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PubMed1998

Creating standards for basic, medical and market research.

Different types of standards that can be created are ideal, realistic, desirable and minimally acceptable. A different approach to viewing types of standards is to view them as existing along a spectrum from very formal to informal. Basic research, medical research and market research can each develop and use standards that are entirely formal or informal or that exist at any stage along that spectrum. Pharma sense dictates that there are times when high, medium or low standards are appropriate. The main goal of all professionals is to know when to use which approach. Situations where pharma sense requires using either high or low standards are mentioned for basic research, clinical research and market research. Standards for basic research are usually established to answer the question: What level of activity must the test compound exhibit to be worthy of passing onto the next test? Issues concerning standards are: Who sets standards? When do standards interfere with achieving useful results on a project? What are the possible consequences of using low standards in research? What are the tradeoffs between quality and quantity of standards? How should appropriate standards be taught? and What are the internal versus external pressures on decision making about standards? By using pharma sense and pharma think to approach any issue or question of research standards on its own, it is likely that a company will determine the appropriate level of standards.

Journal Article↗
PubMed1994

New IEEE standard enables data collection for medical applications.

The IEEE has gone to ballot on a "Standard for Medical Device Communications", IEEE P1073. The lower layer, hardware portions of the standard are expected to be approved by the IEEE Standards Board at their December 11-13, 1994 meeting. Other portions of the standard are in the initial stages of the IEEE ballot process. The intent of the standard is to allow hospitals and other users to interface medical electronic devices to host computer systems in a standard, interchangeable manner. The standard is optimized for acute care environments such as ICU's, operating rooms, and emergency rooms. [1] IEEE General Committee and Subcommittee work has been on-going since 1984. Significant amounts of work have been done to discover and meet the needs of the patient care setting. Surveys performed in 1989 identified the following four key user requirements for medical device communications: 1) Frequent reconfiguration of the network. 2) Allow "plug and play" operation by users. 3) Associate devices with a specific bed and patient. 4) Support a wide range of hospital computer system topologies. Additionally, the most critical difference in the acute care setting is patient safety, which has an overall effect on the standard. The standard that went to ballot meets these requirements. The standard is based on existing ISO standards. P1073 is compliant with the OSI seven layer model. P1073 specifies the entire communication stack, from object-oriented software to hospital unique connectors. The standard will be able to be put forward as a true international standard, much in the way that the IEEE 802.x family of standards (like Ethernet) were presented as draft ISO standards.(ABSTRACT TRUNCATED AT 250 WORDS)

Computer Communication Networks↗
PubMed1996

[Standardization of serum lipid examination: an attempt in Oita].

There is an obvious difference in currently available clinical laboratory data between hospitals. With the advent of information systems, the clinical laboratory information in the future must be standardized so that it can be used in medical treatment and health control throughout the life patients time. Establishing publicly acknowledged standards is essential for standardization to be translated into practice. The standards for clinical laboratory examination in Japan are approved by consensus in the Japanese Committee for Clinical Laboratory Standards (JCCLS). However, standards have yet to be established for most laboratory examinations. This poses is a major obstacle in promoting the standardization. Standardization should be implemented carefully with consideration of the worldwide trend. That is probably the reason why the consultation and approval at JCCLS have been delayed, but it is hoped that standards will be established as soon as possible. The committee for quality control survey in Oita Medical Association organized a Lipid Unit of the Sectional Committee for Standardization in 1994 and has since implemented standardization according to the lipid standardization program of the U.S. Centers for Disease Control and Prevention (CDC) with some modifications. Measures for improvement have been adopted for a trial period in parallel with four surveys, and in September, 1995 all 9 hospitals passed the standardization test performed on the basis of the CDC provisions for certification. The Oita Medical Association plans to expand the lipid standardization to all parts of the prefecture using the trial of standardization by the Lipid Unit as a model.

Blood Chemical Analysis↗
PubMed2006

Differences between European birthweight standards: impact on classification of 'small for gestational age'.

