1Buja A, et al. BMJ Open 2018;8:e020626. doi:10.1136/bmjopen-2017-020626

Open access

Developing a new clinical governance framework for chronic diseases in primary care: an umbrella review

Alessandra Buja,1 Roberto Toffanin,2 Mirko Claus,3 Walter Ricciardi,4 Gianfranco Damiani,4 Vincenzo Baldo,1 Mark H Ebell5

To cite: Buja A, Toffanin R, Claus M, et al. Developing a new clinical governance framework for chronic diseases in primary care: an umbrella review. BMJ Open 2018;8:e020626. doi:10.1136/bmjopen-2017-020626

► Prepublication history for this paper is available online. To view these files, please visit the journal online (http:// dx. doi. org/ 10. 1136/ bmjopen- 2017- 020626).

Received 16 November 2017Revised 18 April 2018Accepted 20 April 2018

For numbered affiliations see end of article.

Correspondence toDr Alessandra Buja; alessandra. buja@ unipd. it

Research

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

AbstrACtObjectives Our goal is to conceptualise a clinical governance framework for the effective management of chronic diseases in the primary care setting, which will facilitate a reorganisation of healthcare services that systematically improves their performance.setting Primary care.Participants Chronic Care Model by Wagner et aland Clinical Governance statement by Scally et alwere taken for reference. Each was reviewed, including their various components. We then conceptualised a new framework, merging the relevant aspects of both.Interventions We conducted an umbrella review of all systematic reviews published by the Cochrane Effective Practice and Organisation of Care Group to identify organisational interventions in primary care with demonstrated evidence of efficacy.results All primary healthcare systems should be patient-centred. Interventions for patients and their families should focus on their values; on clinical, professional and institutional integration and finally on accountability to patients, peers and society at large. These interventions should be shaped by an approach to their clinical management that achieves the best clinical governance, which includes quality assurance, risk management, technology assessment, management of patient satisfaction and patient empowerment and engagement. This approach demands the implementation of a system of organisational, functional and professional management based on a population health needs assessment, resource management, evidence-based and patient-oriented research, professional education, team building and information and communication technologies that support the delivery system. All primary care should be embedded in and founded on an active partnership with the society it serves.Conclusions A framework for clinical governance will promote an integrated effort to bring together all related activities, melding environmental, administrative, support and clinical elements to ensure a coordinated and integrated approach that sustains the provision of better care for chronic conditions in primary care setting.

IntrOduCtIOn The dramatic increase in the burden of chronic diseases in the last 20 years represents a primary concern for health services, and

global health system sustainability demands a massive shift to primary care.1–3 As a conse-quence, the organisation and provision of primary care now faces new challenges (eg, polypharmacy, multimorbidity, fragmenta-tion of care, frequent transitions of care, a need for strong integration and pressure from patients).4 There is currently a growing interest in high-income countries to rede-sign healthcare organisations, focusing on practices that improve the quality of care and guarantee the equitable, timely and effec-tive management of patients with chronic diseases.5 6 In fact, it is now widely recognised that the care and support needed to live with a long-term condition requires a radical re-design of services, by allowing patients to drive the care planning process and by developing a new management of care for people that is proactive, holistic, preventive and patient-centred as for example defined by the ‘House of Care’ model.7 With these pressures, primary care systems may have difficulty ensuring a coordinated approach, and the lack of clarity concerning their goals has led to divergent approaches, and a slow and often disjointed adoption of changes and improvements.8

Clinical governance is an umbrella for the systematic administration and coordina-tion of different processes having a direct impact on healthcare delivery, including

strengths and limitations of this study

► The study gives a new comprehensive framework to drive an effective management of chronic diseases in the primary care setting.

► A systematic review was made showing all rel-evant studies in Cochrane Effective Practice and Organisation of Care Group alongside the dimen-sions of the framework.

► We do not report studies illustrating interventions for a specific unique disease even if chronic disease.

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Open access

the management of patients with chronic conditions. It encompasses the tools, methods and infrastructure devoted to assuring healthcare delivery, continuously improving the quality of the service and striving towards clinical excellence for patients. Clinical governance was first established in the UK,9 and has been implemented in many different countries.10–13 Until now, it has focused largely on in-hospital care, and met with significant difficulties when transferred to primary care.14 Clinical governance for primary care, focusing on the manage-ment of chronic diseases, has specific features and relies on a network of different health professionals working together for their patients’ benefit.15

Our paper aims to conceptualise a clinical gover-nance framework and the tools it needs for the effective management of chronic diseases in the primary care setting, allowing to drive an effective change in health-care services and thereby systematically improving their quality and safety.

MethOdsFor the purposes of our analysis, we used the Chronic Care Model by Wagner et al16 and Clinical Governance statement by Scally et al17 for reference, carefully reviewing each of them and their various components. We then conceptualised a new framework, merging the relevant aspects of both, and also defining and implementing new themes in a way that is relevant for primary care. We ultimately selected five core elements from the original Chronic Care Model (delivery system design, decision support, clinical information systems, self-management support, the community) and six approaches (risk avoid-ance, coherence, infrastructure, culture, quality methods, poor performance) from the clinical governance frame-work described by Scally et al based on their relevance to primary care and chronic disease management.

We then devised a framework arranged like a sunflower, where the stem and leaves represent the structural components of the system needed to supply and support the petals. The petals in turn represent the themes or topics that shape direct actions involving patients or caregivers (the bud of the system). The sunflower is rooted in the earth, from where its structural components receive inputs in the form of water and nutrients; in healthcare, inputs from the ‘soil’ enable the provision of primary care, collabo-ration between service providers and resources from the outside world. The atmosphere in which the sunflower grows informs the views and attitudes that guide the actions of both health professionals and patients.

For each petal (ie, theme or topic), we searched for rele-vant interventions in the Cochrane Library from 2010 to the end of 2016, in the context of chronic care in the primary care setting. The search strategy used in our umbrella review of the Cochrane Library was based on the MeSH terms: (‘general practice*’ or ‘primary care’) and (‘chronic disease*’ or ‘multimorbidity’), plus one of the following: (1) ‘clinical governance’; (2) ‘quality

assurance’ or ‘evidence-based healthcare’; (3) ‘satisfac-tion, patient’; (4) ‘risk management’; (5) ‘empowerment’ or ‘health literacy’ or ‘engagement’; (6) ‘health tech-nology assessment’ or ‘cost-effectiveness’ or ‘cost-utility’. We also identified all systematic reviews published by the Cochrane Effective Practice and Organisation of Care (EPOC) Group that met our criteria. We included all relevant studies published in the Cochrane Review Data-base from 2010 to June 2017, and excluded all studies illustrating interventions for a specific disease, or those not involving patients with chronic disease.

Patient and public involvementThe present study does not involve patients or public.

resultsThe resulting conceptual framework is shown in figure 1. We define three targets where management strategies could be acted:1. The petals consist of the management strategies that

directly inform the interventions and clinical practice that acts on and with the patient and their family; pri-mary care delivery happens at the level of the petals level, with the patient at the centre.

2. The stem represents the underpinning management strategies that support the delivery system, which is the personnel and structures that permit the organisation to support the ‘life of the petals’.

Figure 1 Framework for primary care management of chronic disease. EBHC, Evidence-based healthcare.

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Open access

3. The ground is the environment in which primary care delivery is located, which gives ‘nourishment’ and foundation.

4. Finally, there is the atmosphere, which represents the management strategies that influence the first three targets.

the bud is the centre of the flowerPlacing personalised patient-centred care at the heart of the system is an important way to create catalysts for change and encourage service re-organisation, by focusing on patients’ health needs and motivating health system changes.18 We define patient-centred care as care that is based on continuous, healing relationships among health professionals, patients and their families; care that is customised based on the patients’ needs and values19; ensuring that the patient is the source of control; sharing knowledge and information freely and maintaining transparency.

the petals define what and how to act on and with the patientsThe petals represent the management strategies that should shape directly the interventions on and with the patients. These dimensions include quality management, perceived quality management, empowerment strategies, risk management and health technology assessment. The Institute of Medicine in the USA (now called National Academy of Medicine) defines quality management as the degree to which healthcare services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.20 It usually has two facets: quality assurance and quality improvement. In chronic disease manage-ment, quality assurance concerns the activities and programmes intended to assure or improve the quality of care in a specified medical setting or programme. The concept includes assessing (measuring) the quality of care, identifying problems or shortcomings in the delivery of care, designing activities to overcome these deficiencies and follow-up monitoring to ensure the effectiveness of any corrective action.21 Quality improve-ment involves the process of attaining a new, higher level of performance or quality.22 Adopting the philosophy of evidence-based medicine in planning the diagnosis, care and follow-up of chronic patients has resulted in a more effective and consistent transfer of the lessons learnt from research into routine practice, helping to reach higher quality standards.23 24 For example, a review showed that, in 5 of 17 good-quality randomised controlled trials, several different interventions were able to improve both adherence to prescribed medicines and clinical outcomes. These interventions frequently included enhancing support from family, peers or allied health professionals such as pharmacists, who often delivered education, counselling or daily treatment support, even if no common features could be identified to explain their success25 (table 1A).

However, while many measures of quality of care in the primary care setting have been validated for specific diseases, little has been done to examine the validity or usefulness of these measures in the context of multimor-bidity. To guarantee quality assurance, it is necessary to consider the deliberate and systematic coordination of an organisation’s people, technology, processes and organisa-tional structure in order to add value through innovation, using research to inform practice.26 The systematic coor-dination and organisation of the primary healthcare team to develop proactive, holistic, preventive and patient-cen-tred models of care has primarily been developed for patients with chronic disease and multimorbidity. A review27 concluded that health-service or patient-oriented interventions designed to improve outcomes in people with multimorbidity in primary care and community settings improved mainly mental health and functional outcomes. Another study28 demonstrated the benefits of applying new technologies (telemonitoring) for commu-nity-dwelling patients care with chronic disease and multi-morbidity, which significantly reduced healthcare costs, hospital emergency department admissions, hospital length of stay and mortality.

Risk management concerns the systematic identification, assessment and integrated management of current and potential hazards relating to patient care. This is partic-ularly relevant for the care of complex patients with (‘multimorbidity’).28 The creation of a culture that is free of blame and encourages an open examination of errors and failures is key to improving quality and learning.

Clinical incident reporting is a key feature of a risk management system that can improve identification of errors and how we can learn from them. Leape suggests that successful systems provide a safe non-punitive envi-ronment, and are simple, timely and inexpensive.29 However, the effectiveness of such systems in promoting adverse event recording is not clear. To evaluate the effects of interventions designed to increase clinical inci-dent reporting in healthcare settings, Parmelli et al in 2012 conducted a review of four trials with several meth-odological shortcomings. Despite their limitations, two studies showed the effectiveness of the system implemen-tation: one reported an increase in incident reporting rates, while the second showed a sustained improvement after 9 months.30

One review on non-clinical health professional roles found that older people were more likely to receive appropriate medicines with the provision of a pharma-cist-led intervention.31 This service provided by phar-macists that involves identifying, preventing and solving medication-related problems, as well as promoting the correct use of medicines and encouraging health promotion and education. Another strategy found to be useful was computerised support for decision-making. The review focused primarily on process outcomes, and provided only limited evidence of whether these interven-tions resulted in clinical improvement. Another review found that self-monitoring of medicines and patient

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Open access

Tab

le 1

S

yste

mat

ic r

evie

ws

Aut

hor,

ref.

no

Tit

leO

bje

ctiv

esIn

clus

ion

crit

eria

Mai

n fi

ndin

gs

A: S

yste

mat

ic r

evie

ws

abo

ut q

ualit

y im

pro

vem

ent

Nie

uwla

at R

et

al25

Inte

rven

tions

for

enha

ncin

g m

edic

atio

n ad

here

nce

The

prim

ary

obje

ctiv

e of

thi

s re

view

is t

o as

sess

the

ef

fect

s of

inte

rven

tions

inte

nded

to

enha

nce

pat

ient

ad

here

nce

to p

resc

ribed

med

icat

ions

for

med

ical

co

nditi

ons,

on

bot

h m

edic

atio

n ad

here

nce

and

cl

inic

al o

utco

mes

.

We

incl

uded

unc

onfo

und

ed r

and

omis

ed c

ontr

olle

d t

rials

(RC

Ts) o

f in

terv

entio

ns t

o im

pro

ve a

dhe

renc

e w

ith p

resc

ribed

med

icat

ions

, m

easu

ring

bot

h m

edic

atio

n ad

here

nce

and

clin

ical

out

com

e, w

ith

at le

ast

80%

follo

w-u

p o

f eac

h gr

oup

stu

die

d a

nd, f

or lo

ng-t

erm

tr

eatm

ents

, at

leas

t 6

mon

ths

follo

w-u

p fo

r st

udie

s w

ith p

ositi

ve

find

ings

at

earli

er t

ime

poi

nts.

The

pr e

sent

up

dat

e in

clud

ed 1

09 n

ew s

tud

ies,

brin

ging

the

tot

al n

umb

er t

o 18

2.

In t

he 1

7 st

udie

s of

the

hig

hest

qua

lity,

inte

rven

tions

wer

e ge

nera

lly c

omp

lex

with

se

vera

l diff

eren

t w

ays

to t

ry t

o im

pro

ve m

edic

ine

adhe

renc

e. T

hese

freq

uent

ly

incl

uded

enh

ance

d s

upp

ort

from

fam

ily, p

eers

or

allie

d h

ealth

pro

fess

iona

ls s

uch

as

pha

rmac

ists

, who

oft

en d

eliv

ered

ed

ucat

ion,

cou

nsel

ling

or d

aily

tre

atm

ent

sup

por

t.

Onl

y fiv

e of

the

se R

CTs

imp

rove

d b

oth

med

icin

e ad

here

nce

and

clin

ical

out

com

es,

and

no

com

mon

cha

ract

eris

tics

for

thei

r su

cces

s co

uld

be

iden

tified

. Ove

rall,

eve

n th

e m

ost

effe

ctiv

e in

terv

entio

ns d

id n

ot le

ad t

o la

rge

imp

rove

men

ts.

Sm

ith S

M e

t al

27In

terv

entio

ns fo

r im

pro

ving

out

com

es

in p

atie

nts

with

m

ultim

orb

idity

in

prim

ary

care

and

co

mm

unity

set

tings

To d

eter

min

e th

e ef

fect

iven

ess

of h

ealth

-ser

vice

or

pat

ient

-orie

nted

inte

rven

tions

des

igne

d t

o im

pro

ve

outc

omes

in p

eop

le w

ith m

ultim

orb

idity

in p

rimar

y ca

re a

nd c

omm

unity

set

tings

. Mul

timor

bid

ity w

as

defi

ned

as

two

or m

ore

chro

nic

cond

ition

s in

the

sa

me

ind

ivid

ual.

We

cons

ider

ed R

CTs

, non

-ran

dom

ised

clin

ical

tria

ls (N

RC

Ts),

cont

rolle

d b

efor

e-af

ter

stud

ies

(CB

As)

and

inte

rrup

ted

tim

e se

ries

anal

yses

(ITS

) eva

luat

ing

inte

rven

tions

to

imp

rove

ou

tcom

es fo

r p

eop

le w

ith m

ultim

orb

idity

in p

rimar

y ca

re a

nd

com

mun

ity s

ettin

gs. T

his

incl

udes

stu

die

s w

here

par

ticip

ants

ca

n ha

ve c

omb

inat

ions

of a

ny c

ond

ition

or

have

com

bin

atio

ns o

f p

resp

ecifi

ed c

omm

on c

ond

ition

s. T

he c

omp

aris

on w

as u

sual

car

e as

del

iver

ed in

tha

t se

ttin

g.

