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Calculation of standard transformed Gibbs energies and standard transformed enthalpies of biochemical reactants.

The standard Gibbs energies of formation and standard enthalpies of formation of species involved in biochemical reactions are used to calculate standard transformed Gibbs energies of formation and standard transformed enthalpies of formation of 53 reactants (sums of species) at 298.15 K, pH 7, and ionic strengths of 0, 0.1, and 0. 25 M. The standard transformed Gibbs energies of formation are used to calculate apparent equilibrium constants K' for 22 biochemical reactions for which apparent equilibrium constants have been determined close to these conditions. This comparison is generally satisfactory given the differences in experimental conditions. The transformed formation properties for the 53 reactants make it possible to calculate transformed formation properties for other reactants involved in biochemical reactions with some of these reactants. This is illustrated by calculating standard transformed Gibbs energies of formation for 11 more reactants without information on the standard Gibbs energies of formation of the species. The list of 64 reactants for which standard transformed Gibbs energies of formation are presented can be considerably extended. The use of tables of standard transformed Gibbs energies of formation to store information on apparent equilibrium constants is more efficient than simply storing apparent equilibrium constants because a reactant can be looked up in a table and may be involved in hundreds of reactions. The effects of magnesium ions on several reactions involving ATP are calculated. The advantages of using enzyme-catalyzed reactions for determining thermodynamic properties of complicated molecules in aqueous solution are discussed.

Biochemistry↗

A reliability test of standard-based quantitative PCR: exogenous vs endogenous standards.

The quantitative measurement of gene expression requires consistent and reliable standards. At least two categories of standards, endogenous and exogenous, are currently used for quantitative PCR. The reliability of these two methods, however, has not been carefully compared. We hypothesized that a reliable quantitative PCR assay would be able to detect known dilutions of a given single-stranded (ss-) cDNA. By measuring VEGF ss-cDNA copy numbers or signal ratios of GAPDH/VEGF in 10x and 100x diluted samples of two original ss-cDNA preparations, an exogenous recombinant DNA standard (a VEGF-mimic plasmid) and an endogenously expressed GAPDH standard were tested for their ability to detect dilution factors. Using the recombinant DNA standard, the dilution factor was detected as 10.3 and 135.0 in 10x and 100x diluted samples of the original CaSki cell ss-cDNA, respectively. The detected dilution factors were 12.3 and 226.2, respectively, in 10x and 100x diluted ss-cDNA from U-251 MG cells. On the other hand, with the endogenous GAPDH standard, the dilution factors were detected as 2.7 and 8.0 in the same 10x and 100x dilutions of the original U-251 MG cell ss-cDNA. Using the same endogenous GAPDH standard, the detected dilution factors were both 4.8 in 10x and 100x dilutions of the original CaSki cell ss-cDNA. It was also found that the number of endogenous copies of GAPDH mRNA was about 1000 times higher than VEGF. The high internal lockup ratio of GAPDH vs VEGF copy numbers and the requirement for additional primer pairs make the use of an abundant endogenous standard an unreliable choice in quantitative or semi-quantitative PCR. In contrast, exogenous standard-based quantitative PCR was shown to be an accurate and reliable method for the quantitation of gene expression.

Central Nervous System Neoplasms↗

Setting standards and defining quality of performance in the validation of a standardized-patient examination format.

