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To do so, we need to make tough choices. If a child has a mobile device, make every effort to limit its use. Setting such limits starts with you being a good role model. Are you using your own device to play indiscriminately or do you use it primarily for work or necessary tasks? This also should go for any other child who is over at your house.
How can kids stay in touch with their peers? Phone calls or emails that come in during dinner and other family moments, as well as during homework time, can be returned later. The alternative, of kids having continuous access to mobile, means that their attention to family and schoolwork are continually threatened by a compulsion to return a text, check social networks, or game.
Kids should never be allowed to sleep with phones or other mobile devices in their bedrooms, as many do. Preteen and teen drama and the desire to game can go late into the night, denying kids the sleep they need to perform well at school. For example, rules that kids should keep their phones at home or in their lockers better support learning than allowing them at passing periods, lunch, etc.
The latest Kaiser Family Foundation study found more than half of kids aged 8 to 18 multitask during homework either most or some of the time. The Multitasking Mirage The belief that kids or adults can competently multitask is another invention of our present-day culture. Multitasking, when it comes to paying attention, is a myth. The brain naturally focuses on concepts sequentially, one at a time. Attempting to multitask results in toggling attention back and forth between various tasks, increasing the time to complete them and the chance of errors.
Many kids and adults claim they can effectively multitask. Can they be right? Not likely. Stanford University researchers found frequent multitaskers are actually more distractible and more likely to be sidetracked by irrelevant information than those who multitask less or not at all. A recent study observed the learning habits of middle-school, high-school, and college kids, and found that those who checked Facebook at least once every 15 minutes had lower grade point averages than kids who were less frequent Facebook users.
Because the brain works much like a muscle, by setting up the environment to encourage unitasking, this skill can build over time. Consider the following strategies to help your child develop focus skills. Earlier in the chapter, I suggested ways to limit the distractions of mobile devices. If siblings have completed homework, encourage them to read or go outside rather than turn on a TV that will distract their brother or sister. Keep computers off unless kids need to use them for an assignment.
Designate a family study time. One family I worked with had two teen boys who were failing their classes because of incessant multitasking. Nothing the parents tried made things better until they implemented a family study time. Balance your checkbook, read, or catch up on some work while your kids get their homework done.
Build in study breaks. Study breaks help keep the mind focused and limit potential technology distractions. Because unitasking is a learned skill, children may need more frequent study breaks as they develop this ability. Go for non-technology breaks, since kids who turn to gaming, texting, or TV find it difficult to return to homework. Mirroring typical academic demands, researchers gave to year-old boys vocabulary words to study in the late afternoon.
They divided the boys into three groups that engaged in different activities later that evening. Remarkably, when the kids were tested on the vocabulary words the following day, those who video gamed showed significantly lower performance than the other two groups.
The answer may be related to the very high level of dopamine gaming triggers. Throughout human history, dopamine has served an evolutionary function. I suggest that schools, from elementary to high school, take leadership on the issue of children and technology. I also suggest that schools share pertinent research and talk directly with students to help them recognize that overusing entertainment technologies threatens the goals kids have for themselves, including getting good grades and attending college.
Colleges Should Also Challenge Digital Myths With evidence that gaming, social networking, and texting diminish the academic achievement of young adults, I believe universities and colleges will benefit their students by helping them understand the risks posed by obsessive use of entertainment technologies. While this will help both genders, such discussions are especially important for young men because, as we will see in Chapter 5, boys and young men spend much more time with entertainment technologies, especially video gaming, than do girls and young women.
Sadly, I have talked with many parents whose bright young men have been asked to leave university for failing grades caused by the overuse of video games. Colleges should emphasize prevention. Build awareness by talking openly with incoming freshman at orientation and welcome week. Make systematic efforts to catch problems early. Encourage resident assistants and school counselors to watch for signs of tech obsession or addiction, and to be aware of resources that can treat the problem before it leads to student failure.
I also suggest colleges encourage their students not to multitask in the classroom to establish a better learning environment for all students. A study published in Computers in Human Behavior showed that college students who multitasked with Facebook or texting during class had lower grades than students who did not. Guests included Mark Petric, whose yearold son Daniel murdered his mother and shot his father because they took away his Halo 3 video game.
He became enraged when his father took the video game away because of its violent content. I have a surprise for you. Instead, the teen shot his father in the head— he was severely injured yet survived because the bullet missed his brain—and then turned the gun on his mother, Susan. He shot her in her arms, chest, and back of the head. They found Daniel trying to clean up the horrific scene with a bucket and cloth.
While the others attended to Susan and Mark, Daniel ran out of the house and drove away in the family van. Apprehended a short time later, the only item Daniel had taken from home was his Halo 3 video game. Judge Burge said the evidence led him to conclude that video gaming played a significant role in the violence. She said he regularly gamed online past 2 a. In the week prior to bringing Cameron to therapy, Gloria had approached her son about her concerns, but he ignored her.
When she insisted that he limit his gaming, this six-foot teen slammed his fist through a wall, then stood over her and got her to back down. He told me that he saw nothing wrong with his gaming and insisted his life was going well. He said school was overrated, and he planned to work in video gaming. When I asked how he felt about his aggression towards his mother, Cameron was unapologetic. He blamed her, saying she had no right to limit his gaming. If they do understand their child is struggling with a tech obsession, they tend to feel alone with their problems and that their child or teen is experiencing something unique.
As a result, video game and Internet addiction has been extensively researched, and there are now hundreds of high-quality published studies that collectively support the addictive potential of certain technologies. Video games especially those played online appear to have the greatest potential for addiction, followed by social networks.
Any child, teen, or adult. Some suggest that tech addiction is really just a sign of an underlying psychiatric problem, e. However, a study of 3rd, 4th, 7th, and 8th graders published in the journal Pediatrics found that symptoms of obsessive gaming often came before signs of anxiety or depression. The research does show there are subgroups who are at greater risk for a tech addiction, including adolescent and young adult males, as well as kids with ADHD or an autism spectrum disorder.
What we can say is that tech addiction is becoming more commonplace. Because tech addiction is less understood and recognized in the US, addicted kids are often labeled as having problems with depression, anger, anxiety, learning, or focus—when their core problem is really a harmful obsession with various technologies. This is one reason why the medical and psychiatric communities now believe addiction is best understood not as the compulsive use of a substance but as something that occurs in the brain as the result of substance use or the performance of certain behaviors.
Imaging studies show that video gaming triggers the release of dopamine at levels comparable to an intravenous injection of amphetamine,8 a powerful and addictive psychostimulant. This helps explain why kids can become fixated on digital devices, cease to care about the things that once mattered to them most, and yet have no insight regarding their problem.
Those bringing us our news are often part of conglomerates that have financial ties to companies that sell kids gadgets and apps. Moreover, news sources frequently depend upon ad revenue from an increasingly powerful industry, which can influence the slant of news stories. The hallmark of any addiction is that a person continues the behavior in spite of significantly harmful consequences in real life, often in multiple areas: e.
The effects of a tech addiction are often tragic. Highly capable teens give up their educational and career aspirations in order to spend more time playing with technology. The focus of this chapter is on tech-addicted children but the condition also afflicts adults. A number of parents I work with have divorced primarily because their ex-partner was addicted to gaming. Other parents describe their current partner as cut-off from them, their children, and real life by technology-related behaviors.
As a result, children suffer from an overwhelming feeling of loss and anger, and are more likely to become addicted to technology themselves. Researchers and practitioners often use the symptoms of substance or gambling addiction as a guide to deciding if a person is addicted to video games or the Internet. I have modified the DSM-5 gambling addiction symptoms to identify technology addiction. If most or all of these signs are present, this suggests a possible addiction.
The extremely competitive environment of the consumer tech industry provides possible answers. They use the same behavioral psychology techniques the gambling industry uses to attract and manipulate gamblers. One strategy, variable ratio reinforcement, provides random rewards to users think slot machine and is well known to develop compulsive responses in people as well as animals. Video game makers create experiences in which players never know how and when points will be metered out, or when they will stumble on a special prize.
Compulsion loops are another method tech developers use to get players to spend more time online, and, after they leave, to feel the itch to return. Players feel compelled to return time and time again, keeping the loop going. Game makers use the principles of avoidance players must continue to play to avoid being punished by losing points, having crops die, or seeing animals get sick and arousal violent and sexualized images stimulate users to continue.
Like many alcoholics who face pressure to continue to imbibe from their circle of drinking friends, social factors play a role in getting and keeping kids hooked on tech products. Beginning in elementary school, many boys face extreme peer pressure to give up their lives to online gaming communities. For girls, more than boys, the need to belong on social networks is a powerful motivator to never let go of their phones.
This experimental psychologist designed a tool commonly known as the Skinner Box, a chamber in which behavioral manipulation could be scientifically tested on lab animals. Skinner found that the right mix of rewards and punishments could get rats, pigeons, and chimps to do just about anything. Skinner believed that for this purpose, humans are no different than animals. Our behavior is shaped primarily by outside forces, not our own free will. He concluded that for humans, freedom is an illusion.
