Scanning Paper Records

 

Granted that we tend to be somewhat bold in our approaches to the paperless clinical trial, but in today’s world, it is truly anachronistic to have massive paper records. We just got a very interesting project for an orphan disease and our client suggested that they give us the 23 volumes of the paper IND, although they have all of the documents electronically in “Dropbox.“ We rejected the “kind offer.“

 

All that aside, we started reading a paper published in Clinical Investigations (2013;3:451-465), entitled “GCP-compliant Digital Archiving of Paper-Based Patient Records of Clinical Trial Subjects: A Key Issues Paper,“ which is about digitizing paper records. What is so interesting is that if the industry would use eSource, then it would only have to comply with page 3 and we would be done. What industry leaders now need to do is set clear and feasible standards/rules for eSource systems, as paper records disappear.

 

The following is from the Clinical Investigations manuscript. First the famous ALCOA, but later on, an extension of the definition of Original/Attributable, which we think says it all:

 

1. Accurate

a) The data must be accurately and carefully collected and processed. This means that the data collected must represent the observed reality and may not be manipulated.

2. Legible [to be obsolete for handwritten data as Adobe is always readable]

a) The data must be legibly collected during the data collection process (this is particularly important with hand-written data). Media and storage systems and data processing must furthermore ensure that the data are legible when needed.

3. Contemporaneous [to be obsolete with eSource]

a) The data must be collected promptly after a patient visit. ?Promptly after’ may only be deviated from in exceptional, duly warranted cases.

4. Original [The New Reality]

a) This point is described in detail in the following section.

5. Attributable

The data must be clearly attributable to:

a) The corresponding patient;

b) The individual collecting the data;

c) The time of collection.

A. Complete

1) The data must be complete with reference to the information to be recorded according to the protocol and to the diagnostic, therapeutic and other relevant measures, which were implemented.

B. Consistent

1) The data collected must be consistent and unambiguous.

C. Enduring

1) The data must be reliably stored for the prescribed period of time.

D. Available when needed

1) The data must be available on demand when needed (e.g., during inspections). This also implies that data sets can be timely and selectively retrieved.

 

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Fall is in the air, here in NYC, Sailboat Lake in Central Park – November 2013 ©Target Health 2013.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website

1.35 Million Children Seen in ER for Sports-Related Injuries

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The sport with the most injuries is football, which also has the highest concussion rate. Wrestling and cheerleading have the second and third highest concussion rate. (Credit: © Amy Myers / Fotolia)

 

Every 25 seconds, or 1.35 million times a year, a young athlete suffers a sports injury severe enough to go to the 1) ___ room, according to a new research report released by Safe Kids Worldwide. Sports safety experts at Monroe Carell Jr. Children’s Hospital at Vanderbilt, lead organization for Safe Kids Cumberland Valley, offer strategies to help prevent injuries this sports season.

 

The report, “Game Changers,“ made possible with support from Johnson & Johnson, takes an in-depth look at data from the U.S. Consumer Product Safety Commission’s National Electronic Injury Surveillance System (NEISS) to explore what type of 2) ___ are sidelining young athletes. According to the report that studied the 14 most popular sports, concussions account for 163,000 (12%) of those ER visits. There is a concussion-related ER visit every three minutes. Surprisingly, it is not just high school athletes suffering concussions; athletes ages 12 to 15 make up almost half (47%) of the sports-related concussions seen in the ER, a statistic made even more disturbing by the knowledge that younger children with concussions take a longer time to recover than older children.

 

In 2011, the sport with the most injuries was 3) ___, which also has the highest concussion rate. Wrestling and cheerleading have the second and third highest concussion rate. The sport with the highest percentage of concussion injuries is ice hockey. “With the absence of our ability to prevent most concussions from actually occurring, our next and present best line of defense is the prompt recognition and response to concussions in order to minimize severity and prolonged impairment,“ said Alex Diamond, D.O., assistant professor of Orthopaedics and Rehabilitation and Pediatrics. “This is where we really see the value of education as we rely heavily on those in the community trenches such as parents and coaches to have a high index of suspicion and sit their athlete out if there is any concern for a 4) ___

 

The report also revealed that knee injuries account for one in 10 sports-related injuries. Knee injuries, specifically tears to the anterior cruciate ligament (ACL), are disproportionately affecting young female athletes, who are up to eight times more likely to have an ACL injury than 5) ___ athletes.

