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PubMed2005

Estimation of AUC from 0 to Infinity in Serial Sacrifice Designs.

Nonclinical in vivo animal studies have to be completed before starting clinical studies of the pharmacokinetic behavior of a drug in humans. The drug exposure in animal studies is often measured by the area under the concentration time curve (AUC). The classical complete data design where each animal is sampled for analysis once per time point is usually only applicable for large animals. In the case of rats and mice, where blood sampling is restricted, the batch design or the serial sacrifice design need to be considered. In batch designs samples are taken more than once from each animal, but not at all time points. In serial sacrifice designs only one sample is taken from each animal. This paper presents an estimator for AUC from 0 to infinity in serial sacrifice designs, the corresponding variance and its asymptotic distribution.

Algorithms↗
PubMed2004

Structure of Pseudomonas aeruginosa populations analyzed by single nucleotide polymorphism and pulsed-field gel electrophoresis genotyping.

Pseudomonas aeruginosa has a wide ecological distribution that includes natural habitats and clinical settings. To analyze the population structure and distribution of P. aeruginosa, a collection of 111 isolates of diverse habitats and geographical origin, most of which contained a genome with a different SpeI macrorestriction profile, was typed by restriction fragment length polymorphism based on 14 single nucleotide polymorphisms (SNPs) located at seven conserved loci of the core genome (oriC, oprL, fliC, alkB2, citS, oprI, and ampC). The combination of these SNPs plus the type of fliC present (a or b) allowed the assignment of a genetic fingerprint to each strain, thus providing a simple tool for the discrimination of P. aeruginosa strains. Thirteen of the 91 identified SNP genotypes were found in two or more strains. In several cases, strains sharing their SNP genotype had different SpeI macrorestriction profiles. The highly virulent CHA strain shared its SNP genotype with other strains that had different SpeI genotypes and which had been isolated from nonclinical habitats. The reference strain PAO1 also shared its SNP genotype with other strains that had different SpeI genotypes. The P. aeruginosa chromosome contains a conserved core genome and variable amounts of accessory DNA segments (genomic islands and islets) that can be horizontally transferred among strains. The fact that some SNP genotypes were overrepresented in the P. aeruginosa population studied and that several strains sharing an SNP genotype had different SpeI macrorestriction profiles supports the idea that changes occur at a higher rate in the accessory DNA segments than in the conserved core genome.

Electrophoresis, Gel, Pulsed-Field↗
PubMedDate not supplied

Epidemiology of needlestick injuries among health care workers in a secondary care hospital in Saudi Arabia.

BACKGROUND: Accidental needlestick injuries sustained by health care workers are a common occupational hazard in health care settings. The aim of this study was to review the epidemiology of needlestick injuries in Buraidah Central Hospital, a 212-bed secondary care hospital in Buraidah, Saudi Arabia. METHODS: We conducted a retrospective survey of all self-reported documents related to needlestick injuries, for the period January 2002 through December 2003. The data was analyzed to determine the age, sex and job category of the health care worker suffering the injury as well as the risk factors responsible for needlestick injuries. RESULTS: During the 2-year period, employees reported 73 injuries from needles and other sharp objects. Nurses were involved in 66% of instances, physicians in 19%, technicians in 10%, and nonclinical support staff in 5.5%. The majority (53.4%) of the injuries occurred after use and before disposal of the objects. Syringe needles were responsible for 63% of all injuries. Most injuries occurred during recapping of used needles (29%), during surgery (19%), and by collision with sharps (14%). Disposal-related (11%) causes as well as injuries by concealed sharps (5%) occurred while handling linens or trash containing improperly disposed needles. CONCLUSION: This data emphasizes the importance of increased awareness, training and education of health care workers for reporting and prevention of needlestick injuries.

Adult↗
PubMed2000

Pharmacy database for tracking drug costs and utilization.

