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Guidelines for evaluation of reagent strips. Exemplified by analysis of urine albumin and glucose concentration using visually read reagent strips. International Federation of Clinical Chemistry, Scientific Division.

Reagent strips are frequently used in the practice of laboratory medicine as well as outside the professional laboratories. In the present report, a scheme is presented which allows a reproducible description of the performance of reagent strips. This is exemplified using strips intended for estimation of urinary albumin and glucose. Experimental conditions that are particularly important for these components are given. Suitable and necessary items which should be included in the protocol presenting results of an evaluation are listed. The guidelines might have general applicability in evaluation and description of tests with a limited number of possible results.

Albuminuria↗

[Incidence of primary benign and malignant neoplasms and bone pseudotumoral lesions. An epidemiologic analysis of 585 cases diagnosed at the Faculdade de Medicina of the Universidade Federal de Minas Gerais].

The authors present an epidemiological study of 585 primary bone neoplasms and tumor-like lesions in order to investigate their incidence and distribution according to age, sex and skeletal location. A statistical agreement between the pertinent literature and the collected data was found. In this series, the most common benign neoplasms were the osteochondroma (45.3%) followed by chondroma (19.6%). Among the intermediate and malignant neoplasms, osteosarcoma was the most frequent (30.0%) followed by myeloma (16.0%). Fibrous dysplasia accounted for 46.6% of all tumor-like lesions, followed by solitary bone cyst (18.6%).

Adolescent↗

[Analysis of permanent accident-induced physical damage based on statistics of the federal insurance organization].

The changes in the occurrence of the accidents are continuously reflected in the computer statistics of the State Insurance Co. Comparing the date from 1970, 1975, 1984, 1986 it is evident the rapid increase in rate and number of the accidents happened at home and the decrease of the accidents in the working places. The pedestrian is run down on the road more often. The rate of the manual workers reaches the 90% among the injured. The most of the accidents at school happen on the physical training and during the break-time. The mortality ratio is 0.78%, the rate of the permanent damages of health 5.72%. 70% of all injuries are caused by mechanical trauma, falling in particular. 30% or higher permanent damage of health caused by accident was found in 3.047 injured persons in the year 1983. 74% male, 26% female, 80% of them were in working age. In 85% of the damaged persons the degree of the P.D.H. was 50% or less, only 15% of them became invalid. The traffic accidents has the leading role in provoking severe P.D.H.-s. In the distribution according the injured part of the body the extremities are leading with 62% of participation, the fractures of the leg, ankle and heel bone in particular. The therapeutic results of this letter group could be improved by better, more careful rehabilitation.

Accidents↗

The role of cost-effectiveness analysis in health and medicine. Panel on Cost-Effectiveness in Health and Medicine.

OBJECTIVE: To develop consensus-based recommendations guiding the conduct of cost-effectiveness analysis (CEA) to improve the comparability and quality of studies. The recommendations apply to analyses intended to inform the allocation of health care resources across a broad range of conditions and interventions. This article, first in a 3-part series, discusses how this goal affects the conduct and use of analyses. The remaining articles will outline methodological and reporting recommendations, respectively. PARTICIPANTS: The Panel on Cost-Effectiveness in Health and Medicine, a nonfederal panel with expertise in CEA, clinical medicine, ethics, and health outcomes measurement, was convened by the US Public Health Service (PHS). EVIDENCE: The panel reviewed the theoretical foundations of CEA, current practices, and alternative procedures for measuring and assigning values to resource use and health outcomes. CONSENSUS PROCESS: The panel met 11 times during 2 1/2 years with PHS staff and methodologists from federal agencies. Working groups brought issues and preliminary recommendations to the full panel for discussion. Draft recommendations were circulated to outside experts and the federal agencies prior to finalization. CONCLUSIONS: The panel's recommendations define a "reference case" cost-effectiveness analysis, a standard set of methods to serve as a point of comparison across studies. The reference case analysis is conducted from the societal perspective and accounts for benefits, harms, and costs to all parties. Although CEA does not reflect every element of importance in health care decisions, the information it provides is critical to informing decisions about the allocation of health care resources.