 

Game-Changing Strategies

Children’s Hospital and Safe Kids Cumberland Valley are calling on community members, coaches, parents, sports leagues and athletes to implement four overarching strategies that are making a difference:

 

  • Get educated, then pass it forward. Attend a Safe Kids sports clinic or go to www.childrenshospital.vanderbilt.org/sportssafety to find out how to keep children safe, then tell your friends.
  • Teach athletes injury prevention skills. Instill smart hydration habits, warm-up exercises and stretches to prevent common injuries. Understand stress placed on 6) ___ particular to the sport (pitching arm, knees, etc.) and target exercises to those areas. Encourage young athletes to get plenty of rest.
  • Encourage athletes to speak up about injuries. Athletes can feel like they are letting down their teammates, coaches or parents if they ask to sit out due to an injury. Encourage athletes to speak up about their injuries to help prevent further injury.
  • Support coaches in injury prevention decisions. A Safe Kids Worldwide 2012 survey found half of coaches admit to being pressured by a parent or athlete to keep an injured athlete in the game. Coaches need to be educated and supported in making decisions that protect the immediate and long-term health of young athletes.

 

“We all play a role in the well-being of our young athletes,“ Diamond said. “Therefore, we feel it is vital to empower every individual in the community to help bring about a safer sporting environment and culture for their young athletes, but also for us to provide them with the tools they need to be able to make that difference.“

 

Sports Medicine Physician Advises Parents to Not Let Their Kids Play Football

Prominent sports medicine physician Dr. Pietro Tonino of Loyola University Medical Center has some blunt advice for parents of high school athletes who want to play football this fall: Don’t let them do it. “When you have two human beings collide at a high rate of 7) ___ — especially if one of them is much bigger than the other — then significant injuries are quite possible,“ Tonino said. “I don’t believe it is worth the risk. So I advise parents to try to steer their children to alternative sports. We are just beginning to understand the long-term consequences of injuries sustained at young ages.“

 

The most common football injuries are knee injuries, especially to the anterior or posterior cruciate ligament (ACL/PCL). Other common injuries are ankle sprains, shoulder injuries and overuse injuries that cause back pain and patellar tendonitis (knee pain). Heat 8) ___ is a significant risk during summer training camp. A study published in the journal Pediatrics found that injury rates were similar in football and baseball. But while only 3% of baseball injuries were considered serious (fracture, dislocation, concussion), 14% of football injuries were considered serious. But concussions are Tonino’s biggest concern. Tonino notes that a position statement from the American Medical Society for Sports Medicine says the developing brain differs physiologically from the adult brain. Young athletes may have a more prolonged recovery and are more susceptible to concussions accompanied by a catastrophic injury.

 

While helmets can prevent injuries such as cuts and fractures, 9) ___ have not been shown to reduce the incidence and severity of concussions. This is particularly true if improper tackling techniques are used. “Lowering the head and leading with the head can cause serious head and neck injuries, regardless of the quality of the helmet,“ Tonino said. But despite the high injury risk, there generally is inadequate medical supervision during football games and practices. For example, Tonino surveyed football programs in Chicago public high schools and found that only 10.6% had a physician on the sideline during games; 8.5% had an athletic trainer present; and 89.4% had a paramedic available. During practice, no school had a physician or paramedic present, and only one school had an athletic trainer available. The study was published in The Physician and Sports Medicine journal. (Tonino has served as a team doctor for high school, college and NFL football teams.)

 

Tonino did not let his own two sons play football, but he understands that many other parents will disagree with his advice. In such cases, he advises parents to carefully observe the football program: During summer training camp, practices should be held in early morning or early evening, if possible, to reduce the risk of heat injury. 1) Keep an eye out for concussions. Does your child suffer from headaches, dizziness or difficulty concentrating? 2) Attend a practice. Is there adequate water and ice for players? 3) During games, is there a 10) ___ or athletic trainer on the sidelines? 4) Get to know the coach. During practices, coaches often are the only ones who provide medical supervision.

 

NFL Players May Be at Higher Risk for Depression as They Age

 

National Football League (NFL) players may be at increased risk of depression as they age due to brain damage resulting from concussions, according to two studies released January 17, 2013, that were presented at the American Academy of Neurology’s 65th Annual Meeting in San Diego, March 2013.

 


 

The Centers for Disease Control and Prevention (CDC) estimates that about 1.6 to 3.8 million sports concussions occur each year. “While it is known that sports concussions can cause immediate disturbances in mood and thinking, few studies have investigated the long-term effects that may emerge later in life, especially those related to depression,“ said study author Nyaz Didehbani, PhD, of the Center for BrainHealth at The University of Texas at Dallas. “Our study shows that athletes who have sustained concussions in early 11) ___ may be at a higher risk for developing depression as they age compared to the general population. It is important when a concussive experience occurs that medical professionals appropriately include depression screening in their follow-up assessment. Depression is a treatable condition if the proper and necessary steps are taken.“

 

In the first study, researchers evaluated 34 retired NFL athletes with a history of concussion and 29 people of the same age from the general population with no concussion history. Participants were tested for depression. Concussions were retrospectively graded based on American Academy of Neurology guidelines. The researchers examined thinking skills, mood and the physical symptoms of depression.

