sbu evaluate • report 255/2016
Shaken baby syndrome
The role at the medical investigation of
suspected shaken baby syndrome A systematic Overview
theState's preparation forthemedicalandsocialassessment
Report series This report belongs to the series SBU Assesses (ISSN 1400‐1403). A comprehensive scientific scientific evaluation that includes systematic overview, economic/hälsoekono‐economic analyses and review of social and ethical aspects. Subject matter experts are involved in the work with the support of the employees of the SBU, patients/users. The report is reviewed by independent experts. The degree of scientific reliability in the sam‐manvägda results are assessed on a systematic manner and report's conclusions approved by the SBU's Board.
Declaration of contents ✓ Evaluation of established method
✓ Systematic literature search
✓ Relevansgranskning
✓ Quality review
✓ Aggregate of results
✓ Evidensgradering made by SBU
✓ Evidensgradering made externally
Based on a systematic literature review
✓ The consensus process
✓ Designed in collaboration with experts
Patients/users involved
✓ Ethical aspects
Economic aspects Societal perspective
✓ Approved by the SBU's priorities
and quality group
✓ Approved by the SBU's Board
Keywords Shaken baby syndrome, Babies, Child Abuse, Triad, Subdural Haemorrhage, Cerebral Effect, Fundus Bleeding
Published October 2016
Period of validity Results that are based on a strong scientific basis continues usually to be valid for a long time to come. Other results may have had time to become stale. The branchialsmiles of all areas where the scientific basis is insufficient or limited
Order This report (# 255) can be ordered from Strömberg distribution. Phone: 08‐779 85 96 • Fax: 08‐779 96 10 • e‐mail: [email protected]
Production Graphic production of Emma Österman, SBU. Printed by Elanders Sweden AB, Mölnlycke, 2016. Cover Photo: Shutterstock
Reference number UTV2014/254
Cite this report SBU. Shaken baby syndrome – The role at the medical investigation of suspected shaken baby syndrome.
Stockholm: the State's preparation for the medical and social assessment (SBU); 2016. SBU rapport nr. 255. ISBN 978‐91‐85413‐98‐0.
Content Summary of results 5
1 Objective 7
2 Background 9
What is shaken baby syndrome? 9
Symptoms and findings 10
In health care 10
Terminology 11
Investigation of the damage that can be caused by shaken baby syndrome 11
Other possible causes for the and its sub‐components 12
Triad – symptoms and findings 12
— Subdural 12
— Fundus bleeding 12
— Brain influence 13
Diagnostic methods 13
— Intracranial study 13
— Fundoscopy 14
3 Methodology for the systematic evaluation 15
Question according to PIRO 15
Inclusion and exclusion criteria 16
— Inclusion criteria 16
— Exclusion criteria 16
Methodology for selection of studies 17
Relevansgranskning 17
Quality review 17
Method for aggregate of results 18
The scientific base strength 18
4 Results 19
Flowchart of literature review 20
Evidensgraderade results 20
5 Discussion 25
Methodological issues 26
— Definition of the shaken baby syndrome 27
— Group Division of studies 27
— Circular reasoning in clinic and research 27
— Diagnostic methods 28
Comparisons with the results from other surveys 29
6 Consideration for research 31
What is needed in order to fill the gaps? 32
— International coordination 32
— Important areas of research 32
7 Project team, external reviewers, advice and Board 35
Project group 35
— Special 35
— SBU 36
External auditor 36
Bindings and conflict of interest 37
SBU's scientific advice – the Brage 37
SBU's scientific advice — Eira 37
SBU: s Board 38
8 External collaboration 39
Usually collaboration 39
Network authorities 39
The State's medical‐ethical advice (Smer) 39
9 41 glossary
10 Reference 43
Annex 1 Other possible causes for the subcomponents 51
Annex 2 Biomekanikstudier 55
Annex 3 -ethical analysis of shaken baby syndrome (Smer) 57
Annex 4 search strategies/Appendix 4 available at www.sbu.se/255 Search strategies
Annex 5 Granskningsmallar/Appendix 5 available at www.sbu.se/255 Evaluation Protocols
Annex 6 Exclusive studies and studies available at www.sbu.se/255 with low quality/Appendix 6
Excluded studies and studies with
high risk of bias
Summary of
the results
The systematic litteraturöversikten shows the following evidensgraderade results:
• (D) et there is limited scientific evidence for the triad 1 and
thus its some components may be present at the
skakvage.
• (D) et there is insufficient scientific backing for that assess
the diagnosis thematic accuracy of the triad 1 in order
to identify the skakvage.
Limited scientific basis (b) ygger in studies with high or
medium-high quality with greatly debilitating factors at an
overall assessment. Det is important to clarify that even
limited scientific support for a method adds reliability or
effectiveness does not mean absence of vetenskapligt
support.
Osufficient scientific basis exists when studies are
lacking, the available studies are of low quality or where
studies of similar quality shows contradictory results.
(E) vidensvär tion bygger not on a formal evidensgradering
with GRADE but at a total worthevaluation of the
vetenskapliga base.
1
T re components in a whole, usually consisting of subdural
haemorrhage, fundus hemorrhage and hjärnpåvyoucan.
1
Order
When suspected cases of shaken baby syndrome have the combination of
subdural haemorrhage (bleeding under the hard brain membrane),
fundus bleeding and various Forms of encephalopathy (encephalopathy),
with symptoms such as the example with vetandesänkning, convulsions
and hypoxic apnoea, along come to known as the triad. Ucrossthat
evaluation aims to to answer with any certainty the triad or its
subcomponents can be explained by the shaken baby syndrome of children
under 1 year of age.
2
Background
M isshandel of children described in the medical literature as early as the
1800 's [1] but the knowledge began to get larger spread first far later [2,3].
Barnmisshandel can often be hidden in the family and it is a risk for the
elderly is not diagnosed among other things because the child is not able to
bring their own actions. Shile are over-diagnosing all consideration
for,such as society's interventions and actions can lead to that a family can
shatter on improper grounds. Over-diagnosing would be able to be done
about health care feel to the triad always caused by shaken baby syndrome
and overlook other possible causes.
What is shaken baby syndrome? S kakvåld this means that a person shakes a child so that the child's head is
thrown forward and back. Neuro surgeon Guthkelch , the 1971 forward a
hypothesis about that miss trading can give rise to subdural haemorrhage
but that it fi any visible external head injuries [4]. In the article described
two cases in which parents are admitted to
those of different reasons have shaken the child before it went down. One of
the children had , moreover, fundus bleeding. The relationship between
the skakvage, subdural and fundus bleeding was described by Caffey 1972
and was called then the Whiplash shaken infant syndrome [2]. Skadorna
was considered to occur when the child's head by agitation were exposed
for acceleration,deceleration and rotational forces.
Teorin was questioned in a biomechanical study of Duhaime and Colleagure
1987 [5]. Slutsatsen in this study was that isolated shaking without direct
violence, troligen not provide adequate power for that cause these injuries.
Benämningen on tuntiltonnthet has later changed to Shook baby syndrome
(SBS) and a variety of studies have been published on the relationship
between different clinical and radiographic findings and damage caused by
shaken baby syndrome [6-13].
SBS is a concept that does not exist in the Swedish language and projects the
Group has chosen to use the term shaken baby syndrome for the current type
of våldsinverkan and use der the term triad for the current
symptoms/findings [13]. Pon later years has even the term AHT (Abusive
head trauma) has come to be used in the literature, see Chapter 1 health
care.
Symptoms and findings In the scientific literature , there are various symptoms and findings are
registered as explained by shaken baby syndrome. (F)for the most
prevalent (subdural haemorrhage, eye the bottom bleeding and
hjärnpåvercan) has the name triad used.
Denna ..rt focuses on triad, see section Terminologi. Förexcept triad noted
sometimes at shaken baby syndrome bruises on the body and fractures on to
sample ribs and tibia (metafysfrakturer) but such damage has not been
included in this IslandOverview.
In health care (D) et is on the basis of clinical symptoms such as cramps, decreased
consciousness or other symptoms of brain the influence that the child
received into care. Clinical and radiological examination can initially detect
finds which subdural or other Forms of hjärnpåvercan. Subduralblödning,
fundus bleeding and various Forms of brain influence can get severe
consequences with permanent damage to the brain and/or eyes. Syrebrist
can give so serious brain damage to the child 's death. Permanent damage
may consist of serious cognitive(a) and/or motor disabilities with
comprehensive invyoucan on the child's health, utvelopment and future
qualityTy.
V years staff are encouraged to be aware of the symptoms/findings that are
included in the triad and is obliged to immediately notify the social services
If they are in their operations,such knowledge may about or suspect that a
child 's father badly under 14 Cape. 1 § Social Service Act. In an often -quoted
article by American Academy of Pediatrics, fn 1993 prompted doctors to be
careful with that attention to trauma with brain impact </b1106 > in babies
and be well familiar with the clinical and radiology studies strategic bargain
that can confirm the damage caused by shaken baby syndrome [14]. In the
regional treatment program "For suspicion of physical mistreatment by
diluting the child",
in the Stockholm county administrative County Councils from 2011 stand
[15]:
"The combination of the subdural bleeding and brain damage with
oedema or bleeding speaks very starkt for that baby has been beaten on a
history of trafi leak or fall from high altitude is missing. Seen in
addition, bleeding in the eye the bottoms is a diagnosis of abuse from
the medical point of view absolutely clear".
