MEDICINE

Original article

The Immo Traffic Light System as a

Decision-Making Tool for Prehospital
Spinal Immobilization
A Systematic Review

David Häske, Gunnar Blumenstock, Björn Hossfeld, Christoph Wölfl,

Uwe Schweigkofler, Jan-Philipp Stock

Center for Public

Health and Health
Services Research, Summary
University Hospital of
Tübingen, and Background: Spinal injuries are difficult injuries to assess yet can be associated with significant neurological damage. To avoid
German Red Cross secondary damage, immobilization is considered state of the art trauma care. The indication for spinal immobilization must be
Emergency Services
Reutlingen: Dr. sc.
assessed, however, for potential complications as well as its advantages and disadvantages.
hum. David Häske,
MSc, MBA Methods: This systematic review addressing the question of the correct indication for spinal immobilization in trauma patients
Institute of Clinical was compiled on the basis of our previously published analysis of possible predictors from the Trauma Registry of the German
Epidemiology and Society for Trauma Surgery. A Delphi procedure was then used to develop suggestions for action regarding immobilization
Applied Biometry, based on the results of this review.
University Hospital of
Tübingen: Dr. med.
Gunnar Blumenstock, Results: The search of the literature yielded 576 publications. The 24 publications included in the qualitative analysis report of 2
MA, MPH 228 076 patients. A decision tool for spinal immobilization in prehospital trauma care was developed (Immo traffic light system)
Department of Anes- based on the results of the Delphi procedure. According to this system, severely injured patients with blunt trauma, severe
thesiology, Intensive traumatic brain injury, peripheral neurological symptoms, or spinal pain requiring treatment should be immobilized. Patients with
Care Medicine,
Emergency Medicine a statistically increased risk of spinal injury as a result of the four cardinal features (fall >3m, severe trunk injury, supraclavicular
and Pain Therapy, injury, seniority [age >65 years]) should only have their spinal motion restricted after weighing up the pros and cons. Isolated
Federal Armed penetrating trunk injuries should not be immobilized.
Forces Hospital of
Ulm: PD Dr. med.
Björn Hossfeld Conclusion: High-quality studies demonstrating the benefit of prehospital spinal immobilization are still lacking. Decision tools
such as the Immo traffic light system can help weigh up the pros and cons of immobilization.
Department for
Orthopedic Surgery,
Trauma and Sports Cite this as:
Traumatology – Hand Häske D, Blumenstock G, Hossfeld B, Wölfl C, Schweigkofler U, Stock JP:
and Plastic Surgery, The Immo traffic light system as a decision-making tool for prehospital spinal immobilization—a systematic review.
Musculoskeletal
Center Neuwied, Dtsch Arztebl Int 2022; 119: 753–8. DOI: 10.3238/arztebl.m2022.0291
Marienhaus Hospital
Neuwied: PD Dr.
med. Christoph Wölfl
Department of Trau-
ma and Orthopedic

A
Surgery, BG Trauma bout 1–2 % of all trauma patients suffer injury to This leaves room for individual interpretations, es-
Center, Frankfurt am
Main: PD Dr. med. the spine, while severe neurological damage occurs pecially with regard to patients in whom the indi-
habil. Uwe Schweig- in about one fifth of these (1, 2). Spinal injuries are cation for immobilization is less obvious than in the
kofler
both overestimated and underestimated (3–6). Spinal case of the severely injured patient (9–13).
Department for Anes- immobilization is intended to prevent secondary neur- Furthermore, various disadvantages of immobili-
thesiology, Intensive
Care Medicine, ological damage, but it can also have a detrimental effect zation have been reported, for example, increased
Emergency Medicine, or create a false sense of security. intracranial pressure from cervical collars (14), posi-
Pain Therapy and
Palliative Care, am The use of prehospital spinal immobilization tional pain (15–17), prolonged prehospital times (18),
Steinenberg Hospital, currently relies on decision-making tools that were difficult intubation conditions (19), or pressure ulcers
Reutlingen: Dr. med. originally intended to provide an indication for im- (20).
Jan-Philipp Stock
aging to confirm the diagnosis, such as the NEXUS From a practical point of view, immobilization
criteria or the Canadian C-Spine Rule (7, 8). Ran- would appear an appropriate measure if there were a
domized controlled trials have failed to demonstrate risk of aggravation of the injury by movement, for
any benefit of prehospital immobilization (9–13). example in the case of unstable fractures.

