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PubMed2003

A double-blind, randomized, group-comparative study of the tolerability and efficacy of 6 weeks' treatment with mirtazapine or fluoxetine in depressed Chinese patients.

AIM: To compare the efficacy and tolerability of mirtazapine and fluoxetine treatment in a sample population consisting of Chinese patients suffering moderate-to-severe depression. METHOD: 133 patients with a diagnosis of major depressive episode (DSM-IV) and scoring 15 or more on the 17-item Hamilton Rating Scale for Depression (HAM-D) were randomly assigned to receive 6 weeks of treatment with either mirtazapine (15-45 mg/day) or fluoxetine (20-40 mg/day). Efficacy was assessed using the HAM-D and Clinical Global Impressions scale, with analyses performed on the intent-to-treat sample using the last-observation-carried-forward method. Safety analysis was based on the all-subjects-treated group. RESULTS: Mean daily doses were 34.1 mg for mirtazapine (N = 66) and 30.7 mg for fluoxetine (N = 66). Thirty patients in the mirtazapine group and 22 in the fluoxetine group dropped out. Both drugs proved equally effective for reduction of the overall symptoms of depression throughout the treatment period. At day 42, the mean reductions in HAM-D total score (compared with baseline) were 11.8 and 10.6 for the mirtazapine and fluoxetine groups, respectively; however, the changes were not statistically significant. Both treatments were well tolerated, with more nausea and influenza-like symptoms observed for the fluoxetine group, and greater weight increase and somnolence for the mirtazapine analog. CONCLUSION: Both mirtazapine and fluoxetine were indistinguishable in effectiveness for treatment of depressive symptoms, and both were well tolerated by our population of depressed Chinese patients. In line with analogous Western reports, the safety of mirtazapine and fluoxetine was comparable for our depressed Chinese patients; however, slightly different side effect profiles were noted for the 2 drugs in our study.

Adolescent↗
PubMed2001

Randomized trial of artesunate and mefloquine in comparison with quinine sulfate to treat P. falciparum malaria pregnant women.

To compare the effectiveness and safety of quinine sulfate and artesunate with mefloquine for treating second trimester pregnancy in women who suffered from Plasmodium falciparum malaria. The prospective study was done in Srisangwal Hospital, Mae Hong Son, Thailand. Sixty, second to third trimester pregnant patients with P. falciparum infection, were recruited at random. They received either quinine sulfate 10 mg/kg/day for at least 7 days, 29 women (group I), or oral artesunate 2 mg/kg as the first dose, 1 mg/kg every 12 hours orally for at least 5 days together with split doses of mefloquine, 15 mg/kg and 6 hours later 10 mg/kg orally 1 day after artesunate was stopped, 28 women (group II). Three cases (5%) were lost to follow-up before delivery, one case in group I and two cases in group II. After treatment, the mean hematocrit of group I was significantly less than group II (p = 0.000). The PCT (parasite clearance time) and FCT (fever clearance time) of group II were significantly shorter than group I (p = 0.000). None of the patients in both groups had recrudescences within 28 days. Group I had more adverse effects than group II. No adverse neurological effects in pregnancy were found in both groups. The calcification of placenta and IUGR (Intrauterine growth retard) were not different between the two groups (p = 0.964, 0.363 respectively). The PCT was not different between the calcified placenta group and normal placenta group (p = 0.058), but the TTPP (Total time of parasite presentation) was (p = 0.000). TTPP related to low birth weight and low apgar score at 1 minute might be the cause (p = 0.000, 0.000 F = 5.261, 21.627 respectively). TTPP and PCT related to neonatal blood pH and caused low neonatal blood pH (p = 0.000, 0.001 F = 24.351, 11.162 respectively). The physical and neurological development of the babies at 2, 4, 6 and 12 months follow-up, were normal and there were no congenital abnormalities in either group. TTPP relating to fetal outcome, the longer the TTPP, the worse the fetal outcome, so we should diagnose early and treat P. falciparum malaria in pregnancy to prevent fetal jeopardy. Artesunate with mefloquine could shorten the PCT more than quinine sulfate in pregnancy, so the fetal outcome was better than that of quinine sulfate. In cases of prolonged infection before treatment, artesunate might be the alternative treatment of P. falciparum malaria in pregnancy. However, its safety should be carefully studied further with a larger sample size.