Aev a other regional vårdprprogrammes and Socialstyrman writing about
children as father ill or at risk to endangered bad provides guidance
regarding the care of infants at miss meant abuse [16.17].
U uring recent years have , however, the security with which it is possible to
determine If the findings in the triad are really caused by isolated shaken
baby syndrome been questioned [18-26]. Msteam articles that debated the
topic shaken baby syndrome and finds/symptoms of the triad has been
published in international and national journals and media. Against this
backdrop comes across it as urgent to the determination of shaken baby
syndrome as the cause of the symptoms/findings are based on the best
possible vetenskapliga basis. (E) v in the n s grading is based , however, on
assessment of groups, not individuals. (F)in order to
the judiciary or social services should be able to speak out about the
connection between expo exposure and disease/injury required assessments
of individual cases where, Althoughthe other observations and conditions
weighed in.
Terminology (D) a English term for the triad 's 'shook baby syndrome (SBS), which aims
at the symptoms/findings that may arise after the isolated shaken baby
syndrome it would say shaking but to stay supported against any object.
American Academy of Pediatrics advocated year 2009 a broader term,
Abusive head trauma (AHT) which includes also direct violence against the
head [27]. In the literature used ytterlingare a number of denominations that
fully or partially overlap with terms Shook baby syndrome and Abusive
head trauma, see Chapter 9 Ordförklaringar.
(B) (e) t (e) (c) k n in n gar n (a) used in different ways in the scientific
literature which has contributed to methodological inaccuracies in studies
of the eff by suspected shaken baby syndrome. ProjektgrGroup has
chosen to separate pruncheck the item to isolated shaken baby syndrome
and therefore only include studies with isolated shaken baby syndrome it
would say damage without signs of direct violence against (external
damage ) header. Ffor abbreviations and Glossary see Chapter 9 glossary.
Investigation of the damage that can be caused by shaken baby syndrome For to diagnose suspected brain injuries used datortomografiundersök
ning (DT) and/or MRI (magnetic resonance imaging, MRI). Fundus
bleeding determined by fundoscopy by ophthalmoscopy or fundus
camera.
Other possible causes to the triad and its subcomponents V id symptoms/findings of the triad must to examine whether these can have
other causes than skakvage.
Symtom/bargains such as subdural haemorrhage, fundus hemorrhage and
hjärnpå effect has been described after childbirth and at a number of
different medical conditions such as various seizure condition, some
bleeding disorders, infectious diseases, metabolic diseases, immunological
diseases, bone diseases and vascular malformations, see Bannex 1.
Triad – symptoms and findings Subdural haemorrhage
It is well known that violence against your head can give rise to subdural
haemorrhage. Mekanismen of an adult is to rupture of one or more
bryggvener cause bleeding in the space under the hard brain membrane.
Ofta is in these cases also external signs of violence against the head in the
form of soft tissue bleeding but in other cases , DTsurvey show at there
damage without signs on yttre vage.
V id shaking of an infant come brain moves in step with skull rforelser, but
blödningsmekanismen is disputed and has foreslagits be able to originate
from kapillära damage [28.29]. EINCE No direct violence against the head
occurs at the isolated shaken baby syndrome seen No external signs of
violence against the head such as swelling, soft tissue bleeding, krosskada
or skallbensfraktur. Mjukdelsblöd tions and skull fractures are therefor
symptoms/findings that are not classified as isolated skakvage.
Radiological practices have shown that the subdural haemorrhage in
conjunction with vagi nal delivery can occur, but usually resorbed a such
bleeding within a few weeks [22]. In the space that is created by the
bleeding can it by eff (effusion of fluid) developed a so called hygrom
which contains cerebrospinal fluid. Det has been discussed about a renewed
bleeding in this space would be triggered spontaneously or by a slight shock
to the head [30-33]. Möjligheten to a broader subaraknoidalrum would be
able to increase the risk of subdural haemorrhage has also been discussed
[19.34-36].
Fundus bleeding
Island gonbottenblödning at shaken baby syndrome have been declared
prayo on the tensile forces in the eye's vitreous Islandverförts to the retina
with increased pressure in the venous blood vessels in the retina that
resulted in blood vessel rupture [37-39]. Det has also been expressed that the
repetitive forces at shaking with acceleration and deceleration creates
draws between the vitreous and the retina , as well as a direct damage in the
eyeball. Fundus bleeding has noted,time has been shown to occur even in
the subdural haemorrhage as
assessed have been caused by the disease and it is therefore possible that
the fundus bleeding also would be able to emerge as a result of
subduralblödningen. An explanation would be able to be that an increase in
pressure inside the skull caused by brain swelling leads to increased pressure
in the central eye vein with blodstas in the retina [40.41]. Sambandet between
subdural and fundus bleeding is evidenced by studies that show that
isolated the fundus bleeding is very rare [38.41]. Ögonbottenblödningar has
also shown itself able to occur after normal vaginal childbirth [42].
Brain effects
Brain effects (encephalopathy) may Show itself in the form of inter alia
consciousness , convulsions and andningspåvercan. (D)these
symptoms/findings can asko on the wear damage in the brain or cervical
spinal cord and/or Brain swelling. Brain swelling and damage of brain
tissue caused by sewebrist can also give hjärnpåvyoucan, and permanent
damage to the brain. Even increased intracranial tryck, for example the result
of Brain swelling or subdural haemorrhage, can lead to convulsions,
respiratory effects and consciousness lowering </b1107 > [43.44]. Brain
swelling can be demonstrated with both computed tomography (CT) and
MRI (MRT) and be seen then as the flattening of the brain's grooves and
tillklämning of brain vätskerum. (D) these permits may be temporary and go
back without to cause permanent damage to the brain. (D)a serious condition
can by examination with CT and MRI are seen as impaired diff entiering
between the brain's white and grey matter which representerar a global
irreversibel, ischemic damage.
Diagnostic methods Intracranial study
M INCE DT exploits differences in has also been suspected of x-rays of
substances and tissues with different density, making use of MRI in a
number of different qualities of substances and tissues and provides
thereby a more abundant and often more specifi characterization of the
tissue that is examined.
(B) box technologies offers the opportunity to thin cut through the entire
brain with reconstructions of several planes, and also assessment of the
vessels in the brain through the use of contrast in the vessels. Both
technologies provide similar information about changes in liquid rooms in
and around the brain, such as compression of the brain's fluid-carrying
hålrum at the Brain swelling, widening of the brain's fluid-carrying cavities
at the hydrocefalus, and offset by bleeding and threatening inklämning.
MRT can provide different information than DT, for example if the presence
of both fresh bleeding that deposition of the breakdown products of blood
(hemosiderin) and early ischemic and axonala damage in brain tissue
[45.46].
M INCE an acute subdural haemorrhage of a small child consists of fresh
blood, consists a subacute subdural usually by a mixture of an island in
theupper liquid layer
and a sediment of coagulated blood [47]. (B)lödningens development over
time leads tol differenta DT och MRTavbildningsmönster. Tidsgränsen for
patterns onras up to yo and duration may overlap which makes an age
assessment not sure [48]. Förkalkningar can in rare cases be confused with
fresh blood, particularly within the brain tissue. A bleeding on the DT has a
more robust design than the image pattern you see with different
MRIsequences,< b1137 > what varies and partial Islandoverlap in
appearance depending on the composition and chronology of events in relati
spirit to the injury. (D)isto be considered age assessment of a subdural
haemorrhage with DT to be more reliable than that which can be done with
MRI [49.50]. Att to åldersbedöma a subdural haemorrhage can be
important for that time able to korrelera to the alleged date of injury
occurrence.
(B) both CT and MRI can be used for to assess Brain swelling. Brain swelling
can be seen as flattening of grooves on the brain's surface area and
compression of the brain's Chamber room and öother fluid-filled rooms. DT
is a safer method than MRI in evaluation of fractureis.
Fundoscopy
Two methods can be used for fundoscopy. The most common is the fundus
mirroring with or without dilated pupil. Pon later time have a Photo
graphic method for that image eye bottom developed (Retcam). (D)his
method provides the opportunity to review the findings of other analysts
without knowledge about the background story and question [51,52].
V id autopsy can all the eye to be examined. Even other eye injuries than
those who are in the eyes of the bottom can then be described [53, 54].
Island gonbottenblödning can normally not be assessed with the help of DT
or MR.T. Ma in a recently published MRIstudy have been compared a specific
image ningssekvens by ophthalmoscopy and could then show that the
fundus bleeding could be seen by MRTsurvey of 83 prand percent of cases
[55.56].
In this context, it is important to understand that the assessment of surveys
with DT, MRT and ögonbottenundersökningar part is subjective and that
the individual assessoreven experiencesdevice can affect the final
evaluation/ outcome.
3
Method for the systematic
evaluation
Question according to PIRO U tvärderingen aims to to answer the following: Med what security can we
say that the subdural haemorrhage, fundus hemorrhage and
hjärnpåvyoucan orderis managed by isolated shaken baby syndrome
(without the outer layere signs of violence)?