We describe a quantitative and comparative review of a selection of European birthweight standards for gestational age for singletons, to enable appropriate choices to be made for clinical and research use. Differences between median values at term across standards in 10 regions and misclassification of 'small for gestational age' (SGA), were studied. Sex and parity differences, exclusion criteria, and methods of construction were considered. There was wide variation between countries in exclusion criteria, methods of calculating standards, and median birthweight at term. The lightest standards (e.g. France's medians are 255g lower than Norway's medians) were associated with fewer exclusion criteria. Up to 20% of the population used in the construction of the Scottish standard would be classified as SGA using the Norwegian standard. Substantial misclassification of SGA is possible. Assumptions about variation used in the construction of some standards were not justified. It is not possible to conclude that there are real differences in birthweight standards between European countries. Country-based standards control for some population features but add misclassification due to the differing ways in which standards are derived. Standards should be chosen to reflect clinical or research need. If standards stratified by sex or parity are not available, adjustments should be made. In multinational studies, comparisons should be made between results using both a common standard and country-based standards.

Age Factors↗
PubMed1992

International collaborative study by in vitro bioassays of the first international standard for porcine inhibin.

A lyophilized preparation of inhibin from porcine ovarian follicular fluid, ampoule code 86/690, was made internationally available as a research standard for in vitro bioassays in 1987. A study involving ten participants in eight countries assessed the stability and suitability of this research standard to serve as an international standard. Each of the participants used in vitro assays, the majority of which depended upon the inhibition of release of follicle-stimulating hormone from dispersed rat anterior pituitary cells. The research standard 86/690 was compared with coded ampoules of 86/690 stored under conditions of accelerated thermal degradation and with inhibins from different species. Intra- and interlaboratory variation for estimates of potency of a coded duplicate ampoule of the research standard provided the basis for comparisons of non-identical inhibins, but the fourfold variability of potency estimates for identical ampoules was such that no conclusions about the differences seen for non-identical inhibins could be made. Predictions of stability from consensus estimates of potency of ampoules that have undergone accelerated thermal degradation indicated that the research standard had satisfactory stability. On the basis of this study, the research standard 86/690 was deemed sufficiently stable and suitable to serve as a standard for in vitro bioassays and was established by the World Health Organization Expert Committee on Biological Standardization as the First International Standard for Porcine Inhibin. The possible presence, in biological extracts (standard or sample), of other bioactive proteins, such as activin and follistatin, complicates the quantitative interpretation of bioassay data. A standard of highly purified human inhibin is now required as a standard for immunoassays used for clinical research purposes; sufficient quantities of recombinant human inhibins have recently been donated for ampouling and evaluation by bio- and immunoassay in the subsequent phase of the standardization of inhibins.

Animals↗
PubMed1954

The second international standard for vitamin D: crystalline vitamin D3.

This report was presented to the Subcommittee on Fat-Soluble Vitamins of the WHO Expert Committee on Biological Standardization in 1949 by the Vitamin D Sub-Committee of the Accessory Food Factors Committee of the Medical Research Council of Great Britain and formed the evidence on which the first-mentioned subcommittee based its recommendation of the adoption of crystalline vitamin D(3) as the International Standard for Vitamin D, replacing the solution of irradiated ergosterol which had been adopted as Standard in 1931.The Vitamin D Sub-Committee organized a collaborative assay in which 32 laboratories in seven countries participated. In addition to 29g of crystalline vitamin D(3) generously contributed by five firms, the following preparations were compared for vitamin D activity by biological tests on rats or chicks or both: the then current International Standard, a preparation of the purest calciferol obtainable, the British Standards Institution (BSI) Standard, the United States Pharmacopeia (USP) Reference Cod Liver Oil, and the Swedish provisional standard.Altogether 29 rat assays and 25 chick assays were carried out, and the results were subjected to standard methods of analysis. The BSI Standard and the pure calciferol were found less potent than the Old Standard (potency ratios: 0.916 and 0.933, respectively); and the New Standard may be slightly less potent (0.981), but it is more potent than the BSI Standard (1.071). The USP Reference Oil is less potent than the BSI Standard (0.949), the Old Standard (0.896), and the New Standard (0.886). The fiducial range is generally less than 10%, but even where it is greater, it is still satisfactory for a biological test.

Animals↗
PubMed1994

National standards and guidelines for pesticides in water, sediment, and aquatic organisms: application to water-quality assessments.