Adult↗
PubMed2004

Assessment of pasteurisation of milk and cream produced by on-farm dairies using a fluorimetric method for alkaline phosphatase activity.

The alkaline phosphatase test is used as an indicator of adequate pasteurisation of milk and cream. A proprietary fluorimetric technique (Fluorophos) is a sensitive and quantitative method for the determination of alkaline phosphatase (ALP) activity in milk products. Currently, adequate pasteurisation of milk products is regarded as confirmed in samples that contain a residual bovine ALP activity of < or =500 mU/litre. This is equivalent to the statutory acceptable level of 4ug phenol/ml required by the EC analytical method. The purpose of the present study was to assess the effectiveness of pasteurisation of milk and cream produced by on-farm dairies. In a longitudinal study over a four-year period, 4,999 samples of milk and cream were collected from 130 on-farm dairies and from two large commercial dairies in NW England for comparison. Bovine ALP activity of >500 mU/litre was deemed as a failure and was found in 3.5% of whole milk, 2.4% semiskimmed milk, 5.0% of skimmed milk, and 39% of cream samples from on-farm dairies. Bovine ALP activity of >100 and <500 mU/litre was found in 18.4% of whole milk, 9.3% of semi-skimmed milk, 13.2% skimmed milk and 44.5% of cream samples from on-farm dairies. Results with skimmed milk samples showed significantly lower bovine ALP activity than whole milk. All 409 milk and cream samples from two large commercial dairies passed the fluorimetric test at less than 500 mU/litre of bovine ALP, and 99% of these milk and cream samples had bovine ALP activity of less than 100 mU/litre. The presence of residual bovine phosphatase indicates a failure and may be due to either inadequate pasteurisation or post pasteurisation contamination with raw milk. Residual bovine phosphatase was demonstrated in 108/114 (94.7%) of milk samples with a bovine ALP activity greater than 500 mU/litre, i.e. true failures. Of more concern is that residual bovine phosphatase was found in 395/401 (98.5%) of samples that gave bovine ALP activity greater than 100 mU/litre but equal to or less than 500 mU/litre. Residual bovine phosphatase was demonstrated in 37/108 (30.2%) of cream samples with bovine ALP activity greater than 500 mU/litre. Presence of reactivated bovine phosphatase is not an indication of a failure but can mask the presence of residual bovine phosphatase. Reactivated bovine phosphatase was found in 74/106 (69.8%) of cream samples. Our results confirm that the more sensitive fluorimetric method is suitable for testing pasteurised whole milk and semiskimmed milk, but for statutory purposes the acceptable level of residual bovine phosphatase should be <100 mU/litre. Our findings have highlighted a potential problem when testing skimmed milk and cream samples from on-farm dairies. To ensure public safety we need more stringent standards for the ALP test and new methods that will accurately confirm that pasteurisation of these products has been achieved.

Alkaline Phosphatase↗
PubMedDate not supplied

[Contributions of the epidemiologic method to the rational study of juvenile delinquency].

In this study we analyze some of the contributions of the epidemiological method to the study of juvenile delinquency. We used 68,583 complaints to the Police during 1983-1986 to do so; furthermore, we asked the opinion of the citizens by means of an opinion poll of a representative sample of the population on the subject of public safety. The application of the techniques of Multivariant Analysis (Analysis of the Principal Components) allowed us to reduce the dimensions of the study and fix our attention on 8 specific crimes. We have attempted to design a system, using Predictive Epidemiology, for the evaluation of preventive measures applied to the rational fight against delinquency. Special emphasis is made on the presentation of a system of analysis for the calculation of the real rate of delinquency in a given community.

Epidemiologic Methods↗
PubMed1987

Biometrical aspects in the design and analysis of chimpanzees trials assessing hepatitis virus inactivation.

Hepatitis virus safety of products derived from blood is achieved by screening of individual blood donations and by production processes efficient in eliminating and inactivating residual amounts of hepatitis viruses. A quantitative measure of process inactivation efficiency is the inactivation factor derived from process overchallenging experiments. A product is safe if the corresponding process inactivation factor is as high as the one of a product whose safety has been clinically established. Reliable information on hepatitis safety cannot be obtained by testing commercial end product samples in chimpanzees.

