Factors influencing social and health outcomes after motor vehicle crash injury: an inception cohort study protocol.

PubMed

Jagnoor, Jagnoor; Blyth, Fiona; Gabbe, Belinda; Derrett, Sarah; Boufous, Soufiane; Dinh, Michael; Day, Robert; Button, Gregory; Gillett, Mark; Joseph, Tony; Nicholas, Michael; Ivers, Rebecca; Maher, Chris G; Willcock, Simon; Kenardy, Justin; Collie, Alex; Cameron, Ian D

2014-02-25

There is growing evidence that health and social outcomes following motor vehicle crash injury are related to cognitive and emotional responses of the injured individual, as well as relationships between the injured individual and the compensation systems with which they interact. As most of this evidence comes from other states in Australia or overseas, investigation is therefore warranted to identify the key determinants of health and social outcomes following injury in the context of the New South Wales motor accident insurance scheme. In this inception cohort study, 2400 participants, aged 17 years or more, injured in a motor vehicle crash in New South Wales will be identified though hospital emergency departments, general and physiotherapy practitioners, police records and a government insurance regulator database. Participants will be initially contacted through mail. Baseline interviews will be conducted by telephone within 28 days of the injury and participants will be followed up with interviews at 6, 12 and 24 months post-injury. Health insurance and pharmaceutical prescription data will also be collected. The study results will report short and long term health and social outcomes in the study sample. Identification of factors associated with health and social outcomes following injury, including related compensation factors will provide evidence for improved service delivery, post-injury management, and inform policy development and reforms. Australia New Zealand Clinical trial registry identification number--ACTRN12613000889752. Available at: ANZCTR Registered FISH Study.

Poisson, Poisson-gamma and zero-inflated regression models of motor vehicle crashes: balancing statistical fit and theory.

PubMed

Lord, Dominique; Washington, Simon P; Ivan, John N

2005-01-01

There has been considerable research conducted over the last 20 years focused on predicting motor vehicle crashes on transportation facilities. The range of statistical models commonly applied includes binomial, Poisson, Poisson-gamma (or negative binomial), zero-inflated Poisson and negative binomial models (ZIP and ZINB), and multinomial probability models. Given the range of possible modeling approaches and the host of assumptions with each modeling approach, making an intelligent choice for modeling motor vehicle crash data is difficult. There is little discussion in the literature comparing different statistical modeling approaches, identifying which statistical models are most appropriate for modeling crash data, and providing a strong justification from basic crash principles. In the recent literature, it has been suggested that the motor vehicle crash process can successfully be modeled by assuming a dual-state data-generating process, which implies that entities (e.g., intersections, road segments, pedestrian crossings, etc.) exist in one of two states-perfectly safe and unsafe. As a result, the ZIP and ZINB are two models that have been applied to account for the preponderance of "excess" zeros frequently observed in crash count data. The objective of this study is to provide defensible guidance on how to appropriate model crash data. We first examine the motor vehicle crash process using theoretical principles and a basic understanding of the crash process. It is shown that the fundamental crash process follows a Bernoulli trial with unequal probability of independent events, also known as Poisson trials. We examine the evolution of statistical models as they apply to the motor vehicle crash process, and indicate how well they statistically approximate the crash process. We also present the theory behind dual-state process count models, and note why they have become popular for modeling crash data. A simulation experiment is then conducted to demonstrate how crash data give rise to "excess" zeros frequently observed in crash data. It is shown that the Poisson and other mixed probabilistic structures are approximations assumed for modeling the motor vehicle crash process. Furthermore, it is demonstrated that under certain (fairly common) circumstances excess zeros are observed-and that these circumstances arise from low exposure and/or inappropriate selection of time/space scales and not an underlying dual state process. In conclusion, carefully selecting the time/space scales for analysis, including an improved set of explanatory variables and/or unobserved heterogeneity effects in count regression models, or applying small-area statistical methods (observations with low exposure) represent the most defensible modeling approaches for datasets with a preponderance of zeros.

The MRC CRASH trial--a large, simple randomised trial of steroids in head injury.

PubMed

Wasserberg, J

2004-01-01

CRASH (Corticosteroid randomisation after significant head injury) is a prospective multi-centre randomised double blind study of methylprednisolone versus placebo in mild, moderate and severe head injury. Patients are eligible up to 8 hours from injury. To date the CRASH trial has recruited 9000 patients. The trial is recruiting from 200 hospitals in 50 countries with another 100 centres planning to join the trial. The target for recruitment is 20,000 patients by 2006. The trial is wholly funded by the Medical Research Council of Great Britain and is multidisciplinary, involving doctors and nurses from a range of specialities. A recent systematic review of corticosteroids in head injury demonstrated a risk of death in the corticosteroid treated group 2% lower than in the control group. The 95% confidence interval ranges from a 60%, lower mortality to a 2% higher mortality. This result is compatible with there being no real benefit, but it is also compatible with there being a small benefit of a few percent. An improvement in mortality of 2% would theoretically save 10,000 lives per 500,000 patients treated. The global impact of such a treatment effect would be significant as the number of head injuries world-wide continues to rise.

Surprise braking trials, time-to-collision judgments, and "first look" maneuvers under realistic rear-end crash scenarios

DOT National Transportation Integrated Search

2005-08-01

This project continues to build upon the foundation provided by the human factors experimentation conducted in the previous Crash Avoidance Metrics Partnership (CAMP) Forward Collision Warning (FCW) system efforts. As in the previous CAMP FCW researc...

HEADWAY TIME AND CRASHES AMONG NOVICE TEENS AND EXPERIENCED ADULT DRIVERS IN A SIMULATED LEAD TRUCK BRAKING SCENARIO

PubMed Central

McDonald, Catherine C.; Seacrist, Thomas S.; Lee, Yi-Ching; Loeb, Helen; Kandadai, Venk; Winston, Flaura K.

2014-01-01

Summary Driving simulators can be used to evaluate driving performance under controlled, safe conditions. Teen drivers are at particular risk for motor vehicle crashes and simulated driving can provide important information on performance. We developed a new simulator protocol, the Simulated Driving Assessment (SDA), with the goal of providing a new tool for driver assessment and a common outcome measure for evaluation of training programs. As an initial effort to examine the validity of the SDA to differentiate performance according to experience, this analysis compared driving behaviors and crashes between novice teens (n=20) and experienced adults (n=17) on a high fidelity simulator for one common crash scenario, a rear-end crash. We examined headway time and crashes during a lead truck with sudden braking event in our SDA. We found that 35% of the novice teens crashed and none of the experienced adults crashed in this lead truck braking event; 50% of the teens versus 25% of the adults had a headway time <3 seconds at the time of truck braking. Among the 10 teens with <3 seconds headway time, 70% crashed. Among all participants with a headway time of 2–3 seconds, further investigation revealed descriptive differences in throttle position and brake pedal force when comparing teens who crashed, teens who did not crash and adults (none of whom crashed). Even with a relatively small sample, we found statistically significant differences in headway time for adults and teens, providing preliminary construct validation for our new SDA. PMID:25197724

Nonblocking and orphan free message logging protocols

NASA Technical Reports Server (NTRS)

Alvisi, Lorenzo; Hoppe, Bruce; Marzullo, Keith

1992-01-01

Currently existing message logging protocols demonstrate a classic pessimistic vs. optimistic tradeoff. We show that the optimistic-pessimistic tradeoff is not inherent to the problem of message logging. We construct a message-logging protocol that has the positive features of both optimistic and pessimistic protocol: our protocol prevents orphans and allows simple failure recovery; however, it requires no blocking in failure-free runs. Furthermore, this protocol does not introduce any additional message overhead as compared to one implemented for a system in which messages may be lost but processes do not crash.

Nonblocking and orphan free message logging protocols

NASA Astrophysics Data System (ADS)

Alvisi, Lorenzo; Hoppe, Bruce; Marzullo, Keith

1992-12-01

Currently existing message logging protocols demonstrate a classic pessimistic vs. optimistic tradeoff. We show that the optimistic-pessimistic tradeoff is not inherent to the problem of message logging. We construct a message-logging protocol that has the positive features of both optimistic and pessimistic protocol: our protocol prevents orphans and allows simple failure recovery; however, it requires no blocking in failure-free runs. Furthermore, this protocol does not introduce any additional message overhead as compared to one implemented for a system in which messages may be lost but processes do not crash.

Guest Editor's Introduction: Special section on dependable distributed systems

NASA Astrophysics Data System (ADS)

Fetzer, Christof

1999-09-01

We rely more and more on computers. For example, the Internet reshapes the way we do business. A `computer outage' can cost a company a substantial amount of money. Not only with respect to the business lost during an outage, but also with respect to the negative publicity the company receives. This is especially true for Internet companies. After recent computer outages of Internet companies, we have seen a drastic fall of the shares of the affected companies. There are multiple causes for computer outages. Although computer hardware becomes more reliable, hardware related outages remain an important issue. For example, some of the recent computer outages of companies were caused by failed memory and system boards, and even by crashed disks - a failure type which can easily be masked using disk mirroring. Transient hardware failures might also look like software failures and, hence, might be incorrectly classified as such. However, many outages are software related. Faulty system software, middleware, and application software can crash a system. Dependable computing systems are systems we can rely on. Dependable systems are, by definition, reliable, available, safe and secure [3]. This special section focuses on issues related to dependable distributed systems. Distributed systems have the potential to be more dependable than a single computer because the probability that all computers in a distributed system fail is smaller than the probability that a single computer fails. However, if a distributed system is not built well, it is potentially less dependable than a single computer since the probability that at least one computer in a distributed system fails is higher than the probability that one computer fails. For example, if the crash of any computer in a distributed system can bring the complete system to a halt, the system is less dependable than a single-computer system. Building dependable distributed systems is an extremely difficult task. There is no silver bullet solution. Instead one has to apply a variety of engineering techniques [2]: fault-avoidance (minimize the occurrence of faults, e.g. by using a proper design process), fault-removal (remove faults before they occur, e.g. by testing), fault-evasion (predict faults by monitoring and reconfigure the system before failures occur), and fault-tolerance (mask and/or contain failures). Building a system from scratch is an expensive and time consuming effort. To reduce the cost of building dependable distributed systems, one would choose to use commercial off-the-shelf (COTS) components whenever possible. The usage of COTS components has several potential advantages beyond minimizing costs. For example, through the widespread usage of a COTS component, design failures might be detected and fixed before the component is used in a dependable system. Custom-designed components have to mature without the widespread in-field testing of COTS components. COTS components have various potential disadvantages when used in dependable systems. For example, minimizing the time to market might lead to the release of components with inherent design faults (e.g. use of `shortcuts' that only work most of the time). In addition, the components might be more complex than needed and, hence, potentially have more design faults than simpler components. However, given economic constraints and the ability to cope with some of the problems using fault-evasion and fault-tolerance, only for a small percentage of systems can one justify not using COTS components. Distributed systems built from current COTS components are asynchronous systems in the sense that there exists no a priori known bound on the transmission delay of messages or the execution time of processes. When designing a distributed algorithm, one would like to make sure (e.g. by testing or verification) that it is correct, i.e. satisfies its specification. Many distributed algorithms make use of consensus (eventually all non-crashed processes have to agree on a value), leader election (a crashed leader is eventually replaced by a new leader, but at any time there is at most one leader) or a group membership detection service (a crashed process is eventually suspected to have crashed but only crashed processes are suspected). From a theoretical point of view, the service specifications given for such services are not implementable in asynchronous systems. In particular, for each implementation one can derive a counter example in which the service violates its specification. From a practical point of view, the consensus, the leader election, and the membership detection problem are solvable in asynchronous distributed systems. In this special section, Raynal and Tronel show how to bridge this difference by showing how to implement the group membership detection problem with a negligible probability [1] to fail in an asynchronous system. The group membership detection problem is specified by a liveness condition (L) and a safety property (S): (L) if a process p crashes, then eventually every non-crashed process q has to suspect that p has crashed; and (S) if a process q suspects p, then p has indeed crashed. One can show that either (L) or (S) is implementable, but one cannot implement both (L) and (S) at the same time in an asynchronous system. In practice, one only needs to implement (L) and (S) such that the probability that (L) or (S) is violated becomes negligible. Raynal and Tronel propose and analyse a protocol that implements (L) with certainty and that can be tuned such that the probability that (S) is violated becomes negligible. Designing and implementing distributed fault-tolerant protocols for asynchronous systems is a difficult but not an impossible task. A fault-tolerant protocol has to detect and mask certain failure classes, e.g. crash failures and message omission failures. There is a trade-off between the performance of a fault-tolerant protocol and the failure classes the protocol can tolerate. One wants to tolerate as many failure classes as needed to satisfy the stochastic requirements of the protocol [1] while still maintaining a sufficient performance. Since clients of a protocol have different requirements with respect to the performance/fault-tolerance trade-off, one would like to be able to customize protocols such that one can select an appropriate performance/fault-tolerance trade-off. In this special section Hiltunen et al describe how one can compose protocols from micro-protocols in their Cactus system. They show how a group RPC system can be tailored to the needs of a client. In particular, they show how considering additional failure classes affects the performance of a group RPC system. References [1] Cristian F 1991 Understanding fault-tolerant distributed systems Communications of ACM 34 (2) 56-78 [2] Heimerdinger W L and Weinstock C B 1992 A conceptual framework for system fault tolerance Technical Report 92-TR-33, CMU/SEI [3] Laprie J C (ed) 1992 Dependability: Basic Concepts and Terminology (Vienna: Springer)

Prevention of the development of psychological distress following a motor vehicle crash: study protocol for a randomized controlled trial.

PubMed

Guest, Rebecca; Tran, Yvonne; Gopinath, Bamini; Cameron, Ian D; Craig, Ashley

2016-07-16

It is estimated that up to 50 % of motor vehicle crash survivors develop significant psychological distress, such as depressive mood and anxiety, within 6 months of the crash. Associated impacts include loss of employment, delayed return to work, financial and familial stress, and increased medical and compensation costs. The major aim of this research is to investigate the efficacy of interventions for preventing the development of psychological distress following a motor vehicle crash. The efficacy of two brief interventions will be examined: a cognitive behaviour therapy (CBT) programme, targeting mood and anxiety, and a lifestyle programme, targeting sleep, diet and physical activity. This is a randomized, controlled multisite study. Participants include at least 180 adults injured in a motor vehicle crash who have entered a compensation process. Research will compare outcomes in three groups randomly assigned to: one group of 60 adults, who receive a brief email-delivered CBT programme, with one session every 2 weeks for 10 weeks and telephone contact every 2 weeks; a second group of 60 adults, who receive a brief email-delivered lifestyle intervention involving one session every 2 weeks for 10 weeks with telephone contact; and an active waiting-list control group of 60 adults who are provided claims processing-related reading material along with telephone contact every 2 weeks for 10 weeks. Participants will be recruited within 12 weeks of the motor vehicle crash, and will be comprehensively assessed before and after treatment, and 6 and 12 months post-injury. Assuming an α probability level of 0.05 and a power of 80 %, at least 180 participants will be recruited. The primary outcome measure is the presence and severity of psychological distress or disorder. Secondary outcome measures include assessment of self-efficacy, resilience employment status, social activity and support, lifestyle and physical health factors, along with process outcome measures of treatment acceptability, feasibility and generalizability. This study will determine whether brief email-delivered interventions distributed soon after the injury and entry into the claims process can be effective in preventing the development of psychological distress. ANZCTR, ACTRN12615000326594 . Registered on 9 April 2015.

Young driver education programs that build resilience have potential to reduce road crashes.

PubMed

Senserrick, Teresa; Ivers, Rebecca; Boufous, Soufiane; Chen, Huei-Yang; Norton, Robyn; Stevenson, Mark; van Beurden, Eric; Zask, Avigdor

2009-11-01

The research aimed to explore associations between participation in 2 education programs for school-based learner drivers and subsequent road traffic offenses and crashes among a large cohort of newly licensed drivers. DRIVE is a prospective cohort study of 20822 first-year drivers aged 17 to 24 in New South Wales (NSW), Australia. Participants completed a detailed questionnaire and consented to data linkage in 2003-2004. Questionnaire items included year of participation in 2 specific education programs: a 1-day workshop-only program focusing on driving risks ("driver-focused") and a whole-of-community program also including a 1-day workshop but also longer term follow-up activities and a broader focus on reducing risk-taking and building resilience ("resilience-focused"). Survey data were subsequently linked to police-reported crash and offense data for 1996-2005. Poisson regression models that adjusted for multiple confounders were created to explore offenses and crashes as a driver (dichotomized as 0 vs >or=1) after program participation. Offenses did not differ between groups; however, whereas the driver-focused program was not associated with reduced crash risk, the resilience-focused program was associated with a 44% reduced relative risk for crash (0.56 [95% confidence interval: 0.34-0.93]). The large effect size observed and complementary findings from a comparable randomized, controlled trial in the United States suggest programs that focus more generally on reducing risks and building resilience have the potential to reduce crashes. A large, representative, randomized, controlled trial is urgently needed to confirm road safety benefits and ensure evidence-based spending and practitioner recommendations in this field.

Repeatability study of replicate crash tests: A signal analysis approach.

PubMed

Seppi, Jeremy; Toczyski, Jacek; Crandall, Jeff R; Kerrigan, Jason

2017-10-03

To provide an objective basis on which to evaluate the repeatability of vehicle crash test methods, a recently developed signal analysis method was used to evaluate correlation of sensor time history data between replicate vehicle crash tests. The goal of this study was to evaluate the repeatability of rollover crash tests performed with the Dynamic Rollover Test System (DRoTS) relative to other vehicle crash test methods. Test data from DRoTS tests, deceleration rollover sled (DRS) tests, frontal crash tests, frontal offset crash tests, small overlap crash tests, small overlap impact (SOI) crash tests, and oblique crash tests were obtained from the literature and publicly available databases (the NHTSA vehicle database and the Insurance Institute for Highway Safety TechData) to examine crash test repeatability. Signal analysis of the DRoTS tests showed that force and deformation time histories had good to excellent repeatability, whereas vehicle kinematics showed only fair repeatability due to the vehicle mounting method for one pair of tests and slightly dissimilar mass properties (2.2%) in a second pair of tests. Relative to the DRS, the DRoTS tests showed very similar or higher levels of repeatability in nearly all vehicle kinematic data signals with the exception of global X' (road direction of travel) velocity and displacement due to the functionality of the DRoTS fixture. Based on the average overall scoring metric of the dominant acceleration, DRoTS was found to be as repeatable as all other crash tests analyzed. Vertical force measures showed good repeatability and were on par with frontal crash barrier forces. Dynamic deformation measures showed good to excellent repeatability as opposed to poor repeatability seen in SOI and oblique deformation measures. Using the signal analysis method as outlined in this article, the DRoTS was shown to have the same or better repeatability of crash test methods used in government regulatory and consumer evaluation test protocols.

Computed tomography and clinical outcome in patients with severe traumatic brain injury.

PubMed

Stenberg, Maud; Koskinen, Lars-Owe D; Jonasson, Per; Levi, Richard; Stålnacke, Britt-Marie

2017-01-01

To study: (i) acute computed tomography (CT) characteristics and clinical outcome; (ii) clinical course and (iii) Corticosteroid Randomisation after Significant Head Injury acute calculator protocol (CRASH) model and clinical outcome in patients with severe traumatic brain injury (sTBI). Initial CT (CT i ) and CT 24 hours post-trauma (CT 24 ) were evaluated according to Marshall and Rotterdam classifications. Rancho Los Amigos Cognitive Scale-Revised (RLAS-R) and Glasgow Outcome Scale Extended (GOSE) were assessed at three months and one year post-trauma. The prognostic value of the CRASH model was evaluated. Thirty-seven patients were included. Marshall CT i and CT 24 were significantly correlated with RLAS-R at three months. Rotterdam CT 24 was significantly correlated with GOSE at three months. RLAS-R and the GOSE improved significantly from three months to one year. CRASH predicted unfavourable outcome at six months for 81% of patients with bad outcome and for 85% of patients with favourable outcome according to GOSE at one year. Neither CT nor CRASH yielded clinically useful predictions of outcome at one year post-injury. The study showed encouragingly many instances of significant recovery in this population of sTBI. The combination of lack of reliable prognostic indicators and favourable outcomes supports the case for intensive acute management and rehabilitation as the default protocol in the cases of sTBI.

Adolescent Balloon Analog Risk Task and Behaviors that Influence Risk of Motor Vehicle Crash Injury

PubMed Central

Vaca, Federico E.; Walthall, Jessica M.; Ryan, Sheryl; Moriarty-Daley, Alison; Riera, Antonio; Crowley, Michael J.; Mayes, Linda C.

2013-01-01

Risk-taking propensity is a pivotal facet of motor vehicle crash involvement and subsequent traumatic injury in adolescents. Clinical encounters are important opportunities to identify teens with high risk-taking propensity who may later experience serious injury. Our objective was to compare self-reports of health risk behavior with performance on the Balloon Analog Risk Task (BART), a validated metric of risk-taking propensity, in adolescents during a clinical encounter. 100 adolescent patients from a hospital emergency department and adolescent health clinic completed a computer-based survey of self-reported risk behaviors including substance use behaviors and behaviors that influence crash involvement. They then completed the BART, a validated laboratory-based risk task in which participants earn points by pumping up a computer-generated balloon with greater pumps leading to increased chance of balloon explosion. 20 trials were undertaken. Mean number of pumps on the BART showed a correlation of .243 (p=.015) with self-reported driver/passenger behaviors and attitudes towards driving that influence risk of crash injury. Regression analyses showed that self-reports of substance use and mean number of pumps on the BART uniquely predict self-reports of behaviors influencing the risk of crash injury. The BART is a promising correlate of real-world risk-taking behavior related to traffic safety. It remains a valid predictor of behaviors influencing risk of crash injury when using just 10 trials, suggesting its utility as a quick and effective screening measure for use in busy clinical environments. This tool may be an important link to prevention interventions for those most at-risk for future motor vehicle crash involvement and injury. PMID:24406948

Prediction of Outcome after Moderate and Severe Traumatic Brain Injury: External Validation of the IMPACT and CRASH Prognostic Models

PubMed Central

Roozenbeek, Bob; Lingsma, Hester F.; Lecky, Fiona E.; Lu, Juan; Weir, James; Butcher, Isabella; McHugh, Gillian S.; Murray, Gordon D.; Perel, Pablo; Maas, Andrew I.R.; Steyerberg, Ewout W.

2012-01-01

Objective The International Mission on Prognosis and Analysis of Clinical Trials (IMPACT) and Corticoid Randomisation After Significant Head injury (CRASH) prognostic models predict outcome after traumatic brain injury (TBI) but have not been compared in large datasets. The objective of this is study is to validate externally and compare the IMPACT and CRASH prognostic models for prediction of outcome after moderate or severe TBI. Design External validation study. Patients We considered 5 new datasets with a total of 9036 patients, comprising three randomized trials and two observational series, containing prospectively collected individual TBI patient data. Measurements Outcomes were mortality and unfavourable outcome, based on the Glasgow Outcome Score (GOS) at six months after injury. To assess performance, we studied the discrimination of the models (by AUCs), and calibration (by comparison of the mean observed to predicted outcomes and calibration slopes). Main Results The highest discrimination was found in the TARN trauma registry (AUCs between 0.83 and 0.87), and the lowest discrimination in the Pharmos trial (AUCs between 0.65 and 0.71). Although differences in predictor effects between development and validation populations were found (calibration slopes varying between 0.58 and 1.53), the differences in discrimination were largely explained by differences in case-mix in the validation studies. Calibration was good, the fraction of observed outcomes generally agreed well with the mean predicted outcome. No meaningful differences were noted in performance between the IMPACT and CRASH models. More complex models discriminated slightly better than simpler variants. Conclusions Since both the IMPACT and the CRASH prognostic models show good generalizability to more recent data, they are valid instruments to quantify prognosis in TBI. PMID:22511138

Backing collisions: a study of drivers' eye and backing behaviour using combined rear-view camera and sensor systems.

PubMed

Hurwitz, David S; Pradhan, Anuj; Fisher, Donald L; Knodler, Michael A; Muttart, Jeffrey W; Menon, Rajiv; Meissner, Uwe

2010-04-01

Backing crash injures can be severe; approximately 200 of the 2,500 reported injuries of this type per year to children under the age of 15 years result in death. Technology for assisting drivers when backing has limited success in preventing backing crashes. Two questions are addressed: Why is the reduction in backing crashes moderate when rear-view cameras are deployed? Could rear-view cameras augment sensor systems? 46 drivers (36 experimental, 10 control) completed 16 parking trials over 2 days (eight trials per day). Experimental participants were provided with a sensor camera system, controls were not. Three crash scenarios were introduced. Parking facility at UMass Amherst, USA. 46 drivers (33 men, 13 women) average age 29 years, who were Massachusetts residents licensed within the USA for an average of 9.3 years. Interventions Vehicles equipped with a rear-view camera and sensor system-based parking aid. Subject's eye fixations while driving and researcher's observation of collision with objects during backing. Only 20% of drivers looked at the rear-view camera before backing, and 88% of those did not crash. Of those who did not look at the rear-view camera before backing, 46% looked after the sensor warned the driver. This study indicates that drivers not only attend to an audible warning, but will look at a rear-view camera if available. Evidence suggests that when used appropriately, rear-view cameras can mitigate the occurrence of backing crashes, particularly when paired with an appropriate sensor system.

Backing collisions: a study of drivers’ eye and backing behaviour using combined rear-view camera and sensor systems

PubMed Central

Hurwitz, David S; Pradhan, Anuj; Fisher, Donald L; Knodler, Michael A; Muttart, Jeffrey W; Menon, Rajiv; Meissner, Uwe

2012-01-01

Context Backing crash injures can be severe; approximately 200 of the 2,500 reported injuries of this type per year to children under the age of 15 years result in death. Technology for assisting drivers when backing has limited success in preventing backing crashes. Objectives Two questions are addressed: Why is the reduction in backing crashes moderate when rear-view cameras are deployed? Could rear-view cameras augment sensor systems? Design 46 drivers (36 experimental, 10 control) completed 16 parking trials over 2 days (eight trials per day). Experimental participants were provided with a sensor camera system, controls were not. Three crash scenarios were introduced. Setting Parking facility at UMass Amherst, USA. Subjects 46 drivers (33 men, 13 women) average age 29 years, who were Massachusetts residents licensed within the USA for an average of 9.3 years. Interventions Vehicles equipped with a rear-view camera and sensor system-based parking aid. Main Outcome Measures Subject’s eye fixations while driving and researcher’s observation of collision with objects during backing. Results Only 20% of drivers looked at the rear-view camera before backing, and 88% of those did not crash. Of those who did not look at the rear-view camera before backing, 46% looked after the sensor warned the driver. Conclusions This study indicates that drivers not only attend to an audible warning, but will look at a rear-view camera if available. Evidence suggests that when used appropriately, rear-view cameras can mitigate the occurrence of backing crashes, particularly when paired with an appropriate sensor system. PMID:20363812

The effect of organized systems of trauma care on motor vehicle crash mortality.

PubMed

Nathens, A B; Jurkovich, G J; Cummings, P; Rivara, F P; Maier, R V

2000-04-19

Despite calls for wider national implementation of an integrated approach to trauma care, the effectiveness of this approach at a regional or state level remains unproven. To determine whether implementation of an organized system of trauma care reduces mortality due to motor vehicle crashes. Cross-sectional time-series analysis of crash mortality data collected for 1979 through 1995 from the Fatality Analysis Reporting System. All 50 US states and the District of Columbia. All front-seat passenger vehicle occupants aged 15 to 74 years. Rates of death due to motor vehicle crashes compared before and after implementation of an organized trauma care system. Estimates are based on within-state comparisons adjusted for national trends in crash mortality. Ten years following initial trauma system implementation, mortality due to traffic crashes began to decline; about 15 years following trauma system implementation, mortality was reduced by 8% (95% confidence interval [CI], 3%-12%) after adjusting for secular trends in crash mortality, age, and the introduction of traffic safety laws. Implementation of primary enforcement of restraint laws and laws deterring drunk driving resulted in reductions in crash mortality of 13% (95% CI, 11%-16%) and 5% (95% CI, 3%-7%), respectively, while relaxation of state speed limits increased mortality by 7% (95% CI, 3%-10%). Our data indicate that implementation of an organized system of trauma care reduces crash mortality. The effect does not appear for 10 years, a finding consistent with the maturation and development of trauma triage protocols, interhospital transfer agreements, organization of trauma centers, and ongoing quality assurance.

Patient distribution in a mass casualty event of an airplane crash.

PubMed

Postma, Ingri L E; Weel, Hanneke; Heetveld, Martin J; van der Zande, Ineke; Bijlsma, Taco S; Bloemers, Frank W; Goslings, J Carel

2013-11-01

Difficulties have been reported in the patient distribution during Mass Casualty Incidents. In this study we analysed the regional patient distribution protocol (PDP) and the actual patient distribution after the 2009 Turkish Airlines crash near Amsterdam. Analysis of the patient distribution of 126 surviving casualties of the crash by collecting data on medical treatment capacity, number of patients received per hospital, triage classification, Injury Severity Score (ISS), secondary transfers, distance from the crash site, and the critical mortality rate. The PDP holds ambiguous definitions of medical treatment capacity and was not followed. There were 14 receiving hospitals (distance from crash: 5.8-53.5 km); four hospitals received 133-213% of their treatment capacity, and 5 hospitals received 1 patient. Three hospitals within 20 km of the crash did not receive any casualties. Level I trauma centres received 89% of the 'critical' casualties and 92% of the casualties with ISS ≥ 16. Only 3 casualties were secondarily transferred, and no casualties died in, or on the way to hospital (critical mortality rate=0%). Patient distribution worked out well after the crash as secondary transfers were low and critical mortality rate was zero. However, the regional PDP was not followed in this MCI and casualties were unevenly distributed among hospitals. The PDP is indistinctive, and should be updated in cooperation between Emergency Services, surrounding hospitals, and Schiphol International Airport as a high risk area. Copyright © 2013 Elsevier Ltd. All rights reserved.

Review and publication of protocol submissions to Trials - what have we learned in 10 years?

PubMed

Li, Tianjing; Boutron, Isabelle; Al-Shahi Salman, Rustam; Cobo, Erik; Flemyng, Ella; Grimshaw, Jeremy M; Altman, Douglas G

2016-12-16

Trials has 10 years of experience in providing open access publication of protocols for randomised controlled trials. In this editorial, the senior editors and editors-in-chief of Trials discuss editorial issues regarding managing trial protocol submissions, including the content and format of the protocol, timing of submission, approaches to tracking protocol amendments, and the purpose of peer reviewing a protocol submission. With the clarification and guidance provided, we hope we can make the process of publishing trial protocols more efficient and useful to trial investigators and readers.

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2015-12-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

PubMed Central

Chan, An-Wen; Tetzlaff, Jennifer M.; Altman, Douglas G.; Laupacis, Andreas; Gøtzsche, Peter C.; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A.; Doré, Caroline J.; Parulekar, Wendy R.; Summerskill, William S.M.; Groves, Trish; Schulz, Kenneth F.; Sox, Harold C.; Rockhold, Frank W.; Rennie, Drummond; Moher, David

2016-01-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. PMID:23295957

SPIRIT 2013 statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2013-02-05

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Absorbable energy monitoring scheme: new design protocol to test vehicle structural crashworthiness.

PubMed

Ofochebe, Sunday M; Enibe, Samuel O; Ozoegwu, Chigbogu G

2016-05-01

In vehicle crashworthiness design optimization detailed system evaluation capable of producing reliable results are basically achieved through high-order numerical computational (HNC) models such as the dynamic finite element model, mesh-free model etc. However the application of these models especially during optimization studies is basically challenged by their inherent high demand on computational resources, conditional stability of the solution process, and lack of knowledge of viable parameter range for detailed optimization studies. The absorbable energy monitoring scheme (AEMS) presented in this paper suggests a new design protocol that attempts to overcome such problems in evaluation of vehicle structure for crashworthiness. The implementation of the AEMS involves studying crash performance of vehicle components at various absorbable energy ratios based on a 2DOF lumped-mass-spring (LMS) vehicle impact model. This allows for prompt prediction of useful parameter values in a given design problem. The application of the classical one-dimensional LMS model in vehicle crash analysis is further improved in the present work by developing a critical load matching criterion which allows for quantitative interpretation of the results of the abstract model in a typical vehicle crash design. The adequacy of the proposed AEMS for preliminary vehicle crashworthiness design is demonstrated in this paper, however its extension to full-scale design-optimization problem involving full vehicle model that shows greater structural detail requires more theoretical development.

Identification and referral of impaired drivers through emergency department protocols

DOT National Transportation Integrated Search

2002-02-01

Of patients treated in the emergency department (ED) following a motor vehicle crash (MVC), 15-20% are at high risk for alcohol abuse or alcohol dependency (AA/AD), and are likely to drive after drinking. In order to intervene with patients at high r...

Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting.

PubMed

Zhang, Sheng; Liang, Fei; Li, Wenfeng

2017-11-01

The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding. Copyright © 2017 Elsevier Inc. All rights reserved.

The real-world safety potential of connected vehicle technology.

PubMed

Doecke, Sam; Grant, Alex; Anderson, Robert W G

2015-01-01

This article estimates the safety potential of a current commercially available connected vehicle technology in real-world crashes. Data from the Centre for Automotive Safety Research's at-scene in-depth crash investigations in South Australia were used to simulate the circumstances of real-world crashes. A total of 89 crashes were selected for inclusion in the study. The crashes were selected as representative of the most prevalent crash types for injury or fatal crashes and had potential to be mitigated by connected vehicle technology. The trajectory, speeds, braking, and impact configuration of the selected in-depth cases were replicated in a software package and converted to a file format allowing "replay" of the scenario in real time as input to 2 Cohda Wireless MK2 onboard units. The Cohda Wireless onboard units are a mature connected vehicle technology that has been used in both the German simTD field trial and the U.S. Department of Transport's Safety Pilot project and have been tuned for low false alarm rates when used in the real world. The crash replay was achieved by replacing each of the onboard unit Global Positioning System (GPS) inputs with the simulated data of each of the involved vehicles. The time at which the Cohda Wireless threat detection software issued an elevated warning was used to calculate a new impact speed using 3 different reaction scenarios and 2 levels of braking. It was found that between 37 and 86% of the simulated crashes could be avoided, with highest percentage due a fully autonomous system braking at 0.7 g. The same system also reduced the impact speed relative to the actual crash in all cases. Even when a human reaction time of 1.2 s and moderate braking of 0.4 g was assumed, the impact speed was reduced in 78% of the crashes. Crash types that proved difficult for the threat detection engine were head-on crashes where the approach angle was low and right turn-opposite crashes. These results indicate that connected vehicle technology can be greatly beneficial in real-world crash scenarios and that this benefit would be maximized by having the vehicle intervene autonomously with heavy braking. The crash types that proved difficult for the connected vehicle technology could be better addressed if controller area network (CAN) information is available, such as steering wheel angle, so that driver intent can be inferred sooner. More accurate positioning in the real world (e.g., combining satellite positioning and accelerometer data) would allow the technology to be more effective for near-collinear head-on and rear-end crashes, because the low approach angles that are common in such crashes are currently ignored in order to minimize false alarms due to positioning uncertainty.

Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory.

PubMed

Hróbjartsson, Asbjørn; Pildal, Julie; Chan, An-Wen; Haahr, Mette T; Altman, Douglas G; Gøtzsche, Peter C

2009-09-01

To compare the reporting on blinding in protocols and articles describing randomized controlled trials. We studied 73 protocols of trials approved by the scientific/ethical committees for Copenhagen and Frederiksberg, 1994 and 1995, and their corresponding publications. Three out of 73 trials (4%) reported blinding in the protocol that contradicted that in the publication (e.g., "open" vs. "double blind"). The proportion of "double-blind" trials with a clear description of the blinding of participants increased from 11 out of 58 (19%) when based on publications alone to 39 (67%) when adding the information in the protocol. The similar proportions for the blinding of health care providers were 2 (3%) and 22 (38%); and for the blinding of data collectors, they were 8 (14%) and 14 (24%). In 52 of 58 publications (90%), it was unclear whether all patients, health care providers, and data collectors had been blinded. In 4 of the 52 trials (7%), the protocols clarified that all three key trial persons had been blinded. The reporting on blinding in both trial protocols and publications is often inadequate. We suggest developing international guidelines for the reporting of trial protocols and public access to protocols.

Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.

PubMed

Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P

2017-04-01

Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of low quality and may not reflect what is in the protocol, thus limiting the detection of modifications between planned and published outcomes. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Analysis of Remote Trauma Transfers in South Central Texas with Comparison with Current US Combat Operations: Results of the RemTORN-I Study

DTIC Science & Technology

2013-01-01

product and procoagulant use by paramedical personnel, and clinical trials of freeze-dried plasma, tranexamic acid , and other intravascular...of administering tranexamic acid to bleeding trauma patients using evidence from the CRASH-2 trial. PLoS One. 2011;6(5):e18987. 3. Gonzalez RP

Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board.

PubMed

Zia, Mohammad I; Heslegrave, Ronald; Newton, Gary E

2011-12-01

The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

PubMed Central

Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleža-Jerić, Karmela; Laupacis, Andreas; Moher, David

2013-01-01

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders. PMID:23303884

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleza-Jeric, Karmela; Laupacis, Andreas; Moher, David

2013-01-08

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.

Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols

PubMed Central

Kyte, Derek; Duffy, Helen; Fletcher, Benjamin; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; King, Madeleine; Draper, Heather; Ives, Jonathan; Brundage, Michael; Blazeby, Jane; Calvert, Melanie

2014-01-01

Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols. PMID:25333349

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

PubMed

Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2014-07-16

To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

The citation of relevant systematic reviews and randomised trials in published reports of trial protocols.

PubMed

Pandis, Nikolaos; Fleming, Padhraig S; Koletsi, Despina; Hopewell, Sally

2016-12-07

It is important that planned randomised trials are justified and placed in the context of the available evidence. The SPIRIT guidelines for reporting clinical trial protocols recommend that a recent and relevant systematic review should be included. The aim of this study was to assess the use of the existing evidence in order to justify trial conduct. Protocols of randomised trials published over a 1-month period (December 2015) indexed in PubMed were obtained. Data on trial characteristics relating to location, design, funding, conflict of interest and type of evidence included for trial justification was extracted in duplicate and independently by two investigators. The frequency of citation of previous research including relevant systematic reviews and randomised trials was assessed. Overall, 101 protocols for RCTs were identified. Most proposed trials were parallel-group (n = 74; 73.3%). Reference to an earlier systematic review with additional randomised trials was found in 9.9% (n = 10) of protocols and without additional trials in 30.7% (n = 31), while reference was made to randomised trials in isolation in 21.8% (n = 22). Explicit justification for the proposed randomised trial on the basis of being the first to address the research question was made in 17.8% (n = 18) of protocols. A randomised controlled trial was not cited in 10.9% (95% CI: 5.6, 18.7) (n = 11), while in 8.9% (95% CI: 4.2, 16.2) (n = 9) of the protocols a systematic review was cited but did not inform trial design. A relatively high percentage of protocols of randomised trials involves prior citation of randomised trials, systematic reviews or both. However, improvements are required to ensure that it is explicit that clinical trials are justified and shaped by contemporary best evidence.

Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study.

PubMed

Campbell, M K; Snowdon, C; Francis, D; Elbourne, D; McDonald, A M; Knight, R; Entwistle, V; Garcia, J; Roberts, I; Grant, A; Grant, A

2007-11-01

To identify factors associated with good and poor recruitment to multicentre trials. Part A: database of trials started in or after 1994 and were due to end before 2003 held by the Medical Research Council and Health Technology Assessment Programmes. Part B: interviews with people playing a wide range of roles within four trials that their funders identified as 'exemplars'. Part C: a large multicentre trial (the CRASH trial) of treatment for head injury. The study used a number of different perspectives ('multiple lenses'), and three components. Part A: an epidemiological review of a cohort of trials. Part B: case studies of trials that appeared to have particularly interesting lessons for recruitment. Part C: a single, in-depth case study to examine the feasibility of applying a business-orientated analytical framework as a reference model in future trials. In the 114 trials found in Part A, less than one-third recruited their original target within the time originally specified, and around one-third had extensions. Factors observed more often in trials that recruited successfully were: having a dedicated trial manager, being a cancer or drug trial, and having interventions only available inside the trial. The most commonly reported strategies to improve recruitment were newsletters and mailshots, but it was not possible to assess whether they were causally linked to changes in recruitment. The analyses in Part B suggested that successful trials were those addressing clinically important questions at a timely point. The investigators were held in high esteem by the interviewees, and the trials were firmly grounded in existing clinical practices, so that the trial processes were not alien to clinical collaborators, and the results could be easily applicable to future practice. The interviewees considered that the needs of patients were well served by participation in the trials. Clinical collaborators particularly appreciated clear delineation of roles, which released them from much of the workload associated with trial participation. There was a strong feeling from interviewees that they were proud to be part of a successful team. This pride fed into further success. Good groundwork and excellent communications across many levels of complex trial structures were considered to be extremely important, including training components for learning about trial interventions and processes, and team building. All four trials had faced recruitment problems, and extra insights into the working of trials were afforded by strategies invoked to address them. The process of the case study in Part C was able to draw attention to a body of research and practice in a different discipline (academic business studies). It generated a reference model derived from a combination of business theory and work within CRASH. This enabled identification of weaker managerial components within CRASH, and initiatives to strengthen them. Although it is not clear, even within CRASH, whether the initiatives that follow from developing and applying the model will be effective in increasing recruitment or other aspects of the success of the trial, the reference model could provide a template, with potential for those managing other trials to use or adapt it, especially at foundation stages. The model derived from this project could also be used as a diagnostic tool if trials have difficulties and hence as a basis for deciding what type of remedial action to take. It may also be useful for auditing the progress of trials, such as during external review. While not producing sufficiently definitive results to make strong recommendations, the work here suggests that future trials should consider the different needs at different phases in the life of trials, and place greater emphasis on 'conduct' (the process of actually doing trials). This implies learning lessons from successful trialists and trial managers, with better training for issues relating to trial conduct. The complexity of large trials means that unanticipated difficulties are highly likely at some time in every trial. Part B suggested that successful trials were those flexible and robust enough to adapt to unexpected issues. Arguably, the trialists should also expect agility from funders within a proactive approach to monitoring ongoing trials. Further research into different recruitment patterns (including 'failures') may help to clarify whether the patterns seen in the 'exemplar' trials differ or are similar. The reference model from Part C needs to be further considered in other similar and different trials to assess its robustness. These and other strategies aimed at increasing recruitment and making trials more successful need to be formally evaluated for their effectiveness in a range of trials.

COLLISION AVOIDANCE TRAINING USING A DRIVING SIMULATOR IN DRIVERS WITH PARKINSON’S DISEASE: A PILOT STUDY

PubMed Central

Dawson, Jeffrey D.; Rizzo, Matthew; Anderson, Steven W.; Dastrup, Elizabeth; Uc, Ergun Y.

2011-01-01

Summary Parkinson’s disease (PD) impairs driving performance, and simulator studies have shown increased crashes compared to controls. In this pilot study, eight drivers with PD participated in three drive sessions with multiple simulator intersections of varying visibility and traffic load, where an incurring vehicle posed a crash risk. Over the course of the three sessions (once every 1–2 weeks), we observed reduction in crashes (p=0.059) and reaction times (p=0.006) to the vehicle incursion. These findings suggest that our simulator training program is feasible and potentially useful in drivers with PD. Future research questions include transfer of training to different driving tasks, duration of benefit, and the effect on long term real life outcomes in comparison to a standard intervention (e.g., driver education class) in a randomized trial. PMID:24273752

The Robinson Protocol: a treadmill anaerobic performance test.

PubMed

Robinson, Ellyn M; Graham, Louise B; Headley, Samuel A

2004-08-01

The current investigation was designed to further examine the reliability of the Robinson protocol, which is a run-to-exhaustion treadmill test. Robinson (10) originally examined this protocol with 5 subjects. The significance of the initial exploratory study was the impetus for expanding the study to examine the reliability of the protocol with a larger sample. Fifteen male subjects participated in 3 trial runs on the treadmill. The first trial was a modified McConnell (7) test to determine the aerobic capacity of each subject. The second and third trials were identical Robinson protocols (10). The first trial run mean, in seconds (262.04 +/- 74.50), was not significantly different from the second trial run mean (257.30 +/- 72.65), p = 0.526 (2 tailed). As expected, trial 1 and trial 2 were highly correlated (intraclass) (r = 0.927, p < 0.001). These results provide additional support for the hypothesis that the Robinson protocol with a greater subject pool is a reliable protocol that can be used in research studies interested in examining various physiological interventions or anaerobic training.

Protecting intellectual property associated with Canadian academic clinical trials - approaches and impact

PubMed Central

2012-01-01

Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The ‘open access’ approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The ‘restricted access’ approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who ‘needs to know’ about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results. PMID:23270486

Protecting intellectual property associated with Canadian academic clinical trials--approaches and impact.

PubMed

Ross, Sue; Magee, Laura; Walker, Mark; Wood, Stephen

2012-12-27

Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The 'open access' approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The 'restricted access' approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who 'needs to know' about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results.

Electronic Clinical Trial Protocol Distribution via the World-Wide Web

PubMed Central

Afrin, Lawrence B.; Kuppuswamy, Valarmathi; Slater, Barbara; Stuart, Robert K.

1997-01-01

Clinical trials today typically are inefficient, paper-based operations. Poor community physician awareness of available trials and difficult referral mechanisms also contribute to poor accrual. The Physicians Research Network (PRN) web was developed for more efficient trial protocol distribution and eligibility inquiries. The Medical University of South Carolina's Hollings Cancer Center trials program and two community oncology practices served as a testbed. In 581 man-hours over 18 months, 147 protocols were loaded into PRN. The trials program eliminated all protocol hardcopies except the masters, reduced photocopier use 59%, and saved 1.0 full-time equivalents (FTE), but 1.0 FTE was needed to manage PRN. There were no known security breaches, downtime, or content-related problems. Therefore, PRN is a paperless, user-preferred, reliable, secure method for distributing protocols and reducing distribution errors and delays because only a single copy of each protocol is maintained. Furthermore, PRN is being extended to serve other aspects of trial operations. PMID:8988471

Development and validation of a prognostic model to predict death in patients with traumatic bleeding, and evaluation of the effect of tranexamic acid on mortality according to baseline risk: a secondary analysis of a randomised controlled trial.

PubMed

Perel, P; Prieto-Merino, D; Shakur, H; Roberts, I

2013-06-01

Severe bleeding accounts for about one-third of in-hospital trauma deaths. Patients with a high baseline risk of death have the most to gain from the use of life-saving treatments. An accurate and user-friendly prognostic model to predict mortality in bleeding trauma patients could assist doctors and paramedics in pre-hospital triage and could shorten the time to diagnostic and life-saving procedures such as surgery and tranexamic acid (TXA). The aim of the study was to develop and validate a prognostic model for early mortality in patients with traumatic bleeding and to examine whether or not the effect of TXA on the risk of death and thrombotic events in bleeding adult trauma patients varies according to baseline risk. Multivariable logistic regression and risk-stratified analysis of a large international cohort of trauma patients. Two hundred and seventy-four hospitals in 40 high-, medium- and low-income countries. We derived prognostic models in a large placebo-controlled trial of the effects of early administration of a short course of TXA [Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage (CRASH-2) trial]. The trial included 20,127 trauma patients with, or at risk of, significant bleeding, within 8 hours of injury. We externally validated the model on 14,220 selected trauma patients from the Trauma Audit and Research Network (TARN), which included mainly patients from the UK. We examined the effect of TXA on all-cause mortality, death due to bleeding and thrombotic events (fatal and non-fatal myocardial infarction, stroke, deep-vein thrombosis and pulmonary embolism) within risk strata in the CRASH-2 trial data set and we estimated the proportion of premature deaths averted by applying the odds ratio (OR) from the CRASH-2 trial to each of the risk strata in TARN. For the stratified analysis according baseline risk we considered the intervention TXA (1 g over 10 minutes followed by 1 g over 8 hours) or matching placebo. For the prognostic models we included predictors for death in hospital within 4 weeks of injury. For the stratified analysis we reported ORs for all causes of death, death due to bleeding, and fatal and non-fatal thrombotic events associated with the use of TXA according to baseline risk. A total of 3076 (15%) patients died in the CRASH-2 trial and 1705 (12%) in the TARN data set. Glasgow Coma Scale score, age and systolic blood pressure were the strongest predictors of mortality. Discrimination and calibration were satisfactory, with C-statistics > 0.80 in both CRASH-2 trial and TARN data sets. A simple chart was constructed to readily provide the probability of death at the point of care, while a web-based calculator is available for a more detailed risk assessment. TXA reduced all-cause mortality and death due to bleeding in each stratum of baseline risk. There was no evidence of heterogeneity in the effect of TXA on all-cause mortality (p-value for interaction = 0.96) or death due to bleeding (p= 0.98). There was a significant reduction in the odds of fatal and non-fatal thrombotic events with TXA (OR = 0.69, 95% confidence interval 0.53 to 0.89; p= 0.005). There was no evidence of heterogeneity in the effect of TXA on the risk of thrombotic events (p= 0.74). This prognostic model can be used to obtain valid predictions of mortality in patients with traumatic bleeding. TXA can be administered safely to a wide spectrum of bleeding trauma patients and should not be restricted to the most severely injured. Future research should evaluate whether or not the use of this prognostic model in clinical practice has an impact on the management and outcomes of trauma patients.

Improvements in Clinical Trials Information Will Improve the Reproductive Health and Fertility of Cancer Patients.

PubMed

Dauti, Angela; Gerstl, Brigitte; Chong, Serena; Chisholm, Orin; Anazodo, Antoinette

2017-06-01

There are a number of barriers that result in cancer patients not being referred for oncofertility care, which include knowledge about reproductive risks of antineoplastic agents. Without this information, clinicians do not always make recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information and recommendations that clinicians have available in clinical trial protocols regarding oncofertility management and follow-up, and the information that patients may receive in clinical trials patient information sheets or consent forms. A literature review of the 71 antineoplastic drugs included in the 68 clinical trial protocols showed that 68% of the antineoplastic drugs had gonadotoxic animal data, 32% had gonadotoxic human data, 83% had teratogenic animal data, and 32% had teratogenic human data. When the clinical trial protocols were reviewed, only 22% of the protocols reported the teratogenic risks and 32% of the protocols reported the gonadotoxic risk. Only 56% of phase 3 protocols had gonadotoxic information and 13% of phase 3 protocols had teratogenic information. Nine percent of the protocols provided fertility preservation recommendations and 4% provided reproductive information in the follow-up and survivorship period. Twenty-six percent had a section in the clinical trials protocol, which identified oncofertility information easily. When gonadotoxic and teratogenic effects of treatment were known, they were not consistently included in the clinical trial protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow-up following the completion of cancer treatment. The research team proposes a number of recommendations that should be required for clinicians and pharmaceutical companies developing new trials.

Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis.

PubMed

Ali, Ather; Kahn, Janet; Rosenberger, Lisa; Perlman, Adam I

2012-10-04

Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study. The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Clinicaltrials.gov NCT00970008 (18 August 2009).

Comparison of inter-trial recovery times for the determination of critical power and W' in cycling.

PubMed

Karsten, Bettina; Hopker, James; Jobson, Simon A; Baker, Jonathan; Petrigna, Luca; Klose, Andreas; Beedie, Christopher

2017-07-01

Critical Power (CP) and W' are often determined using multi-day testing protocols. To investigate this cumbersome testing method, the purpose of this study was to compare the differences between the conventional use of a 24-h inter-trial recovery time with those of 3 h and 30 min for the determination of CP and W'. 9 moderately trained cyclists performed an incremental test to exhaustion to establish the power output associated with the maximum oxygen uptake (p[Formula: see text] max ), and 3 protocols requiring time-to-exhaustion trials at a constant work-rate performed at 80%, 100% and 105% of p[Formula: see text] max. Design: Protocol A utilised 24-h inter-trial recovery (CP 24 /W' 24 ), protocol B utilised 3-h inter-trial recovery (CP 3 /W' 3 ), and protocol C used 30-min inter-trial recovery period (CP 0.5 /W' 0.5 ). CP and W' were calculated using the inverse time (1/t) versus power (P) relation (P = W'(1/t) + CP). 95% Limits of Agreement between protocol A and B were -9 to 15 W; -7.4 to 7.8 kJ (CP/W') and between protocol A and protocol C they were -27 to 22 W; -7.2 to 15.1 kJ (CP/W'). Compared to criterion protocol A, the average prediction error of protocol B was 2.5% (CP) and 25.6% (W'), whilst for protocol C it was 3.7% (CP) and 32.9% (W'). 3-h and 30-min inter-trial recovery time protocols provide valid methods of determining CP but not W' in cycling.

Epidemiology of alcohol and other drug use among motor vehicle crash victims admitted to a trauma center.

PubMed

Walsh, J Michael; Flegel, Ron; Cangianelli, Leo A; Atkins, Randolph; Soderstrom, Carl A; Kerns, Timothy J

2004-09-01

The objectives of this research were to (1) determine the incidence and prevalence of alcohol and other drug use among motor vehicle crash (MVC) victims admitted to a regional Level-I trauma center, and (2) to examine the utility of using a rapid point-of-collection (POC) drug-testing device to identify MVC patients with drug involvement. Blood and urine specimens were routinely collected per clinical protocol for each MVC victim at the time of admission. Blood alcohol concentration (BAC) levels were determined per standard clinical protocol. Clinical urine specimens were routinely split so that a POC drug-testing device for the detection of commonly abused drugs (Marijuana, Cocaine, Amphetamines, Methamphetamines, and Opiates) could be compared to that of the standard hospital laboratory analysis of each urine specimen (which also included Barbiturates and Benzodiazepines). In the six-month period of this study, nearly two-thirds of trauma center admissions were victims of motor vehicle crashes. During this time, blood and urine was collected from 322 MVC victims. Toxicology results indicated that 59.3% of MVC victims tested positive for either commonly abused drugs or alcohol. More patients tested positive for drug use than tested positive for alcohol, with 33.5% testing positive for drug use only, 15.8% testing positive for alcohol use only, and 9.9% testing positive for both drugs and alcohol. Less than half (45.2%) of the substance-abusing patients in this study would have been identified by an alcohol test alone. After alcohol, marijuana and benzodiazepines were the most frequently detected drugs. Point of collection (POC) test results correlated well with laboratory results and provide important information to initiate rapid intervention/treatment for substance use problems among injured patients.

Treatment algorithms and protocolized care.

PubMed

Morris, Alan H

2003-06-01

Excess information in complex ICU environments exceeds human decision-making limits and likely contributes to unnecessary variation in clinical care, increasing the likelihood of clinical errors. I reviewed recent critical care clinical trials searching for information about the impact of protocol use on clinically pertinent outcomes. Several recently published clinical trials illustrate the importance of distinguishing efficacy and effectiveness trials. One of these trials illustrates the danger of conducting effectiveness trials before the efficacy of an intervention is established. The trials also illustrate the importance of distinguishing guidelines and inadequately explicit protocols from adequately explicit protocols. Only adequately explicit protocols contain enough detail to lead different clinicians to the same decision when faced with the same clinical scenario. Differences between guidelines and protocols are important. Guidelines lack detail and provide general guidance that requires clinicians to fill in many gaps. Computerized or paper-based protocols are detailed and, when used for complex clinical ICU problems, can generate patient-specific, evidence-based therapy instructions that can be carried out by different clinicians with almost no interclinician variability. Individualization of patient therapy can be preserved by these protocols when they are driven by individual patient data. Explicit decision-support tools (eg, guidelines and protocols) have favorable effects on clinician and patient outcomes and can reduce the variation in clinical practice. Guidelines and protocols that aid ICU decision makers should be more widely distributed.

Marketing and clinical trials: a case study.

PubMed

Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

2007-11-20

Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review.

PubMed

van Lent, Marlies; Rongen, Gerard A; Out, Henk J

2014-12-10

Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials. Retrospective analysis of 226 protocols of drug trials approved in 2010-2011 by three RECs affiliated to academic medical centres in The Netherlands. For each protocol, information on sponsorship, number of participating centres, participating countries, study phase, registration status of the study drug, and type and number of subjects was retrieved. REC comments were extracted from decision letters sent to investigators after review and were classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature. Most protocols received comments regarding participant information and consent forms (n = 182, 80.5%), methodology and statistical analyses (n = 160, 70.8%), and supporting documentation, including trial agreements and certificates of insurance (n = 154, 68.1%). Of the submitted protocols, 122 (54.0%) were non-industry and 104 (46.0%) were industry-sponsored trials. Non-industry trials more often received comments on subject selection (n = 44, 36.1%) than industry-sponsored trials (n = 18, 17.3%; RR, 1.58; 95% CI, 1.01 to 2.47), and on methodology and statistical analyses (n = 95, 77.9% versus n = 65, 62.5%, respectively; RR, 1.18; 95% CI, 1.01 to 1.37). Non-industry trials less often received comments on supporting documentation (n = 72, 59.0%) than industry-sponsored trials (n = 82, 78.8%; RR, 0.83; 95% CI, 0.72 to 0.95). RECs identified important ethical and methodological shortcomings in protocols of both industry-sponsored and non-industry drug trials. Investigators, especially of non-industry trials, should better prepare their research protocols in order to facilitate the ethical review process.

Examination of adult and child bicyclist safety-relevant events using naturalistic bicycling methodology.

PubMed

Hamann, Cara J; Peek-Asa, Corinne

2017-05-01

Among roadway users, bicyclists are considered vulnerable due to their high risk for injury when involved in a crash. Little is known about the circumstances leading to near crashes, crashes, and related injuries or how these vary by age and gender. The purpose of this study was to examine the rates and characteristics of safety-relevant events (crashes, near crashes, errors, and traffic violations) among adult and child bicyclists. Bicyclist trips were captured using Pedal Portal, a data acquisition and coding system which includes a GPS-enabled video camera and graphical user interface. A total of 179 safety-relevant events were manually coded from trip videos. Overall, child errors and traffic violations occurred at a rate of 1.9 per 100min of riding, compared to 6.3 for adults. However, children rode on the sidewalk 56.4% of the time, compared with 12.7% for adults. For both adults and children, the highest safety-relevant event rates occurred on paved roadways with no bicycle facilities present (Adults=8.6 and Children=7.2, per 100min of riding). Our study, the first naturalistic study to compare safety-relevant events among adults and children, indicates large variation in riding behavior and exposure between child and adult bicyclists. The majority of identified events were traffic violations and we were not able to code all risk-relevant data (e.g., subtle avoidance behaviors, failure to check for traffic, probability of collision). Future naturalistic cycling studies would benefit from enhanced instrumentation (e.g., additional camera views) and coding protocols able to fill these gaps. Copyright © 2017 Elsevier Ltd. All rights reserved.

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

PubMed

Kasenda, Benjamin; von Elm, Erik; You, John J; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2016-06-01

Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.

[Constraints on publication rights in industry-initiated clinical trials--secondary publication].

PubMed

Gøtzsche, Peter C; Hróbjartsson, Asbjørn; Johansen, Helle Krogh; Haahr, Mette T; Altman, Douglas G; Chan, An-Wen

2006-06-19

In 22 of 44 industry-initiated clinical trial protocols from 1994-95, it was noted that the sponsor either owned the data or needed to approve the manuscript; another 18 protocols had other constraints. Furthermore, in 16 trials, the sponsor had access to accumulating data, and in an additional 16 trials the sponsor could stop the trial at any time, for any reason. These facts were not noted in any of the trial reports. We found similar constraints on publication rights in 44 protocols from 2004. This tight sponsor control over industry-initiated trials should be changed.

Recruitment failure and futility were the most common reasons for discontinuation of clinical drug trials. Results of a nationwide inception cohort study in the Netherlands.

PubMed

van den Bogert, Cornelis A; Souverein, Patrick C; Brekelmans, Cecile T M; Janssen, Susan W J; Koëter, Gerard H; Leufkens, Hubert G M; Bouter, Lex M

2017-08-01

The objective of the study was to identify the reasons for discontinuation of clinical drug trials and to evaluate whether efficacy-related discontinuations were adequately planned in the trial protocol. All clinical drug trials in the Netherlands, reviewed by institutional review boards in 2007, were followed until December 2015. Data were obtained through the database of the Dutch competent authority (Central Committee on Research Involving Human Subjects [CCMO]) and a questionnaire to the principal investigators. Reasons for trial discontinuation were the primary outcome of the study. Three reasons for discontinuation were analyzed separately: all cause, recruitment failure, and efficacy related (when an interim analysis had demonstrated futility or superiority). Among the efficacy-related discontinuations, we examined whether the data monitoring committee, the stopping rule, and the moment of the interim analysis in the trial progress were specified in the trial protocol. Of the 574 trials, 102 (17.8%) were discontinued. The most common reasons were recruitment failure (33 of 574; 5.7%) and solely efficacy related (30 of 574; 5.2%). Of the efficacy-related discontinuations, 10 of 30 (33.3%) of the trial protocols reported all three aspects in the trial protocol, and 20 of 30 (66.7%) reported at least one aspect in the trial protocol. One out of five clinical drug trials is discontinued before the planned trial end, with recruitment failure and futility as the most common reasons. The target sample size of trials should be feasible, and interim analyses should be adequately described in trial protocols. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluating the Process of Generating a Clinical Trial Protocol

PubMed Central

Franciosi, Lui G.; Butterfield, Noam N.; MacLeod, Bernard A.

2002-01-01

The research protocol is the principal document in the conduct of a clinical trial. Its generation requires knowledge about the research problem, the potential experimental confounders, and the relevant Good Clinical Practices for conducting the trial. However, such information is not always available to authors during the writing process. A checklist of over 80 items has been developed to better understand the considerations made by authors in generating a protocol. It is based on the most cited requirements for designing and implementing the randomised controlled trial. Items are categorised according to the trial's research question, experimental design, statistics, ethics, and standard operating procedures. This quality assessment tool evaluates the extent that a generated protocol deviates from the best-planned clinical trial.

Evaluation of wheelchair drop seat crashworthiness.

PubMed

Bertocci, G; Ha, D; van Roosmalen, L; Karg, P; Deemer, E

2001-05-01

Wheelchair seating crash performance is critical to protecting wheelchair users who remain seated in their wheelchairs during transportation. Relying upon computer simulation and sled testing seat loads associated with a 20 g/48 kph (20 g/30 mph) frontal impact and 50th percentile male occupant were estimated to develop test criteria. Using a static test setup we evaluated the performance of various types of commercially available drop seats against the loading test criteria. Five different types of drop seats (two specimens each) constructed of various materials (i.e. plastics, plywood, metal) were evaluated. Two types of drop seats (three of the total 10 specimens) met the 16650 N (3750 lb) frontal impact test criteria. While additional validation of the test protocol is necessary, this study suggests that some drop seat designs may be incapable of withstanding crash level loads.

Comparison of noninferiority margins reported in protocols and publications showed incomplete and inconsistent reporting.

PubMed

Dekkers, Olaf M; Cevallos, Myriam; Bührer, Jonas; Poncet, Antoine; Ackermann Rau, Sabine; Perneger, Thomas V; Egger, Matthias

2015-05-01

To compare noninferiority margins defined in study protocols and trial registry records with margins reported in subsequent publications. Comparison of protocols of noninferiority trials submitted 2001 to 2005 to ethics committees in Switzerland and The Netherlands with corresponding publications and registry records. We searched MEDLINE via PubMed, the Cochrane Controlled Trials Register (Cochrane Library issue 01/2012), and Google Scholar in September 2013 to identify published reports, and the International Clinical Trials Registry Platform of the World Health Organization in March 2013 to identify registry records. Two readers recorded the noninferiority margin and other data using a standardized data-abstraction form. The margin was identical in study protocol and publication in 43 (80%) of 54 pairs of study protocols and articles. In the remaining pairs, reporting was inconsistent (five pairs, 9%), or the noninferiority margin was either not reported in the publication (five pairs, 9%) or not defined in the study protocol (one pair). The confidence interval or the exact P-value required to judge whether the result was compatible with noninferior, inferior, or superior efficacy was reported in 43 (80%) publications. Complete and consistent reporting of both noninferiority margin and confidence interval (or exact P-value) was present in 39 (72%) protocol-publication pairs. Twenty-nine trials (54%) were registered in trial registries, but only one registry record included the noninferiority margin. The reporting of noninferiority margins was incomplete and inconsistent with study protocols in a substantial proportion of published trials, and margins were rarely reported in trial registries. Copyright © 2015 Elsevier Inc. All rights reserved.