Ove

rall,

the

res

ults

reg

ard

ing

the

effe

ctiv

enes

s of

inte

rven

tions

wer

e m

ixed

. The

re

wer

e no

cle

ar p

ositi

ve im

pro

vem

ents

in c

linic

al o

utco

mes

, hea

lth s

ervi

ce u

se,

med

icat

ion

adhe

renc

e, p

atie

nt-r

elat

ed h

ealth

beh

avio

urs,

hea

lth p

rofe

ssio

nal

beh

avio

urs

or c

osts

. The

re w

ere

mod

est

imp

rove

men

ts in

men

tal h

ealth

out

com

es

from

sev

en s

tud

ies

that

tar

gete

d p

eop

le w

ith d

epre

ssio

n, a

nd in

func

tiona

l out

com

es

from

tw

o st

udie

s ta

rget

ing

func

tiona

l diffi

culti

es in

par

ticip

ants

. Ove

rall,

the

res

ults

in

dic

ate

that

it is

diffi

cult

to im

pro

ve o

utco

mes

for

peo

ple

with

mul

tiple

con

diti

ons.

Th

e re

view

sug

gest

s th

at in

terv

entio

ns t

hat

are

des

igne

d t

o ta

rget

sp

ecifi

c ris

k fa

ctor

s (e

g, t

reat

men

t fo

r d

epre

ssio

n) o

r in

terv

entio

ns t

hat

focu

s on

diffi

culti

es t

hat

peo

ple

exp

erie

nce

with

dai

ly fu

nctio

ning

(eg,

phy

siot

hera

py

trea

tmen

t to

imp

rove

ca

pac

ity fo

r p

hysi

cal a

ctiv

ity) m

ay b

e m

ore

effe

ctiv

e. T

here

is a

nee

d fo

r fu

rthe

r st

udie

s on

thi

s to

pic

, par

ticul

arly

invo

lvin

g p

eop

le w

ith m

ultim

orb

idity

in g

ener

al

acro

ss t

he a

ge r

ange

s.

Ard

iti C

et

al77

Com

put

er-g

ener

ated

re

min

der

s d

eliv

ered

on

pap

er t

o he

alth

care

p

rofe

ssio

nals

; effe

cts

on p

rofe

ssio

nal

pra

ctic

e an

d

heal

thca

re o

utco

mes

To e

valu

ate

the

ben

efits

and

har

ms

of r

ehab

ilita

tion

inte

rven

tions

dire

cted

at

mai

ntai

ning

, or

imp

rovi

ng,

phy

sica

l fun

ctio

n fo

r ol

der

peo

ple

in lo

ng-t

erm

car

e th

roug

h th

e re

view

of R

CTs

clu

ster

RC

Ts (C

RC

Ts).

We

incl

uded

ind

ivid

ual o

r C

RC

Ts R

CTs

and

NR

CTs

tha

t ev

alua

ted

th

e im

pac

t of

com

put

er-g

ener

ated

rem

ind

ers

del

iver

ed o

n p

aper

to

hea

lthca

re p

rofe

ssio

nals

on

pro

cess

es a

nd/o

r ou

tcom

es o

f ca

re.

Ther

e is

mod

erat

e q

ualit

y ev

iden

ce t

hat

com

put

er-g

ener

ated

rem

ind

ers

del

iver

ed o

n p

aper

to

heal

thca

re p

rofe

ssio

nals

ach

ieve

mod

erat

e im

pro

vem

ent

in p

roce

ss o

f car

e.

Two

char

acte

ristic

s em

erge

d a

s si

gnifi

cant

pre

dic

tors

of i

mp

rove

men

t: p

rovi

din

g sp

ace

on t

he r

emin

der

for

a re

spon

se fr

om t

he c

linic

ian

and

pro

vid

ing

an e

xpla

natio

n of

the

rem

ind

er’s

con

tent

or

advi

ce. T

he h

eter

ogen

eity

of t

he r

emin

der

inte

rven

tions

in

clud

ed in

thi

s re

view

als

o su

gges

ts t

hat

rem

ind

ers

can

imp

rove

car

e in

var

ious

se

ttin

gs u

nder

var

ious

con

diti

ons.

Thom

as R

E e

t al

78In

terv

entio

ns t

o in

crea

se in

fluen

za

vacc

inat

ion

rate

s of

th

ose

aged

60

year

s an

d o

lder

in t

he

com

mun

ity

To a

sses

s ac

cess

, pro

vid

er, s

yste

m a

nd s

ocie

tal

inte

rven

tions

to

incr

ease

the

up

take

of i

nflue

nza

vacc

inat

ion

in p

eop

le a

ged

60

year

s an

d o

lder

in t

he

com

mun

ity.

RC

Ts o

f int

erve

ntio

ns t

o in

crea

se in

fluen

za v

acci

natio

n up

take

in

peo

ple

age

d 6

0 ye

ars

and

old

er.

Ther

e ar

e in

terv

entio

ns t

hat

are

effe

ctiv

e fo

r in

crea

sing

com

mun

ity d

eman

d fo

r va

ccin

atio

n, e

nhan

cing

acc

ess

and

imp

rovi

ng p

rovi

der

/sys

tem

res

pon

se. I

n p

artic

ular

, effe

ctiv

e in

terv

entio

ns in

thi

s co

mp

aris

on w

ere

a le

tter

plu

s le

aflet

/pos

tcar

d

com

par

ed w

ith a

lett

er, n

urse

s/p

harm

acis

ts e

duc

atin

g p

lus

vacc

inat

ing

pat

ient

s,

a p

hone

cal

l fro

m a

sen

ior,

a te

lep

hone

invi

tatio

n ra

ther

tha

n cl

inic

dro

p-i

n, fr

ee

groc

erie

s lo

tter

y an

d n

urse

s ed

ucat

ing

and

vac

cina

ting

pat

ient

s. W

e w

ere

unab

le

to p

ool t

rials

of p

ostc

ard

/lett

er/p

amp

hlet

s, c

omm

unic

atio

ns t

ailo

red

to

pat

ient

s, a

cu

stom

ised

lett

er/p

hone

cal

l or

clie

nt-b

ased

ap

pra

isal

s, b

ut s

ever

al t

rials

of t

hese

in

terv

entio

ns s

how

ed t

hey

wer

e ef

fect

ive.

Kro

gsb

øll L

T et

al79

Gen

eral

hea

lth c

heck

s in

ad

ults

for

red

ucin

g m

orb

idity

and

mor

talit

y fr

om d

isea

se

We

aim

ed t

o q

uant

ify t

he b

enefi

ts a

nd h

arm

s of

ge

nera

l hea

lth c

heck

s w

ith a

n em

pha

sis

on p

atie

nt-

rele

vant

out

com

es s

uch

as m

orb

idity

and

mor

talit

y ra

ther

tha

n on

sur

roga

te o

utco

mes

suc

h as

blo

od

pre

ssur

e an

d s

erum

cho

lest

erol

leve

ls.

We

incl

uded

RC

Ts c

omp

arin

g he

alth

che

cks

with

no

heal

th

chec

ks in

ad

ults

uns

elec

ted

for

dis

ease

or

risk

fact

ors.

We

did

no

t in

clud

e ge

riatr

ic t

rials

. We

defi

ned

hea

lth c

heck

s as

scr

eeni

ng

gene

ral p

opul

atio

ns fo

r m

ore

than

one

dis

ease

or

risk

fact

or in

m

ore

than

one

org

an s

yste

m.

Ther

e w

as n

o ef

fect

on

the

risk

of d

eath

, or

on t

he r

isk

of d

eath

due

to

card

iova

scul

ar

dis

ease

s or

can

cer.

We

did

not

find

an

effe

ct o

n th

e ris

k of

illn

ess

but

one

tria

l fo

und

an

incr

ease

d n

umb

er o

f peo

ple

iden

tified

with

hig

h b

lood

pre

ssur

e an

d h

igh

chol

este

rol,

and

one

tria

l fou

nd a

n in

crea

sed

num

ber

with

chr

onic

dis

ease

s. O

ne

tria

l rep

orte

d t

he t

otal

num

ber

of n

ew d

iagn

oses

per

par

ticip

ant

and

foun

d a

20%

in

crea

se o

ver

6 ye

ars

com

par

ed w

ith t

he c

ontr

ol g

roup

. No

tria

ls c

omp

ared

the

tot

al

num

ber

of n

ew p

resc

riptio

ns b

ut t

wo

out

of fo

ur t

rials

foun

d a

n in

crea

sed

num

ber

of

peo

ple

usi

ng d

rugs

for

high

blo

od p

ress

ure.

Tw

o ou

t of

four

tria

ls fo

und

tha

t he

alth

che

cks

mad

e p

eop

le fe

el s

omew

hat

heal

thie

r, b

ut t

his

resu

lt is

not

rel

iab

le.

We

did

not

find

tha

t he

alth

che

cks

had

an

effe

ct o

n th

e nu

mb

er o

f ad

mis

sion

s to

ho

spita

l, d

isab

ility

, wor

ry, t

he n

umb

er o

f ref

erra

ls t

o sp

ecia

lists

, ad

diti

onal

vis

its t

o th

e p

hysi

cian

or

abse

nce

from

wor

k, b

ut m

ost

of t

hese

out

com

es w

ere

poo

rly s

tud

ied

. N

one

of t

he t

rials

rep

orte

d o

n th

e nu

mb

er o

f fol

low

-up

tes

ts a

fter

pos

itive

scr

eeni

ng

resu

lts, o

r th

e am

ount

of s

urge

ry u

sed

. With

the

larg

e nu

mb

er o

f par

ticip

ants

and

d

eath

s in

clud

ed, t

he lo

ng fo

llow

-up

per

iod

s us

ed in

the

tria

ls, a

nd c

onsi

der

ing

that

d

eath

from

car

dio

vasc

ular

dis

ease

s an

d c

ance

r w

ere

not

red

uced

, gen

eral

hea

lth

chec

ks a

re u

nlik

ely

to b

e b

enefi

cial

.

Con

tinue

d

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http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

jopen-2017-020626 on 28 July 2018. Dow

nloaded from

5Buja A, et al. BMJ Open 2018;8:e020626. doi:10.1136/bmjopen-2017-020626

Open access

Aut

hor,

ref.

no

Tit

leO

bje

ctiv

esIn

clus

ion

crit

eria

Mai

n fi

ndin

gs

Arc

ham

bau

lt P

M80

Col

lab

orat

ive

writ

ing

app

licat

ions

in

heal

thca

re: e

ffect

s on

p

rofe

ssio

nal p

ract

ice

and

hea

lthca

re

outc

omes

The

obje

ctiv

es o

f thi

s re

view

wer

e to

: (1)

ass

ess

the

effe

cts

of t

he u

se o

f CW

As

on p

roce

ss (i

nclu

din

g th

e b

ehav

iour

of h

ealth

care

pro

fess

iona

ls) a

nd p

atie

nt

outc

omes

, (2)

crit

ical

ly a

pp

rais

e an

d s

umm

aris

e cu

rren

t ev

iden

ce o

n th

e us

e of

res

ourc

es, c

osts

and

co

st-e

ffect

iven

ess

asso

ciat

ed w

ith C

WA

s to

imp

rove

p

rofe

ssio

nal p

ract

ices

and

pat

ient

out

com

es a

nd

(3) e

xplo

re t

he e

ffect

s of

diff

eren

t C

WA

feat

ures

(eg,

op

en v

s cl

osed

) and

diff

eren

t im

ple

men

tatio

n fa

ctor

s (e

g, t

he p

rese

nce

of a

mod

erat

or) o

n p

roce

ss a

nd

pat

ient

out

com

es.

We

incl

uded

RC

Ts, N

RC

Ts, C

BA

s, IT

S s

tud

ies

and

rep

eate

d

mea

sure

s st

udie

s (R

MS

), in

whi

ch C

WA

s w

ere

used

as

an

inte

rven

tion

to im

pro

ve t

he p

roce

ss o

f car

e, p

atie

nt o

utco

mes

or

heal

thca

re c

osts

.

We

scre

ened

11

993

stud

ies

iden

tified

from

the

ele

ctro

nic

dat

abas

e se

arch

es a

nd 3

46

stud

ies

from

gre

y lit

erat

ure

sour

ces.

We

anal

ysed

the

full

text

of 9

9 st

udie

s. N

one

of

the

stud

ies

met

the

elig

ibili

ty c

riter

ia; t

wo

pot

entia

lly r

elev

ant

stud

ies

are

ongo

ing.

We

did

not

iden

tify

any

stud

ies

that

mea

sure

d t

he e

ffect

of C

WA

s on

how

hea

lthca

re

pro

fess

iona

ls c

are

for

thei

r p

atie

nts.

Fian

der

M e

t al

81In

terv

entio

ns t

o in

crea

se t

he u

se o

f el

ectr

onic

hea

lth

info

rmat

ion

(EH

I) b

y he

alth

care

p

ract

ition

ers

to

imp

rove

clin

ical

p

ract

ice

and

pat

ient

ou

tcom

es

To a

sses

s th

e ef

fect

s of

inte

rven

tions

aim

ed a

t im

pro

ving

or

incr

easi

ng h

ealth

care

pra

ctiti

oner

s’

use

of E

HI o

n p

rofe

ssio

nal p

ract

ice

and

pat

ient

ou

tcom

es.

We

incl

uded

stu

die

s th

at e

valu

ated

the

effe

cts

of in

terv

entio

ns

to im

pro

ve o

r in

crea

se t

he u

se o

f EH

I by

heal

thca

re p

ract

ition

ers

on p

rofe

ssio

nal p

ract

ice

and

pat

ient

out

com

es. W

e d

efine

d

EH

I as

info

rmat

ion

acce

ssed

on

a co

mp

uter

. We

defi

ned

‘use

’ as

logg

ing

into

EH

I. W

e co

nsid

ered

any

hea

lthca

re p

ract

ition

er

invo

lved

in p

atie

nt c

are.

We

incl

uded

RC

Ts, N

RC

Ts, a

nd C

RC

Ts,

cont

rolle

d c

linic

al t

rials

(CC

Ts),

ITS

and

CB

As.

The

com

par

ison

s w

ere:

ele

ctro

nic

vs p

rinte

d h

ealth

info

rmat

ion;

EH

I on

diff

eren

t el

ectr

onic

dev

ices

(eg,

des

ktop

, lap

top

or

tab

let

com

put

ers,

etc

; ce

ll/m

obile

pho

nes)

; EH

I via

diff

eren

t us

er in

terf

aces

; EH

I pro

vid

ed

with

or

with

out

an e

duc

atio

nal o

r tr

aini

ng c

omp

onen

t an

d E

HI

com

par

ed w

ith n

o ot

her

typ

e or

sou

rce

of in

form

atio

n.

The

resu

lts o

f thi

s re

view

sho

wed

tha

t w

hen

pro

vid

ed w

ith a

com

bin

atio

n of

EH

I an

d t

rain

ing,

pra

ctiti

oner

s us

ed t

he in

form

atio

n m

ore

ofte

n. T

wo

stud

ies

mea

sure

d

doc

tors

' use

of e

lect

roni

c tr

eatm

ent

guid

elin

es, b

ut s

how

ed t

hat

the

elec

tron

ic

asp

ect

of t

he g

uid

elin

es d

id n

ot m

ean

that

doc

tors

follo

wed

the

gui

del

ines

. Thi

s re

view

pro

vid

ed n

o in

form

atio

n on

whe

ther

mor

e fr

eque

nt u

se o

f EH

I tra

nsla

ted

into

im

pro

ved

clin

ical

pra

ctic

e or

whe

ther

pat

ient

s w

ere

bet

ter

off w

hen

doc

tors

or

nurs

es

used

hea

lth in

form

atio

n w

hen

trea

ting

them

.