PURPOSE: To evaluate whether written standards increase the reproducibility of a physician-facilitated station in an objective structured clinical examination (OSCE) designed to assess history, physical-examination, and communication skills. METHOD: The OSCE examination at the University of Texas Medical Branch-Galveston consists of ten eight-minute stations. Six of these stations consist of three History, Physical-examination, Problem-solving, and Plan (HPPP) station pairs. Each existing clinical-problem HPPP station was given to two content experts to develop standards for faculty rating scales appropriate for the evaluation of third-year medical students. Three pairs of faculty members were used to determine interrater reliability by scoring videotapes of three HPPP stations' presentation and problem-solving components. Faculty pairs scored tapes of 15 students without using standards and tapes of 15 students using the standards developed. Differences between the reliabilities without and with the standards were tested for significance using Fisher's R to Z transformation. The reproducibility and standard error of measurement (SEM) were extrapolated for increasing amounts of testing time. The HPPP component scores were also correlated with the written examination scores and preceptors' ratings. Data were obtained from the three HPPP stations used in the 1995-96 internal medicine clerkship SP examination. RESULTS: In all, 196 students completed the OSCE examination. The standards developed improved interrater reliability and reached statistical significance (p < .01) for one HPPP station. Reproducibility for the presentation and problem-solving components of the HPPP stations were > .80 after five hours of testing. The problem-solving component correlated at .37 and .19 with written examinations and with ward grades, respectively. CONCLUSION: The data from this study suggest that standards increase the reproducibility of presentation and problem-solving components of an OSCE to a level as high as, or higher than, that associated with the history, physical-examination, and communication components of traditional standardized-patient examinations.

Clinical Clerkship↗

Standardization of Factor VIII. I. Calibration of British Standards for Factor VIII clotting activity.

Calibration of successive British Standards for Factor VIII clotting activity against the International Standard (concentrate) has brought to light substantial discrepancies among laboratories and between assay methods. These discrepancies were less in assays of concentrate standards than in calibration of plasma standards. Standardization of reagents in the two-stage assays substantially improved agreement among laboratories using this method. Standardization of the phospholipid reagent and haemophilic substrate separately had little effect on variation among laboratories performing one-stage assays. Standardization of reagents did not alter the basic discrepancy (approximately 20%) between the one-stage and two-stage assay methods. Omission of the aluminium hydroxide adsorption step from the two-stage method reduced the discrepancy between the two methods to less than 10%. Discrepancies did not occur when one plasma standard was assayed against another. Improvements in the stability of VIII:C in freeze-dried plasma now make it feasible to establish a long-term plasma reference standard.

Adsorption↗

Customized birth weight for gestational age standards: Perinatal mortality patterns are consistent with separate standards for males and females but not for blacks and whites.

BACKGROUND: Some currently available birth weight for gestational age standards are customized but others are not. We carried out a study to provide empirical justification for customizing such standards by sex and for whites and blacks in the United States. METHODS: We studied all male and female singleton live births and stillbirths (22 or more weeks of gestation; 500 g birth weight or over) in the United States in 1997 and 1998. White and black singleton live births and stillbirths were also examined. Qualitative congruence between gestational age-specific growth restriction and perinatal mortality rates was used as the criterion for identifying the preferred standard. RESULTS: The fetuses at risk approach showed that males had higher perinatal mortality rates at all gestational ages compared with females. Gestational age-specific growth restriction rates based on a sex-specific standard were qualitatively consistent with gestational age-specific perinatal mortality rates among males and females. However, growth restriction patterns among males and females based on a unisex standard could not be reconciled with perinatal mortality patterns. Use of a single standard for whites and blacks resulted in gestational age-specific growth restriction rates that were qualitatively congruent with patterns of perinatal mortality, while use of separate race-specific standards led to growth restriction patterns that were incompatible with patterns of perinatal mortality. CONCLUSION: Qualitative congruence between growth restriction and perinatal mortality patterns provides an outcome-based justification for sex-specific birth weight for gestational age standards but not for the available race-specific standards for blacks and whites in the United States.

Journal Article↗

[Standards for neonatal intensive care nursing: unit directed management standards].