 

The study found that those athletes who exhibited greater symptoms on the Beck Depression Inventory scored significantly higher than the minimal range for depressive symptoms. The Beck Depression Inventory measures symptoms related to thinking, mood and the physical signs of depression. The retired athletes included in the study reported an average of four concussions, reinforcing the correlation between depression scores and the number of lifetime concussions.

The second study included 26 retired NFL athletes. Of those, five had depression and 21 did not have depression. Diffusion tensor MRI brain scans were used to measure damage to white matter in the 12) ___. White matter contains tissue and nerve fibers that help carry signals from one part of the brain to another. Damage to white matter occurs in traumatic brain injury and also has been seen in some people with depression.

 

By looking at the amount of white matter damage in one area of the brain, researchers could predict which former players had depression with 100% sensitivity and 95% specificity. Sensitivity is the percentage of actual positives that are correctly identified as positive, and specificity is the percentage of negatives that are correctly identified. The severity of the depressive symptoms was also associated with the degree of white matter damage in a wide range of brain regions.

 

“Aside from providing important insights into the nature of depression as it relates to brain damage in retired NFL athletes who have been exposed to concussive and repetitive head injuries, this study also may help us to understand the similar behavioral symptoms seen in other sports-related head injuries and in combat-related blast injuries seen in armed service members,“ said study author Kyle Womack, MD, of the University of Texas Southwestern Medical Center in Dallas.

 

Both studies were primarily supported by the the BrainHealth Institute for Athletes at the Center for BrainHealth, a research center at the University of Texas at Dallas. The second study also was supported by the National Institutes of Health.

 

Meanwhile, this past September 2013, A high school football player who suffered a blow to the head during a game in Western New York has died. The Buffalo News reported that officials at Women & Children’s Hospital in Buffalo announced the death of 16-year-old Damon Janes in September. Janes was a running back on the Westfield/Brocton football team and lost 13) ___ after a helmet-to-helmet hit during a game against Portville on Friday. The cause of death has yet to be determined. After this helmet-to-helmet hit, more attention is being paid to the risk of 14) ___ injuries in football, and some parents are beginning to wonder whether the game is too dangerous for their children to play. Source: ScienceDaily.com, NIH.gov, The New York Times

 

Editor’s note: As parents become aware of the possibility of brain damage, in its many forms, to their young sons, they may well choose not to allow them to participate in these high contact sports. Very quickly, this may reduce the numbers seeking to play in college, as well as on professional teams.  This trend appears to have begun.

 

ANSWERS: 1) emergency; 2) injuries; 3) football; 4) concussion; 5) male; 6) muscles; 7) speed; 8) stroke; 9) helmets; 10) physician; 11) adulthood; 12) brain; 13) consciousness; 14) head

Football + Injuries

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Charles William Eliot (1834-1926). The educational genius and president of Harvard from 1869 to 1909.

 

“No sport is wholesome in which ungenerous or mean acts which easily escape detection contribute to victory.“ Charles William Eliot, President of Harvard University, opposing football in 1905

 

“While they may be visually exciting, and they may sell tickets, these are today’s gladiators, and we don’t really want to go down the path where our gladiators are dying out there on the arena floor.“ Dr. Tom Talavage of Purdue University, opposing football in 2013

 

The history of sport probably extends as far back as the existence of people, as purposive sportive and active beings. Sport has been a useful way for people to increase their mastery of nature and the environment. The history of sport can teach us a great deal about social changes and about the nature of sport itself. Sport seems to involve basic human skills being developed and exercised for their own sake, in parallel with being exercised for their usefulness. It also shows how society has changed its beliefs and therefore there are changes in the rules. Of course, as we go further back in history the dwindling evidence makes the theories of the origins and purposes of sport difficult to support. Nonetheless, its importance in human history is undeniable.

 

Cave paintings have been found in the Lascaux caves in France that appear to depict sprinting and wrestling in the Upper Paleolithic around 17,300 years ago. Cave paintings in the Bayankhongor Province of Mongolia dating back to Neolithic age of 7000 BCE show a wrestling match surrounded by crowds.

 

Modern American football has its origins in traditional ball games played at villages and schools in Europe for many centuries before America was settled by Europeans. There are reports of early settlers at Jamestown, Virginia playing games with inflated balls in the early 17th century. Early games appear to have had much in common with the traditional “mob football“ played in England, especially on Shrove Tuesday when they used a lemon instead of a ball. The games remained largely unorganized until the 19th century, when intramural games of football began to be played on college campuses. Each school played its own variety of football. Princeton students played a game called “ballown“ as early as 1820. A Harvard tradition known as “Bloody Monday“ began in 1827, which consisted of a mass ballgame between the freshman and sophomore classes. Dartmouth played its own version called “Old division football“, the rules of which were first published in 1871, though the game dates to at least the 1830s.

