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PubMed2000

RFLP band size standards: NIST standard reference material 2390.

The procedural standard for DNA profiling developed by the U.S. advisory board on DNA quality assurance methods mandates annual confirmation of forensic DNA measurement systems against an appropriate reference material supplied by or traceable to the National Institute of Standards and Technology (NIST). NIST Standard Reference Material (SRM) 2390 is a suitable and appropriate standard for HaeIII restriction enzyme-based restriction fragment length polymorphism (RFLP) profiling systems. Originally issued in 1992, an among-laboratory SRM 2390 recertification study was initiated in 1997. Using data provided by the 20 state, local, or commercial forensic laboratory participants, quantitative band sizes values (expected mean values and associated bivariate tolerance intervals) are established for two different-source DNAs (female cell line K562 and healthy male "TAW") for genetic loci D1S7, D2S44, D4S139, D5S110, D1OS28, and D17S79. Methods for validating an RFLP measurement system, validating a control material or other secondary standard, and for tracing a particular set of RFLP measurements to NIST SRM 2390 are described in detail.

DNA Fingerprinting↗
PubMed2000

[The Endotoxin 10,000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10,000 Reference Standard) (Control 0001)].

To establish the fourth lot (Control 0001) of the Endotoxin 10,000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10,000 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined as containing approximately 20,000 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the fourth lot of the Endotoxin 10,000 Reference Standard containing 20,000 EU per vial.

Endotoxins↗
PubMed2001

[The Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard) (Control 0101)].

To establish the second lot (Control 0101) of the Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined as containing approximately 100 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the second lot of the Endotoxin 100 Reference Standard containing 100 EU of endotoxin per vial.

Endotoxins↗
PubMed2002

[The Endotoxin 10000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10000 Reference Standard) (Control 0211)].

To establish the fifth lot (Control 0211) of the Endotoxin 10000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10000 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined a s containing approximately 16,000 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the fifth lot of the Endotoxin 10000 Reference Standard containing 16,000 EU per vial.

Endotoxins↗
PubMed2002

[The Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard) (Control 0201)].

To establish the third lot (Control 0201) of the Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined as containing approximately 130 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the third lot of the Endotoxin 100 Reference Standard containing 130 EU of endotoxin per vial.

Endotoxins↗
PubMed1996

Standardizing flow cytometry: construction of a standardized fluorescence calibration plot using matching spectral calibrators.

Calibration of flow cytometers is becoming an increasingly important issue for both quality control of instrument performance and quantitation of antibody binding capacity of cells. Due to the numerous different instruments and analysis software currently available, a standardized method of calibration is necessary if interlaboratory comparison of instrument performance and antibody binding is to be achieved. This report describes a new methodology to obtain a standard calibration plot that can be derived from all instruments and from which specific instrument-independent performance parameters may be calculated that can be used to directly compare the performance and setup of these instruments. The requirements that the calibrated standards must meet are discussed, as well as the acceptable ranges proposed for the instrument-independent performance parameters. In addition, data are presented from standard calibration plots generated by different flow cytometers in numerous laboratories. The corresponding Primary Performance Parameters calculated from these plots are presented and compared. It is expected that the use of this calibration method may help standardize flow cytometric measurements and will provide instrument-independent performance parameters to monitor quality control of instruments and reagents.

Calibration↗
PubMed2005

Development and reliability of a standard rating system for outcome measurement of foot and ankle disorders I: development of standard rating system.

BACKGROUND: The aim of this study was to report the five scales comprising the rating system that the Japanese Society for Surgery of the Foot (JSSF) devised (JSSF standard rating system) and the newly offered interpretations and criteria for determinations of each assessment item. METHODS: We produced the new scales for the JSSF standard system by modifying the clinical rating systems established by the American Orthopaedic Foot and Ankle Society (AOFAS scales) and the Japanese Orthopaedic Association's foot rating scale (JOA scale). We also provided interpretations of each assessment item and the criteria of determinations in the new standard system. RESULTS: We improved the ambiguous expressions and content in the conventional standard rating systems so they would be easily understood by Japanese people. The result was five scales in total. Four were designed for use specifically for ankle-hindfoot, midfoot, hallux metatarsophalangeal-interphalangeal, and lesser metatarsophalangeal-ineterphalangeal sites; and the fifth was for the foot and ankle with rheumatoid arthritis. Furthermore, we described interpretations and criteria for determinations with regard to evaluation items in each scale. CONCLUSIONS: Conventionally, the AOFAS scales or the JOA scale have been separately applied depending on the sites or disorders concerned, but it was often difficult to decide on scores during practical evaluations because of differing expressions in different languages and also because of ambiguity in the interpretation of each evaluation item and in scoring standards as well. JSSF improved these scales and added definite interpretations of evaluation items as well as criteria for the rating (to be reported here in part I). Because these steps were expected to improve the reliability of outcomes assessed by each scale, we examined the reliability in scores of the newly developed scales, which are reported in part II (in this issue).

