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PubMedDate not supplied

Device standards: the view from the FDA.

This paper constitutes an overview of FDA's functions and activities, offering a brief introduction to the Medical Device Amendments, and performance standard requirements from FDA's point of view. It discusses the agency's voluntary standards policy and the required conditions for deferral of mandatory standards. This paper also describes the Medical Device Standards Survey, and the role of the clinical engineer in standards development. It lists new Problem Definition Studies of the Bureau of Medical Devices which represent the first step in the new standards development process.

Equipment and Supplies↗
PubMed2000

Gabapentin versus vigabatrin as first add-on for patients with partial seizures that failed to respond to monotherapy: a randomized, double-blind, dose titration study. GREAT Study Investigators Group. Gabapentin in Refractory Epilepsy Add-on Treatment.

PURPOSE: Our objective was to compare the efficacy and safety of gabapentin and vigabatrin as first-line add-on treatment in patients with partial epilepsy. METHODS: This was a multicenter, double-blind, randomized dose titration study. After baseline assessment and randomization, the dose could be increased if seizures persisted and reduced if side effects occurred. Health-related quality of life was assessed at baseline and at the end of the study. By a protocol amendment post hoc, all randomized patients were offered a standardized perimetry examination at the end of the study. Improvement rate was the proportion of patients with a reduction of seizure frequency of at least 50% during an 8-week period without any adverse events causing withdrawal. RESULTS: One hundred two patients were randomized and analyzed on an intent-to-treat basis. The improvement rate was 48% in the gabapentin group and 56% in the vigabatrin group. The improvement rate, when per protocol criteria were fulfilled, was 57% in the gabapentin group and 59% in the vigabatrin group. The proportion of seizure-free patients was 31% in the gabapentin group and 39% in the vigabatrin group. There was no difference in quality-of-life scores between the groups. Perimetry after termination of the study on 64 patients showed abnormal results in 3 of 32 patients in the vigabatrin group. CONCLUSION: Approximately one third of the patients in both groups became seizure-free. Although no major differences were seen in terms of the improvement rate between the groups, equivalence between the two drugs was not found.

Acetates↗
PubMed2003

Employment and disability in the United Kingdom: an outline of recent legislative and policy changes.

In 1996, a paper (Floyd, 1996), on the Vocational Rehabilitation Services in the United Kingdom, reviewed the way in which the services had evolved during the past 50 years, since the end of the second world war. The author described the Disabled Persons (Employment) Act 1944 and the development of rehabilitation and placement services and sheltered workshops over the years. He also gave readers a glimpse of possible future changes, and, in particular, speculated that the UK might follow the United States in the professional training and development of employment and vocational rehabilitation personnel. This paper describes first the main services currently provided by Government and then outlines the quite significant legislative changes and one major policy development that have taken place in the past five years. This includes an overview of the Disability Discrimination Act 1995 which came into force in late 1996, a brief look at some of the early outcomes, and describes the latest proposals for amendment. A description of the major policy development (New Deal for Disabled People) is also given but it is too soon to report on its effectiveness. Whether the changes will lead to any lasting improvement in labour market participation by disabled people, remains an unanswered question; certainly, up to the present, from a statistical point of view, it seems that the position remains much the same (Curtis J, forthcoming). The paper concludes with discussion of the latest key issues and returns to the question raised in 1996 about the training of employment and rehabilitation personnel.

Civil Rights↗
PubMed1988

Emergency Decree Amending the Revenue Code (No. 15), 14 January 1988.

Among other things, this Thailand Decree increases tax allowances for spouses and children as follows: 1) the spousal allowance is set at 15,000 Baht; 2) the allowance for a legitimate or adoptive child born or adopted on or before 1987 of the income earner or the income earner's spouse is set at 7000 Baht per child; and 3) the allowance for children born or adopted after 1987 is set at 7000 Baht for up to three children, subtracting first the number of children covered by 2) above.

Adolescent↗
PubMed1993

The Hydroflex penile prosthesis: a test case for the introduction of new urological technology.