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MEDICINE
BOX
Results of the trauma register analysis
(3, 21)
● Predictors of a clinically relevant injury to the spine:
– peripheral motor/neurological deficit
– fall >3 m height
– traumatic brain injury
– seniority (age >65 years)
– severely injured patient
Aims and objectives
The aim of the present article is to use available studies
to develop a practical decision-making tool for spinal
immobilization in prehospital trauma care.
Methods
As part of preliminary work by the authors, an analysis
was conducted using the Trauma Register of the Ger-
man Society for Trauma Surgery (TR-DGU) to identify
predictors of spinal injury (3, 21) (Box).
These were verified in the present review using lit-
erature that complies with the PRISMA statement for
systematic reviews and the PICO scheme (PICO,
population, interventions, comparison, outcome). The
review is registered in the PROSPERO systematic re-
view register (ID: CRD42021232806). Details can be
found in the eMethods section.
Results
Systematic study selection
The literature search initially yielded 576 publications,
of which 24 were included in the study (Figure 1).
Study characteristics
The included reports involved 2 228 076 patients; the
patient number is uncertain for four of the publications.
The results are evaluated purely descriptively due to
heterogeneous data and endpoints and due to study
quality. The literature evaluation revealed low-to-
medium quality studies, with a mean quality index
score of 14.0 for randomized controlled trials (RCTs)
and 11.7 for observational studies (eTable 1 and
eTable 2).
Results of the literature review
The results of the review are presented in line with the
key points highlighted in the previous analysis of the
TR-DGU, and considerations for prehospital imple-
mentation are then added. Data used to calculate
predictive values were reported in only 7 of the 24
publications.
Isolated penetrating trauma
The analysis of the TR-DGU shows a high prevalence
for spinal injuries AIS3+ associated with blunt trauma
754
(odds ratio [OR] = 4.066 for the whole spine and OR =
3.640 for the cervical spine [CSp]), but not after pen-
etrating trauma (3, 21). An unadjusted retrospective
analysis of more than 30 000 patients reported that only
0.034% (n = 12) of conscious patients with penetrating
trauma also had spinal injuries associated with signifi-
cant neurological symptoms (25). An analysis of
45 284 patients with penetrating trauma showed an un-
adjusted mortality in the immobilized group of 14.7%
versus 7.2% (p <0.001) in the non-immobilized group
(positive predictive value [ppV]: 14.7%, 95% confi-
dence interval: [13.1; 16.3]; negative predictive value
[npV]: 92.8% [92.6; 93.0]) (26). Another study demon-
strated that more immobilized than non-immobilized
patients with penetrating cervical trauma died (OR =
2.77 [1.18; 6.46], p = 0.02) (27).
Obviously severely injured patients
The probability of spinal trauma increases with injury
severity and the number of body regions involved (28).
Analysis of the TR-DGU reveals systolic blood
pressure of 90 mmHg or lower as a significant predictor
of a spinal injury (21). This is interpreted as a surrogate
indicator of severe injury.
(Peripheral) motor/neurological deficits
Peripheral motor/neurological deficits are the strongest
predictors of spinal trauma in the TR-DGU analysis
(OR = 3.171 for the whole spine and OR = 7.462 for the
cervical spine, p <0.001) and must therefore be
considered a warning sign (3). Domeier et al. found
neurological symptoms in 14.5 % of patients with spi-
nal injuries (29), and, according to a retrospective
analysis, patients with injury to the spine present
neurological symptoms more often (42% versus 17%,
p = 0.035) (30).
Traumatic brain injury
According to the TR-DGU analysis, spinal injury pre-
sents in 11.9% of patients with seemingly isolated trau-
matic brain injury (TBI) and in as many as 40.7% of
those with TBI associated with multiple injuries (3).
Schinkel et al. confirmed this for patients with severe
TBI (28) and Tian et al. for comatose patients with TBI
(ppV: 11.6% [7.9; 16.4]; npV: 96.0% [93.1; 97.9],
unadjusted) (31).
Spinal pain
Studies on pain along the lines of the present research
question are hard to find. In general, pain should be
considered as a warning sign of possible injury (32,
29).
Kinematics
Various studies have indicated that accident kinematics
may provide evidence of spinal injury (8, 33). Cooper
et al. reported falls as the most common cause of injury
to the spine (unadjusted OR, ppV: 6.0% [4.9; 7.3]; npV:
96.7% [95.9; 97.4]) (34). Oteir and colleagues also
share this assessment (adjusted ppV: 0.3% [0.2; 0.3];
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 MEDICINE

