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The suitability of five different sites (brachial, jugular, caudal tibial vein, external dorsal thoracic vein and the heart) were examined for blood sampling and intravenous injections in Japanese quail. In terms of safety, ease of collection, repeated collections or injections, the jugular vein was found to be the most suitable.
OBJECTIVE: To assess critically the efficacy and safety of lithium and replicate earlier findings in a larger sample of aggressive children with conduct disorder and to assess the utility of the Profile of Mood States (POMS) in this population. METHODS: Children hospitalized for treatment-refractory severe aggressiveness and explosiveness and with diagnosed conduct disorder were subjects in this double-blind, placebo-controlled clinical trial. After a 2-week placebo baseline period, children were randomly assigned to lithium or placebo treatment for 6 weeks of placebo. The main outcome measures were the Global Clinical Judgments (Consensus) Scale, Children's Psychiatric Rating Scale, Conners Teacher Questionnaire, Parent-Teacher Questionnaire, and the POMS. RESULTS: Fifty children (mean age 9.4 years) completed this study. The mean optimal daily dose of lithium was 1,248 mg and the mean serum level was 1.12 mEq/L. Lithium was superior to placebo, although the effects on some measures were more modest than in a previous study. CONCLUSIONS: Lithium appears to be an effective treatment for some severely aggressive children with conduct disorder. Although the POMS appeared to be reliable, it did not detect any response to lithium.
Hypertension (sustained and/or paroxysmal) is the most common symptom of pheochromocytoma. Correct evaluation nearly always leads to the diagnosis, and complete surgical excision is the definitive treatment. Our study deals with preoperative evaluation, operative morbidity and long-term results after surgery. During the 12-year period (1981-1992) 31 patients (48 years, 25-85) with pheochromocytoma were treated at our institution. The selected preoperative management was reviewed on the basis of patient records. Long-term follow-up was carried out consecutively and personally. All patients received alpha-adrenergic blockers to achieve preoperative normotension and volume repletion. All resections were performed by laparotomy; two of the early cases were extended into the chest. 27 of 29 patients (93.1%) had elevated levels of urinary vanillylmandelic acid; a similar sensitivity was noted in the urinary catecholamines (24/26 = 92.3%). In anatomical localization CT-scan was accurate in 100% (27/27). MIGB scintigraphy was of help in 21 of 23 (91.3%) and, in the most recent patients, MRI was helpful in 3 of 3 (100%). No patient died during the first 30 days after surgery. One patient developed an anaphylactic reaction after cephalosporin administration (morbidity: 3.2%). 2 patients (6.4%) with malignant pheochromocytoma developed a recurrent tumor during the follow-up period. Resection of pheochromocytomas by laparotomy has a low perioperative morbidity and mortality after standardized preparation. A positive MIBG scintigraphy allows extra-adrenal localization. Better resolution and multiplanar imaging are the advantages of MRI. Perioperative management and new imaging techniques--eliminating arteriography and venous sampling among others--have simplified surgical treatment and improved its safety.
Protection from contamination by potentially infectious fluids is an increasingly important aspect of hospital safety programs. Technical personnel in clinical laboratories may handle numerous samples of human blood and other fluids daily, and to protect themselves against exposure to bloodborne pathogens they routinely wear laboratory coats. We studied the effectiveness of six disposable (polypropylene; either spun-bond or spun-bond/melt-blown/spun-bond construction) and four reusable (polyester-cotton) laboratory coats in preventing blood passage. Fabrics (1018 samples) were tested at six time durations (1 s-5 min) and five pressures [1.7-13.8 kPa (0.25-2.0 psi)]. A standard spray test used to evaluate resistance to wetting showed that reusable coats were less repellent than disposables (P < 0.05). Pressure testing showed that reusable and spun-bond coats allowed greater blood passage than the spun-bond/melt-blown/spun-bond. Laboratory coats should be chosen that have sufficient resistance to blood or other body fluid passage for the task performed and for the period of time used.