Animals↗
PubMed1997

Clinical pharmacokinetics and tolerability of dotarizine in healthy subjects after single and multiple oral administration.

Dotarizine is a new diphenylmethylpiperazine derivative with Ca2+ channel blocking properties and inhibitory effects on 5-HT2A and 5-HT2C receptors. Previous pilot studies in healthy volunteers demonstrated a good tolerability after single and multiple dosing. Dotarizine appeared to be rapidly and extensively metabolized to an active compound (FI-6020). We aimed to study the physiologic, subjective and psychomotor acute effects of oral dotarizine after single dose administration, to evaluate the tolerability and safety after multiple dosing over 2 weeks, and to study the pharmacokinetic parameters and linearity after single and multiple administration. Two different studies were carried out in 2 groups of 8 healthy male volunteers. Oral single doses of dotarizine 50, 100 and 200 mg were administered in a randomized, double-blind, crossover, placebo-controlled trial. Oral doses of 50 mg twice daily were administered in an open trial over 14 days. Drug effect assessments included vital signs, collection of adverse events, ECG and blood and urine safety evaluations, subjective effects, psychomotor performance tasks and blood sampling. Dotarizine and its metabolite were determined by gas chromatography with N-P detector. The results showed a good tolerability of dotarizine after single oral doses as well as multiple oral doses over 14 days. No clinically relevant adverse events were reported during the study. The highest single dose (200 mg) produced a slight increase in sedation-related symptoms as well as a slight impairment in psychomotor performance tasks. Dotarizine and its major metabolite proved linear kinetics at single doses. The administration of oral doses of dotarizine 50 mg b.i.d. reached the steady state after the 7th day of treatment. The pharmacokinetic parameters remained similar from day 7 to day 14. The terminal elimination half-life of dotarizine and its metabolite appeared to be between 7 and 12 h.

Administration, Oral↗
PubMed2004

Viewing behaviour of spider phobics and non-phobics in the presence of threat and safety stimuli.

OBJECTIVES: To determine whether spider phobics and spider non-phobics differ in attending to threat and safety stimuli in close proximity, or spatially separated. METHOD: A sample group of 16 spider-phobic and 16 spider-non-phobic volunteers were drawn from a student population on the basis of their scores on Watts and Sharrock's Spider Phobia Questionnaire. Attention was assessed by way of participants' viewing behaviour using an ASL 501 head-mounted eye-tracking system. In a control condition, participants viewed a neutral stimulus (a TV video) in the absence of the threat stimulus. In two experimental conditions, the threat stimulus (a live Chilean rose tarantula) was introduced (a) immediately beside the safety stimulus (the only exit of the experimental room), or (b) away from the safety stimulus. RESULTS: In the experimental conditions, phobics reduced their viewing of the TV and increased their viewing of the tarantula and of the exit; the biggest changes occurred when tarantula and exit were together. Phobics also made more eye motions across the experimental room. CONCLUSION: Our results are consistent with previous research employing reaction time to a neutral stimulus as dependent measure. In addition, our results suggest that phobics scan the environment as part of safety behaviour. We suggest that exposure treatments to reduce spider phobia may be facilitated by encouraging patients to stop environmental scanning.

Adult↗
PubMed2005

Monitored anesthesia care provided by registered respiratory care practitioners during cataract surgery: a report of 1957 cases.

