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PubMed2006

Assessing drug risks and benefits: lessons from postmenopausal hormone therapy studies.

The issue of safety standards for new drugs remains unsettled. Limitations of biomarker or observational studies for assessing global safety and efficacy of postmenopausal hormone therapy are highlighted by contrast with randomized clinical trial results. On the other hand, requiring large-scale, long-term outcome trials for every new drug might not be practical. Randomized trials with intermediate outcomes such as coronary angiography, coronary or carotid ultrasound, or coronary calcification present attractive alternatives. Trials with intermediate outcomes can be conducted with much smaller sample sizes and shorter duration, but the adequacy of these types of trials for assessment of safety and efficacy remains a topic of ongoing discussion in the scientific and regulatory communities.

Aged↗
PubMed2004

Excess risk thresholds in ultrasound safety studies: statistical methods for data on occurrence and size of lesions.

Concerns about the safe use of clinical ultrasound (US) at diagnostic pressure levels (below a mechanical index, or MI, = 1.9) have stimulated considerable research in US risk assessment. The objective of the present study was to develop probability-based risk thresholds for US safety studies, to present statistical methods for estimating the thresholds and their standard errors and to compare these methods with the analysis based on a piecewise linear ("hockey stick") model. The excess risk at exposure level x > 0 was defined as the relative increase in the probability of a lesion at that level compared with the background probability of a lesion at exposure x = 0. The risk threshold was then defined as the exposure level at which the excess risk exceeded a specified level (e.g. 5% or 50%). Thus, given pressure-dependent estimates of the excess risk, the thresholds were estimated by solving the risk equation to obtain the pressure at which the target level of excess risk occurs. Threshold estimates of this type have been developed extensively in the literature for incidence (presence or absence) data. Only recently, however, have excess risk threshold estimates been derived for data in which lesion size (depth, surface area) is measured if present and a zero is recorded if the lesion is absent. Tobit regression was used to estimate pressure-dependent percentiles of the size distribution, and the excess risks were estimated from the tobit probability of a positive-valued response. The tobit model provides a well-established approach to modeling data constrained to be nonnegative. Solving the risk equation for the tobit model leads to risk threshold estimates that incorporate the information on size of observed lesions. Results using these probability-based risk estimates were compared with results for a piecewise linear ("hockey stick") model, which has also been used in the US safety literature, although it does not explicitly address the nonnegativity constraint in the sampling model. The comparisons were carried out for data from two previously published studies, from different laboratories, on US-induced lung hemorrhage. The thresholds derived from logistic regression of lesion occurrence and tobit regression of lesion size were quite consistent with each other and within sampling error. The hockey stick thresholds, defined as the exposure level at which the piecewise linear model for the probability of the expected size of a lesion bends upward, corresponded to quite different excess risk values for incidence (lesion occurrence) compared with size (lesion surface area or depth), although these methods have been developed previously for both types of data. The use of probability-based excess risk thresholds is recommended to obtain consistent incidence vs. size thresholds and to ensure that the thresholds are well-defined and interpretable independent of the details of the statistical model.

Animals↗
PubMed2004

Field method for the determination of insoluble or total hexavalent chromium in workplace air.

National Institute for Occupational Safety and Health method 7703 is a portable field procedure for the analysis of workplace air filter samples for hexavalent chromium (CrVI) content immediately after the samples are collected. The field method prescribes CrVI extraction from air filter samples with an ammonium sulfate/ammonium hydroxide extraction buffer using ultrasonic extraction (UE). Strong anion-exchange solid-phase extraction (SAE-SPE) is then used to separate CrVI from trivalent chromium and other interferences. Portable spectrophotometric measurement of CrVI is then conducted using the 1,5-diphenylcarbazide (DPC) method. However, it has been found that the ammonium extraction buffer does not adequately bring insoluble CrVI compounds into solution during the UE process. Thus, it was deemed necessary to modify the field method so that it would provide acceptable recoveries for insoluble CrVI compounds. To this end, a more alkaline extraction solution--sodium carbonate/sodium bicarbonate buffer--was investigated. The modified procedure using the highly alkaline extraction solution was demonstrated to be compatible with SAE-SPE cartridges when determining insoluble CrVI in air filter samples. It was found that the carbonate/bicarbonate buffer was equally effective for complete dissolution of both insoluble and soluble forms of CrVI. Furthermore, the modified procedure met desired performance criteria established for air sampling and analytical methods.