A pharmacy database for tracking drug costs and physician prescribing trends is described. Accuracy problems plagued data systems used to make drug-use-policy decisions at a tertiary care teaching hospital because of structural deficiencies within the systems and their nonclinical orientation. To resolve these problems, a programmer analyst, a clinical supervisor, and a clinical pharmacist developed a hierarchical database of drug costs. The database was designed to be valid for tracking drug costs according to patterns of clinical use. Internal controls were created that could identify and correct cost-tabulation errors arising within the ordering, order-entry, and billing processes. The database was able to tabulate drug costs according to the clinical service on which the patient was being treated at the time so that reports could compare aggregate prescribing trends from one time period to another for the same service. Similarly, the database could track and report drug use by disease or financial classification. Flagging elements were introduced to the database for cancer chemotherapy and antimicrobial drug products to enable reporting by these categories and by therapeutic subcategories within the antimicrobial category. Routine monthly reports were distributed to end users. Development of a database for tracking drug costs and utilization allowed a teaching hospital to derive the cost of medications from billing-charge information and to report data to health care professionals on the basis of important factors like clinical services.

Academic Medical Centers↗
PubMed2003

Screening for enterocins and detection of hemolysin and vancomycin resistance in enterococci of different origins.

The inhibitory activity of 122 out of 426 Enterococcus strains of geographically widespread origin and from different sources (food and feed, animal isolates, clinical and nonclinical human isolates) was tested against a wide range of indicator bacteria. Seventy-two strains, mainly belonging to the species Enterococcus faecium and Enterococcus faecalis were bacteriocinogenic. A remarkable variation of inhibitory spectra occurred among the strains tested, including inhibition of, for instance, only closely related enterococci, other lactic acid bacteria (LAB), food spoilage and pathogenic bacteria. No correlation could be found between the origin of the strains and the type of inhibitory spectrum, although a clustering of human isolates from both fecal and clinical origin was observed in the group of strains inhibiting lactic acid bacteria, Listeria, and either Staphylococcus or Clostridium. No relationship could be established between the presence of enterocin structural genes and the origin of the strain either, and hence no correlation seemed to exist between the presence of known enterocin genes and the activity spectra of these enterococci. The structural gene of enterocin A was widely distributed among E. faecium strains, whereas that of enterocin B only occurred in the presence of enterocin A. The vancomycin resistance phenotype as well as the presence of vancomycin resistance genes was also investigated. The vanA gene only occurred among E. faecium strains. The incidence of beta-hemolysis was not restricted to E. faecalis strains, but among the E. faecium strains the structural genes of cytolysin were not detected. beta-Hemolysis occurred in strains both from food and nonfood origin. It has been concluded that bacteriocin-producing E. faecium strains lacking hemolytic activity and not carrying cytolysin nor vancomycin resistance genes may be useful as starter cultures, cocultures, or probiotics.

Animals↗
PubMed1997

Young Moms' Clinic: a multidisciplinary approach to pregnancy education in teens and in young single women.

STUDY OBJECTIVE: To study outcome of pregnant adolescents and single young women who attended and those who chose not to attend a nonurban, developmentally appropriate, pilot antenatal clinic called the "Young Moms' Clinic." To study "perceived" outcome among the Young Moms' Clinic participants. METHODS: A multidisciplinary clinic was established to provide education about pregnancy, childbirth, infant care, contraception, and healthy lifestyles to young mothers with similar backgrounds. Over a 2-year period, all adolescents and single young mothers aged 13-23 years were invited to attend the Young Moms' Clinic after the first trimester. The Clinic group consisted of the first 101 young women who were invited and chose to attend. The nonclinic group consisted of the first 95 young women who were invited but declined to attend. Both groups had the same obstetric care givers, had a similar number of prenatal visits (median number, 12), and delivered in the same hospital. Univariate and multivariate analyses were performed to determine whether participation in the clinic was an independent factor in outcome. RESULTS: Maternal weight gain and infant birth weight were significantly higher in the Clinic group. Pregnancy complications (preterm labor, intrauterine growth retardation, anemia) were significantly higher in the nonclinic group. Participants in the nonclinic group were almost three times as likely to have cesarean section delivery as those in the Clinic group. Neonatal intensive care unit transfer occurred only in infants of the control group. CONCLUSIONS: Participation of pregnant adolescent and young adult women from a nonurban community in a developmentally targeted pilot, prenatal program resulted in fewer pregnancy complications and improved outcome in comparison with those who chose not to participate in the program. The results may be subject to bias because of self-selection among participants.