Ankle↗
PubMed2006

American Dietetic Association: standards of practice and standards of professional performance for registered dietitians (generalist, specialty, and advanced) in oncology nutrition care.

The Standards of Practice and Standards of Professional Performance in Oncology Nutrition Care serve as a professional resource for self-evaluation and professional development for RDs specializing in oncology nutrition practice. Application of these documents in clinical practice presents the opportunity for quality improvement in oncology nutrition services provided by the RD. Just as the professional self-evaluation and continuing education process is an ongoing cycle, these standards are also a work in progress, and will be reviewed and updated on a regular basis. The Standards of Practice and Standards of Professional Performance are a quality initiative of the ADA and ON DPG that reflect a commitment to improving the quality of nutrition services provided by RDs in oncology settings.

Certification↗
PubMed1992

Effects of self-focus, discrepancy between self and standard, and outcome expectancy favorability on the tendency to match self to standard or to withdraw.

Objective self-awareness theory (Duval & Wicklund, 1972) assumes that the intensity of attempts to match self to standard or to withdraw is a function of degree of self-standard discrepancy. Self-regulation theory (Carver & Scheier, 1981) assumes that the decision to match or withdraw is determined by outcome expectancy favorability. Combining these assumptions, it was predicted that increasing self-standard discrepancy would increase efforts to conform self to standard when outcome expectancies are favorable. When unfavorable, increasing discrepancy was predicted to increase efforts to avoid the situation. Results from Experiments 1 and 2 provided partial support for these hypotheses. Results from Experiment 3 suggested that deviations from prediction were due to outcome expectancy favorability being a function of the rate of progress toward discrepancy reduction relative to the magnitude of self-standard discrepancy.

Achievement↗
PubMed2006

Metabolomics Standards Workshop and the development of international standards for reporting metabolomics experimental results.

Informatics standards and controlled vocabularies are essential for allowing information technology to help exchange, manage, interpret and compare large data collections. In a rapidly evolving field, the challenge is to work out how best to describe, but not prescribe, the use of these technologies and methods. A Metabolomics Standards Workshop was held by the US National Institutes of Health (NIH) to bring together multiple ongoing standards efforts in metabolomics with the NIH research community. The goals were to discuss metabolomics workflows (methods, technologies and data treatments) and the needs, challenges and potential approaches to developing a Metabolomics Standards Initiative that will help facilitate this rapidly growing field which has been a focus of the NIH roadmap effort. This report highlights specific aspects of what was presented and discussed at the 1st and 2nd August 2005 Metabolomics Standards Workshop.

Cell Physiological Phenomena↗
PubMed2003

A prospective randomized clinical trial comparing an individual dose of recombinant FSH based on predictive factors versus a 'standard' dose of 150 IU/day in 'standard' patients undergoing IVF/ICSI treatment.

