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Ambulatory Care
Diabetes and Cardiovascular Disease Interventions by
Community Pharmacists: A Systematic Review
Charity D Evans, Erin Watson, Dean T Eurich, Jeff G Tay I or, Erin M Yakiwchuk, Yvonne M Shevchuk,
Alfred Remillard, and David Blackburn
Community pharmacists have been involved in activities related to the
prevention and management of cardiovascular disease (CVD) and diabetes for many years, with research dating back to the late 1970s. Over the past decade, the number of community pharmacy practice publications has increased substantially. This increase is likely driven by several factors: recommendations that pharmacists should play a more active role in disease management,l-6 a push from within the profession to broaden the role of community pharmacists beyond the traditional dispensing and distribution functions,7 and an increasing need to generate objective evidence supporting these expanded roles.
There have been numerous studies reporting clinically significant benefits of community pharmacist interventions in diabetes and CVD. Some would argue, however, that major advancements in realworld practice have not followed suit.8 It has been suggested that this may be due to a lack of knowledge synthesis (eg, systematic reviews) or ineffective dissemination of the results.8 It is also possible that the published pharmacy research used as evidence for practice change has lacked the quality and/or generalizability necessary to successfully guide and support this change.
Although previous reviews have looked at community pharmacist inter-
Author information provided at end of text.
theannals.com
OBJECTIVE: To systematically review and assess the quality of stqdiesevaluating community pharmacist interventions for preventing or managing diabetes or cardiovascular disease (CVD) and/or thei r major risk factors.
DATA SOURCES: A comprehen.sive literature search was pertormed using MEDLlNE (1950~February 2011), EM8ASE o 980-February 2011), International Pharmaceutical Abstracts (1 970-February 2011), Cumulative .Index to Nursing and Allied Health Literature (1982-June 2007), and Cochrane Central Register of Controlled Trials (1898-February 2011). Search terms included: community pharmacy(ies), community pharmacist(s), cardiovascular, diabetes, and intervention. The grey literature was searched using the ProQuest Dissertations and Theses, Theses Canada, and OAlster databases.
STUDY SELECTION AND DATA EXTRACTION: Articles published in English or French With all study designs were considered for the review. Studies were included if they contained interventions designed to reduce the incidence, risk, or mortality of CVD or diabetes; affect clinical indicators of CVD or diabetes mellitus (including hypertension, dyslipidemia, or hemoglobin Ale); ancj/Qrimprove adherence to treatment strategies. Only studies involving interventions carried out primarily by pharmacists in community pharmacy settings were included. Study quality was assessed using a checklist validated for both randomized and nonrandomized studies.
DATA SYNTHESIS: A total 014142 studieswere initially identified, with. 40 meeting our inclusion criteria. Eleven studies were randomized controlled trials, 4 were cluster randomized trials, and 2 studies had randomized before-after designs. The remaining studies were controlled before~after (n ;;:: 2), cohort (n:::; 4), and uncontrolled beforecafter (n::: 17) designs, Interventions focused on diabetes (n.= 12), hypertension (n = 9), medication adherence (n = 9), lipids (n = 5), evidencebased.medication initiation or optimization (n:::; 3), risk factor prediction scor\ls(n:::; 1), and bocJy mass index (n ::: 1). All studies contained interventions focused at the patient level and the majority of studies (34/40) involved interventions directed at both the physician and patient No specific intervention emerged as superior, and stucJy quality was generally poor, making it difficult to determine the true effect of the interventions.
CONCLUSIONS: Poor study quality, time-intensive interventions, and unproven clinical significance warrant the need for further high-quality studies of community pharmacist interventions for preventing or managing diabetes or CVD and/or their major risk factors.
KEY WORDS: cardiovascular disease, community pharmacy. diabetes, intervention.
Ann Pharrnacother 2011 ;45:615-28.
Published Online, 10 May 2011, theanna/s.com, DOI10.1345/aph.1P615
The Annals of Pharmacotherapy " 2011 May, Volume 45 " 615
CD Evans et al.
ventions involving CVD or diabetes, they had a limited search strategy.5,9.U were focused on a single risk factor,5,9,U,12 were not specific to community pharmacists (eg, hospital or clinic-based),5,lo,H,13 or are now outdated.14 Thus, the purpose of this study was to systematically review the literature to summarize the breadth of community pharmacist interventions that have been developed to prevent or manage diabetes or CVD and/or their major risk factors, and to evaluate the quality of these studies.
Methods
SEARCH STRATEGY
A comprehensive literature search was performed by a librarian (EW) using MEDLINE (l950-February 2011), EMBASE (l980-February 2011), International Pharmaceutical Abstracts (l970-February 2011), and Cochrane Central Register of Controlled Trials (1898-February 2011). Search terms included community pharmacy(ies), community pharmacist(s), cardiovascular, diabetes, and intervention. A comprehensive list of search terms is available from the authors. Searches were initially carried out in June 2007 and then re-run to find additional, new articles in December 2007 and February 2011. In addition, the Cumulative Index to Nursing and Allied Health Literature was initially searched (1982-June 2007): however, partway through the project, the database provider changed, limiting search access and therefore it was not included after June 2007. The grey literature was searched using the ProQuest Dissertations and Theses, Theses Canada, and OAlster databases. Systematic review articles and bibliographies from original studies were hand searched for potentially relevant studies; experts and/or authors were not contacted. No publication date limits were used in the searches.
INCLUSION AND EXCLUSION CRITERIA
To maximize the inventory of pharmacy practice interventions that have been evaluated over the years, all studies published in English or French were considered for the review without regard for the study design. However, only full-text articles were included. Interventions must have been intended to reduce the incidence. risk, or mortality of CVD or diabetes; affect clinical indicators of CVD or diabetes mellitus (including hypertension, dyslipidemia, body weight, or hemoglobin Ale); and/or improve adherence to cardiovascular or diabetes therapies. Only studies involving interventions carried out by pharmacists in community pharmacy settings were included. Interventions that focused solely on patient screening and those that did not report measured outcomes were excluded.