The neonate has the right to quality nursing care and the Neonatal Intensive nursing care practitioner is professionally-ethically and personally liable for quality nursing care. The process of quality improvement is a structured, planned and purposeful action were standards are set and the nursing care is evaluated after which remedial steps are taken to improve quality nursing care. In this study the focus is on the first step in the quality assurance cycle:the setting of standards. The purpose of the study is to describe and formulate standards for Neonatal Intensive nursing care which can be utilised as an accreditation instrument for institutional selfevaluation to improve quality nursing care. Standards for Neonatal Intensive nursing care were developed and validated by utilising a three-phase research method. In phase one subjects for standards were identified by a panel of experts. The identification was done by means of a critical debate, after which a preliminary conceptual framework was formulated. During the second phase a literature control was done to refine the conceptual framework. It consisted of a conceptual framework pertaining to unitmanagement (article 1) and an conceptual framework pertaining to high incidency, high risk interactions in the Neonatal Intensive Care Unit. The conceptual framework pertaining to the high incidency, high risk interactions in the Neonatal Intensive Care Unit consisted of: assessment of the neonate preparedness for neonatal resuscitation mechanical ventilation humidification during ventilation physiotherapy and suctioning of the ventilated neonate weaning during mechanical ventilation ecstubation During the third phase, the standards were validated by means of a consencus debate. An accreditation instrument was developed for institutional selfevaluation to improve quality nursing care in the Neonatal Intensive Care Unit. The standards that were formulated consisted of standards for unitmanagement (article 1) and standards directed at high incidency, high risk interactions in the Neonatal Intensive Care Unit which is published in the second article in this series.

Accreditation↗

Standardization of Factor VIII-IV. Establishment of the 3rd International Standard for Factor VIII: C concentrate.

An international collaborative study was carried out to establish a replacement for the current (2nd) international standard for Factor VIII:C, concentrate. Twenty-six laboratories took part, of which 17 performed one-stage assays, three performed two-stage assays and six used both methods. The proposed new standard, an intermediate purity concentrate, was assayed against the current standard, against a high-purity concentrate and against an International Reference Plasma, coded 80/511, previously calibrated against fresh normal plasma. Assays of the proposed new standard against the current standard gave a mean potency of 3.89 iu/ampoule, with good agreement between laboratories and between one-stage and two-stage assays. There was also no difference between assay methods in the comparison of high-purity and intermediate purity concentrates. In the comparison of the proposed standard with the plasma reference preparation, the overall mean potency was 4.03 iu/ampoule, but there were substantial differences between laboratories, and the two-stage method gave significantly higher results than the one stage method. Of the technical variables in the one-stage method, only the activation time with one reagent appeared to have any influence on the results of this comparison of concentrate against plasma. Accelerated degradation studies showed that the proposed standard is very stable. With the agreement of the participants, the material, in ampoules coded 80/556, has been established by the World Health Organization as the 3rd International Standard for Factor VIII:C, Concentrate, with an assigned potency of 3.9 iu/ampoule.

Antigens↗

Low-molecular-weight heparins or heparinoids versus standard unfractionated heparin for acute ischaemic stroke.

BACKGROUND: Low molecular weight heparins and heparinoids may be associated with lower risks of haemorrhage and more powerful antithrombotic effects than standard unfractionated heparin. OBJECTIVES: The objective of this review was to compare the effects of low molecular weight heparins or heparinoids with those of unfractionated heparin in people with acute confirmed or presumed ischaemic stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group trials register and MedStrategy (1995). We also contacted pharmaceutical companies. Date of most recent search: April 1999. SELECTION CRITERIA: Randomised trials comparing heparinoids or low molecular weight heparins with standard unfractionated heparin in people with acute ischaemic stroke. Only trials where treatment was started within 14 days of stroke onset were included. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected studies for inclusion, assessed trial quality and extracted the data. MAIN RESULTS: Five trials involving 705 people were included. Four trials compared a heparinoid (danaparoid), and one compared a low molecular weight heparin (enoxaparin), with standard unfractionated heparin. Overall, 55/414 (13%) of the patients allocated danaparoid or enoxaparin had deep vein thrombosis compared with 65/291 (22%) of those allocated unfractionated heparin. This reduction was significant (odds ratio 0.52, 95% confidence interval 0.56 - 0.79). However, the number of more major events (pulmonary embolism, death, intra-cranial or extra-cranial haemorrhage) was too small to provide a reliable estimate of more important benefits and risks. No information was reported for recurrent stroke or functional outcome in survivors. REVIEWER'S CONCLUSIONS: Low molecular weight heparin or heparinoid appear to decrease the occurrence of deep vein thrombosis compared to standard unfractionated heparin, but there are too few data to provide reliable information on their effect on other important outcomes, including death and intracranial haemorrhage.

