Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2500™) in Detecting Traumatic Intracranial Hemorrhage in Uganda
Phase: NA
Conditions: Head Trauma, Crushing Skull Injury, Head Injury, Head Injuries, Multiple, Head Injuries, Closed, Head Trauma,Closed, Head Injury Major, Head Injury, Minor, Head Injury, Open, Injury, Craniocerebral, Injury, Head, Multiple Head Injury, Trauma, Head, Head Trauma Injury, Head Trauma, Penetrating, Craniocerebral Injury
Sponsor: Duke University

Assess me nt of Acc urac y, Precisi o n, a n d Feasi bilit y of a Ha n d hel d Near-I nfrare d
Li g ht De vice (I nfra Sca n ner 2 5 0 0 ™) i n Detecti n g Tra u matic I ntracra nial
He m orr ha ge i n U ga n da
D oc u me nt Date: 0 5/ 2 9/ 2 0 2 4
N C T 0 6 4 9 1 1 7 3

1 
1.
Title
Ass ess me nt of Acc urac y, Precisi o n, a n d Feasi bilit y of a Ha n d h el d Near- I nfrare d Li g ht 
De vice (I nfr a Sca n n er 2 5 0 0 ™) i n Detecti n g Tra u matic I ntracra nial H e m orr ha ge  i n 
U ga n da 
2.
St u d y Te a m
D u ke 
Pri nci pal I n v esti gat or: 
Bra dl e y K olls, M D, P h D 
C o -Pri nci pal I n v esti gat or: 
Al va n U kac h u k w u, M B B S, M S G H 
C o -Pri nci pal I n v esti gat or:  
Mic hael Ha gl u n d, M D, P h D, M A C M 
St u d y C o or di n at or:    
Yesel Trill o Or d o nez, B S  
M barar a  
Pri nci pal I n v esti gat or:     
Da vi d Kit ya,  M B C h B, M M E D, F C S  
St u d y C o or di n at or:     
J ose p hi ne Najj u ma,  R N, B N S, M N S 
3.
P ur p ose  of t he St u d y: T he p ur p ose of t his st u d y is t o deter mi ne t he s e nsiti vit y, s p ecificit y,
a n d p ositi ve a n d ne gati ve pre dicti ve v al ues of t he p orta ble near -i nfrare d-b ase d de vice ( p orta ble
NI R -base d  d e vice),  t he  I nfra Sca n ner  2 5 0 0 ™,  t o  detect  i ntracra nial  he m orr ha ge  (I C H)
sec o n dar y t o tra u m a pati e nts prese nti n g t o M barara Re gi o nal Referral H os pital ( M R R H) a n d
Ma ya nja Me m orial H os pital ( M M H)  w h o h a ve s ustai ne d or w h o are s us pecte d of ha vi n g
s ustai ne d hea d tra u m a.
4.
B ac k gr o u n d  a n d  Si g nific a nce:  I n  2 0 1 8,  a n  esti mate d  6 9  milli o n  i n di vi d uals  s ustai ne d
tra u matic  br ai n  i nj ur y  ( T BI),  wit h  t he  maj orit y  of  cases  ori gi nati n g  i n  L MI Cs.1, 2 Wit h
a p pr o xi matel y 9 0 % of all i nj ur y-relate d v e hic ular deat hs o cc urri n g i n L MI Cs, t his alrea d y
e n or m o us c has m i n m ort alit y is e x pecte d t o o nl y gr o w wi der as o btai na bilit y of p ers o n al m ot or
ve hicles b ur ge o ns at rates far e x cee di n g  L MI C  fac ulties t o b uil d le gislat orial, m u nici pal, a n d
me dical i nfrastr uct ur e ca pa ble of s u bsi di n g gr o wi n g i nci de nce of T BI.3 S u b-Sa hara n Africa’s
u n prece d e nte d scarcit y  of me dical res o urces is es peciall y pr o mi ne nt i n  ne ur ol o gical care. A s
of J ul y 2 0 2 3,  t her e are 0.1 5 ne ur os ur ge o ns per 1 0 0, 0 0 0 Africa ns. 4 T his ca n be c o ntraste d wit h
E ur o pe w h ere, per 1 0 0, 0 0 0 citize ns, t here e xist 1 7. 1 ne ur ol o gical b e ds, 4. 8 4 ne ur ol o gists, a n d
2. 4 3 ne ur os ur ge o ns – a r es pecti ve 5 7, 1 6 1, a n d 1 6 -f ol d res o urce dis parit y bet wee n t hes e t w o
c o nti ne nts. E ve n w he n c o m pare d  t o gl o bal a v era ges, t o w hic h Africa  a n d m yria d ot her L MI Cs
c o ntri b ute,  per  ca pita,  t he  w orl d’s  p o p ulati o n  be nefits  fr o m  great er  t h a n  1 2  ti mes  m ore
ne ur ol o gi cal b e ds, 3 0 ti mes  m ore ne ur ol o gists, a n d 5 6 ti mes  m ore n e ur os ur ge o ns p er ca pita
t ha n t he a ver a ge Africa n.5
I n U ga n da, a l o w-i nc o me c o u ntr y i n East Africa, T BI m ortalit y was esti mate d t o be 9. 6 %, wit h
m ortalit y rates of 4. 7 % f or patie nts wit h mil d a n d m o derate T BI a n d 5 5 % f or patie nts wit h
se vere T BI i n 2 0 1 6. 6, 7 I n U ga n da, m ot or bi kes per v a de t he la n dsca p e wit h m ot or bi ke acci de nts
c o ntri b uti n g t o a m aj orit y of t he c o u ntr y’s T BI. Bet wee n 2 0 1 0 a n d 2 0 1 7, M ula g o Nati o nal
Referr al H os pital sa w a d o u bli n g of fatal r oa d traffic i nj uries, fr o m 1 1. 6 % t o 2 2. 8 %. 8  Base d
u p o n t he li mite d literat ure re gar di n g T BI  wit hi n S S A, U ga n d a e x perie nces a m o n g t he hi g hest
rates of T BI a n d T BI-rel ate d m ortalit y i n t he w orl d. M ortalit y o ut c o mes at M R R H are hi g h, 6

2 
w here as m uc h as 5 0. 4 % of deat hs at  a sec o n dar y referral h os pital i n U ga n d a were f o u n d t o be 
d ue t o tra u ma, wit h a 7. 4 % m ortalit y rate f or t h ose a d mitte d. H ea d tra u ma, s pecificall y, 
re pres e nte d  6 8 %  of  all  tra u ma  deat hs  a n d  3 4. 3 %  of  all  deat hs  o verall.9 A  rece nt  st u d y  
c o n d ucte d i n t he i nte nsi ve car e u nit (I C U) at M barara Re gi o nal Referral H os pital ( M R R H), 
w hic h ser v es t he Wester n Re gi o n of U ga n da, n ort her n R wa n d a, easter n D e m ocratic Re p u blic 
of C o n g o, a n d n ort h west er n Ta nza nia, re veale d t h at h ea d i nj ur y acc o u nts f or 7 4 % of a d ult a n d 
6 9 % of pe diatric tra u ma cases, wit h a n o verall m ortalit y of 6 0 % f or patie nts a d mitte d t o t he 
I C U wit h hea d tr a u ma.6 F or c o m paris o n, a 2 0 0 6 U K st u d y s h o w e d t hat i n hea d i nj ur y patie nts 
re q uiri n g i nte nsi ve car e, 7 7 % s ur vi ve d t o lea ve t h e I C U a n d 6 7 % s ur vi ve d t o lea ve h os pital, 
a n I C U m ortalit y rate nearl y t hree -f ol d less t ha n t hat see n i n M barara.1 0 A 2 0 1 4 Fi nis h st u d y 
wit h a si milar I C U s ur vi va bilit y of 7 9 %, re p orte d a n a d diti o nal 1 2 % m ortalit y i n t he sa me 
p o p ulati o n at 6 -m o nt hs. W hile n o l o n g -t er m T BI s ur vi va bilit y dat a e xists f or L MI Cs, gra nte d 
s uc h si g nifica nt p ost-dis c har ge f atalit y i n setti n gs re plet e wit h v a n g uar d h ealt hcare res o urces 
a n d ar me d wit h r o b ust l o n g -ter m n ursi n g a n d re ha bilitati ve ca pacities. Li mite d tra ns p ortati o n 
a n d e mer ge nc y ser vices i nfrastr uct ure c o m p o u n d e xisti n g c ha lle n ges t o C T accessi bilit y.1 1 
U nf ort u natel y, C T sca n n ers are c urre ntl y a m o dalit y of c o nsi dera ble fi na nci al b ur de ns f or b ot h 
patie nt a n d g o v er n me nt al sect ors. Wit h t he a m o u nt o f li ves l ost d u e t o i naccessi bilit y of 
i m me diate brai n i ma gi n g i n L MI Cs, it is i m perati ve t o i de ntif y a n d vali date c ost-effecti ve 
alter nati ves t o C T sca ns.  
 
I n res o ur ce-li mite d setti n gs, tec h ni q ues s uc h as ultras o nic meas ure me nt of t he o ptic n er ve 
s heat hs a n d l ate nc y of t he p u pillar y refle x ha ve bee n us e d t o i nfer i ncrease d i ntracra nial 
press ure (I C P). H o w e ver, t hese tec h ni q ues are n ota bl y cr u d e as t he y pr o vi de n o i nsi g ht i nt o 
t he l ocati o n or eti ol o g y of t he i ncrease i n I C P. O ptic ner ve ultras o u n d is t y picall y p ositi ve o nl y 
o nce I C P > 3 0 m m H g ( n or mal 7 -1 5 m m H g) 1 2 b ut is n ota bl y p o or at c orrel ati vel y q u a ntif yi n g 
I C Ps as t he y gr o w e mer ge ntl y hi g h. O ptic ner v e s heat h dia meter meas ureme nts ta ke u p t o a 
da y  t o  ma nifest,  l o n g  after  irr e para ble  brai n  da ma ge  has  occ urre d.  He nce,  w hile  t hese  
m o dalities  ca n  c orr o b orate  i ncrease d  patie nt  I C P,  t hese  tec h ni q ues  are  i na de q u ate  i n  
deter mi ni n g w hic h patie nts sta n d t o be nefit fr o m s ur ger y wit hi n a reas o na ble ti mefra me a n d, 
f or t h ose w h o d o, i n i nf or mi n g t he s ur gical a p pr oac h t hat c o ul d sa ve s u c h a patie nt's life.  
 