BACKGROUND: The study aim was to compare the use of individual rFSH doses between 100 and 250 IU/day (calculated using the rFSH dose normogram) with a standard dose of rFSH of 150 IU/day. METHODS: This prospective randomized dual-centre clinical trial included 267 first IVF/ICSI cycles using the long agonist protocol in 'standard' patients. Following down-regulation, 262 patients were randomized using computer-generated lists using 'clusters of 10' into the individual dose (study) group (n = 131) or the standard dose (control) group (n = 131). RESULTS: In the study group, 101 patients (77.1%) had an appropriate response (defined as 5-14 oocytes), compared with 86 (65.6%) in the control group (P < 0.05). Fewer than five oocytes were retrieved in two patients (1.5%) in the study group, compared with 14 patients (10.7%) in the control group (P < 0.05). By comparison, >14 oocytes were retrieved from 27 patients (20.6%) in the study group and from 26 (19.8%) control patients (P = NS). Eighty-six per cent of the individual dose patients did not require any dose adjustment on day 8, compared with 45% of the standard dose patients (P < 0.01). The ongoing pregnancy rate per initiated cycle was 36.6% in the study group and 24.4% in the control group (P < 0.01). One patient (0.8%) in the study group, and four patients (3.1%) in the control group, were hospitalized due to ovarian hyperstimulation syndrome. CONCLUSIONS: An individual dose regimen in a well-defined 'standard' patient population increased the proportion of appropriate ovarian responses and decreased the need for dose adjustments during controlled ovarian stimulation. A higher ongoing pregnancy rate was observed in the individual dose group.

Adult↗
PubMed1994

Process standards of nursing care for patients with COPD: validation of standards and criteria by the Delphi technique.

It is common for professional literature to describe quality of care as based on standards. Yet little attention is given to the steps that precede the establishment of these standards. This study answers the question. "Which nursing care standards and criteria should be developed for chronic obstructive pulmonary disease (COPD) patients discharged from a pulmonary rehabilitation center? "Our approach included the following steps: delineating the scope of care and service, identifying indicators, and formulating standards and identifying criteria. Aspects of care included are: establishment and maintenance of a good care relationship with the patient; delineation of the care needs during the home visit; provision of health education, advice, and instruction; support in psychosocial problems; and coordination and continuity of the service. These standards and criteria were validated by the Delphi technique.

Clinical Protocols↗
PubMed2001

Cross-cultural validity and reliability testing of a standard psychiatric assessment instrument without a gold standard.

The objective of this study was to assess the cross-culture validity and reliability of a standard psychiatric assessment instrument without the usual "gold standards." Normally criterion validity testing requires comparison with such a standard--usually another instrument or a professional diagnosis. Instead local informants identified persons with and without "agahinda gakabije" (a locally described grief syndrome) who were then asked if they thought they had this syndrome and also interviewed using the depression section of the Hopkins Symptom Checklist (DHSCL). To assess criterion validity, interviews where respondent and informant agreed on the presence or absence of agahinda gakabije were compared with depression diagnosis using the DHSCL. We also assessed construct validity (using factor analysis), internal reliability (Cronbach's alpha), and test-retest reliability using results from a subsequent community-based survey employing the DHSCL. We found a similar relationship between depression and agahinda gakabije as between depression and grief in western countries, which supports criterion validity. Construct validity and internal reliability were good (Cronbach's alpha = 0.87). Test-retest reliability of a DHSCL-based scale was less adequate (0.67). Although not replacing the usual gold standards for testing criterion validity, this approach may prove useful where these standards are unavailable. As this includes much of the developing world, this could result in more accurate mental health assessments among populations for whom this has hitherto not been possible.

Adult↗
PubMed1980

Standardization of Factor VIII. II. A British Standard for Factor VIII related antigen.

A collaborative study on factor VIII related antigen (VIII R:Ag) has been carried out, involving 11 laboratories in the U.K. Samples of two different freeze-dried plasmas were assayed against participants' own local standards by the Laurell electroimmunoassay method. There was reasonably good agreement on the relative potencies of the two freeze-dried plasmas, but there were considerable differences in the VIII R:Ag content of the plasma pools used as local standards, with values ranging from 83% to 129% of the mean. All participants agreed on the need for a standard for VIII R:Ag, and that the unit be defined by the mean of the local standards. Accordingly, freeze-dried plasma 66/355 was established as the 1st British Standard for factor VIII related antigen, with an assigned potency of 1.05 units per ampoule.

Antigens↗
PubMed2006

Bicalutamide 150 mg plus standard care vs standard care alone for early prostate cancer.