REVIEW METHODS
All duplicate records were removed electronically (RefWorks software, ProQuest LLC, Ann Arbor, MI) and remaining identified abstracts were screened by the reviewers (CDE, DB, EW, DL) to assess their eligibility. Full copies of the potentially eligible studies were obtained and each study was reviewed independently by 2 of 4 possible reviewers (CDE, DB, EW, DL) to determine whether they should be included. Studies were evenly distributed among the 4 reviewers. Discrepancies were resolved by 1 of the reviewers who was not involved in the original review. Data were initially extracted by 2 of 4 possible reviewers (CDE, DB, EW, DL), and included author. year of publication, study design, patient population, sample size, study outcomes, intervention(s), length of intervention(s), and results. Results specific to the primary outcome and conclusions made by the authors were further extracted by CDE. If a primary outcome was not specified, the first outcome reported in the results section was used unless another outcome was specified in a power calculation.
Methodologic quality of the selected studies was assessed independently by 2 authors (CDE, EMY) using a validated quality checklist for both randomized and nonrandomized studies. is Only studies with a control group were scored, as uncontrolled studies are already known to be of low quality.16 The maximum score on the checklist is 32; studies with a score less than 18 were considered to be oflow qualityP Any scoring discrepancies were resolved by a third author (DB). Given the disparity of the studies, a meta-analysis was not performed.
Results
Our search initially resulted in 4142 citations; 40 studies met the inclusion criteria (Figure 1). Interobserver agreement had a K value of 0.8753 for study inclusion among reviewers, indicating excellent agreement. Eleven studies were randomized controlled trials (RCTs) and 4 were cluster randomized (randomized by community pharmacy or district rather than individual subjects). Two studies18,19 that were labeled by the authors as an RCT have been categorized as a randomized before-after design, given the fact that no between-group comparisons were made. In each of the 4 cluster randomized studies identified, the authors inappropriately failed to account for the clustering effect in the analyses,z°,2i The remaining studies were cohort (n = 4), controlled before-after (n = 2). and uncontrolled before-after(n= 17).
Studies were published between 1978 and 2010, with the majority published after 1999 (Table 1). Based on the primary endpoint, interventions focused on diabetes (n = 12),22.34 hypertension (n = 9),19,35.42 medication adherence (n = 9),43.51 and lipids (n = 5).18,52,53.57.59 The remaining stud-
616 " The Annals of Phannacotherapy " 2011 May, Volume 45 theannals.com
ies focused on evidence-based medication initiation or optimization (n = 3),54-56 risk factor prediction scores (n = 1),60 and body mass index (n = 1).61 Study lengths were variable and ranged from 2 to 57 months.
INTERVENTIONS
Based on the descriptions provided by the authors, interventions were classified as either patient-directed (pharmacist activities directed primarily toward patients) and/or physician-directed (pharmacist activities directed primarily toward physicians) (Table 2). All studies contained interventions involving patients, and the majority of studies (34/40) involved interventions directed at both the physician and patient. Overall, we found few differences between the types of interventions tested in the last decade compared to those in the 1970s50 and 1980s49 (Figure 2).
Patient-directed interventions were most commonly in the form of regular follow-up (38/40 [95.0%]) or education (38/40 [95.0%]), with only a small number (4/40 [10.0%]) using reminders (eg, to refill prescriptions). Education was provided by the pharmacist either verbally or through written materials and typically included information relating to the patient's disease state and medications (eg, mechanism
Potentially relevant publications identified from databases (n=4142)
Abstract screened (n=3444)
~
Potentially eligible studies (n = 186)
~
Eligible studies for inclusion (n = 40)
Figure 1. Diagram of literature search.
Dmbetes and Cardiovascular Disease Interventions by Community Pharmacists
of action, adverse effects). Appropriate lifestyle management (diet, exercise, and smoking cessation) was frequently discussed, as was the importance of medication adherence. Follow-ups were conducted in person, by telephone, or mail, and generally occurred at predetermined intervals ranging from 2 weeks24 to 3 months.22,23,31,44,57 However,
some interventions allowed for individualized impromptu follow-ups based on the need perceived by either the patient or pharmacist.27,54 Patient reminders included methods to remind patients to take or refill their medications, or "compliance packaging" of medications.48
The identification of drug-related problems and subsequent therapeutic recommendations was a key component of many physician-directed interventions (26/34 [76.5% D. Recommendations to physicians included therapy initiation, dosage adjustments, and the ordering of laboratory tests. Several interventions (15/40 [37.5%]) included notifying physicians of their patients' involvement in, or progress with, the study through various means (eg fax, telephone). Finally, 9 of 40 (22.5%) interventions required the pharmacist to refer patients to their physicians for appropriate follow-up.
Interventions were typically time intensive, often requiring patient interviews, follow-up, and extensive collabora-
Duplicate records removed (n = 698)
Excluded because not a cardiovascular or diabetes intervention, or did not involve community pharmacists (n = 3258)
[xci uded because: Not community pharmacy-specific (n = 23) Not cardiovascular- or diabetes-specific (n = 13) No clinical outcomes reported (n = SO) Primary focus on screening (n = 14) Interdiscipl inary (n = 8) Language other than English or French (n = 6) Abstract only available (n = 8) Review/Editorial/Letter (n = 20) Duplicate reporting or subgroup analysis (n = 4)
theannals.com The Annals of Pharmacotherapy " 2011 May, Volume 45 " 617
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13
).