National standards and guidelines for pesticides can be useful tools in water-quality assessment for evaluating potential human health or ecological effects of measured pesticide residues in water, bed sediment, or aquatic organisms. However, valid use of a given standard or guideline requires an understanding of its technical basis and underlying assumptions. Each type of standard or guideline is specific for one sampling medium (water, bed sediment, and fish and shellfish tissue) and is aimed at protection of one or more beneficial uses of the hydrologic system (drinking water, fish and shellfish consumption, aquatic organisms, and wildlife). These characteristics can be used to identify which standards and guidelines are appropriate for comparison with measured pesticide concentrations in environmental samples from a given hydrologic system. A review of standards and guidelines can be restricted to the applicable sampling medium. Then, the beneficial uses of the hydrologic system need to be identified and the measured pesticide concentrations compared with standards and guidelines for all beneficial uses that apply to that system. Several key factors that must be considered when applying this general process to water-quality assessment are summarized below. Two precautions need to be considered regarding sampling media: 1. Standards and guidelines for water distinguish between finished drinking water (potable water, often treated) and ambient surface water. If standards and guidelines for drinking water (EPA primary drinking-water regulations and drinking-water health advisories) are applied to measured pesticide concentrations in ambient water samples, the effects of water treatment (such as filtration) need to be considered. 2. Standards and guidelines for fish and shellfish tissue distinguish between edible fish and shellfish tissue and whole fish tissue. Comparison of pesticide concentrations in whole fish tissue with standards or guidelines for edible fish and shellfish tissue is appropriate only as a screening procedure to determine whether additional sampling and analysis for contaminants in edible fish fillets are warranted. For some sampling media (water, fish and shellfish tissues), both standards and guidelines may exist for a given pesticide. Standards and guidelines may differ in their technical bases and in the implications or consequences of finding measured concentrations in exceedance of the standard or guideline value. Therefore, comparison of measured pesticide concentrations with both standards and guidelines is useful because each provides different information about the hydrologic system.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals↗
PubMed2001

Clinical service standards at academic health centers.

OBJECTIVE: To describe the content and variability for clinical service standards related to quality of care among a convenience sample of academic health centers. DESIGN: We used the membership of the University HealthSystem Consortium, an alliance of academic health centers in the United States for clinical services, to survey electronically 53 of these centers regarding clinical service standards. The survey evaluated service standards in four areas; general communications, communications between physicians, ambulatory and inpatient clinical services and administrative standards. RESULTS: Thirty-four institutions responded to the survey (64%). Of these, 16 (47%) had clinical service standards, while the remaining 18 (53%) had not established formal standards. A few of the centers had established standards for patient communications, such as policies for answering telephones by staff. More had developed standards for communications between physicians and most centers had established standards for appointment availability, especially for urgent visits. However, clinical service standards were less typical for inpatient consultative or diagnostic services. A small number of the academic health centers had standards for hours of operation and for handling administrative matters, such as patient complaints. For many clinical service standards at the centers, there were notable variations (e.g. non-urgent primary care visits ranged 3-14 days). CONCLUSION: Some academic health centers have developed and implemented patient-centered clinical service standards for diverse areas of practice, however, the standards used appear to vary for some aspects of care, but not for others.

Academic Medical Centers↗
PubMed1999

Intravenous and oral mono- or combination-therapy in the treatment of severe infections: ciprofloxacin versus standard antibiotic therapy. Ciprofloxacin Study Group.