Air Pollution, Indoor↗
PubMed1998

Safety and pharmacokinetics of a single oral dose of amisulpride in healthy elderly volunteers.

OBJECTIVE: Amisulpride is a substituted benzamide neuroleptic, which binds selectively to dopamine D2 and D3 receptors, mainly in the limbic structures. States of delusion and agitation occur frequently in the population aged more than 65 years, especially in demented patients and this sometimes requires the use of neuroleptics. The objectives of this study were to determine the safety and the pharmacokinetic profile of 50 mg of amisulpride administered orally as a single dose to elderly volunteers. METHODS: Twenty healthy volunteers (10 men and 10 women) aged 65 79 years were included in this open trial. Frequent measurements of blood pressure and heart rate were made and ECG and blood samples were performed up to 72 h after drug intake. RESULTS: The overall clinical and cardiovascular safety was satisfactory. The mean Cmax of the racemate amisulpride in elderly people was 64.1+/-6.7 ng ml(-1), and was not different from the value of 56+/-4.1 ng ml(-1) in young subjects. As with the Cmax, the mean values of t1/2 and AUC in elderly people (15.6+/-1.3 h and 667+/-51 ng. ml(-1).h, respectively) were not different to values observed in young subject (respectively 11.7+/-0.5 h and 603+/-25 ng m1(-1) h). CONCLUSION: A single oral dose of amisulpride was well tolerated and showed a similar pharmacokinetic profile in healthy elderly and young subjects. However, these findings should be confirmed after multiple dosing in a larger population in order to establish the lack of need of dosage adjustment in this elderly population.

Administration, Oral↗
PubMed1996

Supervision of suicidal patients in adult inpatient psychiatric units in general hospitals.

OBJECTIVE: The safety of suicidal patients is expected to be maintained during hospitalization. This study surveyed a sample of adult inpatient psychiatric units in general hospitals across the United States about their use of various levels of supervision for suicidal patients, the advantages and disadvantages of these interventions, and issues of cost and reimbursement for the services. METHODS: A 33-item questionnaire was sent to a nationwide random sample of hospital-based adult inpatient psychiatric units. A total of 105 surveys from all regions of the country were used in the analysis. RESULTS: Although 98 hospitals reported that they used one-to-one continuous observation of suicidal patients, observation of the suicidal patient every 15 minutes was the most frequently used type of supervision, ranked first or second in frequency by 69 hospitals. Patients' safety was the most frequently cited advantage of supervision, and increased staffing the most frequently cited disadvantage. In most cases, the cost of supervision for suicidal patients was absorbed by the hospital, and hospitals were not reimbursed for care based on the severity of patients' illness. CONCLUSIONS: Future research on the effectiveness of various strategies for supervision of suicidal patients should include cost-benefit analyses. Policies for reimbursement for care of suicidal patients should be based on the patient's severity of illness.

Adolescent↗
PubMed1999

Assessment of the genotoxicity of contaminated soil with the Allium/Vicia-micronucleus and the Tradescantia-micronucleus assays.

The present study concerns the genotoxicity of contaminated soil near Metz, France. Three plant bioassays, the Vicia faba (broad bean), the Allium cepa (white onion) and the Tradescantia (spiderwort) micronuclei tests were used to evaluate for genotoxicity. Two soil samples were tested: soil sample A (from an industrial waste site) and soil sample B (from a cokeworks waste site). Maleic hydrazide was used as the positive control. Aqueous extracts of the soil samples were used to treat the roots of Vicia and Allium, and plant cuttings of Tradescantia according to the standard protocol for these plant assays established by the International Program on Chemical Safety and the World Health Organization. The results of these tests showed differential sensitivity in the three different bioassays. Soil sample A was more toxic than soil sample B.

Allium↗
PubMed2005

Health and safety measures available for young labourers in the cottage industries of Karachi.