Inte
rve
nti
on
: a
sp
irin
93
.5%
; lip
id 5
8.2
%;
BP
48
.5%
; H
igh
(1
8)
sm
okin
g 9
4.2
%;
alc
oh
ol
95
.5%
; p
hysic
al
acti
vit
y
ap
pro
pri
ate
se
co
nd
ary
p
reve
nti
on
m
an
ag
em
en
t fo
rCH
D
(mu
ltip
le
facto
rs)
73
.2%
; d
iet4
4.1
%;
BM
I36
.5%
C
om
pa
rato
r: a
spir
in 9
3.3
%;
lipid
54
.7%
; B
P 4
6.8
%;
sm
okin
g 9
2.5
%;
alc
oh
ol
93
.1 %
; p
hysic
al
acti
vit
y
72
.9%
; d
iet
41
.5%
; B
MI3
3.7
%
(all
p va
lue
s
>0
.15
)
A 1
C =
he
mo
glo
bin
A1c
; AN
CO
VA
= a
na
lysis
of
co
va
ria
nce
; B
MI
= b
od
y m
ass i
nd
ex;
BP
= b
loo
d p
ressu
re;
CA
D =
co
ron
ary
art
ery
dis
ea
se
; C
HD
= c
oro
na
ry h
ea
rt d
ise
ase
; C
RT
= c
luste
r ra
nd
om
ize
d t
ria
l; C
V =
ca
rdio
va
scu
lar;
LD
L-C
= lo
w-d
en
sit
y lip
op
rote
in c
ho
leste
rol;
ME
MS
= m
ed
ica
tio
n e
ve
nt
mo
nit
ori
ng
syste
m;
MP
R =
me
dic
ati
on
po
sse
ssio
n r
ati
o;
N/A
= n
ot
ap
plic
ab
le;
NS
= n
ot
sig
nif
ica
nt;
RC
T =
ra
nd
om
ize
d
co
ntr
olle
d t
ria
l; S
BG
M =
se
lf b
loo
d g
luco
se
mo
nit
ori
ng
; T
C =
to
tal
ch
ole
ste
rol.
al
f n
o p
rim
ary
ou
tco
me
sp
eci
fie
d,
we
use
d t
he
fir
st o
utc
om
e r
ep
ort
ed
in
th
e R
esu
lts s
ect
ion
, o
r o
utc
om
e u
se
d in
po
we
r ca
lcu
lati
on
(if
pe
rfo
rme
d).
b
lnte
rve
nti
on
ca
teg
ori
es:
MD
-DR
P =
id
en
tifi
ca
tio
n a
nd
re
po
rtin
g o
f d
rug
-re
late
d p
rob
lem
s a
nd
su
bse
qu
en
t re
co
mm
en
da
tio
ns m
ad
e t
o p
ati
en
t's p
hysic
ian
; M~-NOT =
n
oti
fica
tio
n t
o t
he
ph
ysic
ian
ab
ou
t p
ati
en
t's
pa
rtic
ipa
tio
n o
r p
rog
ress i
n t
he
stu
dy;
MD
-RE
F =
p
ati
en
ts w
ere
re
ferr
ed
to
th
eir
ph
ysic
ian
by t
he
ph
arm
acis
t; P
T-E
O =
p
ati
en
t-d
ire
cte
d e
du
ca
tio
n;
PT
-FU
= r
eg
ula
r p
ati
en
t fo
llo
w-u
p;
PT
-RE
= m
ed
ica
tio
n r
e
min
de
rs o
r co
mp
lia
nce
pa
cka
gin
g.
cB
ase
d o
n r
ep
ort
ed
re
sult
s a
nd
sta
tist
ics.
In
so
me
ca
se
s,
sta
tist
ica
l sig
nif
ica
nce
no
t re
po
rte
d .
dO
ut
of
32
po
ssib
le p
oin
ts;
ba
se
d o
n D
ow
ns a
nd
Bla
ck c
he
cklist15
(h
igh
::>
18/3
2 [5
6%
]; l
ow
<1
8/3
2).
11
(co
nti
nu
ed
on
pa
ge
62
0)
o 15' ~ ,.. '" ~ ~ ~ I§ £ If r it ~ ~. 1:] ~
~ ~ ~ [
0'1
Ta
ble
1.
Ch
ara
cte
rist
ics
of
Incl
ud
ed
Stu
die
s (C
on
tinu
ed
) g
~
t'I:l
.. S
tud
y
Stu
dy
Inte
rve
nti
on
P
rim
ary
In
terv
en
tio
n C
ate
go
ryb
(S
am
ple
Siz
e)
Qu
ality
ill i:l
Re
fere
nce
D
esig
n
Po
pu
lati
on
L
en
gth
O
utc
om
e"
Inte
rve
nti
on
C
om
pa
rato
r R
esu
ltsC
S
co
re
~
~
;:,
'" T
suyu
ki
RC
T
Hig
h r
isk
for
16
we
eks
Co
mp
osi
te:
PT
-ED
; P
T-F
U;
MD
-DR
P;
MD
-NO
T
PT
-ED
; P
T-F
U
Inte
rve
nti
on
: 5
7%
(1
96
/34
4)
Hig
h (
25
) ,....