In , while receiving his Ph. For corporations that make entertainment technologies, these techniques have been revolutionary, greatly influencing the design of video games and social networks. When his paper was published, Hopson was contacted by Microsoft, which offered him a position in video game development. He also helped develop Xbox games popular with kids, including those in the Halo series. Increasingly, they oversee game development.
What increasingly drives product development is user research. User researchers are experts in behavioral psychology and the manipulation of human behavior who rely upon detailed statistical analyses of our behavior to tweak products to be extraordinarily enticing and hence more profitable. On its Redmond, Washington, campus, Microsoft has a sophisticated human research lab called Playtest.
Because of such efforts, Microsoft is considered the gold standard in user research. One-way mirrors and cameras record the facial expressions of subjects while they play. Popular video game maker Valve employs experimental psychologist Mike Ambinder. At his lab, players are hooked up to biofeedback devices that measure skin conductance which shows player arousal level and track their eye movements to gauge where players are looking in real time.
Results inform game development. Experimental psychologists and similar experts continue to study lab subjects to find the best methods to influence behavior. What is different? The subjects now include children. These words hide a darker truth: a cut-throat business environment that fosters the development of consumer technologies so perfectly designed to capture attention that they promote addiction.
Choosing the Virtual World Over the Real One While writing her trilogy of books on our relationship with technology, psychologist Sherry Turkle became increasingly concerned that children would begin to prefer the virtual to the real world. We see the result: Kids who extensively use the games and social networks our society labels appropriate for them, and end up preferring that world to the real one. This is the nature of addiction: People become involved with a substance or behavior at the expense of their real lives.
Why do many kids gravitate to the virtual world? It happens because real life is difficult. Months and months of hard work are required to obtain a single report card grade stamped on a transcript. The latest neuroscience research suggests why.
Imaging studies show that the brains of tech addicts appear to get used to the very high level of dopamine that gaming releases into the brain by raising the threshold for what feels pleasurable. He suffers from an addiction.
The overpowering rewards provided by certain entertainment technologies can rewire the brain and overwhelm its judgment center. Adrian Hon, the neuroscientist who became a game designer, suggests that the industry should become more socially responsible and acknowledge its ability to influence and potentially harm users. The most aggressive companies will hire soft and hard scientists like myself, in addition to quantitative scientists, to optimize the exploitation of youth. The ultimate result will be national regulation, which is already happening in some parts of Asia.
In the meantime, such agents will try to make as much money as possible in this Wild Wild West of gaming. Corporations would surely fight such efforts tooth and nail, claiming their products are protected under the First Amendment as art forms and speech. Yet how can you help your kids when all you hear from industry is that their products are safe and fun—not potential sources of addiction? In the weeks before they came to see me, arguments between Jake and his parents had escalated after the latest progress report showed that he was failing two classes because of missing and late homework.
Jake became enraged, and during the ensuing fit threw his chair against a wall with all his might and threatened to kill himself. By the time the officers arrived, Jake had calmed down. Nevertheless, it was clear from our meetings that Jake saw no reason to change. He insisted that he would find a career in gaming, although Jake could not realistically outline how this would become a reality. What I confronted with Jake, as I do many other tech-addicted teens, is a profound struggle with insight and judgment.
As we discuss in Chapter 9, dramatic changes that normally occur in the adolescent prefrontal cortex and other brain areas compromise these abilities in teens. But adding a tech addiction to the mix is a nasty combination, as addictions hijack the same brain structures that are already compromised in teens, further diminishing their ability to recognize they have a problem and make good decisions about their future.
I better quit. Moms and dads resort to dragging their children to treatment where kids often refuse to participate. Alternatively, teenagers in particular may refuse to attend counseling at all. Doors are broken down, parents are bullied, moms and dads are pushed or hit, and the police may need to be called. Kids faced with the loss of their beloved devices also can experience depression or thoughts of suicide.
Seek professional help. Treating addicted children and teens poses the serious challenges and risks outlined in this chapter. Pediatricians and school counselors or principals are often good resources for finding a counselor. And look for someone who understands the seriousness posed by tech addiction. Be concerned if a prospective counselor attempts to minimize the issue by telling you how easy treatment should be.
If the addiction proves to be severe, out-of-home wilderness and residential treatment programs that have traditionally treated oppositional kids now increasingly offer specific therapies for technology addiction. The Failings of Increased Access Digital-age myths have helped convince many parents that typical technologies bring kids closer to their family, build better brains, and help kids learn. All the while, the risks posed by technology addiction either are not mentioned in the media or downplayed.
So it makes sense that many parents believe kids will benefit from gaining increased access to tablets, phones, and more of the latest gadgets. Is this really true, or does increased access put our kids at risk for addiction? A known risk factor for substance addiction in kids is greater physical access: the more easily kids can get their hands on cigarettes, alcohol, or drugs, the more likely they will develop an addiction to them.
Does providing kids greater physical access to technology similarly put them at greater risk for tech addiction? Another type of access relates to the age at which kids are provided digital devices. As we know from studying substance addiction, the earlier kids start to use alcohol and drugs, the more likely they will become addicted later on. Not surprisingly, we see that the younger children are when they start playing video games, the more likely they will show signs similar to tech addiction as they grow older.
Young brains are more likely to be captivated by powerful, dopamine-triggering technologies than mature brains with a better-developed judgment center. The bottom line is that the policy of increased access appears to put kids at greater risk of technology addiction. But it became increasingly difficult to pry from his hands. Now even though we try to limit its use, he only wants to game.
A US News report highlights the issue. The very high levels of dopamine triggered by video gaming make it extremely difficult to find alternative activities that kids find equally gratifying. Many parents say they do their best to provide children with a variety of activities e. These cravings may also form the underpinnings of future addiction. Instead, they become progressively more willing to do anything to get what satisfies them most, even if it causes significant problems in the rest of their life.
How can this be achieved? We especially must 1 reverse the move to provide younger and younger kids with amusement-based technologies, and 2 as kids grow older, curb their access to these technologies. In the book they wrote soon after the Columbine shootings, Stop Teaching our Kids to Kill, military science scholar Lt. Even if parents are introducing only nonviolent video games at this stage of development, it is going to be so much more difficult to keep the kids away from violent ones.
Just the nature of video games in and of themselves make them potentially addictive. Video game systems are just not developmentally appropriate for children. Yet what parents need to know is that the later we introduce these technologies if at all , the less risk there appears to be of kids developing addiction: high school is better than middle school, and middle school is better than elementary school.
Grossman and DeGaetano suggest that if parents are going to provide kids video games, that waiting until kids are at least 12 to 14 is best. And while social networking appears to pose a lower risk of addiction than video games, the risk of addiction to these products remains. I fully recognize that these recommendations are more conservative than what many others recommend.
So I am hopeful that you will consider the steps to limit exposure to entertainment technologies described in prior chapters. Encourage your daughters to play video games! Boys spend over an hour more each day using entertainment screen technologies excluding phones than girls: 5 hours, 56 minutes for boys compared with 4 hours, 51 minutes for girls.
Among kids who use video gaming consoles such as Xbox and PlayStation, boys spend nearly an hour more each day gaming than girls. So how are our boys doing? Not well. Male college students also video game at significantly higher rates than their female peers. Although males dominate the computer science field, they are increasingly losing out to women in many other professions.
We face a difficult economy and the US is losing manufacturing jobs that allowed generations of young men to earn a good living. Yet there are surely multiple factors explaining the struggles of our boys and young men. The video game world is more real to them than the world of homework and grades and college applications.
The scans showed that video gaming activates the mesocorticolimbic center—an area of the brain associated with reward and addiction—much more in men than women. The reasons emerged in our first meeting. This began when I asked them to describe the life they envisioned for James. They told me they wanted him to realize he would be 18 in a short time and to recognize what this meant.
Their expectations were not ambitious, still they wanted their son to take visible steps towards his post-high-school life, looking into college or work options. He started to gain the perspective to recognize that real life was right around the corner, and that he needed to plan for his future.
The last I heard, James was doing well at junior college and considering transferring to a four-year-school. In Chapter 3, we looked at how video gaming displaces reading and homework. While girls use less amusement-based technologies than boys, they still spend nearly five hours a day using entertainment screen technologies. There are also two important exceptions to the general rule that girls use less entertainment technology than boys: compared to boys, girls spend significantly more time social networking and using cell phones to talk and text with friends.
Just as gender differences in brain physiology help explain why boys are more attracted to gaming than girls, developmental differences between genders help us understand why girls are drawn to social networks and texting. Mirroring what many parents see for themselves, research shows that girls are more driven to seek out peer relationships and are more influenced by them than boys. Much like our National Security Agency monitors electronic chatter, Sarah constantly checked posts on Facebook, Instagram, Twitter, and a host of other social networks.
