Sports Science(Quality work, no plagarism, A+)

MEDICAL NEWS & PERSPECTIVES

cine in W inston-S alem , NC, said the passage of the F ood a n d D rag A dm in­ i s tr a tio n A m e n d m e n ts A ct o f 2 007 s h o u ld have giv en th e ag en cy m o re regulatory am m u n itio n to p u sh com ­ panies to com ply w ith conducting post­ m ark etin g studies. “T he problem prio r to the act’s passage was th a t som e of the com m itm ents to com plete postm arket­ ing studies h ad no deadlines, so it was

hard to claim they were delinquent. And clearly there have been no consequences and no one at the FDA paid attention to th is p r o b le m ,” F u r b e r g sa id . “T h e changes in the regulations should help, b u t w hen I look at the list of studies on the accelerated approval list, som e have been conducted and some are pending, and to m e it is h ard to say the situation has im proved.”

Nissen remains frustrated w ith the in­ action by FDA leadership to improve the a c c e le ra te d a p p ro v a l p ro c e s s . “T h e people at the FDA approving drugs are very pharm a friendly; they view p h a r­ m aceutical m anufacturers as their p rin ­ cipal clients. So we see this lack of en­ forcem ent over and over,” N issen said. “I do n ot th in k we need tough laws; we need tougher regulators.” □

Reports of Concussions From Youth Sports Rise A long W ith Awareness of the Problem Mike Mitka

A n e w s t u d y h a s d o c u m e n t e d a g ro w in g n u m b e r o f e m e r ­ gency d epartm ent visits by chil­ d r e n a n d a d o le s c e n ts w ith s p o r ts -

related co ncussion, b u t it is u n k n o w n w h eth er th e increase reflects a true rise in the n u m b e r of incidents o r better re­ p o rtin g due to greater aw areness.

The study, by researchers from Brown University in Providence, RI, found that from 1997 to 2007, US em ergency de­ partm en t visits for concussions occur­ ring in organized team sp o rts h ad al­ m ost doubled (from 3946 to 7791) in children aged 8 to 13 years and m ore th a n trip le d (fro m 7 2 7 6 to 23 239) a m o n g y o u th s ag ed 14 to 19 y e a rs (BakhosLLet al. P ed ia tric s. doi:10.1542/ peds.2009-3101 [published online Au­ gust 30,2010]. In addition, the research­ ers f o u n d th a t fro m 2001 to 2 0 0 5 , children and adolescents aged 8 to 19 years had an estim ated 502 000 em er­ gency d e p a rtm e n t v isits for c o n c u s ­ sion, w ith about 35% involving 8- to 13- y ear-o ld s a n d h a lf o f th e to ta l v isits related to a sports incident.

The Brown researchers, u sin g data from the N ational S porting G oods As­ sociation, fo u n d th a t for 2001 to 2005, the concu ssio n rate was h ig h est for ice hockey, at 10 per 10 000 participants for 7- to 11-year-olds and 29 per 10 000 par­ ticipants for 12- to 17-year-olds. F o o t­

ball acco u n ted for th e seco n d highest concussion rate, at 8 an d 27 p e r 10 000 for the 2 age groups, respectively.

Lisa L. Bakhos, MD, lead au th o r and now a pediatric em ergency physician at Jersey Shore Medical Center in Neptune, NJ, said a m ajor p art of their retrospec­ tive review of data from the National Elec­ tronic Injury Surveillance System was to provide solid concussion data for the p re - high-school population. She said the rea­ son for the high num bers of em ergency departm ent visits for concussion is u n ­ clear. “W e do n o t know if it is an actual increase; we hope it is increased aware­ ness and reporting,” Bakhos said. “W e do speculate that youth sports are getting ex­ tremely competitive, and kids, in general, are getting bigger; so you end up w ith

8-year-olds in 13-year-old bodies but with the m aturity still o f 8-year-olds.”

Michael A. McCrea, PhD, executive di­ rector of the ProH ealth Care N eurosci­ ence C enter and Research In stitute in W aukesha, Wis, speculated that m ost of the increase in re p o rte d con cu ssio n s could be tied to greater awareness of the problem by patents, coaches, and train­ ers, b u t he added th at some percentage of the increase should be attributed sim ­ ply to m ore concussions. “It feels evo­ lutionary and seems natural to me th at if we saw great speed, s tre n g th , an d mass— all the requirem ents for a colli­ sion— at the professional level, we natu ­ rally saw it trickle do w n to the colle­ giate level, and now it is trickling dow n to the yo u th sports level.

