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Polyp size at CT colonography after electronic subtraction cleansing in an anthropomorphic colon phantom.

PURPOSE: To evaluate the effect of various bowel contrast material concentrations and subtraction software on size measurements of well-defined polyp lesions in a colon phantom at CT colonography. MATERIALS AND METHODS: Repeated scanning and a precise reference standard required the use of a colon phantom in which 21 polyps were randomly distributed. Two readers who had each reviewed computed tomographic (CT) colonographic images from more than 100 cases evaluated polyp size on images obtained when the phantom was partially filled with varying concentrations of contrast material, scanned by using CT colonography, and subjected to electronic subtraction cleansing. The single largest dimension was recorded for each reader for a randomized series of polyps. These measurements were compared with a reference standard that was based on a combination of the manufacturer's polyp size specifications and the subsequent verification of these sizes by an independent consensus panel. Six weeks after initial observations, readers evaluated images of the phantom scanned without the presence of contrast material. Polyp size estimations for the two readers for each series were compared with the reference standard to obtain a mean absolute measurement error for each reader for each series. Data for each reader were compared by using a nonparametric Kruskal-Wallis analysis of variance test. A pair-wise comparison of the experimental and control series was then performed by using the Dunn post hoc test. RESULTS: Contrast material dilutions resulting in an average attenuation of less than 500 HU resulted in complete subtraction and the absence of streak artifacts. There was no statistically significant difference between the average measurement error for contrast attenuations between 300 and 500 HU when compared with that of control. Streak artifact was noticeable for the highest dilution (mean, 840 HU). No statistically significant differences were observed for series in which cleansing software was used in the absence of bowel contrast material. CONCLUSION: The combination of electronic cleansing and bowel contrast enhancement in the range of 300-500 HU results in no substantial change in readers' estimations of polyp size at CT colonography.

Analysis of Variance↗

Quantitation of spreading factor in human biologic fluids.

Spreading factor (SF) is a glycoprotein isolated from human plasma or serum that promotes attachment and spreading of a wide variety of mammalian cells in culture. Under appropriate conditions, this factor also affects cell proliferation and differentiation in vitro. An immunoassay employing a previously characterized monoclonal antibody to SF, with purified SF as a reference standard, was utilized to quantitate levels of SF in human plasma, serum, amniotic fluid, and urinary protein. Specific anti-SF monoclonal antibody-binding activities in individual samples of human serum were identical to specific anti-SF monoclonal antibody-binding activities in the plasma samples from which the sera were derived. Specific anti-SF monoclonal antibody-binding activity in plasma from adults, when compared with purified SF reference standards, represented an average of 4 micrograms of SF per mg plasma protein (range, 2.5 to 7 micrograms/mg). Specific anti-SF monoclonal antibody-binding activity in sera from fetal cord blood, infants, children, or adolescents was not significantly different from that of adults. Specific anti-SF monoclonal antibody-binding activities in amniotic fluid samples from pregnancies of 12 to 23 weeks' gestation were within the range observed in sera of adults. Anti-SF monoclonal antibody-binding activity in concentrated urinary protein, when compared with purified SF reference standards, represented a specific activity of 10.9 micrograms of SF per mg protein.

Adolescent↗

A kinetic enzyme immunoassay for the quantitation of antibodies to a humanized monoclonal antibody in human serum.

A kinetic enzyme immunoassay was developed and validated to quantitate human antibodies to the humanized monoclonal antibody CAMPATH1-1H (C1H) in human serum. The assay was configured using C1H-coated 96-well plates which were blocked with bovine serum albumin, and incubated with dilutions of human serum containing anti-C1H antibody. Antibody was detected using biotinylated C1H followed by streptavidin-conjugated alkaline phosphatase and p-nitrophenyl phosphate. Absorbance data were collected for 10 min, and mOD min-1 data were exported to MultiCalc data analysis software. A 4-parameter logistic-log algorithm was shown to model the data through the range of the standard curve within 15% of nominal values. The overall assay performance coefficient of variation by ANOVA was 9.2%. The lower limit of detection was defined at 160 Units ml-1. The anti-idiotype antibody standard stock solution is stable at 4 degrees C and at -80 degrees C for at least 11 months in buffer. The anti-idiotype antibody controls are stable for at least seven freeze-thaw cycles and at least 6 months in human serum stored at -20 degrees C. A strategy was devised by which to establish the specific antibody potency for any given batch of anti-C1H antibody standard relative to the Reference Standard. This EIA has been used to quantify and characterize anti-C1H antibody in human serum in support of clinical safety and efficacy studies.

