Inter-device Reliability Research Articles

Using a prognostic medical device for early identification of pressure ulcers: protocol for study design.

An objective, physiological measurement taken using a medical device may reduce the incidence of pressure ulcers through earlier detection of problems signs before visual signs appear. Research in this field is hampered by variations in clinical practice and patient-level confounders. The authors outline key considerations for designing a protocol for a study to assess the efficacy and safety of a prognostic medical device in reducing pressure ulcer incidence in a hospital, including comparators, randomisation, sample size, ethics and practical issues. Key issues relating to methodology and ethics are considered alongside a theoretical protocol, which could support future researchers in wound care trials. A prospective, three-armed, multi-centre, stratified cluster-randomised controlled trial is proposed. The third arm is recommended as it is expected that patients will need to be moved for the medical device to be used and repositioning is a preventive strategy. A minimum of 16 200 patients in 33 wards would needed to be recruited to achieve statistical significance. Ethical considerations in terms of consent or assent need to be considered. The hypothetical study designed to evaluate the effectiveness of a diagnostic or prognostic medical device in reducing pressure ulcer incidence in secondary care, while accounting for biases, would require large sample sizes and involves risks of inter-operator and inter-device reliability, heterogeneity of users and the vague clinical interpretation of device results. Robust research in this field has the potential to influence or change policy and practice relating to the prevention of pressure ulcers in secondary care.

The Reliability and Validity of the OneStep Smartphone Application for Gait Analysis among Patients Undergoing Rehabilitation for Unilateral Lower Limb Disability.

An easy-to-use and reliable tool is essential for gait assessment of people with gait pathologies. This study aimed to assess the reliability and validity of the OneStep smartphone application compared to the C-Mill-VR+ treadmill (Motek, Nederlands), among patients undergoing rehabilitation for unilateral lower extremity disability. Spatiotemporal gait parameters were extracted from the treadmill and from two smartphones, one on each leg. Inter-device reliability was evaluated using Pearson correlation, intra-cluster correlation coefficient (ICC), and Cohen's d, comparing the application's readings from the two phones. Validity was assessed by comparing readings from each phone to the treadmill. Twenty-eight patients completed the study; the median age was 45.5 years, and 61% were males. The ICC between the phones showed a high correlation (r = 0.89-1) and good-to-excellent reliability (ICC range, 0.77-1) for all the gait parameters examined. The correlations between the phones and the treadmill were mostly above 0.8. The ICC between each phone and the treadmill demonstrated moderate-to-excellent validity for all the gait parameters (range, 0.58-1). Only 'step length of the impaired leg' showed poor-to-good validity (range, 0.37-0.84). Cohen's d effect size was small (d < 0.5) for all the parameters. The studied application demonstrated good reliability and validity for spatiotemporal gait assessment in patients with unilateral lower limb disability.

Intra and Inter-Device Reliabilities of the Instrumented Timed-Up and Go Test Using Smartphones in Young Adult Population.

The Timed-Up and Go (TUG) test is widely utilized by healthcare professionals for assessing fall risk and mobility due to its practicality. Currently, test results are based solely on execution time, but integrating technological devices into the test can provide additional information to enhance result accuracy. This study aimed to assess the reliability of smartphone-based instrumented TUG (iTUG) parameters. We conducted evaluations of intra- and inter-device reliabilities, hypothesizing that iTUG parameters would be replicable across all experiments. A total of 30 individuals participated in Experiment A to assess intra-device reliability, while Experiment B involved 15 individuals to evaluate inter-device reliability. The smartphone was securely attached to participants' bodies at the lumbar spine level between the L3 and L5 vertebrae. In Experiment A, subjects performed the TUG test three times using the same device, with a 5 min interval between each trial. Experiment B required participants to perform three trials using different devices, with the same time interval between trials. Comparing stopwatch and smartphone measurements in Experiment A, no significant differences in test duration were found between the two devices. A perfect correlation and Bland-Altman analysis indicated good agreement between devices. Intra-device reliability analysis in Experiment A revealed significant reliability in nine out of eleven variables, with four variables showing excellent reliability and five showing moderate to high reliability. In Experiment B, inter-device reliability was observed among different smartphone devices, with nine out of eleven variables demonstrating significant reliability. Notable differences were found in angular velocity peak at the first and second turns between specific devices, emphasizing the importance of considering device variations in inertial measurements. Hence, smartphone inertial sensors present a valid, applicable, and feasible alternative for TUG assessment.