npV: 99.8% [99.8; 99.9]) (35). A prospective cohort FIGURE 1

study of 6500 patients found that mechanism of injury
did not help prediction of the resulting injuries (36).
The TR-DGU analysis showed that only a fall from a

Identification
Database search Other sources
height of more than three meters was a risk factor for (n = 520) (n = 56)
spinal injury (OR = 2.243; p <0.001) (21). It should be
noted that less severely injured patients are not in-
cluded in the TR-DGU (33). Data sets after removing
duplicates Excluded data sets
(n = 492) Other indication: n = 308

Preselection
Severe associated injury Age: n = 24
The TR-DGU analysis showed that spinal injuries are Language: n = 12
Veterinary indication: n = 17
associated with thoracic and abdominal injuries. The Verified data sets Study protocol: n= 9
incidence of thoracolumbar fractures in patients with (n = 492) No access: n = 12
and without severe associated injuries (OR = 1.9, [1.4;
2.6]; p <0.001) also confirms this (34). Schinkel et al. Full text excluded

Suitability
found significantly more thoracic and lumbar spine in- Full texts examined for Other indication: n = 69
juries in connection with corresponding injuries to the suitability Age: n= 6
(n = 110) Language: n= 8
chest and abdomen (28). Veterinary indication: n= 3

Supraclavicular injuries
Data analysis of the TR-DGU failed to classify Studies included for
qualitative analysis
Included

maxillofacial injuries to be predictive of cervical spine

injuries (OR = 0.183 for facial injuries and OR = 0.876
for skull injuries), but here it is important to bear in
mind the selective patient population of the TR-DGU
(3). Other studies show that maxillofacial injuries may
double the risk of cervical spine injury (e1, e2). An in-
creased risk of cervical spine injury has been reported
for geriatric patients in particular after simply tripping
and falling (e3, e4).
Age
Patients older than 65 years are more likely to suffer in-
jury to the cervical spine even after low-energy trauma.
Analysis of the TR-DGU confirmed this risk constel-
lation with an OR of 1.344 ([1.236; 1.461], p <0.001)
(3). McCoy et al. even showed a 3.27-fold increased
risk in patients aged 65 years and over (relative risk
[RR] = 3.27 [1.66; 6.45]; ppV: 12.6% [9.1; 16.8]; npV:
95.4% [92.9; 97.3], unadjusted) (e5). Reduced mobility
and degenerative changes are considered to be causes
(e6, e7).
Suggestion for recommended action
The Immo traffic light system was developed as a sug-
gestion for use by the emergeny medical services for
prehospital spinal immobilization and is based on the
results of the Delphi procedure (Figure 2). The Immo
traffic light system divides trauma patients into three
categories, with the highest priority given to the out-
come of the clinical examination. In addition, a few risk
factors are also taken into consideration following
analysis of the trauma register (3).
Discussion
The aim of the present article was to develop a feas-
ible decision-making tool for justifying spinal
immobilization in prehospital trauma care. This
should not be interpreted as being the same as reach-
ing a diagnosis, which usually requires cross-sectional
(n = 24)
14 primary studies
10 systematic reviews
PRISMA flow diagram of literature search and study selection
imaging (e8). Schweigkofler et al. demonstrated that
spinal injuries in the severely injured patient are as-
sumed to present less frequently than their true inci-
dence (31% versus 34%) (e8). Spinal immobilization
was advocated by the emergency services in order to
prevent neurological damage. Given the lack of
studies demonstrating efficacy of prehospital spinal
immobilization and the numerous publications de-
monstrating potential disadvantages of immobiliz-
ation, there has been an increasingly restrictive ap-
proach when discussing spinal immobilization (11, e9,
e10). The following suggested categorization is aimed
at facilitating risk assessment:
Category Red: Category red includes patients in
whom examination findings indicate the presence of
spinal injury and who should therefore receive full
spinal immobilization. Various guidelines support this
view (37, 11). Apart from a peripheral or central
neurological deficit, associated spinal pain as an ab-
normal finding must be regarded as a red flag. Spinal
immobilization would appear indicated at the latest
when the injured patient requires pharmacological
pain relief. The rescue team must therefore be trained
to interpret pain as a warning sign and provide treat-
ment (29, 32, 38).
Category Yellow: Patients are assigned to category
yellow when the spinal examination is unremarkable
(no pain, no limitation of motion, etc.). However,
patients in this category also present risk factors for
spinal injury.

