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PubMed1993

Evaluation of several common standards for the X-ray microanalysis of thin biological specimens.

The question of the best type of standard to use for X-ray microanalysis of thin biological specimens remains unanswered. Standards embedded in an organic matrix have the advantage that they resemble biological specimens, but their composition is generally not known exactly. We compared several standards and, surprisingly, inorganic binary salts sprayed onto a supporting film were the most suitable: they corresponded closely with several other methods using organic matrices; they were easily produced; and their composition is known. Glutaraldehyde-urea aminoplastic resin thin sections and thin films containing dissolved salts were problematic. The composition of the polymer appears to be variable, and the thin films did not correspond with any other standard tested. Chelex100 bio-standard beads and flakes loaded with accurately determined concentrations of ions, embedded in epoxy resin and thin sectioned, tended to correspond to the results obtained with the binary salts. However, the results from some bio-standards were inexplicably aberrant. An epoxy resin standard was used for bromine, and was found to agree closely with the binary standards.

Electron Probe Microanalysis↗
PubMed1997

A comparison of the standard approach and the NONMEM approach in the estimation of bioavailability in man.

There has recently been concern about confidence intervals calculated using the standard error of parameter estimates from NONMEM, a computer program that uses a non-linear mixed-effects model to calculate relative bioavailability (F), because of possible downward bias of these estimates. In this study an alternate approach, the log-likelihood procedure, was used to calculate the confidence intervals for F from NONMEM. These were then compared with those calculated using the standard error of the parameter estimates, the traditional NONMEM approach, and the standard model-independent method, to determine whether bias exists. By use of data from a single dose, open cross-over study of ibuprofen using 14 healthy male volunteers, NONMEM was shown to give results consistent with those obtained using the standard model-independent method of analysis and could be a useful tool in the determination of F where conditions for using the standard method of analysis are not optimum. The width of the confidence interval for F using the log-likelihood procedure was narrower and non-symmetrical when compared with that obtained using the traditional NONMEM approach. The width of the confidence interval obtained using the traditional NONMEM method was similar to that from the standard approach, however the parameter estimate for F was higher than that obtained from the standard method. This could have been because of an outlier in the data set to which the standard approach is more sensitive. No downward bias was found in the confidence intervals from NONMEM. The bioavailability data set was of relatively low variability and more research with highly variable data is necessary before it can be concluded that the confidence intervals calculated from NONMEM can be used for hypothesis testing.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMedDate not supplied

Calibration standards for multicenter clinical trials of fluorescence spectroscopy for in vivo diagnosis.

In the context of clinical trials, calibration protocols for optical instruments that ensure measurement accuracy and the ability to carry out meaningful comparisons of data acquired from multiple instruments are required. A series of calibration standards and procedures are presented to assess technical feasibility of optical devices for cervical precancer detection. Measurements of positive and negative standards, and tissue are made with two generations of research grade spectrometers. Calibration accuracy, ability of standards to correct and account for changes in experimental conditions, and device components are analyzed. The relative frequency of measured calibration standards is investigated retrospectively using statistical analysis of trends in instrument performance. Fluorescence measurements of standards and tissue made with completely different spectrometers show good agreement in intensity and lineshape. Frequency of wavelength calibration standards is increased to every 2 h to compensate for thermal drifts in grating mount. Variations in illumination energy detected between standards and patient measurements require probe redesign to allow for simultaneous acquisition of illumination power with every patient measurement. The use of frequent and well-characterized standards enables meaningful comparison of data from multiple devices and unambiguous interpretation of experiments among the biomedical optics community.

Calibration↗
PubMed1993

Comparison of the use of Tanner and Whitehouse, NCHS, and Cambridge standards in infancy.

The British (Tanner and Whitehouse) and American (National Center for Health Statistics, NCHS) growth standards are widely used internationally, although the data are now over 30 years old. Routine weight data was retrieved from the child health records of a complete annual cohort of 3418 children aged 18-30 months to test the validity of these standards for modern infants. Compared with the Tanner and Whitehouse standards, Newcastle children rose initially and then fell a mean of 0.7 SDs between 6 weeks and 18 months, resulting in a threefold difference in the proportion of children below the 3rd centile at different ages. NCHS standards showed a similar pattern. When compared with modern standards from the Cambridge growth study, there was a much closer match, although Newcastle children showed a slight gain by the age of 1 year. Existing standards for weight introduce inaccuracy into the estimation of centile position in the early months of life. As both standards show similar problems this probably represents a real secular change due to changes in infant nutrition. These findings support the need to develop new national growth reference standards.