Alemtuzumab↗

Detection and assessment of intracranial aneurysms: value of CT angiography with shaded-surface display.

OBJECTIVE: The purpose of this study was to evaluate the efficacy of circle of Willis CT angiography with shaded-surface display in the detection and assessment of suspected intracranial aneurysms. MATERIALS AND METHODS: Twenty-three patients who had clinical or radiologic suspicion of intracranial aneurysms were studied prospectively with CT angiography and conventional angiography. The images were obtained and interpreted in a double-blind fashion by different radiologists. Conventional angiography, which was the reference standard in this study, diagnosed 17 aneurysms in 15 patients. The usefulness of the two types of images for surgical planning was evaluated by two neurosurgeons. RESULTS: No aneurysms were detected with either technique in eight patients. Both techniques showed 15 aneurysms in 14 patients. The maximum dimensions were less than 3.0 mm in three cases, 3.0-5.0 mm in four cases, and greater than 5.0 mm in eight cases. With conventional angiography used as the reference standard, CT angiography has one false-positive and two false-negative findings, resulting in a sensitivity of 88% (15/17) and a specificity of 89% (8/9). For 12 of 15 aneurysms, CT angiography was rated equal or superior to conventional angiography in depicting all aspects (shape, orientation, neck, and parent vessel) of the aneurysms. CONCLUSION: We were able to detect aneurysms of the circle of Willis as small as 2 mm in size. Using conventional angiography as the reference standard, CT angiography has a sensitivity of 88% and a specificity of 89% for the detection of aneurysms in the circle of Willis. In almost all cases, CT angiography was equal or superior to conventional angiography in characterizing the aneurysms for surgical planning.

Adolescent↗

A simplified alternative to the AOAC official method for cholesterol in multicomponent foods.

An AOAC official method for quantitating cholesterol in multicomponent foods, which was first published in the 13th edition of the Official Methods of Analysis, is rarely used. The method includes so many operations and manipulations--all described in excruciating detail--that most laboratories shun it altogether. Intent on finding an alternative, laboratories have developed their own methods for specific foods. As a result, new methods have proliferated, but still no practical method has been developed for the broader categories of multicomponent foods. The aim of AOAC, which is to promote greater accuracy and uniformity of analytical results primarily through collaborative testing, has not been well served under these circumstances. A different approach guided the work reported in the present paper. This approach was directed toward updating and dramatically simplifying the existing AOAC official method. The method's chloroform-methanol-water mixed-solvent extraction is preserved; however, all the remaining steps have been streamlined, updated, or eliminated by using newer technology. Cholesterol is quantitated with highly specific capillary gas-liquid chromatography using the internal standardization technique. The lipid extract is prepared for the chromatography step by a brief saponification carried out in a culture tube. The resulting method has been validated by using Standard Reference Materials and the standard addition method. Because a simplified method is now available for quantitating cholesterol in the lipid extracts, the expectation is that more attention can be given to the development of improved and efficient extraction methods. This step remains as the central difficulty in any number of methods of analysis for lipid analytes.

Cholesterol↗

Ultrasonographic assessment of thyroid volume in Delhi children.