I n 1 9 9 7, t he first e ver ha n d hel d de vice t hat c o ul d d efi nitel y det ect t he pres e nce a n d l ocati o n of 
e pi d ural a n d s u b d ural he mat o mas was i ntr o d uce d. I nitiall y n a me d t he R u n ma n, t he de vice was 
i nte n de d t o detect i ntracra nial he mat o mas i n re m ote a n d militar y setti n gs t o tria ge w hic h 
cas ualties  s h o ul d  be  airlifte d  t o  me dical  ce nters  e q ui p pe d  t o  offer  n e ur os ur ger y.  After  
n u mer o us iterati o ns, t he I nfra Sca n ner 1 0 0 0 ™ was i ntr o d uce d i n t he mi d -2 0 0 0s. I n 2 0 1 0, t he 
pi v otal  fi ve -site  d o u ble-bli n de d  cli nical  trial  was  p u blis he d  a n d  ulti matel y  le d  t o  F D A  
clear a nce of t h e I nfra Sca n ner 1 0 0 0 ™. I n t h e st u d y, t h e I nfrasca n ner 1 0 0 0 ™ meas ure me nts 
were c o m par e d t o C T sca ns of 3 6 5 patie nts, 9 6 of w hic h were h e mat o ma cases of vari o us sizes, 
de pt hs, a n d l ocati o ns. T he st u d y de m o nstrat e d hi g h se nsiti vit y ( 8 8 %) i n detecti n g h e mat o mas 
> 3. 5cc i n v ol u me a n d < 2. 5 c m fr o m t he s urface of t he brai n a n d a s p ecifi cit y of 9 1 %. Si nce 
t he n, t here h a ve b ee n n u mer o us st u dies t hat ha ve re plicate d t hes e res ults a n d ha ve s u bsta ntiate d 
t hat it is a ca pable t o ol f or pre h os pital dia g n osis of i ntracra nial he mat o mas ( 3 -1 3). W hile t hese 
res ults are pr o misi n g, t h e I nfra Sca n ner de vi ces’ utilit y has o nl y bee n e x a mi ne d t hr o u g h t he 
le ns of pre- h os pital decisi o n- ma ki n g.  
 

3 
I n 2 0 1 3, t he I nfra Sca n n er 2 0 0 0 ™ was i ntr o d uce d, pr o m pti n g o ur gr o u p t o vali date it i n a 
c o nsec uti ve seri es of 5 0 0 hea d i nj ur y p atie nts w h o o btai ne d a hea d C T sca n at D u ke U ni versit y 
H os pital ( D U H). F or all patie nts wit h C T -pr o ve n blee ds ( n = 1 0 4), irres pecti ve of size, i nitial 
NI R sca ns l ocalize d t he  blee d t o t he a p pr o priate q ua dra nt wit h a se nsiti vit y of 8 6 % a n d 
s pecificit y of 9 6 % c o m pare d t o a C T sca n. F or e xtra-a xial blee ds > 3. 5 ml, se nsiti vit y a n d 
s pecificit y wer e 9 4 % a n d 9 6 %, res pecti vel y. F or l o n git u di nal serial resca ns wit h t he NI R, 
se nsiti vit y was 8 9 % ( < 4 da ys fr o m i nj ur y: se nsiti vit y = 9 9 %) a n d s pecificit y was 9 6 %. T he 
de vice de m o nstr ate d 1 0 0 % se nsiti vit y f or all patie nts re q uiri n g cra ni ect o m y or cra ni ot o m y.  
 
Si nce t he D U H st u d y, o ur gr o u p i nitiate d a st u d y of 6 8 4 T BI patie nts at M barara Re gi o n a l 
Referr al H os pital ( M R R H) i n U ga n da usi n g t he I nfra Sca n n er 2 0 0 0 ™. F or all patie nts wit h C T -
pr o ve n  blee ds  ( n = 1 8 0),  irres p ecti ve  of  size,  i nitial  NI R  sca ns  l ocalize d  t he  blee d  t o  t h e  
a p pr o priate q ua dra nt wit h a se nsiti vit y of 8 9 % a n d s pecificit y of 3 8 % c o m p are d t o a C T sca n. 
T hese  fi n di n gs  greatl y differ  fr o m  t h e  D U H  d ata  set,  pr o m pti n g  o ur  tea m  t o  c o n d uct  a  
sec o n dar y a n al ysis of t he M R R H data. We f o u n d e vi de nce t o s u g gest t hat s ki n t o ne varia nce, 
a m o n g ot her patie nt c h ar acteristics, affects t he acc urac y of t h e near -i nfrare d-base d de vi ce.   
 
Pre vi o us  literat ure  f or  si milar  tec h n ol o g y,  s uc h  as  p ulse  o xi metr y,  has  s u g geste d  a n  
o veresti mati o n of S p O 2 i n dar k -s ki n ne d i n di vi d uals. 1 3 – 1 5 I n dar k-s ki n ne d i n di vi d uals, t he s ki n 
atte n uates near -I R m ore,1 6 a n d res ults i n m ore varia bilit y i n t he si g n al rea d bac k. 1 3 T hese 
c o m bi ne d ca n c o ntri b ute t o a wea ker detecti o n b y t he I nfrasca n ner 2 0 0 0 T M  se ns or a n d h e nce 
o ver- esti mati o n of S p O 2. I n t h e I nfrasca n ner 2 0 0 0 T M , t his hi g her near-I R atte n uati o n d ue t o 
t he dar k c ol or of t he s ki n c o ul d ha ve bee n t he s o urce of a p ositi ve rea d o ut. T his ma y acc o u nt 
f or t he a m o u nt of f alse p ositi ve res ults e nc o u ntere d. T his st u d y will d oc u me nt a n d ai m t o 
i ncl u de  re pres e ntati o n  of  p o p ulati o ns  wit h  dar ker  s ki n  t o nes  wit hi n  me dical  de vice  
de vel o p me nt, a matter t hat e xte n ds be y o n d NI R. 1 7 – 2 0 B y a d dressi n g raci al i ne q uities wit hi n 
de vice researc h  a n d d e v el o p me nts, we ca n stre n gt he n t h eir a p plica bilit y i n li mite d -res o urce 
c o nte xts. T he se nsiti vit y a n d s pecificit y of t he ne wer I nfra Sca n ner 2 5 0 0 T M , wit h its ne w 
al g orit h ms a dj usti n g f or s ki n t o ne varia nce, ha v e n ot bee n ri g or o usl y st u die d. Wit h t hese 
res ults, t he D u k e Gl o bal Ne ur os ur ger y a n d N e ur ol o g y ( D G N N) pr o p os es t o i nitiate a trial t o 
re plicate o ur D U H fi n di n gs i n a n L MI C: usi n g t he I nfrasca n ner 2 5 0 0 ™ i n t he bac k gr o u n d of 
t he c urre nt sta n d ar d of care t o q ua ntif y t he acc urac y of t he de vice – t he p ositi ve a n d ne gati ve 
pre dicti ve val ues – i n dia g n osi n g tra u matic I C H relati ve t o C T i n t he U ga n d a n setti n g.  
 
T he pr o p ose d st u d y a d dresses t he critical nee d f or e val uati n g a n d o pti mizi n g t he ha n d hel d 
near -i nfrar e d de vice's ( NI R) perf or ma nce i n dia g n osi n g i ntracra nial blee ds wit hi n t he di verse 
s ki n t o ne ra n ge pre val e nt i n l o w- a n d mi d dle-i nc o me c o u ntries ( L MI Cs), s u c h as U ga n d a. T his 
researc h is esse ntial t o e ns ure t hat NI R ca n be a hi g hl y se nsiti ve, s pecific, a n d re pr o d uci ble 
t o ol acr oss all p o p ulati o ns, re gar dless of s ki n t o ne. Gi ve n t he hi g her pre vale nce a n d m ortalit y 
rates ass oci ate d wit h T BI i n L MI Cs,1, 2 c o u ple d wit h li mite d healt hcare res o urces a n d t he l ac k  
of access t o C T s ca ns, 2 1 t he s uccessf ul a d a ptati o n of NI R tec h n ol o g y f or us e i n t hese setti n gs 
c o ul d i m pr o ve T BI ma n a ge me nt a n d i nf or m ne ur ocritical a n d ne ur os ur gi cal e vi de nce -bas e d 
decisi o n ma ki n g i n s etti n gs w h ere C T s ca n ni n g is u na vaila ble or i m practical. T o w or k t o war d 
t his, t his st u d y pr o p os es t o vali date t h e hi g h s e nsiti vit y, s pecificit y, acc urac y, a n d precisi o n of 
t he  I nfr a Sca n n er  2 5 0 0 ™ i n  detecti n g  tra u matic  i ntracra nial blee ds  w e  ha v e  pre vi o usl y  
de m o nstrate d wit h I nfra S ca n ner 2 0 0 0 ™ at D U H, i n patie nts prese nti n g t o M R R H a n d M M H. 

4 
If a ble t o detect i ntracra nial he mat o mas wit h efficac y si milar t o C T i n t he U ga n da n patie nt 
p o p ulati o n, t his data ca n be use d t o f or m ulate a f ut ure trial usi n g t he de vice as a dia g n ostic t o ol 
t o i nf or m s ur gical ma na ge me nt f or patie nts i n w hi c h o btai ni n g C T sca ns is n ot feasi ble.   
 
Ai m 1: Deter mi ne w het her t he I nfra Sca n n er 2 5 0 0 ™ detects i ntracra nial he m orr ha ge (I C H) 
wit h a de q uate precisi o n r elati ve t o C T sca ns t o b e use d as a n effecti ve tri a ge t o ol t o pri oritize 
i ma gi n g a n d n ee d f or le v el of cli nical m o nit ori n g i n a n Africa n, L MI C p o p ulati o n. 
 
Ai m 2: Use t hes e fi n di n gs t o e val uat e t he I nfra Sca n ner 2 5 0 0 ™'s a bilit y t o acc uratel y detect 
i ntracra ni al he m orr ha ges i n dar ker-s ki n n e d p o p ulati o ns wit hi n L MI Cs.   
 