Adolescent↗
PubMed2004

Clinically abusive relationships in an unselected birth cohort: men's and women's participation and developmental antecedents.

In an unselected birth cohort (N=980, age 24-26 years), individuals in abusive relationships causing injury and/or official intervention (9% prevalence) were compared with participants reporting physical abuse without clinical consequences and with control participants who reported no abuse, on current characteristics and prospective developmental risks. In nonclinically abusive relationships, perpetrators were primarily women. In clinically abusive relationships, men and women used physical abuse, although more women needed medical treatment for injury. Women in clinically abusive relationships had childhood family adversity, adolescent conduct problems, and aggressive personality; men had disinhibitory psychopathology since childhood and extensive personality deviance. These findings counter the hibitory assumption that if clinical abuse was ascertained in epidemiological samples, it would be primarily man-to-woman, explained by patriarchy rather than psychopathology.

Adolescent↗
PubMed2000

Late initiation of dialysis among women and ethnic minorities in the United States.

The ideal timing of initiation of renal replacement (RRT) therapy has been debated. It is currently recommended that RRT be instituted once the GFR falls below 10.5 ml/min per 1.73 m(2), unless edema-free body weight is stable or increased, the normalized protein nitrogen appearance rate is 0.8 g/kg per d or greater, and there are no clinical signs or symptoms of uremia. However, the mean estimated GFR at initiation of dialysis in the United States is 7.1 ml/min per 1.73 m(2). Factors that are associated with timing of initiation of dialysis in the United States are not clear. A cross-sectional study was performed to determine the factors that are associated with late initiation of dialysis as defined by GFR at initiation of less than 5 ml/min per 1.73 m(2) among patients who began dialysis in the United States between 1995 and 1997. Data were obtained from the U.S. Renal Data System, and GFR was estimated using the formula derived from the Modification of Diet in Renal Disease Study. Twenty-three percent of patients started dialysis late. In the multivariate analysis, women (odds ratio [OR] = 1.70), Hispanics and Asians (OR = 1.47 and 1.66, respectively, compared with Caucasians), uninsured patients (OR = 1.55 compared with private insurance), and employed patients (OR = 1.20) were more likely to start dialysis late. Patients with diabetes, cardiac disease, peripheral vascular disease, and poor functional status were less likely to start dialysis late compared with patients without these comorbid conditions. Certain nonclinical patient characteristics, notably female gender, race, and lack of insurance, are related to an increased likelihood of late initiation of dialysis. These factors may reflect reduced access to care. Additional studies are indicated to determine the potential impact of reduced access to care and whether late initiation of dialysis results in adverse clinical and economic outcomes among patients with end-stage renal disease in the United States.

Adult↗
PubMed1997

Resiliency and adult adaptation in women with and without self-reported histories of childhood sexual abuse.

This study investigated the relationship of protective factors (PF) to adult adaptation in a nonclinical sample consisting of 264 undergraduate women: two groups without childhood sexual abuse (CSA), high (n = 109) and low (n = 99) on PF; and two groups with CSA, high (n = 17) and low (n = 27) on PF. The first hypothesis that higher levels of PF would be significantly associated with higher levels of functioning for all individuals was supported by the data. The second hypothesis that the women with CSA and higher levels of PF would appear similar in adaptation to those without CSA was also supported. The findings further suggest that though the protective factors were beneficial for most individuals, they were significantly more helpful for those with CSA.

