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PubMed1996

Ofloxacin versus standard therapy in treatment of community-acquired pneumonia requiring hospitalization. Pneumonia Study Group.

Community-acquired pneumonia occurs 3 to 4 million times per year in the United States, accounting for about 500,000 hospitalizations annually. Empiric treatment is usually instituted because of a lack of early organism-specific diagnostic tests. This study compared empiric therapy with ofloxacin to standard antibiotic regimens (usually a beta-lactam with or without a macrolide) for patients hospitalized for community-acquired pneumonia. Therapy was administered to 298 patients (146 receiving ofloxacin and 152 receiving standard therapy); 227 patients (ofloxacin, 109; standard treatment, 118) were evaluable for treatment efficacy. The most common pyogenic respiratory pathogens were Haemophilus influenzae (30 isolates) and Streptococcus pneumoniae (24 isolates). There was evidence of infection with either Mycoplasma pneumoniae (38 patients), Chlamydia pneumoniae (40 patients), or a Legionella sp. (8 patients) in a total of 79 patients (35%). The clinical success rates were similar in both groups among evaluable patients (92%, ofloxacin; 87%, standard therapy) and among patients with atypical respiratory pathogens (88%, ofloxacin; 81%, standard therapy). The mean numbers (+/- the standard deviations) of intravenous doses of antibiotics were 7.5 +/- 8.0 in the ofloxacin group and 18.4 +/- 18.5 in the standard therapy group (P < 0.001); the mean number of oral doses of ofloxacin per patient was 19.7 +/- 11.2, compared with 30.2 +/- 16.0 oral antibiotic doses in the standard therapy group (P < 0.001). All treatments were well tolerated and associated with no significant clinical or laboratory abnormalities. The findings of this study indicate that ofloxacin is active against traditional bacterial pathogens as well as the major atypical respiratory pathogens. When given as monotherapy for the empiric treatment of community-acquired pneumonia, ofloxacin is as effective as standard antimicrobial therapy.

Adolescent↗
PubMed1999

Can paediatric medical students devise a satisfactory standard of examination for their colleagues?

OBJECTIVES: To determine what standard paediatric medical students would set for examining their peers and how that would compare with the university standard. DESIGN: Single blinded computer marked examination with questionnaire. SETTING: University medical school. SUBJECTS: Medical students during their final paediatric attachment. INTERVENTIONS: Medical students asked to derive 10, five branch negatively marked multiple choice questions (MCQs) to a standard that would fail those without sufficient knowledge. Each 10 were then assessed by another student as to the degree of difficulty and the relevance to paediatrics. One year later student peers sat a mock MCQ examination derived from a random 40 questions (unaware that the mock MCQs had been derived by peers). MAIN OUTCOME MEASURES: Comparison of marks obtained in mock and final MCQ examinations; student perception of the standard in the two examinations assessed by questionnaire. RESULTS: 44 students derived 439 questions, of which 83% were considered an appropriate standard by a classmate. One year later 62 students sat the mock examination. Distribution of marks was better in the mock MCQ examination than the final MCQ examination. Students considered the mock questions to be a more appropriate standard (72% v 31%) and the topics more relevant (88% v 64%) to paediatric medical students. Questions were of a similar clarity in both examinations (73% v 78%). CONCLUSIONS: Students in this study were able to derive an examination of a satisfactory standard for their peers. Involvement of students in deriving examination standards may give them a better appreciation of how standards should be set and maintained.

Child↗
PubMed2005

Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: randomised single blind controlled trial.