A n e w r e p o r t r e m i n d s

t h o s e i n v o l v e d in

o r g a n i z e d t e a m s p o r t s

t h a t e v e n t h e

y o u n g e s t p a r t i c i p a n t s

a r e a t r is k f o r

c o n c u s s i o n .

JAMA, October 27, 2010—Vol 304, No. 16 1 7 7 5

MEDICAL NEWS & PERSPECTIVES

Bakhos and colleagues also found that during the time period w hen reported concussions increased, participation in organized team sports decreased. The re­ searchers estim ated that about 385 000 children aged 7 to 17 participated in the top 5 organized teams posts in 1997, with the nu m b er falling to ju s t over 330 000 participants by 2007.

McCrea does n o t have h ard data, b ut he speculated that the increasing num ber of concussions during a tim e of apparent declining participation in sports m ay be the result of how those children rem ain­ ing in a sport train and compete. “Partici­ pation in sports has become a year-around commitment; you used to play football for 2 m onths and then m ove onto basketball and then maybe track and field,” McCrea said. “So maybe participation is down, but for those playing, say football, the n u m ­

ber o f exposures seems to be certainly higher than seen a decade ago.”

In August, the American Academy of P e d ia tric s issu e d its first clin ical re ­ p o r t o ffe rin g g u id a n c e in th e tre a t­ m e n t a n d m a n a g e m e n t o f s p o r t s - re la te d c o n c u s s io n in c h ild r e n a n d adolescents (H alstead ME, W alter KD; the Council on Sports Medicine and Fit­ n e ss. Pediatrics. 2 0 1 0 ;1 2 6 [ 3 ] :5 9 7 - 615). M ark E. H alstead, MD, a co au ­ th o r o f the clinical re p o rt and assistant p ro fesso r o f o rth o p e d ic s a n d p e d ia t­ rics at W a s h in g to n U n iv e rsity in St Louis, said their guidance lays o u t para­ m eters to be used in assessing w h e n an ath lete can re tu rn to co m p etitio n fol­ low ing a concussion. “Rather th en tell­ ing a player to sit o u t for a set p erio d of tim e, we gradually increase the a th ­ lete’s activities over a 5-day p erio d to

m ake su re th e ath lete do es n o t d e m ­ o n strate sy m p to m s,” H alstead said.

Deciding w hen an athlete is well enough to return to com petition remains a bit o f a mystery, McCrea said, because there is little rigorous evidence to show w hat w orks best. He said the decision to retu rn is especially difficult to m ake for those w ho have had repeated concussions and that such a determ ination is probably best m ade by the treating physician.

“No adult signs his or h e r own retum - to-work slip after they have had a stroke, b u t retum -to-play for concussion for de­ cades has been m anaged by the injured ath le te o r n o n m e d ic a l p ro fe ssio n a ls” su c h as p a re n ts, coaches, or train ers, McCrea said. “But there has been som e positive m ovem ent in creating policy re­ quiring medical clearance before one can re tu rn to an activity.” □

N ational Children's Study Expands Bridget M. K uehn

W IT H N E A R L Y 4 0 O F T H E planned 105 sites across the U nited States recruiting, the p ilot phase o f the N ational C h ild ren ’s

Study is well u n d e r way, after years of uncertain ty .

T he stu d y will follow u p m ore than 100 000 infants and their m others from before c o n cep tio n th ro u g h th e ch ild ’s 21st b irth d a y an d m ay provide critical in fo rm a tio n a b o u t how e n v iro n m e n ­ tal and genetic factors contribute to dis­ ease. U n p reced en ted in its scope and length, the stu d y has faced b o th logis­ tic an d fu n d in g challenges since it was a u th o rized by C ongress as p a rt o f the C h ild ren ’s H ealth Act of 2000.

A lthough the initial estim ate o f the stu d y ’s co st was $2.7 billio n over 25 years, su b seq u en t m edia rep o rts have suggested it could cost m ore than twice as m uch. It is being led by a consortium o f federal agencies; inclu d in g the E u­ nice K ennedy Shriver N ational In sti­ tute of Child Health and H um an Devel­

o p m e n t, th e N a tio n a l I n s t i t u t e o f Environm ental Health Sciences, the US Centers for Disease Control and Preven­ tion, and the US Environm ental Protec­ tion Agency. The planning for the project began in 2000 and included in p u t from the National Academy of Sciences. How­ ever, funding fell short of target am ounts d u rin g the plan n in g phase, leading to concern about the viability o f the study. But funding levels have increased su b ­ stantially since 2007, w hen the im ple­ m entation phase began, and $414.3 mil­ lion has been secured to date.