Anthropometry↗
PubMed2004

Developing national outcome standards for the management of gonorrhoea and genital chlamydia in genitourinary medicine clinics.

BACKGROUND: Measuring clinical performance within a framework of clinical governance is increasingly important for monitoring improvements in patient care. Standards for quality indicators must, however, be achievable and evidence based. We describe an approach to the development of national standards for measuring outcomes of care for gonorrhoea and genital chlamydia in genitourinary medicine clinics. METHODS: Two standards for each infection, one reflecting quality of case management and one reflecting partner management were chosen by consensus. A systematic review of published and unpublished UK studies about gonorrhoea and chlamydia management was carried out and weighted averages calculated for each parameter, stratified by location. Genitourinary medicine practitioners around the country were also asked for their opinion about desirable values for each standard and the results compared. Variability in performance between centres was examined using Shewhart's control charts. RESULTS: We identified 17 reports about gonorrhoea outcomes and 14 about chlamydia. There was marked heterogeneity in results according to geographical location and different standards were set for clinics in and out of London. Opinions from practitioners suggested much higher standards than the values obtained from the systematic review. There was evidence for special cause variation related to management of gonorrhoea and chlamydia in London clinics. CONCLUSIONS: Standards set using expert opinion are unrealistic when compared to evidence of what is achievable. Evidence based methods should therefore be used to derive outcome standards for case management gonorrhoea and chlamydia. The control chart method identified clinics where investigation to find reasons for special cause variation in performance should be undertaken to change practice.

Ambulatory Care↗
PubMed2003

The risks of adverse neonatal outcome among preterm small for gestational age infants according to neonatal versus fetal growth standards.

OBJECTIVE: To evaluate neonatal and fetal growth standards in determining the impact of small for gestational age (SGA) on neonatal mortality and morbidity. DESIGN: A hospital-based cohort study of infants born in a regional tertiary care center and admitted to the neonatal intensive care unit. SETTING AND PARTICIPANTS: A total of 1267 singleton neonates of <34 weeks gestational age, without any congenital anomalies, born between January 1, 1993 and December 31, 2001. OUTCOME MEASURES: Each outcome variable including mortality, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage (IVH), periventricular leukomalacia, and necrotizing enterocolitis was related to growth status as defined by fetal and neonatal growth standards after adjustment for potential confounders. RESULTS: The number of SGA infants was 11.6% (n = 147) of the study population according to neonatal growth standards, but it was increased to 23.3% (n = 295) when fetal growth standards were used. According to fetal growth standards, when SGA was compared with appropriate for gestational age infants, it was associated with an increased risk of respiratory distress syndrome (odds ratio [OR] 1.40; 95% confidence interval [CI] 1.00-1.95), bronchopulmonary dysplasia (OR 2.18; 95% CI 1.33-3.59), IVH (OR 1.67; 95% CI 1.13-2.45), and retinopathy of prematurity (OR 3.88; 95% CI 2.33-6.48). However, only neonatal mortality (OR 3.64; 95% CI 1.64-8.09), retinopathy of prematurity (OR 5.38; 95% CI 2.87-10.90), and necrotizing enterocolitis (OR 2.47; 95% CI 1.21-5.07) were positively associated with SGA when using neonatal growth standards. CONCLUSIONS: Compared with the neonatal growth standards, the fetal growth standards are better in identifying increased risk of respiratory morbidity and IVH among preterm SGA infants.

Cohort Studies↗
PubMed1991

Health Level 7: an application standard for electronic medical data exchange.