OBJECTIVES: To compare the efficacy of standard treatment, standard treatment plus acupuncture, and standard treatment plus stabilising exercises for pelvic girdle pain during pregnancy. DESIGN: Randomised single blind controlled trial. Settings East Hospital, Gothenburg, and 27 maternity care centres in Sweden. PARTICIPANTS: 386 pregnant women with pelvic girdle pain. INTERVENTIONS: Treatment for six weeks with standard treatment (n = 130), standard treatment plus acupuncture (n = 125), or standard treatment plus stabilising exercises (n = 131). MAIN OUTCOME MEASURES: Primary outcome measure was pain (visual analogue scale); secondary outcome measure was assessment of severity of pelvic girdle pain by an independent examiner before and after treatment. RESULTS: After treatment the stabilising exercise group had less pain than the standard group in the morning (median difference = 9, 95% confidence interval 1.7 to 12.8; P = 0.0312) and in the evening (13, 2.7 to 17.5; P = 0.0245). The acupuncture group, in turn, had less pain in the evening than the stabilising exercise group (-14, -18.1 to -3.3; P = 0.0130). Furthermore, the acupuncture group had less pain than the standard treatment group in the morning (12, 5.9 to 17.3; P < 0.001) and in the evening (27, 13.3 to 29.5; P < 0.001). Attenuation of pelvic girdle pain as assessed by the independent examiner was greatest in the acupuncture group. CONCLUSION: Acupuncture and stabilising exercises constitute efficient complements to standard treatment for the management of pelvic girdle pain during pregnancy. Acupuncture was superior to stabilising exercises in this study.

Acupuncture Therapy↗
PubMed2004

The Department of Health's "two week standard" for bowel cancer: is it working?

OBJECTIVE: To determine the effectiveness and efficiency of the Department of Health's new general practitioner referral guidelines for bowel cancer. DESIGN: One year prospective audit. SETTING: District general hospital serving a population of 550 000. SUBJECTS: All patients with bowel cancer; all patients referred on the basis of the two week standard and to a routine colorectal surgical outpatient clinic. MAIN OUTCOME MEASURES: Proportion of cancers referred on the basis of the two week standard and to other colorectal clinics; the proportion with the higher risk criteria and their diagnostic yields; stage of cancers diagnosed in outpatient clinics; and time to treatment. RESULTS: A total of 249 cancers were diagnosed in the index year. Sixty five (26.1%) were referred to two week standard clinics, 40 (16.1%) to routine colorectal surgical outpatient clinics, 54 (22%) to other clinics, and 88 (35.3%) were emergencies. Thirteen patients per week were referred to the two week standard clinics and 85% (54/65) of cancers so referred were seen within two weeks. The diagnostic yield of cancer in the two week standard clinic was 9.4% (65/695) compared with 2.2% (40/1815) in the routine colorectal surgical outpatient clinic (p<0.0001). Eighty five per cent of patients with cancer referred to outpatients matched the guidelines for the two week standard clinics. Only 46% of this group were so referred. Overall, delay to treatment and Dukes' stage were not improved in patients diagnosed in the two week standard clinics. CONCLUSIONS: Most patients with bowel cancer were not referred on the basis of the two week standard although most fulfilled the referral criteria, which had higher diagnostic yields. The two week standard clinics did not shorten the overall time to treatment or improve the stage of disease because the time lags before referral and after the outpatient appointment are the major causes of delay in the bowel cancer patient's journey.

Adult↗
PubMed2000

Double-blind trial of the efficacy and tolerability of doxazosin in the gastrointestinal therapeutic system, doxazosin standard, and placebo in patients with benign prostatic hyperplasia.