 
Setti n g:  I n U ga n d a, as of 2 0 1 9 t here are 5 5 I C U be ds ma ki n g u p a rati o of 1. 3 I C U be ds p er 
milli o n p o p ulati o n. 2 2 1 2 g o ver n me nt ne ur os ur ge o ns, 2 3 a n d 1 1 trai ne d ne ur ol o gists t o ser ve, 2 4 
n ot acc o u nti n g f or t he si g nifica nt i nter nati o nal referrals recei v e d fr o m nei g h b ori n g c o u ntries, 
t he e ntire p o p ulati o n of 4 7. 2 milli o n pe o ple.2 5 M barara Re gi o nal Referral H os pital ( M R R H) is 
a g o ver n me nt o w ne d referral a n d teac hi n g h os pital f or M barara U ni versit y of Scie nce a n d T ec h n ol o g y 
me dical sc h o ol wit h a be d ca pacit y of 6 0 0. Ma ya nj a Me m orial H os pital ( M M H) is a pri vate, n ot -f or-
pr ofit h os pital wit h 1 0 0 be d ca pacit y i n M barara, U ga n da.  
 
5.  Desi g n, Pr o ce d ures , a n d Met h o ds: 
A pr os pecti ve c o h ort st u d y is t o be c o n d ucte d at t he M R R H Di visi o n of Ne ur os ur ge ry a n d  
Ma ya nja Me m orial H os pital ( M M H) fr o m Ma y 2 0 2 4 u ntil Ma y 2 0 2 5 or u ntil o ur sa m ple size 
has bee n met . Pr i or t o t he st u d y, a p pr o val fr o m t h e f oll o wi n g i nstit uti o ns a n d a d mi nistrati o ns 
will occ ur; D u ke U ni versit y I R B a p pr o v al, M barara U ni versit y of Scie n ce a n d T ec h n ol o g y 
( M U S T) I R B a p pr o v al, U ga n da Nati o nal  C o u ncil  f or Scie nce a n d Tec h n ol o g y ( U N C S T)  
a p pr o val, a n d ad mi nis trati ve a p pr o val fr o m b ot h h os pitals will be c ollecte d. 
 
Met h o ds & Pr oce d ures  
W he n a p plica ble (c o ns ci o us patie nt a n d/ or fa mil y or le gall y a ut h orize d re prese ntati ve ( L A R), 
t he st u d y will  be i ntr o d uce d t o t he patie nt  a n d rele va nt  parties bef ore t he researc h  tea m  
a p pr oac h es  t he p atie nt. W hile hea d tra u ma fre q ue ntl y res ults i n i m paire d c o g niti o n a n d/ or 
c o nsci o us ness,  a n d  d ue  t o  t he  ur ge nc y  of  t hese  circ u msta nces , patie nts  are  ofte n  n ot  
acc o m pa ni e d b y ki n, w h e ne ver a p pr o priat e, t he p ur p ose of t he re s earc h a n d t he pr oce d ure will 
be e x plai ne d i n detail  usi n g a n I R B -a p pr o v e d ver bal  c o nse nt  “s cri pt”, wit h all  q uesti o ns 
a ns wer e d t o t he patie nt’s a n d/ or re prese ntati ve’s satisfacti o n.  
 
U p o n prese nt ati o n t o t he c as u alt y u nit at M R R H or M M H  a n d/ or wit hi n 3 0 mi n utes pri or 
t o or f oll o wi n g a C T sc a n, t he st u d y te a m will a p pr o ac h t he p atie nt o r t he p atie nt’s L A R 
f or per missi o n t o sc a n t he p atie nt’s cr a ni u m wit h t he I nfr a Sc a n ner 2 5 0 0 ™ (I m a ge A ). If 
per missi o n is gra nte d, t he st u d y tea m me m ber will se q ue ntiall y mea s ure t he o ptical a bs or pti o n 
f or eac h of t he 8 q ua dr a nts of t he scal p (fr o ntal, te m p oral, pari etal, a n d o cci pital bilaterall y) 
(I m a ge B). T h e de vice is e n gi n eere d s uc h t hat t he li g ht e mitter a n d recei ver are s p ace d 4 c m 
a part, all o wi n g t he li g ht’s i nte nsit y t o b e meas ure d bet wee n a dj ace nt li g ht g ui des (I m a ge C). 
Parti n g c o m bs will be use d t o hel p access t h e s cal p o n patie nts wit h hair t hat pre v e nts t he 
fi ber o ptic ti ps fr o m dir ect c o ntact wit h t he s cal p. A la mi nate d s wat c h dis pla yi n g M o n k S ki n 
T o ne Or bs will be us e d f or later a nal ysis of s ki n t o ne o n t he M o n k S ki n T o ne Scale ( I m a ge 

5 
D ).2 6 T his e ntire pr oce d ure, i ncl u di n g greeti n g , sca n ni n g t he patie nt, s h o ul d ta ke < 1 0 mi n utes. 
Basic de m o gra p hics, ne ur o e x a m, a n d I nfra Sca n n er 2 5 0 0 ™ data will be e ntere d i nt o R E D Ca p 
( A p pe n di x A).  
 
T he c ollecti o n peri o d f or eac h res earc h s u bject c o ncl u des wit hi n 3 0 da ys  f oll o wi n g his or her 
i nitial  c o nse nt,  patie nt  or  L A R  decisi o n  t o  wit h dra w  fr o m  f urt her  partici pati o n,  h os pital  
disc har ge, or patie nt deat h , w hic he ver occ urs first.  
 
 
6.  Eli gi bilit y: A n y p atie nt a ge d 1 2 a n d u p w h o pres e nts t o M barara Re gi o nal Referral H os pital 
(M R R H) or Ma ya nja Me m orial H os pital ( M M H)  wit h s us pecte d hea d tra u ma, w h o is a ble t o 
or  w h o  has  a  L A R  w h o  is  a ble  t o c o nse nt  i n E n glis h, R u n ya n k ole ,  or  L u ga n da  will  be  
c o nsi dere d f or t his st u d y. After bei n g ma d e a ware of t he st u d y b y a p h ysicia n directl y cari n g 
f or t he patie nt a n d a greei n g t o hear m ore a b o ut t he st u d y, t he pr os pecti ve partici pa nt a n d/ or 
t he partici pa nt's L A R will be a p pr oac he d.  
 
7.  E xcl usi o n:   Patie nts  f or  w hic h  w o u n ds  t o  t heir  hea d  are  t o o  lar ge  t o  pr o perl y  us e  t he  
I nfra Sca n ner 2 5 0 0 ™ will be e x cl u de d fr o m t his st u d y. Patie nts will als o b e e x cl u de d if hair 
ca n n ot be a p pr o priatel y parte d t o all o w f or t he fi ber o ptic ti ps of t h e de vi ce t o m a ke direct 
c o ntact wit h t he scal p. Patie nts f or w h o m it is n ot p ossi ble t o o btai n a n I nfrasca n wit hi n 3 0 
mi n utes of t heir C T i ma gi n g will als o be e x cl u de d fr o m t he st u d y. 
 
8.  S u bject Recr uit me nt a n d C o m pe ns ati o n: P ote ntial researc h partici pa nts will be a p pr oac he d 
b y t he res ear c h tea m o nl y if gi v e n per missi o n b y t he p h ysici a n i n c h ar ge of t he patie nt’s care 
after h e or s h e has i nf or me d t he patie nt a n d/ or t he patie nt’s L A R of t he researc h a n d recei ve d 
a ver b al a gree me nt fr o m t he patie nt a n d/ or L A R t o hear m ore a b o ut t he researc h st u d y. E ac h 
partici pa nt will be c o m p e nsate d U G X 1 5, 0 0 0 ( $ 4) f or partici p ati o n i n t his st u d y. T he st u d y 
pers o n nel  will  be  trai ne d  i n  t he  c o nse nt  pr ocess  a n d  will  ma ke  it  a b u n da ntl y  clear  t hat  
a gree m e nt or ref usal t o p artici pate i n t he st u d y will n ot i nfl ue nce t he patie nt’s care i n a n y wa y.  
  
9.  C o nse nt Pr ocess: After bei n g ma de a w are of t he st u d y b y a p h ysicia n directl y cari n g f or t he 
pat ie nt a n d a gr eei n g t o hear m ore a b o ut t he st u d y, t he pr os pecti ve p arti ci pa nt a n d/ or t he 
partici pa nt's L A R will be a p pr oac h e d. U p o n a d missi o n t o M R R H f or s us pecte d hea d tra u ma, 
t he  patie nt’s  p h ysicia n  will  i ntr o d uce  t he  p atie nt  or  t he  patie nt’s  le gall y  a ut h orize d 
re pres e ntati ve t o t h e pr ese nce of t he st u d y. If t he c o nse nti n g p art y a grees t o hear a b o ut t h e 
st u d y, t he st u d y c o or di n at or or res earc h assista nt will greet t he p atie nt a n d s pea k wit h t he 
patie nt  a n d/ or le gall y a ut h orize d re prese ntati ve, t h or o u g hl y descri bi n g t he pr ot oc ol a n d reas o n 
f or t he st u d y. All c o nse nti n g st u d y pers o n nel will be trai ne d i n t he c o nse nt pr ocess a n d will 
pr o vi de a m ple reass ura n ce t o t h e patie nt or c o ns e nti n g p art y t h at t he d ecisi o n t o partici pate 
will n ot, i n a n y wa y, affect his/ he r me dical care. Care will be ta k e n t o t h or o u g hl y a ns wer all 
q uesti o ns pri or t o o btai ni n g fi nal c o nse nt. T he pati e nt a n d/ or le gall y a ut h ori ze d re prese ntati ve 
will be clearl y i nf or m e d t hat t he researc h pr ot oc ol is c o m pletel y o pti o nal, t hat partici pati o n 
will  n ot affect t he treat m e nt t he y recei ve, a n d t hat, s h o ul d t he y gi ve c o nse nt, t he y are free t o 
wit h dra w fr o m t h e st u d y at a n y ti me. Partici pa nts will ha ve t he o p p ort u nit y t o deci de o n t h eir 
i n v ol ve me nt i n t he st u d y u p u ntil t he y recei ve t heir first C T sca n at eit her h os pital, pr o vi de d 
t his decisi o n is ma de bef ore t he e n d of t he 3 0-mi n ute p ost -sca n wi n d o w. If t he y d o n ot c o nse nt 

6 
bef ore t h eir first C T sca n a n d o utsi de t his 3 0 -mi n ute ti mefra me, t he y will be i neli gi ble f or 
i ncl usi o n i n t he st u d y. Partici pa nts will be aff or de d ti me t o wit h dra w fr o m t he st u d y u p u ntil 
3 0 da ys f oll o wi n g i nitial c o nse nt or are disc har ge d fr o m me dical care. T he c o nse nt pr ocess 
will occ ur i n t he cas ualt y u nit at M R R H a n d  M M H  or t he M R R H i nte nsi ve care u nit (I C U). 
T he st u d y t ea m will be rea dil y a vaila ble t o t he pati e nt, le gall y a ut h orize d re prese ntati ve, a n d/ or 
patie nt’s relati ves t hr o u g h o ut t he st u d y f or a n y q u esti o ns or c o ncer ns t he y ma y h a ve.  
  