OBJECTIVE: To evaluate the safety and feasibility of having monitored anesthesia care during cataract surgery provided by registered respiratory care practitioners (RRCPs). DESIGN: Retrospective case series. PARTICIPANTS: One thousand nine hundred fifty-seven consecutive patients undergoing cataract surgery at one surgical center between November 2001 and October 2003. METHODS: Phacoemulsification cataract surgery with intraocular lens insertion was performed using topical anesthesia, with or without IV sedatives. An RRCP, trained to function as an anesthesia assistant, provided monitored anesthesia care during all stages of surgery, with an anesthesiologist immediately available for consultation or assistance as required. MAIN OUTCOME MEASURES: The number of serious medical complications resulting from the anesthesia or surgery was measured. The rate of anesthesiologist intervention required at each stage of surgery--preoperative, intraoperative, and postoperative--was determined, along with the reasons for the interventions. Age, American Society of Anesthesiologists (ASA) risk class (a rating of preoperative physical status), and number of IV sedative agents given were analyzed as potential predictors of the need for anesthesiologist intervention. RESULTS: Among the 1957 cataract surgeries, there were no adverse medical events that resulted in death, hospitalization, or tracheal intubation. Two cases were aborted intraoperatively for medical reasons. A total of 78 cases (4.0%) required anesthesiologist intervention, with 34 (1.7%) requiring preoperative intervention, 43 (2.2%) requiring intraoperative intervention, and 3 (0.2%) requiring postoperative intervention; 4 cases required 2 separate interventions. The mean age of the intervention group (73.9 years) was statistically greater than that of the nonintervention group (71.0) (P = 0.02). A higher ASA rating (>2) correlated with an increased need for anesthesiologist intervention in terms of the total intervention rate (P<0.0001) and the intraoperative rate alone (P<0.0001). The use of more IV sedative agents (2 or 3 vs. 0 or 1) was marginally associated with a higher total intervention rate (P = 0.053) but not with a higher intraoperative intervention rate (P = 0.68). CONCLUSION: With the inherent safety of cataract surgery and the relatively low need for anesthesiologist intervention, we believe it is justified to allow RRCPs, trained as anesthesia assistants, to provide monitored anesthesia care during cataract surgery so long as anesthesiologist support is directly available when required. Potential benefits include cost savings in health care and decreased demand for anesthesiology services. To validate formally the preservation of patient safety from such a change in practice, however, a larger sample size would be required due to the inherently low rate of cataract surgery complications.

Adult↗
PubMed1983

The safety standards of domestic swimming pools 1980-1982.

The accessibility and safety standards of domestic swimming pools were studied for a sample of 1118 five-year-old children. Comparison with data collected in 1980 indicated two major trends. First, there has been an increase in the number of children in this birth cohort who had a swimming pool on their property or on a neighbouring property: in 1980 31 percent of children were living on a property with a swimming pool or had neighbours with a swimming pool; in 1982 this figure had risen to 41 percent. Coupled with this increasing number of swimming pools there was a marked decline in pool safety standards. In 1980 one in five pools lacked any safety features whereas in 1982 nearly half of the pools surveyed lacked these features. This situation of an increasing number of domestic pools associated with declining safety standards may be a factor in the increasing number of child drownings in domestic swimming pools in New Zealand. The mothers were also questioned about their attitudes to fencing legislation or by-laws requiring adequate pool fencing and gates. This showed strong support with 86 percent of mothers being in favour of such regulations and only 9 percent declaring disagreement with such a move.

Attitude↗
PubMed1986

The safety implications of some control changes at urban intersections.

Injury accident data for a sample of New Zealand urban intersections were analysed, looking for an increase or decrease which coincided with a change in control. Increases or decreases were also looked for in certain types of accidents and in accident severity. The control changes considered were from give way signs, stop signs and no control to signals and small roundabouts and also from no control to give way and stop signs.

Accidents, Traffic↗
PubMed2000

An effective protection factor study of respirators used by primary lead smelter workers.

An industrial hygiene study was conducted at a primary lead smelter to determine the effective protection factors for negative pressure and powered air purifying half-mask respirators. The study involved 99 paired personal samples taken in six different work areas, in which randomly chosen subjects from the workforce wore dual sampling pumps connected to closed-face 37-mm cassettes. The cassettes were attached either to the workers' lapels for exposure measurements outside the respirator or to a ported respirator for exposure measurements inside the respirator. Samples were collected throughout the work shift and analyzed for lead according to National Institute of Occupational Safety and Health (NIOSH) Method 7082. Using particle size distribution data obtained for the same workplaces, the within-mask samples were corrected for sampling bias. The negative pressure half-mask respirators showed a mean effective protection factor of 6.5 and a mean corrected effective protection factor of 4.56, with a 5th percentile less than 0.5. Approximately 80 percent and 90 percent of the effective protection factors and the corrected effective protection factors, respectively, were equal to or less than the assigned protection factor of 10. For the powered air purifying half-mask respirators, the means for effective protection factor and corrected effective protection factor were 18.20 and 11.92, respectively, with a 5th percentile of 1.0 or less. Approximately 90 percent and 95 percent of the effective protection factors and the corrected effective protection factors, respectively, were equal to or less than the assigned protection factor of 50. The uncorrected and corrected within-mask lead concentrations for both types of respirators exceeded the Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL) for lead by 19 percent to 58 percent. These results indicate that the straight application of assigned protection factors to actual workplace situations may not always be appropriate.