Tear meniscus height agreement and reproducibility between two corneal topographers and spectral-domain optical coherence tomography

ABSTRACT Clinical relevance Tear meniscus height (TMH) is an important clinical marker in dry eye diagnosis and management. Purpose To evaluate the reproducibility and agreement of TMH measurements in non-clinical participants using the Oculus Keratograph 5 M, Medmont Meridia, and Spectral-domain optical coherence tomography (Spectralis SD-OCT). Methods Fifty-six participants (mean 43.8 ± 22.4 years) were recruited for this cross-sectional study. Image acquisitions were performed on the three devices, sequentially and randomized. The repeatability and reproducibility of inter-observer and inter-device analysis were performed. Repeated measures ANOVA and Bland-Altman Plots were used to evaluate the agreement between devices. Results The mean TMH with the Oculus Keratograph 5 M, Medmont Meridia and Spectralis SD-OCT were 0.29 ± 0.16 mm, 0.24 ± 0.09 mm and 0.27 ± 0.16 mm, respectively. There were no significant inter-observer differences (paired t-tests, p < 0.001). All the devices exhibited good inter-observer reliability (ICC ≥ 0.877), and good repeatability (CV ≤ 16.53%). Inter-device reliability is moderate (ICC = 0.621, p < 0.001). Repeated measures ANOVA revealed that TMH measurements given by the Spectralis SD-OCT are not significantly different from the Oculus Keratograph 5 M (p = 0.19) and the Medmont Meridia (p = 0.38). TMH measurements from Oculus Keratograph 5 M were significantly higher than those from Medmont Meridia (p = 0.02). Correlations between the mean TMH and the difference in the TMH measurements were positive for Oculus Keratograph 5 M and Medmont Meridia (r2 = 0.62, p < 0.001), negative for Medmont Meridia and Spectralis SD-OCT (r2 = -0.59, p < 0.001), and not significant for Oculus Keratograph 5 M and Spectralis SD-OCT (r2 = 0.05, p = 0.74). A strong correlation was found for TMH measured with all devices (r2 = 0.55 to 0.81, p < 0.001). Conclusions The Oculus Keratograph 5 M, Medmont Meridia, and Spectralis SD-OCT provide reliable and reproducible inter-observer TMH measurements. Inter-device reliability is moderate, with a close correlation between Spectralis SD-OCT and the Oculus Keratograph 5 M. Oculus Keratograph 5 M and Medmont Meridia are repeatable devices appropriate for the measurement of TMH, but they are not interchangeable in clinical practice.

Validity and reliability of the My Jump 2 app for detecting interlimb asymmetry in young female basketball players.

The aim of this study was to examine the validity and reliability of the My Jump 2 app for the assessment of interlimb jump asymmetry in young female basketball players. Nine athletes (age 15 ± 0.9 years; weight 62.9 ± 5.8 kg; height 173.6 ± 6.1 cm) performed single-leg drop jumps (DJs) and both-leg drop jumps on a force plate (Kistler Quattro jump) and were simultaneously recorded on two smartphones using the My Jump 2 app. Jump height from flight time and contact time data were statistically analyzed to evaluate the validity of two different camera settings, drop jump performance, and interlimb jump asymmetry in basketball players. The testing was repeated after 1 week for test retest reliability. High test-retest reliability [intraclass correlation coefficient (ICC) > 0.88] was observed in DJ height. High correlation between the force plate and the My Jump 2 app was observed in DJ height (r = 0.99) and DJ contact time (r = 0.98). For the interlimb jump height asymmetries, mean differences were 0.6 percentages for the My Jump 2 app and the force plate, respectively (p = 0.77). Inter-device reliability revealed almost perfect correlation for the DJ height (ICC = 0.99, r = 0.98). The My Jump 2 app is a valid and reliable tool to assess drop jump performance and interlimb asymmetry in young female basketball players.