Advisory Committees↗

[Empirical analysis of expert social medicine assessment of disability based on the decision of the Federal social court].

Objective assessment of need for nursing care should be based on well defined criteria. In 1993, the Federal German Social Court ("Bundessozialgericht", BSG) has given criteria for identifying individuals in permanent need of very intensive nursing care ("Schwerpfledgebedürftige"), who qualified for benefits granted by the Germany statutory health insurance system at that time. The criteria were primarily based on the number of activities of daily living for which the applicants were in need of help. The criteria were largely, but not entirely, consistent with previously established criteria employed by the Medical Service of the Health Insurances ("Medizinischer Dienst der Krankenversicherung", MDK), who was responsible for the assessment. An analysis of 4185 examinations carried out by MDK in the region of Augsburg in 1991-1993 showed that the majority of judgments were in agreement with the criteria given by BSG. However, individuals with psychiatric disorders or symptoms were often rated by MDK as being in permanent need of very intensive nursing care even if BSG criteria were not fulfilled. Exclusive judgement of nursing dependency on the basis of single activities of daily living appears to be inadequate for this group of persons.

Activities of Daily Living↗

Proposition 215: a dilemma.

The author describes the scope of California's Proposition 215 and explains the legal and scientific controversies that surround its enactment. The federal government's response to the law (including its threats to any physicians who might recommend medical marijuana to patients) and the litigation that ensued are outlined. The author recounts the complicated role played by the California Medical Association during this time, as it sought to adhere to the principles of the scientific process while also attempting to resist improper governmental intrusion into the physician-patient relationship. The legal impact of the federal Controlled Substances Act on the availability of marijuana for either research or therapeutic purposes is described. The conflict between Proposition 215 and federal law is explained, and author offers a legal analysis of the extent to which physicians have free speech rights under the federal constitution to discuss and recommend the medical use of marijuana to patients. The California Medical Association's efforts to address and reconcile the competing interests, culminating in written legal guidelines for physicians, are described in detail.

California↗

Stage I adenocarcinoma of the cervix: does lesion size affect treatment options and prognosis?

A retrospective analysis of 93 patients with International Federation of Gynecology and Obstetrics stage I adenocarcinoma of the cervix was performed to determine the significance of tumor size, patient age, tumor grade, lymph node status, and primary treatment modality as prognostic variables of 5-year survival and 5-year progression-free survival (PFS). Multivariate analysis demonstrated that patient age and tumor grade were significant variables prognostic of survival (p < 0.01 and p = 0.01, respectively). Tumor size was a significant (p < 0.01) prognostic variable of PFS in a multivariate model that included tumor size and patient age. An important advantage in survival and PFS for patients with lesions smaller than 3 cm compared with those patients with lesions 3 cm or more was observed (92% vs. 76% and 89% vs. 67%, respectively). Among surgically treated patients, survival and PFS among patients with lesions smaller than 3 cm were significantly improved compared with patients with tumors 3 cm or more (97% vs. 77% [p = 0.03] and 90% vs. 69% [p = 0.03], respectively). Significant improvement in survival and PFS was observed among patients with lesions smaller than 3 cm who were treated with surgery compared with those who received radiation therapy (97% vs. 77% [p = 0.03] and 90% vs. 77% [p = 0.048], respectively).

Adenocarcinoma↗

Linkage analysis of quantitative traits for obesity, diabetes, hypertension, and dyslipidemia on the island of Kosrae, Federated States of Micronesia.