OBJECTIVE: To determine the health problems faced by labourers, 18 years and under, working in the cottage industries of Karachi and know the safety measures available and utilized at these places. DESIGN: Cross-sectional study using two-stage cluster sampling. PLACE AND DURATION: From February 2002 to March 2003, 95 cottage industries from 10 different locations of five districts of Karachi were included. SUBJECTS AND METHODS: All workers, 18 years and below, present were interviewed. The environmental and safety gadgets present at the industry were inspected by the surveyors and the manager was interviewed for presence of health and safety benefits for the workers. RESULTS: A total of 280 workers were interviewed, 26 (9.3%) children were between 9-12 years, 82 (29.3%) were between 13-15 and 172 (61.4%) were between 16-18 years of age. Health benefit was given to only one 13-year-old worker in silk industry; appropriate gadgets were absent in 93 (97.8%) industries, present only in 2 industries (one silk and one loom). First Aid box was present in only one loom industry. Two hundred and forty workers (85.7%) were unaware of the materials they were using. One hundred and ninety-three (69%) children were working in improper light, 199(71%) workers experienced high level of noise, 232(83%) were working in high temperature and 155(55.3%) were working with improper ventilation. Health problems faced included joint pains (n=64, 22.85%), backache (n=85, 30.35%), vertigo (n=48, 17.14%), numbness of fingers (n=77, 27.5%) and fatigue experienced by 143 (51.07%) children. CONCLUSION: The children and adolescents employed in cottage industry are suffering from health problems due to lack of knowledge on their part, and improper ergonomics, environmental and safety conditions at the workplace. The cottage industry should be regulated and brought under labour law. The health sector non-governmental organizations should make concerted efforts for the rehabilitation of this workforce by creating awareness and providing opportunities for education and development of skills.

Accidents, Occupational↗
PubMed2005

Shell rinse and shell crush methods for the recovery of aerobic microorganisms and enterobacteriaceae from shell eggs.

Recovery of bacteria from shell eggs is important for evaluating the efficacy of processing and the quality and safety of the final product. Shell rinse (SR) techniques are easy to perform and widely used. An alternative sampling method involves crushing and rubbing the shell (CR). To determine the most appropriate method for recovering microorganisms from shell eggs, 358 shell eggs were collected from a commercial egg processor and sampled by SR and CR techniques. Total aerobic mesophiles and Enterobacteriaceae were enumerated on plate count and violet red bile glucose agar plates, respectively. Unwashed, in process, and postprocess eggs were evaluated in the study. Aerobic microorganism prevalence for eggshells sampled was similar for both methods (approximately 100%), but the log CFU per milliliter values were higher in the SR than the CR samples (3.2 and 2.2, respectively). Average Enterobacteriaceae recovery was similar for both methods (45 versus 40% for the SR and CR methods, respectively) when all eggs were considered together. This population was detected more often by SR when unwashed eggs were sampled (90 versus 56% for the SR and CR methods, respectively), equally by SR and CR for in-process eggs (30 versus 29.3% for the SR and CR methods, respectively), but more often by CR for postprocess eggs (10 versus 36% for the SR and CR methods, respectively). The SR technique was easier to perform and recovered larger numbers of aerobic organisms, particularly for unwashed eggs. However, the CR technique was more efficient for recovery of Enterobacteriaceae from postprocess eggs. Stage of shell egg processing may be an important consideration when choosing egg sampling methods.

Animals↗
PubMed1982

Use of automobile seat restraints by children in two Canadian cities.

A telephone survey was conducted in Montreal and Calgary to determine the extent to which parents use safety restraints for their children in cars, the types of restraints used and the factors associated with such use. Of the combined sample 39% reported that their child regularly used a restraint, and 47% of the children in Montreal and 55% of those in Calgary wore an age-appropriate safety device. Birth order and the child's and the respondent's ages were significantly related to the use of restraints. However, the respondent's use of seatbelts was the factor most likely to affect the rate of use of restraints for children. Although a large proportion of the parents with younger children owned a carseat, one in four did not use it regularly. Parents who did not use carseats believed they were useless or dangerous; many preferred to hold the child in their laps or arms. The seatbelt law in Quebec and the existence of a carseat rental program in Calgary appear to have had some influence on the rate of the use of restraints for children.

Accidents, Traffic↗
PubMedDate not supplied

[Measurement of airborne asbestos fibers on railroad rolling stock].