BACKGROUND: The alpha(1)-blocker doxazosin mesylate is an established efficacious and welltolerated treatment for benign prostatic hyperplasia (PBH). However, its clinical utility can be limited by the need for multiple titration steps, starting at an initial dose of 1 mg, increased up to 8 mg once daily, to achieve optimal therapeutic response. A new controlled-release gastrointestinal therapeutic system (GITS) formulation of doxazosin mesylate enhances the pharmacokinetic profile and drug delivery rate, reducing the plasma doxazosin mesylate peak-to-trough ratio and minimizing the need for titration. OBJECTIVE: A study was conducted to assess the effects of doxazosin GITS 4 or 8 mg once daily, doxazosin standard 1 mg to 8 mg once daily, and placebo, in 795 men with BPH. This randomized, double-blind, multicenter Scandinavian study included a 2-week washout period, 2-week single-blind placebo run-in phase, and 13-week double-blind treatment phase. Doxazosin GITS was initiated at 4 mg once daily and titrated to 8 mg once daily after 7 weeks, if indicated, and doxazosin standard was initiated at 1 mg once daily, titrated to 2 mg after 1 week, to 4 mg at 3 weeks, and to 8 mg at 7 weeks if indicated, to achieve symptom control. The primary outcome measures were mean changes from baseline to the final visit for International Prostate Symptom Score (I-PSS) and maximum urinary flow rate adjusted for baseline values. RESULTS: Both doxazosin GITS and doxazosin standard significantly improved the symptoms of BPH, as evidenced by least-squares mean reductions in total I-PSS of -8.0+/-0.3 and -8.4+/-0.3 from baseline, respectively, compared with a reduction of -6.0+/-0.4 in patients on placebo. Doxazosin GITS and doxazosin standard produced clinically comparable improvements in maximum urinary flow rates, with a greater improvement observed earlier following treatment with doxazosin GITS than with doxazosin standard. Both active treatments produced significantly greater increases in maximum urinary flow rate compared with placebo. Nearly half of the patients on doxazosin GITS achieved symptom relief at the 4-mg starting dose. A similar number of patients in both doxazosin groups were titrated to the maximum dose of 8 mg for both formulations. The overall incidence of adverse events was similar among patients treated with doxazosin GITS and placebo, and slightly higher in those on doxazosin standard. There was no apparent difference in the type of adverse events reported for the two formulations of doxazosin, although most adverse events were reported at a lower frequency with doxazosin GITS. CONCLUSIONS: Doxazosin GITS is significantly more effective than placebo in reducing the clinical symptoms of BPH and improving maximum urinary flow rate, and as effective as doxazosin standard. A therapeutic effect equivalent to that of doxazosin standard was achieved with doxazosin GITS with fewer titration steps, in a manner that appeared to be better tolerated. Because treatment with doxazosin GITS starts with an effective dose for many patients, it is likely that this clinical profile will result in the need for fewer patient visits than with doxazosin standard therapy.

Adrenergic alpha-Antagonists↗
PubMed1983

A framework for viewing the process of standard setting.

The standard-setting literature is filled with contributions in which issues associated with standards are discussed and various methods for setting standards are presented and reviewed. Almost no attention has been given to guidelines for helping standard-setting groups or committees address the issues and technical matters that arise in selecting and implementing a standard-setting method and finally setting a standard (or standards). This article was prepared to describe sets of context-setting variables and technical matters associated with standard-setting to assist groups or committees desiring to set standards in a systematic way.

Certification↗
PubMed2000

Clinical standards for inpatient specialist rehabilitation services in the UK.

OBJECTIVE: To develop a set of clinical standards for specialist inpatient rehabilitation services in the UK and to undertake a preliminary survey of consultants who provide those services. DESIGN: The proposed set of standards was developed by group consensus followed by an iterative consultation process. A postal survey was conducted on behalf of the British Society for Rehabilitation Medicine (BSRM) amongst its consultant members in the UK (n = 163), who were asked to assess their services in relation to these standards, and to comment on the standards themselves, their usefulness and applicability. RESULTS: The response rate was 61%, of which 81 respondents ran an inpatient rehabilitation service. Overall, the standards appeared to be acceptable to most, and mainly struck the right level, being attained by the majority of services. Specific suggestions were incorporated into the revised standards. Further work is required to establish agreed outcomes that are systematically measured and recorded: only half the respondents (50%) routinely recorded a standardized outcome measure, and only a quarter (26%) routinely reviewed patients to record long-term outcome. CONCLUSIONS: Clinical standards have been developed for specialist inpatient rehabilitation services in the UK. The BSRM proposes to adopt these standards for a test period of 2-3 years in the first instance. It is likely that they will require further refinement with time, and modification is required to adapt them to different subspecialities and settings.

Guideline Adherence↗
PubMed2005

Fine particulate matter national ambient air quality standards: public health impact on populations in the northeastern United States.