The development of the HL7 is proceeding along two lines. Much effort is being spent on solving the ambiguities of version 2.1 and in extending the standard to areas that are not yet well defined. For example, at a recent working group meeting new messages were defined for dealing with pharmacy records, specifically those relating to IVs. As the number of vendors implementing the standard and as the number of organizations using the standard increase, the standard will continue to be refined and expanded along current formats. As often as possible, these efforts will be "backwards compatible" and may be implemented by vendor choice as the need arises. These changes will be distributed as chapter updates to the current release. A parallel effort is underway that will add formality to the development of the standard. These efforts incorporate a number of case tools, including data modeling. The biggest advantage of this approach will be to reduce significantly the ambiguity in data element definitions. Completeness and correctness of data relations will be enhanced as well. New approaches to documentation, including an object-oriented specification of the data model, will increase understandability. There are still a number of domain-specific areas in which the standard needs to be defined and examples generated to show how the standard applies. Forms of data transfer other than text must be accommodated. HL7 again will take advantage of existing work in these areas, such as the work of American College of Radiology/National Equipment Manufacturers Association (ACR/NEMA) in standards relating to image transfer. HL7 will continue to move toward OSI-compatibility.(ABSTRACT TRUNCATED AT 250 WORDS)

Abstracting and Indexing↗
PubMed1999

[Discussion and preliminary application on standard for comprehensive efficacy assessment of traditional Chinese medicine in treating malignant tumor].

OBJECTIVE: To establish a comprehensive efficacy assessment standard on premise of patients' survival period and referring to the response of tumor and host to traditional Chinese medicine (TCM) therapy. METHODS: A standard was established by taking change of tumor size, tumor related symptoms, Karnofsky scoring and body weight of patient as criteria for evaluation. The standard was used to evaluate the comprehensive effect on advanced tumor patients, received various therapeutic regimen of TCM treatment in Xiyuan Hospital from March 1997 to August 1998, and compared with that evaluated by objective response rate (RR) of tumor. RESULTS: By the new standard, comprehensive therapeutic effect of 55 advanced tumor patients was: effective in 17 cases (30.91%), stable in 10 (18.18%) and exacerbative in 28 (50.91%), while by RR, it was completely response in 0, partial response in 3 (5.45%), no change in 41 (74.55%) and progressive disease in 11 (20.00%). Results of evaluation made by the two standard was different significantly, P < 0.005. The median survival period of 18 cases of advanced lung carcinoma patients was 11.5 months. Patients survived longer than the median survival period, mostly were tumor-bearing survival, were attributed to no change by RR, but were listed as effective by the new standard. CONCLUSION: The new standard laid more stress on quality of life than the RR, it reflects better response of tumor and host to treatment, and the prognosis of patients, and associated with the survival period, therefore, it could be conducted as the standard for comprehensive efficacy assessment in treating advanced malignant tumor in clinical practice after further improving.

Adult↗
PubMed2001

[Addition internal standard method in chromatographic quantitative analysis].

Internal standard method is a conventional chromatographic quantitative method which requires one or several internal standards added. The internal standard component must not be contained in the sample and need a good separation between the internal standard and sample components. In many cases selecting an internal standard is not convenient or even restricted by the seperation of components. In this paper, we try to combine the internal standard method and the addition method to form a new chromatographic quantitation method named addition internal standard method. The principles of addition internal standard method are suitable to not only chromatographic quantitation but also polarography etc. The related theory and foundation of the method are defined. The operation steps and the conditions suitable to the method are discussed. The advantages and disadvantages of this method are explained in detail.

Chromatography↗
PubMed2004

Implementing the HL7v3 standard in Croatian primary healthcare domain.

The mission of HL7 Inc. is to provide standards for the exchange, management and integration of data that supports clinical patient care and the management, delivery and evaluation of healthcare services. The scope of this work includes the specifications of flexible, cost-effective approaches, standards, guidelines, methodologies, and related services for interoperability between healthcare information systems. In the field of medical information technologies, HL7 provides the world's most advanced information standards. Versions 1 and 2 of the HL7 standard have on the one hand solved many issues, but on the other demonstrated the size and complexity of the health information sharing problem. As the solution, a complete new methodology has been adopted, which is being encompassed in version 3 recommendations. This approach standardizes the Reference Information Model (RIM), which is the source of all domain models and message structures. Message design is now defined in detail, enabling interoperability between loosely-coupled systems that are designed by different vendors and deployed in various environments. At the start of the Primary Healthcare Information System project, we have decided to go directly to HL7v3. Implementing the HL7v3 standard in healthcare applications represents a challenging task. By using standardized refinement and localization methods we were able to define information models for Croatian primary healthcare domain. The scope of our work includes clinical, financial and administrative data management, where in some cases we were compelled to introduce new HL7v3-compliant models. All of the HL7v3 transactions are digitally signed, using the W3C XML Digital Signature standard.

