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PubMed1991

Prevention of deep vein thrombosis after elective hip surgery. A randomized trial comparing low molecular weight heparin with standard unfractionated heparin.

OBJECTIVE: To determine the relative efficacy and safety of low molecular weight (LMW) heparin (Enoxaparin) compared with standard calcium heparin for the prevention of postoperative deep vein thrombosis in patients undergoing elective hip surgery. DESIGN: A double-blind, randomized, controlled trial. PATIENTS: Six hundred sixty-five consecutive patients undergoing hip replacement at five participating hospitals. INTERVENTIONS: Patients received either fixed-dose LMW heparin, 30 mg subcutaneously twice daily, or fixed-dose standard calcium heparin, 7500 units subcutaneously twice daily; both regimens were started 12 to 24 hours after surgery and continued for 14 days or until discharge if sooner. MEASUREMENTS: All patients had postoperative I-125-fibrinogen leg scanning and impedance plethysmography. If results of one or both tests were positive, then venography was done. Otherwise, venography was done between day 10 and day 14, or sooner if the patient was ready for discharge. RESULTS: Evaluable venograms were obtained in 258 of the 333 patients randomly assigned to receive LMW heparin and in 263 of the 332 patients assigned to receive calcium heparin. For patients with evaluable venograms, thrombosis was detected in 50 patients (19.4%) who received LMW heparin compared with 61 patients (23.2%) who received standard heparin (difference, -3.8%; 95% CI, -11.1% to 3.6%) (P greater than 0.2). Proximal deep vein thrombosis was detected in 5.4% of the patients receiving LMW heparin and in 6.5% of the patients receiving standard heparin (difference, -1.1%; CI, - 5.2% to 3.3%) (P greater than 0.2). For the entire group of 665 patients, venous thrombosis occurred in 17.1% given LMW heparin and in 19.0% given standard heparin. Hemorrhagic complications occurred in 31 patients (9.3%) given standard heparin and in 17 patients (5.1%) given LMW heparin (difference, 4.2%; CI, 0.3% to 8.2%) (P = 0.035). The relative risk reduction was 45%. The rate of major bleeding in the standard heparin group was 5.7% compared with 3.3% in the LMW heparin group (difference, 2.4%; CI, -1.0% to 5.4%) (P = 0.13). The relative risk reduction was 42%. CONCLUSION: Low molecular weight heparin is significantly less hemorrhagic than standard unfractionated heparin; the difference in the rate of deep vein thrombosis, although not statistically significant (P greater than 0.2), favors the use of LMW heparin.

Adult↗
PubMed1993

Efficacy and cost of low-molecular-weight heparin compared with standard heparin for the prevention of deep vein thrombosis after total hip arthroplasty.

PURPOSE: To compare the efficacy, safety, and cost-effectiveness of low-molecular-weight heparin with standard heparin for the prevention of deep vein thrombosis after total hip arthroplasty. DATA IDENTIFICATION: Studies were identified by MEDLINE search and review of bibliographies of retrieved articles. Hospital resources used in treating deep vein thrombosis and bleeding complications after total hip arthroplasty were estimated using retrospectively collected data from 447 patients who participated in a recently completed randomized controlled deep vein thrombosis prophylaxis trial at our center. STUDY SELECTION: Randomized controlled trials directly comparing a low-molecular-weight heparin preparation with standard heparin for the prevention of deep vein thrombosis after total hip arthroplasty were potentially eligible for the meta-analysis. DATA EXTRACTION: Data from eligible studies were extracted independently by two of the authors. Multiple regression analysis of data from the patient cohort was used to estimate the effect of deep vein thrombosis and bleeding on length of hospital stay. A hypothetical North American price for low-molecular-weight heparin was determined based on the ratio between low-molecular-weight heparin and standard heparin in France. Costs were based on weighted per-diem hospital expenditures and physician fees for procedures and reported in 1992 U.S. dollars. RESULTS OF DATA SYNTHESIS: Meta-analysis of six eligible trials determined that low-molecular-weight heparin was significantly more effective than standard heparin at preventing deep vein thrombosis after total hip arthroplasty (common odds ratio, 0.72; 95% CI, 0.53 to 0.95). However, this benefit was restricted to the prevention of proximal deep vein thrombosis (common odds ratio, 0.40; CI, 0.28 to 0.59). No significant differences were found in the rates of distal deep vein thrombosis or total, major, or minor bleeding between the two groups. Based on a 2.6 to 1 price ratio between low-molecular-weight heparin and standard heparin, use of low-molecular-weight heparin would save the health care system about $50,000 per 1000 patients treated. Sensitivity analysis shows that if the low-molecular-weight heparin/standard heparin price ratio exceeds 3.7 (the threshold value lies between 0.8 and 5.5 based on the extremes of the 95% CI of the common odds ratios for deep vein thrombosis and bleeding complications), use of low-molecular-weight heparin is more expensive. At a price ratio of 10, it would cost more than $250,000 to treat 1000 patients with low-molecular-weight heparin compared with standard heparin or about $5000 for each additional deep vein thrombosis prevented with low-molecular-weight heparin. CONCLUSIONS: Low-molecular-weight heparin is more effective and is at least as safe as standard heparin for the prevention of deep vein thrombosis after total hip arthroplasty. Based on the current French price ratio of low-molecular-weight heparin to standard heparin, the use of low-molecular-weight heparin in North America would result in overall savings in cost; however, the relative cost-effectiveness is critically dependent on the price ratio between the two drugs. Further research is needed to compare the cost-effectiveness of low-molecular-weight heparin with other prophylactic regimens and postoperative deep vein thrombosis management strategies.

