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PubMed1982

Subjective vs. objective evaluation of gallbladder opacification during oral cholecystography in comparative clinical trials: implications for studies involving visual assessment.

Radiographs and CT images taken during oral cholecystography in dogs were interpreted in an independent, blind fashion by three radiologists on two occasions and visual assessment of gallbladder density compared to the actual CT values. While there was significant intra- and inter-observer variation, the mean scores for the observers' interpretations of both radiographs and prints correlated well with the actual CT values (p less than 0.05). In five out of six comparisons between first and second readings, the observers gave a lower score on the second reading. The considerable variation reflects the problems inherent in subjective evaluation of agents that produce small but measurable differences in radiographic density. Studies involving such subjective data have to be carefully designed in order to obtain meaningful results.

Administration, Oral↗

PubMed1990

[The dose-response relationship and time course of the neuromuscular blockade by alcuronium].

Although alcuronium has been in clinical use for almost 40 years, there is still considerable controversy in the literature regarding its neuromuscular blocking potency, the time course of the drug action and the side effects. The aim of this study was to investigate the dose-response relationship of alcuronium and to compare the time course of its neuromuscular effects with vecuronium following intubation doses of both compounds. METHODS. The study was carried out in two parts. In the first part 60 patients and in the second part 30 consenting ASA class I or II patients 20-60 years of age were included. The patients were undergoing elective gynecological or intra-abdominal operations. In the first part the patients received six different doses of alcuronium (60, 90, 120, 150, 180 or 210 micrograms/kg) in order to establish its dose-response relationship. Each dose was administered to ten patients. In the second part patients received either 300 micrograms/kg alcuronium (n = 15) or 100 micrograms/kg vecuronium (n = 15), and the time course of these two compounds (onset time, duration 25%, duration 75% and the recovery index) were compared. To test the reversibility, ten patients in each group received 30 micrograms/kg neostigmine at 25% recovery of T1. The neuromuscular effects of alcuronium and vecuronium were quantitated by EMG using the DATEX relaxograph. RESULTS. The log-logit analysis of the dose response data revealed an ED50 of 111 micrograms/kg and an ED95 of 250 micrograms/kg, which is in reasonable agreement with the measured effects following 120 micrograms/kg and 210 micrograms/kg alcuronium, resulting in 52 +/- 21% and 96 +/- 4% T1 depression, respectively. The onset time, duration 25%, duration 75% and spontaneous recovery index following 300 micrograms/kg alcuronium (5.0 +/- 3.4 min, 62 +/- 25 min, 119 +/- 38 min and 58 +/- 34 min) appeared to be significantly longer (P less than 0.05) than those observed after 100 micrograms/kg vecuronium (3.2 +/- 1.2 min, 33 +/- 7 min, 49 +/- 9 min and 18 +/- 7 min), respectively. The most striking finding of this study is the enormous individual variations observed in both neuromuscular potency and the time course of action of alcuronium. Following 150 micrograms/kg (routinely employed in daily clinical practice), the magnitude of T1 depression ranged between 19% and 100%. The same vast individual variations were observed in the time course of action following 300 micrograms/kg of alcuronium. The onset time, duration 25%, duration 75% and spontaneous recovery index ranged between 1.3 and 14 min, 22 and 110 min, 93 and 186 min and 32 and 116 min, respectively. CONCLUSIONS. The ED50 and ED95 values for alcuronium found in this study are in the same order of magnitude as 106.8 micrograms/kg and 135 micrograms/kg for ED50 and with 280 micrograms/kg for ED95, respectively, as reported by others. The long duration with slow recovery and the wide individual variation in the neuromuscular effects observed in our study have been reported earlier. Based on the above observations and because of the availability of better alternatives with fewer side effects, we conclude that alcuronium should be added to the list of obsolete neuromuscular blocking agents, together with gallamine and d-tubocurarine.

Adult↗

PubMed1991

Inter- and intra-laboratory variation in the reporting of skin smears in leprosy.