Obesity, diabetes, hypertension, and heart disease are highly heritable conditions that in aggregate are the major causes of morbidity and mortality in the developed world and are growing problems in developing countries. To map the causal genes, we conducted a population screen for these conditions on the Pacific Island of Kosrae. Family history and genetic data were used to construct a pedigree for the island. Analysis of the pedigree showed highly significant heritability for the metabolic traits under study. DNA samples from 2,188 participants were genotyped with 405 microsatellite markers with an average intermarker distance of 11 cM. A protocol using loki, a Markov chain Monte Carlo sampling method, was developed to analyze the Kosraen pedigree for height, a model quantitative trait. Robust quantitative trait loci for height were found on 10q21 and 1p31. This protocol was used to map a set of metabolic traits, including plasma leptin to chromosome region 5q35; systolic blood pressure to 20p12; total cholesterol to 19p13, 12q24, and 16qter; hip circumference to 10q25 and 4q23; body mass index to 18p11 and 20q13; apolipoprotein B to 2p24-25; weight to 18q21; and fasting blood sugar to 1q31-1q43. Several of these same chromosomal regions have been identified in previous studies validating the use of loki. These studies add information about the genetics of the metabolic syndrome and establish an analytical approach for linkage analysis of complex pedigrees. These results also lay the foundation for whole genome scans with dense sets of SNPs aimed to identifying causal genes.

Body Height↗

Variation in average costs among federally sponsored state-organized cancer detection programs: economies of scale?

BACKGROUND: Societal cost-effectiveness analysis and its variants help decision makers achieve an efficient allocation of resources across the set of all possible health interventions. Sometimes, however, decision makers are focused instead on the efficient allocation of resources within a particular intervention program that has already been implemented. This is especially true when the intervention is being delivered at several different sites. An analysis of average cost across program sites may help program officials to maximize the health benefits that can be achieved with limited resources. In this article, the authors present such an analysis, with special attention paid to the possible existence and implications of economies of scale. METHODS: Focusing on federally sponsored, state-organized cancer detection programs, the authors modeled 19 state programs as productive processes and examined their average costs over a 2- to 5-year period of operation. They considered 3 alternative definitions of output: women served, screens performed, and conditions detected. Average federal costs and average total costs were estimated for each grant period. Multivariate regression analysis was used to help explain the variation in average costs. RESULTS: The average cost estimates were distributed in a skewed pattern with the majority of observations falling close to the median and substantially below the mean. For all measures considered, average cost decreased as output expanded. This inverse relationship between average cost and output level persisted even after controlling for the effects of other predictors, suggesting the possible existence of economies of scale. DISCUSSION: The potential existence of economies of scale calls into question the assumption of a constant average cost frequently made in economic analyses of proposed public health programs. It also implies that a) differences in output level should be taken into account when comparing operating efficiency across program sites; b) conclusions from societal cost-effectiveness analyses may depend on the level of output at which the programs are evaluated; c) cost projections could be inaccurate if they do not take into account the decrease in average cost that occurs as output expands; and d) gains might be possible if similar programs with limited output potential are integrated, perhaps through cost sharing.

Breast Neoplasms↗

Evaluation of the reproducibility of the revised 1988 International Federation of Gynecology and Obstetrics grading system of endometrial cancers with special emphasis on nuclear grading.

An intraobserver and interobserver analysis of the reproducibility of the revised 1988 International Federation of Gynecology and Obstetrics (FIGO) grading system of endometrial cancers was performed in 47 endometrial cancers (94 biopsy specimens). In the revised FIGO grading system the growth pattern still serves as the basic parameter, but nuclear atypia inappropriate for the architectural grade, raises the grade by 1. Ninety-four slides were graded twice by two pathologists. Analysis by the kappa statistics (corrected for agreement by chance) showed an acceptable result for interobserver reproducibility: kappa value 0.65 (95% confidence interval, 0.480 to 0.818). Further study showed this to be a reflection of the reproducibility of the architectural grade: kappa 0.70 (95% confidence interval, 0.565 to 0.850), whereas the reproducibility of the nuclear grade was poor: kappa value 0.55 (95% confidence interval, 0.383 to 0.713). Review of the literature showed great variability in the definition of nuclear grading, indicating that the revised 1988 FIGO grading system is not applicable as standard of reference for studies of endometrial cancers, before agreeing to the definition of inappropriate nuclear atypia.