Cost-Benefit Analysis↗
PubMed1999

Standards for batterer intervention programs in Canada: a history and review.

This article reports on the growing trend of setting standards for intervention with batterers. All existing Canadian standards for batterer intervention programs (BIPs) are examined, including a discussion on how they came into effect and any controversy associated with their development. A brief background of the battering intervention field and the growth of BIP standards in North America is provided, followed by a description of the types and content of Canadian standards. Compliance with standards were mandatory in two regions and voluntary in three others. Two more regions had standards in a draft stage of development. Elements of standards typically included directives on: general program goals; the protocol and procedures programs should follow, including counselling format; and program staff ethics and qualifications. The article concludes with a discussion of the findings and suggestions for improving standards.

Canada↗
PubMed1999

[Changes in prescription patterns for peripheral and cerebral vasoactive drugs before and after establishing prescription standards in France].

OBJECTIVES: Assess changes in the number of prescriptions for peripheral and cerebral vasoactive drugs for the treatment of lower limb arteritis and cerebrovascular disease since the promulgation in 1995 of prescription standards for the treatment of lower limb arteritis. Assess compliance to prescription standards with a detailed analysis of patient features, prescriptions written for lower limb arteritis, cerebrovascular disease and concomitant diseases and evaluate changes in treatment costs for lower limb arteritis and cerebrovascular disease as well as cost of the full prescription, including treatments for associated diseases. METHODS: This study was based on data recorded during the Permanent Study of Medical Prescriptions conducted from March 1994 to February 1995 and from March 1995 to February 1996 by the IMS. Prescription costs were established from the National Description Files of the IMS. Treatment costs were expressed as public price (FF) tax included. Prescriptions meeting the following criteria were selected for each period: prescriptions written by general practitioners for drugs with peripheral and cerebral vasoactivity (excepting calcium antagonists with a cerebral target) belonging to the Anatomic Therapeutic Classes C4A1 of the European Pharmaceutical Marketing Research Association, Bromly 1996; prescriptions for diagnoses 447.6 (arteritis) and 437.9 (cerebrovascular disease) according to the 9th WHO classification. A random sample of 500 prescriptions was selected to calculate costs. RESULTS: Since the advent of the prescription standards in 1995, prescriptions have dropped off by 6.3% for lower limb arteritis and by 14.8% for cerebrovascular disease. There was a 3.7 point decline in the percentage of multiple prescriptions of vasoactive drugs for lower limb arteritis (21.7% prior to March 1995 versus 18% after promulgation of the prescription standards, p > 0.1) and a 1.8 increase in the percentage of multiple prescriptions for cerebrovascular disease (14% prior to March 1995 and 15.8% after promulgation of the prescription standards, p > 0.1). For the treatment of lower limb arteritis, prescription costs fell by a mean 9% per prescription and for the treatment of cerebrovascular disease they rose by a mean 7% per prescription. The price rise, due to multiple prescriptions of vasoactive drugs was 190 FF per prescription for lower limb arteritis and 104 FF per prescription for cerebrovascular disease. CONCLUSION: Despite the retrospective nature of this study where confounding factors could not be controlled, our findings are in agreement with those reported earlier suggesting that cost containment policy implemented by the prescription standards has had little efficacy. In patients with arterial disease of the lower limbs, the percentage of prescriptions not complying with the recommended standards decreased by one-third to one-half over a 2-year period since the prescription standards were first announced in 1994.