Anticoagulants↗

Analysis of medical screening and surveillance in 21 Occupational Safety and Health Administration standards: support for a generic medical surveillance standard.

Twenty-one Occupational Safety and Health Act (OSHA) standards were identified which contain medical service provisions intended to help in the identification and control of harmful health effects of workplace exposures. The utility and effectiveness of these provisions have not previously been evaluated. All 21 standards were reviewed and assigned numerical scores for each of 24 potential medical program elements. Several of these elements were combined to calculate Quality Control, Screening Utility, and Surveillance Utility scores for each standard. Total scores varied greatly, suggesting a lack of consistency and uniformity which was even more obvious when the actual regulatory language was examined. The mean Quality score was only 26% of potential points. Seventeen of 21 standards received less than half the total possible Quality score. When arrayed on a two by two matrix only two standards scored above 50% for both Screening and Surveillance Utility. It was concluded that the medical service provisions in OSHA standards are lacking in consistency and coherence. Two major shortcomings are the lack of quality control elements and the absence of surveillance features which would permit medical program results to be utilized for prevention activities including the identification and control of workplace hazards. A generic occupational medical surveillance standard could address these current weaknesses. Elements of such a generic standard are proposed.

Data Collection↗

In vivo cholesteryl ester selective uptake of mildly and standardly oxidized LDL occurs by both parenchymal and nonparenchymal mouse hepatic cells but SR-BI is only responsible for standardly oxidized LDL selective uptake by nonparenchymal cells.

In blood circulation, low density lipoproteins (LDL) can undergo modification, such as oxidation, and become key factors in the development of atherosclerosis. Although the liver is the major organ involved in the elimination of oxidized LDL (oxLDL), the identity of the receptor(s) involved remains to be defined. Our work aims to clarify the role of the scavenger receptor class B type I (SR-BI) in the hepatic metabolism of mildly and standardly oxLDL as well as the relative contribution of parenchymal (hepatocytes) and nonparenchymal liver cells with a special emphasis on CE-selective uptake. The association of native LDL and mildly or standardly oxLDL labeled either in proteins or in cholesteryl esters (CE) was measured on primary cultures of mouse hepatocytes from normal and SR-BI knock-out (KO) mice. These in vitro assays demonstrated that hepatocytes are able to mediate CE-selective uptake from both LDL and oxLDL and that SR-BI KO hepatocytes have a 60% reduced ability to selectively take CE from LDL but not towards mildly or standardly oxLDL. When lipoproteins were injected in the mouse inferior vena cava, parenchymal and nonparenchymal liver cells accumulated more CE than proteins from native, mildly and standardly oxLDL, indicating that selective uptake of CE from these lipoproteins occurs in vivo in these two cell types. The parenchymal cells contribute near 90% of the LDL-CE selective uptake and SR-BI for 60% of this pathway. Nonparenchymal cells capture mainly standardly oxLDL while parenchymal and nonparenchymal cells equally take up mildly oxLDL. An 82% reduction of standardly oxLDL-CE selective uptake by the nonparenchymal cells of SR-BI KO mice allowed emphasizing the contribution of SR-BI in hepatic metabolism of standardly oxLDL. However, SR-BI is not responsible for mildly oxLDL metabolism. Thus, SR-BI is involved in LDL- and standardly oxLDL-CE selective uptake in parenchymal and nonparenchymal cells, respectively.

Animals↗

A new twist in US health care data standards development: adoption of electronic health care transactions standards for administrative simplification.

To reduce the costs of common administrative transactions, health plans, payers and providers encouraged the US Congress to legislate administrative simplification of specific electronic health data transactions. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 created incentives for a public-private partnership to develop and implement standards for the uniformity of health care data used in electronic administrative health transactions and standards for the privacy and security of individually identifiable health information. The standards' requirements of HIPAA and how they have been met by the US government hold promise for accelerating the uniform adoption of standards developed by accredited standards developing organizations. The transactions designated by Congress, the process of choosing the standards in the Department of Health and Human Services, the principles that guided these choices, and the actual choices, are presented here. A successful partnership for administrative health data standards can pave the way for success in clinical health data standards and their application in computer-based patient record systems.