She scanned for conflict between peers, especially if she was involved. So she checked her phone first thing in the morning, at breaks during school or sometimes during class, lived on her phone after school, and was online until late into the night. Teen gossip, which for prior generations used to quiet down at the end of the school day, now continues around-the-clock for kids like Sarah because of their continual access to technology.
She was too distracted by peeking at the phone clutched in her lap. What helped Sarah? I asked Sarah and her parents if they spent time together as a family. They replied that traditions like family dinners or trips no longer happened because family members were all so busy. However, looking more closely, Sarah and her parents actually were often home at the same time; it was their respective screen engagement—Sarah on her phone in her room and her parents watching TV downstairs—that kept the family from coming together.
I talked with Sarah and her parents together about how important family is, even to teens. They created a new family ritual. Everyone would meet in the kitchen several nights during the week to prepare and eat meals together—with all devices turned off. This helped persuade Sarah to put her phone away for family and study time at home.
And, as we will see in Chapter 10, high-tech companies typically hire computer scientists out of college or graduate engineering programs—schooling that kids are less likely to obtain if they game a lot. In The New Republic, Lydia DePillis describes how Stuyvesant—with the encouragement of computer science teacher Michael Zamansky—tackled the underrepresentation of girls in computer science.
It required that all students at its coed campus take an introductory computer science class in order to graduate. Our kids need our help if we hope to protect them from an industry intent on exploiting these vulnerabilities. He relies on anecdotes, conjecture and speculation. Nonetheless his ideas have often been uncritically repeated and cited as if fact. The digital native-digital immigrant belief is in fact a remarkably harmful myth.
Simply growing up in a world surrounded by digital gadgets does not give children the ability to understand how the use, or frequently the overuse, of such devices affects their lives. Kids can be astoundingly adept at swiping through phones or tablets, however parents—by virtue of their more developed brains and greater life experiences—are much better able to understand how technology can impact emotional well-being, academic growth, and life success. Nonetheless, the main thrust of the native-immigrant belief continues to be advanced: that by virtue of growing up with the latest technologies from ever younger ages and for greater amounts of time, each new generation of kids supposedly knows more about how digital gadgets should be used than their parents.
Welcome to the world of the Digitods: the young children born into the era of mobile technology. These kids are learning faster and better than any generation that has come before them. And they are loving it! But to him, it has always been possible to do so many things with the swipe of a finger, to have hundreds of games packed into a gadget the same size as Goodnight Moon. Technically I was the owner of the iPad, but in some ontological way it felt much more his than mine.
This suggested shift in family power is remarkable because kids spend more time with entertainment screen and phone technologies than any other waking activity—far more than school. Essentially, parents are being encouraged to back away from guiding kids in the activity that now dominates their lives. Whether they are toddlers or teens, kids are simply not capable of this level of insight and instead will enthusiastically disappear into cyberspace amusements for hours or even days on end.
Parents therefore have a responsibility to help kids make good choices about the use of screen and phone technologies. In truth, leading purveyors of the tech products kids use for entertainment including Microsoft, Apple, and cell phone company Verizon help fund the ISTE, and it acts as a lobbying and marketing body for its funders, e.
They are suffering from too much adult control over their lives and not enough freedom. Kids can tweak their games, avatars, social network profiles, or phones in innumerable ways, but this only provides an illusion of control. Malleability is purposely built into these products to encourage kids to spend more time in for-profit domains looking at ads and racking up digital minutes.
Children and teens are also tracked and data mined on these sites so that content and advertising can be better tuned to their whims—all for the sake of the corporate bottom line. This in no way resembles the relatively unconstrained lives of former generations of youth. For example, the Foundation reported that few seventh to twelfth graders have any rules about how much they can talk or text on the phone 27 and 14 percent respectively , while a meager 18 percent of American kids ages 15—18 have any rules whatsoever about how much time they can spend playing video games.
Authoritative parenting has a high level of responsiveness and a high level of demandingness. Authoritative parents do their best to maintain a strong, loving relationship with their child, while providing high expectations and definite limits that help kids to meet parental expectations. There is a clear hierarchy in which parents are the primary authorities in the home, although this is conveyed warmly to kids through a close relationship rather than coercion.
Authoritarian different than authoritative parents tend to score low on responsiveness but high on demandingness. They are less concerned with a loving connection yet set strong limits for kids. Permissive parents are high on responsiveness but low on demandingness. They tend to be loving, have relatively low expectations, and there is no clear hierarchy in the home. Finally, uninvolved parents score low on responsiveness and demandingness.
Of the four parenting styles, authoritative parenting produces the best emotional health and academic outcomes. Children raised using this parenting style have higher self-esteem and life satisfaction, and lower levels of anxiety, depression, and delinquent behavior than those raised using other parenting styles. Parents heavily rely upon tablet computers and other e-devices as babysitters for infants and toddlers, displacing positive interactions with parents or other caregivers.
Many preschool-and elementaryage kids carry mobile devices around the home, on car rides, to appointments, and elsewhere—minimizing parent-child exchanges and displacing the reading that supports school success. By highschool, many teens are in full retreat to their rooms where they play on their phones and other e-gadgets until late into the night. The same parents would never let kids make their own rules about curfews, chores, etc.
How can we provide our children responsiveness and demandingness in this frenzied digital age? To provide demandingness, take the steps provided in Chapter 3 including setting up a home environment that limits playtime devices.
They make an effort to explain the reasoning behind their rules in a developmentally-appropriate fashion. Authoritative Parenting in Action What does authoritative parenting look like in real life? The following examples show how authoritative parenting is used to address typical technology issues. I am willing, however, to negotiate with you about having a friend over once or twice during the week. Scenario 2: A preteen with increasingly obsessive technology use and falling grades protests the computer being removed from his room.
However, I think the negatives outweigh the positives. Such kids are less likely to put in the necessary academic effort for success, so parents constantly have to stay on their case about missing homework assignments, lack of studying, and other consequences of that tech use.
They also affect how children respond to parenting. In industry marketing, TV shows, and throughout our culture, children are bombarded with messages that kids rightfully should demand unlimited amounts of entertainment technologies and that their parents should simply acquiesce. An Associated Press article highlighted the latest American Academy of Pediatrics AAP technology guidelines, clarifying that the recommended total screen entertainment limit of 1 to 2 hours per day included computers, TV, and video games.
The article featured year-old Mark, who said that he spends about four hours each day using the Internet for homework, Facebook, YouTube, and watching movies. Even though limits will foster their happiness and success, kids have been led to believe that unlimited access to screen-based and networking devices is essential to growing up. There are steps we can take to help us overcome these obstacles and encourage our children to work with us on the issue of technology.
One of the most important aspects of this environment is the way we ourselves model technology use. When parents overuse technology, not only will kids copy our example, they can feel abandoned and will demand their own devices to keep them company. Connecting with our kids opens a door for us to guide their tech use, as they are much more apt to listen to caregivers who show a strong investment in them.
If we listen, we may notice our kids asking us to be better media or technology role models. Instead they learn primarily from what they observe of us at home. If we want our kids to engage in activities like reading and homework when at home, we need to role model good work habits for them. So as your child sits at the kitchen table to complete his or her homework, read a book, do some chores, or use the computer for work rather than entertainment kids notice the difference.
If you have to take a call now and then, no big deal, but kids are affected when their parents are constantly pulled away by work texts, calls, and emails. A year-old girl explained to me that she is reticent to open up to her mom because her efforts to do so have been undermined by her mom stealing looks at her phone.
I need to make a distinct choice. Finding a healthy work-family balance is also made difficult because we are spending much more time working than generations past. Kids need undistracted quality time with us far more than a bigger home or an expensive vacation. I also suggest doing all you can to have technology help rather than hurt family connections.
Do what you can to limit the use of real-time technologies, such as texting, that show little respect for the undistracted family moments our children need. Instead, I suggest using technologies such as email that you can check when you have taken a break from the kids. Employers also need to allow us undistracted time with our families at home.
If you meet with resistance, ask your partner to do some research on the topic, or provide some reputable, easy-to-read information. Not making any headway in coming to agreement? In that case, professional family counseling may help.
So do everything you can to make your relationship with your partner loving and strong. Spend time together as a couple, not just parents. In my experience, parents who are struggling often wait far too long before entering counseling. Once they do, seemingly intractable problems often melt away. I have at times worried about how the tech limits my wife and I provide our kids would affect their relationships with peers.
I also can honestly say that the tech rules my wife and I provide our kids have had no discernible effect on their peer relationships, except possibly encouraging them to form friendships with kids who play with tech less and focus on school more. I suggest a credible source of guidance is the parenting method employed by many tech industry leaders to raise their own children and teens.
Earlier in the chapter, we saw that Bill and Melinda Gates provided their kids strong tech limits growing up. Walter Isaacson, who wrote Mr. No one ever pulled out an iPad or computer. In Mr. Parents will benefit from noticing the contradictory messages coming out of the tech industry. Which counsel will you choose when raising your kids? Digital literacy is the ability to understand how technology affects our thoughts, behavior, and lives. When digital literacy is discussed in the popular media, it often refers to the ability to analyze the media and technology that is already being consumed, e.