Oral fleroxacin, 400 mg once a day, and oral amoxicillin/clavulanate potassium (AMX/CP), 400 mg/125 mg three times a day, administered for 4-21 days, were compared for efficacy and safety in the treatment of skin and soft tissue infections. A total of 113 patients were enrolled in a multicenter, randomized, double-blind trial; 57 were assigned to fleroxacin and 56 to AMX/CP. A total of 22 and 33 patients in the fleroxacin and AMX/CP groups, respectively, were evaluable for efficacy. The most common diagnoses were skin abscess (14; 62%) and wound infections (5; 23%) in the fleroxacin group and skin abscess (17; 52%) and skin ulcer (9; 27%) in the AMX/CP group. A total of 20 (91%) of the fleroxacin-treated patients and 29 (88%) of the AMX/CP-treated patients were bacteriologically cured (two fleroxacin- and one AMX/CP-treated patients developed super-infection). The eradication rate for Staphylococcus aureus was 100% (11 of 11) in the fleroxacin group and 89% (17 of 19) in the AMX/CP group; 18 (82%) of the fleroxacin group and 25 (76%) of the AMX/CP group were clinically cured. Adverse events were seen in 22% (12 of 54) of the fleroxacin group and 25% (13 of 53) of the AMX/CP group. None were serious. Bacteriologic and clinical cure rates and safety results for the two groups were similar. The small sample size precluded statistical analysis at the 95% confidence level.
The author's experience using automated disc aspiration for the diagnosis of discitis indicates that skinny needle aspiration biopsy has a very high false-negative rate. A negative skinny-needle biopsy, therefore, must be followed by a procedure to obtain a better sample of pathologic material. Automated disc aspiration, because of its safety and ability to provide a large specimen, is the procedure of choice. Attention, however, must be paid to technical details of the procedure and the poor annular integrity of the infected disc to carry out the procedure safely.
Enzymatic analysis is an independent and separate branch of enzymology and analytical chemistry. It has become one of the most important methodologies used in food analysis. Enzymatic analysis allows the quick, reliable determination of many food ingredients. Often these contents cannot be determined by conventional methods, or if methods are available, they are determined only with limited accuracy. Today, methods of enzymatic analysis are being increasingly used in the investigation of foodstuffs. Enzymatic measurement techniques are used in industry, scientific and food inspection laboratories for quality analysis. This article describes the requirements of an optimal analytical method: specificity, sample preparation, assay performance, precision, sensitivity, time requirement, analysis cost, safety of reagents.
Pharmacological studies of anti-cancer agents in children are essential to determine their clinical safety and efficacy, both of which can differ considerably from that observed in adults. However, the potential clinical impact of taking blood samples, in addition to those required for standard clinical practice is commonly a concern for both medical and allied staff and parents. Frequently quoted 'safe limits' of 3%-5% of total blood volume taken on any one study day are not based on published data and may not be acceptable for all patients. This article reviews some of the reasons why clinical pharmacology data for anti-cancer drugs is often lacking in a paediatric patient population, summarises data from a retrospective study investigating the potential impact of repeated blood sampling for research purposes and discusses how this issue may be more systematically addressed in future studies. Research involving children with cancer should be limited to those studies addressing key scientific questions and should be designed to limit both the number and volume of blood samples required.
Injuries are a major cause of morbidity and mortality to young children. The provision of individually tailored educational materials in primary care settings may be an effective and efficient way to promote adoption of injury prevention measures by parents. A randomized controlled study compared the effectiveness of tailored and generic persuasive communications delivered in a primary care setting on the adoption of home and car safety behaviors. During routine well-child visits, a primarily African-American sample of parents of children ages 6-20 months (n=213) was randomized to receive either tailored or generic information regarding the prevention of injuries to their child. At follow-up, participants who received tailored information reported greater adoption of home and car safety behaviors than those receiving generic information. In addition, within the tailored information group, those who discussed the information with their physician showed significantly greater change than those who did not. However, this difference was not observed among those receiving generic information. Findings support the use of office-based tailored injury prevention education as a component of routine well-child care.