 

All of these games, and others, shared certain commonalities. They remained largely “mob“ style games, with huge numbers of players attempting to advance the ball into a goal area, often by any means necessary. Rules were simple, violence and injury were common. The violence of these mob-style games led to widespread protests and a decision to abandon them. Yale, under pressure from the city of New Haven, banned the play of all forms of football in 1860, while Harvard followed suit in 1861. While the game was being banned in universities, it was growing in popularity in various east coast prep schools. In 1855, manufactured inflatable balls were introduced. These were much more regular in shape than the handmade balls of earlier times, making kicking and carrying easier. Two general types of football had evolved by this time: “kicking“ games and “running“ (or “carrying“) games. A hybrid of the two, known as the “Boston game“, was played by a group known as the Oneida Football Club. The club, considered by some historians as the first formal football club in the United States, was formed in 1862 by schoolboys who played the “Boston game“ on Boston Common. They played mostly among themselves, though they organized a team of non-members to play a game in November 1863, which the Oneidas won easily. The game caught the attention of the press, and the “Boston game“ continued to spread throughout the 1860s.

 

The game began to return to college campuses by the late 1860s. Yale, Princeton, Rutgers, and Brown all began playing “kicking“ games during this time. In 1857, Princeton used rules based on those of the English Football Association. A “running game“, resembling rugby football, was taken up by the Montreal Football Club in Canada in 1868. American football evolved in the US, originating from the sport of rugby football. The first game of American football was played on November 6, 1869 between two college teams, Rutgers and Princeton, under rules resembling rugby and soccer. A set of rule changes drawn up from 1880 onward by Walter Camp, the “Father of American Football“, established the snap, eleven-player teams and the concept of downs, and later rule changes legalized the forward pass, created the neutral zone and specified the size and shape of the football. The last major remnant of rugby was removed in 1888, when tackling below the waist was legalized. From its earliest days as a mob game, football was a violent sport. The 1894 Harvard-Yale game, known as the “Hampden Park Blood Bath“, resulted in crippling injuries for four players; the contest was suspended until 1897. The annual Army-Navy game was suspended from 1894 to 1898 for similar reasons. One of the major problems was the popularity of mass-formations like the flying wedge, in which a large number of offensive players charged as a unit against a similarly arranged defense. The resultant collisions often led to serious injuries and sometimes even death.

 

Football remained a violent sport despite these innovations. Dangerous mass-formations like the flying wedge resulted in serious injuries and occasional deaths among players. A 1905 peak of 19 fatalities nationwide and 159 seriously injured, resulted in a threat by President Theodore Roosevelt to abolish the game unless major changes were made. There were other moves to abolish the game as well. Sixty-two schools met in New York City to discuss rule changes on December 28, 1905, and these proceedings resulted in the formation of the Intercollegiate Athletic Association of the United States, later named the National Collegiate Athletic Association(NCAA).

 

One rule change introduced in 1906, devised to open up the game and reduce injury, was the introduction of the legal forward pass. Though it was underutilized for years, this proved to be one of the most important rule changes in the establishment of the modern game.

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1906 St. Louis Post-Dispatch photograph of Brad Robinson, who threw the first legal forward pass and was the sport’s first triple threat

 

As a result of the 1905-1906 reforms, mass formation plays became illegal and forward passes legal. Other important changes, formally adopted in 1910, were the requirements that at least seven offensive players be on the line of scrimmage at the time of the snap, that there be no pushing or pulling, and that interlocking interference (arms linked or hands on belts and uniforms) was not allowed. These changes greatly reduced the potential for collision injuries. Several coaches emerged who took advantage of these sweeping changes. Amos Alonzo Stagg introduced such innovations as the huddle, the tackling dummy, and the pre-snap shift. Other coaches, such as Pop Warner and Knute Rockne, introduced new strategies that still remain part of the game. Besides these coaching innovations, several rules changes during the first third of the 20th century had a profound impact on the game, mostly in opening up the passing game. In 1914, the first roughing-the-passer penalty was implemented. In 1918, the rules on eligible receivers were loosened to allow eligible players to catch the ball anywhere on the field  previously strict rules were in place only allowing passes to certain areas of the field. Scoring rules also changed during this time: field goals were lowered to three points in 1909 and touchdowns raised to six points in 1912.

 

Star players that emerged in the early 20th century include Jim Thorpe, Red Grange, and Bronko Nagurski; these three made the transition to the fledgling NFL and helped turn it into a successful league. Sportswriter Grantland Rice helped popularize the sport with his poetic descriptions of games and colorful nicknames for the game’s biggest players, including Notre Dame’s “Four Horsemen“ backfield and Fordham University’s linemen, known as the “Seven Blocks of Granite“.

