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OBJECTIVE: To examine the impact of hospital caseload on in-hospital mortality for pediatric congenital heart surgery. DESIGN: Population-based, retrospective cohort study. SETTING: Acute care hospitals in California and Massachusetts. PATIENTS: Children undergoing surgery for congenital heart disease, identified by the presence of procedure codes indicating surgical repair of a congenital heart defect in computerized statewide hospital discharge abstract databases. Cases were grouped into four categories based on the complexity of the procedure. MAIN OUTCOME MEASURES: Adjusted odds ratios (OR) for in-hospital death were estimated using generalized estimating equations that account for the intra-institutional correlation among patients. RESULTS: A total of 2833 cases at 37 centers were identified. Compared with centers performing > 300 cases per year, after controlling for patient characteristics, centers performing < 10 cases per year had an OR for in-hospital death of 7.7 (95% confidence interval (CI) [1.6-37.8]); 10 to 100 cases, OR = 2.9 (95% CI [1.6-5.3]); 101 to 300 cases, OR = 3.0 (95% CI [1.8-4.9]). Independent risk factors for mortality included procedure complexity category (P < .0001), use of cardiopulmonary bypass (P < .0001), young age at surgery (P = .001), and transfer from another acute care hospital (P < .0001). Few differences were found by hospital caseload in length of stay or total hospital charges. CONCLUSIONS: For children with a congenital heart defect who underwent surgery in California in 1988 or Massachusetts in 1989, the risk of dying in-hospital was much lower if the surgery was performed at an institution performing > 300 cases annually. This study was limited by the absence of clinical detail in discharge abstract databases. If these findings are corroborated by other studies, health care delivery strategies that direct children requiring surgical correction of congenital heart defects to high-volume centers may substantially reduce overall mortality.
Inter-observer variations in the registration of dental age-related characteristics have not previously been studied. Examination and registration were made by 6 dentists with varying experience in age estimation. A total of 13 age-related dental characteristics in 30 teeth extracted from adults were assessed macroscopically, by stereomicroscope and from radiographs. The measurements were analysed in a microcomputer, using the SPSS/PC+ statistical package. The results showed that, except for the score on surface roughness, significant differences were found between some of the observers for all types of measurements, when a paired t-test analysis was made. The correlation coefficients between the observers varied and were rather weak for the surface roughness score. The study revealed systematic differences among the observers as well as differences in interpreting the definitions of the scores for the different parameters. Thus age estimation using statistical methods is seen to be dependent upon the experience of the individual observer and interpretation. Care should therefore be taken not to rely too much upon the results of an odontological age estimation. The possible implications of these results for forensic work are also discussed.
By introducing replicate observations into observer agreement studies, one can obtain better measures of observer agreement than heretofore possible. New methodology based on the analysis of latent variables allows a separation of within- and between-observer variation for binary measures of assessment among pairs of observers. Maximum likelihood estimation and hypothesis testing are discussed. The methodology is illustrated using data on the assessment of dysplasia by pathologists.
A new technique for morphometric measurement of vertebral bodies has been described, in which a computerized image analysis system was used to digitize and measure standardized lateral radiographs of the thoracic and lumbar spine. The sources of error in the radiographic system and the image analysis system were assessed using vertebral phantoms and test images. Oblique projection in the radiographic image of a vertebra did not produce a significant error in the measured area. The radiographic magnification was approximately 35%. Optical non-uniformity was detected in the image analysis system, and was ascribed to the lens optics. The maximum intra-observer and inter-observer variations in vertebral area were 3.1% and 5.3% respectively for experienced observers. The technique is applicable to clinical studies of large populations, and has value in investigating vertebral deformity in the management of metabolic bone disease.