The AMS Hydroflex* penile prosthesis was introduced for commercial distribution in 1985 but 5 years later this device was no longer available on the United States market. In an attempt to understand why this device, which initially enjoyed substantial popularity, was abruptly withdrawn from the market, patients who underwent implantation at the University of Wisconsin were interviewed and a critical analysis of the Food and Drug Administration approval process of medical devices was performed. An AMS Hydroflex penile prosthesis was implanted in 17 patients (mean age 57.7 years, range 27 to 84 years). The followup period ranged from 37 to 73 months with a mean of 58 months, and 3 patients died within that time. Of the remaining patients 10 (71%) were satisfied with the device in the first months after implantation but only 6 (43%) were satisfied at the time of followup, 9 (64%) were more satisfied with sexual relationships after receiving the prosthesis and 7 (50%) found the prosthesis simple to operate. Mechanical failure was noticed by 11 patients (79%), of whom 5 (45%) underwent further surgery. Classification of medical devices started with the enactment of the Medical Device Amendment to the Federal Food, Drug and Cosmetic Act, May 28, 1976. All medical devices that were in commercial distribution at that time were classified in 3 regulatory control categories depending upon the degree of regulation necessary to assure safety and effectiveness of each device. Before May 28, 1976 no approved application was necessary for marketing medical devices, and the Food and Drug Administration has variable amounts of information about safety and effectiveness of the different devices marketed prior to that date. Since May 1976 approved applications have been mandated for new or significantly changed devices. The specific process by which the Hydroflex prosthesis, as well as other medical devices, is approved is critically reviewed.

Adult↗
PubMed2001

Phytoextraction of Pb and Cd from a superfund soil: effects of amendments and croppings.

In a growth chamber, maize (Zea mays) and Indian mustard (Brassica juncea) were grown over two croppings in soil from a Superfund site (PbTotal = 65,200 mg/kg and CdTotal = 52mg/kg). Soil treatments consisted of ethylenediaminetetraacetic acid, sodium citrate and composted sewage sludge, each at two rates (EDTA .05%, EDTA .2%, citrate .05%, citrate .2%, CSS 5% and CSS 10%, respectively). In most cases, the EDTA and citrate treatments were superior in terms of solubilizing soil Pb for root uptake and translocation into above-ground biomass. In the first maize crop, the EDTA .2% treatment resulted in 2,435 and 9,389mg/kg Pb in shoot and root tissues, respectively. The CSS treatments typically resulted in lowest Pb and Cd removal efficiencies. Lead remaining in the soil after two croppings was mainly associated with the carbonate, organic, and residual fractions, which represent the less bioavailable forms. Soil Cd was generally more mobile for plant uptake than soil Pb. The EDTA .2% and citrate treatments were most successful in promoting Cd uptake by both maize and mustard. Although Pb concentrations (mg/kg tissue) were lower for maize than mustard, the former removed more total Pb (0.2 mg per pot, mean over all treatments), compared to mustard (0.03 mg), by virtue of its higher biomass production.

Biodegradation, Environmental↗
PubMed2002

Mesoglia & microglia--a historical review of the concept of mononuclear phagocytes within the central nervous system.

More than a century and a half has elapsed since the first accounts of mesodermal phagocytic elements were proposed within the central nervous system. Over the intervening decades, body and substance were added to this concept through the advancement of histological techniques at the disposal of the researcher and the acute and keen-minded skills of the pathologist. Notable among these pioneering efforts were the contributions of W. Ford Robertson, Santiago Ramon y Cajal, Pio del Rio-Hortega and Wilder Penfield amongst an entire cavalcade of other noteworthy figures. The term 'mesoglia' and 'third element of the nervous system' was bestowed upon these cells towards the beginning of the twentieth century to account for their separate origins from neurons and macroglia. It was later amended by del Rio-Hortega in 1919, to 'microglia' in order to further discriminate between true mesodermal elements and oligodendrocytes, previously regarded as a component of 'mesoglia'. This particular contention sparked much controversy among del Rio-Hortega's peers and resulted in an escalation of fruitful research throughout Europe that eventually declined up to the outbreak of the Second World War. The post-war years were a period of the 'dark ages' that cast doubt on the very existence and nature of microglia, until the 'renaissance' of research was once again rejuvenated in the 1960s, by a new cohort of intrigued minds: Cammermeyer, Blinzinger, Kreutzberg and others who saw in the 'third element' the potential that is now commonly ascribed to microglia: the intrinsic immune effector cells of the CNS. It is now universally accepted that microglia are involved as the first line of rapid defence in any pathology of the nervous system, and as such, present a diagnostic tool for the neuropathologist. Although our knowledge of microglia stems from an extensive body of work conducted over the last two decades, much of the earlier work (pre-1960s) has remained somewhat obscure. This is partly accountable due to the limited availability of translated works, and additionally to the lack of a compendium of these articles. This paper will present a comprehensive overview of the pioneering research on mononuclear phagocytes within the central nervous system, which has direct bearing on our present-day understanding of the concept of microglia.