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MEDICINE
FIGURE 2
Yes
Isolated penetrating torso trauma
Yes
No
Obviously severely injured Yes Full
immobilization
No Yes required
● TBI with GCS ≤12?
● Peripheral neurological deficit?
No
Yes Consider
Spinal pain requiring treatment restriction of
movement
NRS ≥5
No
≥ 1 point from the 4 cardinal features rule?
● Fall from >3 m height No
● Severe torso injury immobilization
● Supraclavicular injury required
● Seniority (age >65)
No
The Immo traffic light system for responsive adult patients. The ABC approach to the un-
stable patient has priority over immobilization. With “yellow” patients or patients with more than
one of the 4 cardinal feature points, there should be a sound justification why, after appropriate
risk assessment, immobilization was not performed but instead only restriction of movement.
The subjective parameter “pain” requires assessment and interpretation by a qualified member
of the medical staff, as does the parameter “obviously severely injured”.
TBI, traumatic brain injury; GCS, Glasgow Coma Scale; NRS, numeric rating scale
According to Hauswald et al., there was less
neurologic disability in patients with blunt spinal in-
juries who were not immobilized than in those who
were (OR adjusted = 2.03 [1.03; 3.99]; p = 0.04; ppV:
21.0% [16.8%; 25.8%]; npV: 89.2% [82.2%; 94.1%])
(39). Neurological deterioration in the non-immobi-
lized patient with spinal injuries was not reported
(40). Other authors recommend the use of the
NEXUS criteria (e11). A cautious immobilization
strategy in patients aged 60 years and over did not
retrospectively affect the incidence of neurological
deficit (6.5%, n = 8 versus 5.3, n = 6; p = 0.69) (e12).
Two other literature reviews found no benefit in spi-
nal immobilization; there is also reported evidence
that prehospital immobilization does not appear to be
beneficial (13, e13).
A clinical study involving over 1000 patients dem-
onstrated that imaging studies, and thus presumably
also immobilization of the cervical spine, is only
rarely indicated in the conscious trauma patient with-
out supraclavicular complaints (e14). No clear benefit
was demonstrated for the use of cervical collars either
(2, 10, e15).
On the other hand, it has been reported in various
case series that unstable spinal injuries can occur even
with initially unremarkable neurological findings and
can develop a neurological deficit if left untreated
(e16, e17). In a review of expert medicolegal reports
involving 59 patients with spinal injury, 27 patients
756
were found to have developed neurological deterio-
ration over time; 23 of these were attributed to absent/
inadequate immobilization (e18).
Completely dispensing with spinal immobilization
measures despite the presence of risk factors would
therefore not appear appropriate even if the examin-
ation findings are unremarkable, especially as invol-
untary movements during transport cannot be ruled
out.
The data analysis of the TR-DGU identified four
independent risk factors for spinal injury that were
included in the Immo traffic light system as four car-
dinal features:
● Seniority (age >65 years)
● Fall >3 m
● Supraclavicular injuries
● Severe associated thoracoabdominal injury.
All four predictors taken alone already indicate an—ad-
ditively increasing—risk of spinal injury. The specified
age limit of 65 years should not be regarded as an abso-
lute value; but rather, the risk increases with age as
degenerative changes also increase.
Although only falls from more than three meters
emerged as a predictor of spinal injury in the TR-
DGU analysis, discovery of energetically comparable
kinematics during the physical examination should
lead to increased awareness of spinal injury.
As the severity and number of torso injuries in-
crease, so does the risk for spinal trauma. The
NEXUS criteria understand “distracting injuries” as
inadequate pain perception with respect to the spine;
this has already been critically questioned or refuted
(e19, e11). The authors regard torso injury to be a risk
factor for spinal injury regardless of pain intensity.
The benefits and risks of immobilization should be
weighed against each other in the conscious patient
with unremarkable examination findings (e13,
e20–e22).
Category Green: Category green includes patients
with clinically unremarkable investigation findings of
the spine in the absence of other risk factors, as well
as those who have sustained an isolated penetrating
injury to the torso. Several review articles favor
prompt surgical intervention rather than (cervical
spine) immobilization (17, 18, 27, e13, e23, e24).
Providing immobilization
The ABC approach to the unstable patient has priority
over immobilization in the sense of “treat first, what
kills first”. This a basic principle in emergency medi-
cine and requires no further explanation. As with all
medical measures, potential disadvantages of immobil-
ization should also be taken into account for any differ-
entiated justification.
Suggested action for Category Red: Immobilization
The authors recommend full spinal immobilization for
this category. Published results on the use of a vacuum
mattress or spine board are contradictory, and the
quality of the studies is variable (e15, e25–e27). The
Deutsches Ärzteblatt International | Dtsch Arztebl Int 2022; 119: 753–8