Developing a guideline for clinical trial protocol content: Delphi consensus survey

PubMed Central

2012-01-01

Background Recent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT) protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, the objective of this study was to conduct a three-round Delphi consensus survey to develop and refine minimum content for RCT protocols. Methods Panellists were identified using a multistep iterative approach, met prespecified minimum criteria and represented key stakeholders who develop or use clinical trial protocols. They were asked to rate concepts for importance in a minimum set of items for RCT protocols. The main outcome measures were degree of importance (scale of 1 to 10; higher scores indicating higher importance) and level of consensus for items. Results were presented as medians, interquartile ranges, counts and percentages. Results Ninety-six expert panellists participated in the Delphi consensus survey including trial investigators, methodologists, research ethics board members, funders, industry, regulators and journal editors. Response rates were between 88 and 93% per round. Overall, panellists rated 63 of 88 concepts of high importance (of which 50 had a 25th percentile rating of 8 or greater), 13 of moderate importance (median 6 or 7) and 12 of low importance (median less than or equal to 5) for minimum trial protocol content. General and item-specific comments and subgroup results provided valuable insight for further discussions. Conclusions This Delphi process achieved consensus from a large panel of experts from diverse stakeholder groups on essential content for RCT protocols. It also highlights areas of divergence. These results, complemented by other empirical research and consensus meetings, are helping guide the development of a guideline for protocol content. PMID:23006145

Platelet Activation after Presyncope by Lower Body Negative Pressure in Humans

DTIC Science & Technology

2014-12-29

present study may exacerbate bleeding after trauma and explain the beneficial effect of early treatment with antifibrinolytics, e.g. tranexamic acid [31... tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet 377: 1096–101, 1101. Central

Marketing and clinical trials: a case study

PubMed Central

Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

2007-01-01

Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors. PMID:18028537

An Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective Randomized Control Trials

PubMed Central

Logan, Jennifer K; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

2018-01-01

Purpose Effective clinical trial enrollment can be difficult in a protocol designs that contain one treatment arm that is perceived as being more “aggressive” or “favorable.” There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to enrollment, particularly the influence of timing, in context of three prospective randomized oncology trials where one arm was considered more aggressive. Methods and materials From June 2011 to March 2015, patients who were enrolled on three prospective institutional protocols (an oligometastatic non-small cell lung cancer (NSCLC) trial, and two proton vs. intensity-modulated radiation therapy (IMRT) trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher’s exact test, Student’s t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results 309 eligible patients were approached about trial enrollment. The enrollment success rate (ESR) during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligomet protocol: 5 vs. 3 appointments (P<0.001), NSCLC protocol: 4 vs. 3 appointments (P = 0.0018), esophageal protocol: 3 vs. 2 appointments (P = 0.0086No other factors or patient characteristics significantly affected ESR. Conclusion Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success, and may help overcome accrual barriers without compromising trial design. PMID:28244413

Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers

PubMed Central

Calvert, Melanie; Kyte, Derek; Duffy, Helen; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; Ives, Jonathan; Draper, Heather; Brundage, Michael; Blazeby, Jane; King, Madeleine

2014-01-01

Background Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers. Methods and Findings We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency. Conclusions PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial protocols, in order to facilitate rigorous collection/reporting of PRO data, to effectively inform patient care. PMID:25333995

The added value of ordinal analysis in clinical trials: an example in traumatic brain injury.

PubMed

Roozenbeek, Bob; Lingsma, Hester F; Perel, Pablo; Edwards, Phil; Roberts, Ian; Murray, Gordon D; Maas, Andrew Ir; Steyerberg, Ewout W

2011-01-01

In clinical trials, ordinal outcome measures are often dichotomized into two categories. In traumatic brain injury (TBI) the 5-point Glasgow outcome scale (GOS) is collapsed into unfavourable versus favourable outcome. Simulation studies have shown that exploiting the ordinal nature of the GOS increases chances of detecting treatment effects. The objective of this study is to quantify the benefits of ordinal analysis in the real-life situation of a large TBI trial. We used data from the CRASH trial that investigated the efficacy of corticosteroids in TBI patients (n = 9,554). We applied two techniques for ordinal analysis: proportional odds analysis and the sliding dichotomy approach, where the GOS is dichotomized at different cut-offs according to baseline prognostic risk. These approaches were compared to dichotomous analysis. The information density in each analysis was indicated by a Wald statistic. All analyses were adjusted for baseline characteristics. Dichotomous analysis of the six-month GOS showed a non-significant treatment effect (OR = 1.09, 95% CI 0.98 to 1.21, P = 0.096). Ordinal analysis with proportional odds regression or sliding dichotomy showed highly statistically significant treatment effects (OR 1.15, 95% CI 1.06 to 1.25, P = 0.0007 and 1.19, 95% CI 1.08 to 1.30, P = 0.0002), with 2.05-fold and 2.56-fold higher information density compared to the dichotomous approach respectively. Analysis of the CRASH trial data confirmed that ordinal analysis of outcome substantially increases statistical power. We expect these results to hold for other fields of critical care medicine that use ordinal outcome measures and recommend that future trials adopt ordinal analyses. This will permit detection of smaller treatment effects.

Optimizing Equivalence-Based Instruction: Effects of Training Protocols on Equivalence Class Formation

ERIC Educational Resources Information Center

Fienup, Daniel M.; Wright, Nicole A.; Fields, Lanny

2015-01-01

Two experiments evaluated the effects of the simple-to-complex and simultaneous training protocols on the formation of academically relevant equivalence classes. The simple-to-complex protocol intersperses derived relations probes with training baseline relations. The simultaneous protocol conducts all training trials and test trials in separate…

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

PubMed Central

Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

2016-01-01

Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol. PMID:27352244

Template protocol for clinical trials investigating vaccines—Focus on safety elements☆

PubMed Central

Bonhoeffer, Jan; Imoukhuede, Egeruan B.; Aldrovandi, Grace; Bachtiar, Novilia S.; Chan, Eng-Soon; Chang, Soju; Chen, Robert T.; Fernandopulle, Rohini; Goldenthal, Karen L.; Heffelfinger, James D.; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B.; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

2015-01-01

This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I–IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. PMID:23499603

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

PubMed

Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

2018-02-06

Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.

Redactions in protocols for drug trials: what industry sponsors concealed.

PubMed

Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C

2018-04-01

Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.

Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials

PubMed Central

Schouten, Jeffrey T.; Dixon, Dennis; Varghese, Suresh; Cope, Marie T.; Marci, Joe; Kagan, Jonathan M.

2014-01-01

Background Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. Purpose In this study we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as identify potential correlates of prolonged development and implementation. Methods We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by NIH’s HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/ IV). We also examined several potential correlates to prolonged development and implementation intervals. Results Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2 ½ years) and implementation times (>3years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. Limitations The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects present for a specific study phase may have been masked by combining protocols into phase groupings. Presence of informative censoring, such as withdrawal of some protocols from development if they began showing signs of lost interest among investigators, complicates interpretation of Kaplan-Meier estimates. Because this study constitutes a retrospective examination over an extended period of time, it does not allow for the precise identification of relative factors impacting timing. Conclusions Delays not only increase the time and cost to complete clinical trials, but they also diminish their usefulness by failing to answer research questions in time. We believe that research analyzing the time spent traversing defined intervals across the clinical trial protocol development and implementation continuum can stimulate business process analyses and reengineering efforts that could lead to reductions in the time from clinical trial concept to results, thereby accelerating progress in clinical research. PMID:24980279

Template protocol for clinical trials investigating vaccines--focus on safety elements.

PubMed

Bonhoeffer, Jan; Imoukhuede, Egeruan B; Aldrovandi, Grace; Bachtiar, Novilia S; Chan, Eng-Soon; Chang, Soju; Chen, Robert T; Fernandopulle, Rohini; Goldenthal, Karen L; Heffelfinger, James D; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

2013-11-12

This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. Copyright © 2013 Elsevier Ltd. All rights reserved.

Speed cameras for the prevention of road traffic injuries and deaths.

PubMed

Wilson, Cecilia; Willis, Charlene; Hendrikz, Joan K; Le Brocque, Robyne; Bellamy, Nicholas

2010-11-10

It is estimated that by 2020, road traffic crashes will have moved from ninth to third in the world ranking of burden of disease, as measured in disability adjusted life years. The prevention of road traffic injuries is of global public health importance. Measures aimed at reducing traffic speed are considered essential to preventing road injuries; the use of speed cameras is one such measure. To assess whether the use of speed cameras reduces the incidence of speeding, road traffic crashes, injuries and deaths. We searched the following electronic databases covering all available years up to March 2010; the Cochrane Library, MEDLINE (WebSPIRS), EMBASE (WebSPIRS), TRANSPORT, IRRD (International Road Research Documentation), TRANSDOC (European Conference of Ministers of Transport databases), Web of Science (Science and Social Science Citation Index), PsycINFO, CINAHL, EconLit, WHO database, Sociological Abstracts, Dissertation Abstracts, Index to Theses. Randomised controlled trials, interrupted time series and controlled before-after studies that assessed the impact of speed cameras on speeding, road crashes, crashes causing injury and fatalities were eligible for inclusion. We independently screened studies for inclusion, extracted data, assessed methodological quality, reported study authors' outcomes and where possible, calculated standardised results based on the information available in each study. Due to considerable heterogeneity between and within included studies, a meta-analysis was not appropriate. Thirty five studies met the inclusion criteria. Compared with controls, the relative reduction in average speed ranged from 1% to 15% and the reduction in proportion of vehicles speeding ranged from 14% to 65%. In the vicinity of camera sites, the pre/post reductions ranged from 8% to 49% for all crashes and 11% to 44% for fatal and serious injury crashes. Compared with controls, the relative improvement in pre/post injury crash proportions ranged from 8% to 50%. Despite the methodological limitations and the variability in degree of signal to noise effect, the consistency of reported reductions in speed and crash outcomes across all studies show that speed cameras are a worthwhile intervention for reducing the number of road traffic injuries and deaths. However, whilst the the evidence base clearly demonstrates a positive direction in the effect, an overall magnitude of this effect is currently not deducible due to heterogeneity and lack of methodological rigour. More studies of a scientifically rigorous and homogenous nature are necessary, to provide the answer to the magnitude of effect.

Speed cameras for the prevention of road traffic injuries and deaths.

PubMed

Wilson, Cecilia; Willis, Charlene; Hendrikz, Joan K; Le Brocque, Robyne; Bellamy, Nicholas

2010-10-06

It is estimated that by 2020, road traffic crashes will have moved from ninth to third in the world ranking of burden of disease, as measured in disability adjusted life years. The prevention of road traffic injuries is of global public health importance. Measures aimed at reducing traffic speed are considered essential to preventing road injuries; the use of speed cameras is one such measure. To assess whether the use of speed cameras reduces the incidence of speeding, road traffic crashes, injuries and deaths. We searched the following electronic databases covering all available years up to March 2010; the Cochrane Library, MEDLINE (WebSPIRS), EMBASE (WebSPIRS), TRANSPORT, IRRD (International Road Research Documentation), TRANSDOC (European Conference of Ministers of Transport databases), Web of Science (Science and Social Science Citation Index), PsycINFO, CINAHL, EconLit, WHO database, Sociological Abstracts, Dissertation Abstracts, Index to Theses. Randomised controlled trials, interrupted time series and controlled before-after studies that assessed the impact of speed cameras on speeding, road crashes, crashes causing injury and fatalities were eligible for inclusion. We independently screened studies for inclusion, extracted data, assessed methodological quality, reported study authors' outcomes and where possible, calculated standardised results based on the information available in each study. Due to considerable heterogeneity between and within included studies, a meta-analysis was not appropriate. Thirty five studies met the inclusion criteria. Compared with controls, the relative reduction in average speed ranged from 1% to 15% and the reduction in proportion of vehicles speeding ranged from 14% to 65%. In the vicinity of camera sites, the pre/post reductions ranged from 8% to 49% for all crashes and 11% to 44% for fatal and serious injury crashes. Compared with controls, the relative improvement in pre/post injury crash proportions ranged from 8% to 50%. Despite the methodological limitations and the variability in degree of signal to noise effect, the consistency of reported reductions in speed and crash outcomes across all studies show that speed cameras are a worthwhile intervention for reducing the number of road traffic injuries and deaths. However, whilst the the evidence base clearly demonstrates a positive direction in the effect, an overall magnitude of this effect is currently not deducible due to heterogeneity and lack of methodological rigour. More studies of a scientifically rigorous and homogenous nature are necessary, to provide the answer to the magnitude of effect.

Defining standardized protocols for determining the efficacy of a postmilking teat disinfectant following experimental exposure of teats to mastitis pathogens.

PubMed

Schukken, Y H; Rauch, B J; Morelli, J

2013-04-01

The objective of this paper was to define standardized protocols for determining the efficacy of a postmilking teat disinfectant following experimental exposure of teats to both Staphylococcus aureus and Streptococcus agalactiae. The standardized protocols describe the selection of cows and herds and define the critical points in performing experimental exposure, performing bacterial culture, evaluating the culture results, and finally performing statistical analyses and reporting of the results. The protocols define both negative control and positive control trials. For negative control trials, the protocol states that an efficacy of reducing new intramammary infections (IMI) of at least 40% is required for a teat disinfectant to be considered effective. For positive control trials, noninferiority to a control disinfectant with a published efficacy of reducing new IMI of at least 70% is required. Sample sizes for both negative and positive control trials are calculated. Positive control trials are expected to require a large trial size. Statistical analysis methods are defined and, in the proposed methods, the rate of IMI may be analyzed using generalized linear mixed models. The efficacy of the test product can be evaluated while controlling for important covariates and confounders in the trial. Finally, standards for reporting are defined and reporting considerations are discussed. The use of the defined protocol is shown through presentation of the results of a recent trial of a test product against a negative control. Copyright © 2013 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Frontal and oblique crash tests of HIII 6-year-old child ATD using real-world, observed child passenger postures.

PubMed

Bohman, Katarina; Arbogast, Kristy B; Loeb, Helen; Charlton, Judith L; Koppel, Sjaan; Cross, Suzanne L

2018-02-28

The aim of this study was to evaluate the consequences of frontal and oblique crashes when positioning a Hybrid III (HIII) 6-year-old child anthropometric test device (ATD) using observed child passenger postures from a naturalistic driving study (NDS). Five positions for booster-seated children aged 4-7 years were selected, including one reference position according to the FMVSS 213 ATD seating protocol and 4 based on real-world observed child passenger postures from an NDS including 2 user positions with forward tilting torso and 2 that combined both forward and lateral inboard tilting of the torso. Seventeen sled tests were conducted in a mid-sized vehicle body at 64 km/h (European New Car Assessment Programme [Euro NCAP] Offset Deformable Barrier [ODB] pulse), in full frontal and oblique (15°) crash directions. The rear-seated HIII 6-year-old child ATD was restrained on a high-back booster seat. In 10 tests, the booster seat was also attached with a top tether. In the oblique tests, the ATD was positioned on the far side. Three camera views and ATD responses (head, neck, and chest) were analyzed. The shoulder belt slipped off the shoulder in all ATD positions in the oblique test configuration. In full frontal tests, the shoulder belt stayed on the shoulder in 3 out of 9 tests. Head acceleration and neck tension were decreased in the forward leaning positions; however, the total head excursion increased up to 210 mm compared to te reference position, due to belt slip-off and initial forward leaning position. These results suggest that real-world child passenger postures may contribute to shoulder belt slip-off and increased head excursion, thus increasing the risk of head injury. Restraint system development needs to include a wider range of sitting postures that children may choose, in addition to the specified postures of ATDs in seating test protocols, to ensure robust performance across diverse use cases. In addition, these tests revealed that the child ATD is limited in its ability to mimic real-world child passenger postures. There is a need to develop child human body models that may offer greater flexibility for these types of crash evaluations.

Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

PubMed

Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

2018-01-01

The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and/or trial subjects as specific risk-alleviating measures.

Planning and reporting of quality-of-life outcomes in cancer trials

PubMed Central

Schandelmaier, S.; Conen, K.; von Elm, E.; You, J. J.; Blümle, A.; Tomonaga, Y.; Amstutz, A.; Briel, M.; Kasenda, B.

2015-01-01

Background Information about the impact of cancer treatments on patients' quality of life (QoL) is of paramount importance to patients and treating oncologists. Cancer trials that do not specify QoL as an outcome or fail to report collected QoL data, omit crucial information for decision making. To estimate the magnitude of these problems, we investigated how frequently QoL outcomes were specified in protocols of cancer trials and subsequently reported. Design Retrospective cohort study of RCT protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys. Results Of the 173 cancer trials, 90 (52%) specified QoL outcomes in their protocol, 2 (1%) as primary and 88 (51%) as secondary outcome. Of the 173 trials, 35 (20%) reported QoL outcomes in a corresponding publication (4 modified from the protocol), 18 (10%) were published but failed to report QoL outcomes in the primary or a secondary publication, and 37 (21%) were not published at all. Of the 83 (48%) trials that did not specify QoL outcomes in their protocol, none subsequently reported QoL outcomes. Failure to report pre-specified QoL outcomes was not associated with industry sponsorship (versus non-industry), sample size, and multicentre (versus single centre) status but possibly with trial discontinuation. Conclusions About half of cancer trials specified QoL outcomes in their protocols. However, only 20% reported any QoL data in associated publications. Highly relevant information for decision making is often unavailable to patients, oncologists, and health policymakers. PMID:26133966

Predicting long-term neurological outcomes after severe traumatic brain injury requiring decompressive craniectomy: A comparison of the CRASH and IMPACT prognostic models.

PubMed

Honeybul, Stephen; Ho, Kwok M

2016-09-01

Predicting long-term neurological outcomes after severe traumatic brain (TBI) is important, but which prognostic model in the context of decompressive craniectomy has the best performance remains uncertain. This prospective observational cohort study included all patients who had severe TBI requiring decompressive craniectomy between 2004 and 2014, in the two neurosurgical centres in Perth, Western Australia. Severe disability, vegetative state, or death were defined as unfavourable neurological outcomes. Area under the receiver-operating-characteristic curve (AUROC) and slope and intercept of the calibration curve were used to assess discrimination and calibration of the CRASH (Corticosteroid-Randomisation-After-Significant-Head injury) and IMPACT (International-Mission-For-Prognosis-And-Clinical-Trial) models, respectively. Of the 319 patients included in the study, 119 (37%) had unfavourable neurological outcomes at 18-month after decompressive craniectomy for severe TBI. Both CRASH (AUROC 0.86, 95% confidence interval 0.81-0.90) and IMPACT full-model (AUROC 0.85, 95% CI 0.80-0.89) were similar in discriminating between favourable and unfavourable neurological outcome at 18-month after surgery (p=0.690 for the difference in AUROC derived from the two models). Although both models tended to over-predict the risks of long-term unfavourable outcome, the IMPACT model had a slightly better calibration than the CRASH model (intercept of the calibration curve=-4.1 vs. -5.7, and log likelihoods -159 vs. -360, respectively), especially when the predicted risks of unfavourable outcome were <80%. Both CRASH and IMPACT prognostic models were good in discriminating between favourable and unfavourable long-term neurological outcome for patients with severe TBI requiring decompressive craniectomy, but the calibration of the IMPACT full-model was better than the CRASH model. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials inmore » NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.« less

The effects of sweep numbers per average and protocol type on the accuracy of the p300-based concealed information test.

PubMed

Dietrich, Ariana B; Hu, Xiaoqing; Rosenfeld, J Peter

2014-03-01

In the first of two experiments, we compared the accuracy of the P300 concealed information test protocol as a function of numbers of trials experienced by subjects and ERP averages analyzed by investigators. Contrary to Farwell et al. (Cogn Neurodyn 6(2):115-154, 2012), we found no evidence that 100 trial based averages are more accurate than 66 or 33 trial based averages (all numbers led to accuracies of 84-94 %). There was actually a trend favoring the lowest trial numbers. The second study compared numbers of irrelevant stimuli recalled and recognized in the 3-stimulus protocol versus the complex trial protocol (Rosenfeld in Memory detection: theory and application of the concealed information test, Cambridge University Press, New York, pp 63-89, 2011). Again, in contrast to expectations from Farwell et al. (Cogn Neurodyn 6(2):115-154, 2012), there were no differences between protocols, although there were more irrelevant stimuli recognized than recalled, and irrelevant 4-digit number group stimuli were neither recalled nor recognized as well as irrelevant city name stimuli. We therefore conclude that stimulus processing in the P300-based complex trial protocol-with no more than 33 sweep averages-is adequate to allow accurate detection of concealed information.

A privacy preserving protocol for tracking participants in phase I clinical trials.

PubMed

El Emam, Khaled; Farah, Hanna; Samet, Saeed; Essex, Aleksander; Jonker, Elizabeth; Kantarcioglu, Murat; Earle, Craig C

2015-10-01

Some phase 1 clinical trials offer strong financial incentives for healthy individuals to participate in their studies. There is evidence that some individuals enroll in multiple trials concurrently. This creates safety risks and introduces data quality problems into the trials. Our objective was to construct a privacy preserving protocol to track phase 1 participants to detect concurrent enrollment. A protocol using secure probabilistic querying against a database of trial participants that allows for screening during telephone interviews and on-site enrollment was developed. The match variables consisted of demographic information. The accuracy (sensitivity, precision, and negative predictive value) of the matching and its computational performance in seconds were measured under simulated environments. Accuracy was also compared to non-secure matching methods. The protocol performance scales linearly with the database size. At the largest database size of 20,000 participants, a query takes under 20s on a 64 cores machine. Sensitivity, precision, and negative predictive value of the queries were consistently at or above 0.9, and were very similar to non-secure versions of the protocol. The protocol provides a reasonable solution to the concurrent enrollment problems in phase 1 clinical trials, and is able to ensure that personal information about participants is kept secure. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Active involvement and intervention in patients exposed to whiplash trauma in automobile crashes reduces costs: a randomized, controlled clinical trial and health economic evaluation.

PubMed

Rosenfeld, Mark; Seferiadis, Aris; Gunnarsson, Ronny

2006-07-15

To examine and compare the costs and consequences in a partial economic evaluation of two competing interventions in patients exposed to whiplash trauma in automobile crashes. The interventions were an active involvement and intervention using early mobilization and a standard intervention of rest, recommended short-term immobilization in a cervical collar and a cautious, gradual self-exercise program according to a leaflet. The study was randomized and controlled. The aim of the study was to compare the costs of an active involvement and intervention versus a standard intervention and to relate them to the clinical benefits in patients exposed to whiplash trauma in automobile crashes to facilitate decision-making regarding intervention and resource allocation. There is very little known about the health economic aspects of various interventions in the target treatment group of patients. Based on a prospective, randomized, clinical trial, data on clinical effectiveness and resources used for the active involvement and intervention and standard intervention were collected for a comparative analysis of the costs related to physical therapy treatment and sick leave. A cost-consequence analysis consisting of a modified cost-effectiveness analysis was used. The costs were significantly lower after 6 and 36 months with an active involvement and intervention as compared with the standard intervention. The active involvement and intervention were significantly superior in reducing experienced pain and reducing sick leave. For patients exposed to whiplash trauma in a motor vehicle collision, an active involvement and intervention were both less costly and more effective than a standard intervention.

Site visits to initiate recruitment in a clinical trial: does it matter who conducts the visit? Protocol for implementation in trials.

PubMed

Nollett, Claire; Kelson, Mark; Hood, Kerenza

2016-11-01

The Study Within a Trial (SWAT) program exists to 'embed research within research, so as to resolve uncertainties about the different ways of designing, conducting, analyzing, and interpreting evaluations of health and social care' (1). Published in this journal in 2013, a template for the first SWAT protocol outlined an investigation into the effects of site visits by the principal investigator on recruitment in multicentre randomized controlled trials (1). We have now designed a SWAT protocol to extend this question and ask 'does it matter who conducts the site visit?' Our aim is to provide a protocol that trials can implement to address this research question. © 2016 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.

Meso-modeling of Carbon Fiber Composite for Crash Safety Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lin, Shih-Po; Chen, Yijung; Zeng, Danielle

2017-04-06

In the conventional approach, the material properties for crash safety simulations are typically obtained from standard coupon tests, where the test results only provide single layer material properties used in crash simulations. However, the lay-up effects for the failure behaviors of the real structure were not considered in numerical simulations. Hence, there was discrepancy between the crash simulations and experimental tests. Consequently, an intermediate stage is required for accurate predictions. Some component tests are required to correlate the material models in the intermediate stage. In this paper, a Mazda Tube under high-impact velocity is chosen as an example for themore » crash safety analysis. The tube consists of 24 layers of uni-directional (UD) carbon fiber composite materials, in which 4 layers are perpendicular to, while the other layers are parallel to the impact direction. An LS-DYNA meso-model was constructed with orthotropic material models counting for the single-layer material behaviors. Between layers, a node-based tie-break contact was used for modeling the delamination of the composite material. Since fiber directions are not single-oriented, the lay-up effects could be an important effect. From the first numerical trial, premature material failure occurred due to the use of material parameters obtained directly from the coupon tests. Some parametric studies were conducted to identify the cause of the numerical instability. The finding is that the material failure strength used in the numerical model needs to be enlarged to stabilize the numerical model. Some hypothesis was made to provide the foundation for enlarging the failure strength and the corresponding experiments will be conducted to validate the hypothesis.« less

ASCOT: a text mining-based web-service for efficient search and assisted creation of clinical trials

PubMed Central

2012-01-01

Clinical trials are mandatory protocols describing medical research on humans and among the most valuable sources of medical practice evidence. Searching for trials relevant to some query is laborious due to the immense number of existing protocols. Apart from search, writing new trials includes composing detailed eligibility criteria, which might be time-consuming, especially for new researchers. In this paper we present ASCOT, an efficient search application customised for clinical trials. ASCOT uses text mining and data mining methods to enrich clinical trials with metadata, that in turn serve as effective tools to narrow down search. In addition, ASCOT integrates a component for recommending eligibility criteria based on a set of selected protocols. PMID:22595088

ASCOT: a text mining-based web-service for efficient search and assisted creation of clinical trials.

PubMed

Korkontzelos, Ioannis; Mu, Tingting; Ananiadou, Sophia

2012-04-30

Clinical trials are mandatory protocols describing medical research on humans and among the most valuable sources of medical practice evidence. Searching for trials relevant to some query is laborious due to the immense number of existing protocols. Apart from search, writing new trials includes composing detailed eligibility criteria, which might be time-consuming, especially for new researchers. In this paper we present ASCOT, an efficient search application customised for clinical trials. ASCOT uses text mining and data mining methods to enrich clinical trials with metadata, that in turn serve as effective tools to narrow down search. In addition, ASCOT integrates a component for recommending eligibility criteria based on a set of selected protocols.

Standardized patient walkthroughs in the National Drug Abuse Treatment Clinical Trials Network: common challenges to protocol implementation.

PubMed

Fussell, Holly E; Kunkel, Lynn E; McCarty, Dennis; Lewy, Colleen S

2011-09-01

Training research staff to implement clinical trials occurring in community-based addiction treatment programs presents unique challenges. Standardized patient walkthroughs of study procedures may enhance training and protocol implementation. Examine and discuss cross-site and cross-study challenges of participant screening and data collection procedures identified during standardized patient walkthroughs of multi-site clinical trials. Actors portrayed clients and "walked through" study procedures with protocol research staff. The study completed 57 walkthroughs during implementation of 4 clinical trials. Observers and walkthrough participants identified three areas of concern (consent procedures, screening and assessment processes, and protocol implementation) and made suggestions for resolving the concerns. Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants. The standardized patient walkthrough improves consistency across study sites and reduces potential site variation in study outcomes.

Clinical Trials Management | Division of Cancer Prevention

Cancer.gov

Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded

Optimization of protocol design: a path to efficient, lower cost clinical trial execution

PubMed Central

Malikova, Marina A

2016-01-01

Managing clinical trials requires strategic planning and efficient execution. In order to achieve a timely delivery of important clinical trials’ outcomes, it is useful to establish standardized trial management guidelines and develop robust scoring methodology for evaluation of study protocol complexity. This review will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and the right data are collected to demonstrate that a drug is safe and efficacious, while managing study costs and study complexity based on proposed comprehensive scoring model. Key factors to consider when developing protocols and techniques to minimize complexity will be discussed. A methodology to identify processes at planning phase, approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials will be addressed. PMID:28031939

Nonconformities in real-world fatal crashes--electronic stability control and seat belt reminders.

PubMed

Lie, Anders

2012-01-01

Many new safety systems are entering the market. Vision Zero is a safety strategy aiming at the elimination of fatalities and impairing injuries by the use of a holistic model for safe traffic to develop a safe system. The aim of this article is to analyze fatalities in modern cars with respect to the Vision Zero model with special respect to electronic stability control (ESC) systems and modern seat belt reminders (SBRs). The model is used to identify and understand cases where cars with ESC systems lost control and where occupants were unbelted in a seat with seat belt reminders under normal driving conditions. The model for safe traffic was used to analyze in-depth studies of fatal crashes with respect to seat belt use and loss of control. Vehicles from 2003 and later in crashes from January 2004 to mid-2010 were analyzed. The data were analyzed case by case. Cars that were equipped with ESC systems and lost control and occupants not using the seat belt in a seat with a seat belt reminder were considered as nonconformities. A total of 138 fatal crashes involving 152 fatally injured occupants were analyzed. Cars with ESC systems had fewer loss-of-control-relevant cases than cars without ESC systems. Thirteen percent of the ESC-equipped vehicles had loss-of-control-relevant crashes and 36 percent of the cars without ESC systems had loss-of-control-relevant crashes. The analysis indicates that only one car of the 9 equipped with ESC that lost control did it on a road surface with relevant friction when driving within the speed restriction of the road. In seats with seat belt reminders that are in accordance with the European New Car Assessment Programme's (Euro NCAP) protocol, 93 percent of the occupants were using a seat belt. In seats without reminders this number was 74 percent. This study shows that ESC systems result in a very significant reduction in fatal crashes, especially under normal driving conditions. Under extreme driving conditions such as speeding or extremely low friction (snow or on the side of the road), ESC systems can fail in keeping the car under control. Seat belt reminders result in higher seat belt use rates but the level of unbelted occupants is higher than roadside studies have indicated. The holistic Vision Zero approach helped in the analysis by identifying nonconformities and putting these into the safe systems perspective.

Validation of the abrasion resistance test protocols and performance criteria of EN13595: The probability of soft tissue injury to motorcycle riders by abrasion resistance of their clothing.

PubMed

Meredith, Lauren; Hurren, Christopher; Clarke, Elizabeth; Fitzharris, Michael; Baldock, Matthew; de Rome, Liz; Olivier, Jake; Brown, Julie

2017-06-01

Motorcyclists represent an increasing proportion of road users globally and are increasingly represented in crash statistics. Soft tissue injuries are the most common type of injuries to crashed motorcyclists. These injuries can be prevented through the use of protective clothing designed for motorcycle use. However, the quality of such clothing is not controlled in many countries around the world. A European Standard was developed to assess the performance of clothing but as this is not mandatory, clothing certified to this Standard is difficult to obtain. Given the importance of this Standard, and that it has been validated only once, further validation work is required. In-depth crash investigation data were used to investigate the relationship between the abrasion resistance performance of clothing and real-world injury outcome. Clothing was collected from riders who crashed on public roads in Sydney and Newcastle, Australia. This clothing was tested according to the EU Standard and the time to hole was recorded. Hospital medical records were reviewed and the association between a rider suffering a soft tissue injury and the time-to-hole for the garment was examined. The probability of soft tissue injury for Level 1 Standard garments was between 40-60%, but more than 60% of garments tested failed to meet the minimum requirement. The findings of this study provide qualified support for the Standard, with a marginal association between time-to-hole and injury being found. This work supports the need for improved safety performance and an increased number of high performing garments being available to motorcyclists. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.

Proposed test method for and evaluation of wheelchair seating system (WCSS) crashworthiness.

PubMed

van Roosmalen, L; Bertocci, G; Ha, D R; Karg, P; Szobota, S

2000-01-01

Safety of motor vehicle seats is of great importance in providing crash protection to the occupant. An increasing number of wheelchair users use their wheelchairs as motor vehicle seats when traveling. A voluntary standard requires that compliant wheelchairs be dynamically sled impact tested. However, testing to evaluate the crashworthiness of add-on wheelchair seating systems (WCSS) independent of their wheelchair frame is not addressed by this standard. To address this need, this study developed a method to evaluate the crash-worthiness of WCSS with independent frames. Federal Motor Vehicle Safety Standards (FMVSS) 207 test protocols, used to test the strength of motor vehicle seats, were modified and used to test the strength of three WCSS. Forward and rearward loads were applied at the WCSS center of gravity (CGSS), and a moment was applied at the uppermost point of the seat back. Each of the three tested WCSS met the strength requirements of FMVSS 207. Wheelchair seat-back stiffness was also investigated and compared to motor vehicle seat-back stiffness.

Pregnant woman and road safety: experimental crash test with post mortem human subject.

PubMed

Delotte, Jerome; Behr, Michel; Thollon, Lionel; Arnoux, Pierre-Jean; Baque, Patrick; Bongain, Andre; Brunet, Christian

2008-05-01

Trauma affect between 3 and 7% of all pregnancies in industrialized countries, and the leading cause of these traumas is car crashes. The difficulty to appreciate physiologic and anatomic changes occurring during pregnancy explain that majority of studies were not based on anatomical data. We present a protocol to create a realistic anatomical model of pregnant woman using a post mortem human subject (PMHS). We inserted a physical model of the gravid uterus into the pelvis of a PMHS. 3D acceleration sensors were placed on the subject to measure the acceleration on different body segments. We simulated three frontal impact situations at 20 km/h between two average European cars. Two main kinematics events were identified as possible causes of injuries: lap belt loading and backrest impact. Cadaver experiments provide one interesting complementary approach to study injury mechanisms related to road accidents involving pregnant women. This anatomical accuracy makes it possible to progress in the field of safety devices.

Translation to Primary Care of an Effective Teen Safe Driving Program for Parents.

PubMed

Shope, Jean T; Zakrajsek, Jennifer S; Finch, Stacia; Bingham, C Raymond; O'Neil, Joseph; Yano, Stephen; Wasserman, Richard; Simons-Morton, Bruce

2016-10-01

Addressing teen driver crashes, this study adapted an effective Checkpoints(TM) program for parents of teen drivers for dissemination by primary care practitioners (PCPs) and the web; distributed the PCP/web program through pediatric practices; and examined dissemination to/implementation by parents. The website, youngDRIVERparenting.org, and brief intervention protocol were developed. PCPs delivered interventions and materials to parents, referred them to the website, and completed follow-up surveys. Google Analytics assessed parents' website use. Most PCPs reported delivering interventions with fidelity, and thought the program important and feasible. Brief interventions/website referrals, averaging 4.4 minutes, were delivered to 3465 (87%) of 3990 eligible parents by 133 PCPs over an 18-week average. Website visits (1453) were made by 42% of parents, who spent on average 3:53 minutes viewing 4.2 topics. This program costs little (its website, training and promotional materials are available) and could be one component of a comprehensive approach to reducing teen driver crashes. © The Author(s) 2016.

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees

PubMed Central

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-01-01

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. PMID:26811365

Study protocol of a mixed-methods evaluation of a cluster randomized trial to improve the safety of NSAID and antiplatelet prescribing: data-driven quality improvement in primary care.

PubMed

Grant, Aileen; Dreischulte, Tobias; Treweek, Shaun; Guthrie, Bruce

2012-08-28

Trials of complex interventions are criticized for being 'black box', so the UK Medical Research Council recommends carrying out a process evaluation to explain the trial findings. We believe it is good practice to pre-specify and publish process evaluation protocols to set standards and minimize bias. Unlike protocols for trials, little guidance or standards exist for the reporting of process evaluations. This paper presents the mixed-method process evaluation protocol of a cluster randomized trial, drawing on a framework designed by the authors. This mixed-method evaluation is based on four research questions and maps data collection to a logic model of how the data-driven quality improvement in primary care (DQIP) intervention is expected to work. Data collection will be predominately by qualitative case studies in eight to ten of the trial practices, focus groups with patients affected by the intervention and quantitative analysis of routine practice data, trial outcome and questionnaire data and data from the DQIP intervention. We believe that pre-specifying the intentions of a process evaluation can help to minimize bias arising from potentially misleading post-hoc analysis. We recognize it is also important to retain flexibility to examine the unexpected and the unintended. From that perspective, a mixed-methods evaluation allows the combination of exploratory and flexible qualitative work, and more pre-specified quantitative analysis, with each method contributing to the design, implementation and interpretation of the other.As well as strengthening the study the authors hope to stimulate discussion among their academic colleagues about publishing protocols for evaluations of randomized trials of complex interventions. DATA-DRIVEN QUALITY IMPROVEMENT IN PRIMARY CARE TRIAL REGISTRATION: ClinicalTrials.gov: NCT01425502.

Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.

PubMed

Knirsch, Charles; Alemayehu, Demissie; Botgros, Radu; Comic-Savic, Sabrina; Friedland, David; Holland, Thomas L; Merchant, Kunal; Noel, Gary J; Pelfrene, Eric; Reith, Christina; Santiago, Jonas; Tiernan, Rosemary; Tenearts, Pamela; Goldsack, Jennifer C; Fowler, Vance G

2016-08-15

The etiology of hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) is often multidrug-resistant infections. The evaluation of new antibacterial drugs for efficacy in this population is important, as many antibacterial drugs have demonstrated limitations when studied in this population. HABP/VABP trials are expensive and challenging to conduct due to protocol complexity and low patient enrollment, among other factors. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development by streamlining HABP/VABP clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with HABP/VABP protocol complexity. The Project Team developed potential solutions to streamline HABP/VABP trials using a Quality by Design approach. CTTI recommendations focus on 4 key areas to improve HABP/VABP trials: informed consent processes/practices, protocol design, choice of an institutional review board (IRB), and trial outcomes. Informed consent processes should include legally authorized representatives. Protocol design decisions should focus on eligibility criteria, prestudy antibacterial therapy considerations, use of new diagnostics, and sample size. CTTI recommends that sponsors use a central IRB and discuss trial endpoints with regulators, including defining a clinical failure and evaluating the impact of concomitant antibacterial drugs. Streamlining HABP/VABP trials by addressing key protocol elements can improve trial startup and patient recruitment/retention, reduce trial complexity and costs, and ensure patient safety while advancing antibacterial drug development. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Guidelines for randomized clinical trial protocol content: a systematic review

PubMed Central

2012-01-01

Background All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. Methods We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. Results Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. Conclusions Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed. PMID:23006870

Guidelines for randomized clinical trial protocol content: a systematic review.

PubMed

Tetzlaff, Jennifer M; Chan, An-Wen; Kitchen, Jessica; Sampson, Margaret; Tricco, Andrea C; Moher, David

2012-09-24

All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed.

Ghost Authorship in Industry-Initiated Randomised Trials

PubMed Central

Gøtzsche, Peter C; Hróbjartsson, Asbjørn; Johansen, Helle Krogh; Haahr, Mette T; Altman, Douglas G; Chan, An-Wen

2007-01-01

Background Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability. The prevalence and nature of ghost authorship in industry-initiated randomised trials is not known. Methods and Findings We conducted a cohort study comparing protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994–1995. We defined ghost authorship as present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment. We identified 44 industry-initiated trials. We did not find any trial protocol or publication that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis. We found evidence of ghost authorship for 33 trials (75%; 95% confidence interval 60%–87%). The prevalence of ghost authorship was increased to 91% (40 of 44 articles; 95% confidence interval 78%–98%) when we included cases where a person qualifying for authorship was acknowledged rather than appearing as an author. In 31 trials, the ghost authors we identified were statisticians. It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors. Conclusions Ghost authorship in industry-initiated trials is very common. Its prevalence could be considerably reduced, and transparency improved, if existing guidelines were followed, and if protocols were publicly available. PMID:17227134

Ghost authorship in industry-initiated randomised trials.

PubMed

Gøtzsche, Peter C; Hróbjartsson, Asbjørn; Johansen, Helle Krogh; Haahr, Mette T; Altman, Douglas G; Chan, An-Wen

2007-01-01

Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability. The prevalence and nature of ghost authorship in industry-initiated randomised trials is not known. We conducted a cohort study comparing protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994-1995. We defined ghost authorship as present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment. We identified 44 industry-initiated trials. We did not find any trial protocol or publication that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis. We found evidence of ghost authorship for 33 trials (75%; 95% confidence interval 60%-87%). The prevalence of ghost authorship was increased to 91% (40 of 44 articles; 95% confidence interval 78%-98%) when we included cases where a person qualifying for authorship was acknowledged rather than appearing as an author. In 31 trials, the ghost authors we identified were statisticians. It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors. Ghost authorship in industry-initiated trials is very common. Its prevalence could be considerably reduced, and transparency improved, if existing guidelines were followed, and if protocols were publicly available.

Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial.

PubMed

Roberts, Ian; Yates, David; Sandercock, Peter; Farrell, Barbara; Wasserberg, Jonathan; Lomas, Gabrielle; Cottingham, Rowland; Svoboda, Petr; Brayley, Nigel; Mazairac, Guy; Laloë, Véronique; Muñoz-Sánchez, Angeles; Arango, Miguel; Hartzenberg, Bennie; Khamis, Hussein; Yutthakasemsunt, Surakrant; Komolafe, Edward; Olldashi, Fatos; Yadav, Yadram; Murillo-Cabezas, Francisco; Shakur, Haleema; Edwards, Phil

Corticosteroids have been used to treat head injuries for more than 30 years. In 1997, findings of a systematic review suggested that these drugs reduce risk of death by 1-2%. The CRASH trial--a multicentre international collaboration--aimed to confirm or refute such an effect by recruiting 20000 patients. In May, 2004, the data monitoring committee disclosed the unmasked results to the steering committee, which stopped recruitment. 10008 adults with head injury and a Glasgow coma score (GCS) of 14 or less within 8 h of injury were randomly allocated 48 h infusion of corticosteroids (methylprednisolone) or placebo. Primary outcomes were death within 2 weeks of injury and death or disability at 6 months. Prespecified subgroup analyses were based on injury severity (GCS) at randomisation and on time from injury to randomisation. Analysis was by intention to treat. Effects on outcomes within 2 weeks of randomisation are presented in this report. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN74459797. Compared with placebo, the risk of death from all causes within 2 weeks was higher in the group allocated corticosteroids (1052 [21.1%] vs 893 [17.9%] deaths; relative risk 1.18 [95% CI 1.09-1.27]; p=0.0001). The relative increase in deaths due to corticosteroids did not differ by injury severity (p=0.22) or time since injury (p=0.05). Our results show there is no reduction in mortality with methylprednisolone in the 2 weeks after head injury. The cause of the rise in risk of death within 2 weeks is unclear.

A randomized trial of microdose leuprolide acetate protocol versus luteal phase ganirelix protocol in predicted poor responders.

PubMed

DiLuigi, Andrea J; Engmann, Lawrence; Schmidt, David W; Benadiva, Claudio A; Nulsen, John C

2011-06-30

We performed a randomized trial to compare IVF outcomes in 54 poor responder patients undergoing a microdose leuprolide acetate (LA) protocol or a GnRH antagonist protocol incorporating a luteal phase E(2) patch and GnRH antagonist in the preceding menstrual cycle. Cancellation rates, number of oocytes retrieved, clinical pregnancy rates (PR), and ongoing PRs were similar between the two groups. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial).

PubMed

Fetterplace, Kate; Deane, Adam M; Tierney, Audrey; Beach, Lisa; Knight, Laura D; Rechnitzer, Thomas; Forsyth, Adrienne; Mourtzakis, Marina; Presneill, Jeffrey; MacIsaac, Christopher

2018-01-01

Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes. This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU) will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein) or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein). The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT) from baseline (prior to randomisation) to ICU discharge and other nutritional and patient-centred outcomes. This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12615000876594 UTN: U1111-1172-8563.

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

PubMed

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Crash sequence based risk matrix for motorcycle crashes.

PubMed

Wu, Kun-Feng; Sasidharan, Lekshmi; Thor, Craig P; Chen, Sheng-Yin

2018-04-05

Considerable research has been conducted related to motorcycle and other powered-two-wheeler (PTW) crashes; however, it always has been controversial among practitioners concerning with types of crashes should be first targeted and how to prioritize resources for the implementation of mitigating actions. Therefore, there is a need to identify types of motorcycle crashes that constitute the greatest safety risk to riders - most frequent and most severe crashes. This pilot study seeks exhibit the efficacy of a new approach for prioritizing PTW crash causation sequences as they relate to injury severity to better inform the application of mitigating countermeasures. To accomplish this, the present study constructed a crash sequence-based risk matrix to identify most frequent and most severe motorcycle crashes in an attempt to better connect causes and countermeasures of PTW crashes. Although the frequency of each crash sequence can be computed from crash data, a crash severity model is needed to compare the levels of crash severity among different crash sequences, while controlling for other factors that also have effects on crash severity such drivers' age, use of helmet, etc. The construction of risk matrix based on crash sequences involve two tasks: formulation of crash sequence and the estimation of a mixed-effects (ME) model to adjust the levels of severities for each crash sequence to account for other crash contributing factors that would have an effect on the maximum level of crash severity in a crash. Three data elements from the National Automotive Sampling System - General Estimating System (NASS-GES) data were utilized to form a crash sequence: critical event, crash types, and sequence of events. A mixed-effects model was constructed to model the severity levels for each crash sequence while accounting for the effects of those crash contributing factors on crash severity. A total of 8039 crashes involving 8208 motorcycles occurred during 2011 and 2013 were included in this study, weighted to represent 338,655 motorcyclists involved in traffic crashes in three years (2011-2013)(NHTSA, 2013). The top five most frequent and severe types of crash sequences were identified, accounting for 23 percent of all the motorcycle crashes included in the study, and they are (1) run-off-road crashes on the right, and hitting roadside objects, (2) cross-median crashes, and rollover, (3) left-turn oncoming crashes, and head-on, (4) crossing over (passing through) or turning into opposite direction at intersections, and (5) side-impacted. In addition to crash sequences, several other factors were also identified to have effects on crash severity: use of helmet, presence of horizontal curves, alcohol consumption, road surface condition, roadway functional class, and nighttime condition. Copyright © 2018 Elsevier Ltd. All rights reserved.

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

PubMed

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-05-15

To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

A comparison of VO2max and metabolic variables between treadmill running and treadmill skating.

PubMed

Koepp, Kriston K; Janot, Jeffrey M

2008-03-01

The purpose of this study was to determine differences in VO2max and metabolic variables between treadmill running and treadmill skating. This study also examined VO2max responses during a continuous skating treadmill protocol and a discontinuous skating treadmill protocol. Sixteen male high school hockey players, who had a mean age of 16 +/- 1 years and were of an above-average fitness level, participated in this study. All subjects completed 4 exercise trials: a 1-hour skating treadmill familiarization trial, a treadmill running trial, and 2 randomized skating treadmill trials. Minute ventilation (VE), oxygen consumption VO2), carbon dioxide production VCO2), respiratory exchange ratio (RER), and heart rate were averaged every 15 seconds up to VO2max for each exercise test. The results showed that there was a significant difference (P < 0.05) for VO2max (mL.kg.min) and maximal VCO2 (L.min) between the running treadmill protocol and discontinuous skating treadmill protocol. There was also a significant difference for maximal RER between the discontinuous and continuous skating treadmill protocol and between the discontinuous skating treadmill protocol and running treadmill protocol. In conclusion, the running treadmill elicited a greater VO2max (mL.kg.min) than the skating treadmill did, but when it comes to specificity of ice skating, the skating treadmill may be ideal. Also, there was no significant difference between the discontinuous and continuous skating treadmill protocols. Therefore, a continuous protocol is possible on the skating treadmill without compromising correct skating position and physiologic responses. However, the continuous skating treadmill protocol should undergo validation before other scientists, coaches, and strength and conditioning professionals can apply it correctly.

Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board.

PubMed

Gautier, Isabelle; Janiaud, Perrine; Rollet, Nelly; André, Nicolas; Tsimaratos, Michel; Cornu, Catherine; Malik, Salma; Gentile, Stéphanie; Kassaï, Behrouz

2017-08-23

There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118) before and after the initiation of the EU Pediatric Regulation. All protocols submitted to the IRB00009118 between 2003 and 2014 and conducting research on subjects under eighteen years of age were eligible. The quality of randomized clinical trials was assessed according to the guidelines developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and ranked using the Jadad score. Out of 622 protocols submitted to the Institutional Review Board (IRB), 21% (133/622) included children. Among these 133 pediatric protocols, the number of submitted pediatric protocols doubled between the two studied periods. From 2003 to 2008, 47 protocols including 21 institutionally sponsored were submitted to the IRB and from 2009 until 2014, 86 protocols including 48 institutionally sponsored were submitted. No significant trend was observed on the quality of RCTs. The overall median score of RCTs on the Jadad scale was high (3.5), 70.0% of protocols had a Jadad score ≥ 3, and 30.0% had a score < 3. Following the EU Pediatric Regulation, the number of pediatric protocols submitted to the IRB00009118 tends to increase, but no change was noticed regarding their quality.

Interventions in the alcohol server setting for preventing injuries.

PubMed

Ker, K; Chinnock, P

2006-04-19

Injuries are a significant public health burden and alcohol intoxication is recognised as a risk factor for injuries. There is increasing attention on supply-side interventions, which aim to modify the environment and context within which alcohol is supplied and consumed. To quantify the effectiveness of interventions implemented in the server setting for reducing injuries. We searched the Cochrane Injuries Group Specialised Register (September 2004), Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2004), MEDLINE (January 1966 to September 2004), EMBASE (1980 to 2004, wk 36), other specialised databases and reference lists of articles. We also contacted experts in the field. Randomised controlled trials (RCTs) and non-randomised controlled studies (NRS) of the effectiveness of interventions administered in the server setting which attempted to modify the conditions under which alcohol is served and consumed, to facilitate sensible alcohol consumption and reduce the occurrence of alcohol-related harm. Two authors independently screened search results and assessed the full texts of potentially relevant studies for inclusion. Data were extracted and methodological quality was examined. Due to variability in the intervention types investigated, a pooled analysis was not appropriate. Twenty studies met the inclusion criteria. Overall methodological quality was poor. Five studies used an injury outcome measure; only one of these studies was randomised. The studies were grouped into broad categories according to intervention type. One NRS investigated server training and estimated a reduction of 23% in single vehicle night-time crashes in the experimental area (controlled for crashes in the control area). Another NRS examined the impact of a drink driving service, and reported a reduction in injury road crashes of 15% in the experimental area, with no change in the control; no difference was found for fatal crashes. One NRS investigating the impact of a policy intervention, reported that pre-intervention the serious assault rate in the experimental area was 52% higher than the rate in the control area. After intervention, the serious assault rate in the experimental area was 37% lower than in the control. The only RCT targeting the server setting environment with an injury outcome compared toughened glassware (experimental) to annealed glassware (control) on number of bar staff injuries; a greater number of injuries were detected in the experimental group (relative risk 1.72, 95% CI 1.15 to 2.59). A NRS investigating the impact of a intervention aiming to reduce crime experienced by drinking premises; found a lower rate of all crime in the experimental premises (rate ratio 4.6, 95% CI 1.7 to 12, P = 0.01), no difference was found for injury (rate ratio 1.1. 95% CI 0.1 to 10, P = 0.093). The effectiveness of the interventions on patron alcohol consumption is inconclusive. One randomised trial found a statistically significant reduction in observed severe aggression exhibited by patrons. There is some indication of improved server behaviour but it is difficult to predict what effect this might have on injury risk. There is no reliable evidence that interventions in the alcohol server setting are effective in reducing injury. Compliance with interventions appears to be a problem; hence mandated interventions may be more likely to show an effect. Randomised controlled trials, with adequate allocation concealment and blinding are required to improve the evidence base. Further well conducted non-randomised trials are also needed, when random allocation is not feasible.

Interventions in the alcohol server setting for preventing injuries.

PubMed

Ker, Katharine; Chinnock, Paul

2008-07-16

Injuries are a significant public health burden and alcohol intoxication is recognised as a risk factor for injuries. There is increasing attention on supply-side interventions, which aim to modify the environment and context within which alcohol is supplied and consumed. To quantify the effectiveness of interventions implemented in the server setting for reducing injuries. We searched the Cochrane Injuries Group Specialised Register (September 2004), Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2004), MEDLINE (January 1966 to September 2004), EMBASE (1980 to 2004, wk 36), other specialised databases and reference lists of articles. We also contacted experts in the field. Randomised controlled trials (RCTs) and non-randomised controlled studies (NRS) of the effectiveness of interventions administered in the server setting which attempted to modify the conditions under which alcohol is served and consumed, to facilitate sensible alcohol consumption and reduce the occurrence of alcohol-related harm. Two authors independently screened search results and assessed the full texts of potentially relevant studies for inclusion. Data were extracted and methodological quality was examined. Due to variability in the intervention types investigated, a pooled analysis was not appropriate. Twenty studies met the inclusion criteria. Overall methodological quality was poor. Five studies used an injury outcome measure; only one of these studies was randomised. The studies were grouped into broad categories according to intervention type. One NRS investigated server training and estimated a reduction of 23% in single vehicle night-time crashes in the experimental area (controlled for crashes in the control area). Another NRS examined the impact of a drink driving service, and reported a reduction in injury road crashes of 15% in the experimental area, with no change in the control; no difference was found for fatal crashes. One NRS investigating the impact of a policy intervention, reported that pre-intervention the serious assault rate in the experimental area was 52% higher than the rate in the control area. After intervention, the serious assault rate in the experimental area was 37% lower than in the control. The only RCT targeting the server setting environment with an injury outcome compared toughened glassware (experimental) to annealed glassware (control) on number of bar staff injuries; a greater number of injuries were detected in the experimental group (relative risk 1.72, 95% CI 1.15 to 2.59). A NRS investigating the impact of a intervention aiming to reduce crime experienced by drinking premises; found a lower rate of all crime in the experimental premises (rate ratio 4.6, 95% CI 1.7 to 12, P = 0.01), no difference was found for injury (rate ratio 1.1. 95% CI 0.1 to 10, P = 0.093). The effectiveness of the interventions on patron alcohol consumption is inconclusive. One randomised trial found a statistically significant reduction in observed severe aggression exhibited by patrons. There is some indication of improved server behaviour but it is difficult to predict what effect this might have on injury risk. There is no reliable evidence that interventions in the alcohol server setting are effective in reducing injury. Compliance with interventions appears to be a problem; hence mandated interventions may be more likely to show an effect. Randomised controlled trials, with adequate allocation concealment and blinding are required to improve the evidence base. Further well conducted non-randomised trials are also needed, when random allocation is not feasible.

Dual sensory loss: development of a dual sensory loss protocol and design of a randomized controlled trial

PubMed Central

2013-01-01

Background Dual sensory loss (DSL) has a negative impact on health and wellbeing and its prevalence is expected to increase due to demographic aging. However, specialized care or rehabilitation programs for DSL are scarce. Until now, low vision rehabilitation does not sufficiently target concurrent impairments in vision and hearing. This study aims to 1) develop a DSL protocol (for occupational therapists working in low vision rehabilitation) which focuses on optimal use of the senses and teaches DSL patients and their communication partners to use effective communication strategies, and 2) describe the multicenter parallel randomized controlled trial (RCT) designed to test the effectiveness and cost-effectiveness of the DSL protocol. Methods/design To develop a DSL protocol, literature was reviewed and content was discussed with professionals in eye/ear care (interviews/focus groups) and DSL patients (interviews). A pilot study was conducted to test and confirm the DSL protocol. In addition, a two-armed international multi-center RCT will evaluate the effectiveness and cost-effectiveness of the DSL protocol compared to waiting list controls, in 124 patients in low vision rehabilitation centers in the Netherlands and Belgium. Discussion This study provides a treatment protocol for rehabilitation of DSL within low vision rehabilitation, which aims to be a valuable addition to the general low vision rehabilitation care. Trial registration Netherlands Trial Register (NTR) identifier: NTR2843 PMID:23941667

The Association between Regional Environmental Factors and Road Trauma Rates: A Geospatial Analysis of 10 Years of Road Traffic Crashes in British Columbia, Canada

PubMed Central

Brubacher, Jeffrey R.; Chan, Herbert; Erdelyi, Shannon; Schuurman, Nadine; Amram, Ofer

2016-01-01

Background British Columbia, Canada is a geographically large jurisdiction with varied environmental and socio-cultural contexts. This cross-sectional study examined variation in motor vehicle crash rates across 100 police patrols to investigate the association of crashes with key explanatory factors. Methods Eleven crash outcomes (total crashes, injury crashes, fatal crashes, speed related fatal crashes, total fatalities, single-vehicle night-time crashes, rear-end collisions, and collisions involving heavy vehicles, pedestrians, cyclists, or motorcyclists) were identified from police collision reports and insurance claims and mapped to police patrols. Six potential explanatory factors (intensity of traffic law enforcement, speed limits, climate, remoteness, socio-economic factors, and alcohol consumption) were also mapped to police patrols. We then studied the association between crashes and explanatory factors using negative binomial models with crash count per patrol as the response variable and explanatory factors as covariates. Results Between 2003 and 2012 there were 1,434,239 insurance claim collisions, 386,326 police reported crashes, and 3,404 fatal crashes. Across police patrols, there was marked variation in per capita crash rate and in potential explanatory factors. Several factors were associated with crash rates. Percent roads with speed limits ≤ 60 km/hr was positively associated with total crashes, injury crashes, rear end collisions, and collisions involving pedestrians, cyclists, and heavy vehicles; and negatively associated with single vehicle night-time crashes, fatal crashes, fatal speeding crashes, and total fatalities. Higher winter temperature was associated with lower rates of overall collisions, single vehicle night-time collisions, collisions involving heavy vehicles, and total fatalities. Lower socio-economic status was associated with higher rates of injury collisions, pedestrian collisions, fatal speeding collisions, and fatal collisions. Regions with dedicated traffic officers had fewer fatal crashes and fewer fatal speed related crashes but more rear end crashes and more crashes involving cyclists or pedestrians. The number of traffic citations per 1000 drivers was positively associated with total crashes, fatal crashes, total fatalities, fatal speeding crashes, injury crashes, single vehicle night-time crashes, and heavy vehicle crashes. Possible explanations for these associations are discussed. Conclusions There is wide variation in per capita rates of motor vehicle crashes across BC police patrols. Some variation is explained by factors such as climate, road type, remoteness, socioeconomic variables, and enforcement intensity. The ability of explanatory factors to predict crash rates would be improved if considered with local traffic volume by all travel modes. PMID:27099930

Variability among electronic cigarettes in the pressure drop, airflow rate, and aerosol production.

PubMed

Williams, Monique; Talbot, Prue

2011-12-01

This study investigated the performance of electronic cigarettes (e-cigarettes), compared different models within a brand, compared identical copies of the same model within a brand, and examined performance using different protocols. Airflow rate required to generate aerosol, pressure drop across e-cigarettes, and aerosol density were examined using three different protocols. First 10 puff protocol: The airflow rate required to produce aerosol and aerosol density varied among brands, while pressure drop varied among brands and between the same model within a brand. Total air hole area correlated with pressure drop for some brands. Smoke-out protocol: E-cigarettes within a brand generally performed similarly when puffed to exhaustion; however, there was considerable variation between brands in pressure drop, airflow rate required to produce aerosol, and the total number of puffs produced. With this protocol, aerosol density varied significantly between puffs and gradually declined. CONSECUTIVE TRIAL PROTOCOL: Two copies of one model were subjected to 11 puffs in three consecutive trials with breaks between trials. One copy performed similarly in each trial, while the second copy of the same model produced little aerosol during the third trial. The different performance properties of the two units were attributed to the atomizers. There was significant variability between and within brands in the airflow rate required to produce aerosol, pressure drop, length of time cartridges lasted, and production of aerosol. Variation in performance properties within brands suggests a need for better quality control during e-cigarette manufacture.

Ten-Year Analysis of Transfusion in Operation Iraqi Freedom and Operation Enduring Freedom: Increased Plasma and Platelet Use Correlates with Improved Survival

DTIC Science & Technology

2012-01-01

included the publication of the CRASH-2 trial in 2010, followed by the institution of a CPG regarding tranexamic acid (TXA) use in August 2011. 7,11 This...critically ill patients? Trans- fusion. 2011;51:1644 1650. 11. Shakur H, Roberts I, Bautista R, et al. Effects of tranexamic acid on death, vascular occlusive

Effect of electronic stability control on automobile crash risk.

PubMed

Farmer, Charles

2004-12-01

Per vehicle crash involvement rates were compared for otherwise identical vehicle models with and without electronic stability control (ESC) systems. ESC was found to affect single-vehicle crashes to a greater extent than multiple-vehicle crashes, and crashes with fatal injuries to a greater extent than less severe crashes. Based on all police-reported crashes in 7 states over 2 years, ESC reduced single-vehicle crash involvement risk by approximately 41 percent (95 percent confidence limits 3348) and single-vehicle injury crash involvement risk by 41 percent (2752). This translates to an estimated 7 percent reduction in overall crash involvement risk (310) and a 9 percent reduction in overall injury crash involvement risk (314). Based on all fatal crashes in the United States over 3 years, ESC was found to have reduced single-vehicle fatal crash involvement risk by 56 percent (3968). This translates to an estimated 34 percent reduction in overall fatal crash involvement risk (2145).

Optimisation of pharmacy content in clinical cancer research protocols: Experience of the United Kingdom Chemotherapy and Pharmacy Advisory Service.

PubMed

Debruyne, Philip R; Johnson, Philip J; Pottel, Lies; Daniels, Susanna; Greer, Rachel; Hodgkinson, Elizabeth; Kelly, Stephen; Lycke, Michelle; Samol, Jens; Mason, Julie; Kimber, Donna; Loucaides, Eileen; Parmar, Mahesh Kb; Harvey, Sally

2015-06-01

Clarity and accuracy of the pharmacy aspects of cancer clinical trial protocols is essential. Inconsistencies and ambiguities in such protocols have the potential to delay research and jeopardise both patient safety and collection of credible data. The Chemotherapy and Pharmacy Advisory Service was established by the UK National Cancer Research Network, currently known as National Institute for Health Research Clinical Research Network, to improve the quality of pharmacy-related content in cancer clinical research protocols. This article reports the scope of Chemotherapy and Pharmacy Advisory Service, its methodology of mandated protocol review and pharmacy-related guidance initiatives and its current impact. Over a 6-year period (2008-2013) since the inception of Chemotherapy and Pharmacy Advisory Service, cancer clinical trial protocols were reviewed by the service, prior to implementation at clinical trial sites. A customised Review Checklist was developed and used by a panel of experts to standardise the review process and report back queries and inconsistencies to chief investigators. Based on common queries, a Standard Protocol Template comprising specific guidance on drug-related content and a Pharmacy Manual Template were developed. In addition, a guidance framework was established to address 'ad hoc' pharmacy-related queries. The most common remarks made at protocol review have been summarised and categorised through retrospective analysis. In order to evaluate the impact of the service, chief investigators were asked to respond to queries made at protocol review and make appropriate changes to their protocols. Responses from chief investigators have been collated and acceptance rates determined. A total of 176 protocols were reviewed. The median number of remarks per protocol was 26, of which 20 were deemed clinically relevant and mainly concerned the drug regimen, support medication, frequency and type of monitoring and drug supply aspects. Further analysis revealed that 62% of chief investigators responded to the review. All responses were positive with an overall acceptance rate of 89% of the proposed protocol changes. Review of pharmacy content of cancer clinical trial protocols is feasible and exposes many undetected clinically relevant issues that could hinder efficient trial conduct. Our service audit revealed that the majority of suggestions were effectively incorporated in the final protocols. The refinement of existing and development of new pharmacy-related guidance documents by Chemotherapy and Pharmacy Advisory Service might aid in better and safer clinical research. © The Author(s) 2015.