The payoff of su ch a m assive in vest­ m en t, in term s of u n iq u e in sights on how the interaction betw een genes and th e e n v iro n m e n t lead to b o th c h ild ­ h o o d an d ad u lt disease, is expected to be enorm ous. “W e are em barking u p o n one o f th e ric h e st d ata-co llectio n ef­ forts ever conducted, an d the w ealth of in fo rm a tio n we ho p e to am ass co u ld h a v e a m a jo r im p a c t o n th e h e a lth o f fu tu r e g e n e r a tio n s ,” sa id S tev en H irschfeld, MD, PhD, the stu d y ’s a ct­ ing directo r, in a statem ent.

T he endeavor also m ay provide in ­ sights into the best ways to conduct such a m assive research effort. D uring the s tu d /s pilot phase, each participating site will use 1 o f 3 strategies for recruiting w o m en to p articip ate: referral o f p a­ tients by practitioners; outreach efforts to contact w om en at hom e (via adver­ tisements) and at com m unity events; and the mailing of a questionnaire to w om en to complete and then selection of a group to participate further. Insights from this phase will be used to determ ine the most efficient and cost-effective strategies for recruitm ent for use during the rest of the study. C urrently, the sites are recru it­ ing w o m en w ho are p reg n an t o r w ho m ay s o o n b e c o m e p r e g n a n t fo r th e study’s pilot phase.

Initial resu lts from this phase of the study sh o u ld be available later this year o r in early 2011, H irschfeld said. Early findings from th e s tu d y m ay begin to filter in som etim e in 2013.

M o re in f o rm a tio n o n th e p r o je c t is a v a ila b le o n l i n e a t h tt p : / / w w w .n atio n alchildrensstudy.gov. □

1 7 7 6 JAMA, October 27, 2010—Vol 304, No. 16

Copyright of JAMA: Journal of the American Medical Association is the property of American Medical Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.

MEDICAL NEWS & PERSPECTIVES

cine in W inston-S alem , NC, said the passage of the F ood a n d D rag A dm in­ i s tr a tio n A m e n d m e n ts A ct o f 2 007 s h o u ld have giv en th e ag en cy m o re regulatory am m u n itio n to p u sh com ­ panies to com ply w ith conducting post­ m ark etin g studies. “T he problem prio r to the act’s passage was th a t som e of the com m itm ents to com plete postm arket­ ing studies h ad no deadlines, so it was

hard to claim they were delinquent. And clearly there have been no consequences and no one at the FDA paid attention to th is p r o b le m ,” F u r b e r g sa id . “T h e changes in the regulations should help, b u t w hen I look at the list of studies on the accelerated approval list, som e have been conducted and some are pending, and to m e it is h ard to say the situation has im proved.”

Nissen remains frustrated w ith the in­ action by FDA leadership to improve the a c c e le ra te d a p p ro v a l p ro c e s s . “T h e people at the FDA approving drugs are very pharm a friendly; they view p h a r­ m aceutical m anufacturers as their p rin ­ cipal clients. So we see this lack of en­ forcem ent over and over,” N issen said. “I do n ot th in k we need tough laws; we need tougher regulators.” □

Reports of Concussions From Youth Sports Rise A long W ith Awareness of the Problem Mike Mitka

A n e w s t u d y h a s d o c u m e n t e d a g ro w in g n u m b e r o f e m e r ­ gency d epartm ent visits by chil­ d r e n a n d a d o le s c e n ts w ith s p o r ts -

related co ncussion, b u t it is u n k n o w n w h eth er th e increase reflects a true rise in the n u m b e r of incidents o r better re­ p o rtin g due to greater aw areness.

