open access original research interventions to improve
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1Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
Interventions to improve quantitative measures of parent satisfaction in neonatal care: a systematic review
Susanna Sakonidou ,1 Izabela Andrzejewska,1 James Webbe ,1 Neena Modi,1 Derek Bell,2 Chris Gale 1
To cite: Sakonidou S, Andrzejewska I, Webbe J, et al. Interventions to improve quantitative measures of parent satisfaction in neonatal care: a systematic review. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Received 18 November 2019Revised 3 January 2020Accepted 6 January 2020
1Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK2NIHR CLAHRC for Northwest London, London, UK
Correspondence toDr Susanna Sakonidou; s. sakonidou@ imperial. ac. uk; s. sakonidou@ doctors. org. uk
Original research
© Author(s) (or their employer(s)) 2020. Re- use permitted under CC BY. Published by BMJ.
What is known about the subject?
► Neonatal care significantly affects parents’ mental health; parent satisfaction is increasingly being used as a parent experience measure.
► Parent satisfaction is inversely related to parent stress; interventions improving parent satisfaction have the potential to reduce parent stress, improve parent- infant bonding and infant outcomes.
► Use of interventions measuring parent satisfaction as an outcome in neonatal units is increasing, al-though few are formally evaluated and wider uptake is limited; it is not known the degree to which par-ents are involved in intervention design.
What this study adds?
► There is inconsistency in how parent satisfaction in neonatal care is defined and measured, and the majority of studies do not include parents in inter-vention design.
► There is low- quality evidence that interventions relating to parent involvement may improve parent satisfaction with neonatal care.
► Standardised, validated measures of parent satis-faction and higher quality trials, involving parents in intervention design, are needed.
AbstrACtObjective Interventions improving parent satisfaction can reduce parent stress, may improve parent- infant bonding and infant outcomes. Our objective was to systematically review neonatal interventions relating to parents of infants of all gestations where an outcome was parent satisfaction.Methods We searched the databases MEDLINE, EMBASE, PsychINFO, Cochrane Central Register of Controlled Trials, CINAHL, HMIC, Maternity and Infant Care between 1 January 1946 and 1 October 2017. Inclusion criteria were randomised controlled trials (RCT), cohort studies and other non- randomised studies if participants were parents of infants receiving neonatal care, interventions were implemented in neonatal units (of any care level) and ≥1 quantitative outcome of parent satisfaction was measured. Included studies were limited to the English language only. We extracted study characteristics, interventions, outcomes and parent involvement in intervention design. Included studies were not sufficiently homogenous to enable quantitative synthesis. We assessed quality with the Cochrane Collaboration risk of bias tool (randomised) and the ROBINS- I tool (Risk Of Bias In Non- randomised Studies - of Interventions) (non- randomised studies).results We identified 32 studies with satisfaction measures from over 2800 parents and grouped interventions into 5 themes. Most studies were non- randomised involving preterm infants. Parent satisfaction was measured by 334 different questions in 29 questionnaires (only 6/29 fully validated). 18/32 studies reported higher parent satisfaction in the intervention group. The intervention theme with most studies reporting higher satisfaction was parent involvement (10/14). Five (5/32) studies reported involving parents in intervention design. All studies had high risk of bias.Conclusions Many interventions, commonly relating to parent involvement, are reported to improve parent satisfaction. Inconsistency in satisfaction measurements and high risk of bias makes this low- quality evidence. Standardised, validated parent satisfaction measures are needed, as well as higher quality trials of parent experience involving parents in intervention design.PrOsPErO registration number CRD42017072388.
IntrOduCtIOnOne in 10 newborn babies in high- income countries require neonatal care.1 This is
stressful for parents, who often develop anxiety, depression and post- traumatic stress disorder symptoms.2–4 Parental stress inter-feres with parent- child bonding5 and there is a well- established link between maternal mental health and infant development.6 Parent satisfaction, defined as ‘the perception of parents’ needs and expectations being met’ is inversely related to parental stress.7 As such, it is increasingly being used as a parent expe-rience measure and neonatal service quality indicator. Interventions aimed at improving parent satisfaction have the potential to reduce parent stress, improve parent- infant bonding8 and infant outcomes.9
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A range of parent- centred interventions, such as including parents on ward rounds, have recently become widespread in neonatal practice. Many are implemented on a small scale, without evaluating their impact on parent experience, making long- term integration into neonatal services challenging, while many others are using parent questionnaires. ‘Parent satisfaction’ as an outcome is gaining momentum, as neonatal trusts attempt to match more ‘business- like models’ where effectiveness of inter-ventions (and evidence for change) is measured by quan-titative outcomes. Moreover, where parent experience is measured as ‘parent satisfaction’, some studies include it as a primary outcome, whereas others use it as a secondary indicator to explore the parent point of view.
Furthermore, there are multiple experience measures available in addition to parent satisfaction, including parent stress, anxiety and depression scales; both quanti-tative and qualitative. Finally, it is not known the degree to which parents are involved in the design of such interventions. There have been no previous systematic evaluations focused on interventions measuring parent satisfaction with neonatal care as an outcome.
The aim of this review is to identify and describe neonatal interventions relating to parents of infants of all gestations where an outcome was parent satisfaction. For the reasons outlined above, we have only included studies that reported ≥1 quantitative measure of parent satisfaction. We aim to report each intervention’s effect on parent satisfaction, as well as parent input in interven-tion design.
MEthOdsWe reported this study using Preferred Reporting Items for Systematic Reviews and Meta- Analyses guidelines.10 11 We searched MEDLINE, EMBASE, PsychINFO, Cochrane Central Register of Controlled Trials, CINAHL, HMIC, Maternity and Infant Care (online supplementary file 1) for English papers published between 1 January 1946 and 1 October 2017, with update searches on 1 September 2018.
Inclusion criteria were: randomised controlled trials (RCT) and non- randomised studies (non- RCT) if partic-ipants were parents of infants receiving neonatal care, interventions were implemented in neonatal units and ≥1 quantitative outcome of parent satisfaction was measured. We have restricted our review to studies where ≥1 quantitative outcome of parent satisfaction was measured, in order to enable comparison of inter-ventions, which has previously not been possible in any published review. Including studies with all available measures of parent experience (in addition to parent satisfaction), as well as those only qualitatively evaluated, would make any comparison very difficult. By using these preregistered search criteria, we also ensured we would capture studies measuring parent satisfaction both as primary and as secondary outcomes. We included studies from all neonatal care level units and all healthcare
settings, without excluding studies in low- income or middle- income settings. This was because definitions of neonatal care levels differ between different coun-tries and healthcare settings, making them not easily comparable. Moreover, different levels of care are found within the same hospital settings. We excluded systematic reviews, entirely qualitative studies, grey literature (eg, conference abstracts), studies only reporting protocols or abstracts and full reports not in English.
Two authors (SS, IA) independently double- screened titles and abstracts, reviewed full texts for eligibility and resolved any discrepancies with a third reviewer (JW). We extracted data using a pilot- tested, standardised data extraction form including study characteristics, inter-ventions, outcomes and parent input into interventions’ design. We assessed methodological quality with the Cochrane Collaboration risk of bias tool12 for RCT and the ROBINS- I tool (Risk Of Bias In Non- randomised Studies - of Interventions)13 for non- RCT.
We presented individual study aggregate data in a narrative synthesis, grouped studies into themes using a Grounded Theory Approach14 and planned meta- analysis where data were appropriate for quantitative synthesis.
Patient and public involvementThis review was conceived in response to the clinical need identified by parents with neonatal care experi-ence; a partnership including families with experience of preterm birth identified ‘what emotional and prac-tical support improves attachment and bonding, and does the provision of such support improve outcomes for premature babies and their families?’ as a top 10 research priority.15 Additionally, this review was conceived as part of planning a wider project to pilot a neonatal interven-tion, with parents’ full input.16 Patients were not directly involved in the design, conduct, reporting or dissemina-tion plans of our research.
rEsultsWe identified 8362 studies for screening and assessed 73 full- text articles for eligibility (figure 1). A total of 32 studies describing interventions that measured parent satisfaction in neonatal care as an outcome met the inclusion criteria, reporting data from over 2866 parents, 1 study did not report number of parents. Our anal-ysis included 10 RCT and 22 non- RCT: 3 cohort trials, 18 unspecified designs and 1 implementation project (tables 1–3). We further classified the unspecified non- RCT into two types, depending on how they defined their control groups and how they evaluated parent satisfac-tion (table 3).1. ‘Unit- level effect’: studies that assessed parent satisfac-
tion during a period of routine care (control group) and introduced the intervention at a later time, with a different group of parents. In these studies, improve-ment in parent satisfaction was evaluated between dif-ferent parent groups, on a unit level.
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3Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
Figure 1 Preferred Reporting Items for Systematic Reviews and Meta- Analyses flow diagram of selected studies.
2. ‘Group level effect’: studies that formed intervention and control groups using convenience sampling during the same time period. Both groups (or sometimes only the intervention group) had satisfaction measured af-ter the intervention period (postintervention testing). Baseline parent satisfaction was also measured in both groups (preintervention testing) in some studies. Improvement in parent satisfaction was demonstrated either by comparing outcomes between intervention/control groups following the intervention, or in com-parison with the preintervention data.
Parent participants included mothers (14 studies), mothers and fathers (10 studies) or were not specified (7 studies). One study defined parent participants as a dyad of the mother with her designated support person. Median parent sample size was 63, ranging 7–482. This was higher for RCT (108 studies) compared with non- RCT (61 studies).
Study participants included parents of babies across the full range of gestations (23–42 weeks). Overall, 24/32 (75%) of studies involved preterm infants, 5/32 (16%) term infants and 7 studies did not state the gestational age of infants involved. Most studies (19, 59%) involved only preterm infants (up to 37 weeks); only one study (3%) involved only term infants and five studies (16%) involved both preterm and term infants. Preterm infants were included in 44% of RCT vs 63% of non- RCT.
Most studies were reported as conducted in level III neonatal units (17 studies), followed by level not stated (9 studies), level II–III (3 studies), level II (2 studies) and level I (1 study). Definitions of neonatal levels of care are not standardised but vary across different countries; none of the included studies have explicitly stated which definition applies to them.
Tables 1–3 show the key characteristics of included studies. They include a description of each study’s parent and infant sample, study design and interven-tion, outcome measures (timing and methods), results, parent input into intervention design and study impact on parent satisfaction.
Parent satisfactionOutcome measuresAll 32 studies reported they measured parent satisfac-tion as an a priori outcome. Only one study confirmed this through a protocol. Overall, 18/32 (56%) of studies (4/10, 40% RCT and 14/22, 64% non- RCT) reported a higher level of parent satisfaction associated with the intervention studied. Multiple different outcome meas-ures within the domain of parent satisfaction were used; we grouped these into four categories: i) parent satisfac-tion (no additional description); ii) parent satisfaction with NICU care; iii) parent satisfaction related to specific components such as communication, staff or informa-tion; iv) parent satisfaction with a specific intervention.
Timing of measurementParent satisfaction was mostly measured ‘during infant admission only’ (24 studies; between 1 and 4 times), followed by ‘after infant discharge only’ (5 studies; 1 time) and ‘both during admission and after discharge’ (3 studies; between 1 and 3 times). In the majority of studies (19/32, 59%), no preintervention parent satisfaction measure-ments were conducted in the same parent groups with available postintervention data (ie, paired parent data for satisfaction levels did not exist). Instead, impact of interventions was determined comparing intervention/control group measurements in different time periods (tables 1–3).
Method of measurementParent satisfaction was assessed using 32 different methods: 29 different questionnaires, 2 different single questions and by structured interview in 1 study; in total, 334 different questions were used to assess parent satisfac-tion. Only 6/29 (21%) of questionnaires were reported to be fully validated (both content validation and relia-bility testing); 23/29 (79%) questionnaires were partially or completely unvalidated. The most commonly used questionnaire was the validated Neonatal Index of Parent Satisfaction17 questionnaire (three studies).
Interventions and impact on parent satisfactionWe grouped included studies into five intervention themes: parent involvement (14 studies); information provision/communication (8 studies); clinical care (7 studies); parent emotional support (2 studies); other (1 study). Parent involvement interventions were more commonly assessed in RCT compared with non- RCT .
We categorised interventions as effective or not effective based on whether a statistically significant difference between intervention and control groups was reported for parent satisfaction (boxes 1 and 2). None of the
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Open access
Tab
le 1
In
clud
ed r
and
omis
ed c
ontr
olle
d t
rials
(RC
Ts)
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e),
coun
try
Par
ents
’g
end
er/
sam
ple
siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/N
ICU
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d
par
ent
sati
sfac
tio
n?
1. N
orth
rup
et
al (
2016
), U
SA
Mot
hers
and
fa
ther
s/1
16
<28
/leve
l III
RC
TIn
terv
entio
n: fr
ee
par
king
.
Par
ents
rec
eive
d s
even
p
arki
ng v
ouch
ers
at a
tim
e (v
alue
: US
$10
each
) an
d c
ontin
ued
to
rece
ive
vouc
hers
unt
il in
fant
d
isch
arge
. Eac
h vo
uche
r al
low
ed fr
ee e
ntry
and
ex
it fo
r 24
hou
rs.
Con
trol
: par
ents
rec
eive
d
the
stan
dar
d c
are
and
d
id n
ot r
ecei
ve v
ouch
ers.
Par
ent
satis
fact
ion
with
NIC
U c
are.
Aft
er b
abie
s w
ere
dis
char
ged
(onc
e)
►
Dur
ing
the
first
hi
gh- r
isk
infa
nt
clin
ic v
isit
afte
r d
isch
arge
.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
for
com
par
ison
.
Sat
isfa
ctio
n q
uest
ionn
aire
Valid
atio
n: n
o co
nten
t va
lidity
or
relia
bili
ty t
estin
g re
por
ted
.
Ele
ven
que
stio
ns:
►
Sev
en it
ems
wer
e su
mm
ed (s
core
7–
35) t
o m
easu
re ‘s
upp
ort’
(eg,
in
form
atio
n sh
arin
g).
►
Thre
e ite
ms
mea
sure
d ‘e
mot
iona
l co
nnec
tion’
to
the
infa
nt (s
core
3–
15).
►
One
item
ass
esse
d ‘f
amily
in
volv
emen
t in
infa
nt c
are’
(re
spon
ses:
not
eno
ugh,
just
rig
ht,
too
muc
h).
Gre
ater
sco
res
ind
icat
ed h
ighe
r p
erce
ived
sup
por
t, c
onne
ctio
n an
d
satis
fact
ion.
The
grou
ps
did
not
diff
er s
igni
fican
tly w
ith
resp
ect
to s
atis
fact
ion.
Inte
rven
tio
n C
ont
rol P
val
ueN
ICU
sup
por
t M
ean
(SD
) 30
(2.7
) 28.
7 (3
.7) 0
.07
Em
otio
nal c
onne
ctio
n12
.3 (1
.7) 1
2.3
(1.7
) 0.9
6
Fam
ily in
volv
emen
t‘J
ust
right
’81
.4%
–85%
0.0
7
No
2
2. A
bd
el- L
atif
et a
l (20
15),
Aus
tral
ia
Mot
hers
and
fa
ther
s/6
3
25–4
2/le
vel I
IIC
ross
- ove
r R
CT
Inte
rven
tion:
par
enta
l P
rese
nce
at C
linic
al
Bed
sid
e R
ound
s (P
PC
BR
).
Par
ents
att
end
ed
bed
sid
e cl
inic
al r
ound
s.
Par
ents
had
op
por
tuni
ty
to a
sk q
uest
ions
ab
out
thei
r b
aby’
s co
nditi
on
and
man
agem
ent.
Con
trol
: par
ents
rec
eive
d
the
stan
dar
d c
are
with
no
par
enta
l pre
senc
e at
b
edsi
de
clin
ical
rou
nds.
Par
ent
satis
fact
ion
asse
ssed
by
que
stio
ns o
f thr
ee
dom
ains
:1.
Kno
wle
dge
and
un
der
stan
din
g.2.
Com
mun
icat
ion
and
col
lab
orat
ion.
3. P
rivac
y an
d
confi
den
tialit
y.
Dur
ing
bab
ies’
ad
mis
sion
(onc
e):
►
At
the
end
of
each
stu
dy
arm
, sep
arat
ed
by
a w
asho
ut
per
iod
.
►N
o p
rein
terv
entio
n p
aren
t sa
tisfa
ctio
n d
ata
avai
lab
le
for c
omp
aris
on.
Sat
isfa
ctio
n q
uest
ionn
aire
The
auth
ors
stat
ed ‘t
he r
esea
rch
team
d
esig
ned
the
que
stio
nnai
re’.
Valid
atio
n: n
o co
nten
t va
lidity
or
relia
bili
ty t
estin
g re
por
ted
.
Num
ber
and
form
at o
f que
stio
ns: n
ot
stat
ed.
PP
CB
R h
ad s
igni
fican
tly h
ighe
r ad
just
ed
mea
n (9
5% C
I) sc
ores
for
som
e q
uest
ions
fr
om d
omai
ns 1
and
2.
Dom
ain
3 w
as c
omp
arab
le b
etw
een
the
two
stud
y gr
oup
s.
Inte
rven
tio
n C
ont
rol p
- val
ueD
omai
n 1
que
stio
n:“I
hav
e re
ceiv
ed a
deq
uate
info
rmat
ion
abou
t m
y b
aby’
s co
nditi
on a
nd
man
agem
ent”
Mea
n 4.
321
3.94
7 0.
03
Dom
ain
2 q
uest
ions
:“I
n th
e la
st w
eek
I hav
e b
een
able
to
com
mun
icat
e ef
fect
ivel
y w
ith m
y b
aby’
s he
alth
care
tea
m”
Mea
n 4.
407
4.25
0 0.