Motorcycle crashes potentially preventable by three crash avoidance technologies on passenger vehicles.

PubMed

Teoh, Eric R

2018-07-04

The objective of this study was to identify and quantify the motorcycle crash population that would be potential beneficiaries of 3 crash avoidance technologies recently available on passenger vehicles. Two-vehicle crashes between a motorcycle and a passenger vehicle that occurred in the United States during 2011-2015 were classified by type, with consideration of the functionality of 3 classes of passenger vehicle crash avoidance technologies: frontal crash prevention, lane maintenance, and blind spot detection. Results were expressed as the percentage of crashes potentially preventable by each type of technology, based on all known types of 2-vehicle crashes and based on all crashes involving motorcycles. Frontal crash prevention had the largest potential to prevent 2-vehicle motorcycle crashes with passenger vehicles. The 3 technologies in sum had the potential to prevent 10% of fatal 2-vehicle crashes and 23% of police-reported crashes. However, because 2-vehicle crashes with a passenger vehicle represent fewer than half of all motorcycle crashes, these technologies represent a potential to avoid 4% of all fatal motorcycle crashes and 10% of all police-reported motorcycle crashes. Refining the ability of passenger vehicle crash avoidance systems to detect motorcycles represents an opportunity to improve motorcycle safety. Expanding the capabilities of these technologies represents an even greater opportunity. However, even fully realizing these opportunities can affect only a minority of motorcycle crashes and does not change the need for other motorcycle safety countermeasures such as helmets, universal helmet laws, and antilock braking systems.

"Crashing the gates" - selection criteria for television news reporting of traffic crashes.

PubMed

De Ceunynck, Tim; De Smedt, Julie; Daniels, Stijn; Wouters, Ruud; Baets, Michèle

2015-07-01

This study investigates which crash characteristics influence the probability that the crash is reported in the television news. To this purpose, all news items from the period 2006-2012 about traffic crashes from the prime time news of two Belgian television channels are linked to the official injury crash database. Logistic regression models are built for the database of all injury crashes and for the subset of fatal crashes to identify crash characteristics that correlate with a lower or higher probability of being reported in the news. A number of significant biases in terms of crash severity, time, place, types of involved road users and victims' personal characteristics are found in the media reporting of crashes. More severe crashes are reported in the media more easily than less severe crashes. Significant fluctuations in media reporting probability through time are found in terms of the year and month in which the crash took place. Crashes during week days are generally less reported in the news. The geographical area (province) in which the crash takes place also has a significant impact on the probability of being reported in the news. Crashes on motorways are significantly more represented in the news. Regarding the age of the involved victims, a clear trend of higher media reporting rates of crashes involving young victims or young fatalities is observed. Crashes involving female fatalities are also more frequently reported in the news. Furthermore, crashes involving a bus have a significantly higher probability of being reported in the news, while crashes involving a motorcycle have a significantly lower probability. Some models also indicate a lower reporting rate of crashes involving a moped, and a higher reporting rate of crashes involving heavy goods vehicles. These biases in media reporting can create skewed perceptions in the general public about the prevalence of traffic crashes and eventually may influence people's behaviour. Copyright © 2015 Elsevier Ltd. All rights reserved.

Oncosurgical Management of Liver Limited Stage IV Colorectal Cancer: Preliminary Data and Protocol for a Randomized Controlled Trial.

PubMed

Sutton, Paul; Vimalachandran, Dale; Poston, Graeme; Fenwick, Stephen; Malik, Hassan

2018-05-09

Colorectal cancer is the fourth commonest cancer and second commonest cause of cancer-related death in the United Kingdom. Almost 15% of patients have metastases on presentation. An increasing number of surgical strategies and better neoadjuvant treatment options are responsible for more patients undergoing resection of liver metastases, with prolonged survival in a select group of patients who present with synchronous disease. It is clear that the optimal strategy for the management of these patients remains unclear, and there is certainly a complete absence of Level 1 evidence in the literature. The objective of this study is to undertake preliminary work and devise an outline trial protocol to inform the future development of clinical studies to investigate the management of patients with liver limited stage IV colorectal cancer. We have undertaken some preliminary work and begun the process of designing a randomized controlled trial and present a draft trial protocol here. This study is at the protocol development stage only, and as such no results are available. There is no funding in place for this study, and no anticipated start date. We have presented preliminary work and an outline trial protocol which we anticipate will inform the future development of clinical studies to investigate the management of patients with liver limited stage IV colorectal cancer. We do not believe that the trial we have designed will answer the most significant clinical questions, nor that it is feasible to be delivered within the United Kingdom's National Health Service at this current time. ©Paul Sutton, Dale Vimalachandran, Graeme Poston, Stephen Fenwick, Hassan Malik. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.05.2018.

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement

PubMed Central

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-01-01

Objective To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. Methods We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Results Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. Conclusions The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future. PMID:29872509

Protocols and Hospital Mortality in Critically Ill Patients: The United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study.

PubMed

Sevransky, Jonathan E; Checkley, William; Herrera, Phabiola; Pickering, Brian W; Barr, Juliana; Brown, Samuel M; Chang, Steven Y; Chong, David; Kaufman, David; Fremont, Richard D; Girard, Timothy D; Hoag, Jeffrey; Johnson, Steven B; Kerlin, Mehta P; Liebler, Janice; O'Brien, James; O'Keefe, Terence; Park, Pauline K; Pastores, Stephen M; Patil, Namrata; Pietropaoli, Anthony P; Putman, Maryann; Rice, Todd W; Rotello, Leo; Siner, Jonathan; Sajid, Sahul; Murphy, David J; Martin, Greg S

2015-10-01

Clinical protocols may decrease unnecessary variation in care and improve compliance with desirable therapies. We evaluated whether highly protocolized ICUs have superior patient outcomes compared with less highly protocolized ICUs. Observational study in which participating ICUs completed a general assessment and enrolled new patients 1 day each week. A total of 6,179 critically ill patients. Fifty-nine ICUs in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study. None. The primary exposure was the number of ICU protocols; the primary outcome was hospital mortality. A total of 5,809 participants were followed prospectively, and 5,454 patients in 57 ICUs had complete outcome data. The median number of protocols per ICU was 19 (interquartile range, 15-21.5). In single-variable analyses, there were no differences in ICU and hospital mortality, length of stay, use of mechanical ventilation, vasopressors, or continuous sedation among individuals in ICUs with a high versus low number of protocols. The lack of association was confirmed in adjusted multivariable analysis (p = 0.70). Protocol compliance with two ventilator management protocols was moderate and did not differ between ICUs with high versus low numbers of protocols for lung protective ventilation in acute respiratory distress syndrome (47% vs 52%; p = 0.28) and for spontaneous breathing trials (55% vs 51%; p = 0.27). Clinical protocols are highly prevalent in U.S. ICUs. The presence of a greater number of protocols was not associated with protocol compliance or patient mortality.

Multivariate poisson lognormal modeling of crashes by type and severity on rural two lane highways.

PubMed

Wang, Kai; Ivan, John N; Ravishanker, Nalini; Jackson, Eric

2017-02-01

In an effort to improve traffic safety, there has been considerable interest in estimating crash prediction models and identifying factors contributing to crashes. To account for crash frequency variations among crash types and severities, crash prediction models have been estimated by type and severity. The univariate crash count models have been used by researchers to estimate crashes by crash type or severity, in which the crash counts by type or severity are assumed to be independent of one another and modelled separately. When considering crash types and severities simultaneously, this may neglect the potential correlations between crash counts due to the presence of shared unobserved factors across crash types or severities for a specific roadway intersection or segment, and might lead to biased parameter estimation and reduce model accuracy. The focus on this study is to estimate crashes by both crash type and crash severity using the Integrated Nested Laplace Approximation (INLA) Multivariate Poisson Lognormal (MVPLN) model, and identify the different effects of contributing factors on different crash type and severity counts on rural two-lane highways. The INLA MVPLN model can simultaneously model crash counts by crash type and crash severity by accounting for the potential correlations among them and significantly decreases the computational time compared with a fully Bayesian fitting of the MVPLN model using Markov Chain Monte Carlo (MCMC) method. This paper describes estimation of MVPLN models for three-way stop controlled (3ST) intersections, four-way stop controlled (4ST) intersections, four-way signalized (4SG) intersections, and roadway segments on rural two-lane highways. Annual Average Daily traffic (AADT) and variables describing roadway conditions (including presence of lighting, presence of left-turn/right-turn lane, lane width and shoulder width) were used as predictors. A Univariate Poisson Lognormal (UPLN) was estimated by crash type and severity for each highway facility, and their prediction results are compared with the MVPLN model based on the Average Predicted Mean Absolute Error (APMAE) statistic. A UPLN model for total crashes was also estimated to compare the coefficients of contributing factors with the models that estimate crashes by crash type and severity. The model coefficient estimates show that the signs of coefficients for presence of left-turn lane, presence of right-turn lane, land width and speed limit are different across crash type or severity counts, which suggest that estimating crashes by crash type or severity might be more helpful in identifying crash contributing factors. The standard errors of covariates in the MVPLN model are slightly lower than the UPLN model when the covariates are statistically significant, and the crash counts by crash type and severity are significantly correlated. The model prediction comparisons illustrate that the MVPLN model outperforms the UPLN model in prediction accuracy. Therefore, when predicting crash counts by crash type and crash severity for rural two-lane highways, the MVPLN model should be considered to avoid estimation error and to account for the potential correlations among crash type counts and crash severity counts. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safe speed limits for a safe system: The relationship between speed limit and fatal crash rate for different crash types.

PubMed

Doecke, Sam D; Kloeden, Craig N; Dutschke, Jeffrey K; Baldock, Matthew R J

2018-05-19

The objective of this article is to provide empirical evidence for safe speed limits that will meet the objectives of the Safe System by examining the relationship between speed limit and injury severity for different crash types, using police-reported crash data. Police-reported crashes from 2 Australian jurisdictions were used to calculate a fatal crash rate by speed limit and crash type. Example safe speed limits were defined using threshold risk levels. A positive exponential relationship between speed limit and fatality rate was found. For an example fatality rate threshold of 1 in 100 crashes it was found that safe speed limits are 40 km/h for pedestrian crashes; 50 km/h for head-on crashes; 60 km/h for hit fixed object crashes; 80 km/h for right angle, right turn, and left road/rollover crashes; and 110 km/h or more for rear-end crashes. The positive exponential relationship between speed limit and fatal crash rate is consistent with prior research into speed and crash risk. The results indicate that speed zones of 100 km/h or more only meet the objectives of the Safe System, with regard to fatal crashes, where all crash types except rear-end crashes are exceedingly rare, such as on a high standard restricted access highway with a safe roadside design.

Crash energy absorption of two-segment crash box with holes under frontal load

NASA Astrophysics Data System (ADS)

Choiron, Moch. Agus; Sudjito, Hidayati, Nafisah Arina

2016-03-01

Crash box is one of the passive safety components which designed as an impact energy absorber during collision. Crash box designs have been developed in order to obtain the optimum crashworthiness performance. Circular cross section was first investigated with one segment design, it rather influenced by its length which is being sensitive to the buckling occurrence. In this study, the two-segment crash box design with additional holes is investigated and deformation behavior and crash energy absorption are observed. The crash box modelling is performed by finite element analysis. The crash test components were impactor, crash box, and fixed rigid base. Impactor and the fixed base material are modelled as a rigid, and crash box material as bilinear isotropic hardening. Crash box length of 100 mm and frontal crash velocity of 16 km/jam are selected. Crash box material of Aluminum Alloy is used. Based on simulation results, it can be shown that holes configuration with 2 holes and ¾ length locations have the largest crash energy absorption. This condition associated with deformation pattern, this crash box model produces axisymmetric mode than other models.

[Development of clinical trial education program for pharmaceutical science students through small group discussion and role-playing using protocol].

PubMed

Imakyure, Osamu; Shuto, Hideki; Nishikawa, Fumi; Hagiwara, Yoshifuka; Inoue, Sachiko; Koyanagi, Taeko; Hirakawa, Masaaki; Kataoka, Yasufumi

2010-08-01

The acquirement of basic knowledge of clinical trials and professional attitude in their practices is a general instructional objective in the Model Core Curriculum for Pharmaceutical Education. Unfortunately, the previous program of clinical trial education was not effective in the acquirement of a professional attitude in their practices. Then, we developed the new clinical trial education program using protocol through small group discussion (SGD) and roll-playing. Our program consists of 7 steps of practical training. In step 1, the students find some problems after presentation of the protocol including case and prescription. In step 2, they analyse the extracted problems and share the information obtained in SGD. In steps 3 and 5, five clinical case scenarios are presented to the students and they discuss which case is suitable for entry to the clinical trial or which case corresponds to the discontinuance criteria in the present designed protocol. In steps 4 and 6, the roll-playing is performed by teachers and students as doctors and clinical research coordinators (CRC) respectively. Further, we conducted a trial practice based on this program for the students. In the student's self-evaluation into five grades, the average score of the skill acquisition level in each step was 3.8-4.7 grade. Our clinical trial education program could be effective in educating the candidates for CRC or clinical pharmacists.

Modulation of error-sensitivity during a prism adaptation task in people with cerebellar degeneration

PubMed Central

Shadmehr, Reza; Ohminami, Shinya; Tsutsumi, Ryosuke; Shirota, Yuichiro; Shimizu, Takahiro; Tanaka, Nobuyuki; Terao, Yasuo; Tsuji, Shoji; Ugawa, Yoshikazu; Uchimura, Motoaki; Inoue, Masato; Kitazawa, Shigeru

2015-01-01

Cerebellar damage can profoundly impair human motor adaptation. For example, if reaching movements are perturbed abruptly, cerebellar damage impairs the ability to learn from the perturbation-induced errors. Interestingly, if the perturbation is imposed gradually over many trials, people with cerebellar damage may exhibit improved adaptation. However, this result is controversial, since the differential effects of gradual vs. abrupt protocols have not been observed in all studies. To examine this question, we recruited patients with pure cerebellar ataxia due to cerebellar cortical atrophy (n = 13) and asked them to reach to a target while viewing the scene through wedge prisms. The prisms were computer controlled, making it possible to impose the full perturbation abruptly in one trial, or build up the perturbation gradually over many trials. To control visual feedback, we employed shutter glasses that removed visual feedback during the reach, allowing us to measure trial-by-trial learning from error (termed error-sensitivity), and trial-by-trial decay of motor memory (termed forgetting). We found that the patients benefited significantly from the gradual protocol, improving their performance with respect to the abrupt protocol by exhibiting smaller errors during the exposure block, and producing larger aftereffects during the postexposure block. Trial-by-trial analysis suggested that this improvement was due to increased error-sensitivity in the gradual protocol. Therefore, cerebellar patients exhibited an improved ability to learn from error if they experienced those errors gradually. This improvement coincided with increased error-sensitivity and was present in both groups of subjects, suggesting that control of error-sensitivity may be spared despite cerebellar damage. PMID:26311179

Sleep-related crash characteristics: Implications for applying a fatigue definition to crash reports.

PubMed

Filtness, A J; Armstrong, K A; Watson, A; Smith, S S

2017-02-01

Sleep-related (SR) crashes are an endemic problem the world over. However, police officers report difficulties in identifying sleepiness as a crash contributing factor. One approach to improving the sensitivity of SR crash identification is by applying a proxy definition post hoc to crash reports. To identify the prominent characteristics of SR crashes and highlight the influence of proxy definitions, ten years of Queensland (Australia) police reports of crashes occurring in ≥100km/h speed zones were analysed. In Queensland, two approaches are routinely taken to identifying SR crashes. First, attending police officers identify crash causal factors; one possible option is 'fatigue/fell asleep'. Second, a proxy definition is applied to all crash reports. Those meeting the definition are considered SR and added to the police-reported SR crashes. Of the 65,204 vehicle operators involved in crashes 3449 were police-reported as SR. Analyses of these data found that male drivers aged 16-24 years within the first two years of unsupervised driving were most likely to have a SR crash. Collision with a stationary object was more likely in SR than in not-SR crashes. Using the proxy definition 9739 (14.9%) crashes were classified as SR. Using the proxy definition removes the findings that SR crashes are more likely to involve males and be of high severity. Additionally, proxy defined SR crashes are no less likely at intersections than not-SR crashes. When interpreting crash data it is important to understand the implications of SR identification because strategies aimed at reducing the road toll are informed by such data. Without the correct interpretation, funding could be misdirected. Improving sleepiness identification should be a priority in terms of both improvement to police and proxy reporting. Copyright © 2015 Elsevier Ltd. All rights reserved.

The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial.

PubMed

Roberts, Ian; Shakur, Haleema; Afolabi, Adefemi; Brohi, Karim; Coats, Tim; Dewan, Yashbir; Gando, Satoshi; Guyatt, Gordon; Hunt, B J; Morales, Carlos; Perel, Pablo; Prieto-Merino, David; Woolley, Tom

2011-03-26

The aim of the CRASH-2 trial was to assess the effects of early administration of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage. Tranexamic acid significantly reduced all-cause mortality. Because tranexamic acid is thought to exert its effect through inhibition of fibrinolysis, we undertook exploratory analyses of its effect on death due to bleeding. The CRASH-2 trial was undertaken in 274 hospitals in 40 countries. 20,211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min followed by infusion of 1 g over 8 h) or placebo. Patients were randomly assigned by selection of the lowest numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Both participants and study staff (site investigators and trial coordinating centre staff ) were masked to treatment allocation. We examined the effect of tranexamic acid on death due to bleeding according to time to treatment, severity of haemorrhage as assessed by systolic blood pressure, Glasgow coma score (GCS), and type of injury. All analyses were by intention to treat. The trial is registered as ISRCTN86750102, ClinicalTrials.gov NCT00375258, and South African Clinical Trial Register/Department of Health DOH-27-0607-1919. 10,096 patients were allocated to tranexamic acid and 10,115 to placebo, of whom 10,060 and 10,067, respectively, were analysed. 1063 deaths (35%) were due to bleeding. We recorded strong evidence that the effect of tranexamic acid on death due to bleeding varied according to the time from injury to treatment (test for interaction p<0.0001). Early treatment (≤1 h from injury) significantly reduced the risk of death due to bleeding (198/3747 [5.3%] events in tranexamic acid group vs 286/3704 [7.7%] in placebo group; relative risk [RR] 0.68, 95% CI 0.57-0.82; p<0.0001). Treatment given between 1 and 3 h also reduced the risk of death due to bleeding (147/3037 [4.8%] vs 184/2996 [6.1%]; RR 0.79, 0.64-0.97; p=0.03). Treatment given after 3 h seemed to increase the risk of death due to bleeding (144/3272 [4.4%] vs 103/3362 [3.1%]; RR 1.44, 1.12-1.84; p=0.004). We recorded no evidence that the effect of tranexamic acid on death due to bleeding varied by systolic blood pressure, Glasgow coma score, or type of injury. Tranexamic acid should be given as early as possible to bleeding trauma patients. For trauma patients admitted late after injury, tranexamic acid is less effective and could be harmful. UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation. Copyright © 2011 Elsevier Ltd. All rights reserved.

Comparison of crash rates and rear-end striking crashes among novice teens and experienced adults using the SHRP2 Naturalistic Driving Study.

PubMed

Seacrist, Thomas; Belwadi, Aditya; Prabahar, Abhiti; Chamberlain, Samuel; Megariotis, James; Loeb, Helen

2016-09-01

Motor vehicle crashes are the leading cause of death for teens. Previous teen and adult crash rates have been based upon fatal crashes, police-reported crashes, and estimated miles driven. Large-scale naturalistic driving studies offer the opportunity to compute crash rates using a reliable methodology to capture crashes and driving exposure. The Strategic Highway Research Program 2 (SHRP2) Naturalistic Driving Study contains extensive real-world data on teen and adult driving. This article presents findings on the crash rates of novice teen and experienced adult drivers in naturalistic crashes. A subset from the SHRP2 database consisting of 539 crash events for novice teens (16-19 years, n = 549) and experienced adults (35-54 years, n = 591) was used. Onboard instrumentation such as scene cameras, accelerometers, and Global Positioning System logged time series data at 10 Hz. Scene videos were reviewed for all events to identify rear-end striking crashes. Dynamic variables such as acceleration and velocity were analyzed for rear-end striking events. Number of crashes, crash rates, rear-end striking crash severity, and rear-end striking impact velocity were compared between novice teens and experienced adults. Video review of the SHRP2 crashes identified significantly more crashes (P < 0.01) and rear-end striking crashes (P < 0.01) among the teen group than among the adult group. This yielded crash rates of 30.0 crashes per million miles driven for novice teens compared to 5.3 crashes per million miles driven for experienced adults. The crash rate ratio for teens vs. adults was 5.7. The rear-end striking crash rate was 13.5 and 1.8 per million miles driven for novice teens and experienced adults, respectively. The rear-end striking crash rate ratio for teens vs. adults was 7.5. The rear-end striking crash severity measured by the accelerometers was greater (P < 0.05) for the teen group (1.8 ± 0.9 g; median = 1.6 g) than for the adult group (1.1 ± 0.4 g; median = 1.0 g), suggesting that teen crashes tend to be more serious than adult crashes. Increased rear-end striking impact velocity (P < 0.01) was also observed for novice teens (18.8 ± 13.2 mph; median = 18.9 mph) compared to experienced adults (3.3 ± 1.2 mph; median = 2.8 mph). To our knowledge, this is the first study to compare crash rates between teens and adults using a large-scale naturalistic driving database. Unlike previous crash rates, the reported rates reliably control for crash type and driving exposure. These results conform to previous findings that novice teens exhibit increased crash rates compared to experienced adults.

The safety potential of lane departure warning systems-A descriptive real-world study of fatal lane departure passenger car crashes in Sweden.

PubMed

Sternlund, Simon

2017-05-29

Lane departure crashes account for a significant proportion of passenger car occupant fatalities and serious injuries. Utilizing real-world data involving fatal passenger car crashes in Sweden, the characteristics of lane departure crashes were identified and the safety potential of lane departure warning (LDW) systems was quantified. The material consisted of 104 in-depth studies of fatal passenger car crashes in 2010. The crashes were classified as single-vehicle (n = 48), head-on (n = 52), and overtaking (n = 4) crashes. These crash types were identified as crashes that could have potentially involved lane departure. A case-by-case analysis was carried out and lane departure crashes were identified and characterized using police reports and information collected by crash investigators at the Swedish Transport Administration; for example, inspections and photographs of the crash sites and of the involved vehicles. Lane departure crashes were separated from crashes where loss of control occurred pre-lane departure. Furthermore, loss of control post-lane departures were identified. When studying the pre-stage of lane departure without prior loss of control, crashes were categorized as unintentional drifting, intentional lane change, or evasive maneuver. Using previously published effectiveness information, the potential for LDW systems to prevent crashes was estimated. Of all crashes with passenger car occupant fatalities in Sweden in 2010, 46% (63/138) were found to relate to lane departure without prior loss of control. These crashes accounted for 61% (63/104) of all single-vehicle, head-on, and overtaking crashes. The remaining 41 crashes were due to loss of control pre-lane departure. Unintentional drifting accounted for 81% (51/63) of all lane departure crashes without prior loss of control, which corresponded to 37% (51/138) of all fatal passenger car occupant crashes. LDW systems were found to potentially prevent 33-38 of the 100 fatal head-on and single vehicle crashes. These crashes involved drifting and occurred on roads with visible lane markings, signed posted speed limits ≥70 km/h, and without rumble strips on the corresponding lane departure side. The range of potentially prevented crashes (33-38) is due to the inclusion or exclusion of crashes involving excessive speeding. In this study, approximately half (51/100) of all head-on and single-vehicle crashes were identified as being a consequence of drifting, where LDW systems had the potential to prevent the majority (33-38) of these crashes. The typical lane departure crash without prior loss of control occurred on undivided roads in rural areas with signed posted speed limits ≥70 km/h, where the center and side road markings were visible.

Comparison of two progressive treadmill tests in patients with peripheral arterial disease.

PubMed

Riebe, D; Patterson, R B; Braun, C M

2001-11-01

In a vascular rehabilitation program, 28% of our frail elderly patients are unable to be tested with traditional progressive exercise protocols at program entry due to the high (2.0 miles/h or 3.2 km/h) initial treadmill speeds. The purpose of this investigation was to compare a new progressive treadmill protocol which has a reduced initial speed (1.0 mile/h or 1.6 km/h) to an established protocol performed at 2.0 miles/h (3.2 km/h) to determine the comparability and reproducibility of the new protocol. Eleven patients with arterial claudication performed three symptom-limited exercise tests in random order. Two tests used the new protocol while the remaining trial used the established protocol. Claudication pain was measured using a 5-point scale. Oxygen consumption, heart rate, minute ventilation, respiratory exchange ratio and blood pressure at peak exercise were similar among the three trials. There were strong intraclass correlations for peak oxygen consumption (r = 0.97), onset of claudication (r = 0.96) and maximum walking time (r = 0.98) between the two trials using the new protocol. There was also a significant correlation between the new protocol and the established protocol for peak oxygen consumption (r = 0.90) and maximum walking time (r = 0.89). The new progressive treadmill protocol represents a valid, reliable protocol for patients with arterial claudication. This protocol may be useful for testing patients with a low functional capacity so that clinically appropriate exercise prescriptions can be established and the efficacy of treatments can be determined.

Crash energy absorption of two-segment crash box with holes under frontal load

DOE Office of Scientific and Technical Information (OSTI.GOV)

Choiron, Moch Agus, E-mail: agus-choiron@ub.ac.id; Sudjito,; Hidayati, Nafisah Arina

Crash box is one of the passive safety components which designed as an impact energy absorber during collision. Crash box designs have been developed in order to obtain the optimum crashworthiness performance. Circular cross section was first investigated with one segment design, it rather influenced by its length which is being sensitive to the buckling occurrence. In this study, the two-segment crash box design with additional holes is investigated and deformation behavior and crash energy absorption are observed. The crash box modelling is performed by finite element analysis. The crash test components were impactor, crash box, and fixed rigid base.more » Impactor and the fixed base material are modelled as a rigid, and crash box material as bilinear isotropic hardening. Crash box length of 100 mm and frontal crash velocity of 16 km/jam are selected. Crash box material of Aluminum Alloy is used. Based on simulation results, it can be shown that holes configuration with 2 holes and ¾ length locations have the largest crash energy absorption. This condition associated with deformation pattern, this crash box model produces axisymmetric mode than other models.« less

The effects of sleep loss on young drivers’ performance: A systematic review

PubMed Central

Smith, Simon S.

2017-01-01

Young drivers (18–24 years) are over-represented in sleep-related crashes (comprising one in five fatal crashes in developed countries) primarily due to decreased sleep opportunity, lower tolerance for sleep loss, and ongoing maturation of brain areas associated with driving-related decision making. Impaired driving performance is the proximal reason for most car crashes. There is still a limited body of evidence examining the effects of sleep loss on young drivers’ performance, with discrepancies in the methodologies used, and in the definition of outcomes. This study aimed to identify the direction and magnitude of the effects of sleep loss on young drivers’ performance, and to appraise the quality of current evidence via a systematic review. Based on the Preferred Reporting Items for Systematic Reviews and Meta- Analyses (PRISMA) approach, 16 eligible studies were selected for review, and their findings summarised. Next, critical elements of these studies were identified, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines augmented to rate those elements. Using those criteria, the quality of individual papers was calculated and the overall body of evidence for each driving outcome were assigned a quality ranking (from ‘very low’ to ‘high-quality’). Two metrics, the standard deviation of lateral position and number of line crossings, were commonly reported outcomes (although in an overall ‘low-quality’ body of evidence), with significant impairments after sleep loss identified in 50% of studies. While speed-related outcomes and crash events (also with very low- quality evidence) both increased under chronic sleep loss, discrepant findings were reported under conditions of acute total sleep deprivation. It is crucial to obtain more reliable data about the effects of sleep loss on young drivers’ performance by using higher quality experimental designs, adopting common protocols, and the use of consistent metrics and reporting of findings based on GRADE criteria and the PRISMA statement. Key words: Young drivers, sleep loss, driving performance, PRISMA, the GRADE, systematic review. PMID:28859144

The effects of sleep loss on young drivers' performance: A systematic review.

PubMed

Shekari Soleimanloo, Shamsi; White, Melanie J; Garcia-Hansen, Veronica; Smith, Simon S

2017-01-01

Young drivers (18-24 years) are over-represented in sleep-related crashes (comprising one in five fatal crashes in developed countries) primarily due to decreased sleep opportunity, lower tolerance for sleep loss, and ongoing maturation of brain areas associated with driving-related decision making. Impaired driving performance is the proximal reason for most car crashes. There is still a limited body of evidence examining the effects of sleep loss on young drivers' performance, with discrepancies in the methodologies used, and in the definition of outcomes. This study aimed to identify the direction and magnitude of the effects of sleep loss on young drivers' performance, and to appraise the quality of current evidence via a systematic review. Based on the Preferred Reporting Items for Systematic Reviews and Meta- Analyses (PRISMA) approach, 16 eligible studies were selected for review, and their findings summarised. Next, critical elements of these studies were identified, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines augmented to rate those elements. Using those criteria, the quality of individual papers was calculated and the overall body of evidence for each driving outcome were assigned a quality ranking (from 'very low' to 'high-quality'). Two metrics, the standard deviation of lateral position and number of line crossings, were commonly reported outcomes (although in an overall 'low-quality' body of evidence), with significant impairments after sleep loss identified in 50% of studies. While speed-related outcomes and crash events (also with very low- quality evidence) both increased under chronic sleep loss, discrepant findings were reported under conditions of acute total sleep deprivation. It is crucial to obtain more reliable data about the effects of sleep loss on young drivers' performance by using higher quality experimental designs, adopting common protocols, and the use of consistent metrics and reporting of findings based on GRADE criteria and the PRISMA statement. Key words: Young drivers, sleep loss, driving performance, PRISMA, the GRADE, systematic review.

Gasoline prices and their relationship to drunk-driving crashes.

PubMed

Chi, Guangqing; Zhou, Xuan; McClure, Timothy E; Gilbert, Paul A; Cosby, Arthur G; Zhang, Li; Robertson, Angela A; Levinson, David

2011-01-01

This study investigates the relationship between changing gasoline prices and drunk-driving crashes. Specifically, we examine the effects of gasoline prices on drunk-driving crashes in Mississippi by several crash types and demographic groups at the monthly level from 2004 to 2008, a period experiencing great fluctuation in gasoline prices. An exploratory visualization by graphs shows that higher gasoline prices are generally associated with fewer drunk-driving crashes. Higher gasoline prices depress drunk-driving crashes among young and adult drivers, among male and female drivers, and among white and black drivers. Results from negative binomial regression models show that when gas prices are higher, there are fewer drunk-driving crashes, particularly among property-damage-only crashes. When alcohol consumption levels are higher, there are more drunk-driving crashes, particularly fatal and injury crashes. The effects of gasoline prices and alcohol consumption are stronger on drunk-driving crashes than on all crashes. The findings do not vary much across different demographic groups. Overall, gasoline prices have greater effects on less severe crashes and alcohol consumption has greater effects on more severe crashes. Copyright © 2010 Elsevier Ltd. All rights reserved.

A randomized trial of protocol-based care for early septic shock.

PubMed

Yealy, Donald M; Kellum, John A; Huang, David T; Barnato, Amber E; Weissfeld, Lisa A; Pike, Francis; Terndrup, Thomas; Wang, Henry E; Hou, Peter C; LoVecchio, Frank; Filbin, Michael R; Shapiro, Nathan I; Angus, Derek C

2014-05-01

In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary. In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support. We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support. In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.).

Crash avoidance potential of four large truck technologies.

PubMed

Jermakian, Jessica S

2012-11-01

The objective of this paper was to estimate the maximum potential large truck crash reductions in the United States associated with each of four crash avoidance technologies: side view assist, forward collision warning/mitigation, lane departure warning/prevention, and vehicle stability control. Estimates accounted for limitations of current systems. Crash records were extracted from the 2004-08 files of the National Automotive Sampling System General Estimates System (NASS GES) and the Fatality Analysis Reporting System (FARS). Crash descriptors such as location of damage on the vehicle, road characteristics, time of day, and precrash maneuvers were reviewed to determine whether the information or action provided by each technology potentially could have prevented the crash. Of the four technologies, side view assist had the greatest potential for preventing large truck crashes of any severity; the technology is potentially applicable to 39,000 crashes in the United States each year, including 2000 serious and moderate injury crashes and 79 fatal crashes. Vehicle stability control is another promising technology, with the potential to prevent or mitigate up to 31,000 crashes per year including more serious crashes--up to 7000 moderate-to-serious injury crashes and 439 fatal crashes per year. Vehicle stability control could prevent or mitigate up to 20 and 11 percent of moderate-to-serious injury and fatal large truck crashes, respectively. Forward collision warning has the potential to prevent as many as 31,000 crashes per year, including 3000 serious and moderate injury crashes and 115 fatal crashes. Finally, 10,000 large truck crashes annually were relevant to lane departure warning/prevention systems. Of these, 1000 involved serious and moderate injuries and 247 involved fatal injuries. There is great potential effectiveness for truck-based crash avoidance systems. However, it is yet to be determined how drivers will interact with the systems. Actual effectiveness of crash avoidance systems will not be known until sufficient real-world experience has been gained. Copyright © 2012 Elsevier Ltd. All rights reserved.

A classification tree based modeling approach for segment related crashes on multilane highways.

PubMed

Pande, Anurag; Abdel-Aty, Mohamed; Das, Abhishek

2010-10-01

This study presents a classification tree based alternative to crash frequency analysis for analyzing crashes on mid-block segments of multilane arterials. The traditional approach of modeling counts of crashes that occur over a period of time works well for intersection crashes where each intersection itself provides a well-defined unit over which to aggregate the crash data. However, in the case of mid-block segments the crash frequency based approach requires segmentation of the arterial corridor into segments of arbitrary lengths. In this study we have used random samples of time, day of week, and location (i.e., milepost) combinations and compared them with the sample of crashes from the same arterial corridor. For crash and non-crash cases, geometric design/roadside and traffic characteristics were derived based on their milepost locations. The variables used in the analysis are non-event specific and therefore more relevant for roadway safety feature improvement programs. First classification tree model is a model comparing all crashes with the non-crash data and then four groups of crashes (rear-end, lane-change related, pedestrian, and single-vehicle/off-road crashes) are separately compared to the non-crash cases. The classification tree models provide a list of significant variables as well as a measure to classify crash from non-crash cases. ADT along with time of day/day of week are significantly related to all crash types with different groups of crashes being more likely to occur at different times. From the classification performance of different models it was apparent that using non-event specific information may not be suitable for single vehicle/off-road crashes. The study provides the safety analysis community an additional tool to assess safety without having to aggregate the corridor crash data over arbitrary segment lengths. Copyright © 2010. Published by Elsevier Ltd.

A novel approach for analyzing severe crash patterns on multilane highways.

PubMed

Pande, Anurag; Abdel-Aty, Mohamed

2009-09-01

This study presents a novel approach for analysis of patterns in severe crashes that occur on mid-block segments of multilane highways with partially limited access. A within stratum matched crash vs. non-crash classification approach is adopted towards that end. Under this approach crashes serve as units of analysis and it does not require aggregation of crash data over arterial segments of arbitrary lengths. Also, the proposed approach does not use information on non-severe crashes and hence is not affected by under-reporting of the minor crashes. Random samples of time, day of week, and location (i.e., milepost) combinations were collected for multilane arterials in the state of Florida and matched with severe crashes from the corresponding corridor to form matched strata consisting of severe crash and non-crash cases. For these cases, geometric design/roadside and traffic characteristics were derived based on the corresponding milepost locations. Four groups of crashes, severe rear-end, lane-change related, pedestrian, and single-vehicle/off-road crashes, on multilane arterials segments were compared separately to the non-crash cases. Severe lane-change related crashes may primarily be attributed to exposure while single-vehicle crashes and pedestrian crashes have no significant relationship with the ADT (Average Daily Traffic). For severe rear-end crashes speed limit, ADT, K-factor, time of day/day of week, median type, pavement condition, and presence of horizontal curvature were significant factors. The proposed approach uses general roadway characteristics as independent variables rather than event-specific information (i.e., crash characteristics such as driver/vehicle details); it has the potential to fit within a safety evaluation framework for arterial segments.

Post-trial follow-up methodology in large randomized controlled trials: a systematic review protocol.

PubMed

Llewellyn-Bennett, Rebecca; Bowman, Louise; Bulbulia, Richard

2016-12-15

Clinical trials typically have a relatively short follow-up period, and may both underestimate potential benefits of treatments investigated, and fail to detect hazards, which can take much longer to emerge. Prolonged follow-up of trial participants after the end of the scheduled trial period can provide important information on both efficacy and safety outcomes. This protocol describes a systematic review to qualitatively compare methods of post-trial follow-up used in large randomized controlled trials. A systematic search of electronic databases and clinical trial registries will use a predefined search strategy. All large (more than 1000 adult participants) randomized controlled trials will be evaluated. Two reviewers will screen and extract data according to this protocol with the aim of 95% concordance of papers checked and discrepancies will be resolved by a third reviewer. Trial methods, participant retention rates and prevalence of missing data will be recorded and compared. The potential for bias will be evaluated using the Cochrane Risk of Bias tool (applied to the methods used during the in-trial period) with the aim of investigating whether the quality of the post-trial follow-up methodology might be predicted by the quality of the methods used for the original trial. Post-trial follow-up can provide valuable information about the long-term benefits and hazards of medical interventions. However, it can be logistically challenging and costly. The aim of this systematic review is to describe how trial participants have been followed-up post-trial in order to inform future post-trial follow-up designs. Not applicable for PROSPERO registration.

Pre-crash scenario typology for crash avoidance research

DOT National Transportation Integrated Search

2007-04-01

This report defines a new pre-crash scenario typology for crash avoidance research based on the 2004 General Estimates System (GES) crash database, which consists of pre-crash scenarios depicting vehicle movements and dynamics as well as the critical...

Safety analytics for integrating crash frequency and real-time risk modeling for expressways.

PubMed

Wang, Ling; Abdel-Aty, Mohamed; Lee, Jaeyoung

2017-07-01

To find crash contributing factors, there have been numerous crash frequency and real-time safety studies, but such studies have been conducted independently. Until this point, no researcher has simultaneously analyzed crash frequency and real-time crash risk to test whether integrating them could better explain crash occurrence. Therefore, this study aims at integrating crash frequency and real-time safety analyses using expressway data. A Bayesian integrated model and a non-integrated model were built: the integrated model linked the crash frequency and the real-time models by adding the logarithm of the estimated expected crash frequency in the real-time model; the non-integrated model independently estimated the crash frequency and the real-time crash risk. The results showed that the integrated model outperformed the non-integrated model, as it provided much better model results for both the crash frequency and the real-time models. This result indicated that the added component, the logarithm of the expected crash frequency, successfully linked and provided useful information to the two models. This study uncovered few variables that are not typically included in the crash frequency analysis. For example, the average daily standard deviation of speed, which was aggregated based on speed at 1-min intervals, had a positive effect on crash frequency. In conclusion, this study suggested a methodology to improve the crash frequency and real-time models by integrating them, and it might inspire future researchers to understand crash mechanisms better. Copyright © 2017 Elsevier Ltd. All rights reserved.

Protocols and Hospital Mortality in Critically ill Patients: The United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study

PubMed Central

Sevransky, Jonathan E.; Checkley, William; Herrera, Phabiola; Pickering, Brian W.; Barr, Juliana; Brown, Samuel M; Chang, Steven Y; Chong, David; Kaufman, David; Fremont, Richard D; Girard, Timothy D; Hoag, Jeffrey; Johnson, Steven B; Kerlin, Mehta P; Liebler, Janice; O'Brien, James; O'Keefe, Terence; Park, Pauline K; Pastores, Stephen M; Patil, Namrata; Pietropaoli, Anthony P; Putman, Maryann; Rice, Todd W.; Rotello, Leo; Siner, Jonathan; Sajid, Sahul; Murphy, David J; Martin, Greg S

2015-01-01

Objective Clinical protocols may decrease unnecessary variation in care and improve compliance with desirable therapies. We evaluated whether highly protocolized intensive care units have superior patient outcomes compared with less highly protocolized intensive care units. Design Observational study in which participating intensive care units completed a general assessment and enrolled new patients one day each week. Setting and Patients 6179 critically ill patients across 59 intensive care units in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study Interventions: None Measurements and Main Results The primary exposure was the number of intensive care unit protocols; the primary outcome was hospital mortality. 5809 participants were followed prospectively and 5454 patients in 57 intensive care units had complete outcome data. The median number of protocols per intensive care unit was 19 (IQR 15 to 21.5). In single variable analyses, there were no differences in intensive care unit and hospital mortality, length of stay, use of mechanical ventilation, vasopressors, or continuous sedation among individuals in intensive care units with a high vs. low number of protocols. The lack of association was confirmed in adjusted multivariable analysis (p=0.70). Protocol compliance with two ventilator management protocols was moderate and did not differ between intensive care units with high vs. low numbers of protocols for lung protective ventilation in ARDS (47% vs. 52%; p=0.28) and for spontaneous breathing trials (55% vs. 51%; p=0.27). Conclusions Clinical protocols are highly prevalent in United States intensive care units. The presence of a greater number of protocols was not associated with protocol compliance or patient mortality. PMID:26110488

Intelligent geocoding system to locate traffic crashes.

PubMed

Qin, Xiao; Parker, Steven; Liu, Yi; Graettinger, Andrew J; Forde, Susie

2013-01-01

State agencies continue to face many challenges associated with new federal crash safety and highway performance monitoring requirements that use data from multiple and disparate systems across different platforms and locations. On a national level, the federal government has a long-term vision for State Departments of Transportation (DOTs) to report state route and off-state route crash data in a single network. In general, crashes occurring on state-owned or state maintained highways are a priority at the Federal and State level; therefore, state-route crashes are being geocoded by state DOTs. On the other hand, crashes occurring on off-state highway system do not always get geocoded due to limited resources and techniques. Creating and maintaining a statewide crash geographic information systems (GIS) map with state route and non-state route crashes is a complicated and expensive task. This study introduces an automatic crash mapping process, Crash-Mapping Automation Tool (C-MAT), where an algorithm translates location information from a police report crash record to a geospatial map and creates a pinpoint map for all crashes. The algorithm has approximate 83 percent mapping rate. An important application of this work is the ability to associate the mapped crash records to underlying business data, such as roadway inventory and traffic volumes. The integrated crash map is the foundation for effective and efficient crash analyzes to prevent highway crashes. Published by Elsevier Ltd.

Prognostic value of major extracranial injury in traumatic brain injury: an individual patient data meta-analysis in 39,274 patients.

PubMed

van Leeuwen, Nikki; Lingsma, Hester F; Perel, Pablo; Lecky, Fiona; Roozenbeek, Bob; Lu, Juan; Shakur, Haleema; Weir, James; Steyerberg, Ewout W; Maas, Andrew I R

2012-04-01

Major extracranial injury (MEI) is common in traumatic brain injury (TBI) patients, but the effect on outcome is controversial. To assess the prognostic value of MEI on mortality after TBI in an individual patient data meta-analysis of 3 observational TBI studies (International Mission on Prognosis and Clinical Trial Design in TBI [IMPACT]), a randomized controlled trial (Corticosteroid Randomization After Significant Head Injury [CRASH]), and a trauma registry (Trauma Audit and Research Network [TARN]). MEI (extracranial injury with an Abbreviated Injury Scale ≥ 3 or requiring hospital admission) was related to mortality with logistic regression analysis, adjusted for age, Glasgow Coma Scale motor score, and pupil reactivity and stratified by TBI severity. We pooled odds ratios (ORs) with random-effects meta-analysis. We included 39,274 patients. Mortality was 25%, and 32% had MEI. MEI was a strong predictor for mortality in TARN, with adjusted odds ratios of 2.81 (95% confidence interval [CI], 2.44-3.23) in mild, 2.18 (95% CI, 1.80-2.65) in moderate, and 2.14 (95% CI, 1.95-2.35) in severe TBI patients. The prognostic effect was smaller in IMPACT and CRASH, with pooled adjusted odds ratios of 2.14 (95% CI, 0.93-4.91) in mild, 1.46 (95% CI, 1.14-1.85) in moderate, and 1.18 (95% CI, 1.03-1.55) in severe TBI. When patients who died within 6 hours after injury were excluded from TARN, the effect of MEI was comparable with IMPACT and CRASH. MEI is an important prognostic factor for mortality in TBI patients. However, the effect varies by population, which explains the controversy in the literature. The strength of the effect is smaller in patients with more severe brain injury and depends on time of inclusion in a study.

Road user behaviour changes following a self-explaining roads intervention.

PubMed

Mackie, Hamish W; Charlton, Samuel G; Baas, Peter H; Villasenor, Pablo C

2013-01-01

The self-explaining roads (SER) approach uses road designs that evoke correct expectations and driving behaviours from road users to create a safe and user-friendly road network. Following the implementation of an SER process and retrofitting of local and collector roads in a suburb within Auckland City, lower speeds on local roads and less variation in speed on both local and collector roads were achieved, along with a closer match between actual and perceived safe speeds. Preliminary analyses of crash data shows that the project has resulted in a 30% reduction crash numbers and an 86% reduction in crash costs per annum, since the road changes were completed. In order to further understand the outcomes from this project, a study was carried out to measure the effects of the SER intervention on the activity and behaviour of all road users. Video was collected over nine separate days, at nine different locations, both before and after SER construction. Road user behaviour categories were developed for all potential road users at different location types and then used to code the video data. Following SER construction, on local roads there was a relatively higher proportion of pedestrians, less uniformity in vehicle lane keeping and less indicating by motorists along with less through traffic, reflecting a more informal/low speed local road environment. Pedestrians were less constrained on local roads following SER construction, possibly reflecting a perceptually safer and more user-friendly environment. These behaviours were not generally evident on collector roads, a trend also shown by the previous study of speed changes. Given that one of the objectives of SER is to match road user behaviour with functionally different road categories, the road user behaviour differences demonstrated on different road types within the SER trial area provides further reinforcement of a successful SER trial. Copyright © 2012 Elsevier Ltd. All rights reserved.

The frequency--severity indeterminacy.

PubMed

Hauer, Ezra

2006-01-01

Nothing is known about unreported crashes; the information we have is of reported crashes only. Whether a crash gets reported depends on its severity. It follows by logic that, using only data about reported crashes, it is impossible to say whether a change or difference in crash counts reflects a change or difference in crash frequency or in crash severity. This indeterminacy has practical implications. Examples discussed are of the misattribution of over-representation in reported crashes of older drivers and of trucks to causal factors related to the frequency of crash involvement, and of misinterpretation by researchers of findings about the rollover propensity of SUVs.

Not just a rural occurrence: differences in agricultural equipment crash characteristics by rural-urban crash site and proximity to town.

PubMed

Harland, Karisa K; Greenan, Mitchell; Ramirez, Marizen

2014-09-01

Although approximately one-third of agricultural equipment-related crashes occur near town, these crashes are thought to be a rural problem. This analysis examines differences between agricultural equipment-related crashes by their urban-rural distribution and distance from a town. Agricultural equipment crashes were collected from nine Midwest Departments of Transportation (2005-2008). Crash zip code was assigned as urban or rural (large, small and isolated) using Rural-Urban Commuting Areas. Crash proximity to a town was estimated with ArcGIS. Multivariable logistic regression was used to estimate the odds of crashing in an urban versus rural zip codes and across rural gradients. ANOVA analysis estimated mean distance (miles) from a crash site to a town. Over four years, 4444 crashes involved agricultural equipment. About 30% of crashes occurred in urban zip codes. Urban crashes were more likely to be non-collisions (aOR=1.69[1.24-2.30]), involve ≥2 vehicles (2 vehicles: aOR=1.58[1.14-2.20], 3+ vehicles: aOR=1.68[0.98-2.88]), occur in a town (aOR=2.06[1.73-2.45]) and within one mile of a town (aOR=1.65[1.40-1.95]) than rural crashes. The proportion of crashes within a town differed significantly across rural gradients (P<0.0001). Small rural crashes, compared to isolated rural crashes, were 1.98 (95%CI[1.28-3.06]) times more likely to be non-collisions. The distance from the crash to town differed significantly by the urban-rural distribution (P<0.0001). Crashes with agricultural equipment are unexpectedly common in urban areas and near towns and cities. Education among all roadway users, increased visibility of agricultural equipment and the development of complete rural roads are needed to increase road safety and prevent agricultural equipment-related crashes. Copyright © 2014 Elsevier Ltd. All rights reserved.

Crash avoidance potential of four passenger vehicle technologies.

PubMed

Jermakian, Jessica S

2011-05-01

The objective was to update estimates of maximum potential crash reductions in the United States associated with each of four crash avoidance technologies: side view assist, forward collision warning/mitigation, lane departure warning/prevention, and adaptive headlights. Compared with previous estimates (Farmer, 2008), estimates in this study attempted to account for known limitations of current systems. Crash records were extracted from the 2004-08 files of the National Automotive Sampling System General Estimates System (NASS GES) and the Fatality Analysis Reporting System (FARS). Crash descriptors such as vehicle damage location, road characteristics, time of day, and precrash maneuvers were reviewed to determine whether the information or action provided by each technology potentially could have prevented or mitigated the crash. Of the four crash avoidance technologies, forward collision warning/mitigation had the greatest potential for preventing crashes of any severity; the technology is potentially applicable to 1.2 million crashes in the United States each year, including 66,000 serious and moderate injury crashes and 879 fatal crashes. Lane departure warning/prevention systems appeared relevant to 179,000 crashes per year. Side view assist and adaptive headlights could prevent 395,000 and 142,000 crashes per year, respectively. Lane departure warning/prevention was relevant to the most fatal crashes, up to 7500 fatal crashes per year. A combination of all four current technologies potentially could prevent or mitigate (without double counting) up to 1,866,000 crashes each year, including 149,000 serious and moderate injury crashes and 10,238 fatal crashes. If forward collision warning were extended to detect objects, pedestrians, and bicyclists, it would be relevant to an additional 3868 unique fatal crashes. There is great potential effectiveness for vehicle-based crash avoidance systems. However, it is yet to be determined how drivers will interact with the systems. The actual effectiveness of these systems will not be known until sufficient real-world experience has been gained. Copyright © 2010 Elsevier Ltd. All rights reserved.

Evaluation of safety ratings of roads based on frontal crashes with known crash pulse and injury outcome.

PubMed

Stigson, H

2009-06-01

The objective in this study, using data from crashed cars fitted with on-board crash pulse recorders, was to present differences in average crash severity, distribution of crash severity, and injury outcomes, based on an independent safety rating of roads, also taking road type and speed limit into consideration. Furthermore, the objective was to evaluate differences in injury risk, based on the distribution of crash severity. The investigation included both frontal two-vehicle crashes and single-vehicle crashes with known injury outcome. In total, 209 real-world crashes involving cars fitted with crash pulse recorders were included. For all crashes, average mean acceleration and change of velocity of the vehicle acceleration pulse were measured and calculated. All crash spots were classified according to an independent road safety rating program (European Road Assessment Programme Road Protection Score), where the safety quality of roads is rated in relation to posted speed limits. The crash severity and injury outcome in crashes that occurred on roads with good safety ratings were compared with crashes on roads with poor safety ratings. The data were also divided into subcategories according to posted speed limit and road type, to evaluate whether there was a difference in crash severity and injury outcome within the categories. In total, crash severity was statistically significantly lower in crashes occurring on roads with good safety ratings than in crashes occurring on roads with poor safety ratings. It was found that crash severity and injury risk were lower on roads with good safety ratings with a speed limit of above 90 km/h compared with roads with poor safety ratings, irrespective of speed limit. On the other hand, crash severity was higher on roads with good safety ratings with speed limit of 70 km/h than on roads with poor safety ratings with the same speed limit. Though it was found that a higher speed limit resulted in higher crash severity on roads with poor safety ratings, the opposite was found on roads with good safety ratings. The main reason for this was that lanes for traffic traveling in opposite directions were more often separated at higher speeds on roads with good safety ratings. On divided roads with good safety ratings, there were no crashes resulting in crash severity above the level corresponding to a 10 percent risk of sustaining serious or fatal injury. This indicates that one of the most important safety measures is divided roads.

The Interface of Clinical Decision-Making With Study Protocols for Knowledge Translation From a Walking Recovery Trial.

PubMed

Hershberg, Julie A; Rose, Dorian K; Tilson, Julie K; Brutsch, Bettina; Correa, Anita; Gallichio, Joann; McLeod, Molly; Moore, Craig; Wu, Sam; Duncan, Pamela W; Behrman, Andrea L

2017-01-01

Despite efforts to translate knowledge into clinical practice, barriers often arise in adapting the strict protocols of a randomized, controlled trial (RCT) to the individual patient. The Locomotor Experience Applied Post-Stroke (LEAPS) RCT demonstrated equal effectiveness of 2 intervention protocols for walking recovery poststroke; both protocols were more effective than usual care physical therapy. The purpose of this article was to provide knowledge-translation tools to facilitate implementation of the LEAPS RCT protocols into clinical practice. Participants from 2 of the trial's intervention arms: (1) early Locomotor Training Program (LTP) and (2) Home Exercise Program (HEP) were chosen for case presentation. The two cases illustrate how the protocols are used in synergy with individual patient presentations and clinical expertise. Decision algorithms and guidelines for progression represent the interface between implementation of an RCT standardized intervention protocol and clinical decision-making. In each case, the participant presents with a distinct clinical challenge that the therapist addresses by integrating the participant's unique presentation with the therapist's expertise while maintaining fidelity to the LEAPS protocol. Both participants progressed through an increasingly challenging intervention despite their own unique presentation. Decision algorithms and exercise progression for the LTP and HEP protocols facilitate translation of the RCT protocol to the real world of clinical practice. The two case examples to facilitate translation of the LEAPS RCT into clinical practice by enhancing understanding of the protocols, their progression, and their application to individual participants.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A147).

Characteristics of Single Vehicle Crashes with a Teen Driver in South Carolina, 2005-2008.

PubMed

Shults, Ruth A; Bergen, Gwen; Smith, Tracy J; Cook, Larry; Kindelberger, John; West, Bethany

2017-09-22

Teens' crash risk is highest in the first years of independent driving. Circumstances surrounding fatal crashes have been widely documented, but less is known about factors related to nonfatal teen driver crashes. This study describes single vehicle nonfatal crashes involving the youngest teen drivers (15-17 years), compares these crashes to single vehicle nonfatal crashes among adult drivers (35-44 years) and examines factors related to nonfatal injury producing crashes for teen drivers. Police crash data linked to hospital inpatient and emergency department data for 2005-2008 from the South Carolina Crash Outcomes Data Evaluation System (CODES) were analyzed. Nonfatal, single vehicle crashes involving passenger vehicles occurring on public roadways for teen (15-17 years) drivers were compared with those for adult (35-44 years) drivers on temporal patterns and crash risk factors per licensed driver and per vehicle miles traveled. Vehicle miles traveled by age group was estimated using data from the 2009 National Household Travel Survey. Multivariable log-linear regression analysis was conducted for teen driver crashes to determine which characteristics were related to crashes resulting in a minor/moderate injury or serious injury to at least one vehicle occupant. Compared with adult drivers, teen drivers in South Carolina had 2.5 times the single vehicle nonfatal crash rate per licensed driver and 11 times the rate per vehicle mile traveled. Teen drivers were nearly twice as likely to be speeding at the time of the crash compared with adult drivers. Teen driver crashes per licensed driver were highest during the afternoon hours of 3:00-5:59 pm and crashes per mile driven were highest during the nighttime hours of 9:00-11:59 pm. In 66% of the teen driver crashes, the driver was the only occupant. Crashes were twice as likely to result in serious injury when teen passengers were present than when the teen driver was alone. When teen drivers crashed while transporting teen passengers, the passengers were >5 times more likely to all be restrained if the teen driver was restrained. Crashes in which the teen driver was unrestrained were 80% more likely to result in minor/moderate injury and 6 times more likely to result in serious injury compared with crashes in which the teen driver was restrained. Despite the reductions in teen driver crashes associated with Graduated Driver Licensing (GDL), South Carolina's teen driver crash rates remain substantially higher than those for adult drivers. Established risk factors for fatal teen driver crashes, including restraint nonuse, transporting teen passengers, and speeding also increase the risk of nonfatal injury in single vehicle crashes. As South Carolina examines strategies to further reduce teen driver crashes and associated injuries, the state could consider updating its GDL passenger restriction to either none or one passenger <21years and dropping the passenger restriction exemption for trips to and from school. Surveillance systems such as CODES that link crash data with health outcome data provide needed information to more fully understand the circumstances and consequences of teen driver nonfatal crashes and evaluate the effectiveness of strategies to improve teen driver safety. Published by Elsevier Ltd.

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

PubMed

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

2016-03-22

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

Crash and risky driving involvement among novice adolescent drivers and their parents.

PubMed

Simons-Morton, Bruce G; Ouimet, Marie Claude; Zhang, Zhiwei; Klauer, Sheila E; Lee, Suzanne E; Wang, Jing; Albert, Paul S; Dingus, Thomas A

2011-12-01

We compared rates of risky driving among novice adolescent and adult drivers over the first 18 months of adolescents' licensure. Data-recording systems installed in participants' vehicles provided information on driving performance of 42 newly licensed adolescent drivers and their parents. We analyzed crashes and near crashes and elevated g-force event rates by Poisson regression with random effects. During the study period, adolescents were involved in 279 crashes or near crashes (1 involving injury); parents had 34 such accidents. The incidence rate ratio (IRR) comparing adolescent and parent crash and near-crash rates was 3.91. Among adolescent drivers, elevated rates of g-force events correlated with crashes and near crashes (r = 0.60; P < .001). The IRR comparing incident rates of risky driving among adolescents and parents was 5.08. Adolescents' rates of crashes and near crashes declined with time (with a significant uptick in the last quarter), but elevated g-force event rates did not decline. Elevated g-force events among adolescents may have contributed to crash and near-crash rates that remained much higher than adult levels after 18 months of driving.

Casualty Crash Types for which Teens are at Excess Risk

PubMed Central

Bingham, C. R.; Shope, J. T.

2007-01-01

This study identified casualty crash types for which teen drivers experience excess risk relative to adults. Michigan State Police crash records were used to examine casualty crashes in two statewide populations of drivers who experienced at least one crash from 1989–1996 (pre-graduated driver licensing in Michigan): teens (ages 16–19) and adults (ages 45–65). Rates and rate ratios (RR) based on crash occurrence per 100,000 person miles driven (PMD) compared teens and adults from the two statewide populations. Excess risk was defined as a RR for a specific type of crash that was significantly greater than the RR for all crashes combined. The RRs for all crashes combined for teenage males was 2.41 and 1.75 for teenage females. RRs for teenage males ranged from a low of 2.16 for casualty crashes attributed to alcohol to 8.98 for casualty road departure crashes at night. Among teenage females, RRs ranged from 2.06 for casualty crashes on the weekend to 7.86 for casualty crashes at night with passengers. Casualty crash rates for teenage males ranged from 0.21 per 100,000 PMD for rollover crashes to 1.95 per 100,000 PMD for crashes with passengers. Among teen females, casualty crash rates ranged from 0.21 per 100,000 PMD for drink/driving with passengers to 3.31 per 100,000 PMD for crashes with passengers. Implications for graduated driver licensing, teen driver supervision, and policy are discussed. This study was funded by the National Institute on Alcohol Abuse and Alcoholism and the Centers for Disease Control and Prevention’s National Center for Injury Prevention and Control. PMID:18184510

From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

PubMed Central

Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

2015-01-01

Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

Features Associated with Successful Recruitment of Diverse Patients onto Cancer Clinical Trials: Report from the American College of Surgeons Oncology Group

PubMed Central

Diehl, Kathleen M.; Green, Erin M.; Weinberg, Armin; Frederick, Wayne A.; Holmes, Dennis R.; Green, Bettye; Morris, Arden; Kuerer, Henry M.; Beltran, Robert A.; Mendez, Jane; Gines, Venus; Ota, David M.; Nelson, Heidi; Newman, Lisa A.

2018-01-01

Background The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. Study Design We evaluated the accrual patterns for ten clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999–2009, and analyzed results by race/ethnicity as well as study design. Results Eight of ten protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully-recruiting protocols were: (i) studies designed to recruit patients with regional or advanced-stage disease (2/2 protocols); and (ii) studies that involved some investigational systemic therapy (3/3 protocols). Discussion AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients. PMID:21681382

Crashes of sightseeing helicopter tours in Hawaii.

PubMed

Haaland, Wren L; Shanahan, Dennis F; Baker, Susan P

2009-07-01

Crashes of sightseeing helicopter flights in Hawaii and the resulting tourist deaths prompted the FAA to issue regulations in 1994 specific to air tours in Hawaii. Research was undertaken to examine the effect of the 1994 Rule and to describe the circumstances of such crashes. From National Transportation Safety Board data, 59 crashes of helicopter air tour flights in Hawaii during 1981-2008 were identified; crash investigation reports were read and coded. Crashes in 1995-2008 were compared with those in 1981-1994. The 1994 Rule was followed by a 47% decrease in the crash rate, from 3.4 to 1.8/100,000 flight hours. The number of crashes into the ocean decreased from eight before the Rule to one afterwards. VFR-IMC crashes increased from 5 to 32% of crashes. There were 46 tourists and 9 pilots who died in 16 fatal crashes. Aircraft malfunctions, primarily due to poor maintenance, precipitated 34 (58%) of the crashes and persisted throughout the 28-yr period. Pilot errors were apparent in 23 crashes (39%). Flight from visual to instrument conditions occurred in two cases before the Rule and seven cases after. Terrain unsuitable for landing was cited in 37 crashes (63%). Decreases occurred in the overall number and rate of crashes and in ocean crash landings. The increase in VFR-IMC crashes may be related to the requirement that tour helicopters fly at least 1500 ft. above terrain. Attention is still needed to maintenance, pilot training, and restricting flights to operating areas and conditions that enable safe emergency landings.

Sleep-related vehicle crashes on low speed roads.

PubMed

Filtness, A J; Armstrong, K A; Watson, A; Smith, S S

2017-02-01

Very little is known about the characteristics of sleep related (SR) crashes occurring on low speed roads compared with current understanding of the role of sleep in crashes occurring on high speed roads e.g. motorways. To address this gap, analyses were undertaken to identify the differences and similarities between (1) SR crashes occurring on roads with low (≤60km/h) and high (≥100km/h) speed limits, and (2) SR crashes and not-SR crashes occurring on roads with low speed limits. Police reports of all crashes occurring on low and high speed roads over a ten year period between 2000 and 2009 were examined for Queensland, Australia. Attending police officers identified all crash attributes, including 'fatigue/fell asleep', which indicates that the police believe the crash to have a causal factor relating to falling asleep, sleepiness due to sleep loss, time of day, or fatigue. Driver or rider involvement in crashes was classified as SR or not-SR. All crash-associated variables were compared using Chi-square tests (Cramer's V=effect size). A series of logistic regression was performed, with driver and crash characteristics as predictors of crash category. A conservative alpha level of 0.001 determined statistical significance. There were 440,855 drivers or riders involved in a crash during this time; 6923 (1.6%) were attributed as SR. SR crashes on low speed roads have similar characteristics to those on high speed roads with young (16-24y) males consistently over represented. SR crashes on low speed roads are noticeably different to not-SR crashes in the same speed zone in that male and young novice drivers are over represented and outcomes are more severe. Of all the SR crashes identified, 41% occurred on low speed roads. SR crashes are not confined to high speed roads. Low speed SR crashes warrant specific investigation because they occur in densely populated areas, exposing a greater number of people to risk and have more severe outcomes than not-SR crashes on the same low speed roads. Copyright © 2016 Elsevier Ltd. All rights reserved.

Cost of Crashes Related to Road Conditions, United States, 2006

PubMed Central

Zaloshnja, Eduard; Miller, Ted R.