1 0.  S u bject’s C a p acit y t o Gi ve Le g all y Effecti ve C o nse nt: We e x pect t hat m ost of t he s u bjects 
will be ne ur ol o gicall y a n d/ or c o g niti vel y i m paire d d ue t o t he e xte nt of hea d i nj ur y, m ultis yste m 
tra u ma, a n d/ or me dical treat me nts. Si nce t his is a mi ni mal -ris k st u d y, w e will offer st u d y 
partici pati o n  t o  s u bjects  wit h  di mi nis he d  a bilities  if  t he y  h a ve  a  l e gall y  a ut h orize d  
re pres e ntati ve. F or patie nts wit h less se vere i nj uries a n d t h ose w h o are later h os pitalize d  wit h 
res ol vi n g i nj uries, we e x pect s u bjects t o be c o g niti vel y i ntact a n d ca p a ble of a ut o n o m o usl y 
ma ki n g d ecisi o ns a b o ut t heir r o uti ne me dical care. F or s u c h patie nts, t he y ca n c o nse nt wit h o ut 
t he nee d f or a le gall y a ut h orize d re pres e ntati ve. T he st u d y will als o be offere d t o p atie nts 1 2 
years of a ge a n d ol der. F or patie nts y o u n ger t ha n 1 8 years, we will o btai n asse nt fr o m t he 
s u bject, w he n he or s he is c o g niti vel y a ble, a n d c o nse nt fr o m t heir le gal re pres e ntati ves or 
pare nts.  
  
1 1.  St u d y I nter ve nti o ns: As descri be d a b o v e, wit hi n 3 0 mi n utes of eac h C T sca n, t he st u d y tea m 
will sca n t he st u d y s u bj ect’s cra ni u m wit h t he I nfra Sca n n er 2 5 0 0 ™. T h e pre vi o us m o del, 
I nfra Sca n ner 2 0 0 0 ™ (I m a g e A), s h o ws t he size of t he n o ni n vasi ve fi ber o ptic ti ps t hat ma ke 
c o ntact wit h t he scal p . T he I nfr a Sca n ner 2 5 0 0 ™ has a n i m pr o ve d al g orit h m e m be d de d i n t he 
ne w s oft ware, w hile t he har d ware mec ha nis ms of detecti o n re mai n u nc h a n ge d bet wee n t he 
I nfra Sca n ner 2 0 0 0 ™ a n d I nfr a Sca n n er 2 5 0 0 ™ m o dels.  T he st u d y tea m me m ber will use t he 
de vice t o se q ue ntiall y e mit li g ht t hr o u g h fi b er o pti c li g ht g ui des reste d u p o n t he patie nt's  s cal p 
s o t hat near-i nfr are d li g ht ca n be e mitte d i n eac h of t he q ua dra nts (I m a g e B). T he de vice is 
e n gi n eer e d s uc h t hat t he li g ht e mitter a n d recei ver are s pace d 4 c m a part, all o wi n g t he li g ht’s 
i nte nsit y t o b e meas ur e d bet wee n a djace nt li g ht g ui des (I m a ge C). T his e ntire pr oce d ure 
s h o ul d ta ke < 1 0 mi n utes.  
 
1 2.  De vice Descri pti o n/ Mec h a nis m:  T he f oll o wi n g d escri pti o n is a da pte d fr o m t he I nfra Sca n ner 
W hite Pa per 
2 7 : All bi ol o gical tiss ue is, t o a differi n g e xte nt, per mea ble t o electr o ma g n etic 
ra diati o n of differe nt fr e q ue ncies a n d i nte nsities. T his ca n als o be c o nsi dere d per mea bilit y t o 
p h ot o ns of differe nt e ner g y le vels. T his per mea bilit y t o electr o m a g netic e n er g y is t he basis of 
all i ma gi n g base d o n tr a ns missi o n/scatteri n g c h aract eristics s uc h as X -ra y, C T, a n d near-
i nfrare d (NI R) i ma gi n g. Fr o m t he pri nci ples of s pectr osc o p y, it is als o k n o w n t hat differe nt 
m olec ules a bs or b diff ere nt wa vele n gt hs of electr o ma g n etic ra diati o n ( w hi c h i s s y n o n y m o usl y 
referre d t o as li g ht at s h orter wa v ele n gt hs). Si milarl y, tiss ue scatters ra di ati o n t o differe nt 
de grees. T he I nfr asca n n er is c o ncer ne d wit h NI R i ma gi n g of t he h e m o gl o bi n m olec ules. Fr o m 
a n y li g ht s o ur ce, p h ot o ns f oll o w a c h aracteristic pat h t hr o u g h t h e tar get tiss ue bac k t o a detect or 
o n t he sa me a p pr o xi mate pla ne as t he s o urce. W hile t he li g ht is se verel y att e n uate d d ue t o t he 
scatteri n g a n d a bs or pti o n pr ocess, it is n o net heless e nc o de d wit h t he s pectr osc o pic si g n at ures 
of t he m olec ules e n c o u nt ere d e n r o ute t o t he det ect or ( I m a ge C).      
 

7 
T he  pri nci ple  use d  i n  i de ntif yi n g  i ntracra nial  he mat o mas  wit h  t he  I nfrasca n ner  is  t hat  
e xtra vasc ular bl o o d a bs or bs NI R li g ht m ore t ha n i ntra vasc ular bl o o d. T his is beca use t here is 
a greater ( us uall y 1 0 -f old) c o nce ntrati o n of h e m o gl o bi n i n a n ac ute h e mat o ma t ha n i n n or mal 
brai n tiss ue , w here bl o o d is c o ntai ne d wit hi n vessels. T he I nfrasca n n er c o m pares t he left  a n d 
ri g ht si des of t he brai n i n f o ur differe nt areas. T he a bs or b a nce of NI R li g ht is greater (a n d 
theref or e t he r eflect e d li g ht less) o n t he si de of t he brai n c o ntai ni n g a h e mat o ma t ha n o n t he 
u ni nj ure d si de. Wit h s pecifie d wa vele n gt h ra n ges, o ptical li g ht s o urce(s) or e mitter(s) a n d a 
p h ot o detect or ar e place d at a dista nce, all o wi n g pr o per NI R S a bs or pti o n meas ure me nts i n a 
desire d tiss ue v ol u me . T he wa vele n gt h of 8 0 5 n m  is se nsiti ve o nl y t o bl o o d v ol u me, n ot o x y ge n 
sat urati o n (I m a ge E).    
 
T he I nfr asca n ner is place d s uccessi vel y i n t he left a n d ri g ht fr o ntal ( F), t e m p oral ( T), p arietal 
( P), a n d o cci pital ( O) ar eas of t he hea d , a n d t he a bs or ba nce of li g ht is rec or de d. S pecifi call y, 
t he place me nt is as f oll o ws: 
 
Fr o ntal Left/ Ri g ht f ore h ea d, a b o v e t he fr o ntal si n us; Te m p oral I n t he Left/ Ri g ht te m p oral 
f ossa; Parietal A b o ve t he Left/ Ri g ht ear, mi d wa y b et wee n t he ear a n d t he mi dli ne of t he s k ull; 
Occi pital Be hi n d t he Left/ Ri g ht ear, mi d wa y b et wee n t h e ear a n d t he occi pital pr ot u bera nce 
(I m a ge B). 
 
T he differ e nce i n o ptical de nsit y ( Δ O D) i n eac h of t he f o ur s y m metrical areas is calc ulate d o n 
a pair-wise b asis fr o m t h e f oll o wi n g f or m ula:  
 
 
w here I N = t he i nte nsit y of reflecte d li g ht o n t he n or mal si de, I H = t he i nte nsit y of reflect e d 
li g ht o n t he he mat o ma si de.  
 
I n s u m mar y: T h e I nfr asca n ner i ncl u des t hree c o m p o ne nts: ( 1) t he Sca n ner, ( 2) t he Dis p osa ble 
S hiel d, a n d ( 3) a Cra dle. T he Sca n ner i ncl u des a safe NI R di o de laser a n d a silic o n d etect or. 
T he li g ht t o a n d fr o m t he laser a n d detect or is o pticall y c o u ple d t o t he patie nt’s hea d t hr o u g h 
t he dis p osa ble s hiel d o ptical fi bers. T he o ptical fi bers are l o n g e n o u g h t o reac h t hr o u g h h air 
a n d c o ntact t he scal p. T h e o ptical fi b ers are place d 4 c m a p art, all o wi n g o pti mal detecti o n of 
he mat o mas. T he e xte n de d fi ber o ptics eli mi nates t he nee d t o s ha v e off a n y hair. A n d b eca us e 
t he fi ber o ptic piece is dis p osa ble, it pre ve nts cr oss-c o nta mi nati o n. T he detecte d li g ht passes 
t hr o u g h a n o ptical NI R ba n d-pass filter i n or der t o mi ni mize bac k gr o u n d li g ht i nterfere n ce. 
Electr o nic circ u itr y is i ncl u de d t o c o ntr ol laser p o wer a n d t he detect or si g nal a m plifier gai n. 
T he detect or si g nal is di gitize d a n d a nal yz e d b y a si n gle b oar d c o m p uter, S B C, i n t he Sca n ner. 
T he S B C recei ves t he d ata fr o m t he d etect or a n d a ut o maticall y a dj usts t he setti n gs of t h e 
Sca n ner t o e ns ure g o o d d ata q ualit y. T he dat a is f urt her pr o cesse d b y t he S B C, a n d t he res ults 
are dis pla ye d o n t he s cree n. A R ea d o ut of t he s ca n pr o vi des i nf or mati o n o n t he se v erit y of a 
he mat o ma a n d i de ntifies t he re gi o n of t he brai n blee di n g. A  hi g her o pti cal de nsit y i n t he 
sca n ne d r e gi o n i n dicates a lar ger he mat o ma. 2 7 
 

8 
1 3.  Ris k/ Be nefit Assess me nt:  T here are n o k n o w n healt h ris ks ass ociate d wit h t he use of NI R. 
All data  o bt ai ne d wit h t h e I nfrasca n ner 2 5 0 0 ™ will be bli n de d fr o m p h ysi cia ns partici pati n g 
i n t he care of st u d y patie nts t o e ns ure t here is n o de viati o n fr o m t he sta n dar d of care. W hile 
t here  ar e  neit her  a n y  s pecific  direct  cli nical  be nefits  t o  t he  researc h  partici pa nt  t hr o u g h  
partici pati o n i n t his st u d y, t he i n v ol ve me nt ma y pr o vi de si g nifica nt f ut ure be nefits t o t he 
c o m m u nit y  a n d  e n h a nce  T BI  care  i n  U ga n da  a n d  L MI Cs  gl o ball y.  T his  c o ntri b uti o n  t o  
a d va nci n g m e dical k n o wle d ge a n d i m pr o vi n g T BI m a na ge me nt strat e gies  u n ders c ores t he 
i m p orta nce of p artici pati o n. Partici pa nts will be c o m pe nsate d a p pr o xi matel y U G X 1 5, 0 0 0 ( $ 4 
U S D) f or t heir c o ntri b uti o n t o t his val ua ble researc h eff ort. 
 