Arteritis↗
PubMedDate not supplied

Louder than words. A multi-institutional system sets ethical standards for corporate action.

After establishing its Resource Center for Ethical concerns, Wheaton Franciscan Services, Inc. (WFSI), Wheaton, IL, set out to develop corporate ethics standards. The standards were to manifest a vision that acknowledged the mutuality of relationships among providers and those they serve, and among local and global communities. To establish "ownership" of the standards, WFSI wanted to involve as many people as possible in the planning process. Center staff established a 25-member working task force with broad representation of disciplines and system institutions, then prepared a position paper to serve as a basis for the formulation of the standards. The paper examined current issues in corporate ethics, the theoretical basis of corporate ethics, the appropriateness of corporate ethics for Catholic-sponsored institutions, and the role ethics standards play in an institutional setting. Staff then prepared the first draft of corporate standards. At the first workshop in October 1988, task force members critiqued the draft and modified the proposed corporate standards. Staff sent the draft for critique to a total of 157 persons throughout the system and encouraged them to pass it around to get the advice of others. From the feedback, staff compiled a third draft, which was ultimately approved. WFSI's Corporate Ethics Standards addresses provision of services, relationship with employees, social responsibility, confidentiality, and conflict of interest.

Catholicism↗
PubMed1993

Developments in health informatics within the standards associations of Australia and New Zealand.

Activities to support the development and adoption of Standards in health informatics are now well started. The Standards Association of Australia formed a committee (IT/14) on Medical Informatics which met for the first time in February 1991: early in 1992 it changed its name to reflect a broader concern with "Health Informatics" rather than the rather narrower interpretation that many had chosen to place on the term "Medical Informatics". The Standards Association of New Zealand held the inaugural meeting of persons interested in constituting committee SC606 on Health Informatics in August of this year. A growing program of active collaboration between Australia and New Zealand was formalised in July of this year, whereby standards will for the most part be jointly developed and adopted regionally, and whereby the separate committees will be merged wherever practicable to form a single head Joint Technical Committee (JTC) for each domain of involvement. The focus in Australia and New Zealand is at present very much on the need for standards to implement national health information networks. The progressive definition of network standards is prompting increased interest in the standards implemented within the systems and installations that must connect to the networks. The initial implementation of a national health information system in New Zealand is scheduled for 1st July 1993: detailed plans for an Australian health communications network are well advanced although no date for its implementation has been proposed. This paper outlines the general structure of the standards committees in the Antipodes, and of their various sub-committees. It will also outline broad terms of reference of these groups, and the major areas of current interests, activity and developments.

Australia↗
PubMedDate not supplied

Developing radiology procedure cost standards.

Containing costs is at the forefront of healthcare management, particularly as managed care replaces fee-for-service care. The first step in costs is to gain an understanding of the "building blocks" or components of procedure costs. The department of radiology at Duke University Medical Center and Health System, in conjunction with the department of management engineering, developed labor and supply standards to predict direct procedure costs throughout the radiology department, where 285,000 procedures are performed annually. This team concept resulted in a consistent approach to building procedure standards that predict direct costs across all sections. Step by step instructions are given for the following standards. Variable labor standards represent the average amount of staff time required for each procedure. Variable supply standards represent the average amount of consumable supply resources required per procedure. Fixed labor time standards predict the amount of fixed time resources necessary to operate the department of radiology at Duke University hospital. Cost per procedure uses the standards developed in the other sections. These basic steps will help readers determine their own direct costs per procedure for most radiology procedures (excluding capital and indirect costs). When these standards and costs are identified, the next step is to identify the areas to reduce such costs without affecting the quality of patient care.

Cost Allocation↗
PubMed1997

Standards of performance for new stationary sources and emission guidelines for existing sources: hospital/medical/infectious waste incinerators--EPA. Final rule.

