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Logistics in designing clinical trials for etanidazole (SR 2508): an RTOG experience.

In a Phase II study of etanidazole (SR 2508), the dose of 17 x 2 g/m2 (total drug dose: 34 g/m2) was tested in 33 patients and the toxicity was deemed acceptable. A Phase III trial is now in progress comparing conventional radiotherapy with conventional radiotherapy plus etandizole (2 g/m2 i.v. 30 to 60 min before radiotherapy each Monday, Wednesday, and Friday to 34 g/m2 in 17 doses) in patients with unresectable head and neck carcinomas. A recent analysis showed only 14.7% grade 1 and 3.9% Grade 2 peripheral neuropathy. In the initial study design, 133 evaluable patients per treatment arm could achieve an 80% level of power of detecting a 15% difference in local-regional control rates between the radiotherapy arm (25% local-regional control at 2 years) and the radiotherapy plus etanidazole arm (assuming a 40% rate). Allowing for 20 ineligible cases in each arm, a total number of 306 was required. An interim analysis showed that 27% of the patients assigned to radiotherapy plus etanidazole are receiving less than 14 doses of the drug. It is assumed that less than 14 drug doses will not produce any therapeutic gain, therefore, a true 40% local-regional control rate in the radiotherapy plus etanidazole arm will be observed as a 36% rate when analyzed by assigned treatment. Using this information, the study was modified to have an 80% level of power in detecting a difference between a 25% local-regional control rate in the radiotherapy group and a 36% rate in the radiotherapy plus etanidazole group. Allowing for a 10% patient ineligibility rate, 518 patients are required. With 12 patients entered per month, it is estimated that patient accrual to this study will continue through October 1991.

Carcinoma, Squamous Cell↗

A quantitative risk analysis approach to port hydrocarbon logistics.

A method is presented that allows quantitative risk analysis to be performed on marine hydrocarbon terminals sited in ports. A significant gap was identified in the technical literature on QRA for the handling of hazardous materials in harbours published prior to this work. The analysis is extended to tanker navigation through port waters and loading and unloading facilities. The steps of the method are discussed, beginning with data collecting. As to accident scenario identification, an approach is proposed that takes into account minor and massive spills due to loading arm failures and tank rupture. Frequency estimation is thoroughly reviewed and a shortcut approach is proposed for frequency calculation. This allows for the two-fold possibility of a tanker colliding/grounding at/near the berth or while navigating to/from the berth. A number of probability data defining the possibility of a cargo spill after an external impact on a tanker are discussed. As to consequence and vulnerability estimates, a scheme is proposed for the use of ratios between the numbers of fatal victims, injured and evacuated people. Finally, an example application is given, based on a pilot study conducted in the Port of Barcelona, where the method was tested.

Accidents, Occupational↗

The logistics and cost-effectiveness of circulatory support: advantages of the ABIOMED BVS 5000.

BACKGROUND: In 1994, the ABIOMED BVS 5000 was incorporated into our acute cardiac assist armamentarium. This report is a general overview of our experience. A hypothetical cost analysis focusing on specific devices and device-related personnel contrasted the BVS 5000 with our prior model of centrifugal pump use. METHODS: In 3 years, 22 patients were supported with the BVS 5000, as a biventricular assist device in 40%, right ventricular assist device in 27%, and left ventricular assist device in 32%. Indications were postcardiotomy support in 12, acute myocarditis in 2, bridge to transplant in 4, and failed heart transplant in 4. The cost analysis was performed retrospectively. The actual cost of disposable blood pumps, including replacement pumps, and cannulae constituted the BVS cost. The hypothetical centrifugal costs included the disposables, replacement cones, as well as the labor costs of the continuous perfusionist coverage. RESULTS: Of the 22 patients, 10 (45%) were weaned and 13 (59%) were successfully discharged. Five patients were transplanted while on BVS 5000 support, accounting for a higher rate of discharge. Comparison of "actual" BVS costs with "projected" centrifugal costs revealed differences based upon the intended application of the BVS. In bridge-to-transplant patients with long duration of support, the daily cost of support was dramatically lower with the BVS 5000. For short-term postcardiotomy support, acute myocarditis, or failed transplant, the differences were small. CONCLUSIONS: Because the BVS 5000 was readily managed by the intensive care unit nursing staff, this system displaced centrifugal systems in our program. Outcome measures of weaning and successful discharge were improved relative to our prior experience with centrifugal pumps. Even without taking indirect costs into account, the hypothetical cost analysis supported continued use of the BVS system for acute cardiac assistance.

