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PubMed2001

Scores and grades: a sampling of how college students and food safety professionals interpret restaurant inspection results.

Controversy surrounds the use of posted restaurant inspection scores and grades. There is much debate about how well a score or grade conveys risks to potential diners, and questions remain about how the public interprets posted scores and grades, regardless of how they are derived. To determine how such scores and grades are perceived, the authors surveyed a sample of Maryland college students and food safety professionals about what a posted inspection score of 86 means and what a letter grade of C means. There was no clear consensus about the meaning of the scores and grades described in the surveys. The majority of respondents felt that a restaurant should be either open or closed, and that the public should not have to decipher the meaning of a posted sign. The response of the sample is especially significant given that many respondents claimed that they would not eat at a restaurant with either a posted letter grade of C or a posted score of 86. Although these results do not come from a random sample, they nevertheless suggest that the public has a limited understanding of such signs and, at the same time, bases dining decisions on them. Thus, environmental health professionals must carefully consider how the public can be better educated about signs, how the signs can be less ambiguous, and whether posted restaurant inspection results are even advisable in their current form.

Adult↗
PubMed1994

Improved method for mutagenicity testing of gaseous compounds by using a gas sampling bag.

A simple and safety gas exposure method was developed using a gas sampling bag as an exposure vessel and a preparation vessel of diluted gas. The gas exposure conditions such as amount of S9 in the plate, volume of gas for the plate, amount of top agar, exposure period and exposure temperature were examined by mutagenicity testing of 1,3-butadiene using the gas sampling bag. Mutagenicity tests of 14 compounds and 1,3-butadiene on S. typhimurium TA98, TA100, TA1535 and TA1537, and E. coli WP2 uvrA were also examined by the developed gas exposure method. 1,3-Butadiene, propyne (methyl acetylene), monochlorodifluoromethane, ethylchloride, diborane and silane were mutagenic. 1-Butene, 2-butene, 2-methylpropene, methyl vinyl ether, trichlorofluoromethane, dichlorodifluoromethane, 1,2-dichloro-1,1,2,2-tetrafluoroethane, 1,1-difluoroethane and phosphine were not mutagenic on S. typhimurium TA98, TA100, TA1535 and TA1537, and E. coli WP2 uvrA with or without metabolic activation. These results were compatible with a previous report, and this developed method has the advantage that it can be tested easily and safely for combustible and self-combustible substances such as 1,3-butadiene and silane.

Animals↗
PubMed2003

The US Agency for Healthcare Research and Quality's activities in patient safety research.

PURPOSE: To update the international community on the US Agency for Healthcare Research and Quality's (AHRQ) recent and current activities in improving patient safety. DATA SOURCES: Review of the literature concerning the importance of patient safety as a health care quality issue, international perspectives on patient safety, a review of research solicitations, and early results of funded studies. STUDY SELECTION: A representative sample of patient safety studies from those currently being funded by AHRQ. RESULTS: In response to a growing interest in patient safety in general and a recent US Institute of Medicine report on patient safety in particular, the US Agency for Healthcare Research and Quality has refocused its quality research mission. In the fiscal year 2002, AHRQ spent US$55 million on patient safety research. This investment was spread across six complementary research areas: (1) health systems error reporting, analysis, and safety improvement research demonstrations; (2) Clinical Informatics to Promote Patient Safety (CLIPS); (3) Centers of Excellence for patient safety research and practice (COE); (4) Developmental Centers for Evaluation and Research in Patient Safety (DCERPS); (5) The Effect of Health Care Working Conditions on Quality of Care; and (6) Partnerships for Quality: Patient Safety Research Dissemination and Education. Internal teams of researchers at AHRQ have published studies on patient safety, such as documenting the impact of medication errors. In addition to funding research on patient safety, AHRQ is an integral partner in several national and international collaborations to form strategic synergies that build upon each member organization's strengths, reduce redundant efforts, and benefit from each other's successes. As evidence on patient safety is generated, AHRQ also serves the important mission of disseminating information to the public. CONCLUSION: The patient safety research field has undergone a period of rapid evolution. It is now incumbent upon the international health care quality improvement community to translate the future results of this research investment into improved safety for patients.