P (Population): (B) arn ≤ 12 months
In (inndextest): Tthe Riad at suspected skakvset I
R (Referenstest, gold standard(d)): (E) rkänt or witnessed documented
shaken baby syndrome or other trauma
O (Utfallsmått): (D) iagnostisk reliability
P rojektet has been carried out according to the method that is to be found in SBU's
Handbook [57].
Inclusion and exclusion criteria Inclusion criteria
Study design
S tudietyper such as case-controloll, cohort, and registry studies as well as
studies with SWquality analysis method.
Observations
(E) nly studies with 10 or more cases have been included in order to reduce
the risk of random errors in the selection. For possible alternative(a)
explanations of the symptoms/ findings have the project team assessed that
it sufficed with a published case for that question the hypothesis that the
triad always has been caused by </b157 > shaken baby syndrome. Articles
on alternative explanations have not been controlled and is therefor not to
because of the results. If a subgroup of children who were victims of
shaken baby syndrome and/ or a subgroup with age ≤ 12 months (median
and/or medelvärde) concluded in AHTstudy </b1126 > r has the project
team included these. Genomsnittsåldern for children who were victims of
shaken baby syndrome has been set to be 2-3 months [58] and project group
has therefore defined the project to the studies of children with average age
or median age ≤ 12 months.
Language
Articles in English, German, French and the normalwash-up languages have
been included.
Miscellaneous
P rojektgruppen have agreed on the only cases of shaken baby syndrome as is
witnessed or in which any admitted to have shaken the child taken with in
the evaluation.
Exclusion criteria
P rojektgrgroup has excluded studies with Colre than 10 cases and
AHforstudies of added outer layer(e) injury to the head and/or with
fractures and other injuries.
(B) iomekaniska studies and studies that deal with other possible causes
to the triad that has been identified in the literature search has been
handled separately and presented in (B)annex 1 and 2.
Methodology for selection of studies M ed starting point in projektets issues was carried out systematic
searches of bibliographic databases in close cooperation between SBU's
information tionsspecialist and the experts in the project group.
Litteraluckysincreasegiven perform des in databases PubMed, Embase and
Cochrane Library to and with the 15 October 2015. Additional studies have
been sought through the scientific articles ' rafterenslistor and in
systematic Islandversikter. For a detailed description of the search terms
and restrictions that the userused, see Bannex 4 at www. sbu.se/255.
Relevansgranskning (D) (e) abstract lists that genesboth by the literature search were reviewed by two
thing savvy independent of v.arandra. Studies that assessed rpupiladopt for
your project's issues of at least one of the experts was read in full text. Full-text
articles were reviewed by two experts independent of each other with respect to
the inclusion criteria. Studies that at the review in full text does not meet the
inclusion criteria were excluded with an indication of the main reasons for
exclusion,
see Bannex 6 on www.sbu.se/255. Vid disagreement was resolved the
question in the first place by en this floodon between the two experts who
read the article. In some cases, involve the entire des project group in the
discussion and decision on inclusion or exclusion was taken in consensus.
Quality review P å because of the special research field has projektgrGroup modifi
SBU: s template for that kvalitetsgranska studies in pruncheck the item and
assess the risk of systematic errors (cirkelresonemang, section
Cirkelresonemang in clinic and Research </b143 > ning). Mallen includes
among other things the type of study (prospective study, the diagnostic
study, biomekanikstudie , etc.), the study's main focus , and If the study treats
subduralblödning, fundus bleeding and/or hjärnpåvyoucan. Review mallen
are reported in detail in Bannex 5 on www.sbu.se/255. Enly studies of
medium-high or high quality has been taken into account in the results and
discussion in accordance with SBImplement method [11].
S ystematiska Islandversikter on the area has been controlled with AMSTAR
[57]. Rresults in this report have been based on the primary studies and not
on other systematic Islandversikter, see Chapter 5 Discussion.
Method of weighting of results Meta-analysis is a statistical way to quantitatively sum up the results from
several studies and thereby get a larger data sets and a safer rate ning of the
statistical uncertainty. In order to sum up the results required that studies
have been done with similar method and that analyses have been adjusted
for similar lightundsfaktoryou. Because only one of the two in-depth studies
have a reference group has No meta-analysis could be performed.
The scientific base strength The strength of the scientific dossier (evidensstyr) can specify how adds
litling the estimate of the results are. The vetenskapliga surface is analyzed
with respect to the risk of systematic errors. These include study quality,
överonformity between studies, the uncertainty in the sammanvowned the
results, the risk of publikationsbias and the risk for non- Islandverförbarhet
to the clinical situation.
N any meta-analysis has not been possible to do but the results are based on a
merger of the included studies. Evidensvärtion bygger not on a formal
evidensgradering with GRADE but on a total valuation of the scientific
dossier. (B)egränsat scientific basis (b)ygger on studies with high or
medium-high quality with greatly debilitating factors at an overall
assessment. Insufficient vetenskapligt a basis fortrue when studies are
lacking, available studies have low kvconfidentiality or where studies of
similar kv, that heterosexuality is showing contradictory results. Det is
important to clarify that even limited scientific scientific support for a
method's reliability or an effect does not imply the absence of vetenskapligt
support.
4
Results
S the increase in gave 3 773 abstract of which 1 065 was commissioned in full
text. Av these exklud Ed 1 035 since they do not meet the inclusion criteria.
Efter quality review remained 30 articles of which two of medium quality but
no study of high quality. The main reason for that so few studies met the
quality requirements were
that there was a lack of documentation on the cases was recognized or
witnessed cases of skakold. The results are based , therefore, on the only two
studies with yourname skakvage. Any balance of the results of a metaanalysis has therefore not been possible. Projektgruppen have had a
discussion on coherence in the included studies.
Flow chart of literature review Figur e 4.1 Flowchart of
literature.
Evidensgraderade results The systematic litteraturöversikten shows the following
evidensgraderade results:
• The fi insufficient scientific basis for to assess the diagnosis tito
the accuracy of the triad for to identify the skakvage.
• (D) et there is limited scientific evidence for the triad , and hence
its subcomponents can be present at the skakvage.
(D) (e) two included studies of moderate quality studies are with
recognized cases, both from France. The study of VIncheon and
Associates is a prospective study. The study is based on a
registry of traumatic head injuries to children under two years of
age who received the hospital between January 2001 and February
2009 in a catchment area of approximately 4 million inhabitants
[59]. Materialet comprises 412 cases, of which 124 were classified as
added head injury (innflicted head injury, IHI) and 288 as accident
damage (Accidental trauma, AT).
In the group with added damage (IHI group) were 45 cases with
recognition, of which 30 cases in which shaken baby syndrome
been recognized and 15 cases where others external violence
recognised.
In the article missing , however, detailed descriptions of how the suspect
has gone about as well as how the recognition emerged. (D)his Group
children compared with 39 cases of witnessed the accident damage that
owned rooms in public environment (AT group).
In the Group of inflicted injuries had 37 of 45 children (82 percent)
subdural haemorrhage comparet with 17 out of 39 children (44 per cent) in
the Group accident injuries. Trettiosju of 44 children (84 percent) in the
Group of inflicted injuries had fundus bleeding, comparet with 6 of 35
children (17 %) in Group accident fallsskador. In the Group to suffer head
injury found to be 12 of 45 children (27 prcent) had brain ischemia comparet
with 1 of 39 children (3 pr%) in Group with accident damage.
Study of Adamsbaum and employeee is a retrospective observational
study that includes 29 recognized cases of shaken baby syndrome (where
direct violence against the head as de vits in 5 cases) as compared with 83
cases without recognition [60]. Innklusionskrite Ries in the study are
subdural as shown with DT and a recognition from the suspect. Then one of
the inclusion criteria in shaken baby syndromesgruppen is considered
subdural haemorrhage, only the results of fundus bleeding in this study.
In the Group with recognized cases (Group A) had 24 cases (83 %) eyes the
bottom bleeding. In cases where someone recognized described the
shaking as violent (100 per cent) and in some cases have repeated shaking
recognised (55 per cent). Intime correlation could be seen between the
density of subdural and number of tryingepade shaking of the child. In this
article , see detailed descriptions of how the suspect passed about in 14 of
29 cases. In the other Group (Group B) Code of your cases with children
who had been shaken in order to revive the child, olycksfallsskador and
children where no explanation regarding the permit specified and This
group can therefore not be considered to be an acceptable reference.
(B) both Vinchon and employees as well as Adamsbaum and coworkers
reported that shaken baby syndrome can lead to subdural and fundus
bleeding. In the study of Vinchon and employees exhibiting group with
recognized shaken baby syndrome a larger proportion of subdural
haemorrhage, fundus hemorrhage and brain ischemia that may give rise
to brain impact, than the group who injured at <b161 > a witnessed the
accident. Adamsbaum and employees compare children who were victims of
recognized shaken baby syndrome with group children where the suspect
not recognized which may lead to inklusionsbias in one or both of the
compareda groups. (E)since only one of the two studies have a referensgrup
has no meta-analysis could be performed.