BACKGROUND: Ultrasonographic measurement of thyroid volume is increasingly being used to assess prevalence of iodine deficiency in a community. OBJECTIVES: To assess thyroid volume by ultrasonography in normal Delhi children, and compare them with the recently adopted WHO reference standards. METHODS: One hundred and three children aged of 6-10 years were enrolled from the paediatric outpatient clinic in a prospective study. Thyroid volume was estimated by ultrasound, and urinary iodine levels were measured for all subjects by spot urine samples. RESULTS: Goitre prevalence was 24.3% on clinical assessment. Urinary iodine levels fell in the range of mild to moderate deficiency in 61% of the children. None of the children met the WHO recommended ultrasonographic criteria for goitre (thyroid volume >97th percentile of the reference standards), when WHO age-specific norms were used for comparison. On applying body surface area (BSA)-specific norms, only two children were classified as having goitre. CONCLUSIONS: The WHO standards for thyroid volume by ultrasonography tended to underestimate goitre prevalence.

Body Mass Index↗

[Atherosclerotic cardiovascular disease, lipemic disorders, hypertension, obesity and diabetes mellitus in the population of a metropolitan area of southeastern Brazil. III--Hypertension].

OBJECTIVE: The prevalencies of hypertension are analysed by sex and age group, in social groupings established in accord with social criteria. With a view better to understanding the social dimension of the disease, prevalencies were characterised by type of occupation. MATERIAL AND METHODS: The sample consisted of 1,041 people and corresponds to the sum of the samples representing the "study areas" established by the use of socio-economic and geographical criteria. Four social strata were defined in obedience to a socioeconomic gradient. Hypertension was defined by the Joint National Committee (JNC), 140/90 mmHg, and of the World Health Organization (WHO), 160/95 mmHg, standard references. RESULTS: According to the JNC and WHO standard references the prevalencies of hypertension, age adjusted, were of approximately the following: stratum (I + II) 60 and 37%; stratum III 50 and 39%; stratum IV 55 e 46%. Among women the prevalencies were 40 and 38% (stratum I + II); 56 and 47% (stratum III) and 55 and 46% (stratum IV). For the men belonging to the economically active population, classified by occupation, it was showed that the freelance professionals, consisting of businessmen of small firms, small traders and liberal professionals, presented a prevalence of about 60 and 37%; the skilled workers, employed in factories of 35 and 14%; the daily freelance workers, unskilled laborers and unemployed, of 59 and 40%. The women were divided by occupation as belonging or not to the economically active population (EAP) and presented the following prevalencies: 39 and 47%, respectively, according to the JNC standard, and 27 and 45%, respectively, according to the WHO standard. Thus it may be seen that these results run counter to the hypothesis that women integrated into the labour market are more exposed to the risk factors for non-transmissible diseases. CONCLUSION: Thus it may be concluded that the categories most affected by the present economic were those most affected by hypertension. On the other hand the possibility of there being and a intense social determination in the etiology of hypertension in this population is demonstrated.

Adult↗

Diagnostic performance of the Sanity 2.0 assay to detect resistance to rifampicin, isoniazid, and fluoroquinolones in tuberculosis.