In this article we identify the magnitude of general and susceptible populations within the northeastern United States that would benefit from compliance with alternative U.S. Environmental Protection Agency (EPA) annual and 24-hr mass-based standards for particulate matter (PM) with an aerodynamic diameter < or = 2.5 microm (PM2.5). Understanding the scale of susceptibility in relation to the stringency or protectiveness of PM standards is important to achieving the public health protection required by the Clean Air Act of 1970. Evaluative tools are therefore necessary to place into regulatory context available health and monitoring data appropriate to the current review of the PM National Ambient Air Quality Standards (NAAQS). Within the New England, New Jersey, and New York study area, 38% of the total population are < 18 or > or =65 years of age, 4-18% of adults have cardiopulmonary or diabetes health conditions, 12-15% of children have respiratory allergies or lifetime asthma, and 72% of all persons (across child, adult, and elderly age groups) live in densely populated urban areas with elevated PM2.5 concentrations likely creating heightened exposure scenarios. The analysis combined a number of data sets to show that compliance with a range of alternative annual and 24-hr PM2.5 standard groupings would affect a large fraction of the total population in the Northeast. This work finds that current PM2.5 standards in the eight-state study area affect only 16% of the general population, who live in counties that do not meet the existing annual/24-hr standard of 15/65 microg/m3. More protective PM2.5 standards recommended or enacted by California and Canada would protect 84-100% of the Northeast population. Standards falling within current ranges recommended by the U.S. EPA would protect 29-100% of the Northeast population. These considerations suggest that the size of general and susceptible populations affected by the stringency of alternative PM standards has broad implications for risk management and direct bearing on the U.S. EPA's current NAAQS review and implementation.

Adolescent↗
PubMedDate not supplied

Legal implications of standard setting in nursing.

Patients are increasingly holding health professionals to account for their care. The practice of standard setting has important legal implications. Standard setting can be seen to aid the communication process in healthcare and can therefore help avoid expensive litigation. Standard setting can improve the quality of patient care. Standard documentation could be disclosed in a medical/nursing negligence case. Standards should not be automatically applied. Standard setting can be patchy, misdirected and irrelevant to actual problems. Standards can create unreal patient expectations of care. Patient care may suffer if unrealistic or unreasonable standards are in place. Standard setting can show that there is a controlled environment of care.

Documentation↗
PubMed1997

Amendments to the Center for Devices and Radiological Health federal performance standard for laser products.

Federal law requires that all laser products that are imported into or introduced into commerce in the United States comply with the performance standard published in the Code of Federal Regulations (CRF), Title 21, Parts 1040.10 and 1040.11, administered by the Center for Devices and Radiological Health (CDRH), US Food and Drug Administration. Although it contains somewhat different requirements for hazard classification, engineering controls and labeling, the ANSI Z136.1 standard defers to the CDRH standard. The CDRH standard became effective in August, 1976 and was amended, in 1978 and also in 1985. In the early 1990s, US experts met to formulate an approach to bring the requirements of the CDRH standard and those of the International Electrotechnical Commission (IEC) standard, IEC 825, into closer agreement in order to lower barriers to international trade and to remove any excessive compliance burdens on manufacturers. In 1993, the CDRH published, formally in the Federal Register and informally, a Notice of Intent to amend the CDRH standard. Responses to those notices have now been analyzed and informal draft amendments were distributed in 1996. This draft is now being prepared for formal issuance as a Notice of Proposed Rulemaking. Meanwhile, the IEC standard was amended in 1993 and republished as IEC 825-1; these amendments created considerable controversy since they resulted in over classification of the hazard of many products, especially light emitting diodes (LEDs) that have a large divergence and increased source dimensions. Additional amendments are now being developed to correct this problem. The CDRH has carefully monitored developments in the IEC and actively participated in its proceedings as a guide in developing its own proposal. This paper describes the major changes that are being proposed for the CDRH standard and presents some rationale for the major changes. The more significant changes include expansion of applicability to include LEDs, reduced emission durations for classification, revised measurement for hazard classification, reduced performance requirements for lower power visible radiation products, and revised requirements for medical products.

Air Pollutants, Radioactive↗
PubMed2006

Practice standards for quality clinical decision-making in nursing.