Animals↗
PubMed2000

The Wellcome Trust Medical Photographic Library Digitization Project: a case study.

This study shows the planning process and the first stages of the implementation of a project to digitize over 120,000 photographic negatives and transparencies from The Wellcome Trust's Medical Photographic Library collection. It shows how and why decisions were made and the resulting resourcing implications. Following the planning and proposal stages it details the results of tests carried out after equipment installation, and the subsequent revisions of original estimates and amendments to decisions on resolution levels. The implementation of the scanning project is described along with some modifications made to the work processes as a result of early experience of the project. In conclusion, it suggests that a constant process of review of processes, equipment and planning is necessary to maintain a successful digitization project.

Charities↗
PubMed1994

Phase I and pharmacokinetic studies of topotecan administered as a 72 or 120 h continuous infusion.

Topotecan (SK&F 104864-A, NSC 609699) is a water-soluble, semi-synthetic analog of camptothecin which is an inhibitor of topoisomerase I. Since topoisomerase I is cell specific for S phase, we undertook a phase I study to determine the maximum tolerated dose and toxicities of continuous infusion (CI) topotecan. This phase I trial first explored a 5 day CI every 21 day schedule. Doses of topotecan included 0.17, 0.34 and 0.68 mg/m2/day. Fourteen patients [median age 60; median performance status (PS) of 1] with refractory malignancies received 59 courses of drug. Hematologic toxicities occurred only at the highest dose level; NCI grade 3-4 granulocytopenia and thrombocytopenia occurred in 4/8 and 3/8 patients, respectively. The protocol was amended to a 3 day infusion in an effort to ameliorate toxicity and obtain greater dose intensity (DI). Doses of 0.68, 0.85, 1.05, 1.3 and 1.6 mg/m2/day were evaluated. Thirty-two patients (median age 60; median PS of 1) received a total of 115 courses. The major toxicity seen was hematologic with 9/32 and 5/32 patients demonstrating grade 3-4 granulocytopenia and thrombocytopenia, respectively. Non-hematologic toxicities were mild (grade 1-2) in the two schedules and included nausea, vomiting, fatigue and alopecia. At the maximum tolerated dose (MTD) on the 5 day schedule, patients received 0.87 mg/m2/week, whereas they received 1.08 mg/m2/week at the MTD on the 3 day schedule (24% increase in relative dose intensity). A steady-state plasma lactone concentration of 5.5 mg/ml of topotecan was achieved at the phase II recommended dose of 1.6 ng/m2/day as a 3 day continuous infusion.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2006

Diversity of Planctomycetes in soil in relation to soil history and environmental heterogeneity.

Members of the Planctomycetes, which were once thought to occur primarily in aquatic environments, have been discovered in soils on five continents, revealing that these Bacteria are a widespread and numerically abundant component of microbial communities in soil. We examined the diversity of Planctomycetes in soil samples obtained from experimental plots at an agricultural site in order to assess the extent of Planctomycetes diversity in soil, to determine whether management effects such as past land cover and compost addition affected the composition of the Planctomycetes community, and to determine whether the observations made could provide insight into the ecological distribution of these organisms. Analysis of Planctomycetes 16S rRNA gene sequences revealed a total of 312 +/- 35 unique phylotypes in the soil at the site examined. The majority of these Planctomycetes sequences were unique, and the sequences had phylogenetic affiliations that included all major lineages in the Planctomycetaceae, as well as several novel groups of deeply divergent Planctomycetes. Both soil management history and compost amendment had significant effects on the Planctomycetes diversity, and variations in soil organic matter, Ca2+ content, and pH were associated with variations in the Planctomycetes community composition. In addition, Planctomycetes richness increased in proportion to the area sampled and was correlated with the spatial heterogeneity of nitrate, which was associated with the soil management history at the orchard site examined. This report provides the first systematic assessment of the diversity of Planctomycetes in soil and also provides evidence that the diversity of this group increases with area as defined by the general power law description of the taxon-area relationship.

Agriculture↗
PubMed2005

Modern concepts of treatment and prevention of chemical injuries.