As a result of human error, an estimated 1 in 12,000 blood transfusions is given to the wrong patient. The cause of nearly all of these errors is failure of hospital personnel to identify positively intended transfusion recipients, their blood samples for cross-matching, or their correct blood components. We describe our experience using a point-of-care bar code transfusion safety system that links patients' bar-coded wristbands, with bar-coded labels on blood sample tubes, blood component bags, and nurses' identification badges. The result was 100 % accuracy of matching patients, their blood samples, and components for transfusions. For verifying information before starting blood transfusions, nurses preferred bar code "double checks" to conventional visual "double checks" by a second nurse. Methods are needed to reinforce nurses' proficiency with technological approaches to transfusion safety, such as software-driven bar code scanning, in situations where transfusions are administered infrequently.
OBJECTIVE: To facilitate clinicians' judgement concerning physical restraint decisions by identifying potentially reversible injury risk factors that differentiate representative samples of restrained and unrestrained nursing home residents. DESIGN: Comparison of restrained and unrestrained nursing home residents on a safety assessment for the frail elderly (SAFE) protocol. SETTING: Long-term care facilities in the Greater Los Angeles Area. PARTICIPANTS: One hundred eight physically restrained and 111 unrestrained nursing home residents. INTERVENTION: None. MAIN OUTCOME MEASURES: (1) Internal, Interrater, and test/retest reliability of the overall SAFE protocol and of the four major factors measured by SAFE; (2) The relationship of SAFE scores to expert judgment of resident injury risk; (3) Differences between large samples of restrained and unrestrained residents on specific SAFE score factors. RESULTS: Two walking, one transition, and one judgment factor are reliably measured by the SAFE protocol. SAFE scores were significantly correlated with expert judgment of risk for injury and showed large differences between restrained and unrestrained residents, even after differences in ambulation ability between the two groups were accounted for. CONCLUSION: The SAFE is a reliable protocol that measures behavioral factors related to falls and risk for injury among nursing home residents with a broad range of cognitive impairment. Factors that significantly differentiate restrained and unrestrained groups should be targeted for rehabilitation and remediation in physical restraint reduction efforts. Removing or changing restraints for the large sample (50%) of restrained residents who were not ambulatory will not significantly increase their mobility, since the majority of this group could not independently propel their wheelchairs. Increased mobility for the large group of both restrained and unrestrained residents will likely be realized only if restraint reduction programs are combined with interventions to improve both mobility and the specific behavioral performance factors measured by SAFE.
Sizing data generated by the military for use in fitting respirators have been the normative basis for commercial respirator sizing. Anthropometric data developed for males and females of military age in the 1950s and 1960s are still in use today and form the only comprehensive body of information available on this subject. The twofold objective of this study was to: (1) develop an anthropometric database detailing the face size distributions of respirator users using both traditional measurement methods and three-dimensional scanning systems; and (2) use the database to establish fit test panels to be incorporated into the National Institute for Occupational Safety and Health's respirator certification and international standards. A stratified sampling plan was used with three age strata, two gender strata, and four race/ethnic group strata. The plan called for an equal sample size of 166 in each cell. Subjects were obtained at 41 sites from 8 states. In addition to height and weight, 18 facial dimensions and neck circumferences were measured using traditional methods. A total of 3997 subjects were measured using traditional methods, and 1013 of them were also scanned using a 3-D head scanner. As this was a volunteer sample, subjects did not appear in the specific proportions needed for the sampling plan. The resulting data were weighted to correspond to the U.S. population. This article presents the summary statistics for the traditional measurement data only. Multivariate analyses of the data from this study and military data revealed that using historical, military data would be inadequate for describing the anthropometric variability of the current U.S. work force.