UNLABELLED: Effective tuberculosis (TB) management relies on prompt diagnosis of Mycobacterium tuberculosis complex (MTBC) and associated drug resistance. The Sanity 2.0 assay is a high-resolution melting assay designed for direct respiratory sample testing, enabling simultaneous detection of MTBC and resistance to rifampicin (RIF), isoniazid (INH), and fluoroquinolones (FQ) in a single step. This study evaluated its diagnostic performance in two registered multicenter trials among bacteriologically confirmed TB patients. Diagnostic performance was evaluated for MTBC detection, as well as for the identification of resistance to RIF, INH, and FQ, using phenotypic drug susceptibility testing, whole-genome sequencing, and a composite reference standard. Agreement analyses were conducted between the Sanity 2.0 assay and Xpert MTB/RIF and Xpert MTB/XDR. Among 611 patients, the Sanity 2.0 assay detected MTBC in 563 patients, exhibiting a sensitivity of 92.1% (95% CI: 89.7-94.0). For detecting resistance to RIF, INH, and FQ, sensitivities exceeded 90%, with specificities of 95.8% (95% CI: 88.5-98.6), 100.0% (95% CI: 96.4-100.0), and 97.8% (95% CI: 93.8-99.3) against the composite reference standard, respectively. The agreement with Xpert MTB/RIF for RIF detection was 98.6% (95% CI: 96.9-99.3). For INH and FQ resistance, the agreement with Xpert MTB/XDR was 92.0% (95% CI: 88.5-94.5) and 94.3% (95% CI: 91.2-96.3), respectively. The Sanity 2.0 assay is a rapid and user-friendly platform capable of detecting both MTBC and key drug resistance. It demonstrated good diagnostic performance and could potentially be an effective alternative to guide individualized anti-TB treatment, especially in resource-limited settings. IMPORTANCE: Rapid and accurate detection of both Mycobacterium tuberculosis complex (MTBC) and key drug resistance is critical to improving tuberculosis treatment outcomes and reducing transmission. However, current molecular diagnostic workflows often require sequential testing, which can delay the initiation of effective and individualized therapy. We evaluated the Sanity 2.0 assay, an integrated high-resolution melting test that simultaneously detects MTBC and resistance to rifampicin, isoniazid, and fluoroquinolone resistance directly from respiratory samples in about 2-3 hours. The assay demonstrated excellent performance, with MTBC detection sensitivity of 92.1% and drug resistance sensitivities exceeding 90% and specificities over 95% against a composite reference standard, as well as strong concordance with World Health Organization-endorsed molecular assays. Implementation of the Sanity 2.0 assay could streamline TB diagnostic workflows; enable rapid, single-step resistance profiling; and facilitate timely, individualized treatment-particularly in resource-limited settings where rapid and comprehensive resistance testing remains a critical unmet need.

Humans↗

Determination of 6-(2'-chlorophenyl)-4-hydroxy-4H-imidazo[1,5-a] [1,4]benzodiazepine-3-carboxamide, a mixed agonist-antagonist anxiolytic agent, in human plasma and urine by gas chromatography-negative-ion chemical-ionization mass spectrometry.

A simple, sensitive and specific assay was developed for the determination in plasma and urine of 6-(2'-chlorophenyl)-4-hydroxy-4H-imidazo[1,5-alpha] [1,4]benzodiazepine- 3-carboxamide, compound I, a mixed agonist-antagonist anxiolytic agent. A hexadeuterated analogue of the compound was added to plasma or urine as the reference standard. The titled compound was extracted with benzene at pH 11. Following evaporation of the solvent, the residue was reacted with pentafluoropropionic anhydride in the presence of triethylamine. The derivatizing reagents were evaporated, and the carbonitrile derivative of the analyte was extracted into ethyl acetate at pH 11. The residue remaining after removal of the ethyl acetate was silylated with bis(trimethylsilyl)trifluoroacetamide, and a portion of this solution was analyzed by gas chromatography-negative-ion chemical-ionization mass spectrometry. The mass spectrometer was set to monitor, in the gas chromatographic effluent, the M-. ion of the titled compound and its hexadeuterated reference standard. The ratio of these two ions was calculated and converted to a concentration of analyte using a calibration curve that was generated from the analyses of control plasma fortified with various amounts of analyte and a fixed amount of the hexadeuterated reference standard. The limit of quantitation of the assay was 1 ng/ml for plasma and urine.

Anti-Anxiety Agents↗

Colorimetric carbon dioxide detector to determine accidental tracheal feeding tube placement.