. ~
;::s
(20
02
)56
C
V e
ve
nts
p
hys
icia
n
(n =
34
4)
(n =
33
1)
Co
mp
ara
tor:
31
% (
10
21
33
1)
;::s
ord
ers
fa
stin
g
OR
3.0
; 9
5%
C1
2.2
to
4.1
(p
< 0
.00
1)
:;:,
t:;""'
lipid
pa
ne
l,
<Q,
init
iate
s n
ew
~
cho
lest
ero
l-:;:
, lo
we
rin
g d
rug
, ~
or
incre
ase
s
:;:,
do
se
of
curr
en
t 8 ~
cho
lest
ero
l dru
g
~ N
ola
(2
00
0)6
0
Co
ntr
olle
d
Kn
ow
n C
AD
6
mo
nth
s
Ch
an
ge
in
ris
k P
T-E
O;
PT
-FU
; M
O-O
RP
(n
= 2
5)
Usu
al ca
re
Inte
rve
nti
on
: -0
.6 (
17
.0 -
-7 1
6.4
) L
ow
(1
3)
~
be
fore
-aft
er
or
lipid
le
ve
ls
facto
r p
red
icti
on
(n
= 2
6)
Co
mp
ara
tor:
+0
.6 (
16
.5 -
-7 1
7.1
) re
qu
irin
g
sco
res fr
om
(p
= N
S)
.. tr
ea
tme
nt
ba
se
line
N
Eu
sse
n
RC
T
Ne
w u
se
rs o
f 1
2 m
on
ths
Dis
con
tin
ua
tio
n
PT
-ED
; P
T-F
U (
n =
51
3)
Usu
al ca
re
Inte
rve
nti
on
: 2
3%
H
igh
(2
5)
a (2
010)
51
sta
tin
s ra
tes
1 ye
ar
(n =
50
3)
Co
mp
ara
tor:
26
%
'- '-H
R 0
.84
(9
5%
Cl
0.6
5 t
o 1
.10
)
~ N
iete
rt
RC
T
Pts
. a
t le
ast
7 7
mo
nth
s
Tim
e t
o r
efi
ll P
ho
ne
gro
up
: P
T-F
U;
PT
-RE
U
su
al ca
re
Ph
on
e g
rou
p:
me
dia
n 1
08
da
ys
Hig
h (
20
) ~
(20
09
)43
d
ays o
ve
rdu
e
(da
ys)
(n =
10
18
) (n
=1
01
4)
Fa
x g
rou
p:
11
6 m
ed
ian
da
ys
&
for
dia
be
tes,
F
ax g
rou
p: M~-NOT (
pt.
la
te f
or
Co
mp
ara
tor:
me
dia
n 1
06
da
ys
§ h
yp
ert
en
sio
n,
refi
lls)
(n =
10
16
) P
ho
ne
vs c
om
pa
rato
r:
HR
0.9
3 (
97
.5%
Cl
0.8
2 t
o
'" lip
id,
1.0
6)
;:;; d
ep
ressio
n,
Fa
x v
s c
om
pa
rato
r: H
R 0
.87
(9
8.3
% C
l 0
.76
to
o
r p
sych
osis
1
.00
) m
ed
ica
tio
n
Ph
on
e v
s f
ax:
HR
0.9
3 (
95
% C
l 0
.83
to
1.0
5)
Vri
jen
s (2
00
8)4
4
CR
T
Pts
. ta
kin
g
12
mo
nth
s
Pro
po
rtio
n o
f P
T-E
D;
PT
-FU
; P
T-R
E (
n =
19
4)
Usu
al ca
re (
n =
19
8)
Inte
rve
nti
on
: 9
5.8
9%
H
igh
(1
8)
ato
rva
sta
tin
d
ays th
at
the
C
om
pa
rato
r: 8
9.3
7%
fo
r a
t le
ast
pill
bo
ttle
(p
< 0
.00
1)
3 m
on
ths
(ME
MS
) w
as
op
en
ed
Bo
uvy(2
00
3)4
6
RC
T
He
art
fa
ilure
, 6
mo
nth
s
Me
dic
ati
on
P
T-E
O;
PT
-FU
; M~-NOT (
n =
74
) U
su
al c
are
(n
= 7
8)
Inte
rve
nti
on
: 1
40
17
65
6 d
ays
Lo
w (
15
) p
ts.
takin
g a
n
on
ad
he
ren
ce
C
om
pa
rato
r: 3
37
/61
96
da
ys
loo
p d
iure
tic
(da
ys w
ith
ou
t R
R 0
.32
(9
5%
Cl 0
.19
to
0.5
5)
me
dic
ati
on
as
ide
nti
fie
d b
y
ME
MS
)
Ska
er
(19
93
)48
R
CT
T
yp
e 2
3
60
da
ys
Ad
he
ren
ce
P
T-R
E;
ma
il re
min
de
r (n
= 7
9)
Usu
al ca
re (
n =
78
) M
ail
0.7
3;
co
mp
lian
ce
pa
cka
gin
g 0
.71
; m
ail
+
Lo
w (
12
) d
iab
ete
s,
(M P
R)
Co
mp
lia
nce
pa
cka
gin
g (
n =
53
) co
mp
lia
nce
0.8
7;
co
mp
ara
tor
0.5
8 (
p ~ 0
.05
fo
r n
ew
ly
Re
min
de
r +
pa
cka
gin
g (
n =
48
) a
ll g
rou
ps v
s c
om
pa
rato
r g
rou
p)
dia
gn
ose
d;
pts
.
;;t.
rece
ivin
g
'" a
firs
t §
pre
scri
pti
on
;::s
:;:
, fo
r g
lyb
uri
de
t:;"
"' 5
mg
bid
8 ~
~ '" ~ 1:
;- ~ ~ '" ~ ~ 1:
;-
~ ~ ~ 1t ~ ~ .. N 2 "- s:: ~ & [ t; .. ~ -
Ascio
ne
(1
98
5)4
9
McK
en
ne
y
(19
78
)50
RC
T
Co
ho
rt
Ta
kin
g a
t le
ast
1 C
V
dru
g
Hyp
ert
en
sio
n
Stu
die
s w
ith
ou
t a
co
ntr
ol
gro
up
Tu
rna
cila
r (2
00
9)3
4
Fe
ra (
20
08
)23
Ga
rre
tt (
20
05
j27
Cra
no
r (2
003)
30
(Ash
evill
e
Pro
Ject
)
Cra
no
r (2
00
3)2
9
Na
u (
2002
)31
Be
rrin
ge
r (1
99
9)3
2
Fin
ch
am
(1
99
8)3
3
Un
co
ntr
olle
d
Typ
e 2
b
efo
re-a
fte
r d
iab
ete
s
Un
co
ntr
olle
d
Dia
be
tes
be
fore
-aft
er
Un
co
ntr
olle
d
Dia
be
tes
be
fore
-aft
er
Un
co
ntr
olle
d
Dia
be
tes
be
fore
-aft
er
Un
co
ntr
olle
d
Typ
e 2
b
efo
re-a
fte
r d
iab
ete
s
Un
co
ntr
olle
d
Dia
be
tes
be
fore
-aft
er
Un
co
ntr
olle
d
Dia
be
tes
be
fore
-aft
er
4 m
on
ths
4 m
on
ths
Pro
po
rtio
n o
f p
ts.