Comparison of raw accelerometry data from ActiGraph, Apple Watch, Garmin, and Fitbit using a mechanical shaker table.

The purpose of this study was to evaluate the reliability and validity of the raw accelerometry output from research-grade and consumer wearable devices compared to accelerations produced by a mechanical shaker table. Raw accelerometry data from a total of 40 devices (i.e., n = 10 ActiGraph wGT3X-BT, n = 10 Apple Watch Series 7, n = 10 Garmin Vivoactive 4S, and n = 10 Fitbit Sense) were compared to reference accelerations produced by an orbital shaker table at speeds ranging from 0.6 Hz (4.4 milligravity-mg) to 3.2 Hz (124.7mg). Two-way random effects absolute intraclass correlation coefficients (ICC) tested inter-device reliability. Pearson product moment, Lin's concordance correlation coefficient (CCC), absolute error, mean bias, and equivalence testing were calculated to assess the validity between the raw estimates from the devices and the reference metric. Estimates from Apple, ActiGraph, Garmin, and Fitbit were reliable, with ICCs = 0.99, 0.97, 0.88, and 0.88, respectively. Estimates from ActiGraph, Apple, and Fitbit devices exhibited excellent concordance with the reference CCCs = 0.88, 0.83, and 0.85, respectively, while estimates from Garmin exhibited moderate concordance CCC = 0.59 based on the mean aggregation method. ActiGraph, Apple, and Fitbit produced similar absolute errors = 16.9mg, 21.6mg, and 22.0mg, respectively, while Garmin produced higher absolute error = 32.5mg compared to the reference. ActiGraph produced the lowest mean bias 0.0mg (95%CI = -40.0, 41.0). Equivalence testing revealed raw accelerometry data from all devices were not statistically significantly within the equivalence bounds of the shaker speed. Findings from this study provide evidence that raw accelerometry data from Apple, Garmin, and Fitbit devices can be used to reliably estimate movement; however, no estimates were statistically significantly equivalent to the reference. Future studies could explore device-agnostic and harmonization methods for estimating physical activity using the raw accelerometry signals from the consumer wearables studied herein.

Smartphone-Facilitated In-Situ Hearing Aid Audiometry for Community-Based Hearing Testing.

Hearing loss prevalence is increasing, with an estimated 2.5 billion people affected globally by 2050. Scalable service delivery models using innovative technologies and task-shifting are World Health Organization priorities to improve access to hearing care, particularly in low- and middle-income countries. Smartphone-facilitated audiometry in the community using hearing aids covered by noise-attenuating ear cups ("in-situ") could support more accessible hearing care when provided by less trained individuals such as community health workers (CHWs). This study aimed to determine the validity of this method for potential hearing aid fitting. Study objectives included determining the maximum permissible ambient noise level (MPANL), inter-device reliability, clinical threshold accuracy, reliability, and performance in real-world settings. Experiment 1: 15 normal-hearing adult participants were evaluated to determine MPANLs for circumaural Peltor 3M earcups covering Lexie Lumen hearing aids with smartphone-facilitated in-situ audiometry. MPANLs were calculated by measuring the difference in attenuation between thresholds obtained with standard headphones and in-situ hearing aids. Experiment 2: Pure-tone frequency and intensity output of 14 same-model Lexie Lumen hearing aids were measured to determine inter-device reliability. Pure-tone stimuli were measured and analyzed to determine sound pressure levels in decibels and pure-tone frequency when connected to a test box 2cc coupler. Experiment 3: 85 adult participants were tested in a sound booth to determine the accuracy of automated in-situ pure-tone audiometry (PTA) compared to clinical PTA (500, 1000, 2000, 3000, 4000, 6000 Hz) facilitated by an audiologist. The first 39 participants were tested twice to determine test-retest reliability. Experiment 4: In a community setting, 144 adult participants were tested with automated in-situ audiometry facilitated by CHWs using a smartphone app. These participants were subsequently tested with automated mobile PTA (500, 1000, 2000, 4000 Hz). An additional 44 participants were tested twice to determine test-retest reliability. Experiment 1: MPANLs of the Peltor 3M earcup-covered hearing aids were higher than standard headphones across all frequencies, ranging from 24 to 47.3 dB SPL. Experiment 2: Inter-device performance reliability was high, with all inter-device differences across all intensities and frequencies less than 3 dB. Frequency output was consistent and differed less than 0.7% between devices. Experiments 3 and 4: 85.2% and 83.3% of automated in-situ audiometry thresholds were within 10 dB of thresholds obtained in the sound booth and in a community setting, respectively. Acceptable test-retest intraclass correlation coefficient (ICC) was evident across all thresholds obtained in a sound booth (ICC = 0.85 to 0.93) and in a community setting (ICC = 0.83 to 0.97). Smartphone-facilitated in-situ audiometry allows for reliable and valid community-based testing. A simple smartphone user interface and automated in-situ audiometry allow CHWs with minimal training to facilitate the testing. With the additional capability to program hearing aids via the smartphone after the initial test, this approach would have the potential to support widespread access to personalized hearing aid fittings facilitated by CHWs in low- and middle-income countries. This approach also supports self-fitting options based on in-situ thresholds, enabling testing and fitting via over the counter hearing aids.