2009-01-01

This is the first study to estimate the cost of crashes related to road conditions in the U.S. To model the probability that road conditions contributed to the involvement of a vehicle in the crash, we used 2000–03 Large Truck Crash Causation Study (LTCCS) data, the only dataset that provides detailed information whether road conditions contributed to crash occurrence. We applied the logistic regression results to a costed national crash dataset in order to calculate the probability that road conditions contributed to the involvement of a vehicle in each crash. In crashes where someone was moderately to seriously injured (AIS-2-6) in a vehicle that harmfully impacted a large tree or medium or large non-breakaway pole, or if the first harmful event was collision with a bridge, we changed the calculated probability of being road-related to 1. We used the state distribution of costs of fatal crashes where road conditions contributed to crash occurrence or severity to estimate the respective state distribution of non-fatal crash costs. The estimated comprehensive cost of traffic crashes where road conditions contributed to crash occurrence or severity was $217.5 billion in 2006. This represented 43.6% of the total comprehensive crash cost. The large share of crash costs related to road design and conditions underlines the importance of these factors in highway safety. Road conditions are largely controllable. Road maintenance and upgrading can prevent crashes and reduce injury severity. PMID:20184840

The impact of Michigan's text messaging restriction on motor vehicle crashes.

PubMed

Ehsani, Johnathon P; Bingham, C Raymond; Ionides, Edward; Childers, David

2014-05-01

The purpose of this study was to determine the effects of Michigan's universal text messaging restriction (effective July 2010) across different age groups of drivers and crash severities. Changes in monthly crash rates and crash trends per 10,000 licensed drivers aged 16, 17, 18, 19, 20-24, and 25-50 years were estimated using time series analysis for three levels of crash severity: (1) fatal/disabling injury; (2) nondisabling injury; and (3) possible injury/property damage only (PDO) crashes for the period 2005-2012. Analyses were adjusted for crash rates of drivers' aged 65-99 years, Michigan's unemployment rate, and gasoline prices. After the introduction of the texting restriction, significant increases were observed in crash rates and monthly trends in fatal/disabling injury crashes and nondisabling injury crashes, and significant decreases in possible injury/PDO crashes. The magnitude of the effects where significant changes were observed was small. The introduction of the texting restriction was not associated with a reduction in crash rates or trends in severe crash types. On the contrary, small increases in the most severe crash types (fatal/disabling and nondisabling injury) and small decreases in the least severe crash types (possible injury/PDO) were observed. These findings extend the literature on the effects of cell phone restrictions by examining the effects of the restriction on newly licensed adolescent drivers and adult drivers separately by crash severity. Published by Elsevier Inc.

Reporting of methods was better in the Clinical Trials Registry-India than in Indian journal publications.

PubMed

Tharyan, Prathap; George, Aneesh Thomas; Kirubakaran, Richard; Barnabas, Jabez Paul

2013-01-01

We sought to evaluate if editorial policies and the reporting quality of randomized controlled trials (RCTs) had improved since our 2004-05 survey of 151 RCTs in 65 Indian journals, and to compare reporting quality of protocols in the Clinical Trials Registry-India (CTRI). An observational study of endorsement of Consolidated Standards for the Reporting of Trials (CONSORT) and International Committee of Medical Journal Editors (ICMJE) requirements in the instructions to authors in Indian journals, and compliance with selected requirements in all RCTs published during 2007-08 vs. our previous survey and between all RCT protocols in the CTRI on August 31, 2010 and published RCTs from both surveys. Journal policies endorsing the CONSORT statement (22/67, 33%) and ICMJE requirements (35/67, 52%) remained suboptimal, and only 4 of 13 CONSORT items were reported in more than 50% of the 145 RCTs assessed. Reporting of ethical issues had improved significantly, and that of methods addressing internal validity had not improved. Adequate methods were reported significantly more frequently in 768 protocols in the CTRI, than in the 296 published trials. The CTRI template facilitates the reporting of valid methods in registered trial protocols. The suboptimal compliance with CONSORT and ICMJE requirements in RCTs published in Indian journals reduces credibility in the reliability of their results. Copyright © 2013 Elsevier Inc. All rights reserved.

Injury severity analysis in taxi-pedestrian crashes: An application of reconstructed crash data using a vehicle black box.

PubMed

Chung, Younshik

2018-02-01

In-vehicle recording devices have enabled recent changes in methodological paradigms for traffic safety research. Such devices include event data recorders (EDRs), vehicle black boxes (VBBs), and various sensors used in naturalistic driving studies (NDSs). These technologies may help improve the validity of models used to assess impacts on traffic safety. The objective of this study is to analyze the injury severity in taxi-pedestrian crashes using the accurate crash data from VBBs, such as the time-to-collision (TTC), speed, angle, and region of the crash. VBB data from a two-year period (2010-2011) were collected from taxis operating in Incheon, South Korea. An ordered probit model was then applied to analyze the injury severity in crashes. Five variables were found to have a greater effect on injury severity: crash speed, crashes in no-median sections, crashes where the secondary impact object of pedestrians was the crash vehicle, crashes where the third impact object of pedestrians was another moving vehicle, and crashes where the third impact region of pedestrians was their head. However, injuries were less severe in crashes where the first impact region on the pedestrian was their leg, crashes with the car moving in a straight line, and crashes involving junior high school students. Copyright © 2017 Elsevier Ltd. All rights reserved.

Sensitivity of head and cervical spine injury measures to impact factors relevant to rollover crashes.

PubMed

Mattos, G A; Mcintosh, A S; Grzebieta, R H; Yoganandan, N; Pintar, F A

2015-01-01

Serious head and cervical spine injuries have been shown to occur mostly independent of one another in pure rollover crashes. In an attempt to define a dynamic rollover crash test protocol that can replicate serious injuries to the head and cervical spine, it is important to understand the conditions that are likely to produce serious injuries to these 2 body regions. The objective of this research is to analyze the effect that impact factors relevant to a rollover crash have on the injury metrics of the head and cervical spine, with a specific interest in the differentiation between independent injuries and those that are predicted to occur concomitantly. A series of head impacts was simulated using a detailed finite element model of the human body, the Total HUman Model for Safety (THUMS), in which the impactor velocity, displacement, and direction were varied. The performance of the model was assessed against available experimental tests performed under comparable conditions. Indirect, kinematic-based, and direct, tissue-level, injury metrics were used to assess the likelihood of serious injuries to the head and cervical spine. The performance of the THUMS head and spine in reconstructed experimental impacts compared well to reported values. All impact factors were significantly associated with injury measures for both the head and cervical spine. Increases in impact velocity and displacement resulted in increases in nearly all injury measures, whereas impactor orientation had opposite effects on brain and cervical spine injury metrics. The greatest cervical spine injury measures were recorded in an impact with a 15° anterior orientation. The greatest brain injury measures occurred when the impactor was at its maximum (45°) angle. The overall kinetic and kinematic response of the THUMS head and cervical spine in reconstructed experiment conditions compare well with reported values, although the occurrence of fractures was overpredicted. The trends in predicted head and cervical spine injury measures were analyzed for 90 simulated impact conditions. Impactor orientation was the only factor that could potentially explain the isolated nature of serious head and spine injuries under rollover crash conditions. The opposing trends of injury measures for the brain and cervical spine indicate that it is unlikely to reproduce the injuries simultaneously in a dynamic rollover test.

Comparison of teen and adult driver crash scenarios in a nationally representative sample of serious crashes.

PubMed

McDonald, Catherine C; Curry, Allison E; Kandadai, Venk; Sommers, Marilyn S; Winston, Flaura K

2014-11-01

Motor vehicle crashes are the leading cause of death and acquired disability during the first four decades of life. While teen drivers have the highest crash risk, few studies examine the similarities and differences in teen and adult driver crashes. We aimed to: (1) identify and compare the most frequent crash scenarios-integrated information on a vehicle's movement prior to crash, immediate pre-crash event, and crash configuration-for teen and adult drivers involved in serious crashes, and (2) for the most frequent scenarios, explore whether the distribution of driver critical errors differed for teens and adult drivers. We analyzed data from the National Motor Vehicle Crash Causation Survey, a nationally representative study of serious crashes conducted by the U.S. National Highway Traffic Safety Administration from 2005 to 2007. Our sample included 642 16- to 19-year-old and 1167 35- to 54-year-old crash-involved drivers (weighted n=296,482 and 439,356, respectively) who made a critical error that led to their crash's critical pre-crash event (i.e., event that made the crash inevitable). We estimated prevalence ratios (PR) and 95% confidence intervals (CI) to compare the relative frequency of crash scenarios and driver critical errors. The top five crash scenarios among teen drivers, accounting for 37.3% of their crashes, included: (1) going straight, other vehicle stopped, rear end; (2) stopped in traffic lane, turning left at intersection, turn into path of other vehicle; (3) negotiating curve, off right edge of road, right roadside departure; (4) going straight, off right edge of road, right roadside departure; and (5) stopped in lane, turning left at intersection, turn across path of other vehicle. The top five crash scenarios among adult drivers, accounting for 33.9% of their crashes, included the same scenarios as the teen drivers with the exception of scenario (3) and the addition of going straight, crossing over an intersection, and continuing on a straight path. For two scenarios ((1) and (3) above), teens were more likely than adults to make a critical decision error (e.g., traveling too fast for conditions). Our findings indicate that among those who make a driver critical error in a serious crash, there are few differences in the scenarios or critical driver errors for teen and adult drivers. Copyright © 2014 Elsevier Ltd. All rights reserved.

Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials.

PubMed

Moler, Frank W; Silverstein, Faye S; Meert, Kathleen L; Clark, Amy E; Holubkov, Richard; Browning, Brittan; Slomine, Beth S; Christensen, James R; Dean, J Michael

2013-09-01

To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Multicenter randomized controlled trials. Pediatric intensive care and cardiac ICUs in the United States and Canada. Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Therapeutic hypothermia or therapeutic normothermia. From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials.

Costs of Alcohol-Involved Crashes, United States, 2010

PubMed Central

Zaloshnja, Eduard; Miller, Ted R.; Blincoe, Lawrence J.

2013-01-01

This paper estimates total and unit costs of alcohol-involved crashes in the U.S. in 2010. With methods from earlier studies, we estimated costs per crash survivor by MAIS, body part, and fracture/dislocation involvement. We multiplied them times 2010 crash incidence estimates from NHTSA data sets, with adjustments for underreporting of crashes and their alcohol involvement. The unit costs are lifetime costs discounted at 3%. To develop medical costs, we combined 2008 Health Care Utilization Program national data for hospitalizations and ED visits of crash survivors with prior estimates of post-discharge costs. Productivity losses drew on Current Population Survey and American Time Use Survey data. Quality of life losses came from a 2011 AAAM paper and property damage from insurance data. We built a hybrid incidence file comprised of 2008–2010 and 1984–86 NHTSA crash surveillance data, weighted with 2010 General Estimates System weights. Fatality data came from the 2010 FARS. An estimated 12% of 2010 crashes but only 0.9% of miles driven were alcohol-involved (BAC > .05). Alcohol-involved crashes cost an estimated $125 billion. That is 22.5% of the societal cost of all crashes. Alcohol-attributable crashes accounted for an estimated 22.5% of US auto liability insurance payments. Alcohol-involved crashes cost $0.86 per drink. Above the US BAC limit of .08, crash costs were $8.37 per mile driven; 1 in 788 trips resulted in a crash and 1 in 1,016 trips in an arrest. Unit costs for crash survivors by severity are higher for impaired driving than for other crashes. That suggests national aggregate impaired driving cost estimates in other countries are substantial underestimates if they are based on all-crash unit costs. PMID:24406941

Driver injury severity outcome analysis in rural interstate highway crashes: a two-level Bayesian logistic regression interpretation.

PubMed

Chen, Cong; Zhang, Guohui; Liu, Xiaoyue Cathy; Ci, Yusheng; Huang, Helai; Ma, Jianming; Chen, Yanyan; Guan, Hongzhi

2016-12-01

There is a high potential of severe injury outcomes in traffic crashes on rural interstate highways due to the significant amount of high speed traffic on these corridors. Hierarchical Bayesian models are capable of incorporating between-crash variance and within-crash correlations into traffic crash data analysis and are increasingly utilized in traffic crash severity analysis. This paper applies a hierarchical Bayesian logistic model to examine the significant factors at crash and vehicle/driver levels and their heterogeneous impacts on driver injury severity in rural interstate highway crashes. Analysis results indicate that the majority of the total variance is induced by the between-crash variance, showing the appropriateness of the utilized hierarchical modeling approach. Three crash-level variables and six vehicle/driver-level variables are found significant in predicting driver injury severities: road curve, maximum vehicle damage in a crash, number of vehicles in a crash, wet road surface, vehicle type, driver age, driver gender, driver seatbelt use and driver alcohol or drug involvement. Among these variables, road curve, functional and disabled vehicle damage in crash, single-vehicle crashes, female drivers, senior drivers, motorcycles and driver alcohol or drug involvement tend to increase the odds of drivers being incapably injured or killed in rural interstate crashes, while wet road surface, male drivers and driver seatbelt use are more likely to decrease the probability of severe driver injuries. The developed methodology and estimation results provide insightful understanding of the internal mechanism of rural interstate crashes and beneficial references for developing effective countermeasures for rural interstate crash prevention. Copyright © 2016 Elsevier Ltd. All rights reserved.

Blockchain protocols in clinical trials: Transparency and traceability of consent.

PubMed

Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

2017-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility.

Blockchain protocols in clinical trials: Transparency and traceability of consent

PubMed Central

Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

2018-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility. PMID:29167732

Remote Damage Control Resuscitation and the Solstrand Conference: Defining the Need, the Language, and a Way Forward

DTIC Science & Technology

2013-01-01

the occa- sional emergency resuscitative thoracotomy. The United Kingdom has also reported the successful prehospital use of tranexamic acid (TXA...treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet 2011;377:1096-101...1101 e1-2. 56. Abramovich A, Lipsky AM, Feinstein U. Tranexamic acid in the prehospital setting: the Israel Defense forces’ initial experience. J

The effect on teen driving outcomes of the Checkpoints Program in a state-wide trial.

PubMed

Simons-Morton, Bruce G; L Hartos, Jessica; Leaf, William A; Preusser, David F

2006-09-01

Crash rates among teenagers are highly elevated during the first months of licensure. Parent-imposed driving restrictions on initial driving privileges can reduce exposure to high-risk driving conditions, thus reducing crash risk while teens' driving proficiency develops. This report describes the effect of the Checkpoints Program on driving limits and outcomes. Connecticut teens who obtained a learners permit over a 9-month period were recruited, providing a final sample of 3743 who obtained driver licenses. Families were randomized to the intervention or comparison condition. Intervention families received by mail a series of persuasive communications related to high-risk teen driving and a parent-teen driving agreement, while comparison families received on the same schedule general information on driving and vehicle maintenance. Relative to the comparison group, teens and parents in the Checkpoints Program reported significantly greater limits on high-risk teen driving conditions at licensure, 3-, and 6-months post-licensure; and intervention teens reported significantly less risky driving at each reporting period. By the 12-month follow up teens in the intervention group were significantly less likely than those in the comparison group to have had a traffic violation. However, no treatment group effect was found for crashes. This is the first study to report significant effects on teen driving behavior and performance of education designed to increase parental-imposed teen driving limits.

Involving American Indians and medically underserved rural populations in cancer clinical trials.

PubMed

Guadagnolo, B Ashleigh; Petereit, Daniel G; Helbig, Petra; Koop, David; Kussman, Patricia; Fox Dunn, Emily; Patnaik, Asha

2009-12-01

To assess cancer clinical trial recruitment and reasons for nonaccrual among a rural, medically underserved population served by a community-based cancer care center. We prospectively tracked clinical trial enrollment incidence among all new patients presenting at the Rapid City Regional Cancer Care Institute. Evaluating physicians completed questionnaires for each patient regarding clinical trial enrollment status and primary reasons for nonenrollment. Patients who identified as American Indian were referred to a program where patients were assisted in navigating the medical system by trained, culturally competent staff. Between September 2006 and January 2008, 891 new cancer patients were evaluated. Seventy-eight patients (9%; 95% confidence intervals, 7-11%) were enrolled on a clinical treatment trial. For 73% (95% confidence intervals, 69-75%) of patients (646 of 891) lack of relevant protocol availability or protocol inclusion criteria restrictiveness was the reason for nonenrollment. Only 45 (5%; 95% confidence intervals, 4-7%) patients refused enrollment on a trial. Of the 78 enrolled on a trial, 6 (8%; 95% confidence intervals, 3-16%) were American Indian. Three additional American Indian patients were enrolled under a nontreatment cancer control trial, bringing the total percentage enrolled of the 94 American Indians who presented to the clinic to 10% (95% confidence intervals, 5-17%). Eligibility rates were unable to be calculated and cross validation of the number in the cohort via registries or ICD-9 codes was not performed. Clinical trial participation in this medically underserved population was low overall, but approximately 3-fold higher than reported national accrual rates. Lack of availability of protocols for common cancer sites as well as stringent protocol inclusion criteria were the primary obstacles to clinical trial enrollment. Targeted interventions using a Patient Navigation program were used to engage AI patients and may have resulted in higher clinical trial enrollment among this racial/ethnic group.

Involving American Indians and medically underserved rural populations in cancer clinical trials

PubMed Central

Guadagnolo, B Ashleigh; Petereit, Daniel G; Helbig, Petra; Koop, David; Kussman, Patricia; Dunn, Emily Fox; Patnaik, Asha

2010-01-01

Purpose To assess cancer clinical trial recruitment and reasons for nonaccrual among a rural, medically underserved population served by a community-based cancer care center. Methods We prospectively tracked clinical trial enrollment incidence among all new patients presenting at the Rapid City Regional Cancer Care Institute. Evaluating physicians completed questionnaires for each patient regarding clinical trial enrollment status and primary reasons for nonenrollment. Patients who identified as American Indian were referred to a program where patients were assisted in navigating the medical system by trained, culturally competent staff. Results Between September 2006 and January 2008, 891 new cancer patients were evaluated. Seventy-eight patients (9%; 95% confidence intervals, 7–11%) were enrolled on a clinical treatment trial. For 73% (95% confidence intervals, 69–75%) of patients (646 of 891) lack of relevant protocol availability or protocol inclusion criteria restrictiveness was the reason for nonenrollment. Only 45 (5%; 95% confidence intervals, 4–7%) patients refused enrollment on a trial. Of the 78 enrolled on a trial, 6 (8%; 95% confidence intervals, 3–16%) were American Indian. Three additional American Indian patients were enrolled under a nontreatment cancer control trial, bringing the total percentage enrolled of the 94 American Indians who presented to the clinic to 10% (95% confidence intervals, 5–17%). Limitations Eligibility rates were unable to be calculated and cross validation of the number in the cohort via registries or ICD-9 codes was not performed. Conclusion Clinical trial participation in this medically underserved population was low overall, but approximately 3-fold higher than reported national accrual rates. Lack of availability of protocols for common cancer sites as well as stringent protocol inclusion criteria were the primary obstacles to clinical trial enrollment. Targeted interventions using a Patient Navigation program were used to engage AI patients and may have resulted in higher clinical trial enrollment among this racial/ethnic group. PMID:19933720

The Pattern of Road Traffic Crashes in South East Iran

PubMed Central

Rad, Mahdieh; Martiniuk, Alexandra LC.; Ansari-Moghaddam, Alireza; Mohammadi, Mahdi; Rashedi, Fariborz; Ghasemi, Ardavan

2016-01-01

Background: In the present study, the epidemiologic aspects of road traffic crashes in South East of Iran are described. Methods: This cross-sectional study included the profile of 2398 motor vehicle crashes recorded in the police office in one Year in South East of Iran. Data collected included: demographics, the type of crash, type of involved vehicle, location of crash and factors contributing to the crash. Descriptive statistics were used for data analysis. Results: Collisions with other vehicles or objects contributed the highest proportion (62.4%) of motor vehicle crashes. Human factors including careless driving, violating traffic laws, speeding, and sleep deprivation/fatigue were the most important causal factors accounting for 90% of road crashes. Data shows that 41% of drivers were not using a seat belt at the time of crash. One- third of the crashes resulted in injury (25%) or death (5%). Conclusions: Reckless driving such as speeding and violation of traffic laws are major risk factors for crashes in the South East of Iran. This highlights the need for education along with traffic law enforcement to reduce motor vehicle crashes in future. PMID:27157159

The Pattern of Road Traffic Crashes in South East Iran.

PubMed

Rad, Mahdieh; Martiniuk, Alexandra Lc; Ansari-Moghaddam, Alireza; Mohammadi, Mahdi; Rashedi, Fariborz; Ghasemi, Ardavan

2016-09-01

In the present study, the epidemiologic aspects of road traffic crashes in South East of Iran are described. This cross-sectional study included the profile of 2398 motor vehicle crashes recorded in the police office in one Year in South East of Iran. Data collected included: demographics, the type of crash, type of involved vehicle, location of crash and factors contributing to the crash. Descriptive statistics were used for data analysis. Collisions with other vehicles or objects contributed the highest proportion (62.4%) of motor vehicle crashes. Human factors including careless driving, violating traffic laws, speeding, and sleep deprivation/fatigue were the most important causal factors accounting for 90% of road crashes. Data shows that 41% of drivers were not using a seat belt at the time of crash. One- third of the crashes resulted in injury (25%) or death (5%). Reckless driving such as speeding and violation of traffic laws are major risk factors for crashes in the South East of Iran. This highlights the need for education along with traffic law enforcement to reduce motor vehicle crashes in future.

Measurement of intracranial pressure and short-term outcomes of patients with traumatic brain injury: a propensity-matched analysis

PubMed Central

Ferreira, Cesar Biselli; Bassi, Estevão; Lucena, Lucas; Carreta, Hernandez; Miranda, Leandro Costa; Tierno, Paulo Fernando Guimarães Mazorcchi; Amorim, Robson Luis; Zampieri, Fernando Godinho; Malbouisson, Luis Marcelo Sá

2015-01-01

Objective To assess the impact of intracranial pressure monitoring on the short-term outcomes of traumatic brain injury patients. Methods Retrospective observational study including 299 consecutive patients admitted due to traumatic brain injury from January 2011 through July 2012 at a Level 1 trauma center in São Paulo, Brazil. Patients were categorized in two groups according to the measurement of intracranial pressure (measured intracranial pressure and non-measured intracranial pressure groups). We applied a propensity-matched analysis to adjust for possible confounders (variables contained in the Crash Score prognostic algorithm). Results Global mortality at 14 days (16%) was equal to that observed in high-income countries in the CRASH Study and was better than expected based on the CRASH calculator score (20.6%), with a standardized mortality ratio of 0.77. A total of 28 patients received intracranial pressure monitoring (measured intracranial pressure group), of whom 26 were paired in a 1:1 fashion with patients from the non-measured intracranial pressure group. There was no improvement in the measured intracranial pressure group compared to the non-measured intracranial pressure group regarding hospital mortality, 14-day mortality, or combined hospital and chronic care facility mortality. Survival up to 14 days was also similar between groups. Conclusion Patients receiving intracranial pressure monitoring tend to have more severe traumatic brain injuries. However, after adjusting for multiple confounders using propensity scoring, no benefits in terms of survival were observed among intracranial pressure-monitored patients and those managed with a systematic clinical protocol. PMID:26761468

Measurement of intracranial pressure and short-term outcomes of patients with traumatic brain injury: a propensity-matched analysis.

PubMed

Ferreira, Cesar Biselli; Bassi, Estevão; Lucena, Lucas; Carreta, Hernandez; Miranda, Leandro Costa; Tierno, Paulo Fernando Guimarães Mazorcchi; Amorim, Robson Luis; Zampieri, Fernando Godinho; Malbouisson, Luis Marcelo Sá

2015-01-01

To assess the impact of intracranial pressure monitoring on the short-term outcomes of traumatic brain injury patients. Retrospective observational study including 299 consecutive patients admitted due to traumatic brain injury from January 2011 through July 2012 at a Level 1 trauma center in São Paulo, Brazil. Patients were categorized in two groups according to the measurement of intracranial pressure (measured intracranial pressure and non-measured intracranial pressure groups). We applied a propensity-matched analysis to adjust for possible confounders (variables contained in the Crash Score prognostic algorithm). Global mortality at 14 days (16%) was equal to that observed in high-income countries in the CRASH Study and was better than expected based on the CRASH calculator score (20.6%), with a standardized mortality ratio of 0.77. A total of 28 patients received intracranial pressure monitoring (measured intracranial pressure group), of whom 26 were paired in a 1:1 fashion with patients from the non-measured intracranial pressure group. There was no improvement in the measured intracranial pressure group compared to the non-measured intracranial pressure group regarding hospital mortality, 14-day mortality, or combined hospital and chronic care facility mortality. Survival up to 14 days was also similar between groups. Patients receiving intracranial pressure monitoring tend to have more severe traumatic brain injuries. However, after adjusting for multiple confounders using propensity scoring, no benefits in terms of survival were observed among intracranial pressure-monitored patients and those managed with a systematic clinical protocol.

A trial of retrofitted advisory collision avoidance technology in government fleet vehicles.

PubMed

Thompson, James P; Mackenzie, Jamie R R; Dutschke, Jeffrey K; Baldock, Matthew R J; Raftery, Simon J; Wall, John

2018-06-01

In-vehicle collision avoidance technology (CAT) has the potential to prevent crash involvement. In 2015, Transport for New South Wales undertook a trial of a Mobileye 560 CAT system that was installed in 34 government fleet vehicles for a period of seven months. The system provided headway monitoring, lane departure, forward collision and pedestrian collision warnings, using audio and visual alerts. The purpose of the trial was to determine whether the technology could change the driving behaviour of fleet vehicle drivers and improve their safety. The evaluation consisted of three components: (1) analysis of objective data to examine effects of the technology on driving behaviour, (2) analysis of video footage taken from a sample of the vehicles to examine driving circumstances that trigger headway monitoring and forward collision warnings, and (3) a survey completed by 122 of the 199 individuals who drove the trial vehicles to examine experiences with, and attitudes to, the technology. Analysis of the objective data found that the system resulted in changes in behaviour with increased headway and improved lane keeping, but that these improvements dissipated once the warning alerts were switched off. Therefore, the system is capable of altering behaviour but only when it is actively providing alerts. In-vehicle video footage revealed that over a quarter of forward collision warnings were false alarms, in which a warning event was triggered despite there being no vehicle travelling ahead. The surveyed drivers recognised that the system could improve safety but most did not wish to use it themselves as they found it to be distracting and felt that it would not prevent them from having a crash. The results demonstrate that collision avoidance technology can improve driving behaviour but drivers may need to be educated about the potential benefits for their driving in order to accept the technology. Copyright © 2018 Elsevier Ltd. All rights reserved.

A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT)

PubMed Central

Lall, Ranjit; Withers, Emma J; Finnegan, Susanne; Underwood, Martin; Hulme, Claire; Sheridan, Ray; Skelton, Dawn A; Martin, Finbarr; Lamb, Sarah E

2016-01-01

Introduction Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. Methods and analysis A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver ‘active’ interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to ‘active’ intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. Ethics and dissemination The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the recommended SPIRIT Checklist. Amendments will be reported to relevant regulatory parties. Trial registration number ISRCTN 71002650; Pre-results. PMID:26781504

Underreporting, crash severity and fault assignment of minor crashes in China - a study based on self-reported surveys.

PubMed

Yang, Hongtai; Cherry, Christopher R; Su, Fan; Ling, Ziwen; Pannell, Zane; Li, Yanlai; Fu, Zhijian

2018-05-25

Unreported minor crashes have importance as a surrogate for more serious crashes that require infrastructure, education, and enforcement strategies; and they still inflict damages. To study factors that influence underreporting, cause, and severity of minor crashes; a survey was performed in Kunming and Beijing to collect self-reported personal characteristics and crash history data of the three major urban road users in China: automobile drivers, bicycle riders and electric bike (e-bike) riders. Underreporting rates of automobile to automobile, automobile to non-motorized vehicle, and non-motorized vehicle to non-motorized vehicle crashes are 56%, 77% and 94%, respectively. Minor crashes with higher reported injury severity levels are more likely to be reported. E-bike riders without a driver's license are more likely to cause crashes. Licensing and education could be an effective way to reduce their crashes. The party that is not at fault in a crash is more likely to sustain high level of injury.

Selection of comparison crash types for quasi-induced exposure risk estimation.

PubMed

Keall, Michael; Newstead, Stuart

2009-03-01

The objective of this study was to find a comparison crash type that best represented exposure on the road and to identify situations where the induced exposure risk estimates were likely to be biased. Counts of crash involvements were compared with distance driven estimates derived from a register of licensed motor vehicles to identify the most appropriate comparison crash type for induced exposure estimation, which is the crash type whose counts are best correlated with vehicle distance driven. The best sets of comparison crashes for disaggregations by driver age and gender and vehicle type were found to be multi-vehicle crashes in which the vehicle was damaged in the rear or multi-vehicle crashes in which the driver was adjudged to be not at fault. Likely bias of induced exposure risk estimates was identified, even for these best sets of comparison crashes, according to vehicle size (with large vehicles underrepresented) and owner age and gender (with young owners and female owners overrepresented). This research identified some important features of crash occurrence useful for making choices of comparison crash types when controlling for exposure. None of the crash types considered as comparison crashes performed perfectly. Even the crash types that seemed to best reflect exposure on the road still appeared to over- or underestimate distance driven according to owner age group, gender, and vehicle size.

Death and injury in aerial spraying: pre-crash, crash, and post-crash prevention strategies.

PubMed

Richter, E D; Gordon, M; Halamish, M; Gribetz, B

1981-01-01

To prevent crash-related death and injury among spray pilots, a program including pre-crash, crash and post-crash stages of intervention for aircraft, physical environment, and pilots and ground crews was proposed in accordance with a matrix of options derived from road crash epidemiology. In addition to the dangers of fixed obstacles, low-altitude runs, and heavy work schedules, work hazards included combined exposures to noise, vibration, G forces, heat stress, pesticides, and dehydration. Together, these exposures were believed to have produced slight, but crucial decreases in pilot performance, alertness and skill. For aircraft, the major pre-crash measure was cockpit air cooling, with filter technologies to prevent in-flight pesticide exposure. Crash and post-crash design changes to reduce energy transfers to the pilot's body (thermal, kinetic) were the most important recommendations, because absolute prevention of the crash event was unlikely. For the environment, pre-crash recommendations included marking fixed obstacles, such as power and telephone lines, but preferably their elimination. Other measures included drainage pits with sodium hydroxide points to neutralize parathion and prevent dispersion of parathion-containing mists. Pilot pre-crash measures (more fluid intake, biological monitoring--EMG, urinary alkyl phosphate, cholinesterase testing) required special organizational arrangements. Systematic application of options from the foregoing matrix suggest that the high risk of death and injury from aerial spraying is unnecessary.

Traffic crash statistics report, 1998

DOT National Transportation Integrated Search

1999-01-01

The information contained in this Traffic Crash Facts booklet is extracted from law : enforcement agency long-form reports of traffic crashes. A law enforcement officer must submit a : long-form crash report when investigating: : Motor vehicle crashe...

Traffic crash statistics report, 1995

DOT National Transportation Integrated Search

1996-01-01

The information contained in this Traffic Crash Facts booklet is extracted from law enforcement : agency long-form reports of traffic crashes. A law enforcement officer must submit a long-form crash report : when investigating: : Motor vehicle crashe...

Traffic crash statistics report, 1996

DOT National Transportation Integrated Search

1997-11-01

The information contained in this Traffic Crash Facts booklet is extracted from law enforcement : agency long-form reports of traffic crashes. A law enforcement officer must submit a long-form crash report : when investigating: : Motor vehicle crashe...

Traffic crash statistics report, 1994

DOT National Transportation Integrated Search

1995-01-01

The information contained in this Traffic Crash Data booklet is extracted from law enforcement : agency long-form reports of traffic crashes. A law enforcement officer must submit a long-form crash report : when investigating: : Motor vehicle crashes...

Traffic crash statistics report, 2004

DOT National Transportation Integrated Search

2005-01-01

The information contained in this Traffic Crash Data booklet is extracted from law enforcement : agency long-form reports of traffic crashes. A law enforcement officer must submit a long-form crash report : when investigating: : Motor vehicle crashes...

Traffic crash statistics report, 1997

DOT National Transportation Integrated Search

1998-01-01

The information contained in this Traffic Crash Facts booklet is extracted from law enforcement agency : long-form reports of traffic crashes. A law enforcement officer must submit a long-form crash report when : investigating: : Motor vehicle crashe...

The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation.

PubMed

Lelijveld, Natasha; Bailey, Jeanette; Mayberry, Amy; Trenouth, Lani; N'Diaye, Dieynaba S; Haghparast-Bidgoli, Hassan; Puett, Chloe

2018-04-24

Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child's weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM. This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant. We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies. ISRCTN 30393230 , date: 16/03/2017.

Relating crash frequency and severity: evaluating the effectiveness of shoulder rumble strips on reducing fatal and major injury crashes.

PubMed

Wu, Kun-Feng; Donnell, Eric T; Aguero-Valverde, Jonathan

2014-06-01

To approach the goal of "Toward Zero Deaths," there is a need to develop an analysis paradigm to better understand the effects of a countermeasure on reducing the number of severe crashes. One of the goals in traffic safety research is to search for an effective treatment to reduce fatal and major injury crashes, referred to as severe crashes. To achieve this goal, the selection of promising countermeasures is of utmost importance, and relies on the effectiveness of candidate countermeasures in reducing severe crashes. Although it is important to precisely evaluate the effectiveness of candidate countermeasures in reducing the number of severe crashes at a site, the current state-of-the-practice often leads to biased estimates. While there have been a few advanced statistical models developed to mitigate the problem in practice, these models are computationally difficult to estimate because severe crashes are dispersed spatially and temporally, and cannot be integrated into the Highway Safety Manual framework, which develops a series of safety performance functions and crash modification factors to predict the number of crashes. Crash severity outcomes are generally integrated into the Highway Safety Manual using deterministic distributions rather than statistical models. Accounting for the variability in crash severity as a function geometric design, traffic flow, and other roadway and roadside features is afforded by estimating statistical models. Therefore, there is a need to develop a new analysis paradigm to resolve the limitations in the current Highway Safety Manual methods. We propose an approach which decomposes the severe crash frequency into a function of the change in the total number of crashes and the probability of a crash becoming a severe crash before and after a countermeasure is implemented. We tested this approach by evaluating the effectiveness of shoulder rumble strips on reducing the number of severe crashes. A total of 310 segments that have had shoulder rumble strips installed during 2002-2009 are included in the analysis. It was found that shoulder rumble strips reduce the total number of crashes, but have no statistically significant effect on reducing the probability of a severe crash outcome. Copyright © 2014 Elsevier Ltd. All rights reserved.

Crash risk factors for interstate large trucks in North Carolina.

PubMed

Teoh, Eric R; Carter, Daniel L; Smith, Sarah; McCartt, Anne T

2017-09-01

Provide an updated examination of risk factors for large truck involvements in crashes resulting in injury or death. A matched case-control study was conducted in North Carolina of large trucks operated by interstate carriers. Cases were defined as trucks involved in crashes resulting in fatal or non-fatal injury, and one control truck was matched on the basis of location, weekday, time of day, and truck type. The matched-pair odds ratio provided an estimate of the effect of various driver, vehicle, or carrier factors. Out-of-service (OOS) brake violations tripled the risk of crashing; any OOS vehicle defect increased crash risk by 362%. Higher historical crash rates (fatal, injury, or all crashes) of the carrier were associated with increased risk of crashing. Operating on a short-haul exemption increased crash risk by 383%. Antilock braking systems reduced crash risk by 65%. All of these results were statistically significant at the 95% confidence level. Other safety technologies also showed estimated benefits, although not statistically significant. With the exception of the finding that short-haul exemption is associated with increased crash risk, results largely bolster what is currently known about large truck crash risk and reinforce current enforcement practices. Results also suggest vehicle safety technologies can be important in lowering crash risk. This means that as safety technology continues to penetrate the fleet, whether from voluntary usage or government mandates, reductions in large truck crashes may be achieved. Practical application: Results imply that increased enforcement and use of crash avoidance technologies can improve the large truck crash problem. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Effect of Accounting for Crash Severity on the Relationship between Mass Reduction and Crash Frequency and Risk per Crash

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wenzel, Tom P.

2016-05-20

Previous analyses have indicated that mass reduction is associated with an increase in crash frequency (crashes per VMT), but a decrease in fatality or casualty risk once a crash has occurred, across all types of light-duty vehicles. These results are counter-intuitive: one would expect that lighter, and perhaps smaller, vehicles have better handling and shorter braking distances, and thus should be able to avoid crashes that heavier vehicles cannot. And one would expect that heavier vehicles would have lower risk once a crash has occurred than lighter vehicles. However, these trends occur under several alternative regression model specifications. This reportmore » tests whether these results continue to hold after accounting for crash severity, by excluding crashes that result in relatively minor damage to the vehicle(s) involved in the crash. Excluding non-severe crashes from the initial LBNL Phase 2 and simultaneous two-stage regression models for the most part has little effect on the unexpected relationships observed in the baseline regression models. This finding suggests that other subtle differences in vehicles and/or their drivers, or perhaps biases in the data reported in state crash databases, are causing the unexpected results from the regression models.« less

Indiana crash facts 1997

DOT National Transportation Integrated Search

1997-01-01

Indiana Crash Facts 1997...is the fifth annual publication : of Indiana Crash Facts. This year significant changes have been made : to the book, including the consolidation of the Alcohol Crash Facts and : the Crash Facts book into one publication. A...

Indiana crash facts 1996

DOT National Transportation Integrated Search

1996-01-01

According to Indiana State Police Crash Reports, : 221,465 traffic crashes were reported in Indiana : during 1996 (Table 1). Of these, 870 were fatal : crashes in which 982 people died. There were an : additional 52,058 personal injury crashes and a ...

The trend of road traffic crashes at urban signalised intersection

NASA Astrophysics Data System (ADS)

Farhana Nasarrudin, Nurul; Razelan, Intan Suhana Mohd

2018-04-01

Road traffic crash is one of the main contributing factors for deaths in the world. Intersection is listed as the second road type which road crashes occurred frequently. Hence, the traffic light was installed to minimise the road crashes at intersection. However, the crashes are still occurring and arising. The objective of this study was to exhibit the trend of road crashes at the signalised intersections. The data of road crashes for the past 6 years were analysed using descriptive analysis. The results showed that the road traffic crashes at three- and four-legged signalised intersection recorded the increasing trend. In conclusion, this finding shows that the road traffic crashes for these types of signalised intersection in Malaysia is rising. It is also one the contributors to the increasing number of crashes in Malaysia. This finding will encourage the local authority to conduct awareness programs on the safety at the signalised intersection.

Effects of blind spot monitoring systems on police-reported lane-change crashes.

PubMed

Cicchino, Jessica B

2018-06-21

To examine the effectiveness of blind spot monitoring systems in preventing police-reported lane-change crashes. Poisson regression was used to compare crash involvement rates per insured vehicle year in police-reported lane-change crashes in 26 U.S. states during 2009-2015 between vehicles with blind spot monitoring and the same vehicle models without the optional system, controlling for other factors that can affect crash risk. Crash involvement rates in lane-change crashes were 14% lower (95% confidence limits -24% to -2%) among vehicles with blind spot monitoring than those without. Blind spot monitoring systems are effective in preventing police-reported lane-change crashes when considering crashes of all severities. If every U.S. vehicle in 2015 were equipped with blind spot monitoring that performed like the study systems, it is estimated that about 50,000 crashes could have been prevented.

Identifying work-related motor vehicle crashes in multiple databases.

PubMed

Thomas, Andrea M; Thygerson, Steven M; Merrill, Ray M; Cook, Lawrence J

2012-01-01

To compare and estimate the magnitude of work-related motor vehicle crashes in Utah using 2 probabilistically linked statewide databases. Data from 2006 and 2007 motor vehicle crash and hospital databases were joined through probabilistic linkage. Summary statistics and capture-recapture were used to describe occupants injured in work-related motor vehicle crashes and estimate the size of this population. There were 1597 occupants in the motor vehicle crash database and 1673 patients in the hospital database identified as being in a work-related motor vehicle crash. We identified 1443 occupants with at least one record from either the motor vehicle crash or hospital database indicating work-relatedness that linked to any record in the opposing database. We found that 38.7 percent of occupants injured in work-related motor vehicle crashes identified in the motor vehicle crash database did not have a primary payer code of workers' compensation in the hospital database and 40.0 percent of patients injured in work-related motor vehicle crashes identified in the hospital database did not meet our definition of a work-related motor vehicle crash in the motor vehicle crash database. Depending on how occupants injured in work-related motor crashes are identified, we estimate the population to be between 1852 and 8492 in Utah for the years 2006 and 2007. Research on single databases may lead to biased interpretations of work-related motor vehicle crashes. Combining 2 population based databases may still result in an underestimate of the magnitude of work-related motor vehicle crashes. Improved coding of work-related incidents is needed in current databases.

Difference between car-to-cyclist crash and near crash in a perpendicular crash configuration based on driving recorder analysis.

PubMed

Ito, Daisuke; Hayakawa, Kosei; Kondo, Yuma; Mizuno, Koji; Thomson, Robert; Piccinini, Giulio Bianchi; Hosokawa, Naruyuki

2018-08-01

Analyzing a crash using driving recorder data makes it possible to objectively examine factors contributing to the occurrence of the crash. In this study, car-to-cyclist crashes and near crashes recorded on cars equipped with advanced driving recorders were compared with each other in order to examine the factors that differentiate near crashes from crashes, as well as identify the causes of the crashes. Focusing on cases where the car and cyclist approached each other perpendicularly, the differences in the car's and cyclist's parameters such as velocity, distance and avoidance behavior were analyzed. The results show that car-to-cyclist crashes would not be avoidable when the car approaching the cyclist enters an area where the average deceleration required to stop the car is more than 0.45 G (4.4 m/s 2 ). In order for this situation to occur, there are two types of cyclist crash scenarios. In the first scenario, the delay in the drivers' reaction in activating the brakes is the main factor responsible for the crash. In this scenario, time-to-collision when the cyclist first appears in the video is more than 2.0 s. In the second scenario, the sudden appearance of a cyclist from behind an obstacle on the street is the factor responsible for the crash. In this case, the time-to-collision is less than 1.2 s, and the crash cannot be avoided even if the driver exhibited avoidance maneuvers. Copyright © 2018 Elsevier Ltd. All rights reserved.

Risk and type of crash among young drivers by rurality of residence: findings from the DRIVE Study.

PubMed

Chen, H Y; Ivers, R Q; Martiniuk, A L C; Boufous, S; Senserrick, T; Woodward, M; Stevenson, M; Williamson, A; Norton, R

2009-07-01

Most previous literature on urban/rural differences in road crashes has a primary focus on severe injuries or deaths, which may be largely explained by variations of medical resources. Little has been reported on police-reported crashes by geographical location, or crash type and severity, especially among young drivers. DRIVE is a prospective cohort study of 20,822 drivers aged 17-24 in NSW, Australia. Information on risk factors was collected via online questionnaire and subsequently linked to police-reported crashes. Poisson regression was used to analyse risk of various crash types by three levels of rurality of residence: urban, regional (country towns and surrounds) and rural. Compared to urban drivers, risk of crash decreased with increasing rurality (regional adjusted RR: 0.7, 95% CI 0.6-0.9; rural adjusted RR: 0.5, 95% CI 0.3-0.7). Among those who crashed, risk of injurious crash did not differ by geographic location; however, regional and rural drivers had significantly higher risk of a single versus multiple vehicle crash (regional adjusted RR 1.8, 95% CI 1.3-2.5; rural adjusted RR: 2.0, 95% CI 1.1-3.6), which was explained by speeding involvement and road alignment at the time or site of crash. Although young urban drivers have a higher crash risk overall, rural and regional residents have increased risk of a single vehicle crash. Interventions to reduce single vehicle crashes should aim to address key issues affecting such crashes, including speeding and specific aspects of road geometry.

Results of the Australasian (Trans-Tasman Oncology Group) radiotherapy benchmarking exercise in preparation for participation in the PORTEC-3 trial.

PubMed

Jameson, Michael G; McNamara, Jo; Bailey, Michael; Metcalfe, Peter E; Holloway, Lois C; Foo, Kerwyn; Do, Viet; Mileshkin, Linda; Creutzberg, Carien L; Khaw, Pearly

2016-08-01

Protocol deviations in Randomised Controlled Trials have been found to result in a significant decrease in survival and local control. In some cases, the magnitude of the detrimental effect can be larger than the anticipated benefits of the interventions involved. The implementation of appropriate quality assurance of radiotherapy measures for clinical trials has been found to result in fewer deviations from protocol. This paper reports on a benchmarking study conducted in preparation for the PORTEC-3 trial in Australasia. A benchmarking CT dataset was sent to each of the Australasian investigators, it was requested they contour and plan the case according to trial protocol using local treatment planning systems. These data was then sent back to Trans-Tasman Oncology Group for collation and analysis. Thirty three investigators from eighteen institutions across Australia and New Zealand took part in the study. The mean clinical target volume (CTV) volume was 383.4 (228.5-497.8) cm(3) and the mean dose to a reference gold standard CTV was 48.8 (46.4-50.3) Gy. Although there were some large differences in the contouring of the CTV and its constituent parts, these did not translate into large variations in dosimetry. Where individual investigators had deviations from the trial contouring protocol, feedback was provided. The results of this study will be used to compare with the international study QA for the PORTEC-3 trial. © 2016 The Royal Australian and New Zealand College of Radiologists.

Target crashes and safety benefits estimation methodology for pedestrian crash avoidance/mitigation systems

DOT National Transportation Integrated Search

2014-04-01

Through the analysis of national crash databases from the National Highway Traffic Safety Administration, pre-crash scenarios are identified, prioritized, and described for the development of objective tests for pedestrian crash avoidance/mitigation ...

The Stock Market Crashes of 1929 and 1987: Linking History and Personal Finance Education

ERIC Educational Resources Information Center

Lopus, Jane S.

2005-01-01

This article discusses two twentieth-century stock market crashes: the crash of 1929 and the crash of 1987. When this material is presented to students, they see important parallels between the two historical events. But despite remarkable similarities in the severity and many other aspects of the two crashes, the crash of 1929 was followed by the…

Changes in fatal and nonfatal crash rates on a toll highway.

PubMed

Doege, T C; Levy, P S

1976-02-01

Rates of crashes, crashes with injuries, and crashes with fatalities were lower during the 6 months of March 1-August 31, 1974, following a 5-15 mph (8-24 kph) decrease in speed limits on the Illinois Tollway, than the corresponding rates for any of the 6 preceding years, 1968-1973. During the same months of 1968-1974, rates of crashes and of crashes with injuries showed peaks without consistent trends, but rates and percentages of fatal crashes decreased. The data agree with the hypothesis that reducing speed limits on toll roads may lead to substantial reductions in rate of crashes and injuries.

The effect of crash experience on changes in risk taking among urban and rural young people.

PubMed

Lin, Mau-Roung; Huang, Wenzheng; Hwang, Hei-Fen; Wu, Hong-Dar Isaac; Yen, Lee-Lan

2004-03-01

A 20-month prospective study was conducted to investigate the effect of motorcycle crash experience on changes in risk taking among 2514 urban and 2304 rural students in Taiwan. Risk taking was assessed using a 14-item self-administered questionnaire at the beginning and end of the study. A risk-taking score for each student at the initial and the last follow-up assessments was generated from adding up points across all 14 items. For exposure variables, the study documented past motorcycle crash history at the initial assessment and collected detailed information about any motorcycle crash involvement that occurred during the study period. A general linear mixed model was applied to assess the effects of prior and recent crash involvements on the path of risk-taking behavior. The results show that at the initial assessment, students with crash experience had higher risk-taking levels than those without crash experience. However, crash experience, irregardless of whether it was measured in terms of crash history prior to the study, crash frequency, time elapsed since the last crash, or crash severity, did not significantly change the risk-taking path among students, even though its effect differed between urban and rural areas.

Traffic environment and demographic factors affecting impaired driving and crashes

PubMed Central

Romano, Eduardo O.; Peck, Raymond C.; Voas, Robert B.

2012-01-01

Introduction Data availability has forced researchers to examine separately the role of alcohol among drivers who crashed and drivers who did not crash. Such a separation fails to account fully for the transition from impaired driving to an alcohol-related crash. Method In this study, we analyzed recent data to investigate how traffic-related environments, conditions, and drivers’ demographics shape the likelihood of a driver being either involved in a crash (alcohol impaired or not) or not involved in a crash (alcohol impaired or not). Our data, from a recent case–control study, included a comprehensive sampling of the drivers in nonfatal crashes and a matched set of comparison drivers in two U.S. locations. Multinomial logistic regression was applied to investigate the likelihood that a driver would crash or would not crash, either with a blood alcohol concentration (BAC)=.00 or with a BAC≥.05. Conclusions To our knowledge, this study is the first to examine how different driver characteristics and environmental factors simultaneously contribute to alcohol use by crash-involved and non-crash-involved drivers. This effort calls attention to the need for research on the simultaneous roles played by all the factors that may contribute to motor vehicle crashes. PMID:22385743

Reporting on cyclist crashes in Australian newspapers.

PubMed

Boufous, Soufiane; Aboss, Ahmad; Montgomery, Victoria

2016-10-01

To assess information on cyclist crashes reported in Australian newspapers. The Factiva news archive was searched for articles on cyclist crashes published in major Australian newspapers between 2010 and 2013. Information on the circumstances of cyclist crashes were extracted and coded. A total of 160 cyclist crashes were covered by 198 newspaper articles, with 44% of crashes resulting in cyclist fatalities. Crashes reported by more than one newspaper were more likely to involve public figures or protracted court cases. Individual characteristics of cyclists as well as the location of the crash were reported for more than 80% of crashes. The road user at fault was reported for more than half of crashes. In contrast, information on helmet use, alcohol and cycling lanes was mentioned for only about 10% of crashes. Fewer than one in five articles mentioned prevention strategies including education campaigns, legislative and infrastructure changes. Australian newspapers tend to focus on the most dramatic and more 'newsworthy' aspects of cyclist crashes. Cycling advocates need to work with journalists to improve the quality of this coverage. Better communication between cycling advocates and journalists is likely to have a positive impact on the safety and the uptake of cycling in the community. © 2016 Public Health Association of Australia.

Head-on crashes on two-way interurban roads: a public health concern in road safety.

PubMed

Olabarria, Marta; Santamariña-Rubio, Elena; Marí-Dell'Olmo, Marc; Gotsens, Mercè; Novoa, Ana M; Borrell, Carme; Pérez, Katherine

2015-09-01

To describe the magnitude and characteristics of crashes and drivers involved in head-on crashes on two-way interurban roads in Spain between 2007 and 2012, and to identify the factors associated with the likelihood of head-on crashes on these roads compared with other types of crash. A cross-sectional study was conducted using the National Crash Register. The dependent variables were head-on crashes with injury (yes/no) and drivers involved in head-on crashes (yes/no). Factors associated with head-on crashes and with being a driver involved in a head-on crash versus other types of crash were studied using a multivariate robust Poisson regression model to estimate proportion ratios (PR) and confidence intervals (95% CI). There were 9,192 head-on crashes on two-way Spanish interurban roads. A total of 15,412 men and 3,862 women drivers were involved. Compared with other types of crash, head-on collisions were more likely on roads 7 m or more wide, on road sections with curves, narrowings or drop changes, on wet or snowy surfaces, and in twilight conditions. Transgressions committed by drivers involved in head-on crashes were driving in the opposite direction and incorrectly overtaking another vehicle. Factors associated with a lower probability of head-on crashes were the existence of medians (PR=0.57; 95%CI: 0.48-0.68) and a paved shoulder of less than 1.5 meters (PR=0.81; 95%CI: 0.77-0.86) or from 1.5 to 2.45 meters (PR=0.90; 95%CI: 0.84-0.96). This study allowed the characterization of crashes and drivers involved in head-on crashes on two-way interurban roads. The lower probability observed on roads with median strips point to these measures as an effective way to reduce these collisions. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

Exploring the effects of roadway characteristics on the frequency and severity of head-on crashes: case studies from Malaysian federal roads.

PubMed

Hosseinpour, Mehdi; Yahaya, Ahmad Shukri; Sadullah, Ahmad Farhan

2014-01-01

Head-on crashes are among the most severe collision types and of great concern to road safety authorities. Therefore, it justifies more efforts to reduce both the frequency and severity of this collision type. To this end, it is necessary to first identify factors associating with the crash occurrence. This can be done by developing crash prediction models that relate crash outcomes to a set of contributing factors. This study intends to identify the factors affecting both the frequency and severity of head-on crashes that occurred on 448 segments of five federal roads in Malaysia. Data on road characteristics and crash history were collected on the study segments during a 4-year period between 2007 and 2010. The frequency of head-on crashes were fitted by developing and comparing seven count-data models including Poisson, standard negative binomial (NB), random-effect negative binomial, hurdle Poisson, hurdle negative binomial, zero-inflated Poisson, and zero-inflated negative binomial models. To model crash severity, a random-effect generalized ordered probit model (REGOPM) was used given a head-on crash had occurred. With respect to the crash frequency, the random-effect negative binomial (RENB) model was found to outperform the other models according to goodness of fit measures. Based on the results of the model, the variables horizontal curvature, terrain type, heavy-vehicle traffic, and access points were found to be positively related to the frequency of head-on crashes, while posted speed limit and shoulder width decreased the crash frequency. With regard to the crash severity, the results of REGOPM showed that horizontal curvature, paved shoulder width, terrain type, and side friction were associated with more severe crashes, whereas land use, access points, and presence of median reduced the probability of severe crashes. Based on the results of this study, some potential countermeasures were proposed to minimize the risk of head-on crashes. Copyright © 2013 Elsevier Ltd. All rights reserved.

Evaluating and improving recruitment and retention in an mHealth clinical trial: an example of iterating methods during a trial.

PubMed

Pfammatter, Angela Fidler; Mitsos, Alexa; Wang, Shirlene; Hood, Susan Hammett; Spring, Bonnie

2017-01-01

Recruitment and retention strategy investigations in mHealth clinical trials are rare. Technology presents an opportunity to intensely and remotely evaluate recruitment, use of mobile apps, and retention, leading to new insights for continuous improvement of mHealth trials. The objective of this paper is to present a case study in which a trial evaluated and changed strategies during a clinical trial to improve recruitment, adherence to study protocols, and retention in the mHealth trial. In Fall 2015, the NUYou trial enrolled 150 college freshmen in an mHealth protocol. Three months after study initiation, NUYou struggled to meet recruitment goals and maintain anticipated usage levels of the study smartphone application. Two sets of data were collected to improve recruitment and retention: a survey about recruitment was sent to the target population and surveys regarding usability of the app was sent to the study sample. Survey results informed improvements in recruitment strategies, the study retention protocol, and the smartphone application. Survey results revealed several insights including misunderstanding components of the trial by potential participants, low perceived usefulness of the app, and little recall or impact of the incentive structure. After implementation of user-centered improvements, the second cohort of NUYou recruitment in the fall of 2016 produced an equal sample size in 4 weeks less time. Winter quarter of 2016 compared to 2017 demonstrated an improvement in retention via app use and completion of weekly in-app surveys. Recruitment and retention in clinical trials continues to be a critical challenge and mHealth trials may present both unique challenges and opportunities. To our knowledge, this is the first study to describe a systematic evaluation followed by changes and further evaluation to recruitment, use of the mHealth application, adherence to study protocol, and retention during an mHealth clinical trial. Future work should adopt and explicitly study these processes to optimize both enrollment and retention in these types of trials to preserve validity and reliability of research results.

Evolution of practice during the Interventional Management of Stroke III Trial and implications for ongoing trials.

PubMed

Broderick, Joseph P; Palesch, Yuko Y; Demchuk, Andrew M; Yeatts, Sharon D; Khatri, Pooja; Hill, Michael D; Jauch, Edward C; Jovin, Tudor G; Yan, Bernard; von Kummer, Rüdiger; Molina, Carlos A; Goyal, Mayank; Mazighi, Mikael; Schonewille, Wouter J; Engelter, Stefan T; Anderson, Craig; Spilker, Judith; Carrozzella, Janice; Janis, L Scott; Foster, Lydia D; Tomsick, Thomas A

2014-12-01

We explored changes in the patient population and practice of endovascular therapy during the course of the Interventional Management of Stroke (IMS) III Trial. Changes in baseline characteristics, use of baseline CT angiography, treatment times and specifics, and outcomes were compared between the first 4 protocols and the fifth and final protocol. Compared with subjects treated in the first 4 protocol versions (n=610), subjects treated in fifth and final protocol (n=46) were older (75 versus 68 years, P<0.0002) and less likely to have a pretreatment Rankin of 0 (76% versus 89%, P=0.01), were more likely to have a pretreatment CT angiography (65% versus 45%, P=0.009), had quicker median times in the endovascular arm from onset to start of intra-arterial therapy (209 versus 250 minutes, P=0.002) and to reperfusion (269 versus 344 minutes, P<0.0001), had a higher mean dose of total tissue-type plasminogen activator in the endovascular arm (74.0 versus 63.7 mg, P<0.0001), and were less likely to receive intra-arterial tissue-type plasminogen activator as part of the endovascular procedure (16% versus 44%, P=0.015). There were no significant differences in functional and safety outcomes between subjects treated in the 2 treatments arms in either the first 4 protocols or fifth protocol although the small sample size in the fifth protocol provided limited power. Endovascular technology and diagnostic approaches to acute stroke patients changed substantially during the IMS III Trial. Efforts to decrease the time to delivery of endovascular therapy were successful. © 2014 American Heart Association, Inc.

Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial

PubMed Central

Wall, Peter DH; Dickenson, Edward J; Robinson, David; Hughes, Ivor; Realpe, Alba; Hobson, Rachel; Griffin, Damian R; Foster, Nadine E

2016-01-01

Introduction Femoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility. Methods In phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events. Results The final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12–26 weeks in 6–10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6 weeks, but there were no serious adverse events. Conclusion PHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839). Trial registration number ISRCTN 09754699. PMID:27629405

Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Driscoll, B.; Keller, H.; Jaffray, D.

2013-08-15

Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producingmore » predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) as well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from the expected phantom result when scanning at low mAs and low kVp in terms of quantitative metrics (Injected Mass Error 15.4%), goodness of fit (R{sup 2}) of 0.91, and ROI sensitivity (increase in minimum input function ROI radius by 146 ± 86%). These tests also confirmed that the ASIR reconstruction process was beneficial in reducing noise without substantially increasing partial volume effects and that vendor specific modes (e.g., axial shuttle) did not significantly affect the phantom results. The phantom and QA protocol were finally able to quickly (<90 min) and successfully validate the DCE-CT imaging protocol utilized at the three separate institutions of a multicenter clinical trial; thereby enhancing the confidence in the patient data collected.Conclusions: A DCE QA protocol was developed that, in combination with a dynamic multimodality flow phantom, allows the intrascanner variability to be separated from other sources of variability such as the impact of injection protocol and ROI selection. This provides a valuable resource that can be utilized at various clinical trial institutions to test conformance with imaging protocols and accuracy requirements as well as ensure that the scanners are performing as expected for dynamic scans.« less

Reductions in injury crashes associated with red light camera enforcement in oxnard, california.

PubMed

Retting, Richard A; Kyrychenko, Sergey Y

2002-11-01

This study estimated the impact of red light camera enforcement on motor vehicle crashes in one of the first US communities to employ such cameras-Oxnard, California. Crash data were analyzed for Oxnard and for 3 comparison cities. Changes in crash frequencies were compared for Oxnard and control cities and for signalized and nonsignalized intersections by means of a generalized linear regression model. Overall, crashes at signalized intersections throughout Oxnard were reduced by 7% and injury crashes were reduced by 29%. Right-angle crashes, those most associated with red light violations, were reduced by 32%; right-angle crashes involving injuries were reduced by 68%. Because red light cameras can be a permanent component of the transportation infrastructure, crash reductions attributed to camera enforcement should be sustainable.

Injury Risk Functions in Frontal Impacts Using Data from Crash Pulse Recorders

PubMed Central

Stigson, Helena; Kullgren, Anders; Rosén, Erik

2012-01-01

Knowledge of how crash severity influences injury risk in car crashes is essential in order to create a safe road transport system. Analyses of real-world crashes increase the ability to obtain such knowledge. The aim of this study was to present injury risk functions based on real-world frontal crashes where crash severity was measured with on-board crash pulse recorders. Results from 489 frontal car crashes (26 models of four car makes) with recorded acceleration-time history were analysed. Injury risk functions for restrained front seat occupants were generated for maximum AIS value of two or greater (MAIS2+) using multiple logistic regression. Analytical as well as empirical injury risk was plotted for several crash severity parameters; change of velocity, mean acceleration and peak acceleration. In addition to crash severity, the influence of occupant age and gender was investigated. A strong dependence between injury risk and crash severity was found. The risk curves reflect that small changes in crash severity may have a considerable influence on the risk of injury. Mean acceleration, followed by change of velocity, was found to be the single variable that best explained the risk of being injured (MAIS2+) in a crash. Furthermore, all three crash severity parameters were found to predict injury better than age and gender. However, age was an important factor. The very best model describing MAIS2+ injury risk included delta V supplemented by an interaction term of peak acceleration and age. PMID:23169136

Selecting exposure measures in crash rate prediction for two-lane highway segments.

PubMed

Qin, Xiao; Ivan, John N; Ravishanker, Nalini

2004-03-01

A critical part of any risk assessment is identifying how to represent exposure to the risk involved. Recent research shows that the relationship between crash count and traffic volume is non-linear; consequently, a simple crash rate computed as the ratio of crash count to volume is not proper for comparing the safety of sites with different traffic volumes. To solve this problem, we describe a new approach for relating traffic volume and crash incidence. Specifically, we disaggregate crashes into four types: (1) single-vehicle, (2) multi-vehicle same direction, (3) multi-vehicle opposite direction, and (4) multi-vehicle intersecting, and define candidate exposure measures for each that we hypothesize will be linear with respect to each crash type. This paper describes initial investigation using crash and physical characteristics data for highway segments in Michigan from the Highway Safety Information System (HSIS). We use zero-inflated-Poisson (ZIP) modeling to estimate models for predicting counts for each of the above crash types as a function of the daily volume, segment length, speed limit and roadway width. We found that the relationship between crashes and the daily volume (AADT) is non-linear and varies by crash type, and is significantly different from the relationship between crashes and segment length for all crash types. Our research will provide information to improve accuracy of crash predictions and, thus, facilitate more meaningful comparison of the safety record of seemingly similar highway locations.

Intersection crash prediction modeling with macro-level data from various geographic units.

PubMed

Lee, Jaeyoung; Abdel-Aty, Mohamed; Cai, Qing

2017-05-01

There have been great efforts to develop traffic crash prediction models for various types of facilities. The crash models have played a key role to identify crash hotspots and evaluate safety countermeasures. In recent, many macro-level crash prediction models have been developed to incorporate highway safety considerations in the long-term transportation planning process. Although the numerous macro-level studies have found that a variety of demographic and socioeconomic zonal characteristics have substantial effects on traffic safety, few studies have attempted to coalesce micro-level with macro-level data from existing geographic units for estimating crash models. In this study, the authors have developed a series of intersection crash models for total, severe, pedestrian, and bicycle crashes with macro-level data for seven spatial units. The study revealed that the total, severe, and bicycle crash models with ZIP-code tabulation area data performs the best, and the pedestrian crash models with census tract-based data outperforms the competing models. Furthermore, it was uncovered that intersection crash models can be drastically improved by only including random-effects for macro-level entities. Besides, the intersection crash models are even further enhanced by including other macro-level variables. Lastly, the pedestrian and bicycle crash modeling results imply that several macro-level variables (e.g., population density, proportions of specific age group, commuters who walk, or commuters using bicycle, etc.) can be a good surrogate exposure for those crashes. Copyright © 2017 Elsevier Ltd. All rights reserved.

An evaluation of the real-world safety effect of a lane change driver support system and characteristics of lane change crashes based on insurance claims data.