Computer Security↗

Ensuring global standards for medical graduates: a pilot study of international standard-setting.

Increasing physician and patient mobility has led to a move toward internationalization of standards for physician competence. The Institute for International Medical Education proposed a set of outcome-based standards for student performance, which were then measured using three assessment tools in eight leading schools in China: a 150-item multiple-choice examination, a 15-station OSCE and a 16-item faculty observation form. The purpose of this study was to empanel a group of experts to determine whether international student-level performance standards could be set. The IIME convened an international panel of experts in student education with specialty and geographic diversity. The group was split into two, with each sub-group establishing standards independently. After a discussion of the borderline student, the sub-groups established minimally acceptable cut-off scores for performance on the multiple-choice examination (Angoff and Hofstee methods), the OSCE station and global rating performance (modified Angoff method and holistic criterion reference), and faculty observation domains (holistic criterion reference). Panelists within each group set very similar standards for performance. In addition, the two independent parallel panels generated nearly identical performance standards. Cut-off scores changed little before and after being shown pilot data but standard deviations diminished. International experts agreed on a minimum set of competences for medical student performance. In addition, they were able to set consistent performance standards with multiple examination types. This provides an initial basis against which to compare physician performance internationally.

Clinical Competence↗

Consistency of standards and stability of pass/fail decisions with examinee-based standard-setting methods in a small-scale objective structured clinical examination.

PROBLEM STATEMENT AND BACKGROUND: The apparent feasibility and the face validity of the examinee-based methods such as the borderline-group methods provide support for their increasing adoption by health profession schools. Before that can occur, however, more information on the quality of the standards produced by these techniques is required. The purpose of the present study was to assess the quality of the standards produced on a small-scale objective structured clinical examination (OSCE) by the borderline-group and contrasting-groups examinee-based standard-setting procedures. METHOD: These two examinee-based criterion-referenced standard-setting procedures were done for an undergraduate fourth-year surgical OSCE and the consistency of the standards and the decisions arising from the standards were assessed. RESULTS: Both techniques provided consistent and realistic standards. CONCLUSIONS: There is sufficient theoretical and empirical evidence to support the use of examinee-based standard-setting techniques in small-scale OSCEs that use expert examiners.

Clinical Clerkship↗

The effect of 'standard drink' labelling on the ability of drinkers to pour a 'standard drink'.

Australia's National Health Policy on Alcohol has recommended that beverage containers be labelled so that alcohol content is 'readily understandable by the public'. Health promotion to increase the responsible use of alcohol now relies extensively on the concept of a standard drink--usually defined as 10 g of ethyl alcohol. Numerous difficulties confront a drinker who wishes to apply the standard drink system to monitor alcohol intake. This report describes a series of experimental tests of the proposal that these difficulties are minimised if alcohol containers have their alcohol content indicated in terms of standard drinks in addition to the usual percentage alcohol by volume method. Subjects were drinkers recruited from a Perth shopping mall and were tested only on beverage types they had consumed within the previous week. They were required to pour what they judged to be a single standard drink from a 750 ml bottle of either wine or beer. Beer drinkers achieved greater accuracy in this task when the bottles had standard drink labels, even when the glass size and beverage strength were varied. Wine drinkers had equal difficulty with this task whether standard drink or percentage labels were used. The addition of a 'ladder' up the side of a wine bottle with graduations in standard drinks would be necessary for wine drinkers to achieve a high level of accuracy. We conclude that labelling drink containers with their alcohol content in terms of standard drinks would better equip all drinkers to follow the advice of health educators.

Adolescent↗

Standard errors of the principal component loadings for unstandardized and standardized variables.

