Evidence map›Paper›PMID 30016396›Full record

Trial reportEuropean heart journal. Quality of care & clinical outcomes2019

Remote monitoring and clinical outcomes: details on information flow and workflow in the IN-TIME study.

Daniela Husser, Johann Christoph Geller, Miloš Taborsky, Rolf Schomburg, Frank Bode, Jens Cosedis Nielsen, Christoph Stellbrink, Carsten Meincke, Søren Pihlkjær Hjortshøj, Jürgen Schrader and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in European heart journal. Quality of care & clinical outcomes, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. 2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
    Article
  9. Article
  10. Review
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Daniela HusserHeart Center Leipzig, Strümpelstr., 39, Leipzig, Germany.
Johann Christoph GellerZentralklinik Bad Berka, Robert-Koch-Allee 9, Bad Berka, Germany.
Miloš TaborskyOlomouc University Hospital, I.P., Pavlova 6, Olomouc, Czech Republic.
Rolf SchomburgSegeberger Kliniken, Am Kurpark 1, Bad Segeberg, Germany.
Frank BodeSana Kliniken Ostholstein, Mühlenkamp 5, Oldenburg, Germany.
Jens Cosedis NielsenAarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus, Denmark.
Christoph StellbrinkKlinikum Bielefeld, Teutoburger Str. 50, Bielefeld, Germany.
Carsten MeinckeVivantes Klinikum Neukölln, Rudower Straße 48, Berlin, Germany.
Søren Pihlkjær HjortshøjAalborg University Hospital, Søndre Skovvej 15, Aalborg, Denmark.
Jürgen SchraderBiotronik SE & Co.KG, Woermannkehre 1, Berlin, Germany.
Thorsten LewalterPeter Osypka Heart Center, Am Isarkanal 36, München, Germany.
Gerhard HindricksHeart Center Leipzig, Strümpelstr., 39, Leipzig, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsRandomized clinical trials investigating a possible outcome effect of remote monitoring in patients with implantable defibrillators have shown conflicting results. This study analyses the information flow and workflow details from the IN-TIME study and discusses whether differences of message content, information speed and completeness, and workflow may contribute to the heterogeneous results. METHODS AND

resultsIN-TIME randomized 664 patients with an implantable cardioverter/defibrillator indication to daily remote monitoring vs. control. After 12 months, a composite clinical score and all-cause mortality were improved in the remote monitoring arm. Messages were received on 83.1% of out-of-hospital days. Daily transmissions were interrupted 2.3 times per patient-year for more than 3 days. During 1 year, absolute transmission success declined by 3.3%. Information on medical events was available after 1 day (3 days) in 83.1% (94.3%) of the cases. On all working days, a central monitoring unit informed investigators of protocol defined events. Investigators contacted patients with a median delay of 1 day and arranged follow-ups, the majority of which took place within 1 week of the event being available.

conclusionOnly limited data on the information flow and workflow have been published from other studies which failed to improve outcome. However, a comparison of those data to IN-TIME suggest that the ability to see a patient early after clinical events may be inferior to the set-up in IN-TIME. These differences may be responsible for the heterogeneity found in clinical effectiveness of remote monitoring concepts.

Indexed as

Defibrillators, ImplantableTime and Motion StudiesWorkflowFemaleFollow-Up StudiesHeart FailureHumansMaleMonitoring, AmbulatoryRemote Sensing TechnologyReproducibility of ResultsTime FactorsTreatment OutcomeDefibrillatorHeart failureimplantatbleTelemedicine

Identifiers

PMID30016396
PMCPMC6440440

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.