PURPOSE: To determine the accuracy of colorimetric CO2 detection compared to the reference standard two-step radiological confirmation of feeding tube position. METHODS: A prospective study was conducted with patients presenting to a 21-bed medical-surgical intensive care unit. An adapter was developed using an endotracheal tube adapter to connect a colorimetric CO2 detector to a feeding tube in an airtight manner. In part I of the study a feeding tube connected to the colorimeter was inserted into the endotracheal tubes of ten ventilated patients to test the device's ability to detect tracheal placement. In part II patients undergoing feeding tube insertion had tube position confirmed with the colorimeter as well as the reference standard two-step x-ray. RESULTS: In phase I the colorimeter correctly identified tracheal placement in all ten patients. In phase II 93/100 procedures ultimately were eligible; the colorimeter had a sensitivity of 0.88 (95% confidence interval: 0.65-1.00) and specificity of 0.99 (0.97-1.00). The device missed one of the eight tracheal placements. Agreement between the colorimeter and two-step x-ray interpretations was excellent (Kappa 0.86; standard error 0.10). CONCLUSION: We describe a novel, convenient method to confirm esophageal feeding tube placement. The device is easily assembled and inexpensive, but should not be reused. Colorimetric determination of tracheal feeding tube placement with this device has excellent agreement with the reference standard two-step radiological technique.

Carbon Dioxide↗

Method for the simultaneous determination of retinol and beta-carotene concentrations in human tissues and plasma.

To understand differential tissue distribution of retinoids and carotenoids, as it might influence biological processes in humans, we developed and demonstrated a method for measuring them in selected human tissues. The method includes internal standards and a secondary reference standard to eliminate the need for external standard calibration and to minimize sample-handling errors. Tissues were digested (saponified) in ethanolic KOH. Retinol and beta-carotene were extracted with organic solvent containing internal standards. Analytes were separated using isocratic liquid chromatography and quantified at 325 nm for retinol and 450 nm for beta-carotene. Plasma was analyzed in a similar way but without saponification. Retinal-O-ethyloxime and beta-apo-12'-carotenal-O-t-butyloxime served as internal standards. Plasma, breast, and fat from breast surgery patients and colon, liver, muscle, and fat from colon surgery patients were analyzed. Within-day relative standard deviations (RSDs) for plasma were <0.04 for beta-carotene and <0.03 for retinol, between-day RSDs were <0.05 for beta-carotene and <0.04 for retinol. Saponification ensured complete extraction of retinol and beta-carotene and removal of triglycerides that "foul" chromatographic columns. It seems retinol and beta-carotene concentrations in tissues and blood of cancer patients are the same or higher than those in corresponding tissues of patients without these cancers.

Adult↗

Laboratory evaluations of elmex inter X toothbrushes for interproximal access efficacy and posterior tooth surface cleaning.

Laboratory methods have been developed to evaluate the ability of toothbrush bristles to remove artificial plaque deposits at interproximal sites (Interproximal Access Efficacy; IAE) and on distal tooth surfaces (Posterior Tooth Surface Cleaning; PTSC). In the testing performed for this study, six toothbrushes were evaluated. These were: elmex inter X Sensitive; elmex inter X Sensitive Short Head; elmex inter X medium; elmex inter X Medium Short Head; Oral-B Cross Action 40 medium; and the ADA reference standard toothbrush. Six toothbrushes of each design were tested four times under wet brushing conditions in all assays. In the IAE studies, toothbrushing was conducted using a vertical or horizontal brushing motion, simulated anterior or posterior teeth, and a brushing weight of 250 g. The bristles were placed at a 90 degree angle to the tooth surface, and brushing was performed for 15 seconds at two strokes per second with 50 mm strokes. IAE was recorded as the maximum width of simulated plaque deposit removed. For the PTSC evaluations, a horizontal brushing motion was used on posterior tooth shapes, with a 250 g brushing pressure for ten seconds. PTSC was determined as the maximum measurement of artificial plaque deposit removed from the mid-facial area to the maximum post-distal area of the most posterior simulated tooth shape. All data were assessed with ANOVA and the post hoc Tukey test. In the individual IAE tests, with vertical or horizontal brushing on anterior and posterior simulated teeth, and on overall IAE mean values, the four elmex inter X toothbrushes were significantly higher (p < 0.01-0.001) than the ADA reference standard and the Oral-B Cross Action 40 toothbrushes. The mean PTSC values for all toothbrushes were significantly higher (p < 0.01-0.001) compared to the ADA Reference Standard toothbrush mean PTSC. All elmex inter X brushes were statistically significantly higher (p < 0.01-0.001) compared to the Oral-B Cross Action 40 product. The elmex inter X Medium had a significantly higher (p < 0.05-0.001) PTSC compared to the PTSC mean values of the other elmex inter X products tested.