Validation and inter-device reliability of a behavior monitoring collar to measure rumination, feeding activity, and idle time of lactating dairy cows

Inter-device precision and accuracy are not investigated for precision livestock farming (PLF) technologies, but are fundamental for the use of data in populational metrics and to compare cows' data. This study aimed to validate a behavior monitoring collar (BMC; CowMed, Santa Maria, RS, Brazil) and its inter-device reliability. First, comparing observations with the BMC and second the inter-device precision and accuracy for rumination, feeding activity, and idle time of lactating dairy cows. Holstein cows (n = 23) were housed in a voluntary milk system free-stall barn and fitted with 2 devices within the same cow. Observations were made over 2 periods of one day (0700 to 1100h; 1400 to 1700h); the 7h per cow were summarized for each behavior to assess the agreement of observed behavior and BMC data. To assess the inter-device reliability 26d of BMC data was summarized by day per cow for both devices. Pearson correlation (r), coefficient of determination (R2), Lin's concordance correlation coefficient (ρc), linear regression, and Bland-Altman plots (BAP) were calculated for each period of observation. For the validation, we found high correlations for feeding activity, very high for idle time, but low correlations for rumination. The BAP was deemed acceptable and without bias; BAP mean differences ± SD were 0.83 ± 4.01, −0.48 ± 4.15, and 7.17 ± 3.94 min/h for rumination, feeding activity, and idle time, respectively. The slope of the linear regression did not differ from 1 for all behaviors but idle. For inter-device comparison, we found moderate correlations for feeding activity, idle time and a low correlation for rumination. The BAP was deemed acceptable and without bias; BAP mean differences were −0.36 ± 2.84, 0.45 ± 3.51, and −0.06 ± 2.81 min/h for rumination, feeding activity, and idle time, respectively. All slopes of the linear regressions differed from 1 but feeding time. Thus, the inter-device did not meet the accuracy criteria. In summary, this study validated the precision of the BMC for recording feeding activity of lactating dairy cows.

Reliability and Validity of the Repetition-Counting Feature of the Push Band 2.0 at Different Repetition Speeds

Purpose: To assess the interdevice reliability and validity of the repetition-counting feature of the Push Band 2.0. Methods: Thirty college-aged participants (aged 18–24 years) simultaneously wore two Push Band 2.0 devices and performed 10 common resistance training exercises at four different tempos over the course of two testing sessions. Twelve repetitions were completed with visual confirmation for each set of exercises and compared with repetition estimates from the Push Band 2.0. Interdevice reliability was quantified using single measures intraclass correlation coefficients with 95% confidence intervals while validity was assessed via mean absolute percent error and mean percent error. Results: Interdevice reliability was found to be good to very good regardless of exercise type or tempo, as all intraclass correlation coefficients were &gt;.770. Validity of the repetition-counting feature of the device was dependent on both exercise type and tempo, as exercises that did not involve rotation of the device throughout the movement demonstrated greater mean absolute percent error (31.0% average of all four tempos) and mean percent error (−29.9% average of all four tempos) than those that required such rotation (average mean absolute percent error of 3.5% and mean percent error of −1.6% across all four tempos). Conclusions: This study supports the reliability of the repetition-counting feature of the Push Band 2.0. However, device accuracy appears to be dependent on the type of movement and the speed at which the movement is performed, with greater accuracy observed during faster exercise tempos and exercises involving rotation of the device during movement execution.

