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Genucom knee analysis system: reproducibility and database development.

The Genucom is a relatively new computerized system that performs a multidimensional analysis of knee laxity. Therefore, the purposes of the present investigation were twofold: 1) to estimate the reproducibility of the testing system in its ability to obtain similar test values on the same test subject within a back-to-back two-test protocol and 2) to develop a database of normal values as a standard against which values of suspected ligament injury can be compared to reliably determine whether, in fact, ligament injury has occurred. In the reproducibility phase of the study, 20 subjects were tested in two trials each of eight tests, yielding 20 separate test values per trial, accounting for each angle of flexion and plane of force tested. Both legs were tested, providing an N of 40. Test-retest correlations of the two trials and dependent t-tests indicated that the Genucom provided generally stable and reproducible results. In the normal value database phase of the study, 218 different subjects were given one trial of the same eight tests. Testing of both legs provided an N greater than 400. Means and standard deviations were calculated for each test.

Adult↗

Symmetry and reproducibility of kinematic parameters during various running techniques.

PURPOSE: This study examined the validity of the assumption of lower-extremity kinematic parameter reproducibility and symmetry during running with different velocities and stride frequencies. METHODS: Each of 12 female long-distance runners ran on a treadmill in combinations of three different velocities (2.5, 3.0, and 3.5 m.s-1) and three different stride frequencies (preferred and +/- 10% from preferred). The left and right sides of the athletes were filmed using video cameras placed orthogonally to the sagittal plane. A total number of three step cycles for each running condition were recorded (250 Hz). For each side of the body, 19 sagittal kinematic parameters from the lower extremity were evaluated. RESULTS: Intraclass correlation coefficients (ICC) for both legs were high (generally > 0.80). Only the angular velocity parameters demonstrated correlation values below 0.70. The symmetry index for the linear and angular displacement parameters and the contact times during all running techniques were less than 8%, whereas those for the angular velocity parameters and flight times were higher than 15%. CONCLUSION: The present results suggested that the degree of reproducibility and symmetry of kinematic data do not vary with a deliberate change in running technique but rather depend on the parameter itself. With respect to the economy of data analysis, the present findings indicate that recording a single monolateral trial would provide reproducible and symmetric values for most kinematic parameters.

Adult↗

Reproducibility of Doppler ultrasound measurement of resistance index in renal allografts.

In recent years measurements of arterial blood flow in the renal allograft have been studied in an attempt to provide a non-invasive method of diagnosing and monitoring post-transplant renal dysfunction. Many studies have involved measurement of the resistance index (RI) of arterial blood flow. Although the reproducibility of the technique has been studied in other areas of application, no such studies have been performed on the renal allograft. In this study we attempted to evaluate the reproducibility of the measurement of the RI of the interlobar artery in the renal allograft. 18 renal allograft recipients with stable functioning grafts were studied twice by each of two experienced sonographers using a colour-coded duplex Doppler ultrasound scanner, in order to determine the intraobserver and interobserver variability in the measurement of RI of the interlobar arteries in the allograft. Variability was small and although interobserver variability exceeded intraobserver variability, both were within repeatability limits adopted by the British Standards Institution. The results suggest that measurement of the RI of the interlobar artery of renal allografts is repeatable and reproducible when performed by experienced operators.

Adult↗

Reproducibility of and file format effect on digital subtraction radiography of simulated external root resorptions.