Adult↗
PubMed2005

Stability of response characteristics of a Delphi panel: application of bootstrap data expansion.

BACKGROUND: Delphi surveys with panels of experts in a particular area of interest have been widely utilized in the fields of clinical medicine, nursing practice, medical education and healthcare services. Despite this wide applicability of the Delphi methodology, there is no clear identification of what constitutes a sufficient number of Delphi survey participants to ensure stability of results. METHODS: The study analyzed the response characteristics from the first round of a Delphi survey conducted with 23 experts in healthcare quality and patient safety. The panel members had similar training and subject matter understanding of the Malcolm Baldrige Criteria for Performance Excellence in Healthcare. The raw data from the first round sampling, which usually contains the largest diversity of responses, were augmented via bootstrap sampling to obtain computer-generated results for two larger samples obtained by sampling with replacement. Response characteristics (mean, trimmed mean, standard deviation and 95% confidence intervals) for 54 survey items were compared for the responses of the 23 actual study participants and two computer-generated samples of 1000 and 2000 resampling iterations. RESULTS: The results from this study indicate that the response characteristics of a small expert panel in a well-defined knowledge area are stable in light of augmented sampling. CONCLUSION: Panels of similarly trained experts (who possess a general understanding in the field of interest) provide effective and reliable utilization of a small sample from a limited number of experts in a field of study to develop reliable criteria that inform judgment and support effective decision-making.

Consensus Statements as Topic↗
PubMed1988

Considerations in the use of laboratory robots: aspects of safety and accuracy.

A general-purpose laboratory robot was configured to prepare blood samples for the HBsAg and anti-HIV tests. Several issues were studied in order to eliminate problems and optimize the system. These included pipetting accuracy, intersample carryover, reagent interference, splashing and aerosol generation and user-related issues. A number of general guidelines were developed to assist others in developing and implementing systems for this and similar applications.

Evaluation Studies as Topic↗
PubMed2006

Experiences of health professionals who conducted root cause analyses after undergoing a safety improvement programme.

BACKGROUND: Research on root cause analysis (RCA), a pivotal component of many patient safety improvement programmes, is limited. OBJECTIVE: To study a cohort of health professionals who conducted RCAs after completing the NSW Safety Improvement Program (SIP). HYPOTHESIS: Participants in RCAs would: (1) differ in demographic profile from non-participants, (2) encounter problems conducting RCAs as a result of insufficient system support, (3) encounter more problems if they had conducted fewer RCAs and (4) have positive attitudes regarding RCA and safety. DESIGN, SETTING AND PARTICIPANTS: Anonymous questionnaire survey of 252 health professionals, drawn from a larger sample, who attended 2-day SIP courses across New South Wales, Australia. OUTCOME MEASURES: Demographic variables, experiences conducting RCAs, attitudes and safety skills acquired. RESULTS: No demographic variables differentiated RCA participants from non-participants. The difficulties experienced while conducting RCAs were lack of time (75.0%), resources (45.0%) and feedback (38.3%), and difficulties with colleagues (44.5%), RCA teams (34.2%), other professions (26.9%) and management (16.7%). Respondents reported benefits from RCAs, including improved patient safety (87.9%) and communication about patient care (79.8%). SIP courses had given participants skills to conduct RCAs (92.8%) and improve their safety practices (79.6%). Benefits from the SIP were thought to justify the investment by New South Wales Health (74.6%) and committing staff resources (72.6%). Most (84.8%) of the participants wanted additional RCA training. CONCLUSIONS: RCA participants reported improved skills and commitment to safety, but greater support from the workplace and health system are necessary to maintain momentum.

Health Personnel↗
PubMed2003

The antiparasitic moxidectin: safety, tolerability, and pharmacokinetics in humans.