The fi also other published cases that have been excluded (the wrong
population, the wrong study design), but where there are detailed
descriptions of the admission that speaks in the same direction as the two
studies of medium-high quality [61,62].
Because the fi so few studies with medium/high quality has it not been
possible to assess the diagnostic accuracy of the triad in order to identify
shaken baby syndrome.
Table 4.1 Characteristics of included studies.
5
Discussion
Literature search identified only two studies of medium kvto corporal
punishment, Although that relatively many met the inclusion criteria. (D)
thenumber one is anmärkningsvärt with a view on the shaken baby
syndrome is very seriously and get dramatic consequences for both the
child and the family. Forskningsområdet is complicated, but it defends don't
such as circular reasoning and a lack of recognition of data collection. Det is
important to Islandversikter on the area presents the methodological
deficiencies that research field characterized by.
Sstudies of Adamsbaum and employees as well as VIncheon and
colleagues assessed the achievement of medium kvto corporal punishment.
Alsoa If both studies have methodological limitations speaks the for to
isolated shaken baby syndrome can give rise to the triad.
(D) a prospective study of Vinchon and Associates includes more than 400
cases in which 124 rating that added head trauma and 288 as accident
damage. Fyrtiofem was recognized cases of added , damage of which 30
cases were recognized in isolation shaken baby syndrome (IHI group).
Trettionio case was witnessed accidents (Asuch group). The advantages
with this study is that all the trauma cases as submitted to the hospital
recorded exploration effective during many years. Sstudy endpoint is also a
clear reference together with injuries after witnessing an accident. (D)his
Group of children is , however, significantly older. Tto the study's
limitations are related to the lack of detailed Description of how the
tremors passed to and when they occurred. VIncheon and colleagues
analyze the part components was for himself, but the authors introducerar
also a different Combi nation of the triad , which consists by subdural
haemorrhage, fundus bleeding and absence of visible damage on the head.
Data on hjärnpåvyoucan see , however, registered in the study in the form
of , inter alia, cramps, reduction of consciousness and coma. Group of
isolated shaken baby syndrome will per definition to include only those
cases that do not have external signs of violence while the group of accidental
injury will to include cases that have signs of external violence.
Projektgruppen has in
a early stage contacted doctor Vinchon for to undanran opportunitya vinssa
oclearhets but inte received answers on all questions. Frågorna force among
other things how the fundus bleeding defined, how the authors have
calculated the sensitivity, specificity and predictive(a) worthit for the triad,
wasfor the valt a deviant triad (wear byaro of visible damage instead of
brain effects) , as well as how the admission gone to and what that isfelt.
Study of Adamsbaum and employeee is a retrospektiv observationsstudie
which includes 29 recognized cases of shaken baby syndrome. In the study
reported detailed admission in 14 cases. It can however not be excluded
that the among the cases without detailed admission may have tocome
shake after that that child had symptoms at hjärnpåvercan. Studiegruppen
is compared with a reference group consisting of 83 cases without
recognition but this is not a "pure" reference group because it can access case
by shaken baby syndrome even among those as not recognized.
A criterion for all the cases in the study is the subdural haemorrhage, which
means that only the results of fundus bleeding can be taken into account.
At review of the literature has the project team identified the other
conditions or events that can give rise to the three symptoms/findings in
the triad.
A some of these conditions or events does not lead to permanent damage or
are very rare, but shows that triad or subcomponents in the can be caused by
other things than shaking. Da is , therefore, important to Islandverväga the
ability of these differential diagnoses in the investigation of suspected
skakvage. Decisions that are taken
of social service or Court is based alsoan on other bases/other evidence
than the medical assessment. In the further processing of cases way other
possible causes to the triad or its subcomponents .
An analysis of studies in biomechanics, see (B)annex 2, showing conflicting
results and No conclusions can be drawn about where the border runs for
the forces that generate these damages on child.
Methodological problems By the time of the vetenskapliga basis for the diagnosis of shaken baby
syndrome in children under 1 year of age (mean age or median age ≤ 12
months) have shown that the published studies have methodological
problems.
Definition of shaken baby syndrome
P rojektet has been limited to studies in which shaken baby syndrome been
deemed to be the primary cause for the resulting damage, but others
studies have had a further
defi tion, for example suffer head trauma. It is then not always been
possible att distinguish if an injury caused by shaken baby syndrome or by
direct violence against the head.
Group Division of studies
A other methodological problems have been that shaken baby syndrome not
always been witnessed or been recognized of the suspect which leads to a
proper rating of the cases in shaken baby syndromes r and referensgrup
becomes uncertain, and thus run the risk of leading to an incorrect
evaluation of the relationship between the triad and shaken baby syndrome.
At the same time as it is a risk for false attribution constitute this the only
possibility to get insight into what that happened to the infant unless it does
not see video documentation.
P å because of the risk of false confessions have any recognition in these
studies are treated with caution.
P rojektgruppens choice to accept only recognized cases, is thus tainted with
methodological p.r.operation issues. Erkännandet would be able to be false
on the basis of that it emerged through a hearing. Det would be able to be
false even on the basis of that the suspect felt himself forced to admit [63-65].
Circular reasoning in clinic and research
In the social service act is apparent to all who get knowledge about or
suspect that a child father ill should report it to social welfare. Registration
required is the staff in the health and medical careit, tandvårit, pre-school,
school, socialservice and the probation service who is obliged to
immediately notify the social services If they are in their activities ,
knowledge about or suspect that a child 's father badly (the social service
act 14 . 1 c §).
In many cases, are investigating a child protection team case of suspected
shaken baby syndrome, and during the years races have these teams
developed criteria for when certain symptoms and findings may be linked to
isolated shaken baby syndrome, after it to other </b138 > possible causes of
symptoms and findings have been omitted [66.67%]. SOME of these criteria
are linked to the care nadshavarens believeheatis required. Vårdnadshavara
deemed not reliable if he is not able to give a satisfactory explanation of
how symptoms and findings , to the example of the child fallen </b1105 >
from low altitude and not a exterior damage. Changed the data – for
example, that the custodian first indicated that he/she has not shaken the
baby but then says that as actually </b1153 > occurred, but only after it to
the child stopped to breathe or become unconscious – means also to
guardian's credibility diminishes. </b1190 > If shaking occurred as a
consequence of that child suddenly a symptom (for example stopped
breathing) would it however be reasonable to assume that the root cause of
the child's condition arose< b1224 > already before the child was shaken,
and consequently that the shaking is not been the cause of the symptoms.
Ma if such a Declaration is not deemed as acceptable is the case still
classified as shaken baby syndrome.
(B) arnsky ddsteamens criteria is primarily based on current clinical
approaches [66.67%]. Problem occurs later if/when the criteria are not prevas
prerequisite solved by researchere at systematic studies of the relationship
between triadsymtomen and shaken baby syndrome. This means that the
teams ' interpretations come to characterize the vetenskapliga survey and
hypothesis, which in its turn leads to that the existing approach is
strengthened instead of to the przvas. Ma if you already before the study
proceeded from there you want to study, it would say how the link between
the findings and symptoms and shaken baby syndrome look out (according
to< A1115 > team's criteria), ends up being in a circular argument. Tillämpat
on this way leads the reasoning to high risk för systematic error (bias) which
in its turn leads < b1167 > to that man does not know what the man jämför
(shaken baby syndromesgruppen may include children who have not been
shaken , and the reference group could include those that have shaken). Att
based on such compareelser calculate sensitivity, specifications, as well as
predictive worthit, leads to incorrect conclusions. It leads also to that
incidensberäkningar becomes invalid.
(F) ör to avoid this circular reasoning in the studies must study cases and
reference are identified on an opposition-free way. Projektgruppen has
chosen to as study cases accept only cases where someone witnessed (or
through video surveillance documented) an event with shaking or where
any of the detail recognized themselves have shaken baby.
Diagnostic methods
(B) stimate by the time of the emergence of a subdural haemorrhage is unsafe.
(D)his insecurity is also greater among children under one year of age, on the
basis of the subdural haemorrhage of a child is something different to their
character than in an adult. A subdural haemorrhage of a small child consists
usually of a övre vätskeskikt and a sediment of coagulated blood, which if
subduralblödningen is subacute can exhibit different also been suspected
</b184 >[47]. OSecurity is through development, ling av me DT och
MRTmethods(a) reducingt anysuch comparirt med earlyre [46], but it must be
continued careful at age assessment when it is different bleeding patterns
that partly Islandoverlap [48].
In both controlollerade experiments as observational studies , systematic
errors occur when different observatöryou don't always make the same
observations and/or make different interpretations of observations.
Oyouknow between different under the viewfinder in a study may vary
depending by how trained observers are. (D) thenumber one applies
generally in observations and assessments, and of course alsoa at
examinations and assessments of symptoms/findings after suspected
skakvage.
In one study showed it out for example that variation was high between
investigated th e interpretation of fundus bleeding it would say it was lowcoherence between different assessors [51].