OBJECTIVE: To evaluate, in simulated external root resorptions (ERR), two factors that may affect results of digital subtraction radiography (DSR): (1) intraobserver and interobserver reproducibility and (2) effects of digital file formats (TIFF, BMP and JPEG) on the estimation of mineral loss. METHODS: Eleven incisors were radiographed three times (NR, no resorption; SR, small--#1/4 round bur; and LR, large--#2 round bur) on standardized projections. The resulting images were reproduced and saved as TIFF, JPEG and BMP file formats. The pairs of TIFF images (NR x SR and NR x LR) were subtracted three times at 1 week intervals by three observers. One observer subtracted pairs of images (NR x SR and NR x LR) for all file formats. For each subtraction the resorption area was selected and mean pixel density values were calculated. RESULTS: Analysis of variance (ANOVA) (P = 0.05) showed no statistical differences for intraobserver and interobserver values. Mean pixel density values were: observer A, 121.60 +/- 2.56 (NR x SR) and 111.84 +/- 4.04 (NR x LR); observer B, 121.86 +/- 2.50 (NR x SR) and 110.92 +/- 3.36 (NR x LR); and observer C, 121.70 +/- 2.39 (NR x SR) and 111.10 +/- 2.67 (NR x LR). Also, no statistical differences were found between file formats for LR (TIFF, 110.88 +/- 2.79; JPEG, 111.35 +/- 3.35; BMP, 111.00 +/- 2.70) and for SR between TIFF (121.30 +/- 2.34) and JPEG (120.46 +/- 1.51) or BMP (121.67 +/- 2.18) file formats. Differences were found between the JPEG and BMP groups. CONCLUSIONS: DSR is reproducible in simulated ERR, and JPEG or BMP file formats do not affect results.

Analysis of Variance↗

Validity, reproducibility, and clinical significance of noninvasive brachial-ankle pulse wave velocity measurement.

The present study was conducted to evaluate the validity and reproducibility of noninvasive brachial-ankle pulse wave velocity (baPWV) measurements and to examine the alteration of baPWV in patients with coronary artery disease (CAD). Simultaneous recordings of baPWV by a simple, noninvasive method and aortic pulse wave velosity (PWV) using a catheter tip with pressure manometer were performed in 41 patients with CAD, vasospastic angina, or cardiomyopathy. In 32 subjects (15 controls and 17 patients with CAD), baPWV was recorded independently by two observers in a random manner. In 55 subjects (14 controls and 41 patients with CAD), baPWV was recorded twice by a single observer on different days. baPWV were compared among 172 patients with CAD (aged 62 +/- 8 years); 655 age-matched patients without CAD but with hypertension, diabetes mellitus, or dyslipidemia; and 595 age-matched healthy subjects without these risk factors. baPWV correlated well with aortic PWV (r=0.87, p<0.01). Pearson's correlation coefficients of interobserver and intraobserver reproducibility were r=0.98 and r=0.87, respectively. The corresponding coefficients of variation were 8.4% and 10.0%. baPWV were significantly higher in CAD patients than in non-CAD patients with risk factors, for both genders (p<0.01). In addition, baPWV were higher in non-CAD patients with risk factors than in healthy subjects without risk factors. Thus, the validity and reproducibility of baPWV measurements are considerably high, and this method seems to be an acceptable marker reflecting vascular damages. baPWV measured by this simple, noninvasive method is suitable for screening vascular damages in a large population.

Adult↗

Reproducibility of arterial stiffness indices (pulse wave velocity and augmentation index) simultaneously assessed by automated pulse wave analysis and their associated risk factors in essential hypertensive patients.

Arterial stiffness is a strong determinant of cardiovascular risk. Pulse wave velocity (PWV) and the augmentation index (AIx) are widely used as arterial stiffness indices. We studied the reproducibility of these indices and their association with cardiovascular risk factors in hypertensives. We measured brachial blood pressure (BP), brachial-ankle PWV (baPWV) and carotid AIx (cAIx) twice (at the baseline and 4 weeks after the baseline) using an automatic device in 103 hypertensives. The mean intraobserver-intersession difference was 29.0 cm/s with an SD of 201.6 cm/s for baPWV, and 0.5% with an SD of 5.9% for cAIx, and the Bland-Altman plots demonstrated the good reproducibility of baPWV and cAIx. Both baPWV and cAIx (the average of the 1st and the 2nd measurements) were significantly correlated with age, systolic BP (SBP), and pulse pressure (all, p <0.005); however, these factors were not correlated with each other (r =0.06, NS). cAIx was correlated with height, heart rate (HR), total cholesterol, and low density lipoprotein cholesterol (LDL-C) (all, p <0.05). In multiple regression analysis, age, SBP, and HR emerged as significant independent predictors of baPWV (adjusted R(2)=0.43, p <0.0001), while height, SBP, HR, and LDL-C emerged as significant independent predictors of cAIx (adjusted R(2)=0.58, p <0.0001). Both PWV and AIx measured using an automatic device were fairly reproducible, and their associated risk factors appeared to be different. Automated simultaneous measurement of these arterial stiffness indices may be useful for risk stratification of hypertensives.