Five hundred and forty patients with severe infection were enrolled in a multicentre, prospective, randomized, non-blinded study to compare the efficacy and safety of i.v. ciprofloxacin with i.v. standard therapy. Five hundred and thirty-one patients received at least one dose of study drug for pneumonia (310), septicaemia (112) or skin and skin structure infection (109). Intravenous ciprofloxacin (400 mg, every 8 h) or i.v. ciprofloxacin (400 mg, every 8 h) plus a beta-lactam were compared with a standard monotherapy (beta-lactam) or combination (aminoglycoside plus a beta-lactam) therapy. Patients were treated parenterally for a minimum of 2 or 3 days, then at the discretion of the investigator could be switched to oral therapy (ciprofloxacin 750 mg, every 12 h or a standard oral therapy). Patients were randomized in the ratio of 2:1 for the ciprofloxacin and standard therapy treatment groups and stratified to monotherapy if the APACHE II score was < or = 20 or to combination therapy if the APACHE II score was 21-29. Three hundred and ninety-five (74%) patients were valid for the efficacy analysis: these comprised 242 pneumonia (167 ciprofloxacin and 75 standard therapy), 70 septicaemia (47 ciprofloxacin and 23 standard therapy), and 83 skin infections (56 ciprofloxacin and 27 standard). The primary efficacy variable was clinical response and the secondary efficacy assessment was bacteriological response at the end of therapy (2 or 3 days after treatment). The mean duration of therapy for patients receiving only i.v. monotherapy or combination therapy was shorter (9-10 days) than for patients receiving sequential i.v./p.o. therapy (14-17 days). At the end of therapy, overall clinical resolution/improvement (success) for monotherapy was 138/166 (83%) for the ciprofloxacin group, compared with 74/87 (85%) for standard-treated patients (95% CI = -11.5% to 7.6%), and for combination therapy the response was 43/51 (84%) for the ciprofloxacin group and 14/20 (70%) for standard-treated patients (95% CI = -6.3% to 34.9%). For pneumonia, the most frequent infection treated, clinical success rates following monotherapy were 85% for ciprofloxacin and 83% for standard-treated patients and 83% for ciprofloxacin compared with 69% for standard-treated patients in the combination therapy group. Bacteriological eradication/presumed eradication following monotherapy was 85/102 (83%) for ciprofloxacin and 31/46 (67%) for standard-treated patients (95% CI = 1.6% to 30.3%), and that for combination therapy was 29/36 (81%) for ciprofloxacin and 7/10 (70%) for standard-treated patients (95% CI = -18.3% to 39.5%). Drug-related adverse events, primarily diarrhoea and nausea, were reported in 22% of ciprofloxacin-treated patients and 20% of standard-treated patients. In summary, ciprofloxacin administered alone or in combination was found to be effective in treating a wide range of severe infections.

Administration, Oral↗
PubMed2005

Interplay between intensity standardization and inhomogeneity correction in MR image processing.

Image intensity standardization is a postprocessing method designed for correcting acquisition-to-acquisition signal intensity variations (nonstandardness) inherent in magnetic resonance (MR) images. Inhomogeneity correction is a process used to suppress the low frequency background nonuniformities (inhomogeneities) of the image domain that exist in MR images. Both these procedures have important implications in MR image analysis. The effects of these postprocessing operations on improvement of image quality in isolation has been well documented. However, the combined effects of these two processes on MR images and how the processes influence each other have not been studied thus far. In this paper, we evaluate the effect of inhomogeneity correction followed by standardization and vice-versa on MR images in order to determine the best sequence to follow for enhancing image quality. We conducted experiments on several clinical and phantom data sets (nearly 4000 three-dimensional MR images were analyzed) corresponding to four different MRI protocols. Different levels of artificial nonstandardness, and different models and levels of artificial background inhomogeneity were used in these experiments. Our results indicate that improved standardization can be achieved by preceding it with inhomogeneity correction. There is no statistically significant difference in image quality obtained between the results of standardization followed by correction and that of correction followed by standardization from the perspective of inhomogeneity correction. The correction operation is found to bias the effect of standardization. We demonstrate this bias both qualitatively and quantitatively by using two different methods of inhomogeneity correction. We also show that this bias in standardization is independent of the specific inhomogeneity correction method used. The effect of this bias due to correction was also seen in magnetization transfer ratio (MTR) images, which are naturally endowed with the standardness property. Standardization, on the other hand, does not seem to influence the correction operation. It is also found that longer sequences of repeated correction and standardization operations do not considerably improve image quality. These results were found to hold for the clinical and the phantom data sets, for different MRI protocols, for different levels of artificial nonstandardness, for different models and levels of artificial inhomogeneity, for different correction methods, and for images that were endowed with inherent standardness as well as for those that were standardized by using the intensity standardization method. Overall, we conclude that inhomogeneity correction followed by intensity standardization is the best sequence to follow from the perspective of both image quality and computational efficiency.

Algorithms↗
PubMed1998

Medico-economic analysis of diacerein with or without standard therapy in the treatment of osteoarthritis.