1 4.  C osts t o t he S u bject: N o a d diti o nal c osts t o t he patie nt will be i nc urre d as a res ult of t his a d d -
o n researc h pr ot o c ol.  
 
1 5.  St atistic al C o nsi der ati o ns: O bjecti ves: T he pri m ar y o bjecti ve of t his st u d y is t o esti mate t he 
test c haract eristics (se nsiti vit y, s pecificit y, a n d t h e false p ositi ve a n d false ne gati ve rates) of 
t he  p orta ble  NI R-bas e d  de vice  (I nfra Sca n ner  2 5 0 0 ™)  i n  t he  i d e ntificati o n  of  a n y  size  
he mat o ma a m o n g patie nts h os pitalize d at M R R H or M M H w h o ha v e s ustai ne d or w h o are 
s us pecte d of h a vi n g  s ust ai ne d hea d tra u ma. C T s ca n  res ults will ser ve as t he g ol d sta n dar d. 
T he  se nsiti vit y,  s pecificit y,  a n d  false  p ositi ve  a n d  false  ne gati ve  rates  will  be  esti mate d. 
C o nti n u o us  varia bles  will  be  s u m marize d  wit h  mea ns/ me dia ns,  sta n dar d  de viati o ns,  a n d  
ra n ges, a n d  will  be a nal yz e d usi n g on e -w a y a n al ysis  of v aria n ce ( A N O V A).  Cate g orical  
varia bles will be s u m marize d wit h fre q ue nc y c o u nts a n d perce nta ges a n d a nal yze d usi n g t he 
χ² test or Fis her’s e x act test w here a p pr o priate.  Se nsiti vit y, s p ecificit y, false -p ositi ve, a n d fals e -
ne gati ve val u es  will be calc ulate d f or I nfra Sca n ner 2 5 0 0 ™ vers us C T as a g ol d sta n d ar d, wit h 
a n esti mate d 9 5 % c o nfi d e nce i nter val ( CI). Recei ver o p erati n g c haracteristic ( R O C) c ur ves 
a n d area u n der t he c ur v e ( A U C) wit h 9 5 % CI will be pl otte d. L o gistic  re gressi o n will be fit t o 
e x a mi ne t he ass ociati o n bet wee n I nfra Sca n ner 2 5 0 0 ™ res ults (c o n diti o ne d o n C T res ults) a n d 
p ote ntial c o nf o u n ders s uc h as a ge, se x, s ki n c ol or, hair le n gt h, hairst yl e , sk ull fract ure, scal p 
lacer ati o n, p ol ytr a u ma, a n d scal p he mat o ma. Mi ni m u m bl o o d v ol u me detecte d as p ositi ve b y 
I nfra Sca n ner 2 5 0 0 ( mi ni m u m res ol uti o n) will be re p orte d. All statistical tests will be t w o-
si de d,  a n d  si g nifi ca nce  will  be  assesse d  at  α  =  0. 0 5.  A nal ys es  will  be  perf or me d  usi n g  R 
( B ost o n, M A). 
 
A sec o n dar y o bjecti ve is t o esti mate t he test c haracteristics of t he I nfra Sca n ner 2 5 0 0 ™ i n t he 
i de ntificati o n of he mat o mas wit hi n its detecti o n li mits ( v ol u me > 3. 5 m L a n d de pt h < 2. 5 c m) 
c o m pare d t o C T sca n res ults as t he g ol d sta n dar d. 
 
E x pl orat or y o bjecti ves i n cl u de: 
1.  E x a mi ni n g t he i m pact of fact ors s uc h as he m at o ma t y pe, l o cati o n, patie nt a ge, a n d s ki n 
t o ne o n test c har acteristics of t he I nfra Sca n n er 2 5 0 0 ™ 
2.  Deter mi ni n g t h e mi ni m u m res ol uti o n detecta ble b y t he I nfra Sca n ner 2 5 0 0 ™ 
3.  A nal yzi n g t he effects  of  e xtracra nial  he ma t o mas, lacerati o ns, a n d s welli n g o n t he 
de vice's perf or ma n ce c haracteristics  
4.  Esti mati n g Recei ver O perati n g C haract eristic ( R O C) c ur ves  
  
St u d y Desi g n:  

9 
a)  Eli gi bilit y:  
A n y p atie nt a ge d 1 2 a n d u p w h o prese nts t o M R R H or M M H wit h a s us pecte d hea d 
tra u ma sca n will b e c o nsi dere d f or t his st u d y. Bas e d o n pre vi o usl y re p orte d data, we 
e x pect  t hat  tr ue  he mat o ma  will  be  prese nt  i n  a p pr o xi matel y 4 6 %  of  p artici pa nts  
o verall. 2 8 
 
b)  Sta n dar d of c o m paris o n: 
All patie nts e ntere d i nt o t he trial will ha ve u n der g o n e o ne cra ni al C T sca n pri or t o  
e nr oll me nt a n d will be c o nse nte d f or t he st u d y. All patie nts e nr olle d will u n der g o o ne 
cra nial sca n usi n g t he I nfra Sca n ner  2 5 0 0 ™ wit hi n 3 0 mi n utes of t he C T sca n . Patie nts 
a n d care pr o vi ders will b e bli n de d t o t he res ults of I nfra Sca n ner 2 5 0 0 ™. T h e sta n dar d 
f or  c o m paris o n  will  be  deter mi ne d  as  f oll o ws.   A  C T  res ult  t hat  is  p ositi ve  f or  
he mat o ma will be c o nsi dere d a tr u e p ositi ve, a n d a C T res ult t hat is n e gati ve f or 
he mat o ma will be c o nsi d ere d a tr ue ne gati ve.  
 
Defi niti o ns of Se nsiti vit y, S pecificit y, False P ositi ve, False Ne gati ve:  
Let T +  de n ote t he e ve nt t hat t he test is p ositi ve f or he mat o ma, a n d D +  de n ote t he e ve nt 
t hat a h e mat o ma is pres e nt. Se nsiti vit y, P( T+ / D+ ), will be defi ne d f or eac h patie nt's 
I nfra Sca n ner r es ults as t he pr o ba bilit y t hat a tr ue he mat o ma, as deter mi ne d b y a C T 
sca n, will be detecte d.  Si milarl y, let T - de n ot e t h e e v e nt t hat t he test is ne gati ve f or 
he mat o ma a n d D - d e n ote t he e v e nt t hat a h e mat o ma is n ot prese nt. 2 9 S pecificit y, P( T -
/ D-), will be defi ne d as  t he pr o ba bilit y of bei n g ne gati ve f or a he mat o ma o n t he 
I nfra Sca n ner 2 5 0 0 ™ sca n wit hi n 3 0 mi n utes of C T gi v e n t he p atie nt has n o he mat o ma 
prese nt.   
 
T he false p ositi ve rate will be defi ne d as P F +  = P( D -/ T+ ) = P( T+ / D-)[ 1-P( D + )]/ P( T+ ).  
Si milarl y,  t he  f alse  n e gati ve  rat e  will  be  d efi ne d  as  P F-  =  P( D + / T-)  =  [ 1-
P( T + / D+ )] P( D+ )/[ 1-P( T + )].  Esti mates f or t he false p ositi ve a n d fals e ne gati ve rates will 
be pr o vi de d f or a r a n ge of val ues f or t h e pre v ale nce of he mat o mas.  
 
c)  Sa m ple Size  
C o m p uta ti o n of t he re q uire d n u m ber of patie nts is base d o n esti mati n g t he se nsiti vit y 
of eac h met h o d t o wit hi n at m ost +/ - 0. 0 9 9 wit h 9 5 % c o nfi d e nce.  T h e 9 5 % c o nfi de nce 
i nter val f or t he se nsiti vit y base d o n pre vi o us fi n di n gs,2 8 a n d t he sa m ple size calc ulat or 
pr o vi de d. 2 9, 3 0 
 
Wit h 8 4 patie nts wit h p ositi ve fi n di n gs of he mat o ma (i.e. C T - pr o ve n I C H), se nsiti vit y 
ca n be esti mate d t o be wit hi n at m ost +/ - 0. 0 9 9 wit h 9 5 % c o nfi de n ce. 3 1  Ass u mi n g 
4 6 % of patie nts ha ve tr u e he mat o mas detecte d, 2 8 1 7 1 patie nts w h o o btai n C T sca ns 
m ust be accr u e d. Acc o u nti n g f or t his, a n d all o wi n g f or a 5 % dr o p o ut rate t he re q uire d 
sa m ple size f or t his trial is 1 8 0 t otal s u bjects.2 9, 3 0 We esti mate t hat 5 0 % of T BI p atie nts 
will o btai n C T sca ns, t h us a p pr o xi matel y 3 6 0 T BI p atie nts will prese nt t o M R R H 
a n d/ or M M H t o reac h o ur desire d sa m pl e size.  
 
 
d)  Recr uit me nt a n d Rete nti o n  

1 0  
It is a ntici pate d t hat of all partici pa nts > 1 2 years of a ge t hat prese nt wit h s us pecte d 
T BI, at least 4 0 patie nts per m o nt h will be accr ue d . St u d y e nr oll me nt s h o ul d t h us be 
c o m plete d wit hi n a p pr o xi matel y 1 0 m o nt hs. T he c ollecti o n peri o d f or eac h researc h 
s u bject  c o ncl u des  wit hi n  3 0  da ys  f oll o wi n g  t heir  i nitial  c o nse nt,  patie nt  or  L A R  
decisi o n t o wit h dra w fr o m f urt her p artici pati o n, h os pital disc har ge, or patie nt deat h; 
w hic he ver o cc urs first.  
 