Aged↗

Assessment of reproducibility and accuracy in templating hybrid total hip arthroplasty using digital radiographs.

In 20 patients undergoing hybrid total hip arthroplasty, the reproducibility and accuracy of templating using digital radiographs were assessed. Digital images were manipulated using either a ten-pence coin as a marker to scale for magnification, or two digital-line methods using computer software. On-screen images were templated with standard acetate templates and compared with templating performed on hard-copy digital prints. The digital-line methods were the least reliable and accuracy of sizing compared with the inserted prostheses varied between -1.6% and +10.2%. The hard-copy radiographs showed better reproducibility than the ten-pence coin method, but were less accurate with 3.7% undersizing. The ten-pence coin method was the most accurate, with no significant differences for offset or acetabulum, and undersizing of only 0.9%. On-screen templating of digital radiographs with standard acetate templates is accurate and reproducible if a radiopaque marker such as a ten-pence coin is included when the original radiograph is taken.

Acetabulum↗

Breaking the reproducibility barrier with standardized protocols for plant-microbiome research.

Inter-laboratory replicability is crucial yet challenging in microbiome research. Leveraging microbiomes to promote soil health and plant growth requires understanding underlying molecular mechanisms using reproducible experimental systems. In a global collaborative effort involving five laboratories, we aimed to help advance reproducibility in microbiome studies by testing our ability to replicate synthetic community assembly experiments. Our study compared fabricated ecosystems constructed using two different synthetic bacterial communities, the model grass Brachypodium distachyon, and sterile EcoFAB 2.0 devices. All participating laboratories observed consistent inoculum-dependent changes in plant phenotype, root exudate composition, and final bacterial community structure, where Paraburkholderia sp. OAS925 could dramatically shift microbiome composition. Comparative genomics and exudate utilization linked the pH-dependent colonization ability of Paraburkholderia, which was further confirmed with motility assays. The study provides detailed protocols, benchmarking datasets, and best practices to help advance replicable science and inform future multi-laboratory reproducibility studies.

Plants↗

Evaluation of serum protein profiling by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry for the detection of prostate cancer: I. Assessment of platform reproducibility.

BACKGROUND: Protein expression profiling for differences indicative of early cancer has promise for improving diagnostics. This report describes the first stage of a National Cancer Institute/Early Detection Research Network-sponsored multiinstitutional evaluation and validation of this approach for detection of prostate cancer. METHODS: Two sequential experimental phases were conducted to establish interlaboratory calibration and standardization of the surface-enhanced laser desorption (SELDI) instrumental and assay platform output. We first established whether the output from multiple calibrated Protein Biosystem II SELDI-ionization time-of-flight mass spectrometry (TOF-MS) instruments demonstrated acceptable interlaboratory reproducibility. This was determined by measuring mass accuracy, resolution, signal-to-noise ratio, and normalized intensity of three m/z "peaks" present in a standard pooled serum sample. We next evaluated the ability of the calibrated and standardized instrumentation to accurately differentiate between selected cases of prostate cancer and control by use of an algorithm developed from data derived from a single site 2 years earlier. RESULTS: When the described standard operating procedures were established at all laboratory sites, the across-laboratory measurements revealed a CV for mass accuracy of 0.1%, signal-to-noise ratio of approximately 40%, and normalized intensity of 15-36% for the three pooled serum peaks. This was comparable to the intralaboratory measurements of the same peaks. The instrument systems were then challenged with sera from a selected group of 14 cases and 14 controls. The classification agreement between each site and the established decision algorithm were examined by use of both raw peak intensity boosting and ranked peak intensity boosting. All six sites achieved perfect blinded classification for all samples when boosted alignment of raw intensities was used. Four of six sites achieved perfect blinded classification with ranked intensities, with one site passing the criteria of 26 of 28 correct and one site failing with 19 of 28 correct. CONCLUSIONS: These results demonstrate that "between-laboratory" reproducibility of SELDI-TOF-MS serum profiling approaches that of "within-laboratory" reproducibility as determined by measuring discrete m/z peaks over time and across laboratories.

