Data-supported timely management in cooperation with a physician-staffed centre for telemedicine in advanced cardiac failure extract
RESULTS: The information retrieval identified 4 RCTs as relevant for the research question of the present benefit assessment. No planned or ongoing studies were identified. The last search was conducted on 9 May 2019. In the included studies, the data were either measured automatically by the implan...
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| Format: | eBook |
| Language: | English |
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Köln, Germany
Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen
[2019], 2019
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| Edition: | Version 1.0 |
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | RESULTS: The information retrieval identified 4 RCTs as relevant for the research question of the present benefit assessment. No planned or ongoing studies were identified. The last search was conducted on 9 May 2019. In the included studies, the data were either measured automatically by the implanted device (implantable cardioverter defibrillator [ICD] or cardiac resynchronization therapy [CRT]) and transmitted daily without involvement of the patients, or the patients themselves performed measurements once a day using external, non-invasive devices, and assessed their state of health. The data were then transmitted automatically. The risk of bias was high in all studies. The follow-up observation period was between 12 months and 24 months. CONCLUSION: The 4 included studies investigated 2 different telemonitoring strategies with defined minimum requirements. On 28 March 2019, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) with the assessment of data-supported timely management in cooperation with a physician-staffed centre for telemedicine (hereinafter also referred to as "telemonitoring with defined minimum requirements") for patients with advanced cardiac failure.RESEARCH QUESTION: The aim of the present report is the benefit assessment of telemonitoring with defined minimum requirements in addition to standard care and the resulting interventions as management strategy in comparison with standard care without telemonitoring in patients with advanced cardiac failure regarding patient-relevant outcomes. METHODS: The target population of the benefit assessment consisted of patients with advanced cardiac failure. Studies with at least 6 months of follow-up observation were included. A systematic literature search for studies was conducted in the following databases: MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. In parallel, a search for relevant systematic reviews was conducted in the databases MEDLINE, Embase and the Cochrane Database of Systematic Reviews. In addition, the following information sources and search techniques were considered: study registries, documents sent by the G-BA, the websites of G-BA and IQWiG, as well as the screening of reference lists and author queries. In order to assess the qualitative certainty of the results, the criteria of the risk of bias across outcomes were evaluated, and the risk of bias was classified as low or high. If the studies were comparable regarding the research question and relevant characteristics and no relevant heterogeneity was observed, the individual results were pooled quantitatively by means of meta-analyses. There was no hint of a benefit or harm of telemonitoring with defined minimum requirements for the following outcomes: hospitalization overall, cardiovascular hospitalization, stroke, cardiac arrhythmia requiring treatment, thromboembolic events, shocks delivered by a cardiac device and morbidity due to cardiac failure. Due to the incomplete data, no conclusion on the benefit was drawn for the following outcomes: serious adverse events (SAEs), depressive symptoms, cardiac decompensation, health status and health-related quality of life In telemonitoring type 1, the data were automatically measured by the implanted device (ICD or CRT-defibrillator [CRT-D]), no involvement of the patient was necessary. In telemonitoring type 2, it was the patient's task to measure the data using external, non-invasive devices. Including all studies, there was no hint of a benefit or harm of telemonitoring for the outcome "all-cause mortality". Data for the subgroups of patients with and without depressive symptoms were only available for telemonitoring type 2. For the outcome "all-cause mortality", there was an indication of a benefit for patients without depressive symptoms. The joint consideration of telemonitoring type 1 and type 2 showed a hint of a benefit for the outcome "cardiovascular mortality". The experimental intervention was telemonitoring with defined minimum requirements in addition to standard care and the resulting interventions as management strategy. Telemonitoring had to have the following specifics: at least daily transmission of at least the following parameters to a telemonitoring centre: heart rate and rhythm, as well as information on the general state of health (e.g. from self-assessment questionnaires or data on physical activity); close analysis of the data by a telemonitoring centre under the responsibility of a physician in addition to the treating physician; defined maximum reaction times of the telemonitoring centre (up to 1 working day) or of the treating physician (within 24 hours after knowledge). The comparator treatment was standard care without telemonitoring. Patient-relevant outcomes were considered in the assessment. Only randomized controlled trials (RCTs) were included in the benefit assessment. |
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| Item Description: | "Translation of chapters 1 to 8 and Appendix A of the rapid report N19-01 Datengestütztes, zeitnahes Management in Zusammenarbeit mit einem ärztlichen telemedizinischen Zentrum bei fortgeschrittener Herzinsuffizienz (Version 1.0; Status: 27 September 2019 [German original], 28 November 2019 [English translation])"--Title page |
| Physical Description: | 1 PDF file (viii, 65 pages) illustrations |