Comparisons with results from other views Projektgrrevelations have identifi seven systematic literatureIslandversikter
that contains the same or partly the same question as this report [68-74]. Dessa
systematic Islandversikter is included not in the profit and loss part but the
project team has therereceived reviewed and assessed these as they are often
mentioned in the scientific literature. All systematic Islandversikter has the
project team assessed as having low quality (high risk of bias) , among
other things, for that many of them are based </b199 > itself on studies
where a team has assessed that a child shaken if the child has triad (cirkel
reasoning, section Cirkel reasoning in clinic and research). A different
problem in the systematic Islandversikterna is that shaken baby syndrome is
not specified, and that it used the more Island-wide term AHT but that in
detail describe what that are included in the groups that compares.
6
Consideration
for research
(E) INCE this of course is impossible for scientists to expose children to shaken
baby syndrome, used in biomechanical studies dolls/models fitted with
inbyggda measuring instrument for that examine how the mechanical forces
seem on children. Rresults are not conclusive and results from animal models
are of different reasons difficult to Islandverföra to the children.
Projektgrthe revelations was therefore referred to the observational
studies where exposure (in this case shaking) adopted be given. Most
reliable are prospective cohort studies and ideally livingthe the that
included in a shaken baby syndromeskohort consist of such cases in
which someone isknown shaken baby syndrome and where these
arefeeling redoshown in detail and where it is shown in what
circumstances the recognition has emerged.
In many of the reviewed studies are children who belong to the reference
group signifikant older than children in shaken baby syndromesgruppen.
The brain, bones and neck muscles look differently out of a 2 -month -old
children compared with a child at 8 months. Children who are 0-2 months
old can be assumed to be more sensitive to shaken baby syndrome than
an older child. If we compare the two groups of children (shaken baby
syndromesfall and children with olycksfallsskada) who not is age-matched
can it lead to selektionsbias and incorrect conclusions. Studies with
matched age groups would mean the ability to calculate the sensitivity and
specificity and predictive values. (D)on the other hand, would be able to
Express themselves more secure if the probability to triad caused by
skakvage.
The lack of knowledge about the pathophysiology at utvecklingen of
subdural and fundus bleeding in conjunction with vaginal childbirth. Adven
If majo the majority of förlossningsbetingade hemorrhage did not give
symptoms and disappears
(resorbed) within a few months , occasional bleeding may be converted to
a hygrIf [19, 30.36]. Dessa separated water retention is surrounded by a
mem brane in which it formed the small vessels, which in its turn is
considered to lead to a new bleeding (reblödning) and a chronic subdural
blood accumulation. Det can not be ruled out that a reblödning in some
cases can give symptoms [19.36]. (D) thenumber one might be able to be a
reason to be a child suddenly affected by brain effects (becomes
consciousness sänkt, stop breathing and/ellyou have cramps) and that
custody seas on the basis of this looking for care. Hypotetiskt seen would
one such reblödning could be triggered spontaneously or at a less trauma. It
is therefore urgent that it conducted research concerning the
pathophysiology and natural history of subdural and fundus bleeding.
Even the development of higher performancee models within biomeka
technique, to the example models that take into account the impact on both
the brain and cervical spine would be able to contribute to increased
knowledge about shaken baby syndrome.
What is needed in order to fill the gaps? The reasons for the gaps in this area are of different nature and need therefore
be managed on different ways; from a coordination within the entire research
field on what that should be researched , to that do the studies on a
methodologically correct manner, as well as to fully describe how studies
have been carried out.
International coordination
(F) ör to improve Diagnostics in the area needed a broad coordination at
international level in order to get enough big study groups. (F)orskare in the
field would be able to agree on what that is most important to do research on
and interact in order to allow for more comprehensive studies , as well as
more similar study design so that the results can be compared. An
international register över recognized and väldoku documented cases
would be established.
Urgent research areas
S Pecific important are studies that aim to improve the the diagnostic reliable
ity by diagnostic imaging of the brain, cervical spine and eye [75]. Det
needed also retreate methods for the study of the identified the natural
history. Alsoa differential diagnoses such as förlossningsrelaterade bleeding
in children need to be studied in order to identify the natural course [22, 36,
76,77]. Studies also are needed for to increase the understanding of the
pathophysiology behind triad. Even better I lovee models of Biomechanics
might be able to increase the understanding of the skakvage.
In as far as possible, subject to , of course, all the established quality
criteria to be met. Viktigt is also to researchers is blinded for the suspects up
komstmekanismen, and that the results be presented so that they allow
calculation of diagnostic reliability. (D)a later means therefore that each
individual finds must be assessed in both the study group and
referensgrup.
A of the reasons for that, it is difficultfor to obtain evidence on the field is that
many studies are flawed description of methodology and results. Below
describes some viewpoints and aspects that should be taken into account
in order to study the quality should be assessed and for the meta-analyses
should be carried out on a Add precaution :
S the studies should:
• consist of a prospective observational studies with yourfamous and well
document related cases with reliable methodology and where the risk of
false confessions have been minimized
• be age-matched (study group and referensgrup)
• contain detailed accounts of how the learning materials collected,
including including documentation of investigative techniques, and
detailed accounting of the complementary studies which have been
carried out in order to exclude the differential diagnoses
• ready view to analysts of symptoms/findings varit blinded (IE. v arit
ovetande) If fyndens reason and how this blinding has been implemented
• ready view raw data, sensitivity/specificity , and confidence intervals
• use sufficiently large materials which are examined with uniform methodology
• present detailed readyviews of yourfeeling and what that isfelt and how
the recognition went to.
7
Project team,
external
reviewers, advice
and Board
Project group Experts
Göran ElindEr
pr ofessor in Paediatrics at Karolinska innstitutet, former senior consultant in child and
adolescent medicine, Sachsska barnsjuk House, Södersjukhuset, Stockholm
andErs Siksson
professor in forensic medicine at the Umeå University, Islandverläkare in forensic
medicine at the forensic medicine alvisket
BouBou HallBErG
with Dr., everläkare in Pediatrics and Neonatology, Karolinska innstitutet and
Karolinska hospital, Stockholm
niEls lynøE
professor in medical ethics and medical specialists in general medicine, Karolinska
Institute, Stockholm
PIA Maly soundGrEn
pr ofessor in radiology, Islandverläkare Radiology and Neuroradiology,
Lund University Hospital, Lund
Måns rosén
former adjunct professor of medical methodevaluationevaluation,
Karolinska Institutet, Stockholm
Bearsn-Erik Erlandsson (B)annex 2 Biomekanikstudier (external
ECTkande) professor in medical technology,
school of technology and health, KBasic T's technical high school, Stockholm
SBU
Frida MowaFIn
Project Manager
MariannE HEiBErt arnlind
Project Manager until september 2015
Irene EdEBErt
Deputy Project Manager(e)
Hanna oloFsson
information specialist
(a)nd (a) GranatH
project administrator
lau r a lintaMo
investigators
(a)nna BjörklövenF
Communications Manager
External examiners SBU hires external Auditors of their reports. Dessa has come with valuable
comments, which in high grade contributed to to improve the report.
In the final version of the report is it possible that the SBU could not
accommodate all the change or amendment from the external examiners,
among other things, for that they have not always been consistent. De
external examiners are therefore not necessarily being the emergency
behind all parts of report.
(E) xternal reviewers who have chosen to be named:
stEvEn lucas *
with Dr., everläkare in children and young childhood medicine, Academic
hospital,
U ppsala
Tiit MatHiEsEn
a visiting professor, everläkare, Neurokirurgiska clinic, Karolinska hospital,
Stockholm
titti M
pr ofessor , (J)legal faculty, Lund University
nils-Eric saHlin
pr ofessor , Medical faculty,
Lund University
arnE stray-PEdErsEn * position, Institutt for klinisk medisin , Universitetet in Oslo
innGEMs tHiBlin*
pr ofessor , Department of surgical vetenskaper, Uppsala University
*
S (e) opinion on www.sbu.se/255
Bindings and conflict of interest S akkunniga and the Reviewer has in accordance with SBU: s requirements
submitted declaration concerning bonds and conflict of interest. (D)these
documents are available on the SBU's Cabinet. SBU has assessed that the
conditions that are reported there are compatible with the requirements of
objectivity and impartiality.
SBU's scientific advice – the Brage SBU: s vetenskapliga Council has reviewed the vetenskapliga basis in the report.
lars H
President, professor, vårdvetenskap, Lund University
cHristEl BtsEvani
registered nurse, with dr, vårdvetenskap, Malmö högskola
PE r carlsson professor, health economics, Linköping University
Bearsn-Erik Erlandsson professor, medical technology, KBasic T's technical high
school, Stockholm
ARnE GErdnEr
pr ofessor , social work, School of Health Sciences in Jönköping
lEnnart isElius
Associate Professor, Hhealth and care inårdsdirektör, County Council of
Västmanland
MussiE MsGHina
Associate Professor, everläkare, Psychiatry, Karolinska University
Hospital,
Stockholm
lars sandMan
pr ofessor , ourdetik, University of Borås
Br itt-MariE stålnackE professor/Island v erläkare, rehabilitation
medicine, Umeå Universitet
enantE twtMan
pr ofessor , tandvind, Halmstad , and Copenhagen University
SBU's scientific advice ‐ Eira SBU: s vetenskapliga Council has reviewed the vetenskapliga basis in the report.
kjEll a.s.