Community-Institutional Relations↗
PubMed1996

[Chorionic villus sampling in multiple pregnancies].

Prenatal genetic diagnosis is recommended in multiple pregnancies because of the increased prevalence of genetic abnormalities in such fetuses. It can be done early by chorionic villus sampling or later by amniocentesis. Several studies have demonstrated the efficacy and safety of chorionic villus sampling in multiple pregnancies. Our study describes the results of this method in a twin pregnancy and in 3 triplet pregnancies, which represent 3% of the chorionic villus samplings performed in our ultrasound unit during 1989-95. All genetically deformed fetuses in these pregnancies were identified by chorionic villus sampling and the method was not associated with fetal loss. Our results confirm the safety and efficacy of chorionic villus sampling as expressed in the world literature.

Chorionic Villi Sampling↗
PubMed2003

[Nursing accidents at the workplace and their relation with the security and occupational health status].

The purpose of this study was to examine the accidents and incidents that take place in the workplace and their relationship with the occupational health and safety climate. The sample for this study was chosen by convenience and was composed of 154 professional nurses. The Occupational Health and Safety Climate Scale. (Roduguez et al., 2000) was used for the research. The results of the study reveal that the variables that contribute to understanding the determinants of the occupational health and safety climate are the individual's relationships with peers and supervisors, the number of trainings in the area of occupational health and safety and the number of accidents that the individual has experienced.

Accidents, Occupational↗
PubMed1996

Reducing patient eligibility criteria in cancer clinical trials.

PURPOSE: To discuss patient eligibility criteria in phase III cancer clinical trials in the larger setting of the complexity of these trials, to review the various reasons for imposing restrictive eligibility requirements, to discuss the problems caused by these requirements, to argue that these requirements should be greatly relaxed in most cancer clinical trials, to provide some guiding principles and practical suggestions to facilitate such a relaxation, and to give an example of how eligibility requirements were reduced in a recent clinical trial in acute lymphocytic leukemia. METHODS: Implicit and explicit reasons for including eligibility criteria in clinical trials are reviewed. Safety concerns and sample size issues receive special attention. The types of problems restrictive eligibility criteria cause with respect to scientific interpretation, medical applicability, complexity, costs, and patient accrual are described. RESULTS: A list of three items that each eligibility criterion should meet in order to be included is proposed and applied to a recent trial in acute lymphocytic leukemia. CONCLUSION: Phase III clinical trials in cancer should have much broader eligibility criteria than the traditionally restrictive criteria commonly used. Adoption of less restrictive eligibility criteria for most studies would allow broader generalizations, better mimic medical practice, reduce complexity and costs, and permit more rapid accrual without compromising patient safety or requiring major increases in sample size.

Clinical Trials, Phase III as Topic↗
PubMed2003

Application of Bacillus anthracis PCR to simulated clinical samples.

We evaluated PCR for the detection of Bacillus anthracis DNA from simulated clinical specimens relevant for the microbiological diagnosis of anthrax or exposure to B. anthracis spores. In simulated blood specimens, the lowest limit of detection was 400 CFU per mL of blood, which may be sufficient for samples from patients with septic anthrax. Screening nasal swabs by PCR may not be sensitive enough to rule out dangerous exposure to anthrax spores, as a minimum of 2000 spores per sample was required for detectable amplification. As spores survived some standard DNA purification methods, special attention should be paid to laboratory safety when preparing samples possibly containing live spores.

Anthrax↗
PubMed1994

A comparison of pregnancy loss between transcervical and transabdominal chorionic villus sampling.