05
“In
the
last
wee
k I h
ave
colla
bor
ated
with
m
y b
aby’
s he
alth
care
tea
m in
the
pla
nnin
g of
car
e fo
r m
y b
aby”
Mea
n 3.
843
3.42
6 0.
02
“In
the
last
wee
k I h
ave
bee
n ab
le t
o as
k th
e he
alth
care
tea
m q
uest
ions
ab
out
my
bab
y’s
care
”M
ean
4.64
2 4.
259
0.00
4
No
1 Con
tinue
d
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RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e),
coun
try
Par
ents
’g
end
er/
sam
ple
siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/N
ICU
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
r ove
d
par
ent
sati
sfac
tio
n?
3. B
asta
ni e
t al
(201
5), I
ran
Mot
hers
/100
30–3
7M
ean
(SD
)
Con
trol
: 33.
90
(2.3
3)
Inte
rven
tion:
34
(1.9
)
/leve
l not
sta
ted
RC
T(b
lock
ra
ndom
isat
ion)
Inte
rven
tion:
fam
ily
cent
red
car
e (F
CC
).
Mot
hers
allo
wed
acc
ess
to t
heir
bab
y at
any
tim
e, p
artic
ipat
ed in
th
e ca
re p
roce
ss a
nd
wer
e p
rovi
ded
with
in
form
atio
n ab
out
neon
atal
car
e.
Con
trol
: mot
hers
re
ceiv
ed t
he s
tand
ard
ca
re w
here
the
y w
ere
only
allo
wed
to
be
pre
sent
at
the
time
of
the
infa
nt’s
ent
ry t
o th
e N
ICU
, and
wer
e on
ly
rout
inel
y in
form
ed.
Mat
erna
l sa
tisfa
ctio
n re
latin
g to
thr
ee t
hem
es:
1.
Par
enta
l p
rese
nce.
2.
Par
ticip
atio
n in
ne
onat
al c
are.
3.
Info
rmat
ion
abou
t ne
onat
al
car e
.
Dur
ing
bab
ies’
ad
mis
sion
(tw
ice)
:
►
24 h
ours
aft
er
adm
issi
on.
►
At
the
time
of
dis
char
ge.
Sat
isfa
ctio
n q
uest
ionn
aire
(val
idat
ed)
A m
odifi
ed s
atis
fact
ion
que
stio
nnai
re
was
use
d, b
ased
on
a p
aren
tal
satis
fact
ion
inst
rum
ent
dev
elop
ed fo
r m
easu
ring
satis
fact
ion
in p
aed
iatr
ic
inte
nsiv
e ca
re u
nits
.
18 q
uest
ions
Gra
ded
0 (v
ery
dis
satis
fied
) to
4 (v
ery
satis
fied
).
The
over
all s
atis
fact
ion
rate
was
cl
assi
fied
bas
ed o
n th
e m
ean
scor
es
(sco
re <
50%
, bet
wee
n 75
%–5
0% a
nd
>75
%).
In t
he F
CC
gro
up, p
rein
terv
entio
n an
d
pos
tinte
rven
tion
diff
eren
ce in
mat
erna
l sa
tisfa
ctio
n w
as s
tatis
tical
ly s
igni
fican
t p
<0.
001.
Inte
rven
tio
n C
ont
rol P
val
ueM
ean
(SD
)
At
24 h
ours
22.3
6 (8
.90)
22.
06 (9
.77)
0.8
7
At
dis
char
ge
59.2
8 (6
.86)
30.
18 (1
4.09
)<0.
01
Unc
lear
M
othe
rs
det
erm
ined
th
e re
liab
ility
of
the
sa
tisfa
ctio
n to
ol a
nd
app
rove
d t
he
educ
atio
nal
pam
phl
et.
Aut
hors
did
no
t re
por
t if
mot
hers
ha
d d
irect
in
put
in t
he
inte
rven
tion
des
ign.
1
4. C
lark
e-
Pou
nder
et
al
(201
5), U
SA
Mot
hers
and
fa
ther
s/1
9 fa
mili
es
23–3
9/le
vel I
IIR
CT
Inte
rven
tion:
sha
ring
info
rmat
ion
obta
ined
fr
om p
aren
t in
terv
iew
s w
ith t
he p
rimar
y N
ICU
p
rovi
der
.
Par
ents
inte
rvie
wed
us
ing
the
NIC
U-
adap
ted
D
ecis
ion-
Mak
ing
Tool
(N
- DM
T). I
nfor
mat
ion
obta
ined
was
pla
ced
in
the
elec
tron
ic m
edic
al
reco
rd (E
MR
) and
sha
red
w
ith t
he p
rimar
y ne
onat
al
pro
vid
er v
ia e
mai
l. D
aily
ro
und
s on
all
infa
nts
wer
e au
dio
- rec
ord
ed fo
r 3
day
s af
ter
enro
lmen
t to
see
if in
form
atio
n fr
om t
he N
- DM
T w
as
inco
rpor
ated
into
dai
ly
care
pla
nnin
g.
Con
trol
: the
con
tent
of a
re
cent
soc
ial w
ork
note
w
as c
omm
unic
ated
with
th
e p
rimar
y p
rovi
der
vi
a em
ail,
crea
ting
an
atte
ntio
nal c
ontr
ol g
roup
.
Par
ent
satis
fact
ion
with
car
e.D
urin
g b
abie
s’
adm
issi
on (o
nce)
:
►
2 w
eeks
aft
er
stud
y en
try.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
for
com
par
ison
.
Sat
isfa
ctio
n q
uest
ionn
aire
A
n N
- DM
T- sp
ecifi
c q
uest
ionn
aire
was
us
ed.
Valid
atio
n: p
artia
lly r
epor
ted
. Aut
hors
st
ated
rel
iab
ility
tes
ting
took
pla
ce;
no in
form
atio
n on
con
tent
val
idity
p
rovi
ded
.
Eig
ht q
uest
ions
: for
exa
mp
le,‘‘
My
bab
y’s
doc
tors
con
sid
ered
my
goal
s an
d h
opes
for
my
bab
y d
urin
g d
ecis
ion-
mak
ing’
’.
Like
rt s
cale
(1 s
tron
gly
agre
e–4
stro
ngly
dis
agre
e). T
otal
N- D
MT
scor
e ra
nge
8–32
.
Ther
e w
as n
o si
gnifi
cant
diff
eren
ce in
sa
tisfa
ctio
n w
ith c
are
as m
easu
red
by
the
N- D
MT
scal
e b
etw
een
the
cont
rol g
roup
an
d in
terv
entio
n gr
oup
s in
a u
niva
riab
le
mod
el o
r m
ultip
le v
aria
ble
mod
el
cont
rolli
ng fo
r ge
stat
iona
l age
.
Inte
rven
tio
n C
ont
rol
Med
ian
(ran
ge)
26 (1
5–28
) 28.
8 (1
9–32
)
No
P v
alue
rep
orte
d.
Ther
e w
as, h
owev
er, a
pat
tern
of
dec
reas
ed s
atis
fact
ion
with
car
e am
ong
the
inte
rven
tion
grou
p c
omp
ared
with
the
co
ntro
l gro
up a
cros
s th
e N
- DM
T- sp
ecifi
c su
rvey
que
stio
ns, a
lthou
gh t
he d
iffer
ence
s w
ere
not
stat
istic
ally
sig
nific
ant.
Yes
Info
rmat
ion
obta
ined
from
p
aren
ts u
sing
th
e N
- DM
T w
as p
lace
d in
th
e E
MR
and
sh
ared
with
th
e p
rimar
y N
ICU
pro
vid
er
via
emai
l (fo
rmin
g th
e in
terv
entio
n).
2
Tab
le 1
C
ontin
ued
Con
tinue
d
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
6 Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e),
coun
try
Par
ents
’g
end
er/
sam
ple
siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/N
ICU
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d
par
ent
sati
sfac
tio
n?
5. H
old
itch-
D
avis
et
al
(201
3), U
SA
Mot
hers
/208
Pre
term
infa
nts
Mea
n (S
D)
Ove
rall
grou
p 2
7.2
(3.0
)/4
cen
tres
, lev
els
II–III
RC
Tth
ree
grou
ps
(two
inte
rven
tion
and
on
e co
ntro
l)P
ostin
terv
entio
n te
stin
g on
ly
Inte
rven
tions
:1.
Mot
hers
wer
e ta
ught
ho
w t
o m
assa
ge in
fant
s w
ith a
udito
ry, t
actil
e,
visu
al a
nd v
estib
ular
st
imul
atio
n.2.
Kan
garo
o ca
re.
Con
trol
: att
entio
n co
ntro
l gro
up. M
othe
rs
spen
t a
sim
ilar
amou
nt
of t
ime
with
the
stu
dy
nurs
e d
iscu
ssin
g th
e eq
uip
men
t ne
eded
for
pre
term
infa
nt c
are
at
hom
e. S
tud
y nu
rses
p
rovi
ded
ed
ucat
ion
and
su
pp
ort
for
all t
hree
gr
oup
s. M
othe
rs w
ere
not
pre
vent
ed fr
om
enga
ging
in in
terv
entio
ns
of t
he o
ther
gro
ups
but
d
id n
ot r
ecei
ve fo
rmal
ed
ucat
ion
from
the
st
udy
nurs
e on
the
oth
er
inte
rven
tions
.
1.
Par
ent (
mot
her)
sa
tisfa
ctio
n w
ith t
he
inte
rven
tion.
2.
Sat
isfa
ctio
n w
ith t
he
help
fuln
ess
of t
he s
tud
y nu
rse.
3.
Whe
ther
the
m
othe
r w
ould
r e
com
men
d
the
stud
y to
ot
hers
and
th
e d
egre
e of
ch
ange
in t
he
mot
her
as a
p
erso
n an
d a
s a
mot
her
as a
re
sult
of b
eing
in
the
stu
dy.
Dur
ing
adm
issi
on
per
iod
and
p
ostd
isch
arge
:
►A
t th
e tim
e of
d
isch
arge
.
►A
t 2
mon
ths
corr
ecte
d a
ge.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
for
com
par
ison
.
Sat
isfa
ctio
n q
uest
ionn
aire
Th
e q
uest
ionn
aire
was
des
igne
d b
y th
e st
udy
team
.
Valid
atio
n: p
artia
lly r
epor
ted
. Aut
hors
st
ated
rel
iab
ility
tes
ting
took
pla
ce;
no in
form
atio
n on
con
tent
val
idity
p
rovi
ded
.
26 q
uest
ions
: rel
atin
g to
thr
ee
dim
ensi
ons
of s
atis
fact
ion:
effi
cacy
, ca
ring
and
tec
hnic
al q
ualit
y.
Like
rt (1
leas
t sa
tisfie
d–5
mos
t sa
tisfie
d).
No
sign
ifica
nt d
iffer
ence
s oc
curr
ed
bet
wee
n th
e gr
oup
s.
Mot
hers
in a
ll th
ree
grou
ps
wer
e sa
tisfie
d
with
the
inte
rven
tion
(mea
n sc
ores
of
3.3
or h
ighe
r on
a 5
- poi
nt s
cale
) and
the
he
lpfu
lnes
s of
the
nur
se (m
ean
scor
es o
f 4.
6 or
hig
her
on a
5- p
oint
sca
le).
No
2
6. F
ranc
k et
al
(201
1), U
KM
othe
rs a
nd
fath
ers
/169
Mea
n (S
D)
Con
trol
: 31.
94
(5.1
7)
Inte
rv: 2
9.40
(3.1
7)
/4 c
entr
es, l
evel
III
Clu
ster
RC
TIn
terv
entio
n: in
crea
sing
p
aren
tal i
nvol
vem
ent
in
infa
nt p
ain
man
agem
ent
in t
he N
ICU
.
Par
ents
rec
eive
d a
b
ookl
et p
rovi
din
g ev
iden
ce- b
ased
in
form
atio
n ab
out
pai
n an
d c
omfo
rtin
g in
fant
s in
the
NIC
U s
ettin
g.
Par
ents
rec
eive
d t
wo
visi
ts fr
om a
res
earc
h nu
rse
show
ing
them
how
to
ap
ply
the
com
fort
ing
tech
niq
ues
des
crib
ed in
th
e b
ookl
et.
Con
trol
: as
par
t of
usu
al
care
, par
ents
in b
oth
the
inte
rven
tion
and
co
ntro
l gro
ups
rece
ived
a
det
aile
d b
ookl
et w
ith
gene
ric in
form
atio
n ab
out
NIC
U c
are.
P
aren
ts in
the
con
trol
gr
oup
als
o re
ceiv
ed t
wo
visi
ts fr
om a
res
earc
h nu
rse
liste
ning
to
wha
t p
aren
ts h
ad t
o sa
y ab
out
thei
r N
ICU
exp
erie
nce
(att
entio
n p
lace
bo)
.
At
bas
elin
e:
Par
ent
satis
fact
ion
with
NIC
U c
are.
One
wee
k af
ter
the
inte
rven
tion:
1.
Sat
isfa
ctio
n w
ith
info
rmat
ion
abou
t p
ain
cont
rol.
2.
Sat
isfie
d
nurs
es
mak
e in
fant
co
mfo
rtab
le.
3.
Sat
isfie
d p
ain
med
icin
es h
elp
in
fant
.
Dur
ing
bab
ies’
ad
mis
sion
(tw
ice)
:
►
At
bas
elin
e (w
ithin
3–7
d
ays
of
adm
issi
on).
►
1 w
eek
afte
r th
e in
terv
entio
n.
Ind
ivid
ual q
uest
ions
Va
lidat
ion:
no
cont
ent
valid
ity o
r re
liab
ility
tes
ting
rep
orte
d.
1. A
t b
asel
ine:
par
ent
satis
fact
ion
was
mea
sure
d b
y on
e q
uest
ion:
‘sat
isfa
ctio
n w
ith N
ICU
car
e’ (1
ver
y sa
tisfie
d–6
ver
y un
satis
fied
) as
par
t of
the
bas
elin
e p
aren
t ch
arac
teris
tics
que
stio
nnai
re.
2. O
ne w
eek
afte
r th
e in
terv
entio
n:
Thre
e q
uest
ions
usi
ng t
he w
ord
‘s
atis
fied
’ wer
e se
lect
ed fr
om t
he
valid
ated
Par
ent
Att
itud
es A
bou
t In
fant
N
ocic
eptio
n su
rvey
(Lik
ert
scal
e 1
very
sa
tisfie
d–6
ver
y un
satis
fied
).
At
bas
elin
e: t
here
was
no
sign
ifica
nt
diff
eren
ce in
sat
isfa
ctio
n b
etw
een
inte
rven
tion
and
con
trol
gro
up.
Inte
rven
tio
n C
ont
rol
Mea
n 1.
45 (0
.71)
1.5
1 (0
.76)
(SD
)P
val
ue m
issi
ng
1 w
eek
afte
r th
e in
terv
entio
n: in
terv
entio
n p
aren
ts w
ere
mor
e sa
tisfie
d w
ith t
he
info
rmat
ion
abou
t p
ain
cont
rol r
ecei
ved
th
an c
ontr
ol p
aren
ts.
Inte
rven
tio
n C
ont
rol
Mea
n 2.
10 (0
.97)
3.2
8 (1
.27)
(SD
)P
val
ue<
0.00
1
Yes
The
boo
klet
w
as r
evie
wed
b
y 12
par
ents
of
infa
nts
who
ha
d b
een
care
d fo
r in
N
ICU
s in
the
U
K.
1
Tab
le 1
C
ontin
ued
Con
tinue
d
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
7Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e),
coun
try
Par
ents
’g
end
er/
sam
ple
siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/N
ICU
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d
par
ent
sati
sfac
tio
n?
7. L
ivin
gsto
n et
al (
2009
), U
SA
Mot
hers
/12
Mea
n (S
D)
Con
trol
:33
.4 (6
.4)
Inte
rven
tion:
38.
5 (3
.1)
/leve
l III
RC
TIn
terv
entio
n: t
ouch
and
m
assa
ge.
Mot
hers
att
end
ed a
1
hour
mas
sage
cla
ss
taug
ht b
y a
nurs
e ce
rtifi
ed in
fant
mas
sage
in
stru
ctor
(CIM
I) an
d
wer
e as
ked
to
par
ticip
ate
in a
t le
ast
thre
e b
edsi
de
mas
sage
inst
ruct
ion
sess
ions
tau
ght
with
in
the
next
wee
k. In
fant
s re
ceiv
ed m
assa
ge fo
r se
ven
cons
ecut
ive
day
s, fr
om t
he m
othe
r or
a C
IMI.
The
touc
h p
roce
dur
e la
sted
20
min
.
Con
trol
: inf
ants
rec
eive
d
all u
sual
hos
pita
l se
rvic
es in
clud
ing
med
ical
car
e, p
hysi
cal
and
occ
upat
iona
l th
erap
y se
rvic
es
and
dev
elop
men
tally
su
pp
ortiv
e nu
rsin
g ca
re.
1.
Car
egiv
er
(mot
her)
sa
tisfa
ctio
n w
ith t
heir
infa
nt’s
car
e.2.
C
areg
iver
sa
tisfa
ctio
n w
ith t
he
neon
atal
un
it an
d t
he
mas
sage
th
erap
ist.
Dur
ing
bab
ies’
ad
mis
sion
(thr
ee
times
):
►
At
bas
elin
e
►O
n co
mp
letin
g th
e 7
day
m
assa
ge
pro
gram
me.
►
1 m
onth
fo
llow
ing
inte
rven
tion.
Sat
isfa
ctio
n q
uest
ionn
aire
Tw
o q
uest
ionn
aire
s w
ere
dev
elop
ed b
y th
e re
sear
ch t
eam
.
Valid
atio
n: n
o co
nten
t va
lidity
or
relia
bili
ty t
estin
g re
por
ted
.
