Evidence map›Paper›PMID 35771801›Full record

ArticlePloS one2022

Evaluation of Sibel's Advanced Neonatal Epidermal (ANNE) wireless continuous physiological monitor in Nairobi, Kenya.

Jesse Coleman, Amy Sarah Ginsburg, William Macharia, Roseline Ochieng, Dorothy Chomba, Guohai Zhou, Dustin Dunsmuir, Shuai Xu, J Mark Ansermino

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 37% 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.

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

6 citing papers in PubMed, 9 citations in OpenAlex.

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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

9 authors at 5 institutions in 3 countries.

Jesse ColemanEvaluation of Technologies for Neonates in Africa (ETNA), Nairobi, Kenya.ORCID 0000-0002-3601-7854
Amy Sarah GinsburgUniversity of Washington, Seattle, Washington, United States of America.
William MachariaDepartment of Pediatrics, Aga Khan University, Nairobi, Kenya.
Roseline OchiengDepartment of Pediatrics, Aga Khan University, Nairobi, Kenya.
Dorothy ChombaDepartment of Pediatrics, Aga Khan University, Nairobi, Kenya.ORCID 0000-0002-0038-7896
Guohai ZhouCenter for Clinical Investigation, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.ORCID 0000-0002-8826-403X
Dustin DunsmuirAnesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.
Shuai XuQuerrey Simpson Institute for Bioelectronics, Department of Biomedical Engineering, McCormick School of Engineering, Department of Dermatology & Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Evanston, Illinois, United States of America.
J Mark AnserminoAnesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.ORCID 0000-0001-8427-2035
Aga Khan University Nairobi · KEUniversity of British Columbia · CABrigham and Women's Hospital · USNorthwestern University · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeonatal multiparameter continuous physiological monitoring (MCPM) technologies assist with early detection of preventable and treatable causes of neonatal mortality. Evaluating accuracy of novel MCPM technologies is critical for their appropriate use and adoption.

methodsWe prospectively compared the accuracy of Sibel's Advanced Neonatal Epidermal (ANNE) technology with Masimo's Rad-97 pulse CO-oximeter with capnography and Spengler's Tempo Easy reference technologies during four evaluation rounds. We compared accuracy of heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and skin temperature using Bland-Altman plots and root-mean-square deviation analyses (RMSD). Sibel's ANNE algorithms were optimized between each round. We created Clarke error grids with zones of 20% to aid with clinical interpretation of HR and RR results.

resultsBetween November 2019 and August 2020 we collected 320 hours of data from 84 neonates. In the final round, Sibel's ANNE technology demonstrated a normalized bias of 0% for HR and 3.1% for RR, and a non-normalized bias of -0.3% for SpO2 and 0.2°C for temperature. The normalized spread between 95% upper and lower limits-of-agreement (LOA) was 4.7% for HR and 29.3% for RR. RMSD for SpO2 was 1.9% and 1.5°C for temperature. Agreement between Sibel's ANNE technology and the reference technologies met the a priori-defined thresholds for 95% spread of LOA and RMSD. Clarke error grids showed that all HR and RR observations were within a 20% difference.

conclusionOur findings suggest acceptable agreement between Sibel's ANNE and reference technologies. Clinical effectiveness, feasibility, usability, acceptability, and cost-effectiveness investigations are necessary for large-scale implementation.

Indexed as

OximetryRespiratory RateHumansInfant, NewbornKenyaMonitoring, PhysiologicOxygenOxygen

Identifiers

PMID35771801
PMCPMC9246120
OpenAlexW4283752707

What OpenQuestion holds

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LicenceCC BY
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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.