A study in healthy male volunteers was completed to evaluate the safety, tolerability, and pharmacokinetics of a single oral dose of the antiparasitic moxidectin (MOX). This drug is registered worldwide as a veterinary antiparasitic agent for use in companion and farm animals. This is the first study of MOX in humans. All subjects were between the ages of 18 and 45 years, with normal cardiac, hematologic, hepatic, and renal function. Doses of MOX studied were 3, 9, 18, and 36 mg in cohorts of 6 subjects each (5:1, MOX:placebo). At the 9-mg and 36-mg doses, two separate cohorts were completed, one in the fasted state and one after the consumption of a high-fat breakfast. For all other cohorts, administration was in the fasted state. Safety and tolerability were assessed by physical examinations, ongoing evaluation of adverse events (AEs), and measurement of laboratory values. Pharmacokinetic (PK) samples were collected just prior to dosing and at various time points until 80 days postdose. Safety assessments from all dose groups studied suggested that MOX was generally safe and well tolerated, with a slightly higher incidence of transient, mild, and moderate central nervous system AEs as the dose increased as compared to placebo. The PKs of MOX were dose proportional within the dose range studied, and the elimination half-life (t1/2 elim) was long (mean: 20.2-35.1 days). At the 9-mg and 36-mg doses, a high-fat breakfast was shown to delay and increase the overall absorption but did not increase maximal concentrations when compared to administration in the fasted state. In summary, the results from this study indicate that MOX is safe and well tolerated in humans between the doses of 3 mg and 36 mg.

Administration, Oral↗
PubMed2004

Evaluation of glucose controllers in virtual environment: methodology and sample application.

OBJECTIVE: Adaptive systems to deliver medical treatment in humans are safety-critical systems and require particular care in both the testing and the evaluation phase, which are time-consuming, costly, and confounded by ethical issues. The objective of the present work is to develop a methodology to test glucose controllers of an artificial pancreas in a simulated (virtual) environment. MATERIAL AND METHODS: A virtual environment comprising a model of the carbohydrate metabolism and models of the insulin pump and the glucose sensor is employed to simulate individual glucose excursions in subjects with type 1 diabetes. The performance of the control algorithm within the virtual environment is evaluated by considering treatment and operational scenarios. RESULTS: The developed methodology includes two dimensions: testing in relation to specific life style conditions, i.e. fasting, post-prandial, and life style (metabolic) disturbances; and testing in relation to various operating conditions, i.e. expected operating conditions, adverse operating conditions, and system failure. We define safety and efficacy criteria and describe the measures to be taken prior to clinical testing. The use of the methodology is exemplified by tuning and evaluating a model predictive glucose controller being developed for a wearable artificial pancreas focused on fasting conditions. CONCLUSION: Our methodology to test glucose controllers in a virtual environment is instrumental in anticipating the results of real clinical tests for different physiological conditions and for different operating conditions. The thorough testing in the virtual environment reduces costs and speeds up the development process.

Algorithms↗
PubMed1997

Reducing MMPI-2 defensiveness: the effect of specialized instructions on retest validity in a job applicant sample.

The MMPI-2 is often used for screening job applicants when public safety or security are at risk. Inherent in such applications is concern for profile validity and test defensiveness. In this study, we examine the impact of revised instructions on profile validity for a group of job applicants who initially produced invalid profiles. Participants were 271 male applicants for airline pilot positions. Of these, 72 produced invalid defensive MMPI-2 profiles during preemployment screening. The MMPI-2 was readministered to these applicants with instructions informing them of validity scales and instructing them to respond in a more open, honest manner. Comparisons were made between valid and invalid profiles for initial administrations and between valid and invalid profiles at readministration. Some clinical scales were more elevated for valid, nondefensive profiles. Most content scales showed more elevation for valid profiles, and 12% of the applicants who were retested produced significant elevations (T>or=65) on the content scales. Profiles were similar to those produced by employed pilots of a previous study.

Journal Article↗
PubMed1993

[Investigation of repeated marrow sampling from dogs].

In order to apply a marrow aspiration technique to the safety study employing dog, a series of 4 marrow aspirations from the sternum of Beagle dog at intervals of 30 days were performed. No remarkable changes were observed in general conditions, body weight, body temperature, hematology and bone marrow differential cell counts. Except a temporal increase of CPK activity at day 1, no significant changes were also observed in serum biochemical analysis.

Animals↗