Reliability of a novel electro-medical device for wheal size measurement in allergy skin testing: An exploratory clinical trial.
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ABSTRACT:
SUBMITTER: Morales-Palacios MP
PROVIDER: S-EPMC10087902 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Reliability of a novel electro-medical device for wheal size measurement in allergy skin testing: An exploratory clinical trial.
Morales-Palacios María de la Paz MP Núñez-Córdoba Jorge M JM Tejero Eduardo E Matellanes Óscar Ó Quan Paola Leonor PL Carvallo Álvaro Á Sánchez-Fernández Sergio S Urtasun Maite M Larrea Carla C Íñiguez María Teresa MT Giménez Rosa R Goikoetxea Maria José MJ D'Amelio Carmen M CM Ferrer Marta M Gastaminza Gabriel G
Allergy 20220820 1
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Project description:BackgroundWithin a large prospective study, the Global Asthma and Allergy European Network (GA(2) LEN) has collected skin prick test (SPT) data throughout Europe to make recommendations for SPT in clinical settings.ObjectiveTo improve clinical interpretation of SPT results for inhalant allergens by providing quantitative decision points.MethodsThe GA(2) LEN SPT study with 3068 valid data sets was used to investigate the relationship between SPT results and patient-reported clinical relevance for each of the 18 inhalant allergens as well as SPT wheal size and physician-diagnosed allergy (rhinitis, asthma, atopic dermatitis, food allergy). The effects of age, gender, and geographical area on SPT results were assessed. For each allergen, the wheal size in mm with an 80% positive predictive value (PPV) for being clinically relevant was calculated.ResultsDepending on the allergen, from 40% (blatella) to 87-89% (grass, mites) of the positive SPT reactions (wheal size ≥ 3 mm) were associated with patient-reported clinical symptoms when exposed to the respective allergen. The risk of allergic symptoms increased significantly with larger wheal sizes for 17 of the 18 allergens tested. Children with positive SPT reactions had a smaller risk of sensitizations being clinically relevant compared with adults. The 80% PPV varied from 3 to 10 mm depending on the allergen.ConclusionThese 'reading keys' for 18 inhalant allergens can help interpret SPT results with respect to their clinical significance. A SPT form with the standard allergens including mm decision points for each allergen is offered for clinical use.
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Project description:BackgroundSkin prick test (SPT) is a common test for diagnosing immunoglobulin E-mediated allergies. In clinical routine, technicalities, human errors or patient-related biases, occasionally results in suboptimal diagnosis of sensitization.ObjectiveAlthough not previously assessed qualitatively, lancet weight is hypothesized to be important when performing SPT to minimize the frequency of false positives, false negatives, and unwanted discomfort.MethodsAccurate weight-controlled SPT was performed on the volar forearms and backs of 20 healthy subjects. Four predetermined lancet weights were applied (25 g, 85 g, 135 g and 265 g) using two positive control histamine solutions (1 mg/mL and 10 mg/mL) and one negative control (saline). A total of 400 SPTs were conducted. The outcome parameters were: wheal size, neurogenic inflammation (measured by superficial blood perfusion), frequency of bleeding, and the lancet provoked pain response.ResultsThe mean wheal diameter increased significantly as higher weights were applied to the SPT lancet, e.g. from 3.2 ± 0.28 mm at 25 g to 5.4 ± 1.7 mm at 265 g (p<0.01). Similarly, the frequency of bleeding, the provoked pain, and the neurogenic inflammatory response increased significantly. At 265 g saline evoked two wheal responses (/160 pricks) below 3 mm.Conclusion and clinical relevanceThe applied weight of the lancet during the SPT-procedure is an important factor. Higher lancet weights precipitate significantly larger wheal reactions with potential diagnostic implications. This warrants additional research of the optimal lancet weight in relation to SPT-guidelines to improve the specificity and sensitivity of the procedure.
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Project description:BackgroundMany treatments aim to slow down or reverse the visible signs of skin aging and thereby improve skin quality. Measurement devices are frequently employed to measure the effects of these treatments to improve skin quality, for example, skin elasticity, color, and texture. However, it remains unknown which of these devices is most reliable and valid.Materials and methodsMEDLINE, Embase, Cochrane Central, Web of Science, and Google Scholar databases were searched. Instruments were scored on reporting construct validity by means of convergent validity, interobserver, intraobserver, and interinstrument reliability.ResultsFor the evaluation of skin color, 11 studies were included describing 16 measurement devices, analyzing 3172 subjects. The most reliable device for skin color assessment is the Minolta Chromameter CR-300 due to good interobserver, intraobserver, and interinstrument reliability. For skin elasticity, seven studies assessed nine types of devices analyzing 290 subjects in total. No intra and interobserver reliability was reported. Skin texture was assessed in two studies evaluating 72 subjects using three different types of measurement devices. The PRIMOS device reported excellent intra and interobserver reliability. None of the included reviewed devices could be determined to be valid based on construct validity.ConclusionThe most reliable devices to evaluate skin color and texture in ordinary skin were, respectively, the Minolta Chromameter and PRIMOS. No reliable device is available to measure skin elasticity in ordinary skin and none of the included devices could be determined to be designated as valid.