OBJECTIVE: To evaluate the comparative safety of transcervical and transabdominal chorionic villus sampling (CVS). METHODS: From May 1988 to January 1992, CVS was performed by two operators at 9-12 weeks' gestation in 1048 singleton pregnancies. The sampling method for each patient, transabdominal or transcervical, was chosen primarily based upon placental location; the transabdominal route was used for anterior or fundal location and the transcervical route for posterior placentation. Perinatal outcome was assessed by post-procedure patient telephone contact, mid-gestation ultrasound evaluation, postpartum questionnaire completed by the referring obstetrician, and telephone interview with each patient after delivery. RESULTS: Complete follow-up was available in 1012 cases (97%). Excluding 39 elective abortions, 35 of 973 euploid pregnancies aborted spontaneously. The difference in fetal loss rate between transcervical and transabdominal CVS approached statistical significance (5.2 versus 2.9%; P = .058). Bleeding before CVS (P = .006) and multiple placental aspirations (P = .022) were associated with fetal loss for the entire study group. An interaction between uterine position and sampling method was also indicated; an increased loss rate was associated with transcervical CVS in the presence of uterine retroversion (P = .0017). CONCLUSION: Despite choosing the preferred CVS method for each patient, an increased loss rate may be associated with transcervical sampling in the presence of uterine retroversion.

Abdomen↗
PubMed2005

Ultrasound scan-guided core sampling for diagnosis versus freehand FNAC of the thyroid gland.

BACKGROUND AND AIM: Freehand fine needle aspiration cytology (FNAC) is an obligatory investigation of the thyroid nodule. Between 5.0-43.1% of FNAC samples are reported as being initially unsatisfactory. In our unit, thyroid freehand FNAs are performed with a small needle (21 or 23G). Non-dominant nodules as part of multinodular goitres, difficult to palpate nodules or nodules with previously unsatisfactory freehand FNACs are sampled under ultrasound scan (USS) guidance with the larger 20G cutting core sampling technique. We aimed to compare the satisfactory sampling rate and safety of the two different methods. PATIENTS AND METHODS: Cytology forms were reviewed for 262 freehand FNACs and USS-guided core samples, performed in our unit over a two-year interval (1 July 1999 to 30 June 2001). RESULTS: Ultrasound-guided core samples for cytology were unsatisfactory (AC0-1) in 19/121 (15.6%) of the cases, compared with 66/141 (46.8%) of freehand FNACs (p value = < 0.0001). Ten out of eleven patients (91%) had a satisfactory USS-guided core after an unsatisfactory freehand FNA; 7/15 patients (46.7%) had satisfactory repeat freehand FNACs following an initial unsatisfactory freehand FNAC (p value = 0.0191). There were no complications as a result of either freehand FNAC or USS-guided core sampling. CONCLUSION: USS-guided cores provided more satisfactory samples for assessment than freehand FNACs. The USS-guided technique is safe despite the use of the larger cuffing needle. The USS-guided core sampling was also a useful tool for repeat thyroid nodule sampling after an unsatisfactory freehand FNAC.

Biopsy, Fine-Needle↗
PubMed2005

Sample size and power analysis for endometrial safety studies.

Endometrial safety studies are required for the approval of progestin components. The Committee for Proprietary Medicinal Products requirement is the actual percentage below 2% and the upper limit of the one-sided exact 95% confidence interval not more than 2% above the point estimate. The more recent U.S. Food and Drug Administration requirement is the actual percentage < or = 1% and the upper limit of the one-sided exact 95% confidence interval < or =4%. I studied the sample size and power needed to satisfy both requirements based on the exact confidence intervals for the binomial parameter and the Poisson parameter. I discovered that a larger sample size does not always lead to a higher power. I presented a best sample size that satisfies both requirements and recommended that the patient enrollment should be closely monitored during the study.

Aged↗
PubMed1996

A content analysis of safety behaviors of television characters: implications for children's safety and injury.

Examined frequency and characteristics of safety behaviors in television programs popular with child audiences. A sample of 52 programs was coded for safety event location, demographic characteristics of safety models, social and physical contexts of safety events, and successful or unsuccessful outcomes of safety behaviors. Results indicate an overall rate of 13 safety behaviors per hour, with hour half of all safety behaviors located in commercial advertisements. Most safety behaviors were performed by made adult characters, had limited relevance for children, and were not associated with either positive or negative outcomes. Findings are discussed in terms of their relevance for observational learning of safety behaviors by child viewers.

