale and Satisfaction with Life Scale), sense of coherence-13, psychological distress (Hospital Anxiety and Depression Scale), and illness perception (Brief Illness Perception Questionnaire). In this sample, 137 (3.5%) had HF at the time of investigation, 298 (7.5%) had a history of HF, and 3524 (89.0%) had no current or past episode of HF. Patients with current or past HF were older and had a higher prevalence of complex congenital heart disease, arrhythmias, implantable cardioverter-defibrillators, other clinical comorbidities, and mood disorders than those who never had HF. Patients with HF had worse physical functioning, mental functioning, quality of life, satisfaction with life, sense of coherence, depressive symptoms, and illness perception scores. Magnitudes of differences were large for physical functioning and illness perception and moderate for mental functioning, quality of life, and depressive symptoms. Conclusions HF in adults with congenital heart disease is associated with poorer patient-reported outcomes, with large effect sizes for physical functioning and illness perception. Registration URL: https://clinicaltrials.gov; Unique identifier: NCT02150603.
| S-EPMC9238599 | biostudies-literature
Project description:Background Patient-reported outcomes (PROs) are important measures of treatment response in heart failure. We assessed temporal trends in and factors associated with inclusion of PROs in heart failure randomized controlled trials (RCTs). Methods and Results We searched MEDLINE, Embase, and CINAHL for studies published between January 2000 and July 2020 in journals with an impact factor ≥10. We assessed temporal trends using the Jonckheere-Terpstra test and conducted multivariable logistic regression to explore trial characteristics associated with PRO inclusion. We assessed the quality of PRO reporting using the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. Of 417 RCTs included, PROs were reported in 226 (54.2%; 95% CI, 49.3%-59.1%), with increased reporting between 2000 and 2020 (P<0.001). The odds of PRO inclusion were greater in RCTs that were published in recent years (adjusted odds ratio [aOR] per year, 1.08; 95% CI, 1.04-1.12; P<0.001), multicenter (aOR, 1.89; 95% CI, 1.03-3.46; P=0.040), medium-sized (aOR, 2.35; 95% CI, 1.26-4.40; P=0.008), coordinated in Central and South America (aOR, 5.93; 95% CI, 1.14-30.97; P=0.035), and tested health service (aOR, 3.12; 95% CI, 1.49-6.55; P=0.003), device/surgical (aOR, 6.66; 95% CI, 3.15-14.05; P<0.001), or exercise (aOR, 4.66; 95% CI, 1.81-12.00; P=0.001) interventions. RCTs reported a median of 4 (interquartile interval , 3-6) of a possible of 11 CONSORT PRO items. Conclusions Just over half of all heart failure RCTs published in high impact factor journals between 2000 and 2020 included PROs, with increased inclusion of PROs over time. Trials that were large, tested pharmaceutical interventions, and coordinated in North America / Europe had lower adjusted odds of reporting PROs relative to other trials. The quality of PRO reporting was modest.
| S-EPMC8751837 | biostudies-literature
Project description:This paper addresses patient-reported outcomes (PROs) and telemonitoring in congestive heart failure (CHF), both increasingly important topics. The interest in CHF trials is shifting from hard end-points such as hospitalization and mortality, to softer end-points such health-related quality of life. However, the relation of these softer end-points to objective parameters is not well studied. Telemonitoring is suitable for collecting both patient-reported outcomes and objective parameters. Most telemonitoring studies, however, do not take full advantage of the available sensor technology and intelligent data analysis. The Chiron clinical observational study was performed among 24 CHF patients (17 men and 7 women, age 62.9 ± 9.4 years, 15 NYHA class II and 9 class III, 10 of ishaemic, aetiology, 6 dilated, 2 valvular, and 6 of multiple aetiologies or cardiomyopathy) in Italy and UK. A large number of physiological and ambient parameters were collected by wearable and other devices, together with PROs describing how well the patients felt, over 1,086 days of observation. The resulting data were mined for relations between the objective parameters and the PROs. The objective parameters (humidity, ambient temperature, blood pressure, SpO2, and sweeting intensity) could predict the PROs with accuracies up to 86% and AUC up to 0.83, making this the first report providing evidence for ambient and physiological parameters to be objectively related to PROs in CHF patients. We also analyzed the relations in the predictive models, gaining some insights into what affects the feeling of health, which was also generally not attempted in previous investigations. The paper strongly points to the possibility of using PROs as primary end-points in future trials.