Adult↗

Urinary flow rate recording: the impact of a single dose of a diuretic on clinic logistics and flow rate parameters.

PURPOSE: We determine the impact of a single dose of a diuretic given to patients scheduled for flow rate recording on clinic waiting time and flow rate parameters, and whether such practice induces artifacts in recording independent of those inherent in repeat recordings. MATERIALS AND METHODS: A total of 99 volunteers with a mean age plus or minus standard deviation of 54 +/- 10.9 years with no known urological condition participated in an open label, crossover study. On 2 separate occasions they came to the clinic for a flow rate recording, and were randomized to receive 20 mg. furosemide upon arrival at the first or second visit. Clinic waiting time, pre-void bladder volume, voided volume, maximum flow rate and other parameters were captured in a database and analyzed. RESULTS: Independent of diuretic use an increase in voided volume and maximum flow rate (19.8 to 21.2 ml. per second) was noted from the first to second visit. Diuretic use independent of sequence induced an increase in voided volume and significant reduction in waiting time (155 versus 81 minutes, p <0.001) without affecting maximum flow rate (19.9 versus 21.1 ml. per second, p = 0.058). Diuretic use on the second visit enhanced the learning effect on maximum flow rate, while first visit use negated the learning effect on the second visit. Waiting time reduction was significant independent of sequence. The positive correlation between voided volume and maximum flow rate remained unchanged with or without the diuretic. CONCLUSIONS: Repeat flow rate recordings are associated with a measurable learning effect leading to an increase in maximum flow rate. The use of 20 mg. furosemide reduces waiting time without inducing additional artifacts or significant changes in flow rate parameters. This practice is recommended for busy offices or clinical research centers to enhance urine flow, patient satisfaction and ultimately compliance with care.

Adult↗

Analyzing bioterror response logistics: the case of smallpox.

To evaluate existing and alternative proposals for emergency response to a deliberate smallpox attack, we embed the key operational features of such interventions into a smallpox disease transmission model. We use probabilistic reasoning within an otherwise deterministic epidemic framework to model the 'race to trace', i.e., attempting to trace (via the infector) and vaccinate an infected person while (s)he is still vaccine-sensitive. Our model explicitly incorporates a tracing/vaccination queue, and hence can be used as a capacity planning tool. An approximate analysis of this large (16 ODE) system yields closed-form estimates for the total number of deaths and the maximum queue length. The former estimate delineates the efficacy (i.e., accuracy) and efficiency (i.e., speed) of contact tracing, while the latter estimate reveals how congestion makes the race to trace more difficult to win, thereby causing more deaths. A probabilistic analysis is also used to find an approximate closed-form expression for the total number of deaths under mass vaccination, in terms of both the basic reproductive ratio and the vaccination capacity. We also derive approximate thresholds for initially controlling the epidemic for more general interventions that include imperfect vaccination and quarantine.

Bioterrorism↗

Economic outcome under Medicare prospective payment at a tertiary-care institution: the effects of demographic, clinical, and logistic factors on duration of hospital stay and part A charges for medical back problems (DRG 243).

We investigated the effects of prospectively identified factors on the duration of hospital stay and part A charges in 240 hospitalizations (of 230 patients) for the diagnosis-related group "medical back problems" (DRG 243) at a tertiary-care institution in 1985 to determine whether heterogeneity existed within this reimbursement category. We confirmed our initial postulates that nonosteoporotic fractures and neck problems, as well as hospitalizations primarily for myelography after outpatient neurologic evaluation, had considerably different economic outcomes and thus excluded these categories from further analysis. Statistical analysis (forward stepwise regression) of the remaining 132 patients who had "general medical back problems" showed that increasing age, associated osteoporosis, and therapeutic injections best explained variation in the natural logarithm of duration of stay (R2 = 0.16). Total number of diagnoses, spondylosis, associated osteoporosis, age, therapeutic injections, and performance of special procedures best explained the variation in the logarithm of part A charges (R2 = 0.29). The ability to identify factors within a specified category that affect the duration of hospitalization and part A charges jeopardizes the fairness of prospective payment, and we believe that DRG 243 should be adjusted for age, comorbidity, and readily identifiable clinical syndromes that have disparate economic consequences. Because of poorly substantiated efficacy and a significant association with longer hospital stays and higher part A charges, clinicians should review the use of therapeutic injections for medical back problems. Analysis of case-mix such as ours should be helpful in promoting efficient practice and ensuring the fairness of any reimbursement system.

