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Telemedicine in heart failure (HF) management may positively impact health outcomes, but varied effects in studies hinder guidance in HF guidelines. Evidence on the effectiveness of telemedicine in HF subpopulations is limited. We conducted a scoping review to evaluate and synthesise evidence on the effectiveness of telemedicine across HF subpopulations that could guide telemedicine strategies in routine practice. Meta-analyses concerning randomised controlled trials (RCTs) with subgroup analyses on telemedicine effectives were identified in PubMed. We identified 15 RCTs, encompassing 21 different subgroups based on characteristics of HF patients. Findings varied across studies and no definite evidence was found about which patients benefit most from telemedicine. Subgroup definitions were inconsistent, not always a priori defined and subgroups contained few patients. Some studies found heterogeneous effects of telemedicine on mortality and hospitalisation across subgroups defined by: New York Heart Association (NYHA) classification, previous HF decompensation, implantable device, concurrent depression, time since hospital discharge and duration of HF. Patients represented in the RCTs were mostly male, aged 65-75 years, with HF with reduced ejection fraction and NYHA class II/III. Traditional RCTs have not been able to provide clinicians with guidance; continuous real-world evidence generation could enhance monitoring and identify who benefits from telemedicine.
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INTRODUCTION: Meta-analyses show postive effects of telemedicine in heart failure (HF) management on hospitalisation, mortality and costs. However, these effects are heterogeneous due to variation in the included HF population, the telemedicine components and the quality of the comparator usual care. Still, telemedicine is gaining acceptance in HF management. The current nationwide study aims to identify (1) in which subgroup(s) of patients with HF telemedicine is (cost-)effective and (2) which components of telemedicine are most (cost-)effective. METHODS AND ANALYSIS: The RELEASE-HF ('REsponsible roLl-out of E-heAlth through Systematic Evaluation - Heart Failure') study is a multicentre, observational, registry-based cohort study that plans to enrol 6480 patients with HF using data from the HF registry facilitated by the Netherlands Heart Registration. Collected data include patient characteristics, treatment information and clinical outcomes, and are measured at HF diagnosis and at 6 and 12 months afterwards. The components of telemedicine are described at the hospital level based on closed-ended interviews with clinicians and at the patient level based on additional data extracted from electronic health records and telemedicine-generated data. The costs of telemedicine are calculated using registration data and interviews with clinicians and finance department staff. To overcome missing data, additional national databases will be linked to the HF registry if feasible. Heterogeneity of the effects of offering telemedicine compared with not offering on days alive without unplanned hospitalisations in 1 year is assessed across predefined patient characteristics using exploratory stratified analyses. The effects of telemedicine components are assessed by fitting separate models for component contrasts. ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). Results will be published in peer-reviewed journals and presented at (inter)national conferences. Effective telemedicine scenarios will be proposed among hospitals throughout the country and abroad, if applicable and feasible. TRIAL REGISTRATION NUMBER: NCT05654961.
Assuntos
Insuficiência Cardíaca , Telemedicina , Humanos , Estudos de Coortes , Países Baixos , Sistema de Registros , Telemedicina/métodos , Estudos Observacionais como AssuntoRESUMO
OBJECTIVES: To assess the internal and external validity of a cluster randomized controlled trial (cRCT) evaluating a decision tool with supportive interventions for the empirical treatment of urinary tract infections (UTIs) in nursing homes (NHs), and to identify facilitators and barriers in implementing this antibiotic stewardship intervention. DESIGN: Mixed-methods process evaluation study. SETTING AND PARTICIPANTS: Physicians, nursing staff, client council members, and residents of Dutch NHs. METHODS: We used cRCT data of the ANNA study (Antibiotic Prescribing and Non-prescribing in Nursing Home Residents With Signs and Symptoms Ascribed to Urinary Tract Infection). In addition, we sent out an online evaluation questionnaire, conducted semistructured interviews with physicians and nursing staff, and consulted client council members. RESULTS: Internal validity was lowered: control group physicians participated in several non-study-related activities regarding UTI. External validity was good: almost all intervention components had a high fidelity (52%-74%) and were perceived as relevant (physicians: 7.2-8.6 of 10, nursing staff: 6.5-8.5 of 10) and feasible (physicians: 7.5 of 10, nursing staff 6.4 of 10), with feasibility for residents with dementia and urine incontinence needing attention. The most common reason for deviating from the advice generated by the decision tool was an unclear illness presentation. Identified facilitators to implementation were confidence in the intervention, repeated intervention encounter, and having "champions" in the NH. Barriers were limited involvement of nursing staff, unstable nursing teams, residents' and representatives' belief that antibiotics should be prescribed, and a low antibiotic prescribing threshold within the NH culture. CONCLUSIONS AND IMPLICATIONS: Lowered internal validity may have reduced the study effect. Attention should be paid to the feasibility of the intervention in residents with dementia and urinary incontinence. Improvement opportunities for implementation were higher nursing staff involvement and repeated intervention offering.