Adaptation, Psychological↗
PubMed1997

Psychometric properties of the Depression Anxiety Stress Scales (DASS) in clinical samples.

The psychometric properties of the Depression Anxiety Stress Scales (DASS) were evaluated in two studies using large clinical samples (N = 437 and N = 241). In Study 1, the three scales comprising the DASS were shown to have excellent internal consistency and temporal stability. An exploratory factor analysis (principal components extraction with varimax rotation) yielded a solution that was highly consistent with the factor structure previously found in nonclinical samples. Between-groups comparisons indicated that the DASS distinguished various anxiety and mood disorder groups in the predicted direction. In Study 2, the conceptual and empirical latent structure of the DASS was upheld by findings from confirmatory factor analysis. Correlations between the DASS and other questionnaire and clinical rating measures of anxiety, depression, and negative affect demonstrated the convergent and discriminant validity of the scales. In addition to supporting the psychometric properties of the DASS in clinical anxiety and mood disorders samples, the results are discussed in the context of current conceptualizations of the distinctive and overlapping features of anxiety and depression.

Adolescent↗
PubMed2005

[Evaluation of information for generic drugs based on importance and necessity].

Limited use of generics in Japan has been justified on the basis of problematic quality, distribution and information. Of these three problem areas, the state of provision of information in particular has never been objectively evaluated. We therefore sought to evaluate information according to its necessity and importance to medical practice. To establish criteria for evaluation, we weighted 36 separate pieces of drug information found in package inserts and interview forms according to necessity and importance, based on the results of a survey of nationwide medical institutions with DI offices. We then used the evaluation criteria to evaluate currently available drugs with 20 or more products per formulation. We evaluated 14 formulations (324 products). Generic drugs were found to have 25.3+/-18.7 to 46.1+/-14.2% (Mean+/-S.D.) the information of brand name drugs when products were compared for quantity of information by formulation. However, comparison according to manufacturer returned a larger range of variation at 14.4+/-8.6 to 64.3+/-14.2% (Mean+/-S.D.). These data reveal that manufacturer differences play a large role in the provision of drug information. Drug information was also compared separately by category for both brand name and generic drugs. Generic drugs were found to have insufficient information on clinical data, pharmacokinetics, safety, side effects, and nonclinical tests. Brand name drugs also scored low points for information on pharmacokinetics. It is imperative that both brand name and generic drugs provide more information on pharmacokinetics.

Drug Industry↗
PubMed2004

Muscle contractions and auditory perception in tinnitus patients and nonclinical subjects.

Evidence has been accumulating linking subjective tinnitus to the somatosensory system. Most subjective tinnitus patients can change the psychoacoustic attributes of their tinnitus with forceful head and neck contractions. This study assessed the significance of such somatic modulation of tinnitus by testing nonclinical subjects. Like tinnitus patients, about 80% of nonclinical subjects, who had ongoing tinnitus at the time of testing (whether or not they were previously aware of it), could modulate their tinnitus with head and neck contractions. Over half of those with no tinnitus at the time of testing could elicit a tinnitus-like auditory perception with head and neck contractions. The finding that forceful head and neck contractions, as well as loud sound exposure, were significantly more likely to modulate ongoing auditory perception in people with tinnitus than in those without tinnitus supports the concept of a neural threshold for tinnitus. Somatic influences upon auditory perception are not limited to tinnitus sufferers but appear to be a fundamental property of the auditory system.

Acoustic Stimulation↗
PubMed1997

Characteristics of current hospital-sponsored and nonhospital birth centers.