Flod

gren

G e

t al

83To

ols

dev

elop

ed a

nd

dis

sem

inat

ed b

y gu

idel

ine

pro

duc

ers

to

pro

mot

e th

e up

take

of

thei

r gu

idel

ines

To e

valu

ate

the

effe

ctiv

enes

s of

imp

lem

enta

tion

tool

s d

evel

oped

and

dis

sem

inat

ed b

y gu

idel

ine

pro

duc

ers,

w

hich

acc

omp

any

or fo

llow

the

pub

licat

ion

of a

C

PG

, to

pro

mot

e up

take

. A s

econ

dar

y ob

ject

ive

is t

o d

eter

min

e w

hich

ap

pro

ache

s to

gui

del

ine

imp

lem

enta

tion

are

mos

t ef

fect

ive.

We

incl

uded

RC

Ts a

nd C

RC

Ts, C

BA

s an

d IT

S s

tud

ies

eval

uatin

g th

e ef

fect

s of

gui

del

ine

imp

lem

enta

tion

tool

s d

evel

oped

by

reco

gnis

ed g

uid

elin

e p

rod

ucer

s to

imp

rove

the

up

take

of t

heir

own

guid

elin

es. T

he g

uid

elin

e co

uld

tar

get

any

clin

ical

are

a.

Two

of t

he fo

ur in

clud

ed s

tud

ies

rep

orte

d o

n ho

w w

ell h

ealth

care

pro

fess

iona

ls

stic

k to

gui

del

ine

reco

mm

end

atio

ns w

hen

pro

vid

ing

care

to

thei

r p

atie

nts,

d

epen

din

g on

whe

ther

the

y re

ceiv

ed a

CP

G w

ith a

too

l aim

ed a

t im

pro

ving

the

use

of

the

CP

G, o

r if

they

rec

eive

d t

he C

PG

onl

y. T

he r

esul

ts o

f thi

s re

view

sho

w t

hat

heal

thca

re p

rofe

ssio

nals

who

rec

eive

d a

gui

del

ine

tool

tog

ethe

r w

ith t

he C

PG

on

the

man

agem

ent

of n

on-s

pec

ific

low

bac

k p

ain

or o

rder

ing

thyr

oid

-fun

ctio

n te

sts

pro

bab

ly s

tick

mor

e cl

osel

y to

the

rec

omm

end

atio

ns, c

omp

ared

with

tho

se w

ho

rece

ived

the

CP

G o

nly.

A g

uid

elin

e to

ol a

imed

at

imp

rovi

ng t

he u

se o

f a g

uid

elin

e,

may

lead

to

little

or

no d

iffer

ence

in c

ost

to t

he h

ealth

ser

vice

.

Che

n C

E e

t al

84W

alk-

in c

linic

s vs

p

hysi

cian

offi

ces

and

em

erge

ncy

room

s fo

r ur

gent

car

e an

d

chro

nic

dis

ease

m

anag

emen

t

To a

sses

s th

e q

ualit

y of

car

e an

d p

atie

nt s

atis

fact

ion

of w

alk-

in c

linic

s co

mp

ared

with

tha

t of

tra

diti

onal

p

hysi

cian

offi

ces

and

em

erge

ncy

room

s fo

r p

eop

le

who

pre

sent

with

bas

ic m

edic

al c

omp

lain

ts fo

r ei

ther

ac

ute

or c

hron

ic is

sues

.

Stu

dy

des

ign:

RC

Ts, N

RC

Ts a

nd C

BA

s. P

opul

atio

n: s

tand

alon

e p

hysi

cal c

linic

s no

t re

qui

ring

adva

nce

app

oint

men

ts o

r re

gist

ratio

n, t

hat

pro

vid

ed b

asic

med

ical

car

e w

ithou

t ex

pec

tatio

n of

follo

w-u

p. C

omp

aris

ons:

tra

diti

onal

prim

ary

care

pra

ctic

es o

r em

erge

ncy

room

s.

Wal

k-in

clin

ics

are

grow

ing

in p

opul

arity

aro

und

the

wor

ld, b

ut it

is u

ncle

ar if

the

m

edic

al c

are

pro

vid

ed b

y w

alk-

in c

linic

s is

com

par

able

to

that

of p

hysi

cian

s' o

ffice

s or

em

erge

ncy

room

s.

Sco

tt A

et

al85

The

effe

ct o

f fina

ncia

l in

cent

ives

on

the

qua

lity

of h

ealth

care

p

rovi

ded

by

prim

ary

care

phy

sici

ans

(PC

Ps)

The

aim

of t

his

revi

ew is

to

exam

ine

the

effe

ct o

f ch

ange

s in

the

met

hod

and

leve

l of p

aym

ent

on t

he

qua

lity

of c

are

pro

vid

ed b

y P

CP

s an

d t

o id

entif

y:i.

the

diff

eren

t ty

pes

of fi

nanc

ial i

ncen

tives

tha

t ha

ve im

pro

ved

qua

lity;

ii.

the

char

acte

ristic

s of

pat

ient

pop

ulat

ions

for

who

m q

ualit

y of

car

e ha

s b

een

imp

rove

d b

y fin

anci

al in

cent

ives

;iii

. th

e ch

arac

teris

tics

of P

CP

s w

ho h

ave

resp

ond

ed

to fi

nanc

ial i

ncen

tives

.

RC

Ts, C

BA

s an

d IT

S e

valu

atin

g th

e im

pac

t of

diff

eren

t fin

anci

al

inte

rven

tions

on

the

qua

lity

of c

are

del

iver

ed b

y P

CP

s. Q

ualit

y of

ca

re w

as d

efine

d a

s p

atie

nt-r

epor

ted

out

com

e m

easu

res,

clin

ical

b

ehav

iour

s an

d in

term

edia

te c

linic

al a

nd p

hysi

olog

ical

mea

sure

s.

The

use

of fi

nanc

ial i

ncen

tives

to

rew

ard

PC

Ps

for

imp

rovi

ng t

he q

ualit

y of

prim

ary

heal

thca

re s

ervi

ces

is g

row

ing.

How

ever

, the

re is

insu

ffici

ent

evid

ence

to

sup

por

t or

not

sup

por

t th

e us

e of

fina

ncia

l inc

entiv

es t

o im

pro

ve t

he q

ualit

y of

prim

ary

heal

thca

re. I

mp

lem

enta

tion

shou

ld p

roce

ed w

ith c

autio

n an

d in

cent

ive

sche

mes

sh

ould

be

mor

e ca

refu

lly d

esig

ned

bef

ore

imp

lem

enta

tion.

In a

dd

ition

to

bas

ing

ince

ntiv

e d

esig

n m

ore

on t

heor

y, t

here

is a

larg

e lit

erat

ure

dis

cuss

ing

exp

erie

nces

w

ith t

hese

sch

emes

tha

t ca

n b

e us

ed t

o d

raw

out

a n

umb

er o

f les

sons

tha

t ca

n b

e le

arnt

and

tha

t co

uld

be

used

to

influ

ence

or

mod

ify t

he d

esig

n of

ince

ntiv

e sc

hem

es. M

ore

rigor

ous

stud

y d

esig

ns n

eed

to

be

used

to

acco

unt

for

the

sele

ctio

n of

phy

sici

ans

into

ince

ntiv

e sc

hem

es. T

he u

se o

f ins

trum

enta

l var

iab

le t

echn

ique

s sh

ould

be

cons

ider

ed t

o as

sist

with

the

iden

tifica

tion

of t

reat

men

t ef

fect

s in

the

p

rese

nce

of s

elec

tion

bia

s an

d o

ther

sou

rces

of u

nob

serv

ed h

eter

ogen

eity

. In

rand

omis

ed t

rials

, car

e m

ust

be

take

n in

usi

ng t

he c

orre

ct u

nit

of a

naly

sis

and

mor

e at

tent

ion

shou

ld b

e p

aid

to

blin

din

g. S

tud

ies

shou

ld a

lso

exam

ine

the

pot

entia

l un

inte

nded

con

seq

uenc

es o

f inc

entiv

e sc

hem

es b

y ha

ving

a s

tron

ger

theo

retic

al

bas

is, i

nclu

din

g a

bro

ader

ran

ge o

f out

com

es, a

nd c

ond

uctin

g m

ore

exte

nsiv

e su

bgr

oup

ana

lysi

s. S

tud

ies

shou

ld m

ore

cons

iste

ntly

des

crib

e (i)

the

typ

e of

pay

men

t sc

hem

e at

bas

elin

e or

in t

he c

ontr

ol g

roup

, (ii)

how

pay

men

ts t

o m

edic

al g

roup

s w

ere

used

and

dis

trib

uted

with

in t

he g

roup

s an

d (i

ii) t

he s

ize

of t

he n

ew p

aym

ents

as

a p

erce

ntag

e of

tot

al r

even

ue. F

urth

er r

esea

rch

com

par

ing

the

rela

tive

cost

s an

d e

ffect

s of

fina

ncia

l inc

entiv

es w

ith o

ther

beh

avio

ur c

hang

e in

terv

entio

ns is

als

o re

qui

red

.

Tab

le 1

C

ontin

ued

Con

tinue

d

on January 16, 2020 by guest. Protected by copyright.

http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

jopen-2017-020626 on 28 July 2018. Dow

nloaded from

6 Buja A, et al. BMJ Open 2018;8:e020626. doi:10.1136/bmjopen-2017-020626

Open access

Aut

hor,

ref.

no

Tit

leO

bje

ctiv

esIn

clus

ion

crit

eria

Mai

n fi

ndin

gs

Youn

g et

al86

Hom

e or

fost

er h

ome

care

vs

inst

itutio

nal

long

-ter

m c

are

for

func

tiona

lly d

epen

den

t ol

der

peo

ple

To a

sses

s th

e ef

fect

s of

long

-ter

m h

ome

or fo

ster

ho

me

care

vs

inst

itutio

nal c

are

for

func

tiona

lly

dep

end

ent

old

er p

eop

le.

We

incl

uded

RC

Ts a

nd N

RC

Ts, C

BA

s an

d IT

S s

tud

ies

com

ply

ing

with

the

Coc

hran

e E

ffect

ive

Pra

ctic

e an

d O

rgan

isat

ion

of C

are

(EP

OC

) Gro

up s

tud

y d

esig

n cr

iteria

and

com

par

ing

the

effe

cts

of lo

ng-t

erm

hom

e ca

re v

s in

stitu

tiona

l car

e fo

r fu

nctio

nally

d

epen

den

t ol

der

peo

ple

.

Ther

e ar

e in

suffi

cien

t hi

gh-q

ualit

y p

ublis

hed

dat

a to

sup

por

t an

y p

artic

ular

m

odel

of c

are

for

func

tiona

lly d

epen

den

t ol

der

peo

ple

. Com

mun

ity-b

ased

car

e w

as n

ot c

onsi

sten

tly b

enefi

cial

acr

oss

all t

he in

clud

ed s

tud

ies;

the

re w

ere

som

e d

ata

sugg

estin

g th

at c

omm

unity

-bas

ed c

are

may

be

asso

ciat

ed w

ith im

pro

ved

q

ualit

y of

life

and

phy

sica

l fun

ctio

n co

mp

ared

with

inst

itutio

nal c

are.

How

ever

, co

mm

unity

alte

rnat

ives

to

inst

itutio

nal c

are

may

be

asso

ciat

ed w

ith in

crea

sed

ris

k of

hos

pita

lisat

ion.

Fut

ure

stud

ies

shou

ld a

sses

s he

alth

care

util

isat

ion,

per

form

ec

onom

ic a

naly

sis

and

con

sid

er c

areg

iver

bur

den

.

Nka

nsah

N e

t al

87E

ffect

of o

utp

atie

nt

pha

rmac

ists

' non

-d

isp

ensi

ng r

oles

on

pat

ient

out

com

es a

nd

pre

scrib

ing

pat

tern

s

To e

xam

ine

the

effe

ct o

f out

pat

ient

pha

rmac

ists

' no

n-d

isp

ensi

ng r

oles

on

pat

ient

and

hea

lth

pro

fess

iona

l out

com

es.

RC

Ts c

omp

arin

g (1

) pha

rmac

ist

serv

ices

tar

gete

d a

t p

atie

nts

vs

serv

ices

del

iver

ed b

y ot

her

heal

th p

rofe

ssio

nals

; (2)

pha

rmac

ist

serv

ices

tar

gete

d a

t p

atie

nts

vs t

he d

eliv

ery

of n

o co

mp

arab

le

serv

ice;

(3) p

harm

acis

t se

rvic

es t

arge

ted

at

heal

th p

rofe

ssio

nals

vs

ser

vice

s d

eliv

ered

by

othe

r he

alth

pro

fess

iona

ls; (

4) p

harm

acis

t se

rvic

es t

arge

ted

at

heal

th p

rofe

ssio

nals

vs

the

del

iver

y of

no

com

par

able

ser

vice

.

Onl

y on

e in

clud

ed s

tud

y co

mp

ared

pha

rmac

ist

serv

ices

with

oth

er h

ealth

p

rofe

ssio

nal s

ervi

ces,

hen

ce w

e ar

e un

able

to

dra

w c

oncl

usio

ns r

egar

din

g co

mp

aris

ons

1 an

d 3

. Mos

t in

clud

ed s

tud

ies

sup

por

ted

the

rol

e of

pha

rmac

ists

in

med

icat

ion/

ther

apeu

tic m

anag

emen

t, p

atie

nt c

ouns

ellin

g an

d p

rovi

din

g he

alth

p

rofe

ssio

nal e

duc

atio

n w

ith t

he g

oal o

f im

pro

ving

pat

ient

pro

cess

of c

are

and

clin

ical

ou

tcom

es, a

nd o

f ed

ucat

iona

l out

reac

h vi

sits

on

phy

sici

an p

resc

ribin

g p

atte

rns.

Th

ere

was

gre

at h

eter

ogen

eity

in t

he t

ypes

of o

utco

mes

mea

sure

d a

cros

s al

l stu

die

s.

Ther

efor

e, a

sta

ndar

dis

ed a

pp

roac

h to

mea

sure

and

rep

ort

clin

ical

, hum

anis

tic a

nd

pro

cess

out

com

es fo

r fu

ture

ran

dom

ised

con

trol

led

stu

die

s ev

alua

ting

the

imp

act

of o

utp

atie

nt p

harm

acis

ts is

nee

ded

. Het

erog

enei

ty in

stu

dy

com

par

ison

gro

ups,

ou

tcom

es a

nd m

easu

res

mak

es it

cha

lleng

ing

to m

ake

gene

ralis

ed s

tate

men

ts

rega

rdin

g th

e im

pac

t of

pha

rmac

ists

in s

pec

ific

sett

ings

, dis

ease

sta

tes

and

pat

ient

p

opul

atio

ns.

Gon

çalv

es-B

rad

ley

DC

et

al88

Dis

char

ge p

lann

ing

from

hos

pita

lTo

ass

ess

the

effe

ctiv

enes

s of

pla

nnin

g th

e d

isch

arge

of

ind

ivid

ual p

atie

nts

mov

ing

from

hos

pita

l.R

CTs

tha

t co

mp

ared

an

ind

ivid

ualis

ed d

isch

arge

pla

n w

ith r

outin

e d

isch

arge

car

e th

at w

as n

ot t

ailo

red

to

ind

ivid

ual p

artic

ipan

ts.

Par

ticip

ants

wer

e ho

spita

l inp

atie

nts.