Croatia↗
PubMed1983

ELISA for IgM and IgG antibodies against tick-borne encephalitis virus: quantification and standardization of results.

A method for standardizing specific antibody determination by ELISA is presented. Tick-borne encephalitis (TBE)-ELISA results are expressed in arbitrary units by comparing extinction values of test sera (tested in triplicate at a fixed dilution) with the extinction-curve of a standard serum run in the same test. The standard serum was given an arbitrary value of 1000 Vienna Units, and the corresponding units for the test serum are read from the standard curve. As a standard for IgM antibody determination, a pool of sera was taken from patients with recent TBE at about the time of maximal IgM antibody production. This IgM-standard was used for a three-layer as well as for a four-layer ELISA. The IgG standard for detection of IgG antibodies in the three-layer ELISA consisted of sera from persons with a past infection. To exclude low nonspecific results only values higher then 50 Vienna Units are regarded as undoubtedly positive. This method for standardizing ELISA gives reproducible results, even when plates coated on different days with different batches of antigen were used.

Antibodies, Viral↗
PubMed1982

Method for determining serum pepsinogen concentration, using pepsin standards and ultraviolet absorbance.

A simplification of the traditional hemoglobin methods for determining serum pepsinogen concentration was developed. In this method, 10% trichloroacetic acid solution was added to control samples, and hemoglobin substrate was added to controls and active enzyme samples; standards and samples were incubated for 18 hours, the proteins in the active tubes were precipitated with trichloroacetic acid and removed by filtration, and the absorbances of the supernatant of each standard and sample at 280 nm were measured. The major differences between this method and other methods for determining pepsinogen values are that the preacidification of serum with hydrochloric acid was eliminated, the incubation period was reduced to 18 hours (down from 24 hours), the relative pepsinogen concentration was determined by measuring the concentration of hydrolysis products, using ultraviolet, rather than visible absorbance, and a pepsin standard curve was used to determine the serum pepsinogen concentration. Comparison of freshly prepared pepsinogen and pepsin standard curves indicated that the pepsinogen preparations were slightly more active than the pepsin preparations (on a weight-to-weight basis) on the same substrate. Pepsin standards are used because they are more stable than pepsinogen standards. Three linear standard curve ranges were used: O 10 to 100, 50 to 300, and 100 to 500 ng of pepsinogen/ml of serum. The use of pepsin standard curves permits some variability of the incubation conditions without altering the results. For best results, the hemoglobin substrate solution should be prepared daily. This method may be useful in diagnosing ostertagiasis.

Animals↗
PubMed1996

Software standards and the laboratory information system.

Software standards simplify communication and cooperation between applications provided by different software vendors. However, adherence to a rigid standard can stifle innovation. Open standards, which are not proprietary to any particular vendor, are particularly useful. Many standard-setting organizations have provided useful tools for laboratory informatics, including the American Society for Testing and Materials (ASTM), Institute of Electrical and Electronics Engineers, National Committee for Clinical Laboratory Standards, and the College of American Pathologists. Data communication standards, such as ASTM 1238, HL7, and Digital Image Communication of Medicine, have reduced the cost and improved the timeliness of interfaces. Nomenclatures, particularly the Systematized Nomenclature of Medicine (SNOMED), have facilitated the structuring of medical information, and decision rules can be communicated with ASTM E1460. Laboratory Observation Identifier Names and Codes has eased the problem of identifying tests during interchange of laboratory data. Implementation standards are useful references for those deploying information systems. Standards have provided multiple benefits to laboratories and to the health care organizations of which they are a component.

Clinical Laboratory Information Systems↗
PubMed1999

Clinical epidemiological quality in molecular genetic research: the need for methodological standards.