OBJECTIVES: (1) To describe contemporary birth centers in terms of the population served, organizational and financial characteristics, services provided, mission and philosophy, and planning and marketing techniques. (2) To compare hospital-sponsored and nonhospital models with regard to the above characteristics. METHOD: Data from the National Survey of Women's Health Centers conducted in 1994 are analyzed using t-tests and chi-square tests. RESULTS: Contemporary birth centers serve a diverse population of women and provide a range of clinical and nonclinical services. Birth centers are both hospital-sponsored and nonhospital, with the former growing at a faster rate. Compared to hospital-sponsored centers, nonhospital centers serve a larger proportion of uninsured women, provide a broader range of clinical services, and are more committed to women-centered care. Centers utilize different marketing methods and are involved in a number of organizational changes to better position themselves in the changing health care environment. CONCLUSIONS: Birth centers offer an attractive option to consumers and are a viable model for delivering women-centered care. Given that all "birth center" facilities do not share the same philosophy and service mix, women need to have some assurance of what a "birth center" will, and will not, provide.

Adult↗
PubMed2001

Psychometric properties and factor structure of the Worry Domains Questionnaire.

The Worry Domains Questionnaire (WDQ) is a content-based measure of nonpathological worry. The current study investigates an adapted WDQ for clinical assessment. The WDQ was completed by 570 participants (286 clinical, 284 nonclinical). Internal consistency of the WDQ domains was found to be adequate. Clinical participants obtained significantly higher WDQ scores than control participants. WDQ scores were moderately correlated with several clinical self-report measures. A seven-factor structure and a higher order worry factor model were separately subjected to structural equation modeling in the clinical sample. The factor groupings originally outlined by the scale's authors (with minor revisions) provided the best description of the clinical data set. Evidence of differences in the worry factor structures of clinical and control samples did emerge. This study provides initial support of the psychometric suitability of the adapted WDQ for use in clinical populations.

Adult↗
PubMed1998

Cardiovascular risk factors in economically disadvantaged women: a study of prevalence and awareness.

This study examined the prevalence of cardiovascular risk factors among low-income women and assessed the level of awareness and attitudes about these risk factors in the community. A survey instrument was developed and administered by a single researcher to a convenience sample of women in health clinics and nonclinical community settings. These settings included: an academic clinic, community clinics, women's shelters, free meal sites, community centers, public housing units, and private homes in Philadelphia, Pennsylvania. Two hundred two women were selected without regard to age or race. The mean number of cardiovascular risk factors per subject was 2.6 (SD 1.4). Each of eight established cardiovascular risk factors was identified by 4% to 34% of subjects. Among those women with a specific risk factor, only 0% to 45% reported that they were at increased risk due to the presence of that factor. The prevalence of cardiovascular risk factors among low-income women is substantial. Knowledge and understanding of these risk factors is suboptimal, particularly among women personally affected by risk factors for cardiovascular disease.

Adolescent↗
PubMed1994

Interruption of oxygen therapy during intrahospital transport of non-ICU patients: elimination of a common problem through caregiver education.

UNLABELLED: Hospital inpatients frequently leave their rooms for diagnostic procedures and for other reasons. For some, interruption of oxygen therapy during transport could lead to serious complications. In our institution, non-ICU patient transport is done mainly by nonclinical personnel from an independent transport service. MATERIALS & METHODS: We reviewed respiratory care department and transport service records for 5 arbitrarily selected days to determine the number of non-ICU patients receiving O2 therapy, the number of times these patients were transported, and the number of occasions on which O2 was used during the transport. We then interviewed the primary nurse for each patient transported without O2 and reviewed the charts of those patients to determine whether this practice was consistent with the therapy as it had been ordered. After our initial investigation showed a high rate of transport without prescribed O2, we sent memoranda to all nursing units describing proper procedures for transport of patients for whom O2 had been ordered. We then repeated the audit. Because the second audit showed the need, we conducted education sessions with all nursing personnel on the affected units and posted guidelines for O2 use during transport. A third audit was then conducted. In addition, we performed a telephone survey of respiratory care department managers to learn the patient-transport practices in all hospitals in our state with more than 200 beds, using a structured questionnaire. RESULTS: During the initial 125 patient-days of O2 therapy, O2 accompanied patients on only 30 of 55 transports (55%). After distribution of memoranda, O2 use increased to 28 of 35 transports (80%) during 82 patient-days. The second educational effort resulted in O2 use with all 35 transports (100%) performed during 99 patient-days. Survey results from 24 hospitals with 225-680 beds showed that 11 (46%) had separate transport services and that decisions on O2 use during patient transport were generally made by nursing staff. Although respiratory care departments supplied the O2 equipment, their personnel were involved in non-ICU transports in only 5/24 hospitals. CONCLUSIONS: Patients receiving O2 therapy on acute-care wards are often transported to other areas of the hospital without O2. This potentially dangerous practice can be corrected by respiratory care practitioners through educational efforts targeted toward those responsible for administering O2 therapy in non-ICU hospital areas.