| S-EPMC5832202 | biostudies-literature
Project description:AimsAdmission rates for acute decompensated heart failure (HF) declined during the COVID-19 pandemic. However, the impact of this reduction on hospital mortality is unknown. We describe temporal trends in the presentation of patients with acute HF and their in-hospital outcomes at two referral centres in London during the COVID-19 pandemic.Methods and resultsA total of 1372 patients hospitalized for HF in two referral centres in South London between 7 January and 14 June 2020 were included in the study and their outcomes compared with those of equivalent patients of the same time period in 2019. The primary outcome was all-cause in-hospital mortality. The number of HF hospitalizations was significantly reduced during the COVID-19 pandemic, compared with 2019 (P < 0.001). Specifically, we observed a temporary reduction in hospitalizations during the COVID-19 peak, followed by a return to 2019 levels. Patients admitted during the COVID-19 pandemic had demographic characteristics similar to those admitted during the equivalent period in 2019. However, in-hospital mortality was significantly higher in 2020 than in 2019 (P = 0.015). Hospitalization in 2020 was independently associated with worse in-hospital mortality (hazard ratio 2.23, 95% confidence interval 1.34-3.72; P = 0.002).ConclusionsDuring the COVID-19 pandemic there was a reduction in HF hospitalization and a higher rate of in-hospital mortality. Hospitalization for HF in 2020 is independently associated with more adverse outcomes. Further studies are required to investigate the predictors of these adverse outcomes to help inform potential changes to the management of HF patients while some constraints to usual care remain.
| S-EPMC7461082 | biostudies-literature
Project description:BackgroundWith the onset of coronavirus disease 2019 (COVID-19), the delivery of routine outpatient heart failure (HF) care abruptly shifted to telehealth. Appropriate HF management extensively relies upon patient-reported symptoms. With the growing attention towards patient-centered care, our team recognized an invaluable opportunity to solicit patient-reported subjective experiences regarding telehealth.MethodsIn total, 127 patients with a known diagnosis of HF were contacted by phone for participation in an online questionnaire. The tool consisted of questions generated by the investigators and from prior validated patient-reported experience measures. The intention was to assess the quality of care in our HF clinic and to solicit feedback regarding telehealth.ResultsThirty-five patients provided a response. Questions with the most favorable outcomes were in line with our predetermined themes of interpersonal matter, communication, and perceived quality of care. The worst performing questions exhibited a lack of satisfaction with and perceived quality of telehealth. Only 9% (n = 3) preferred follow-up via telehealth, 69% (n = 22) preferred in-person, and 22% (n = 7) were indifferent.ConclusionsGiven the multitude of benefits of telehealth, especially appropriate social distancing, telehealth is quite likely here to stay. In sum, with the rapid change in care delivery, patients currently perceive the care delivered via telehealth to be of inferior quality. This lack of quality can be largely attributed to the lack of physical examination, depersonalization of healthcare, and likely, a lack of familiarity with the platform. We urge our colleagues to solicit similar feedback from their patients to improve their own telehealth efforts.
| S-EPMC8139753 | biostudies-literature
Project description:AimsThe aim of this study is to use six previously described heart failure with preserved ejection fraction (HFpEF) phenotypes to describe differences in (i) the biological response to spironolactone, (ii) clinical endpoints, and (iii) patient-reported health status by HFpEF phenotype and treatment arm in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial (TOPCAT).Methods and resultsWe analysed 1767 patients in TOPCAT from the Americas. Using 11 clinical variables, patients were classified according to six HFpEF phenotypes previously identified in the I-PRESERVE and CHARM-Preserved studies. Kansas City Cardiomyopathy Questionnaire (KCCQ) measured health status. All phenotypes showed increase in potassium with spironolactone, although only three phenotypes showed significant increase in creatinine, and two phenotypes showed significant decrease in systolic blood pressure. Rate of the TOPCAT primary outcome (cardiovascular death, aborted cardiac arrest, or heart failure hospitalization) differed by HFpEF phenotype (P < 0.001) but not by treatment arm within each HFpEF phenotype. Baseline KCCQ score differed by HFpEF phenotype (P < 0.001), although some phenotypes with poor health status had lower rates of the TOPCAT primary outcome, and some phenotypes with better health status had higher rates of the TOPCAT primary outcome. However, within 3/6 phenotypes, higher baseline KCCQ score was associated with lower risk of the TOPCAT primary outcome. Change in KCCQ scores at 4 and 12 months did not differ among HFpEF phenotypes overall or by treatment arm.ConclusionsComplex, data-driven HFpEF phenotypes differ according to biological response to spironolactone, baseline health status, and clinical endpoints. These differences may inform the design of targeted clinical trials focusing on improvement in outcomes most relevant for specific HFpEF phenotypes.