Analysis of Variance↗

Ultrafine particles cause cytoskeletal dysfunctions in macrophages.

Essential cytoskeletal functions of macrophages are migration, phagocytosis of foreign materials, and intracellular transport and digestion The influence of fine and ultrafine test particles (UFP), such as TiO(2), elemental carbon, commercial carbon black, diesel exhaust particulate matter, and urban dust (UrbD), on cytoskeleton-related functions of macrophages, such as phagocytosis, phagosome transport mechanisms, and mechanical cytoskeletal integrity, were studied by flow cytometry and by cytomagnetometry. Additionally, necrosis and apoptosis caused by the test particles was detected. The diameter of the test particles ranged from 12 to 220 nm and the Brunauer-Emmet-Teller specific surface area ranged from 6 to 600 m(2)/g. Primary alveolar macrophages from beagle dogs (BD-AM), obtained by bronchoalveolar lavage, were used as well as macrophages originating from the cell line J774A.1. For cytomagnetometry studies, spherical 1.8-microm ferromagnetic particles served as probes for cytoskeletal functions and were incubated together with the macrophages 24 h prior to UFP exposure. Macrophages were exposed in vitro with 10-320 microg UFP/ml/10(6) cells up to 24 h. In all experiments, J774A.1 macrophages were more sensitive than BD-AM to UFP exposure. Cytoskeletal dysfunctions evaluated by cytomagnetometry were an impaired phagosome transport and an increased cytoskeletal stiffness and occurred at concentrations of 100 microg UFP/ml/10(6) cells and above, in both BD-AM and J774A.1. Only fine TiO(2) did not show any effect. Urban dust (standard reference material 1649a) and diesel exhaust particles (DEP, standard reference material 1650) caused comparable cytoskeletal dysfunctions to elemental carbon with high specific surface area. Cytoskeletal dysfunctions induced by DEP or UrbD could be reduced after washing the particles by dichloromethane. UFP caused an impaired phagocytosis of 1-microm diameter fluorescent latex beads, inhibited cell proliferation, and decreased cell viability. All recorded cytotoxic parameters showed only weak correlations with the specific surface area or the total number of UFP, which can result from the different types of particles and different surface compositions. UFP cause cytoskeletal toxicity in vitro in macrophages, which can cause cellular dysfunctions, such as impaired proliferation, impaired phagocytic activity, and retarded intracellular transport processes as well as increased cell stiffness and can result in impaired defense ability in the lung.

Air Pollutants↗

Quality assurance in the biological monitoring of lead exposure in China.

Based on the statistical data of the nationwide occupational diseases reporting in 1986-1988, lead poisoning stood the first place of chronic occupational poisonings in China. Biological monitoring of lead exposure is of paramount importance in both occupational and environmental health. In order to ensure lead testing data valid enough for taking actions of prevention and control, a quality assurance scheme including selection of reliable analytical techniques, establishing reference laboratory, application of standard reference materials, and conducting internal and external quality control program was implemented in China. Since the rigid assurance procedure was conducted during studies on "background levels of lead in non-exposure population" and "revision of the diagnostic criteria for lead", compatible and reliable results were obtained.

Aminolevulinic Acid↗

Screening for speech and language delay in preschool children: systematic evidence review for the US Preventive Services Task Force.