Chemical injuries are commonly encountered following exposure to acids and alkali, including hydrofluoric acid, formic acid, anhydrous ammonia, cement, and phenol. Other specific agents that cause chemical burns include white phosphorus, elemental metals, nitrates, hydrocarbons, and tar. Even though there are more than 65,000 chemicals available on the market, and an estimated 60,000 new chemicals produced each year, the potential deleterious effects of these chemicals on humans are still unknown. The Superfund Amendments and Reauthorization Act contains extensive provisions for emergency planning and the rights of communities to know about toxic chemical releases. Since 1990, the Agency for Toxic Substances and Disease Registry (ATSDR) has maintained an active, state-based Hazardous Substances Emergency Events Surveillance (HSEES) system to describe the public health consequences risked by access to hazardous chemicals. Most chemical agents damage the skin by producing a chemical reaction rather than hyperthermic injury. Although some chemicals produce considerable heat as a result of an exothermic reaction when they come in contact with water, their ability to produce direct chemical changes on the skin accounts for the most skin injury. Specific chemical changes depend on the agent, including acids, alkalis, corrosives, oxidizing and reducing agents, desiccants, vesicants, and protoplasmic poisons. The concentration of toxic agent and duration of its contact primarily determine degree of skin destruction. Hazardous materials (hazmats) are substances that may injure life and damage the environment if improperly handled. HAZMAT accidents are particularly dangerous for responding personnel, who are in danger from the moment of arrival on the scene until containment of the accident. Consequently, the Superfund Amendment and Reauthorization Act mandates community preparedness for dealing with hazmat accidents. Paramedics and members of the hazmat response team (usually firefighters) must work together to identify toxic chemicals and assess hazardous environments. The contingency plan for hazmat management can be divided into two parts: initiation of the site plan and evacuation. In coping with hazmat incidents, two distinct goals must be achieved concomitantly. First, hazmats must be contained, fire and explosions must be extinguished, and the site eventually must be cleaned. Second, those exposed to hazmats must be treated at the scene of contamination as well as in the hospital and rehabilitation setting.

Acids↗
PubMedDate not supplied

Trends in rates of live births and abortions following state restrictions on public funding of abortion.

Abortion rates rose following the expanded legalization of abortion by the Supreme Court decision in Roe v. Wade. As a result, the impact of the restriction on Federal funding of abortions under the Hyde Amendment in 1977 was not clear. However, abortion rates had plateaued by 1985, when State funding of Medicaid abortions was restricted in Colorado, North Carolina, and Pennsylvania. Analysis of statewide data from the three States indicated that following restrictions on State funding of abortions, the proportion of reported pregnancies resulting in births, rather than in abortions, increased in all three States. In 1985, the first year of State restrictions on the use of public funds for abortion, Colorado, North Carolina, and Pennsylvania recorded 1.9 to 2.4 percent increases in the proportion of reported pregnancies resulting in live births, after years of declining rates. With adjustments for underreporting of abortion, there was an overall 1.2 percent rise in the proportion of pregnancies resulting in live births in those States. Nationally the proportion rose only 0.4 percent. By 1987, the three States had experienced increases above 1984 levels of 1.6 to 5.9 percent in the proportion of reported pregnancies resulting in live births. The experiences of the three States can be used in projecting an expected increase in the proportions of reported pregnancies resulting in live births, rather than in abortions, for similar States. A projection for California, for example, showed that an increase could be expected in the first year of restrictions on the use of public funds for abortion of at least 4,000 births, which could be expected largely to affect women of low income.

Abortion, Legal↗
PubMed1996

Reducing the use of the target animal batch safety test for veterinary vaccines.

The need to submit each batch of every veterinary vaccine to a target animal safety test is questioned. It is proposed that a risk/benefit analysis should be conducted, on a product by product basis, to determine whether the continued application of this test to each batch of a product is beneficial and justified. For an established product, the analysis should consider: the number of batches manufactured; the length of time for which the product has been manufactured; the testing experience and the incidence of reported adverse reactions; the level of GMP compliance and the standard of QA practised by the manufacturer; the method and conditions of manufacture; the use of animals for other batch tests; the recommendations for the use of the product. For a newly developed product the analysis should take into account: the safety data generated during development; the inherent risks in the product and its manufacture; the use of the other animal tests. It is suggested that the continued use of the test could be reduced on a phased basis e.g. after 10 consecutive satisfactory tests the frequency could be reduced by limiting it to the first batch of each production campaign or to every n th batch. Furthermore, the possibility of discontinuing the test altogether, for the product in question, could be considered. A return to full testing frequency would be required in the event of: a test failure; a batch related adverse reaction; introduction of a new seed; a change of manufacturer; a process of modification; a specification amendment; or an interruption of batch continuity. When a manufacturer has established consistency of production and testing, an alternative approach to the need for batch testing, with a view to avoiding or minimising the use of animals, is both desirable and possible.