PubMed

Isaksson-Hellman, Irene; Lindman, Magdalena

2018-02-28

Lane changes, which frequently occur when vehicles travel on major roads, may contribute to critical situations that significantly affect the traffic flow and traffic safety. Thus, knowledge of lane change situations is important for infrastructure improvements as well as for driver support systems and automated driving development projects. The objectives of this study were to evaluate the crash avoidance performance of a lane change driver support system, the Blind Spot Information System (BLIS) in Volvo car models, and to describe the characteristics of lane change crashes by analyzing detailed information from insurance claim reports. An overall evaluation of the safety effect of BLIS was performed by analyzing crash rate differences in lane change situations for cars with and without the optionally mounted BLIS system based on a population of 380,000 insured vehicle years. Further, crashes in which the repair cost of the host vehicle exceeded approximately US$1,250 were selected and compared. Finally, the study examined different precrash factors and crash configurations, using in-depth insurance claims data from representative lane change crash cases including all severity levels in a population of more than 200,000 insured vehicle years. The technology did not significantly reduce the overall number of crashes when all types of lane change crashes and severity levels were considered, though a significant crash-reducing effect of 31% for BLIS cars was found when more severe crashes with a repair cost exceeding US$1,250 were analysed. Cars with the BLIS technology also have a 30% lower claim cost on average for reported lane change crashes, indicating reduced crash severity. When stratifying the data into specific situations, by collecting precrash information in a case-by-case study, the influence of BLIS was indicated to differ for the evaluated situations, although no significant results were found. For example, during general lane change maneuvers (i.e., not while exiting or entering highways or during weaving/merging situations) the crash rate was reduced by 14%, whereas in weaving/merging situations the crash rate increased. The insurance data analyzed provided useful information about real-world lane change crash characteristics by covering collisions in all crash severities and thus revealed information beyond what is available in, for example, data sets of police-reported crashes. This will guide further development of driver support systems. For crashes with repair cost exceeding US$1,250, a significant crash reduction was found, although the technology did not significantly reduce the total number of lane change crashes. An average lower insurance claim cost for cars equipped with the BLIS technology also indicated that the technology contributes to reduced crash severity even if crashes were not totally avoided. Stratifying the data into different lane change crash situations gave indications of the condition-specific performance of the system, even if the results were not statistically significant at the 95% level.

Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

PubMed

Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

2016-08-01

Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers stated that "all adverse events were recorded." For one trial, we identified an additional 1,318 adverse events that were not listed or mentioned in the CSR itself but could be identified through manually counting individual adverse events reported in an appendix. We discovered that the majority of patients had multiple episodes of the same adverse event that were only counted once, though this was not described in the CSRs. We also discovered that participants treated with orlistat experienced twice as many days with adverse events as participants treated with placebo (22.7 d versus 14.9 d, p-value < 0.0001, Student's t test). Furthermore, compared with the placebo group, adverse events in the orlistat group were more severe. None of this was stated in the CSR or in the published paper. Our analysis was restricted to one drug tested in the mid-1990s; our results might therefore not be applicable for newer drugs. In the orlistat trials, we identified important disparities in the reporting of adverse events between protocols, clinical study reports, and published papers. Reports of these trials seemed to have systematically understated adverse events. Based on these findings, systematic reviews of drugs might be improved by including protocols and CSRs in addition to published articles.

Analysis of injury severity of drivers involved in single- and two-vehicle crashes on highways in Ontario.

PubMed

Lee, Chris; Li, Xuancheng

2014-10-01

This study analyzes driver's injury severity in single- and two-vehicle crashes and compares the effects of explanatory variables among various types of crashes. The study identified factors affecting injury severity and their effects on severity levels using 5-year crash records for provincial highways in Ontario, Canada. Considering heteroscedasticity in the effects of explanatory variables on injury severity, the heteroscedastic ordered logit (HOL) models were developed for single- and two-vehicle crashes separately. The results of the models show that there exists heteroscedasticity for young drivers (≤30), safety equipment and ejection in the single-vehicle crash model, and female drivers, safety equipment and head-on collision in the two-vehicle crash models. The results also show that young car drivers have opposite effects between single-car and car-car crashes, and sideswipe crashes have opposite effects between car-car and truck-truck crashes. The study demonstrates that separate HOL models for single-vehicle and different types of two-vehicle crashes can identify differential effects of factors on driver's injury severity. Copyright © 2014 Elsevier Ltd. All rights reserved.

Rationale, Timeline, Study Design, and Protocol Overview of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials

PubMed Central

Moler, Frank W.; Silverstein, Faye S.; Meert, Kathleen L.; Clark, Amy E.; Holubkov, Richard; Browning, Brittan; Slomine, Beth S.; Christensen, James R.; Dean, Michael

2014-01-01

Objective To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Design Multicenter randomized controlled trials. Setting Pediatric intensive care and cardiac ICUs in the United States and Canada. Patients Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Interventions Therapeutic hypothermia or therapeutic normothermia. Measurements and Main Results From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Conclusions Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials. PMID:23842585

The Effect of Alcohol and Road Traffic Policies on Crash Rates in Botswana, 2004–2011: A Time-Series Analysis

PubMed Central

Sebego, Miriam; Naumann, Rebecca B.; Rudd, Rose A.; Voetsch, Karen; Dellinger, Ann M.; Ndlovu, Christopher

2015-01-01

In Botswana, increased development and motorization have brought increased road traffic-related death rates. Between 1981 and 2001, the road traffic-related death rate in Botswana more than tripled. The country has taken several steps over the last several years to address the growing burden of road traffic crashes and particularly to address the burden of alcohol-related crashes. This study examines the impact of the implementation of alcohol and road safety-related policies on crash rates, including overall crash rates, fatal crash rates, and single-vehicle nighttime fatal (SVNF) crash rates, in Botswana from 2004 to 2011. The overall crash rate declined significantly in June 2009 and June 2010, such that the overall crash rate from June 2010 to December 2011 was 22% lower than the overall crash rate from January 2004 to May 2009. Additionally, there were significant declines in average fatal crash and SVNF crash rates in early 2010. Botswana’s recent crash rate reductions occurred during a time when aggressive policies and other activities (e.g., education, enforcement) were implemented to reduce alcohol consumption and improve road safety. While it is unclear which of the policies or activities contributed to these declines and to what extent, these reductions are likely the result of several, combined efforts. PMID:24686164

The impact of alcohol and road traffic policies on crash rates in Botswana, 2004-2011: a time-series analysis.

PubMed

Sebego, Miriam; Naumann, Rebecca B; Rudd, Rose A; Voetsch, Karen; Dellinger, Ann M; Ndlovu, Christopher

2014-09-01

In Botswana, increased development and motorization have brought increased road traffic-related death rates. Between 1981 and 2001, the road traffic-related death rate in Botswana more than tripled. The country has taken several steps over the last several years to address the growing burden of road traffic crashes and particularly to address the burden of alcohol-related crashes. This study examines the impact of the implementation of alcohol and road safety-related policies on crash rates, including overall crash rates, fatal crash rates, and single-vehicle nighttime fatal (SVNF) crash rates, in Botswana from 2004 to 2011. The overall crash rate declined significantly in June 2009 and June 2010, such that the overall crash rate from June 2010 to December 2011 was 22% lower than the overall crash rate from January 2004 to May 2009. Additionally, there were significant declines in average fatal crash and SVNF crash rates in early 2010. Botswana's recent crash rate reductions occurred during a time when aggressive policies and other activities (e.g., education, enforcement) were implemented to reduce alcohol consumption and improve road safety. While it is unclear which of the policies or activities contributed to these declines and to what extent, these reductions are likely the result of several, combined efforts. Copyright © 2014 Elsevier Ltd. All rights reserved.

Predicting motorcycle crash injury severity using weather data and alternative Bayesian multivariate crash frequency models.

PubMed

Cheng, Wen; Gill, Gurdiljot Singh; Sakrani, Taha; Dasu, Mohan; Zhou, Jiao

2017-11-01

Motorcycle crashes constitute a very high proportion of the overall motor vehicle fatalities in the United States, and many studies have examined the influential factors under various conditions. However, research on the impact of weather conditions on the motorcycle crash severity is not well documented. In this study, we examined the impact of weather conditions on motorcycle crash injuries at four different severity levels using San Francisco motorcycle crash injury data. Five models were developed using Full Bayesian formulation accounting for different correlations commonly seen in crash data and then compared for fitness and performance. Results indicate that the models with serial and severity variations of parameters had superior fit, and the capability of accurate crash prediction. The inferences from the parameter estimates from the five models were: an increase in the air temperature reduced the possibility of a fatal crash but had a reverse impact on crashes of other severity levels; humidity in air was not observed to have a predictable or strong impact on crashes; the occurrence of rainfall decreased the possibility of crashes for all severity levels. Transportation agencies might benefit from the research results to improve road safety by providing motorcyclists with information regarding the risk of certain crash severity levels for special weather conditions. Copyright © 2017 Elsevier Ltd. All rights reserved.

Impact of roadway geometric features on crash severity on rural two-lane highways.

PubMed

Haghighi, Nima; Liu, Xiaoyue Cathy; Zhang, Guohui; Porter, Richard J

2018-02-01

This study examines the impact of a wide range of roadway geometric features on the severity outcomes of crashes occurred on rural two-lane highways. We argue that crash data have a hierarchical structure which needs to be addressed in modeling procedure. Moreover, most of previous studies ignored the impact of geometric features on crash types when developing crash severity models. We hypothesis that geometric features are more likely to determine crash type, and crash type together with other occupant, environmental and vehicle characteristics determine crash severity outcome. This paper presents an application of multilevel models to successfully capture both hierarchical structure of crash data and indirect impact of geometric features on crash severity. Using data collected in Illinois from 2007 to 2009, multilevel ordered logit model is developed to quantify the impact of geometric features and environmental conditions on crash severity outcome. Analysis results revealed that there is a significant variation in severity outcomes of crashes occurred across segments which verifies the presence of hierarchical structure. Lower risk of severe crashes is found to be associated with the presence of 10-ft lane and/or narrow shoulders, lower roadside hazard rate, higher driveway density, longer barrier length, and shorter barrier offset. The developed multilevel model offers greater consistency with data generating mechanism and can be utilized to evaluate safety effects of geometric design improvement projects. Published by Elsevier Ltd.

Characteristics of cyclist crashes in Italy using latent class analysis and association rule mining

PubMed Central

De Angelis, Marco; Marín Puchades, Víctor; Fraboni, Federico; Pietrantoni, Luca

2017-01-01

The factors associated with severity of the bicycle crashes may differ across different bicycle crash patterns. Therefore, it is important to identify distinct bicycle crash patterns with homogeneous attributes. The current study aimed at identifying subgroups of bicycle crashes in Italy and analyzing separately the different bicycle crash types. The present study focused on bicycle crashes that occurred in Italy during the period between 2011 and 2013. We analyzed categorical indicators corresponding to the characteristics of infrastructure (road type, road signage, and location type), road user (i.e., opponent vehicle and cyclist’s maneuver, type of collision, age and gender of the cyclist), vehicle (type of opponent vehicle), and the environmental and time period variables (time of the day, day of the week, season, pavement condition, and weather). To identify homogenous subgroups of bicycle crashes, we used latent class analysis. Using latent class analysis, the bicycle crash data set was segmented into 19 classes, which represents 19 different bicycle crash types. Logistic regression analysis was used to identify the association between class membership and severity of the bicycle crashes. Finally, association rules were conducted for each of the latent classes to uncover the factors associated with an increased likelihood of severity. Association rules highlighted different crash characteristics associated with an increased likelihood of severity for each of the 19 bicycle crash types. PMID:28158296

Distracted Driving and Risk of Crash or Near-crash Involvement among Older Drivers using Naturalistic Driving Data with a Case-crossover Study Design.

PubMed

Huisingh, Carrie; Owsley, Cynthia; Levitan, Emily B; Irvin, Marguerite R; MacLennan, Paul; McGwin, Gerald

2018-05-17

The purpose of this study was to examine the association between secondary task involvement and risk of crash and near-crash involvement among older drivers using naturalistic driving data. Data from drivers aged ≥70 years in the Strategic Highway Research Program (SHRP2) Naturalistic Driving Study database was utilized. The personal vehicle of study participants was equipped with four video cameras enabling recording of the driver and the road environment. Secondary task involvement during a crash or near-crash event was compared to periods of non-crash involvement in a case-crossover study design. Conditional logistic regression was used to generate odds ratios (OR) and 95% confidence intervals (CI). Overall, engaging in any secondary task was not associated with crash (OR=0.94, 95% CI 0.68-1.29) or near-crash (OR=1.08, 95% CI 0.79-1.50) risk. The risk of a major crash event with cell phone use was 3.79 times higher than the risk with no cell phone use (95% CI 1.00-14.37). Other glances into the interior of the vehicle were associated with an increased risk of near-crash involvement (OR=2.55, 95% CI 1.24-5.26). Other distractions external to the vehicle were associated with a decreased risk of crash involvement (OR=0.53, 95% CI 0.30-0.94). Interacting with a passenger and talking/singing were not associated with crash or near-crash risk. Older drivers should avoid any cell phone use and minimize non-driving related eye glances towards the interior of the vehicle while driving. Certain types of events external to the vehicle are associated with a reduced crash risk among older drivers.

Overloading among crash-involved vehicles in China: identification of factors associated with overloading and crash severity.

PubMed

Zhang, Guangnan; Li, Yanyan; King, Mark J; Zhong, Qiaoting

2018-03-21

Motor vehicle overloading is correlated with the possibility of road crash occurrence and severity. Although overloading of motor vehicles is pervasive in developing nations, few empirical analyses have been performed on factors that might influence the occurrence of overloading. This study aims to address this shortcoming by seeking evidence from several years of crash data from Guangdong province, China. Data on overloading and other factors are extracted for crash-involved vehicles from traffic crash records for 2006-2010 provided by the Traffic Management Bureau in Guangdong province. Logistic regression is applied to identify risk factors for overloading in crash-involved vehicles and within these crashes to identify factors contributing to greater crash severity. Driver, vehicle, road and environmental characteristics and violation types are considered in the regression models. In addition to the basic logistic models, association analysis is employed to identify the potential interactions among different risk factors during fitting the logistic models of overloading and severity. Crash-involved vehicles driven by males from rural households and in an unsafe condition are more likely to be overloaded and to be involved in higher severity overloaded vehicle crashes. If overloaded vehicles speed, the risk of severe traffic crash casualties increases. Young drivers (aged under 25 years) in mountainous areas are more likely to be involved in higher severity overloaded vehicle crashes. This study identifies several factors associated with overloading in crash-involved vehicles and with higher severity overloading crashes and provides an important reference for future research on those specific risk factors. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Weather impacts on single-vehicle truck crash injury severity.

PubMed

Naik, Bhaven; Tung, Li-Wei; Zhao, Shanshan; Khattak, Aemal J

2016-09-01

The focus of this paper is on illustrating the feasibility of aggregating data from disparate sources to investigate the relationship between single-vehicle truck crash injury severity and detailed weather conditions. Specifically, this paper presents: (a) a methodology that combines detailed 15-min weather station data with crash and roadway data, and (b) an empirical investigation of the effects of weather on crash-related injury severities of single-vehicle truck crashes. Random parameters ordinal and multinomial regression models were used to investigate crash injury severity under different weather conditions, taking into account the individual unobserved heterogeneity. The adopted methodology allowed consideration of environmental, roadway, and climate-related variables in single-vehicle truck crash injury severity. Results showed that wind speed, rain, humidity, and air temperature were linked with single-vehicle truck crash injury severity. Greater recorded wind speed added to the severity of injuries in single-vehicle truck crashes in general. Rain and warmer air temperatures were linked to more severe crash injuries in single-vehicle truck crashes while higher levels of humidity were linked to less severe injuries. Random parameters ordered logit and multinomial logit, respectively, revealed some individual heterogeneity in the data and showed that integrating comprehensive weather data with crash data provided useful insights into factors associated with single-vehicle truck crash injury severity. The research provided a practical method that combined comprehensive 15-min weather station data with crash and roadway data, thereby providing useful insights into crash injury severity of single-vehicle trucks. Those insights are useful for future truck driver educational programs and for truck safety in different weather conditions. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

Investigations of Crashes Involving Pregnant Occupants

PubMed Central

Klinich, Kathleen DeSantis; Schneider, Lawrence W.; Moore, Jamie L.; Pearlman, Mark D.

2000-01-01

Case reports of 16 crashes involving pregnant occupants are presented that illustrate the main conclusions of a crash-investigation program that includes 42 crashes investigated to date. Some unusual cases that are exceptions to the overall trends are also described. The study indicates a strong association between adverse fetal outcome and both crash severity and maternal injury. Proper restraint use, with and without airbag deployment, generally leads to acceptable fetal outcomes in lower severity crashes, while it does not affect fetal outcome in high-severity crashes. Compared to properly restrained pregnant occupants, improperly restrained occupants have a higher risk of adverse fetal outcome in lower severity crashes, which comprise the majority of all motor-vehicle collisions. PMID:11558095

Quality assurance of the SCOPE 1 trial in oesophageal radiotherapy.

PubMed

Wills, Lucy; Maggs, Rhydian; Lewis, Geraint; Jones, Gareth; Nixon, Lisette; Staffurth, John; Crosby, Tom

2017-11-15

SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres. A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins. 36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm 3 ; and PTV volumes 221.9-513.3 cm 3 . For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark case, to 64% on trial. Sixty-five percent of centres, who returned the trial questionnaire, stated that their standard practice had changed as a result of their participation in the SCOPE1 trial. The SCOPE 1 QA programme outcomes lend support to the trial's clinical conclusions. The range of patient planning outcomes for the benchmark case indicated, at the outset of the trial, the significant degree of variation present in UK oesophageal radiotherapy planning outcomes, despite the presence of a protocol. This supports the case for increasingly detailed definition of practice by means of consensus protocols, training and peer review. The incidence of minor inconsistencies of technique highlights the potential for improved QA systems and the need for sufficient resource for this to be addressed within future trials. As indicated in questionnaire responses, the QA exercise as a whole has contributed to greater consistency of oesophageal radiotherapy in the UK via the adoption into standard practice of elements of the protocol. The SCOPE1 trial is an International Standard Randomized Controlled Trial, ISRCTN47718479 .

Statistical analysis of vehicle crashes in Mississippi based on crash data from 2010 to 2014.

DOT National Transportation Integrated Search

2017-08-15

Traffic crash data from 2010 to 2014 were collected by Mississippi Department of Transportation (MDOT) and extracted for the study. Three tasks were conducted in this study: (1) geographic distribution of crashes; (2) descriptive statistics of crash ...

New Jersey Crash Record Geocoding : Improving the State's Crash Database to Enhance Data‐Driven Decisions

DOT National Transportation Integrated Search

2010-06-01

The New Jersey Crash Record Geocoding Initiative was designed as a provisional measure to address missing crash locations. The purpose of the initiative was twofold. Primarily, students worked to locate crashes that had no location information after ...

Comprehensive and human capital crash costs by maximum police-reported injury severity within selected crash types.

PubMed

Zaloshnja, Eduard; Miller, Ted; Council, Forrest; Persaud, Bhagwant

2004-01-01

This paper presents estimates for both the economic and comprehensive costs per crash for three police-coded severity groupings within 16 selected crash types and within two speed limit categories (or=50 mph). The economic costs are hard dollar costs. The comprehensive costs include economic costs and quality of life losses. We merged previously developed costs per victim keyed on the Abbreviated Injury Scale (AIS) into US crash data files that scored injuries in both the AIS and police-coded severity scales to produce per crash estimates. The most costly crashes were non-intersection fatal/disabling injury crashes on a road with a speed limit of 50 miles per hour or higher where multiple vehicles crashed head-on or a single vehicle struck a human (over 1.69 and $1.16 million per crash, respectively). The annual cost of police-reported run-off-road collisions, which include both rollovers and object impacts, represented 34% of total costs.

Vehicular crash data used to rank intersections by injury crash frequency and severity.

PubMed

Liu, Yi; Li, Zongzhi; Liu, Jingxian; Patel, Harshingar

2016-09-01

This article contains data on research conducted in "A double standard model for allocating limited emergency medical service vehicle resources ensuring service reliability" (Liu et al., 2016) [1]. The crash counts were sorted out from comprehensive crash records of over one thousand major signalized intersections in the city of Chicago from 2004 to 2010. For each intersection, vehicular crashes were counted by crash severity levels, including fatal, injury Types A, B, and C for major, moderate, and minor injury levels, property damage only (PDO), and unknown. The crash data was further used to rank intersections by equivalent injury crash frequency. The top 200 intersections with the highest number of crash occurrences identified based on crash frequency- and severity-based scenarios are shared in this brief. The provided data would be a valuable source for research in urban traffic safety analysis and could also be utilized to examine the effectiveness of traffic safety improvement planning and programming, intersection design enhancement, incident and emergency management, and law enforcement strategies.

Comprehensive and Human Capital Crash Costs by Maximum Police-Reported Injury Severity Within Selected Crash Types

PubMed Central

Zaloshnja, Eduard; Miller, Ted; Council, Forrest; Persaud, Bhagwant

2004-01-01

This paper presents estimates for both the economic and comprehensive costs per crash for three police-coded severity groupings within 16 selected crash types and within two speed limit categories (<=45 and >=50 mph). The economic costs are hard dollar costs. The comprehensive costs include economic costs and quality of life losses. We merged previously developed costs per victim keyed on the Abbreviated Injury Scale (AIS) into US crash data files that scored injuries in both the AIS and police-coded severity scales to produce per crash estimates. The most costly crashes were non-intersection fatal/disabling injury crashes on a road with a speed limit of 50 miles per hour or higher where multiple vehicles crashed head-on or a single vehicle struck a human (over 1.69 and $1.16 million per crash, respectively). The annual cost of police-reported run-off-road collisions, which include both rollovers and object impacts, represented 34% of total costs. PMID:15319129

Predicting reduced visibility related crashes on freeways using real-time traffic flow data.

PubMed

Hassan, Hany M; Abdel-Aty, Mohamed A

2013-06-01

The main objective of this paper is to investigate whether real-time traffic flow data, collected from loop detectors and radar sensors on freeways, can be used to predict crashes occurring at reduced visibility conditions. In addition, it examines the difference between significant factors associated with reduced visibility related crashes to those factors correlated with crashes occurring at clear visibility conditions. Random Forests and matched case-control logistic regression models were estimated. The findings indicated that real-time traffic variables can be used to predict visibility related crashes on freeways. The results showed that about 69% of reduced visibility related crashes were correctly identified. The results also indicated that traffic flow variables leading to visibility related crashes are slightly different from those variables leading to clear visibility crashes. Using time slices 5-15 minutes before crashes might provide an opportunity for the appropriate traffic management centers for a proactive intervention to reduce crash risk in real-time. Copyright © 2013 Elsevier Ltd. All rights reserved.

The October 2014 United States Treasury bond flash crash and the contributory effect of mini flash crashes

PubMed Central

Levine, Zachary S.; Floridi, Luciano

2017-01-01

We investigate the causal uncertainty surrounding the flash crash in the U.S. Treasury bond market on October 15, 2014, and the unresolved concern that no clear link has been identified between the start of the flash crash at 9:33 and the opening of the U.S. equity market at 9:30. We consider the contributory effect of mini flash crashes in equity markets, and find that the number of equity mini flash crashes in the three-minute window between market open and the Treasury Flash Crash was 2.6 times larger than the number experienced in any other three-minute window in the prior ten weekdays. We argue that (a) this statistically significant finding suggests that mini flash crashes in equity markets both predicted and contributed to the October 2014 U.S. Treasury Bond Flash Crash, and (b) mini-flash crashes are important phenomena with negative externalities that deserve much greater scholarly attention. PMID:29091931

Analysis of near crashes among teen, young adult, and experienced adult drivers using the SHRP2 naturalistic driving study.

PubMed

Seacrist, Thomas; Douglas, Ethan C; Huang, Elaine; Megariotis, James; Prabahar, Abhiti; Kashem, Abyaad; Elzarka, Ayya; Haber, Leora; MacKinney, Taryn; Loeb, Helen

2018-02-28

Motor vehicle crashes are the leading cause of death among young drivers. Though previous research has focused on crash events, near crashes offer additional data to help identify driver errors that could potentially lead to crashes as well as evasive maneuvers used to avoid them. The Strategic Highway Research Program 2 (SHRP2) Naturalistic Driving Study (NDS) contains extensive data on real-world driving and offers a reliable methodology to quantify and study near crashes. This article presents findings on near crashes and how they compare to crash events among teen, young adult, and experienced adult drivers. A subset from the SHRP2 database consisting of 1,653 near crashes for teen (16-19 years, n = 550), young adult (20-24 years, n = 748), and experienced adult (35-54 years, n = 591) drivers was used. Onboard instrumentation including scene cameras, accelerometers, and Global Positioning System logged time series data at 10 Hz. Scene videos were reviewed for all events to classify near crashes based on 7 types: rear-end, road departure, intersection, head-on, side-swipe, pedestrian/cyclist, and animal. Near crash rates, incident type, secondary tasks, and evasive maneuvers were compared across age groups and between crashes and near crashes. For rear-end near crashes, vehicle dynamic variables including near crash severity, headway distance, time headway, and time to collision at the time of braking were compared across age groups. Crashes and near crashes were combined to compare the frequency of critical events across age. Teen drivers exhibited a significantly higher (P <.01) near crash rate than young adult and experienced adult drivers. The near crash rates were 81.6, 56.6, and 37.3 near crashes per million miles for teens, young adults, and experienced adults, respectively. Teens were also involved in significantly more rear-end (P <.01), road departure (P <.01), side-swipe (P <.01), and animal (P <.05) near crashes compared to young and experienced adults. Teens exhibited a significantly greater (P <.01) critical event rate of 102.2 critical events per million miles compared to 72.4 and 40.0 critical events per million miles for young adults and experienced adults, respectively; the critical event rate ratio was 2.6 and 1.8 for teens and young adults, respectively. To our knowledge, this is the first study to examine near crashes among teen, young adult, and experienced adult drivers using SHRP2 naturalistic data. Near crash and critical event rates significantly decreased with increasing age and driver experience. Overall, teens were more than twice as likely to be involved in critical events compared to experienced adults. These data can be used to develop more targeted driver training programs and help manufacturers design active safety systems based on the most common driving errors for vulnerable road users.

Paediatric head injuries in the Kwazulu-Natal Province of South Africa: a developing country perspective.

PubMed

Okyere-Dede, Ebenezer K; Nkalakata, Munyaradzi C; Nkomo, Tshepo; Hadley, G P; Madiba, Thandinkosi E

2013-01-01

We investigated the causes, management and outcome of head injuries in paediatric patients admitted to the paediatric surgery unit at King Edward VIII Hospital over a 3-year period, from 1999 to 2001. There were 506 patients (331 male; M:F ratio 2:1) and the mean age was 71.99 +36.8 months (2 weeks to 180 months). The injuries were due to: motor vehicle crashes (324); falls (121); assault (30); inadvertent injury (23); and unknown (11). Forty-nine patients (9%) were admitted with a Glasgow Coma Scale ≤8. The most common intracranial pathology on computed tomography was: intracranial haematoma/haemorrhage (44); contusion (16); and brain oedema (10). Nineteen patients (3.4%) underwent neurosurgical intervention and the rest were managed conservatively. Eighteen died in hospital (3.6%). The mean hospital stay was 5 ± 12 days. Twenty-three patients (4.5%) were discharged with neurological sequelae. Few paediatric patients are admitted with severe head injury: the majority from blunt injury caused by motor vehicle crashes. Management mainly requires simple neurological observation in a general ward with a surprisingly good prognosis. Specific protocols for paediatric head injuries have been proposed based on these findings.

New York City Department of Health response to terrorist attack, September 11, 2001.

PubMed

2001-09-28

In response to two jet aircraft crashing into and causing the collapse of the 110-storied World Trade Center (WTC) towers and the subsequent destruction of nearby portions of lower Manhattan, the New York City Department of Health (NYCDOH) immediately activated its emergency response protocol, including the mobilization of an Emergency Operations Center. Surveillance, clinical, environmental, sheltering, laboratory, management information systems, and operations were among the preestablished emergency committees. Because of its proximity to the WTC site, an emergency clinic was established at NYCDOH for triage and treatment of injured persons. NYCDOH focused its initial efforts on assessing the public health and medical impact of the attack and the resources needed to respond to it such as the care and management of large numbers of persons injured or killed by the crash; subsequent fire and building collapse; the health and safety of rescue workers; the environmental health risks (e.g., asbestos, smoke, dust, or chemical inhalation); other illnesses related to the disruption of the physical infrastructure (e.g., waterborne and foodborne diseases); and mental health concerns. Despite the evacuation and relocation of NYCDOH's headquarters, the department continued essential public health services, including death registration.

Fatality rate of pedestrians and fatal crash involvement rate of drivers in pedestrian crashes: a case study of Iran.

PubMed

Kashani, Ali Tavakoli; Besharati, Mohammad Mehdi

2017-06-01

The aim of this study was to uncover patterns of pedestrian crashes. In the first stage, 34,178 pedestrian-involved crashes occurred in Iran during a four-year period were grouped into homogeneous clusters using a clustering analysis. Next, some in-cluster and inter-cluster crash patterns were analysed. The clustering analysis yielded six pedestrian crash groups. Car/van/pickup crashes on rural roads as well as heavy vehicle crashes were found to be less frequent but more likely to be fatal compared to other crash clusters. In addition, after controlling for crash frequency in each cluster, it was found that the fatality rate of each pedestrian age group as well as the fatal crash involvement rate of each driver age group varies across the six clusters. Results of present study has some policy implications including, promoting pedestrian safety training sessions for heavy vehicle drivers, imposing limitations over elderly heavy vehicle drivers, reinforcing penalties toward under 19 drivers and motorcyclists. In addition, road safety campaigns in rural areas may be promoted to inform people about the higher fatality rate of pedestrians on rural roads. The crash patterns uncovered in this study might also be useful for prioritizing future pedestrian safety research areas.

Under-reporting of road traffic crash data in Ghana.

PubMed

Salifu, Mohammed; Ackaah, Williams

2012-01-01

Having reliable estimates of the shortfalls in road traffic crash data is an important prerequisite for setting more realistic targets for crash/casualty reduction programmes and for a better appreciation of the socio-economic significance of road traffic crashes. This study was carried out to establish realistic estimates of the overall shortfall (under-reporting) in the official crash statistics in Ghana over an eight-year period (1997-2004). Surveys were conducted at hospitals and among drivers to generate relevant alternative data which were then matched against records in police crash data files and the official database. Overall shortfalls came from two sources, namely, 'non-reporting' and 'under-recording'. The results show that the level of non-reporting varied significantly with the severity of the crash from about 57% for property damage crashes through 8% for serious injury crashes to 0% for fatal crashes. Crashes involving cyclists and motorcyclists were also substantially non-reported. Under-recording on the other hand declined significantly over the period from an average of 37% in 1997-1998 to 27% in 2003-2004. Thus, the official statistics of road traffic crashes in Ghana are subject to significant shortfalls that need to be accounted for. Correction factors have therefore been suggested for adjusting the official data.

Characteristics of the Injury Environment in Far-Side Crashes

PubMed Central

Digges, K.; Gabler, H; Mohan, P.; Alonso, B.

2005-01-01

The population of occupants in far-side crashes that are documented in the US National database (NASS/CDS) was studied. The annual number of front seat occupants with serious or fatal injuries in far-side planar and rollover crashes was 17,194. The crash environment that produces serious and fatal injuries to belted front seat occupants in planar far-side crashes was investigated in detail. It was found that both the change in velocity and extent of damage were important factors that relate to crash severity. The median severity for crashes with serious or fatal injuries was a lateral delta-V of 28 kph and an extent of damage of CDC 3.6. Vehicle-to-vehicle impacts were simulated by finite element models to determine the intrusion characteristics associated with the median crash condition. These simulations indicated that the side damage caused by the IIHS barrier was representative of the damage in crashes that produce serious injuries in far-side crashes. Occupant simulations of the IIHS barrier crash at 28 kph showed that existing dummies lack biofidelity in upper body motion. The analysis suggested test conditions for studying far-side countermeasures and supported earlier studies that showed the need for an improved dummy to evaluate safety performance in the far-side crash environment. PMID:16179148

Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program.

PubMed

Yamanaka, Ashley; Fialkowski, Marie Kainoa; Wilkens, Lynne; Li, Fenfang; Ettienne, Reynolette; Fleming, Travis; Power, Julianne; Deenik, Jonathan; Coleman, Patricia; Leon Guerrero, Rachael; Novotny, Rachel

2016-09-02

Quality assurance plays an important role in research by assuring data integrity, and thus, valid study results. We aim to describe and share the results of the quality assurance process used to guide the data collection process in a multi-site childhood obesity prevalence study and intervention trial across the US Affiliated Pacific Region. Quality assurance assessments following a standardized protocol were conducted by one assessor in every participating site. Results were summarized to examine and align the implementation of protocol procedures across diverse settings. Data collection protocols focused on food and physical activity were adhered to closely; however, protocols for handling completed forms and ensuring data security showed more variability. Quality assurance protocols are common in the clinical literature but are limited in multi-site community-based studies, especially in underserved populations. The reduction in the number of QA problems found in the second as compared to the first data collection periods for the intervention study attest to the value of this assessment. This paper can serve as a reference for similar studies wishing to implement quality assurance protocols of the data collection process to preserve data integrity and enhance the validity of study findings. NIH clinical trial #NCT01881373.

Physiological, Perceptual, and Affective Responses to Six High-Intensity Interval Training Protocols.

PubMed

Follador, Lucio; Alves, Ragami C; Ferreira, Sandro Dos S; Buzzachera, Cosme F; Andrade, Vinicius F Dos S; Garcia, Erick D S de A; Osiecki, Raul; Barbosa, Sara C; de Oliveira, Letícia M; da Silva, Sergio G

2018-04-01

This study examined the extent to which different high-intensity interval training (HIIT) and sprint interval training (SIT) protocols could influence psychophysiological responses in moderately active young men. Fourteen participants completed, in a randomized order, three cycling protocols (SIT: 4 × 30-second all-out sprints; Tabata: 7 × 20 seconds at 170% ⋮O 2max ; and HIIT: 10 × 60 seconds at 90% HR max ) and three running HIIT protocols (4 × 4 minutes at 90%-95% HR max , 5 × at v⋮O 2max , and 4 × 1,000 meters at a rating of perceived exertion (RPE) of 8, from the OMNI-Walk/Run scale). Oxygen uptake (⋮O 2 ), heart rate, and RPE were recorded during each interval. Affective responses were assessed before and after each trial. The Tabata protocol elicited the highest ⋮O 2 and RPE responses, and the least pleasant session-affect among the cycling trials. The v⋮O 2max elicited the highest ⋮O 2 and RPE responses and the lowest mean session-affect among the running trials. Findings highlight the limited application of SIT and some HIIT protocols to individuals with low fitness levels.

Adjuvant and induction chemotherapy in non-small cell lung cancer.

PubMed

Pirker, R; Malayeri, R; Huber, H

1999-01-01

About 25%-30% of patients with non-small cell lung cancer can be resected with curative intent. However, systemic relapses occur in up to 70% of these patients. Thus, postoperative adjuvant chemotherapy was evaluated in several randomised trials but the results of these trials were inconclusive with a survival benefit only in some trials. Shortcomings of these trials included low number of patients, poor patient compliance and inadequate chemotherapy protocols. A recent meta-analysis suggested an absolute survival benefit of 5% at five years for postoperative cisplatin-based chemotherapy as compared to surgery alone. Thus adjuvant chemotherapy with both improved chemotherapy protocols and improved anti-emetics is currently re-evaluated in several randomised trials on large patient populations.

Influence of pedestrian age and gender on spatial and temporal distribution of pedestrian crashes.

PubMed

Toran Pour, Alireza; Moridpour, Sara; Tay, Richard; Rajabifard, Abbas

2018-01-02

Every year, about 1.24 million people are killed in traffic crashes worldwide and more than 22% of these deaths are pedestrians. Therefore, pedestrian safety has become a significant traffic safety issue worldwide. In order to develop effective and targeted safety programs, the location- and time-specific influences on vehicle-pedestrian crashes must be assessed. The main purpose of this research is to explore the influence of pedestrian age and gender on the temporal and spatial distribution of vehicle-pedestrian crashes to identify the hotspots and hot times. Data for all vehicle-pedestrian crashes on public roadways in the Melbourne metropolitan area from 2004 to 2013 are used in this research. Spatial autocorrelation is applied in examining the vehicle-pedestrian crashes in geographic information systems (GIS) to identify any dependency between time and location of these crashes. Spider plots and kernel density estimation (KDE) are then used to determine the temporal and spatial patterns of vehicle-pedestrian crashes for different age groups and genders. Temporal analysis shows that pedestrian age has a significant influence on the temporal distribution of vehicle-pedestrian crashes. Furthermore, men and women have different crash patterns. In addition, results of the spatial analysis shows that areas with high risk of vehicle-pedestrian crashes can vary during different times of the day for different age groups and genders. For example, for those between ages 18 and 65, most vehicle-pedestrian crashes occur in the central business district (CBD) during the day, but between 7:00 p.m. and 6:00 a.m., crashes among this age group occur mostly around hotels, clubs, and bars. This research reveals that temporal and spatial distributions of vehicle-pedestrian crashes vary for different pedestrian age groups and genders. Therefore, specific safety measures should be in place during high crash times at different locations for different age groups and genders to increase the effectiveness of the countermeasures in preventing and reducing vehicle-pedestrian crashes.

Crash avoidance needs and countermeasure profiles for safety applications based on light-vehicle-to-pedestrian communications

DOT National Transportation Integrated Search

2016-08-01

This research supports establishing an updated understanding of the pedestrian crash problem and defining a way to connect the crash problem with vehicle-to-pedestrian (V2P) communication crash avoidance technology. It describes 5 priority pre-crash ...

A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT).

PubMed

Bruce, Julie; Lall, Ranjit; Withers, Emma J; Finnegan, Susanne; Underwood, Martin; Hulme, Claire; Sheridan, Ray; Skelton, Dawn A; Martin, Finbarr; Lamb, Sarah E

2016-01-18

Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver 'active' interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to 'active' intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the recommended SPIRIT Checklist. Amendments will be reported to relevant regulatory parties. ISRCTN 71002650; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Naturalistic Assessment of Novice Teenage Crash Experience

PubMed Central

Lee, Suzanne E.; Simons-Morton, Bruce G.; Klauer, Sheila E.; Ouimet, Marie Claude; Dingus, Thomas A.

2011-01-01

Background Crash risk is highest during the first months after licensure. Current knowledge about teenagers’ driving exposure and the factors increasing their crash risk is based on self-reported data and crash database analyses. While these research tools are useful, new developments in naturalistic technologies have allowed researchers to examine newly-licensed teenagers’ exposure and crash risk factors in greater detail. The Naturalistic Teenage Driving Study (NTDS) described in this paper is the first study to follow a group of newly-licensed teenagers continuously for 18 months after licensure. The goals of this paper are to compare the crash and near-crash experience of drivers in the NTDS to national trends, to describe the methods and lessons learned in the NTDS, and to provide initial data on driving exposure for these drivers. Methods A data acquisition system was installed in the vehicles of 42 newly-licensed teenage drivers 16 years of age during their first 18 months of independent driving. It consisted of cameras, sensors (accelerometers, GPS, yaw, front radar, lane position, and various sensors obtained via the vehicle network), and a computer with removable hard drive. Data on the driving of participating parents was also collected when they drove the instrumented vehicle. Findings The primary findings after 18 months included the following: (1) crash and near-crash rates among teenage participants were significantly higher during the first six months of the study than the final 12 months, mirroring the national trends; (2) crash and near-crash rates were significantly higher for teenage than adult (parent) participants, also reflecting national trends; (3) teenaged driving exposure averaged between 507-710 kilometers (315-441 miles) per month over the study period, but varied substantially between participants with standard errors representing 8-14 percent of the mean; and (4) crash and near-crash types were very similar for male and female teenage drivers.. Discussion The findings are the first comparing crash and near-crash rates among novice teenage drivers with those of adults using the same vehicle over the same period of time. The finding of highly elevated crash rates of novice teenagers during the first six months of licensure are consistent with and confirm the archival crash data showing high crash risk for novice teenagers. The NTDS convenience sample of teenage drivers was similar to the U.S. teenage driver population in terms of exposure and crash experience. The dataset is expected be a valuable resource for future in-depth analyses of crash risk, exposure to risky driving conditions, and comparisons of teenage and adult driving performance in various driving situations. PMID:21545880

The drink driving situation in Vietnam.

PubMed

Ngoc, Luu Bich; Thieng, Nguyen Thi; Huong, Nguyen Lan

2012-01-01

To identify the extent and nature of the problem and the main contributing factors to drink driving crashes; determine the current mechanisms in place, particularly in terms of legislation and its enforcement; and identify baseline data and relevant stakeholders. The situational assessment was based on the collection of secondary data from available reports and documents, in-depth interviews with key representatives at a central level, and field surveys in provinces. Vietnam has experienced phenomenal growth in motor vehicles, especially motorcycles, in the last decade (400%). This initially led to an increase in deaths from road crashes, but since 2006 the number has stayed fairly level according to police statistics. However, comparisons with health data suggest that the number of deaths is much higher and there are clearly a number of problems with the relevant data systems. Data on the percentage of drivers exceeding legal limits are not available, but police statistics indicated that drinking alcohol was a contributory factor in 7 percent of motor vehicle crashes. This is likely to be an underestimate, because the police and health services do not have the equipment to measure the blood alcohol concentration (BAC) levels of all drivers in crashes. Motorcycle riders and young people are in the high-risk groups. There are strict BAC limits starting at over zero and severe punishments for drunk drivers involved in serious crashes. However, the police do not have adequate manpower or equipment to conduct regular and frequent roadside checking for drivers who have been drinking. There have also been a number of education programs on road safety including drinking and driving, but these have not included sustained and intensive campaigns targeting the high-risk groups. The National Traffic Safety Committee (NTSC) is responsible for coordinating the relevant agencies but there is still a problem with lack of information sharing between agencies. This study completed a comprehensive situational assessment that examined the problem of drinking and driving and identified some of the weaknesses in the current prevention system. Vietnam currently has 2 international projects on road safety and it is hoped that these together with support from the International Center for Alcohol Policies (ICAP) Global Actions program will provide opportunities for strengthening drinking and drive prevention initiatives by improving the road crash and injury database, building the capacity of the key organizations, strengthening the coordination mechanisms, and implementing and evaluating trial drink-drive interventions. Copyright © 2012 Taylor & Francis Group, LLC

Barriers and enablers to implementing clinical treatment protocols for fever, hyperglycaemia, and swallowing dysfunction in the Quality in Acute Stroke Care (QASC) Project--a mixed methods study.

PubMed

Dale, Simeon; Levi, Christopher; Ward, Jeanette; Grimshaw, Jeremy M; Jammali-Blasi, Asmara; D'Este, Catherine; Griffiths, Rhonda; Quinn, Clare; Evans, Malcolm; Cadilhac, Dominique; Cheung, N Wah; Middleton, Sandy

2015-02-01

The Quality in Acute Stroke Care (QASC) trial evaluated systematic implementation of clinical treatment protocols to manage fever, sugar, and swallow (FeSS protocols) in acute stroke care. This cluster-randomised controlled trial was conducted in 19 stroke units in Australia. To describe perceived barriers and enablers preimplementation to the introduction of the FeSS protocols and, postimplementation, to determine which of these barriers eventuated as actual barriers. Preimplementation: Workshops were held at the intervention stroke units (n = 10). The first workshop involved senior clinicians who identified perceived barriers and enablers to implementation of the protocols, the second workshop involved bedside clinicians. Postimplementation, an online survey with stroke champions from intervention sites was conducted. A total of 111 clinicians attended the preimplementation workshops, identifying 22 barriers covering four main themes: (a) need for new policies, (b) limited workforce (capacity), (c) lack of equipment, and (d) education and logistics of training staff. Preimplementation enablers identified were: support by clinical champions, medical staff, nursing management and allied health staff; easy adaptation of current protocols, care-plans, and local policies; and presence of specialist stroke unit staff. Postimplementation, only five of the 22 barriers identified preimplementation were reported as actual barriers to adoption of the FeSS protocols, namely, no previous use of insulin infusions; hyperglycaemic protocols could not be commenced without written orders; medical staff reluctance to use the ASSIST swallowing screening tool; poor level of engagement of medical staff; and doctors' unawareness of the trial. The process of identifying barriers and enablers preimplementation allowed staff to take ownership and to address barriers and plan for change. As only five of the 22 barriers identified preimplementation were reported to be actual barriers at completion of the trial, this suggests that barriers are often overcome whilst some are only ever perceived rather than actual barriers. © 2015 Sigma Theta Tau International.

Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.

PubMed

Yeh, Hsin-Chieh; Clark, Jeanne M; Emmons, Karen E; Moore, Reneé H; Bennett, Gary G; Warner, Erica T; Sarwer, David B; Jerome, Gerald J; Miller, Edgar R; Volger, Sheri; Louis, Thomas A; Wells, Barbara; Wadden, Thomas A; Colditz, Graham A; Appel, Lawrence J

2010-08-01

The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the 'Practice-based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.' We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach. The Collaborative Research Group consists of three individual studies: 'Be Fit, Be Well' (Washington University in St. Louis/Harvard University), 'POWER Hopkins' (Johns Hopkins), and 'POWER-UP' (University of Pennsylvania). There are a total of 15 participating clinics with ~1100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support. The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial. The challenges of the organizational design include the complex decision-making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols.

Head Tilt Posturography to Enhance Balance Control Assessment for Astronauts: A Case Study

NASA Technical Reports Server (NTRS)

Hwang, E. Y.; Paloski, W. H.

2006-01-01

For many years, we have used a standard clinical computerized dynamic posturography (CDP) protocol to assess recovery of integrated sensory-motor function in astronauts returning from space flight. The most reliable indications of postflight crew performance capabilities have been obtained from the sensory organization tests (SOTs) within the CDP protocol, particularly SOTs 5 (eyes closed, surface support sway referenced) and 6 (eyes open, surface support and visual surround sway referenced), which are sensitive to changes in availability and/or utilization of vestibular cues. We have observed, however, that some astronauts exhibiting visible signs of incomplete sensory-motor recovery are able to score within clinical norms on standard SOTs 5 and 6 trials, perhaps as a result of cognitive strategies driven by their naturally competitive natures. To improve the sensitivity of the CDP protocol for assessing recovery of integrated sensory-motor function and fitness to return to duties and/or activities of daily living, we have introduced pitch plane head tilt SOT trials to our protocol. In a preliminary study of 5 short duration (11day missions) astronauts, we showed that they were unable to maintain balance on landing day when performing dynamic head tilt trials, despite scoring within the clinically normal range on the standard SOT trials. The present case report illustrates the advantages of including head tilt trials for assessing sensory-motor recovery in long duration crewmembers.

The Traffic Adaptive Data Dissemination (TrAD) Protocol for both Urban and Highway Scenarios.

PubMed

Tian, Bin; Hou, Kun Mean; Zhou, Haiying

2016-06-21

The worldwide economic cost of road crashes and injuries is estimated to be US$518 billion per year and the annual congestion cost in France is estimated to be €5.9 billion. Vehicular Ad hoc Networks (VANETs) are one solution to improve transport features such as traffic safety, traffic jam and infotainment on wheels, where a great number of event-driven messages need to be disseminated in a timely way in a region of interest. In comparison with traditional wireless networks, VANETs have to consider the highly dynamic network topology and lossy links due to node mobility. Inter-Vehicle Communication (IVC) protocols are the keystone of VANETs. According to our survey, most of the proposed IVC protocols focus on either highway or urban scenarios, but not on both. Furthermore, too few protocols, considering both scenarios, can achieve high performance. In this paper, an infrastructure-less Traffic Adaptive data Dissemination (TrAD) protocol which takes into account road traffic and network traffic status for both highway and urban scenarios will be presented. TrAD has double broadcast suppression techniques and is designed to adapt efficiently to the irregular road topology. The performance of the TrAD protocol was evaluated quantitatively by means of realistic simulations taking into account different real road maps, traffic routes and vehicular densities. The obtained simulation results show that TrAD is more efficient in terms of packet delivery ratio, number of transmissions and delay in comparison with the performance of three well-known reference protocols. Moreover, TrAD can also tolerate a reasonable degree of GPS drift and still achieve efficient data dissemination.

The Traffic Adaptive Data Dissemination (TrAD) Protocol for both Urban and Highway Scenarios

PubMed Central

Tian, Bin; Hou, Kun Mean; Zhou, Haiying

2016-01-01

The worldwide economic cost of road crashes and injuries is estimated to be US$518 billion per year and the annual congestion cost in France is estimated to be €5.9 billion. Vehicular Ad hoc Networks (VANETs) are one solution to improve transport features such as traffic safety, traffic jam and infotainment on wheels, where a great number of event-driven messages need to be disseminated in a timely way in a region of interest. In comparison with traditional wireless networks, VANETs have to consider the highly dynamic network topology and lossy links due to node mobility. Inter-Vehicle Communication (IVC) protocols are the keystone of VANETs. According to our survey, most of the proposed IVC protocols focus on either highway or urban scenarios, but not on both. Furthermore, too few protocols, considering both scenarios, can achieve high performance. In this paper, an infrastructure-less Traffic Adaptive data Dissemination (TrAD) protocol which takes into account road traffic and network traffic status for both highway and urban scenarios will be presented. TrAD has double broadcast suppression techniques and is designed to adapt efficiently to the irregular road topology. The performance of the TrAD protocol was evaluated quantitatively by means of realistic simulations taking into account different real road maps, traffic routes and vehicular densities. The obtained simulation results show that TrAD is more efficient in terms of packet delivery ratio, number of transmissions and delay in comparison with the performance of three well-known reference protocols. Moreover, TrAD can also tolerate a reasonable degree of GPS drift and still achieve efficient data dissemination. PMID:27338393

76 FR 53660 - Federal Motor Vehicle Safety Standards; Seat Belt Assemblies

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-29

... further require integration of electrical signals from existing front and side crash sensor information... require additional crash sensors for rollover and rear-end crash events for vehicles without such sensors. Crash imminent sensors, or sensors that detect an impending crash, may also be needed. It is also...

49 CFR 238.403 - Crash energy management.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 4 2014-10-01 2014-10-01 false Crash energy management. 238.403 Section 238.403... Equipment § 238.403 Crash energy management. (a) Each power car and trailer car shall be designed with a crash energy management system to dissipate kinetic energy during a collision. The crash energy...

49 CFR 238.403 - Crash energy management.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Crash energy management. 238.403 Section 238.403... Equipment § 238.403 Crash energy management. (a) Each power car and trailer car shall be designed with a crash energy management system to dissipate kinetic energy during a collision. The crash energy...

49 CFR 238.403 - Crash energy management.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Crash energy management. 238.403 Section 238.403... Equipment § 238.403 Crash energy management. (a) Each power car and trailer car shall be designed with a crash energy management system to dissipate kinetic energy during a collision. The crash energy...

49 CFR 238.403 - Crash energy management.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Crash energy management. 238.403 Section 238.403... Equipment § 238.403 Crash energy management. (a) Each power car and trailer car shall be designed with a crash energy management system to dissipate kinetic energy during a collision. The crash energy...

Facilities and Methods Used in Full-scale Airplane Crash-fire Investigation

NASA Technical Reports Server (NTRS)

Black, Dugald O.

1952-01-01

The facilities and the techniques employed in the conduct of full scale airplane crash-fire studies currently being conducted at the NACA Lewis laboratory are discussed herein. This investigation is part of a comprehensive study of the airplane crash-fire problem. The crash configuration chosen, the general physical layout of the crash site, the test methods, the instrumentation, the data-recording systems, and the post-crash examination procedure are described

Comparative analysis of PA-31-350 Chieftain (N44LV) accident and NASA crash test data

NASA Technical Reports Server (NTRS)

Hayduk, R. J.

1979-01-01

A full scale, controlled crash test to simulate the crash of a Piper PA-31-350 Chieftain airplane is described. Comparisons were performed between the simulated crash and the actual crash in order to assess seat and floor behavior, and to estimate the acceleration levels experienced in the craft at the time of impact. Photographs, acceleration histories, and the tested airplane crash data is used to augment the accident information to better define the crash conditions. Measured impact parameters are presented along with flight path velocity and angle in relation to the impact surface.

Real World Crash Evaluation of Vehicle Stability Control (VSC) Technology

PubMed Central

Bahouth, G.

2005-01-01

This study quantifies the effect of Vehicle Stability Control (VSC) in reducing crash involvement rates for a subset of vehicles in the US fleet. Crash rates for a variety of impact types before and after VSC technology was implemented are compared. Police-reported crashes from six available US state files from 1998–2002 were analyzed including 13,987 crash-involved study vehicles not equipped with the technology and 5,671 crashes of vehicles equipped with VSC as a standard feature. Overall, an 11.2% (95% CI: 2.4%, 21.1%) reduction in multi-vehicle frontal crash involvement was identified for VSC-equipped vehicles. A 52.6% (95% CI: 42.5%, 62.7%) reduction in single-vehicle crash rates was found. PMID:16179137

Real world crash evaluation of vehicle stability control (VSC) technology.

PubMed

Bahouth, G

2005-01-01

This study quantifies the effect of Vehicle Stability Control (VSC) in reducing crash involvement rates for a subset of vehicles in the US fleet. Crash rates for a variety of impact types before and after VSC technology was implemented are compared. Police-reported crashes from six available US state files from 1998-2002 were analyzed including 13,987 crash-involved study vehicles not equipped with the technology and 5,671 crashes of vehicles equipped with VSC as a standard feature. Overall, an 11.2% (95% CI: 2.4%, 21.1%) reduction in multi-vehicle frontal crash involvement was identified for VSC-equipped vehicles. A 52.6% (95% CI: 42.5%, 62.7%) reduction in single-vehicle crash rates was found.

New evidence concerning fatal crashes of passenger vehicles before and after adding antilock braking systems.

PubMed

Farmer, C M

2001-05-01

Fatal crash rates for passenger cars and vans were compared for the last model year before four-wheel antilock brakes were introduced and the first model year for which antilock brakes were standard equipment. A prior study, based on fatal crash experience through 1995, reported that vehicle models with antilock brakes were more likely than identical but 1-year-earlier models to be involved in crashes fatal to their own occupants, but were less likely to be involved in crashes fatal to occupants of other vehicles. Overall, there was no significant effect of antilocks on the likelihood of fatal crashes. Similar analyses, based on fatal crash experience during 1996-98, yielded very different results. During 1996-98, vehicles with antilock brakes were again less likely than earlier models to be involved in crashes fatal to occupants of other vehicles, but they were no longer overinvolved in crashes fatal to their own occupants.

Neighborhood Influences on Vehicle-Pedestrian Crash Severity.

PubMed

Toran Pour, Alireza; Moridpour, Sara; Tay, Richard; Rajabifard, Abbas

2017-12-01

Socioeconomic factors are known to be contributing factors for vehicle-pedestrian crashes. Although several studies have examined the socioeconomic factors related to the location of the crashes, limited studies have considered the socioeconomic factors of the neighborhood where the road users live in vehicle-pedestrian crash modelling. This research aims to identify the socioeconomic factors related to both the neighborhoods where the road users live and where crashes occur that have an influence on vehicle-pedestrian crash severity. Data on vehicle-pedestrian crashes that occurred at mid-blocks in Melbourne, Australia, was analyzed. Neighborhood factors associated with road users' residents and location of crash were investigated using boosted regression tree (BRT). Furthermore, partial dependence plots were applied to illustrate the interactions between these factors. We found that socioeconomic factors accounted for 60% of the 20 top contributing factors to vehicle-pedestrian crashes. This research reveals that socioeconomic factors of the neighborhoods where the road users live and where the crashes occur are important in determining the severity of the crashes, with the former having a greater influence. Hence, road safety countermeasures, especially those focussing on the road users, should be targeted at these high-risk neighborhoods.

Investigation of Roadway Geometric and Traffic Flow Factors for Vehicle Crashes Using Spatiotemporal Interaction

NASA Astrophysics Data System (ADS)

Gill, G.; Sakrani, T.; Cheng, W.; Zhou, J.

2017-09-01

Traffic safety is a major concern in the transportation industry due to immense monetary and emotional burden caused by crashes of various severity levels, especially the injury and fatality ones. To reduce such crashes on all public roads, the safety management processes are commonly implemented which include network screening, problem diagnosis, countermeasure identification, and project prioritization. The selection of countermeasures for potential mitigation of crashes is governed by the influential factors which impact roadway crashes. Crash prediction model is the tool widely adopted by safety practitioners or researchers to link various influential factors to crash occurrences. Many different approaches have been used in the past studies to develop better fitting models which also exhibit prediction accuracy. In this study, a crash prediction model is developed to investigate the vehicular crashes occurring at roadway segments. The spatial and temporal nature of crash data is exploited to form a spatiotemporal model which accounts for the different types of heterogeneities among crash data and geometric or traffic flow variables. This study utilizes the Poisson lognormal model with random effects, which can accommodate the yearly variations in explanatory variables and the spatial correlations among segments. The dependency of different factors linked with roadway geometric, traffic flow, and road surface type on vehicular crashes occurring at segments was established as the width of lanes, posted speed limit, nature of pavement, and AADT were found to be correlated with vehicle crashes.

Crash test rating and likelihood of major thoracoabdominal injury in motor vehicle crashes: the new car assessment program side-impact crash test, 1998-2010.

PubMed

Figler, Bradley D; Mack, Christopher D; Kaufman, Robert; Wessells, Hunter; Bulger, Eileen; Smith, Thomas G; Voelzke, Bryan

2014-03-01

The National Highway Traffic Safety Administration's New Car Assessment Program (NCAP) implemented side-impact crash testing on all new vehicles since 1998 to assess the likelihood of major thoracoabdominal injuries during a side-impact crash. Higher crash test rating is intended to indicate a safer car, but the real-world applicability of these ratings is unknown. Our objective was to determine the relationship between a vehicle's NCAP side-impact crash test rating and the risk of major thoracoabdominal injury among the vehicle's occupants in real-world side-impact motor vehicle crashes. The National Automotive Sampling System Crashworthiness Data System contains detailed crash and injury data in a sample of major crashes in the United States. For model years 1998 to 2010 and crash years 1999 to 2010, 68,124 occupants were identified in the Crashworthiness Data System database. Because 47% of cases were missing crash severity (ΔV), multiple imputation was used to estimate the missing values. The primary predictor of interest was the occupant vehicle's NCAP side-impact crash test rating, and the outcome of interest was the presence of major (Abbreviated Injury Scale [AIS] score ≥ 3) thoracoabdominal injury. In multivariate analysis, increasing NCAP crash test rating was associated with lower likelihood of major thoracoabdominal injury at high (odds ratio [OR], 0.8; 95% confidence interval [CI], 0.7-0.9; p < 0.01) and medium (OR, 0.9; 95% CI, 0.8-1.0; p < 0.05) crash severity (ΔV), but not at low ΔV (OR, 0.95; 95% CI, 0.8-1.2; p = 0.55). In our model, older age and absence of seat belt use were associated with greater likelihood of major thoracoabdominal injury at low and medium ΔV (p < 0.001), but not at high ΔV (p ≥ 0.09). Among adults in model year 1998 to 2010 vehicles involved in medium and high severity motor vehicle crashes, a higher NCAP side-impact crash test rating is associated with a lower likelihood of major thoracoabdominal trauma. Epidemiologic study, level III.

Identifying crash-prone traffic conditions under different weather on freeways.

PubMed

Xu, Chengcheng; Wang, Wei; Liu, Pan

2013-09-01

Understanding the relationships between traffic flow characteristics and crash risk under adverse weather conditions will help highway agencies develop proactive safety management strategies to improve traffic safety in adverse weather conditions. The primary objective is to develop separate crash risk prediction models for different weather conditions. The crash data, weather data, and traffic data used in this study were collected on the I-880N freeway in California in 2008 and 2010. This study considered three different weather conditions: clear weather, rainy weather, and reduced visibility weather. The preliminary analysis showed that there was some heterogeneity in the risk estimates for traffic flow characteristics by weather conditions, and that the crash risk prediction model for all weather conditions cannot capture the impacts of the traffic flow variables on crash risk under adverse weather conditions. The Bayesian random intercept logistic regression models were applied to link the likelihood of crash occurrence with various traffic flow characteristics under different weather conditions. The crash risk prediction models were compared to their corresponding logistic regression model. It was found that the random intercept model improved the goodness-of-fit of the crash risk prediction models. The model estimation results showed that the traffic flow characteristics contributing to crash risk were different across different weather conditions. The speed difference between upstream and downstream stations was found to be significant in each crash risk prediction model. Speed difference between upstream and downstream stations had the largest impact on crash risk in reduced visibility weather, followed by that in rainy weather. The ROC curves were further developed to evaluate the predictive performance of the crash risk prediction models under different weather conditions. The predictive performance of the crash risk model for clear weather was better than those of the crash risk models for adverse weather conditions. The research results could promote a better understanding of the impacts of traffic flow characteristics on crash risk under adverse weather conditions, which will help transportation professionals to develop better crash prevention strategies in adverse weather. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

An evaluation of the effect of Ohio's graduated driver licensing law on motor vehicle crashes and crash outcomes involving drivers 16 to 20 years of age.

PubMed

Conner, Kristen A; Smith, Gary A

2017-05-19

Nationally, motor vehicle crashes are the leading cause of death among youth ages 16 to 20 years. Graduated driver licensing (GDL) laws have been implemented to reduce motor vehicle crashes among teen drivers. Studies have shown decreases in teen crash rates and crash-related fatality rates following enactment of GDL laws. However, GDL laws typically apply to teens only until their 18th birthday; therefore, the effect, if any, that GDL laws have on youth drivers ages 18 to 20 years and whether these programs should be extended to include these older youth warrant further study. The objective of this study was to evaluate the effects of Ohio's 2007 revised GDL law on motor vehicle crashes and crash-related injuries for crashes involving teen drivers ages 16 to 20 years, with a focus on the effects on crashes involving drivers ages 18 to 20 years. Cross-sectional analysis of motor vehicle crashes involving drivers ages 16 to 20 years in Ohio in the pre-GDL (2004-2006) and post-GDL (2008-2010) periods was performed. Descriptive statistics and population-based crash rates for drivers and occupants ages 16 to 20 years were calculated, as well as rate ratios and 95% confidence intervals (CIs) comparing crashes in the pre-GDL and post-GDL periods. Compared with the pre-GDL period, the post-GDL period was associated with lower crash rates for drivers age 16 years (relative risk [RR] = 0.94; 95% CI, 0.90-0.98), age 17 years (RR = 0.90; 95% CI, 0.88-0.93), age 18 years (RR = 0.95; 95% CI, 0.92-0.97), and ages 16-17 years combined (RR = 0.92; 95% CI, 0.90-0.95). Crash rate was higher for the post-GDL period for drivers age 19 years (RR = 1.04; 95% CI, 1.01-1.07), age 20 years (RR = 1.09; 95% CI, 1.05-1.13), and ages 18-20 years combined (RR = 1.02; 95% CI, 1.00-1.03). Unlike previous studies, this investigation used linked data to evaluate the outcomes of all occupants in crashes involving drivers ages 16-20 years. The post-GDL period was associated with lower crash, injury crash, and fatal crash involvement among drivers and occupants ages 16-17 years but higher overall crash involvement for drivers and occupants ages 19 years, 20 years, and 18-20 years combined. These findings support extending GDL restrictions to novice drivers ages 18 through 20 years to reduce crashes in that group.

Interventions for investigating and identifying the causes of stillbirth.