Adenocarcinoma↗

[Income and smoking behavior in Germany--a secondary analysis of data from the 1995 microcensus].

We investigated to what extent two major parameters of the economic situation, namely the household income and the type of the major source of income, are related to smoking behaviour. Study variables are current cigarette smoking and ex-smoking. Databasis is the Public Use File of the "Microcensus 1995", which is a representative survey for Germany, conducted under the auspices of the German Federal Statistical Bureau. Included in the analysis were 185,822 persons aged 18 years and older. 30.9% of males and 18.2% of females are current smokers. 39% of males and 31.2% of females, who had been smokers at any time, stopped smoking. For persons aged 18 to 64 years, we observed strong income-related differences in the smoking prevalence. The higher the income the lower was the rate of smokers. Higher rates for ex-smokers were observed for persons older than 30 years, who had a high household income. For study subjects with a primary income based on unemployment or social welfare payments, we found for both sexes a remarkably higher smoking prevalence. Due to the fact that the underlying causes for the higher prevalence of smoking in the poorer segments of the population are not very well understood, it is rather difficult to establish a comprehensive prevention strategy for this high-risk population group.

Adolescent↗

Management recommendations of the Federal Institute for Risk Assessment (BfR) after the international BfR symposium "Towards a Risk Analysis of Antibiotic Resistance".

The results of four expert working groups on the risk analysis process on antimicrobial resistance are described. They focus on the procedures recommended by the FAO/WHO CODEX Alimentarius Commission in 1999 including hazard identification, hazard characterization, exposure assessment and risk characterization. In all four areas, the current scientific knowledge was evaluated and recommendations for risk management options were given. They will form the basis for mitigating the health risk due to resistant microorganisms.

Animal Husbandry↗

Unresolved legal and ethical issues in research of adults with severe traumatic brain injury: analysis of an ongoing protocol.

This paper synthesizes federal and state laws and bioethics literature with observations from an ongoing research protocol to identify, define, and clarify the unresolved legal and ethical issues regarding research involving adults with traumatic brain injury (TBI). Solutions that protect rights and minimize unnecessary impediments to valuable clinical and scientific inquiry are also illustrated using the same protocol. Research was performed at intensive care, inpatient rehabilitation, and long-term acute chronic hospitals. Our research protocol identified five areas of law impacting adults with TBI: advanced directives, healthcare surrogacy acts, probate acts, power of attorney acts, and the Health Insurance Portability and Accountability Act. The published bioethics literature and responses from local human subject institutional review boards (IRBs) suggest that some of the unresolved ethical issues in research include defining vulnerability, defining informed voluntary consent, determining competency and/or decision-making capacity, using caregivers as subjects, and conducting multisite cooperative studies. Collaboration with IRB members and administrators as well as legal and research ethic scholars developed procedures that protect rights while avoiding unnecessary impediments to research. Investigations of persons with TBI and other cognitive impairments are governed by complicated and inconsistent regulations within the Common Rule and federal and state statues. A need for clear and consistent regulatory guidance regarding multisite studies of TBI persists. In lieu of regulatory guidance, carefully researched solutions for critical peer review are needed to guide future multisite investigations of TBI.

Brain Injuries↗

Semantic challenges in database Federation: lessons learned.

In this project an integrated analysis of data from disparate surgery and anaesthesiology departmental information systems was carried out. Due to the lack of shared primary keys, a multi-stage "soft" matching method was implemented. Results of the matching steps are described in detail. Inconsistencies were shown to exist for identifying data, semantic definition of documentation content and documented data itself. Minimum requirements for interdisciplinary documentation in autonomous systems should include shared semantic definitions of documentation content as well as robust and regularly validated interfaces for identifying data.

Database Management Systems↗