refi
llin
g
pre
scri
pti
on
s
late
Pro
po
rtio
n o
f a
dh
ere
nt
pts
. (r
ece
ivin
g ±
15
%
of
pre
scri
be
d
do
se
)
3 m
on
ths
Ch
an
ge
in
me
an
fa
sti
ng
blo
od
g
luco
se
Min
imu
m 3
C
ha
ng
e i
n m
ea
n
mo
nth
s
A1
C (
%)
fro
m
ba
se
lin
e
Min
imu
m 3
m
on
ths
7-9
mo
nth
s
Up
to
5
ye
ars
9 m
on
ths
(me
dia
n)
12
mo
nth
s
Ch
an
ge
in
me
an
A
1C
("I
o)f
rom
b
ase
lin
e
Ch
an
ge
fro
m
ba
se
lin
e i
n
pro
po
rtio
n o
f p
ati
en
ts w
ith
A
1C
<:7
.0%
Ch
an
ge
fro
m
ba
se
lin
e i
n
me
an
A1
C (
%)
Ch
an
ge
fro
m
ba
se
lin
e in
p
rop
ort
ion
of
pis
. w
ith
at
lea
st o
nce
-da
ily
SB
GM
PT
-ED
; P
T-F
U;
PT
-RE
(n
=
52
)
PT
-ED
; P
T-F
U;
MD
-D
RP
; M
D-N
OT
(n
= 7
0)
PT
-ED
; P
TcF
U;
MO
-OR
P (
n =
43
)
PT
-ED
; P
T-F
U; M~-NOT (
n =
91
4)
PT
-ED
; P
T-F
U;
MO
-OR
P; M~-NOT;
MO
-RE
F (
n =
25
6)
PT
-ED
; P
T-F
U;
MD
-RE
F (
n =
85
)
Usu
al ca
re (
n =
5
0)
Usu
al c
are
(n =
6
6)
N/A
N/A
N/A
N/A
PT
-ED
; P
T-F
U;
MD
-DR
P;
MD
-NO
T
N/A
(n
= 4
7)
PT
-ED
: P
T-F
U:
MO
-OR
P (
n =
82
) N
/A
2 m
on
ths
Pro
po
rtio
n o
f p
ts.
PT
-ED
(n
= 5
1)
ha
vin
g a
fo
ot
N/A
exa
min
ati
on
p
erf
orm
ed
vs
ba
se
lin
e
Inte
rve
nti
on
: 4
1%
fill
ed
pre
scri
pti
on
s l
ate
C
om
pa
rato
r: 5
3%
fill
ed
pre
scri
pti
on
s l
ate
(p
= N
S)
Inte
rve
nti
on
: 6
2.9
% (
44
/70
) C
om
pa
rato
r: 3
4.8
% (
23
/66
) (p
< 0
.00
5)
At
stu
dy e
nd
: -3
8.5
mg
/dL
(1
67
.2 m
g/d
L -
-+ 1
28
,7
mg
/dL
) (p
< 0
.00
1)
Aft
er
me
an
10
.2 m
on
ths:
-0.4
(7
.6 -
-+ 7
.4)
(p <
0.0
01
)
Aft
er
me
an
10
:9 m
on
ths:
-0.8
(7
.9 -
-+ 7
.1)
(p <
0.0
01
)
At
stu
dy e
nd
: +
15
% (
42
% -
-+ 5
7%
) (p
= 0
.04
)
Aft
er
last f
ollo
w-u
p:
+1
8.1
% (
45
.5%
--+
63
.6%
) (p
= 0.
32
)
Lo
w (
14
)
Lo
w (
14
)
N/A
N/A
N/A
N/A
At
stu
dy e
nd
: -0
.4 (
7.8
--+
7.4
) (p
=
NS
) N
/A
At
stu
dy e
nd
: N
/A
Insu
lin u
se
rs: -1
2%
(1
8/2
4 -
-+ 1
51
24
) (p
> 0
.05
) O
ral a
ge
nt u
se
rs:
+2
1 %
(8
/28
--+
15
/28
) (p
> 0
.05
)
At
stu
dy e
nd
: +
35
.2%
(1
8/5
1 -
-+ 3
6/5
1)
(p v
alu
e n
ot
rep
ort
ed
) N
/A
A 1
C =
he
mo
glo
bin
A1c
; AN
CO
VA
= a
na
lysis
of
co
va
ria
nce
; B
MI
= b
od
y m
ass i
nd
ex;
BP
= b
loo
d p
ress
ure
; C
AD
= c
oro
na
ry a
rte
ry d
ise
ase
; C
HD
= c
oro
na
ry h
ea
rt d
ise
ase
; C
RT
= c
luste
r ra
nd
om
ize
d t
ria
l; C
V =
ca
rdio
va
scu
lar;
LD
L-C
= l
ow
-de
nsit
y l
ipo
pro
tein
ch
ole
ste
rol;
ME
MS
= m
ed
ica
tio
n e
ve
nt
mo
nit
ori
ng
syste
m;
MP
R =
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theannals.com
Dmbetes and Cardiovascular Disease Interventions by Community Pharmacists
tion with physicians. Of 16 studies with available data, the median time per patient activity (typically patient interviews or consultations) was 27 minutes, with some lasting up to 65 minutes.50,61 However, only 3 studies commented on the complexity of their interventions; 1 reported the adjustments that had to be made to "accommodate the increased time commitment needed for the project"57; I used pharmacists who were not involved in dispensing activities32; and 1 considered the feasibility and practical implications of implementing the intervention into community pharmacy practice.41
Overall, favorable results were reported or concluded by the authors in 31 of 40 (77.5%) studies, with more favorable results reported in studies without a control group (85.7% [18/21] vs 68.4% [13/19] in those with a control group) (Table 1). Accurately evaluating the impact of the specific interventions was difficult, as many authors did not specify a primary endpoint or incompletely reported the results. 19,29,32-34,36,47 Regardless, the 3 most commonly tested interventions (patient education, patient follow-up, and the identification of drug-related problems and subsequent physician recommendations) were deemed effective in producing a "significant" difference in their primary outcome in the majority of the studies; however, it was impossible to determine whether any intervention type was superior. \Vbile these results are promising, the authors' favorable conclusions were not supported by any reported data in at least 2 of the reviewed studies.26,49
None of the studies demonstrated any benefits to major health outcomes and were mainly restricted to relatively small differences in drug utilization, laboratory outcomes, or medication adherence. In addition to a lack of information about health outcomes, improvements in surrogate markers were either of small magnitude or of limited clinical significance. In fact, the results of 7 studies considered to be of highest quality were of questionable importance. For example, in the MEDMAN study,S4 a pharmacist intervention lasting I year resulted in nonsignificant increases in utilization of coronary heart disease medications for secondary prevention; the greatest increase was seen with lipid-lowering therapy in 58% of the treatment group versus 55% of controls. Similarly, the studies by Nietert et al.43