Adolescent↗
PubMedDate not supplied

[Monitoring microbiological safety of small systems of water distribution. Comparison of two sampling programs in a town in central Italy].

OBJECTIVE: To determine the frequency of sampling in small water distribution systems (<5,000 inhabitants) and compare the results according to different hypotheses in bacteria distribution. DESIGN AND SETTING: We carried out two sampling programs to monitor the water distribution system in a town in Central Italy between July and September 1992; the Poisson distribution assumption implied 4 water samples, the assumption of negative binomial distribution implied 21 samples. Coliform organisms were used as indicators of water safety. The network consisted of two pipe rings and two wells fed by the same water source. The number of summer customers varied considerably from 3,000 to 20,000. RESULTS: The mean density was 2.33 coliforms/100 ml (sd= 5.29) for 21 samples and 3 coliforms/100 ml (sd= 6) for four samples. However the hypothesis of homogeneity was rejected (p-value <0.001) and the probability of II type error with the assumption of heterogeneity was higher with 4 samples (beta= 0.24) than with 21 (beta= 0.05). CONCLUSION: For this small network, determining the samples' size according to heterogeneity hypothesis strengthens the statement that water is drinkable compared with homogeneity assumption.

Binomial Distribution↗
PubMed1997

PK/PD modelling of high-dose diltiazem--absorption-rate dependency of the hysteresis loop.

To investigate bioequivalence of 2 different sustained-release diltiazem formulations the preparations each containing 180 mg diltiazem-HCl were given to 20 healthy male volunteers in an open, randomized, 2-way crossover design. Blood samples were taken before drug administration and at 14 times until 30 hours post application. 12-lead ECGs were recorded at the same time points, and atrioventricular conduction time was monitored as a safety parameter. Plasma samples of 8 subjects were assayed by HPLC. Peak values of plasma concentrations and prolongation of the PQ interval were taken from the plasma concentration or ECG data directly, AUCs of pharmacokinetic and pharmacodynamic effects were calculated by the linear trapezoidal rule, MRTs were calculated as the first moment over AUC. Bioequivalence was tested according to Schuirman (ratios of parameters and shortest 90% confidence intervals) using pharmacokinetic and pharmacodynamic data sets. Relative bioavailability of the test preparation with respect to AUC0-30 was 110% with the 90% confidence interval ranging from 100 to 130%. Bioavailability with respect to Cmax was significantly higher (190%) with a 90% confidence interval not even including 100%. Consequently, MRT was significantly lower with the test preparation (80%), again with a confidence interval not including unity. Relative bioavailability of the test product in terms of pharmacodynamic parameters was 160% in the extent of the effect (AUEC0-10), 190% even with the rate of the effect (Emax) and 80% with the mean residence time (MRTE). All parameters differ significantly between the products, Bioinequivalence was therefore concluded from these results. The functional relationship between pharmacokinetic and pharmacodynamic parameters could be described by hysteresis loops, however, with a clockwise rotation. This cannot be explained in the classical way by the time-lag between central and effect compartments. Two alternative conceivable explanations, namely formation of antagonistic metabolites or downregulation, were tested for plausibility. A comparison of the present results to literature data favors the model of downregulation/tolerance development. This model is additionally supported by the finding that the shape of the hysteresis is dependent on the absorption rate of diltiazem, calculated as mean input time according to MIT = MRT - 1/lambda z. It is concluded that acute tolerance develops at least with the electrophysiological action of diltiazem after oral application and that the extent of tolerance development increases when decreasing its absorption rate. Bioequivalence assessment of diltiazem is possible using pharmacodynamic parameters, however, since PK/PD relationships are influenced by the absorption rate, extent parameters may be misinterpreted when rate parameters of the test formulations are different.

