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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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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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

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nloaded from

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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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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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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

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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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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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