President, professor, Stockholm
HE #NS andErsHEd professor of psychology, Associate Professor of
Criminology, Örebro University
kristina BEnGts BoströM
Associate Professor, Billingen ourdcentral, Beavde
cH ristina ASKrGH professor, women's clinic, Sahlgrsport for the
Italian, Gothenburg
anna EHrEnBErG professor, vårdvetenskap, High School DAlders
theGEMs EnGlitterM
pr ofessor , Psychiatry, ethics,
Örebro University
nils FEltElius
Associate Professor, Läkemedelsverket
y l v (a) n
Associate Professor, physiotherapy,
CAMTÖ, Region Islandrebro County
stEn-kE stEnBErG professor, social research, Stockholm University
ka take ina stEEn carlsson
file dr, health economics, IHE Lund
SBU: s Board SBU: s the Board has reviewed and approved the results.
nina rEHnqvist
President SBU: s Board proffessor, Karolinska Institutet
susanna axElaib
generaldir ektör, SBU
HEiki ErkErs President, graduates SSR
Eva Franzén
Research and developmentecklingschef,
The State's Institutionsstyrelse
on the other hand,said Furén-tHulin
Section Manager,
S Sweden Municipalities and County Councils
jan-inGv s jönsson huvudsekreterare for Scientific Council for
medicine, Vetenskapsrådet
Bjorn klinGE
pr ofessor , Dental faculty, Malmö högskola, and Karolinska innstitutet
lars-torstA larsson
Associate Professor, ofsharing a Manager, Socialstyrelsen
stEFan lindGrA professor, President, SIslands medical society
STIG nyMan
President, Disability Federation
sinEva riBEiro
Chairperson, Vyeardcovenant
(a) GnE take von scHotinG Chairman, National winnersChurch group for
knowledge management in social services (NSK's)
HEidi stEnsMyrEn
President, SSweden Medical Association
andErs sylvan County Director, Västerbottens Läns Landsting
Håkan sörMan
ver kställande Director,
S Sweden Municipalities and County Councils
k arin tEnGvald professor emerita, Linköping University
8
External
collaboration
Usually the interaction P rojektledningen have met the National Association Fo Familjers Rights
(RFFR) in the beginning of the pruncheck the item for to inform and take
in the views.
Network agencies R representatives from Barnombudsmannen, innspektionen for health and
welfare, Kriminalvårit, Socialstyrelsen, Sweden's Municipalities and
County Councils, Polismyndigheten, Rättsmedicinalverket and the
Prosecutor's Office, has been offered the opportunity to hit the SBU for that
get information about
the report's results in conjunction with the report was released.
The State's medical‐ethical advice (Smer) (D) a ethical analysis has been conducted of the Smore.
Glossary
AHT (eng Abusive head trauma)
Head injury added by child abuse
At (eng Accidental trauma)
Accident trauma, accident damage
Has also been suspected of
X‐rays attenueras (absorbed) in the body
various very depending on the tissue density
ASK (eng Brain edema)
Cerebral edema (Brain swelling)
Cerebrospinal fluid
(eng CSF cerebrospinal fluid)
Fluid that surrounds the brain and spinal cord
CT (eng Computed tomography)
Computed tomography (x‐ray)
EDH (eng Epidural
hemorrhage, Epidural
hematoma)
Brain edema
Epiduralblödning, bleeding between the hard meninges and skull bones
Hydrocephalus
Increased amount of cerebrospinal fluid in the brain cavity ("water‐kalle")
Hygrom
The accumulation of fluid, can relate to education after bleeding
IHI (eng Inflicted head injury)
Head injury added by child abuse
IHT (eng Inflicted head trauma)
Head injury added by child abuse
Interdisciplinary
(multidisciplinary)
team
Team with diverse professional backgrounds who are working together in an area or on a question
MRI (Magnetic
resonance
imaging )
MRI
MRI (Magnetic
resonance
tomography)
MRI (see MRI)
nAHI (eng Nonaccidental head injury)
Head injury added by child abuse
Brain swelling
NAHT (eng Non-abusive
head trauma)
Head trauma caused by other than child abuse, usually by accident damage
NAT (eng Non-accidental trauma)
Damage added by child abuse
SAH (eng Subarachnoidal
hemorrhage)
Subarachnoid haemorrhage, haemorrhage between the soft meninges
SBS ( Shaken baby syndrome)
A syndrome consisting of three components, the triad
SDH (eng Subdural hemorrhage,
Subdural hematoma)
Subdural haemorrhage, haemorrhage during the hard meninges
Subaraknoidalrum
The room between the soft meninges
Syndrome
Symptom complex, a group of symptoms that belong together and which occur together in a same and patient more frequently than that can be explained by random chance
Triad
Three components in a whole. At SBS refers to a triad usually consisting of subdural haemorrhage, fundus bleeding and encephalopathy
10
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Annex 1
Other possible causes of
the subcomponents
At clinical diagnosis is made the differential diagnostic
Islandpanacheownerships. In these cases the child is received with
hjärnrelaterade symptoms that needver utredas . In this report has therefore
the differential diagnoses that emerged in our data base search containing
alternative(a) explanations for the various symptoms/findings of triad, was
of itself or to the triad in its entirety </b165 > noted. (D)these articles are in
the rule of the case reports of individual patients without reference test and
has therefore not been included in the quality control. Projektgruppen has
nevertheless considered that there exists a intresse to here readyto show
these sorts of Options(a) explanations to the triad.
Table 1
Other possible causes
(differential diagnosis)
of the triad and its
components.
Diseases or
conditions
causing
hemorrhagic
symptoms
Infections
Vascular mal
formation
The table continues on the next page
Disease/condition
Reported
findings from
the triad
Reference
number
(number of
cases, or
cases/study
population size)
Reported
finding from the
triad
von Willebrand's disease
SDH, RH
[78] (1)
Delta storage pool disease
SDH, PRAY, RH
[79] (1)
Hyperfibrinogenemia
RH (including vitreous hemorrhage)
[80] (1)
Hemophilia A
SDH/RH
[81] (2) RH
[82] (1) SDH
Factor X deficiency
SDH
[83] (2)
Idiopathic thrombocytopenic purpura
ICH
[84] (1)
Kasabach‐Merrit syndrome
thrombocytopenia
RH
[85] (1)
Hepatitis
RH, ASK, SDH
[86] (1)
Albers‐Schönberg disease
SDH
[87] (1)
Vitamin K deficiency
SDH (ICH)/BE/RH
[88] (3) SDH
[89] (17) SDH
[90] (1) SDH
[91] (16) SDH,
[92] (1) SDH, PRAY, RH
[93] (1) SDH, ASK
Menkes disease (Copper deficiency)
SDH
[94] (1)
Unspecified
RH, SDH
[95] (1)
[96] (3)
Infection
RH
[97] (4)
Infection with or without hypoxia
SDH (intradural bleeding)
[21] (10/30)
Aneurysm, Arterio‐
venous malformation
SDH (SAH)/BE/RH
[98] (1) SDH
[99] (1) SDH, ASK
[100] (1) SDH, ASK
[101] (1) SDH, RH
Prenatal and
birth-related
injuries
Disease/condition
Reported
findings from
the triad
Reference number
(number of cases, or
cases/study
population size)
Reported finding
from the triad
Countries
RH
[102] (11)
Delivery injury
SDH (ICH)/RH
[18] (2) SDH
[103] (3) ICH
[96] (3) SDH
[56] (53) RH
[104] (10) RH
Normal delivery (or prenatal)
SDH/RH
[77] (17/97) SDH
[39] (94/252) RH
[76] (32/63) SDH
Prenatal trauma
RH
[105] (2)
Congenital SDH
SDH
[106] (1)
Congenital heart disease
SDH
[22] (66/152)
Table 1
continued
Large head size
Enlarged SAID space/External hydrocephalus/Benign enlargement of the subarachnoid spaces
SDH [31] (6/108)
[32] (4/177)
[107] (7)
[33] (3)
[96] (6)
External hydrocephalus RH, SDH [108] (1)
[109] (6)
Immunological diseases
Hemo‐phagocytic lymphohistiocytosis
SDH, SAH (ICH), PRAY, RH
[113] (1)
Transplacental acquisition of anti‐Ro antibodies
SDH [114] (2)
Skeletal
diseases
Osteogenesis imperfecta SDH, RH
[115] (3)
Brittle bone disease
SDH/RH
[116] (20/20) SDH
(11/20) RH
Other Hypoxia and resuscitation RH [117] (1/33) [118] (1)
Hypoxia SDH/intradural
bleeding
[21] (20/30)
Choking and resuscitation SDH (SAH), RH [119] (1)
Resuscitation in patients with retinopathy of countries
Hypernatremia and dehydration
RH [118] (2)
[117] (1/33)
ICH, ASK [120] (1)
Leukemia RH [95] (3)
Vaccine‐induced vitamin C deficiency
SDH, ASK [121] (2)
ASK = Brain edema; ICH = Intracranial hemorrhage; RH = Retinal hemorrhage;
SAH = Subarachnoid hemorrhage; SDH = Subdural hematoma
Annex 2
Biomekanikstudier
For to study the Biomechanics behind shaken baby syndrome and shaken
baby syndromesrelaterade questions have different physical and virtual
models are designed as a simulation of the babies who are shaken and that
aims to to measure certain effects of the mixing cycle. Trettio scientific
articles about Biomechanics as identified in the search have stude rats
approachinge. A few Islandversiktsartiklar gives a good understanding of the
problem area, but also the understanding of genesella traumatic brain
damage, regardless of age. (D)(e) the majority of articles readyshows model
tests and simulations of biomechanical character and many articles
readyshows , moreover, preliminary data, while getting
have repeated their studies. The articles are very different in their design,
ranging from case histories of various modelluppbyggnader which will be
ofclear mechanisms at shaken baby syndrome. A couple of articles consists
of comments to a different article. In one such example , it should be noted
that the authors to a previously published article has shrimp nat error on a 10
power if an injury should be able to occur or not [122]. SOME studies
demonstrate clearly contradictory results. His follows examples of this.