Adult↗

Diphtheria: the logistics of mass swabbing.

Although diphtheria is a rare disease it is necessary to swab contacts of all cases in order to identify carriers. The selection of individuals who should be swabbed and the organisation of mass swabbing so that there is the minimum of delay between collection, culture and reporting are described. With this organisation it is possible for a laboratory to culture at least 1000 swabs in any one day.

Carrier State↗

The effects of low-pay and unemployment on psychological well-being: a logistic regression approach.

The paper explores the relationship between unemployment and mental distress. The analysis draws upon data from the 1992 British Household Panel Study (BHPS). Six different measures of mental distress are used. Controlling for a number of individual characteristics, unemployed individuals are found to suffer significantly higher odds of experiencing a marked rise in anxiety, depression and loss of confidence and a reduction in self-esteem and the level of general happiness even compared with individuals in low-paid employment. This finding highlights the involuntary nature of unemployment. The results also suggest that all six measures of psychological well-being are lower in middle age compared with younger and older age groups. In addition, women appear to be less affected by unemployment than men.

Adult↗

Salmonella in slaughter pigs: the effect of logistic slaughter procedures of pigs on the prevalence of Salmonella in pork.

A substantial part of the finishing pigs in the Netherlands is infected with Salmonella. Infection of pigs with Salmonella can occur already on the farm. Pigs can also get infected or contaminated during transport, lairage or slaughter. The aim of this study was to evaluate the effect of separating pigs from Salmonella-infected farms from pigs from Salmonella-free farms during transport, lairage and slaughter on the prevalence of Salmonella on pork after slaughter. Two experiments were carried out. In the first experiment, farms were selected to participate, based on serology of the pigs (Dutch Salmonella ELISA). The pigs were slaughtered at the beginning of the day: firstly, sero-negative herds, secondly, sero-positive herds and thirdly, again sero-negative herds. The latter were slaughtered to investigate the effect of a contaminated slaughterline due to a previously slaughtered positive herd. In the second experiment, farms were selected to participate, based on both serology and bacteriology of the pigs on the farm. Two hundred pigs from Salmonella-free farms were slaughtered after 200 pigs from Salmonella-infected farms. Results showed that the prevalence of Salmonella in pork samples of sero-negative herds was lower than in samples of sero-positive herds. Results also showed that Salmonella contamination of carcasses after slaughter was partially caused by Salmonella-infected herds that were slaughtered before, and partially by residential flora of the slaughterhouse. It is concluded that separate slaughter of sero-negative pig herds can be useful to decrease the prevalence of Salmonella-contaminated pork after slaughter. To avoid cross-contamination by residential flora from trucks, lairage and slaughterline, cleaning and disinfection have to be improved.

Abattoirs↗

Ground versus air transport of trauma victims: medical and logistical considerations.

Emergency aeromedical transport for trauma victims varies widely, from 10% or less in some programs to more than 90% in others. There is the potential in all such programs for dramatic, lifesaving efforts as well as for costly and dangerous overuse. We propose the following preliminary guidelines for emergency aeromedical transport of trauma victims. Trauma scene flights should be dispatched only for seriously injured patients who are potentially salvageable. Trauma scene flights are not justified if the flight does not significantly reduce the interval between injury and patient arrival at an appropriate hospital (eg, from motor vehicle accident with entrapment) unless the flight delivers needed medical expertise or equipment to the scene. Critically injured patients should be returned to the closest hospital of appropriate capabilities and demonstrated expertise. Flight services should be a public service fully integrated into the metropolitan emergency medical services system. Scene flights should be dispatched within medical guidelines established by the regional emergency medical services system. Emergency aeromedical evacuation of trauma victims should assist the regionalization of trauma care to centers with special capabilities for the management of seriously injured patients. Promulgation of more detailed guidelines will depend on the accumulation of clinical experience and will be possible only if consistent efforts are made to obtain measures of injury severity, categories of injury, and long-term outcomes of management.

Aircraft↗

Materials management and logistics in the emergency department.

The modern ED must create a clinical environment that has a predictable and sustainable production process equal to the needs of the patients. This means careful analysis of supply and equipment needs but also of costs and revenue challenges. Prediction models and contemporary supply chain management tools go a long way in assisting the manager to meet this need and in maintaining a clinically competent and financially stable ED.

Budgets↗