OBJECTIVE: To evaluate, in the ongoing Early Prostate Cancer (EPC) trial programme, the efficacy and tolerability of bicalutamide 150 mg once daily in addition to standard care for localized or locally advanced, nonmetastatic prostate cancer. PATIENTS AND METHODS: The EPC programme comprises three randomized, double-blind, placebo-controlled trials designed for combined analysis. Following standard care, 8113 men with localized (T1-2, N0/Nx) or locally advanced (T3-4, any N; or any T, N+) prostate cancer (all M0) received oral bicalutamide 150 mg once daily or oral placebo. The primary endpoints were progression-free survival (PFS) and overall survival. RESULTS: The large EPC trial programme is defining men who benefit or do not from early or adjuvant antiandrogen therapy. At a median follow-up of 7.4 years, in localized disease there is no benefit to PFS by adding bicalutamide to standard care, and there is a trend (hazard ratio, HR, 1.16; 95% confidence intervals, CI, 0.99-1.37; P = 0.07) towards decreased survival in patients otherwise undergoing watchful waiting. However, in locally advanced disease, bicalutamide significantly improved PFS irrespective of standard care. Bicalutamide significantly improved overall survival in patients receiving radiotherapy (HR 0.65; 95% CI 0.44-0.95; P = 0.03); this was driven by a lower risk of prostate cancer-related deaths. Bicalutamide produced a trend towards improved overall survival in patients with locally advanced disease otherwise undergoing watchful waiting (HR 0.81; 95% CI 0.66-1.01; P = 0.06). No survival difference was evident in the prostatectomy subgroup. CONCLUSIONS: This ongoing programme is clarifying the role of early or adjuvant antiandrogen therapy in prostate cancer. Patients with localized disease do not appear to derive clinical benefit from added bicalutamide. However, adding bicalutamide 150 mg to standard care provides significant clinical benefits in patients with locally advanced prostate cancer, irrespective of primary therapy.

Aged↗
PubMed2002

Asymptotic standard errors of estimated standard errors in structural equation modelling.

Asymptotic standard errors of the estimated asymptotic standard errors for parameter estimates in structural equation modelling are derived using the delta method with the assumption of multivariate normality for observed variables. The derivation covers the cases with and without restrictions on parameters. The result can be used to derive the asymptotic standard error of the z score (a parameter estimate divided by its estimated standard error), which is frequently substantially different from one. The case of standardized observed variables is dealt with as a typical example with restrictions on parameters. For actual covariance (correlation) structure models, the exploratory factor analysis model with factor rotation and the confirmatory factor analysis model are presented with numerical examples. Simulations are performed to assess the accuracy of our method for normally and non-normally distributed variables.

Behavior↗
PubMed1986

Stevens' power law and time perception: effect of filled intervals, duration of the standard, and number of presentations of the standard.

Subjects estimated the duration of five different time intervals, either filled or unfilled, in relation to one or two standard intervals. Half of the subjects were presented with the standard at the beginning of the experiment only, and half were presented with the standard before every interval. The five estimations were then used to calculate, for each subject, the exponent in Stevens' Power Law which describes the form of the power relationship. The resulting over-all exponent of .91, although nearly linear, was significantly different from 1.0. The data were then analyzed by a 2 X 2 X 2 analysis of variance which showed a significant interaction between presenting the standard either once or before each interval with the duration of the standard.

Female↗
PubMed1958

Third international standard for posterior pituitary; re-named third international standard for oxytocic, vasopressor and antidiuretic substances in 1956.

In October 1955, stocks of the Second International Standard for Posterior Pituitary were running low and the Department of Biological Standards of the National Institute for Medical Research, London, was asked to proceed with the arrangements for an international collaborative assay of material for the Third Standard. A single 142-g batch of posterior-pituitary-lobe powder was obtained and distributed in ampoules, in approximately 30-mg quantities. Samples were sent to 19 laboratories in 10 countries. In all, 185 assays were carried out, 122 for oxytocic activity, 53 for vasopressor activity and 10 for antidiuretic activity.On the basis of the results, which were analysed statistically at the National Institute for Medical Research, it was agreed that the potency of the Third Standard (re-named International Standard for Oxytocic, Vasopressor and Antidiuretic Substances in 1956, in view of the recent synthesis of oxytocin and vasopressin) should be expressed as 2.0 International Units per milligram. The International Unit therefore remains unchanged as 0.5 mg of the dry powder.

Biological Assay↗