Absorption↗
PubMedDate not supplied

Screening for intimate partner violence in a primary care setting: the validity of "feeling safe at home" and prevalence results.

BACKGROUND: We conducted a study to assess the validity of a screening question commonly used to detect intimate partner violence (IPV) in primary care settings. We also analyzed prevalence and risk factors of IPV. METHODS: We used an embedded domestic violence detection instrument in a general health questionnaire at one family medicine clinic. Questionnaire scales included a modified version of the Conflict Tactics Scale (CTS), depression and alcohol use scales, and a personal safety question ("Do you feel safe at home?"). We assessed the sensitivity, specificity, and predictive value of the personal safety question in our sample using responses to the modified CTS and the personal safety question. Three hundred ninety-nine female patients over the age of 18 completed the survey. RESULTS: CTS results revealed 44.3% of women experienced any violence, 43.5% of women experienced psychological violence in the presence or absence of physical violence, and 10.3% experienced physical violence in the presence or absence of psychological violence in the previous 90 days. The sensitivity of a single question used to detect any violence ("Do you feel safe at home?") was 8.8%; the specificity was 91.2%. Racial identity, marital status, and depression influenced the likelihood of IPV. CONCLUSIONS: These preliminary results call into question the utility of the safety question "Do you feel safe at home" for detecting cases of intimate partner violence in a primary care sample.

Adolescent↗
PubMed2003

Posttraumatic stress disorder, alcohol use, and perceived safety after the terrorist attack on the pentagon.

OBJECTIVE: The authors examined posttraumatic stress disorder (PTSD), alcohol use, and perceptions of safety in a sample of survivors of the September 11, 2001, terrorist attack on the Pentagon. METHODS: Analyses were conducted to examine the effect of past traumatic experience, trauma exposure, initial emotional response, and peritraumatic dissociation on probable PTSD, substance use, and perceived safety among 77 survivors seven months after the attack. RESULTS: Eleven respondents (14 percent) had PTSD. Those with PTSD reported higher levels of initial emotional response and peritraumatic dissociation. Ten respondents (13 percent) reported increased use of alcohol. Women were more than five times as likely as men to have PTSD and almost seven times as likely to report increased use of alcohol. Persons with higher peritraumatic dissociation were more likely to develop PTSD and report increased alcohol use. Those with lower perceived safety at seven months had higher initial emotional response and greater peritraumatic dissociation and were more likely to have PTSD, to have increased alcohol use, and to be female. CONCLUSIONS: The association of perceived safety with gender, the presence of PTSD, and increased alcohol use among survivors of the terrorist attack on the Pentagon warrants further study.

Adult↗
PubMed1995

'What I said' versus 'what you heard': a comparison of physicians' and parents' reporting of anticipatory guidance on child safety issues.

OBJECTIVE: Unintentional injuries are the number one cause of death for infants. Many of these injuries could be prevented if parents took additional safety precautions. In this study physicians' and parents' perspectives regarding the part that physicians play in educating first time parents about child safety issues were compared. METHODS: All pediatricians and family physicians in London, Ontario were surveyed by mail (68% return rate) regarding their practices, attitudes, and beliefs related to parent education about child safety issues. A sample of 114 first time mothers, including 38 each with 6, 12, and 18 month old infants, completed a telephone interview. All parents had physicians who had returned questionnaires. RESULTS: There was good correspondence between parents' and physicians' judgments about the safety issues most often covered, and what role physicians should adopt regarding parent education about child safety issues. In addition, they both agreed that parents seldom seek out safety information by asking questions. Relative to parent reports, however, physicians significantly overestimated the time they spent on safety issues and the degree of their direct involvement in communicating this information. The best predictor of time spent by physicians on safety issues was their rating of the importance of assuming the role of parent educator. The best predictor of parents asking questions about child safety was their rating of the adequacy of physicians' responses to previously asked questions. CONCLUSIONS: The results suggest that both physicians and parents contribute to undermine communication about child safety during well-baby visits.

Accident Prevention↗