Concurrent Validity and Reliability of the Sprint Force-Velocity Profile Assessed with K-AI Wearable Tech.

Establishing a sprint acceleration force-velocity profile is a way to assess an athlete's sprint-specific strength and speed production capacities. It can be determined in field condition using GNSS-based (global navigation satellite system) devices. The aims of this study were to (1) assess the inter-unit and the inter-trial reliability of the force-velocity profile variables obtained with K-AI Wearable Tech devices (50 Hz), (2) assess the concurrent validity of the input variables (maximal sprint speed and acceleration time constant), and (3) assess the validity of the output variables (maximal force output, running velocity and power). Twelve subjects, including one girl, performed forty-one 30 m sprints in total, during which the running speed was measured using two GPS (global positioning system) devices placed on the upper back and a radar (Stalker® Pro II Sports Radar Gun). Concurrent validity, inter-device and inter-trial reliability analyses were carried out for the input and output variables. Very strong to poor correlation (0.99 to 0.38) was observed for the different variables between the GPS and radar devices, with typical errors ranging from small to large (all < 7.6%). Inter-unit reliability was excellent to moderate depending on the variable (ICC values between 0.65 and 0.99). Finally, for the inter-trial reliability, the coefficients of variation were low to very low (all < 5.6%) for the radar and the GPS. The K-AI Wearable Tech used in this study is a concurrently valid and reliable alternative to radar for assessing a sprint acceleration force-velocity profile.

A Comparison of Optical Biometers Used in Children for Myopia Control.

Abstract Purpose To assess the reproducibility (i.e., inter-device reliability) of the biometers Topcon MYAH, Oculus Myopia Master, and Haag-Streit Lenstar LS900 with the Carl Zeiss IOLMaster 700 and the intra-subject repeatability in myopic children in order to reliably detect axial growth for myopia management. Methods Twenty-two myopic children (11.1 ± 2.4 yr) with a spherical equivalent of − 3.53 ± 2.35 D were examined with each of the biometers to assess axial length (AL) and corneal parameters (steepK, flatK, meanK, vectors J0, J45), and16 of these children agreed to a second round of measurements. Reproducibility of the first measurements between the IOLMaster and every other biometer was assessed employing a Bland-Altman approach and paired Studentʼs t-test. Repeatability was assessed as intra-subject standard deviation and was used to estimate the minimum time interval required between two AL measurements to reliably detect axial growth of an eye of at least 0.1 mm/year. Results Repeatability for AL measurements was as follows: IOLMaster: 0.05 mm, Myopia Master: 0.06 mm, Myah: 0.06 mm, Lenstar: 0.04 mm; the respective minimal time interval for axial growth assessment in myopia management was estimated as 5.6, 6.6, 6.7, and 5.0 months, respectively. Best reproducibility of the AL measurement was found between IOLMaster and Lenstar [95% Limits of Agreement (LoA) for reproducibility − 0.06 to 0.02]. As regards to the measured means, Lenstar gave measures of AL that were longer than with the IOLMaster by 0.02 mm (p &lt; 0.001). Myopia Master measures of meanK were significantly lower (by 0.21 D with p &lt; 0.001) than the values from the IOLMaster. As for J0, all biometers deviated significantly from IOLMaster measurements (p &lt; 0.05). Conclusion Generally good agreement was observed between all the biometers. When assessing myopia progression in children, a time frame of at least 6 months between the AL measurements is advisable in order to reliably determine any deviation from a normal growth pattern.