| S-EPMC7261552 | biostudies-literature
Project description:AimsThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is a widely used patient-reported outcome measure in heart failure (HF). The KCCQ was validated in patients with HF with reduced ejection fraction (HFrEF), leaving knowledge gaps regarding its applicability in HF with preserved ejection fraction (HFpEF). This study addresses the psychometric properties of internal consistency and reliability, construct, and known-group validity of KCCQ in both HFrEF and HFpEF. We aimed to evaluate the psychometric properties of the KCCQ and their prognostic significance in HFpEF and HFrEF, within a large prospective multinational HF cohort.Methods and resultsWe examined the 23-item KCCQ in the prospective multinational ASIAN-HF study [4470 HFrEF (ejection fraction <40%); 921 HFpEF (ejection fraction ≥50%)]. Internal consistency (using Cronbach's alpha) showed high reliability in HFrEF and HFpeF: functional status score: 0.89 and 0.91 and clinical summary score: 0.89 and 0.90, respectively. Confirmatory factor analysis in HFrEF validated the five original domains of KCCQ (physical function, symptoms, self-efficacy, social limitation, and quality of life); in HFpEF, questions measuring physical function and social limitation had strong correlation (r = 0.66) and different domains emerged. We proposed an additional physical independence summary score, especially in HFpEF (comprising the original physical function and social limitation domains), which showed good internal consistency (α = 0.89) and has comparable receiver operating characteristic curve 0.766 ± 0.037 with the clinical summary score (receiver operating characteristic curve 0.774 ± 0.037), in predicting 1 year death and/or HF hospitalization.ConclusionsOur results confirmed the robustness of the KCCQ clinical summary score in HF regardless of ejection fraction group. In the assessment of physical capacity in HFpEF, our results suggest strong interaction with social limitation, and we propose a summary score comprising both components be used.
| S-EPMC7524068 | biostudies-literature
Project description:BackgroundPatient-reported outcomes (PROs) can be obtained outside hospitals and are of great significance for evaluation of patients with chronic heart failure (CHF). The aim of this study was to establish a prediction model using PROs for out-of-hospital patients.MethodsCHF-PRO were collected in 941 patients with CHF from a prospective cohort. Primary endpoints were all-cause mortality, HF hospitalization, and major adverse cardiovascular events (MACEs). To establish prognosis models during the two years follow-up, six machine learning methods were used, including logistic regression, random forest classifier, extreme gradient boosting (XGBoost), light gradient boosting machine, naive bayes, and multilayer perceptron. Models were established in four steps, namely, using general information as predictors, using four domains of CHF-PRO, using both of them and adjusting the parameters. The discrimination and calibration were then estimated. Further analyze were performed for the best model. The top prediction variables were further assessed. The Shapley additive explanations (SHAP) method was used to explain black boxes of the models. Moreover, a self-made web-based risk calculator was established to facilitate the clinical application.ResultsCHF-PRO showed strong prediction value and improved the performance of the models. Among the approaches, XGBoost of the parameter adjustment model had the highest prediction performance with an area under the curve of 0.754 (95% CI: 0.737 to 0.761) for death, 0.718 (95% CI: 0.717 to 0.721) for HF rehospitalization and 0.670 (95% CI: 0.595 to 0.710) for MACEs. The four domains of CHF-PRO, especially the physical domain, showed the most significant impact on the prediction of outcomes.ConclusionCHF-PRO showed strong prediction value in the models. The XGBoost models using variables based on CHF-PRO and the patient's general information provide prognostic assessment for patients with CHF. The self-made web-based risk calculator can be conveniently used to predict the prognosis for patients after discharge.Clinical trial registrationURL: http://www.chictr.org.cn/index.aspx ; Unique identifier: ChiCTR2100043337.
| S-EPMC10053412 | biostudies-literature
Project description:ObjectivesWe aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE.MethodsA cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification.ResultsAt baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score.ConclusionsOur study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF.Trial registration numberNCT01794715; Results.
| S-EPMC5372075 | biostudies-literature
Project description:Background:The interest of health care agencies, private payers and policy makers for patient-reported outcomes (PRO) is continuously increasing. There is a substantial need to improve capacity to collect and interpret relevant PRO data to support implementation of patient-centered research and optimal care in haemophilia. The Patient Reported Outcomes, Burdens and Experiences (PROBE) Project aims to develop a patient-led research network, to develop a standardized questionnaire to gather patient-reported outcomes and to perform a feasibility study of implementing the PROBE questionnaire. Methods:A pilot questionnaire was developed using focus group methodology. Content and face validity were assessed by a pool of persons living with haemophilia (PWH) and content experts through interactive workshops. The PROBE questionnaire was translated with the forward-backward approach. PROBE recruited national haemophilia patient non-governmental organizations (NGOs) to administer the questionnaire to people with and without haemophilia. PROBE measured the time to complete the questionnaire and gathered feedback on its content and clarity; staff time and cost required to implement the questionnaire were also collected. Results:The PROBE questionnaire is comprised of four major sections (demographic data, general health problems, haemophilia-related health problems and health-related quality of life using EQ-5D-5L and EQ-VAS). Seventeen NGOs participated in the pilot study of the PROBE Project, recruiting 656 participants. Of these, 71% completed the questionnaire within 15 min, and all participants completed within 30 min. The median total staff and volunteer time required for the NGOs to carry out the study within their country was 9 h (range 2 to 40 h). NGO costs ranged from $22.00 to $543.00 USD per country, with printing and postage being the most commonly reported expenditures. Conclusions:The PROBE questionnaire assesses patient-important reported outcomes in PWH and control participants, with a demonstrated short completion time. PROBE proved the feasibility to engage diverse patient communities in the structured generation of real-world outcome research at all stages. Trial registration:Trial registration: NCT02439710.
| S-EPMC5828307 | biostudies-literature