aim is complete immobilization of the entire spine.
Several studies suggest a possible increase in intra-
cranial pressure associated with the use of a rigid cervi-
cal collar in patients with higher grade traumatic brain
injury (e28–e31). Therefore, alternative methods of im-
mobilization of the cervical spine, such as head blocks
or a manual technique, should be considered, especially
in the presence of signs and symptoms of intracranial
pressure (pupillary dilation, extension synergisms, ex-
tension response to painful stimulus, progressive cloud-
ing of consciousness). The decisive factor is ultimately
the successful immobilization of the cervical spine, not
the procedure itself (e14, e19, e25, e26).
Trauma patients with significantly impaired con-
sciousness or disorientation without adequate torso
control should receive spinal immobilization.
Suggested action for Category Yellow: Restrict
movement
Patients in this category require restriction of move-
ment of the spinal segment at risk in order to prevent
major involuntary spinal movements by maintaining
torso control (e31, e32).
Aids to be considered for this purpose are a
stretcher combined with a cervical collar (CSp), spine
board with head blocks, or a vacuum mattress, if
necessary, in combination with head blocks or cervi-
cal collar—these are to be used as determined by the
affected body region. Manual restriction of cervical
spine mobility is also a possibility. A cervical collar
does not immobilize completely (e33–e37), but the
restriction of movement is merely intended to stabil-
ize against involuntary movement while torso control
is maintained, which a cervical collar for the cervical
spine undoubtedly provides (e32–e36). The above-
mentioned limitations in the use of the cervical collar
in patients with severe traumatic brain injury do not
apply to this category since these patients are neur-
ologically unremarkable.
Limitations
Apart from the register analysis, the Immo traffic light
system is also based on systematic literature searches of
studies of no high methodological quality. This carries
with it the risk of unknown confounders which must be
taken into account in the evaluation. Validation of the
Immo traffic light system for everyday care is yet to be
carried out.
Conflict of interest statement
The authors declare that no conflict of interest exists.
Manuscript received on 24 January 2022, revised version accepted on:
21.July 2022.
Translated from the original German by Dr. Grahame Larkin
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Corresponding author
Dr. David Häske, MSc, MBA
Center for Public Health and Health Services Research
University Hospital of Tübingen
Osianderstr. 5
72076 Tübingen, Germany
david.haeske@med.uni-tuebingen.de
Cite this as:
Häske D, Blumenstock G, Hossfeld B, Wölfl C, Schweigkofler U, Stock JP:
The Immo traffic light system as a decision-making tool for prehospital spinal
immobilization—a systematic review. Dtsch Arztebl Int 2022; 119: 753–8.
DOI: 10.3238/arztebl.m2022.0291
►Supplementary material
eReferences, eMethods section, eTable:
www.aerzteblatt-international.de/m2022.0291
Deutsches Ärzteblatt International | Dtsch Arztebl Int 2022; 119: 753–8