The purpose of this study is to formulate practice standards for quality clinical decision-making in nursing. Clinical decision-making is a critical component of nursing practice, as the life of the patient is at stake. The quality of clinical decision-making is, therefore, essential in delivering quality nursing care. The facilitation of quality clinical decision-making in nursing requires the development of standards to monitor, evaluate and implement remedial actions that improve on the quality of clinical decision-making (Muller, 2002:203; Beyea & Nicoll, 1999: 495). However, there are no such practice standards against which the quality of clinical decision-making by nurses can be evaluated and assessed. A qualitative, explorative, descriptive and standard formulation research design (Mouton & Marais, 1990:45-46; Muller, 1990:49-55) has been followed to develop standards for quality clinical decision-making in nursing. Standard development was based on the principles described by Muller (in Booyens, 1998: 607-608; 636-637), and consists of development and quantification phases that are modified to meet the requirements for instrument development, as described by Lynn (1986: 382-385). The formulation of these practice-standards was derived deductively from a conceptual framework. The conceptual framework was constructed based on an exploration and description of the expectations of the stakeholders about quality clinical decision-making in nursing and a literature study on clinical decision-making. To ensure the credibility of the standards for clinical decision-making in nursing, principles of logic, prolonged engagement, triangulation, peer-group discussion, dense description, step-wise repetition and an investigative audit (Lincoln & Guba, 1985:289-331) were adhered to. Two experts were consulted to validate the standards for quality clinical decision-making in nursing.

Attitude of Health Personnel↗
PubMed1986

A standardized parenteral nutrition solution: prescribing, use, processing, and material cost implications.

The influence of a standardized parenteral nutrition solution (TPN) on prescribing patterns, use, preparation time, and material costs was studied. The percentage of patients receiving the standardized TPN was derived from a 5-month utilization study. A retrospective chart review evaluated 50 patients receiving nonstandardized TPN (Group I) and 48 patients receiving standardized TPN (Group II). A stopwatch motion study of the IV admixture service evaluated processing and compounding time. Material cost savings resulting from standardized TPN use was evaluated. Order changes in Group I patients occurred on the average of once every 3.4 days. Alterations in electrolyte composition accounted for 73% of order changes. Prescribing error frequency was 9.3% in Group I patients. After implementation of the standardized TPN solution, 73% of patients receiving TPN during the study period were prescribed the standardized solution. Prescribing error frequency was 0% in Group II patients. The standardized TPN solution decreased processing and compounding time by 55% (p less than 0.01) and decreased material cost by 19%. Although some patients require individualized solution formulae, a majority of adult patients tolerate standardized TPN without adverse metabolic complications. A standardized TPN solution can decrease processing and compounding time, favorably affect prescribing patterns, and lower solution costs without adversely affecting patient safety.

Costs and Cost Analysis↗
PubMed1999

Limitations of occupational air contaminant standards, as exemplified by the neurotoxin N-hexane.

Available industry guidelines and federal standards have failed to fully protect workers from chemical toxicity: none exist for most chemicals, many are biased toward what can easily be achieved, and many were developed long after health consequences became evident. Limitations of occupational air contaminant standards in the United States are well illustrated by standard-setting for the neurotoxin n-hexane. In the 1940s, the American Conference of Governmental Industrial Hygienists (ACGIH) first promulgated industrial guidelines known as "threshold limit values" (TLVs), including an 8-hour time-weighted average of 500 ppm for inspired n-hexane. Despite subsequent recognition of the neurotoxicity of n-hexane with industrial outbreaks of polyneuropathy beginning in the 1960s, the TLV for n-hexane remained unchanged until 1976 when a value of 100 ppm was adopted. Because a growing number of clinical reports have identified clinical and subclinical neurotoxicity from n-hexane near, at, and below the current time-weighted average TLV of 50 ppm, even this level is too high to protect all workers. In part due to procedural and political constraints, the Occupational Safety and Health Administration (OSHA) has independently developed only a small number of exposure standards in the past 25 years, and has been incapable of providing needed revisions for existing standards. Most OSHA standards--including those for n-hexane--were adopted in 1971 from the 1968 ACGIH TLVs and have never been revised. From 1971 to 1989 the OSHA permissible exposure level (PEL) for n-hexane remained at 500 ppm, 5-10 times as great as other contemporary standards. To help correct its regulatory backlong, OSHA promulgated 375 new or revised PELs in 1989--including a new standard of 50 ppm for n-hexane--but all of these were vacated by the 11th U.S. Court of Appeals in 1992. As a result, the current OSHA PEL for n-hexane remains at the 500 ppm level adopted in 1971, which even then was too high based upon available scientific evidence. New information over this long period, including that obtained from industrial outbreaks of disease due to chemical exposures, has not been incorporated into revised federal standards.