A d

isch

arge

pla

n ta

ilore

d t

o th

e in

div

idua

l pat

ient

pro

bab

ly b

rings

ab

out

a sm

all

red

uctio

n in

hos

pita

l len

gth

of s

tay

and

red

uces

the

ris

k of

rea

dm

issi

on t

o ho

spita

l at

3 m

onth

s fo

llow

-up

for

old

er p

eop

le w

ith a

med

ical

con

diti

on. D

isch

arge

pla

nnin

g m

ay le

ad t

o in

crea

sed

sat

isfa

ctio

n w

ith h

ealth

care

for

pat

ient

s an

d p

rofe

ssio

nals

. Th

ere

is li

ttle

evi

den

ce t

hat

dis

char

ge p

lann

ing

red

uces

cos

ts t

o th

e he

alth

ser

vice

.

B: R

isk

man

agem

ent

Par

mel

li et

al30

Inte

rven

tions

to

incr

ease

clin

ical

in

cid

ent

rep

ortin

g in

he

alth

care

To a

sses

s th

e ef

fect

s of

inte

rven

tions

des

igne

d t

o in

crea

se c

linic

al in

cid

ent

rep

ortin

g in

hea

lthca

re

sett

ings

.

RC

Ts, C

BA

s an

d IT

S o

f int

erve

ntio

ns d

esig

ned

to

incr

ease

clin

ical

in

cid

ent

rep

ortin

g in

hea

lthca

re.

Bec

ause

of t

he li

mita

tions

of t

he s

tud

ies

it is

not

pos

sib

le t

o d

raw

con

clus

ions

for

clin

ical

pra

ctic

e. A

nyon

e in

trod

ucin

g a

syst

em in

to p

ract

ice

shou

ld g

ive

care

ful

cons

ider

atio

n to

con

duc

ting

an e

valu

atio

n us

ing

a ro

bus

t d

esig

n.

Tab

le 1

C

ontin

ued

Con

tinue

d

on January 16, 2020 by guest. Protected by copyright.

http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

jopen-2017-020626 on 28 July 2018. Dow

nloaded from

7Buja A, et al. BMJ Open 2018;8:e020626. doi:10.1136/bmjopen-2017-020626

Open access

Aut

hor,

ref.

no

Tit

leO

bje

ctiv

esIn

clus

ion

crit

eria

Mai

n fi

ndin

gs

Rya

n R

et

al89

Inte

rven

tions

to

imp

rove

saf

e an

d

effe

ctiv

e m

edic

ines

us

e b

y co

nsum

ers:

an

over

view

of s

yste

mat

ic

revi

ews

To a

sses

s th

e ef

fect

s of

inte

rven

tions

whi

ch t

arge

t he

alth

care

con

sum

ers

to p

rom

ote

safe

and

effe

ctiv

e m

edic

ines

use

, by

synt

hesi

sing

rev

iew

-lev

el

evid

ence

.

We

incl

uded

sys

tem

atic

rev

iew

s p

ublis

hed

on

the

Coc

hran

e D

atab

ase

of S

yste

mat

ic R

evie

ws

and

the

Dat

abas

e of

Ab

stra

cts

of R

evie

ws

of E

ffect

s. W

e id

entifi

ed r

elev

ant

revi

ews

by

hand

se

arch

ing

dat

abas

es fr

om t

heir

star

t d

ates

to

Mar

ch 2

012.

Look

ing

acro

ss r

evie

ws,

for

mos

t ou

tcom

es, m

edic

ines

sel

f-m

onito

ring

and

sel

f-m

anag

emen

t p

rogr

amm

es a

pp

ear

gene

rally

effe

ctiv

e to

imp

rove

med

icin

es u

se,

adhe

renc

e, a

dve

rse

even

ts a

nd c

linic

al o

utco

mes

; and

to

red

uce

mor

talit

y in

peo

ple

se

lf-m

anag

ing

antit

hrom

bot

ic t

hera

py.

How

ever

, som

e p

artic

ipan

ts w

ere

unab

le t

o co

mp

lete

the

se in

terv

entio

ns, s

ugge

stin

g th

ey m

ay n

ot b

e su

itab

le fo

r ev

eryo

ne.

Oth

er p

rom

isin

g in

terv

entio

ns t

o im

pro

ve a

dhe

renc

e an

d o

ther

key

med

icin

es-u

se

outc

omes

, whi

ch r

equi

re fu

rthe

r in

vest

igat

ion

to b

e m

ore

cert

ain

of t

heir

effe

cts,

in

clud

e:

►si

mp

lified

dos

ing

regi

men

s: w

ith p

ositi

ve e

ffect

s on

ad

here

nce;

►

inte

rven

tions

invo

lvin

g p

harm

acis

ts in

med

icin

es m

anag

emen

t, s

uch

as

med

icin

es r

evie

ws

(with

pos

itive

effe

cts

on a

dhe

renc

e an

d u

se, m

edic

ines

p

rob

lem

s an

d c

linic

al o

utco

mes

) and

pha

rmac

eutic

al c

are

serv

ices

(con

sulta

tion

bet

wee

n p

harm

acis

t an

d p

atie

nt t

o re

solv

e m

edic

ines

pro

ble

ms,

dev

elop

a c

are

pla

n an

d p

rovi

de

follo

w-u

p; w

ith p

ositi

ve e

ffect

s on

ad

here

nce

and

kno

wle

dge

).S

ever

al o

ther

str

ateg

ies

show

ed s

ome

pos

itive

effe

cts,

par

ticul

arly

rel

atin

g to

ad

here

nce,

and

oth

er o

utco

mes

, but

the

ir ef

fect

s w

ere

less

con

sist

ent

over

all a

nd s

o ne

ed fu

rthe

r st

udy.

The

se in

clud

ed:

►

del

ayed

ant

ibio

tic p

resc

riptio

ns: e

ffect

ive

to d

ecre

ase

antib

iotic

use

but

with

m

ixed

effe

cts

on c

linic

al o

utco

mes

, ad

vers

e ef

fect

s an

d s

atis

fact

ion;

►

pra

ctic

al s

trat

egie

s lik

e re

min

der

s, c

ues

and

/or

orga

nise

rs, r

emin

der

pac

kagi

ng

and

mat

eria

l inc

entiv

es: w

ith p

ositi

ve, a

lthou

gh s

omew

hat

mix

ed e

ffect

s on

ad

here

nce;

►

educ

atio

n d

eliv

ered

with

sel

f-m

anag

emen

t sk

ills

trai

ning

, cou

nsel

ling,

sup

por

t,

trai

ning

or

enha

nced

follo

w-u

p; i

nfor

mat

ion

and

cou

nsel

ling

del

iver

ed t

oget

her

or e

duc

atio

n/in

form

atio

n as

par

t of

pha

rmac

ist-

del

iver

ed p

acka

ges

of c

are:

with

p

ositi

ve e

ffect

s on

ad

here

nce,

med

icin

es u

se, c

linic

al o

utco

mes

and

kno

wle

dge

, b

ut w

ith m

ixed

effe

cts

in s

ome

stud

ies;

►

finan

cial

ince

ntiv

es: w

ith p

ositi

ve, b

ut m

ixed

, effe

cts

on a

dhe

renc

e.S

ever

al s

trat

egie

s al

so s

how

ed p

rom

ise

in p

rom

otin

g im

mun

isat

ion

upta

ke, b

ut

req

uire

furt

her

stud

y to

be

mor

e ce

rtai

n of

the

ir ef

fect

s. T

hese

incl

uded

org

anis

atio

nal

inte

rven

tions

; rem

ind

ers

and

rec

all;

finan

cial

ince

ntiv

es; h

ome

visi

ts; f

ree

vacc

inat

ion;

la

y he

alth

wor

ker

inte

rven

tions

and

faci

litat

ors

wor

king

with

phy

sici

ans

to p

rom

ote

imm

unis

atio

n up

take

. Ed

ucat

ion

and

/or

info

rmat

ion

stra

tegi

es a

lso

show

ed s

ome

pos

itive

but

eve

n le

ss c

onsi

sten

t ef

fect

s on

imm

unis

atio

n up

take

, and

nee

d fu

rthe

r as

sess

men

t of

effe

ctiv

enes

s an

d in

vest

igat

ion

of h

eter

ogen

eity

.

Pat

ters

on S

M e

t al

90In

terv

entio

ns

to im

pro

ve t

he

app

rop

riate

use

of

pol

ypha

rmac

y fo

r ol

der

p

eop

le

This

rev

iew

sou

ght

to d

eter

min

e w

hich

inte

rven

tions

, al

one

or in

com

bin

atio

n, a

re e

ffect

ive

in im

pro

ving

th

e ap

pro

pria

te u

se o

f pol

ypha

rmac

y an

d r

educ

ing

med

icat

ion-

rela

ted

pro

ble

ms

in o

lder

peo

ple

.

A r

ange

of s

tud

y d

esig

ns w

ere

elig

ible

. Elig

ible

stu

die

s d

escr

ibed

in

terv

entio

ns a

ffect

ing

pre

scrib

ing

aim

ed a

t im

pro

ving

ap

pro

pria

te

pol

ypha

rmac

y in

peo

ple

age

d 6

5 ye

ars

of a

ge a

nd o

lder

in w

hich

a

valid

ated

mea

sure

of a

pp

rop

riate

ness

was

use

d (e

g, B

eers

cr

iteria

, Med

icat

ion

Ap

pro

pria

tene

ss In

dex

).

This

rev

iew

exa

min

es s

tud

ies

in w

hich

hea

lthca

re p

rofe

ssio

nals

hav

e ta

ken

actio

n to

mak

e su

re t

hat

old

er p

eop

le a

re r

ecei

ving

the

mos

t ef

fect

ive

and

saf

est

med

icat

ion

for

thei

r ill

ness

. Act

ions

tak

en in

clud

ed p

rovi

din

g p

harm

aceu

tical

ca

re, a

ser

vice

pro

vid

ed b

y p

harm

acis

ts t

hat

invo

lves

iden

tifyi

ng, p

reve

ntin

g an

d

reso

lvin

g m

edic

atio

n-re

late

d p

rob

lem

s, a

s w

ell a

s p

rom

otin

g th

e co

rrec

t us

e of

m

edic

atio

ns a

nd e

ncou

ragi

ng h

ealth

pro

mot

ion

and

ed

ucat

ion.

Ano

ther

str

ateg

y w

as c

omp

uter

ised

dec

isio

n su

pp

ort,

whi

ch in

volv

es a

pro

gram

me

on t

he d

octo

r’s

com

put

er t

hat

help

s hi

m/h

er t

o se

lect

ap

pro

pria

te t

reat

men

t.Th

is r

evie

w p

rovi

des

lim

ited

evi

den

ce t

hat

inte

rven

tions

, suc

h as

pha

rmac

eutic

al

care

, may

be

succ

essf

ul in

ens

urin

g th

at o

lder

peo

ple

are

rec

eivi

ng t

he r

ight

m

edic

ines

, but

it is

not

cle

ar w

heth

er t

his

alw

ays

resu

lts in

clin

ical

imp

rove

men

t.

Iver

s N

et

al91

Aud

it an

d fe

edb

ack:

ef

fect

s on

pro

fess

iona

l p

ract

ice

and

he

alth

care

out

com

es

To a

sses

s th

e ef

fect

s of

aud

it an

d fe

edb

ack

on t

he

pra

ctic

e of

hea

lthca

re p

rofe

ssio

nals

and

pat

ient

ou

tcom

es a

nd t

o ex

amin

e fa

ctor

s th

at m

ay e

xpla

in

varia

tion

in t

he e

ffect

iven

ess

of a

udit

and

feed

bac

k.

Ran

dom

ised

tria

ls o

f aud

it an

d fe

edb

ack

(defi

ned

as

a su

mm

ary

of c

linic

al p

erfo

rman

ce o

ver

a sp

ecifi

ed p

erio

d o

f tim

e) t

hat

rep

orte

d o

bje

ctiv

ely

mea

sure

d h

ealth

pro

fess

iona

l pra

ctic

e or

p

atie

nt o

utco

mes

. In

the

case

of m

ultif

acet

ed in

terv

entio

ns, o

nly

tria

ls in

whi

ch a

udit

and

feed

bac

k w

as c

onsi

der

ed t

he c

ore,

es

sent

ial a

spec

t of

at

leas

t on

e in

terv

entio

n ar

m w

ere

incl

uded

.

Aud

it an

d fe

edb

ack

gene

rally

lead

s to

sm

all b

ut p

oten

tially

imp

orta

nt im

pro

vem

ents

in

pro

fess

iona

l pra

ctic

e. T

he e

ffect

iven

ess

of a

udit

and

feed

bac

k se

ems

to d

epen

d

on b

asel

ine

per

form

ance

and

how

the

feed

bac

k is

pro

vid

ed. F

utur

e st

udie

s of

aud

it an

d fe

edb

ack

shou

ld d

irect

ly c

omp

are

diff

eren

t w

ays

of p

rovi

din

g fe

edb

ack.

Tab

le 1

C

ontin

ued

Con

tinue

d

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http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

jopen-2017-020626 on 28 July 2018. Dow

nloaded from

8 Buja A, et al. BMJ Open 2018;8:e020626. doi:10.1136/bmjopen-2017-020626

Open access

Aut

hor,

ref.

no

Tit

leO

bje

ctiv

esIn

clus

ion

crit

eria

Mai

n fi

ndin

gs

Gill

aize

au F

et

al92

Com

put

eris

ed a

dvi

ce

on d

rug

dos

age

to

imp

rove

pre

scrib

ing

pra

ctic

e

To a

sses

s w

heth

er c

omp

uter

ised

ad

vice

on

dru

g d

osag

e ha

s b

enefi

cial

effe

cts

on p

atie

nt o

utco

mes

co

mp

ared

with

rou

tine

care

(em

piri

c d

osin

g w

ithou

t co

mp

uter

ass

ista

nce)

.

We

incl

uded

RC

Ts, N

RC

Ts, C

BA

s an

d IT

S o

f com

put

eris

ed a

dvi

ce

on d

rug

dos

age.

The

par

ticip

ants

wer

e he

alth

care

pro

fess

iona

ls

resp

onsi

ble

for

pat

ient

car

e. T

he o

utco

mes

wer

e an

y ob

ject

ivel

y m

easu

red

cha

nge

in t

he h

ealth

of p

atie

nts

resu

lting

from

co

mp

uter

ised

ad

vice

(suc

h as

the

rap

eutic

dru

g co

ntro

l, cl

inic

al

imp

rove

men

t, a

dve

rse

reac

tions

).

Com

put

eris

ed a

dvi

ce fo

r d

rug

dos

age

can

ben

efit

peo

ple

tak

ing

cert

ain

dru

gs

com

par

ed w

ith e

mp

iric

dos

ing

(whe

re a

dos

e is

cho

sen

bas

ed o

n a

doc

tor'

s ob

serv

atio

ns a

nd e

xper

ienc

e) w

ithou

t co

mp

uter

ass

ista

nce.

Whe

n us

ing

the

com

put

er s

yste

m, h

ealth

care

pro

fess

iona

ls p

resc

ribed

ap

pro

pria

tely

hig

her

dos

es o

f the

dru

gs in

itial

ly fo

r am

inog

lyco

sid

e an

tibio

tics

and

the

cor

rect

dru

g d

ose

was

rea

ched

mor

e q

uick

ly fo

r or

al a

ntic

oagu

lant

s. It

sig

nific

antly

dec

reas

ed

thro

mb

oem

bol

ism

(blo

od c

lott

ing)

eve

nts

for

antic

oagu

lant

s an

d t

end

ed t

o re

duc

e un

wan

ted

effe

cts

for

amin

ogly

cosi

de

antib

iotic

s an

d a

ntire

ject

ion

dru

gs (a

lthou

gh n

ot

an im

por

tant

diff

eren

ce).

It te

nded

to

red

uce

the

leng

th o

f hos

pita

l sta

y co

mp

ared

w

ith r

outin

e ca

re w

ith c

omp

arab

le o

r b

ette

r co

st-e

ffect

iven

ess.