 

Strong Proponent of Football

Charles William Eliot was a visionary American academic who was selected as Harvard’s president in 1869. He transformed the provincial college into the preeminent American research university. Eliot served until 1909, having the longest term as president in the university’s history. He was a cousin of the Nobel Prize-winning poet T.S. Eliot. Eliot’s educational vision incorporated important elements of Unitarian and Emersonian ideas about character development, framed by a pragmatic understanding of the role of higher education in economic and political leadership. His concern in “The New Education“ was not merely curriculum, but the ultimate utility of education. A college education could enable a student to make intelligent choices, but should not attempt to provide specialized vocational or technical training. Although technical training should be more explicitly vocational, it should also include instruction in history, languages, political economy, as well as providing a broad knowledge of science and mathematics. Only by differentiating the two levels of the educational process and making each as comprehensive as possible, could higher education hope to prepare students to cope with the rapid pace of technological, economic, and political change. A truly useful education, in Eliot’s view, included a commitment to public service, specialized training, and a capacity to change and adapt.

 

During his tenure, Eliot opposed football and tried unsuccessfully to abolish the game at Harvard. In 1905, The New York Times reported that he called it “a fight whose strategy and ethics are those of war“, that violation of rules cannot be prevented, that “the weaker man is considered the legitimate prey of the stronger“ and that “no sport is wholesome in which ungenerous or mean acts which easily escape detection contribute to victory.“ He also made public objections to baseball, basketball, and hockey. He was quoted as saying that rowing and tennis were the only clean sports. Eliot once said, “Well, this year I’m told the team did well because one pitcher had a fine curve ball. I understand that a curve ball is thrown with a deliberate attempt to deceive. Surely this is not an ability we should want to foster at Harvard.“

 

The final meeting of the Rules Committee tasked with reshaping football, was held on April 6, 1906, at which time the forward pass officially became a legal play. The New York Times reported in September 1906 on the rationale for the changes: “The main efforts of the football reformers have been to “open up the game“ – that is to provide for the natural elimination of the so-called mass plays and bring about a game in which speed and real skill shall supersede so far as possible mere brute strength and force of weight.“ However the Times also reflected widespread skepticism as to whether the forward pass could be effectively integrated into the game: “There has been no team that has proved that the forward pass is anything but a doubtful, dangerous play to be used only in the last extremity.“ The forward pass was not allowed in Canadian football until 1929.

 

Between 1906 and 1908, a movement developed to eliminate football from university sports programs on grounds that it was too brutal and was attracting professionalism to the college campuses. There were proposals to replace football in American universities with either soccer or Canadian rugby.

 

As mentioned above, in 1905, a rash of football fatalities almost snuffed out the sport before it began, leading to bans from Illinois school boards and the president’s intervention. One of the fatalities was Vernon Wise. In November 1905, Vernon Wise, the 17-year-old son of a hardware wholesaler, lined up at right end for the Oak Park junior varsity football team. Slight of build and fragile, Wise wasn’t much of a player, even on a second team whose players averaged 138 pounds, but he was tenacious, “nervy,“ and popular, enough that he was named captain of the team – which he declined, in favor of his friend, the team fullback. A handful of fans, mostly younger students, were watching as Wise threw himself at a Hyde Park opponent, who collapsed on top of him, followed by a “struggling mass“ of players. Wise was knocked unconscious, and taken to a doctor; his replacement was kicked in the head on the next play, the fourth casualty of the game, after which it was called. Wise briefly regained consciousness, during which he told his mother that he would give up the game, “even if I don’t get the [letter] sweater.“ Two hours after the hit, he died of a broken back.

 

Wise was hardly alone in his death on the football field. In the previos November of 1904, prior, a Chicago man whose 16-year-old son died of peritonitis after a football game, pushed state legislation to get the sport banned, joining with an Indiana state senator and a Wisconsin man (whose sons had died the month before) to eliminate the sport in the tri-state area, along with Michigan. But for some reason, Wise’s death gripped the local press, in part because the Oak Park and Cook County school boards took up the proposition to replace the popular sport with lacrosse and soccer, respectively. The Alton school board banned the sport after its high school’s right tackle died in an October game; “Capt. E.D. Enos of the Alton team, whose collar bone was broken in the same game, was at the funeral swathed in bandages.“

 

The rash of local injuries came just a couple weeks before the president of the United States, Teddy Roosevelt, telegraphed Harvard president Charles Eliot asking him to address the year’s record of 19 deaths – “more than double that of the yearly average for the last five years, the total for that period being forty-five“ – for fear the sport’s bloody reputation would get it banned outright instead of changed to protect the players. In particular, Roosevelt pushed the “open game,“ whose players, he said, “escaped with less than their usual quota of accidents.“ It was meant to save the game from the vicious scrums seen in the Edison films, below, which look quaint in black-and-white but caused the debilitating or fatal injuries that felled players like Wise.