Animal Testing Alternatives↗
PubMed2003

Selenium speciation, solubility, and mobility in land-disposed dredged sediments.

Pilot-scale tests for the land disposal of Se-enriched sediments from the San Luis Drain were performed in the San Joaquin Valley, California. Three test plots were instrumented and monitored on a dirt-road embankment near the sediment source area, providing an opportunity to measure Se oxidation and solubilization rates over a period of 2-3 yr. Soil, soil water, and groundwater data indicated that the amendment did not cause movement of dissolved Se below a depth of 15 cm. The low permeability of underlying sediments and the overall low Se solubility limit Se movement toward the groundwater table. Selenium remained in reduced forms and largely immobile at this site, although in-situ Se oxidation was measurable. Soluble Se concentrations increased from less than 0.5% to approximately 2.5% in the first 207 d following sediment application. Minor Se solubilization occurred after 439 and 704 d. Changes in Se fractionation measured using sequential extractions and Se speciation based on X-ray spectroscopy (XANES) results were in qualitative agreement. XANES results indicated initially rapid oxidation of organo-Se and/or elemental Se to selenite during the first 207 d, followed by minor oxidation after 439 d. Further solubilization of the Se inventory is anticipated, but at a low rate of 1-2% per year, comparable to rates measured in other studies.

Geologic Sediments↗
PubMedDate not supplied

[Proposals on health surveillance contained in the bill No. 2389 presented by Senator Smuraglia].

The Italian Interassociative Council for the Prevention has examined the bill n. 2389 of senator Smuraglia, expressing appreciation for the initiative (demanded since a long time by the operators of the field) and for the remarkable commitment in the drawing up of such an extensive and well-organized text. At the same time the IICP set up and forwarded to senator Smuraglia some notes and additional proposals, as well as proposals for partial changes, on the following topics:--employer's functions--relationship between the employer and the surveillance bodyprevention and protection service--medical surveillance and "Competent Doctor" threshold limit values--informational system--institutional expertise--omologation--penalty system. In this report we quote the notes expressed with reference to the chapter about the medical surveillance and the competent doctor, of interest of this meeting. We can anticipate with satisfaction that senator Smuraglia admitted many of our proposals and that on their basis he signed a few amendments. Between the proposals we suggested I would like to mention the one concerning the overcoming of the existing medical surveillance system. This is a strict system, essentially outlined by the Law 303/56 (article n. 33) and by the Law 1124/65, by now inadequate with reference to the new working reality and to the current pathology correlated to it. We submit some considerations and the first hypothesis on the constructions of a model of medical surveillance more flexible and open, in conformity with the new reality and the recommendations of the E.U.

Clinical Competence↗
PubMed2005

Driver mortality in frontal crashes: comparison of newer and older airbag designs.

In 1997, the National Highway Traffic Safety Administration amended its requirements for frontal crash performance under Federal Motor Vehicle Safety Standard 208 to temporarily allow 30 mi/h (48 km/h) sled tests with unbelted dummies as an alternative to 30 mi/h head-on rigid-barrier vehicle tests. This change permitted automakers to reduce airbag inflation forces so that they would be less likely to injure occupants who are close to airbags when they first deploy. Most vehicle models were sled-certified starting in model year 1998. Airbag-related deaths have decreased since 1997; however, controversy persists about whether reduced inflation forces might be decreasing protection for some occupants in high-severity frontal crashes. To examine the effects of the regulatory changes, this study computed rate ratios (RR) and 95% confidence intervals (95% CI) for passenger vehicle driver deaths per vehicle registration during 2000-2002 at principal impact points of 12 o'clock for 1998-99 model year vehicles relative to 1997 models. Passenger vehicles included in the study had both driver and passenger front airbags, had the same essential designs during the 1997-1999 model years, and had been sled-certified for drivers throughout model years 1998 and 1999. An adjustment was made for the higher annual mileage of newer vehicles. Findings were that the effect of the regulatory change varied by vehicle type. For cars, sport utility vehicles, and minivans combined, there was an 11 percent decrease in fatality risk in frontal crashes after changing to sled certification (RR = 0.89; 95% CI = 0.82-0.96). Among pickups, however, estimated frontal fatality risk increased 35 percent (RR = 1.35; 95% CI = 1.12-1.62). For a broad range of frontal crashes (11, 12, and 1 o'clock combined), the results indicated a modest net benefit of the regulatory change across all vehicle types and driver characteristics. However, the contrary finding for pickups needs to be researched further.