Supplementary material to:
The Immo Traffic Light System as a Decision-Making Tool for Prehospital Spinal
Immobilization
A Systematic Review
by David Häske, Gunnar Blumenstock, Björn Hossfeld, Christoph Wölfl, Uwe Schweigkofler, and Jan-Philipp Stock
Dtsch Arztebl Int 2022; 119: 753–8. DOI: 10.3238/arztebl.m2022.0291
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I
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eMETHODS SECTION

As part of preliminary work, the authors conducted an analysis of the

Trauma Register of the German Society for Trauma Surgery (TR-DGU),
which was used to identify predictors of spinal injury (3, 21).

The Trauma Register of the German Society for Trauma Surgery

The TR-DGU was founded in 1993. Since then, over 450 000 treatment
histories have been documented. Participating departments are primarily
located in Germany, but departments from other European and non-
European countries are increasingly contributing to the register. The aim of
this multicenter database is to gather pseudonymized and standardized
documentation of severely injured patients. Data acquisition is conducted
prospectively in four consecutive phases:
● Prehospital
● Resuscitation room and subsequent surgery
● Intensive care unit
● Discharge
TR-DGU inclusion criteria are either admission to hospital via the resusci-
tation room with subsequent need for intensive care or arrival at the hospi-
tal with vital signs, but death before admission to the intensive care unit.
The basic population is defined as patients with a maximum abbreviated in-
jury scale severity score (MAIS) of three or more and patients with an
MAIS of two who either died or were in the ICU (22). Currently, around
80% meet this criterion for the basic population, of which 54% had an in-
jury severity score (ISS) of 16 or more (22).
This analysis produced independent predictors of injury to the spine
(Box). A Delphi procedure using systematically selected literature was
then applied to develop a feasible decision-making tool.

Systematic review
These predictors were verified in the present review using literature that
complies with the PRISMA statement for systematic reviews and the PICO
(population, interventions, comparison, outcome) scheme. The review is
registered in the PROSPERO systematic review registry (ID:
CRD42021232806).

Search
A systematic literature search for articles in English or German was per-
formed using the electronic databases PubMed and Web of Science with
the following search terms and filters: (spine OR spinal*) AND (immobil-
ization OR stabilization) AND (trauma OR injur*) AND (prehospital OR
pre-hospital OR out-of-hospital OR emerg*); filters: clinical study, clinical
trial, meta-analysis, observational study, randomized controlled trial,
review, systematic review). A 10-year period from February 2011 thru Feb-
ruary 2021 was searched. This period was chosen because the introduction
of certified training courses changed health care strategies while safety
features and equipment in the vehicles were also improved.
The bibliographies of the retrieved publications as well as Google
Scholar and the SpringerLink Library were also searched to find addi-
tional publications.

Inclusion criteria
Published studies recommending indications for spinal immobilization
were included.

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Study selection and evaluation

After exclusion of duplicates, all titles and abstracts were independently
reviewed by two authors, and a decision was made on whether to obtain
full-text access according to the inclusion criteria. Full texts were assessed
for their relevance and included where appropriate. There was the option to
call in an additional author if there were any discrepancies.
Randomized controlled trials (RCTs) and observational studies were
evaluated for their quality using the Downs and Black checklist (23).
Systematic reviews were assessed for randomized and non-
randomized trials using AMSTAR 2 (24). The quality index comprised
the following criteria: “critically low”, “low”, “moderate” and “high”
(eTable 1 and eTable 2).