This paper defines the variations in the reporting of skin smears between a base and field laboratory in a leprosy control program. Ten percent of all slides read by the field laboratory in a control area were re-read by the base laboratory. There was almost no variation in the reporting of negative slides, but a variation of 1 + was present in approximately 92% of positive slides. Thus, there was agreement in approximately 8% of positive slides. This paper also defines the variations in the reporting of positive slides under "ideal" conditions by describing the results of a study on intra- and inter-observer variations among technicians at the base laboratory. There was between 45% and 55% agreement within observers and about 36% agreement between observers. The results of both studies are compared. Simple guidelines are derived to monitor the reporting of skin smears in leprosy control programs.

Humans↗

PubMed1991

Nucleolar organizer regions in benign and malignant prostatic disease.

A modified silver stain technique for visualizing nucleolar organizer regions (AgNOR counting) was applied to 24 benign and 23 malignant prostatic biopsies. Marked inter-observer variation was found, particularly in sections with high AgNOR counts. After averaging the AgNOR counts of both observers, there was no significant difference in counts between the benign and the malignant biopsies. The AgNOR count appeared to be increased in tumours up to Gleason histological grade 6, but not in tumours of Gleason histological grade 7 or more.

Humans↗

PubMed1993

Revised equations for calculating CO2 production from doubly labeled water in humans.

The Schoeller model for calculating rate of CO2 production (rCO2) from doubly labeled water (DLW) relies on the assumption that deuterium and oxygen-18 overestimate body water by 4 and 1%, respectively. However, the deuterium-to-oxygen-18 dilution space ratio (DSR) varies considerably, and it is unknown whether this is due to analytical or biological sources. From 161 published values in adult humans, we derived a mean DSR of 1.0427 +/- 0.0218. Propagation of error suggests that analytical uncertainty accounts for 20-50% of the observed variation in the DSR, whereas reliability testing in vivo and in vitro demonstrate that 70-100% of observed interindividual variation in the DSR can be attributed to analytical uncertainty. The discrepancy between propagated error and experimental reliability suggest that it is unwise to rely on propagation of error when evaluating sources of error in DLW. The new constant of 1.0427 was used to revise existing equations for calculating rCO2 from DLW. Compared with the existing equation, the revised equation improved the accuracy (-0.38 vs. +10.3%) and the precision (9.3 vs 10.7%) of rCO2 calculations in previously published validation studies. We conclude that 1) variation in the oxygen-18-to-deuterium DSR is primarily influenced by analytical noise and warrants use of a fixed ratio, 2) existing equations should be revised because the original DSR may have been underestimated, and 3) the modified equations improve the accuracy and precision of rCO2 calculated from DLW.

Carbon Dioxide↗

PubMed1997

Variability of gallbladder emptying after oral stimulation.

BACKGROUND: To date, the intraindividual reproducibility of fasting and postprandial gallbladder (GB) volumes has not been established satisfactorily. Hence we examined the variability of postprandial GB motility, using the biplane Simpson method as a new sonographic tool for GB volume determination. METHODS: The biplane Simpson method was validated in vitro and in vivo and compared with the sum-of-cylinders method. Thereafter, postprandial GB emptying after a defined test meal was examined in 10 healthy volunteers over 108 min on days 1, 31, and 61. RESULTS: The results of the biplane Simpson method correlated with real volumes (r = 0.99) and provided a intra- and inter-observer variation of less than 5%. Intraindividually, differences in fasting GB volume ranged from 1.9 to 24.0 ml within the observation period. The patterns of GB emptying also showed fluctuations characterized by a rather large interindividual and intraindividual variability. CONCLUSIONS: The biplane Simpson method is a reliable tool for measuring GB volumes. The fasting and the postprandial GB volumes vary considerably within individuals when measured over a period of 2 months.

Adult↗

PubMed1999

Calcium isotope fractionation between soft and mineralized tissues as a monitor of calcium use in vertebrates.

Calcium from bone and shell is isotopically lighter than calcium of soft tissue from the same organism and isotopically lighter than source (dietary) calcium. When measured as the (44)Ca/(40)Ca isotopic ratio, the total range of variation observed is 5.5 per thousand, and as much as 4 per thousand variation is found in a single organism. The observed intraorganismal calcium isotopic variations and the isotopic differences between tissues and diet indicate that isotopic fractionation occurs mainly as a result of mineralization. Soft tissue calcium becomes heavier or lighter than source calcium during periods when there is net gain or loss of mineral mass, respectively. These results suggest that variations of natural calcium isotope ratios in tissues may be useful for assessing the calcium and mineral balance of organisms without introducing isotopic tracers.

