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Reporting of patient-centred outcomes in heart failure trials: are patient preferences being ignored?

ABSTRACT: Older people often suffer from multiple diseases. Therefore, universal cross-disease outcomes (e.g. functional status, quality of life, overall survival) are more relevant than disease-specific outcomes, and a range of potential outcomes are needed for medical decision-making. To assess how patient-relevant outcomes have penetrated randomized controlled trials (RCTs), reporting of these outcomes was reviewed in heart failure trials that included patients with multimorbidity. We systematically reviewed RCTs (Jan 2011-June 2012) and evaluated reported outcomes. Heart failure was chosen as condition of interest as this is common among older patients with multimorbidity. The main outcome was the proportion of RCTs reporting all-cause mortality, all-cause hospital admission, and outcomes in four domains of health, i.e. functional, signs and symptoms, psychological, and social domains. Of the 106 included RCTs, 50 (47 %) reported all-cause mortality and cardiovascular mortality and 29 (27 %) reported all-cause hospitalization and cardiovascular hospitalization. Of all trials, 68 (64 %) measured outcomes in the functional domain, 80 (75 %) in the domain of signs and symptoms, 65 (61 %) in the psychological domain, and 59 (56 %) in the social domain. Disease-specific instruments were more often used than non-disease-specific instruments. This review shows increasing attention for more patient-relevant outcomes; this is promising and indicates more awareness of the importance of a variety of outcomes desirable for patients. However, patients' individual goal attainments were universally absent. For continued progress in patient-centred care, efforts are needed to develop these outcomes, study their merits and pitfalls, and intensify their use in research.

SUBMITTER: Blom JW

PROVIDER: S-EPMC4464642 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe management of heart failure (HF) is challenging because of the complexities in recommended therapies. Integrated disease management (IDM) is an effective model, promoting guideline-directed care, but the impact of IDM in the community setting requires further evaluation.MethodsA retrospective evaluation of community-based IDM. Patient characteristics were described, and outcomes using a pre- and post-intervention design were HF-related health-service use, quality of life, and concordance with guideline-directed medical therapy (GDMT).Results715 patients were treated in the program (2016 to 2023), 219 in a community specialist-care clinic, and 496 in 25 primary-care clinics. The overall cohort was predominantly male (60%), with a mean age of 73.5 years (± 10.7), and 60% with HF with reduced ejection fraction. In patients with ≥ 6 months of follow-up (n = 267), pre vs post annualized rates of HF-related acute health-service use decreased from 36.3 to 8.5 hospitalizations per 100 patients per year, P < 0.0001, from 31.8 to 13.1 emergency department visits per 100 patients per year, P < 0.0001, and from 152.8 to 110.0 urgent physician visits per 100 patients per year, P = 0.0001. The level of concordance with GDMT improved; the number of patients receiving triple therapy and quadruple therapy increased by 10.1% (95% confidence interval [CI], 2.4%,17.8%) and 19.6% (95% CI, 12.0%, 27.3%), respectively. Within these groups, optimal dosing was achieved in 42.5% (95% CI, 32.0%, 53.6%) and 35.0% (95% CI, 23.1%, 48.4%), respectively. In patients with at least one follow-up visit (n = 286), > 50% experienced a clinically relevant improvement in their quality of life.ConclusionsA community-based IDM program for HF, may reduce HF-related acute health-service use, improve quality of life and level of concordance with GDMT. These encouraging preliminary outcomes from a real-world program evaluation require confirmation in a randomized controlled trial.

Project description:IntroductionChina faces the prospect of a large growth in the prevalence of heart failure (HF). However, there is limited knowledge about outcomes in patients after HF hospitalisations, including patient-reported outcomes (PROs). This paper is to present the study goal, methodology and data collection of the China Patient-centred Evaluative Assessment of Cardiac Events Prospective Heart Failure Study (China PEACE 5p-HF Study).Methods and analysisThe China PEACE 5p-HF Study, a prospective cohort study, will enrol 5000 patients with HF during 2016-2018 from 52 diverse hospitals throughout China and the follow-up period will be 12 months. Information on patients' medical history, in-hospital treatment and in-hospital outcomes are being abstracted from medical records. Details of patients' demographics, socioeconomic status, cardiovascular risk factors, access to healthcare services are being collected through comprehensive baseline interviews. Generic and disease-specific health status, depression, stress, anxiety and cognitive function are being administered using validated PRO instruments. Follow-up interviews will capture PROs and hospitalisation events at 1, 6 and 12 months follow-up. Standardised transthoracic echocardiograms and 6 min walk tests are being done in patients who enrolled in hospitals with these facilities at baseline and at 1 and 12 months after discharge. Collection of blood and urine samples are also being conducted at baseline, 1 and 12 months follow-up and stored for future analyses.Ethics and disseminationThe National Center for Cardiovascular Diseases/Fuwai Hospital ethics committee approved this study, and all collaborating hospitals received approval from their local ethics committee. Written informed consent will be obtained from all patients. Findings will be disseminated in future peer-reviewed papers and will help to support improvements in the quality of care for HF nationwide.Trial registration numberNCT02878811.

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Reporting of patient-centred outcomes in heart failure trials: are patient preferences being ignored?

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