Calibration↗

Reproducibility of maximal exercise ergometer testing in patients with cystic fibrosis.

OBJECTIVES: Exercise testing in patients with cystic fibrosis (CF) has become an important tool in assessing disease severity and predicting overall outcome. The reproducibility of maximal exercise testing was examined in adult subjects with stable CF. METHODS: Nine subjects with CF underwent a total of three maximal exercise tests carried out under identical circumstances over a 28-day period. Oxygen uptake (VO2), minute ventilation (VE), respiratory frequency (f), heart rate (HR), and arterial oxygen saturation (SaO2) were measured at rest, at end exercise, and at 40% and 70% of maximum workload. RESULTS: There were no significant differences in these measurements among the three tests. Reproducibility of exercise performance was assessed using the coefficient of variation. The mean within-subject coefficient of variation for test variables at end exercise are as follows: VO2, 6.9%; VE, 6.2%; f, 5.8%; IIR, 3.0%; and SaO2, 1.1%. The mean within-subject coefficient of variation for test variables at 40% and 70% of maximal work rates are as follows: VO2, 5.2% and 4.6%; SaO2, 0.3% and 0.9%; HR, 4.0% and 3%; VE, 5.7% and 6.5%; and f, 5.8% and 7.2%, respectively. CONCLUSIONS: Variables measured during clinical cycle ergometer exercise testing in adult patients with stable CF are reproducible. No learning effect was found on repeated testing.

Adult↗

A rapid, economical, and reproducible method for human serum delipidation and albumin and IgG removal for proteomic analysis.

Serum is a readily available source for diagnostic assays, but the identification of disease-specific serum biomarkers has been impeded by the dominance of human serum albumin (HSA) and immunoglobulin G (IgG) in the serum proteome. Therefore, in order to observe lower-abundance serum proteins, removal or depletion of at least these two proteins is required. However, the depletion method needs to be inexpensive and reproducible. We describe such a protocol that combines delipidation by centrifugation, IgG removal with Protein G Sepharose, and HSA depletion with sodium chloride/ethanol precipitation. The protocol is streamlined to increase reproducibility and is compatible with many proteomic platforms, including two-dimensional gel electrophoresis, and high-performance liquid chromatography either offline or coupled online with a mass spectrometer. The reproducible depletion of lipids, IgG, and HSA permits a higher load of the remaining serum proteins, facilitating the identification of disease biomarkers.

Biomarkers↗

Reproducibility of DXA in obese women.

Dual-energy X-ray absorptiometry (DXA) measurements were analyzed using two versions of software (Hologic V8.1a and V8.21) to compare the short- and long-term precisions of the measurements. Software V8.21 was designed by the manufacturer to better address magnification effects on estimations of soft tissue lean mass. Twenty weight-stable, obese postmenopausal Caucasian women aged 40-70 yr participated in the study. Total and regional body composition measurements were obtained at baseline and after 3 mo, using a fan beam Hologic QDR 4500A absorptiometer. For the estimation of precision, duplicate scans obtained on the same day for nine women were analyzed using both versions of the software. The correlations between duplicate scans ranged from 0.886 to 0.998 and were similar between software versions. The CVs for fat and lean weights and bone mineral content (BMC) were 1.2%, 1.1%, and 1.7%, respectively, for software V8.21 compared to 1.3%, 1.3%, and 2.1%, respectively, for V8.1a. Systematic differences were found between software versions with higher values for fat and lean weights for software version V8.21. The 3-mo, long-term reproducibility of body composition estimates from DXA was only slightly less than short-term reproducibility for both software versions (coefficient of variation [CV] range from 1.3% for BMC weight to 11.0% for arm fat). Software V8.21 yielded smaller percentage mean differences between scale and DXA-estimated weights (-2.4% and -7.2% at baseline and -2.9% and -7.6% at 3 mo, respectively) and higher fat and lean weights (49.12 and 47.1 kg and 49.6 and 44.6 kg, respectively) than V8.1a. Reproducibility of all variables was comparable between software versions.