Animals↗

PubMed1997

Reliability evaluation of classifying radial head fractures by the system of Mason.

Inter-observer and intra-observer reliability for classifying radial head fractures by the system of Mason was analyzed. Twenty-three cases of isolated radial head fractures and twenty-five sets of corresponding AP and lateral radiographs representing these fractures were assembled. The cases were reviewed and assessed independently according to the system of Mason by twenty practicing orthopedic surgeons. On two occasions, the inter-observer and intra-observer variation was analyzed by standard unweighted Kappa statistics. In both observations, complete agreement was seen in only 16% of the cases. Kappa statistic values indicated that 69% of the cases at first observation and 45% of the cases at second observation suggest moderate to poor agreement. Intra-observer agreement between the first and second observation was graded fair to poor in 60% of the cases. Individual observer consistency was, on average, only 78% (range 60% to 92%). The demonstrated wide degree of variation suggests that the Mason classification is unreliable.

Confidence Intervals↗

PubMed1999

Variability in digital assessment of cortical and posterior subcapsular cataract.

To identify validity of the standardised Nidek EAS-1000 retroillumination image analysis, images of 450 consecutive patients were analysed for the standard 6.5 mm and for the maximal pupil size. The software allows for separation of cortical and posterior subcapsular opacities and defines threshold for cataract automatically at 12% below the brightest point of the histogram of pixel luminescence. The results were compared with clinical Wilmer cataract grading. Correlation between clinical and digital assessment was 0.48* for cortical opacities in maximal pupil size, 0. 47* in 6.5 mm pupil size analyses, and 0.71* for posterior subcapsular opacities (*p < 0.001). In 24.6% of maximal pupil size analyses and in 11.7% of standard pupil size analyses standardisation revealed confounding features, such as other opacities of media, refractive shadows etc., that masqueraded as cataract and interfered with the cortical opacity measurements. Automatic standardized analysis has reduced many sources of observer variation (level of illumination, pupil size and threshold adjustment), but the revealed range of confounding opacities and artifacts still requires observer interpretation.

Aged↗

PubMed1990

A scale for neurosurgical audit.

A neurosurgical audit scale has been devised to provide a measure of disability and outcome. The audit scale was tested for observer variation and sensitivity against the Karnofsky scale, the Rosser disability scale and the Rosser distress scale. The highest ratio of observer concurrence compared with chance was noted for the neurosurgical audit scale, and the lowest ratio for the Rosser distress score. Sensitivity was almost identical for each of the scales. The neurosurgical audit scale lends itself to audit based on a computer database for which the input is the discharge summary. This achieves audit without additional work for either medical or secretarial staff.

Disability Evaluation↗

PubMed1998

Geographical variation in male courtship behaviour and sexual isolation in wolf spiders of the genus Schizocosa.

We surveyed 12 populations of the wolf spider Schizocosa crassipes (Walckenaer) and S. nr. crassipes in Tennessee, Mississippi, Louisiana and Florida, in the U.S. to determine the extent of variation in male courtship behaviour when observed in standard laboratory conditions. We observed variation in both the frequency of occurrence and the sequence of the four principal male courtship behaviours and, when compared statistically, most of these behaviours differed between populations. Although there was no clinal pattern in the frequency of courtship behaviour, we observed geographically consistent patterns in the sequence in which male courtship behaviours are displayed. We conducted two subsequent studies to determine whether sexual isolation among selected populations existed. In the first study, we performed male-female reciprocal crosses of brush-legged spiders (S. nr. crassipes) between two populations from the Yazoo-Mississippi Delta physiographical region and one population from the Loess Bluff region of Mississippi and measured mating success, number of matings that produced egg sacs, and the number of egg sacs that hatched young. The results of that experiment suggest that sexual isolation occurs among populations in different physiographical regions but not between populations within regions of the state. In a second crossing study, we paired the brush-legged spiders from one of the Mississippi physiographical regions (Yazoo-Mississippi Delta) with Schizocosa ocreata (Hentz) from Ohio. The results of that cross suggest that the Mississippi Delta population is more similar to the northern S. ocreata populations than to S. crassipes. We discuss the results of the crossing experiments in terms of what was revealed about geographical patterns in male courtship behaviour. Copyright 1998 The Association for the Study of Animal Behaviour.