The study, by researchers from Brown University in Providence, RI, found that from 1997 to 2007, US em ergency de­ partm en t visits for concussions occur­ ring in organized team sp o rts h ad al­ m ost doubled (from 3946 to 7791) in children aged 8 to 13 years and m ore th a n trip le d (fro m 7 2 7 6 to 23 239) a m o n g y o u th s ag ed 14 to 19 y e a rs (BakhosLLet al. P ed ia tric s. doi:10.1542/ peds.2009-3101 [published online Au­ gust 30,2010]. In addition, the research­ ers f o u n d th a t fro m 2001 to 2 0 0 5 , children and adolescents aged 8 to 19 years had an estim ated 502 000 em er­ gency d e p a rtm e n t v isits for c o n c u s ­ sion, w ith about 35% involving 8- to 13- y ear-o ld s a n d h a lf o f th e to ta l v isits related to a sports incident.

The Brown researchers, u sin g data from the N ational S porting G oods As­ sociation, fo u n d th a t for 2001 to 2005, the concu ssio n rate was h ig h est for ice hockey, at 10 per 10 000 participants for 7- to 11-year-olds and 29 per 10 000 par­ ticipants for 12- to 17-year-olds. F o o t­

ball acco u n ted for th e seco n d highest concussion rate, at 8 an d 27 p e r 10 000 for the 2 age groups, respectively.

Lisa L. Bakhos, MD, lead au th o r and now a pediatric em ergency physician at Jersey Shore Medical Center in Neptune, NJ, said a m ajor p art of their retrospec­ tive review of data from the National Elec­ tronic Injury Surveillance System was to provide solid concussion data for the p re - high-school population. She said the rea­ son for the high num bers of em ergency departm ent visits for concussion is u n ­ clear. “W e do n o t know if it is an actual increase; we hope it is increased aware­ ness and reporting,” Bakhos said. “W e do speculate that youth sports are getting ex­ tremely competitive, and kids, in general, are getting bigger; so you end up w ith

8-year-olds in 13-year-old bodies but with the m aturity still o f 8-year-olds.”

Michael A. McCrea, PhD, executive di­ rector of the ProH ealth Care N eurosci­ ence C enter and Research In stitute in W aukesha, Wis, speculated that m ost of the increase in re p o rte d con cu ssio n s could be tied to greater awareness of the problem by patents, coaches, and train­ ers, b u t he added th at some percentage of the increase should be attributed sim ­ ply to m ore concussions. “It feels evo­ lutionary and seems natural to me th at if we saw great speed, s tre n g th , an d mass— all the requirem ents for a colli­ sion— at the professional level, we natu ­ rally saw it trickle do w n to the colle­ giate level, and now it is trickling dow n to the yo u th sports level.

A n e w r e p o r t r e m i n d s

t h o s e i n v o l v e d in

o r g a n i z e d t e a m s p o r t s

t h a t e v e n t h e

y o u n g e s t p a r t i c i p a n t s

a r e a t r is k f o r

c o n c u s s i o n .

JAMA, October 27, 2010—Vol 304, No. 16 1 7 7 5

MEDICAL NEWS & PERSPECTIVES

Bakhos and colleagues also found that during the time period w hen reported concussions increased, participation in organized team sports decreased. The re­ searchers estim ated that about 385 000 children aged 7 to 17 participated in the top 5 organized teams posts in 1997, with the nu m b er falling to ju s t over 330 000 participants by 2007.

McCrea does n o t have h ard data, b ut he speculated that the increasing num ber of concussions during a tim e of apparent declining participation in sports m ay be the result of how those children rem ain­ ing in a sport train and compete. “Partici­ pation in sports has become a year-around commitment; you used to play football for 2 m onths and then m ove onto basketball and then maybe track and field,” McCrea said. “So maybe participation is down, but for those playing, say football, the n u m ­

ber o f exposures seems to be certainly higher than seen a decade ago.”

In August, the American Academy of P e d ia tric s issu e d its first clin ical re ­ p o r t o ffe rin g g u id a n c e in th e tre a t­ m e n t a n d m a n a g e m e n t o f s p o r t s - re la te d c o n c u s s io n in c h ild r e n a n d adolescents (H alstead ME, W alter KD; the Council on Sports Medicine and Fit­ n e ss. Pediatrics. 2 0 1 0 ;1 2 6 [ 3 ] :5 9 7 - 615). M ark E. H alstead, MD, a co au ­ th o r o f the clinical re p o rt and assistant p ro fesso r o f o rth o p e d ic s a n d p e d ia t­ rics at W a s h in g to n U n iv e rsity in St Louis, said their guidance lays o u t para­ m eters to be used in assessing w h e n an ath lete can re tu rn to co m p etitio n fol­ low ing a concussion. “Rather th en tell­ ing a player to sit o u t for a set p erio d of tim e, we gradually increase the a th ­ lete’s activities over a 5-day p erio d to

m ake su re th e ath lete do es n o t d e m ­ o n strate sy m p to m s,” H alstead said.