►
Firs
t q
uest
ionn
aire
(at
bas
elin
e):
a b
rief s
elf-
rep
ort
que
stio
nnai
re
abou
t ca
regi
ver
satis
fact
ion
with
the
ir in
fant
’s c
are
until
tha
t m
omen
t. N
o fu
rthe
r d
etai
ls
rep
orte
d.
►
Sec
ond
que
stio
nnai
re (o
n co
mp
letin
g th
e 7-
day
mas
sage
p
rogr
amm
e an
d 1
mon
th
follo
win
g in
terv
entio
n): a
10
min
sa
tisfa
ctio
n q
uest
ionn
aire
rel
atin
g to
infa
nt’s
res
pon
se a
nd c
areg
iver
sa
tisfa
ctio
n w
ith t
he n
eona
tal u
nit
and
the
mas
sage
the
rap
ist.
Num
ber
of q
uest
ions
: not
sta
ted
.
Like
rt s
cale
(1 v
ery
dis
satis
fied
–4 v
ery
satis
fied
).
Sam
ple
sta
tem
ents
:“H
ow s
atis
fied
do
you
feel
giv
ing
mas
sage
to
your
infa
nt?”
; “I f
eel t
hat
mas
sage
imp
rove
d m
y in
fant
’s h
osp
ital
stay
”.
It is
unc
lear
in t
he r
epor
t if
spec
ific
bet
wee
n- gr
oup
com
par
ison
s an
d
stat
istic
al a
naly
sis
wer
e co
nduc
ted
.
At
bas
elin
e an
d d
ay 7
:A
ll ca
regi
vers
wer
e hi
ghly
sat
isfie
d
with
the
med
ical
tre
atm
ent
thei
r in
fant
re
ceiv
ed.
At
day
7 a
nd 1
mon
th fo
llow
- up
:A
ll ca
r egi
vers
par
ticip
atin
g in
the
mas
sage
gr
oup
rep
orte
d h
igh
leve
ls o
f sat
isfa
ctio
n re
gard
ing
thei
r re
latio
nshi
p w
ith t
heir
infa
nt a
nd t
he m
assa
ge p
rogr
amm
e’s
imp
act
on t
hat
rela
tions
hip
.
Slig
ht im
pro
vem
ents
in s
atis
fact
ion
rega
rdin
g tim
e th
e ca
regi
ver
spen
t w
ith
the
infa
nt a
nd in
volv
emen
t in
the
infa
nt’s
ca
re w
ere
obse
rved
bet
wee
n d
ay 7
an
d t
he 1
mon
th fo
llow
- up
(no
furt
her
info
rmat
ion
rep
orte
d).
No
3
8. K
oh e
t al
(200
7),
Aus
tral
ia
Mot
hers
/200
Not
sta
ted
/not
st
ated
RC
TIn
terv
entio
n: p
rovi
sion
of
tap
ed c
onve
rsat
ions
w
ith n
eona
tolo
gist
s to
m
othe
rs.
The
initi
al c
onve
rsat
ion
and
sub
seq
uent
co
nver
satio
ns o
f si
gnifi
canc
e w
ith a
ne
onat
olog
ist
wer
e ta
ped
and
ana
lyse
d (f
or
bot
h gr
oup
s). M
othe
rs
rece
ived
a t
ape
of e
ach
conv
ersa
tion
and
a t
ape
reco
rder
.
Con
trol
: usu
al c
are.
M
othe
rs w
ere
not
give
n th
e ta
pe
or r
ecor
der
.
Sat
isfa
ctio
n w
ith
conv
ersa
tions
he
ld w
ith t
he
neon
atol
ogis
t.
Sat
isfa
ctio
n w
ith
the
tap
e.
Dur
ing
adm
issi
on
per
iod
and
p
ostd
isch
arge
:
►
At
10 d
ays.
►
At
4 m
onth
s.
►A
t 12
mon
ths.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
for
com
par
ison
.
Ind
ivid
ual q
uest
ions
and
a s
atis
fact
ion
scal
e Va
lidat
ion:
no
cont
ent
valid
ity o
r re
liab
ility
tes
ting
rep
orte
d.
Num
ber
of q
uest
ions
: not
sta
ted
.
Like
rt s
cale
(1–5
mos
t sa
tisfie
d)
Que
stio
ns r
elat
ed t
o:sa
tisfa
ctio
n w
ith a
mou
nt a
nd q
ualit
y of
info
rmat
ion
pre
sent
ed, d
octo
rs’
com
mun
icat
ion
skill
s, p
atie
nt’s
p
artic
ipat
ion
in t
he c
onve
rsat
ion.
A s
atis
fact
ion
scal
e w
as u
sed
to
asse
ss:
satis
fact
ion
with
the
tap
e.
No
diff
eren
ces
wer
e fo
und
bet
wee
n th
e tw
o gr
oup
s in
sat
isfa
ctio
n w
ith
conv
ersa
tions
.
Mot
hers
of b
abie
s w
ith a
poo
r ou
tcom
e in
the
tap
e gr
oup
wer
e, h
owev
er,
sign
ifica
ntly
mor
e sa
tisfie
d w
ith t
he
conv
ersa
tions
: In
terv
enti
on
Co
ntro
lM
ean
(95%
CI)
115
(104
–123
.2) 1
00.5
(94.
1–10
9.4)
P v
alue
0.0
051
Mos
t (7
1%–9
2%) o
f the
mot
hers
giv
en
the
tap
es s
tate
d t
hat
they
hel
ped
the
ir un
der
stan
din
g, r
emin
ded
the
m o
f wha
t ha
d b
een
said
, and
hel
ped
the
ir fa
mily
to
und
erst
and
and
rec
all i
nfor
mat
ion.
No
1
Tab
le 1
C
ontin
ued
Con
tinue
d
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
8 Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e),
coun
try
Par
ents
’g
end
er/
sam
ple
siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/N
ICU
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d
par
ent
sati
sfac
tio
n?
9. M
itche
ll-
DiC
enso
et
al (1
996)
, C
anad
a
Mot
hers
and
fa
ther
s/48
2
Mea
n (S
D)
Inte
rven
tion:
35.
1 (4
.5)
Con
trol
: 35
(4.3
)
/leve
l III
RC
TIn
terv
entio
n: c
linic
al
nurs
e sp
ecia
list/
neon
atal
p
ract
ition
er t
eam
(CN
S/
NP
) car
e.
Infa
nts
of in
terv
entio
n p
aren
ts w
ere
assi
gned
to
be
care
d fo
r b
y th
e C
NS
/NP
tea
m d
urin
g th
e d
ay a
nd b
y p
aed
iatr
ic
resi
den
ts d
urin
g th
e ni
ght.
Con
trol
: pae
dia
tric
re
sid
ents
car
ed fo
r in
fant
s of
con
trol
p
aren
ts a
roun
d t
he
cloc
k. N
eona
tolo
gist
s su
per
vise
d b
oth
team
s.
Par
ent
satis
fact
ion
with
car
e.D
urin
g ad
mis
sion
p
erio
d a
nd
pos
tdis
char
ge
(twic
e):
►
On
fifth
day
af
ter
adm
issi
on
(full
surv
ey).
►
Aft
er d
isch
arge
ov
er t
he p
hone
(o
nly
que
stio
ns
rela
ted
to
satis
fact
ion
with
dis
char
ge
pro
cess
).
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
for
com
par
ison
.
Sat
isfa
ctio
n q
uest
ionn
aire
(val
idat
ed)
The
stud
y te
am d
evel
oped
and
use
d
the
valid
ated
NIP
S q
uest
ionn
aire
.
Num
ber
of q
uest
ions
: not
sta
ted
.
NIP
S s
core
ran
ge (2
7–18
9); h
ighe
r sc
ores
ind
icat
ing
grea
ter
satis
fact
ion
with
car
e.
No
stat
istic
ally
sig
nific
ant
diff
eren
ce
bet
wee
n gr
oup
s.
Inte
rven
tio
n C
ont
rol P
val
ueN
IPS
140
139
0.6
7M
ean
Diff
eren
ce in
mea
ns 1
.0, 9
5% C
I (−
3.6
to 5
.6)
No
2
10. B
royl
es
et a
l (19
92),
US
A
Mot
hers
/25
Mea
n (S
D)
Con
trol
:34
(4)
Inte
rven
tion:
33
.4 (4
)
/leve
l III
RC
TIn
terv
entio
n: D
etai
led
co
nsen
t.
Mot
hers
wer
e gi
ven
info
rmat
ion
abou
t m
echa
nica
l ven
tilat
ion.
D
etai
led
ris
k/b
enefi
t d
iscl
osur
e w
as p
rovi
ded
b
oth
verb
ally
and
in
writ
ing.
Con
trol
:m
othe
rs w
ere
give
n a
brie
f ver
bal
des
crip
tion
abou
t m
echa
nica
l ve
ntila
tion
sup
ple
men
ted
w
ith d
etai
led
ver
bal
an
d w
ritte
n d
iscl
osur
e if
des
ired
by
them
(flex
ible
co
nsen
t).
Mat
erna
l sa
tisfa
ctio
n w
ith
the
info
rmat
ion
pro
vid
ed a
bou
t m
echa
nica
l ve
ntila
tion.
Dur
ing
bab
ies’
ad
mis
sion
(onc
e):
►
24–4
8 ho
urs
afte
r th
e in
terv
entio
n
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
for
com
par
ison
.
An
inte
rvie
w e
valu
atin
g m
ater
nal
satis
fact
ion
with
the
info
rmat
ion
pro
vid
ed a
bou
t m
echa
nica
l ven
tilat
ion.
Valid
atio
n: a
psy
chia
tris
t w
ith a
sp
ecia
l in
tere
st in
inte
rvie
win
g te
chni
que
s w
as c
onsu
lted
in d
esig
ning
and
st
and
ard
isin
g th
is a
sses
smen
t.
A r
esea
rch
nurs
e co
nduc
ted
the
in
terv
iew
, ‘ch
ecki
ng’ e
ach
mot
her
agai
nst
one
optio
n re
gard
ing:
Am
ount
of i
nfor
mat
ion:
►
Rig
ht a
mou
nt–t
oo m
uch–
too
little
.
►In
form
atio
n m
ade
cop
ing:
m
ore
diffi
cult–
easi
er–n
o ef
fect
–unc
erta
in.
This
stu
dy
is m
easu
ring
and
com
par
ing
satis
fact
ion
with
tw
o d
iffer
ent
inte
rven
tions
(det
aile
d v
s fle
xib
le c
onse
nt
pro
cess
), ne
ither
of w
hich
form
ally
re
pre
sent
the
usu
al r
outin
e ca
re fo
r al
l b
abie
s (n
o co
ntro
l).
Sm
all n
umb
ers.
No
dat
a in
dic
atin
g st
atis
tical
ana
lysi
s co
nduc
ted
or
evid
ence
of
sta
tistic
ally
sig
nific
ant
resu
lts.
Det
aile
d F
lexi
ble
Rig
ht 7
5% m
othe
rs 1
00%
am
oun
t o
f in
form
atio
n To
o 2
5% m
othe
rs li
ttle
info
rmat
ion
Mad
e 67
% m
othe
rs 6
9% c
op
ing
eas
ier
No
3
NIC
U, n
eona
tal i
nten
sive
car
e un
it; N
IPS
, Neo
nata
l Ind
ex o
f Par
ent
Sat
isfa
ctio
n.
Tab
le 1
C
ontin
ued
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
9Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
Tab
le 2
In
clud
ed p
rosp
ectiv
e co
hort
stu
die
sP
rosp
ecti
ve c
oho
rt s
tud
ies
by
pub
licat
ion
year
Aut
hor
(dat
e),
coun
try
Par
ents
’ gen
der
/sa
mp
le s
ize
Infa
nts’
ges
tati
on
age
in w
eeks
/NIC
U
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d
par
ent
sati
sfac
tio
n?
1. D
e B
erna
rdo
et a
l (20
17),
Italy
Mot
hers
and
fa
ther
s/96
Mea
n (S
D)
Con
trol
:34
.2 (5
.25)
In
terv
entio
n: 3
2.7
(5.2
5)
/leve
l III
Non
- ran
dom
ised
, p
rosp
ectiv
e co
hort
p
ilot
stud
y
Uni
t le
vel e
ffec
t:Tw
o d
iffer
ent
time
per
iod
s
Inte
rven
tion:
FC
C.
Par
ents
had
acc
ess
to N
ICU
fo
r 8
hour
s/d
ay. T
he N
ICU
was
w
iden
ed a
nd p
aed
iatr
ic n
urse
s ta
ught
par
ents
pro
ced
ures
/p
ract
ices
for
10 d
ays.
Par
ents
co
uld
ob
serv
e cl
inic
al b
edsi
de
roun
ds,
hol
d m
eetin
gs w
ith t
he
phy
sici
ans,
use
the
roo
ms
and
ki
tche
n.
Con
trol
: par
ents
wer
e p
erm
itted
to
visi
t th
eir
bab
y in
N
ICU
for
1 ho
ur a
day
.
Par
ent
satis
fact
ion
rela
ting
to t
hree
sp
ecifi
c d
omai
ns:
1.
Kno
wle
dge
and
U
nder
stan
din
g.2.
C
omm
unic
atio
n an
d
colla
bor
atio
n.3.
P
rivac
y an
d
confi
den
tialit
y.
Dur
ing
bab
ies’
ad
mis
sion
(o
nce)
►A
t d
isch
arge
(pre
- FC
C c
ohor
t an
d
pos
t- FC
C c
ohor
t).
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
for
com
par
ison
(d
iffer
ent
par
ent
grou
ps
pre
inte
rven
tion
and
p
ostin
terv
entio
n).
Sat
isfa
ctio
n q
uest
ionn
aire
.
Valid
atio
n: t
he a
utho
rs s
tate
th
e su
rvey
‘was
des
igne
d a
nd
valid
ated
by
Ab
del
- Lat
if et
al’.
No
cont
ent
valid
ity o
r re
liab
ility
tes
ting
rep
orte
d in
the
orig
inal
pap
er.
Nin
e q
uest
ions
thre
e q
uest
ions
: Rel
ated
to
adeq
uate
and
tim
ely
info
rmat
ion
abou
t th
e b
aby’
s co
nditi
on.
thre
e q
uest
ions
: Rel
ated
to
com
mun
icat
ion
and
col
lab
orat
ion
with
the
hea
lthca
re t
eam
.
Thre
e q
uest
ions
: Rel
ated
to
resp
ect
of p
atie
nt p
rivac
y.Li
kert
(1 s
tron
gly
dis
agre
e–5
stro
ngly
agr
ee).
7/9
ind
ivid
ual s
tate
men
ts
in t
he p
aren
t sa
tisfa
ctio
n q
uest
ionn
aire
sco
red
hig
her
in t
he F
CC
com
par
ed w
ith t
he
NFC
C (s
tatis
tical
ly s
igni
fican
t d
iffer
ence
).
Exa
mp
le s
tate
men
t:“I
hav
e re
ceiv
ed a
deq
uate
in
form
atio
n ab
out
my
bab
y’s
cond
ition
and
man
agem
ent”
.
Inte
rven
tio
n C
ont
rol
Med
ian
5 (3
.45–
5) 4
(3–5
)
P v
alue
<0.
05
No
1
2. P
ette
ys
et a
l (20
15),
US
A
Not
sta
ted
/10
par
ents
incl
uded
in
sam
ple
an
alys
is
24–3
6+/le
vel I
IIA
pro
spec
tive
coho
rt d
esig
n.
A fe
asib
ility
stu
dy.
Gro
up le
vel e
ffec
t:
Inte
rven
tion/
co
ntro
l gro
ups
Pos
tinte
rven
tion
test
ing
only
Inte
rven
tion:
PC
.
PC
nur
ses
pro
vid
ed im
por
tant
co
ntin
uity
of c
are
for
NIC
U
infa
nts
clin
ical
ly r
equi
ring
PC
an
d a
t le
ast
wee
kly
verb
al
sup
por
t of
par
ents
. The
PC
se
rvic
e al
so c
oord
inat
ed fa
mily
co
nfer
ence
s, p
rovi
ded
or
req
uest
ed o
rder
s to
imp
rove
in
fant
sym
pto
m m
anag
emen
t an
d c
omfo
rt a
nd a
dd
ress
ed
par
enta
l cop
ing
and
sel
f- ca
re.
Con
trol
: usu
al c
linic
al c
are
for
infa
nts
not
req
uirin
g P
C.
Ove
rall
satis
fact
ion
with
car
e re
ceiv
ed.
Dur
ing
bab
ies’
ad
mis
sion
(o
nce)
►A
t d
isch
arge
(or
stud
y cl
osur
e fo
r in
fant
s w
ho r
emai
ned
ho
spita
lised
).
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
for
com
par
ison
.
Sat
isfa
ctio
n q
uest
ionn
aire
A
res
earc
her-
crea
ted
que
stio
nnai
re
bas
ed o
n ex
tens
ive
curr
ent
liter
atur
e re
view
.
Valid
atio
n: P
artia
lly r
epor
ted
. A
utho
rs s
tate
d c
onte
nt v
alid
ity
test
ing
took
pla
ce; n
o in
form
atio
n on
rel
iab
ility
tes
ting
pro
vid
ed.
One
que
stio
n
Like
rt (1
ext
rem
ely
dis
satis
fied
–4
to e
xtre
mel
y sa
tisfie
d).
Op
tiona
l fre
e te
xt (d
escr
iptio
n of
sp
ecifi
c ex
per
ienc
es im
pac
ting
satis
fact
ion
with
car
e).
Par
ent
satis
fact
ion
resp
onse
nu
mb
ers
wer
e sm
all (
n=10
), th
us s
tatis
tical
com
par
ison
of
par
enta
l sat
isfa
ctio
n b
etw
een
coho
rts
was
not
pos
sib
le.