This 9-month pragmatic study compared 2 therapeutic regimens in the management of osteoarthritis of the hip and knee. Patients received either diacerein 100 mg/day plus standard osteoarthritic therapy for 6 months, followed by a 3-month monitoring period without diacerein, or standard therapy alone for the entire 9-month period. A total of 207 patients with osteoarthritis of the knee and hip were enrolled. Improvements in Lequense's functional index and quality-of-life scores (revised Arthritis Impact Measurement Scales Health Status Questionnaire and Nottingham Health Profile), and decreases in nonsteroidal anti-inflammatory drug and analgesic consumption were significantly greater with diacerein plus standard therapy than with standard therapy alone. The overall assessment of therapy by patients was good or excellent for 60% of those who received diacerein plus standard therapy, compared with 26% who received standard therapy alone. Medical and paramedical procedures carried out in addition to those stipulated in the protocol (medical consultations, physiotherapy, nursing, etc.), osteoarthritis-related, were fewer and less costly in the diacerein plus standard therapy group than in the standard therapy group. The average outpatient cost (in 1995 French francs) of osteoarthritis treatment in the standard therapy group was FF2272 compared with FF2360 in the diacerein plus standard therapy group. The cost-effectiveness ratios per point scored on Lequesne's index were FF1893 for the standard therapy group and FF1072 for the diacerein plus standard therapy group, leading to a saving of 43% with diacerein plus standard therapy. The marginal cost (additional cost corresponding to the clinical benefit obtained by adding diacerein to standard treatment) was FF88 per point scored on Lequesne's index.

Aged↗
PubMed2001

[Standards, options and recommendations: nutritional support in palliative or terminal care of adult patients with progressive cancer].

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the National Federation of Comprehensive Cancer Centres (FNCLCC), the 20 French Cancer Centers and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines according to the definitions of the Standards, Options and Recommendations project for nutritional support in adult patients with advanced or terminal cancer. METHODS: Data were identified by searching Medline, web sites and using the personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to 95 independent reviewers. RESULTS: The main recommendations for nutritional support in adult patients with advanced or terminal cancer are: 1) Palliative care has been defined in a consensual way and is governed by the law (standard). Nutritional support is a palliative care which aim is to maintain and restore the "well-being" of the patient (standard). 2) Digestive symptoms and nutritional troubles are frequently noted in patients with advanced or terminal cancer (standard, level of evidence B2). Karnofsky index (KPS) and performance status (PS) are functional scores with a prognostic value and have to be used (standard, level of evidence B2). 3) Anorexia has a bad predictive value in patients with advanced or terminal cancer (standard, level of evidence B2). 4) In France, patients with advanced or terminal cancer are referred to medical institutions, palliative care units or remained at home (standard). Patients need a multidisciplinary follow-up (standard). An active participation of patients and/or their family circle is very important and physicians have to pay attention for their opinions (standard). 5) Dietetic counseling can help patients to improve their alimentation and its drawbacks (standard). 6) Palliative nutritional care often includes medicinal treatments (standard). 7) Artificial nutrition can slow down nutritional degradation, avoid dehydration and improve quality of life in patients with advanced stage cancer (especially head and neck cancer for enteral nutrition and digestive occlusions for parenteral nutrition) and unable to eat adapted meals (standard, level of evidence C). 8) When life expectancy is below 3 months with a KPS 3/4 50% (or PS > 2), artificial nutrition is not recommended (recommendation, expert agreement). 9) The assessment of nutritional care in patients with advanced or terminal cancer has to include functional scores measurement, quality of life and satisfaction degree of the patient and/or their family (standard, expert agreement).

Adult↗
PubMed1999

Age-adjusted death rates: consequences of the Year 2000 standard.

