Evidence map›Paper›PMID 30241511›Full record

Trial reportBMC geriatrics2018

Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial.

Antonio Lopez-Villegas, Daniel Catalan-Matamoros, Remedios Lopez-Liria, Terje Enebakk, Hilde Thunhaug, Knut Tore Lappegård

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC geriatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02237404 (Sustainability of Cardiology Services), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.9field-weighted citation impact, top 13% of its field
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.

NCT02237404 nacompletednot on this map

Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers.

TypeinterventionalSponsorUniversity of TromsoRan2014 to 2017Enrolled50ConditionsCardiovascular DiseaseArmsTelemedicine System
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 18 citations in OpenAlex.

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  9. Remote Monitoring of CIEDs-For Both Safety, Economy and Convenience?International journal of environmental research and public health · 2021
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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

6 authors at 3 institutions in 2 countries.

Antonio Lopez-VillegasSocial Involvement of Critical and Emergency Medicine, CTS-609 Research Group, Hospital de Poniente, Almeria, Spain.
Daniel Catalan-MatamorosDepartment of Journalism and Communication, Universidad Carlos III de Madrid, Calle Madrid 133, 28903 Getafe, Madrid, Spain. dcatalan@ual.es.ORCID 0000-0001-7783-4984
Remedios Lopez-LiriaNursing Science, Physiotherapy and Medicine, Faculty of Health Sciences, University of Almeria, Almería, Spain.
Terje EnebakkDivision of Medicine, Nordland Hospital, Bodø, Norway.
Hilde ThunhaugDivision of Medicine, Nordland Hospital, Bodø, Norway.
Knut Tore LappegårdDivision of Medicine, Nordland Hospital, Bodø, Norway.
Nordland Hospital · NOUniversidad Carlos III de Madrid · ESUniversity of Almería · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWith an ageing population and widening indications for pacemakers implantation, the number of persons carrying an implant is steadily increasing. The routine follow-up is thus a heavy burden for the respective NHS as well as for the patients and their relatives. Most of them of the studies have been performed in densely populated areas and nearby to the hospital. It is thus unknown whether these results could be applied also in rural areas such as Northern Norway with a more scattered population. The aim of this study was to assess the effectiveness of tele-monitoring (TM) in patients with pacemakers regarding reliability, safety and health-related quality of life, compared to traditional follow-up in outpatient clinic in a setting where geographical effects could possible influence the results.

methodsThe NORDLAND study is a controlled, randomized, non-masked clinical trial in pacemaker patients, with data collection carried out during the pre-implant stage and after 6 months. Between August of 2014 and November of 2015, 50 patients were assigned to either a tele-monitoring group (n = 25) or a conventional hospital monitoring (HM) group (n = 25). The EuroQol-5D (EQ-5D) utilities and visual analogue scale (VAS) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) were used to measure Health-Related Quality of Life. Baseline characteristics and number of hospital visits were also analyzed.

resultsThe baseline characteristics of the two study groups were similar for EQ-5D utilities (TM:0.81; HM:0.76; p = 0.47), EQ-5D VAS (TM: 64.00; HM:64.88; p = 0.86) and the MLHFQ (TM:20.20; HM:28.96; p = 0.07). At the 6 month follow-up, there were no significant differences between the groups in EQ-5D utilities (TM: 0.81; HM: 0.76; p = 0.54) and EQ-5D VAS scores (TM: 72.71; HM: 59.79; p = 0.08). The MLHFQ score was improved in both groups (TM: -4.40; HM: -15.13; p <  0.001). The number of in-office visits was similar in both groups (TM: 1.24 vs HM: 1.12; P = 0.30).

conclusionsThe NORDLAND trial shows that HRQoL is improved after implant in both groups. Without significant differences with regards to effectiveness and safety. In addition, provides a scientifically rigorous method to the field of HRQoL evaluations in patients with pacemakers.

trial registrationClinicalTrials.gov NCT02237404 , September 11, 2014.

Indexed as

AgedAged, 80 and overFemaleHumansMaleMiddle AgedNorwayPacemaker, ArtificialQuality of LifeReproducibility of ResultsSurveys and QuestionnairesTelemedicineTime FactorsVisual Analog ScaleHealth-related quality of lifeOlder adultsPacemaker follow-upRandomized studyRemote monitoringTelemedicine

Identifiers

PMID30241511
PMCPMC6150964
OpenAlexW2891072794

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.