(D) uhaime and coworkers present a biomechanical model for shaken baby
syndrome [5]. The work is regarded as a reference work that many other
researchers have been deleted from and then further developed. In the article
turns solid that you can not achieve the harmful effects of shaking.
Cory and (J) theones ' article [123] bygger on a biomechanical model that has
modi fi after Duhaimes model [5]. Cory and co-workers ' article shows
that this model is marred with irregularities and the result shows that the
forces at shaking of a child many times can Islandexceed the powers which
are necessary in order that the damage will occur.
The v etenskapliga substrate from the studied articles is thus diverging rande and no
definitea conclusions can be drawn regarding the powers that are necessary for that
damage will occur.
Annex 3
Ethical analysis of shaken
baby syndrome
The State's medical‐ethical advice S tatens medical ethical advice (S) have implemented an ethical analysis of
whether Council "shaken baby syndrome" in connection to Statens
preparation for medical and social assessment (SBU) report on the subject.
S more has not made any own scientific assessment of the base material.
The analysis is based therefore on the results that the SBU had come
forward to report in and that can be summarized in the following points:
• (D)et , there is insufficient scientific backing for that assess the diagnosis
TICAL accuracy of triad for that identify the skakvage.
• There are limited vetenskapligt basis for the triad (subduralblöd ning,
fundus bleeding and various Forms of brain influence) and thus its
subcomponents can be present at the skakvage.
• TRiad or subcomponents in the can be caused by other things than shaking.
Outline Analysis begins with a conceptual analysis of the term shaken baby
syndrome. The fortsatta ethical analysis are structured on the basis of two
dimensions. In the one identified the parties who have intressen in question
and in the other are identified which ethical valuen that is relevant in the
context of a possible shaken baby syndromessituation. Slutligen dinskuter.as
avvägningen between different central heatit and the heatdekonflikter that
may occur at this balancing.
Conceptual problems A conceptually understood issues about shaken baby syndrome is that the
term as such is etiolo policy, it would say that it in itself includes the reason
for the observed damage in the child . (B)the concept of shaken baby
syndrome has been used as one of a small child found triad subdural
haemorrhage, fundus bleeding and various Forms of brainaffectedcan.
In SBImplement review of the scientific literature has been found in a
limited vetenskapligt basis for the triad or its subcomponents can be present
at the shaken baby syndrome, but it has also found that the triad or its part
components can be caused by other things than shaking.
Es the SBImplement report is the scientific dossier insufficient " to assess
the diagnostic accuracy of the triad for to identify the shaken baby
syndrome".
The doctor that meets the family of the injured child has possibly also
other sources than those that x-ray, neurological examination and
fundoscopy offers. Det can be other injuries on the body which supports the
suspicion of abuse as well as observations in conversations with health
nadshavarna. Det is an ethical requirement that all this way in the physician's
judgement in the face of a possible notification of concern to social welfare.
The doctor have a duty to accurately describe everything that transpired
during the investigation, both the damage that emerged as the information
that the guardians have to leave If the sequence of events and circumstances
in Island incidentally. It is also of the utmost importance that all injuries are
documented thoroughly, both for health care needs that are ahead of a
possible future judicial process.
V ACH decisions in health and medical services, either out of these is of
diagnostic or therapeutic grade art, based on both facts and values. </b146 >
Med facts referred to in this samman hang description of all rpupiladopt
findings that were made with the help of physical, radiological, laboratorybased and other medical examinations of the child. It should , however,
take into account that even facts may contain evaluative element, such as
assessments of x-ray findings. The next step that occurs in the doctor's job
is to evaluate the medical findings and the content of the stories about the
events. (D) thenumber one work is of a different nature than the facts related
description. His has the doctor a significant ethical responsibility that in rate
expectations only based on vetenskap and proven theory,what experiences
theunit.
Parties Utgångspunkten for analysis is that a small child is received to the health
and medical care along with a or two guardians with damage that gives
rise to a clinical suspicion If that assault can be a reason for the child's
injuries. If the child's injuries include the so called triad of symptoms and
findings arises the question whether this may have been caused by shaken
baby syndrome. RINCE in this mode, fi the fl partners which have
legitimate interests of how the situation is handled. It is the child, its
guardians and caregivers in various professions.
In occurring cases can also be the child's siblings to be affected by the process.
In a later stage , the situation also come to include social service
personnel and political officers (eg. in the social welfare board) as well as
the police, prosecutors and the judiciary's different instances.
Values (B) arnet has a very special position in the current situation of several reasons
that are based on ethical values. (D)a is in these contexts for very small
children. It means that the child completely lack the ability to self report on
what that occurred and therefore of obvious reasons not able to defend their
own interests. De damage which is present in the context where shaken baby
syndrome can be suspected can be of serious art, both acute as in the longer
term. Skadorna can be immediatesuch life-threatening or result in a risk of
permanent legislative decisionbe ruled out, what applies to the child's
utvelopment, health and future qualityTy.
A ethical analysis of shaken baby syndrome should of these reasons primarily
deleted from a child 's perspective. (D)a central ethical question is how the
child's intressen on best way can be exploited because there never can be
acceptable that a small child becomes a victim of domestic abuse.
It is an ethical duty to the small and vulnerable child's interests are
catered for by any other person. In the normal case is that parents who
have the task to defend the child's interests. In a situation where the shaken
baby syndrome are suspected as it is , however, often some of the
guardians (or both) that may be caused to the injury. (D) thenumber one
means to him/this then possibly not fulfilled their parental responsibility.
In the scenario that this outline is falling because the immediate
responsibility for to protect the child's central values on the health
professionals who meet the family at the hospital. In one such situation
must staff Act according to their professional dizzykesetik and based on the
existing legislation.
It can be about that in the first place take vital emergency medical
measures that are needed by the child's health status. Barnet must have
access to all emergency and other necessary medical interventions for
the cure and relieve the acute injuries and for to prevent future sequelae.
(D) thenumber one has , of course, the first priority in the processing.
If suspicion arises about the damage caused by the violence as is the
doctor's responsibility to investigate this suspicion based on science and
the beprIslandwhat experiencedevice. Det is also the physician's obligation
to under 14 Cape. 1 § social services Act (2001:453) report to social welfare
if there exists suspicion about that child 's father badly.
S of all in have an explicit responsibility for the protection of children in a
number of different ways. (D) thenumber one follows the example of the
Social Service Act and Act with specific provi sions for care of the young
(1990:52). The last Act Specifies the opportunities for social action in
consultation with the parents while the other teams are giving the
community the opportunity to take measures to the protection of the child
without custody officers consent. An outer measure is that the social
welfare board may take possession of the child for care outside the home.
(B) arnkonv entionen, as for the present is on its way to be incorporated in
Swedish law legislation, indicates a number of basic rights that all children
have, such as the right to the protection of life and health, </b143 >right to
grow up in good conditions and the right to good care. (D) thenumber one
document is formulated on the basis of a rights perspective but rests also on
the Central ethical principles about adult society's responsibility for child's
life to the protection of what that is Central values for all children.
N is the doctor will recruit guardians if the damage can be caused by any of
these known external event, so is it unusual that this allowed </b145 > in
time (Lowenstein , 2004). It is important that the doctor in this situation not
to take over the judiciary's role to determine a possible crime or accuse any
single individual. Vårdnadshavs have legitimate intressen of to some of
those central values are taken into account in the situation. Till these include
the right to good care, which custody seas vanligen is concerned about the
independence of reason or evmay intent (Leuthner 2001). (V)Moreover , it is
an important value for him/them to be listened to in an adequate manner and
that the handling of the situation at the hospital is done based on an
impartial and unprejudiced basis with regard to of all possible causes of
the observed damage.
(F) ör the nursing staff is there a Central value to meet out of respect for their
professional on professional assignments , both from a medically as an ethical
perspective. It is the most common genetic doctor who has to task to evaluate
the likelihood of that the observed damage as the child exhibits can be the
guarantee of any adult person,< b181 > usually someone of the guardians,
and thus able to be characters on skak violence. (F)for the physician is that
of considerable value to get the necessary notice of his decision on a
possible notification of concern. A decision on the complaint is fraught with
significant legislative decisionalso for both child custody seaIslands and
therefore must be well founded and well thought out. One such decision
should always be made in consultation with at least one other medicale.