PURPOSE: For nearly 60 years, official U.S. mortality statistics have been age-adjusted using the age distribution from the U.S. population for the year 1940. A new population standard, the projected Year 2000 U.S. standard, has been approved for use by the Department of Health and Human Services (DHHS). It will be implemented for official U.S. Government statistics published for deaths occurring in 1999. The new standard reflects the older age distribution of the population; 6.8% of the population was age 65 years or more in 1940, as compared to 12.6% projected for 2000. METHODS: This paper investigates the consequences of the new age distribution standard by comparing death rates by time, place, and population characteristics, adjusted to both the 1940 and projected 2000 population standards. RESULTS: The new standard changes the level of the age-adjusted death rate for total mortality and for many causes of death, as compared to the 1940 standard. For example, the 1995 death rate for diseases of the heart is 138 per 100,000 population when adjusted using the 1940 standard, but is 296 per 100,000 using the Year 2000 standard. The new standard may change the comparison of age-adjusted rates if there are substantial differences in the age-specific rates. For example, the ratio of age-adjusted death rates for ischemic heart disease in black relative to white males is 1.07 using the 1940 standard, but is 0.96 using the Year 2000 standard. CONCLUSIONS: The new Year 2000 age standard has the potential to change both levels and comparisons of age-adjusted rates. Age-adjustment is an averaging process, and consequently, has the potential to view the data effectively as a whole while possibly obscuring important age-specific details.

Adolescent↗
PubMed1985

Standardization of dyes and stains for automated cell pattern recognition.

An extensive review is presented of the various factors involved in the standardization of dyes and stains for cytologic material, which is a crucial point in achieving objective and reproducible measurements of cells for recognition by automated microscopy (high-resolution cell image analysis; automated cell pattern recognition [ACPR]). Two principal methods of standardization are considered at length: (1) standardization based on the physical and chemical characterization of the dyes (physicochemical standardization), as adopted by the German Bureau of Standards, and (2) standardization based on direct visual assessment of stain performance (performance standardization), as adopted by the United States Biological Stain Commission. The procedures, achievements and problems of both methodologies are discussed, as are such related matters as staining time, solution pH, etc., especially with regard to the two most important stains in diagnostic cytology: the Papanicolaou stain and the Romanowsky-Giemsa stain. The standardization of these two stains is considered in detail, with an eye towards their suitability for ACPR. The mechanisms of the staining results produced by these stains are examined, as are the extant problems with each. The Papanicolaou stain, while neither standardized nor stoichiometric, has proven to be of use in cytophotometry. Similarly, the Romanowsky-Giemsa stain, while standardized, is also not a stoichiometric stain. Yet both have been successfully used in some aspects of ACPR; no "ideal" stain has yet been found that would make cell samples ideally suited for machine evaluation. It is concluded that the standardization of biologic dyes and stains, which can contribute to the success of ACPR, should be undertaken by multidisciplinary expert panels, in which the current concerned organizations could play a role. It is also concluded that ACPR may, in fact, contribute to the standardization of dyes and stains: that computer-directed morphometry and automated image analysis with sophisticated statistical analysis may become major tools in the validation of data on staining. For example, computer analysis could be used to pinpoint the particular variant of the Papanicolaou stain that leads to the best overall reproducibility of cell descriptors, in effect achieving "preliminary standardization by computer judgment of stain performance."

Adjuvants, Pharmaceutic↗
PubMed1988

A California air standard to protect vegetation from ozone.

Evidence shows that the current national primary ambient air quality standard, if attained, would still permit substantial injury to vegetation. Thus, in March 1987, the California Air Resources Board (CARB) began consideration of the evidence for the effects of ozone (O3) on vegetation, and of several possible state ambient air quality standards designed to protect vegetation, especially crops, from O3 injury. In its review, the CARB addressed a number of issues relevant to such a standard. One issue considered by the CARB is the relationship of an ambient air quality standard to natural background levels of O3, which would greatly influence the practicality of attainment. Attainment of a standard close to natural background could entail excessive costs. Another issue considered is the occurrence of oxidants other than O3 that can damage vegetation. Throughout much of California, O3 accounts for over 90% of the oxidant air pollutants, and the CARB considered whether, in keeping with current practice, O3 should be used as a surrogate for total oxidant air pollutants. A major new piece of information presented to the CARB was an assessment of the economic effects of several potential standards. This assessment, produced by University of California scientists at Riverside and Davis, calculated the benefits of the potential standards in comparison to current O3 levels and estimated natural O3 background. This assessment was developed using field chamber response data, local crop data, and local O3 concentration data as inputs to the California Agricultural Resources Model, which accounts for both supply and demand effects. Because of California's varied climate, agricultural production occurs on a year-round basis, with overlapping growing seasons for many crops. Over long periods of time, O3 levels may vary markedly because of the influence of various factors, and a 1-h standard may not be an accurate indicator of growing season O3 exposure. A moving three-month averaging time has been proposed as a way to approximate the growing seasons of California's 200 crops. However, a sufficiently stringent 1-h standard would serve as a surrogate for a growing season standard. The CARB reviewed evidence supporting both long-term and short-term standards. Agriculture dominates the economies of some regions within California but is a minor components of other regional economies. Because the San Joaquin Valley is California's most important agricultural area, the CARB reviewed evidence for a regional standard for this area that would be more stringent than standards for other parts of the state.