1 6.  D at a  a n d  S af et y  M o nit ori n g:  Patie nts  will  be  u n der  c o nti n u o us  s u per visi o n  d uri n g  t he  
e ntiret y of eac h data c ollecti o n peri o d. O utsi de t he ~ 1 0 -mi n ute wi n d o w of t he data c ollecti o n 
peri o d, t he patie nt is n ot s u bjecte d t o a n y researc h i nter ve nti o n or i nfl ue nc e d b y t he researc h 
i n a n y wa y. As p art of t h eir treat me nt, p atie nts will be u n der h os pital care f or t he dia g n oses f or 
w hic h t he y wer e a d mitte d, a n d t h e researc h tea m will be i n c o nti n ual c o ntact wit h t he tea m 
re gar di n g t heir cli nical stat us a n d e nr oll me nt i n t he st u d y. 
 
T he PI will be res p o nsi ble f or sec uri n g a n d m o nit ori n g t he data, i ncl u di n g a q uarterl y re vi e w 
of data st ora ge pr oce d ures. 
 
1 7.  Pri v a c y, D at a St or a g e, a n d C o nfi de nti alit y: Patie nts will be n u m bere d as e x peri me ntal 
s u bjects. Data will be st ore d i n a sec ure d ata bas e. F or a n al ysis, d ata will be f ull y de -i de ntifie d. 
E x peri me nters’ n otes will be st ore d i n a l oc ke d ca bi net i n t he PI's office i n t he De part me nt of 
Ne ur os ur ger y a n d i n di gital f or m o n t he D H T S- m ai ntai ne d ser v er.  
 
1 8.  Li mit ati o n of st u d y  
T his st u d y will n ot i ncl u de patie nts w h os e i nj uries i m pe de t he use of t he d e vice o nt o t h e scal p 
w hic h ma y e x cl u de T BI cases of gr eater se v erit y, p ote ntiall y biasi n g res ults t o war ds less se v ere 
T BI cases.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A B B R E VI A TI O N S LI S T  
 
M R R H - M barar a Re gi o nal Referral H os pital  

1 1  
M M H - Ma ya nja Me m orial H os pital  
T BI - Tra u matic Brai n I nj ur y  
L MI C - L o w - a n d Mi d dle-I nc o m e C o u ntr y 
S S A - S u b- Sa hara n Africa  
D U H - D u ke U ni v ersit y H os pital 
D H T S - D u ke Healt h Tec h n ol o g y S ol uti o ns   
C T - C o m p uter T o m o gr a p h y  
S p O 2 - O x y ge n Sat urati o n  
S B C - si n gle b oar d c o m p uter 
L A R - fa mil y or le gall y a ut h orize d re pres e ntati ve 
 
 
 
 
 
 
 
 
 
 
 
I ma ge A  - Dis pla y of I nfrasca n n er de vi ce wit h e x a m ple of fi ber -o ptic ti ps ma ki n g c o nt act 
wit h scal p. T he sca n n er i ncl u des a saf e NI R di o de laser a n d a silic o n detect or. T he li g ht t o a n d 
fr o m t he laser a n d detect or is o pticall y c o u pl e d t o t he patie nt’s hea d t hr o u g h t he dis p osa ble 
s hiel d o ptical fi bers. T he o ptical fi bers are l o n g e n o u g h t o reac h t hr o u g h h air a n d c o ntact t he 
scal p. T he o ptical fi b ers are place d 4 c m a part 
 
I ma ge B - Hea d l ocati o n of I nfr asca n n er Meas ure me nts. T he I nfrasca n n er is place d 
s uccessi vel y i n t he left a n d ri g ht fr o ntal ( F), te m p oral ( T), p arietal ( P), a n d occi pital ( O) areas 
of t he hea d, a n d t he a bs or ba nce of li g ht is rec or d e d. 
 
I ma ge C  - De picti o n of li g ht pat h fr o m fi b er o ptic s o urce t hr o u g h t he s cal p i nter me diate tiss ue 
a n d t hr o u g h t he fi ber o pti c detect or.  Fr o m a n y li g ht s o urce, p h ot o ns f oll o w a c haracteristic 
pat h t hr o u g h t he t ar get tiss ue bac k t o a d etect or o n t he sa me a p pr o xi mate pla ne as t he s o urce. 
W hile t he li g ht is se verel y atte n u ate d d ue t o t he s catteri n g a n d a bs or pti o n pr ocess, it is 
n o net heless e nc o d e d wit h t he s pectr osc o pic si g n at ures of t he m olec ules e n c o u ntere d e n r o ute 
t o t he detect or. 
 
I ma ge D - T h e scale s ki n t o ne will be meas ure d a gai nst wit h 1 bei n g t he li g htest a n d 1 0 b ei n g 
t he dar kest  
 
I ma ge E  -  T h e bl ue li ne de picts t he detect e d NI R wa vele n gt h at 8 0 5 n m a n d t he a bs or pti o n 
fact or is dis pla ye d t o be s e nsiti ve o nl y t o bl o o d v ol u me at 8 0 5 n m. 
 
I ma ge A  

1 2  
 
 
 
I ma ge B  
 
 
 
I ma ge C  
 
 
 
I ma ge D - M O N K S KI N T O N E S C A L E ( 1 - 1 0) 

1 3
I ma ge E
A p pe n di x A  

1 4  
V ari a bl e  
T y p e  
D e s cri pti o n  
FI T B R H ar m o ni z ati o n - 
V ari a bl e N a m e  
fi ni s h e d 
T/ F  
D et ail s if t h e s ur v e y w a s 
c o m pl et e d  
 
r a 
T e xt E ntr y  
N a m e of R e s e ar c h 
A s si st a nt c o m pl eti n g t h e 
s ur v e y  
 
n a m e  
T e xt E ntr y  
N a m e of p ati e nt  
 
i d 
T e xt E ntr y  
St u d y I D n u m b er of 
p ati e nt  
S u bj e ctI D N u m  
a g e  
N u m eri c  
A g e of p ati e nt  
A g e Yr s  
s e x  
M/ F  
S e x of p ati e nt  
G e n d er T y p  
s ki n t o n e  
N u m eri c  
M o n k S ki n T o n e S c al e 
( 1-1 0)  
 
r e gi o n 
Dr o p d o w n  
R e gi o n of U g a n d a w h er e 
p ati e nt li v e s  
C ntr y R e s d n c e N a m e  
di stri ct  
Dr o p d o w n  
Di stri ct of U g a n d a w h er e 
p ati e nt li v e s  
 
c o u ntr y _ ot h er  
T e xt E ntr y  
C o u ntr y of r e si d e n c e if 
n ot U g a n d a  
C ntr y R e s d n c e N a m e  
st u d y _ sit e  
Dr o p d o w n  
N a m e of sit e w h er e 
p ati e nt e nr oll e d  
Sit e N a m e  
a d mit _ m o nt h  
Dr o p d o w n  
M o nt h of a d mi s si o n  
Vi sit D at e  
a d mit _ d a y  
Dr o p d o w n  
D a y of t h e m o nt h of 
a d mi s si o n  
Vi sit D at e  
a d mit _ y e ar  
Dr o p d o w n  
Y e ar of a d mi s si o n  
Vi sit D at e  
a d mit _ h o ur s  
N u m eri c  
H o ur of a d mi s si o n ( u si n g 
2 4 h o ur ti mi n g)  
S cr e e n Vi sit D at e Ti m e  
a d mit _ mi n s  
N u m eri c  
Mi n ut e of t h e h o ur of 
a d mi s si o n ( u p t o 5 9 
mi n s)  
S cr e e n Vi sit D at e Ti m e  
t e m p 
N u m eri c  
T e m p er at ur e o n 
a d mi s si o n  
 
a d mit _ e y e  
N u m eri c  
A d mit G C S e y e o p e ni n g  G C S E y e R e s p n s S c al e  
a d mit _ v er b al  
N u m eri c  
A d mit G C S v er b al  
G C S V er b al R s p n s S c al e  
a d mit _ m ot or  
N u m eri c  
A d mit G C S m ot or  
G C S M ot or R e s p n s S c al e  
a d mit _ g c s  
N u m eri c  
A d mit G C S t ot al  
G C S T ot al S c or e  
n e ur o _ m o nt h  
Dr o p d o w n  
M o nt h of  n e ur o e x a m  
 
n e ur o _ d a y  
Dr o p d o w n  
D a y of t h e m o nt h of 
n e ur o e x a m  
 
n e ur o _ y e ar  
Dr o p d o w n  
Y e ar of n e ur o e x a m  
 
n e ur o _ h o ur s  
N u m eri c  
H o ur of n e ur o e x a m 
( u si n g 2 4 h o ur ti mi n g) 
 
n e ur o _ mi n s  
N u m eri c  
Mi n ut e of t h e h o ur of 
n e ur o e x a m ( u p t o 5 9 
mi n s)  
 