Journal Article↗

PubMed1992

Inter-observer variability in a computer-assisted optic nerve head assessment system.

A computer-assisted optic nerve head analysis system was used to measure parameters of the optic nerve head from one eye from each of 15 subjects. The subjects comprised three groups of five, being glaucomatous, ocular hypertensive, and normal. The 15 images produced were analysed in a randomized masked fashion by ten observers of varying levels of experience to test the inter-observer variability of the measurements. An analysis of variance demonstrated significant differences in the measurements made by the different observers. Fisher's F-test showed that all the parameters assessing the pallor area of the optic nerve head had significantly lower inter-image variance (reported previously) compared with inter-observer variance (at the 5% level). Variability in taking measurements of the pallor area of the optic nerve head is mainly due to observer variations rather than the image variations.

Glaucoma↗

PubMed1993

Reproducibility of the human masseteric jaw-jerk reflex in association with the menstrual cycle.

The jaw jerk was elicited by chin taps in the relaxed masseter muscle of the preferred chewing side in five young females. Recordings were made during three randomized sessions and under standardized conditions: two sessions between the seventh and the 15th day of the female menstrual cycle and the third within the last 5 days of the cycle. Both latency and duration of the reflex were generally reproducible over time. Individual between-session variation was occasionally present, with a general tendency for lower values in the end-cycle session, but this did not affect the overall results. Systematic subject variation, such as central excitatory-state variance of the timing of the experiments, and possibly some other uncontrolled technical error, may have contributed to the observed variation.

Adult↗

PubMed1994

Variations in maximum amplitude of facial expressions between and within normal subjects.

Definitive proof of efficacy of preventions and therapeutic interventions, and of risk factors in lower motor neuron facial paralyses continue to be confounded by the lack of repeatable quantitative measures of outcome. Clinical and research experience with human facial expression repeatedly demonstrates wide variations between subjects. To our knowledge, little information is available to isolate and describe the differences in dynamic facial expression between and within normal subjects. The purpose of this study is to use a statistical model to analyze the components of the observed variations of maximum amplitude measurement of image change during normal human subject facial expressions. Seventeen consecutive normal adult human subjects with no current or past evidence of facial nerve or ear disease were studied. Videotapes of command facial expressions were taken using specific and standardized conditions. The tapes were analyzed using a new computer-assisted image-change analysis program capable of generating dimensional data for the maximum amplitude of expression. These data were statistically analyzed using a General Linear Model with Nested variables to isolate and define component variations and errors. The General Linear Model predicted 88% of the observed total variation (p < 0.05).* A model performance this high suggests that most of the important independent variables were being studied. The major component of the variations was the difference among (between) subjects. Seventy-seven percent of the predicted variation was due to this difference (p < 0.05). Little of the variation (1%) seemed to be within-subjects. Test-retest agreement was acceptable.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1991

Quantitative genetic variation of esterase activity associated with a gene amplification in Culex quinquefasciatus.

Amplification of the esterase B1 gene is responsible for insecticide resistance in the mosquito Culex quinquefasciatus. We used a mating scheme to isolate chromosomes carrying amplified esterase genes from a long-selected laboratory strain (Tem-R) to determine whether observed variation in esterase activity had a genetic basis. The amplified esterase genes segregated as a block and a possible newly arisen esterase B1 copy-number variant was found among the progeny of females which carried amplified B1 genes on only one homologue. A quantitative genetic analysis found significant genetic variation of esterase activity among families which carried different amplification-bearing chromosomes from the Tem-R strain. Esterase B1 copy-number variation among these Tem-R chromosomes is the most likely basis for the observed genetic variation in esterase activity.

Analysis of Variance↗

PubMed2004

Observer variability when evaluating patient movement from electronic portal images of pelvic radiotherapy fields.