Journal Article↗
PubMed1994

Quality standard for the treatment of bacteremia. The Infectious Diseases Society of America.

OBJECTIVE: The objective of this quality standard is to optimize the treatment of bacteremia in hospitalized patients by ensuring that the antibiotic given is appropriate in terms of the blood culture susceptibility of the pathogen. Although this standard may appear to be minimal in scope, it is needed because appropriate antimicrobial treatment is not given in 5% to 17% of cases. To implement the standard, physicians, pharmacists, and microbiologists will need to devise a coordinated strategy. OPTIONS: We considered criteria for appropriate dosing, most cost-effective selection, proper antibiotic levels in serum, least toxicity, narrowest spectrum, specific clinical indications, and optimal duration of treatment. All these criteria were rejected as the basis for the standard because they were too controversial and too difficult to be applied by a nonphysician chart reviewer. In contrast, the selection of an antibiotic to which the pathogen is sensitive is a noncontroversial criterion and easy for a chart reviewer to apply. OUTCOMES: The standard is designed to reduce the incidence of adverse outcomes of septicemia such as renal failure, prolonged hospitalization, and death. EVIDENCE: Several well-designed clinical trials without randomization as well as case-controlled studies have confirmed the benefit of using an antibiotic that is appropriate in light of the susceptibility of the isolate in blood culture. Prospective, randomized, placebo-controlled trials are not available. VALUES: Our premise is that the presence of bacteremia is a risk factor for serious adverse outcomes. We also believe that the administration of antibiotics must always be guided by the susceptibility report for the pathogen(s) obtained from blood cultures. This concern is more critical for pathogens from the blood than for those from most other body sites. We had evidence that susceptibility reports for pathogens from positive blood cultures were not always used properly. We used group discussion to reach a consensus among the members of the Quality Standards Subcommittee. BENEFITS, HARMS, AND COSTS: Through the implementation of this standard, at least 5% of bacteremias could be treated more appropriately. An unknown number of deaths would likely be prevented, and mortality from bacteremia treated inappropriately would probably be reduced. The primary undesirable feature of the standard is an increased workload of pharmacists and microbiologists. RECOMMENDATIONS: Treatment of bacteremia with an antibiotic that is appropriate in terms of the pathogen's blood-culture susceptibility is a minimal standard of care for all patients. VALIDATION: We consulted more than 50 experts in infectious diseases from the fields of medicine, surgery, pediatrics, obstetrics and gynecology, nursing, epidemiology, pharmacology, and government. In addition, the methods for its implementation were reviewed by the American Society of Hospital Pharmacists and were tested by one of the members of the Quality Standards Subcommittee. SPONSORS: The Quality Standards Subcommittee of the Clinical Affairs Committee of the Infectious Diseases Society of America (IDSA) developed the standard. The subcommittee was composed of representatives of the IDSA (Drs. Gross and McGowan), the Society for Hospital Epidemiology of America (Dr. Wenzel), the Surgical Infection Society (Dr. Dellinger), the Pediatric Infectious Diseases Society (Dr. Krause), the Centers for Disease Control and Prevention (Dr. Martone), the Obstetrics and Gynecology Infectious Diseases Society (Dr. Sweet), and the Association of Practitioners of Infection Control (Ms. Barrett). Funding was provided by the IDSA and the other cooperating organizations. This standard is endorsed by the IDSA.

Anti-Bacterial Agents↗
PubMed1994

Quality standard for the treatment of bacteremia. Infectious Diseases Society of America.