In February 1995 the Italian Railways Health Department set up a special study group in order to assess the effectiveness of the measures adopted against hazards due to the presence of asbestos in rolling stock currently in use on the rail network. The group set up specific procedures for sampling and analysis, on the basis of the criteria fixed for civil buildings in Ministerial Decree of 6/9/94, which was subsequently applied to rolling stock by Ministerial Decree of 26/10/95. In accordance with these procedures the study group carried out environmental studies via test runs programmed by the Railways Technical Departments, on trains made up of different types of vehicles. Insulated, completely or partially deinsulated and originally non-insulated vehicles were studied. Samples were analysed via scanning electron microscopy (SEM) with elementary dispersion X spectroscopy (EDXS) carried out by highly qualified public laboratories (ISPESL--National Institute for Prevention and Work Safety, ARPA--Regional Environmental Protection Agency, CRA--Veneto Region, University Departments). Altogether, from the start of the programme up to September 1998, 1464 samples in 170 test runs on 619 rolling stock vehicles were examined. These involved 83 locomotives, 83 electric rail-cars and 453 carriages. The results showed that in over 99% of the samples the fibre concentrations were below 2 fibres/litre, which is the value fixed by law for buildings and rail vehicles in order to qualify for effective decontamination status. Values exceeding 2 fibres/litre were found in only 4 vehicles, which were withdrawn or blocked for further checks. As a precaution, 18 vehicles where concentrations over 1 but less than 2 fibres/litre were found, were also blocked and their return to service has been postponed for further checks and analyses until the results show concentrations below 1 fibre/litre. Environmental analyses carried out up to the present indicate an overall situation comparable to that usually found in the general environmental without any asbestos dispersion sources. Surveillance and investigations are still under way in order to achieve the aims of the safety programme set up by the Italian Railways to ensure health and environmental protection.

Air Pollution, Indoor↗
PubMed1999

Pharmacokinetics, safety, and tolerability of single intravenous infusions of an adenosine agonist, AMP 579, in healthy male volunteers.

The pharmacokinetics of an adenosine agonist, AMP 579, following intravenous administration were evaluated. Single AMP 579 doses of 20 to 150 micrograms/kg were infused intravenously over 6 hours using a constant-rate or two-step rate of infusion to healthy male volunteers. Plasma and urine samples were collected for measurement of AMP 579 concentration using a validated HPLC assay. An assessment of safety and tolerability was also performed. Based on a noncompartmental method of analysis, the pharmacokinetics of AMP 579 were characterized by rapid systemic clearance (0.77 to 0.85 L/h/kg), a moderate steady-state volume of distribution (0.80 to 0.94 L/kg), and a short terminal elimination half-life (0.84 to 1.13 h). AMP 579 exhibited dose (infusion rate)-proportional pharmacokinetics over the dose range. In addition, little or no unchanged AMP 579 was found in the urine. The primary cardiovascular pharmacodynamic response that was observed was a dose-related increase in mean ventricular heart rate. Fifteen minutes prior to the end of the infusion, volunteers administered the highest dose (150 micrograms/kg) exhibited a mean (range) 59% (36%-69%) increase in heart rate as compared to a mean (range) 18% (0%-73%) increase for the placebo group. No clinically relevant changes in the systolic or diastolic blood pressure were observed. The information obtained in this study should allow the design of AMP 579 dosage regimens that would maximize plasma AMP 579 concentrations and minimize the incidence of adverse events.

Adolescent↗
PubMed1997

Treatment of multidrug-resistant pulmonary tuberculosis with interferon-gamma via aerosol.

BACKGROUND: Multidrug-resistant tuberculosis (MDR-TB) is associated with substantial morbidity, despite drug therapy. Interferon-gamma, a cytokine produced mainly by CD4 T lymphocytes, can activate alveolar macrophages, important effector cells in host immunity against Mycobacterium tuberculosis. We investigated safety and tolerability of aerosolised interferon-gamma in patients with MDR-TB, and assessed its efficacy in terms of sputum-smear grades. METHODS: We did an open-label trial of aerosol interferon-gamma given to five patients with smears and cultures positive for pulmonary MDR-TB, despite documented adherence to therapy. The patients received aerosol interferon-gamma 500 micrograms three times a week for 1 month. Safety and tolerability were assessed, and, as well as routine clinical assessments, sputum samples for smear and culture were collected at entry and weekly. Computed tomography scans of the chest were done at baseline and after therapy ended. FINDINGS: Interferon-gamma was well tolerated by all patients. In all five, bodyweight stabilised or increased. Sputum acid-fast-bacillus smears became negative in all patients, and the time to positive culture increased (from 17 to 24 days, not significant), which suggested that the mycobacterial burden had decreased. The size of cavitary lesions was reduced in all patients, 2 months after treatment had ended. INTERPRETATION: Preliminary data suggest that aerosol interferon-gamma is a well-tolerated treatment that may be useful as adjunctive therapy in patients with MDR-TB who are otherwise not responding well to therapy.