BACKGROUND: PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Published in the public domain by the American Academy of Pediatrics. Speech and language development is a useful indicator of a child's overall development and cognitive ability and is related to school success. Identification of children at risk for developmental delay or related problems may lead to intervention services and family assistance at a young age, when the chances for improvement are best. However, optimal methods for screening for speech and language delay have not been identified, and screening is practiced inconsistently in primary care. PURPOSE: We sought to evaluate the strengths and limits of evidence about the effectiveness of screening and interventions for speech and language delay in preschool-aged children to determine the balance of benefits and adverse effects of routine screening in primary care for the development of guidelines by the US Preventive Services Task Force. The target population includes all children up to 5 years old without previously known conditions associated with speech and language delay, such as hearing and neurologic impairments. METHODS: Studies were identified from Medline, PsycINFO, and CINAHL databases (1966 to November 19, 2004), systematic reviews, reference lists, and experts. The evidence review included only English-language, published articles that are available through libraries. Only randomized, controlled trials were considered for examining the effectiveness of interventions. Outcome measures were considered if they were obtained at any time or age after screening and/or intervention as long as the initial assessment occurred while the child was < or =5 years old. Outcomes included speech and language measures and other functional and health outcomes such as social behavior. A total of 745 full-text articles met our eligibility criteria and were reviewed. Data were extracted from each included study, summarized descriptively, and rated for quality by using criteria specific to different study designs developed by the US Preventive Services Task Force. RESULTS: The use of risk factors for selective screening has not been evaluated, and a list of specific risk factors to guide primary care physicians has not been developed or tested. Sixteen studies about potential risk factors for speech and language delay in children enrolled heterogeneous populations, had dissimilar inclusion and exclusion criteria, and measured different risk factors and outcomes. The most consistently reported risk factors included a family history of speech and language delay, male gender, and perinatal factors. Other risk factors reported less consistently included educational levels of the mother and father, childhood illnesses, birth order, and family size. The performance characteristics of evaluation techniques that take < or =10 minutes to administer were described in 24 studies relevant to screening. Studies that were rated good to fair quality reported wide ranges of sensitivity and specificity when compared with reference standards (sensitivity: 17-100%; specificity: 45-100%). Most of the evaluations, however, were not designed for screening purposes, the instruments measured different domains, and the study populations and settings were often outside of primary care. No "gold standard" has been developed and tested for screening, reference standards varied across studies, few studies compared the performance of > or =2 screening techniques in 1 population, and comparisons of a single screening technique across different populations are lacking. Fourteen good- and fair-quality randomized, controlled trials of interventions reported significantly improved speech and language outcomes compared with control groups. Improvement was demonstrated in several domains including articulation, phonology, expressive language, receptive language, lexical acquisition, and syntax among children in all age groups studied and across multiple therapeutic settings. Improvement in other functional outcomes such as socialization skills, self-esteem, and improved play themes were demonstrated in some, but not all, of the 4 studies that measured them. In general, studies of interventions were small and heterogeneous, may be subject to plateau effects, and reported short-term outcomes based on various instruments and measures. As a result, long-term outcomes are not known, interventions could not be compared directly, and generalizability is questionable. CONCLUSIONS: Use of risk factors to guide selective screening is not supported by studies. Several aspects of screening have been inadequately studied to determine optimal methods, including which instrument to use, the age at which to screen, and which interval is most useful. Trials of interventions demonstrate improvement in some outcome measures, but conclusions and generalizability are limited. Data are not available addressing other key issues including the effectiveness of screening in primary care settings, role of enhanced surveillance by primary care physicians before referral for diagnostic evaluation, non-speech and language and long-term benefits of interventions, and adverse effects of screening and interventions.

Child, Preschool↗

Evaluation of the BAX system for detection of Salmonella in selected foods: collaborative study.