The

re w

as n

o ev

iden

ce o

f effe

cts

on d

eath

or

clin

ical

sid

e ev

ents

for

insu

lin (l

ow b

lood

sug

ar

(hyp

ogly

caem

ia)),

ana

esth

etic

age

nts,

ant

ireje

ctio

n d

rugs

(dru

gs t

aken

to

pre

vent

re

ject

ion

of a

tra

nsp

lant

ed o

rgan

) and

ant

idep

ress

ants

.

Alld

red

DP

et

al93

Inte

rven

tions

to

optim

ise

pre

scrib

ing

for

old

er p

eop

le in

car

e ho

mes

The

obje

ctiv

e of

the

rev

iew

was

to

det

erm

ine

the

effe

ct o

f int

erve

ntio

ns t

o op

timis

e ov

eral

l pre

scrib

ing

for

old

er p

eop

le li

ving

in c

are

hom

es.

We

incl

uded

RC

Ts e

valu

atin

g in

terv

entio

ns a

imed

at

optim

isin

g p

resc

ribin

g fo

r ol

der

peo

ple

(age

d 6

5 ye

ars

or o

lder

) liv

ing

in

inst

itutio

nalis

ed c

are

faci

litie

s. S

tud

ies

wer

e in

clud

ed if

the

y m

easu

red

one

or

mor

e of

the

follo

win

g p

rimar

y ou

tcom

es:

adve

rse

dru

g ev

ents

; hos

pita

l ad

mis

sion

s; m

orta

lity

or s

econ

dar

y ou

tcom

es, q

ualit

y of

life

(usi

ng v

alid

ated

inst

rum

ent);

med

icat

ion-

rela

ted

pro

ble

ms;

med

icat

ion

app

rop

riate

ness

(usi

ng v

alid

ated

in

stru

men

t); m

edic

ine

cost

s.

We

coul

d n

ot d

raw

rob

ust

conc

lusi

ons

from

the

evi

den

ce d

ue t

o va

riab

ility

in d

esig

n,

inte

rven

tions

, out

com

es a

nd r

esul

ts. T

he in

terv

entio

ns im

ple

men

ted

in t

he s

tud

ies

in t

his

revi

ew le

d t

o th

e id

entifi

catio

n an

d r

esol

utio

n of

med

icat

ion-

rela

ted

pro

ble

ms

and

imp

rove

men

ts in

med

icat

ion

app

rop

riate

ness

; how

ever

, evi

den

ce o

f a c

onsi

sten

t ef

fect

on

resi

den

t-re

late

d o

utco

mes

was

not

foun

d. T

here

is a

nee

d fo

r hi

gh-q

ualit

y C

RC

Ts t

estin

g cl

inic

al d

ecis

ion

sup

por

t sy

stem

s an

d m

ultid

isci

plin

ary

inte

rven

tions

th

at m

easu

re w

ell-

defi

ned

, im

por

tant

res

iden

t-re

late

d o

utco

mes

.

C: P

atie

nt s

atis

fact

ion

Bal

lini L

et

al33

Inte

rven

tions

to

red

uce

wai

ting

times

for

elec

tive

pro

ced

ures

To a

sses

s th

e ef

fect

iven

ess

of in

terv

entio

ns a

imed

at

red

ucin

g w

aitin

g tim

es fo

r el

ectiv

e ca

re, b

oth

dia

gnos

tic a

nd t

hera

peu

tic.

We

cons

ider

ed R

CTs

, CB

As

and

ITS

des

igns

tha

t m

et E

PO

C

min

imum

crit

eria

and

eva

luat

ed t

he e

ffect

iven

ess

of a

ny

inte

rven

tion

aim

ed a

t re

duc

ing

wai

ting

times

for

any

typ

e of

el

ectiv

e p

roce

dur

e. W

e co

nsid

ered

stu

die

s re

por

ting

one

or

mor

e of

the

follo

win

g ou

tcom

es: n

umb

er o

r p

rop

ortio

n of

p

artic

ipan

ts w

hose

wai

ting

times

wer

e ab

ove

or b

elow

a s

pec

ific

time

thre

shol

d, o

r p

artic

ipan

ts' m

ean

or m

edia

n w

aitin

g tim

es.

Com

par

ator

s co

uld

incl

ude

any

typ

e of

act

ive

inte

rven

tion

or

stan

dar

d p

ract

ice.

As

only

a h

and

ful o

f low

-qua

lity

stud

ies

are

pre

sent

ly a

vaila

ble

, we

cann

ot d

raw

any

fir

m c

oncl

usio

ns a

bou

t th

e ef

fect

iven

ess

of t

he e

valu

ated

inte

rven

tions

in r

educ

ing

wai

ting

times

. How

ever

, int

erve

ntio

ns in

volv

ing

the

pro

visi

on o

f mor

e ac

cess

ible

se

rvic

es (o

pen

acc

ess

or d

irect

boo

king

/ref

erra

l) sh

ow s

ome

pro

mis

e.

She

pep

rd S

et

al34

Hos

pita

l at

hom

e:

hom

e-b

ased

end

-of-

life

care

To d

eter

min

e if

pro

vid

ing

hom

e-b

ased

end

-of-

life

care

red

uces

the

like

lihoo

d o

f dyi

ng in

hos

pita

l and

w

hat

effe

ct t

his

has

on p

atie

nts'

sym

pto

ms,

qua

lity

of li

fe, h

ealth

ser

vice

cos

ts a

nd c

areg

iver

s, c

omp

ared

w

ith in

pat

ient

hos

pita

l or

hosp

ice

care

.

RC

Ts, i

nter

rup

ted

tim

e se

ries,

or

cont

rolle

d b

efor

e an

d a

fter

st

udie

s ev

alua

ting

the

effe

ctiv

enes

s of

hom

e-b

ased

end

-of-

life

care

with

inp

atie

nt h

osp

ital o

r ho

spic

e ca

re fo

r p

eop

le a

ged

18

yea

rs a

nd o

lder

.

The

evid

ence

incl

uded

in t

his

revi

ew s

upp

orts

the

use

of h

ome-

bas

ed e

nd-o

f-lif

e ca

re

pro

gram

mes

for

incr

easi

ng t

he n

umb

er o

f peo

ple

who

will

die

at

hom

e, a

lthou

gh t

he

num

ber

s of

peo

ple

ad

mitt

ed t

o ho

spita

l whi

le r

ecei

ving

end

-of-

life

care

sho

uld

be

mon

itore

d. F

utur

e re

sear

ch s

houl

d s

yste

mat

ical

ly a

sses

s th

e im

pac

t of

hom

e-b

ased

en

d-o

f-lif

e ca

re o

n ca

regi

vers

.

Dw

amen

a F

et a

l94In

terv

entio

ns fo

r p

rovi

der

s to

pro

mot

e a

pat

ient

-cen

tred

ap

pro

ach

in c

linic

al

cons

ulta

tions

To a

sses

s th

e ef

fect

s of

inte

rven

tions

for

heal

thca

re

pro

vid

ers

that

aim

to

pro

mot

e p

atie

nt-c

entr

ed c

are

app

roac

hes

in c

linic

al c

onsu

ltatio

ns.

In t

he o

rigin

al r

evie

w, s

tud

y d

esig

ns in

clud

ed R

CTs

, CC

Ts, C

BA

s an

d IT

S s

tud

ies

of in

terv

entio

ns fo

r he

alth

care

pro

vid

ers

that

p

rom

ote

pat

ient

-cen

tred

car

e in

clin

ical

con

sulta

tions

.

Inte

rven

tions

to

pro

mot

e p

atie

nt-c

entr

ed c

are

with

in c

linic

al c

onsu

ltatio

ns a

re

effe

ctiv

e ac

ross

stu

die

s in

tra

nsfe

rrin

g p

atie

nt-c

entr

ed s

kills

to

pro

vid

ers.

How

ever

, th

e ef

fect

s on

pat

ient

sat

isfa

ctio

n, h

ealth

beh

avio

ur a

nd h

ealth

sta

tus

are

mix

ed.

Ther

e is

som

e in

dic

atio

n th

at c

omp

lex

inte

rven

tions

dire

cted

at

pro

vid

ers

and

p

atie

nts

that

incl

ude

cond

ition

-sp

ecifi

c ed

ucat

iona

l mat

eria

ls h

ave

ben

efici

al e

ffect

s on

hea

lth b

ehav

iour

and

hea

lth s

tatu

s, o

utco

mes

not

ass

esse

d in

stu

die

s re

view

ed

pre

viou

sly.

The

latt

er c

oncl

usio

n is

ten

tativ

e at

thi

s tim

e an

d r

equi

res

mor

e d

ata.

Th

e he

tero

gene

ity o

f out

com

es, a

nd t

he u

se o

f sin

gle

item

con

sulta

tion

and

hea

lth

beh

avio

ur m

easu

res

limit

the

stre

ngth

of t

he c

oncl

usio

ns.

In t

he p

rese

nt u

pd

ate,

we

wer

e ab

le t

o lim

it th

e st

udie

s to

RC

Ts,

thus

lim

iting

the

like

lihoo

d o

f sam

plin

g er

ror.

This

is e

spec

ially

imp

orta

nt b

ecau

se t

he p

rovi

der

s w

ho v

olun

teer

fo

r st

udie

s of

pat

ient

-cen

tred

car

e m

etho

ds

are

likel

y to

be

diff

eren

t fr

om t

he g

ener

al p

opul

atio

n of

pro

vid

ers.

D:P

atie

nt a

nd c

areg

iver

eng

agem

ent

Léga

ré F

et

al37

Inte

rven

tions

for

imp

rovi

ng t

he

adop

tion

of s

hare

d

dec

isio

n m

akin

g (S

DM

) by

heal

thca

re

pro

fess

iona

ls

To d

eter

min

e th

e ef

fect

iven

ess

of in

terv

entio

ns t

o im

pro

ve h

ealth

care

pro

fess

iona

ls’ a

dop

tion

of S

DM

.R

CTs

and

NR

CTs

, CB

As

and

ITS

stu

die

s ev

alua

ting

inte

rven

tions

to

imp

rove

hea

lthca

re p

rofe

ssio

nals

' ad

optio

n of

SD

M w

here

the

p

rimar

y ou

tcom

es w

ere

eval

uate

d u

sing

ob

serv

er-b

ased

out

com

e m

easu

res

or p

atie

nt-r

epor

ted

out

com

e m

easu

res.

It is

unc

erta

in w

heth

er in

terv

entio

ns t

o im

pro

ve a

dop

tion

of S

DM

are

effe

ctiv

e gi

ven

the

low

qua

lity

of t

he e

vid

ence

. How

ever

, any

inte

rven

tion

that

act

ivel

y ta

rget

s p

atie

nts,

hea

lthca

re p

rofe

ssio

nals

or

bot

h, is

bet

ter

than

non

e. A

lso,

inte

rven

tions

ta

rget

ing

pat

ient

s an

d h

ealth

care

pro

fess

iona

ls t

oget

her

show

mor

e p

rom

ise

than

th

ose

targ

etin

g on

ly o

ne o

r th

e ot

her.

Tab

le 1

C

ontin

ued

Con

tinue

d

on January 16, 2020 by guest. Protected by copyright.

http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

jopen-2017-020626 on 28 July 2018. Dow

nloaded from

9Buja A, et al. BMJ Open 2018;8:e020626. doi:10.1136/bmjopen-2017-020626

Open access

Aut

hor,

ref.

no

Tit

leO

bje

ctiv

esIn

clus

ion

crit

eria

Mai

n fi

ndin

gs

Sta

cey

et a

l38D

ecis

ion

aid

s fo

r p

eop

le fa

cing

hea

lth

trea

tmen

t or

scr

eeni

ng

dec

isio

ns

To a

sses

s th

e ef

fect

s of

dec

isio

n ai

ds

in p

eop

le

faci

ng t

reat

men

t or

scr

eeni

ng d

ecis

ions

.W

e in

clud

ed p

ublis

hed

RC

Ts c

omp

arin

g d

ecis

ion

aid

s w

ith

usua

l car

e an

d/o

r al

tern

ativ

e in

terv

entio

ns. F

or t

his

upd

ate,

we

excl

uded

stu

die

s co

mp

arin

g d

etai

led

vs

sim

ple

dec

isio

n ai

ds.

Com

par

ed w

ith u

sual

car

e ac

ross

a w

ide

varie

ty o

f dec

isio

n co

ntex

ts, p

eop

le

exp

osed

to

dec

isio

n ai

ds

feel

mor

e kn

owle

dge

able

, bet

ter

info

rmed

and

cle

arer

ab

out

thei

r va

lues

, and

the

y p

rob

ably

hav

e a

mor

e ac

tive

role

in d

ecis

ion

mak

ing

and

m

ore

accu

rate

ris

k p

erce

ptio

ns. T

here

is g

row

ing

evid

ence

tha

t d

ecis

ion

aid

s m

ay

imp

rove

val

ues-

cong

ruen

t ch

oice

s. T

here

are

no

adve

rse

effe

cts

on h

ealth

out

com

es

or s

atis

fact

ion.

New

for

this

up

dat

ed is

evi

den

ce in

dic

atin

g im

pro

ved

kno

wle

dge

and

ac

cura

te r

isk

per

cep

tions

whe

n d

ecis

ion

aid

s ar

e us

ed e

ither

with

in o

r in

pre

par

atio

n fo

r th

e co

nsul

tatio

n.

Cic

iriel

lo S

et

al95

Mul

timed

ia e

duc

atio

nal

inte

rven

tions

for

cons

umer

s ab

out

pre

scrib

ed a

nd

over

-the

-cou

nter

m

edic

atio

ns

To a

sses

s th

e ef

fect

s of

mul

timed

ia p

atie

nt e

duc

atio

n in

terv

entio

ns a

bou

t p

resc

ribed

and

ove

r-th

e-co

unte

r m

edic

atio

ns in

peo

ple

of a

ll ag

es, i

nclu

din

g ch

ildre

n an

d c

arer

s.

RC

Ts a

nd q

uasi

-RC

Ts o

f mul

timed

ia-b

ased

pat

ient

ed

ucat

ion

abou

t p

resc

ribed

or

over

-the

-cou

nter

med

icat

ions

in p

eop

le o

f all

ages

, inc

lud

ing

child

ren

and

car

ers,

if t

he in

terv

entio

n ha

d b

een

targ

eted

for

thei

r us

e.

We

foun

d t

hat

mul

timed

ia e

duc

atio

n p

rogr

amm

es a

bou

t m

edic

atio

ns a

re s

uper

ior

to n

o ed

ucat

ion

or e

duc

atio

n p

rovi

ded

as

par

t of

usu

al c

linic

al c

are

in im

pro

ving

p

atie

nt k

now

led

ge. T

here

was

wid

e va

riab

ility

in t

he r

esul

ts fr

om t

he s

ix s

tud

ies

that

com

par

ed m

ultim

edia

ed

ucat

ion

with

usu

al c

are

or n

o ed

ucat

ion.