Administration, Inhalation↗
PubMed1975

Improvement of the attractiveness of spodoptera littoralis sex pheromone, and its possible use in safety belts around cultivated areas to control the pest in Israel.

A comparison of the field attractiveness of five samples of American-synthesized and one sample of Japanese-synthesized (Z,E)-9,11-tetradecadien-1-01 acetate (9,11-TDDA), the sex pheromone of Spodoptera littoralis Boisd. and S. litura (F.), showed that traps baited with one of the American-produced samples and the Japanese product were equally effective in attracting and capturing S. littoralis males in cotton and alfalfa fields of Israel. Optimum captures were obtained for periods up to three months with 4800 mug of 9,11-TDDA plus 8 mg of an antioxidant; higher doses were not advantageous. Paper squares were superior to two types of rubber septa and to closed polyethylene vials as dispensers for the pheromone; the polyethylene vials were least effective. In terms of numbers of moths captured, open polyethylene vials were as effective as paper dispensers when both were baited with 9-11-TDDA plus antioxidant. Admixture of (Z,E)-9,12-tetradecadien-1-o1 acetate (9,12-TDDA) with 9,11-TDDA was antagonistic at ratios of 1:20 and 1:50, but ratios from 1:500 to 1:1600 were synergistic, increasing moth catches up to 2.5-fold. Pheromone traps placed in Caesarea sand dunes located at least 3 km from the nearest host area captured larger numbers of males than traps placed in cultivated areas. It is therefore recommended that safety belts of pheromone traps, about 500 m apart, be used around cultivated areas to prevent invasion of the pest from outside and to attract males present inside such areas, thus reducing both the male population and mating through mass trapping and disruption of sex communication.

Animals↗
PubMed2005

Eight-year immunogenicity and safety of interferon beta-1a-Avonex treatment in patients with multiple sclerosis.

An open-label extension study of the phase III trial of intramuscular interferon beta-1a (IFNbeta-1a-Avonex) was conducted to evaluate the immunogenicity and safety of IFNbeta-1a-Avonex over six years in patients with relapsing multiple sclerosis (MS). Patients who participated in the pivotal phase III study were offered enrolment; entry was also open to patients who had not participated. All patients received IFNbeta-1a-Avonex 30 microg intramuscularly once weekly for six years, for a treatment duration of up to eight years in patients who received IFNbeta-1a-Avonex in the phase III trial. Serum levels of IFNbeta antibodies were measured every six months using a screening enzyme-linked immunosorbent assay (ELISA) followed by an antiviral cytopathic effect assay to detect neutralizing antibodies (NAbs) in serum samples positive on ELISA. The incidence of adverse events and laboratory test results assessed safety. Of 382 total patients, 218 had participated in the phase III study (103 placebo, 115 IFNbeta-1a-Avonex) and 164 had not participated; 24 of the 164 were IFNbeta-naïve. At baseline, 281 patients were negative for IFNbeta antibodies (NAb-). NAbs (titre > or = 20) developed at any time over six years in 5% of these patients. Of 140 patients who had been on IFNbeta-1b-Betaseron, 49 were positive for NAbs (NAb+) at baseline; 11 of 115 who had been on IFNbeta-1a-Avonex were NAb+ at baseline. Thirty-nine of 49 patients who had been on Betaseron and were NAb+ had titres < 100; 36 of these 39 seroconverted to NAb- while on IFNbeta-1a-Avonex, with a median time of approximately six months. Ten patients who had been on Betaseron had NAb titres > or = 100; five remained NAb+ during six years on IFNbeta-1a-Avonex and five seroconverted to NAb-, but only after at least two years. Five patients who had been on IFNbeta-1a-Avonex during the clinical trial were NAb+ with titres < 100 at baseline; four seroconverted to NAb-, with a median time of two to three years. Six patients who had been on IFNbeta-1a-Avonex had NAb titres > or = 100; five of these remained NAb+ at six years. No patient with a NAb titre > 1000 seroconverted to NAb-, whether initially treated with IFNbeta-1a-Avonex or -Betaseron. Adverse events were similar to those observed in the pivotal phase III trial. Results from this trial indicated that IFNbeta-1a-Avonex was associated with a low incidence of NAbs and was well tolerated for up to eight years. Further, the results indicate that persistence of NAbs is dependent on titre and IFNbeta product.

Activities of Daily Living↗
PubMed2002

Evaluation of the safety and efficacy of testicular biopsies in llamas.