1 5  
i nfr a _ e y e 
N u m eri c  
I nfr a s c a n n er G C S e y e 
o p e ni n g  
G C S E y e R e s p n s S c al e  
i nfr a _ v er b al 
N u m eri c  
I nfr a s c a n n er G C S v er b al G C S V er b al R s p n s S c al e  
i nfr a _ m ot or 
N u m eri c  
I nfr a s c a n n er G C S m ot or G C S M ot or R e s p n s S c al e  
i nfr a _ g c s 
N u m eri c  
I nfr a s c a n n er G C S t ot al 
G C S T ot al S c or e  
i nj ur y _ m o nt h 
Dr o p d o w n  
M o nt h of T BI  
I nj D at e Ti m e 
i nj ur y _ d a y 
Dr o p d o w n  
D a y of t h e m o nt h of T BI  
I nj D at e Ti m e 
i nj ur y _ y e ar 
Dr o p d o w n  
Y e ar of T BI  
I nj D at e Ti m e 
i nj ur y _ h o ur s 
N u m eri c  
H o ur of n e ur o e x a m 
( u si n g 2 4 h o ur ti mi n g) 
 
i nj ur y _ mi n s 
N u m eri c  
Mi n ut e of t h e h o ur of 
n e ur o e x a m ( u p t o 5 9 
mi n s)  
 
h air _ s c al p _ a c c e s s  
Y/ N  
h air st at u s o c c ul d e s 
a c c e s s t o s c al p  
 
h air _ s c al p _ a c c e s s _r e a s o
n 
T e xt E ntr y  
T e xt e ntr y if h air st at u s 
di d n ot all o w f or a c c e s s t o 
s c al p  
 
tr a u m a 
Dr o p d o w n  
C a u s e of tr a u m a  
 
tr a u m a _ ot h er 
T e xt E ntr y  
T e xt e ntr y if c a u s e of 
tr a u m a w a s n ot li st e d 
 
p ol ytr a u m a  
Y/ N  
P ol ytr a u m a pr e s e nt  
 
rt a 
Dr o p d o w n  
C a u s e of r o a d tr affi c 
a c ci d e nt  
 
rt a _ ot h er 
T e xt E ntr y  
T e xt e ntr y if c a u s e of 
R T A w a s n ot li st e d  
 
s c al p  
Y/ N  
S c al p or f a c e h e m at o m a 
pr e s e nt  
 
s c al p _t e xt  
T e xt E ntr y  
L o c ati o n of s c al p  or f a ci al 
h e m at o m a  
 
f a ci al _ bl e e d 
M ulti -s el e ct  
Bl e e di n g fr o m e y e s, 
e ar s, or n o s e pr e s e nt  
 
s k ull  
Y/ N  
S k ull fr a ct ur e pr e s e nt  
 
s k ull _ b o n e s  
M ulti -s el e ct  
L o c ati o n of s k ull fr a ct ur e   
s c al p _i nj ur y  
Y/ N  
O p e n s c al p i nj ur y 
pr e s e nt  
 
s ur g er y _ pl a n n e d  
Y/ N  
A s ur g er y w a s pl a n n e d  
 
s ur g er y  
Y/ N  
A s ur g er y w a s c o m pl et e d   
s ur g er y _ m o nt h  
Dr o p d o w n  
M o nt h of s ur g er y  
 
s ur g er y _ d a y  
Dr o p d o w n  
D a y of t h e m o nt h of 
s ur g er y  
 
s ur g er y _ y e ar  
Dr o p d o w n  
Y e ar of s ur g er y  
 
s ur g er y _t y p e  
M ulti -s el e ct  
T y p e of s ur g er y 
p erf or m e d  
 
s ur g er y _t y p e _ ot h er  
T e xt E ntr y  
T e xt e ntr y if s ur g er y t y p e 
n ot li st e d  
 

1 6  
ct  
Y/ N  
A C T w a s c o m pl et e d  
 
ct _ m o nt h  
Dr o p d o w n  
M o nt h of C T  
 
ct _ d a y  
Dr o p d o w n  
D a y of t h e m o nt h of C T  
 
ct _ y e ar  
Dr o p d o w n  
Y e ar of C T  
 
ct _ h o ur s  
N u m eri c  
H o ur of C T ( u si n g 2 4 
h o ur ti mi n g)  
 
ct _ mi n s  
N u m eri c  
Mi n ut e of t h e h o ur of C T 
( u p t o 5 9 mi n s) 
 
ct _ n o  
M ulti -s el e ct  
D et ail s w h y a C T w a s n ot 
c o m pl et e d  
 
ct _ n o _ ot h er  
T e xt E ntr y  
T e xt e ntr y f or n o C T if 
n ot li st e d  
 
i nfr a _ 1 _ m o nt h 
Dr o p d o w n  
M o nt h of fir st 
i nfr a s c a n n er 
 
i nfr a _ 1 _ d a y 
Dr o p d o w n  
D a y of t h e m o nt h of fir st 
i nfr a s c a n n er 
 
i nfr a _ 1 _ y e ar 
Dr o p d o w n  
Y e ar of fir st i nfr a s c a n n er   
i nfr a _ 1 _ h o ur s 
N u m eri c  
H o ur of fir st i nfr a s c a n n er 
( u si n g 2 4 h o ur ti mi n g) 
 
i nfr a _ 1 _ mi n s 
N u m eri c  
Mi n ut e of t h e h o ur of fir st 
i nfr a s c a n n er ( u p t o 5 9 
mi n s)  
 
i nfr a _ 1 _ p o siti v e 
Y/ N  
Fir st i nfr a s c a n n er wit h a 
p o siti v e r e s ult  
 
i nfr a _ 1 _fr o nt al 
N u m eri c  
Fir st i nfr a s c a n n er 
n u m eri c r e s ult i n fr o nt al 
ar e a  
 
i nfr a _ 1 _ p ari et al 
N u m eri c  
Fir st i nfr a s c a n n er 
n u m eri c r e s ult i n p ari et al 
ar e a  
 
i nfr a _ 1 _t e m p or al 
N u m eri c  
Fir st i nfr a s c a n n er 
n u m eri c r e s ult i n 
t e m p or al ar e a 
 
i nfr a _ 1 _ o c ci pit al 
N u m eri c  
Fir st i nfr a s c a n n er 
n u m eri c r e s ult i n o c ci pit al 
ar e a  
 
o ut c o m e _ m o nt h  
Dr o p d o w n  
M o nt h of o ut c o m e  
 
o ut c o m e _ d a y  
Dr o p d o w n  
D a y of t h e m o nt h of 
o ut c o m e  
 
o ut c o m e _ y e ar  
Dr o p d o w n  
Y e ar of o ut c o m e  
 
o ut c o m e  
Dr o p d o w n  
O ut c o m e of p ati e nt  
 
di s c _ e y e  
N u m eri c  
Di s c h ar g e G C S e y e 
o p e ni n g  
G C S E y e R e s p n s S c al e  
di s c _ v er b al  
N u m eri c  
Di s c h ar g e G C S v er b al  
G C S V er b al R s p n s S c al e  
di s c _ m ot or  
N u m eri c  
Di s c h ar g e G C S m ot or  
G C S M ot or R e s p n s S c al e  
di s c _ g c s  
N u m eri c  
Di s c h ar g e G C S t ot al  
G C S T ot al S c or e  

1 7  
g o s e  
N u m eri c  
G O S E o n di s c h ar g e  
Gl a s g o w O ut c o m e S c al E xt S c
or e  
ct _ p o s  
Y/ N  
C T wit h p o siti v e fi n di n g s   
ct _fl  
Dr o p d o w n  
T y p e of bl e e d o n C T 
fr o nt al l eft 
 
ct _fr  
Dr o p d o w n  
T y p e of bl e e d o n C T 
fr o nt al ri g ht 
 
ct _ pl  
Dr o p d o w n  
T y p e of bl e e d o n C T 
p ari et al l eft  
 
ct _ pr  
Dr o p d o w n  
T y p e of bl e e d o n C T 
p ari et al ri g ht  
 
ct _tl  
Dr o p d o w n  
T y p e of bl e e d o n C T 
t e m p or al l eft 
 
ct _tr  
Dr o p d o w n  
T y p e of bl e e d o n C T 
t e m p or al ri g ht 
 
ct _ ol  
Dr o p d o w n  
T y p e of bl e e d o n C T 
o c ci pit al l eft  
 
ct _ or  
Dr o p d o w n  
T y p e of bl e e d o n C T 
o c ci pit al ri g ht  
 
ct _l o c  
Dr o p d o w n  
L o c ati o n of bl e e d o n C T   
ct _ s z  
Y/ N  
Si z e wit hi n d e vi c e li mit s  
 
ct _ d e pt h  
Y/ N  
D e pt h wit hi n d e vi c e li mit s   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1 8  
Bi bli o gr a p h y  
1.  
De wa n M C, Ratta ni A, G u pta S, et al. Esti mati n g t he gl o b al i nci de nce of tra u matic brai n 
i nj ur y. J Ne ur os ur g . 2 0 1 8; 1 3 0( 4): 1 0 8 0- 1 0 9 7. d oi: 1 0. 3 1 7 1/ 2 0 1 7. 1 0.J N S 1 7 3 5 2 
2.   
Veer a p pa n V R, G a briel PJ, S hl o bi n N A, et al. Gl o bal Ne ur os ur ger y i n t he C o nte xt of 
Gl o bal P u blic Healt h Practice -A Literat ure R e vie w of Case St u dies. W orl d Ne ur os ur g . 
2 0 2 2; 1 6 5: 2 0- 2 6. d oi: 1 0. 1 0 1 6/j. w ne u. 2 0 2 2. 0 6. 0 2 2  
3.   
Or ga nizati o n W H. Gl o b al St at us Re p ort o n R o a d S afety 2 0 1 8 . W orl d Healt h Or ga nizati o n; 
2 0 1 9: 4 1 9.  
4.  
U kac h u k w u A, Still M, Seas A, et al. F ulfilli n g t he S pecialist Ne u r os ur ger y W or kf orce 
Nee ds i n Africa: Liter at ure Re vie w a n d Pr ojecti o ns T o war ds 2 0 3 0. J N S. 
5.   
J a nca A, Aarli J A, Prili p k o L, D u a T, Sa x e na S, Sarace n o B. W H O/ W F N S ur ve y of 
ne ur ol o gi cal ser vi ces: a w orl d wi de pers p ecti ve. J Ne ur ol Sci . 2 0 0 6; 2 4 7( 1): 2 9- 3 4. 
d oi: 1 0. 1 0 1 6/j.j ns. 2 0 0 6. 0 3. 0 0 3  
6.   
Tte n d o S S, Was A, Prest o n M A, M u n yar u ger o E, Kerr y V B, Firt h P G. Retr os pecti ve 
descri pti ve st u d y of a n i nte nsi ve care u nit at a u ga n da n re gi o nal referral h os pital. W orl d J 
S ur g . 2 0 1 6; 4 0( 1 2): 2 8 4 7- 2 8 5 6. d oi: 1 0. 1 0 0 7/s 0 0 2 6 8- 0 1 6- 3 6 4 4- 5 
7.   
Fer n a n dez L L, Gris w ol d D P, Aristiza bal S, Sa nc hez D M, R u bia n o A M. A bilit y of 
I nfras ca n ner 2 0 0 0 t o pre dict p ost-tra u matic cra nial he m orr ha ge v ol u me i n l o w-res o ur ce 
setti n gs: a pr ot oc ol f or a m ulti-ce nter pr os pecti ve, o bser vati o nal st u d y. J S ur g Pr ot oc Res 
Met h o d ol . 2 0 2 2; 2 0 2 2( 1). d oi: 1 0. 1 0 9 3/js pr m/s nac 0 0 4 
8.   
Vaca S D, Fe n g A Y, K u S, et al. B o da B o das a n d R oa d Traffi c I nj uries i n U ga n da: A n 
O ver vie w of Traffic Safet y Tr e n ds fr o m 2 0 0 9 t o 2 0 1 7. I nt J E nvir o n Res P u blic He alt h. 
2 0 2 0; 1 7( 6). d oi: 1 0. 3 3 9 0/ijer p h 1 7 0 6 2 1 1 0  
9.   
Firt h P G, M us ha gar a R, M usi n g uzi N, et al. S ur gi cal, o bstetric, a n d a nest h etic m ortalit y 
meas ure me nt at a u ga n d a n sec o n dar y referral h os pital. A nest h A n al g . 2 0 2 1; 1 3 3( 6): 1 6 0 8-
1 6 1 6. d oi: 1 0. 1 2 1 3/ A N E. 0 0 0 0 0 0 0 0 0 0 0 0 5 7 3 4  
1 0.   H ya m J A, Welc h C A, Harris o n D A, Me n o n D K. Case mi x, o utc o mes a n d c o m paris o n of 
ris k pre dicti o n m o dels f or a d missi o ns t o a d ult, ge neral a n d s p ecialist critical care u nits f or 
hea d i nj ur y: a sec o n dar y a nal ysis of t he I C N A R C Case Mi x Pr o gra m me Data base. Crit 
C are . 2 0 0 6; 1 0 S u p pl 2: S 2. d oi: 1 0. 1 1 8 6/cc 5 0 6 6 
1 1.  
Ni gat u A M, Yil ma T M, Gezie L D, et al. Me dical i ma gi n g c o ns ultati o n practices a n d 
c halle n ges at p u blic h os pitals i n t he A m hara re gi o nal state, N ort h west Et hi o pia: a 
descri pti v e p he n o me n ol o gical st u d y. B M C H e alt h Serv Res . 2 0 2 3; 2 3( 1): 7 8 7. 
d oi: 1 0. 1 1 8 6/s 1 2 9 1 3- 0 2 3- 0 9 6 5 2- 9  
1 2.   M u na k o mi S, M Das J. I ntracr a nial Press ure M o nit ori n g. I n: St at Pe arls . Stat Pearls 
P u blis hi n g; 2 0 2 3.  