How
ever
, 100
% o
f re
spon
din
g P
C p
aren
ts (n
=2)
re
por
ted
bei
ng ‘e
xtre
mel
y sa
tisfie
d’ w
ith c
are,
whe
reas
on
ly 5
0% o
f res
pon
din
g us
ual
care
par
ents
(n=
4) r
epor
ted
ex
trem
e sa
tisfa
ctio
n.
No
3 Con
tinue
d
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
10 Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
Pro
spec
tive
co
hort
stu
die
s b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e),
coun
try
Par
ents
’ gen
der
/sa
mp
le s
ize
Infa
nts’
ges
tati
on
age
in w
eeks
/NIC
U
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d
par
ent
sati
sfac
tio
n?
3. S
teve
ns
et a
l (20
11),
US
A
Mot
hers
/147
. For
th
e O
PB
Y N
ICU
, 58
sur
veys
wer
e re
turn
ed. F
or t
he
SFR
NIC
U, 8
9 w
ere
retu
rned
Mea
n (S
D)
Con
trol
: 35
(4)
Inte
rven
tion:
34
(3)
/leve
l not
sta
ted
Coh
ort
tria
l. Th
is
rese
arch
was
p
art
of a
larg
e p
rosp
ectiv
e ev
alua
tion.
Uni
t le
vel e
ffec
t:Tw
o d
iffer
ent
time
per
iod
s
Inte
rven
tion:
SFR
NIC
U fo
r ne
onat
al c
are.
Par
ents
cou
ld v
isit
thei
r b
aby,
ro
om- i
n, d
o ka
ngar
oo c
are
and
bre
ast
feed
at
any
time,
in
ind
ivid
ual r
oom
s (c
onta
inin
g b
ed, d
esk,
clo
set,
tel
epho
ne,
chai
r, re
frig
erat
or fo
r b
reas
t-
milk
sto
rage
).
Con
trol
: OP
BY
NIC
U. T
he
trad
ition
al O
PB
Y N
ICU
was
ty
pic
al o
f fac
ilitie
s b
uilt
bef
ore
1980
. All
neon
ates
, fam
ily
mem
ber
s, s
taff,
mon
itors
and
eq
uip
men
t w
ere
visi
ble
for
all n
eona
tes
in e
ach
room
. P
orta
ble
par
titio
ns w
ere
pla
ced
aro
und
the
incu
bat
or
for
bre
ast
feed
ing
and
ka
ngar
oo c
are.
Par
ent
satis
fact
ion
with
diff
eren
t el
emen
ts o
f NIC
U:
►
Del
iver
y.
►E
nviro
nmen
t.
►N
urse
s.
►P
hysi
cian
s.
►D
isch
arge
.
►P
erso
nal.
►
Ove
rall
asse
ssm
ent.
Aft
er b
abie
s w
ere
dis
char
ged
(onc
e)
►
Mai
led
with
in 6
0 d
ays
of d
isch
arge
of
par
ents
’ inf
ants
from
th
e N
ICU
.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
for
com
par
ison
(d
iffer
ent
par
ent
grou
ps
pre
inte
rven
tion
and
p
ostin
terv
entio
n).
Sat
isfa
ctio
n q
uest
ionn
aire
A
que
stio
nnai
re fr
om P
ress
G
aney
Ass
ocia
tes
was
use
d. A
lso
incl
uded
wer
e th
ree
que
stio
ns
add
ed b
y th
e in
vest
igat
ors.
Valid
atio
n: P
artia
lly r
epor
ted
. Th
e or
igin
al q
uest
ionn
aire
was
va
lidat
ed q
uest
ionn
aire
but
no
cont
ent
valid
ity o
r re
liab
ility
tes
ting
was
rep
orte
d r
egar
din
g th
e th
ree
que
stio
ns a
dd
ed b
y th
e st
udy
team
.
Fort
y- tw
o q
uest
ions
in t
otal
(sev
en
cate
gorie
s):
del
iver
y , e
nviro
nmen
t, n
urse
s,p
hysi
cian
s, d
isch
arge
, per
sona
l,ov
eral
l ass
essm
ent.
Like
rt (1
ver
y p
oor–
5 ve
ry g
ood
).
Sta
tistic
ally
sig
nific
ant
imp
rove
men
t w
as fo
und
fo
r th
e su
rvey
cat
egor
ies
of
Env
ironm
ent,
Ove
rall
and
the
To
tal s
urve
y.
Est
imat
ed n
umb
ers
from
re
por
t’s fi
gure
s as
num
ber
s no
t p
rovi
ded
):
Med
ian
SFR
OP
BY
P v
alue
Env
ironm
ent
4.7
3.7<
0.00
1O
vera
ll 5
4.8
0.01
8To
tal 4
.7 4
.5 0
.045
16 it
ems
com
pos
ite s
core
fo
r FC
C:
4.4
4.0
0.01
7
Yes
Form
er
NIC
U
par
ents
wer
e in
volv
ed in
al
l pha
ses
of
pla
nnin
g fo
r th
e ne
w S
FR
NIC
U.
1
FCC
, fam
ily c
entr
ed c
are;
NIC
U, n
eona
tal i
nten
sive
car
e un
it; O
PB
Y, O
pen
- bay
; PC
, pal
liativ
e ca
re; S
FR, s
ingl
e- fa
mily
roo
m.
Tab
le 2
C
ontin
ued
studies reported statistically significantly lower parent satisfaction in the intervention group compared with the control group. We classified studies as unclear if effective if they included small sample numbers or if statistical anal-ysis was not performed (box 3). Finally, we highlighted studies where only the intervention group was assessed and only postintervention, where comparison to a control group was not possible (box 4).
Overall, 18/32 studies (56%) reported higher parent satisfaction in the intervention group; 4/10 RCT and 14/22 non- RCT. The intervention theme where higher satisfaction was most consistently reported was parent involvement (10/14 studies). Due to the large heteroge-neity of outcome measure scales, a quantitative synthesis and meta- analysis was not possible.
Parent input into design of interventionsFive studies (5/32, 16%) reported involving parents in intervention design, of which two reported improvement of parent satisfaction. The number of included studies was too small to estimate any effect of parent co- design on the success of interventions at study level.
Methodological qualityFor the majority of RCT, key study characteristics, such as randomisation, allocation concealment and blinding of outcome assessment, were either not stated or unclear (figure 2). Only one RCT had an available study protocol (retrospectively registered) and none described blinding of study participants and/or personnel. All RCT scored a high/unclear risk of bias in at least 4/6 Cochrane tool categories, except for one, which scored a high/unclear risk in 3/6 categories.
We assessed 21/22 non- RCT studies using the ROBINS- I tool13, excluding the implementation project. All 21 studies were assessed as having an overall serious risk of bias and 7/21 of studies (33%) were further categorised as having critical risk of bias (figure 3). Blinding of partic-ipants, personnel and outcome assessment was poorly reported across all non- RCT and no study reported a published study protocol. None of the included non- RCT measured or corrected for important parent/infant confounding variables, or other relevant neonatal unit co- interventions taking place at the same time as the intervention.
We were unable to use the Standards for Reporting Imple-mentation Studies (StaRI) Statement Tool18 for assessing the implementation project, as the reporting was incomplete.
There was no association between methodological quality assessments and the studies’ reported effect on parent satisfaction. All 4/10 RCT that reported a higher level of parent satisfaction associated with their interven-tion, scored a high/unclear risk of bias in at least 4/6 Cochrane tool categories, one of which scored high/unclear risk in all categories. Out of the 14/22 non- RCT reporting an improved parent satisfaction, two were deemed to be at critical risk of bias on the ROBINS- I tool, while the rest we assessed to be at serious risk of bias.
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
11Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
Tab
le 3
In
clud
ed ‘o
ther
’ non
- ran
dom
ised
con
trol
led
tria
ls (n
on- R
CT)
‘Oth
er’ n
on-
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e), c
oun
try
Par
ents
’ g
end
er/s
amp
le
Siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/NIC
U
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d p
aren
t sa
tisf
acti
on?
1. K
adiv
ar e
t al
(2
017)
, Ira
nM
othe
rs/6
8≤3
0–36
/leve
l not
sta
ted
Non
- ran
dom
ised
,co
nven
ienc
e sa
mp
ling.
Gro
up le
vel e
ffec
t:In
terv
entio
n/co
ntro
l gro
ups.
Pre
inte
rven
tion
and
p
ostin
terv
entio
n te
stin
g.
Inte
rven
tion:
inte
rnet
- bas
ed
educ
atio
n.
Mot
hers
use
d a
n ed
ucat
iona
l web
site
se
t up
by
the
rese
arch
tea
m (fi
les
and
cl
ips)
. Mot
hers
cou
ld v
isit
the
web
site
fr
om 1
7:00
to
18:0
0 fo
r 10
day
s. T
hey
wer
e al
so a
llow
ed t
o us
e th
e w
ebsi
te
outs
ide
of t
he a
bov
e ho
urs
and
to
rep
ort
the
dur
atio
n of
usi
ng t
he
web
site
to
the
rese
arch
er. M
othe
rs
had
to
use
the
web
site
at
leas
t 3
times
dur
ing
10 d
ays,
eac
h tim
e fo
r at
le
ast
30 m
in.
Con
trol
: mot
hers
in t
he c
ontr
ol
grou
p r
ecei
ved
the
rou
tine
educ
atio
n p
rovi
ded
in t
he N
ICU
.
Mat
erna
l sat
isfa
ctio
nD
urin
g b
abie
s’ a
dm
issi
on
(twic
e):
►
Day
1 o
f in
terv
entio
n.
►D
ay 1
0 of
in
terv
entio
n.
Sat
isfa
ctio
n q
uest
ionn
aire
(V
alid
ated
)
The
‘Wha
t B
eing
The
Par
ent
of a
Bab
y is
Lik
e- R
evis
ed’
Que
stio
nnai
re w
as u
sed
. Th
e or
igin
al E
nglis
h ve
rsio
n b
y P
ridha
m a
nd C
hang
was
tr
ansl
ated
to
Per
sian
.
Ele
ven
que
stio
ns.
Tota
l sat
isfa
ctio
n sc
ore
rang
e (1
1–99
).
Ther
e w
as a
sig
nific
ant
diff
eren
ce
in t
he m
ean
scor
e of
sat
isfa
ctio
n b
etw
een
case
s an
d c
ontr
ols
whi
le
the
mea
n sc
ore
of s
atis
fact
ion
incr
ease
d in
bot
h gr
oup
s.
Co
mp
aris
on
of
the
mea
n sc
ore
b
etw
een
the
two
gro
ups
sho
wed
th
at t
he le
vel o
f sa
tisf
acti
on
was
si
gni
fica
ntly
hig
her
in t
he c
ase
gro
up v
s th
e co
ntro
l gro
up.
Inte
rven
tio
n C
ont
rol
bef
ore
inte
rven
tio
nM
ean
(SD
) 81.
62 (1
3.50
) 85.
71
(9.4
6)P
val
ue 0
.993
afte
r in
terv
enti
on
Mea
n (S
D) 9
3.88
(5.3
8) 9
0.12
(7
.78)
P v
alue
0.0
24
No
1
2. K
adiv
ar e
t al
. (2
017)
, Ira
nM
othe
rs/7
0M
ean
(SD
)
Con
trol
31.
6 (2
.4)
Inte
rv: 3
2.9
(3.1
)
/leve
l not
sta
ted
Non
- ran
dom
ised
,co
nven
ienc
e sa
mp
ling.
Uni
t le
vel e
ffec
t:Tw
o d
iffer
ent
time
per
iod
s.
Inte
rven
tion:
nar
rati
ve w
riti
ng.
Mot
hers
did
nar
rativ
e w
ritin
g at
leas
t th
ree
times
unt
il th
e 10
th d
ay o
f ad
mis
sion
.
Con
trol
: mot
hers
in t
he c
ontr
ol g
roup
re
ceiv
ed t
he r
outin
e N
ICU
tre
atm
ent
and
car
e.
Mot
hers
’ sat
isfa
ctio
n w
ith
med
ical
car
e p
rovi
ded
by
phy
sici
ans,
med
ical
stu
den
ts
and
nur
ses
dur
ing
neon
atal
ad
mis
sion
to
the
NIC
U.
Dur
ing
bab
ies’
ad
mis
sion
(tw
ice)
:
►
Day
3 o
f in
terv
entio
n.
►D
ay 1
0 of
in
terv
entio
n.
Sat
isfa
ctio
n q
uest
ionn
aire
(V
alid
ated
)
The
NIP
S q
uest
ionn
aire
by
Mitc
hell
et a
l was
use
d a
nd
tran
slat
ed t
o P
ersi
an.
24 q
uest
ions
(Lik
ert
scal
e)
Like
rt (1
alw
ays
or n
ot
satis
fied
–7 n
ever
or
com
ple
tely
sat
isfie
d).
A
high
er s
core
ind
icat
es m
ore
satis
fact
ion.
The
sat
isfa
ctio
n le
vel o
f th
e m
oth
ers
in t
he in
terv
enti
on
gro
up in
crea
sed
sig
nifi
cant
ly
dur
ing
the
stu
dy.
The
resu
lts o
f ind
epen
den
t t-
test
sh
owed
a s
igni
fican
t d
iffer
ence
in
the
sat
isfa
ctio
n ch
ange
s of
th
e m
othe
rs o
n th
e 3r
d a
nd 1
0th
day
of N
ICU
ad
mis
sion
bet
wee
n in
terv
entio
n an
d c
ontr
ol g
roup
s,
ind
icat
ing
the
effe
ctiv
enes
s of
na
rrat
ive
writ
ing.
The
resu
lts o
f pai
red
t- t
est
also
sh
owed
a s
igni
fican
t d
iffer
ence
in
the
mea
n sa
tisfa
ctio
n le
vel o
f the
m
othe
rs b
etw
een
the
3rd
and
the
10
th d
ay in
the
inte
rven
tion
grou
p.
Inte
rv C
ont
rol
Aft
er in
terv
enti
on
Mea
n 13
7 (1
5.2)
102
.3 (2
5.6)
(SD
)P
val
ue 0
.001
No
1
3. G
arin
go e
t al
. (2
016)
, US
AN
ot s
tate
d/9
23–3
9/le
vel I
IIN
on- r
and
omis
ed,
conv
enie
nce
sam
plin
g.
Gro
up le
vel e
ffec
t:
Inte
rven
tion/
cont
rol g
roup
sP
ostin
terv
entio
n gr
oup
te
stin
g on
ly.
Inte
rven
tion:
tel
e- ro
und
ing
.
Infa
nts
of in
terv
entio
n p
aren
ts w
ere
care
d fo
r b
y an
OFF
SN
who
was
p
rese
nt v
ia a
rem
ote-
cont
rolle
d r
obot
. Th
e O
FFS
N a
sses
sed
infa
nts
via
the
rob
ot’s
inte
grat
ed s
teth
osco
pe,
with
as
sist
ance
from
the
nur
sing
sta
ff.
Dur
ing
rout
ine
hour
s, t
he O
FFS
N w
as
calle
d t
o d
iscu
ss a
ny is
sues
with
the
p
atie
nt. E
mer
genc
ies/
out
of h
ours
w
ere
cove
red
by
an O
NS
N.
Con
trol
: inf
ants
of c
ontr
ol p
aren
ts
rece
ived
ON
SN
car
e. T
he a
tten
din
g ne
onat
olog
ist
mad
e d
aily
pat
ient
ro
und
s w
ith t
he N
ICU
tea
m. A
fter
p
atie
nt r
ound
s, t
he N
ICU
sta
ff, u
nder
th
e su
per
visi
on o
f the
att
end
ing
neon
atol
ogis
t im
ple
men
ted
the
ca
re p
lan.
Sat
isfa
ctio
n w
ith t
elem
edic
ine.
Dur
ing
bab
ies’
ad
mis
sion
(o
nce)
:
►
At
the
time
of
dis
char
ge.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
fo
r co
mp
aris
on.
Sat
isfa
ctio
n q
uest
ionn
aire
Va
lidat
ion:
no
cont
ent
valid
ity
or r
elia
bili
ty t
estin
g re
por
ted
.
Num
ber
of q
uest
ions
: not
st
ated
.
Like
rt (1
exc
elle
nt–5
ver
y p
oor)
.
Onl
y th
e in
terv
enti
on
gro
up
was
ass
esse
d a
nd o
nly
po
stin
terv
enti
on.
The
auth
ors
rep
orte
d t
hat
the
par
ents
sur
veye
d w
ere
‘sat
isfie
d w
ith t
heir
exp
erie
nce.
10
0% r
esp
ond
ed t
hat
they
felt
com
fort
able
tal
king
to
the
OFF
SN
on
the
mob
ile r
obot
and
wou
ld
allo
w t
heir
infa
nt o
r th
emse
lves
to
be
care
d fo
r b
y a
phy
sici
an v
ia
tele
med
icin
e in
the
futu
re’.
No
4
Con
tinue
d
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
12 Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
‘Oth
er’ n
on-
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e), c
oun
try
Par
ents
’ g
end
er/s
amp
le
Siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/NIC
U
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d p
aren
t sa
tisf
acti
on?
4. G
lob
us e
t al
. (2
016)
, Isr
ael
Mot
hers
an
d fa
ther
s/to
tal s
urve
ys
retu
rned
: 178
~
40%
in e
ach
grou
p <
32/le
vel I
IIN
on- r
and
omis
ed,
conv
enie
nce
sam
plin
g.
Uni
t le
vel e
ffec
t:Tw
o d
iffer
ent
time
per
iod
s.
Inte
rven
tion:
SM
Si.
Par
ents
wer
e up
dat
ed d
aily
reg
ard
ing
the
heal
th s
tatu
s of
the
ir in
fant
vi
a S
MS
from
the
EM
R. A
ll S
MS
m
essa
ges
wer
e se
nt a
t 09
:00,
in
clud
ing
one-
sent
ence
sec
tions
with
up
dat
ed in
form
atio
n (e
g, lo
catio
n of
th
e in
fant
’ s c
rib a
nd c
urre
nt w
eigh
t).