The lack of compliance with universal precautions (UP) is well documented across a wide variety of healthcare professions and has been reported both before and after the enactment of the Occupational Safety and Health Administration's Bloodborne Pathogens Standard. Gershon, Karkashian, and Felknor (1994) found that several factors correlated significantly with healthcare workers' lack of compliance with UP, including a measure of organizational safety climate (e.g., the employees' perception of their organizational culture and practices regarding safety). We conducted a secondary analysis using data from a cross-sectional survey of a convenience sample of 1,746 healthcare workers at risk of occupational exposure to bloodborne pathogens to assess the validity and reliability of Gershon's measure of safety climate. Findings revealed no relationship between safety climate and employees' gender, age, education, tenure in position, profession, hours worked per day, perceived risk, attitude toward risk, and training. An association was demonstrated between safety climate and (1) healthcare worker compliance with UP and (2) the availability of personal protective equipment, providing support for the construct validity of this measure of safety climate. These findings could be used by occupational health professionals to assess employees' perceptions of the safety culture and practices in the workplace and to guide the institution's risk management efforts in association with U.P.
More than 1/3 of back injuries among nurses result from patient transfers. So, a rigorous between-subjects quasi-experimental methodology having broad clinical applicability was developed to evaluate the effects of a one-hour didactic back safety and patient transfer training lecture/demonstration upon 42 recently hired hospital nurses. The design implemented independent random samples including independent control groups, though practical constraints required all 42 to participate in the training. Training effects were assessed for each of three back safety transfer skill self-efficacy measures and their composite total self-efficacy score. Four monthly training sessions, each serving different nurses, achieved significant and substantial impacts on both composite total back safety procedure self-efficacy (where effect sizes ranged from approximately 0.8 to 1.8 standard deviations) and on each individual back safety transfer skill self-efficacy measure. After training, 85% to 100% of the nurses rated their back safety procedure self-efficacy within three points of the maximum composite total of 30 on the self-efficacy scale. Results may help improve nursing services and identify training strategies to reduce healthcare worker back injuries.
A technique is described for on-site screening of workplace atmospheres for benzene in the presence of many potentially interfering substances. The technique allows benzene monitoring with reasonable specificity at the part per million (ppm) level in confined spaces. A commercially available portable gas chromatograph (GC), shown in the laboratory to be capable of resolving benzene from a complex mixture of hydrocarbons, was compared in the field with other portable GCs, sorbent tube samples, and detector tubes. During three field evaluations samples were collected in Tedlar bags, which allowed replicate, on-site analyses by up to three portable gas chromatographs and three types of detector tubes. Additionally, replicate samples were collected from each bag onto charcoal tubes for subsequent laboratory analysis by capillary column flame ionization gas chromatography and by gas chromatography/mass spectrometry. The portable GCs resolved samples to the extent that an integratable response with the retention time of benzene was seen. In some samples this response was not due solely to the presence of benzene, but such instances would overestimate the concentration and provide a more conservative result. The portable GCs had a total analysis time of less than 10 minutes and detected concentrations of benzene below the Occupational Safety and Health Administration's permissible exposure limit of 1 ppm (in most samples, below 0.1 ppm, although the limit of quantitation was matrix dependent). While benzene concentration measurements using detector tubes were less precise, they agreed in almost every instance with the other techniques regarding whether the space was within the 1 ppm "safe for entry" concentration.