Adhesives↗
PubMed2000

[Standards, Options and Recommendations (SOR) for tumor markers in breast cancer. SOR Working Group].

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 review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To define, according to the definitions of the Standards, Options and Recommendations project, the characteristics of various tumour markers in breast cancer and the potential role of these markers in the management of patients with this malignancy. METHODS: Data were identified by searching Medline and the personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to 43 independent reviewers, and to the medical committees of the 20 French Cancer Centres. RESULTS: The main recommendations are: 1) CA 15.3 and CEA are the serum tumour markers most often used in breast cancer (standard). 2) If the CA 15.3 is raised at presentation, there is no place for the measurement of other tumour markers (standard, expert agreement). 3) All analyses for each patient must be performed in the same laboratory, using the same technique (standard, expert agreement). 4) CA 15.3 should not be used for screening or diagnosis. 5) The level of CA 15.3 before treatment is a recognised prognostic factor, the independent value of which has not been proven (standard, level of evidence C). 6) If the initial value of CA 15.3 is greater than 50 kU.L(-1), disseminated disease should be actively sought before any treatment decisions are made (standard, expert agreement). 7) An initial elevation of CA 15.3 that does not return to normal, reflects a lack of response to treatment and is a strong adverse prognostic factor (standard, level of evidence C). 8) The accuracy of tumours markers (especially CA 15.3) as early indicators of metastatic disease is well recognised (standard) but the clinical benefit has not been established. 9) There is a correlation between tumour markers and clinical response in the treatment of metastatic disease (level of evidence C). The level of CA 15.3 in metastatic disease does not predict response to treatment.

Biomarkers, Tumor↗
PubMed2000

[Standards, options, and recommendations for initial management of patients with malignant ovarian epithelial tumors].

UNLABELLED: Suprapubic and transvaginal pelvic ultrasound exploration is indicated for suspected ovarian tumor (standard). Diagnosis and search for extension require surgery and pathology examination. Systematic preoperative computed tomography is not recommended (standard). Surgery for cancer of the ovary is a specialized procedure requiring skill in cancer, gynecology, visceral surgery and laparoscopic surgery. If the patient is referred to a specialized center after a primary procedure considered to be inadequate, a new procedure is recommended for staging. Residual tumor volume after the primary procedure has prognostic value. Systematic second look procedures are not recommended for routine practice (standard). For patients with grade IA G1 tumors, there is no indication for complementary treatment (standard). For patients with grade IA G2-3 or clear cell tumors, IB, IC, IIA, there is no standard. OPTIONS: no complementary treatment, complementary chemotherapy using platinum, complementary external abdominopelvic radiotherapy. A complementary treatment is recommended for grades IC and IIA. Complementary treatment for grades IIB (no residual tissue), IIC (with residual tissue), III (no residual tissue), is based on: complementary chemotherapy with platinium, complementary external abdominopelvic radiotherapy (options). Complementary treatment for advanced forms (IIB (with residual tissue), IIC (with residual tissue), III (with residual tissue) and IV) is based on polychemotherapy with platinium (standard). OPTIONS: platinium combined with paclitaxel (intravenous), platinium combined with cyclophosphamide and/or doxorubicin (intravenous) or intraperitoneal cisplatin combined with cyclophosphamide (intravenous). The chemotherapy work-up includes physical examination, assay of serum markers (particularly CA125) and abdominopelvic computed tomography (proof level B) (standard). Physical examination is recommended for monitoring patients in complete remission with no sign of suspected recurrence (standard). This document was reviewed in April 1977. The working group again validated the Standards, OPTIONS and Recommendations, without modifications in June 1999.