 

Out of the extreme testosterone levels, leading to violence, the modern game of football was born: the forward pass, the ten-yard first down, the lengthening of the line of scrimmage, a new emphasis on penalties and improving the quality of refereeing to prevent the dangerous “mucker“ play on the lines, and the creation of the NCAA’s predecessor. The movement to ban football, which was quite strong at the time, faded. Fatalities plunged, and the crisis settled down. However, coming as no surprise, injuries would rise again, precipitating another crisis in 1909-1910 that’s not nearly as famous. One problem for not doing more to change the game or abolish it, was a lack of good data. Not until 1931 were statistics regularly kept on football fatalities. Over the years, those numbers would show a pattern of deaths that would return to the numbers that nearly ended football in America before it began.

 

The violence continued. Between 1965 and 1969, more than 100 players at all levels died of brain injuries, an average of about 20 per year – about the same number as died in 1905, but from brain injuries alone. The mounting number of head injuries, and the pioneering work of University of Michigan neuroscientist Richard Schneider during the 1960s, led to significant equipment and rule changes that altered the sport and made it profoundly safer, at least in the short run. Schneider established a laboratory model at the University of Michigan to study head and neck injuries, and these experiments ultimately led to the development of the protective helmets used today. In addition, he used game and practice films to study the mechanisms causing these injuries, and his findings led to major rules changes banning so-called spearing and butt-blocking. The result was a dramatic reduction in the incidence of athletics-related “serious“ head and spinal cord injury, as documented in the National Football Head and Neck Injury Register and the National Center for Catastrophic Sport Injury Research data statistics. The change was extraordinary; between rule changes and the 1973 creation of NOCSAE, the National Operating Committee on Standards for Athletic Equipment, head-injury fatalities in high school football declined by three-quarters. But the new equipment, meant to protect from sudden death, forces a tradeoff with the death of a thousand blows that claimed Dave Duerson and possibly Junior Seau. The bad news is that the old regulations provide scant protection against concussions. While a hard plastic helmet lined with cushioning can protect the skull from fracturing, a concussion occurs on the inside of the head, when the brain quickly decelerates and impacts bone. This means that helmet designers face an inevitable tradeoff: If the head isn’t shielded from the strongest physical impacts – and this is best done with soft, pliable materials – then it can break and bleed. But the very act of protecting players from those severe collisions means that the head will bounce around the cushioned helmet, thus allowing the brain to move within its bony cage. The worst impact will be internal.

 

It is being said that what the NFL owners wanted was high-impact spectacular plays and touchdowns to sell tickets, and they got what they wanted, and bought it with the bodies and brains of their players. At all levels, those involved with football saw an increasing problem, and worked with the tools of science and engineering to address it. And by the measures of brain deaths, quadriplegia, and cervical injuries, they were wildly successful. But similar advances were also leading to bigger, stronger, faster players at all levels. Meanwhile, the science that was so good on severe head injuries was comparatively primitive on concussions, which only became a subject of intensive study in sports medicine in the 1980s.

 

In recent years, it’s become clear that the severity of a concussion is only indirectly related to the physical force of the impact. Sometimes, players walk away from savage hits. And sometimes they are felled by incidental contact. While data compiled from the Head Impact Telemetry System, or HITS, captures the extreme physical forces at work during a football game – it’s not uncommon for a player to sustain hits equivalent to the impact of a 25 mph car crash – there is no clear threshold for injury. The mind remains a black box; nobody really understands why it breaks. Bone-shaking hits – “high impact spectacular play“ – often get blamed for the rash of concussions and the long-term mental problems they cause. But research at Purdue suggests that a culprit is the totality of hits a player sustains over the course of a season or a career: “The most important implication of the new findings is the suggestion that a concussion is not just the result of a single blow, but it’s really the totality of blows that took place over the season,“ said Eric Nauman, an associate professor of mechanical engineering and an expert in central nervous system and musculoskeletal trauma. “The one hit that brought on the concussion is arguably the straw that broke the camel’s back.“

 

To try and prevent injuries, players are required to wear a set of equipment. At a minimum players must wear a football helmet and a set of shoulder pads, but individual leagues may require additional padding such as thigh pads and guards, knee pads, chest protectors, and mouthguards. Most injuries occur in the lower extremities, particularly in the knee, but a significant number also affect the upper extremities. The most common types of injuries are strains, sprains, bruises, fractures, dislocations, and concussions. Concussions are particularly concerning, as repeated concussions can increase a person’s risk in later life for chronic traumatic encephalopathy and mental health issues such as dementia, Parkinson’s disease, and depression. Concussions are often caused by helmet-to-helmet or upper-body contact between opposing players, although helmets have prevented more serious injuries such as skull fractures. Various programs are aiming to reduce concussions by reducing the frequency of helmet-to-helmet hits; USA Football’s “Heads Up Football“ program is aiming to reduce concussions in youth football by teaching coaches and players about the signs of a concussion, the proper way to wear football equipment and ensure it fits, and proper tackling methods that avoid helmet-to-helmet contact. Sources: http://www.grantland.com/story/_/id/7443714/jonah-lehrer-concussions-adolescents-future-football, “The Fragile Teenage Brain“ by Jonah Leher; The New York Times, Wikipedia

 

Editor’s note: In the early part of the 20th Century, my own father, participated in football at the Horace Mann School and Brown University, He suffered from many injuries, the worst being shoulder dislocations and shoulder injuries great enough to, in the end, keep him from playing on the Brown team. I grew up witnessing a huge long scar across my father’s back, which he talked about with great pride. Football and many other sports were very Important to him his entire life.