How

ever

, al

l but

one

of t

he s

ix s

tud

ies

favo

ured

mul

timed

ia e

duc

atio

n. W

e al

so fo

und

tha

t m

ultim

edia

ed

ucat

ion

is s

uper

ior

to u

sual

car

e or

no

educ

atio

n in

imp

rovi

ng s

kill

leve

ls. T

he r

evie

w a

lso

sugg

este

d t

hat

mul

timed

ia w

as a

t le

ast

as e

ffect

ive

as o

ther

fo

rms

of e

duc

atio

n, in

clud

ing

writ

ten

educ

atio

n or

brie

f ed

ucat

ion

from

a h

ealth

p

rovi

der

. How

ever

, the

se fi

ndin

gs w

ere

bas

ed o

n a

smal

l num

ber

of s

tud

ies,

man

y of

whi

ch w

ere

of lo

w q

ualit

y. M

ultim

edia

ed

ucat

ion

did

not

imp

rove

com

plia

nce

with

m

edic

atio

ns (i

e, t

he d

egre

e to

whi

ch a

pat

ient

cor

rect

ly fo

llow

s ad

vice

ab

out

his

or

her

med

icat

ion)

com

par

ed w

ith u

sual

car

e or

no

educ

atio

n. W

e co

uld

not

det

erm

ine

the

effe

ct o

f mul

timed

ia e

duc

atio

n on

oth

er o

utco

mes

, suc

h as

pat

ient

sat

isfa

ctio

n,

self-

effic

acy

(con

fiden

ce in

the

ir ab

ility

to

per

form

hea

lth-r

elat

ed t

asks

) and

hea

lth

outc

omes

.

The

revi

ew fi

ndin

gs t

here

fore

sug

gest

s th

at m

ultim

edia

ed

ucat

ion

pro

gram

mes

ab

out

med

icat

ions

cou

ld b

e us

ed a

long

sid

e us

ual c

are

pro

vid

ed b

y he

alth

pro

vid

ers.

The

re

is n

ot e

noug

h ev

iden

ce t

o re

com

men

d it

as

a re

pla

cem

ent

for

writ

ten

educ

atio

n or

ed

ucat

ion

by

a he

alth

pro

fess

iona

l. M

ultim

edia

ed

ucat

ion

coul

d b

e us

ed in

stea

d

of d

etai

led

ed

ucat

ion

give

n b

y a

heal

th p

rovi

der

whe

n it

is n

ot p

ossi

ble

or

pra

ctic

al

for

heal

th p

rofe

ssio

nals

to

pro

vid

e th

is s

ervi

ce. T

his

revi

ew fo

und

tha

t th

ere

wer

e d

iffer

ence

s b

etw

een

the

typ

es o

f ed

ucat

ion

pro

vid

ed t

o th

e co

ntro

l gro

ups

and

wha

t re

sults

wer

e m

easu

red

. Thi

s lim

ited

the

ab

ility

to

sum

mar

ise

resu

lts a

cros

s st

udie

s,

so m

ost

of t

he c

oncl

usio

ns o

f thi

s re

view

wer

e b

ased

on

resu

lts fr

om a

sm

all n

umb

er

of s

tud

ies.

Mor

e st

udie

s of

mul

timed

ia e

duc

atio

nal p

rogr

amm

es a

re n

eed

ed t

o m

ake

the

resu

lts o

f thi

s re

view

mor

e re

liab

le.

E: C

ost

-eff

ecti

vene

ss h

ealt

h te

chno

log

y as

sess

men

t; c

ost

-eff

ecti

vene

ss, c

ost

-uti

lity

Ath

erto

n H

et

al96

Em

ail f

or c

linic

al

com

mun

icat

ion

bet

wee

n p

atie

nts/

care

give

rs a

nd

heal

thca

re

pro

fess

iona

ls

To a

sses

s th

e ef

fect

s of

hea

lthca

re p

rofe

ssio

nals

and

p

atie

nts

usin

g em

ail t

o co

mm

unic

ate

with

eac

h ot

her,

on p

atie

nt o

utco

mes

, hea

lth s

ervi

ce p

erfo

rman

ce,

serv

ice

effic

ienc

y an

d a

ccep

tab

ility

.

RC

Ts, q

uasi

-RC

Ts, C

BA

s an

d IT

S s

tud

ies

exam

inin

g in

terv

entio

ns

usin

g em

ail t

o al

low

pat

ient

s to

com

mun

icat

e cl

inic

al c

once

rns

to

a he

alth

care

pro

fess

iona

l and

rec

eive

a r

eply

, and

tak

ing

the

form

of

(1) u

nsec

ured

em

ail,

(2) s

ecur

e em

ail o

r (3

) web

mes

sagi

ng. A

ll he

alth

care

pro

fess

iona

ls, p

atie

nts

and

car

egiv

ers

in a

ll se

ttin

gs

wer

e co

nsid

ered

.

Eig

ht o

f the

tria

ls lo

oked

at

emai

l com

par

ed w

ith s

tand

ard

met

hod

s of

co

mm

unic

atio

n. W

here

em

ail w

as c

omp

ared

with

sta

ndar

d m

etho

ds

of

com

mun

icat

ion,

we

foun

d t

hat

we

coul

d n

ot p

rop

erly

det

erm

ine

wha

t ef

fect

em

ail

was

hav

ing

on p

atie

nt/c

areg

iver

out

com

es, a

s th

ere

wer

e m

issi

ng d

ata

and

the

re

sults

of t

he d

iffer

ent

stud

ies

varie

d. F

or h

ealth

ser

vice

use

out

com

es t

he s

ituat

ion

was

the

sam

e, b

ut s

ome

resu

lts s

eem

ed t

o sh

ow t

hat

an e

mai

l int

erve

ntio

n m

ay le

ad

to a

n in

crea

sed

num

ber

of e

mai

ls a

nd t

elep

hone

cal

ls b

eing

rec

eive

d b

y he

alth

care

p

rofe

ssio

nals

.

O

ne o

f the

tria

ls lo

oked

at

emai

l cou

nsel

ling

com

par

ed w

ith t

elep

hone

cou

nsel

ling.

W

e fo

und

tha

t it

only

look

ed a

t p

atie

nt o

utco

mes

, and

foun

d fe

w d

iffer

ence

s b

etw

een

grou

ps.

Whe

re t

here

wer

e d

iffer

ence

s, t

hese

sho

wed

tha

t te

lep

hone

cou

nsel

ling

lead

s to

gre

ater

cha

nges

in li

fest

yle

than

em

ail c

ouns

ellin

g.

Non

e of

the

tria

ls m

easu

red

how

em

ail a

ffect

s he

alth

care

pro

fess

iona

ls a

nd o

nly

one

mea

sure

d w

heth

er e

mai

l can

cau

se h

arm

. All

of t

he t

rials

wer

e b

iase

d in

som

e w

ay

and

whe

n w

e m

easu

red

the

qua

lity

of a

ll of

the

res

ults

we

foun

d t

hem

to

be

of lo

w o

r ve

ry lo

w q

ualit

y.

As

a re

sult

the

resu

lts o

f thi

s re

view

sho

uld

be

view

ed w

ith c

autio

n.

The

natu

re o

f the

res

ults

mea

ns t

hat

we

cann

ot m

ake

any

reco

mm

end

atio

ns fo

r ho

w

emai

l mig

ht b

est

be

used

in c

linic

al p

ract

ice.

Tab

le 1

C

ontin

ued

Con

tinue

d

on January 16, 2020 by guest. Protected by copyright.

http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

jopen-2017-020626 on 28 July 2018. Dow

nloaded from

10 Buja A, et al. BMJ Open 2018;8:e020626. doi:10.1136/bmjopen-2017-020626

Open access

Aut

hor,

ref.

no

Tit

leO

bje

ctiv

esIn

clus

ion

crit

eria

Mai

n fi

ndin

gs

Flod

gren

G e

t al

82In

tera

ctiv

e te

lem

edic

ine

(TM

): ef

fect

s on

pro

fess

iona

l p

ract

ice

and

he

alth

care

out

com

es

To a

sses

s th

e ef

fect

iven

ess,

acc

epta

bili

ty a

nd c

osts

of

inte

ract

ive

TM a

s an

alte

rnat

ive

to, o

r in

ad

diti

on

to, u

sual

car

e (ie

, fac

e-to

-fac

e ca

re o

r te

lep

hone

co

nsul

tatio

n).

We

cons

ider

ed R

CTs

of i

nter

activ

e TM

tha

t in

volv

ed d

irect

p

atie

nt-p

rovi

der

inte

ract

ion

and

was

del

iver

ed in

ad

diti

on t

o, o

r su

bst

itutin

g fo

r, us

ual c

are

com

par

ed w

ith u

sual

car

e al

one,

to

par

ticip

ants

with

any

clin

ical

con

diti

on. W

e ex

clud

ed t

elep

hone

on

ly in

terv

entio

ns a

nd w

holly

aut

omat

ic s

elf-

man

agem

ent

TM

inte

rven

tions

.

The

find

ings

in o

ur r

evie

w in

dic

ate

that

the

use

of T

M in

the

man

agem

ent

of h

eart

fa

ilure

ap

pea

rs t

o le

ad t

o si

mila

r he

alth

out

com

es a

s fa

ce-t

o-fa

ce o

r te

lep

hone

d

eliv

ery

of c

are;

the

re is

evi

den

ce t

hat

TM c

an im

pro

ve t

he c

ontr

ol o

f blo

od g

luco

se

in t

hose

with

dia

bet

es.

The

cost

to

a he

alth

ser

vice

, and

acc

epta

bili

ty b

y p

atie

nts

and

hea

lthca

re

pro

fess

iona

ls, i

s no

t cl

ear

due

to

limite

d d

ata

rep

orte

d fo

r th

ese

outc

omes

. The

ef

fect

iven

ess

of T

M m

ay d

epen

d o

n a

num

ber

of d

iffer

ent

fact

ors,

incl

udin

g th

ose

rela

ted

to

the

stud

y p

opul

atio

n, e

g, t

he s

ever

ity o

f the

con

diti

on a

nd t

he d

isea

se

traj

ecto

ry o

f the

par

ticip

ants

, the

func

tion

of t

he in

terv

entio

n, e

g, if

it is

use

d fo

r m

onito

ring

a ch

roni

c co

nditi

on, o

r to

pro

vid

e ac

cess

to

dia

gnos

tic s

ervi

ces,

as

wel

l as

the

heal

thca

re p

rovi

der

and

hea

lthca

re s

yste

m in

volv

ed in

del

iver

ing

the

inte

rven

tion.

Wee

ks G

et

al97

Non

-med

ical

p

resc

ribin

g vs

med

ical

p

resc

ribin

g fo

r ac

ute

and

chr

onic

dis

ease

m

anag

emen

t in

p

rimar

y an

d s

econ

dar

y ca

re

To a

sses

s cl

inic

al, p

atie

nt-r

epor

ted

and

res

ourc

e us

e ou

tcom

es o

f non

-med

ical

pre

scrib

ing

for

man

agin

g ac

ute

and

chr

onic

hea

lth c

ond

ition

s in

prim

ary

and

se

cond

ary

care

set

tings

com

par

ed w

ith m

edic

al

pre

scrib

ing

(usu

al c

are)

.

RC

Ts, C

RC

Ts, C

BA

s (w

ith a

t le

ast

two

inte

rven

tion

and

tw

o co

ntro

l site

s) a

nd IT

S (w

ith a

t le

ast

thre

e ob

serv

atio

ns b

efor

e an

d

afte

r th

e in

terv

entio

n) c

omp

arin

g: (1

) non

-med

ical

pre

scrib

ing

vs

med

ical

pre

scrib

ing

in a

cute

car

e; (2

) non

-med

ical

pre

scrib

ing

vs

med

ical

pre

scrib

ing

in c

hron

ic c

are;

(3) n

on-m

edic

al p

resc

ribin

g vs

med

ical

pre

scrib

ing

in s

econ

dar

y ca

re; (

4) n

on-m

edic

al

pre

scrib

ing

vs m

edic

al p

resc

ribin

g in

prim

ary

care

; (5)

com

par

ison

s b

etw

een

diff

eren

t no

n-m

edic

al p

resc

riber

gr

oup

s an

d (6

) non

-med

ical

hea

lthca

re p

rovi

der

s w

ith fo

rmal

p

resc

ribin

g tr

aini

ng v

s th

ose

with

out

form

al p

resc

ribin

g tr

aini

ng.

The

find

ings

sug

gest

tha

t no

n-m

edic

al p

resc

riber

s, p

ract

isin

g w

ith v

aryi

ng b

ut h

igh

leve

ls o

f pre

scrib

ing

auto

nom

y, in

a r

ange

of s

ettin

gs, w

ere

as e

ffect

ive

as u

sual

car

e m

edic

al p

resc

riber

s. N

on-m

edic

al p

resc

riber

s ca

n d

eliv

er c

omp

arab

le o

utco

mes

for

syst

olic

blo

od p

ress

ure,

gly

cate

d h

aem

oglo

bin

, low

-den

sity

lip

opro

tein

, med

icat

ion

adhe

renc

e, p

atie

nt s

atis

fact

ion

and

hea

lth-r

elat

ed q

ualit

y of

life

.

It w

as d

ifficu

lt to

det

erm

ine

the

imp

act

of n

on-m

edic

al p

resc

ribin

g co

mp

ared

with

m

edic

al p

resc

ribin

g fo

r ad

vers

e ev

ents

and

res

ourc

e us

e ou

tcom

es d

ue t

o th

e in

cons

iste

ncy

and

var

iab

ility

in r

epor

ting

acro

ss s

tud

ies.

F: L

ead

ersh

ip, v

alue

s, v

isio

n

Flod

gren

G e

t al

98Lo

cal o

pin

ion

lead

ers:

ef

fect

s on

pro

fess

iona

l p

ract

ice

and

he

alth

care

out

com

es

To a

sses

s th

e ef

fect

iven

ess

of t

he u

se o

f loc

al

opin

ion

lead

ers

in im

pro

ving

pro

fess

iona

l pra

ctic

e an

d p

atie

nt o

utco

mes

.

Stu

die

s el

igib

le fo

r in

clus

ion

wer

e R

CTs

inve

stig

atin

g th

e ef

fect

iven

ess

of u

sing

op

inio

n le

ader

s to

dis

sem

inat

e ev

iden

ce-

bas

ed p

ract

ice

and

rep

ortin

g ob

ject

ive

mea

sure

s of

pro

fess

iona

l p

erfo

rman

ce a

nd/o

r he

alth

out

com

es.

Op

inio

n le

ader

s al

one

or in

com

bin

atio

n w

ith o

ther

inte

rven

tions

may

suc

cess

fully

p

rom

ote

evid

ence

-bas

ed p

ract

ice,

but

effe

ctiv

enes

s va

ries

bot

h w

ithin

and

bet

wee

n st

udie

s. T

hese

res

ults

are

bas

ed o

n he

tero

gene

ous

stud

ies

diff

erin

g in

ter

ms

of t

ype

of in

terv

entio

n, s

ettin

g an

d o

utco

mes

mea

sure

d. I

n m

ost

of t

he s

tud

ies,

the

rol

e of

th

e op

inio

n le

ader

was

not

cle

arly

des

crib

ed, a

nd it

is t

here

fore

not

pos

sib

le t

o sa

y w

hat

the

bes

t w

ay is

to

optim

ise

the

effe

ctiv

enes

s of

op

inio

n le

ader

s.

Gre

en C

J e

t al

99P

harm

aceu

tical

p

olic

ies:

effe

cts

of r

estr

ictio

ns o

n re

imb

urse

men

t

To d

eter

min

e th

e ef

fect

s of

a p

harm

aceu

tical

p

olic

y re

stric

ting

the

reim

bur

sem

ent

of s

elec

ted

m

edic

atio

ns o

n d

rug

use,

hea

lthca

re u

tilis

atio

n,

heal

th o

utco

mes

and

cos

ts (e

xpen

ditu

res)

.

Incl

uded

wer

e st

udie

s of

pha

rmac

eutic

al p

olic

ies

that

res

tric

t co

vera

ge a

nd r

eim

bur

sem

ent

of s

elec

ted

dru

gs o

r d

rug

clas

ses,

of

ten

usin

g ad

diti

onal

pat

ient

-sp

ecifi

c in

form

atio

n re

late

d t

o he

alth

sta

tus

or n

eed

. We

incl

uded

RC

Ts, N

RC

Ts, I

TS a

naly

ses,

R

MS

and

CB

As

set

in la

rge

care

sys

tem

s or

juris

dic

tions

.