PubMed

Wojcieszek, Aleena M; Shepherd, Emily; Middleton, Philippa; Gardener, Glenn; Ellwood, David A; McClure, Elizabeth M; Gold, Katherine J; Khong, Teck Yee; Silver, Robert M; Erwich, Jan Jaap Hm; Flenady, Vicki

2018-04-30

Identification of the causes of stillbirth is critical to the primary prevention of stillbirth and to the provision of optimal care in subsequent pregnancies. A wide variety of investigations are available, but there is currently no consensus on the optimal approach. Given their cost and potential to add further emotional burden to parents, there is a need to systematically assess the effect of these interventions on outcomes for parents, including psychosocial outcomes, economic costs, and on rates of diagnosis of the causes of stillbirth. To assess the effect of different tests, protocols or guidelines for investigating and identifying the causes of stillbirth on outcomes for parents, including psychosocial outcomes, economic costs, and rates of diagnosis of the causes of stillbirth. We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 May 2017). We planned to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs. We planned to include studies published as abstract only, provided there was sufficient information to allow us to assess study eligibility. We planned to exclude cross-over trials.Participants included parents (including mothers, fathers, and partners) who had experienced a stillbirth of 20 weeks' gestation or greater.This review focused on interventions for investigating and identifying the causes of stillbirth. Such interventions are likely to be diverse, but could include:* review of maternal and family history, and current pregnancy and birth history;* clinical history of present illness;* maternal investigations (such as ultrasound, amniocentesis, antibody screening, etc.);* examination of the stillborn baby (including full autopsy, partial autopsy or noninvasive components, such as magnetic resonance imaging (MRI), computerised tomography (CT) scanning, and radiography);* umbilical cord examination;* placental examination including histopathology (microscopic examination of placental tissue); and* verbal autopsy (interviews with care providers and support people to ascertain causes, without examination of the baby).We planned to include trials assessing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth, compared with the absence of a test, protocol or guideline, or usual care (further details are presented in the Background, see Description of the intervention).We also planned to include trials comparing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth with another, for example, the use of a limited investigation protocol compared with a comprehensive investigation protocol. Two review authors assessed trial eligibility independently. We excluded five studies that were not RCTs. There were no eligible trials for inclusion in this review. There is currently a lack of RCT evidence regarding the effectiveness of interventions for investigating and identifying the causes of stillbirth. Seeking to determine the causes of stillbirth is an essential component of quality maternity care, but it remains unclear what impact these interventions have on the psychosocial outcomes of parents and families, the rates of diagnosis of the causes of stillbirth, and the care and management of subsequent pregnancies following stillbirth. Due to the absence of trials, this review is unable to inform clinical practice regarding the investigation of stillbirths, and the specific investigations that would determine the causes.Future RCTs addressing this research question would be beneficial, but the settings in which the trials take place, and their design, need to be given careful consideration. Trials need to be conducted with the utmost care and consideration for the needs, concerns, and values of parents and families. Assessment of longer-term psychosocial variables, economic costs to health services, and effects on subsequent pregnancy care and outcomes should also be considered in any future trials.

Severe injury in multiple impacts: Analysis of 1997-2015 NASS-CDS.

PubMed

Viano, David C; Parenteau, Chantal S

2018-07-04

This is a descriptive study of the incidence and risk for severe injury in single-impact and multi-impact crashes by belt use and crash type using NASS-CDS. 1997-2015 NASS-CDS data were used to determine the distribution of crashes by the number of impacts and severe injury (Maximum Abbreviated Injury Score [MAIS] 4+F) to >15-year-old nonejected drivers by seat belt use in 1997+ MY vehicles. It compares the risk for severe injury in a single impact and in crashes involving 2, 3, or 4+ impacts in the collision with a focus on a frontal crash followed by other impacts. Most vehicle crashes involve a single impact (75.4% of 44,889,518 vehicles), followed by 2-impact crashes (19.6%), 3-impact crashes (5.0%) and 4+ impacts (2.6%). For lap-shoulder-belted drivers, the distribution of severe injury was 42.1% in a single impact, 29.3% in 2 impacts, 13.4% in 3 impacts, and 15.1% in 4+ impact crashes. The risk for a belted driver was 0.256 ± 0.031% in a single impact, 0.564 ± 0.079% in 2 impacts, 0.880 ± 0.125% in 3 impacts, and 2.121 ± 0.646% in 4+ impact. The increase in risk from a single crash to multi-impact collisions was statistically significant (P < .001). In a single impact, 53.8% of belted drivers were in a frontal crashes, 22.4% in side crashes, 20% in rear crashes, and 1.7% in rollover crashes. The risk for severe injury was highest in a rollover at 0.677 ± 0.250%, followed by near-side impact at 0.467 ± 0.084% and far-side impact at 0.237 ± 0.071%. Seat belt use was 82.4% effective in preventing severe injury (MAIS 4+F) in a rollover, 47.9% in a near-side impact, and 74.8% in a far-side impact. In 2-impact crashes with a belted driver, the most common sequence was a rear impact followed by a frontal crash at 1,843,506 (21.5%) with a risk for severe injury of 0.100 ± 0.058%. The second most common was a frontal impact followed by another frontal crash at 1,257,264 (14.7%) with a risk of 0.401 ± 0.057%. The risk was 0.658 ± 0.271% in a frontal impact followed by a rear impact. A near-side impact followed by a rear crash had the highest risk for severe injury at 2.073 ± 1.322%. Restraint systems are generally developed for a single crash or sled test. The risk for severe injury was significantly higher in 2-, 3-, and 4+-impact crashes than a single impact. The majority (57.9%) of severe injuries occurred in multi-impact crashes with belted drivers. The evaluation of restraint performance warrants additional study in multi-impact crashes.

Crash protection of stock car racing drivers--application of biomechanical analysis of Indy car crash research.

PubMed

Melvin, John W; Begeman, Paul C; Faller, Ronald K; Sicking, Dean L; McClellan, Scott B; Maynard, Edwin; Donegan, Michael W; Mallott, Annette M; Gideon, Thomas W

2006-11-01

Biomechanical analysis of Indy car crashes using on-board impact recorders (Melvin et al. 1998, Melvin et al. 2001) indicates that Indy car driver protection in high-energy crashes can be achieved in frontal, side, and rear crashes with severities in the range of 100 to 135 G peak deceleration and velocity changes in the range of 50 to 70 mph. These crashes were predominantly single-car impacts with the rigid concrete walls of oval tracks. This impressive level of protection was found to be due to the unique combination of a very supportive and tight-fitting cockpit-seating package, a six-point belt restraint system, and effective head padding with an extremely strong chassis that defines the seat and cockpit of a modern Indy car. In 2000 and 2001, a series of fatal crashes in stock car racing created great concern for improving the crash protection for drivers in those racecars. Unlike the Indy car, the typical racing stock car features a more spacious driver cockpit due to its resemblance to the shape of a passenger car. The typical racing seat used in stock cars did not have the same configuration or support characteristics of the Indy car seat, and five-point belt restraints were used. The tubular steel space frame chassis of a stock car also differs from an Indy car's composite chassis structure in both form and mechanical behavior. This paper describes the application of results of the biomechanical analysis of the Indy car crash studies to the unique requirements of stock car racing driver crash protection. Sled test and full-scale crash test data using both Hybrid III frontal crash anthropomorphic test devices (ATDs) and BioSID side crash ATDs for the purpose of evaluating countermeasures involving restraint systems, seats and head/neck restraints has been instrumental in guiding these developments. In addition, the development of deformable walls for oval tracks (the SAFER Barrier) is described as an adjunct to improved occupant restraint through control of the crash forces acting on a racing car. NASCAR (National Association for Stock Car Auto Racing, Inc) implemented crash recording in stock car racing in its three national series in 2002. Data from 2925 crashes from 2002 through the 2005 season are summarized in terms of crash severity, crash direction, injury outcome, and protective system performance.

Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery

PubMed Central

Lien, Victoria Peixin; Ong, Hwee Kuan; Er, Pei Ling; Hao, Ying; Khan, Shariq Ali; Liu, Christopher Weiyang

2017-01-01

Introduction Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions—physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. Methods and analysis This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. Ethics and dissemination This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. Trial registration number NCT02921932 (ClinicalTrials.gov) PMID:28778994

Database improvements for motor vehicle/bicycle crash analysis

PubMed Central

Lusk, Anne C; Asgarzadeh, Morteza; Farvid, Maryam S

2015-01-01

Background Bicycling is healthy but needs to be safer for more to bike. Police crash templates are designed for reporting crashes between motor vehicles, but not between vehicles/bicycles. If written/drawn bicycle-crash-scene details exist, these are not entered into spreadsheets. Objective To assess which bicycle-crash-scene data might be added to spreadsheets for analysis. Methods Police crash templates from 50 states were analysed. Reports for 3350 motor vehicle/bicycle crashes (2011) were obtained for the New York City area and 300 cases selected (with drawings and on roads with sharrows, bike lanes, cycle tracks and no bike provisions). Crashes were redrawn and new bicycle-crash-scene details were coded and entered into the existing spreadsheet. The association between severity of injuries and bicycle-crash-scene codes was evaluated using multiple logistic regression. Results Police templates only consistently include pedal-cyclist and helmet. Bicycle-crash-scene coded variables for templates could include: 4 bicycle environments, 18 vehicle impact-points (opened-doors and mirrors), 4 bicycle impact-points, motor vehicle/bicycle crash patterns, in/out of the bicycle environment and bike/relevant motor vehicle categories. A test of including these variables suggested that, with bicyclists who had minor injuries as the control group, bicyclists on roads with bike lanes riding outside the lane had lower likelihood of severe injuries (OR, 0.40, 95% CI 0.16 to 0.98) compared with bicyclists riding on roads without bicycle facilities. Conclusions Police templates should include additional bicycle-crash-scene codes for entry into spreadsheets. Crash analysis, including with big data, could then be conducted on bicycle environments, motor vehicle potential impact points/doors/mirrors, bicycle potential impact points, motor vehicle characteristics, location and injury. PMID:25835304

What are the differences in driver injury outcomes at highway-rail grade crossings? Untangling the role of pre-crash behaviors.

PubMed

Liu, Jun; Khattak, Asad J; Richards, Stephen H; Nambisan, Shashi

2015-12-01

Crashes at highway-rail grade crossings can result in severe injuries and fatalities to vehicle occupants. Using a crash database from the Federal Railroad Administration (N=15,639 for 2004-2013), this study explores differences in safety outcomes from crashes between passive controls (Crossbucks and STOP signs) and active controls (flashing lights, gates, audible warnings and highway signals). To address missing data, an imputation model is developed, creating a complete dataset for estimation. Path analysis is used to quantify the direct and indirect associations of passive and active controls with pre-crash behaviors and crash outcomes in terms of injury severity. The framework untangles direct and indirect associations of controls by estimating two models, one for pre-crash driving behaviors (e.g., driving around active controls), and another model for injury severity. The results show that while the presence of gates is not directly associated with injury severity, the indirect effect through stopping behavior is statistically significant (95% confidence level) and substantial. Drivers are more likely to stop at gates that also have flashing lights and audible warnings, and stopping at gates is associated with lower injury severity. This indirect association lowers the chances of injury by 16%, compared with crashes at crossings without gates. Similar relationships between other controls and injury severity are explored. Generally, crashes occurring at active controls are less severe than crashes at passive controls. The results of study can be used to modify Crash Modification Factors (CMFs) to account for crash injury severity. The study contributes to enhancing the understanding of safety by incorporating pre-crash behaviors in a broader framework that quantifies correlates of crash injury severity at active and passive crossings. Copyright © 2015 Elsevier Ltd. All rights reserved.

Comparison of four statistical and machine learning methods for crash severity prediction.

PubMed

Iranitalab, Amirfarrokh; Khattak, Aemal

2017-11-01

Crash severity prediction models enable different agencies to predict the severity of a reported crash with unknown severity or the severity of crashes that may be expected to occur sometime in the future. This paper had three main objectives: comparison of the performance of four statistical and machine learning methods including Multinomial Logit (MNL), Nearest Neighbor Classification (NNC), Support Vector Machines (SVM) and Random Forests (RF), in predicting traffic crash severity; developing a crash costs-based approach for comparison of crash severity prediction methods; and investigating the effects of data clustering methods comprising K-means Clustering (KC) and Latent Class Clustering (LCC), on the performance of crash severity prediction models. The 2012-2015 reported crash data from Nebraska, United States was obtained and two-vehicle crashes were extracted as the analysis data. The dataset was split into training/estimation (2012-2014) and validation (2015) subsets. The four prediction methods were trained/estimated using the training/estimation dataset and the correct prediction rates for each crash severity level, overall correct prediction rate and a proposed crash costs-based accuracy measure were obtained for the validation dataset. The correct prediction rates and the proposed approach showed NNC had the best prediction performance in overall and in more severe crashes. RF and SVM had the next two sufficient performances and MNL was the weakest method. Data clustering did not affect the prediction results of SVM, but KC improved the prediction performance of MNL, NNC and RF, while LCC caused improvement in MNL and RF but weakened the performance of NNC. Overall correct prediction rate had almost the exact opposite results compared to the proposed approach, showing that neglecting the crash costs can lead to misjudgment in choosing the right prediction method. Copyright © 2017 Elsevier Ltd. All rights reserved.

Analysis of naturalistic driving videos of fleet services drivers to estimate driver error and potentially distracting behaviors as risk factors for rear-end versus angle crashes.

PubMed

Harland, Karisa K; Carney, Cher; McGehee, Daniel

2016-07-03

The objective of this study was to estimate the prevalence and odds of fleet driver errors and potentially distracting behaviors just prior to rear-end versus angle crashes. Analysis of naturalistic driving videos among fleet services drivers for errors and potentially distracting behaviors occurring in the 6 s before crash impact. Categorical variables were examined using the Pearson's chi-square test, and continuous variables, such as eyes-off-road time, were compared using the Student's t-test. Multivariable logistic regression was used to estimate the odds of a driver error or potentially distracting behavior being present in the seconds before rear-end versus angle crashes. Of the 229 crashes analyzed, 101 (44%) were rear-end and 128 (56%) were angle crashes. Driver age, gender, and presence of passengers did not differ significantly by crash type. Over 95% of rear-end crashes involved inadequate surveillance compared to only 52% of angle crashes (P < .0001). Almost 65% of rear-end crashes involved a potentially distracting driver behavior, whereas less than 40% of angle crashes involved these behaviors (P < .01). On average, drivers spent 4.4 s with their eyes off the road while operating or manipulating their cell phone. Drivers in rear-end crashes were at 3.06 (95% confidence interval [CI], 1.73-5.44) times adjusted higher odds of being potentially distracted than those in angle crashes. Fleet driver driving errors and potentially distracting behaviors are frequent. This analysis provides data to inform safe driving interventions for fleet services drivers. Further research is needed in effective interventions to reduce the likelihood of drivers' distracting behaviors and errors that may potentially reducing crashes.

Prevalence of teen driver errors leading to serious motor vehicle crashes.

PubMed

Curry, Allison E; Hafetz, Jessica; Kallan, Michael J; Winston, Flaura K; Durbin, Dennis R

2011-07-01

Motor vehicle crashes are the leading cause of adolescent deaths. Programs and policies should target the most common and modifiable reasons for crashes. We estimated the frequency of critical reasons for crashes involving teen drivers, and examined in more depth specific teen driver errors. The National Highway Traffic Safety Administration's (NHTSA) National Motor Vehicle Crash Causation Survey collected data at the scene of a nationally representative sample of 5470 serious crashes between 7/05 and 12/07. NHTSA researchers assigned a single driver, vehicle, or environmental factor as the critical reason for the event immediately leading to each crash. We analyzed crashes involving 15-18 year old drivers. 822 teen drivers were involved in 795 serious crashes, representing 335,667 teens in 325,291 crashes. Driver error was by far the most common reason for crashes (95.6%), as opposed to vehicle or environmental factors. Among crashes with a driver error, a teen made the error 79.3% of the time (75.8% of all teen-involved crashes). Recognition errors (e.g., inadequate surveillance, distraction) accounted for 46.3% of all teen errors, followed by decision errors (e.g., following too closely, too fast for conditions) (40.1%) and performance errors (e.g., loss of control) (8.0%). Inadequate surveillance, driving too fast for conditions, and distracted driving together accounted for almost half of all crashes. Aggressive driving behavior, drowsy driving, and physical impairments were less commonly cited as critical reasons. Males and females had similar proportions of broadly classified errors, although females were specifically more likely to make inadequate surveillance errors. Our findings support prioritization of interventions targeting driver distraction and surveillance and hazard awareness training. Copyright © 2010 Elsevier Ltd. All rights reserved.

Assessing the role of pavement macrotexture in preventing crashes on highways.

PubMed

Pulugurtha, Srinivas S; Kusam, Prasanna R; Patel, Kuvleshay J

2010-02-01

The objective of this article is to assess the role of pavement macrotexture in preventing crashes on highways in the State of North Carolina. Laser profilometer data obtained from the North Carolina Department of Transportation (NCDOT) for highways comprising four corridors are processed to calculate pavement macrotexture at 100-m (approximately 330-ft) sections according to the American Society for Testing and Materials (ASTM) standards. Crash data collected over the same lengths of the corridors were integrated with the calculated pavement macrotexture for each section. Scatterplots were generated to assess the role of pavement macrotexture on crashes and logarithm of crashes. Regression analyses were conducted by considering predictor variables such as million vehicle miles of travel (as a function of traffic volume and length), the number of interchanges, the number of at-grade intersections, the number of grade-separated interchanges, and the number of bridges, culverts, and overhead signs along with pavement macrotexture to study the statistical significance of relationship between pavement macrotexture and crashes (both linear and log-linear) when compared to other predictor variables. Scatterplots and regression analysis conducted indicate a more statistically significant relationship between pavement macrotexture and logarithm of crashes than between pavement macrotexture and crashes. The coefficient for pavement macrotexture, in general, is negative, indicating that the number of crashes or logarithm of crashes decreases as it increases. The relation between pavement macrotexture and logarithm of crashes is generally stronger than between most other predictor variables and crashes or logarithm of crashes. Based on results obtained, it can be concluded that maintaining pavement macrotexture greater than or equal to 1.524 mm (0.06 in.) as a threshold limit would possibly reduce crashes and provide safe transportation to road users on highways.

Spinal injury in car crashes: crash factors and the effects of occupant age.

PubMed

Bilston, Lynne E; Clarke, Elizabeth C; Brown, Julie

2011-08-01

Motor vehicle crashes are the leading cause of serious spinal injury in most developed nations. However, since these injuries are rare, systematic analyses of the crash factors that are predictive of spinal injury have rarely been performed. This study aimed to use a population-reference crash sample to identify crash factors associated with moderate to severe spinal injury, and how these vary with occupant age. The US National Automotive Sampling System Crashworthiness Data System (NASS) data for 1993-2007 were analysed using logistic regression to identify crash factors associated with Abbreviated Injury Scale (AIS)2+ spinal injury among restrained vehicle passengers. Risk of moderate or severe spinal injury (AIS2+) was associated with higher severity crashes (OR=3.5 (95% CI 2.6 to 4.6)), intrusion into an occupant's seating position (OR=2.7 (95% CI 1.9 to 3.7)), striking a fixed object rather than another car (OR=1.7 (95% CI 1.3 to 2.1)), and use of a shoulder-only belt (OR=2.7 (95% CI 1.5 to 4.8)). Older occupants (65 years or older) were at higher risk of spinal injury than younger adults in frontal, side and rollover crashes. Children under 16 were at a lower risk of spinal injury than adults in all crash types except frontal crashes. While the risk of serious spinal injury in motor vehicle crashes is low, these injuries are more common in crashes of higher severity or into fixed objects, and in the presence of intrusion. There are elevated risks of spinal injury for older occupants compared with younger adults, which may reflect changes in biomechanical tolerances with age. Children appear to be at lower risk of serious spinal injury than adults except in frontal crashes.

An investigation of the speeding-related crash designation through crash narrative reviews sampled via logistic regression.

PubMed

Fitzpatrick, Cole D; Rakasi, Saritha; Knodler, Michael A

2017-01-01

Speed is one of the most important factors in traffic safety as higher speeds are linked to increased crash risk and higher injury severities. Nearly a third of fatal crashes in the United States are designated as "speeding-related", which is defined as either "the driver behavior of exceeding the posted speed limit or driving too fast for conditions." While many studies have utilized the speeding-related designation in safety analyses, no studies have examined the underlying accuracy of this designation. Herein, we investigate the speeding-related crash designation through the development of a series of logistic regression models that were derived from the established speeding-related crash typologies and validated using a blind review, by multiple researchers, of 604 crash narratives. The developed logistic regression model accurately identified crashes which were not originally designated as speeding-related but had crash narratives that suggested speeding as a causative factor. Only 53.4% of crashes designated as speeding-related contained narratives which described speeding as a causative factor. Further investigation of these crashes revealed that the driver contributing code (DCC) of "driving too fast for conditions" was being used in three separate situations. Additionally, this DCC was also incorrectly used when "exceeding the posted speed limit" would likely have been a more appropriate designation. Finally, it was determined that the responding officer only utilized one DCC in 82% of crashes not designated as speeding-related but contained a narrative indicating speed as a contributing causal factor. The use of logistic regression models based upon speeding-related crash typologies offers a promising method by which all possible speeding-related crashes could be identified. Published by Elsevier Ltd.

Randomized trial for answers to clinical questions: evaluating a pre-appraised versus a MEDLINE search protocol.

PubMed

Patel, Manesh R; Schardt, Connie M; Sanders, Linda L; Keitz, Sheri A

2006-10-01

The paper compares the speed, validity, and applicability of two different protocols for searching the primary medical literature. A randomized trial involving medicine residents was performed. An inpatient general medicine rotation was used. Thirty-two internal medicine residents were block randomized into four groups of eight. Success rate of each search protocol was measured by perceived search time, number of questions answered, and proportion of articles that were applicable and valid. Residents randomized to the MEDLINE-first (protocol A) group searched 120 questions, and residents randomized to the MEDLINE-last (protocol B) searched 133 questions. In protocol A, 104 answers (86.7%) and, in protocol B, 117 answers (88%) were found to clinical questions. In protocol A, residents reported that 26 (25.2%) of the answers were obtained quickly or rated as "fast" (<5 minutes) as opposed to 55 (51.9%) in protocol B, (P = 0.0004). A subset of questions and articles (n = 79) were reviewed by faculty who found that both protocols identified similar numbers of answer articles that addressed the questions and were felt to be valid using critical appraisal criteria. For resident-generated clinical questions, both protocols produced a similarly high percentage of applicable and valid articles. The MEDLINE-last search protocol was perceived to be faster. However, in the MEDLINE-last protocol, a significant portion of questions (23%) still required searching MEDLINE to find an answer.

Geo-spatial and log-linear analysis of pedestrian and bicyclist crashes involving school-aged children.

PubMed

Abdel-Aty, Mohamed; Chundi, Sai Srinivas; Lee, Chris

2007-01-01

There is a growing concern with the safety of school-aged children. This study identifies the locations of pedestrian/bicyclist crashes involving school-aged children and examines the conditions when these crashes are more likely to occur. The 5-year records of crashes in Orange County, Florida where school-aged children were involved were used. The spatial distribution of these crashes was investigated using the Geographic Information Systems (GIS) and the likelihoods of crash occurrence under different conditions were estimated using log-linear models. A majority of school-aged children crashes occurred in the areas near schools. Although elementary school children were generally very involved, middle and high school children were more involved in crashes, particularly on high-speed multi-lane roadways. Driver's age, gender, and alcohol use, pedestrian's/bicyclist's age, number of lanes, median type, speed limits, and speed ratio were also found to be correlated with the frequency of crashes. The result confirms that school-aged children are exposed to high crash risk near schools. High crash involvement of middle and high school children reflects that middle and high schools tend to be located near multi-lane high-speed roads. The pedestrian's/bicyclist's demographic factors and geometric characteristics of the roads adjacent to schools associated with school children's crash involvement are of interest to school districts.

Helicopter crashes related to oil and gas operations in the Gulf of Mexico.

PubMed

Baker, Susan P; Shanahan, Dennis F; Haaland, Wren; Brady, Joanne E; Li, Guohua

2011-09-01

The hazards inherent in flight operations in the Gulf of Mexico prompted investigation of the number and circumstances of crashes related to oil and gas operations in the region. The National Transportation Safety Board (NTSB) database was queried for helicopter crashes during 1983 through 2009 related to Gulf of Mexico oil or gas production. The crashes were identified based on word searches confirmed by a narrative statement indicating that the flight was related to oil or gas operations. During 1983-2009, the NTSB recorded a total of 178 helicopter crashes related to oil and gas operations in the Gulf of Mexico, with an average of 6.6 crashes per year (5.6 annually during 1983-1999 vs. 8.2 during 2000-2009). The crashes resulted in a total of 139 fatalities, including 41 pilots. Mechanical failure was the most common precipitating factor, accounting for 68 crashes (38%). Bad weather led to 29 crashes (16%), in which 40% of the 139 deaths occurred. Pilot error was cited by the NTSB in 83 crashes (47%). After crashes or emergency landings on water, 15 helicopters sank when flotation devices were not activated automatically or by pilots. Mechanical failure, non-activation of flotation, and pilot error are major problems to be addressed if crashes and deaths in this lethal environment are to be reduced.

Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

Cancer.gov

A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom

Accelerating Pediatric Cancer Drug Development: Challenges and Opportunities for Pediatric Master Protocols.

PubMed

Khan, Tahira; Stewart, Mark; Blackman, Samuel; Rousseau, Raphaël; Donoghue, Martha; Cohen, Kenneth; Seibel, Nita; Fleury, Mark; Benettaib, Bouchra; Malik, Raleigh; Vassal, Gilles; Reaman, Gregory

2018-01-01

Although outcomes for children with cancer have significantly improved over the past 40 years, there has been little progress in the treatment of some pediatric cancers, particularly when advanced. Additionally, clinical trial options and availability are often insufficient. Improved genomic and immunologic understanding of pediatric cancers, combined with innovative clinical trial designs, may provide an enhanced opportunity to study childhood cancers. Master protocols, which incorporate the use of precision medicine approaches, coupled with the ability to quickly assess the safety and effectiveness of new therapies, have the potential to accelerate early-phase clinical testing of novel therapeutics and which may result in more rapid approval of new drugs for children with cancer. Designing and conducting master protocols for children requires addressing similar principles and requirements as traditional adult oncology trials, but there are also unique considerations for master protocols conducted in children with cancer. The purpose of this paper is to define the key challenges and opportunities associated with this approach in order to ensure that master protocols can be adapted to benefit children and adolescents and ensure that adequate data are captured to advance, in parallel, the clinical development of investigational agents for children with cancer.

Using linked data to evaluate hospital charges for motor vehicle crash victims in Pennsylvania : Crash Outcome Data Evaluation System (CODES) linked data demonstration project

DOT National Transportation Integrated Search

1998-10-01

The report uses police-reported crash data that have been linked to hospital discharge data to evaluate charges for hospital care provided to motor vehicle crash victims in Pennsylvania. Approximately 17,000 crash victims were hospitalized in Pennsyl...

Injury severity data for front and second row passengers in frontal crashes.

PubMed

Atkinson, Theresa; Leszek Gawarecki; Tavakoli, Massoud

2016-06-01

The data contained here were obtained from the National Highway Transportation Safety Administration׳s National Automotive Sampling System - Crashworthiness Data System (NASS-CDS) for the years 2008-2014. This publically available data set monitors motor vehicle crashes in the United States, using a stratified random sample frame, resulting in information on approximately 5000 crashes each year that can be utilized to create national estimates for crashes. The NASS-CDS data sets document vehicle, crash, and occupant factors. These data can be utilized to examine public health, law enforcement, roadway planning, and vehicle design issues. The data provided in this brief are a subset of crash events and occupants. The crashes provided are exclusively frontal crashes. Within these crashes, only restrained occupants who were seated in the right front seat position or the second row outboard seat positions were included. The front row and second row data sets were utilized to construct occupant pairs crashes where both a right front seat occupant and a second row occupant were available. Both unpaired and paired data sets are provided in this brief.

Injury severity data for front and second row passengers in frontal crashes

PubMed Central

Atkinson, Theresa; Leszek Gawarecki; Tavakoli, Massoud

2016-01-01

The data contained here were obtained from the National Highway Transportation Safety Administration׳s National Automotive Sampling System – Crashworthiness Data System (NASS-CDS) for the years 2008–2014. This publically available data set monitors motor vehicle crashes in the United States, using a stratified random sample frame, resulting in information on approximately 5000 crashes each year that can be utilized to create national estimates for crashes. The NASS-CDS data sets document vehicle, crash, and occupant factors. These data can be utilized to examine public health, law enforcement, roadway planning, and vehicle design issues. The data provided in this brief are a subset of crash events and occupants. The crashes provided are exclusively frontal crashes. Within these crashes, only restrained occupants who were seated in the right front seat position or the second row outboard seat positions were included. The front row and second row data sets were utilized to construct occupant pairs crashes where both a right front seat occupant and a second row occupant were available. Both unpaired and paired data sets are provided in this brief. PMID:27077084

Perception-based road hazard identification with Internet support.

PubMed

Tarko, Andrew P; DeSalle, Brian R

2003-01-01

One of the most important tasks faced by highway agencies is identifying road hazards. Agencies use crash statistics to detect road intersections and segments where the frequency of crashes is excessive. With the crash-based method, a dangerous intersection or segment can be pointed out only after a sufficient number of crashes occur. A more proactive method is needed, and motorist complaints may be able to assist agencies in detecting road hazards before crashes occur. This paper investigates the quality of safety information reported by motorists and the effectiveness of hazard identification based on motorist reports, which were collected with an experimental Internet website. It demonstrates that the intersections pointed out by motorists tended to have more crashes than other intersections. The safety information collected through the website was comparable to 2-3 months of crash data. It was concluded that although the Internet-based method could not substitute for the traditional crash-based methods, its joint use with crash statistics might be useful in detecting new hazards where crash data had been collected for a short time.

A logistic model of the effects of roadway, environmental, vehicle, crash and driver characteristics on hit-and-run crashes.

PubMed

Tay, Richard; Rifaat, Shakil Mohammad; Chin, Hoong Chor

2008-07-01

Leaving the scene of a crash without reporting it is an offence in most countries and many studies have been devoted to improving ways to identify hit-and-run vehicles and the drivers involved. However, relatively few studies have been conducted on identifying factors that contribute to the decision to run after the crash. This study identifies the factors that are associated with the likelihood of hit-and-run crashes including driver characteristics, vehicle types, crash characteristics, roadway features and environmental characteristics. Using a logistic regression model to delineate hit-and-run crashes from nonhit-and-run crashes, this study found that drivers were more likely to run when crashes occurred at night, on a bridge and flyover, bend, straight road and near shop houses; involved two vehicles, two-wheel vehicles and vehicles from neighboring countries; and when the driver was a male, minority, and aged between 45 and 69. On the other hand, collisions involving right turn and U-turn maneuvers, and occurring on undivided roads were less likely to be hit-and-run crashes.

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial.

PubMed

Shih, Sophy T F; Davis-Lameloise, Nathalie; Janus, Edward D; Wildey, Carol; Versace, Vincent L; Hagger, Virginia; Asproloupos, Dino; O'Reilly, Sharleen L; Phillips, Paddy A; Ackland, Michael; Skinner, Timothy; Oats, Jeremy; Carter, Rob; Best, James D; Dunbar, James A

2014-06-30

The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes. The original protocol was published in Trials (http://www.trialsjournal.com/content/14/1/339). This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity. The new exclusion criterion "surgical or medical intervention to treat obesity" has been added to the original protocol. The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP. The screening procedures have also been updated to reflect the current recruitment operation. The first eligibility screening is now taking place either during or after pregnancy, depending on recruitment strategy. Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

How blockchain-timestamped protocols could improve the trustworthiness of medical science

PubMed Central

Irving, Greg; Holden, John

2017-01-01

Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle. We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies. PMID:27239273

How blockchain-timestamped protocols could improve the trustworthiness of medical science.

PubMed

Irving, Greg; Holden, John

2016-01-01

Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle. We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies.

Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

PubMed

Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

2017-10-01

Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study purpose, 7 accurately and 4 inaccurately compared with the reference standard. Seventy-one of 72 noninferiority trial protocols or SAPs provided no rationale for selection of noninferiority hypothesis. None provided a clinical rationale for the chosen amount of decreased efficacy. Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials. Noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.

Influence of Injury Risk Thresholds on the Performance of an Algorithm to Predict Crashes with Serious Injuries

PubMed Central

Bahouth, George; Digges, Kennerly; Schulman, Carl

2012-01-01

This paper presents methods to estimate crash injury risk based on crash characteristics captured by some passenger vehicles equipped with Advanced Automatic Crash Notification technology. The resulting injury risk estimates could be used within an algorithm to optimize rescue care. Regression analysis was applied to the National Automotive Sampling System / Crashworthiness Data System (NASS/CDS) to determine how variations in a specific injury risk threshold would influence the accuracy of predicting crashes with serious injuries. The recommended thresholds for classifying crashes with severe injuries are 0.10 for frontal crashes and 0.05 for side crashes. The regression analysis of NASS/CDS indicates that these thresholds will provide sensitivity above 0.67 while maintaining a positive predictive value in the range of 0.20. PMID:23169132

Time to publication for publicly funded clinical trials in Australia: an observational study.

PubMed

Strand, Linn Beate; Clarke, Philip; Graves, Nicholas; Barnett, Adrian G

2017-03-22

To examine the length of time between receiving funding and publishing the protocol and main paper for randomised controlled trials. An observational study using survival analysis. Publicly funded health and medical research in Australia. Randomised controlled trials funded by the National Health and Medical Research Council of Australia between 2008 and 2010. Time from funding to the protocol paper and main results paper. Multiple variable survival models examining whether study characteristics predicted publication times. We found 77 studies with a total funding of $A59 million. The median time to publication of the protocol paper was 6.4 years after funding (95% CI 4.1 to 8.1). The proportion with a published protocol paper 8 years after funding was 0.61 (95% CI 0.48 to 0.74). The median time to publication of the main results paper was 7.1 years after funding (95% CI 6.3 to 7.6). The proportion with a published main results paper 8 years after funding was 0.72 (95% CI 0.56 to 0.87). The HRs for how study characteristics might influence timing were generally close to one with narrow CIs, the notable exception was that a longer study length lengthened the time to the main paper (HR=0.62 per extra study year, 95% CI 0.43 to 0.89). Despite the widespread registration of clinical trials, there remain serious concerns of trial results not being published or being published with a long delay. We have found that these same concerns apply to protocol papers, which should be publishable soon after funding. Funding agencies could set a target of publishing the protocol paper within 18 months of funding. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Spatial panel analyses of alcohol outlets and motor vehicle crashes in California: 1999–2008

PubMed Central

Ponicki, William R.; Gruenewald, Paul J.; Remer, Lillian G.

2014-01-01

Although past research has linked alcohol outlet density to higher rates of drinking and many related social problems, there is conflicting evidence of density’s association with traffic crashes. An abundance of local alcohol outlets simultaneously encourages drinking and reduces driving distances required to obtain alcohol, leading to an indeterminate expected impact on alcohol-involved crash risk. This study separately investigates the effects of outlet density on (1) the risk of injury crashes relative to population and (2) the likelihood that any given crash is alcohol-involved, as indicated by police reports and single-vehicle nighttime status of crashes. Alcohol outlet density effects are estimated using Bayesian misalignment Poisson analyses of all California ZIP codes over the years 1999–2008. These misalignment models allow panel analysis of ZIP-code data despite frequent redefinition of postal-code boundaries, while also controlling for overdispersion and the effects of spatial autocorrelation. Because models control for overall retail density, estimated alcohol-outlet associations represent the extra effect of retail establishments selling alcohol. The results indicate a number of statistically well-supported associations between retail density and crash behavior, but the implied effects on crash risks are relatively small. Alcohol-serving restaurants have a greater impact on overall crash risks than on the likelihood that those crashes involve alcohol, whereas bars primarily affect the odds that crashes are alcohol-involved. Off-premise outlet density is negatively associated with risks of both crashes and alcohol involvement, while the presence of a tribal casino in a ZIP code is linked to higher odds of police-reported drinking involvement. Alcohol outlets in a given area are found to influence crash risks both locally and in adjacent ZIP codes, and significant spatial autocorrelation also suggests important relationships across geographical units. These results suggest that each type of alcohol outlet can have differing impacts on risks of crashing as well as the alcohol involvement of those crashes. PMID:23537623

Incidence and crash mechanisms of aortic injury during the past decade.

PubMed

Schulman, Carl I; Carvajal, Daniel; Lopez, Peter P; Soffer, Dror; Habib, Fahim; Augenstein, Jeffrey

2007-03-01

Aortic injuries were traditionally thought to be the result of severe frontal crashes. Newer data has suggested other crash types such as nearside crashes may also be important in aortic injury. We hypothesized the implementation of recent safety measures would decrease the incidence of aortic injury associated with fatal motor vehicle crashes. The autopsy reports of all traffic fatalities for motor vehicle occupants in a large urban county for the years 1993 to 2004 were examined. The demographics, impact types, safety measures used, and the presence of any aortic injury were recorded. Trends were evaluated for significance by weighted linear regression. The incidence of aortic injury associated with fatal motor vehicle crashes has remained unchanged during the past 12 years (r = 0.057, p = 0.45). There is a trend toward decreased aortic injuries associated with frontal crashes (r = 0.26, p = 0.089) but no change in aortic injuries associated with nearside or farside crashes (r = 0.053, p = 0.47), when the crash resulted in a fatality. This is despite an increase in seat belt use and increased presence of airbags during the same time period. Despite improved safety measures designed to minimize the occurrence of aortic injuries, the incidence of blunt aortic injury in fatal motor vehicle crashes has not decreased during the past decade. Although not statistically significant, there is a trend toward decreased frontal impacts in fatal motor vehicle crashes associated with aortic injuries. The nearside crash mechanism continues to play a prominent role, and efforts at improving vehicle safety should be focused on crash mechanisms as they relate to aortic injury.

Investigation of pedestrian crashes on two-way two-lane rural roads in Ethiopia.

PubMed

Tulu, Getu Segni; Washington, Simon; Haque, Md Mazharul; King, Mark J

2015-05-01

Understanding pedestrian crash causes and contributing factors in developing countries is critically important as they account for about 55% of all traffic crashes. Not surprisingly, considerable attention in the literature has been paid to road traffic crash prediction models and methodologies in developing countries of late. Despite this interest, there are significant challenges confronting safety managers in developing countries. For example, in spite of the prominence of pedestrian crashes occurring on two-way two-lane rural roads, it has proven difficult to develop pedestrian crash prediction models due to a lack of both traffic and pedestrian exposure data. This general lack of available data has further hampered identification of pedestrian crash causes and subsequent estimation of pedestrian safety performance functions. The challenges are similar across developing nations, where little is known about the relationship between pedestrian crashes, traffic flow, and road environment variables on rural two-way roads, and where unique predictor variables may be needed to capture the unique crash risk circumstances. This paper describes pedestrian crash safety performance functions for two-way two-lane rural roads in Ethiopia as a function of traffic flow, pedestrian flows, and road geometry characteristics. In particular, random parameter negative binomial model was used to investigate pedestrian crashes. The models and their interpretations make important contributions to road crash analysis and prevention in developing countries. They also assist in the identification of the contributing factors to pedestrian crashes, with the intent to identify potential design and operational improvements. Copyright © 2015. Published by Elsevier Ltd.

Epidemiology of pedestrian–MVCs by road type in Cluj, Romania

PubMed Central

Hamann, Cara; Peek-Asa, Corinne; Rus, Diana

2017-01-01

Objective Pedestrian–motor vehicle (PMV) crash rates in Romania are among the highest in all of Europe. The purpose of this study was to examine the characteristics of pedestrian–MVCs in Cluj County, Romania, on the two major types of roadways: national or local. Methods Cluj County police crash report data from 2010 were used to identify pedestrian, driver and crash characteristics of pedestrian–MVCs. Crashes with available location data were geocoded and road type (national or local) for each crash was determined. Distributions of crash characteristics were examined by road type and multivariable logistic regression models were built to determine predictors of crash road type. Results Crashes occurring on national roads involved more teenagers and adults, while those on local roads involved more young children (0–12) and older adults (65+) (p<0.01). Crashes on national roads were more likely to have marked pedestrian crossings and shoulders compared with local crashes. Pedestrian–MVCs that involved a moving violation by the motorist were more likely to occur on national roadways (adjusted OR=1.93, 95% CI 1.07 to 3.49). Conclusions Pedestrian–MVCs pose a considerable health burden in Romania. Results from this study suggest that factors leading to PMV crashes on national roads are more likely to involve driver-related causes compared with local roads. Intervention priorities to reduce pedestrian crashes on national roads should be directed towards driver behaviour on national roads. Further examination of driver and pedestrian behaviours related to crash risk on both national and local roads, such as distraction and speeding, is warranted. PMID:25178278

Costs of Crashes to Government, United States, 2008

PubMed Central

Miller, Ted R; Bhattacharya, Soma; Zaloshnja, Eduard; Taylor, Dexter; Bahar, Geni; David, Iuliana

2011-01-01

We estimated how much the Federal government and state/local government pay for different kinds of crashes in the United States. Government costs include reductions in an array of public services (emergency, incident management, vocational rehabilitation, coroner court processing of liability litigation), medical payments, social safety net assistance to the injured and their families, and taxes foregone because victims miss work. Government also pays when its employees crash while working and covers fringe benefits for crash-involved employees and their benefit-eligible dependents in non-work hours. We estimated government shares of crash costs by component. We applied those estimates to existing US Department of Transportation estimates of crash costs to society and employers. Government pays an estimated $35 billion annually because of crashes, an estimated 12.6% of the economic cost of crashes (Federal 7.1%, State/local 5.5%). Government bears a higher percentage of the monetary costs of injury crashes than fatal crashes or crashes involving property damage only. Government is increasingly recovering the medical cost of crashes from auto insurers. Nevertheless, medical costs and income and sales tax losses account for 75% of government's crash costs. For State/local government to break even on a 100%-State funded investment in road safety, the intervention would need to have an unrealistically high benefit-cost ratio of 34. Government invests in medical treatment of illness to save lives and improve quality of life. Curing a child's leukemia, for example, is not less costly than leaving that leukemia untreated. Safety should not be held to a different standard. PMID:22105409

Predicting Crashes Using Traffic Offences. A Meta-Analysis that Examines Potential Bias between Self-Report and Archival Data

PubMed Central

af Wåhlberg, Anders; Freeman, James; Watson, Barry; Watson, Angela

2016-01-01

Background Traffic offences have been considered an important predictor of crash involvement, and have often been used as a proxy safety variable for crashes. However the association between crashes and offences has never been meta-analysed and the population effect size never established. Research is yet to determine the extent to which this relationship may be spuriously inflated through systematic measurement error, with obvious implications for researchers endeavouring to accurately identify salient factors predictive of crashes. Methodology and Principal Findings Studies yielding a correlation between crashes and traffic offences were collated and a meta-analysis of 144 effects drawn from 99 road safety studies conducted. Potential impact of factors such as age, time period, crash and offence rates, crash severity and data type, sourced from either self-report surveys or archival records, were considered and discussed. After weighting for sample size, an average correlation of r = .18 was observed over the mean time period of 3.2 years. Evidence emerged suggesting the strength of this correlation is decreasing over time. Stronger correlations between crashes and offences were generally found in studies involving younger drivers. Consistent with common method variance effects, a within country analysis found stronger effect sizes in self-reported data even controlling for crash mean. Significance The effectiveness of traffic offences as a proxy for crashes may be limited. Inclusion of elements such as independently validated crash and offence histories or accurate measures of exposure to the road would facilitate a better understanding of the factors that influence crash involvement. PMID:27128093

A Method of Managing Severe Traumatic Brain Injury in the Absence of Intracranial Pressure Monitoring: The Imaging and Clinical Examination Protocol.

PubMed

Chesnut, Randall M; Temkin, Nancy; Dikmen, Sureyya; Rondina, Carlos; Videtta, Walter; Petroni, Gustavo; Lujan, Silvia; Alanis, Victor; Falcao, Antonio; de la Fuenta, Gustavo; Gonzalez, Luis; Jibaja, Manuel; Lavarden, Arturo; Sandi, Freddy; Mérida, Roberto; Romero, Ricardo; Pridgeon, Jim; Barber, Jason; Machamer, Joan; Chaddock, Kelley

2018-01-01

The imaging and clinical examination (ICE) algorithm used in the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure (BEST TRIP) randomized controlled trial is the only prospectively investigated clinical protocol for traumatic brain injury management without intracranial pressure (ICP) monitoring. As the default literature standard, it warrants careful evaluation. We present the ICE protocol in detail and analyze the demographics, outcome, treatment intensity, frequency of intervention usage, and related adverse events in the ICE-protocol cohort. The 167 ICE protocol patients were young (median 29 years) with a median Glasgow Coma Scale motor score of 4 but with anisocoria or abnormal pupillary reactivity in 40%. This protocol produced outcomes not significantly different from those randomized to the monitor-based protocol (favorable 6-month extended Glasgow Outcome Score in 39%; 41% mortality rate). Agents commonly employed to treat suspected intracranial hypertension included low-/moderate-dose hypertonic saline (72%) and mannitol (57%), mild hyperventilation (adjusted partial pressure of carbon dioxide 30-35 mm Hg in 73%), and pressors to maintain cerebral perfusion (62%). High-dose hyperosmotics or barbiturates were uncommonly used. Adverse event incidence was low and comparable to the BEST TRIP monitored group. Although this protocol should produce similar/acceptable results under circumstances comparable to those in the trial, influences such as longer pre-hospital times and non-specialist transport personnel, plus an intensive care unit model of aggressive physician-intensive care by small groups of neurotrauma-focused intensivists, which differs from most high-resource models, support caution in expecting the same results in dissimilar settings. Finally, this protocol's ICP-titration approach to suspected intracranial hypertension (vs. crisis management for monitored ICP) warrants further study.

Participation in Pediatric Oncology Research Protocols: Racial/ethnic, Language and Age-based Disparities

PubMed Central

Aristizabal, Paula; Singer, Jenelle; Cooper, Renee; Wells, Kristen J.; Nodora, Jesse; Milburn, Mehrzad; Gahagan, Sheila; Schiff, Deborah E.; Martinez, Maria Elena

2015-01-01

Background Survival rates in pediatric oncology have improved dramatically, in part due to high patient participation in clinical trials. Although racial/ethnic inequalities in clinical trial participation have been reported in adults, pediatric data and studies comparing participation rates by socio-demographic characteristics are scarce. The goal of this study was to assess differences in research protocol participation for childhood cancer by age, sex, race/ethnicity, parental language, cancer type and insurance status. Procedure Data on enrollment in any protocol, biospecimen, or therapeutic protocols were collected and analyzed for newly diagnosed pediatric patients with cancer from 2008–2012 at Rady Children’s Hospital. Results Among the 353 patients included in the analysis, 304 (86.1%) were enrolled in any protocol. Enrollment in biospecimen and therapeutic protocols was 84.2% (261/310) and 81.1% (206/254), respectively. Logistic regression analyses revealed significant enrollment underrepresentation in any protocol for Hispanics compared to Non-Hispanic whites (81% vs. 91%; Odds Ratio [OR], 0.43; 95% Confidence Interval [CI], 0.21–0.90; p=0.021) and among children of Spanish-speaking vs. English-speaking parents (78% vs. 89%; OR, 0.45; 95%CI, 0.23–0.87; p=0.016). Compared to patients aged 0–4 years, significant underrepresentation was also found among patients 15–21 years old (92% vs.72%; OR, 0.21; 95% CI, 0.09–0.48; p<0.001). Similar trends were observed when analyzing enrollment in biospecimen and therapeutic protocols separately. Conclusions There was significant underrepresentation in protocol participation for Hispanics, children of Spanish-speaking parents, and patients ages 15–21. Research is urgently needed to understand barriers to research participation among these groups underrepresented in pediatric oncology clinical trials. PMID:25755225

Bridging the gap in complementary and alternative medicine research: manualization as a means of promoting standardization and flexibility of treatment in clinical trials of acupuncture.

PubMed

Schnyer, Rosa N; Allen, John J B

2002-10-01

An important methodological challenge encountered in acupuncture clinical research involves the design of treatment protocols that help ensure standardization and replicability while allowing for the necessary flexibility to tailor treatments to each individual. Manualization of protocols used in clinical trials of acupuncture and other traditionally-based complementary and alternative medicine (CAM) systems facilitates the systematic delivery of replicable and standardized, yet individually-tailored treatments. To facilitate high-quality CAM acupuncture research by outlining a method for the systematic design and implementation of protocols used in CAM clinical trials based on the concept of treatment manualization. A series of treatment manuals was developed to systematically articulate the Chinese medical theoretical and clinical framework for a given Western-defined illness, to increase the quality and consistency of treatment, and to standardize the technical aspects of the protocol. In all, three manuals were developed for National Institutes of Health (NIH)-funded clinical trials of acupuncture for depression, spasticity in cerebral palsy, and repetitive stress injury. In Part I, the rationale underlying these manuals and the challenges encountered in creating them are discussed, and qualitative assessments of their utility are provided. In Part II, a methodology to develop treatment manuals for use in clinical trials is detailed, and examples are given. A treatment manual provides a precise way to train and supervise practitioners, enable evaluation of conformity and competence, facilitate the training process, and increase the ability to identify the active therapeutic ingredients in clinical trials of acupuncture.

From road to lab to math: the co-evolution of technological, regulatory, and organizational innovations for automotive crash testing.

PubMed

Leonardi, Paul M

2010-04-01

Today, in the midst of economic crisis, senior executives at US automakers and influential industry analysts frequently reflect on the progression that safety testing has taken from the crude trials done on the road, to controlled laboratory experiments, and to today's complex math-based simulation models. They use stories of this seemingly linear and natural sequence to justify further investment in simulation technologies. The analysis presented in this paper shows that change in the structures of automakers' organizations co-evolved with regulations specifying who was at fault in vehicle impacts, how vehicles should be built to withstand the force of an impact, and how testing should be done to assure that vehicles met those requirements. Changes in the regulatory environment were bolstered by new theories about crash test dynamics and changing technologies with which to test those theories. Thus, as new technological and regulatory innovations co-evolved with innovations in organizational structuring, ideas about how to best conduct crash tests shifted and catalyzed new cycles of technological, regulatory, and organizational innovation. However, this co-evolutionary story tells us that the move from road to lab to math was not natural or linear as today's managerial rhetoric would have us believe. Rather, the logic of math-based simulation was the result of technological, regulatory and organizational changes that created an industry-wide ideology that supported the move toward math while making it appear natural within the shifting structure of the industry.

Crash probability estimation via quantifying driver hazard perception.

PubMed

Li, Yang; Zheng, Yang; Wang, Jianqiang; Kodaka, Kenji; Li, Keqiang

2018-07-01

Crash probability estimation is an important method to predict the potential reduction of crash probability contributed by forward collision avoidance technologies (FCATs). In this study, we propose a practical approach to estimate crash probability, which combines a field operational test and numerical simulations of a typical rear-end crash model. To consider driver hazard perception characteristics, we define a novel hazard perception measure, called as driver risk response time, by considering both time-to-collision (TTC) and driver braking response to impending collision risk in a near-crash scenario. Also, we establish a driving database under mixed Chinese traffic conditions based on a CMBS (Collision Mitigation Braking Systems)-equipped vehicle. Applying the crash probability estimation in this database, we estimate the potential decrease in crash probability owing to use of CMBS. A comparison of the results with CMBS on and off shows a 13.7% reduction of crash probability in a typical rear-end near-crash scenario with a one-second delay of driver's braking response. These results indicate that CMBS is positive in collision prevention, especially in the case of inattentive drivers or ole drivers. The proposed crash probability estimation offers a practical way for evaluating the safety benefits in the design and testing of FCATs. Copyright © 2017 Elsevier Ltd. All rights reserved.

Factors influencing pediatric Injury Severity Score and Glasgow Coma Scale in pediatric automobile crashes: results from the Crash Injury Research Engineering Network.

PubMed

Ehrlich, Peter F; Brown, J Kristine; Sochor, Mark R; Wang, Stewart C; Eichelberger, Martin E

2006-11-01

Motor vehicle crashes account for more than 50% of pediatric injuries. Triage of pediatric patients to appropriate centers can be based on the crash/injury characteristics. Pediatric motor vehicle crash/injury characteristics can be determined from an in vitro laboratory using child crash dummies. However, to date, no detailed data with respect to outcomes and crash mechanism have been presented with a pediatric in vivo model. The Crash Injury Research Engineering Network is comprised of 10 level 1 trauma centers. Crashes were examined with regard to age, crash severity (DeltaV), crash direction, restraint use, and airbag deployment. Multiple logistic regression analysis was performed with Injury Severity Score (ISS) and Glasgow Coma Scale (GCS) as outcomes. Standard age groupings (0-4, 5-9, 10-14, and 15-18) were used. The database is biases toward a survivor population with few fatalities. Four hundred sixty-one motor vehicle crashes with 2500 injuries were analyzed (242 boys, 219 girls). Irrespective of age, DeltaV > 30 mph resulted in increased ISS and decreased GCS (eg, for 0-4 years, DeltaV < 30: ISS = 10, GCS = 13.5 vs DeltaV > 30: ISS = 19.5, GCS = 10.6; P < .007, < .002, respectively). Controlling for DeltaV, children in lateral crashes had increased ISS and decreased GCS versus those in frontal crashes. Airbag deployment was protective for children 15 to 18 years old and resulted in a lower ISS and higher GCS (odds ratio, 2.1; 95% confidence interval, 0.9-4.6). Front-seat passengers suffered more severe (ISS > 15) injuries than did backseat passengers (odds ratio, 1.7; 95% confidence interval, 0.7-3.4). A trend was noted for children younger than 12 years sitting in the front seat to have increased ISS and decreased GCS with airbag deployment but was limited by case number. A reproducible pattern of increased ISS and lower GCS characterized by high severity, lateral crashes in children was noted. Further analysis of the specific injuries as a function and the crash characteristic can help guide management and prevention strategies.

Hotspots and causes of motor vehicle crashes in Baltimore, Maryland: A geospatial analysis of five years of police crash and census data

PubMed Central

Dezman, Zachary; de Andrade, Luciano; Vissoci, Joao Ricardo; El-Gabri, Deena; Johnson, Abree; Hirshon, Jon Mark; Staton, Catherine A.

2017-01-01

Introduction Road traffic injuries are a leading killer of youth (aged 15–29) and are projected to be the 7th leading cause of death by 2030. To better understand road traffic crash locations and characteristics in the city of Baltimore, we used police and census data, to describe the epidemiology, hotspots, and modifiable risk factors involved to guide further interventions. Materials and methods Data on all crashes in Baltimore City from 2009 to 2013 were made available from the Maryland Automated Accident Reporting System. Socioeconomic data collected by the US CENSUS 2010 were obtained. A time series analysis was conducted using an ARIMA model. We analyzed the geographical distribution of traffic crashes and hotspots using exploratory spatial data analysis and spatial autocorrelation. Spatial regression was performed to evaluate the impact of socioeconomic indicators on hotspots. Results In Baltimore City, between 2009 and 2013, there were a total of 100,110 crashes reported, with 1% of crashes considered severe. Of all crashes, 7% involved vulnerable road users and 12% had elderly or youth involvement. Reasons for crashes included: distracted driving (31%), speeding (6%), and alcohol or drug use (5%). After 2010, we observed an increasing trend in all crashes especially from March to June. Distracted driving then youth and elderly drivers were consistently the highest risk factors over time. Multivariate spatial regression model including socioeconomic indicators and controlling for age, gender and population size did not show a distinct predictor of crashes explaining only 20% of the road crash variability, indicating crashes are not geographically explained by socioeconomic indicators alone. Conclusion In Baltimore City, road traffic crashes occurred predominantly in the high density center of the city, involved distracted driving and extremes of age with an increase in crashes from March to June. There was no association between socioeconomic variables where crashes occurred and hotspots. In depth analysis of how modifiable risk factors are impacted by geospatial characteristics and the built environment is warranted in Baltimore to tailor interventions. PMID:27614672

Hotspots and causes of motor vehicle crashes in Baltimore, Maryland: A geospatial analysis of five years of police crash and census data.

PubMed

Dezman, Zachary; de Andrade, Luciano; Vissoci, Joao Ricardo; El-Gabri, Deena; Johnson, Abree; Hirshon, Jon Mark; Staton, Catherine A

2016-11-01

Road traffic injuries are a leading killer of youth (aged 15-29) and are projected to be the 7th leading cause of death by 2030. To better understand road traffic crash locations and characteristics in the city of Baltimore, we used police and census data, to describe the epidemiology, hotspots, and modifiable risk factors involved to guide further interventions. Data on all crashes in Baltimore City from 2009 to 2013 were made available from the Maryland Automated Accident Reporting System. Socioeconomic data collected by the US CENSUS 2010 were obtained. A time series analysis was conducted using an ARIMA model. We analyzed the geographical distribution of traffic crashes and hotspots using exploratory spatial data analysis and spatial autocorrelation. Spatial regression was performed to evaluate the impact of socioeconomic indicators on hotspots. In Baltimore City, between 2009 and 2013, there were a total of 100,110 crashes reported, with 1% of crashes considered severe. Of all crashes, 7% involved vulnerable road users and 12% had elderly or youth involvement. Reasons for crashes included: distracted driving (31%), speeding (6%), and alcohol or drug use (5%). After 2010, we observed an increasing trend in all crashes especially from March to June. Distracted driving then youth and elderly drivers were consistently the highest risk factors over time. Multivariate spatial regression model including socioeconomic indicators and controlling for age, gender and population size did not show a distinct predictor of crashes explaining only 20% of the road crash variability, indicating crashes are not geographically explained by socioeconomic indicators alone. In Baltimore City, road traffic crashes occurred predominantly in the high density center of the city, involved distracted driving and extremes of age with an increase in crashes from March to June. There was no association between socioeconomic variables where crashes occurred and hotspots. In depth analysis of how modifiable risk factors are impacted by geospatial characteristics and the built environment is warranted in Baltimore to tailor interventions. Copyright © 2016 Elsevier Ltd. All rights reserved.

IL-6, Antioxidant Capacity and Muscle Damage Markers Following High-Intensity Interval Training Protocols.

PubMed

Cipryan, Lukas

2017-02-01

The aim of this study was to investigate changes of interleukin-6 (IL-6), total antioxidant capacity (TAC) and muscle damage markers (creatine kinase (CK), myoglobin and lactate dehydrogenase (LDH)) in response to three different high-intensity interval training (HIIT) protocols of identical external work. Twelve moderately-trained males participated in the three HIIT trials which consisted of a warm-up, followed by 12 min of 15 s, 30 s or 60 s HIIT sequences with the work/rest ratio 1. The biochemical markers of inflammation, oxidative stress and muscle damage were analysed POST, 3 h and 24 h after the exercise. All HIIT protocols caused an immediate increase in IL-6, TAC, CK, myoglobin and LDH. The most pronounced between-trials differences were found for the POST-exercise changes in IL-6 (Effect size ± 90% confidence interval: 1.51 ± 0.63, 0.84 ± 0.34 and 1.80 ± 0.60 for the 15s/15s, 30s/30s and 60s/60s protocol, respectively) and myoglobin (1.11 ± 0.29, 0.45 ± 0.48 and 1.09 ± 0.22 for the 15s/15s, 30s/30s and 60s/60s protocol, respectively). There were no substantial between-trial differences in other biochemical variables. In conclusion, the 15s/15s and 60s/60s protocols might be preferred to the 30s/30s protocols in order to maximize the training stimulus.

Featured Article: Evaluating Smartphone-Based Virtual Reality to Improve Chinese Schoolchildren's Pedestrian Safety: A Nonrandomized Trial.

PubMed

Schwebel, David C; Wu, Yue; Li, Peng; Severson, Joan; He, Yefei; Xiang, Henry; Hu, Guoqing

2018-06-01

This nonrandomized trial evaluated whether classroom-based training in a smartphone-based virtual reality (VR) pedestrian environment (a) teaches schoolchildren to cross streets safely, and (b) increases their self-efficacy for street-crossing. Fifty-six children, aged 8-10 years, attending primary school in Changsha, China participated. Baseline pedestrian safety assessment occurred in the VR environment and through unobtrusive observation of a subsample crossing a street for 11 days outside school. Self-efficacy was assessed through both self-report and observation. Following baseline, children engaged in the VR for 12 days in their classrooms, honing complex cognitive-perceptual skills required to engage safely in traffic. Follow-up assessment replicated baseline. Probability of crash in the VR decreased posttraining (0.40 vs. 0.09), and observational data found the odds of looking at oncoming traffic while crossing the first lane of traffic increased (odds ratio [OR] = 2.4). Self-efficacy increases occurred in self-report (proportional OR = 4.7 crossing busy streets) and observation of following crossing-guard signals (OR = 0.2, first lane). Pedestrian safety training via smartphone-based VR provides children the repeated practice needed to learn the complex skills required to cross streets safely, and also helps them improve self-efficacy to cross streets. Given rapid motorization and global smartphone penetration, plus epidemiological findings that about 75,000 children die annually worldwide in pedestrian crashes, smartphone-based VR could supplement existing policy and prevention efforts to improve global child pedestrian safety.

Multi-level assessment protocol (MAP) for adoption in multi-site clinical trials

PubMed Central

Guydish, J.; Manser, S.T.; Jessup, M.; Tajima, B.; Sears, C.; Montini, T.

2010-01-01

The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) is intended to test promising drug abuse treatment models in multi-site clinical trials, and to support adoption of new interventions into clinical practice. Using qualitative research methods we asked: How might the technology of multi-site clinical trials be modified to better support adoption of tested interventions? A total of 42 participants, representing 8 organizational levels ranging from clinic staff to clinical trial leaders, were interviewed about their role in the clinical trial, its interactions with clinics, and intervention adoption. Among eight clinics participating in the clinical trial, we found adoption of the tested intervention in one clinic only. In analysis of interview data we identified four conceptual themes which are likely to affect adoption and may be informative in future multi-site clinical trials. We offer the conclusion that planning for adoption in the early stages of protocol development will better serve the aim of integrating new interventions into practice. PMID:20890376

How to customize a bona fide psychotherapy for generalized anxiety disorder? A two-arms, patient blinded, ABAB crossed-therapist randomized clinical implementation trial design [IMPLEMENT 2.0].

PubMed

Flückiger, Christoph; Wolfer, Christine; Held, Judith; Hilpert, Peter; Rubel, Julian; Allemand, Mathias; Zinbarg, Richard E; Vîslă, Andreea

2018-04-03

Bona fide psychotherapy approaches are effective treatments for generalized anxiety disorder (GAD) compared to no-treatment conditions. Treatment manuals and protocols allow a relatively high degree of freedom for the way therapists implement these overall treatment packages and there is a systematic lack of knowledge on how therapists should customize these treatments. The present study experimentally examines two implementation strategies of customizing a bona fide psychotherapy approach based on a 16 session time-limited cognitive-behavioral therapy (CBT) protocol and their relation to the post-session and ultimate treatment outcomes. This trial contrasts two different implementation strategies of how to customize the in-session structure of a manual-based CBT-protocol for GAD. The patients will be randomly assigned to two implementation conditions: (1) a systematic focus on subtle changes lasting from 7 to 20 min at the check-in phase of every psychotherapy session and (2) a state-of-the-art (SOTA) check-in phase lasting several minutes mainly focused on the session goals. Potential therapist effects will be examined based on an ABAB crossed-therapist design. Treatment outcomes will be assessed at the following times: post-session outcomes, treatment outcome at post assessment and 6- as well as 12-month follow-up. The proposed randomized clinical implementation trial addresses the clinically relevant question of how to customize a bona fide psychotherapy protocol experimentally contrasting two implementation strategies. Through the development and testing of the proposed implementation design, this trial has the potential to inform therapists about efficacious implementation strategies of how to customize a manual-based treatment protocol in respect to the timing of the in-session structure. This trial was registered at ClinicalTrials.gov ( NCT03079336 ) at March 14, 2017.

The implementation and adherence to evidence-based protocols for psychotherapy for depression: the perspective of therapists in Dutch specialized mental healthcare.