The asymptotic standard errors of the estimates of the principal component loadings for standardized variables are derived under the assumption of multivariate normality. The standard errors are obtained for the usual unrotated case where a loading matrix is orthogonal and for the cases with orthogonally or obliquely rotated components. The corresponding standard errors for unstandardized variables and the asymptotic correlations among the estimators of the parameters for the unstandardized and standardized variables are simultaneously derived, together with the standard errors for the standardized variables. Results of a simulation illustrate the accuracy of the theoretical asymptotic standard errors and correlations.

Humans↗

Standardization of protein C in plasma: establishment of an international standard.

An international collaborative study, involving 18 laboratories, was carried out to establish an international standard for protein C in plasma. The proposed standard, which consisted of a freeze-dried ampouled plasma preparation coded 86/622, was assayed against fresh normal plasma and the participants' local standards. Protein C activity assays were placed in four groups, depending on the method of activation and detection of protein C. The combined potencies (units per ampoule) for the proposed international standard were: thrombin activation/clotting assays, 0.86; thrombin activation/chromogenic assays, 0.81; snake venom activation/clotting assays, 0.81 and snake venom activation/chromogenic assays, 0.82. Measurement of protein C antigen gave potency estimates of 0.81 and 0.82 unites per ampoule for the Laurell electroimmunoassay and ELISA techniques, respectively. The good agreement in potency estimates between the different methods indicates that the overall combined figure (226 assays) for the international standard of 0.82 international units per ampoule should serve for all methods. Accelerated degradation studies have indicated that the standard should be suitably stable when stored at -20 degrees C. The freeze-dried plasma 86/622 has been established by the WHO Expert Committee on Biological Standardization as the 1st International Standard for Protein C in Plasma; with an assigned unitage of 0.82 international units per ampoule.

Blood Coagulation Tests↗

Reporting standards for endovascular surgery: should existing standards be modified for newer procedures?

Appropriate standards for reports on endovascular procedures are discussed in terms of whether existing standards suffice or should be revised. SVS/ISCVS and SCVIR reporting standards form the basis for recommendations. The recently revised SVS/ISCVS "recommended standards for reports dealing with lower extremity ischemia" serves appropriately for most outcome comparisons for occlusive disease, that is, where open surgical and endovascular procedures should be assessed by the same standards. Existing endovascular reporting standards are used to augment these where specific considerations pertinent only to endovascular procedures, such as description of lesion, are needed. In some aspects, such as the reporting of complications that are specific to endovascular procedures (eg, contrast-related, medication-related, device-related, and some entry site and deployment-related complications), recent SCVIR recommendations are endorsed. Although some of these apply, additional reporting standards are required for reporting the results of endograft treatment of aneurysmal disease. The former are identified, and the latter are taken from recent recommendations for reports on the endograft repair of infrarenal AAAs and experiences from recent endograft trials. Public disclosures, at professional meetings or press releases, of data lacking the objectivity and uniformity of these reporting standards, because of the time lag before firm data can reach peer-reviewed journals, may mislead and impede progress.

Forecasting↗

Standardization of high-resolution flow cytometric DNA analysis by the simultaneous use of chicken and trout red blood cells as internal reference standards.

Determination of nuclear DNA content by flow cytometry requires comparison with a reference standard. The use of external standards such as lymphocytes or granulocytes is time-consuming and inaccurate. Chicken red blood cells (CRBC) have a DNA content of 35% of the human diploid value and have been widely used as internal standard. The ratio calculated on the basis of the peak channel numbers of the standard and the sample and used to indicate the DNA content (DNA ratio) is, however, very sensitive to changes in the zero level adjustment of the flow cytometer. If two internal standards are used the DNA ratio becomes independent of the zero level. Rainbow trout red blood cells (TRBC) have a DNA content of 80% of human diploid cells. A mixture of CRBC and TRBC was prepared and stored in small aliquots at -80 degrees C. This mixture was added to the sample before staining. The day-to-day variation of the DNA ratio obtained by use of the two standards was smaller than that obtained by CRBC alone. The possibility of sex related differences in DNA content of CRBC and TRBC was examined. The results indicated that a new batch of standards should be tested against the old batch to avoid the introduction of a systematic error.

Animals↗