While this is important, I suggest that we also turn our focus to teaching kids another, often overlooked, component of digital literacy: the ability to recognize the tremendous opportunity costs of spending long hours with amusement-based technologies. These parent-child conversations might begin when they ask you a question about their use of technology. For example, if you delay providing digital devices until later in toddlerhood—remember the AAP suggestion of no more than 2 hours of high-quality content a day after the age of 2—and begin to put firm limits on entertainment technologies when your children are very young, they will likely come to you, at a younger age than you may expect, to ask the reason for limits.
A good way to begin teaching kids about digital literacy is to help them understand how seemingly minor decisions that they make as a child or teen—how much time they spend gaming, social networking, or watching TV—can profoundly affect their future. We need to help kids see that their desire to become a veterinarian, a teacher, or any number of long-term goals can be easily thwarted if they become caught up in the heavy tech habits snaring many of their peers.
Too often parents avoid these conversations, because they expect that their kids are already aware of potential consequences. Or some parents assume that their kids consciously choose to game, social network, or text rather than study. They need help from parents, teachers, and others invested in their future. When you talk with your kids about technology, you may be surprised to find what your child or teen has already noticed.
Instead, we can gently remind them that activities like school, reading, and extracurricular involvements bring them pleasure. This helps kids develop their own insight about appropriate uses of technology. Questioning authority is developmentally normal for kids, especially as they enter and move through their teen years. Entertainmentbased tech companies co-opt this instinct, convincing kids to reject the conformity of their families so they can supposedly find their own way using trendy technologies.
We should help our kids understand that while they may not want to follow our lead for the rest of their lives, being played or controlled by giant tech corporations is a bad alternative. Ask your kids about their aspirations, and then ask them what they think commercial technology companies want most from kids.
What strategies do those corporations use to encourage kids to use, or even overuse, their products? If you have teens, consider watching with them the powerful documentary Consuming Kids: The Commercialization of Childhood. Teens can also work together to limit their use of entertainment technologies.
Fifteen-year-old Neeka, a high school sophomore from Ann Arbor, MI, got better grades after making a pact with her sister to limit her Facebook time. One goal of this literacy should be to help kids learn to resist social pressure to indulge in entertainment technologies. Boys, especially, experience pressure from peers to engage in intensive online gaming communities.
Girls, more than boys, are coerced by peers to be constantly available by social network and text. All kids experience social pressure to get smartphones that provide them increased access to academics-thwarting technologies. Schools can ease this pressure through broad-based efforts to talk with students and their parents about the research that shows the more kids use video games, TV, or social networks, the less well they do academically.
A study of 9-toyear-old students found that those who spent more time social networking had lower grades than kids who spent less time using the technology. In what should be an eye-opener for schools, these heavy social networking kids acted as frequent recruiters—getting large numbers of fellow students to visit their favorite sites.
Schools should talk with their students about the risks of being a peer-follower on matters of technology. They should help kids and their parents understand that the tech-focused lifestyle normalized by our culture is a poor fit with the increasingly rigorous admission requirements of colleges. We therefore need to help children develop real-world communication skills and encourage and support their face-to-face interactions with adults and peers. In the revised edition of Odd Girl Out, leadership authority Rachel Simmons explores the emotional costs of online relationships compared to real-world connections and shows that parents can help.
An effective way to provide guidance is by raising examples like this, asking your child if he or she has ever experienced the misunderstanding of an online remark, and talking about the advantages of real-world interactions. Another benefit to getting kids involved in real-world activities is that it can improve the quality of their relationships. Remember from Chapter 1 that kids who spend greater amounts of time online are more likely to cyberbully or be cyberbullied than kids who spend less time online.
I therefore suggest encouraging younger children to be involved in sports, drama, or other experiences where they interact with peers and adults in real time. Teens are also well served by volunteer or occupational experiences that demand offline interactions.
Unfortunately television, on the whole, has not educated children well. TV generally detracts from academic success. All things considered, television is a crummy babysitter. Distract kids of every age with more iPhone, iPod Touch and iPad applications and game[s]. Filling Early Childhood with Digital Media Assurances that the latest tech gadgets can both occupy and teach young ones help parents feel good about handing these devices to their kids.
Also, children should be aware of the cues in their bodies as they learn. Unfortunately, these technologies are so new that their long-term impact—which is how they must be gauged—has not been determined. In fact, despite a lot of hype, in many cases the effects of the newer screen technologies appear to be much like those of the old-fashioned TV. The Center on Media and Human Development at Northwestern University, looking at how children ages 2 to 5 use technologies like the iPad or iPod touch, found that only about a quarter of parents use the device with their kids at least most of the time.
Instead, the truth is likely just the reverse. They joined child experts behind a two-way mirror to watch 3-to 5-year-olds using an iPad. Raising young kids is tough business. Wall Street Journal reporter and father Ben Worthen described what happened when he and his wife provided an iPad to their toddler.
It became a nightly battle to get him to put it down. These concerns led Ben and his wife to stop giving the iPad to their son. A use it or lose it principle exists. Should We Really Be Surprised? In addition to watching a lot of TV on new devices, what are kids doing? In spite of lofty promises, we need to be honest with ourselves about what the popular new technologies are designed for and how they are typically used.
Tablets, smartphones, and iPods are synonymous with gaming and entertainment—especially for kids. When we provide kids one of these devices, it sends a powerful message about how they should spend their time. In contrast, when we provide children a book, we send the message that reading is important. Unfortunately, I believe this helps prime generations of children to spend long hours with entertainment-based video games.
A Pew Research Center report confirms my concern, showing that by the time kids reach the ages of 12 to 17, entertainment-based titles dominate their video game time. But that can be difficult to find because tech companies know parents are looking for direction and make efforts to provide their own profit-driven guidance much as the tobacco industry once did , often disguised as objective information. It is this industry manipulation of information that helps construct and promote technology myths that hurt children.
Constructing a Technology Myth Some years ago, when social networks were just coming on the scene, questions surfaced about how this technology would affect children. On the other hand, tech corporations—knowing that parents had questions about social networking—had a financial incentive to convince moms and dads that this technology was the next great thing. It was a pivotal moment for the emerging phenomenon of social networking, because parents, schools, and even the popular media needed leadership on the issue.
These myths in turn deceive parents, in this case about the relative importance of social networks vs. Moving forward, child-serving organizations should recognize the potential harm that can be done by partnering with consumer tech companies to create technology guidelines. I suggest limiting this to one hour or less a day for toddlers and preschoolers.
I also believe parents best serve their children by not exposing them to interactive technologies long past the age of two, difficult as that may be. In this section, we look at action steps that will help you achieve this goal and surmount these challenges. Instead, they stay inside staring at screens. Since younger kids often need supervision outdoors, getting them out of the house may demand that we take part.
Families I work with tell me that taking walks with their children in nature—seeing a deer run, or a swooping owl at dusk, or even watching birds in the park or at backyard feeders—have helped their kids develop interest in a life away from screens. Reading to my daughters, now ages 7 and 11, has been—and continues to be—one of the most enjoyable and rewarding experiences of my life.
The Read-Aloud Handbook, by educational consultant Jim Trelease, is a great guide to choosing engaging books to read to kids of various ages,48 and so are librarians and bookstore staff. These experiences are much more taxing strategies than handing over a device.
Be secure in the knowledge that a little boredom is good for kids. Downtime has a bad label in our current zeitgeist. It has us believing that kids must constantly be engaged, often with a device. But boredom is often the precursor to imagination, learning, and creative thought.
What should we do when our kids complain of boredom? For kids who could find something to do themselves, gentle encouragement and our ability to tolerate a few grumbles is often enough to foster their inner resourcefulness. This often leads kids to become surprisingly resourceful. In such cases, we may need to foster this ability in our kids. To begin with, make sure your kids have access to alternatives to screens. Creativity-promoting props see Chapter 2 help provide your child with raw materials that can turn boredom into something interesting or even magical.
You also can sit down with your kids for a few minutes to brainstorm alternative activities. Non-Screen Activities for Young Kids I find that what parents do to raise young children with limited screen time is unique to each family and often reflects the special interests of parents. When our kids were young, my wife would engage them in make-believe or floor play.
While I did this as well, I especially liked wandering out into the world, so I would bundle up our girls and hit the road in a jogging stroller, stopping to talk with neighbors or dogs, or to explore a fish pond. Our kids also listened to books and sing-alongs on tape. Arranging play dates or enrolling kids in community programs are also good ways to keep young kids engaged. Even with the help of extended family and childcare, caring for my kids during their earliest years was exhausting—far more challenging than I was prepared for.
Going Screenless in Restaurants and Other Out-ofHome Settings Caring for young kids in places like restaurants poses its own difficulties. A common modern solution is to offer children a smartphone or tablet computer whose magnetic appeal allows parents to enjoy a dinner or time to themselves.