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Project description:BackgroundDysfunction of human respiratory and electro-cardiac activities could affect the ability of the heart to pump blood and the lungs to inhale oxygen. Thus, a device could simultaneously measure electro-cardiac signal and respiratory pressure could provide vital signs for predicting early warning of cardio-pulmonary function-related chronic diseases such as cardiovascular disease, and respiratory system disease.ResultsIn this study, a flexible device integrated with piezo-resistive sensing element and voltage-sensing element was developed to simultaneously measure human respiration and electro-cardiac signal (including respiratory pressure, respiration frequency, and respiration rhythm; electro-cardio frequency, electro-cardio amplitude, and electro-cardio rhythm). When applied to the measurement of respiratory pressure, the piezo-resistive performance of the device was enhanced by nano-copper modification, which detection limitation of pressure can reduce to 100 Pa and the sensitivity of pressure can achieve to 0.053 ± 0.00079 kPa-1. In addition, the signal-to-noise ratio during bio-electrical measurement was increased to 10.7 ± 1.4, five times better than that of the non-modified device.ConclusionThis paper presents a flexible device for the simultaneous detection of human respiration and cardiac electrical activity. To avoid interference between the two signals, the layout of the electrode and the strain sensor was optimized by FEA simulation analysis. To improve the piezo-resistive sensitivity and bio-electric capturing capability of the device, a feather-shaped nano-copper was modified onto the surface of carbon fiber. The operation simplicity, compact size, and portability of the device open up new possibilities for multi-parameter monitoring.
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Project description: Not available
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Project description:BackgroundAs extract-based skin testing as well as in vitro tests for major allergens have their own advantages, both procedures are usually performed in routine settings. In times of shortages in medical staff and supplies, we asked ourselves, how many patients would be underdiagnosed, if only one test could be used.MethodsIn a retrospective analysis, we investigated a cohort of 2646 patients seen by a single physician in a large Austrian outpatient allergy clinic in 2018. Only patients with an allergen source-specific history and pairs of extract-based skin prick (SPT) and in vitro molecular allergy tests to major allergens were included.ResultsFor all tested allergen sources, sensitivity was higher for SPT than for sIgE-based molecular allergy testing. Concerning 1006 birch pollen-allergic patients, 791 (78.6%) had positive results with both tests, while 153 (15.2%) only with the SPT and 62 (6.2%) only with the sIgE to Bet v1. The other allergen sources showed similar results: For house dust mite 816/1120 (72.9%), grass pollen 1077/1416 (76.1%) and cat 433/622 (69.6%) remained test-positive with both procedures, whereas in 276 (24.6%), 224 (15.8%) and 173 (27.8%) times only the SPT and 28 (2.5%), 115 (8.1%) and 16 (2.6%) times only the sIgE to Der p1/2/23, Phl p1/5 and Fel d1 showed a positive result. Each comparison was statistically significant (each p < 0.0001, Chi-squared test).ConclusionsScreening for allergy with major molecular allergens has lower sensitivity when compared with extract-based skin tests. A combination of both is required for an optimal sensitivity.
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Project description:Background and purpose (aims)Measurement error of intraoral quantitative sensory testing (QST) has been assessed using traditional methods for reliability, such as intraclass correlation coefficients (ICCs). Most studies reporting QST reliability focused on assessing one source of measurement error at a time, e.g., inter- or intra-examiner (test-retest) reliabilities and employed two examiners to test inter-examiner reliability. The present study used a complex design with multiple examiners with the aim of assessing the reliability of intraoral QST taking account of multiple sources of error simultaneously.MethodsFour examiners of varied experience assessed 12 healthy participants in two visits separated by 48h. Seven QST procedures to determine sensory thresholds were used: cold detection (CDT), warmth detection (WDT), cold pain (CPT), heat pain (HPT), mechanical detection (MDT), mechanical pain (MPT) and pressure pain (PPT). Mixed linear models were used to estimate variance components for reliability assessment; dependability coefficients were used to simulate alternative test scenarios.ResultsMost intraoral QST variability arose from differences between participants (8.8-30.5%), differences between visits within participant (4.6-52.8%), and error (13.3-28.3%). For QST procedures other than CDT and MDT, increasing the number of visits with a single examiner performing the procedures would lead to improved dependability (dependability coefficient ranges: single visit, four examiners=0.12-0.54; four visits, single examiner=0.27-0.68). A wide range of reliabilities for QST procedures, as measured by ICCs, was noted for inter- (0.39-0.80) and intra-examiner (0.10-0.62) variation.ConclusionReliability of sensory testing can be better assessed by measuring multiple sources of error simultaneously instead of focusing on one source at a time. In experimental settings, large numbers of participants are needed to obtain accurate estimates of treatment effects based on QST measurements. This is different from clinical use, where variation between persons (the person main effect) is not a concern because clinical measurements are done on a single person.ImplicationsFuture studies assessing sensory testing reliability in both clinical and experimental settings would benefit from routinely measuring multiple sources of error. The methods and results of this study can be used by clinical researchers to improve assessment of measurement error related to intraoral sensory testing. This should lead to improved resource allocation when designing studies that use intraoral quantitative sensory testing in clinical and experimental settings.
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Project description:BackgroundPrecision is crucial in determining the appropriate procedure for implementing further trials. We conducted a study to explore the reliability of a novel measuring system for human skin color.MethodsThe novel skin color measuring system was used to capture the skin color of four volunteers (2 males and 2 females) from the same location on each subject by the same operator. The measurement was repeated for different poses and instrument factors (camera and shooting protocol) in the red, green, and blue (RGB) system. The average color depth in each image was calculated and converted from 0 to 255. The spread of measures and the Bland-Altman plot was displayed to determine each variance source's random error, with the interclass correlation coefficients applied to reflect the reliability.ResultThe RGB color depth in the experiment ranged from 190, 152, and 122 to 208, 170, and 142. The 95% confidential interval of the differences from the means in RGB colors for the different protocols were ±2.8, ±2.6, and ±2.1, respectively. The largest variation in the replicate trials was observed when subjects were in a supine position (standard deviation: 2). The interclass correlation coefficients were greater than 90%, suggesting that the developed system is highly precise.ConclusionThis study demonstrated that the developed device could stably and reliably detect human skin color across different common sources of variation, and thus could be applied clinically to explore relationships between health/disease and skin color changes.
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