and Eussen et al.51 showed small, nonsignificant changes in the timing of medication refills or discontinuation rates, respectively. Lipid-lowering success was the focus of a study by Tsuyuki et al.56 in which the absolute improvement in the primary endpoint was strikingly high (57% vs 31 %; p < 0.001); however, the primary (composite) endpoint included a requisition for a fasting lipid profile. Although the improvement in this endpoint demonstrated that the pharmacist intervention influenced some change, the clinical importance of ordering a lipid panel is likely small. Vrijens et al.44 showed that a pharmacist intervention increased the proportion of days a pill bottle was opened from 89% to
The Annals of Pharmacotherapy " 2011 May, Volume 45 " 623
CD Evans et al.
96%. In this case, the improvement was statistically significant, but the patient population appeared to be adherent regardless of the intervention.
STUDY QUALITY
Quality scores for the studies evaluated (only those with a control group) were poor, as only 8 of 23 (34.8%) studies received a score of 18 out of 32 (56%) or greater. IS All 8 studies were published in the last decade. Sample sizes ranged from 8 to 1493. Only 14 of 40 (35.0%) studies described an a priori power calculation, and only 6 of these achieved adequate power for analysis of the primary endpoint.
Studies published from 2004 to 2009 scored relatively higher on items assessing reporting quality than did studies
published before 2004. In most cases, poorly reported studies lacked an adequate description and/or comparison of subjects at baseline, and did not report p values (or confidence intervals) for the study results. Identification of predetermined outcomes was poor, particularly in the uncontrolled before-after studies, where only 9 of 17 (52.9%) of these studies clearly specified a primary endpoint.
Randomized studies scored relatively better than the nonrandomized designs, as expected, but only 7 of 17 achieved a score of 18 out of 32 or higher. Of the randomized design studies, only 1 reported blinding of the personnel involved in data collection and analysis, and only 3 reported blinding of the intervention allocation. Intention-to-treat analysis was mentioned in 9 of 17 (52.9%) randomized studiesI9,3S,38,43,44,48,SI,S4,s6; however, only 5 of these studies
performed an appropriate intention-to-treat analysis.
Table 2. Categorization of Interventions
Category
Patient-directed
education
follow-up
reminders
Physician-directed
drug-related problems-recommendations
notification
referral
100
90 If) 80 c 0 70 +d c 60 (I) :>
50 10-(I) ....
40 c ....
30 0 ~ Cl 20
10
0
<1990 (n = 2)
Description
Initial education andlor counseling session provided directly to pts.
Regular contact with pts. (in-person, phone, mail)
Medication reminders and/or compliance packaging (no pt. education)
Identification of actual or potential drug-related problems andlor therapeutic recommendations made to physician by the pharmacist in response to identified drug-related problems
Physician notified about pt.'s study involvement and/or progress (no specific recommendations made)
Pt. referred to physician by pharmacist
1990-1999 (n = 6)
Year
2000-2009 (n = 32)
III Patient Education
D Patient Follow -up
~ Patient Reminders
III Drug-Related
Problems/Recommendations
"' Alysician Notification
[l Alysician Referral
Figure 2. Proportion of interventions published by decade. Patient Education: initial education and/or counseling session provided directly to patient; Patient Follow-up: regular contact with patients (in-person, phone, mail); Patient Reminders: medication reminders and/or compliance packaging (no patient education provided); Drug-Related Problems/Recommendations: I dentification of actual or potential drug-related problems andlor therapeutic recommendations made to physician by the pharmacist in response to identified drug-related problems; Physician Notification: physician notified about patient's study involvement and/or progress (no specific recommendations made); Physician Referral: patient referred to physician by pharmacist.
624 " The Annals of Phannacotherapy " 2011 May, Volume 45 theannals.com
Discussion
To the best of our knowledge, this is the first systematic review that has summarized interventions specific to community pharmacists that focus on both diabetes and CVD and all their major risk factors. All identified studies involved patient-directed interventions such as education and follow-up. Most studies also involved physician-directed interventions, the most common of which was the identification of drug-related problems and provision of therapeutic recommendations. The majority of studies were published in the last 10 years, although the interventions have remained similar over the past 30 years. Studies were generally of poor quality and evaluated interventions that typically appeared to be time intensive.