This action promulgates new source performance standards (NSPS or standards) and emission guidelines (EG or guidelines) to reduce air emissions from hospital/medical/infectious waste incinerator(s) (HMIWI) by adding subpart Ec, standards of performance for new HMIWI, and subpart Ce, emission guidelines for existing HMIWI, to 40 CFR part 60. The standards and guidelines implement sections 111 and 129 of the Clean Air Act (CAA) as amended in 1990. The standards and guidelines apply to units whose primary purpose is the combustion of hospital waste and/or medical/infectious waste. Sources are required to achieve emission levels reflecting the maximum degree of reduction in emissions of air pollutants that the Administrator has determined is achievable, taking into consideration the cost of achieving such emission reduction, any nonair-quality health and environmental impacts, and energy requirements. The promulgated standards and guidelines establish emission limits for particulate matter (PM), opacity, sulfur dioxide (SO2), hydrogen chloride (HCl), oxides of nitrogen (NOx), carbon monoxide (CO), lead (Pb), cadmium (Cd), mercury (Hg), dioxins and dibenzofurans (dioxins/ furans), and fugitive ash emissions. Some of the pollutants being regulated are considered to be carcinogens and at sufficient concentrations can cause toxic effects following exposure. The standards and guidelines also establish requirements for HMIWI operator training/qualification, waste management plans, and testing/monitoring of pollutants and operating parameters. Additionally, the guidelines for existing HMIWI contain equipment inspection requirements and the standards for new HMIWI include sitting requirements.

Air Pollutants↗
PubMed1999

Compliance with methodological standards when evaluating ophthalmic diagnostic tests.

PURPOSE: To draw attention to the importance of methodological standards when carrying out evaluations of ophthalmic diagnostic tests by reviewing the extent of compliance with these standards in reports of evaluations published within the ophthalmic literature. METHODS: Twenty published evaluations of ophthalmic screening/diagnostic tests or technologies were independently assessed by two reviewers for compliance with the following methodological standards: specification of the spectrum composition for populations used in the evaluation, analysis of pertinent subgroups, avoidance of work-up (verification) bias, avoidance of review bias, presentation of precision of results for test accuracy, presentation of indeterminate test results, and presentation of test reproducibility. RESULTS: Compliance ranged from just 10% (95%CI, 1%-32%) for presentation of test reproducibility data and avoidance of review bias to 70% (95%CI, 46%-88%) for avoidance of work-up bias and presentation of indeterminate test results. Only 5 of the 20 evaluations complied with four or more of the methodological standards and none with more than five of the standards. CONCLUSIONS: The evaluations of ophthalmic diagnostic tests discussed in this article show limited compliance with accepted methodological standards but are no worse than previously described for evaluations published in general medical journals. Adherence to these standards by researchers can improve the study design and reporting of evaluations of new diagnostic techniques. Limited compliance, combined with a lack of awareness of the standards among users of research evidence, may lead to the inappropriate adoption of new diagnostic technologies, with a consequent waste of health care resources.

Bias↗
PubMed2000

[Blood pressure measurement by primary care physicians: comparison with the standard method].

OBJECT: To examine the usual methods of blood pressure (BP) measurement by primary care physicians and to compare them with the standard methods. METHOD DESIGN: Cross-sectional survey by self-administered questionnaire. SUBJECTS: Primary care physicians who graduated from Jichi Medical School and were working at clinics. Each standard method for 20 items was defined as the one that was most frequently recommended by 6 guidelines (USA 3, UK 1, Canada 1, Japan 1) and a recent comprehensive review about BP measurement. RESULTS: Of 333 physicians, 190 (58%) responded (median age 33, range 26 to 45 years). Standard methods and percentages of physicians who follow them are: [BP measurement, 17 items] supported arm 96%; measurement to 2 mmHg 91%; sitting position 86%; mercury sphygmomanometer 83%; waiting > or = 1 minute between readings 58%; palpation to assess systolic BP before auscultation 57%; check accuracy of home BP monitor 56%; Korotkoff Phase V for diastolic BP 51%; bilateral measurements on initial visit 44%; small cuff available 41%; > or = 2 readings in patients with atrial fibrillation 38%; > or = 2 readings on one visit 20%; cuff deflation rate of 2 mmHg/pulse 14%; large cuff available 13%; check accuracy of monitor used for home visit 8%; waiting time > or = 5 minute 3%; readings from the arm with the higher BP 1%. [Knowledge about BP monitor, 2 items] appropriate size bladder: length 11%; width 11%. [Check of sphygmomanometer for leakage, inflate to 200 mmHg then close valve for 1 minute] leakage < 2 mmHg 6%; median 10 (range 0-200) mmHg. Average percentage of all 20 items was 39%. Number of methods physicians follow as standard: median 8 (range 4 to 15) and this number did not correlate with any background characteristics of the physicians. Furthermore, we also obtained information on methods not compared with the standard. Fifty-four percentage of physicians used more standard methods in deciding the start or change of treatment than in measuring BP of patients with good control. About 80% of physicians use home BP readings in diagnosis or treatment of hypertension, but about half of physicians with ambulatory BP monitors use their measured readings. CONCLUSION: Primary care physicians used various techniques for routine BP measurement and no physician completely followed the standard. Such measurements may affect the diagnosis and treatment of hypertension, but measuring all BPs solely by the standard is not practical. We need to have a practical and efficient method of BP measurement for routine practice in the primary care setting.