OBJECTIVE: The objective of this quality standard is to optimize the treatment of bacteremia in hospitalized patients by ensuring that the antibiotic given is appropriate in terms of the blood culture susceptibility of the pathogen. Although this standard may appear to be minimal in scope, it is needed because appropriate antimicrobial treatment is not given in 5%-17% of cases. To implement the standard, physicians, pharmacists, and microbiologists will need to devise a coordinated strategy. OPTIONS: We considered criteria for appropriate dosing, most cost-effective selection, proper antibiotic levels in serum, least toxicity, narrowest spectrum, specific clinical indications, and optimal duration of treatment. All these criteria were rejected as the basis for the standard because they were too controversial and too difficult to be applied by a nonphysician chart reviewer. In contrast, the selection of an antibiotic to which the pathogen is sensitive is a noncontroversial criterion that is easy for a chart reviewer to apply. OUTCOMES: The standard is designed to reduce the incidence of adverse outcomes of septicemia, such as renal failure, prolonged hospitalization, and death. EVIDENCE: Several well-designed clinical trials without randomization as well as case-controlled studies have confirmed the benefit of using an antibiotic that is appropriate in light of the susceptibility of the isolate in blood culture. Prospective, randomized, placebo-controlled trials are not available. VALUES: Our premise is that the presence of bacteremia is a risk factor for serious adverse outcomes. We also believe that the administration of antibiotics must always be guided by the susceptibility report for the pathogen(s) obtained from blood cultures. This concern is more critical for pathogens from the blood than for those from most other body sites. We had evidence that susceptibility reports for pathogens from positive blood cultures were not always used properly. We used group discussion to reach a consensus among the members of the Quality Standards Subcommittee. BENEFITS, HARMS, AND COSTS: Through the implementation of this standard, at least 5% of cases of bacteremia could be treated more appropriately. An unknown number of deaths would likely be prevented, and mortality from bacteremia treated inappropriately would probably be reduced. The primary undesirable feature of the standard is an increased workload for pharmacists and microbiologists. RECOMMENDATIONS: Treatment of bacteremia with an antibiotic that is appropriate in terms of the pathogen's blood-culture susceptibility is a minimal standard of care for all patients. VALIDATION: We consulted more than 50 experts in infectious diseases from the fields of medicine, surgery, pediatrics, obstetrics and gynecology, nursing, epidemiology, pharmacology, and government. In addition, the methods for its implementation were reviewed by the American Society of Hospital Pharmacists and were tested by one of the members of the Quality Standards Subcommittee. SPONSORS: The Quality Standards Subcommittee of the Clinical Affairs Committee of the Infectious Diseases Society of America (IDSA) developed the standard. The subcommittee was composed of representatives of the IDSA (P.A.G. and J.E.M.), the Society for Hospital Epidemiology of America (R.P.W.), the Surgical Infection Society (E.P.D.), the Pediatric Infectious Diseases Society (P.J.K.), the Centers for Disease Control and Prevention (W.J.M.), the Obstetrics and Gynecology Infectious Diseases Society (R.L.S.), and the Association of Practitioners of Infection Control (T.L.B.). Funding was provided by the IDSA and the other cooperating organizations. The standard is endorsed by the IDSA.

Anti-Bacterial Agents↗
PubMed1993

Comparison of the transmittance and coloration requirements of the four national sunglass standards.

There are four national standards on nonprescription sunglasses and two international draft standards at different levels of development and activity. The variation in test specifications and pass/fail criteria among the national standards makes comparisons difficult and agreement on international standards slow. Arguments about the relative stringency of standards may be, as a consequence, ill-informed and self-defeating. In this study I compared the requirements of the four national sunglass standards and then the compliance of 253 sunglass and fashion spectacle lenses with the standards in the erythemal ultraviolet (UV), near UV, luminous transmittance, and coloration. The methods and criteria of the four standards vary quite substantially but the lenses failing to comply are frequently the same. The differences and similarities among the standards are clearly demonstrated. In the erythemal UV, the standards form two pairs in their stringency (Australian and British Standards as against German and U.S. Standards). In the near UV, the British Standard stands out as being more stringent. In the luminous transmittance region there is a basic agreement. In coloration requirements, even though there is extreme variation of methods, these too provide very similar results. The U.S. requirements on signal transmittance do not serve a useful function. Some comments on the differences in labeling requirements are made.

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