Liquid-gate 2D material-on-insulator transistors for sensing applications

This research investigates the use of 2D materials (specifically graphene) as active channel in liquid-gate transistors used as detectors of biological targets on functionalized surfaces. However, before these sensors can be effectively used, it is crucial to establish a reliable sensing platform within two-dimensional materials as active channels, and to evaluate the fabrication, lithography, and reliability of these devices. In this study, we analyzed the inter-device variability and reliability of the transistors, as well as the potential factors that may exacerbate these issues under operative conditions. We performed structural characterization to confirm the quality of the materials, followed by photolithography and processing to create liquid-gate sensors. We then conducted electrical evaluations of the devices, which revealed significant reliability issues and inter-device variability. To address these problems, we propose the use of an intergate-coupling effect that utilizes both front- and back-gates simultaneously. Our findings have important implications for the design and optimization of 2D materials-based liquid-gate sensors for biological applications.

Inter-Device Reliability of a Three-Dimensional Markerless Motion Capture System Quantifying Elementary Movement Patterns in Humans.

With advancements in technology able to quantify wide-ranging features of human movement, the aim of the present study was to investigate the inter-device technological reliability of a three-dimensional markerless motion capture system (3D-MCS), quantifying different movement tasks. A total of 20 healthy individuals performed a test battery consisting of 29 different movements, from which 214 different metrics were derived. Two 3D-MCS located in close proximity were utilized to quantify movement characteristics. Independent sample t-tests with selected reliability statistics (i.e., intraclass correlation coefficient (ICC), effect sizes, and mean absolute differences) were used to evaluate the agreement between the two systems. The study results suggested that 95.7% of all metrics analyzed revealed negligible or small between-device effect sizes. Further, 91.6% of all metrics analyzed showed moderate or better agreement when looking at the ICC values, while 32.2% of all metrics showed excellent agreement. For metrics measuring joint angles (198 metrics), the mean difference between systems was 2.9 degrees, while for metrics investigating distance measures (16 metrics; e.g., center of mass depth), the mean difference between systems was 0.62 cm. Caution is advised when trying to generalize the study findings beyond the specific technology and software used in this investigation. Given the technological reliability reported in this study, as well as the logistical and time-related limitations associated with marker-based motion capture systems, it may be suggested that 3D-MCS present practitioners with an opportunity to reliably and efficiently measure the movement characteristics of patients and athletes. This has implications for monitoring the health/performance of a broad range of populations.

On the Optimization of Graphene Liquid-Gate Transistors for Sensing Applications

This work faces the use of graphene liquid-gate transistors as sensors. Before dealing with a functionalized surface and biological targets, achieving a reliable sensing platform within this novel material as an active channel, fabrication, lithography, and reliability have to be extensively evaluated. In this work, we have analyzed the inter-device variability and the reliability of the sensors together with the phenomena which can increase these issues under operative conditions. High quality material corroboration has been evaluated through structural characterization (optical, XPS and Raman). Then photolithography and processing for liquid-gate sensor have been performed. Finally, electrical evaluation of the devices has been carried out demonstrating reliability issues and considerable inter-device variability. We propose in this work the use of integrate-coupling effect (front and back-gate simultaneously) to alleviate the inter-device variability and reliability problems.

Lumbar multifidus muscle ultrasound imaging: Is handheld technology reliable?

BackgroundAdvancement in ultrasound imaging technology has led to the development of handheld devices that are more accessible to physical therapists due to decreased cost, reduced size, and improved ease of use relative to current established units. Physical therapists use ultrasound imaging of the lumbar multifidus muscle (LMM) to assist in rehabilitation of patients with lumbar pathology. ObjectivesTo identify the inter-device reliability of measuring the LMM thickness during a sustained contraction when comparing handheld (Butterfly iQ+) and established (SonoSite M-Turbo) ultrasound units. A secondary purpose was to determine the reliability of a student physical therapist using both devices. DesignA reliability measurement study MethodA blinded examiner identified the LMM at the L4 vertebral level and measured the thickness of the contracted muscle utilizing both the handheld and established ultrasound devices. ICC values were calculated to determine the inter-device and intra-rater reliability. ResultsThe study included 42 healthy participants, 30 females and 12 males, with a mean age of 38.5 years. The inter-device reliability during a sustained LMM contraction was excellent (ICC = 0.92, 95% CI: 0.87–0.94) and the intra-rater reliability was good for both the handheld (ICC = 0.85, 95% CI: 0.73–0.92) and established (ICC = 0.89, 95% CI: 0.82–0.93) ultrasound units. ConclusionResults support the use of handheld ultrasound by physical therapists and students to measure the LMM thickness. Future studies could investigate the reliability of handheld ultrasound in a variety of musculoskeletal and pathological structures important to PT practice.