Adult↗
PubMed2000

[Standards, Options and Recommendations (SOR) for endocrine therapy in patients with non metastatic breast cancer. FNCLCC].

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres 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 systematic 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 Standards, Options and Recommendations for endocrine therapy in patients with non metastatic breast cancer. METHODS: Data have been identified by literature search using Medline, Embase, Cancerlit and Cochrane databases - until july 1999 - and the personal reference lists of the expert group. Once the guidelines were defined, the document was submitted for review to 125 independent reviewers. RESULTS: The main recommendations for the endocrine therapy of patients with non metastatic breast cancer are: 1) Endocrine therapy modalities depend on menopausal status or age of women: ovarian suppression for premenopausal women, antiestrogen drug therapy for postmenopausal women (standard). 2) Tamoxifen (20 mg/d - 5 years) is beneficial to women with positive estrogen receptor tumor (standard, level of evidence A). There is no indication of tamoxifen treatment for women with negative estrogen receptor tumor (standard, level of evidence A). 3) For postmenopausal women with positive estrogen receptor tumor, tamoxifen is the standard adjuvant treatment (level of evidence A). For postmenopausal women with negative estrogen receptor, adjuvant chemotherapy has to be considered (option, level of evidence A). No adjuvant treatment has to be considered for women with poor health condition (option). 4) For premenopausal women with estrogen receptor tumor, results of clinical trials of chemotherapy versus endocrine therapy, suggest a benefit for endocrine therapy. However, there is no sufficient evidence to consider endocrine therapy alone as a standard adjuvant treatment. 5) For premenopausal women, chemotherapy + ovarian suppression or chemotherapy + tamoxifen are not better than chemotherapy alone (level of evidence A). 6) For postmenopausal women, administration of chemotherapy plus adjuvant tamoxifen versus the same tamoxifen alone, is of additional benefit in reducing recurrences but not in prolonging overall survival (standard, level of evidence A). 7) Balance of known benefits (delay to recurrence and death) and risks (side-effects of therapy) for adjuvant chemoendocrine therapy has to be taken into consideration before decision making. Chemoendocrine therapy can be indicated for women at high risk of developing metastatic disease (recommendation, experts agreement).

Antineoplastic Agents, Hormonal↗
PubMed2001

SITA standard in optic neuropathies and hemianopias: a comparison with full threshold testing.