CONTEXT: A genetic basis has been identified for many medical conditions and some molecular tests have been commercialized. However, little attention has been given to the quality of clinical epidemiology in molecular studies. OBJECTIVE: To examine the clinical epidemiological quality of recent publications on molecular genetic analysis. DESIGN: Cross-sectional study of original research articles published in 1995, identified by manually searching 4 general clinical journals. Of 83 articles identified, 40 were selected for analysis; these 40 discussed molecular genetic techniques, studied 10 or more patients, and had inferential conclusions. MAIN OUTCOME MEASURE: Compliance of the selected articles with 7 methodological standards for clinical epidemiological science (reproducibility, objectivity, delineation of case group, adequacy of spectrum in case group, delineation of comparison group, adequacy of comparison group, and quantitative summary of results). RESULTS: Among the 40 inferential articles that studied 10 or more patients, only 5 (12.5%) complied with all 7 applicable standards, and 10 (25.0%) complied with all but 1 standard, whereas 25 articles (62.5%) failed to comply with 2 or more standards and 9 (22.5%) failed 4 or 5 standards. Most articles did not comply with standards for reproducibility (n = 25, 62.5%) or objectivity (n = 27, 67.5%); however, the majority of articles did comply with standards for adequacy of case group (n = 35, 87.5 %), adequacy of comparison group (n = 35, 87.5%), and quantitative summary of results (n = 36, 90%). CONCLUSIONS: Despite major laboratory advances in molecular genetic analysis, our data suggest that reported applications in clinical journals often have troubling omissions, deficiencies, and lack of attention to the different, but necessary, principles of clinical epidemiological science. Without suitable attention to fundamental methodological standards, the expected benefits of molecular genetic testing may not be achieved.

Clinical Medicine↗
PubMed1997

The effect of the OSHA lead exposure in construction standard on blood lead levels among iron workers employed in bridge rehabilitation.

Over 50,000 workers are at risk of occupational exposure to lead in the course of renovating the nation's deteriorating infrastructure. In mid-1993, to control exposure to lead in the construction setting OSHA promulgated a Lead in Construction Standard. In this study, we assessed the effect of the mandated changes in exposure conditions which followed the introduction of this new standard. We analyzed changes in baseline and maximum blood lead concentrations and in maximum increments in blood lead levels before and after introduction of the standard among iron workers employed in the renovation of a large, lead-painted, steel bridge in New York City. Results indicated that baseline and maximum blood lead levels fell significantly after the implementation of the provisions of the standard, as did maximum increments in blood lead concentrations. Seventy-six percent of the workers maintained blood lead concentrations below 20 micrograms/dl after the OSHA standard, as compared with 66% prior to its implementation. Increments of 20 micrograms/dl or more occurred considerably more frequently before introduction of the standard (13% before vs. 4% after; p = 0.01). Evidence of decreased exposure to lead was observed among iron workers who were present both before and after the introduction of the OSHA standard, as well as among iron workers newly hired after the OSHA provisions were put in place. These findings document the effectiveness of the OSHA construction lead standard in controlling exposure to lead in this complex and variable environment. The data indicate the utility of blood lead determinations in assessing the outcome of industrial hygiene interventions to reduce exposures to lead in the construction setting.

Adult↗
PubMed1998

OSHA's renewed mandate for regulatory flexibility review: in support of the 1984 ethylene oxide standard.

BACKGROUND: The Regulatory Flexibility Act of 1980 requires that all federal agencies consider the impact of regulations on small entities. One of the provisions of the Act requires review of regulations ever 10 years to determine whether such regulations should be continued without changes, rescinded, or amended to make them more effective or less burdensome on businesses. The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 amended and expanded the Regulatory Flexibility Act. Most significantly, SBREFA entitles aggrieved small entities or their representative (e.g., trade associations) to sue OSHA for failure to fulfill Regulatory Flexibility Act requirements. In response to this new political reality, OSHA held the first public meeting of their kind in June of 1997 to gather information on the ethylene oxide and lock-out/tag-out standards for the purposes of Regulatory Flexibility review. METHOD: This paper presents the development of the Regulatory Flexibility review process and details our analysis of the ethylene oxide standard using OSHA's eight Regulatory Flexibility review criteria. RESULTS: Great progress in ethylene oxide health and safety has been made since the promulgation of the standard in 1984, including a considerable decrease in average workshift exposures. Yet, important concerns remain, such as the lack of safer substitutes for EtO's most common uses, the widespread occurrence of accidental exposures to EtO that are not captured by personal monitoring, and the recent increase in the occurrence of catastrophic EtO explosions. CONCLUSIONS: Because of the considerable study that has been devoted to EtO and to the EtO standard, there is a very strong cases for either making the EtO standard more worker protective, or continuing the standard without change while improving outreach and enforcement efforts to address shortcomings. Other valuable standards for which fewer data exist may be inappropriately threatened by the Regulatory Flexibility review process. Importantly, Regulatory Flexibility review could be constructive if accompanied by appropriations to fund sound evaluation studies. Instead, it will likely divert OSHA's limited resources from the numerous urgent health hazard that await initial rule-making. As signified by the designation of "intervention effectiveness research" as one of the 21 priorities on the National Occupational Research Agenda, evaluation studies of OSHA standards and other interventions are urgently needed. The occupational health community's response to this need will play a crucial role in preserving hard-won protections, as well as in developing other urgently needed protections in the future.

