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@ARTICLE{Breteler:1040923,
      author       = {Breteler, Martine J. M. and Leigard, Ellen and Hartung,
                      Lisa C. and Welch, John R. and Brealey, David A. and
                      Fritsch, Sebastian J. and Konrad, David and Hertzberg,
                      Daniel and Bell, Max and Rienstra, Heleen and Rademakers,
                      Frank E. and Kalkman, Cor J.},
      title        = {{R}eliability of an all-in-one wearable sensor for
                      continuous vital signs monitoring in high-risk patients: the
                      {NIGHTINGALE} clinical validation study},
      journal      = {Journal of clinical monitoring and computing},
      volume       = {39},
      issn         = {0748-1977},
      address      = {Dordrecht [u.a.]},
      publisher    = {Springer Science + Business Media B.V.},
      reportid     = {FZJ-2025-02053},
      pages        = {1087–1100},
      year         = {2025},
      abstract     = {Continuous vital signs monitoring with wearable systems may
                      improve early recognition of patient deterioration on
                      hospital wards. The objective of this study was to determine
                      whether the wearable Checkpoint Cardio’s CPC12S, can
                      accurately measure heart rate (HR), respiratory rate (RR),
                      oxygen saturation (SpO2), blood pressure (BP) and
                      temperature continuously. In an observational multicenter
                      method comparison study of 70 high-risk surgical patients
                      admitted to high-dependency wards; HR, RR, SpO2, BP and
                      temperature were simultaneously measured with the CPC12S
                      system and with ICU-grade monitoring systems in four
                      European hospitals. Outcome measures were bias and $95\%$
                      limits of agreement (LoA). Clinical accuracy was assessed
                      with Clarke Error Grid analyses for HR and RR. A total of
                      3,212 h of vital signs data (on average 26 h per patient)
                      were analyzed. For HR, bias $(95\%$ LoA) of the pooled
                      analysis was 0.0 (-3.5 to 3.4), for RR 1.5 (-3.7 to 7.5) and
                      for SpO2 0.4 (-3.1 to 4.0). The CPC12S system overestimated
                      BP, with a bias of 8.9 and wide LoA (-23.3 to 41.2).
                      Temperature was underestimated with a bias of -0.6 and LoA
                      of -1.7 to 0.6. Clarke Error Grid analyses showed that
                      adequate treatment decisions regarding changes in HR and RR
                      would have been made in $99.2\%$ and $92.0\%$ of cases
                      respectively. The CPC12S system showed high accuracy for
                      measurements of HR. The accuracy of RR, SpO2 were slightly
                      overestimated and core temperature underestimated, with LoA
                      outside the predefined clinical acceptable range. The
                      accuracy of BP was unacceptably low.},
      cin          = {JSC / CASA},
      ddc          = {610},
      cid          = {I:(DE-Juel1)JSC-20090406 / I:(DE-Juel1)CASA-20230315},
      pnm          = {5112 - Cross-Domain Algorithms, Tools, Methods Labs (ATMLs)
                      and Research Groups (POF4-511) / SDI-S - SDI-S: Smart Data
                      Innovation Services - Experimentelle Erprobung und
                      Entwicklung von KI-Dienstverbünden für Innovationen auf
                      industriellen Daten (01IS22095D) / NIGHTINGALE - Connecting
                      Patients and Carers using wearable sensor technology
                      (727534)},
      pid          = {G:(DE-HGF)POF4-5112 / G:(BMBF)01IS22095D /
                      G:(EU-Grant)727534},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {40100556},
      UT           = {WOS:001448808900001},
      doi          = {10.1007/s10877-025-01279-x},
      url          = {https://juser.fz-juelich.de/record/1040923},
}