PubMed

Bruijniks, Sanne J E; Franx, Gerdien; Huibers, Marcus J H

2018-06-14

Although psychotherapy is an effective treatment for depression, a large number of patients still do not receive care according to the protocols that are used in clinical trials. Instead, patients often receive a modified version of the original intervention. It is not clear how and when treatment protocols are used or modified in the Dutch specialized mental health care and whether these changes lead to suboptimal adherence to treatment protocols. In the context of an ongoing multicenter trial that investigates whether twice-weekly sessions of protocolized interpersonal psychotherapy (IPT) and cognitive behavioral therapy (CBT) for depression lead to better treatment outcomes compared to once-weekly sessions, two focus groups using semi-structured interviews were organized. Aims were to increase insight in the adherence to and modifications of CBT and IPT protocols in the Dutch specialized mental health care for depression. Participants were fifteen therapists from seven mental health locations part of five mental health organizations. Verbatim transcripts were coded and analyzed using qualitative software. Three themes emerged: modification as the common practice, professional and patient factors influencing the adherence to protocols and organizational boundaries and flexibility. Treatment modification appeared to happen on a frequent basis, even in the context of a trial. Definitions of treatment modifications were multiple and varied from using intuition to flexible use of the same protocol. Therapist training and supervision, the years of work experience and individual characteristics of the therapist and the patient were mentioned to influence the adherence to protocols. Modifications of the therapists depended very much on the culture within the mental health locations, who differed in terms of the flexibility offered to therapists to choose and modify treatment protocols. Not all treatment modifications were in line with existing evidence or guidelines. Regular supervision, team meetings and a shared vision were identified as crucial factors to increase adherence to treatment protocols, whereas additional organizational factors, among which a change of mindset, may facilitate adequate implementation.

Improving delirium care in the intensive care unit: The design of a pragmatic study

PubMed Central

2011-01-01

Background Delirium prevalence in the intensive care unit (ICU) is high. Numerous psychotropic agents are used to manage delirium in the ICU with limited data regarding their efficacy or harms. Methods/Design This is a randomized controlled trial of 428 patients aged 18 and older suffering from delirium and admitted to the ICU of Wishard Memorial Hospital in Indianapolis. Subjects assigned to the intervention group will receive a multicomponent pharmacological management protocol for delirium (PMD) and those assigned to the control group will receive no change in their usual ICU care. The primary outcomes of the trial are (1) delirium severity as measured by the Delirium Rating Scale revised-98 (DRS-R-98) and (2) delirium duration as determined by the Confusion Assessment Method for the ICU (CAM-ICU). The PMD protocol targets the three neurotransmitter systems thought to be compromised in delirious patients: dopamine, acetylcholine, and gamma-aminobutyric acid. The PMD protocol will target the reduction of anticholinergic medications and benzodiazepines, and introduce a low-dose of haloperidol at 0.5-1 mg for 7 days. The protocol will be delivered by a combination of computer (artificial intelligence) and pharmacist (human intelligence) decision support system to increase adherence to the PMD protocol. Discussion The proposed study will evaluate the content and the delivery process of a multicomponent pharmacological management program for delirium in the ICU. Trial Registration ClinicalTrials.gov: NCT00842608 PMID:21645330

Idaho traffic crashes, 2007

DOT National Transportation Integrated Search

2007-01-01

Idaho Traffic Crashes 2007 provides an annual description of motor vehicle crash characteristics for : crashes that have occurred within the State of Idaho. This document is used by state and local : transportation, law enforcement, health, and other...

Crash countermeasure and mobility effects.

DOT National Transportation Integrated Search

2012-04-19

The Michigan Department of Transportation (MDOT) has undertaken several initiatives to reduce crashes on its roadway network. In 2009, there were 2,201 reported crashes involving pedestrians and 866 reported crashes involving bicyclists in Michigan. ...

Traffic crash statistics report, 2005

DOT National Transportation Integrated Search

2006-01-01

The information contained in this Traffic Crash Statistics booklet is extracted from law enforcement : agency long-form reports of traffic crashes. A law enforcement officer must submit a long-form : crash report when investigating: : Motor vehic...

Large truck crash facts 2005

DOT National Transportation Integrated Search

2007-02-01

This annual edition of Large Truck Crash Facts contains descriptive statistics about fatal, injury, and property damage only crashes involving large trucks in 2005. Selected crash statistics on passenger vehicles are also presented for comparison pur...

Cell phone use and traffic crash risk: a culpability analysis.

PubMed

Asbridge, Mark; Brubacher, Jeff R; Chan, Herbert

2013-02-01

The use of a cell phone or communication device while driving is illegal in many jurisdictions, yet evidence evaluating the crash risk associated with cell phone use in naturalistic settings is limited. This article aims to determine whether cell phone use while driving increases motor vehicle crash culpability. Method Drivers involved in crashes where police reported cell phone use (n = 312) and propensity matched drivers (age, sex, suspect alcohol/drug impairment, crash type, date, time of day, geographical location) without cell phone use (n = 936) were drawn from Insurance Corporation of British Columbia Traffic Accident System data. A standardized scoring tool, modified to account for Canadian driving conditions, was used to determine crash culpability from police reports on all drivers from the crashes. The association between crash culpability and cell phone use was determined, with additional subgroup analyses based on crash severity, driver characteristics and type of licence. A comparison of crashes with vs without cell phones revealed an odds ratio of 1.70 (95% confidence interval 1.22-2.36; P = 0.002). This association was consistent after adjustment for matching variables and other covariates. Subgroup analyses demonstrated an association for male drivers, unimpaired drivers, injured and non-injured drivers, and for drivers aged between 26 and 65 years. Crash culpability was found to be significantly associated with cell phone use by drivers, increasing the odds of a culpable crash by 70% compared with drivers who did not use a cell phone. This increased risk was particularly high for middle-aged drivers.

Impact of pavement conditions on crash severity.

PubMed

Li, Yingfeng; Liu, Chunxiao; Ding, Liang

2013-10-01

Pavement condition has been known as a key factor related to ride quality, but it is less clear how exactly pavement conditions are related to traffic crashes. The researchers used Geographic Information System (GIS) to link Texas Department of Transportation (TxDOT) Crash Record Information System (CRIS) data and Pavement Management Information System (PMIS) data, which provided an opportunity to examine the impact of pavement conditions on traffic crashes in depth. The study analyzed the correlation between several key pavement condition ratings or scores and crash severity based on a large number of crashes in Texas between 2008 and 2009. The results in general suggested that poor pavement condition scores and ratings were associated with proportionally more severe crashes, but very poor pavement conditions were actually associated with less severe crashes. Very good pavement conditions might induce speeding behaviors and therefore could have caused more severe crashes, especially on non-freeway arterials and during favorable driving conditions. In addition, the results showed that the effects of pavement conditions on crash severity were more evident for passenger vehicles than for commercial vehicles. These results provide insights on how pavement conditions may have contributed to crashes, which may be valuable for safety improvement during pavement design and maintenance. Readers should notice that, although the study found statistically significant effects of pavement variables on crash severity, the effects were rather minor in reality as suggested by frequency analyses. Copyright © 2013 Elsevier Ltd. All rights reserved.

Fatal crashes involving large numbers of vehicles and weather.

PubMed

Wang, Ying; Liang, Liming; Evans, Leonard

2017-12-01

Adverse weather has been recognized as a significant threat to traffic safety. However, relationships between fatal crashes involving large numbers of vehicles and weather are rarely studied according to the low occurrence of crashes involving large numbers of vehicles. By using all 1,513,792 fatal crashes in the Fatality Analysis Reporting System (FARS) data, 1975-2014, we successfully described these relationships. We found: (a) fatal crashes involving more than 35 vehicles are most likely to occur in snow or fog; (b) fatal crashes in rain are three times as likely to involve 10 or more vehicles as fatal crashes in good weather; (c) fatal crashes in snow [or fog] are 24 times [35 times] as likely to involve 10 or more vehicles as fatal crashes in good weather. If the example had used 20 vehicles, the risk ratios would be 6 for rain, 158 for snow, and 171 for fog. To reduce the risk of involvement in fatal crashes with large numbers of vehicles, drivers should slow down more than they currently do under adverse weather conditions. Driver deaths per fatal crash increase slowly with increasing numbers of involved vehicles when it is snowing or raining, but more steeply when clear or foggy. We conclude that in order to reduce risk of involvement in crashes involving large numbers of vehicles, drivers must reduce speed in fog, and in snow or rain, reduce speed by even more than they already do. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Spatial analysis to identify high risk areas for traffic crashes resulting in death of pedestrians in Tehran

PubMed Central

Moradi, Ali; Soori, Hamid; Kavousi, Amir; Eshghabadi, Farshid; Jamshidi, Ensiyeh; Zeini, Salahdien

2016-01-01

Background: More than 20% of deaths from traffic crashes are related to pedestrians. This figure in Tehran, the capital of Iran, reaches to 40%. This study aimed to determine the high-risk areas and spatially analyze the traffic crashes, causing death to pedestrians in Tehran. Methods: Mapping was used to display the distribution of the crashes. Determining the distribution pattern of crashes and the hot spots/ low-risk areas were done, using Moran’s I index and Getis-Ord G, respectively. Results: A total of 198 crashes were studied; 92 of which, (46.4%) occurred in 2013 to 2014 and other 106 cases (63.6%) occurred in 2014 to 2015. The highest and the lowest frequency of crashes was related to January (26 cases) and June (10 cases), respectively. One hundred fifty- eight cases (79.8%) of crashes occurred in Tehran highways. Moran’s index showed that the studied traffic crashes had a cluster distribution (p<0.001). Getis- Ord General G index indicated that the distribution of hot and cold spots of the studied crashes was statistically significant (p<0.001). Conclusion: The majority of traffic crashes causing death to pedestrians occurred in highways located in the main entrances and exits of Tehran. Given the important role of environmental factors in the occurrence of traffic crashes related to pedestrians, identification of these factors requires more studies with casual inferences. PMID:28210615

Comparison of Adjacency and Distance-Based Approaches for Spatial Analysis of Multimodal Traffic Crash Data

NASA Astrophysics Data System (ADS)

Gill, G.; Sakrani, T.; Cheng, W.; Zhou, J.

2017-09-01

Many studies have utilized the spatial correlations among traffic crash data to develop crash prediction models with the aim to investigate the influential factors or predict crash counts at different sites. The spatial correlation have been observed to account for heterogeneity in different forms of weight matrices which improves the estimation performance of models. But very rarely have the weight matrices been compared for the prediction accuracy for estimation of crash counts. This study was targeted at the comparison of two different approaches for modelling the spatial correlations among crash data at macro-level (County). Multivariate Full Bayesian crash prediction models were developed using Decay-50 (distance-based) and Queen-1 (adjacency-based) weight matrices for simultaneous estimation crash counts of four different modes: vehicle, motorcycle, bike, and pedestrian. The goodness-of-fit and different criteria for accuracy at prediction of crash count reveled the superiority of Decay-50 over Queen-1. Decay-50 was essentially different from Queen-1 with the selection of neighbors and more robust spatial weight structure which rendered the flexibility to accommodate the spatially correlated crash data. The consistently better performance of Decay-50 at prediction accuracy further bolstered its superiority. Although the data collection efforts to gather centroid distance among counties for Decay-50 may appear to be a downside, but the model has a significant edge to fit the crash data without losing the simplicity of computation of estimated crash count.

Clarity: An Open Source Manager for Laboratory Automation

PubMed Central

Delaney, Nigel F.; Echenique, José Rojas; Marx, Christopher J.

2013-01-01

Software to manage automated laboratories interfaces with hardware instruments, gives users a way to specify experimental protocols, and schedules activities to avoid hardware conflicts. In addition to these basics, modern laboratories need software that can run multiple different protocols in parallel and that can be easily extended to interface with a constantly growing diversity of techniques and instruments. We present Clarity: a laboratory automation manager that is hardware agnostic, portable, extensible and open source. Clarity provides critical features including remote monitoring, robust error reporting by phone or email, and full state recovery in the event of a system crash. We discuss the basic organization of Clarity; demonstrate an example of its implementation for the automated analysis of bacterial growth; and describe how the program can be extended to manage new hardware. Clarity is mature; well documented; actively developed; written in C# for the Common Language Infrastructure; and is free and open source software. These advantages set Clarity apart from currently available laboratory automation programs. PMID:23032169

A Systems Approach to Designing Effective Clinical Trials Using Simulations

PubMed Central

Fusaro, Vincent A.; Patil, Prasad; Chi, Chih-Lin; Contant, Charles F.; Tonellato, Peter J.

2013-01-01

Background Pharmacogenetics in warfarin clinical trials have failed to show a significant benefit compared to standard clinical therapy. This study demonstrates a computational framework to systematically evaluate pre-clinical trial design of target population, pharmacogenetic algorithms, and dosing protocols to optimize primary outcomes. Methods and Results We programmatically created an end-to-end framework that systematically evaluates warfarin clinical trial designs. The framework includes options to create a patient population, multiple dosing strategies including genetic-based and non-genetic clinical-based, multiple dose adjustment protocols, pharmacokinetic/pharmacodynamics (PK/PD) modeling and international normalization ratio (INR) prediction, as well as various types of outcome measures. We validated the framework by conducting 1,000 simulations of the CoumaGen clinical trial primary endpoints. The simulation predicted a mean time in therapeutic range (TTR) of 70.6% and 72.2% (P = 0.47) in the standard and pharmacogenetic arms, respectively. Then, we evaluated another dosing protocol under the same original conditions and found a significant difference in TTR between the pharmacogenetic and standard arm (78.8% vs. 73.8%; P = 0.0065), respectively. Conclusions We demonstrate that this simulation framework is useful in the pre-clinical assessment phase to study and evaluate design options and provide evidence to optimize the clinical trial for patient efficacy and reduced risk. PMID:23261867

Dry needling in a manual physiotherapy and therapeutic exercise protocol for patients with chronic mechanical shoulder pain of unspecific origin: a protocol for a randomized control trial.

PubMed

Tejera-Falcón, Emma; Toledo-Martel, Nuria Del Carmen; Sosa-Medina, Francisco Manuel; Santana-González, Fátima; Quintana-de la Fe, Miriam Del Pino; Gallego-Izquierdo, Tomás; Pecos-Martín, Daniel

2017-09-18

Shoulder pain of musculoskeletal origin is the main cause of upper limb pain of non-traumatic origin. Despite being one of the most common reasons for consultation, there is no established protocol for treatment due to the complexity of its etiology. However, it has been shown that the presence of myofascial trigger points on the shoulder muscles is a common condition associated with patients suffering from shoulder pain. This protocol has been created which describes the design of a randomized controlled trial to evaluate the effectiveness of the inclusion of dry needling (DN) within a protocol of manual physiotherapy and therapeutic exercise in the treatment of chronic shoulder pain of unspecific origin. Thirty-six participants aged 18-65 years will be recruited having mechanical chronic shoulder pain on unspecific origin and meeting the inclusion criteria. These will be randomized to one of two interventions, (i) DN, manual physiotherapy and therapeutic exercise or (ii) sham DN, manual physiotherapy and therapeutic exercise. The protocol will cover 6 weeks of treatment, with a 6-month follow-up. Our main outcome measure will be the Visual Analogue Scale for pain. This is the first study to combine the use of DN, manual physiotherapy and an exercise program with a 6-month follow-up, thus becoming a new contribution to the treatment of chronic shoulder pain, while new lines of research may be established to help determine the effects of DN on chronic shoulder pain and the frequency and proper dosage. International Standard Randomized Controlled Trial Number Register: ISRCTN30604244 ( http://www.controlled-trials.com ) 29 June 2016.

Identification of CRASH, a gene deregulated in gynecological tumors.

PubMed

Evtimova, Vesna; Zeillinger, Robert; Kaul, Sepp; Weidle, Ulrich H

2004-01-01

We have identified CRASH, a human asparaginase-like protein which is composed of 308 amino acids and exhibits 32% homology to human aspartylglucosaminadase at the amino acid level. Database analysis revealed that the gene corresponding to CRASH is composed of 7 exons and 6 introns. Steady-state level of CRASH mRNA was found to be increased in 5 cell lines derived from metastatic lesions compared with 2 cell lines derived from primary mammary carcinoma and HMEC (human mammary epithelial cells). We found that the mRNA level of CRASH correlates with the metastatic propensity of several isogenic human colon cancer and pancreatic carcinoma cell lines. CRASH corresponds to a recently identified sperm autoantigen and furthermore we have demonstrated inducibility of CRASH mRNA by androgen and progesterone. Investigation of several types of human cancers and their corresponding normal tissues revealed high levels of CRASH mRNA in uterine, mammary and ovarian tumors compared with the corresponding normal tissues. CRASH mRNA expression was analysed in breast cancer samples with disclosed clinico-pathological features and corresponding normal tissues. The levels of CRASH mRNA were significantly up-regulated in tumors compared with normal breast tissues and correlate with lack of estrogen receptor expression of the tumors.

Prevalence and factors associated with road traffic crash among taxi drivers in Hanoi, Vietnam.

PubMed

La, Quang Ngoc; Lee, Andy H; Meuleners, Lynn B; Van Duong, Dat

2013-01-01

Injury due to road traffic crash is a major cause of ill health and premature deaths in developing countries. Taxis provide a main mode of public transport in Vietnam but there has been little research on the risk of crash for taxi drivers. This retrospective study collected information on taxi crashes for the period 2006-2009 by interviewing drivers from five taxi companies in Hanoi, Vietnam, using a structured questionnaire. Of the total 1214 participants recruited, 276 drivers reported at least one crash, giving an overall crash prevalence of 22.7%. Among the crashed group, 50 drivers (18.1%) were involved in two to four crashes. Logistic regression analysis further identified age of driver, type of driving licence, employment status, perceived sufficiency of income, seat-belt usage, and traffic infringement history to be significantly associated with the crash risk. Further prospective and qualitative studies are recommended to provide detailed crash characteristics as well as behaviour and perception of taxi drivers, so that an effective intervention can be developed to improve road safety and to prevent injury of these commercial drivers. Copyright © 2012 Elsevier Ltd. All rights reserved.

Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee.

PubMed

von Elm, Erik; Röllin, Alexandra; Blümle, Anette; Huwiler, Karin; Witschi, Mark; Egger, Matthias

2008-04-05

Not all clinical trials are published, which may distort the evidence that is available in the literature. We studied the publication rate of a cohort of clinical trials and identified factors associated with publication and nonpublication of results. We analysed the protocols of randomized clinical trials of drug interventions submitted to the research ethics committee of University Hospital (Inselspital) Bern, Switzerland from 1988 to 1998. We identified full articles published up to 2006 by searching the Cochrane CENTRAL database (issue 02/2006) and by contacting investigators. We analyzed factors associated with the publication of trials using descriptive statistics and logistic regression models. 451 study protocols and 375 corresponding articles were analyzed. 233 protocols resulted in at least one publication, a publication rate of 52%. A total of 366 (81%) trials were commercially funded, 47 (10%) had non-commercial funding. 346 trials (77%) were multi-centre studies and 272 of these (79%) were international collaborations. In the adjusted logistic regression model non-commercial funding (Odds Ratio [OR] 2.42, 95% CI 1.14-5.17), multi-centre status (OR 2.09, 95% CI 1.03-4.24), international collaboration (OR 1.87, 95% CI 0.99-3.55) and a sample size above the median of 236 participants (OR 2.04, 95% CI 1.23-3.39) were associated with full publication. In this cohort of applications to an ethics committee in Switzerland, only about half of clinical drug trials were published. Large multi-centre trials with non-commercial funding were more likely to be published than other trials, but most trials were funded by industry.

Road traffic crashes among farm vehicle drivers in southern China: A cross-sectional survey.

PubMed

Zhang, Xujun; Yang, Yaming; Chen, Yu; Yao, Hongyan; Wu, Ming; Cui, Mengjing; Li, Yang; Hu, Jie; Zhang, Cong; Li, Zhen; Stallones, Lorann; Xiang, Huiyun

2017-01-02

The objective of this study was to identify the prevalence and potential risk factors of farm vehicle-related road traffic crashes among farm vehicle drivers in southern China. A cross-sectional study was used to interview 1,422 farm vehicle drivers in southern China. Farm vehicle-related road traffic crashes that occurred from December 2013 to November 2014 were investigated. Data on farm vehicle-related road traffic crashes and related factors were collected by face-to-face interviews. The prevalence of farm vehicle-related road traffic crashes among the investigated drivers was 7.2%. Farm vehicle-related road traffic crashes were significantly associated with self-reported vision problem (adjusted odds ratio [AOR] = 6.48, 95% confidence interval [CI], 3.86-10.87), self-reported sleep disorders (AOR = 10.03, 95% CI, 6.28-15.99), self-reported stress (AOR = 20.47, 95% CI, 9.96-42.08), reported history of crashes (AOR = 5.40, 95% CI, 3.47-8.42), reported history of drunk driving (AOR = 5.07, 95% CI, 2.97-8.65), and reported history of fatigued driving (AOR = 5.72, 95% CI, 3.73-8.78). The number of road traffic crashes was highest in the daytime and during harvest season. In over 96% of farm vehicle-related road traffic crashes, drivers were believed to be responsible for the crash. Major crash-causing factors included improper driving, careless driving, violating of traffic signals or signs, and being in the wrong lane. Findings of this study suggest that farm vehicle-related road traffic crashes have become a burgeoning public health problem in China. Programs need to be developed to prevent farm vehicle-related road traffic crashes in this emerging country.

Epidemiology of pedestrian-MVCs by road type in Cluj, Romania.

PubMed

Hamann, Cara; Peek-Asa, Corinne; Rus, Diana

2015-04-01

Pedestrian-motor vehicle (PMV) crash rates in Romania are among the highest in all of Europe. The purpose of this study was to examine the characteristics of pedestrian-MVCs in Cluj County, Romania, on the two major types of roadways: national or local. Cluj County police crash report data from 2010 were used to identify pedestrian, driver and crash characteristics of pedestrian-MVCs. Crashes with available location data were geocoded and road type (national or local) for each crash was determined. Distributions of crash characteristics were examined by road type and multivariable logistic regression models were built to determine predictors of crash road type. Crashes occurring on national roads involved more teenagers and adults, while those on local roads involved more young children (0-12) and older adults (65+) (p<0.01). Crashes on national roads were more likely to have marked pedestrian crossings and shoulders compared with local crashes. Pedestrian-MVCs that involved a moving violation by the motorist were more likely to occur on national roadways (adjusted OR=1.93, 95% CI 1.07 to 3.49). Pedestrian-MVCs pose a considerable health burden in Romania. Results from this study suggest that factors leading to PMV crashes on national roads are more likely to involve driver-related causes compared with local roads. Intervention priorities to reduce pedestrian crashes on national roads should be directed towards driver behaviour on national roads. Further examination of driver and pedestrian behaviours related to crash risk on both national and local roads, such as distraction and speeding, is warranted. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Geographic Region, Weather, Pilot Age and Air Carrier Crashes: a Case-Control Study

PubMed Central

Li, Guohua; Pressley, Joyce C.; Qiang, Yandong; Grabowski, Jurek G.; Baker, Susan P.; Rebok, George W.

2009-01-01

Background Information about risk factors of aviation crashes is crucial for developing effective intervention programs. Previous studies assessing factors associated with crash risk were conducted primarily in general aviation, air taxis and commuter air carriers. Methods A matched case-control design was used to examine the associations of geographic region, basic weather condition, and pilot age with the risk of air carrier (14 CFR Part 121) crash involvement. Cases (n=373) were air carrier crashes involving aircraft made by Boeing, McDonnell Douglas, and Airbus, recorded in the National Transportation Safety Board’s aviation crash database during 1983 through 2002, and controls (n=746) were air carrier incidents involving aircraft of the same three makes selected at random from the Federal Aviation Administration’s aviation incident database. Each case was matched with two controls on the calendar year when the index crash occurred. Conditional logistic regression was used for statistical analysis. Results With adjustment for basic weather condition, pilot age, and total flight time, the risk of air carrier crashes in Alaska was more than three times the risk for other regions [adjusted odds ratio (OR) 3.18, 95% confidence interval (CI) 1.35 – 7.49]. Instrument meteorological conditions were associated with an increased risk for air carrier crashes involving pilot error (adjusted OR 2.26, 95% CI 1.15 – 4.44) and a decreased risk for air carrier crashes without pilot error (adjusted OR 0.57, 95% CI 0.40 – 0.87). Neither pilot age nor total flight time was significantly associated with the risk of air carrier crashes. Conclusions The excess risk of air carrier crashes in Alaska and the effect of adverse weather on pilot-error crashes underscore the importance of environmental hazards in flight safety. PMID:19378910

Geographic region, weather, pilot age, and air carrier crashes: a case-control study.

PubMed

Li, Guohua; Pressley, Joyce C; Qiang, Yandong; Grabowski, Jurek G; Baker, Susan P; Rebok, George W

2009-04-01

Information about risk factors of aviation crashes is crucial for developing effective intervention programs. Previous studies assessing factors associated with crash risk were conducted primarily in general aviation, air taxis, and commuter air carriers. A matched case-control design was used to examine the associations of geographic region, basic weather condition, and pilot age with the risk of air carrier (14 CFR Part 121) crash involvement. Cases (N = 373) were air carrier crashes involving aircraft made by Boeing, McDonnell Douglas, and Airbus recorded in the National Transportation Safety Board's aviation crash database during 1983 through 2002, and controls (N = 746) were air carrier incidents involving aircraft of the same three makes selected at random from the Federal Aviation Administration's aviation incident database. Each case was matched with two controls on the calendar year when the index crash occurred. Conditional logistic regression was used for statistical analysis. With adjustment for basic weather condition, pilot age, and total flight time, the risk of air carrier crashes in Alaska was more than three times the risk for other regions ladjusted odds ratio (OR) 3.18, 95% confidence interval (CI) 1.35-7.49]. Instrument meteorological conditions were associated with an increased risk for air carrier crashes involving pilot error (adjusted OR 2.26, 95% CI 1.15-4.44) and a decreased risk for air carrier crashes without pilot error (adjusted OR 0.60, 95% CI 0.37-0.96). Neither pilot age nor total flight time were significantly associated with the risk of air carrier crashes. The excess risk of air carrier crashes in Alaska and the effect of adverse weather on pilot-error crashes underscore the importance of environmental hazards in flight safety.

MINIMAL HEPATIC ENCEPHALOPATHY IS ASSOCIATED WITH MOTOR VEHICLE CRASHES: THE REALITY BEYOND THE DRIVING TEST

PubMed Central

Bajaj, Jasmohan S; Saeian, Kia; Schubert, Christine M; Hafeezullah, Muhammad; Franco, Jose; Varma, Rajiv R; Gibson, Douglas P; Hoffmann, Raymond G; Stravitz, R Todd; Heuman, Douglas M; Sterling, Richard K; Shiffman, Mitchell; Topaz, Allyne; Boyett, Sherry; Bell, Debulon; Sanyal, Arun J

2009-01-01

Patients with minimal hepatic encephalopathy (MHE) have impaired driving skills, but association of MHE with motor vehicle crashes is unclear. Standard psychometric tests (SPT) or inhibitory control test (ICT) can be used to diagnose MHE. The aim was to determine the association of MHE with crashes and traffic violations over the preceding year and on 1-year follow-up. Cirrhotics were diagnosed with MHE by ICT (MHEICT) and SPT (MHESPT). Self and department-of-transportation (DOT)-reports were used to determine crashes and violations over the preceding year. Agreement between self and DOT-reports was analyzed. Patients then underwent 1 year follow-up for crash/violation occurrence. Crashes in those with/without MHEICT and MHESPT were compared. 167 cirrhotics had DOT-reports, of which 120 also had self-reports. A significantly higher proportion of MHEICT cirrhotics experienced crashes in the preceding year compared to those without MHE by self-report (17% vs. 0%, p=0.0004) and DOT-reports (17% vs. 3%, p=0.004, relative risk:5.77). SPT did not differentiate between those with/without crashes. A significantly higher proportion of patients with crashes had MHEICT compared to MHESPT, both self-reported (100% vs. 50%, p=0.03) and DOT-reported (89% vs. 44%, p=0.01). There was excellent agreement between self and DOT-reports for crashes and violations (Kappa 0.90 and 0.80). 109 patients were followed prospectively. MHEICT patients had a significantly higher future crashes/violations compared to those without (22% vs. 7%, p=0.03) but MHESPT did not. MHEICT (Odds ratio:4.51) and prior year crash/violation (Odds ratio:2.96) were significantly associated with future crash/violation occurrence. PMID:19670416

Analysis of the frequency and severity of rear-end crashes in work zones.

PubMed

Qi, Yi; Srinivasan, Raghavan; Teng, Hualiang; Baker, Robert

2013-01-01

The objective of this study was to identify the factors that influence the frequency and severity of rear-end crashes in work zones because rear-end crashes represent a significant proportion of crashes that occur in work zones. Truncated count data models were developed to identify influencing factors on the frequency of read-end crashes in work zones and ordered probit models were developed to evaluate influencing factors on the severity of rear-end crashes in work zones. Most of the variables identified in this study for these 2 models were significant at the 95 percent level. The statistics for models indicate that the 2 developed models are appropriate compared to alternative models. Major findings related to the frequency of rear-end crashes include the following: (1) work zones for capacity and pavement improvements have the highest frequency compared to other types of work zones; (2) work zones controlled by flaggers are associated with more rear-end crashes compared to those controlled by arrow boards; and (3) work zones with alternating one-way traffic tended to have more rear-end crashes compared to those with lane shifts. Major findings related to the severity of the rear-end crashes include the following: (1) rear-end crashes associated with alcohol, night, pedestrians, and roadway defects are more severe, and those associated with careless backing, stalled vehicles, slippery roadways, and misunderstanding flagging signals are less severe; (2) truck involvement and a large number of vehicles in a crash are both associated with increased severity, and (3) rear-end crashes that happened in work zones for bridge, capacity, and pavement are likely to be more severe than others.

Analysis of work zone rear-end crash risk for different vehicle-following patterns.

PubMed

Weng, Jinxian; Meng, Qiang; Yan, Xuedong

2014-11-01

This study evaluates rear-end crash risk associated with work zone operations for four different vehicle-following patterns: car-car, car-truck, truck-car and truck-truck. The deceleration rate to avoid the crash (DRAC) is adopted to measure work zone rear-end crash risk. Results show that the car-truck following pattern has the largest rear-end crash risk, followed by truck-truck, truck-car and car-car patterns. This implies that it is more likely for a car which is following a truck to be involved in a rear-end crash accident. The statistical test results further confirm that rear-end crash risk is statistically different between any two of the four patterns. We therefore develop a rear-end crash risk model for each vehicle-following pattern in order to examine the relationship between rear-end crash risk and its influencing factors, including lane position, the heavy vehicle percentage, lane traffic flow and work intensity which can be characterized by the number of lane reductions, the number of workers and the amount of equipment at the work zone site. The model results show that, for each pattern, there will be a greater rear-end crash risk in the following situations: (i) heavy work intensity; (ii) the lane adjacent to work zone; (iii) a higher proportion of heavy vehicles and (iv) greater traffic flow. However, the effects of these factors on rear-end crash risk are found to vary according to the vehicle-following patterns. Compared with the car-car pattern, lane position has less effect on rear-end crash risk in the car-truck pattern. The effect of work intensity on rear-end crash risk is also reduced in the truck-car pattern. Copyright © 2014 Elsevier Ltd. All rights reserved.

Omitted variable bias in crash reduction factors.

DOT National Transportation Integrated Search

2015-09-01

Transportation planners and traffic engineers are increasingly turning to crash reduction factors to evaluate changes in road : geometric and design features in order to reduce crashes. Crash reduction factors are typically estimated based on segment...

Idaho traffic crashes, 2009

DOT National Transportation Integrated Search

2009-01-01

Idaho Traffic Crashes 2009 provides an annual description of motor vehicle crash characteristics for : crashes that have occurred on public roads within the State of Idaho. This document is used by state and : local transportation, law enforcement, h...

Idaho traffic crashes, 2008

DOT National Transportation Integrated Search

2008-01-01

Idaho Traffic Crashes 2008 provides an annual description of motor vehicle crash characteristics for : crashes that have occurred on public roads within the State of Idaho. This document is used by state and : local transportation, law enforcement, h...

2007 South Dakota motor vehicle traffic crash summary

DOT National Transportation Integrated Search

2008-01-01

The Motor Vehicle Traffic Crash Summary is divided into two main sections, Historical : Trends and 2007 Motor Vehicle Traffic Crash Profile. The Historical Trend section : provides information on alcohol involvement in motor vehicle crashes, severity...

2006 South Dakota motor vehicle traffic crash summary

DOT National Transportation Integrated Search

2007-05-01

The Motor Vehicle Traffic Crash Summary is divided into two main sections, Historical : Trends and 2006 Motor Vehicle Traffic Crash Profile. The Historical Trend section : provides information on alcohol involvement in motor vehicle crashes, severity...

2008 South Dakota motor vehicle traffic crash summary

DOT National Transportation Integrated Search

2009-06-01

The Motor Vehicle Traffic Crash Summary is divided into two main sections, Historical : Trends and 2008 Motor Vehicle Traffic Crash Profile. The Historical Trend section : provides information on alcohol involvement in motor vehicle crashes, severity...

2009 South Dakota motor vehicle traffic crash summary

DOT National Transportation Integrated Search

2010-06-01

The Motor Vehicle Traffic Crash Summary is divided into two main sections, Historical : Trends and 2009 Motor Vehicle Traffic Crash Profile. The Historical Trend section : provides information on alcohol involvement in motor vehicle crashes, severity...

Objective tests for forward looking pedestrian crash avoidance/mitigation systems.

DOT National Transportation Integrated Search

2014-06-01

This report documents the work completed by the Crash Avoidance Metrics Partnership (CAMP) Crash Imminent Braking : (CIB) Consortium during the project titled Objective Tests for Forward Looking Pedestrian Crash Avoidance/Mitigation : Systems. ...

Assessing and Managing Risk with Suicidal Individuals

ERIC Educational Resources Information Center

Linehan, Marsh M.; Comtois, Katherine A.; Ward-Ciesielski, Erin F.

2012-01-01

The University of Washington Risk Assessment Protocol (UWRAP) and Risk Assessment and Management Protocol (UWRAMP) have been used in numerous clinical trials treating high-risk suicidal individuals over several years. These protocols structure assessors and treatment providers to provide a thorough suicide risk assessment, review standards of care…

Scanning secondary derived crashes from disabled and abandoned vehicle incidents on uninterrupted flow highways.

PubMed

Chimba, Deo; Kutela, Boniphace

2014-09-01

Extent of secondary crashes derived from primary incidents involving abandoned and disabled vehicles are presented in this paper. Using years 2004 to 2010 incident and crash data on selected Tennessee freeways, the study identified secondary crashes that resulted from disabled and abandoned vehicle primary incidents. The relationship between time and distance gaps before the secondary crash with respect to individual incident characteristics were evaluated through descriptive statistics and linear regression. The time and distance gap analysis indicated that a large portion of secondary crashes occurred within 20 min after the primary incidents and within a distance of 0.5 miles upstream. While 76% of incidents involved shoulder, most secondary crashes were related to the closing of right lanes. Overall, 58% of the secondary crashes occurred within 30 min after the occurrence of the primary incidents. Most of the vehicles in the incidents that involved towing and caused secondary crashes were towed or removed out of the travel way within 60 min from the time of occurrence. The study found that most (95%) secondary crashes were property damage only (PDO), while 49% were rear-end crashes. The negative binomial model was used to evaluate the impact of roadway geometry and traffic factors associated with frequency of these secondary crashes. It was found that the posted speed limit, congested segments, segments with high percentages of trucks, and peak hour volumes increased the likelihood of secondary crash occurrence. Roadway segments with wider medians, shoulders, and multilanes decrease the likelihood of secondary crashes caused by abandoned and disabled vehicles as the primary incidents. Practical applications The paper recommends that wider shoulders be provided on any section of freeway to accommodate abandoned or disabled vehicles to avoid blocking of travel lane(s). Copyright © 2014 National Safety Council and Elsevier Ltd. All rights reserved.

Does crash risk increase when emergency vehicles are driving with lights and sirens?

PubMed

Missikpode, Celestin; Peek-Asa, Corinne; Young, Tracy; Hamann, Cara

2018-04-01

Emergency vehicles, such as police, ambulances, and fire vehicles, need to arrive at the scene of emergencies as quickly as possible, and thus they often travel in emergency mode - using their lights and sirens and often bypassing traffic signals. We examined whether travelling in emergency mode increased crash risk among police, ambulance and fire vehicles. We conducted a quasi-induced exposure analysis using data from the Iowa Crash Database for the period of 2005 through 2013. The data are maintained by the Iowa Department of Transportation (IADOT), Office of Driver Services (ODS) and includes all investigating police officer's reports of motor vehicle crashes. The quasi-induced exposure method is an approach to calculate crash risk in the absence of exposure data using vehicles without a contributing cause (did not contribute to the crash) as a proxy for the baseline driving population. From 2005 - 2013, police vehicles were involved in 2406 crashes and ambulances and fire vehicles were involved in 528 crashes. Police vehicles were 1.8 times more likely to crash while driving in emergency mode than usual mode; this was a statistically significant increase. Ambulance and fire vehicles were not more likely to crash in emergency mode compared with usual mode. For police, other factors that contributed to crash risk included gender, age, icy/snowy roads, unpaved roads, and intersections. For ambulances and fire vehicles, other factors that contributed to crash risk included gender, age, weekends, icy/snowy roads and urban locations. Crash risk increased when police vehicles drove with lights and sirens but did not increase for ambulance and fire vehicles. Further research is necessary to develop and evaluate strategies to mitigate crash risk among police vehicles. Cultural approaches which prioritize transportation safety in conjunction with reaching the scene as quickly as possible may be warranted. Copyright © 2018 Elsevier Ltd. All rights reserved.

Gasoline prices and traffic crashes in Alabama, 1999-2009.

PubMed

Chi, Guangqing; McClure, Timothy E; Brown, David B

2012-09-01

The price of gasoline has been found to be negatively associated with traffic crashes in a limited number of studies. However, most of the studies have focused either on fatal crashes only or on all crashes but measured over a very short time period. In this study, we examine gasoline price effects on all traffic crashes by demographic groups in the state of Alabama from 1999 to 2009. Using negative binomial regression techniques to examine monthly data from 1999 to 2009 in the state of Alabama, we estimate the effects of changes in gasoline price on changes in automobile crashes. We also examine how these effects differ by age group (16-20, 21-25, 26-30, 31-64, and 65+), gender (male and female), and race/ethnicity (non-Hispanic white, non-Hispanic black, and Hispanic). The results show that gasoline prices have both short-term and long-term effects on reducing total traffic crashes and crashes of each age, gender, and race/ethnicity group (except Hispanic due to data limitations). The short-term and long-term effects are not statistically different for each individual demographic group. Gasoline prices have a stronger effect in reducing crashes involving drivers aged 16 to 20 than crashes involving drivers aged 31 to 64 and 65+ in the short term; the effects, however, are not statistically different across other demographic groups. Although gasoline price increases are not favored, our findings show that gasoline price increases (or decreases) are associated with reductions (or increases) in the incidence of traffic crashes. If gasoline prices had remained at the 1999 level of $1.41 from 1999 to 2009, applying the estimated elasticities would result in a predicted increase in total crashes of 169,492 (or 11.3%) from the actual number of crashes. If decision makers wish to reduce traffic crashes, increasing gasoline taxes is a possible option-however, doing so would increase travel costs and lead to equity concerns. These findings may help to shape transportation safety planning and policy making.

Vehicle crashworthiness ratings in Australia.

PubMed

Cameron, M; Mach, T; Neiger, D; Graham, A; Ramsay, R; Pappas, M; Haley, J

1994-08-01

The paper reviews the published vehicle safety ratings based on mass crash data from the United States, Sweden, and Great Britain. It then describes the development of vehicle crashworthiness ratings based on injury compensation claims and police accident reports from Victoria and New South Wales, the two most populous states in Australia. Crashworthiness was measured by a combination of injury severity (of injured drivers) and injury risk (of drivers involved in crashes). Injury severity was based on 22,600 drivers injured in crashes in the two states. Injury risk was based on 70,900 drivers in New South Wales involved in crashes after which a vehicle was towed away. Injury risk measured in this way was compared with the "relative injury risk" of particular model cars involved in two car crashes in Victoria (where essentially only casualty crashes are reported), which was based on the method developed by Folksam Insurance in Sweden from Evans' double-pair comparison method. The results include crashworthiness ratings for the makes and models crashing in Australia in sufficient numbers to measure their crash performance adequately. The ratings were normalised for the driver sex and speed limit at the crash location, the two factors found to be strongly related to injury risk and/or severity and to vary substantially across makes and models of Australian crash-involved cars. This allows differences in crashworthiness of individual models to be seen, uncontaminated by major crash exposure differences.

Is the useful field of view a good predictor of at-fault crash risk in elderly Japanese drivers?

PubMed

Sakai, Hiroyuki; Uchiyama, Yuji; Takahara, Miwa; Doi, Shun'ichi; Kubota, Fumiko; Yoshimura, Takayoshi; Tachibana, Atsumichi; Kurahashi, Tetsuo

2015-05-01

Although age-related decline in the useful field of view (UFOV) is well recognized as a risk factor for at-fault crash involvement in elderly drivers, there is still room to study its applicability to elderly Japanese drivers. In the current study, we thus examined the relationship between UFOV and at-fault crash history in an elderly Japanese population. We also explored whether potential factors that create awareness of reduced driving fitness could be a trigger for the self-regulation of driving in elderly drivers. We measured UFOV and at-fault crash history from 151 community-dwelling Japanese aged 60 years or older, and compared UFOV of at-fault crash-free and crash-involved drivers. We also measured self-evaluated driving style using a questionnaire. UFOV in crash-involved drivers was significantly lower than that in crash-free drivers. No significant difference was found in self-evaluated driving style between crash-free and crash-involved drivers. In addition, there was no significant association between UFOV and self-evaluated driving style. The present study showed that UFOV is a good predictor of at-fault crash risk in elderly Japanese drivers. Furthermore, our data imply that it might be difficult for elderly drivers to adopt appropriate driving strategies commensurate with their current driving competence. © 2014 Japan Geriatrics Society.

Multivariate spatial models of excess crash frequency at area level: case of Costa Rica.

PubMed

Aguero-Valverde, Jonathan

2013-10-01

Recently, areal models of crash frequency have being used in the analysis of various area-wide factors affecting road crashes. On the other hand, disease mapping methods are commonly used in epidemiology to assess the relative risk of the population at different spatial units. A natural next step is to combine these two approaches to estimate the excess crash frequency at area level as a measure of absolute crash risk. Furthermore, multivariate spatial models of crash severity are explored in order to account for both frequency and severity of crashes and control for the spatial correlation frequently found in crash data. This paper aims to extent the concept of safety performance functions to be used in areal models of crash frequency. A multivariate spatial model is used for that purpose and compared to its univariate counterpart. Full Bayes hierarchical approach is used to estimate the models of crash frequency at canton level for Costa Rica. An intrinsic multivariate conditional autoregressive model is used for modeling spatial random effects. The results show that the multivariate spatial model performs better than its univariate counterpart in terms of the penalized goodness-of-fit measure Deviance Information Criteria. Additionally, the effects of the spatial smoothing due to the multivariate spatial random effects are evident in the estimation of excess equivalent property damage only crashes. Copyright © 2013 Elsevier Ltd. All rights reserved.

Truck crash severity in New York city: An investigation of the spatial and the time of day effects.

PubMed

Zou, Wei; Wang, Xiaokun; Zhang, Dapeng

2017-02-01

This paper investigates the differences between single-vehicle and multi-vehicle truck crashes in New York City. The random parameter models take into account the time of day effect, the heterogeneous truck weight effect and other influencing factors such as crash characteristics, driver and vehicle characteristics, built environment factors and traffic volume attributes. Based on the results from the co-location quotient analysis, a spatial generalized ordered probit model is further developed to investigate the potential spatial dependency among single-vehicle truck crashes. The sample is drawn from the state maintained incident data, the publicly available Smart Location Data, and the BEST Practices Model (BPM) data from 2008 to 2012. The result shows that there exists a substantial difference between factors influencing single-vehicle and multi-vehicle truck crash severity. It also suggests that heterogeneity does exist in the truck weight, and it behaves differently in single-vehicle and multi-vehicle truck crashes. Furthermore, individual truck crashes are proved to be spatially dependent events for both single and multi-vehicle crashes. Last but not least, significant time of day effects were found for PM and night time slots, crashes that occurred in the afternoons and at nights were less severe in single-vehicle crashes, but more severe in multi-vehicle crashes. Copyright © 2016. Published by Elsevier Ltd.

2010 South Dakota motor vehicle traffic crash summary

DOT National Transportation Integrated Search

2011-01-01

The Motor Vehicle Traffic Crash Summary is divided into two main sections, Historical Trends and 2010 Motor Vehicle Traffic Crash Profile. The Historical Trend section provides information on alcohol involvement in motor vehicle crashes, severity of ...

2007 Oregon state highway accident rate tables

DOT National Transportation Integrated Search

2008-09-01

State highway crash rate tables present crash frequencies in relation to traffic volume and : highway mileage. The four major sections of this publication are: : I Results of Analysis : II State Highway Crash Rates : III Fatal Traffic Crash Summaries...

2009 Oregon state highway accident rate tables

DOT National Transportation Integrated Search

2010-08-01

State highway crash rate tables present crash frequencies in relation to traffic volume and : highway mileage. The four major sections of this publication are: : I Results of Analysis : II State Highway Crash Rates : III Fatal Traffic Crash Summaries...

Illinois crash facts and statistics, 2002

DOT National Transportation Integrated Search

2002-01-01

This publication, Illinois Traffic Crash Facts : and Statistics for 2002, is designed to provide an : overview of motor vehicle crash experience in : Illinois. In addition to a plethora of crash data, the : publication includes key events in th...

Illinois crash facts and statistics, 2004-2005

DOT National Transportation Integrated Search

2005-01-01

The 2004-2005 Illinois Crash Facts & Statistics publication : is designed to provide the public with an overview of motor : vehicle crashes that occur in Illinois. This publication not : only consists of crash data but includes information abou...

Illinois crash facts and statistics, 2001

DOT National Transportation Integrated Search

2001-01-01

This publication, Illinois Traffic Crash Facts : and Statistics for 2001, is designed to provide an : overview of motor vehicle crash experience in : Illinois. In addition to a plethora of crash data, the : publication includes key events in th...

Illinois crash facts and statistics, 2003

DOT National Transportation Integrated Search

2003-01-01

This publication, Illinois Traffic Crash Facts : and Statistics for 2003, is designed to provide an : overview of motor vehicle crash experience in : Illinois. In addition to a plethora of crash data, the : publication includes key events in th...

2004 Oregon state highway accident rate tables

DOT National Transportation Integrated Search

2005-08-01

State highway crash rate tables present crash frequencies in relation to traffic volume and : highway mileage. The four major sections of this publication are: : I Results of Analysis : II State Highway Crash Rates : III Fatal Traffic Crash Summaries...

2008 Oregon state highway accident rate tables

DOT National Transportation Integrated Search

2009-08-01

State highway crash rate tables present crash frequencies in relation to traffic volume and : highway mileage. The four major sections of this publication are: : I Results of Analysis : II State Highway Crash Rates : III Fatal Traffic Crash Summaries...

2006 Oregon state highway accident rate tables

DOT National Transportation Integrated Search

2007-07-01

State highway crash rate tables present crash frequencies in relation to traffic volume and : highway mileage. The four major sections of this publication are: : I Results of Analysis : II State Highway Crash Rates : III Fatal Traffic Crash Summaries...

2010 Oregon state highway accident rate tables

DOT National Transportation Integrated Search

2011-11-01

State highway crash rate tables present crash frequencies in relation to traffic volume and : highway mileage. The four major sections of this publication are: I. Results of Analysis, II. State Highway Crash Rates, III. Fatal Traffic Crash Summaries,...

Large truck and bus crash facts, 2010.

DOT National Transportation Integrated Search

2012-09-01

This annual edition of Large Truck and Bus Crash Facts contains descriptive statistics about fatal, injury, and : property damage only crashes involving large trucks and buses in 2010. Selected crash statistics on passenger : vehicles are also presen...

Large truck and bus crash facts, 2007.

DOT National Transportation Integrated Search

2009-03-01

This annual edition of Large Truck and Bus Crash Facts contains descriptive statistics about fatal, injury, and : property damage only crashes involving large trucks and buses in 2007. Selected crash statistics on passenger : vehicles are also presen...

Large truck and bus crash facts, 2008. 

DOT National Transportation Integrated Search

2010-03-01

This annual edition of Large Truck and Bus Crash Facts contains descriptive statistics about fatal, injury, and : property damage only crashes involving large trucks and buses in 2008. Selected crash statistics on passenger : vehicles are also presen...

Large truck and bus crash facts, 2011.

DOT National Transportation Integrated Search

2013-10-01

This annual edition of Large Truck and Bus Crash Facts contains descriptive statistics about fatal, injury, and : property damage only crashes involving large trucks and buses in 2011. Selected crash statistics on passenger : vehicles are also presen...

Large truck and bus crash facts, 2013.

DOT National Transportation Integrated Search

2015-04-01

This annual edition of Large Truck and Bus Crash Facts contains descriptive statistics about fatal, injury, and property damage only crashes involving large trucks and buses in 2013. Selected crash statistics on passenger vehicles are also presented ...

Large truck and bus crash facts, 2009.

DOT National Transportation Integrated Search

2011-10-01

This annual edition of Large Truck and Bus Crash Facts contains descriptive statistics about fatal, injury, and : property damage only crashes involving large trucks and buses in 2009. Selected crash statistics on passenger : vehicles are also presen...

Large truck and bus crash facts, 2012.

DOT National Transportation Integrated Search

2014-06-01

This annual edition of Large Truck and Bus Crash Facts contains descriptive statistics about fatal, injury, and property damage only crashes involving large trucks and buses in 2012. Selected crash statistics on passenger vehicles are also presented ...

Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy

PubMed Central

Jang, Soobin; Park, Sunju; Jang, Bo-Hyoung; Park, Yu Lee; Lee, Ju Ah; Cho, Chung-Sik; Go, Ho-Yeon; Shin, Yong Cheol; Ko, Seong-Gyu

2017-01-01

Introduction Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. Methods and analysis The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. Ethics and dissemination This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11–1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants, and the investigators will explain the study to the participants in detail. As an ethical clinical trial, the control group will also be given conventional cessation treatments, including NRT and counselling. Participants will be screened and provided with a registration number to protect their personal information. Informed consent will be obtained from the participants prior to enrolling them in the trial. Participants will be allowed to withdraw at anytime without penalty. Trial registration number ClinicalTrials.gov (NCT02768025); pre-results. PMID:28576892

Clinical Trials of Blood Pressure Lowering and Antihypertensive Medication: Is Cognitive Measurement State-of-the-Art?

PubMed

Elias, Merrill F; Torres, Rachael V; Davey, Adam

2018-05-07

Randomized controlled trials of blood pressure (BP) lowering and antihypertensive medication use on cognitive outcomes have often been disappointing, reporting mixed findings and small effect sizes. We evaluate the extent to which cognitive assessment protocols used in these trials approach state-of-the-art. Overall, we find that a primary focus on cognition and the systematic selection of cognitive outcomes across trials take a backseat to other trial goals. Twelve trials investigating change in cognitive functioning were examined and none met criteria for state-of-the-art assessment, including use of at least 4 tests indexing 2 cognitive domains. Four trials investigating incident dementia were also examined. Each trial used state-of-the-art diagnostic criteria to assess dementia, although follow-up periods were relatively short, with only 2 trials lasting for at least 3 years. Weaknesses in each trial may act to obscure or weaken the positive effects of BP lowering on cognitive functioning. Improving trial designs in terms of cognitive outcomes selected and length of follow-up periods employed could lead to more promising findings. We offer logical steps to achieve state-of-the-art assessment protocols, with examples, in hopes of improving future trials.

Computer simulations and experimental study on crash box of automobile in low speed collision

NASA Astrophysics Data System (ADS)

Liu, Yanjie; Ding, Lin; Yan, Shengyuan; Yang, Yongsheng

2008-11-01

Based on the problems of energy-absorbing components in the automobile low speed collision process, according to crash box frontal crash test in low speed as the example, the simulation analysis of crash box impact process was carried out by Hyper Mesh and LS-DYNA. Each parameter on the influence modeling was analyzed by mathematics analytical solution and test comparison, which guaranteed that the model was accurate. Combination of experiment and simulation result had determined the weakness part of crash box structure crashworthiness aspect, and improvement method of crash box crashworthiness was discussed. Through numerical simulation of the impact process of automobile crash box, the obtained analysis result was used to optimize the design of crash box. It was helpful to improve the vehicles structure and decrease the collision accident loss at most. And it was also provided a useful method for the further research on the automobile collision.

Asphyxia in Motor Vehicle Crashes: Analysis of Crash-Related Variables Using National Automotive Sampling System Crashworthiness Data System and Forensic Case Studies.

PubMed

Storvik, Steven G; Campbell, Julius Q; Wheeler, Jeffrey B

2017-06-01

Rates of death because of asphyxia in motor vehicle crashes have been previously estimated using county and statewide data sets, but national estimates have not been reported. The literature regarding asphyxia in motor vehicle crashes primarily involves discussions about clinical findings, and crash-related variables have been sparsely reported. The current study calculated a nationwide fatality rate for asphyxia in motor vehicle crashes of 1.4%. Seventeen case studies of asphyxia were also reported providing crash-, vehicle-, and occupant-related variables. These included type of accident, crash severity, seat belt use, containment status, extent of occupant compartment intrusion, height, weight, and injury pattern. The data presented can be used to better understand the injury mechanism, identify risk factors, develop possible protective countermeasures, and create situational awareness for emergency responders and investigators.

The mean time-limited crash rate of stock price

NASA Astrophysics Data System (ADS)

Li, Yun-Xian; Li, Jiang-Cheng; Yang, Ai-Jun; Tang, Nian-Sheng

2017-05-01

In this article we investigate the occurrence of stock market crash in an economy cycle. Bayesian approach, Heston model and statistical-physical method are considered. Specifically, Heston model and an effective potential are employed to address the dynamic changes of stock price. Bayesian approach has been utilized to estimate the Heston model's unknown parameters. Statistical physical method is used to investigate the occurrence of stock market crash by calculating the mean time-limited crash rate. The real financial data from the Shanghai Composite Index is analyzed with the proposed methods. The mean time-limited crash rate of stock price is used to describe the occurrence of stock market crash in an economy cycle. The monotonous and nonmonotonous behaviors are observed in the behavior of the mean time-limited crash rate versus volatility of stock for various cross correlation coefficient between volatility and price. Also a minimum occurrence of stock market crash matching an optimal volatility is discovered.

Strengthening of the Hip and Core Versus Knee Muscles for the Treatment of Patellofemoral Pain: A Multicenter Randomized Controlled Trial

PubMed Central

Ferber, Reed; Bolgla, Lori; Earl-Boehm, Jennifer E.; Emery, Carolyn; Hamstra-Wright, Karrie

2015-01-01

Context: Patellofemoral pain (PFP) is the most common injury in running and jumping athletes. Randomized controlled trials suggest that incorporating hip and core strengthening (HIP) with knee-focused rehabilitation (KNEE) improves PFP outcomes. However, no randomized controlled trials have, to our knowledge, directly compared HIP and KNEE programs. Objective: To compare PFP pain, function, hip- and knee-muscle strength, and core endurance between KNEE and HIP protocols after 6 weeks of rehabilitation. We hypothesized greater improvements in (1) pain and function, (2) hip strength and core endurance for patients with PFP involved in the HIP protocol, and (3) knee strength for patients involved in the KNEE protocol. Design: Randomized controlled clinical trial. Setting: Four clinical research laboratories in Calgary, Alberta; Chicago, Illinois; Milwaukee, Wisconsin; and Augusta, Georgia. Patients or Other Participants: Of 721 patients with PFP screened, 199 (27.6%) met the inclusion criteria (66 men [31.2%], 133 women [66.8%], age = 29.0 ± 7.1 years, height = 170.4 ± 9.4 cm, weight = 67.6 ± 13.5 kg). Intervention(s): Patients with PFP were randomly assigned to a 6-week KNEE or HIP protocol. Main Outcome Measure(s): Primary variables were self-reported visual analog scale and Anterior Knee Pain Scale measures, which were conducted weekly. Secondary variables were muscle strength and core endurance measured at baseline and at 6 weeks. Results: Compared with baseline, both the visual analog scale and the Anterior Knee Pain Scale improved for patients with PFP in both the HIP and KNEE protocols (P < .001), but the visual analog scale scores for those in the HIP protocol were reduced 1 week earlier than in the KNEE group. Both groups increased in strength (P < .001), but those in the HIP protocol gained more in hip-abductor (P = .01) and -extensor (P = .01) strength and posterior core endurance (P = .05) compared with the KNEE group. Conclusions: Both the HIP and KNEE rehabilitation protocols produced improvements in PFP, function, and strength over 6 weeks. Although outcomes were similar, the HIP protocol resulted in earlier resolution of pain and greater overall gains in strength compared with the KNEE protocol. PMID:25365133

Sleep deficiency and motor vehicle crash risk in the general population: a prospective cohort study.

PubMed

Gottlieb, Daniel J; Ellenbogen, Jeffrey M; Bianchi, Matt T; Czeisler, Charles A

2018-03-20

Insufficient sleep duration and obstructive sleep apnea, two common causes of sleep deficiency in adults, can result in excessive sleepiness, a well-recognized cause of motor vehicle crashes, although their contribution to crash risk in the general population remains uncertain. The objective of this study was to evaluate the relation of sleep apnea, sleep duration, and excessive sleepiness to crash risk in a community-dwelling population. This was a prospective observational cohort study nested within the Sleep Heart Health Study, a community-based study of the health consequences of sleep apnea. The participants were 1745 men and 1456 women aged 40-89 years. Sleep apnea was measured by home polysomnography and questionnaires were used to assess usual sleep duration and daytime sleepiness. A follow-up questionnaire 2 years after baseline ascertained driving habits and motor vehicle crash history. Logistic regression analysis was used to examine the relation of sleep apnea and sleep duration at baseline to the occurrence of motor vehicle crashes during the year preceding the follow-up visit, adjusting for relevant covariates. The population-attributable fraction of motor vehicle crashes was estimated from the sample proportion of motor vehicle crashes and the adjusted odds ratios for motor vehicle crash within each exposure category. Among 3201 evaluable participants, 222 (6.9%) reported at least one motor vehicle crash during the prior year. A higher apnea-hypopnea index (p < 0.01), fewer hours of sleep (p = 0.04), and self-reported excessive sleepiness (p < 0.01) were each significantly associated with crash risk. Severe sleep apnea was associated with a 123% increased crash risk, compared to no sleep apnea. Sleeping 6 hours per night was associated with a 33% increased crash risk, compared to sleeping 7 or 8 hours per night. These associations were present even in those who did not report excessive sleepiness. The population-attributable fraction of motor vehicle crashes was 10% due to sleep apnea and 9% due to sleep duration less than 7 hours. Sleep deficiency due to either sleep apnea or insufficient sleep duration is strongly associated with motor vehicle crashes in the general population, independent of self-reported excessive sleepiness.

Sleep-deprived young drivers and the risk for crash: the DRIVE prospective cohort study.

PubMed

Martiniuk, Alexandra L C; Senserrick, Teresa; Lo, Serigne; Williamson, Ann; Du, Wei; Grunstein, Ronald R; Woodward, Mark; Glozier, Nick; Stevenson, Mark; Norton, Robyn; Ivers, Rebecca Q

2013-07-01

Short sleep duration is common in adolescents and young adults, and short sleep duration is a risk factor for motor vehicle crash. To assess the association between hours of sleep and the risk for motor vehicle crash, including the time of day of crash and types of crash (single, multiple vehicle, run off road, and intersection). Prospective cohort study. New South Wales, Australia. Questionnaire responses were obtained from 20,822 newly licensed drivers aged 17 to 24 years. Participants held a first-stage provisional license between June 2003 and December 2004 prospectively linked to licensing and police-reported crash data, with an average of 2 years of follow-up. Analyses were conducted on a subsample of 19,327 participants for which there was full information. Sleeping 6 or fewer hours per night. The main outcome variable was police-reported crash. Multivariable Poisson regression models were used to investigate the role of sleep duration on the risk for crash. On average, those who reported sleeping 6 or fewer hours per night had an increased risk for crash compared with those who reported sleeping more than 6 hours (relative risk [RR], 1.21; 95% CI, 1.04-1.41). Less weekend sleep was significantly associated with an increased risk for run-off-road crashes (RR, 1.55; 95% CI, 1.21-2.00). Crashes for individuals who had less sleep per night (on average and on weekends) were significantly more likely to occur between 8 pm and 6 am (RR, 1.86; 95% CI, 1.11-3.13, for midnight to 5:59 am and RR, 1.66; 95% CI, 1.15-2.39, for 8:00 pm to 11:59 pm). Less sleep per night significantly increased the risk for crash for young drivers. Less sleep on weekend nights increased the risk for run-off-road crashes and crashes occurring in the late-night hours. This provides rationale for governments and health care providers to address sleep-related crashes among young drivers.

Propensity scores-potential outcomes framework to incorporate severity probabilities in the highway safety manual crash prediction algorithm.

PubMed

Sasidharan, Lekshmi; Donnell, Eric T

2014-10-01

Accurate estimation of the expected number of crashes at different severity levels for entities with and without countermeasures plays a vital role in selecting countermeasures in the framework of the safety management process. The current practice is to use the American Association of State Highway and Transportation Officials' Highway Safety Manual crash prediction algorithms, which combine safety performance functions and crash modification factors, to estimate the effects of safety countermeasures on different highway and street facility types. Many of these crash prediction algorithms are based solely on crash frequency, or assume that severity outcomes are unchanged when planning for, or implementing, safety countermeasures. Failing to account for the uncertainty associated with crash severity outcomes, and assuming crash severity distributions remain unchanged in safety performance evaluations, limits the utility of the Highway Safety Manual crash prediction algorithms in assessing the effect of safety countermeasures on crash severity. This study demonstrates the application of a propensity scores-potential outcomes framework to estimate the probability distribution for the occurrence of different crash severity levels by accounting for the uncertainties associated with them. The probability of fatal and severe injury crash occurrence at lighted and unlighted intersections is estimated in this paper using data from Minnesota. The results show that the expected probability of occurrence of fatal and severe injury crashes at a lighted intersection was 1 in 35 crashes and the estimated risk ratio indicates that the respective probabilities at an unlighted intersection was 1.14 times higher compared to lighted intersections. The results from the potential outcomes-propensity scores framework are compared to results obtained from traditional binary logit models, without application of propensity scores matching. Traditional binary logit analysis suggests that the probability of occurrence of severe injury crashes is higher at lighted intersections compared to unlighted intersections, which contradicts the findings obtained from the propensity scores-potential outcomes framework. This finding underscores the importance of having comparable treated and untreated entities in traffic safety countermeasure evaluations. Copyright © 2014 Elsevier Ltd. All rights reserved.

Predicting crash frequency for multi-vehicle collision types using multivariate Poisson-lognormal spatial model: A comparative analysis.

PubMed

Hosseinpour, Mehdi; Sahebi, Sina; Zamzuri, Zamira Hasanah; Yahaya, Ahmad Shukri; Ismail, Noriszura

2018-06-01

According to crash configuration and pre-crash conditions, traffic crashes are classified into different collision types. Based on the literature, multi-vehicle crashes, such as head-on, rear-end, and angle crashes, are more frequent than single-vehicle crashes, and most often result in serious consequences. From a methodological point of view, the majority of prior studies focused on multivehicle collisions have employed univariate count models to estimate crash counts separately by collision type. However, univariate models fail to account for correlations which may exist between different collision types. Among others, multivariate Poisson lognormal (MVPLN) model with spatial correlation is a promising multivariate specification because it not only allows for unobserved heterogeneity (extra-Poisson variation) and dependencies between collision types, but also spatial correlation between adjacent sites. However, the MVPLN spatial model has rarely been applied in previous research for simultaneously modelling crash counts by collision type. Therefore, this study aims at utilizing a MVPLN spatial model to estimate crash counts for four different multi-vehicle collision types, including head-on, rear-end, angle, and sideswipe collisions. To investigate the performance of the MVPLN spatial model, a two-stage model and a univariate Poisson lognormal model (UNPLN) spatial model were also developed in this study. Detailed information on roadway characteristics, traffic volume, and crash history were collected on 407 homogeneous segments from Malaysian federal roads. The results indicate that the MVPLN spatial model outperforms the other comparing models in terms of goodness-of-fit measures. The results also show that the inclusion of spatial heterogeneity in the multivariate model significantly improves the model fit, as indicated by the Deviance Information Criterion (DIC). The correlation between crash types is high and positive, implying that the occurrence of a specific collision type is highly associated with the occurrence of other crash types on the same road segment. These results support the utilization of the MVPLN spatial model when predicting crash counts by collision manner. In terms of contributing factors, the results show that distinct crash types are attributed to different subsets of explanatory variables. Copyright © 2018 Elsevier Ltd. All rights reserved.