Absorptiometry, Photon↗

Reproducibility of DXA estimations of body fat in HIV lipodystrophy: implications for clinical research.

Dual-energy X-ray absorptiometry (DXA) estimates of body fat are increasingly used for the evaluation of human immunodeficiency virus lipodystrophy (HIV LD); however, limited data are available on their reproducibility. This information is essential for using this tool as an end point in treatment trials or as a diagnostic tool. This study evaluates the reproducibility of DXA body fat estimation in HIV-positive subjects with and without lipodystrophy. Thirty subjects representing a spectrum of severity of fat redistribution underwent same-day repeat whole-body DXA scans (Hologic QDR 4500A scanner). Root mean square coefficients of variation (RMS-CV) were used to estimate minimum detectable differences (MDDs) for body fat content in different regions. Absolute MDD was calculated by multiplying the MDD by the mean fat-mass value for each anatomical area. The RMS-CV ranged from 4.0% for arm fat to 1.6% for total fat. Relative and absolute MDD values ranged from 11.0% or 160 g for arm fat to 4.3% or 628 g for total fat. DXA measurements of regional body fat mass in subjects with HIV show similar reproducibility to other populations. Minimal detectable differences were smaller than differences observed in published studies for all measurements. DXA is a sensitive tool for detecting changes in peripheral fat among patients with HIV lipodystrophy.

Absorptiometry, Photon↗

Reproducibility of pediatric whole body bone and body composition measures by dual-energy X-ray absorptiometry using the GE Lunar Prodigy.

The use of dual-energy X-ray absorptiometry (DXA) in pediatrics is increasing. It is safe, readily available, and easily performed, but there is little information on reproducibility. The aim of this study is to evaluate the reproducibility of whole body DXA scans in children. Total and regional bone mineral density, bone mineral content, nonbone, lean fat mass, and percent fat were measured twice by whole body DXA (GE Lunar Prodigy) in 49 subjects (5 to 17 yr). Within each subject, between subjects, and reading standard deviations for each body component were evaluated as well as intraclass correlations (IC) and coefficients of variation (CV). Total body measurements had better IC and CV than regional results from the whole body scan, with legs and arms better than trunk and spine. IC values were >or=0.989 for total body, >or=0.976 for legs and arms, and >or=0.875 for trunk and spine. CV values ranged 0.18 to 1.97% for total body, and 0.96 to 6.91% for regional measures. These values confirm that body composition and bone mass by DXA are highly reproducible among pediatric subjects. The results of this study can be used by clinicians and researchers for interpretation of longitudinal observations and for power calculations.

Absorptiometry, Photon↗

[Experimental investigation on the reproducibility of ensemble-averaged electromyographic gait analysis data in the area of experimental and clinical orthopaedics].

With suitable application and signal processing methods, surface electromyography is a comparatively simple instrument for investigating the temporal pattern of the muscular activity of a walking subject. The influence of changes both in the external experimental conditions (e.g. orthopedic shoe design) and in the human locomotor system (due to disease or therapy) on the individual muscular gait characteristics can be documented in this way. The usefulness of this kind of investigation is basically limited by the reproducibility of the gait analytical findings of the subject, who is examined at different times with unchanged bodily state and under identical experimental conditions unchanged. In our experiments we observed that the reproducibility of electromyographic activity curves obtained by ensemble averaging over a sufficiently high number of full strides differs for different muscles and in different subjects. Within the same experimental session it is very high and considerably better than in experiments done on different days. In examinations done on different days the basic characteristics of the activity curves are reproduced better than the absolute height of the amplitudes. In view of these findings the differences observed in the gait analysis of patients in the course of operative or conservative therapy have to be interpreted very carefully as to their true origin.