Imp

lem

entin

g re

stric

tions

to

cove

rage

and

rei

mb

urse

men

t of

sel

ecte

d m

edic

atio

ns

can

dec

reas

e th

ird-p

arty

dru

g sp

end

ing

with

out

incr

easi

ng t

he u

se o

f oth

er h

ealth

se

rvic

es (s

ix s

tud

ies)

. Rel

axin

g re

imb

urse

men

t ru

les

for

dru

gs u

sed

for

seco

ndar

y p

reve

ntio

n ca

n al

so r

emov

e b

arrie

rs t

o ac

cess

. Pol

icy

des

ign,

how

ever

, nee

ds

to b

e b

ased

on

rese

arch

qua

ntify

ing

the

harm

and

ben

efit

pro

files

of t

arge

t an

d a

ltern

ativ

e d

rugs

to

avoi

d u

nwan

ted

hea

lth s

yste

m a

nd h

ealth

effe

cts.

Hea

lth im

pac

t ev

alua

tion

shou

ld b

e co

nduc

ted

whe

re d

rugs

are

not

inte

rcha

ngea

ble

. Im

pac

ts o

n he

alth

eq

uity

, re

latin

g to

the

fair

and

just

dis

trib

utio

n of

hea

lth b

enefi

ts in

soc

iety

(eg,

sus

tain

able

ac

cess

to

pub

licly

fina

nced

dru

g b

enefi

ts fo

r se

nior

s an

d lo

w-i

ncom

e p

opul

atio

ns),

also

req

uire

exp

licit

mea

sure

men

t.

Jia

L et

al10

0S

trat

egie

s fo

r ex

pan

din

g he

alth

in

sura

nce

cove

rage

in

vuln

erab

le p

opul

atio

ns

To a

sses

s th

e ef

fect

iven

ess

of s

trat

egie

s fo

r ex

pan

din

g he

alth

insu

ranc

e co

vera

ge in

vul

nera

ble

p

opul

atio

ns.

RC

Ts, N

RC

Ts, C

BA

s an

d IT

S s

tud

ies

that

eva

luat

ed t

he e

ffect

s of

st

rate

gies

on

incr

easi

ng h

ealth

insu

ranc

e co

vera

ge fo

r vu

lner

able

p

opul

atio

ns. W

e d

efine

d s

trat

egie

s as

mea

sure

s to

imp

rove

th

e en

rolm

ent

of v

ulne

rab

le p

opul

atio

ns in

to h

ealth

insu

ranc

e sc

hem

es. T

wo

cate

gorie

s an

d s

ix s

pec

ified

str

ateg

ies

wer

e id

entifi

ed a

s th

e in

terv

entio

ns.

Com

mun

ity-b

ased

cas

e m

anag

ers

who

pro

vid

e he

alth

insu

ranc

e in

form

atio

n,

app

licat

ion

sup

por

t an

d n

egot

iate

with

the

insu

rer

pro

bab

ly in

crea

se e

nrol

men

t of

ch

ildre

n in

hea

lth in

sura

nce

sche

mes

. How

ever

, the

tra

nsfe

rab

ility

of t

his

inte

rven

tion

to o

ther

pop

ulat

ions

or

othe

r se

ttin

gs is

unc

erta

in. H

and

ing

out

insu

ranc

e ap

plic

atio

n m

ater

ials

in h

osp

ital e

mer

genc

y d

epar

tmen

ts m

ay h

elp

incr

ease

the

enr

olm

ent

of

child

ren

in h

ealth

insu

ranc

e sc

hem

es. F

urth

er s

tud

ies

eval

uatin

g th

e ef

fect

iven

ess

of

diff

eren

t st

rate

gies

for

exp

and

ing

heal

th in

sura

nce

cove

rage

in v

ulne

rab

le p

opul

atio

n ar

e ne

eded

in d

iffer

ent

sett

ings

, with

car

eful

att

entio

n gi

ven

to s

tud

y d

esig

n.

G: I

nteg

rati

on

Ree

ves

S e

t al

42In

terp

rofe

ssio

nal

colla

bor

atio

n (IP

C) t

o im

pro

ve p

rofe

ssio

nal

pra

ctic

e an

d

heal

thca

re o

utco

mes

To a

sses

s th

e im

pac

t of

pra

ctic

e-b

ased

inte

rven

tions

d

esig

ned

to

imp

rove

IPC

am

ong

heal

thca

re a

nd

soci

al c

are

pro

fess

iona

ls, c

omp

ared

with

usu

al c

are

or t

o an

alte

rnat

ive

inte

rven

tion,

on

at le

ast

one

of t

he fo

llow

ing

prim

ary

outc

omes

: pat

ient

hea

lth

outc

omes

, clin

ical

pro

cess

or

effic

ienc

y ou

tcom

es o

r se

cond

ary

outc

omes

(col

lab

orat

ive

beh

avio

ur).

We

incl

uded

ran

dom

ised

tria

ls o

f pra

ctic

e-b

ased

IPC

in

terv

entio

ns in

volv

ing

heal

th a

nd s

ocia

l car

e p

rofe

ssio

nals

co

mp

ared

with

usu

al c

are

or t

o an

alte

rnat

ive

inte

rven

tion.

Giv

en t

hat

the

cert

aint

y of

evi

den

ce fr

om t

he in

clud

ed s

tud

ies

was

jud

ged

to

be

low

to

very

low

, the

re is

not

suf

ficie

nt e

vid

ence

to

dra

w c

lear

con

clus

ions

on

the

effe

cts

of IP

C in

terv

entio

ns. N

ever

thel

ess,

due

to

the

diffi

culti

es h

ealth

pro

fess

iona

ls

enco

unte

r w

hen

colla

bor

atin

g in

clin

ical

pra

ctic

e, it

is e

ncou

ragi

ng t

hat

rese

arch

on

the

num

ber

of i

nter

vent

ions

to

imp

rove

IPC

has

incr

ease

d s

ince

thi

s re

view

w

as la

st u

pd

ated

. Whi

le t

his

field

is d

evel

opin

g, fu

rthe

r rig

orou

s, m

ixed

-met

hod

st

udie

s ar

e re

qui

red

. Fut

ure

stud

ies

shou

ld fo

cus

on lo

nger

acc

limat

isat

ion

per

iod

s b

efor

e ev

alua

ting

new

ly im

ple

men

ted

IPC

inte

rven

tions

, and

use

long

er fo

llow

-up

to

gene

rate

a m

ore

info

rmed

und

erst

and

ing

of t

he e

ffect

s of

IPC

on

clin

ical

pra

ctic

e.

Tab

le 1

C

ontin

ued

Con

tinue

d

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j.com/

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J Open: first published as 10.1136/bm

jopen-2017-020626 on 28 July 2018. Dow

nloaded from

11Buja A, et al. BMJ Open 2018;8:e020626. doi:10.1136/bmjopen-2017-020626

Open access

self-management programmes were generally effective in improving the use of medicines, adherence to prescrip-tions, reducing adverse events and improving clinical outcomes. It also found a lower mortality rate among people self-managing their antithrombotic therapy.30 The same review revealed numerous other promising inter-ventions to improve adherence and other key outcomes related to medicine usage (table 1B).

Patient satisfactionPatient satisfaction is fundamental in the case of patients with chronic disease who are likely to be involved in a lasting relationship with healthcare services. It is linked to patients’ expectations of ideal care and their actual expe-rience of care,32 and it is considered by most as a multidi-mensional construct including multiple domains such as accessibility, organisational characteristics of the system, clinical and communication skills and the doctor-patient relationship, among others. Long waiting lists for non-ur-gent health procedures are quite common and may affect the health professional-patient relationship, causing distress for patients and their caregivers and distrust of the healthcare system. Improving access by implementing an open access or direct booking for some health prob-lems or referrals has been shown to improve patient satis-faction.33 Home-based interventions for end-of-life care have also been shown to improve both patient and care-givers satisfaction34 (table 1C).

Patient and caregiver engagement refers to a patient-cen-tred and family centred collaborative approach that is tailored to match the fundamental realities of chronic care. Patient and caregiver engagement helps patients discover and develop their inherent capacity to take responsibility for their own life.35 Empowering patients by providing information and increasing their contribu-tion to the planning of services can greatly influence the development of clinical governance on clinical processes and on organisational matters. Contributions from patients will affect the responsiveness and performance of healthcare services, and the process by means of which quality improvement initiatives are identified and priori-tised.36 Recent reviews of interventions promoting shared medical decision making, with active involvement of both patients and health professionals, have found moderate evidence of better patient involvement. In addition, deci-sion aids (pamphlets, videos or video-based tools) may improve patient’s knowledge of their care options, so they feel more informed and better able to participate in deci-sion making37 38 (table 1D).

Health technology assessment (HTA) refers to the system-atic assessment of the properties and effects of a health technology, addressing the direct and intended effects of the technology, as well as its indirect and unintended consequences. The main aims of HTA are to inform deci-sion-making regarding health technologies (bearing in mind the finite resources available), to drive the intro-duction of innovations and to identify ineffective or harmful technologies.39 Whether it involves introducing A

utho

r, re

f. n

oT

itle

Ob

ject

ives

Incl

usio

n cr

iter

iaM

ain

find

ing

s

Sm

ith S

M e

t al

101

Sha

red

car

e ac

ross

th

e in

terf

ace

bet

wee

n p

rimar

y an

d s

pec

ialty

ca

re in

man

agem

ent

of

long

-ter

m c

ond

ition

s

To d

eter

min

e th

e ef

fect

iven

ess

of s

hare

d c

are

heal

th s

ervi

ce in

terv

entio

ns d

esig

ned

to

imp

rove

the

m

anag

emen

t of

chr

onic

dis

ease

acr

oss

the

prim

ary/

spec

ialty

car

e in

terf

ace.

We

cons

ider

ed R

CTs

, NR

CTs

, CB

As

and

ITS

eva

luat

ing

the

effe

ctiv

enes

s of

sha

red

car

e in

terv

entio

ns fo

r p

eop

le w

ith

chro

nic

cond

ition

s in

prim

ary

care

and

com

mun

ity s

ettin

gs. T

he

inte

rven

tion

was

com

par

ed w

ith u

sual

car

e in

tha

t se

ttin

g.

This

rev

iew

sug

gest

s th

at s

hare

d c

are

is e

ffect

ive

for

man

agin

g d

epre

ssio

n. S

hare

d

care

inte

rven

tions

for

othe

r co

nditi

ons

shou

ld b

e d

evel

oped

with

in r

esea

rch

sett

ings

, so

tha

t fu

rthe

r ev

iden

ce c

an b

e co

nsid

ered

bef

ore

they

are

intr

oduc

ed r

outin

ely

into

he

alth

sys

tem

s.

Hay

es S

L et

al10

2C

olla

bor

atio

n b

etw

een

loca

l hea

lth a

nd lo

cal

gove

rnm

ent

agen

cies

fo

r he

alth

imp

rove

men

t

To e

valu

ate

the

effe

cts

of in

tera

genc

y co

llab

orat

ion

bet

wee

n lo

cal h

ealth

and

loca

l gov

ernm

ent

agen

cies

on

hea

lth o

utco

mes

in a

ny p

opul

atio

n or

age

gro

up.

RC

Ts, C

CTs

, CB

As

and

ITS

whe

re t

he s

tud

y re

por

ted

ind

ivid

ual

heal

th o

utco

mes

aris

ing

from

inte

rage

ncy

colla

bor

atio

n b

etw

een

heal

th a

nd lo

cal g

over

nmen

t ag

enci

es c

omp

ared

with

sta

ndar

d

care

. Stu

die

s w

ere

sele

cted

ind

epen

den

tly in

dup

licat

e, w

ith n

o re

stric

tion

on p

opul

atio

n su

bgr

oup

or

dis

ease

.

Col

lab

orat

ion

bet

wee

n lo

cal h

ealth

and

loca

l gov

ernm

ent

is c

omm

only

con

sid

ered

b

est

pra

ctic

e. H

owev

er, t

he r

evie

w d

id n

ot id

entif

y an

y re

liab

le e

vid

ence

tha

t in

tera

genc

y co

llab

orat

ion,

com

par

ed w

ith s

tand

ard

ser

vice

s, n

eces

saril

y le

ads

to

heal

th im

pro

vem

ent.

A fe

w s

tud

ies

iden

tified

com

pon

ent

ben

efits

but

the

se w

ere

not

refle

cted

in o

vera

ll ou

tcom

e sc

ores

and

cou

ld h

ave

resu

lted

from

the

use

of

sign

ifica

nt a

dd

ition

al r

esou

rces

. Alth

ough

age

ncie

s ap

pea

r en

thus

iast

ic a

bou

t co

llab

orat

ion,

diffi

culti

es in

the

prim

ary

stud

ies

and

inco

mp

lete

imp

lem

enta

tion

of in

itiat

ives

hav

e p

reve

nted

the

dev

elop

men

t of

a s

tron

g ev

iden

ce b

ase.

If t

hese

w

eakn

esse

s ar

e ad

dre

ssed

in fu

ture

stu

die

s (e

g, b

y p

rovi

din

g gr

eate

r d

etai

l on

the

imp

lem

enta

tion

of p

rogr

amm

es; u

sing

mor

e ro

bus

t d

esig

ns, i

nteg

rate

d p

roce

ss

eval

uatio

ns t

o sh

ow h

ow w

ell t

he p

artn

ers

of t

he c

olla

bor

atio

n w

orke

d t

oget

her

and

m

easu

rem

ent

of h

ealth

out

com

es),

it co

uld

pro

vid

e a

bet

ter

und

erst

and

ing

of w

hat

mig

ht w

ork

and

why

. It

is p

ossi

ble

tha

t lo

cal c

olla

bor

ativ

e p

artn

ersh

ips

del

iver

ing

envi

ronm

enta

l int

erve

ntio

ns m

ay r

esul

t in

hea

lth g

ain

but

the

evi

den

ce b

ase

for

this

is

ver

y lim

ited

. Eva

luat

ions

of i

nter

agen

cy c

olla

bor

ativ

e ar

rang

emen

ts fa

ce m

any

chal

leng

es. T

he r

esul

ts d

emon

stra

te t

hat

colla

bor

ativ

e co

mm

unity

par

tner

ship

s ca

n b

e es

tab

lishe

d t

o d

eliv

er in

terv

entio

ns b

ut it

is im

por

tant

to

agre

e go

als,

met

hod

s of

wor

king

, mon

itorin

g an

d e

valu

atio

n b

efor

e im

ple

men

tatio

n to

pro

tect

pro

gram

me

fidel

ity a

nd in

crea

se t

he p

oten

tial f

or e

ffect

iven

ess.

CP

G, c

linic

al p

ract

ice

guid

elin

e; C

WA

, col

lab

orat

ive

writ

ing

app

licat

ions

.

Tab

le 1

C

ontin

ued

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j.com/

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J Open: first published as 10.1136/bm

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electrostimulators for treating incontinence, or disin-vesting in old medical ventilators for long-term domicil-iary respiratory support, or a new clinical pathway for diabetes, HTA is a robust method for orienting deci-sion-makers and clinicians towards the best available choices (table 1E).

the atmosphereThe atmosphere dimensions defined at this level shape the interventions given to patients, as petal dimensions, and describe activities between professionals inside the organisation, as well as the relationship with the civil society. Dimensions of the atmosphere include vision and values, integrated care and accountability.

