Evaluation of Technologies for Neonates in Africa (ETNA), Nairobi, Kenya.
University of Washington, Seattle, Washington, United States of America.
PLoS One. 2022 Jun 30;17(6):e0267026. doi: 10.1371/journal.pone.0267026. eCollection 2022.
Neonatal 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.
We 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.
Between 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.
Our 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.
新生儿多参数连续生理监测 (MCPM) 技术有助于早期发现可预防和可治疗的新生儿死亡原因。评估新型 MCPM 技术的准确性对于其正确使用和采用至关重要。
我们前瞻性地比较了 Sibel 的先进新生儿表皮 (ANNE) 技术与 Masimo 的 Rad-97 脉搏 CO- 血氧计和二氧化碳描记法与 Spengler 的 Tempo Easy 参考技术在四轮评估中的准确性。我们使用 Bland-Altman 图和均方根偏差分析 (RMSD) 比较了心率 (HR)、呼吸率 (RR)、氧饱和度 (SpO2) 和皮肤温度的准确性。在每一轮之间优化了 Sibel 的 ANNE 算法。我们创建了 Clarke 误差网格，其中包括 20%的区域，以帮助临床解释 HR 和 RR 结果。
在 2019 年 11 月至 2020 年 8 月期间，我们从 84 名新生儿中收集了 320 小时的数据。在最后一轮，Sibel 的 ANNE 技术表现出 HR 的归一化偏差为 0%，RR 的归一化偏差为 3.1%，SpO2 的非归一化偏差为-0.3%，温度的非归一化偏差为 0.2°C。95%上下限（LOA）之间的归一化分布为 HR 的 4.7%和 RR 的 29.3%。SpO2 的 RMSD 为 1.9%，温度的 RMSD 为 1.5°C。Sibel 的 ANNE 技术与参考技术之间的一致性符合 LOA 和 RMSD 的 95%分布的预先确定的阈值。Clarke 误差网格显示，所有 HR 和 RR 观察值的差异均在 20%以内。
我们的研究结果表明，Sibel 的 ANNE 与参考技术之间存在可接受的一致性。需要进行临床效果、可行性、可用性、可接受性和成本效益调查，以便进行大规模实施。