Continuity of Patient Care↗
PubMed2005

Association of race/ethnicity with emergency department wait times.

OBJECTIVE: To determine whether wait times for children treated in emergency departments (EDs) nationally are associated with patient race/ethnicity. METHODS: Data were obtained from the National Hospital Ambulatory Medical Care Survey, which collects information on patient visits to EDs throughout the United States. We examined data for patients < or =15 years of age who presented to EDs during the 4-year period of 1997-2000. Sample weights were applied to the identified patient records to yield national estimates. For the purposes of this study, race/ethnicity was analyzed for 3 major groups, ie, non-Hispanic white (NHW), non-Hispanic black (NHB), and Hispanic white (HW). RESULTS: During the 4-year study period, 20633 patient visits were surveyed, representing a national sample of 92.9 million children < or =15 years of age. The race/ethnicity distribution included 9019 NHW children (59.5%), 3910 NHB children (23.9%), and 2991 HW children (16.6%). The wait time for all groups was 43.6 +/- 1.7 minutes (mean +/- SEM). There were significant unadjusted intergroup differences in wait times (38.5 +/- 1.6 minutes, 48.7 +/- 0.5 minutes, and 54.5 +/- 0.1 minutes for NHW, NHB, and HW children, respectively). Visit immediacy (triage status), when reported, was categorized as <15 minutes for 2203 children (17.1%), 15 to 60 minutes for 5324 (41.4%), 1 to 2 hours for 3010 (25.1%), and >2 to 24 hours for 1910 (16.4%). There were significant unadjusted differences in triage status according to race, with 14.6% of NHW patients being placed in the >2-hour immediacy range, compared with 18.8% of NHB patients and 20.0% of HW patients. In a linear regression analysis with logarithmically transformed wait time as a dependent variable and with adjustment for potential confounders, including hospital location, geographic region, and payer status, both NHB and HW patients waited longer than NHW patients, although the results were statistically significant only for HW patients. CONCLUSIONS: These nationally representative data suggest that children who come to EDs have wait times that vary according to race/ethnicity. There are several potential explanations for this observation, including discrimination, cultural incompetence, language barriers, and other social factors. These data and similar data from the National Hospital Ambulatory Medical Care Survey are useful in identifying nonclinical influences on the delivery of pediatric emergency care.

Adolescent↗
PubMed2005

Is fetal gender a risk factor for severe congenital cytomegalovirus infection?

Cytomegalovirus is the main cause of congenital viral infection and amniotic fluid viral load appears to be the single nonclinical prognostic factor. However, as in other infectious diseases, host genetics may influence the severity of the disease. To test this hypothesis, we looked retrospectively at the fetal gender in cases of severe congenital cytomegalovirus infection in our database. We also analyzed the international English literature covering this subject between 1985 and 2003. The proportion of females with brain abnormalities was statistically different from that of males (62/258: 24% vs 30/251: 12%, p = 0.004). The risk of abnormal brain development in infected fetuses was twice as high in females than in males (Chi(2) = 8.7; OR = 2, IC [1.26-3.21]). In our cases, amniotic fluid CMV DNA load was not significantly higher in males than in females (p = 0.06) and was also similar in severely and non-severely infected fetuses (p = 0.09).

Adult↗