Deciding w hen an athlete is well enough to return to com petition remains a bit o f a mystery, McCrea said, because there is little rigorous evidence to show w hat w orks best. He said the decision to retu rn is especially difficult to m ake for those w ho have had repeated concussions and that such a determ ination is probably best m ade by the treating physician.

“No adult signs his or h e r own retum - to-work slip after they have had a stroke, b u t retum -to-play for concussion for de­ cades has been m anaged by the injured ath le te o r n o n m e d ic a l p ro fe ssio n a ls” su c h as p a re n ts, coaches, or train ers, McCrea said. “But there has been som e positive m ovem ent in creating policy re­ quiring medical clearance before one can re tu rn to an activity.” □

N ational Children's Study Expands Bridget M. K uehn

W IT H N E A R L Y 4 0 O F T H E planned 105 sites across the U nited States recruiting, the p ilot phase o f the N ational C h ild ren ’s

Study is well u n d e r way, after years of uncertain ty .

T he stu d y will follow u p m ore than 100 000 infants and their m others from before c o n cep tio n th ro u g h th e ch ild ’s 21st b irth d a y an d m ay provide critical in fo rm a tio n a b o u t how e n v iro n m e n ­ tal and genetic factors contribute to dis­ ease. U n p reced en ted in its scope and length, the stu d y has faced b o th logis­ tic an d fu n d in g challenges since it was a u th o rized by C ongress as p a rt o f the C h ild ren ’s H ealth Act of 2000.

A lthough the initial estim ate o f the stu d y ’s co st was $2.7 billio n over 25 years, su b seq u en t m edia rep o rts have suggested it could cost m ore than twice as m uch. It is being led by a consortium o f federal agencies; inclu d in g the E u­ nice K ennedy Shriver N ational In sti­ tute of Child Health and H um an Devel­

o p m e n t, th e N a tio n a l I n s t i t u t e o f Environm ental Health Sciences, the US Centers for Disease Control and Preven­ tion, and the US Environm ental Protec­ tion Agency. The planning for the project began in 2000 and included in p u t from the National Academy of Sciences. How­ ever, funding fell short of target am ounts d u rin g the plan n in g phase, leading to concern about the viability o f the study. But funding levels have increased su b ­ stantially since 2007, w hen the im ple­ m entation phase began, and $414.3 mil­ lion has been secured to date.

The payoff of su ch a m assive in vest­ m en t, in term s of u n iq u e in sights on how the interaction betw een genes and th e e n v iro n m e n t lead to b o th c h ild ­ h o o d an d ad u lt disease, is expected to be enorm ous. “W e are em barking u p o n one o f th e ric h e st d ata-co llectio n ef­ forts ever conducted, an d the w ealth of in fo rm a tio n we ho p e to am ass co u ld h a v e a m a jo r im p a c t o n th e h e a lth o f fu tu r e g e n e r a tio n s ,” sa id S tev en H irschfeld, MD, PhD, the stu d y ’s a ct­ ing directo r, in a statem ent.

T he endeavor also m ay provide in ­ sights into the best ways to conduct such a m assive research effort. D uring the s tu d /s pilot phase, each participating site will use 1 o f 3 strategies for recruiting w o m en to p articip ate: referral o f p a­ tients by practitioners; outreach efforts to contact w om en at hom e (via adver­ tisements) and at com m unity events; and the mailing of a questionnaire to w om en to complete and then selection of a group to participate further. Insights from this phase will be used to determ ine the most efficient and cost-effective strategies for recruitm ent for use during the rest of the study. C urrently, the sites are recru it­ ing w o m en w ho are p reg n an t o r w ho m ay s o o n b e c o m e p r e g n a n t fo r th e study’s pilot phase.

Initial resu lts from this phase of the study sh o u ld be available later this year o r in early 2011, H irschfeld said. Early findings from th e s tu d y m ay begin to filter in som etim e in 2013.

M o re in f o rm a tio n o n th e p r o je c t is a v a ila b le o n l i n e a t h tt p : / / w w w .n atio n alchildrensstudy.gov. □

1 7 7 6 JAMA, October 27, 2010—Vol 304, No. 16

Copyright of JAMA: Journal of the American Medical Association is the property of American Medical Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.