We have determined the allelic structures on 106 Caucasian chromosomes at the minisatellite locus MS205 (D16S309). In addition to the internal structures deduced by minisatellite variant repeat (MVR) mapping, the genotypes at six flanking substitutional polymorphic sites have been analysed. The minisatellite structures show a polarity of variation at MS205, with most observed variation due to differences at one extremity of the tandem repeat array. This locus, therefore, provides a further example of polarity of variation at human minisatellites. Analysis of haplotypes at flanking polymorphic sites suggests that there may be a higher frequency of exchange near the highly unstable end of the minisatellite, and thus that exchanges of flanking polymorphisms may be due to co-conversion or recombination events occurring during unequal exchanges between minisatellite alleles.
To validate an in-vitro bioassay for assessing chromatin stability of human sperm, 38 semen samples from infertile men were studied using sodium dodecyl sulphate, an anionic detergent which disorganizes only the cytoplasmic membrane. Assay sensitivity was 50 sperm, whilst the within- and between-assay variation, and the between-observer variation were found to be within the accepted range for this type of bioassay. The influence of different in-vitro treatments currently used in some clinical assisted fertilization programmes was evaluated: a destabilizing effect occurred in Grade I (stable) and Grade III (swollen) sperm. In the former, all treatments reduced stable sperm; in the latter, a significant (P less than 0.001) increase in swollen sperm was shown with two methods that used Ham's F-10 as culture medium. Different chromatin patterns found in the treated sperm suggest the possibility that the recovered samples could be modified compared to their status at the time of isolation.
The pharmacokinetics and bioavailability of theophylline have been investigated in eight healthy subjects following application of the drug in form of a tablet, a retard tablet (enteric-coated), and a suppository (Euphyllin) in comparison with an intravenous preparation. Peak plasma concentrations were measured 1.5 hours (tablet), 6 hours (retard tablet) and 4 hours (suppository) after drug administration, respectively. The absolute bioavailability was of th tablet 105 +/- 25%, of the retard table 81 +/- 23%, of the suppository 74 +/- 25%. The variations observed were primarily due to variations in the other pharmacokinetic parameters, only to a lesser extent to variable absorption of theophylline.
PURPOSE: We assessed the intra-observer and interobserver variation in measurements of prostatic volume using transrectal ultrasound. MATERIALS AND METHODS: Two volume estimations were performed by 1 observer in 40 patients and by 2 observers in 75. RESULTS: Mean prostatic volumes measured ranged from 18.9 to 87.0 ml. (median 39.8) for 1 observer and from 15.5 to 95.4 ml. (median 42.4) for 2 observers. The mean difference plus or minus standard deviation and limits of agreement between the paired volume estimations were 0.1 +/- 3.3 ml. and -6.5 +/- 6.7 ml., respectively, for 1 observer, and -0.3 +/- 5.3 ml and -10.9 to 10.3 ml., respectively, for 2 observers. The mean difference was 9.8% for 2 observers. The mean difference was 9.8% for 2 observers compared to 4.6% for 1. CONCLUSIONS: The results show that there is considerable variation in repeated measurements of prostatic volume and the variation is greatest for 2 observers compared to 1 observer.
Observations carried out on 106 polecat brains showed that the system of basilar arteries of the brain is similar to those in other cornivorous species. The observed variation was manifested in a differentiation connections of the vessels, in occurence of some variations and in asymmetry. Some cases of such variations were hitherto observed only in some ruminants.
A method is described to determine accurately skin redness during a course of radiotherapy using reflectance spectroscopy utilizing information from across the visible spectrum according to the L*a*b* color coordinate system. The method was used to quantify the development of skin erythema during and after electron beam irradiation of the chest wall following mastectomy. A number of factors were identified which could influence the wide variation in response seen between patients. These were: intra- and inter-observer variation; intra- and inter-patient variation and variation in the actual dose delivered. Statistical analysis, including an analysis of variance of inter- and intra-patient variation, revealed that the major factor that accounts for the observed difference between patients is a true inter-patient variation, with a coefficient of variation, corrected for intra-patient variation, of 43%. Within the narrow dose range administered in this study, there was no demonstrable dose-effect relationship, raising questions about the role of cell death in the basal layer of the epidermis in the pathogenesis of radiation induced erythema.
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.
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.
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.
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.
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.