While this may seem like a good solution at the time, later you may find yourself looking at your screen-fixated preteens and teens and wondering where things went wrong. Bring along books, crayons, and paper. Engage with kids during dinner. Draw a picture together or take your kids for a walk around the restaurant to talk about things that you see. Moreover, such experiences are an essential part of helping children realize the joy of engaging with real people and the real world.
Understandably, parents need alone time and time together as a couple if there are two parents at home. If at all possible, invest in a regular babysitter or obtain childcare so you can get out of the house, enjoy a dinner, go to a movie, etc.
Find a trusted neighbor or family member with whom to trade child-care. It Takes a Village One of the saddest consequences of digital myths is the diminished appreciation for the importance of extended families in raising children. Parents can question the need to see grandma because they believe time with an iPad is just as good. Decisions to move far away from extended family are made with too little consideration of the consequences, as technology is believed to be a good childcare option.
Since the beginning of humankind, extended families have played an invaluable role in raising kids. Do all you can to reach out to extended family. They still need help. I also suggest accessing mature babysitters who can engage your kids without screens. But the belief that detachment from family is a normal part of growing up is another harmful myth.
A study in The Journal of Youth and Adolescence reports that while a strong relationship with both parents and peers enhances the emotional health of kids 12 to 19 years old, the connection to parents actually matters more. Why is it better for kids to have their primary bonds with parents?
In addition, parents invest in their children in a way that peers never can. Most of us would give our lives for our kids. In contrast, the strongest-appearing peer relationships can slowly fade, or even evaporate over the course of a few hours. Not surprisingly, as these kids watch the peer contact they so deeply depend on suddenly collapse, they can fall into depression and even consider suicide.
Children should also form their primary alliances with parents because dominant peer bonds put kids at greater risk for delinquent behaviors and drug use. In contrast, kids who have strong and primary attachments to parents resist peer pressure more readily and make better life choices.
She was harassed daily about her appearance— her weight, clothes, and a mole on her cheek—even though nothing about her looks was out of the ordinary. Not feeling the love she needed from her mom and dad, Kayla felt compelled to seek constant attention from peers including those with behavior problems , making her an easy target for them. Strengthening the bond with her parents helped Kayla, which in turn diminished her need to seek affirmation from all-too-often destructive peer contacts.
Over time, such experiences helped Robert feel that his online friends cared for him more and understood him better than his parents. However, these friendships were focused largely around emotional problems. Contrary to our current ethic, middle-school-age-and-up kids such as Robert should not spend most of their lives electronically engaged with everyone and everything but family.
Sure, kids need time to themselves and to be able to talk with friends. Robert was helped when his parents realized that their ritual of watching shows downstairs for most of the evening left him feeling less wanted, and also encouraged him to seek out online contacts. They also shut off the TV for much of the evening. At first, everything seemed strangely silent, but then signs of family emerged—talk of school, peers, and other conversations which had long been absent. Such experiences helped Robert feel heard and important, which in turn lifted his mood.
Growing up with my brother, who is my best friend, was immensely helpful to me. A new multi-body modeling method is proposed in this paper which can save a lot of time and has high-fidelity meanwhile. Following works were carried out to validate this new method. First, a small van was tested following the FMVSS protocol for the validation of the proposed modeling method.
The vehicle body was divided into two main parts, the deformable upper body and the rigid lower body, modeled by different waysbased on an FE model. The specific method of modeling is offered in this paper. Finally, the trajectories of the vehicle from test and simulation were comparedand the match was very good. Acceleration of left B pillar was taken into consideration, which turned out fitting the test result well in the time of event.
The final deformation status of the vehicle in test and simulation showed similar trend. This validated model provides a reliable wayfor further research in occupant injuries during rollovers. Bayesian hierarchical modeling for detecting safety signals in clinical trials. Detection of safety signals from clinical trial adverse event data is critical in drug development, but carries a challenging statistical multiplicity problem.
Bayesian hierarchical mixture modeling is appealing for its ability to borrow strength across subgroups in the data, as well as moderate extreme findings most likely due merely to chance. We implement such a model for subject incidence Berry and Berry, using a binomial likelihood, and extend it to subject-year adjusted incidence rate estimation under a Poisson likelihood. We use simulation to choose a signal detection threshold, and illustrate some effective graphics for displaying the flagged signals.
Cervical and thoracic spine injury from interactions with vehicle roofs in pure rollover crashes. Around one third of serious injuries sustained by belted, non-ejected occupants in pure rollover crashes occur to the spine. Dynamic rollover crash test methodologies have been established in Australia and the United States, with the aims of understanding injury potential in rollovers and establishing the basis of an occupant rollover protection crashworthiness test protocol that could be adopted by consumer new car assessment programmes and government regulators internationally.
However, for any proposed test protocol to be effective in reducing the high trauma burden resulting from rollover crashes, appropriate anthropomorphic devices that replicate real-world injury mechanisms and biomechanical loads are required. To date, consensus regarding the combination of anthropomorphic device and neck injury criteria for rollover crash tests has not been reached.
The aim of the present study is to provide new information pertaining to the nature and mechanisms of spine injury in pure rollover crashes, and to assist in the assessment of spine injury potential in rollover crash tests. Real-world spine injury cases that resulted from pure rollover crashes in the United States between and are identified, and compared with cadaver experiments under vertical load by other authors.
The analysis is restricted to contained, restrained occupants that were injured from contact with the vehicle roof structure during a pure rollover , and the role of roof intrusion in creating potential for spine injury is assessed. Recommendations for assessing the potential for spine injury in rollover occupant protection crash test protocols are made.
Foot roll-over evaluation based on 3D dynamic foot scan. Foot roll-over is commonly analyzed to evaluate gait pathologies. The current study utilized a dynamic foot scanner DFS to analyze foot roll-over. The right feet of ten healthy subjects were assessed during gait trials with a DFS system integrated into a walkway. A foot sole picture was computed by vertically projecting points from the 3D foot shape which were lower than a threshold height of 15 mm.
A 'height' value of these projected points was determined; corresponding to the initial vertical coordinates prior to projection. Similar to pedobarographic analysis, the foot sole picture was segmented into anatomical regions of interest ROIs to process mean height average of height data by ROI and projected surface area of the projected foot sole by ROI.
Results showed that these variables evolved differently to plantar pressure data previously reported in the literature, mainly due to the specificity of each physical quantity millimeters vs Pascals. Compared to plantar pressure data arising from surface contact by the foot, the current method takes into account the whole plantar aspect of the foot, including the parts that do not make contact with the support surface.
The current approach using height data could contribute to a better understanding of specific aspects of foot motion during walking, such as plantar arch height and the windlass mechanism. Results of this study show the underlying method is reliable. Further investigation is required to validate the DFS measurements within a clinical context, prior to implementation into clinical practice. Epidemiology of moderate-to-severe injury patterns observed in rollover crashes.
Previous epidemiological studies have highlighted the high risk of injury to the head, thorax, and cervical spine in rollover crashes. However, such results provide limited information on whole-body injury distribution and multiple region injury patterns necessary for the improvement and prioritization of rollover -focused injury countermeasures.
Sampled cases representing approximately , U. A retrospective cohort study, based on a survey of population-based data, was used to identify relevant whole body injury patterns. Among belted occupants injured in rollover crashes, The most frequent multi-region injury pattern involved the head and upper extremity, but this pattern only accounted for 2.
The results indicated that for rollover -dominated crashes, the frequently observed injury patterns involved isolated body regions. In contrast, multi-region injury patterns are more frequently observed in rollovers with significant planar impacts. Identification of region-specific injury patterns in pure rollover crashes is essential for clarifying injury mitigation targets and developing whole-body injury metrics specifically applicable to rollovers.
Q May a Q May a plan An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials. Background Adequate reporting of safety in publications of randomized controlled trials RCTs is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine CAM treatments.
Clear and concise information on the definition, frequency, and severity of adverse events AEs is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section.
Results Two-hundred and five trials were included in the review. For all trials , the median percentage of words devoted to the reporting of safety in the results section was 2. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement.
Vehicle lift-off modelling and a new rollover detection criterion. The modelling and development of a general criterion for the prediction of rollover threshold is the main purpose of this work. Vehicle dynamics models after the wheels lift-off and when the vehicle moves on the two wheels are derived and the governing equations are used to develop the rollover threshold.
These models include the properties of the suspension and steering systems. In order to study the stability of motion, the steady-state solutions of the equations of motion are carried out. Based on the stability analyses, a new relation is obtained for the rollover threshold in terms of measurable response parameters. The presented criterion predicts the best time for the prevention of the vehicle rollover by applying a correcting moment.
It is shown that the introduced threshold of vehicle rollover is a proper state of vehicle motion that is best for stabilising the vehicle with a low energy requirement. Path-following in model predictive rollover prevention using front steering and braking. In this paper vehicle path-following in the presence of rollover risk is investigated. Vehicles with high centre of mass are prone to roll instability.
