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      Accuracy and reliability of a wireless vital signs monitor for hospitalized patients in a low-resource setting

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          Abstract

          Objective

          The purpose of this study was to evaluate the accuracy and reliability of neoGuard in comparison to a conventional bedside monitor on patients in a low-resource clinical setting.

          Design

          This was a single-arm methods comparison study involving the use of a wearable vital signs monitor (neoGuard TM) versus a conventional bedside monitor (Edan iM8).

          Setting

          The study was conducted at Jinja Regional Referral Hospital, a tertiary care hospital situated in Eastern Uganda.

          Participants

          Thirty patients (10 male, 20 female) were enrolled from the adult recovery ward at JRRH. Participants were eligible for the study if they were at least 18 years of age, had 2 sets of normal vital sign measurements obtained 1 h apart, and were able and willing to provide informed consent.

          Main Outcome and Measures

          The primary outcome measures were (i) bias (mean deviation) and (ii) limits of agreement [95% CI]. Bland-Altman plots were generated to illustrate the level of agreement between the neoGuard TM technology and the Edan iM8 monitor.

          Results

          Bland-Altman analysis was performed for 24 participants; datasets from six participants were excluded due to missing or invalid measurements. Findings showed a moderate level of agreement for measurement of SpO 2, PR, and RR, with >80% of subject means falling within the predefined acceptability limits. However, there was also notable variation in accuracy between subjects, with large standard deviations observed for measurement of all four parameters. While the level of agreement for measurement of temperature was low, this is partly explained by limitations in the comparison method.

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          Most cited references25

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          Racial Bias in Pulse Oximetry Measurement

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            Agreement between methods of measurement with multiple observations per individual.

            Limits of agreement provide a straightforward and intuitive approach to agreement between different methods for measuring the same quantity. When pairs of observations using the two methods are independent, i.e., on different subjects, the calculations are very simple and straightforward. Some authors collect repeated data, either as repeated pairs of measurements on the same subject, whose true value of the measured quantity may be changing, or more than one measurement by one or both methods of an unchanging underlying quantity. In this paper we describe methods for analysing such clustered observations, both when the underlying quantity is assumed to be changing and when it is not.
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              Dark skin decreases the accuracy of pulse oximeters at low oxygen saturation: the effects of oximeter probe type and gender.

              Pulse oximetry may overestimate arterial oxyhemoglobin saturation (Sao2) at low Sao2 levels in individuals with darkly pigmented skin, but other factors, such as gender and oximeter probe type, remain less studied. We studied the relationship between skin pigment and oximeter accuracy in 36 subjects (19 males, 17 females) of a range of skin tones. Clip-on type sensors and adhesive/disposable finger probes for the Masimo Radical, Nellcor N-595, and Nonin 9700 were studied. Semisupine subjects breathed air-nitrogen-CO2 mixtures via a mouthpiece to rapidly achieve 2- to 3-min stable plateaus of Sao2. Comparisons of Sao2 measured by pulse oximetry (Spo2) with Sao2 (by Radiometer OSM-3) were used in a multivariate model to assess the source of errors. The mean bias (Spo2 - Sao2) for the 70%-80% saturation range was 2.61% for the Masimo Radical with clip-on sensor, -1.58% for the Radical with disposable sensor, 2.59% for the Nellcor clip, 3.6% for the Nellcor disposable, -0.60% for the Nonin clip, and 2.43% for the Nonin disposable. Dark skin increased bias at low Sao2; greater bias was seen with adhesive/disposable sensors than with the clip-on types. Up to 10% differences in saturation estimates were found among different instruments in dark-skinned subjects at low Sao2. Multivariate analysis indicated that Sao2 level, sensor type, skin color, and gender were predictive of errors in Spo2 estimates at low Sao2 levels. The data suggest that clinically important bias should be considered when monitoring patients with saturations below 80%, especially those with darkly pigmented skin; but further study is needed to confirm these observations in the relevant populations.
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                Author and article information

                Journal
                Digit Health
                Digit Health
                DHJ
                spdhj
                Digital Health
                SAGE Publications (Sage UK: London, England )
                2055-2076
                26 May 2022
                Jan-Dec 2022
                : 8
                : 20552076221102262
                Affiliations
                [1 ]Neopenda, PBC, Chicago, IL, USA
                [2 ]Department of Biostatistics and Epidemiology, Ringgold 58589, universityMakerere University School of Public Health (MUSPH); , Kampala, Uganda
                [3 ]Jinja Regional Referral Hospital (JRRH), Jinja, Uganda
                Author notes
                [*]Assumpta Nantume, Neopenda, PBC, 965 West Chicago, Chicago, IL, 60642, USA. Email: assumpta@ 123456neopenda.com
                Author information
                https://orcid.org/0000-0002-6700-9443
                Article
                10.1177_20552076221102262
                10.1177/20552076221102262
                9152187
                35656284
                5f0dbdfc-f2fa-485b-94a7-0db585dc0e14
                © The Author(s) 2022

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 17 March 2022
                : 4 May 2022
                Funding
                Funded by: IKEA Foundation (through Efficiency for Access Research & Development Fund);
                Award ID: RD0002
                Funded by: UK aid (through Efficiency for Access Research & Development Fund);
                Award ID: RD0002
                Categories
                Feasibility Study
                Custom metadata
                ts19
                January-December 2022

                vital signs,wearable,wireless,technology,newborn health,digital health

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