Info
rmat
ion
rega
rdin
g ac
ute
even
ts/
det
erio
ratio
n of
the
infa
nt’s
med
ical
co
nditi
on w
as n
ot in
clud
ed in
the
S
MS
, but
was
del
iver
ed p
erso
nally
to
the
par
ents
in r
eal t
ime.
Con
trol
: rou
tine
care
pre
- SM
S
imp
lem
enta
tion.
1.
Par
ent
satis
fact
ion
rela
ted
to
par
ent
com
mun
icat
ion
with
the
med
ical
sta
ff.
2.
Ove
rall
par
ent
satis
fact
ion
with
tre
atm
ent
and
sta
ff
attit
udes
thr
ough
out
hosp
italis
atio
n.
Dur
ing
bab
ies’
ad
mis
sion
(o
nce)
:
►
pre
- SM
S c
ohor
t an
d
pos
t- S
MS
coh
ort.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
for
com
par
ison
(d
iffer
ent
par
ent
grou
ps
pre
inte
rven
tion
and
p
ostin
terv
entio
n).
Sat
isfa
ctio
n q
uest
ionn
aire
Th
e ‘P
aren
ts' a
ttitu
des
re
gard
ing
thei
r ex
per
ienc
e d
urin
g th
eir
infa
nts'
ho
spita
lisat
ion
in t
he N
ICU
’ q
uest
ionn
aire
was
use
d, a
s w
ell a
s se
lect
ed it
ems
from
a
liter
atur
e re
view
of s
imila
r q
uest
ionn
aire
s, in
clud
ing
that
by
York
Hos
pita
l and
by
Con
ner
and
Nel
son.
Valid
atio
n: n
o co
nten
t va
lidity
or
rel
iab
ility
tes
ting
rep
orte
d.
Sel
ecte
d it
ems
rela
ted
to
four
asp
ects
of t
he N
ICU
ex
per
ienc
e. T
wo
out
of fo
ur
dire
ctly
ass
esse
d p
aren
t sa
tisfa
ctio
n:
1. P
aren
tal a
sses
smen
t of
th
eir
com
mun
icat
ion
with
the
m
edic
al s
taff.
Like
rt s
cale
(1 d
o no
t ag
ree
at
all–
5 st
rong
ly a
gree
).
2. O
vera
ll sa
tisfa
ctio
n w
ith
trea
tmen
t an
d s
taff
attit
udes
th
roug
hout
hos
pita
lisat
ion.
Vis
ual a
nalo
gue
scal
e (s
core
s ra
nge
0–10
). H
ighe
r sc
ores
re
flect
gre
ater
sat
isfa
ctio
n.
Ove
rall,
in b
oth
per
iod
s, p
aren
ts
exp
ress
ed a
hig
h d
egre
e of
sa
tisfa
ctio
n re
gard
ing
the
med
ical
tr
eatm
ent,
the
info
rmat
ion
give
n an
d t
he c
omm
unic
atio
n w
ith t
he m
edic
al s
taff.
Ove
rall
satis
fact
ion
with
tre
atm
ent
and
w
ith s
taff
attit
udes
thr
ough
out
hosp
italis
atio
n w
as s
light
ly g
reat
er
in t
he p
ost-
SM
S c
ohor
t b
ut d
id n
ot
reac
h st
atis
tical
sig
nific
ance
.
In t
he p
ost
- SM
S c
oho
rt,
a st
atis
tica
lly s
igni
fica
nt
imp
rove
men
t w
as n
ote
d
reg
ard
ing
phy
sici
an a
vaila
bili
ty
and
pat
ienc
e, p
aren
tal f
eelin
gs
of
com
fort
in a
pp
roac
hing
the
p
hysi
cian
s an
d n
urse
s an
d
reg
ular
ly r
ecei
ving
info
rmat
ion
reg
ard
ing
the
infa
nts'
med
ical
st
atus
fro
m t
he p
hysi
cian
s.
Po
st- S
MS
Pre
- SM
SM
ean
(SD
) 4.1
(1.0
) 3.7
(1.3
) P
valu
e 0.
03S
pec
ific
que
stio
n: “
I was
ple
ased
w
ith t
he fr
eque
ncy
with
whi
ch I
rece
ived
info
rmat
ion
rega
rdin
g m
y in
fant
”.
Alth
ough
imp
rove
men
t in
all
othe
r ca
tego
ries
was
doc
umen
ted
, it
did
no
t re
ach
stat
istic
al s
igni
fican
ce.
No
1
5. K
azem
ian
et a
l. (2
016)
, Ira
nM
othe
rs/2
20
new
bor
ns
(ass
umed
220
m
othe
rs)
>37
/leve
l not
sta
ted
Non
- ran
dom
ised
, co
nven
ienc
e sa
mp
ling.
Gro
up le
vel e
ffec
t:
Inte
rven
tion/
cont
rol g
roup
s
Pos
tinte
rven
tion
test
ing
only
.
Inte
rven
tion:
ro
om
ing
- in
care
.
Mot
hers
and
bab
ies
wer
e ad
mitt
ed t
o a
diff
eren
t at
mos
phe
re t
o th
e ro
utin
e ca
re. T
his
faci
litat
ed t
he m
othe
rs
and
neo
nate
s w
ith s
epar
ate
bed
s al
ong
with
pho
toth
erap
y d
evic
es a
nd
nurs
ing
clin
ical
sup
ervi
sion
.
Con
trol
: the
rou
tine
care
pra
ctis
ed
in t
his
neon
atal
uni
t su
pp
orte
d
par
tial s
tay
of m
othe
rs b
esid
e th
eir
neon
ates
, whi
le s
ittin
g on
cha
irs;
how
ever
, mos
t of
the
tim
e th
e m
othe
r- in
fant
dya
d w
as s
epar
ated
.
Mat
erna
l sat
isfa
ctio
n w
ith t
he
neon
atal
car
e se
rvic
es a
nd
hosp
ital s
tay
com
fort
.
Dur
ing
bab
ies’
ad
mis
sion
(o
nce)
:
►
Not
sta
ted
exa
ctly
w
hen.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
fo
r co
mp
aris
on.
Sat
isfa
ctio
n q
uest
ionn
aire
Va
lidat
ion:
no
cont
ent
valid
ity
or r
elia
bili
ty t
estin
g re
por
ted
.
The
auth
ors
stat
e, ‘a
val
idat
ed
self-
mad
e q
uest
ionn
aire
was
em
plo
yed
, whi
ch w
as fi
lled
in
by
som
e tr
aine
d m
idw
ives
’. N
o fu
rthe
r in
form
atio
n on
va
lidat
ion
pro
cess
es, n
umb
er
of q
uest
ions
or
nam
e of
the
q
uest
ionn
aire
was
pro
vid
ed.
Like
rt (5
ver
y sa
tisfie
d–1
d
issa
tisfie
d).
The
leve
l of
sati
sfac
tio
n w
as
sig
nifi
cant
ly h
ighe
r in
the
in
terv
enti
on
gro
up, c
om
par
ed
wit
h th
at in
the
co
ntro
l gro
up.
Inte
rv C
ont
rol
Sat
isfa
ctio
n %
26.
6 18
.8 P
va
lue
0.02
7
No
1
Tab
le 3
C
ontin
ued
Con
tinue
d
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
13Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
‘Oth
er’ n
on-
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e), c
oun
try
Par
ents
’ g
end
er/s
amp
le
Siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/NIC
U
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d p
aren
t sa
tisf
acti
on?
6. V
an d
e V
ijver
and
E
vans
(201
5), U
KN
ot s
tate
d/1
05N
ot s
tate
d/n
ot s
tate
dN
on- r
and
omis
ed,
conv
enie
nce
sam
plin
g.
Uni
t le
vel e
ffec
t:Th
ree
diff
eren
t tim
e p
erio
ds.
Inte
rven
tion:
bab
y d
iary
.
Eac
h p
aren
t re
ceiv
ed a
co
mm
unic
atio
n d
iary
on
thei
r in
fant
’s
adm
issi
on t
o th
e un
it. S
taff
wro
te- i
n in
fant
sta
tus
upd
ates
and
kep
t an
in
fant
inte
ract
ion
log
with
par
ents
. P
aren
ts w
rote
in m
emor
ies
and
q
uest
ions
for
staf
f to
add
ress
dur
ing
face
- to-
face
com
mun
icat
ion.
Con
trol
: rou
tine
care
, bef
ore
imp
lem
enta
tion
of t
he d
iarie
s.
Sat
isfa
ctio
n w
ith c
omm
unic
atio
n fr
om n
eona
tal s
taff
.D
urin
g b
abie
s’ a
dm
issi
on
(thre
e tim
es):
►
On
the
day
of
bab
ies’
dis
char
ge a
t st
udy
bas
elin
e.
►O
n th
e d
ay o
f b
abie
s’ d
isch
arge
at
1 m
onth
.O
n th
e d
ay o
f bab
ies’
d
isch
arge
at
15 m
onth
s.
Sat
isfa
ctio
n q
uest
ionn
aire
Th
e st
udy
team
des
igne
d a
q
uest
ionn
aire
, bas
ed o
n th
e D
epar
tmen
t of
Hea
lth a
nd t
he
Nat
iona
l Ins
titut
e fo
r H
ealth
an
d C
are
Exc
elle
nce
qua
lity
stan
dar
ds
for
spec
ialis
t ne
onat
al c
are.
Valid
atio
n: n
o co
nten
t va
lidity
or
rel
iab
ility
tes
ting
rep
orte
d.
Five
que
stio
ns (‘
yes
or n
o’).
Sm
all n
umb
ers.
No
dat
a in
dic
atin
g s
tati
stic
al a
naly
sis
cond
ucte
d o
r ev
iden
ce o
f st
atis
tica
lly s
igni
fica
nt r
esul
ts.
“I w
as r
ecei
ving
reg
ular
co
mm
unic
atio
n fr
om s
taff
”94
%—
1 m
onth
pos
tdia
ry c
ohor
t93
%—
15 m
onth
s p
ostd
iary
coh
ort
77%
—p
red
iary
coh
ort
“My
que
stio
ns a
nd c
once
rns
wer
e b
eing
ad
dre
ssed
”10
0%—
1 m
onth
pos
tdia
ry c
ohor
t93
%—
15 m
onth
s p
ostd
iary
coh
ort
91%
—p
red
iary
coh
ort
“I fe
el m
ore
invo
lved
in m
y b
aby'
s ca
re”
92%
—1
mon
th p
ostd
iary
coh
ort
100%
—15
mon
ths
pos
tdia
ry
coho
rt88
%—
pre
dia
ry c
ohor
t
Yes.
The
inte
rven
tion
conc
ept
was
cr
eate
d b
y th
e p
roje
ct le
ader
s fo
llow
ing
anal
ysis
of
bas
elin
e su
rvey
res
ults
an
d u
sed
aft
er
mul
tidis
cip
linar
y in
put
and
d
iscu
ssio
n w
ith
staf
f and
par
ents
.
3
7. V
oos
and
Par
k.
(201
4), U
SA
Not
sta
ted
/62
Not
sta
ted
/leve
l III
Non
- ran
dom
ised
, co
nven
ienc
e sa
mp
ling.
Uni
t le
vel e
ffec
t: T
wo
diff
eren
t tim
e p
erio
ds.
Inte
rven
tion:
OU
po
licy.
Par
ents
wer
e al
low
ed a
cces
s to
the
ir b
aby
24 h
ours
a d
ay, 7
day
s a
wee
k. C
ontr
ol: p
aren
ts p
re- O
U
imp
lem
enta
tion
rece
ived
rou
tine
care
. Th
e un
it w
as c
lose
d t
o p
aren
ts d
urin
g nu
rse
chan
ge o
f shi
ft in
mor
ning
s an
d e
veni
ngs.
Par
ent
satis
fact
ion
with
how
m
uch
time
par
ents
get
to
spen
d
with
the
ir b
aby.
Aft
er b
abie
s w
ere
dis
char
ged
(onc
e):
►
Aft
er p
re- O
U
par
ents
wer
e d
isch
arge
d.
►
Aft
er p
ost-
OU
p
aren
ts w
ere
dis
char
ged
.
Sin
gle
que
stio
n (fr
om a
va
lidat
ed q
uest
ionn
aire
)
The
que
stio
n “D
id y
ou g
et
to s
pen
d a
s m
uch
time
as
you
wan
ted
with
you
r b
aby?
” w
as u
sed
from
the
Nat
iona
l R
esea
rch
Cor
por
atio
n P
icke
r p
aren
t su
rvey
.
One
que
stio
n (‘y
es o
r no
’).
Sm
all n
umb
ers.
No
dat
a in
dic
atin
g s
tati
stic
al a
naly
sis
cond
ucte
d o
r ev
iden
ce o
f st
atis
tica
lly s
igni
fica
nt r
esul
ts.
“Did
you
get
to
spen
d a
s m
uch
time
as y
ou w
ante
d w
ith y
our
bab
y?”
Yes.
Pre
- OU
78%
(18/
23)
Pos
t- O
U 9
2% (3
6/39
)
Yes.
The
NIC
U h
as a
Fa
mily
- cen
tred
ca
re c
omm
ittee
in
clud
ing
par
ents
, w
hich
con
duc
ted
th
is p
roje
ct.
3
8. S
egre
et
al.
(201
3), U
SA
Mot
hers
/23
Mea
n (S
D) 3
1.57
(5
.30)
/leve
l III
For
the
outc
ome
of p
aren
t sa
tisfa
ctio
n:
Non
- ran
dom
ised
, co
nven
ienc
e sa
mp
ling.
Gro
up le
vel e
ffec
t:
Inte
rven
tion/
cont
rol g
roup
s
Pos
tinte
rven
tion
grou
p
test
ing
only
.
Inte
rven
tion:
LV
.
Mot
hers
met
with
the
LV
pro
vid
er
for
up t
o si
x 50
min
LV
ses
sion
s,
cond
ucte
d in
a p
rivat
e ho
spita
l, ev
ery
2–3
day
s, w
ithin
1 m
onth
. Vis
its
enta
iled
gre
etin
g, d
ebrie
fing,
up
dat
ing
on c
urre
nt is
sues
, wor
king
an
agen
da
thro
ugh
liste
ning
and
pro
ble
m
solv
ing
and
pro
vid
ing
clos
ure
thro
ugh
sum
mar
y.
Con
trol
: wom
en w
ho d
id n
ot m
eet
the
spec
ific
crite
ria (e
g, m
inim
um s
core
on
dep
ress
ion
scal
e) w
ere
not
invi
ted
to
join
the
tre
atm
ent
tria
l and
rec
eive
d
rout
ine
NIC
U c
are/
sup
por
t in
stea
d.
Sat
isfa
ctio
n w
ith t
he t
reat
men
t an
d t
he o
utco
me.
Dur
ing
bab
ies’
ad
mis
sion
(o
nce)
:
►
Not
sta
ted
exa
ctly
w
hen.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
fo
r co
mp
aris
on.
Sat
isfa
ctio
n q
uest
ionn
aire
Th
e C
lient
Sat
isfa
ctio
n Q
uest
ionn
aire
was
use
d.
Valid
atio
n: p
artia
lly r
epor
ted
. A
utho
rs s
tate
d r
elia
bili
ty
test
ing
took
pla
ce; n
o in
form
atio
n on
con
tent
val
idity
p
rovi
ded
.
Eig
ht q
uest
ions
.
Form
at o
f que
stio
ns: n
ot
stat
ed.
Onl
y th
e in
terv
enti
on
gro
up
was
ass
esse
d a
nd o
nly
po
stin
terv
enti
on.
The
auth
ors
rep
orte
d:
“The
maj
ority
of w
omen
who
re
ceiv
ed L
Vs
wer
e hi
ghly
sat
isfie
d
with
the
inte
rven
tion”
.
“The
ave
rage
sco
re fo
r th
e C
lient
S
atis
fact
ion
Que
stio
nnai
re w
as
29.9
1, c
omp
arab
le t
o le
vels
of
satis
fact
ion
rep
orte
d b
y cl
ient
s re
ceiv
ing
dep
ress
ion
trea
tmen
t fr
om a
men
tal h
ealth
pro
fess
iona
l”.
“91.
3% o
f our
par
ticip
ants
rat
ed
the
qua
lity
of h
elp
the
y re
ceiv
ed a
s ex
celle
nt”.
No
4
9. P
alm
a et
al.
(201
2), U
SA
Not
sta
ted
/26
fam
ilies
ret
urne
d
the
surv
ey
cont
aini
ng t
he
satis
fact
ion
mea
sure
)
Not
sta
ted
/leve
l II
Non
- ran
dom
ised
, co
nven
ienc
e sa
mp
ling.
Uni
t le
vel e
ffec
t:Tw
o d
iffer
ent
time
per
iod
s.
Inte
rven
tion:
YB
DU
. A d
aily
par
ent
upd
ate
lett
er g
ener
ated
fro
m
the
EM
R.
Par
ents
wer
e gi
ven
dai
ly Y
BD
U
rep
orts
, prin
ted
aut
omat
ical
ly fr
om
the
EM
R. T
he Y
BD
U in
clud
ed
info
rmat
ion
abou
t an
infa
nt’s
sta
tus
dur
ing
the
pas
t 24
hou
rs a
nd a
ha
nd- w
ritte
n up
dat
e b
y th
e in
fant
’s
care
pro
vid
er.
Con
trol
: par
ents
rec
eive
d r
outin
e ca
re
and
usu
al v
erb
al u
pd
ates
(6 m
onth
s p
re- a
dop
tion
of Y
BD
U).
Sat
isfa
ctio
n w
ith Y
BD
U.
Dur
ing
bab
ies’
ad
mis
sion
(o
nce)
:
►
Not
sta
ted
exa
ctly
w
hen.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
fo
r co
mp
aris
on(d
iffer
ent
par
ent
grou
ps
pre
inte
rven
tion
and
p
ostin
terv
entio
n).