Algorithms↗

The reproducibility of urinalysis using multiple reagent test strips.

Ninety urine samples were examined twice by 3 "observers" (two persons, using only visual observation, and one person using a spectrophotometric analyser) using multiple reagent teststrips. To determine reproducibility, inter- and intra-observer agreement were calculated and expressed as Cohen's kappa and as weighted kappa. The results show negligible intra-observer differences between the visual and spectrophotometric observation. The lack of agreement between inter- and intra-observer urinalysis results, using multiple reagent test strips was disappointing, considering the simplicity of the test procedure. Further improvement of reproducibility, e.g. by enhancing the discoloration of the test pads, is necessary. Reproducibility is not improved by using a spectrophotometric analyser instead of visual reading of the test strips.

Esterases↗

Poor reproducibility of false-positive tilt testing results in healthy volunteers.

Positive responses to head-up tilt testing occur in healthy subjects. However, the reproducibility of "false-positive" tilt testing results has not been clarified. To study the reproducibility of "false-positive" responses, we prospectively performed 2 tilt tests separated by 1 to 10 (mean 3.2) weeks in 20 healthy males aged 23 to 40 years (mean 30 years). The baseline tilt test (80 degrees for 30 minutes) ended positive in 4 (20%) subjects on the initial test and 2 (10%) on the second test with only 1 (5%) who had consecutive positive responses. No additional positive responses were noted during the isoproterenol (0.01 microgram/kg/min)-tilt test for 10 minutes. We demonstrated that a false-positive response occurred in 5 (25%) of 20 young males who underwent 2 tilt tests, however, only 1 (5%) subject had consecutive positive responses. Poor reproducibility may be characteristic of false-positive responses in head-up tilt testing.

Adult↗

Chest roentgenogram in the evaluation of heart defects in asymptomatic infants and children with a cardiac murmur: reproducibility and accuracy.

OBJECTIVES: To evaluate the reproducibility and the accuracy of pediatric radiologists' assessments of chest radiographs with respect to the presence or absence of heart defects in children with an asymptomatic heart murmur. DESIGN: Ninety-eight children, ages 1 month to 15 years (median, 30.1 months), referred for evaluation of a heart murmur were consecutively included. They all had a standard chest radiograph and a color Doppler echocardiograph (CDE) performed. Six specialists in pediatric radiology evaluated the chest radiographs independently on two occasions 6 months apart. The radiologists were asked to classify each set of films into one of two categories: heart disease or no heart disease. The outcome of the CDE was considered the definite diagnosis. kappa statistics were used to analyze the reproducibility of the radiologic assessments. Sensitivity, specificity, and the predictive value of a positive and a negative test were used for evaluation of the accuracy of the radiologic assessments. RESULTS: Mean intra- and interobserver kappa values were all <0.6, and the majority were <0.4. Mean sensitivity was 0.3 (range: 0.17-0.52), mean predictive value of a positive test was 0.4, implying that 60% of the positive assessments were falsely positive. Mean specificity was 0.86 (range: 0.75-0.93) and the mean predictive value of a negative test was 0.80 implying that 20% of the negative assessments were falsely negative. CONCLUSION: We found a low reproducibility, as well as a low accuracy, of the radiologic assessments of the chest radiographs of children with an asymptomatic heart murmur with respect to the presence or absence of heart disease. A false-positive radiologic assessment of the chest radiograph with respect to heart defects causes unnecessary anxiety and further examinations, whereas a false-negative assessment might result in omission of relevant investigations and proper identification of the heart defect. We cannot recommend the use of chest radiographs in the initial evaluation of the asymptomatic child with a heart murmur. If a heart defect cannot be excluded by clinical examination a CDE must be performed.

Adolescent↗