BACKGROUND AND PURPOSE: A study has been performed to evaluate inter-observer variability when assessing pelvic patient movement using an electronic portal imaging device (EPID). MATERIALS AND METHODS: Four patient image sets were used with 3-6 portal images per set. The observer group consisted of nine radiographers with 3-18 months clinical EPID experience. The observers outlined bony landmarks on a digital simulator image and used matching software to evaluate field placement errors (FPEs) on each portal image relative to the reference simulator image. Data were evaluated statistically, using a two-component analysis of variance technique, to quantify both the inter-observer variability in evaluating FPEs and inter-fraction variability in patient position relative to the residuals of the analysis. Intra-observer variability was also estimated using four of the observers carrying out three sets of repeat readings. RESULTS: Eight sets of variance data were analysed, based on FPEs in two orthogonal directions for each of the four patient image sets studied. Initial analysis showed that both inter-observer variation and inter-fraction-patient position variation were statistically significant (P<0.05) in seven of the eight cases evaluated. The averaged root-mean-square (RMS) deviation of the observers from the group mean was 1.1 mm, with a maximum deviation of 5.0 mm recorded for an individual observer. After additional training and re-testing of two of the observers who recorded the largest deviations from the group mean, a subsequent analysis showed the inter-observer variability for the group to be significant in only three of the eight cases, with averaged RMS deviation reduced to 0.5 mm, with a maximum deviation of 2.7 mm. The intra-observer variability was 0.5 mm, averaged over the four observers tested. CONCLUSIONS: We have developed a quantitative approach to evaluate inter-observer variability in terms of its statistical significance compared to inter-fraction patient movement. This will assist us in training and assessing observers required to perform this task on a routine basis.

Electronics↗

PubMed2000

Patient management strategies and transplantation techniques in european stem cell transplantation centers offering breast cancer patients high-dose chemotherapy with peripheral blood stem cell support: a joint report from the EORTC and EBMT.

BACKGROUND AND OBJECTIVES: It is increasingly being realized that there are very considerable variations in individual hospitals' strategies for managing a particular group of patients, even if using similar therapeutic regimens. Such variations make it impossible to generalize estimations of treatment costs from one setting to others. The objective of this study is to examine the extent of variation in the current approaches in Europe to peripheral blood stem cell transplantation (PBSCT) in breast carcinoma. DESIGN AND METHODS: A questionnaire was developed and sent to the EBMT member institutions. The questionnaire comprised 85 questions covering the technical and clinical issues involved and the strategies followed for the management of the patients. This paper reports the results of the survey primarily by means of descriptive, univariate frequency distributions. The results of a more analytical approach, aiming at explaining patterns in the variations observed are also presented. RESULTS: A completed questionnaire was returned by 162 centers; 60% university hospitals, 14% cancer centers and the rest general hospitals. Considerable variations are observed between the centers with respect to all aspects of patient management and technical procedures investigated. In many respects, general hospitals follow different routines from university hospitals and dedicated cancer centers. INTERPRETATION AND CONCLUSIONS: Variability to the extent observed indicates an important scope for optimization of the procedures and a large potential for reduction of costs and perhaps for improvement of outcomes. Economic evaluations, for instance comparing PBSCT with autologous BMT as support for high dose chemotherapy, can not be generalized from one setting to another without careful examination of the procedures and strategies followed in each setting. European hospitals treating breast cancer patients with high dose chemotherapy supported by transplantation of peripheral blood stem cells use very different technical procedures for mobilization, harvest and re-implantation of stem cells. In addition, there are also wide variations in the way they manage the patients, e.g. with regard to the criteria for discharge from hospital after re-implantation.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1983

Antigen-induced release of histamine from serosal mast cells, lung, and tracheal tissue: variation with tissue and rat strain in relation to serum IgE-antibody level.

Rats of the Brown Norway (BN)2, Fischer, PVG and Sprague Dawley (SD) strains were immunized intraperitoneally with graded doses of ovalbumin (OA) together with either alum or Silica gel. At specified times after immunization, in vitro histamine release from serosal mast cells and from chopped lung and tracheal tissue was determined after challenge with OA. The development of the capacity to respond in these tests seemed to vary within strain independently for mast cells, lung, and tracheal tissue with immunization dose of antigen and nature of adjuvant. These variations were not closely correlated to observed variations in serum levels of OA-IgE antibody or ratio OA-IgE to total IgE as determined by radioimmunoassay. Furthermore, variations between strains in response capacity did not correlate to inter strain variation in median serum OA-IgE antibody level. These results do not clearly conform to the possibility that one single class of IgE mediates anaphylactic reactivity of various tissues of the rat.

Animals↗