Evaluation of the reproductive function of Lama glama is generally considered to be a challenging task due to the difficulty of obtaining representative semen samples. One method that has been proposed for evaluation of testicular function in these animals is histologic examination of testicular needle biopsies. This study was undertaken to examine the safety and efficacy of using needle biopsies to assess testicular function in this species. One randomly selected testicle from each of 16 sexually mature llamas was biopsied with a 14-gauge self-firing biopsy instrument. The llamas were evaluated over a 6-week period with thermography for temperature changes of the scrotum. At the end of the 6-week trial, the llamas were castrated and sections of each testis were fixed in Bouin's solution for histologic examination. Immediately prior to castration, an additional biopsy was taken from each testis to compare the tissue obtained via biopsy with sections from the corresponding testis obtained after castration. A qualitative grading scale was used to compare the seminiferous tubules from each testis. No difference was found between the biopsied and the nonbiopsied testes (P = 0.69). The percentage of normal tubules between the biopsied and the nonbiopsied sides also did not differ (P = 0.70). Furthermore, the percentage of normal seminiferous tubules did not differ between the needle biopsy samples and the corresponding tissue samples obtained at castration (P = 0.48). The number of round seminiferous tubules counted in each biopsy section ranged from 3 to 67. There was no significant difference in the thermographic images of the scrotum between the biopsied and the nonbiopsied testes. This study supports testicular biopsies as a safe and useful procedure in the evaluation of testicular function.

Animals↗
PubMed2004

Pharmacokinetics and safety of recombinant anti-RhD in healthy RhD-negative male volunteers.

In this first-in-man study, we assessed the pharmacokinetics, safety and tolerability of MonoRho, a human recombinant monoclonal anti-RhD immunoglobulin G1 (IgG1) antibody. Eighteen RhD-negative healthy male volunteers were randomized in two groups to receive a single administration of 300 micro g of MonoRho either intravenously or intramuscularly. There were no symptoms of allergic or anaphylactic type reaction in any subject, and there was no evidence of any MonoRho-related changes in laboratory safety parameters. None of the subjects mounted a detectable immune response to MonoRho. Serum samples were obtained up to 91 days after injection to measure anti-D IgG concentrations by flow cytometry. After intramuscular administration of MonoRho, anti-D IgG concentrations gradually increased reaching peak levels after a mean of 3.4 days. After 3 weeks, the mean anti-D IgG concentrations after intravenous and intramuscular administration became virtually equal to each other and remained so thereafter. In both the treatment groups, the mean elimination half-life was about 18 days and thus similar to that described for plasma-derived anti-D IgG. The bioavailability of MonoRho after intramuscular administration was estimated as 46%. The excellent tolerability and safety of MonoRho as well as its expected elimination half-life supports the continued clinical development of this compound.

Adult↗
PubMed1990

Parental injury prevention endeavors: a function of health beliefs?

Investigating parents' beliefs about injury prevention may yield important information for planning preventive interventions. A comprehensive description of parents' beliefs about injury prevention is presented in this study, and effects of child age and sex are described. In addition, a health belief model was successfully used to predict parent-reported teaching of safety skills and preventive environmental interventions. The model successfully cross-validated the prediction in two independent samples. Parents reported low feelings of susceptibility or worry about injury. The variables most associated with parental preventive endeavors were the belief that intervention can avoid injury, a realistically high appraisal of the amount of time involved, and feelings of high knowledge and competence to teach safety skills. Implications of these data for designing more effective behavioral interventions are described.

Accident Prevention↗
PubMed2006

Risk, trust, and safety culture in U.K. train operating companies.

Organizational safety culture reflects the attitudes and behaviors that individuals share in considering and reacting to hazards and risks. We first argue that trust is an underdeveloped and important concept in relation to theories of safety culture and high-reliability organizations. The article then reports findings from a two-year qualitative study of train operating companies (TOCs) in the United Kingdom, which sought to explore in detail the linkages between safety culture and the postprivatized railway industry. In-depth interviews and focus groups were carried out with a sample of over 500 employees, from four organizations, and representing all key functional levels. Our analysis suggests that the 1993 privatization, and subsequent organizational restructuring of the U.K. railway industry, has had important repercussions for both safety culture and trust relationships. We explore our findings in relation to three key constructs within "safe organizations" theories (namely, flexibility, commitment, and learning), and discuss how the safe organization model might be usefully supplemented by a consideration of trust issues.

Journal Article↗