Field based assessment of a tri-axial accelerometers validity to identify steps and reliability to quantify external load.

Background: The monitoring of accelerometry derived load has received increased attention in recent years. However, the ability of such measures to quantify training load during sport-related activities is not well established. Thus, the current study aimed to assess the validity and reliability of tri-axial accelerometers to identify step count and quantify external load during several locomotor conditions including walking, jogging, and running. Method: Thirty physically active college students (height = 176.8 ± 6.1 cm, weight = 82.3 ± 12.8 kg) participated. Acceleration data was collected via two tri-axial accelerometers (Device A and B) sampling at 100 Hz, mounted closely together at the xiphoid process. Each participant completed two trials of straight-line walking, jogging, and running on a 20 m course. Device A was used to assess accelerometer validity to identify step count and the test-retest reliability of the instrument to quantify the external load. Device A and Device B were used to assess inter-device reliability. The reliability of accelerometry-derived metrics Impulse Load (IL) and Magnitude g (MAG) were assessed. Results: The instrument demonstrated a positive predictive value (PPV) ranging between 96.98%–99.41% and an agreement ranging between 93.08%–96.29% for step detection during all conditions. Good test-retest reliability was found with a coefficient of variation (CV) <5% for IL and MAG during all locomotor conditions. Good inter-device reliability was also found for all locomotor conditions (IL and MAG CV < 5%). Conclusion: This research indicates that tri-axial accelerometers can be used to identify steps and quantify external load when movement is completed at a range of speeds.

Inter-device reliability of the NPi-200 and NPi-300 pupillometers

The pupillary evaluation is an essential part of the neurological examination. Research suggests that the traditional examination of the pupil with a handheld flashlight has limited interrater reliability. Automated pupillometers were developed to provide an objective scoring of various pupillary parameters. The NPi-200 pupillometer is used for quantitative pupillary examinations, the NPi-300 was launched in July 2021 with enhanced features. The purpose of this study is to compare results from the NPi-200 to the NPi-300 to ensure that data are translatable across both platforms. This study examines the inter-device reliability of the NPi-200 compared to the NPi-300 in two cohorts: 20 patients at risk for cerebral edema and 50 healthy controls. Paired assessments of the devices were made from all participants. Each assessment included bilateral PLR readings within a 5-minute interval. Data showed high agreement between the two devices for the Neurological Pupil Index (NPi) reading (k = 0.94; CI: 0.91–0.99) and for pupil diameter assessment (k = 0.91; CI: 0.87–0.96). There is a very high level of agreement between the NPi-200 and NPi-300 among healthy controls and critically ill patients. Clinicians and researchers can interpret the results from either device equally.

Field evaluation of the diagnostic performance of EasyScan GO: a digital malaria microscopy device based on machine-learning