The doctor has also an intresse of that have adequate training and expertise in
the area of child abuse for being able to handle these ethical and
psychological very difficult situations in a professional manner.
N is it concerns social services separates itself
responsibilityarsförhållandena radically compared with health and
careinthe. Decision-making mandate regarding measures without consent
fall on the social welfare board politicians; in acute situations represented by
its words Chairman by delegation. Udossier for the decision to be taken ,
however, until by perso nal within social services. (D)his staff have
professional ethics rules for his work which should be taken into account in
situations of current kind. (F)for social service personnel is the a Central
value to safeguard the child's interests and to protect the child from
threats against life , health and development. It is a Central value for the
social services that the information which they receive from health and
health care is medically CorrECT, well researched and formulated in such a
way that conclusions if the reason for the observed damage not reported
but secure foundations.
If the case, emergency or in a later stage, later Islandvergår to the police,
Prosecutor and Court (s) so have these instances a similar interest when it
comes to infOrma forinflation from health and health care. If and when a
case ends up in Court, so it is important for the Court to have access to special
scientific expertise which pronounces itself in accordance with ethical
principles and applicable legal rules for certificates and opinions.
Value conflicts (D) et there are some significant value conflicts in conjunction with shaken
baby syndrome. One of the more important concerns the question of whose
intressen who should weigh heaviest – child's or care nadshavarens. Utifrån a
child perspective so it can not be any doubt about that child's intressen have
highest priority in several respects. Barnet has for the first a need of to get his
injury examined and treated at a professional international and competent
way in health and health care. If the damage can be suspected to be
forcaused by assault , there is an apparent need forv of protection for their
lives and their health.
It or the guardians, who are suspected to be caused to the shaken baby
syndrome has on the other side a legitimate intresse of to not be judged
innocent (a). Hare available , therefore a potential value conflicts that can be
described as an ethical dilemma in the sense that it does not have any very
trouble-free solution.
(D) etta dilemma can also be expressed in terms of risks for under the
respective Islandverdiagnostik. Med elderly is not diagnosed means that
children who actually suffered for shaken baby syndrome not get identified
and thus not receive the society's protection against further abuse or lack
of HEAäxtvillkor in General. Still underdiagno stik can take place on the
grounds of lack of competence or observans in health and health care or to
owill or inability of staff to on a professional way utr eda suspicions about
the skakvage.
Colonel erdiagnostik can occur if the doctor who meets the child with the
current triad at an immediate way to value this as a proof of that shaken
baby syndrome and be shaken baby syndrome is the cause of the observed
damage. (D) theet tube itself thus on a confusion between a hypothesis
about a possible cause of the child's injuries and an alleged safe
knowledge about that it is such a clear and safe coupling between cause and
effect.
A such a procedure creates thus risk for that the continuation of the
proceedings in a such case mainly will be characterized by a so called
validation approach (Meltzer et al. in press). Med this means that further
measures are made only in order to confirm the hypothesis and that the
information that would be able to falsify hypo thesis is not taken into
account in sufficient extent.
Both under and over-diagnosing is deeply problematic from an ethical
point of view. A överDiagnostics protects many children, both those with
secured shaken baby syndrome that reason as a part of other. It leads ,
however, to the families being split of which some on the wrong basis. (A)
tt separating children from their parents/guardians are a seriousarligt
surgery which only should be made if the child runs the obvious risk to
endanger badly in home met. Att , even the family's other children can be
disposed of can further aggravate the situation.
The Wo dekonflikt as here outlined between the child's and guardian's/nas
intressen needs related to the legal principle that No innocent person
should be condemned
for a brott. Colonelerdiagnostik of the shaken baby syndrome , to the impact
that a number of children to be protected, of which a part really been
exposed to shaken baby syndrome, but that this is happening to the price of
that a number of parents/guardians become frihetsberIslandvade without
to be own ga to any brott. Underdiagnostik of shaken baby syndrome
joints on the other side of that child as father ill have to Live left in a harmful
home environments with risk of future violent incidents.
The medical controversy around shaken baby syndrome that has been going
on in Sweden as well as in large parts of the world is above all if it is a secured
scientific scientific support for that symtomtriaden subdural
haemorrhage, fundus hemorrhage and hjärnpåvyoucan be caused by
shaken baby syndrome and only by skakvage. SBU's report shows that there
is scientific evidence, if than limited, for the triad can be caused by shaken
baby syndrome but that there also exist other diseases and events that can
result in the triad , or parts of it.
(D) etta raises the question about what your doctor can and should
pronounce itself on when it comes to shaken baby syndrome. Det are
ethically of the utmost importance to physicians and other healthcare
professionals are observant on damage of small children who can
conceivably </b175 >be caused by human hand despite the fact that the
guardians are denying everything . (D)a clinical investigation and treatment
of the damage must be carried out with full force. (F)he question is If the
doctor
in a slightly later stage can Express themselves with scientific certainty
about the cause of the observed damage. The doctor has, as previously
pointed out, a number of different information to take into account in this
assessment of the possible causes of damage. Att on the basis of the mere
presence of the triad rule to this with Security caused by shaken baby
syndrome must , however, be regarded as incompatible with the
authorities forl l oka ren's professional ethics as applicable regulations
concerning attestation (Albert et al. 2012).
(D) etta the finding does not prevent that there can be reasons to do a so called
oros notification trots this uncertainty because a child's need of protection is a
broader issue than the about the cause of the current damage.
Conclusions S more have in this ethical analysis of shaken baby syndrome been deleted
from SBUreport konsta Ting to the vetenskapliga dossier concerning
shaken baby syndrome is limited. There is limited scientific support for that
on the so called triad of sym tom or its subcomponents can be present at
shaken baby syndrome but the report shows that there are differential
diagnoses that also can give rise to the tre symptoms/findings in the triad.
(G) (iv) et this finding is so is the term shaken baby syndrome ethically
problematic because it in itself includes an etiologic findings. Smore mean
that it is ethically problematic to within health and medical care with
Security set to some specific damage of small children </b162 > per
automatics are proof of that these arose mit through shaken baby syndrome.
One such over-diagnosing of shaken baby syndrome should not be present
when the scientific knowledge is so limited (Riggs & Hobbs 2011).
S more mean that it also is ethically problematic with the elderly is not
diagnosed in bemär kelsen to kids who actually been vulnerable for shaken
baby syndrome not get identified and understood within health and medical
care. Denna risk can however be limited by improved professional
development of child abuse in general and shaken baby syndrome in
particular within both health and health care and social services.
Smer would point out the importance of the health and health care system
takes into account the obligation that the social welfare report cases where
children in any way suspected danger . (D) thenumber one applies in any
particular case of suspicions of child abuse of various kinds. (H)health and
care staff must be able to combine a high observans of suspected shaken baby
syndrome with a caution when it comes to pronounce itself on the cause of
the observed damage then the vetenskapliga knowledge does not allow
safe conclusions on this area.
Smer recommends that the term shaken baby syndrome not used will
continue on the basis of the likelihood of confusion between the hypothesis
and secure knowledge (Christian & BCap 2009). An alternative term should
be etiologic neutral.
References Alber t DM, Weisberger Blanchard J & Knox AMONG OTHERS. Ensuring
appropriate specialists,such testimony for cases involving the "shaken
baby". JAMA 2012; 308: 39 40.
Christian CW & Block r. Abusive head traumas in infants and children.
Pediatrics 2009: 123: 1409 1411.
Leuthner SR. Ethical challenges in the care of the shaken baby. Journal of
Aggrprogression, Maltreatment & Traum(a) 2001; 5: 341 347.
L owenstein LF. RECt research and views on shaking baby Sinrome.
International Journal of Psychiatry in Medicine 2004; 34: 131 141.
Meltzer CC, Sze G, Rommelfanger KS, Kinlaw K, Banja JD & Wolpe PR.
Guidelines for the ethical use of neuroimages in medical testimony:
scratchest of a multidisciplinary conference. American Journal of
Neuroradiology 2014; 35: 632 637.
Riggs JE & Hobbs Gr. innfant homicide and accidental death in the United
States, 1940 2005: ethics and epidemiological classification. Journal of
Medical Ethics 2011; 37: 445448.
The ethical analysis has been taken up by thengemar Engström, expert in
Smore, in consultation with Kjell Asplund and Chatrine Pålsson Ahlgren.
(B) If the agency decision If this text was adopted at Statens medicalethical
Council regular sam provision on 26 August 2016. In the decision attended
members Kjell Asplund (Chairman), Finn Bengtsson, Sven Olov
Edvinsson, Katie P Ahlgra, Åsa GybergK, Barbro westerholm and
Anders Åkesson.
During the preparation of the case took part also the expert Lars Berge
Kleber, inngemar Engström, Göran , Hermerén, Ann j.Johansson, Olle
Olaib, Bengt Rönngren, Nils Eric Sahlin, Anna 'singer and Elisabet
Wennlund.
(F) ör the Council, the
kjEll a.s.
O interview with Chairman in Statens medical ethical advice
SBU – The State's preparation for medical and social evaluation
Web site: www.sbu.se • twitter: @SBU_se • phone: 08‐412 32 00 reportnumber255•published2016•isbn978‐91‐85413‐98‐0