Data analysis
Different study designs were included to reflect the heterogeneous nature
of the data, and their results were described qualitatively. If event frequen-
cies were reported in the included sources, an additional calculation of
predictive values with 95% exact confidence intervals was performed for
the unadjusted four-field tables using the Clopper and Pearson method.

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eTABLE 1

Results of the literature review using the Downs & Black checklist 1998

Oosterwold et al. 2017

Underbrink et al. 2018

Vanderlan et al. 2009

Hauswald et al. 1998

Haut et al. 2010 (26)

Domeier et al. 1997
Connell et al. 2003

Cooper et al. 1995

McCoy et al. 2017

Häske et al. 2020

Reich et al. 2016

Oteir et al. 2017

Tian et al. 2009

Flabouris 2001

(e12)
(25)

(34)

(e5)

(29)

(30)

(39)

(32)

(35)

(e1)

(31)

(27)
(3)
Reporting 9 6 8 8 8 10 8 10 9 9 10 8 8 10
External validity 1 1 2 2 2 3 2 1 2 2 2 2 1 2
Internal validity – confounding 1 2 5 2 3 3 4 3 4 5 3 4 4 1
Internal validity – bias 2 1 2 2 2 2 1 4 3 3 2 3 3 4
Power 0 0 0 0 0 0 0 3 0 0 0 0 0 0
Total score (mean quality index) 13 10 17 14 15 18 15 21 18 19 17 17 16 17

0–10 points are achievable in the subscale “Reporting”, in subscale “External validity” 0–3 points, in subscale “Internal validity – confounding” 0–7 points, in subscale “Internal validity – bias” 0–6
points, and in subscale “Power” 0–1 point.
The mean quality index score for randomized controlled trials (RCTs) should be at least 14.0 points and for non-RCTs 11.7.
In all, 0–27 points are possible for the mean quality index score.

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 eTABLE 2

Assessment of the systematic reviews using AMSTAR 2

Connor et al. 2013

(17)
Hawkridge et al. 2020
(e38)
Hood & Considine 2015
(10)
McDonald et al. 2016
(40)
Oteir et al. 2015
(18)
Sundstrøm et al. 2014
(2)
Theodore et al. 2013
(e39)
Velopulos et al. 2018
(e24)
Walters et. al. 2013
(e23)

Quality index low moderate moderate moderate moderate low low moderate low
1. PICO No Yes Yes Yes Yes Yes Yes Yes Yes
2. Statement No Partial Yes Partial Yes Partial Yes Partial Yes No No Partial Yes No
3. Study design Yes Yes Yes No Yes Yes Yes Yes Yes
4. Literature search No No No Yes No No No Yes No
5. Publications: study selection Yes Yes Yes Yes Yes Yes Yes Yes no
6. Publications: data extraction Yes Yes Yes Yes Yes Yes Yes Yes Yes
7. Excluded studies No Yes Yes Yes Yes Yes No Yes No
8. Included studies Yes Yes Partial Yes Yes Yes Yes Yes Yes Partial Yes
9.1. Techniques for assessing the risk of bias in
Partial Yes Partial Yes Partial Yes Partial Yes Partial Yes Partial Yes Partial Yes Partial Yes no
RCTs

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9.2. Techniques for assessing the risk of bias in
Yes Yes Yes Yes Yes No No Yes Partial Yes
RSI
10. Funding Yes Yes Yes Yes Yes Yes Yes Yes Yes
11.1. Statistical combination of results RCT No No No No No No No No No
11.2. Statistical combination of results NRSI No No No No No No No Yes Yes
12. Impact of risk of bias Yes Yes Yes Yes No No Yes Yes Yes
13. Discussed risk of bias Yes Yes Yes Yes Yes no no Yes no
14. Explanation Yes Yes Yes Yes Yes Yes Yes Yes Yes
15. Quantitative synthesis No No No No No No No Yes No
16. Conflict of interest Yes Yes No Yes Yes Yes Yes Yes Yes

The criteria may be answered with Yes, Partial Yes or No if the items are fulfilled, fulfilled at times or not fulfilled, respectively. The total score gives the Quality Index.
NRSI, non-randomized studies of interventions; PICO, population, intervention, comparison, outcome; RCT, randomized controlled trial

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