Sat
isfa
ctio
n q
uest
ionn
aire
A
que
stio
nnai
re in
clud
ing
item
s re
gard
ing
adop
tion
of
and
sat
isfa
ctio
n w
ith Y
BD
U
was
use
d.
Valid
atio
n: n
o co
nten
t va
lidity
or
rel
iab
ility
tes
ting
rep
orte
d.
Num
ber
and
form
at o
f q
uest
ions
: not
sta
ted
.
Onl
y th
e in
terv
enti
on
gro
up
was
ass
esse
d a
nd o
nly
po
stin
terv
enti
on.
The
auth
ors
rep
orte
d:
“Whe
n as
ked
to
rate
the
sta
tem
ent
‘I lik
e re
ceiv
ing
Your
Bab
y’s
Dai
ly
Up
dat
e’, 9
6% o
f fam
ilies
who
use
d
YB
DU
as
an in
form
atio
n so
urce
re
spon
ded
with
the
hig
hest
rat
ing,
‘a
lway
s’”.
No
4
Tab
le 3
C
ontin
ued
Con
tinue
d
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
14 Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
‘Oth
er’ n
on-
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e), c
oun
try
Par
ents
’ g
end
er/s
amp
le
Siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/NIC
U
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d p
aren
t sa
tisf
acti
on?
10. V
oos
et a
l. (2
011)
, US
AN
ot s
tate
d/2
8N
ot s
tate
d/le
vel n
ot
stat
edN
on- r
and
omis
ed,
conv
enie
nce
sam
plin
g.
Uni
t le
vel e
ffec
t:Tw
o d
iffer
ent
time
per
iod
s.
Inte
rven
tion:
FC
Rs.
Par
ents
wer
e in
vite
d t
o at
tend
ro
und
s an
d c
hoos
e th
eir
leve
l of
invo
lvem
ent
(att
end
eve
ry d
ay/n
ot a
t al
l/per
iod
ical
ly).
For
confi
den
tialit
y co
ncer
ns, p
aren
ts w
ere
aske
d
to s
tep
out
sid
e w
hile
rou
nds
of
othe
rs’ i
nfan
ts t
ook
pla
ce. T
he s
taff
augm
ente
d F
CR
s b
y m
eetin
g w
ith
par
ents
aga
in a
fter
rou
nds
if ne
eded
.
Con
trol
: par
ents
rec
eive
d r
outin
e ca
re. P
rior
to F
CR
imp
lem
enta
tion
par
ents
wer
e as
ked
to
leav
e th
e un
it d
urin
g ro
und
s.
Glo
bal
sat
isfa
ctio
n w
ith t
he N
ICU
ex
per
ienc
e.D
urin
g b
abie
s’ a
dm
issi
on
(twic
e):
►
Prio
r to
FC
R.
►
6 m
onth
s af
ter
star
ting
FCR
.
Sat
isfa
ctio
n q
uest
ionn
aire
(V
alid
ated
)
The
NIP
S q
uest
ionn
aire
.
24 q
uest
ions
: loo
king
at
satis
fact
ion
in d
iffer
ent
area
s of
the
NIC
U (m
edic
al
care
give
rs, c
omm
unic
atio
n,
test
s an
d p
roce
dur
es).
Like
rt s
cale
(1–7
poi
nts)
.
A s
ubse
t o
f N
IPS
item
s re
late
d
to c
om
mun
icat
ion
(ie, b
eing
ke
pt
info
rmed
as
to c
hang
es in
th
e in
fant
’s c
ond
itio
n, m
eeti
ng
wit
h p
hysi
cian
s, a
nd in
form
atio
n ab
out
long
- ter
m e
xpec
tati
ons
) yi
eld
ed a
sig
nifi
cant
incr
ease
fr
om
pre
- FC
R t
o p
ost
- FC
R
sco
res.
po
st- F
CR
pre
- FC
R P
val
ueN
IPS
5.5
4.4
<0.
01 s
core
Th
e av
erag
e sc
ore
on t
he N
IPS
did
no
t ch
ange
sig
nific
antly
.
No
1
11. W
eiss
et
al.
(201
0), U
SA
Mot
hers
/84
Mea
n (S
D)
Pre
inte
rven
tion
grou
p: 3
2 (4
.4)
Pos
tinte
rven
tion
grou
p: 3
2 (9
)/le
vel I
II
Non
- ran
dom
ised
, co
nven
ienc
e sa
mp
ling
Uni
t le
vel e
ffec
t:Tw
o d
iffer
ent
time
per
iod
s.
Inte
rven
tion:
an in
terv
enti
on
to in
crea
se P
MP
av
aila
bili
ty a
nd c
om
mun
icat
ion
freq
uenc
y.
(1) A
brie
f ed
ucat
ion
mod
ule
for
PM
Ps
was
intr
oduc
ed, (
2) p
aren
ts
rece
ived
a c
onta
ct c
ard
with
PM
P
nam
es, j
ob d
escr
iptio
ns a
nd c
onta
ct
info
rmat
ion,
(3) a
pos
ter
of t
he fa
ces,
na
mes
and
titl
es o
f the
PM
Ps
was
p
lace
d a
t N
ICU
ent
ranc
e.
Con
trol
: par
ents
rec
eive
d r
outin
e ca
re
in t
he p
rein
terv
entio
n co
hort
, with
out
the
abov
e.
Par
ent
satis
fact
ion
with
p
hysi
cian
and
nur
se p
ract
ition
er
com
mun
icat
ion.
Dur
ing
bab
ies’
ad
mis
sion
(tw
ice)
:
►
Pre
inte
rven
tion.
►
Pos
tinte
rven
tion.
Sat
isfa
ctio
n Q
uest
ionn
aire
(V
alid
ated
)
A p
ilot
surv
ey w
ritte
n b
y P
ress
G
aney
and
the
Pic
ker
Inst
itute
w
as u
sed
and
rev
ised
bas
ed
on p
aren
t re
spon
ses.
Six
op
en- e
nded
que
stio
ns
(qua
ntity
of c
omm
unic
atio
n)
Six
Lik
ert
scal
e q
uest
ions
(r
ange
que
stio
ns (a
vaila
bili
ty,
und
erst
and
ing,
rec
ipro
city
, em
pat
hy, o
vera
ll sa
tisfa
ctio
n).
Ove
rall
sati
sfac
tio
n, b
ased
o
n th
e o
rdin
al a
naly
sis
of
the
5- p
oin
t Li
kert
sca
le, w
as
sig
nifi
cant
ly h
ighe
r af
ter
the
inte
rven
tio
n (p
<0.
01).
Ove
rall
sati
sfac
tio
n,
dic
hoto
mis
ed in
to a
sat
isfi
ed
sub
gro
up a
nd a
dis
sati
sfied
su
bg
roup
fo
r ea
ch c
oho
rt, w
as
also
sig
nifi
cant
ly in
crea
sed
aft
er
the
inte
rven
tio
n.
Po
st- i
nter
v P
rein
terv
Very
97%
(32/
33)7
4% (3
7/50
) sa
tisfi
ed/
So
mew
hat
sati
sfied
P v
alue
<0.
01
No
A
utho
rs s
tate
d
that
onl
y af
ter
tria
lling
the
in
terv
entio
n m
any
par
ents
(bot
h sa
tisfie
d a
nd
unsa
tisfie
d) g
ave
sugg
estio
ns t
o im
pro
ve it
.
1
12. F
oste
r et
al.
(200
8), A
ustr
alia
Mot
hers
and
fa
ther
s/93
5 sp
ecia
l car
e nu
rser
ies
Mea
n (S
D)
Hea
db
ox: 3
6.5
(2.6
) C
PAP
:36
(3)
/leve
l I
Non
- ran
dom
ised
, co
nven
ienc
e sa
mp
ling
Gro
up le
vel e
ffec
t:
Inte
rven
tion
1/in
terv
entio
n 2
grou
ps
Pos
tinte
rven
tion
test
ing
only
.
Inte
rven
tion
1: in
fant
s re
ceiv
ed
head
bo
x o
xyg
en t
reat
men
t fo
r re
spir
ato
ry d
istr
ess.
Inte
rven
tion
2: in
fant
s re
ceiv
ed
CPA
P t
reat
men
t fo
r re
spir
ato
ry
dis
tres
s.
Sat
isfa
ctio
n w
ith t
reat
men
t (ie
, he
adb
ox o
xyge
n or
CPA
P).
Dur
ing
bab
ies’
ad
mis
sion
(o
nce)
:
►
With
in 5
day
s of
the
b
abie
s’ a
dm
issi
on.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
fo
r co
mp
aris
on.
Sin
gle
que
stio
n Va
lidat
ion:
no
cont
ent
valid
ity
or r
elia
bili
ty t
estin
g re
por
ted
.
One
Lik
ert
scal
e q
uest
ion
(1
not
at a
ll sa
tisfie
d–5
ext
rem
ely
satis
fied
).
Par
ents
wit
h b
abie
s re
ceiv
ing
C
PAP
rat
ed t
heir
sat
isfa
ctio
n w
ith
the
bab
y’s
trea
tmen
t st
atis
tica
lly s
igni
fica
ntly
hig
her
than
the
hea
db
ox
gro
up m
ean
rati
ng.
Hea
db
ox
CPA
PM
ean
3.71
(1.3
1) 4
.51
(0.7
9) (S
D)
P v
alue
0.0
01
The
CPA
P g
roup
ave
rage
d
bet
wee
n ve
ry a
nd e
xtre
mel
y sa
tisfie
d c
omp
ared
with
par
ents
of
bab
ies
rece
ivin
g he
adb
ox, w
ho
aver
aged
bet
wee
n sa
tisfie
d a
nd
very
sat
isfie
d r
atin
gs.
No
1
13. B
yers
et
al.
(200
6), U
SA
Onl
y m
othe
rs
rep
orte
d/3
5P
rete
rm in
fant
s
Mea
n (S
D)
Con
trol
: 28.
9 (3
.44)
Inte
rv: 2
8.6
(3.3
7)
/leve
l II/
III
For
the
outc
ome
of p
aren
t sa
tisfa
ctio
n:
Non
- ran
dom
ised
, co
nven
ienc
e sa
mp
ling
Gro
up le
vel e
ffec
t:
Inte
rven
tion/
cont
rol g
roup
s
Pos
tinte
rven
tion
test
ing
only
.
Inte
rven
tion:
infa
nts
rece
ived
in
div
idua
lised
, dev
elo
pm
enta
lly
sup
po
rtiv
e FC
C.
Infa
nts
rece
ived
car
e w
ithin
the
fr
amew
ork
and
phi
loso
phy
of
ind
ivid
ualis
ed, d
evel
opm
enta
lly
sup
por
tive
fam
ily c
entr
ed
inte
rven
tions
.
Con
trol
: inf
ants
rec
eive
d t
he
trad
ition
al N
ICU
sta
ndar
d o
f car
e.
Par
ent
satis
fact
ion
rela
ting
to:
►
Par
enta
l per
cep
tions
of
staf
f car
ing
►
Ed
ucat
ion
rece
ived
►
Pre
par
atio
n fo
r th
e p
aren
tal
role
►
Ove
rall
satis
fact
ion
with
the
N
ICU
exp
erie
nce.
Dur
ing
bab
ies’
ad
mis
sion
(o
nce)
:
►
On
the
day
bef
ore
dis
char
ge.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
fo
r co
mp
aris
on.
Sat
isfa
ctio
n q
uest
ionn
aire
Th
e N
ICU
’s p
aren
tal
satis
fact
ion
tool
was
use
d.
Valid
atio
n: p
artia
lly r
epor
ted
. A
utho
rs s
tate
d c
onte
nt
valid
ity t
estin
g to
ok p
lace
, b
ut ‘b
ecau
se o
f the
dis
par
ate
natu
re o
f the
item
s, s
urve
y re
liab
ility
was
not
ass
esse
d’.
Ele
ven
que
stio
ns
Like
rt s
cale
(1–5
str
ongl
y ag
ree)
.
Ind
epen
den
t t-
test
ana
lysi
s o
f p
aren
t sa
tisf
acti
on/
per
cep
tio
n sc
ore
s sh
ow
ed n
o s
igni
fica
nt
diff
eren
ce b
etw
een
gro
ups.
Exa
mp
le s
tate
men
t: “
I was
sa
tisfie
d w
ith t
he c
ar m
y b
aby
and
I r
ecei
ved
in t
he N
ICU
”
Inte
rv C
ont
rol
Mea
n 4.
94 (0
.23)
4.7
1 (0
.47)
(SD
)P
val
ue 0
.064
Bot
h gr
oup
s re
por
ted
ver
y hi
gh
satis
fact
ion
with
the
ir N
ICU
ex
per
ienc
e (4
.4–5
.0)
No
2
Tab
le 3
C
ontin
ued
Con
tinue
d
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
15Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
‘Oth
er’ n
on-
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e), c
oun
try
Par
ents
’ g
end
er/s
amp
le
Siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/NIC
U
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d p
aren
t sa
tisf
acti
on?
14. M
ills
et a
l. (2
006)
, US
AN
ot s
tate
d/n
ot
stat
ed
Par
ents
of
infa
nts
from
six
hosp
itals
Not
sta
ted
/leve
l not
st
ated
Imp
lem
enta
tion
pro
ject
PD
SA
qua
lity
imp
rove
men
t te
stin
g.
Inte
rven
tion:
5 P
BP
s in
the
are
a o
f d
isch
arg
e p
lann
ing
.
The
pro
ject
tea
m it
erat
ivel
y im
ple
men
ted
5 P
BP
s:1.
C
reat
ed a
n ea
sy- t
o- us
e, e
asy-
to
- acc
ess
dis
char
ge p
lann
ing
tool
kit.
2.
Res
truc
ture
d c
omm
unic
atio
n to
ols
and
pro
cess
es t
o re
flect
a
‘pla
n fo
r th
e d
ay, t
he s
tay
and
th
e w
ay’ t
o d
isch
arge
.3.
M
axim
ised
the
imp
act
and
use
of
car
egiv
er e
duc
atio
nal t
ools
, an
d u
pd
ated
mat
eria
ls a
nd
del
iver
y sy
stem
s fo
r ca
regi
ver
educ
atio
n.4.
U
sed
var
ious
con
tinuo
us
qua
lity
imp
rove
men
t to
ols
and
p
roce
sses
to
ensu
re p
aren
t/ca
regi
ver
and
sta
ff sa
tisfa
ctio
n.5.
A
naly
sed
and
enh
ance
d
inte
ract
ions
with
and
tra
nsfe
rs
into
the
com
mun
ity.
Con
trol
: N/A
. No
dis
cret
e co
ntro
l gr
oup
. PD
SA
qua
lity
imp
rove
men
t m
etho
dol
ogy
was
ap
plie
d t
o p
aren
t p
artic
ipan
ts.
Gen
eral
sat
isfa
ctio
n:
►
With
car
e
►P
aren
ts’ f
eelin
gs a
bou
t p
rep
ared
ness
for
dis
char
ge
►A
bili
ty a
nd c
onfid
ence
in
feed
ing
►
Fam
iliar
ity w
ith t
heir
infa
nt
►Fe
elin
g lik
e a
par
ent
►
Par
ticip
atio
n in
car
e
►A
deq
uacy
of i
nfor
mat
ion
from
sta
ff a
bou
t m
edic
al
and
car
e is
sues
.
Dur
ing
bab
ies’
ad
mis
sion
(fo
ur t
imes
):
►
Not
rep
orte
d e
xact
ly
whe
n.
Sat
isfa
ctio
n q
uest
ionn
aire
Th
e in
tern
et- b
ased
p
aren
t sa
tisfa
ctio
n su
rvey
‘h
owsy
ourb
aby.
com
’ tha
t w
as
dev
elop
ed, e
spec
ially
for
this
N
ICU
pop
ulat
ion
was
use
d.
Valid
atio
n: n
o co
nten
t va
lidity
or
rel
iab
ility
tes
ting
rep
orte
d.
Num
ber
and
form
at o
f q
uest
ions
: not
sta
ted
.
Thro
ugh
mul
tiple
rap
id- c
ycle
p
roje
cts,
the
pro
ject
’s c
olla
bor
ativ
e gr
oup
mad
e ch
ange
s w
ithin
the
5
PB
P p
lans
.
Par
ent
sati
sfac
tio
n m
easu
res
wer
e us
ed t
o lo
ngit
udin
ally
m
oni
tor
the
chan
ges
mad
e,
rath
er t
han
mak
e d
irec
t g
roup
co
mp
aris
on.
No
dat
a in
dic
atin
g
stat
isti
cal a
naly
sis
cond
ucte
d
or
evid
ence
of
stat
isti
cally
si
gni
fica
nt r
esul
ts.
Par
ent
satis
fact
ion
surv
ey r
esul
ts
(all
cent
res
com
bin
ed) w
ere
high
acr
oss
four
mea
sure
men
t q
uart
iles.
No
spec
ific
inte
rqua
rtile
an
alys
is w
as r
epor
ted
.
Par
ent
read
ines
s fo
r d
isch
arge
w
as h
igh
at t
he b
egin
ning
and
th
roug
hout
the
col
lab
orat
ive.
P
aren
ts’ r
ecei
ving
‘jus
t th
e rig
ht
amou
nt o
f inf
orm
atio
n’ r
egar
din
g ca
r se
at t
rials
and
saf
e sl
eep
d
emon
stra
ted
som
e va
riab
ility
th
roug
hout
the
col
lab
orat
ive.
No
3
15. W
iele
nga
et
al. (
2006
), Th
e N
ethe
rland
s
Mot
hers
and
fa
ther
s/46
Mea
n (S
D)
Con
trol
: 28.
5 (2
6.0–
29.9
) In
terv
: 28.