Environmental Monitoring↗
PubMed2003

Work-related falls among union carpenters in Washington State before and after the Vertical Fall Arrest Standard.

BACKGROUND: Washington State enacted a change in their fall standard for the construction industry in 1991, preceding the Safety Standard for Fall Protection in the Construction Industry promulgated by Federal OSHA in 1994. METHODS: We evaluated changes in the rate of falls from elevations and measures of severity among a large cohort of union carpenters after the fall standard change in Washington State, taking into account the temporal trends in their overall injury rates. RESULTS: There was a significant decrease in the rate of falls from height after the standard went into effect, even after adjusting for the overall decrease in work-related injuries among this cohort. Much of the decrease was immediate, likely representing the publicity surrounding fatal falls and subsequent promulgation of the standard. The greatest decrease was seen between 3 and 3(1/2) years after the standard went into effect. There was a significant reduction in mean paid lost days per event after the standard change and there was a significant reduction in mean cost per fall when adjusting for age and the temporal trend for costs among non-fall injuries. CONCLUSIONS: Through the use of observational methods we have demonstrated significant effects of the Washington State Vertical Fall Arrest Standard among carpenters in the absence of a control or comparison group. Without controlling for the temporal trend in overall injury rates, the rate of decline in falls appeared significantly greater, but the more pronounced, but delayed, decline was not seen. The analyses demonstrate potential error in failing to account for temporal patterns or assuming that a decline after an intervention is related to the intervention.

Accidental Falls↗
PubMed1993

Detection of intraarticular abnormalities in osteoarthritis of the knee. A pilot study comparing needle arthroscopy with standard arthroscopy.

OBJECTIVE: To determine whether intraarticular abnormalities in osteoarthritis (OA) of the knee can be detected as well by needle arthroscopy as by standard arthroscopy. METHODS: Needle arthroscopy followed by standard arthroscopy was performed on 10 patients with knee OA (diagnosed according to American College of Rheumatology criteria) whose symptoms were not entirely attributable to the OA and were therefore an indication for further evaluation. Each knee was assessed for abnormalities of the menisci, articular cartilage (6 sites), and synovium (6 sites). RESULTS: Evaluation of the 18 menisci visualized with both techniques yielded the same results: 6 abnormal and 12 normal. Among the 54 articular cartilage sites evaluable with both procedures, 16 were judged normal by both needle arthroscopy and standard arthroscopy. Of the 38 cartilage sites judged abnormal by standard arthroscopy, 34 (89%) were abnormal by needle arthroscopy. Both techniques indicated cartilage changes were the same at 42 (78%) of the 54 sites; changes at the other 12 sites were 1 grade higher by standard arthroscopy than by needle arthroscopy. Both needle arthroscopy and standard arthroscopy revealed 51 evaluable sites in the synovium. Of 34 areas judged abnormal by standard arthroscopy, 24 (71%) were also judged abnormal by needle arthroscopy; 17 areas were judged normal by both techniques. The 2 techniques assigned the same macroscopic score in 27 (53%) of 51 areas of the synovium, with a higher grade by standard arthroscopy in all but 1 of the other 16 areas. CONCLUSION: These pilot data suggest that in knee OA, needle arthroscopy can 1) accurately detect meniscal abnormalities, 2) detect cartilage abnormalities, but may underestimate the severity, and 3) detect most synovial abnormalities, but often underestimates the severity. Needle arthroscopy is a potentially valuable rheumatologic tool for the assessment of OA of the knee.

Adult↗