 

Please see the following videos

President Theodore Roosevelt at the Army/Navy Game in 1902

Football: Chicago/Michigan Game in 1902

Princeton/Yale Football Game in 1903

Gabapentin May Treat Alcohol Dependence

 

Alcohol use disorders affect about 18 million people in the United States and have an estimated societal cost of $225 billion each year, primarily from lost productivity, but also from health care and property damage costs. Currently, three medications are approved by the FDA for treating alcohol dependence: disulfram, an older drug that blocks the metabolism of alcohol and causes nausea; acamprosate, which helps support abstinence and can ease symptoms of withdrawal; and naltrexone, which can help people reduce heavy drinking.

 

According to a paper published online in JAMA Internal Medicine (4 November 2013), the generic anticonvulsant medication gabapentin shows promise as an effective treatment for alcohol dependence. The study found that alcohol dependent patients using gabapentin were more likely to stop drinking or refrain from heavy drinking than those taking placebo. Gabapentin is already widely prescribed to treat pain conditions and epilepsy.

 

For the study, 150 alcohol dependent patients were randomly assigned to receive a moderate or high dose of gabapentin (900 milligrams or 1,800 milligrams) or a placebo. Results showed that over the 12-week treatment, compared to placebo, patients receiving the 1,800-milligram dose were twice as likely to refrain from heavy drinking (45% vs. 23%) and four times as likely to stop drinking altogether (17% vs. 4%). Participants receiving gabapentin also reported improved sleep and mood and fewer alcohol cravings. The medication appeared to be well tolerated with few side effects. Participants who received the 900-milligram dose of gabapentin saw similar but less dramatic improvements in their drinking levels, sleep, mood, and cravings when compared to the 1,800-milligram dose.

 

According to the authors, the results of the study on gabapentin showed similar or greater positive outcomes when compared to existing FDA-approved treatments for alcohol dependence, and it’s the only medication shown to improve sleep and mood in people who are quitting or reducing their drinking, and it’s already widely used in primary care.

Associations Between Alzheimer Disease Biomarkers, Neurodegeneration, and Cognition in Cognitively Normal Adults

 

Criteria for preclinical Alzheimer disease (AD) propose beta-amyloid (AB) plaques to initiate neurodegeneration within AD-affected regions. However, some cognitively normal older individuals harbor neural injury similar to patients with AD, without concurrent A? burden. Such findings challenge the proposed sequence and suggest that AB-independent precursors underlie AD-typical neurodegenerative patterns. As a result, a study published online in JAMA Neurology (28 October 2013) was performed to examine relationships between AB and non-AB factors as well as neurodegeneration within AD regions in cognitively normal older adults. The study quantified neurodegenerative abnormalities using imaging biomarkers and examined cross-sectional relationships with AB deposition; white matter lesions (WMLs), a marker of cerebrovascular disease; and cognitive functions.

 

The investigation was a cross-sectional study in a community-based convenience sample of 72 cognitively normal older individuals (mean [SD] age, 74.9 [5.7] years; 48 women; mean [SD] 17.0 [1.9] years of education) of the Berkeley Aging Cohort. Each individual underwent a standardized neuropsychological test session, magnetic resonance imaging, and positron emission tomography scanning. For study outcomes, 3 AD-sensitive neurodegeneration biomarkers were measured: hippocampal volume, glucose metabolism, and gray matter thickness, the latter 2 sampled from cortical AD-affected regions. To quantify neurodegenerative abnormalities, each biomarker was age adjusted, dichotomized into a normal or abnormal status (using cutoff thresholds derived from an independent AD sample), and summarized into 0, 1, or more than 1 abnormal neurodegenerative biomarker. Degree and topographic patterns of neurodegenerative abnormalities were assessed and their relationships with cognitive functions, WML volume, and AB deposition (quantified using carbon 11-labeled Pittsburgh compound B positron emission tomography).

 

Results showed that of the cognitively normal elderly individuals, 40% (n=29) displayed at least 1 abnormal neurodegenerative biomarker, 26% (n=19) of whom had no evidence of elevated Pittsburgh compound B retention. In those people who were classified as having abnormal cortical thickness, degree and topographic specificity of neurodegenerative abnormalities were similar to patients with AD. Accumulation of neurodegenerative abnormalities was related to poor memory and executive functions as well as larger WML volumes but not elevated Pittsburgh compound B retention.