3 (2
5.6–
29.9
)
/leve
l III
Non
- ran
dom
ised
, co
nven
ienc
e sa
mp
ling
Uni
t le
vel e
ffec
t:tw
o d
iffer
ent
time
per
iod
s.
Inte
rven
tion:
NID
CA
P.
Infa
nts
rece
ived
car
e ac
cord
ing
to
NID
CA
P p
rinci
ple
s an
d p
aren
ts w
ere
taug
ht h
ow t
o p
rovi
de
it. C
areg
ivin
g p
lans
wer
e d
esig
ned
bas
ed o
n th
e in
fant
’s c
urre
nt d
evel
opm
enta
l sta
ge,
med
ical
con
diti
on a
nd fa
mily
nee
ds.
C
areg
iver
s le
arnt
to
wat
ch s
ensi
tivel
y an
d n
ote
the
infa
nt’s
rea
ctio
ns t
o d
iffer
ent
typ
es o
f han
dlin
g an
d c
are,
m
akin
g co
ntin
uous
ad
just
men
ts.
Con
trol
: inf
ants
rec
eive
d t
rad
ition
al
neon
atal
car
e p
ract
ised
at
that
tim
e.
Par
ent
satis
fact
ion
rela
ting
to:
►
Ove
rall
ratin
g
►C
are
of t
he b
aby
►
Com
mun
icat
ion
with
sta
ff
►In
volv
emen
t in
car
e -B
eing
p
rep
ared
►
Sup
por
t
►B
eing
a p
aren
t
►B
eing
nea
r yo
ur b
aby
►
Tota
l sco
re.
Aft
er b
abie
s w
ere
dis
char
ged
(on
day
of
dis
char
ge/t
rans
fer)
:
►
Pre
- NID
CA
P c
ohor
t.
►P
ost-
NID
CA
P
coho
rt.
Sat
isfa
ctio
n q
uest
ionn
aire
(V
alid
ated
)
The
NIC
U- P
SF
was
use
d
and
tra
nsla
ted
from
Eng
lish
to D
utch
.
Six
ty- t
wo
que
stio
ns.
Clo
sed
and
op
en- e
nded
q
uest
ions
.
Diff
eren
t ra
ting
scal
es u
sed
(5
- poi
nt r
atin
g sc
ale
from
‘e
xtre
mel
y sa
tisfie
d’ t
o ‘n
ot
at a
ll sa
tisfie
d’ o
r ‘e
xcel
lent
’ to
‘poo
r’).
Tota
l sco
re r
ange
(50–
243
poi
nts)
.
The
inte
rven
tio
n g
roup
’s m
ean
tota
l sco
re w
as s
igni
fica
ntly
hi
ghe
r th
an t
he c
ont
rol.
Inte
rv C
ont
rol
Mea
n (S
D)
185.
67 (1
7.74
) 174
.04
(20.
98)
P v
alue
0.0
41
Alm
ost
all s
epar
ate
conc
epts
sh
owed
an
incr
ease
in t
heir
mea
n sc
ores
. The
con
cep
t of
‘bei
ng
a p
aren
t’ h
ad a
slig
htly
low
er
mea
n sc
ore
(9.3
9, S
D=
1.73
) in
the
inte
rven
tion
grou
p t
han
in t
he
cont
rol g
roup
(9.7
8, S
D=
2.09
).
The
co
ncep
t o
f ‘p
rep
ared
nes
s’
sho
wed
sta
tist
ical
ly s
igni
fica
nt
diff
eren
ce:
Inte
rv C
ont
rol
Mea
n 16
.38
13.8
3P
val
ue 0
.038
No
1
Tab
le 3
C
ontin
ued
Con
tinue
d
on May 13, 2022 by guest. P
rotected by copyright.http://bm
jpaedsopen.bmj.com
/bm
jpo: first published as 10.1136/bmjpo-2019-000613 on 15 M
arch 2020. Dow
nloaded from
16 Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
‘Oth
er’ n
on-
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e), c
oun
try
Par
ents
’ g
end
er/s
amp
le
Siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/NIC
U
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
rove
d p
aren
t sa
tisf
acti
on?
16. P
entic
uff a
nd
Arh
eart
(200
5), U
SA
Dya
ds
(bot
h p
aren
ts o
r m
othe
r w
ith
her
sup
por
t p
erso
n)/1
22
mot
hers
Res
ults
bas
ed
only
on
mot
hers
’ d
ata.
Not
sta
ted
/leve
l III
A r
epea
ted
mea
sure
s d
esig
n:
►
Firs
t 2
year
s (c
ontr
ol
grou
p d
ata
colle
ctio
n).
►
Year
3 (s
taff
trai
ning
).
►Ye
ar 4
(im
ple
men
ting
the
inte
rven
tion)
.
►Ye
ar 5
(col
lect
ing
dat
a fr
om t
he in
terv
entio
n gr
oup
). U
nit
leve
l eff
ect:
Tw
o d
iffer
ent
time
per
iod
s.
Inte
rven
tion:
The
new
bo
rn
ind
ivid
ualis
ed IP
C-
CP
M
inte
rven
tio
n.
Bot
h th
e m
othe
r an
d fa
ther
(or
the
mot
her
and
her
des
igna
ted
sup
por
t p
erso
n) w
ere
show
n ho
w t
o us
e th
e IP
C a
nd a
tten
ded
thr
ee C
PM
(w
ith n
eona
tolo
gist
s/ne
onat
al n
urse
p
ract
ition
ers)
.
Con
trol
: dur
ing
the
cont
rol p
hase
, p
rofe
ssio
nals
car
ried
out
usu
al
com
mun
icat
ion
and
inte
ract
ion
with
co
ntro
l gro
up p
aren
ts.
Sat
isfa
ctio
n w
ith p
artic
ipat
ion
in
dec
isio
n m
akin
g w
as m
easu
red
b
y fiv
e co
llab
orat
ion
ind
ices
: S
atis
fact
ion
with
1.
Car
e2.
R
elat
ions
hip
s w
ith
pro
fess
iona
ls3.
D
ecis
ion
inp
ut4.
Th
e p
roce
ss o
f dec
isio
n m
akin
g5.
D
ecis
ions
mad
e.
Dur
ing
bab
ies’
ad
mis
sion
(th
ree
times
):
►
With
in 0
–3 d
ays.
►
9–12
day
s.
►25
–28
day
s of
an
infa
nt’s
ad
mis
sion
to
the
NIC
U.
Thre
e sa
tisfa
ctio
n q
uest
ionn
aire
s 1.
Tw
o su
bsc
ales
of t
he
inve
stig
ator
- des
igne
d
‘Par
ents
’ Und
erst
and
ing
of
Infa
nt C
are
and
Out
com
es
Que
stio
nnai
re’ w
ere
used
to
mea
sure
Sat
isfa
ctio
n w
ith
Car
e (1
).
Valid
atio
n: p
artia
lly r
epor
ted
. A
utho
rs s
tate
d c
onte
nt
valid
ity t
estin
g to
ok p
lace
; no
info
rmat
ion
on r
elia
bili
ty
test
ing
pro
vid
ed.
Thirt
y q
uest
ions
.
Five
- poi
nt L
iker
t sc
ale.
2. A
sub
scal
e of
the
in
vest
igat
or- d
esig
ned
‘R
elat
ions
hip
s w
ith
Pro
fess
iona
l and
Dec
isio
n In
put
Que
stio
nnai
re’ w
as u
sed
to
mea
sure
sat
isfa
ctio
n w
ith
rela
tions
hip
s (2
).
Valid
atio
n: p
artia
lly r
epor
ted
. A
utho
rs s
tate
d c
onte
nt
valid
ity t
estin
g to
ok p
lace
; no
info
rmat
ion
on r
elia
bili
ty
test
ing
pro
vid
ed.
Twel
ve q
uest
ions
.
Five
- poi
nt L
iker
t sc
ale
3. V
alid
ated
.Th
e ‘C
olla
bor
atio
n an
d
Sat
isfa
ctio
n A
bou
t C
are
Que
stio
nnai
re’ d
evel
oped
by
Bag
gs, w
as u
sed
to
mea
sure
S
atis
fact
ion
with
dec
isio
n in
put
(3),
with
dec
isio
n p
roce
ss (4
) and
with
dec
isio
ns
mad
e (5
).
Nin
e q
uest
ions
.
7- p
oint
sca
le (1
str
ongl
y d
isag
ree−
7 st
rong
ly a
gree
).
The
inte
rven
tio
n g
roup
was
m
ore
sat
isfi
ed w
ith
the
amo
unt
of
dec
isio
n in
put
the
y ha
d
(3) a
nd w
ith
the
pro
cess
by
whi
ch m
edic
al d
ecis
ions
wer
e m
ade
(4).
Inte
rv C
ont
rol P
val
ueD
ecis
ion
inp
ut a
mou
nt (3
)M
ean
33.4
4 30
.05
0.05
8
Pro
cess
of d
ecis
ion
mak
ing
(4)
Mea
n 12
0.20
104
.95
0.01
2
Ther
e w
ere
no s
tatis
tical
ly
sign
ifica
nt d
iffer
ence
s b
etw
een
cont
rol a
nd in
terv
entio
n gr
oup
s in
sat
isfa
ctio
n w
ith t
heir
infa
nts’
ca
re (1
), w
ith r
elat
ions
hip
s w
ith
NIC
U p
rofe
ssio
nals
(2) a
nd w
ith
the
dec
isio
ns m
ade
for
infa
nt
trea
tmen
t (5
).
No
1
17. B
yers
et
al.
(200
3), U
SA
Mot
hers
/19
Mea
n (S
D)
Con
trol
: 29
(2.0
0)
Inte
rv: 2
8.9
(2.4
2)
/leve
l II–
III
For
the
outc
ome
of p
aren
t sa
tisfa
ctio
n:
Non
- ran
dom
ised
, co
nven
ienc
e sa
mp
ling
Gro
up le
vel e
ffec
t:
Inte
rven
tion/
cont
rol g
roup
s
Pre
inte
rven
tion
and
p
ostin
terv
entio
n te
stin
g.
Inte
rven
tion:
co
- bed
din
g p
rem
atur
e m
ulti
ple
- ges
tati
on
infa
nts
in
incu
bat
ors
.
Infa
nts
wer
e nu
rsed
in t
he s
ame
incu
bat
or u
sing
a c
o- b
edd
ing
pro
toco
l (eg
, rec
ord
ing
all o
f the
ca
re p
rovi
ded
to
one
infa
nt b
efor
e p
rovi
din
g ca
re t
o th
e se
cond
infa
nt).
Con
trol
: sin
gle-
bed
din
g p
rem
atur
e m
ultip
le- g
esta
tion
infa
nts
in
incu
bat
ors.
Par
ent
satis
fact
ion
rela
ted
to:
►
Sta
ff c
once
rn
►S
upp
ort
of fa
mily
►
Sta
ff e
xpla
natio
ns
►In
fant
env
ironm
ent,
►
Com
fort
with
feed
ing
►
Kan
garo
o ca
re
enco
urag
emen
t
►S
taff
exp
lana
tion
of s
igns
of
infa
nt s
tres
s
►V
isiti
ng s
ched
ule
►
Ove
rall
satis
fact
ion
with
the
N
ICU
exp
erie
nce.
Dur
ing
bab
ies’
ad
mis
sion
(tw
ice)
:
►
At
bas
elin
e.
►5
day
s la
ter.
Sat
isfa
ctio
n q
uest
ionn
aire
Th
e N
ICU
’s s
tand
ard
par
enta
l sa
tisfa
ctio
n to
ol w
as u
sed
.
Valid
atio
n: p
artia
lly r
epor
ted
. A
utho
rs s
tate
d c
onte
nt
valid
ity t
estin
g to
ok p
lace
, b
ut b
ecau
se o
f the
dis
par
ate
natu
re o
f the
item
s, s
urve
y re
liab
ility
cou
ld n
ot b
e as
sess
ed.
Ele
ven
que
stio
ns.
5- p
oint
Lik
ert-
typ
e sc
ale.
The
onl
y si
gni
fica
nt d
iffer
ence
fo
r a
po
stin
terv
enti
on
item
w
as a
hig
her
sco
re f
or
the
item
‘A
ttem
pts
wer
e m
ade
to c
reat
e a
qui
et e
nvir
onm
ent
for
my
bab
y’.
Inte
rv C
ont
rol P
val
ueM
ean
4.80
3.8
9 0.
033
Ind
epen
den
t t-
test
s co
mp
arin
g th
e co
- bed
ded
and
con
trol
gr
oup
par
enta
l sco
res
foun
d n
o si
gnifi
cant
diff
eren
ces
in t
heir
par
enta
l sat
isfa
ctio
n sc
ores
, ex
cep
t fo
r hi
gher
bas
elin
e p
aren
tal
satis
fact
ion
scor
es (p
=0.
029)
in t
he
co- b
edd
ed g
roup
.
No
1
Tab
le 3
C
ontin
ued
Con
tinue
d
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arch 2020. Dow
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17Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
‘Oth
er’ n
on-
RC
T b
y p
ublic
atio
n ye
ar
Aut
hor
(dat
e), c
oun
try
Par
ents
’ g
end
er/s
amp
le
Siz
e
Infa
nts’
ges
tati
on
age
in w
eeks
/NIC
U
leve
lS
tud
y d
esig
nIn
terv
enti
on
Out
com
e m
easu
res
Tim
ing
of
mea
sure
men
tM
etho
d o
f m
easu
rem
ent
Res
ults
Par
ent
co-
des
ign?
Imp
r ove
d p
aren
t sa
tisf
acti
on?
18. P
oliz
zi e
t al
. (2
003)
, US
AM
othe
rs a
nd
fath
ers/
33M
ean
(SD
)
Con
trol
: 32.
97 (1
.9)
Inte
rv: 3
3.08
(1.3
1)
/leve
l III
A r
etro
spec
tive,
com
par
ativ
e,
des
crip
tive
des
ign.
Uni
t le
vel e
ffec
t.
Inte
rven
tion:
co
- bed
din
g m
ulti
ple
- g
esta
tio
n in
fant
s in
the
NIC
U.
Mul
tiple
- ges
tatio
n in
fant
s w
ere
nurs
ed in
the
sam
e in
cub
ator
or
crib
. The
inte
rven
tion
was
eva
luat
ed
retr
osp
ectiv
ely
afte
r im
ple
men
tatio
n of
a c
o- b
edd
ing
pra
ctic
e p
roto
col.
Con
trol
: tra
diti
onal
ly b
edd
ed g
roup
(b
abie
s w
ere
rout
inel
y p
lace
d in
se
par
ate
incu
bat
ors
or c
ribs)
.
Par
enta
l sat
isfa
ctio
n as
m
easu
red
by
nine
que
stio
ns
rela
ting
to p
aren
t p
erce
ptio
ns
and
the
ir b
aby’
s ca
re.
Aft
er b
abie
s w
ere
dis
char
ged
(onc
e):
►
All
par
ents
wer
e m
aile
d t
he s
urve
y. A
se
cond
sur
vey
was
se
nt t
o th
ose
who
d
id n
ot r
esp
ond
af
ter
2 m
onth
s.N
o p
rein
terv
entio
n p
aren
t sa
tisfa
ctio
n d
ata
avai
lab
le
for
com
par
ison
.
Sat
isfa
ctio
n q
uest
ionn
aire
Th
e p
aren
tal p
erce
ptio
n/sa
tisfa
ctio
n to
ol w
as u
sed
.
Valid
atio
n: p
artia
lly r
epor
ted
. A
utho
rs s
tate
d c
onte
nt
valid
ity t
estin
g to
ok p
lace
; no
info
rmat
ion
on r
elia
bili
ty
test
ing
pro
vid
ed. 6
/9
que
stio
ns w
ere
from
a s
imila
r to
ol t
hat
was
val
idat
ed b
y th
e Ve
rmon
t O
xfor
d N
ICU
Qua
lity
Imp
rove
men
t In
itiat
ive.
Nin
e q
uest
ions
(suc
h as
“I
was
sat
isfie
d w
ith t
he c
are
my
bab
ies
rece
ived
in t
he
hosp
ital”
).
Like
rt (1
str
ongl
y d
isag
ree–
5 st
rong
ly a
gree
).
Mot
hers
rep
orte
d o
vera
ll sa
tisfa
ctio
n w
ith t
he N
ICU
car
e an
d s
taff,
as
wel
l as
adeq
uacy
of
the
ir ab
ility
to
care
for
thei
r in
fant
s af
ter
dis
char
ge, w
ith s
core
s ra
ngin
g fr
om 4
.19
to 4
.71.
The
onl
y su
rvey
item
sco
re
that
was
si
gni
fica
ntly
diff
eren
t b
etw
een
gro
ups
was
fo
r th
e it
em
“I w
as e
nco
ura
ged
by
the
h
osp
ital
st
aff
to b
ond
wit
h m
y
bab
ies”
.
Inte
rv C
ont
rol P
val
ueM
ean
4.71
4.3
6 0.
049
No
1
19. L
egau
lt an
d
Gou
let
(199
5),
Can
ada
Mot
hers
/61
com
ple
ted
bot
h te
sts
Mea
n (r
ange
)
30 (2
4–35
)
/leve
l II
Tim
e- se
ries
des
ign
Gro
up le
vel e
ffec
t: S
ame
grou
p e
xpos
ed t
o b
oth
met
hod
s w
ith p
ostm
etho
d
test
ing
only
.
Inte
rven
tion:
Kan
gar
oo
met
hod
o
f re
mo
ving
an
infa
nt f
rom
an
incu
bat
or.
Mot
hers
wer
e ta
ught
the
‘kan
garo
o m
etho
d’ (
skin
- to-
skin
con
tact
): in
fant
wea
rs a
dia
per
/hea
d c
ap a
nd
is p
lace
d in
a v
ertic
al p
ositi
on o
n th
e p
aren
t’s b
ared
che
st. A
bla
nket
co
vers
the
infa
nt a
nd t
he p
aren
t’s
clot
hing
is fa
sten
ed a
roun
d t
he in
fant
. Th
e p
aren
t si
ts in
a r
ocki
ng c
hair,
in
clin
ed s
o th
at t
he in
fant
’s h
ead
is
at
60.