BACKGROUND: Factor XIII (FXIII) is a transglutaminase that cross-links fibrin and other proteins to improve clot strength and resistance to fibrinolysis. Both congenital and acquired FXIII deficiency may result in a bleeding diathesis, and plasma-derived FXIII has been used to treat many of these clinical conditions. OBJECTIVES: A clinical study was designed and performed to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant FXIII (rFXIII) administration to healthy adult volunteers. PATIENTS AND METHOD: Fifty healthy adult volunteers were enrolled in this randomized, double-blinded, placebo-controlled study. A single dose of rFXIII, ranging from 2 U kg(-1) to 50 U kg(-1), or placebo was administered. Safety was evaluated by capturing adverse events, clinical safety laboratory studies, and clinical score for deep venous thrombosis. Blood samples were taken for pharmacokinetic and immunogenicity analysis throughout the 28-day follow-up period. RESULTS: Recombinant FXIII was well tolerated, with no serious adverse events or dose-related toxicities. Following a single i.v. injection of 50 U kg(-1) rFXIII, the estimated terminal half-life was 270-320 h, the volume of distribution ranged from 40 to 75 mL kg(-1), and FXIII activity increased 1.77% per 1 U kg(-1) rFXIII administered. Increase in circulating A2B2 and decrease in free FXIII-B subunit indicate in vivo formation of FXIII heterotetramer. An immunogenic response to rFXIII or yeast, the production host, was not observed. CONCLUSIONS: Recombinant FXIII was well tolerated at doses of up to 50 U kg(-1) in healthy adult volunteers. The safety, pharmacological and immunological profile of rFXIII suggests it should be studied in patients with congenital FXIII deficiency as well as evaluated as a systemic hemostat in patients with acquired FXIII deficiency or hemorrhage.
OBJECTIVE: To test the tolerability and safety of the universal plasma Uniplas [solvent/detergent (SD)-treated plasma], infused regardless of the patient's blood group. DESIGN: Prospective, parallel group, controlled and observer-blinded study, randomized with respect to patients requiring plasma transfusion. SETTING: Cardiothoracic operating room and ICU in a university hospital. PATIENTS: Eighty-four patients undergoing open-heart surgery comparing three parallel treatment groups and one control group. INTERVENTIONS: The Uniplas treatment group was subdivided into patients with blood group A, B or AB, and group O. The treatment group receiving Octaplas of type AB, was not subdivided. Patients who did not require any plasma transfusion served as control. MEASUREMENTS: Complement activation (C3bc, TCC), direct antiglobulin test (DAT) and other immunohaematological tests, tests for haemolysis, and relevant clinical observations during treatment phase. Blood samples were collected again after 6 months for evaluation of viral safety. RESULTS: Of the 84 patients, 29 served as control group. Uniplas was transfused in 36 of the patients (1-23 units). Octaplas was transfused in 19 patients (1-11 units). During the study no clinical adverse events related to plasma transfusion were observed. The degree of complement activation C3bc and TCC, a recommended test for biocompatibility, did not show any increased activation after Uniplas or Octaplas transfusion. No haemolytic reactions, positive DAT-tests or viral transmissions were observed after Uniplas transfusion. CONCLUSION: In open-heart surgery, Uniplas, which can be transfused regardless of a patient's blood group, was well-tolerated and gave no adverse drug reactions.
OBJECTIVES: The purpose of this study was to determine adherence to selected recommended safety standards in North Carolina child care centers. METHODS: A self administered questionnaire eliciting information about safety practices in child care was mailed to a randomly selected sample of 409 North Carolina child care centers. RESULTS: One hundred and ninety five usable questionnaires were returned from child care centers in 75 counties. Results indicated that all of the standards included in the state's child regulations were being adhered to by at least 80% of the centers. However, adherence to recommended standards not included in the state's regulations was quite variable, with one standard implemented by less than 5% of the centers. The lowest rates of adherence were found for standards specifying that resilient surface material be used under playground equipment (4%) and that certain foods that may present a choking hazard to small children not be served (27%). CONCLUSIONS: Many hazards not addressed in North Carolina child care regulations are present in child care centers. Some safety standards are not adhered to due to lack of knowledge or limited resources. Inclusion of national standards in state child care regulations appears to reduce, but not eliminate, the likelihood of hazards being reported. Further research should include on-site inspections and attention to safety in family child care.