BackgroundMicroscopic examination of Giemsa-stained blood films remains the reference standard for malaria parasite detection and quantification, but is undermined by difficulties in ensuring high-quality manual reading and inter-reader reliability. Automated parasite detection and quantification may address this issue.MethodsA multi-centre, observational study was conducted during 2018 and 2019 at 11 sites to assess the performance of the EasyScan Go, a microscopy device employing machine-learning-based image analysis. Sensitivity, specificity, accuracy of species detection and parasite density estimation were assessed with expert microscopy as the reference. Intra- and inter-device reliability of the device was also evaluated by comparing results from repeat reads on the same and two different devices. This study has been reported in accordance with the Standards for Reporting Diagnostic accuracy studies (STARD) checklist.ResultsIn total, 2250 Giemsa-stained blood films were prepared and read independently by expert microscopists and the EasyScan Go device. The diagnostic sensitivity of EasyScan Go was 91.1% (95% CI 88.9–92.7), and specificity 75.6% (95% CI 73.1–78.0). With good quality slides sensitivity was similar (89.1%, 95%CI 86.2–91.5), but specificity increased to 85.1% (95%CI 82.6–87.4). Sensitivity increased with parasitaemia rising from 57% at < 200 parasite/µL, to ≥ 90% at > 200–200,000 parasite/µL. Species were identified accurately in 93% of Plasmodium falciparum samples (kappa = 0.76, 95% CI 0.69–0.83), and in 92% of Plasmodium vivax samples (kappa = 0.73, 95% CI 0.66–0.80). Parasite density estimates by the EasyScan Go were within ± 25% of the microscopic reference counts in 23% of slides.ConclusionsThe performance of the EasyScan Go in parasite detection and species identification accuracy fulfil WHO-TDR Research Malaria Microscopy competence level 2 criteria. In terms of parasite quantification and false positive rate, it meets the level 4 WHO-TDR Research Malaria Microscopy criteria. All performance parameters were significantly affected by slide quality. Further software improvement is required to improve sensitivity at low parasitaemia and parasite density estimations.Trial registration ClinicalTrials.gov number NCT03512678.

Validation of the Portable Next-Generation VECTRA H2 3D Imaging System for Periocular Anthropometry.

PurposePortable three-dimensional imaging systems are becoming increasingly common for facial measurement analysis. However, the reliability of portable devices may be affected by the necessity to take three pictures at three time points. The purpose of this study was to evaluate the effectiveness of portable devices for assessing the periocular region.MethodsIn 60 Caucasian volunteers (120 eyes), four facial scans (twice for each instrument) using the portable VECTRA H2 and static VECTRA M3 devices were performed; patients' heads were kept straight, looking ahead, with a neutral facial expression. One assessor set 52 periocular landmarks in the periocular area of each image and subsequently assessed intra- and inter-device reliability by comparing two within-device measurements and one between-device measurement, respectively.ResultsThe mean absolute difference (MAD) (0.13 and 0.12 units), relative error of measurement (REM) (0.61 and 0.68%), technical error of measurement (TEM)(1.02 and 0.80 units), relative TEM (rTEM) (5.51 and 4.43%), and intraclass correlation coefficient (ICC) (0.89, 0.89) showed good intra-device reliability for M3 and H2; MAD (0.63, 0.62 units), REM (2.83, 2.69%), TEM (1.31, 1.10 units), rTEM (7.62, 5.57%), and ICC (0.79, 0.83) indicated that inter-device reliability deteriorated compared to intra-device reliability and that the inter-device reliability of the first scan (moderate) was lower than that of the average of the two scans (good).ConclusionsThe portable VECTRA H2 device proved reliable in assessing most periocular linear distances, curve distances, and angles; some improvement in inter-device reliability can be achieved by using the average of two scans.

Analysis of keratometric measurements in accordance with axial length in an aged population

To investigate keratometric measurements according to axial length in an aged population. Patients requiring cataract surgery with keratometric measurements from four different ophthalmic devices (autorefractor/keratometer, Scheimpflug imaging, corneal topography/ray-tracing aberrometry, and partial coherence interferometry) between January 2016 and March 2021 were reviewed retrospectively. Cases for which four ophthalmic devices were deployed in the same order a day were included in this investigation. The corneal curvature of the flattest and steepest meridian, mean corneal curvature, corneal astigmatism, steepest axis location, and axial length were evaluated. In total, 250 eyes (137 patients) were included in the analysis. A negative correlation was found between mean corneal curvature and axial length, with correlation coefficients of 0.587, 0.592, 0.588, 0.591, 0.588, and 0.562 for autorefractor/keratometer, Scheimpflug imaging, corneal topography/ray-tracing aberrometry, partial coherence interferometry, total corneal refractive power of Scheimpflug imaging, and simulated keratometry of corneal topography/ray-tracing aberrometry measurements, respectively. No statistically significant differences were found for corneal astigmatism according to axial length. In axial length group of less than 26.0 mm, negative correlation was found between axial length and mean frontal corneal curvature while no correlation was found between axial length and corneal astigmatism. All four ophthalmic devices showed good inter-device reliability for mean corneal curvature but not corneal astigmatism.