A multilaboratory study was conducted to compare the automated BAX System to the standard cultural methods for detection of Salmonella in selected foods. Five food types--frankfurters, raw ground beef, mozzarella cheese, raw frozen tilapia fish, and orange juice--at 3 inoculation levels, were analyzed by each method. A sixth food type, raw ground chicken, was tested using 3 naturally contaminated lots. A total of 16 laboratories representing government and industry participated. In this study, 1386 samples were analyzed, of which 1188 were paired samples and 198 were unpaired samples. Of the 1188 paired samples, 461 were positive by both methods and 404 were negative by both methods. Thirty-seven samples were positive by the BAX System but negative by the standard reference method, and 11 samples were positive by standard cultural method and negative by the BAX System. Of the 198 unpaired samples, 106 were positive by the BAX System and 60 were positive by the standard cultural method. A Chi square analysis of each of the 6 food types, at the 3 inoculation levels tested, was performed. For all foods, the BAX System demonstrated results comparable to those of the standard reference methods based on the Chi square results.

Animals↗

The accuracy of risk scores in predicting preterm birth--a systematic review.

This review aims to determine the accuracy with which published risk scores predict spontaneous preterm birth in pregnant women. Studies were identified without language restrictions through nine different databases (up to June 2002), and manual searching of bibliographies of known primary and review articles. Two reviewers selected studies independently and extracted data on their characteristics, quality and accuracy. Accuracy data were used to form 2 x 2 contingency tables of the results of risk scoring with spontaneous preterm birth as the reference standard. Heterogeneity was assessed and its reasons were explored. Summary estimates of accuracy were produced within clinically appropriate subgroups. There were 19 primary accuracy articles that met the selection criteria, including a total of 67390 women. There are 12 different risk-scoring systems, the one developed by Creasy being the most commonly evaluated. Quality features of an ideal study, such as blinding and consecutive enrolment, were frequently missing from the included studies, no study fulfilled all criteria for high quality study, and there was heterogeneity between their accuracy estimates. The reference standard most often used was birth before 37 weeks' gestation. The point estimates for the likelihood ratios (LRs) varied widely among the studies. LRs for an abnormal score (LR+) ranged from 1.0 (95% confidence interval (CI) 0.6-1.4) to 38.8 (95% CI 23.5-63.9) while that for a normal score (LR-) ranged from 0.1 (95% CI 0.02-0.6) to 1.2 (95% CI 0.9-1.6). In otherwise asymptomatic women, risk scoring in early pregnancy has a wide range of accuracy in predicting spontaneous preterm birth before 37 weeks' gestation. The evidence is of a relatively poor quality and lacks clinically important reference standards.

Female↗

Bioavailability study of dried microencapsulated ferrous sulfate--SFE 171--by means of the prophylactic-preventive method.

Microencapsulated ferrous sulfate with soy lecithin (SFE-171) has been used as an iron source for the fortification of milk and dairy products. With the purpose to extend the use of this agent to other kind of foods or even to pharmaceutical preparations for oral administration, the SFE-171 was turned into a fluid powder (SFE-171-P) by means of vacuum drying. The iron bioavailability (BioFe) of SFE-171-P was evaluated in this work by means of the prophylactic-preventive method in rats, using ferrous sulfate as reference standard. Both iron sources were separately added to a basal diet of low iron content in a concentration of 10 mg iron/kg diet. Two groups of 10 weaned rats 25 days old received the fortified diets during 28 days, while a third group of the same size received the basal diet without iron additions. The weights and haemoglobin concentrations (HbC) of every animal were determined before and after the treatment, thus allowing the calculation of the mass of iron incorporated into haemoglobin (HbFe) during this period. The BioFe of the iron sources were obtained as the percentage ratio between the HbFe and the mass of iron consumed by each animal. The results were also given as Relative Biological Value (RBV), which relates the BioFe of the studied source with that of the reference standard. The liver iron concentration (LIC) of each animal was determined at the end of the experiment in order to evaLuate the influence of the studied iron sources on the liver iron stores. SFE-171-P presented BioFe, RBV and LIC values of (47 +/- 7)%, 109% and (46.6 +/- 3.4) mg/kg respectively, while the corresponding values for the reference standard were of (43 +/- 7)%, 100% and (45.0 +/- 4.7) mg/kg. These results show that the drying process used to produce the SFE-171-P does not affect its bioavailability, which is also adequate for the potential use of this product in food fortification or with pharmaceutical purposes.

Animals↗