Poor study quality has plagued pharmacy practice research studies for years,6Z-64 and problems range from poor design to poor reporting. Although RCTs are considered the gold standard for the evaluation of treatment efficacy and effectiveness, the majority of studies in this review used a nonrandomized design. In fact, 17 of the studies did not use a control group, and 2 studies with a control group made no between-group comparisons. Although it may be challenging to find adequate controls for studies conducted in small community pharmacy settings, the lack of a control group makes it difficult to conclude a causal relationship between the intervention being evaluated and the subsequent outcome( s). 65
Based on the studies examined in this review, reporting of results seems to have improved over time, and is likely due to the development of guidelines for the reporting of both randomized and observational studies.66,67 However, poor reporting was still an issue even in more recent publications, especially in the nonrandomized studies. The lack of a clearly identified primary outcome and appropriate statistical comparisons (ie, p values and confidence intervals) was common and made it difficult to evaluate and interpret the results. In some cases the authors suggested favorable outcomes that were either inconsistent with the results reported,26~9 or not supported by statistical evidence.33,3~7
A major challenge when designing pharmacy research is the matter of blinding. In most cases, it is difficult for either the subjects or researchers to be blinded, especially if the intervention involves direct patient care. However, because blinding is a factor in most quality assessment scores, some argue that the quality of pharmacy practice studies will always be underestimated.8 Blinding those responsible for the data collection and analysis, and the concealment of intervention allocation in RCTs, can reduce bias and improve study quality; however, these strategies were rarely undertaken in published studies.
Study quality was likely influenced by several factors. First, contemporary techniques to minimize bias and confounding may have been unknown to many investigators
Dmbetes and Cardiovascular Disease Interventions by Community Pharmacists
who conducted their research before the 1990s. Indeed, we found that studies published since 2000 were generally of higher quality compared to all others. Interestingly, we could not identify major differences in the types of interventions used in lower-quality versus high-quality studies. Similarly, we could not find any notable differences in the types of pharmacist interventions tested throughout the years. For example, in 1978, McKenney et al.so evaluated a pharmacist intervention that was completely comparable to more recent interventions published in the pharmaceutical care era.
The majority of interventions involved in-depth consultations with individual patients (and subsequently physicians or other health-care professionals) for the purpose of identifying and resolving actual and potential drug-related problems.68,69 In general, these strategies appeared to be time-intensive, and their impact on patient outcomes remains unproven. Also, the extent to which these strategies could be integrated into current community pharmacy settings is not clear. Only 3 studies commented on the impact the intervention had on staffing and time of employees. Even highly successful interventions53 will have little benefit if they cannot be implemented in real-world settings.70-73
We believe that more research is needed to evaluate strategies that can be implemented in current community pharmacy practice.
A limitation of our search strategy is that we included only full-text articles published in English or French. Although 6 studies were excluded based on language, it is unlikely that the intervention(s) being evaluated in those studies differed significantly from those in the included studies. Categorization of interventions and quality assessments were based on what was reported in the published studies and we did not contact authors for extra details. As , with any systematic review, there is the potential for publication bias.
The quality checklist used has its own limitations. The lack of reference standard for the total quality score forces reviewers to make a judgment call on what they consider to be an acceptable level of quality.74 We chose a score of 18/32 or higher based on a previously published review,17 although much lower acceptable levels of quality have also been used.74 The checklist also required subjective judgments, which were often made more difficult by the poor reporting of some studies. However, by using 2 independent reviewers and a third to resolve any discrepancies, we can have confidence in our assessments.
Summary
The majority of community pharmacy studies reviewed from the past 30 years appear to show benefit in the reduction or management of diabetes or CVD and their risk factors. However, study quality was generally poor, interven-
theannals.com The Annals of Pharmacotherapy " 2011 May, Volume 45 " 625
CD Evans et al.
tions were time intensive, and none of the stndies demonstrated any benefits to major health outcomes. Therefore, the clinical importance of these interventions remains unclear, and further well-designed, well-conducted studies are needed to guide community pharmacists in this important area of practice.
Charity D Evans PhD, at time of writing, PhD Candidate, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada; now, Postdoctoral Research Fellow, Univensity of British Columbia, Vancouver
Erin Watson MLlS, Health Sciences Librarian, Health Science library, Saskatoon
Dean T Eurich PhD, Assistant Professor, School of Public Health, University of Alberta, Edmonton, Alberta, Canada
Jeff G Taylor PhD, Professor, College of Pharmacy and Nutrition, University of Saskatchewan
Erin M Yakiwchuk, MSc Candidate, College of Pharmacy and Nutrition, University of Saskatchewan
Yvonne M Shevchuk PharmD, Associate Dean (Academic), College of Pharmacy and Nutrition, University of Saskatchewan
Alfred Remillard BSc(Pharm) PharmD BCPP, Associate Dean-Research and Graduate Affairs, College of Pharmacy and Nutrition, University of Saskatchewan
David Blackburn PharmD, Associate Professor; Research Chair in Patient Adherence, College of Pharmacy and Nutrition, University of Saskatchewan
Correspondence: Dr. Blackburn, [email protected]
Reprints/Online Access: www.theannals.com/cgiireprintiaph.1 P615
Conflict of interest: Authors reported none
This study was funded by a research grant from Saskatchewan Health and Merck-Frosst Schering. The funding agencies were not involved in the study design, drafting of the manuscript, or the decision to submit the manuscript. Dr. Evans received funding through a Clinical Research Initiative Fellowship from the Canadian Institute of Health Research. Dr. Eurich receives a salary support award from the Alberta Heritage Foundation for Medical Research (Population Health Investigator).
We thank Darcy Lamb MSc for his help in reviewing abstracts and studies.
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Intervenciones en el Tratamiento de Diabetes y Enfermedad Cardiovascular por Farmaceuticos Comunitarios: Un Repaso
Sistematico
CD Evans, E Watson, DT Eurich, JG Taylor, EM Yakiwchuk, YM Shevchuk, A Remillard, y D Blackburn
Ann Phannacother 2011;45:615-28.