PURPOSE: To compare visual sensitivity, fatigue effect, and probability plot data between Full Threshold (FT) Humphrey automated perimetry and Swedish Interactive Threshold Algorithm (SITA) standard strategies in patients with optic neuropathies and hemianopias. METHODS: Twenty-four patients with nonglaucomatous optic neuropathies and 18 patients with a relative homonymous or bitemporal hemianopia were tested with both conventional perimetry (Humphrey 24-2 program) and "back to back" SITA standard tests (SITA 1, SITA 2) to approximate the test time of the FT test conditions. Also, 28 normal subjects between the ages of 20 and 80 were tested with this protocol. The visual field quadrants with the most damage were used to evaluate any fatigue effect (i.e., possible lack of fatigue effect with SITA standard due to the shorter test time) and to compare probability plot data between FT, SITA 1, and SITA 2. Pointwise total and pattern deviation probability plot defects were weighted by degree of significance and summed. RESULTS: Test times for normal subjects were 45 seconds longer for FT than for the combined test time of SITA 1 + SITA 2. Patients' test times were 40 seconds longer for hemianopias and 90 seconds longer for optic neuropathies with FT than the combined times for two SITA tests. There were higher sensitivities found with SITA 1 compared with Full Threshold (1.06 dB, P< 0.001) and SITA 2 with Full Threshold (0.73 dB, P< 0.001) in the most damaged quadrant for the optic neuropathy patients; for the hemianopia patients the difference in values were between SITA 1 and Full Threshold (0.96 dB, P = 0.07) and between SITA 2 and Full Threshold (0.11 dB, P = 0.87). The second SITA standard test had lower sensitivity than the first SITA standard test by 0.82 dB in hemianopias and by 0.71 dB in optic neuropathy patients. Analysis of the total and pattern deviation probability plot data showed slightly more defects (number and magnitude) with SITA 1 compared to FT for both groups, but the differences were not statistically significant. CONCLUSIONS: Sensitivities were higher in patients with hemianopias or optic neuropathies using SITA standard compared with FT by approximately 1 dB. The probability plot comparison suggests SITA standard is at least as good as FT for detection of visual loss in individual examinations. However, efficacy of SITA standard for serial examinations has not yet been evaluated.

Adult↗
PubMed2002

A survey of physical dosimetry to date and in the near future: Part 1. Review of standards and regulatory issues.

This article summarizes the status of the relevant standards and current regulatory issues for use of physical dosimetry devices for the occupational worker in the United States. Included is a summary of relevant standards from the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the American National Standards Institute (ANSI), the United States Nuclear Regulatory Commission NUREG-Series, the National Voluntary Laboratory Accreditation Program (NVLAP), the Department of Energy Laboratory Accreditation Program (DOELAP), and the U.S. Military Specifications and Standards (MIL-STD). Proposed changes to ANSI N13.11-1993, "American National Standard for Dosimetry-Personnel Dosimetry Performance Criteria for Testing," are listed. The strategic changes that the United States Nuclear Regulatory Commission (NRC) is making in rulemaking activities related to dosimetry and standards are given. The status of Measurement Program Description (MPD) C.18, "Implementation of Electronic Dosimetry for Primary Dosimetry," from the Council on Ionizing Radiation Measurements and Standards (CIRMS) is given.

Humans↗
PubMed2002

Standardization of health informatics--results and challenges.

OBJECTIVES: This review article aims to highlight the importance of standards for effective communication and provides an overview of international standardization activities. METHODS: This article is based on the experience of the author of European standardization in CEN, which he leads, and the global work of ISO, where he is leading the security working group, and an overview of the work of DICOM, IEEE and HL7, partly using their web presentations. RESULTS: Health communication is highly dependent of the general development of information technology with standards coming from ISO/IEC JTCI, ITU and several other organizations e.g. IETF, the World Wide Web consortium and Open group. A number of standardization initiatives have been in progress for more than ten years with the aim to facilitate different aspects of the exchange of health information. Electronic record architecture, Message structures, Concept representation, Device communication including imaging and Security are the main areas. CONCLUSIONS: Important results have been achieved, and in some fields and parts of the world, standards are widely used today. Unfortunately, we are still facing the fact that most healthcare information systems cannot exchange information with all systems for which this would be desired. Either the existing standards are not sufficiently implemented, or the required standards and necessary national implementation guidelines do not yet exist. This causes unacceptable risks to patients, inefficient use of healthcare resources, and sub-optimal development of medical knowledge. Fortunately, the different bodies are now largely co-operating to achieve global consensus.

Computer Communication Networks↗
PubMed2002

Standardization issues: in vitro assessment of nebulizer performance.

The delivery of nebulized drugs is poorly controlled and the choice of the most appropriate delivery device is poorly understood, particularly because of off-license prescriptions and a lack of evidence-based medicine. Standardized in vitro methods for measuring nebulizer performance have been adopted in Europe, by the 2001 publication of a European Standard, prEN13544-1. These standardized methods were subsequently incorporated within the European Respiratory Society nebulizer guidelines, which will provide clinicians with useful information to improve nebulizer therapies. Standards for measuring nebulizer performance should be considered in North America and elsewhere. Careful consideration should be given to either adopting the methods embodied in the European Standard or developing the basis for developing that standard further through the International Standards Organization. Either way, confusion among clinicians would be reduced and nebulizer safety and aerosol delivery efficiency increased by standardizing in vitro methods of nebulizer performance assessment.