Accidents, Traffic↗
PubMed2004

Cisplatin, paclitaxel and escalating doses of doxorubicin (TAP) in advanced ovarian cancer: a phase I trial.

BACKGROUND: The objectives of this phase I trial were to determine the maximum tolerated dose (MTD) and the recommended dose (RD) for phase II/III trials of doxorubicin (DOX) combined with paclitaxel (PTX) and cisplatin (CDDP) in patients with advanced ovarian cancer (AOC). METHODS: Twenty-eight patients with stage III/IV AOC received fixed doses of PTX (110 mg/m(2) over 24 h on day 1) and CDDP (75 mg/m(2) on day 2) and an escalating dose of DOX (20, 30, 40 or 50 mg/m(2) on day 1) every 3 weeks. The patients received up to six cycles of chemotherapy. At level 1, one of the original dose-limiting toxicities (DLTs), grade (G) 4 neutropenia lasting for 4 days or longer, occurred in four of six patients. The criterion for DLT was amended to 'G4 neutropenia lasting for 8 days or longer accompanied with G4 leukopenia' and four additional patients were evaluated at level 1. RESULTS: According to the new criteria, DLT was observed only in one of nine patients except one ineligible patient at level 1 and two of six patients at level 4. G4 neutropenia and G4 leukopenia occurred in 85% and 44%, respectively, in the first course of chemotherapy. Non-hematological toxicity was generally mild or moderate. MTD was not determined at the planned dose levels. A clinical response was observed in 16 of 19 (84%) evaluable patients. Further dose escalation was not performed and RD was determined as level 4 because more than 30% of cycles required some modification of chemotherapy at level 4. CONCLUSION: The combination of TAP including 50 mg/m(2) of DOX is feasible and well tolerated as first line chemotherapy in AOC, warranting further study of this regimen.

Adolescent↗
PubMed2004

Comparing driver frontal mortality in vehicles with redesigned and older-design front airbags.

In 1997, the National Highway Traffic Safety Administration amended its requirements for frontal crash performance under Federal Motor Vehicle Safety Standard 208 to temporarily allow 30 mph (48 kph) sled tests with unbelted dummies as an alternative to 30 mph head-on rigid-barrier vehicle tests. This change permitted automakers to reduce airbag inflation forces so that they would be less likely to injure occupants who are close to airbags when they first deploy. Most vehicle models were sled-certified starting in model year 1998. Airbag-related deaths have decreased since 1997; however, controversy persists about whether reduced inflation forces might be decreasing protection for some occupants in high-severity frontal crashes. To examine the effects of the regulatory changes, this study computed rate ratios (RR) and 95 percent confidence intervals (95% CI) for passenger vehicle driver deaths per vehicle registration during 2000-02 at principal impact points of 12 o'clock for 1998-99 model year vehicles relative to 1997 models. Passenger vehicles included in the study had both driver and passenger front airbags, had the same essential designs during the 1997-99 model years, and had been sled-certified for drivers throughout model years 1998 and 1999. An adjustment was made for the higher annual mileage of newer vehicles. Findings were that the effect of the regulatory change varied by vehicle type. For cars, sport utility vehicles, and minivans combined, there was an 11 percent decrease in fatality risk in frontal crashes after changing to sled certification (RR=0.89; 95% CI=0.82-0.96). Among pickups, however, estimated frontal fatality risk increased 35 percent (RR=1.35; 95% CI=1.12-1.62). For a broad range of frontal crashes (11, 12, and 1 o'clock combined), the results indicated a modest net benefit of the regulatory change across all vehicle types and driver characteristics. However, the contrary finding for pickups needs to be researched further.

Accidents, Traffic↗