Planar Impacts in Rollover Crashes: Significance, Distribution and Injury Epidemiology

PubMed Central

Bose, Dipan; Kerrigan, Jason R.; Foster, Jonathan B.; Crandall, Jeff R.; Tobaru, Shigeo

2011-01-01

While one third of all fatal motor vehicle crashes involve rollover of the vehicle, a substantially large portion of these rollover crashes involve planar impacts (e.g., frontal, side or rear impact) that influence the crash kinematics and subsequently the injury outcome. The objective of the study was to evaluate the distribution of planar impacts in rollover crashes, and in particular, to describe the differences in the underlying crash kinematics, injury severity and the regional distribution of injuries when compared to the rollover-dominated crashes without significant planar impact (i.e., primary rollovers). Sampled cases (n=6,900) from the U.S. National Automotive Sampling System – Crashworthiness Data System, representing approximately 3.3 million belted drivers involved in a rollover crash in years 1998–2008, were analyzed. Single vehicle rollover crashes with significant planar impact (21% of all rollover crashes) were in general more likely to result in occupant fatality and involved higher incidence of moderate to severe injuries compared to single vehicle primary rollovers (p<0.05). A substantial proportion of the planar impact rollovers ended in single quarter turn crashes (30%), mostly resulting from a frontal impact (59%). While chest was the most frequently injured body region among all rollover victims sustaining severe injuries, severe injuries sustained in primary rollovers were more isolated (single body region) in comparison to the ones sustained in rollovers with planar impacts. The results emphasize the higher risk of rollover victims sustaining an injury and the differences in distribution of injuries sustained when a planar impact is associated with the rollover crash. PMID:22105400

Modeling left-turn crash occurrence at signalized intersections by conflicting patterns.

PubMed

Wang, Xuesong; Abdel-Aty, Mohamed

2008-01-01

In order to better understand the underlying crash mechanisms, left-turn crashes occurring at 197 four-legged signalized intersections over 6 years were classified into nine patterns based on vehicle maneuvers and then were assigned to intersection approaches. Crash frequency of each pattern was modeled at the approach level by mainly using Generalized Estimating Equations (GEE) with the Negative Binomial as the link function to account for the correlation among the crash data. GEE with a binomial logit link function was also applied for patterns with fewer crashes. The Cumulative Residuals test shows that, for correlated left-turn crashes, GEE models usually outperformed basic Negative Binomial models. The estimation results show that there are obvious differences in the factors that cause the occurrence of different left-turn collision patterns. For example, for each pattern, the traffic flows to which the colliding vehicles belong are identified to be significant. The width of the crossing distance (represented by the number of through lanes on the opposing approach of the left-turning traffic) is associated with more left-turn traffic colliding with opposing through traffic (Pattern 5), but with less left-turning traffic colliding with near-side crossing through traffic (Pattern 8). The safety effectiveness of the left-turning signal is not consistent for different crash patterns; "protected" phasing is correlated with fewer Pattern 5 crashes, but with more Pattern 8 crashes. The study indicates that in order to develop efficient countermeasures for left-turn crashes and improve safety at signalized intersections, left-turn crashes should be considered in different patterns.

Visual Sensory and Visual-Cognitive Function and Rate of Crash and Near-Crash Involvement Among Older Drivers Using Naturalistic Driving Data

PubMed Central

Huisingh, Carrie; Levitan, Emily B.; Irvin, Marguerite R.; MacLennan, Paul; Wadley, Virginia; Owsley, Cynthia

2017-01-01

Purpose An innovative methodology using naturalistic driving data was used to examine the association between visual sensory and visual-cognitive function and rates of future crash or near-crash involvement among older drivers. Methods The Strategic Highway Research Program (SHRP2) Naturalistic Driving Study was used for this prospective analysis. The sample consisted of N = 659 drivers aged ≥70 years and study participation lasted 1 or 2 years for most participants. Distance and near visual acuity, contrast sensitivity, peripheral vision, visual processing speed, and visuospatial skills were assessed at baseline. Crash and near-crash involvement were based on video recordings and vehicle sensors. Poisson regression models were used to generate crude and adjusted rate ratios (RRs) and 95% confidence intervals, while accounting for person-miles of travel. Results After adjustment, severe impairment of the useful field of view (RR = 1.33) was associated with an increased rate of near-crash involvement. Crash, severe crash, and at-fault crash involvement were associated with impaired contrast sensitivity in the worse eye (RRs = 1.38, 1.54, and 1.44, respectively) and far peripheral field loss in both eyes (RRs = 1.74, 2.32, and 1.73, respectively). Conclusions Naturalistic driving data suggest that contrast sensitivity in the worse eye and far peripheral field loss in both eyes elevate the rates of crash involvement, and impaired visual processing speed elevates rates of near-crash involvement among older drivers. Naturalistic driving data may ultimately be critical for understanding the relationship between vision and driving safety. PMID:28605807

The effectiveness of electronic stability control in reducing real-world crashes: a literature review.

PubMed

Ferguson, Susan A

2007-12-01

Electronic stability control (ESC) is designed to help drivers maintain heading control of their vehicles in high-speed or sudden maneuvers and on slippery roads. The wider proliferation of ESC across the vehicle fleet has allowed evaluation of its effects in real-world crashes in many countries, including Japan, Germany, Sweden, France, Great Britain, and the United States. This article provides a summary of the findings. Studies that examined the real-world effectiveness of ESC were reviewed. Crash effects have been examined for different roadways, using differing analytic methods, different crash severities, and different make/model vehicles including both cars and SUVs. The review discusses the methodological differences and examines the findings according to vehicle type, crash type and severity, and road conditions. The overwhelming majority of studies find that ESC is highly effective in reducing single-vehicle crashes in cars and SUVs. Fatal single-vehicle crashes involving cars are reduced by about 30-50% and SUVs by 50-70%. Fatal rollover crashes are estimated to be about 70-90% lower with ESC regardless of vehicle type. A number of studies find improved effectiveness in reducing crashes when road conditions are slippery. There is little or no effect of ESC in all multi-vehicle crashes; however, there is a 17-38% reduction in more serious, fatal multi-vehicle crashes. Given the extraordinary benefits of ESC in preventing crashes, especially those with more serious outcomes, the implementation of ESC should be accelerated to cover the full range of passenger vehicles in both developed and developing markets.

Increased inequality in mortality from road crashes among Arabs and Jews in Israel.

PubMed

Magid, Avi; Leibovitch-Zur, Shalhevet; Baron-Epel, Orna

2015-01-01

Previous studies in several countries have shown that the economically disadvantaged seem to have a greater risk of being involved in a car crash. The aim of the present study was to compare rates and trends in mortality and injury from road crashes by age among the Arab and Jewish populations in Israel. Data on road crashes with casualties (2003-2011) from the Israeli Central Bureau of Statistics were analyzed. Age-adjusted road crash injury rates and mortality rates for 2003 to 2011 were calculated and time trends for each age group and population group are presented. Time trend significance was evaluated by linear regression models. Arabs in Israel are at increased risk of injury and mortality from road crashes compared to Jews. Road crash injury rates have significantly decreased in both populations over the last decade, although the rates have been persistently higher among Arabs. Road crash mortality rates have also decreased significantly in the Jewish population but not in the Arab population. This implies an increase in the disparity in mortality between Jews and Arabs. The most prominent differences in road crash injury and mortality rates between Arabs and Jews can be observed in young adults and young children. The reduction in road crashes in the last decade is a positive achievement. However, the reductions are not equal among Arabs and Jews in Israel. Therefore, an increase in the disparities in mortality from road crashes is apparent. Public health efforts need to focus specifically on decreasing road crashes in the Arab community.

Crash Rates of Quebec Drivers with Medical Conditions

PubMed Central

Dow, Jamie; Gaudet, Michel; Turmel, Émilie

2013-01-01

Using a databank that combines comprehensive medical data with the driving records of 96% of the drivers in Quebec, odds ratios were calculated for crash risk involving death or serious injury according to the diagnosis of medical conditions traditionally associated with increased crash risk. Results were controlled for age, sex, residence (rural/urban), possession of a professional licence (classes 1 – 4), previous involvement in a crash with injury or death and for the presence of other medical conditions. In addition, crash risk was calculated for drivers with multiple conditions. There was a slight to moderate increase in crash risk for most of the conditions and an incremental increase in crash risk as the number of conditions increased. PMID:24406946

Establishing an effective TMS protocol for craving in substance addiction: Is it possible?

PubMed

Enokibara, Mailu; Trevizol, Alisson; Shiozawa, Pedro; Cordeiro, Quirino

2016-01-01

Repetitive transcranial magnetic stimulation (TMS) is a non-invasive tool with known therapeutic efficacy in various neuropsychiatric disorders, such as depression, schizophrenia, mania, and anxiety disorders. We hereby, briefly present a brief review and meta-analysis on the use of TMS for craving in substance addiction. We present our brief review and meta-analysis following the recommendations of the Cochrane group. A total of eight randomized controlled trials fulfilled eligibility criteria and were selected. A total of 199 patients were studied. We found active stimulation to be superior than sham protocols only for trials focused on right DLPFC (with Hedge's g = 1.48; ES (95%CI: 0.126-2.834), p = 0.032. Main meta-analysis limitations include small number of studies, high heterogeneity among studies, and high publication bias. However challenging, our exploratory analysis underscored the amelioration of craving in substance addiction for trials using high frequency TMS protocols over the right DLPFC. We hereby, propose the use of this particular TMS protocol as a promising tool in clinical research. © American Academy of Addiction Psychiatry.

Study protocol of a randomized controlled trial comparing integrative body-mind-spirit intervention and cognitive behavioral therapy in fostering quality of life of patients with lung cancer and their family caregivers.

PubMed

Lau, Bobo Hi-Po; Chow, Amy Y M; Wong, Daniel F K; Chan, Jessie S M; Chan, Celia H Y; Ho, Rainbow T H; So, Tsz-Him; Lam, Tai-Chung; Lee, Victor Ho-Fun; Lee, Anne W M; Chow, Sau Fong; Chan, Cecilia L W

2018-01-01

Compared to cancers at other sites, lung cancer often results in greater psychosocial distress to both the patients and their caregivers, due to the poor prognosis and survival rate, as well as the heavy symptom burden. In recent years, making protocols of proposed or on-going studies publicly available via clinical trial registries and/or peer-reviewed journals has benefited health sciences with timely communication of the latest research trends and improved transparency in reporting. However, such practice is yet to be a common sight in evidence-informed social work. Hence, this paper discusses the value of publishing protocols in social work research and presents the protocol of a randomized controlled trial that compares the effectiveness of integrative body-mind-spirit intervention with cognitive behavioral therapy for enhancing quality of life of patients with lung cancer and their family caregivers. The data collection process was still on-going at the time of manuscript submission.

Cable median barrier failure analysis and prevention.

DOT National Transportation Integrated Search

2012-12-01

Cross-median crashes have been identified as one of the highest injury or fatality risk crash types. Although crossmedian : crashes account for only 2% to 5% of all median crash events, they are disproportionately represented in the number : and freq...

A comprehensive engineering analysis of motorcycle crashes in Maryland.

DOT National Transportation Integrated Search

2010-12-01

The goal of this study was to identify recurring or common road characteristics of motorcycle crashes : in Maryland from 1998 to 2007. Motorcycle crash data was obtained from the National Highway : Traffic Safety Administrations Crash Outcome Data...

1997 New Mexico traffic crash information

DOT National Transportation Integrated Search

1998-06-01

This edition of New Mexico Traffic Crash Information reviews : traffic crash data in New Mexico from January through : December, 1997. It presents crash data in the form of graphs : for those who prefer an impressionistic view and tables for : those ...

1995 New Mexico traffic crash information

DOT National Transportation Integrated Search

1996-09-01

This edition of New Mexico Traffic Crash Information reviews : traffic crash data in New Mexico from January through : December, 1995. It presents crash data in the form of graphs : for those who prefer an impressionistic view and tables for : those ...

Frequency of target crashes for IntelliDrive safety systems

DOT National Transportation Integrated Search

2010-10-01

This report estimates the frequency of different crash types that would potentially be addressed by various categories of Intelligent Transportation Systems as part of the IntelliDriveSM safety systems program. Crash types include light-vehicle crash...

Commercial bus crashes in North Carolina 1995-1999

DOT National Transportation Integrated Search

2000-04-01

Tables and figures are shown to depict a statistical representation of commercial bus crashes in North Carolina. Information displayed includes crash frequency, crashes by county, accident severity, time of day, month of the year, class of roadway, r...

Problem definition for pre-crash sensing advanced restraints.

DOT National Transportation Integrated Search

2009-04-01

This report presents the results of crash analyses that defined and prioritized target crashes for advanced restraint systems based on pre-crash sensors. These analyses targeted the driver and front-seat passenger 13 or older, traveling in light vehi...

Developing inexpensive crash countermeasures for Louisiana local roads.

DOT National Transportation Integrated Search

2014-03-01

Although 40% of all crashes in Louisiana are on local roads, local road safety improvement programs have not received : the attention needed to reduce crashes. Local road crash countermeasures are an important part of the overall efforts to : reduce ...

2000 New Mexico traffic crash information

DOT National Transportation Integrated Search

2002-03-01

This edition of New Mexico Traffic Crash Information reviews traffic : crash data in New Mexico from January through December, 2000. : It presents crash data in the form of graphs for those who prefer : an impressionistic view and tables for those wh...

2005 New Mexico traffic crash information

DOT National Transportation Integrated Search

2006-11-01

This edition of New Mexico Traffic Crash Information reviews traffic : crash data in New Mexico from January through December, 2005. : It presents crash data in the form of graphs for those who prefer : an impressionistic view and tables for those wh...

2001 New Mexico traffic crash information

DOT National Transportation Integrated Search

2003-01-01

This edition of New Mexico Traffic Crash Information reviews traffic : crash data in New Mexico from January through December, 2001. : It presents crash data in the form of graphs for those who prefer : an impressionistic view and tables for those wh...

2008 New Mexico traffic crash information

DOT National Transportation Integrated Search

2010-05-01

This edition of New Mexico Traffic Crash Information reviews : traffic crash data in New Mexico from January through December, : 2008. It presents crash data in the form of graphs for those who : prefer an impressionistic view and tables for those wh...

1996 New Mexico traffic crash information

DOT National Transportation Integrated Search

1997-06-01

This edition of New Mexico Traffic Crash Information reviews : traffic crash data in New Mexico from January through : December, 1997. It presents crash data in the form of graphs : for those who prefer an impressionistic view and tables for : those ...

1998 New Mexico traffic crash information

DOT National Transportation Integrated Search

1999-06-01

This edition of New Mexico Traffic Crash Information reviews : traffic crash data in New Mexico from January through : December, 1998. It presents crash data in the form of graphs : for those who prefer an impressionistic view and tables for : those ...

2002 New Mexico traffic crash information

DOT National Transportation Integrated Search

2004-02-01

This edition of New Mexico Traffic Crash Information reviews traffic : crash data in New Mexico from January through December, 2002. : It presents crash data in the form of graphs for those who prefer : an impressionistic view and tables for those wh...

2004 Wisconsin traffic crash facts

DOT National Transportation Integrated Search

2005-07-01

2004 Facts and Figures - 784 persons were killed in Wisconsin motor vehicle traffic crashes. This is an average of two lives lost each day on Wisconsin trafficways. - 55,258 persons were injured in 38,451 reported injury crashes and 714 fatal crashes...

2004 South Dakota motor vehicle traffic crash summary

DOT National Transportation Integrated Search

2005-01-01

The South Dakota Motor Vehicle Traffic Crash Summary was developed to provide an overview of : the South Dakota traffic crash picture, as well as make frequently requested information available. : Beginning in 2004, South Dakota developed its Crash D...

2005 Oregon state highway accident rate tables

DOT National Transportation Integrated Search

2006-08-01

State highway crash rate tables present crash frequencies in relation to traffic volume and highway mileage. The four major sections of this publication are: I Results of Analysis II State Highway Crash Rates III Fatal Traffic Crash Summaries IV Appe...

2005 South Dakota motor vehicle traffic crash summary

DOT National Transportation Integrated Search

2006-05-01

The South Dakota Motor Vehicle Traffic Crash Summary was developed to provide an overview of : the South Dakota traffic crash picture, as well as make frequently requested information available. : Beginning in 2004, South Dakota developed its Crash D...

Socio-economic analysis of fatal crash trends : final report.

DOT National Transportation Integrated Search

2005-12-01

This report describes the analysis of fatal crash patterns and explores the impact of socioeconomic factors and safety regulations on statewide crash rates. This analysis separated statewide crash rates between 2002 and 2004 into two samples, 1) thos...

Further development of Motorcycle Autonomous Emergency Braking (MAEB), what can in-depth studies tell us? A multinational study.

PubMed

Savino, Giovanni; Rizzi, Matteo; Brown, Julie; Piantini, Simone; Meredith, Lauren; Albanese, Bianca; Pierini, Marco; Fitzharris, Michael

2014-01-01

In 2006, Motorcycle Autonomous Emergency Braking (MAEB) was developed by a European Consortium (Powered Two Wheeler Integrated Safety, PISa) as a crash severity countermeasure for riders. This system can detect an obstacle through sensors in the front of the motorcycle and brakes automatically to achieve a 0.3 g deceleration if the collision is inevitable and the rider does not react. However, if the rider does brake, full braking force is applied automatically. Previous research into the potential benefits of MAEB has shown encouraging results. However, this was based on MAEB triggering algorithms designed for motorcycle crashes involving impacts with fixed objects and rear-end crashes. To estimate the full potential benefit of MAEB, there is a need to understand the full spectrum of motorcycle crashes and further develop triggering algorithms that apply to a wider spectrum of crash scenarios. In-depth crash data from 3 different countries were used: 80 hospital admittance cases collected during 2012-2013 within a 3-h driving range of Sydney, Australia, 40 crashes with Injury Severity Score (ISS)>15 collected in the metropolitan area of Florence, Italy, during 2009-2012, and 92 fatal crashes that occurred in Sweden during 2008-2009. In the first step, the potential applicability of MAEB among the crashes was assessed using a decision tree method. To achieve this, a new triggering algorithm for MAEB was developed to address crossing scenarios as well as crashes involving stationary objects. In the second step, the potential benefit of MAEB across the applicable crashes was examined by using numerical computer simulations. Each crash was reconstructed twice-once with and once without MAEB deployed. The principal finding is that using the new triggering algorithm, MAEB is seen to apply to a broad range of multivehicle motorcycle crashes. Crash mitigation was achieved through reductions in impact speed of up to approximately 10 percent, depending on the crash scenario and the initial vehicle pre-impact speeds. This research is the first attempt to evaluate MAEB with simulations on a broad range of crash scenarios using in-depth data. The results give further insights into the feasibility of MAEB in different speed ranges. It is clear then that MAEB is a promising technology that warrants further attention by researchers, manufacturers, and regulators.

An empirical analysis of farm vehicle crash injury severities on Iowa's public road system.

PubMed

Gkritza, Konstantina; Kinzenbaw, Caroline R; Hallmark, Shauna; Hawkins, Neal

2010-07-01

Farm vehicle crashes are a major safety concern for farmers as well as all other users of the public road system in agricultural states. Using data on farm vehicle crashes that occurred on Iowa's public roads between 2004 and 2006, we estimate a multinomial logit model to identify crash-, farm vehicle-, and driver-specific factors that determine farm vehicle crash injury severity outcomes. Estimation findings indicate that there are crash patterns (rear-end manner of collision; single-vehicle crash; farm vehicle crossed the centerline or median) and conditions (obstructed vision and crash in rural area; dry road, dark lighting, speed limit 55 mph or higher, and harvesting season), as well as farm vehicle and driver-contributing characteristics (old farm vehicle, young farm vehicle driver), where targeted intervention can help reduce the severity of crash outcomes. Determining these contributing factors and their effect is the first step to identifying countermeasures and safety strategies in a bid to improve transportation safety for all users on the public road system in Iowa as well as other agricultural states. Copyright 2010 Elsevier Ltd. All rights reserved.

The effects of roadway characteristics on farm equipment crashes: A GIS approach

NASA Astrophysics Data System (ADS)

Greenan, Mitchell Joseph

Tractors and other self-propelled farm equipment, such as combines, sprayers, and towed grain carts, are often used on public roadways as the primary means for traveling from homestead to homestead or from homestead to a distributer. Increased roadway exposure has led to a growing concern for crashes involving farm equipment on the public roadway. A handful of studies exist examining public roadway crashes involving farm equipment using crash data, but none thus far have evaluated road segment data to identify road-specific risk factors. The objective of this study is to identify if roadway characteristics (traffic density, speed limit, road type, surface type, road width, and shoulder width) affect the risk of a crash involving farm equipment on Iowa public roadways. A retrospective cohort study of Iowa roads was conducted to identify the types of roads that are at an increased risk of having a farm-equipment crash on them. Crash data from the Iowa Department of Transportation (to identify crashes) were spatial linked to Iowa roadway data using Geographic Information Systems (GIS). Logistic regression was used to calculate ORs and 95% CL. Out of 319,705 road segments in Iowa, 0.4% segments (n=1,337) had a farm equipment crash from 2005-2011. The odds of having a farm equipment crash were significantly higher for road segments with increased traffic density and speed limit. Roads with an average daily traffic volume of at least 1,251 vehicles were at a 5.53 times greater odds of having a crash than roads with a daily traffic volume between 0-30 vehicles. (CI: 3.90-7.83). Roads with a posted speed limit between 50mph and 60mph were at a 4.88 times greater odds of having a crash than roads with a posted speed limit of 30mph or less. (CI: 3.85-6.20). Specific roadway characteristics such as roadway and shoulder width were also associated with the risk of a crash. For every 5 foot increase in road width, the odds for a crash decreased by 6 percent (CI: 0.89-0.99) and for every 5 foot increase in shoulder width, the odds of a crash decreased by 8 percent. (CI: 0.86-0.98). Although not statically significant, unpaved roads increased the odds of a crash by 17 percent. (CI: 0.91-1.50) Lastly, it was found that Farm to Market routes increased the odds of a crash by two fold compared to local roads (which make up roughly 67 percent of Iowa public roads). (CI: 1.72-2.43) When the same model was stratified by rurality (urban/rural), it was found that high traffic density leads to a higher risk of a crash in rural areas. Iowa routes and Farm to Market routes had a greater odds of a crash in urban than rural areas, and road and shoulder width were more protective in rural than urban areas. When only using roads with a crash involving an injury versus all other roads as the outcome, Iowa routes and roads with increased speed limits had higher odds for an injury-involved crash, while increased road width were more protective against crashes involving injuries. Findings from the study suggest that several roadway characteristics were associated with farm-equipment crashes. Through administrative and engineering controls, the six static explanatory variables used in this study may be modified to decrease the risk of a farm equipment crash. Speed limit can be modified through administrative controls while traffic density, road and shoulder width, road type, and surface type can be modified through engineering controls. Results from this study provide information that will aid policy-makers in developing safer roads for farm equipment.

Crash involvement of motor vehicles in relationship to the number and severity of traffic offenses. An exploratory analysis of Dutch traffic offenses and crash data.

PubMed

Goldenbeld, Charles; Reurings, Martine; Van Norden, Yvette; Stipdonk, Henk

2013-01-01

To establish the statistical relationship between offenses and crashes when the unit of analysis is the vehicle instead of the driver, to show the influence of the severity (e.g., minor speed offenses) on this relationship, and to research whether the form of this relationship is similar in different enforcement contexts. An exploratory analysis was conducted using Dutch traffic offense and crash data. Crash data included all police-registered crashes involving motorized and registered vehicles in 2009; offense data included all non-criminal traffic offenses registered during 2005-2009 (mostly camera detected). Together these comprise an estimated 97 percent of all traffic offenses registered in this period. The analysis was done on a level of identified vehicles rather than persons. Vehicles involved in crashes were matched to vehicles involved in traffic offenses. The offense frequency distributions of registered crash involved vehicles and a random selection of vehicles was analyzed. Two comparisons were made: (1) privately owned vehicles versus company-owned vehicles and (2) vehicles for which only minor speed offenses were registered versus vehicles for which at least one major speed offense was registered. An increase in traffic offense frequency coincides with a stronger increase in relative crash involvement. This relationship was adequately described by a power function. The slightly more than linear increase in the crash risk for vehicles with only minor speed offenses suggests that minor speed offenses (<10 km/h over the limit) contributed slightly to crashes. This relationship was unlikely to be caused by increased distance traveled only. For vehicles with at least one or more major speed violation an approximately quadratic increase of crash risk with increasing speed offense frequency was found. A comparison of Dutch and Canadian data showed a much more progressive offense-crash relationship in the Dutch data. The crash involvement of vehicles increased more than linearly with the number of minor traffic violations. Thus, automatic detection of minor offenses bears relevance to safety. The substantial increase in crash rates with speed offense frequency for vehicles with at least one major speed violation suggests that these vehicles represent a specific group with a significantly increased crash risk, especially in the case of many minor offenses. The more progressive relationship between offenses and crashes in The Netherlands when compared to Canada was hypothesized to result from the higher intensity camera enforcement levels and less severe consequences in the Dutch enforcement and adjudication system.

Analyses of rear-end crashes based on classification tree models.

PubMed

Yan, Xuedong; Radwan, Essam

2006-09-01

Signalized intersections are accident-prone areas especially for rear-end crashes due to the fact that the diversity of the braking behaviors of drivers increases during the signal change. The objective of this article is to improve knowledge of the relationship between rear-end crashes occurring at signalized intersections and a series of potential traffic risk factors classified by driver characteristics, environments, and vehicle types. Based on the 2001 Florida crash database, the classification tree method and Quasi-induced exposure concept were used to perform the statistical analysis. Two binary classification tree models were developed in this study. One was used for the crash comparison between rear-end and non-rear-end to identify those specific trends of the rear-end crashes. The other was constructed for the comparison between striking vehicles/drivers (at-fault) and struck vehicles/drivers (not-at-fault) to find more complex crash pattern associated with the traffic attributes of driver, vehicle, and environment. The modeling results showed that the rear-end crashes are over-presented in the higher speed limits (45-55 mph); the rear-end crash propensity for daytime is apparently larger than nighttime; and the reduction of braking capacity due to wet and slippery road surface conditions would definitely contribute to rear-end crashes, especially at intersections with higher speed limits. The tree model segmented drivers into four homogeneous age groups: < 21 years, 21-31 years, 32-75 years, and > 75 years. The youngest driver group shows the largest crash propensity; in the 21-31 age group, the male drivers are over-involved in rear-end crashes under adverse weather conditions and the 32-75 years drivers driving large size vehicles have a larger crash propensity compared to those driving passenger vehicles. Combined with the quasi-induced exposure concept, the classification tree method is a proper statistical tool for traffic-safety analysis to investigate crash propensity. Compared to the logistic regression models, tree models have advantages for handling continuous independent variables and easily explaining the complex interaction effect with more than two independent variables. This research recommended that at signalized intersections with higher speed limits, reducing the speed limit to 40 mph efficiently contribute to a lower accident rate. Drivers involved in alcohol use may increase not only rear-end crash risk but also the driver injury severity. Education and enforcement countermeasures should focus on the driver group younger than 21 years. Further studies are suggested to compare crash risk distributions of the driver age for other main crash types to seek corresponding traffic countermeasures.

Association of State Alcohol Policies With Alcohol-Related Motor Vehicle Crash Fatalities Among US Adults.

PubMed

Naimi, Timothy S; Xuan, Ziming; Sarda, Vishnudas; Hadland, Scott E; Lira, Marlene C; Swahn, Monica H; Voas, Robert B; Heeren, Timothy C

2018-05-29

Motor vehicle crashes are a leading cause of mortality. However, the association between the restrictiveness of the alcohol policy environment (ie, based on multiple existing policies) and alcohol-related crash fatalities has not been characterized previously to date. To examine the association between the restrictiveness of state alcohol policy environments and the likelihood of alcohol involvement among those dying in motor vehicle crashes in the United States. This investigation was a repeated cross-sectional study in which state alcohol policies (operationalized by the Alcohol Policy Scale [APS]) from 1999 to 2014 were related to motor vehicle crash fatalities from 2000 to 2015 using data from the Fatality Analysis Reporting System (1-year lag). Alternating logistic regression models and generalized estimating equations were used to account for clustering of multiple deaths within a crash and of multiple crashes occurring within states. The study also examined independent associations of mutually exclusive subgroups of policies, including consumption-oriented policies vs driving-oriented policies. The study setting was the 50 US states. Participants were 505 614 decedents aged at least 21 years from motor vehicle crashes from 2000 to 2015. Odds that a crash fatality was alcohol related (fatality stemmed from a crash in which ≥1 driver had a blood alcohol concentration [BAC] ≥0.08%). From 2000 to 2015, there were 505 614 adult motor vehicle crash fatalities in the United States, of which 178 795 (35.4%) were alcohol related. Each 10-percentage point increase in the APS score (corresponding to more restrictive state policies) was associated with reduced individual-level odds of alcohol involvement in a crash fatality (adjusted odds ratio [aOR], 0.90; 95% CI, 0.89-0.91); results were consistent among most demographic and crash-type strata. More restrictive policies also had protective associations with alcohol involvement among crash fatalities associated with BACs from greater than 0.00% to less than 0.08%. After accounting for driving-oriented policies, consumption-oriented policies were independently protective for alcohol-related crash fatalities (aOR, 0.97; 95% CI, 0.96-0.98 based on a 10-percentage point increased APS score). Strengthening alcohol policies, including those that do not specifically target impaired driving, could reduce alcohol-related crash fatalities. Policies may also protect against crash fatalities involving BAC levels below the current legal limit for driving in the United States.

Relationship of Near-Crash/Crash Risk to Time Spent on a Cell Phone While Driving.

PubMed

Farmer, Charles M; Klauer, Sheila G; McClafferty, Julie A; Guo, Feng

2015-01-01

The objective of this study was to examine in a naturalistic driving setting the dose-response relationship between cell phone usage while driving and risk of a crash or near crash. How is the increasing use of cell phones by drivers associated with overall near-crash/crash risk (i.e., during driving times both on and off the phone)? Day-to-day driving behavior of 105 volunteer subjects was monitored over a period of 1 year. A random sample was selected comprised of 4 trips from each month that each driver was in the study, and in-vehicle video was used to classify driver behavior. The proportion of driving time spent using a cell phone was estimated for each 3-month period and correlated with overall crash and near-crash rates for each period. Thus, it was possible to test whether changes in an individual driver's cell phone use over time were associated with changes in overall near-crash/crash risk. Drivers in the study spent 11.7% of their driving time interacting with a cell phone, primarily talking on the phone (6.5%) or simply holding the phone in their hand or lap (3.7%). The risk of a near-crash/crash event was approximately 17% higher when the driver was interacting with a cell phone, due primarily to actions of reaching for/answering/dialing, which nearly triples risk (relative risk = 2.84). However, the amount of driving time spent interacting with a cell phone did not affect a driver's overall near-crash/crash risk. Vehicle speeds within 6 s of the beginning of each call on average were 5-6 mph lower than speeds at other times. Results of this naturalistic driving study are consistent with the observation that increasing cell phone use in the general driving population has not led to increased crash rates. Although cell phone use can be distracting and crashes have occurred during this distraction, overall crash rates appear unaffected by changes in the rate of cell phone use, even for individual drivers. Drivers compensate somewhat for the distraction by conducting some of the more demanding tasks, such as reaching for or dialing a cell phone, at lower speeds. It is also possible that cell phones and other electronic devices in cars are changing how drivers manage their attention to various tasks and/or changing the kinds of secondary tasks in which they engage.

Quality assurance audit: a prospective non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LY02).

PubMed

Christie, D; Le, T; Watling, K; Cornes, D; O'Brien, P; Hitchins, R

2009-04-01

A quality assurance (QA) audit of the Trans Tasman Radiation Oncology Group and Australasian Lymphoma and Leukaemia Group trial (TROG 99.04/ALLG LY02) began after accrual of 25 patients. The trial is a prospective non-randomized study of standard treatment for osteolymphoma. Data relating to informed consent, eligibility, chemotherapy and radiotherapy were reviewed. The audit showed a relatively low level of major variations from the protocol, with an overall rate of 3.6%. As this trial has accrued slowly over a long period, the concept of QA has also developed. Amendments were made to the protocol accordingly. In the future, QA procedures should be predetermined, conducted rapidly in real time, and appropriately funded in order to be relevant to the ongoing conduct of the trial.

2009 New Mexico traffic crash information

DOT National Transportation Integrated Search

2011-05-01

This edition of New Mexico Traffic Crash Information reviews traffic crash data in New Mexico from January through December, 2009. It presents crash data in the form of graphs for those who prefer an impressionistic view and tables for those who requ...

1999 New Mexico traffic crash information

DOT National Transportation Integrated Search

2001-03-01

This edition of New Mexico Traffic Crash Information reviews traffic crash data in New MExico from January through Decemeber, 1999. It presents crash data in the form of graphs for those who prefer an impressionistic view and tables for those who req...

2002 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2003-11-01

The State Highway Motor Carrier Crash Rate Tables is a publication in four parts. Its : purpose is to assist readers in computing Motor Carrier crash rates for specific sections : of State Highways. This report differs from the State Highway Crash Ra...

Illinois crash facts and statistics, 2010

DOT National Transportation Integrated Search

2011-01-01

The number of reported motor vehicle crashes decreased from the previous year to fewer than 290,000 crashes in calendar year 2010. In addition, the number of persons injured in crashes dropped below 89,000 and the number of fatalities on Illinois roa...

Crashes involving farm tractors and other farm vehicles/equipment in North Carolina 1995-1999

DOT National Transportation Integrated Search

2000-04-01

Tables and figures are shown to depict a statistical representation of crashes involving farm tractors and other farm vehicles or equipment, in North Carolina. Information displayed includes crash frequency, crashes by county, accident severity, type...

1999 Iowa crash facts : a summary of motor vehicle crash statistics on Iowa roadways

DOT National Transportation Integrated Search

1999-01-01

All information concerning Iowa traffic crashes was taken from report forms : provided by investigating officers and drivers involved in crashes. : All statistics are gathered and calculated by the Iowa Department of Transportations Office of Driv...

2010 Wisconsin traffic crash facts

DOT National Transportation Integrated Search

2011-01-01

562 persons were killed in Wisconsin motor vehicle traffic crashes. This is an average of just over one life lost each day on Wisconsin traffic arteries. : 40,889 persons were injured in 29,380 reported injury crashes and 517 fatal crashes. 3,845, or...

GIS-Based crash referencing and analysis system

DOT National Transportation Integrated Search

1999-02-01

One area where a Geographic Information System (GIS) has yet to be extensively applied is in the analysis of crash data. Computerized crash analysis systems in which crash data, roadway inventory data, and traffic operations data can be merged are us...

2003 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2005-04-01

The State Highway Motor Carrier Crash Rate Tables is a publication in four parts. Its : purpose is to assist readers in computing Motor Carrier crash rates for specific sections of : State Highways. This report differs from the State Highway Crash Ra...

2006 New Mexico traffic crash information

DOT National Transportation Integrated Search

2007-10-01

This edition of New Mexico Traffi c Crash Information : reviews traffi c crash data in New Mexico from January : through December, 2006. It presents crash data in the : form of graphs for those who prefer an impressionistic view : and tables for thos...

2007 New Mexico traffic crash information

DOT National Transportation Integrated Search

2009-12-01

This edition of New Mexico Traffi c Crash Information reviews : traffi c crash data in New Mexico from January through December, : 2007. It presents crash data in the form of graphs for those who : prefer an impressionistic view and tables for those ...

Exploring rear-end roadway crashes from the driver's perspective

DOT National Transportation Integrated Search

1998-10-01

This pilot study examined rear-end crashes from the driver's perspective to identify self-reported reasons and causes of such crashes, to identify commonalities in the self-reported causes and locations and circumstances of these crashes, and to expl...

Advanced Crash Avoidance Technologies (ACAT) Program - Final Report of the GM-VTTI Backing Crash Countermeasures Project

DOT National Transportation Integrated Search

2011-08-01

The Backing crash Countermeasures project, part of the U.S. Department of Transportation's Advanced Crash Avoidance Technologies (ACAT) program, developed a basic methodological framework and computerbased simulation model to estimate the effectiv...

2004 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2005-11-01

The State Highway Motor Carrier Crash Rate Tables is a publication in four parts. Its : purpose is to assist readers in computing Motor Carrier crash rates and Truck-At-Fault : crash rates for specific sections of State Highways. This report differs ...

2006 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2007-08-01

The State Highway Motor Carrier Crash Rate Tables is a publication in four parts. Its : purpose is to assist readers in computing Motor Carrier crash rates and Truck-At-Fault : crash rates for specific sections of State Highways. This report differs ...

2009 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2010-11-01

The State Highway Motor Carrier Crash Rate Tables is a publication in four parts. Its purpose is to assist readers in computing Motor Carrier crash rates and Truck-At-Fault crash rates for specific sections of State Highways. This report differs from...

2005 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2006-01-01

The State Highway Motor Carrier Crash Rate Tables is a publication in four parts. Its : purpose is to assist readers in computing Motor Carrier crash rates and Truck-At-Fault : crash rates for specific sections of State Highways. This report differs ...

2007 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2008-11-01

The State Highway Motor Carrier Crash Rate Tables is a publication in four parts. Its : purpose is to assist readers in computing Motor Carrier crash rates and Truck-At-Fault : crash rates for specific sections of State Highways. This report differs ...

Fatal Crash Involvements -- What Are The Odds?

DOT National Transportation Integrated Search

1997-07-01

The risk of being involved in a fatal crash varies considerably depending on : specific crash characteristics, i.e., those of the driver, vehicle and : environment. A generally accepted measure of the risk of a fatal crash is the : ratio between the ...

Traffic safety facts : distracted driving 2009

DOT National Transportation Integrated Search

2010-09-01

In 2009, there were 30,797 fatal crashes in the United States, : which involved 45,230 drivers. In those crashes, 33,808 : people were killed. Distraction was reported for 11 percent : (5,084) of the drivers involved in fatal crashes. In these crashe...

A Front-End Analysis Of Rear-End Crashes

DOT National Transportation Integrated Search

1992-05-17

THIS PAPER DESCRIBES THE APPLICATION OF A SEVEN-STEP CRASH PROBLEM ANALYSIS METHODOLOGY, AS DESCRIBED IN THE PRECEDING PAPER BY LEASURE (1), TO REAR-END CRASHES. THE PAPER SHOWS HOW MODELING OF REAR-END CRASH SCENARIOS AND CANDIDATE COUNTERMEASURE AC...

1997 Iowa crash summary : a summary of motor vehicle crash statistics on Iowa roadways

DOT National Transportation Integrated Search

1997-01-01

All information concerning Iowa : traffic crashes was taken from report forms provided by investigating officers and drivers involved in : crashes. : All statistics are gathered and calculated by the Iowa Department of Transportations Office of Dr...

1996 Iowa crash summary : a summary of motor vehicle crash statistics on Iowa roadways

DOT National Transportation Integrated Search

1996-01-01

All information concerning Iowa : traffic crashes was taken from report forms provided by investigating officers and drivers involved in : crashes. : All statistics are gathered and calculated by the Iowa Department of Transportations Office of Dr...

1998 Iowa crash summary : a summary of motor vehicle crash statistics on Iowa roadways

DOT National Transportation Integrated Search

1998-01-01

All information concerning Iowa : traffic crashes was taken from report forms provided by investigating officers and drivers involved in : crashes. : All statistics are gathered and calculated by the Iowa Department of Transportations Office of Dr...

Pre-crash scenario framework for crash avoidance systems based on vehicle-to-vehicle communications

DOT National Transportation Integrated Search

2011-06-13

This paper prioritizes and statistically describes precrash : scenarios as a basis for the identification of : crash avoidance functions enhanced or enabled by : vehicle-to-vehicle (V2V) communication technology. : Pre-crash scenarios depict vehicle ...

Guidelines for reducing wrong-way crashes on freeways.

DOT National Transportation Integrated Search

2014-05-01

Each year, hundreds of fatal wrong-way driving (WWD) crashes occur across the United States, and thousands : of injuries are reported in traffic crashes caused by wrong-way drivers. Although WWD crashes have been a : concern since the advent of acces...

Characteristics and contributory causes related to large truck crashes (phase II) : all crashes.

DOT National Transportation Integrated Search

2012-03-01

Statistics clearly demonstrate that large-truck crashes contribute to a significant percentage of high-severity crashes. It is : therefore important for the highway safety community to identify the characteristics and contributory causes of these typ...

Spatially referenced crash data system for application to commercial motor vehicle crashes.

DOT National Transportation Integrated Search

2003-05-01

The Maryland Spatial Analysis of Crashes (MSAC) project involves the design of a : prototype of a geographic information system (GIS) for the State of Maryland that has : the capability of providing online crash information and statistical informatio...

2008 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2009-10-01

The State Highway Motor Carrier Crash Rate Tables is a publication in four parts. Its : purpose is to assist readers in computing Motor Carrier crash rates and Truck-At-Fault : crash rates for specific sections of State Highways. This report differs ...

Relationship between speed and lateral position on curves.

DOT National Transportation Integrated Search

2012-09-01

Excessive speed is often cited as a primary driver factor in crashes, particularly rural two-lane crashes. It has also been suggested that speed plays a significant role in crashes on curves. : However, the relationship between speed and crashes on c...

Injury risks for on-road farm equipment and horse and buggy crashes in Pennsylvania: 2010-2013.

PubMed

Gorucu, Serap; Murphy, Dennis J; Kassab, Cathy

2017-04-03

The purpose of this study was to investigate characteristics associated with farm equipment and horse and buggy roadway crashes in relation to person, incident, and injury characteristics to identify appropriate points for injury incident prevention. Information on crashes occurring on public roads during the years 2010-2013 was obtained from the Pennsylvania Department of Transportation (PennDOT) and analyzed. There were 344 farm equipment and 246 horse and buggy crashes during the 4-year study period. These crashes involved 666 and 504 vehicles and 780 and 838 people, respectively. In incidents with farm equipment, the non-farm equipment drivers had an almost 2 times greater injury risk than farm equipment operators. Horse and buggy crashes were almost 3 times more injurious to the horse and buggy drivers than the drivers of the other vehicles. The average crash rate for farm equipment was 198.4 crashes per 100,000 farm population and for horse and buggy the crash rate was calculated as 89.4 crashes per 100,000 Amish population per year. This study suggests that road safety and public health programs should focus not only on farm equipment operators and horse and buggy drivers but on other motorists sharing the roadway with them.

Impact of federal compliance reviews of trucking companies in reducing highway truck crashes.

PubMed

Chen, Guang Xiang

2008-01-01

The compliance review (CR) is a federal program monitoring motor carrier safety performance and regulatory compliance. This study sought to assess the impact of CRs on reviewed trucking companies in reducing truck crashes. Data was from the Motor Carrier Management Information System. Study subjects were trucking companies established during 1990-1995, had at least one truck, and remained active until April 2004. Truck crash data of these companies was examined from 1996 to 2003. The crash rates in 2003 and annual percentage changes in number of crashes were computed. Analyses were stratified by company size, organization, operation classification, and safety rating. Companies that received CRs had a higher crash rate than never-reviewed companies. Reviewed companies experienced a 39-15% reduction in number of crashes in the year the CR was performed. The reduction in crashes was observed in all reviewed companies regardless of company size, operation classification, type of organization, or safety rating. The reduction in crashes was sustained for at least 7 years after CRs. The study results were controlled for the year in which CRs were performed, crash trend, and CR selection bias. However, further studies, especially a randomized prospective longitudinal study, are needed to overcome the limitations that are associated with an observation study.

Red-Light-Running Crashes' Classification, Comparison, and Risk Analysis Based on General Estimates System (GES) Crash Database.

PubMed

Zhang, Yuting; Yan, Xuedong; Li, Xiaomeng; Wu, Jiawei; Dixit, Vinayak V

2018-06-19

Red-light running (RLR) has been identified as one of the prominent contributing factors involved in signalized intersection crashes. In order to reduce RLR crashes, primarily, a better understanding of RLR behavior and crashes is needed. In this study, three RLR crash types were extracted from the general estimates system (GES), including go-straight (GS) RLR vehicle colliding with go-straight non-RLR vehicle, go-straight RLR vehicle colliding with left-turn (LT) non-RLR vehicle, and left-turn RLR vehicle colliding with go-straight non-RLR vehicle. Then, crash features within each crash type scenario were compared, and risk analyses of GS RLR and LT RLR were also conducted. The results indicated that for the GS RLR driver, the speed limit displayed the highest effects on the percentages of GS RLR collision scenarios. For the LT RLR driver, the number of lanes displayed the highest effects on the percentages of LT RLR collision scenarios. Additionally, the drivers who were older than 50 years, distracted, and had a limited view were more likely to be involved in LT RLR accidents. Furthermore, the speeding drivers were more likely to be involved in GS RLR accidents. These findings could give a comprehensive understanding of RLR crash features and propensities for each RLR crash type.

Influence of pavement condition on horizontal curve safety.

PubMed

Buddhavarapu, Prasad; Banerjee, Ambarish; Prozzi, Jorge A

2013-03-01

Crash statistics suggest that horizontal curves are the most vulnerable sites for crash occurrence. These crashes are often severe and many involve at least some level of injury due to the nature of the collisions. Ensuring the desired pavement surface condition is one potentially effective strategy to reduce the occurrence of severe accidents on horizontal curves. This study sought to develop crash injury severity models by integrating crash and pavement surface condition databases. It focuses on developing a causal relationship between pavement condition indices and severity level of crashes occurring on two-lane horizontal curves in Texas. In addition, it examines the suitability of the existing Skid Index for safety maintenance of two-lane curves. Significant correlation is evident between pavement condition and crash injury severity on two-lane undivided horizontal curves in Texas. Probability of a crash becoming fatal is appreciably sensitive to certain pavement indices. Data suggested that road facilities providing a smoother and more comfortable ride are vulnerable to severe crashes on horizontal curves. In addition, the study found that longitudinal skid measurement barely correlates with injury severity of crashes occurring on curved portions. The study recommends exploring the option of incorporating lateral friction measurement into Pavement Management System (PMS) databases specifically at curved road segments. Copyright © 2012 Elsevier Ltd. All rights reserved.

The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation

PubMed Central

2011-01-01

Background The OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale. Methods/design Quantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control). Discussion Although process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation. Trial Registration ISRCTN No: ISRCTN43769277 PMID:21288341

Vaccine Immunotherapy for Prostate Cancer

DTIC Science & Technology

2012-05-01

adenovirus/PSA (Ad/PSA) vaccine for the treatment of prostate cancer. Two protocols have been used in the trial: #1 - Phase II study of Adenovirus/PSA...this award is to conduct a Phase II clinical trial (Study) of an adenovirus/PSA (Ad/PSA) vaccine for the treatment of prostate cancer. Two protocols...suddenly prior to study treatment . And one patient previously reported as a screen failure became eligible and was treated. This subject was not

A data grid for imaging-based clinical trials

NASA Astrophysics Data System (ADS)

Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.

2007-03-01

Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

Chewing gum for the treatment of postoperative nausea and vomiting: a pilot randomized controlled trial.

PubMed

Darvall, J N; Handscombe, M; Leslie, K

2017-01-01

A novel treatment, chewing gum, may be non-inferior to ondansetron in inhibiting postoperative nausea and vomiting (PONV) in female patients after laparoscopic or breast surgery. In this pilot study, we tested the feasibility of a large randomized controlled trial. We randomized 94 female patients undergoing laparoscopic or breast surgery to ondansetron 4 mg i.v. or chewing gum if PONV was experienced in the postanaesthesia care unit (PACU). The primary outcome was full resolution of PONV, with non-inferiority defined as a difference between groups of <15% in a per protocol analysis. Secondary outcomes were PACU stay duration, anti-emetic rescue use, and acceptability of anti-emetic treatment. The feasibility of implementing the protocol in a larger trial was assessed. Postoperative nausea and vomiting in the PACU occurred in 13 (28%) ondansetron patients and 15 (31%) chewing gum patients (P=0.75). Three chewing gum patients could not chew gum when they developed PONV. On a per protocol basis, full resolution of PONV occurred in five of 13 (39%) ondansetron vs nine of 12 (75%) chewing gum patients [risk difference 37% (6.3-67%), P=0.07]. There was no difference in secondary outcomes between groups. Recruitment was satisfactory, the protocol was acceptable to anaesthetists and nurses, and data collection was complete. In this pilot trial, chewing gum was not inferior to ondansetron for treatment of PONV after general anaesthesia for laparoscopic or breast surgery in female patients. Our findings demonstrate the feasibility of a larger, multicentred randomized controlled trial to investigate this novel therapy. Australian New Zealand Clinical Trials Registry: ACTRN12615001327572. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery.

PubMed

Abdullah, Hairil Rizal; Lien, Victoria Peixin; Ong, Hwee Kuan; Er, Pei Ling; Hao, Ying; Khan, Shariq Ali; Liu, Christopher Weiyang

2017-08-04

Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions-physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. NCT02921932 (ClinicalTrials.gov). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Evolution de la reanimation transfusionnelle du blesse hemorragique grave au sein des forces militaires americaines (Evolution of US Military Transfusion Support for Resuscitation of Trauma and Hemorrhagic Shock)

DTIC Science & Technology

2013-04-15

Trauma Registry; Fresh whole blood; 1:1:1 component therapy; Platelet:RBC; FFP:RBC; Freeze-dried plasma; Tranexamic acid ∗ Auteur correspondant. Adresse e...Effects of tranexamic acid on death, vascular occlu- sive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a...randomised, placebo-controlled trial. Lancet 2010;376:23–32. [74] Morrison JJ, et al. Military application of tranexamic acid in trauma emer- gency

Motor vehicle crash-related subdural hematoma from real-world head impact data.

PubMed

Urban, Jillian E; Whitlow, Christopher T; Edgerton, Colston A; Powers, Alexander K; Maldjian, Joseph A; Stitzel, Joel D

2012-12-10

Abstract Approximately 1,700,000 people sustain a traumatic brain injury (TBI) each year and motor vehicle crashes (MVCs) are a leading cause of hospitalization from TBI. Acute subdural hematoma (SDH) is a common intracranial injury that occurs in MVCs associated with high mortality and morbidity rates. In this study, SDH volume and midline shift have been analyzed in order to better understand occupant injury by correlating them to crash and occupant parameters. Fifty-seven head computed tomography (CT) scans were selected from the Crash Injury Research Engineering Network (CIREN) with Abbreviated Injury Scale (AIS) level 3+ SDH. Semi-automated methods were used to isolate the intracranial volume. SDH and additional occupant intracranial injuries were segmented across axial CT images, providing a total SDH injury volume. SDH volume was correlated to crash parameters and occupant characteristics. Results show a positive correlation between SDH volume and crash severity in near-side and frontal crashes. Additionally, the location of the resulting hemorrhage varied by crash type. Those with greater SDH volumes had significantly lower Glasgow Coma Scale (GCS) scores at the crash site in near-side crashes. Age and fracture type were found to be significant contributors to SDH volume. This study is a volumetric analysis of real world brain injuries and known MVC impacts. The results of this study demonstrate a relationship among SDH volume, crash mechanics, and occupant characteristics that provide a better understanding of the injury mechanisms of MVC-associated TBI.

An empirical Bayes safety evaluation of tram/streetcar signal and lane priority measures in Melbourne.

PubMed

Naznin, Farhana; Currie, Graham; Sarvi, Majid; Logan, David

2016-01-01

Streetcars/tram systems are growing worldwide, and many are given priority to increase speed and reliability performance in mixed traffic conditions. Research related to the road safety impact of tram priority is limited. This study explores the road safety impacts of tram priority measures including lane and intersection/signal priority measures. A before-after crash study was conducted using the empirical Bayes (EB) method to provide more accurate crash impact estimates by accounting for wider crash trends and regression to the mean effects. Before-after crash data for 29 intersections with tram signal priority and 23 arterials with tram lane priority in Melbourne, Australia, were analyzed to evaluate the road safety impact of tram priority. The EB before-after analysis results indicated a statistically significant adjusted crash reduction rate of 16.4% after implementation of tram priority measures. Signal priority measures were found to reduce crashes by 13.9% and lane priority by 19.4%. A disaggregate level simple before-after analysis indicated reductions in total and serious crashes as well as vehicle-, pedestrian-, and motorcycle-involved crashes. In addition, reductions in on-path crashes, pedestrian-involved crashes, and collisions among vehicles moving in the same and opposite directions and all other specific crash types were found after tram priority implementation. Results suggest that streetcar/tram priority measures result in safety benefits for all road users, including vehicles, pedestrians, and cyclists. Policy implications and areas for future research are discussed.

Injury and side impact air bag deployment in near and far sided motor vehicle crashes, United States, 2000-2005.

PubMed

Stadter, Greg; Grabowski, Jurek G; Burke, Christine; Aldaghlas, Tayseer A; Robinson, Linda; Fakhry, Samir M

2008-12-01

Side impact crashes, the most lethal type, account for 26% of all motor vehicle crashes in the United States. The purpose of this study is to delineate side impact airbag (SIAB) deployment rates, injury rates, and analyze crash factors associated with SIAB deployment and occupant injury. All passenger vehicles equipped with SIABs that were involved in a side impact crash were identified from the National Automotive Sampling System database. Crashes with multiple impacts, ejections, unbelted drivers or rollovers were excluded from the study. The outcome variables of interest were SIAB deployment and driver injury. SIAB deployment was compared in similar crashes to analyze the impact on driver's injury severity score. Other crash factors were also examined to analyze what role they play in SIAB deployment rates and injury rates, such as plane of contact, striking object and Delta-V. The data set for this study contained 247 drivers in near and far side crashes in vehicles with installed SIABs. Overall SIAB deployment was 43% in side impact crashes. A significant factor associated with both the SIAB deployment rate and the driver's injury rate was increased Delta-V. SIABs do not deploy consistently in crashes with a high Delta-V or with a lateral primary direction of force and a front plane of contact. In these two scenarios, further research is warranted on SIAB deployments. With SIAB deployment, it appears drivers are able to sustain a higher Delta-V impact without serious injury.

Assessment of the safety benefits of vehicles' advanced driver assistance, connectivity and low level automation systems.

PubMed

Yue, Lishengsa; Abdel-Aty, Mohamed; Wu, Yina; Wang, Ling

2018-08-01

The Connected Vehicle (CV) technologies together with other Driving Assistance (DA) technologies are believed to have great effects on traffic operation and safety, and they are expected to impact the future of our cities. However, few research has estimated the exact safety benefits when all vehicles are equipped with these technologies. This paper seeks to fill the gap by using a general crash avoidance effectiveness framework for major CV&DA technologies to make a comprehensive crash reduction estimation. Twenty technologies that were tested in recent studies are summarized and sensitivity analysis is used for estimating their total crash avoidance effectiveness. The results show that crash avoidance effectiveness of CV&DA technology is significantly affected by the vehicle type and the safety estimation methodology. A 70% crash avoidance rate seems to be the highest effectiveness for the CV&DA technologies operating in the real-world environment. Based on the 2005-2008 U.S. GES Crash Records, this research found that the CV&DA technologies could lead to the reduction of light vehicles' crashes and heavy trucks' crashes by at least 32.99% and 40.88%, respectively. The rear-end crashes for both light vehicles and heavy trucks have the most expected crash benefits from the technologies. The paper also studies the effectiveness of Forward Collision Warning technology (FCW) under fog conditions, and the results show that FCW could reduce 35% of the near-crash events under fog conditions. Copyright © 2018 Elsevier Ltd. All rights reserved.

Injury Outcome in Crashes with Guardrail End Terminals.

PubMed

Johnson, Nicholas S; Gabler, Hampton C

2015-01-01

The goal of this study is to evaluate the crash performance of guardrail end terminals in real-world crashes. Guardrail end terminals are installed at the ends of guardrail systems to prevent the rail from spearing through the car in an end-on collision. Recently, there has been a great deal of controversy as to the safety of certain widely used end terminal designs, partly because there is surprisingly little real-world crash data for end terminals. Most existing studies of end terminal crashes used data from prior to the mid-1990s. Since then, there have been large improvements to vehicle crashworthiness and seat belt usage rates, as well as new roadside safety hardware compliant with National Cooperative Highway Research Program (NCHRP) Report 350, "Recommended Procedures for the Safety Performance Evaluation of Highway Features." Additionally, most existing studies of injury in end terminal crashes do not account for factors such as the occurrence of rollover. This analysis uses more recent crash data that represent post-1990s vehicle fleet changes and account for a number of factors that may affect driver injury outcome and rollover occurrence. Passenger vehicle crashes coded as involving guardrail end terminals were identified in the set of police-reported crashes in Michigan in 2011 and 2012. End terminal performance was expected to be a function of end terminal system design. State crash databases generally do not identify specific end terminal systems. In this study, the coded crash location was used to obtain photographs of the crash site prior to the crash from Google Street View. These site photographs were manually inspected to identify the particular end terminal system involved in the crash. Multiple logistic regression was used to test for significant differences in the odds of driver injury and rollover between different terminal types while accounting for other factors. A total of 1,001 end terminal crashes from the 2011-2012 Michigan State crash data were manually inspected to identify the terminal that had been struck. Four hundred fifty-one crashes were found to be suitable for analysis. Serious to fatal driver injury occurred in 3.8% of end terminal crashes, moderate to fatal driver injury occurred in 11.8%, and 72.3% involved property damage only. No significant difference in moderate to fatal driver injury odds was observed between NCHRP 350 compliant end terminals and noncompliant terminals. Car drivers showed odds of moderate to fatal injury 3.6 times greater than LTV drivers in end terminal crashes. Rollover occurrence was not significantly associated with end terminal type. Car drivers have greater potential for injury in end terminal crashes than light truck/van/sport utility vehicle drivers. End terminal designs compliant with NCHRP 350 did not appear to carry different odds of moderate driver injury than noncompliant end terminals. The findings account for driver seat belt use, rollover occurrence, terminal orientation (leading/trailing), control loss, and the number of impact events. Rollover and nonuse of seat belts carried much larger increases in injury potential than end terminal type. Rollover did not appear to be associated with NCHRP 350 compliance.

Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol.

PubMed

Zhang, Yan; Phy, Jennifer; Scott-Johnson, Chris; Garos, Sheila; Orlando, Jennie; Prien, Samuel; Huang, Jaou-Chen

2017-04-04

The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture's impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process was published to describe the parameters of best practice acupuncture for Assisted Reproductive Technology and future research. However, there has been no clinical trial utilizing this protocol to assess the effects of acupuncture. This study aims to assess the implementation of Dephi consensus acupuncture protocol and to examine the impact of acupuncture on stress and uterine and ovarian blood flow among women between ages 21-42 years seeking IVF. This study is a one site prospective, two-arm randomized controlled non-blind clinical trial conducted in a medical school-affiliated fertility center . Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group using computer generated tables. Both groups will have 3 regular clinical visits as their standard IVF care during an approximately 2 to 3 weeks window. Women who are randomized into the acupuncture group would receive three sessions based on the Delphi consensus acupuncture protocol in addition to the standard care. The first treatment will be administered between days 6 to 8 of the stimulated IVF cycle. The second session will be performed on the day of embryo transfer at least 1 h prior to the transfer. The third session will be performed within 48 h post-embryo transfer. Participants will be followed for their pregnancy test and pregnancy outcome when applicable. The outcomes stress and blood flow will be measured by a validated perceived stress scale and vasoactive molecules, respectively. Although recruitment and scheduling could be challenging at times, the Delphi consensus acupuncture protocol was implemented as planned and well-accepted by the patients. Because of the time-specified sessions around patients' IVF cycle, it is highly recommended to have on-site study acupuncturist(s) to accommodate the schedule. ClinicalTrials NCT02591186 registered on October 7, 2015.

Analysis of traffic crash data in Kentucky : 1997-2001.

DOT National Transportation Integrated Search

2002-08-01

This report documents an analysis of traffic crash data in Kentucky for the years of 1997 through 2001. A primary objective of this study was to determine average crash statistics for Kentucky highways. Average and critical numbers and rates of crash...

2001 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2002-11-01

This is a three-part report. This report differs from the State Highway Crash Rate : Tables in that it contains crash data on motor carrier crashes only, and does not include : data for highway spurs, frontage roads, and the non-add segments of...

2000 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2002-01-01

This is a three-part report. This report differs from the State Highway Crash Rate : Tables in that it contains crash data on motor carrier crashes only, and does not include : data for highway spurs, frontage roads, and the non-add segments of...

1999 Oregon motor carrier crash rate tables

DOT National Transportation Integrated Search

2000-12-01

This is a three-part report. This report differs from the State Highway Crash Rate : Tables in that it contains crash data on motor carrier crashes only, and does not include : data for highway spurs, frontage roads, and the non-add segments of...

Quantifying roadside assessment for highway safety.

DOT National Transportation Integrated Search

2017-09-01

Many of Kentuckys two-lane rural roads pose an above average risk for fixed object crashes. In Kentucky, run-off-road (ROR) collisions with fixed objects account for 18.9% of all crashes and 41.6% of fatal crashes. Accordingly, ROR crashes are a s...

Crash data and rates for age-sex groups of drivers, 1996

DOT National Transportation Integrated Search

1998-01-01

The results of this research note are based on 1996data for fatal crashes, driver licenses, and estimates of total crashes based upon data obtained from the nationally representative sample of crashes gathered in the General Estimates System (GES). T...

Developing an effective shoulder and centerline rumble strips/stripes policy to accommodate all roadway users.

DOT National Transportation Integrated Search

2015-03-01

Lane departure crashes including single-vehicle-run-off-road crashes, opposite direction sideswipe and head-on crashes are considered the most sever : crashes and often dominated by sleep deprivation/fatigue, and distracted driving. According to the ...

Development of test scenarios for off-roadway crash countermeasures based on crash statistics

DOT National Transportation Integrated Search

2002-09-01

This report presents the results from an analysis of off-roadway crashes and proposes a set of crash-imminent scenarios to objectively test countermeasure systems for light vehicles (passenger cars, sport utility vehicles, vans, and pickup trucks) ba...

Analysis of traffic crash data in Kentucky (1997-2001)

DOT National Transportation Integrated Search

2002-08-01

This report documents an analysis of traffic crash data in Kentucky for the years of 1997 through 2001. A primary objective of this study was to determine average crash statistics for Kentucky highways. Average and critical numbers and rates of crash...

Analysis of traffic crash data in Kentucky (1996-2000)

DOT National Transportation Integrated Search

2001-09-01

This report documents an analysis of traffic crash data in Kentucky for the years of 1996 through 2000. A primary objective of this study was to determine average crash statistics for Kentucky highways. Average and critical numbers and rates of crash...

Analysis of traffic crash data in Kentucky : 1996-2000.

DOT National Transportation Integrated Search

2001-09-01

This report documents an analysis of traffic crash data in Kentucky for the years of 1996 through 2000. A primary objective of this study was to determine average crash statistics for Kentucky highways. Average and critical numbers and rates of crash...

Analysis of traffic crash data in Kentucky : 2004-2008.

DOT National Transportation Integrated Search

2009-09-01

The report documents an analysis of traffic crash data in Kentucky for the years of 2004 through 2008. A primary objective of this study was to determine average crash statistics for Kentucky highways. Average and critical numbers and rates of crashe...