Untripped rollover risk is increased in high centre of gravity vehicles and high-friction road condition. Researches introduce strategies to handle the short-duration rollover condition. In these researches, however, trajectory tracking is affected and not thoroughly investigated. This paper puts stress on tracking error from rollover prevention. A lower level model predictive front steering controller is adopted to deal with rollover and tracking error as a priority sequence.
A brake control is included in lower level controller which directly obeys an upper level controller ULC command. The ULC manages vehicle speed regarding primarily tracking error. Simulation results show that the proposed control framework maintains roll stability while tracking error is confined to predefined error limit. Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention.
While core outcome sets COS are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. Our methods include 1 identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, 2 identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and 3 developing a COS through consensus processes including everyone involved.
Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety -related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions.
Occupant injury in rollover crashes - Contribution of planar impacts with objects and other vehicles. Planar impacts with objects and other vehicles may increase the risk and severity of injury in rollover crashes. Four different types of multiple event rollovers were defined: single and multi-vehicle crashes for which the rollover is the most severe event SV Prim and MV Prim and single and multi-vehicle crashes for which the rollover is not the most severe event SV Non-Prim and MV Non-Prim.
Belted, contained or partially ejected, adult occupants in vehicles that completed lateral quarter turns were assigned to one of the five rollover categories. The results showed that the frequency of injury in non-primary rollovers SV Non-Prim and MV Non-Prim involving no more than one roof inversion is substantially greater than in SV Pure, but that this disparity diminishes for crashes involving multiple inversions.
It can further be concluded that for a given number of roof inversions, the distribution of injuries and crash characteristics in SV Pure and SV Prim crashes are sufficiently similar for these categories to be considered collectively for purposes of understanding etiologies and developing strategies for prevention.
Safety of Sculptra: a review of clinical trial data. The development of facial lipoatrophy as a result of highly active antiretroviral therapy HAART used to treat patients with human immunodeficiency virus HIV has adversely affected patient quality of life and compliance with therapy.
Thanks to modern pharmacotherapies, HIV can now be viewed as a chronic disease; however, this welcome change has exacerbated the effect of facial lipoatrophy since HIV-infected patients can now expect to live longer and healthier lives but remain subject to public scrutiny of their ongoing disease state.
The device affords long-lasting restoration while still being non-permanent, thus providing an extended but adjustable cosmetic effect. The safety profile of this product has been observed in four investigator-initiated clinical trials of more than HIV patients and in numerous investigator reports, with no serious adverse events or infections deemed associated with the product.
Maintenance of the excellent safety profile for this injectable device requires adherence to a novel technique and appreciation of its unique attributes. Field relevance of a suite of rollover tests to real-world crashes and injuries. The objective of this study was to assess the distribution of rollover accidents occurring in the field and to compare the vehicle kinematics in the predominant field crash modes with available laboratory tests.
For this purpose, US accident data were analyzed to identify types and circumstances for vehicle rollovers. Rollovers were most commonly induced when the lateral motion of the vehicle was suddenly slowed or stopped. This type of rollover mechanism is referred to as "trip-over". Three additional tests have been devised to more fully address the field relevant conditions identified in this study.
Accident data were also used to identify injuries in belted drivers so the information could later be used to better understand occupant kinematics in various roll conditions. Head injuries occurred from contact with the roof, pillar and the interior, while thoracic injuries resulted from contact with the interior and steering wheel assembly.
Field data are useful in the development of laboratory test conditions for rollovers as it provides insights on the. Motor vehicle seat belt restraint system analysis during rollover. The multi-planar and multiple impact long duration accident sequence of a real world rollover results in multidirectional vehicle acceleration pulses and multiplanar occupant motions not typically seen in a planar crash sequence.
Various researchers have documented that, while contemporary production emergency locking seatbelt retractors ELRs have been found to be extremely effective in the planar crashes in which they are extensively evaluated, when subjected to multi-planar acceleration environments their response may be different than expected.
Specifically, accelerations in the vertical plane have been shown to substantially affect the timeliness of the retractors inertial sensor moving out of its neutral position and locking the seat belt. An analysis of the vehicle occupant motions relative to the acceleration pulses sensed at the retractor location indicates a time phase shift that, under certain circumstances, can result in unexpected seat belt spool out and occupant excursions in these multi-planar, multiple impact crash sequences.
This paper will review the various previous studies focusing on the retractors response to these multidirectional, including vertical, acceleration environments and review statistical studies based upon U. A significant number of real world accident case studies will be reviewed wherein the performance of ELR equipped seatbelt systems spooled out. Finally, the typical occupant injury and the associated mechanism due to belt spool out in real world accidents will be delineated.
Thoracic injuries to contained and restrained occupants in single-vehicle pure rollover crashes. Around one in three contained and restrained seriously injured occupants in single-vehicle pure rollover crashes receive a serious injury to the thorax.
With dynamic rollover test protocols currently under development, there is a need to understand the nature and cause of serious thoracic injuries incurred in rollover events. This will allow decisions to be made with regards to adoption of a suitable crash test dummy and appropriate thoracic injury criteria in such protocols. Valid rollover occupant protection test protocols will lead to vehicle improvements that will reduce the high trauma burden of vehicle rollover crashes. This paper presents an analysis of contained and restrained occupants involved in single-vehicle pure rollover crashes that occurred in the United States between and inclusive.
Serious thoracic injury typology and causality are determined. A logistic regression model is developed to determine associations between the incidence of serious thoracic injury and the human, vehicle and environmental characteristics of the crashes. Recommendations are made with regards to the appropriate assessment of potential thoracic injury in dynamic rollover occupant protection crash test protocols.
The modern Sport Utility Vehicle SUV fleet continues to go through a transformation in response to the concern that they are at an increased risk of rollover. Our research objective was to look at changes in rollover rates for single vehicle crashes in the modern SUV fleet corresponding to NCAP rollover testing model years and the impact of electronic stability control ESC and lowered center of gravity.
Additional significant predictors of rollover included SUV size, driver age and alcohol use. Inadequate safety reporting in pre-eclampsia trials : a systematic evaluation. Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. To assess safety reporting in pre-eclampsia trials.
Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. We included 60 randomised trials. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Pre-eclampsia trials regularly omit critical information related to safety.
Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms.
Developing coreoutcomes could help to improve safety reporting in preeclampsia trials. Perception of side rollover hazards in a Pennsylvania rural population while operating an all-terrain vehicle ATV. All-terrain vehicles ATVs are unstable on steep and rough terrain, and thus, rollover is the most common accident which can result in a high rate of fatal outcomes, with higher rates for young and male drivers.
This paper investigates the ability of rural Pennsylvania ATV drivers to correctly evaluate slopes, and the mean slope angle at which the most and least conservative drivers indicate a beginning of concern of a roll-over.
The study was conducted using a simulator, a commercial ATV firmly fixed on an hydraulically-lifted platform. As the platform was being raised, participants were asked to report when they became uncomfortable and then when they would not drive across a slope at such an angle. The difference between the reported and the actual angles in both conditions were analyzed.
Fifty-five individuals, mostly male and younger than 20 years, participated in riding on the simulator. Participants began to feel uncomfortable at Overestimation of lateral roll angles is the most common result. This is in favor of safety when drivers are informed about a slope limit ATVs should not be operated on. Health savings accounts and health reimbursement arrangements: assets, account balances, and rollovers , This is up from , when there were 1.
The percentage of individuals without a rollover decreased from 23 percent in to 10 percent in and increased slightly to 13 percent in It was also found that individuals who used cost or quality information had higher account balances and higher rollovers compared with those who did not use such information. However, no relationship was found between either account balance or rollover amounts and various cost-conscious behaviors such as checking pricing before getting services or asking for generic drugs instead of brand names, among other things.
A comprehensive review of rollover accidents involving vehicles equipped with Electronic Stability Control ESC systems. This study investigated police accident reports from 9 states to examine and characterize rollover crashes involving ESC-equipped vehicles. The focus was on the sequence of critical events leading to loss of control and rollover , and the interactions between the accident, driver, and environment. Results show that, while ESC is effective in reducing loss of control leading to certain rollover crashes, its effectiveness is diminished in others, particularly when the vehicle departs the roadway or when environmental factors such as slick road conditions or driver factors such as speeding, distraction, fatigue, impairment, or overcorrection are present.
This study with three Appalachian county agricultural education programs examined the feasibility, effectiveness, and impact of integrating a cost-effective rollover protective structure CROPS project into high school agricultural mechanics classes. The project aimed to 1 reduce the exposure to tractor overturn hazards in three rural counties through the installation of CROPS on seven tractors within the Cumberland Plateau in the east region; 2 increase awareness in the targeted rural communities of cost-effective ROPS designs developed by the National Institution for Occupational Safety and Health NIOSH to encourage ROPS installations that decrease the costs of a retrofit; 3 test the feasibility of integration of CROPS construction and installations procedures into the required agricultural mechanics classes in these agricultural education programs; and 4 explore barriers to the implementation of this project in high school agricultural education programs.