Administration, Inhalation↗
PubMed2003

[Demonstration of trivalent iron in decalcified bone marrow specimens. Comparative study of standard Perls stain on sections and the Perls pre-reaction on fragments].

UNLABELLED: In the literature the usefulness of the Perls reaction for Iron (Fe+++) stores estimation on bone marrow is largely accepted. However, due to decalcification, there is a considerable disagreement about the accuracy of this staining on osteomedullary tissue. In fact loss of Fe+++ has been claimed by some Authors, and denied by others. In order to check this controversial point in this paper Perls reaction, as a methodological variant, was directly anticipated on fragments (pre-Perls). In this way numerous osteomedullary sternal specimens from autopsies (non hematological cases) were observed in comparison with normal Perls reaction on sections (standard-Perls). In standard-Perls series (A) decalcification was achieved by HCl (alone or in combination with EDTA) or by formic acid. On pre-Perls treated fragments decalcification was an intrinsic effect of the hydrochloride component during Prussian Blue formulation. Nine different procedures of fixation were tested respectively for standard-Perls and pre-Perls. Pre-Perls was performed on pre-fixed (B series) as well as post-fixed material (C series). For the microscopical evaluation was applied the classical grading system proposed by Lundin for histology. Maximum grade was only observed in B and C, was the same in both these series and varied from 2 to 4 depending on autopsic case. Results strongly indicate the superiority of pre-Perls versus standard-Perls, with a differential grading ranging from 2 to 4 grades, in seven procedures of B (two procedures were equivalent in A and B) and in all the procedures of C. The comparison between B and C series showed inferiority of B in four procedures. For control (D series) standard-Perls was systematically performed on sections from pre-Perls: no differences between pre-Perls and pre-Perls + standard-Perls were observed indicating a complete permeation of fragments by Perls reagents. In general terms morphology in pre-Perls B was better than in pre-Perls C and substantially identical to standard procedures of A. Other data are analytically reported. CONCLUSIONS: Pre-Perls staining (with special reference to five procedures of B) seems to be recommendable for decalcified bone marrow biopsies, in conjunction with standard processing, when an high sensitivity in detection of Fe+++ deposits is required or in absence of aspirate. Pathologists could subsequently decide if this methodological variant is suitable or not for an effective alternative choice in their routine according to morphological and immunohistochemical adequacy.

Bone Marrow↗
PubMed1954

The provisional international standard antityphoid serum.

The Provisional International Standard Antityphoid Serum, prepared in 1935, provided standards of the O and the Vi antibodies, both contained in a single serum preparation, and was used for standardizing the potency of therapeutic antityphoid serum.The "Provisional Standard Serum for Vi Agglutination", which is one of the series of proposed Standard Agglutinating Sera for Typhoid and Paratyphoid A and B Fevers, is based on the Provisional International Standard Antityphoid Serum.It is recommended that the Provisional International Standard Antityphoid Serum, in conjunction with a standard typhoid vaccine, be used in the test for the determination of the "functional efficacy" of the Vi antibody. This is one of the several tests recommended for the official control of the immunizing potency of typhoid vaccines.

Antibodies↗
PubMed1964

THE SECOND INTERNATIONAL STANDARD FOR BACITRACIN.

The National Institute for Medical Research, London, was requested by the WHO Expert Committee on Biological Standardization to establish a second International Standard for Bacitracin since stocks of the first International Standard were running low. A batch of 500 g of zinc bacitracin was obtained in 1962 and was distributed into ampoules in 100-mg amounts and dried in vacuum; the ampoules were then filled with dry nitrogen and sealed. This proposed replacement material has been assayed biologically in terms of the first International Standard in seven laboratories in five countries by means of plate diffusion assays.In spite of a large difference in purity between the first and proposed second standards, the variation in the potencies obtained for the proposed second standard were small, although significant. This material has been established as the second International Standard for Bacitracin with a defined potency of 74 mg. The International Unit of Bacitracin is defined as the activity of 0.01351 mg of the second International Standard for Bacitracin.

Bacitracin↗