EXTRACTO
OBJETIVO: Repasar sistemiticamente y evaluar la calidad de los estudios que reportaron intervenciones hechas pm farmaceuticos en la prevencion y el manejo de la diabetes y enfermedad cardiovascular y/o sus factores de riesgo mayores.
FUENTESDE INFORMAOON: Se condujo una busqueda comprensiva usando MEDLINE, EMBASE, Abstractos Farmaceuticos Internacionales, Cumulutive Index to Nursing and Allied Health Literature (CINAHL), y el Cochrane Central Register to Controlled Trials. Tambien se realiz6 una blisqueda de la literatura "gris" usando los bancos de datos llamados ProQuest Dissertations and Thesis, Theses Canada, y OAlster.
SELECOON DE ESTUDlOS Y EXTRACCION DE DATOS: Artfculos publicados en idiomas ingles 0 frances fueron considerados para repaso. Se incluyo estudios si estos contenian intervenciones diseiiadas que redujeron la incidencia, el riesgo 0 la mortalidad de las enfermedades cardiovasculares 0
diabetes; indicadores clfnicos que afectaron las enfermedades cardiovasculares 0 diabetes (incluyendo hipertension, dislipidemia 0 Ale): y/o meJoraron las estrategias de adherencia al tratamiento. Se induyo solo aquellos estudios que contuvieron intervenciones que fueron llevadas a cabo principalmente por farmaceuticos en farmacias comunitarias. Se evaluola calidad de estudios utilizando una lista de verificacion para validar los estudios aleatorios y no aleatorios.
SINTESISDEDATOS: Se identificaron inicialmente un total de 4142 estudios y 40 de estos cumplieron con los criterios de inclusion. Once de estos fueron estudios aleatorios controlados, cuatro fueron estudios aleatorios agrupados y dos fueron de diseiio aleatorios de antes-y-despues. Los demas fueron estudios controlados de antes-y-despues (n = 2), cohorte (n = 4) Y no controlados de antes-y-despues (n = 17). Las intervenciones enfocaron en diabetes (n = 12), hipertension (n = 7), adherencia a medica-
mentos (n = 9), lfpidos (n =5), iniciacion u optimizacion de medicamentos basado en evidencia (n = 3), puntuaci6n de predicci6n de factmes de riesgo (n = 1) e indice de masa corporal (n = 1). Todos los estudios contenian intervenciones que enfocaron al nivel del paciente y la mayorla (34/40) fueron dirigidos a los m6dicos y pacientes. No hubo intervenciones especificas que probaron ser superiores y la calidad de los estudios fue generalmente de pobre calidad, haciendo diffcil determinar el efecto verdadero de las intervenciones.
CONCLUSIONES: Estudios de calidad pobre, intervenciones de tiempo intensivos e importancia clfnica no probada justifican la necesidad de realizar mas estudios de alta calidad.
Traducido por Carlos da Camara
Une Revue Systematique des Interventions des Pharmaciens dans la
Prise en Charge du Diabete et des Maladies Cardiovasculaires
CD Evans, E Watson, DT Eurich, JG Taylor, EM Yakiwchuk, YM Shevchuk, A Remillard, et D Blackburn
Ann Phannacother2011;45:615-28.
OBJECfIF: Revoir la litterature et la qualite des etudes evaluant les interventions des pharmaciens pratiquant en milieu communautaire au niveau de la prevention ou du traitement du diabete, des maladies cardiovasculaires ainsi que de leurs facteurs de risque.
SOURCES D'INFORMATION: Une recherche documentaire a ere effectuee dans les banques de donnees MEDLINE, EMBASE, International Pharmaceutical Abstracts, CINAHL et dans le registre central Cochrane pour les essais cliniques. Les banques de donn6es OAIster, Theses Canada et ProQuest (dissertations et theses) ont aussi ete consult6es pour identifier la litterature grise.
SELECTION DE IJINFORMATION: Tous les articles pub lies en anglais ou en fran<;:ais ont ete consideres pour cette revue. Les etudes etaient inc1uses si le devis methodologique comportait une intervention destinee it 1) reduire l'incidence, le risque ou la mortalite reliee au diabete oll aux maladies cardiovasculaires; 2) modifier les indicateurs cliniques du diabete oll des maladies cardiovasculaires (incluant notamment l'hypertension, I'hemoglobine glyquee et la dyslipidemie); et/ou 3) ameliorer I'observance au traitement Seules les etudes dont les interventions etaient principalement effectuees par des pharmaciens exer<;:ant en milieu communautaire ont ete retenues. L'utilisation d'une liste de contrale valid6e a permis d' evaluer la qualite des etudes.
RESUME: Des 4142 etudes initialement identifi6es, seulement 40 ont rencontre les criteres d'inclusion preetablis. De ce nombre, onze etudes etaient des etudes controlees avec repartition aleatoire, les autres ayant des devis methodologiques varies. Les interventions Giblees par ces 40 etudes etaient au niveau du diabete (n = 12), de ['hypertension (n = 7), de l'observance (n = 9), des dyslipidemies (n = 5), de l'initiation ou l' optimisation des medicaments initiaux (n = 3), de !'indice de masse corporelle (n = 1) et des scores de prediction des facteurs de risque (n = 1). Les 40 etudes comportaient des interventions au niveau des patients alors que 34 d'entre elles ciblaient les patients et leurs medecins. Aucune intervention sp6cifique ne s' est demarqu6e puisque les etudes etaient dans I' ensemble de faible qualite et ne pouvaient condure quant it I'impact des interventions sur la sante des patients.
CONCLUSIONS: Le fait que les etudes disponibles soient de faible qualite, que les interventions cibl6es soient des interventions demandant beaucoup de temps, et que le reel impact dinique de ces interventions ait ere peu documente sont tOllS des facteurs justifiant la necessite d' effectuer des etudes additionnelles ayant un meilleur modele experimental.
Traduit par Sylvie Robert
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