Eighty-two rural students and three agricultural educators participated in assembly and installation instruction. Findings demonstrated the feasibility and utility of a CROPS education program in a professionally supervised secondary educational setting. New curriculum and knowledge measures also resulted from the work.
Lessons learned and recommendations for a phase 2 implementation and further research are included. Six-day randomized safety trial of intravaginal lime juice. Nigerian women reportedly apply lime juice intravaginally to protect themselves against HIV. In vitro data suggest that lime juice is virucidal, but only at cytotoxic concentrations. This is the first controlled, randomized safety trial of lime juice applied to the human vagina. Product application also was randomized: during 1 interval, product was applied using a saturated tampon and in the other by douche.
Vaginal pH, symptoms, signs of irritation observed via naked eye examination and colposcopy, microflora, and markers of inflammation in cervicovaginal lavages were evaluated after 1 hour and on days 3 and 7. We observed a dose-dependent pattern of symptoms and clinical and laboratory findings that were consistent with a compromised vaginal barrier function.
The brief reduction in pH after vaginal lime juice application is unlikely to be virucidal in the presence of semen. Lime juice is unlikely to protect against HIV and may actually be harmful. ORNL provided the day-to-day management of the project. The expertise mix of this team coupled with complementary research needs and interests, and a positive can-do attitude provided an extremely positive experimental research opportunity for all involved.
The work conducted by this team focused on initial efforts to generate data and information on heavy truck rollover not currently available in the industry. It reflects efforts within Phases 1 and 2 of a longer-term four-phase research program. A Peterbilt class-8 tractor and Wabash dry freight van trailer were the test vehicles utilized in this effort. Both were instrumented with a number of sensors to capture the dynamics of the tractor and trailer as it engaged in various testing maneuvers that included: an evasive maneuver, swept sine, constant radius, and a run-off-the-road maneuver.
The run-off-the-road maneuver was discontinued because the test track could not safety accommodate such a maneuver. These maneuvers were carried out utilizing both standard dual tires and new-generation dual tires in six test series. Two test series also included the use of a wider-slider suspension. Outriggers were placed on the test vehicle to assure that an actual rollover would not occur, however, the tests were designed to generate lift-off of tires during the tests.
One of the main. Design of an unified chassis controller for rollover prevention, manoeuvrability and lateral stability. This paper describes a unified chassis control UCC strategy to prevent vehicle rollover and improve both manoeuvrability and lateral stability.
Since previous researches on rollover prevention are only focused on the reduction of lateral acceleration, the manoeuvrability and lateral stability cannot be guaranteed. For this reason, it is necessary to design a UCC controller to prevent rollover and improve lateral stability by integrating electronic stability control, active front steering and continuous damping control.
This integration is performed through switching among several control modes and a simulation is performed to validate the proposed method. Simulation results indicate that a significant improvement in rollover prevention, manoeuvrability and lateral stability can be expected from the proposed UCC system. U02 : heavy truck rollover characterization phase-A final report. Evaluation of engineering plastic for rollover protective structure ROPS mounting.
Agriculture has one of the highest fatality rates of any industry in America. Tractor rollovers are a significant contributor to the high death rate. Rollover protective structures ROPS have helped lower these high fatality rates on full-size tractors. However, a large number of older tractors still do not use ROPS due to the difficulty of designing and creating a mounting structure.
To help reduce this difficulty, engineering plastics were evaluated for use in a ROPS mounting structure on older tractors. The use of engineering plastics around axle housings could provide a uniform mounting configuration as well as lower costs for aftermarket ROPS. Various plastics were examined through shear testing, scale model testing, and compressive strength testing.
Once a material was chosen based upon strength and cost, full-scale testing of the plastic's strength on axle housings was conducted. Initial tests revealed that the ROPS mounting structure and axle housing combination had higher torsional strength with less twisting than the axle housing alone. An engineering plastic ROPS mounting structure was easily successful in withstanding the forces applied during the static longitudinal and lateral ROPS tests.
Field upset testing revealed that the mounting structure could withstand the impact loads seen during actual upsets without a failure. During both static testing and field upset testing, no permanent twisting of the mounting structure was found. Engineering plastic could therefore be a viable option for a universal ROPS mounting structure for older tractors. Cervical spine injury in rollover crashes: Anthropometry, excursion, roof deformation, and ATD prediction.
While rollover crashes are rare, approximately one third of vehicle occupant fatalities occur in rollover crashes. Most severe-to-fatal injuries resulting from rollover crashes occur in the head or neck region, due to head and neck interaction with the roof during the crash. While many studies have used anthropomorphic test devices ATDs to predict head and neck injury, the biofidelity of ATDs in rollover has not been established.
This study aims to build on previous research to compare the dynamic response and injuries sustained by four post mortem human surrogates PMHS to those predicted by six different ATDs in full-scale rollover crash tests. Additionally, this study evaluates injuries sustained by PMHS relative to possible contributing factors including occupant kinematics, occupant anthropometry, and vehicle roof deformation.
While the vehicle kinematics and roof deformation were comparable for all tests, three out of the four PMHS sustained cervical spine injury, but only the tallest specimen sustained cervical spine fracture. Neck flexion at the time of head-to-roof contact appears to have affected cervical spine injury risk in these cases. Published by Elsevier Ltd. Cost effectiveness of a dealer's intervention in retrofitting rollover protective structures.
Objective: To evaluate the cost effectiveness of a 4. Design: Randomized controlled trial , decision analysis, and cost effectiveness analysis. Setting: One treatment county and one control county in the State of Kentucky. Intervention: A campaign by a local tractor and equipment dealership to encourage farmers to purchase and install ROPS and seatbelt retrofit kits for older tractors. Main outcome measures: Number of injuries averted and cost per injury averted.
Results: The dealership's 4. When extrapolated statewide, 6. Conclusions: Tractor manufacturer promotions can influence their dealerships to promote ROPS retrofits by their customers. A manufacturer backed dealer ROPS retrofit campaign was cost effective in reducing overturn related injuries. Rollover car crashes ROCs are serious public safety concerns worldwide.
To determine the incidence and outcomes of ROCs with or without ejection of occupants in the State of Qatar. Group I had higher injury severity score and sustained significantly more head, chest, and abdominal injuries in comparison to Group II.
Patients in Group I had a 5-fold increased risk for age-adjusted mortality OR 5. ROCs with ejection are associated with higher rate of morbidity and mortality compared to ROCs without ejection. As an increased number of young Qatari males sustain ROCs with ejection, these findings highlight the need for research-based injury prevention initiatives in the country. The percentage of individuals without a rollover remained at 13 percent in In contrast, obese individuals have less money in their account than the nonobese.
There is very little difference in account balances by level of exercise. Very small differences were found in account balances and rollover amounts between individuals who used cost or quality information, compared with those who did not use such information.
However, next to no relationship was found between either account balance or rollover amounts and various cost-conscious behaviors. When a difference. Bonhoeffer, Jan; Imoukhuede, Egeruan B. 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. Quality of reporting in clinical trials of preharvest food safety interventions and associations with treatment effect. Randomized controlled trials RCTs are the gold standard for evaluating treatment efficacy.
Therefore, it is important that RCTs are conducted with methodological rigor to prevent biased results and report results in a manner that allows the reader to evaluate internal and external validity. Our objective was to evaluate preharvest food safety trials using a modification of the CONSORT criteria to assess methodological quality and completeness of reporting, and to investigate associations between reporting and treatment effects.
There were widespread deficiencies in the reporting of many trial features. Although 91 trials had more than one outcome, no trials specified the primary outcome of interest. There were significant bivariable associations between the proportion of positive treatment effects and failure to report the number of subjects lost to follow-up, the number of animals housed together in a group, the level of treatment allocation, and possible study limitations.
The results suggest that there are substantive deficiencies in reporting of preharvest food safety trials , and that these deficiencies may be associated with biased treatment effects. The creation and adoption of standards for reporting in preharvest food safety trials will help to ensure the inclusion of important trial details. There has been an increased emphasis on the proactive and comprehensive evaluation of safety endpoints to ensure patient well-being throughout the medical product life cycle.
In fact, depending on the severity of the underlying disease, it is important to plan for a comprehensive safety evaluation at the start of any development program. Statisticians should be intimately involved in this process and contribute their expertise to study design, safety data collection, analysis, reporting including data visualization , and interpretation. In this manuscript, we review the challenges associated with the analysis of safety endpoints and describe the safety data that are available to influence the design and analysis of premarket clinical trials.
We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from clinical trials compared to other sources. Clinical trials are an important source of safety data that contribute to the totality of safety information available to generate evidence for regulators, sponsors, payers, physicians, and patients.
Study of neurontin: titrate to effect, profile of safety STEPS trial : a narrative account of a gabapentin seeding trial. Seeding trials , clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail.