Con
trol
: tra
diti
onal
met
hod
. N
ewb
orns
wea
ring
a d
iap
er a
nd a
he
ad c
ap, a
re w
rap
ped
in a
bla
nket
an
d p
lace
d in
the
ir p
aren
t’s a
rms.
Mot
hers
’ sat
isfa
ctio
n w
ith:
►
Eac
h m
etho
d o
f rem
ovin
g an
infa
nt fr
om in
cub
ator
►
Her
feel
ings
aft
er e
ach
met
hod
.
Dur
ing
bab
ies’
ad
mis
sion
(tw
ice)
:
►
Aft
er t
he
inte
rven
tion.
►
Aft
er t
he c
ontr
ol
met
hod
.
No
pre
inte
rven
tion
par
ent
satis
fact
ion
dat
a av
aila
ble
fo
r co
mp
aris
on.
Sat
isfa
ctio
n q
uest
ionn
aire
Th
e ‘M
ater
nal S
atis
fact
ion
Que
stio
nnai
re’ w
as u
sed
. It
was
dev
elop
ed b
y in
tegr
atin
g co
mp
onen
ts d
escr
ibed
b
y A
ffons
o et
al a
nd t
he
clin
ical
exp
erie
nce
of t
he
inve
stig
ator
s.
Valid
atio
n: p
artia
lly r
epor
ted
. A
utho
rs s
tate
d c
onte
nt
valid
ity t
estin
g to
ok p
lace
; no
info
rmat
ion
on r
elia
bili
ty
test
ing
pro
vid
ed.
Fift
een
que
stio
ns
Like
rt (1
ver
y m
uch–
5 d
o no
t kn
ow).
An
open
- end
ed q
uest
ion
invi
ted
the
mot
her
to li
st a
nd
exp
lain
any
thin
g el
se r
elat
ed
to h
er e
xper
ienc
e.
Reg
ard
less
of
the
met
hod
te
sted
, mo
ther
s ex
pre
ssed
hig
h le
vels
of
sati
sfac
tio
n (it
was
the
fi
rst
tim
e si
nce
giv
ing
bir
th t
hat
they
co
uld
ho
ld t
heir
infa
nts)
.
Thre
e st
atem
ents
pro
ved
mor
e p
ower
ful i
n d
iscr
imin
atin
g b
etw
een
the
met
hod
s:
Rat
ed h
ighe
r af
ter
the
kang
aro
o
met
hod
tes
t:
►“I
like
the
con
tact
with
my
bab
y’s
skin
”(p
=0.
0001
)
Rat
ed h
ighe
r af
ter
the
trad
itio
nal
met
hod
tes
t:
►“I
like
to
talk
to
and
whi
sper
to
my
bab
y“ (p
=0.
015)
►
“I lo
oked
into
my
bab
y’s
eyes
an
d s
tare
d a
t hi
s/he
r fa
ce“
(p=
0.00
01)
No
1
Num
ber
in la
st c
olum
n ill
ustr
ates
eac
h in
terv
entio
n’s
rep
orte
d e
ffect
on
par
ent
satis
fact
ion:
1. P
aren
t sa
tisfa
ctio
n w
as s
tatis
tical
ly s
igni
fican
tly h
ighe
r in
the
inte
rven
tion
grou
p; 2
. Par
ent
satis
fact
ion
was
not
rep
orte
d t
o b
e st
atis
tical
ly s
igni
fican
tly d
iffer
ent
in t
he in
terv
entio
n gr
oup
; 3. U
ncle
ar if
par
ent
satis
fact
ion
imp
rove
d (s
mal
l stu
dy
num
ber
s an
d/o
r no
sta
tistic
al a
naly
sis
per
form
ed);
4. O
nly
the
inte
rven
tion
grou
p w
as a
sses
sed
.C
PAP,
con
tinuo
us o
xyge
n p
ositi
ve a
irway
pre
ssur
e; E
MR
, ele
ctro
nic
med
ical
rec
ord
; FC
R, f
amily
cen
tred
rou
nd; I
PC
- CP
M, I
nfan
t P
rogr
ess
Cha
rt- C
are
Pla
nnin
g M
eetin
gs; L
V, li
sten
ing
visi
ts; N
/A, n
ot a
vaila
ble
; NID
CA
P, N
ewb
orn
Ind
ivid
ualis
ed D
evel
opm
enta
l Car
e an
d A
sses
smen
t P
rogr
amm
e; N
IPS
, Neo
nata
l Ind
ex o
f Par
ent
Sat
isfa
ctio
n; O
FFS
N, o
ff- si
te n
eona
tolo
gist
; ON
SN
, on-
site
neo
nato
logi
st; O
U, o
pen
uni
t; P
BP,
pot
entia
lly b
ette
r p
ract
ice;
P
DS
A, P
lan
Do
Stu
dy
Act
; PM
P, p
rinci
pal
med
ical
pro
vid
ers;
SM
Si,
shor
t m
essa
ge s
ervi
ces
imp
lem
enta
tion;
YB
DU
, you
r b
aby’
s d
aily
up
dat
e.
Tab
le 3
C
ontin
ued
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rotected by copyright.http://bm
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arch 2020. Dow
nloaded from
18 Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
box 1 ‘Effective’ interventions in themes
theme: parent involvementMore NICU access, parents on WRs, education (De Bernardo et al, Italy, 2017)Rooming- in care (Kazemian et al, Iran, 2016)Parental presence at clinical bedside rounds (Abdel- Latif et al, Australia, 2015) RCTMore NICU access, care involvement, education (Bastani et al, Iran, 2015) RCTEducation regarding pain management (Franck et al, UK, 2011) RCTSingle- family NICU rooms (Stevens et al, USA, 2011)Family centered rounds (Voos et al, USA, 2011)Newborn Individualised Developmental Care and Assessment Programme (Wielenga et al, The Netherlands, 2006)Infant progress charts filled by parents and three care planning meetings (Penticuff and Arheart, USA, 2005)Kangaroo care (Legault and Goulet, Canada, 1995)theme: information provision / communicationInternet- based education (Kadivar et al, Iran, 2017)Daily SMS from electronic patient record (Globus et al, Israel, 2016)Staff education, staff contact card given to parents, staff poster at NICU reception (Weiss et al, USA, 2010)Provision of taped conversations with neonatologists to mothers (Koh et al, Australia, 2007) RCTtheme: clinical carea. Headbox oxygen for respiratory distressb. Continuous oxygen positive airway pressure for respiratory distress
(Foster et al, Australia, 2008)Co- bedding infants in incubators (prospective) (Byers et al, USA, 2003)Co- bedding infants in incubators (retrospective) (Polizzi et al, USA, 2003)theme: parent emotional supportNarrative writing (Kadivar et al, Iran, 2017)
Interventions where parent satisfaction was reported to be statistically significantly higher in the intervention group.NICU, neonatal intensive care unit; RCT, randomised controlled trial; WR, ward round
box 2 ‘Ineffective’ interventions in themes
theme: parent involvementa. Massage with auditory, tactile, visual and vestibular stimulationb. Kangaroo care (Holditch- Davis et al, USA, 2013) RCTIndividualised, developmentally supportive family centred care interventions (Byers et al, USA, 2006)theme: information provision/communicationSharing information obtained from parent interviews with the primary NICU provider (Clarke- Pounder et al, USA, 2015) RCTtheme: clinical careClinical nurse specialist/neonatal practitioner team care (Mitchell- DiCenso et al, Canada, 1996) RCTtheme: otherFree parking (Northrup et al, USA, 2016) RCT
Interventions where parent satisfaction was not reported to be statistically significantly different in the intervention group.RCT, randomised controlled trial.
box 3 ‘Unclear if effective’ interventions in themes
theme: parent involvementOpen unit policy: 24/7 NICU access (Voos and Park, USA, 2014)Touch and massage for 7 days (Livingston et al, USA, 2009) RCTtheme: information provision/communicationClinical staff enter updates in baby diary (Van de Vijver and Evans, UK, 2015)Detailed information provided during consenting (Broyles et al, USA, 1992) RCTtheme: clinical carePalliative care (Petteys et al, USA, 2015)Five potentially better practices in the area of discharge planning (Mills et al, USA, 2006)
Interventions where small study numbers and/or no statistical analysis performed).RCT, randomised controlled trial.
box 4 Interventions in themes where ‘only the intervention group was assessed and only postintervention’
theme: information provision/communicationDaily parent update letter from electronic patient record (Palma et al, USA, 2012)theme: clinical careTele- rounding robot, off- site neonatologist (Garingo et al, USA, 2016)theme: parent emotional supportListening visits (Segre et al, USA, 2013)
dIsCussIOnParent satisfaction with neonatal care is increasingly recognised as an important measure of parent experi-ence and is being used to evaluate hospitals and health-care providers; use of interventions to improve parent satisfaction in neonatal units is increasing. This is the largest review of interventions where an outcome was parent satisfaction with neonatal care and includes 32 studies. We find low- quality evidence that interventions targeting ‘parent involvement’ may improve parent satisfaction with neonatal care, but this result must be interpreted cautiously in view of the high risk of bias in included studies.
Overall, our review highlights the complexity of evaluating parent satisfaction. As a multidimensional construct, parent satisfaction can be affected just as much by interventions directly relating to infant care (eg, Kangaroo care) as well as interventions relating to neonatal care facilities (eg, Free parking). By grouping included interventions into themes (boxes 1–4), we have highlighted the variety of interventions available, as well as the majority of interventions being those relating to ‘parent involvement’.
A key reason for only selecting parent satisfaction as the outcome of interest was to focus on a single compo-nent of parent experience, in order to reduce outcome heterogeneity and allow direct comparison. Despite this
on May 13, 2022 by guest. P
rotected by copyright.http://bm
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arch 2020. Dow
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19Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
Figure 2 Cochrane Collaboration risk of bias tool assessment (randomised controlled trial). Green: low risk of bias; yellow: unclear risk of bias; red: high risk of bias.
Figure 3 ROBINS- I risk of bias assessment (non- randomised controlled trial).
approach, the key methodological limitation identified in this review was inconsistency in how parent satisfaction is defined and measured; it is notable that the majority of questionnaires (23/29) lack validation. In keeping with neonatal studies more widely,19 this study confirms incon-sistent outcome selection as a major source of research waste in neonatal studies examining parent experience, and further finds that there is limited involvement of parents in study design.
Strengths of our review include identifying studies with both mother and father participants, inclusion of the full range of infant gestations and a wide range of interventions. We followed a preregistered protocol and report this review in line with PRISMA guidelines.11 To further aid direct comparison of interventions, we only included studies that evaluated parent experience using ≥1 quantitative outcome of parent satisfaction. One limitation of this approach is that by excluding studies which evaluated parent experience using other measures (eg, stress, anxiety and depression scales), we are unable
to comment on interventions that targeted these other components of parent experience.
Another limitation is that we have only included studies in the English language, due to resource and time constraints. By not including studies in other languages, it is possible our results are more focused on work conducted in specific countries. Furthermore, we acknowledge that much of the research in parent experi-ence is qualitatively evaluated. By restricting our review to studies where ≥1 quantitative outcome of parent satisfac-tion is measured, we have not included any interventions with solely qualitative outcomes. This was in an attempt to enable direct comparison of interventions, which has previously not been possible in any published review. By not including studies evaluated by qualitative measures only, it is possible our results are more focused on a particular type of interventions where quantitative eval-uation would be preferable and/or easier. It also means we may not have included all studies ever conducted on a particular intervention, where some were only evaluated qualitatively, making some interventions appear more ‘widespread’ than others.
Brett et al20 systematically reviewed interventions aimed at improving the parent experience more widely, but only included parents of preterm infants. Their large number of outcome domains and heterogeneity of outcome measures (including studies that reported only quali-tative outcomes) meant the authors we unable to draw firm conclusions about the efficacy of interventions and that comparison and meta- analysis was not possible. The majority of our review’s studies have been published in the 7 years since the review by Brett et al, highlighting the increasing interest in this area. However, despite including all gestations and focusing on a specific aspect of parent experience, heterogeneity in measurement of parent satisfaction meant we were also unable to conduct a quantitative synthesis. Inconsistency and lack of vali-dation of instruments measuring parent satisfaction in neonatal care (specifically with family centred care) has also previously been highlighted by Dall’Oglio et al.21
Although 31% of included studies were RCT, all were assessed as having a high risk of bias. RCTs are tradition-ally considered the highest- ranking form of evidence, however it is worth considering whether such a design is feasible or desirable to evaluate interventions targeting parent satisfaction. Parents in neonatal care talk to each other, compare notes and invariably create parent- support communities; hence it is inherently difficult to avoid contamination between parents receiving an inter-vention and those who are not, meaning that blinding of parents or health professionals is near impossible. Furthermore, parent satisfaction is likely to be particu-larly susceptible to the Hawthorne effect,22 requiring longer- term follow- up. These factors may explain the low number of RCT identified in our review and the high risk of bias seen in those that were included. In non- RCT studies, the main methodological concern is the degree to which unmeasured and uncontrolled confounders
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arch 2020. Dow
nloaded from
20 Sakonidou S, et al. BMJ Paediatrics Open 2020;4:e000613. doi:10.1136/bmjpo-2019-000613
Open access
may explain any differences seen between groups. The non- RCT studies included in this review were classed as having either a serious or critical risk of bias. The over-whelming majority of studies did not adequately report baseline variables or report other interventions during the study period, making it impossible to assess studies for selection bias or treatment bias. Furthermore, limita-tions such as contamination bias and the Hawthorne effect affect non- RCT as well. Only two non- RCT studies evaluated the outcome of interest (parent satisfaction) both before and after the intervention, in the same group of parents (group level effect), with most studies evaluating different parent groups preintervention and postinter-vention (unit level effect). An inherent weakness of this latter approach is that it assumes parent satisfaction is a static measure at the unit level, which is unlikely to be true. As a result of these numerous important limitations identified across all included studies, we find only low- quality evidence in support of interventions to improve parent satisfaction with neonatal care, despite a majority of studies reporting a beneficial effect of interventions. These limitations may explain the limited uptake of these interventions by the wider neonatal community.
Changing neonatal unit practices to incorporate any new intervention requires robust evidence. We demon-strate here that such evidence is not currently available for improving parent satisfaction. We highlight the use of non- randomised study designs, inconsistency in defini-tion and measurement of parent satisfaction, the use of unvalidated questionnaires, methodological limitations and a lack of parent involvement as contributors. Our review empirically documents the extent of these issues in studies that use quantitative parent satisfaction surveys, and their contribution to research waste in neonatology.
Given the importance of parent satisfaction for both parent and offspring well- being, higher quality trials that involve parents, use of standardised definitions and vali-dated parent satisfaction measures are needed. Given the nature and challenges of the neonatal care environment and the limitations we have identified in existing research, a cluster RCT may be the most appropriate study design to rigorously evaluate interventions to improve parent satisfaction with neonatal care.
COnClusIOnsMany interventions, commonly relating to parent involve-ment, are reported to improve parent satisfaction with neonatal care but inconsistency in definition and meas-urement of parent satisfaction and high risk of bias in all studies makes this low- quality evidence. Standardised definitions and validated parent satisfaction measures are needed, as well as higher quality trials of parent experi-ence, involving parents in intervention design.
Correction notice This article has been corrected since it was first published. Provenance and peer review statement has been corrected.
twitter Chris Gale @DrCGale
Contributors SS and CG conceived this systematic review. The protocol was created by SS and CG. Searches were performed by SS and IA. All search results were reviewed by SS and JW. Coding was completed by SS and JW. Data analysis was completed by SS. The first draft of the manuscript was written by SS; SS, CG and JW edited and reviewed the manuscript. All authors approved the manuscript. This article presents independent research supported by the National Institute for Health Research (NIHR).
Funding This work is sponsored by Imperial College London and supported by a peer- reviewed National Institute of Health Research Doctoral Research Fellowship, awarded to SS (DRF-2017-10-172).
disclaimer The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Competing interests SS has received research grants from the National Institute of Health Research (NIHR), the NIHR CLAHRC NWL, Rosetrees Trust and CW+ charity. NM is Director of the Neonatal Data Analysis Unit at Imperial College London. In the last 5 years, NM has served on the Board of Trustees of the Royal College of Paediatrics and Child Health, David Harvey Trust, Medical Women’s Federation and Medact; and is a member of the Nestle Scientific Advisory Board. NM has received research grants from the British Heart Foundation, Medical Research Council, National Institute of Health Research, Westminster Research Fund, Collaboration for Leadership in Applied Health and Care Northwest London, Healthcare Quality Improvement Partnership, Bliss, Prolacta Life Sciences, Chiesi, Shire and HCA International; travel and accommodation expenses from Nutricia, Prolacta, Nestle and Chiesi; honoraria from Ferring Pharmaceuticals and Alexion Pharmaceuticals for contributions to expert advisory boards and Chiesi for contributing to a lecture programme. CG is funded by the UK Medical Research Council (MRC) through a Clinician Scientist Fellowship award. He has received support from Chiesi Pharmaceuticals to attend an educational conference; in the past 5 years, he has been investigator on received research grants from Medical Research Council, National Institute of Health Research, Canadian Institute of Health Research, Department of Health in England, Mason Medical Research Foundation, Westminster Medical School Research Trust and Chiesi Pharmaceuticals.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.
Open access This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https:// creativecommons. org/ licenses/ by/ 4. 0/.
OrCId idsSusanna Sakonidou http:// orcid. org/ 0000- 0003- 1639- 8669James Webbe http:// orcid. org/ 0000- 0001- 8546- 3212Chris Gale http:// orcid. org/ 0000- 0003- 0707- 876X
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