A well-led organisation will monitor whether the vision and values of clinical governance are being clearly and effectively communicated to all members of the staff. This communication gives staff a common and consistent purpose, and clear expectations. A clear vision engenders an open-minded and questioning culture, and ensures that both the ethos and the day-to-day delivery of clin-ical governance remain an integral part of every clinical service. Apart from health system issues, one of the major barriers to the successful transfer of evidence into locally accepted policies lies in ineffective and unaccountable leaders and managers40 (table 1F).

Integrated care is a concept that brings together the inputs, delivery, management and organisation of services related to patients’ diagnosis, treatment, care, rehabilitation and health promotion. As individuals move across healthcare settings and services, the model of care requires integration and cooperation between a multiplicity of professionals. This integration and coop-eration demands a high degree of collaboration between healthcare professionals involved in these services, as well as organisational support. This integration should operate within a primary care system, and through effec-tive communications between specialist and primary care providers, to guarantee better transitions of care for patients with chronic disease. The latter has significant positive effects in reducing hospital readmissions and mortality41–43 (table 1G).

A robust, comprehensive and transparent accountability, with measurement of performance in healthcare activi-ties can ensure that the system is accountable to society at large, to health professionals and others involved in deliv-ering care and to patients. A fundamental shift is needed from a demand-driven model valuing the volume of the production, to a new model where the providers are accountable for the care outcomes and value that matter to patients and the broader population. Driving account-ability for outcomes and value leads to several key bene-fits: it encourages innovation along entire care pathways, to raise quality and reduce cost; it incentivises collabo-ration between providers to coordinate care to deliver outcomes; it clarifies for policy-makers what is being achieved by the money being spent and it gives people a stronger voice in their own care and in defining what

matters.44 45 Such a system can support effective auditing, which can improve care processes in health districts over the long term.45

the stem defines the means to reach the petalsIt is also important to ensure that key underpinning strategies (such as information technology, education and training, research and dissemination) support the delivery system to reach the defined petals dimensions. For example, any service re-organisation should involve building better information communication and tech-nology systems, to enable a better exchange of infor-mation throughout a newly rearranged organisation. An effective workforce also needs appropriate technical support, such as access to valid best evidence, to support its clinical decisions. To be useful, the data in informa-tion systems must be valid, up-to-date and presented in a way that offers insight. It should also be integrated with the electronic health record, and not provide excessive alerts that lead to ‘alert fatigue’. Finally, it should focus on research that provides evidence of improved patient-ori-ented outcomes, rather than disease or surrogate markers of improvement.46

Data to highlight differences in patient outcomes, shortfalls in standards, comparisons with other services and time trends are essential. Interconnected electronic health records support clinicians’ efforts to improve outcomes across the full continuum of care, while ensuring accountability, engaging patients in making decisions and managing their care, improving safety and care coordination and avoiding any waste of resources.47 Data are essential to managing performance, normally in relation to two subsets of activities: performance evalua-tion and performance improvement. Both make use of indicators for assessment purposes, and the latter also to monitor a healthcare organisation’s performance during an improvement process.48 For patients with multiple chronic conditions, it is also necessary to devise team indicators and indicators that encompass all the care provided to a given patient.

Improving the training of healthcare professionals will be important in any effort to re-organise a healthcare system. For example, if more nurses are going to take on the role of case study managers, they will need additional training to build their skill base.49 Ideally, continuing professional education should not be limited to updating professionals’ technical skills, knowledge of new research and improved clinical decision-making. In addition, it should enable all members of the staff to develop skills that allow them to practice to the maximum of their training, and to assure that their skills are aligned with the organisation's objectives.

the earth defines the ground where primary care is deliveredCommunity participation should be part of health-care service planning and evaluation. It is also essential to mobilise community resources to meet the needs of people with long-term conditions, creating a culture and

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mechanisms that promote safe, good-quality care. It has been suggested that positive outcomes for people with long-term conditions are only achieved when individuals and their families and community partners are informed, motivated and work together.50 Families and individuals are then supported by the broader community, which in turn influences the broader policy environment, and vice versa. In this model, integrated policies span different types of disease and prevention strategies, consistent financing, the development of human resources, legisla-tive frameworks and partnerships.

dIsCussIOnA framework for clinical governance promotes an inte-grated effort to bring together all relevant activities, melding environmental, administrative, support and clinical elements to ensure a coordinated and integrated approach, and thus sustain the provision of better care for patients with chronic disease and multimorbidity.

Quality assuranceThere are numerous challenges to providing coordi-nated and high-quality primary care to patients with chronic disease. For instance, the quality of the manage-ment of patients with multiple chronic conditions should be examined, taking the completeness of care into account.51 52 There is often a lengthy gap between the generation of new research-based evidence and the application of this evidence in clinical practice. This is true for clinical management, and for organisational management of patients. Knowledge management is achieved by creating, sharing and applying knowledge, as well as through feeding the valuable lessons learnt and best practices into the ‘corporate memory’ to foster continued organisational learning.51 This broad remit of knowledge management and the sharing of knowl-edge among organisational fields includes developing values, structures and information technology. It places emphasis on how value can be added: the petals should be revitalised by the atmosphere and ground. Moreover, quality assurance in patients with chronic illness implies using measures to assess the impact of interventions for chronic conditions on a patient’s daily functioning and quality of life. A number of measures from the Medical Outcomes Study have been used in studies of multimor-bidity in primary healthcare.53 An advantage of using such measures for patients with multimorbidity lies in that it does not focus on the care provided for specific diseases. Overuse of healthcare has also been assessed by examining hospitalisation rates for ambulatory care sensi-tive conditions, that is, conditions for which it is believed that well-organised delivery of high-quality primary care services can prevent the need for hospitalisation.54 55 Overuse of healthcare has also been measured in terms of the frequency of hospitalisation and emergency depart-ment attendance for patients with multiple morbidities.56 These measures are not disease-specific, so they could

be used to assess overall quality of care for patients with multiple health problems. One of the main challenges, which takes a different form in each context, is to develop appropriate incentives that promote and encourage a collective commitment to this alternative paradigm of continuous performance improvement.57 The organi-sational leadership should maintain the organisation’s focus on the use of information for improvement rather than sanction or punishment. This involves being able to establish a trusting and working relationship with the potential users, and to move away from a controlling or paternalistic approach.

Client satisfactionAn important consequence of how care of patients with chronic disease is managed relates to perceived quality or satisfaction, which itself is associated with the health of the population as a whole.32 Patient satisfaction is associated with clinical outcomes, patient retention and medical malpractice claims, so it is a proxy, but nonethe-less is a very effective indicator of the success of a primary care system. Different tools have been developed to assess perceived health quality for chronic diseases. A recent European project58 focused on perceptions of quality in primary healthcare in seven countries, highlighting the natural impact of waiting time on patient satisfaction, and the more complex association between equity and access to primary healthcare services. There is strong evidence that one of the most important determinants affecting satisfaction with health services is the patient-practitioner relationship, including the information the former receives from the latter.59 This is a crucial issue in the long-term management of chronic conditions. Different conceptual frameworks have been created to under-stand patient satisfaction, which is recognised as a crit-ical issue to developing service improvement strategies. For example, Dagger et al32 have proposed service quality as a multidimensional, higher order construct, with four overarching dimensions (interpersonal quality, technical quality, environment quality and administrative quality) and nine subdimensions. They suggest that consumers assess service quality at a global level, a dimensional level and at a subdimensional level, with each level influencing perceptions at the level above.

Patient activation and self-managementThe evidence linking patient activation, including person’s beliefs, motivation and actions for self-care, with health outcomes, the patient experience and cost has grown substantially over the past decade.60 Higher acti-vation levels in chronically ill patients are associated with higher levels of adherence to treatments, self-monitoring of conditions and regular chronic care. Patient activation to enhance patients' skills, knowledge and confidence in their ability to take healthy action and manage their disease should therefore be one of the main goals of a primary care health system. Patient activation can increase the motivation for self-management for chronic diseases,

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such as creating durable healthy lifestyle changes and improving adherence to treatment recommendations. In this respect, self-management reaches beyond traditional disease management by incorporating the wider concept of prevention, emphasising the notion that people who are chronically ill still need preventive services to promote their wellness and mitigate any further deterioration of their health. Self-management is consequently an excel-lent way to address chronic conditions as a major public health issue.61 Researchers have also placed a strong emphasis on the crucial role of family in patient self-man-agement, recognising that enhancing families’ self-man-agement generates better health outcomes.62 Despite its important beneficial effects, many factors threaten effec-tive empowerment, including individual patient charac-teristics, poor technological or IT infrastructure, poor educational or communications strategies and commu-nication and language barriers between healthcare providers and patients.

Performance monitoringWhere performance monitoring systems are adopted as a management approach, performance tends to be better than when such systems are not in place. Reverse causality could be argued, higher quality primary care organisations may be more likely to implement perfor-mance evaluation. Healthcare professionals are gener-ally keen to measure, know and demonstrate that they are making an important difference for their patients. Although there is little evidence of its effect on health outcomes or overall value for money,63 64 the emphasis on performance management in primary care is growing. A recent report highlighted how performance management is influenced by its own understanding, the systems used and the evaluator-evaluated relation-ship.48 Performance management needs an appropriate set of valid of indicators relevant to primary care prac-tice that recognise the complexities of different clinical pathways, multimorbidity, educational and counselling activities, goals and other activities typical in primary care.65

An example of such indicators was identified by the Australian Institute of Primary Care,66 which classified them as discipline-specific, disease-specific or systemic; these indicators could effectively inform primary care governance. Where instances of poor quality were not assessed, the management was to be ineffective, staff concerns about standards of care were marginalised or worse, adequate improvement systems were not in place and the service was not seen through the patients’ eyes. Clinical pathways are quite popular as a format for trans-lating guidelines into practice and facilitating an inte-grated approach to care that is supported by scientific evidence, but is also respectful of organisational issues. These pathways design an optimal pathway (or series of pathways) for managing clinical problems within a healthcare organisation. Their development engages all of the professionals responsible for managing the

disease or problem, and provides an opportunity to establish clinical and organisational indicators, and to define information flows. Certainly, the management of multiple conditions using clinical pathways requires a comprehensive approach that should consider many aspects, such as establishing the patient’s priorities, eval-uating the disease and treatment burdens and having a discussion of the benefits and risks of specific interven-tions. As part of the patient-health professional relation-ship, the individualised management plan constitutes the foundation of a shared explicit decision-making process. It is a written agreement that includes all rele-vant decisions, such as starting or stopping a treatment, anticipating the possible disease evolution and future healthcare appointments. It should assign responsibility for processes and interventions to specific health profes-sionals, to ensure appropriate communication with the patient and caregivers, and with other providers.67 68

Clinical risk managementIn 2012, WHO prioritised clinical risk management in primary care, forming its Safer Primary Care Expert Working Group that recently produced a technical series.69 70 International data suggest that safety incidents in primary care are mainly diagnostic and prescribing errors, with a rate estimated between <1 and up to 24 safety incidents per 100 consultations reviewed.71 Key elements influencing patient safety are related to struc-tural and technological prerequisites (eg, electronic health records, decision support systems), including organisational structure (eg, leadership, governance structure, organisation of work shifts, workload); human factors (eg, individual perception, diligence, decision-making ability, professionalism, interpersonal and group dynamics) and community characteristics (eg, epidemiological profile, resilience), and external influences (eg, media and public opinion). At the inter-national level, the commitment to improving safety in primary care has focused mainly on building and imple-menting incident-reporting systems, and on proactive or reactive risk analysis systems (eg, analysis of crit-ical incidents and adverse events, root cause analysis, failure mode effect analysis). Several interventions in primary care at the local level have been suggested by national agencies, including improving incident and adverse event reporting, integrating comprehensive risk management systems and continuous learning environments. Specifically, pharmacist-led medication review, computerised physician order entry, computer-ised decision support systems, error alert systems and education of professionals have all been shown to be effective interventions that could potentially prevent up to half of all errors.71

education and learningA continuous, proactive learning environment in primary care enables health professionals to deepen their knowl-edge and expand their skills, which even at the end of

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formal postgraduate professional medical are insufficient to ensure competence and performance over a life-long career. In addition, continuing professional development systems whose relevance has been widely recognised,72. Ways to keep clinicians updated with practice relevant information have evolved since the late 1990s, in the form of useful criteria to identify patient-oriented, evidence-based information. One example is the Information Mastery framework, which emphasises Patient-Ori-ented Evidence that Matters (POEMs) of Slawson et al.46 POEMs are studies that are relevant to primary care deci-sion-making, have been assessed for validity and have the potential to change practice. Each year, only about 200–250 studies from the top 100 clinical journals meet these criteria. An evolution of this concept has been translated into an online resource, Essential Evidence Plus, which is unique in comparison to other point-of-care tools in that it provides daily emailed POEMs to subscribers.73

Regarding the telephone and email consultation skills of clinicians, which are important for effective remote consulting, we do not yet have strong evidence regarding how health professionals should be trained to make the best use of this communication challenge.52 Educa-tional gaming is potentially a way to improve health professionals’ knowledge and skills, in particular for its motivating competitive nature. However, evidence of its effectiveness is limited, with only two studies identified and no difference seen between the intervention and control groups.74

Interprofessional education is increasingly recom-mended as an approach that has the potential to improve communication between different types of healthcare providers, as well as an improved understanding of the skills and capabilities of different team members, and better team functioning. However, the evidence regarding its effectiveness is limited. In one study, improvements in diabetic health outcomes, greater attainment of health-care quality goals and improved patient satisfaction and team behaviour have been reported and sustained over time.75

This framework however has a number of limitations. First of all, the umbrella review considered only EPOC Group and Cochrane Library database, other systematic review or meta-analysis not included in this paper could be examined to support and develop evidence-based healthcare management. Another limitation is the diffi-cult to derive evidence easily transferable by researches in healthcare services. In fact, the generalisability or transferability of healthcare services research findings from one setting to another could be also often prob-lematic. Furthermore, the importance of local organisa-tional context and culture, and the structural differences in health organisations and health systems make chal-lenging the exportation of organisational models. However, the a culture that supports and encourages innovation in organisational models should stimulate managers in routinely reviewing the findings of relevant

research studies and research syntheses before making important decisions.76

COnClusIOnsThe number of patients with chronic diseases will continue to increase with the ageing of the population, and the ongoing existence of risk factors for chronic diseases. We offer this framework with the aim of shedding light on how to reorganise primary care health systems, identifying and implementing an organic approach to optimising care for patients with chronic disease. Implementing such a framework will be a responsibility shared by the public and private health sectors, as well as by the communities where patients live and the primary health system oper-ates. Strengthening partnerships with and between these sectors will be crucial to achieving the vision of a quality of care for multiple chronic conditions.

Author affiliations1Unit of Hygiene and Public Health, Department of Cardiologic, Vascular, Thoracic Sciences and Public Health, Laboratory of Health Care Services and Health Promotion Evaluation, University of Padova, Padova, Italy2Past Administrative Directorship, ex-ULSS 4, Veneto, Italy3Department of Cardiologic, Vascular, Thoracic Sciences and Public Health, School of Hygiene and Preventive Medicine, University of Padova, Padova, Italy4Department of Public Health, Università Cattolica Sacro Cuore - Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy5College of Public Health, University of Georgia, Athens, Greece, USA

Contributors AB, RT and VB: conceptualisation, design of the methodologies, wrote and approved the final manuscript as submitted. MC: review analysis, wrote and revised the manuscript, approved the final manuscript as submitted. GD: conceptualisation, supervision of the study, approved the final manuscript as submitted. MHE and WR: supervision, critically reviewed the manuscript, approved the final manuscript as submitted.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Patient consent Obtained.

Provenance and peer review Not commissioned; externally peer reviewed.

data sharing statement No additional data available.

Open access This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.

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