Evidence map›Paper›PMID 38059857›Full record

Observational studyEuropean heart journal. Quality of care & clinical outcomes2024

Behavioural digital biomarkers enable real-time monitoring of patient-reported outcomes: a substudy of the multicentre, prospective observational SafeHeart study.

Maarten Z H Kolk, Diana M Frodi, Joss Langford, Caroline J Meskers, Tariq O Andersen, Peter Karl Jacobsen, Niels Risum, Hanno L Tan, Jesper H Svendsen, Reinoud E Knops and 2 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in European heart journal. Quality of care & clinical outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Review
  2. Beyond one-time PROMs: high-frequency single-item mobile ePROM tracking of postoperative recovery in spine surgery-a prospective feasibility study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
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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

12 authors.

Maarten Z H KolkDepartment of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0003-0624-1510
Diana M FrodiDepartment of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-7074-5575
Joss LangfordActivinsights Ltd, Kimbolton, UK.ORCID 0000-0002-3204-5866
Caroline J MeskersDepartment of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Tariq O AndersenDepartment of Computer Science, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-9342-5520
Peter Karl JacobsenDepartment of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0003-2165-1286
Niels RisumDepartment of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-0357-9164
Hanno L TanDepartment of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0002-7905-5818
Jesper H SvendsenDepartment of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-8466-8515
Reinoud E KnopsDepartment of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0002-0772-3573
Søren Z DiederichsenDepartment of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Fleur V Y TjongDepartment of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0001-9608-0081

Funding

Horizon 2020 Framework Programme 113994
6 · The paper itself

Abstract

aimsPatient-reported outcome measures (PROMs) serve multiple purposes, including shared decision-making and patient communication, treatment monitoring, and health technology assessment. Patient monitoring using PROMs is constrained by recall and non-response bias, respondent burden, and missing data. We evaluated the potential of behavioural digital biomarkers obtained from a wearable accelerometer to achieve personalized predictions of PROMs. METHODS AND

resultsData from the multicentre, prospective SafeHeart study conducted at Amsterdam University Medical Center in the Netherlands and Copenhagen University Hospital, Rigshospitalet in Copenhagen, Denmark, were used. The study enrolled patients with an implantable cardioverter defibrillator between May 2021 and September 2022 who then wore wearable devices with raw acceleration output to capture digital biomarkers reflecting physical behaviour. To collect PROMs, patients received the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL 5-Dimensions 5-Level (EQ5D-5L) questionnaire at two instances: baseline and after six months. Multivariable Tobit regression models were used to explore associations between digital biomarkers and PROMs, specifically whether digital biomarkers could enable PROM prediction. The study population consisted of 303 patients (mean age 62.9 ± 10.9 years, 81.2% male). Digital biomarkers showed significant correlations to patient-reported physical and social limitations, severity and frequency of symptoms, and quality of life. Prospective validation of the Tobit models indicated moderate correlations between the observed and predicted scores for KCCQ [concordance correlation coefficient (CCC) = 0.49, mean difference: 1.07 points] and EQ5D-5L (CCC = 0.38, mean difference: 0.02 points).

conclusionWearable digital biomarkers correlate with PROMs, and may be leveraged for real-time prediction. These findings hold promise for monitoring of PROMs through wearable accelerometers.

Indexed as

Patient Reported Outcome MeasuresAgedBiomarkersDefibrillators, ImplantableFemaleFollow-Up StudiesHumansMaleMiddle AgedNetherlandsProspective StudiesQuality of LifeSurveys and QuestionnairesWearable Electronic DevicesBiomarkersDigital healthPatient-reported outcome measureQuality of lifeWearable technology

Identifiers

PMID38059857
PMCPMC11873796

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.