Antineoplastic Agents, Hormonal↗
PubMed1998

[Reduction and replacement of animal tests required in standards for safety testing]

Animal tests which have to be performed according to national (DIN) and international standards (EN and ISO) are evaluated according to the 3Rs principle of Russel and Burch in order to reduce suffering and numbers of test animals and also to completely replace them by non-animal methods. When on January 1, 1995, the EU Medical Devices Directive 93/42/EEC was accepted by all EU member states, animal tests that were essential parts of DIN, EN and ISO standards got a new legal status since for biocompatibility testing EU Directive 93/42/EEC is refering to these standards. In the present study all DIN standards were collected, in which animal testing is required, and they were then evaluated from the view points of both scientific state of the art and of consumer protection to decide if these animal tests can be replaced by non-animal methods. Our search of the literature revealed not only that to each of the animal tests promising alternatives have been proposed but also that only a few of them have sufficiently been validated to date. Moreover, we found that several of the animal tests described in DIN standards are not any more representing the current state of the art in the biomedical sciences. Therefore, these animal tests should immediately be deleted from the standards. Thus we are proposing to the DIN institue, the national agency for standards in Germany, immediate action which is required to update each of these DIN standards according to EU Directive 86/609/EEC for the protection of experimental animals. Our proposals are recommending to completely delete some of the animal tests from the standards, or to replace them by validated alternatives or to conduct formal validation studies with the most promising alternatives.

Journal Article↗
PubMed2000

Attention Deficit Hyperactivity Disorder: scaling and standard setting using Rasch measurement.

This paper explores the dimensionality of responses to the Adult Behavior Checklist Revised, a screening assessment for Attention Deficit Hyperactivity Disorder (ADHD) in college students, and demonstrates a standard setting process for diagnostic rating scales. Responses from 317 undergraduate college students were used to investigate dimensionality; 8 judges were used for the standard setting procedure. A series of Rasch rating scale analyses support the interpretation of Inattention and Impulsivity/Hyperactivity variables. Principal component analyses of residuals identified the existence of secondary variables that may have clinical implications for the evaluation and treatment of ADHD. For the standard setting process, judges generally displayed less variability than expected by the model. Several judges were in disagreement as to the level of symptomatology needed to indicate potential ADHD. The derived standard for Inattention was found to be more stringent than a previously suggested standard while the derived standard for Hyperactive/Impulsive more lenient. Prevalence rates found a diagnosis of Hyperactive/Impulsive to be more common than a diagnosis of Inattention. Efficient screening assessments for ADHD in college students are needed in order to determine who may qualify for further evaluation and special services. The standard setting process attempts to identify judge disagreement regarding the level of symptomatology (the standard) needed to qualify for additional evaluation and identify judge response strings not consistent with the item difficulties. Recommendations suggesting additional work on the screening assessment and standard setting process are outlined.

Adolescent↗
PubMed2002

General practice and computing standards.

BACKGROUND: 'Standards' refer to common standards for communication and exchange of information about goods and services. Embedded within these common standards are gold standards for quality, privacy, safety and performance. Technical and semantic standards are essential building blocks for the required information and communication infrastructure to support the secure management and sharing of high quality information across general practice and the health care system. OBJECTIVE: To describe the current developments and implications of terminology, architecture and messaging standards in general practice. CONCLUSION: The current Health Online framework and National Health Information Standards Plan, with nationally coordinated implementation strategies like HealthConnect and the Better Medication Management System, are encouraging, However, there is little common understanding of technical and semantic standards among clinicians, administrators and researchers in general practice and health care system. The state-Commonwealth and private-public dichotomies are other barriers. As part of their roles as gate-openers in an integrated health care system, GPs must explicitly promote the implementation of national communication and information exchange standards.

Australia↗