 

According to the authors, the study confirms that a substantial proportion of cognitively normal older adults harbor neurodegeneration, without AB burden and that associations of neurodegenerative abnormalities with cerebrovascular disease and cognitive performance indicate that neurodegenerative pathology can emerge through non-AB pathways within regions most affected by AD.

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area.

Personalized Medicine: The Future is Now

 

There are now a host of astonishing advances in medical science that are helping to create a new age of promise and possibility for patients. Today cancer drugs are increasingly prescribed based a diagnostic device that can determine whether a patient will respond to the drug based on their tumor’s genetic characteristics. Medical imaging can be used to identify the best implantable device to treat a specific patient with clogged coronary arteries; and progress in regenerative medicine and stem cell therapy using a patient’s own cells could lead to the replacement or regeneration of their missing or damaged tissues. Given these trends, the future of medicine is rapidly approaching the promising level of care and cure once imagined by Hollywood in futuristic dramas like Star Trek.

 

But these examples are not science fiction. They are very real achievements that demonstrate the era of “personalized medicine“ where advances in the science of drug development, the study of genes and their functions, the availability of increasingly powerful computers and other technologies, combined with our greater understanding of the complexity of disease, makes it possible to tailor treatments to the needs of an individual patient. We now know that patients with similar symptoms may have different diseases with different causes. Individual patients who may appear to have the same disease may respond differently (or not at all) to treatments of that disease.

 

FDA has been playing a critical role in the growth of this new era for a number of years and has created the organizational infrastructure and has put in place the regulatory processes and policies needed to meet the challenges of regulating these complex products and coordinating their review and oversight. FDA has created a new report as part of its ongoing efforts in this field. Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development describes many of the exciting developments and looming advances in personalized medicine, lays out the historical progress in this field, and examines FDA’s regulatory role: from ensuring the availability of safe and effective diagnostic devices, to addressing the challenges of aligning a drug with a diagnostic device, to post-market surveillance.

 

Source FDA Voice

Thanksgiving Is Coming Soon. Try This Low-Cal Turkey Stuffing

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Photo: Joyce Hays, ©Target Health Inc. 2013

 

Ingredients

 

1 large onion, chopped

2 Tablespoons extra virgin olive oil

1 box of Cremini mushrooms, cleaned (not washed), sliced

1 can water chestnuts, drained, chopped

2 Tablespoons raisins, chopped

3 or 4 cloves garlic, chopped

1 teaspoon Bell’s Turkey seasoning

Pinch black pepper (grind to your taste)

1/2 cup fresh parsley, chopped

2 Granny Smith apples, cleaned, cored, chopped

1 Carrot, cleaned, diced

2 stalks fresh celery, cleaned, chopped

1 cup cashews or walnuts, chopped

Chicken stock or canned broth – use to add liquid if stuffing is too dry

 

Directions

 

1. Into a large fry pan, put all of the above ingredients, except for the cut up apples.

2. Stir for about 15 minutes and remove from heat.

3. If mixture seems too dry, add some of the chicken stock or broth, instead of more oil.

4. Add the cut up apples to the stuffing in the pan and stir together.

5. Add the stuffing to the turkey and roast accordingly.

 

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Here we’re cooking everything except the apples © Joyce Hays 2013

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I cut the apples into pieces not too small (see photo above) © Joyce Hays 2013

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Last easy step, add the apples to the rest of the stuffing, heat and stir for about 5 minutes © Joyce Hays 2013

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Pop in the Oven  ©Joyce Hays 2013

 

After preparing your turkey the way you like it, add the stuffing loosely into the body

cavity. Our organic (raised without antibiotics) turkey in the photo comes with legs

and tail fastened, already. Continue to roast, in your usual way.

 

Once you get used to stuffing without bread or sausage, you will love this recipe. Very quickly, you won’t want to go back to your mother’s calorie laden stuffing. The point is, we are people who gain weight easily, so we have to be careful. If you’re not one of these, you are really lucky. But keep in mind the health aspect of eating. Even thin people have to be conscious of artery blocking plaque, etc.

 

We’re having turkey and stuffing, using the natural juices after roasting instead of making higher calorie gravy. We also have fresh sweet baby peas and butternut squash. Sometimes, we have cranberry sauce, but usually low-cal applesauce (or cinnamon applesauce) with no sugar added. We like chilled sauvignon blanc with roast turkey. For Thanksgiving, I might add a delicious easy casserole of parsnips, sweet potatoes, carrots, pecans and butternut squash to the above menu. (Maybe I will do this casserole for the next ON TARGET, newsletter). For some reason, we do not feel deprived, not having a traditional dessert, like pumpkin or pecan pie. Everything on Thanksgiving is so flavorful and rich, that we don’t miss dessert. A little extra schnapps will do, maybe with grapes and cheese.

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Beautiful Sauvignon Blanc grapes

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Bon Appetit!

 

1888, Festival of Painters (Denmark), by Peder Severin Kroyer