1 9  
1 3.  
Fei ner J R, Se veri n g ha us J W, Bic kler P E. Dar k s ki n decreases t he acc urac y of p ulse 
o xi meters at l o w o x y ge n sat urati o n: t he effects of o xi meter pr o be t y pe a n d ge n d er. A n est h 
A n al g . 2 0 0 7; 1 0 5( 6 S u p pl): S 1 8- S 2 3. d oi: 1 0. 1 2 1 3/ 0 1.a ne. 0 0 0 0 2 8 5 9 8 8. 3 5 1 7 4. d 9 
1 4.   G ottlie b E R, Zie gler J, M orle y K, R us h B, Celi L A. Assess me nt of racial a n d et h nic 
differe n ces i n o x y ge n s u p ple me ntati o n a m o n g p atie nts i n t he i nte nsi ve care u nit. J A M A 
I nter n Me d. 2 0 2 2; 1 8 2( 8): 8 4 9- 8 5 8. d oi: 1 0. 1 0 0 1/ja mai nter n me d. 2 0 2 2. 2 5 8 7 
1 5.   Val b ue na V S M, Seel ye S, Sj o di n g M W, et al. Racial bias a n d re pr o d uci bilit y i n p ulse 
o xi metr y a m o n g me di cal a n d s ur gical i n patie nts i n ge n eral care i n t he Vet era ns H ealt h 
A d mi nistrati o n 2 0 1 3- 1 9: m ultice nter, retr os p ecti ve c o h ort st u d y. B MJ . 2 0 2 2; 3 7 8:e 0 6 9 7 7 5. 
d oi: 1 0. 1 1 3 6/ b mj- 2 0 2 1- 0 6 9 7 7 5  
1 6.   Ries A L, Pre witt L M, J o h ns o n JJ. S ki n c ol or a n d ear o xi metr y. C hest . 1 9 8 9; 9 6( 2): 2 8 7- 2 9 0. 
d oi: 1 0. 1 3 7 8/c hest. 9 6. 2. 2 8 7  
1 7.   O k u nl ola O E, Li p ni c k M S, Batc hel der P B, Ber nst ei n M, Fei ner J R, Bic kler P E. P ulse 
o xi meter perf or ma nce, racial i ne q uit y, a n d t he w or k a hea d. R es pir C are . 2 0 2 2; 6 7( 2): 2 5 2-
2 5 7. d oi: 1 0. 4 1 8 7/res pcar e. 0 9 7 9 5  
1 8.   J a mali H, Castill o L T, M or ga n C C, et al. Racial dis parit y i n o x y ge n s at urati o n 
meas ure me nts b y p ulse o xi metr y: e vi de n ce a n d i m plicati o ns. A n n A m T h or ac S oc . 
2 0 2 2; 1 9( 1 2): 1 9 5 1- 1 9 6 4. d oi: 1 0. 1 5 1 3/ A n nals A T S. 2 0 2 2 0 3 - 2 7 0 C M E 
1 9.   Bra u n L. R ace, et h nicit y a n d l u n g f u ncti o n: A brief hist or y. C a n J R es pir T her . 
2 0 1 5; 5 1( 4): 9 9- 1 0 1.  
2 0.   Bra u n T, K u nz U, Sc h ulz C, Lie ber A, Will y C. [ Near- i nfrare d s pectr osc o p y f or t he 
detecti o n of tra u m atic i ntracr a nial he m orr ha ge: Feasi bilit y st u d y i n a G er m a n ar m y fiel d 
h os pital i n Af g ha nista n]. U nf allc hir ur g . 2 0 1 5; 1 1 8( 8): 6 9 3- 7 0 0. d oi: 1 0. 1 0 0 7/s 0 0 1 1 3- 0 1 3-
2 5 4 9- 0  
2 1.   Al b utt K, P u nc ha k M, Ka yi ma P, N a ma n ya D B, A n ders o n G A, S hri me M G. Access t o 
safe, ti mel y, a n d aff or d a ble s ur gi cal care i n u ga n da: A stratifie d ra n d o mize d e valuati o n of 
nati o n wi de p u blic sect or s ur gical ca p acit y a n d c ore s ur gical i n dicat ors. W orl d J S ur g . 
2 0 1 8; 4 2( 8): 2 3 0 3- 2 3 1 3. d oi: 1 0. 1 0 0 7/s 0 0 2 6 8- 0 1 8- 4 4 8 5- 1  
2 2.  
At u ma n ya P, Se n da gire C, Wa b ule A, et al. Assess me nt of t he c urre nt ca p acit y of i nte nsi ve 
care u nits i n U ga n d a; A descri pti ve st u d y. J Crit C are. 2 0 2 0; 5 5: 9 5- 9 9. 
d oi: 1 0. 1 0 1 6/j.jcrc. 2 0 1 9. 1 0. 0 1 9  
2 3.   U kac h u k w u A- E K, Still M E H, Seas A, et al. F ulfilli n g t he s pecialist ne ur os ur gical 
w or kf or ce nee ds i n Africa: a s yst e matic re vi e w a n d pr ojecti o n t o war d 2 0 3 0. J Ne ur os ur g . 
2 0 2 3; 1 3 8( 4): 1 1 0 2- 1 1 1 3. d oi: 1 0. 3 1 7 1/ 2 0 2 2. 2.J N S 2 1 1 9 8 4  
2 4.   K oltai D C, D u n n T W, S mit h PJ, et al. S oci oc ult ural deter mi na nts a n d p atter ns of 
healt hcar e utilizati o n f or e pile ps y care i n U ga n d a. E pile psy Be h av . 2 0 2 1; 1 1 4( Pt 
B): 1 0 7 3 0 4. d oi: 1 0. 1 0 1 6/j. ye b e h. 2 0 2 0. 1 0 7 3 0 4  

2 0  
2 5.   T he W orl d Ba n k. W orl d Devel o p m e nt I n dic at ors: D at a B a nk . T he W orl d Ba n k; 2 0 2 2. 
2 6.   M o n k E. T he m o n k s ki n t o ne scale. Ma y 4, 2 0 2 3. d oi: 1 0. 3 1 2 3 5/ osf.i o/ p df 4c  
2 7.  
I nfra Sca n. I nfrasca n ner – W hite Pa per A Ha n d hel d Brai n H e mat o ma D etect or. Access e d 
Fe br u ar y 4, 2 0 2 4. htt ps://i nfrasca n n er. c o m/ w p-c o nte nt/ u pl oa ds/ 2 0 1 8/ 1 1/I nfrasca n ner-
w hite - pa per- 0 2. 1 8. p df 
2 8.  
D G N N. Assess me nt of a Ha n d hel d Near -I nfrare d Li g ht De vice (I nfras ca n n er 2 0 0 0 T M) i n 
Detecti n g S u b d ural a n d E pi d ural He mat o mas i n M barara, U ga n d a. 2 0 2 4.  
2 9.   B u derer N M. Statistical met h o d ol o g y: I. I n c or p orati n g t he pre vale n ce of disease i nt o t he 
sa m ple size calc ulati o n f or se nsiti vit y a n d s pecificit y. Ac a d E mer g Me d . 1 9 9 6; 3( 9): 8 9 5-
9 0 0. d oi: 1 0. 1 1 1 1/j. 1 5 5 3- 2 7 1 2. 1 9 9 6.t b 0 3 5 3 8. x  
3 0.  
Arifi n W N. Sa m ple size calc ulat or  . P u blis he d o nli ne 2 0 2 4. Accesse d Fe br uar y 4, 2 0 2 4. 
htt p:// w narifi n. git h u b.i o  
3 1.   R o berts o n C S, Za ger E L, Nara ya n R K, et al. Cli nical e val u ati o n of a p orta ble near- i nfrare d 
de vice f or detecti o n of tr a u matic i ntracra nial he m at o mas. J Ne ur otr a u m a . 
2 0 1 0; 2 7( 9): 1 5 9 7- 1 6 0 4. d oi: 1 0. 1 0 8 9/ ne u. 2 0 1 0. 1 3 4 0