We examined all documents relating to the clinical trial Study of Neurontin: Titrate to Effect, Profile of Safety STEPS produced during the Neurontin marketing, sales practices, and product liability litigation, including company internal and external correspondence, reports, and presentations, as well as depositions elicited in legal proceedings of Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert, most which were created between and Using a systematic search strategy, we identified and reviewed all documents related to the STEPS trial in order to identify key themes related to the trial 's conduct and determine the extent of marketing involvement in its planning and implementation.
Documents consistently described the trial itself, not trial results, to be a marketing tactic in the company's marketing plans. Documents demonstrated that at least 2 external sources questioned the validity of the study before execution, and that data quality during the study was often compromised. Furthermore, documents described company analyses examining the impact of participating as a STEPS investigator on rates and dosages of gabapentin prescribing, finding a positive association.
None of these findings were reported in 2 published articles. The STEPS trial was a seeding trial , used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.
Background Occupant injuries in rollover crashes are associated with vehicle structural performance, as well as the restraint system design. For a better understanding of the occupant kinematics and injury index in certain rollover crash, it is essential to carry out dynamic vehicle rollover simulation with dummy included.
Objective This study focused on effects of curtain airbag CAB parameters on occupant kinematics and injury indexes in a rollover crash. Besides, optimized parameters of the CAB were proposed for the purpose of decreasing the occupant injuries in such rollover scenario. The restraint system, including a validated CAB module, was introduced for occupant kinematics simulation and injury evaluation.
Results After introducing the curtain airbag, the maximum head acceleration was reduced from The neck Fz was decreased from Conclusions Avoiding hard contact is critical for the occupant protection in the rollover crashes. The simulation results indicated that occupant kinematics and certain injury indexes were improved with the help of CAB in such rollover scenario.
Appropriate TTF setting and inflator selection could benefit occupant kinematics and injury indexes. Besides, it was advised to optimize the curtain airbag thickness around the head contact area to improve head and neck injury indexes. A generic analytical foot rollover model for predicting translational ankle kinematics in gait simulation studies.
The objective of this paper is to develop an analytical framework to representing the ankle-foot kinematics by modelling the foot as a rollover rocker, which cannot only be used as a generic tool for general gait simulation but also allows for case-specific modelling if required.
Previously, the rollover models used in gait simulation have often been based on specific functions that have usually been of a simple form. Furthermore, a normalized generic foot rollover model has been established based on a normative foot rollover shape dataset of 12 normal healthy subjects.
To evaluate model accuracy, the predicted ankle motions and the centre of pressure CoP were compared with measurement data for both subject-specific and general cases. However, we found that the foot cannot be very accurately represented by a rollover model just after heel strike HS and just before toe off TO , probably due to shear deformation of foot plantar tissues ankle motion can occur without any foot rotation.
The proposed foot rollover model can be used in both inverse and forward dynamics gait simulation studies and may also find applications in rehabilitation engineering. Copyright Elsevier Ltd. Unrestrained drivers and vehicle commanders had greater than expected torso injuries, while restrained vehicle commanders and passengers had greater than expected upper extremity injuries.
While reporting bias may exist, nevertheless these results show that occupant restraint use confers substantial life-saving protection to HMMWV occupants in rollover accidents. Therefore, commanders, safety officers, and peers should continue to promote and enforce restraint use consistently during all Army ground operations and training involving HMMWVs. Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the Clinical Trials.
Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the Clinical Trials.
The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas cardiovascular diseases, mental health and oncology.
Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. A total of phase IV trials were identified, including focusing on drug safety alone and evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor.
Phase IV trials evaluating drug safety in the Clinical Trials. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. Testing cardiovascular drug safety and efficacy in randomized trials. Randomized trials provide the gold standard evidence on which rests the decision to approve novel therapeutics for clinical use.
They are large and expensive and provide average but unbiased estimates of efficacy and risk. Concern has been expressed about how unrepresentative populations and conditions that pertain in randomized trials might be of the real world, including concerns about the homogeneity of the biomedical and adherence characteristics of volunteers entered into such trials , the dose and constancy of drug administration and the mixture of additional medications that are restricted in such trials but might influence outcome in practice.
A distinction has been drawn between trials that establish efficacy and those that demonstrate effectiveness, drugs that patients actually consume in the real world for clinical benefit. However, randomized controlled trials remain the gold standard for establishing efficacy and the testing of effectiveness with less rigorous approaches is a secondary, albeit important consideration. Despite this, there is an appreciation that average results may conceal considerable interindividual variation in drug response, leading to a failure to appreciate clinical value or risk in subsets of patients.
Thus, attempts are now being made to individualize risk estimates by modulating those derived from large randomized trials with the individual baseline risk estimates based on demographic and biological criteria-the individual Numbers Needed to Treat to obtain a benefit, such as a life saved. Here, I will consider some reasons why large phase 3 trials -by far the most expensive element of drug development-may fail to address the unmet medical needs, which should justify such effort and investment.
They are large and expensive and provide average, but unbiased estimates of efficacy and risk. Integration of vehicle yaw stabilisation and rollover prevention through nonlinear hierarchical control allocation. This work presents an approach to rollover prevention that takes advantage of the modular structure and optimisation properties of the control allocation paradigm. It eliminates the need for a stabilising roll controller by introducing rollover prevention as a constraint on the control allocation problem.
The major advantage of this approach is the control authority margin that remains with a high-level controller even during interventions for rollover prevention. In this work, the high-level control is assigned to a yaw stabilising controller. It could be replaced by any other controller. The constraint for rollover prevention could be replaced by or extended to different control objectives.
This work uses differential braking for actuation. The use of additional or different actuators is possible. The developed control algorithm is computationally efficient and suitable for low-cost automotive electronic control units. The predictive design of the rollover prevention constraint does not require any sensor equipment in addition to the yaw controller.
The method is validated using an industrial multi-body vehicle simulation environment. Testing and injury potential analysis of rollovers with narrow object impacts. Recent statistics highlight the significant risk of serious and fatal injuries to occupants involved in rollover collisions due to excessive roof crush.
The government has reported that in Rollover crashes rely primarily upon the roof structures to maintain occupant survival space. A test device and methodology is presented which facilitates dynamic, repeatable rollover impact evaluation of complete vehicle roof structures with such narrow objects. These tests allow for the incorporation of Anthropomorphic Test Dummies ATDs which can be instrumented to measure accelerations, forces and moments to evaluate injury potential.
High-speed video permits for detailed analysis of occupant kinematics and evaluation of injury causation. Criteria such as restraint performance, injury potential, survival space and the effect of roof crush associated with various types of design alternatives, countermeasures and impact circumstances can also be evaluated.
In addition to presentation of the methodology, two representative vehicle crash tests are also reported. Results indicated that the reinforced roof structure significantly reduced the roof deformation compared to the production roof structure. Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management.
Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative CTTI sought to 1 identify challenges to investigator receipt and management of investigational new drug IND safety reports at oncologic investigative sites and coordinating centers and 2 facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals.
CTTI, a public-private partnership to improve the conduct of clinical trials , distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule Code of Federal Regulations Title 21 Section The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events.
The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming eg, downloading reports due to slow sites or difficulties associated with particular operating systems or software.
To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by. Injuries to Occupants of U. This research conducted on occupant injuries in U. Rollovers are especially hazardous to.
Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety , and efficacy data.
Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The first interim analysis found higher day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later.
The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Series: Pragmatic trials and real world evidence: Paper 7. Safety , quality and monitoring. Pragmatic trials offer the opportunity to obtain real-life data on the relative effectiveness and safety of a treatment before or after market authorization. This is the penultimate paper in a series of eight, describing the impact of design choices on the practical implementation of pragmatic trials.
This paper focuses on the practical challenges of collecting and reporting safety data and of monitoring trial conduct while maintaining routine clinical care practice. Current ICH guidance recommends that all serious adverse events and all drug-related events must be reported in an interventional trial.
Different options available to support the collection and reporting of safety data while minimizing study-related follow-up visits are discussed. A risk-based approach to monitoring trial conduct is also discussed, highlighting the difference in the balance of risks likely to occur in a pragmatic trial compared to traditional clinical trials and the careful consideration that must be given to the mitigation and management of these risks to maintain routine care.
Published by Elsevier Inc. Template protocol for clinical trials investigating vaccines--focus on safety elements. 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. The effect of passenger load on unstable vehicles in fatal, untripped rollover crashes. Consumers may be unaware of the risk of rollover crashes posed by passenger loads in vehicles with poor roll stability.
This analysis demonstrates that certain sports utility vehicles and small pickup trucks have designs that are so unstable that the weight of the passengers in the vehicle affects its propensity to roll over. This effect occurs even though the weight of the loaded vehicle is less than the manufacturer's gross vehicle weight rating.
The risk of a fatal, "untripped" rollover crash in vehicles with low roll stability is increased as each passenger is added to the vehicle load. Randomized clinical trials and observational studies in the assessment of drug safety. Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects.
For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs.
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