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Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.

ABSTRACT: Anemia remains an important global health problem. Inexpensive, accurate, and noninvasive solutions are needed to monitor and evaluate anemia in resource-limited settings. We evaluated the performance of multiple point-of-care hemoglobin devices, including a novel noninvasive smartphone application tested on Apple® and Android® cell phones, Masimo Pronto®, and HemoCue® Hb-301 and Hb-801, against a gold-standard hematology analyzer (reference hemoglobin) using venous blood. We examined correlations between hemoglobin devices and reference hemoglobin, device accuracy (average bias, Bland-Altman plots, clinical performance) and classification bias (sensitivity, specificity) among 299 refugees (10mo-65y) in Atlanta, GA. Semi-structured interviews (n = 19) with participants and staff assessed usability and acceptability. Mean reference hemoglobin was 13.7 g/dL (SD:1.8) with 12.5% anemia. Noninvasive hemoglobin devices were not well correlated with reference hemoglobin (Apple® R2 = 0.08, Android® R2 = 0.11, Masimo Pronto® R2 = 0.29), but stronger correlations were reported with HemoCue® Hb-301 (R2 = 0.87) and Hb-801 (R2 = 0.88). Bias (SD) varied across each device: Apple®: -1.6 g/dL (2.0), Android®: -0.7 g/dL (2.0), Masimo Pronto®: -0.4 g/dL (1.6), HemoCue® Hb-301: +0.4 g/dL (0.7) and HemoCue® Hb-801: +0.2 g/dL (0.6). Clinically acceptable performance (within ± 1 g/dL of reference hemoglobin) was higher for the invasive devices (HemoCue® Hb-301: 90.3%; HemoCue® Hb-801: 93.4%) compared to noninvasive devices (Apple®: 31.5%; Android®: 34.6%; Masimo Pronto®: 49.5%). Sensitivity and specificity were 63.9% and 48.2% for Apple®, 36.1% and 67.6% for Android®, 45.7% and 85.3% for Masimo Pronto®, 54.3% and 97.6% for HemoCue® Hb-301, and 66.7% and 97.6% for HemoCue® Hb-801. Noninvasive devices were considered easy to use and were the preferred method by participants. Among the only studies to compare multiple point-of-care approaches to hemoglobin testing, the diagnostic ability of HemoCue® was comparable to reference hemoglobin, while noninvasive devices had high user acceptability but considerable biases. Improvements in noninvasive device performance and further testing in anemic populations are recommended before broader use.

SUBMITTER: Young MF

PROVIDER: S-EPMC8284642 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Measurement of blood hemoglobin (Hb) concentration is a routine procedure. Using a non-invasive point-of-care device reduces pain and discomfort for the patient and allows time saving in patient care. The aims of the present study were to assess the concordance of Hb levels obtained non-invasively with the Pronto-7 monitor (version 2.1.9, Masimo Corporation, Irvine, USA) or with the NBM-200MP monitor (Orsense, Nes Ziona, Israel) and the values obtained from the usual colorimetric method using blood samples and to determine the source of discordance.We conducted two consecutive prospective open trials enrolling patients presenting in the emergency department of a university hospital. The first was designed to assess Pronto-7™ and the second NBM-200MP™. In each study, the main outcome measure was the agreement between both methods. Independent factors associated with the bias were determined using multiple linear regression. Three hundred patients were prospectively enrolled in each study. For Pronto-7™, the absolute mean difference was 0.56 g.L(-1) (95% confidence interval [CI] 0.41 to 0.69) with an upper agreement limit at 2.94 g.L(-1) (95% CI [2.70;3.19]), a lower agreement limit at -1.84 g.L(-1) (95% CI [-2.08;-1.58]) and an intra-class correlation coefficient at 0.80 (95% CI [0.74;0.84]). The corresponding values for the NBM-200MP™ were 0.21 [0.02;0.39], 3.42 [3.10;3.74], -3.01 [-3.32;-2.69] and 0.69 [0.62;0.75]. Multivariate analysis showed that age and laboratory values of hemoglobin were independently associated with the bias when using Pronto-7™, while perfusion index and laboratory value of hemoglobin were independently associated with the bias when using NBM-200MP™.Despite a relatively limited bias in both cases, the large limits of agreement found in both cases render the clinical usefulness of such devices debatable. For both devices, the bias is independently and inversely associated with the true value of hemoglobin.ClinicalTrials.gov NCT01321580 and NCT01321593.

Project description:BackgroundWearable devices have the potential to promote a healthy lifestyle because of their real-time data monitoring capabilities. However, device usability is a critical factor that determines whether they will be adopted on a large scale. Usability studies on wearable devices are still scarce.ObjectiveThis study aims to compare the functions and attributes of seven mainstream wearable devices and to evaluate their usability.MethodsThe wearable devices selected were the Apple Watch, Samsung Gear S, Fitbit Surge, Jawbone Up3, Mi Band, Huawei Honor B2, and Misfit Shine. A mixed method of feature comparison and a System Usability Scale (SUS) evaluation based on 388 participants was applied; the higher the SUS score, the better the usability of the product.ResultsFor features, all devices had step counting, an activity timer, and distance recording functions. The Samsung Gear S had a unique sports track recording feature and the Huawei Honor B2 had a unique wireless earphone. The Apple Watch, Samsung Gear S, Jawbone Up3, and Fitbit Surge could measure heart rate. All the devices were able to monitor sleep, except the Apple Watch. For product characteristics, including attributes such as weight, battery life, price, and 22 functions such as step counting, activity time, activity type identification, sleep monitoring, and expandable new features, we found a very weak negative correlation between the SUS scores and price (r=-.10, P=.03) and devices that support expandable new features (r=-.11, P=.02), and a very weak positive correlation between the SUS scores and devices that support the activity type identification function (r=.11, P=.02). The Huawei Honor B2 received the highest score of mean 67.6 (SD 16.1); the lowest Apple Watch score was only 61.4 (SD 14.7). No significant difference was observed among brands. The SUS score had a moderate positive correlation with the user's experience (length of time the device was used) (r=.32, P<.001); participants in the medical and health care industries gave a significantly higher score (mean 61.1, SD 17.9 vs mean 68.7, SD 14.5, P=.03).ConclusionsThe functions of wearable devices tend to be homogeneous and usability is similar across various brands. Overall, Mi Band had the lowest price and the lightest weight. Misfit Shine had the longest battery life and most functions, and participants in the medical and health care industries had the best evaluation of wearable devices. The perceived usability of mainstream wearable devices is unsatisfactory and customer loyalty is not high. A consumer's SUS rating for a wearable device is related to their personal situation instead of the device brand. Device manufacturers should put more effort into developing innovative functions and improving the usability of their products by integrating more cognitive behavior change techniques.

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Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.

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