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Transcript of Analisis Jurnal Blok Endokirn
7/24/2019 Analisis Jurnal Blok Endokirn
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RINGKASAN KASUS PPK
Seorang wanita umur 67 tahun dengan hipertensi dan obesitas datang ke
dokter puskesmas untuk mengontrol tekanan darahnya karena merasa
nyeri kepala dan pusing. Pasien tidak merasakan gejala klinis DM, hanya
ditemukan poliuri dan lemah di kaki. Karena ada program dokter keluarga,
maka wanita tersebut mengecek gula darah sewaktu dan hasilnya !
mg"d#. Dokter memberikan obat berupa $dalat %ni&edipi, obat
antihipertensi', glibenklamid, met&ormin, dan glukode(.
The Well-Built, Patient-Oriented Clinical Question
Question Co!onent "our QuestionP-Patien or Po!ulation Siapakah yang diteliti)
Pasien nondiabetes dengan umur
*+ tahun, M- atau lebih %
untuk asia', K/D 0+12+ mg"dl dan
231200 mg"dl setelah jam
menerima 7+ g glukosa oral.I-Inter#ention 4bat apa yang diberikan dalam
penelitian)
Met&ormin 5+3 mg ("hariC-Co!arison $pa pembandingnya)
Perbaikan pola gaya hidup
O-Outcoe $pa saja hasil yang diharapkan)Perbaikan gaya hidup dan
met&ormin menurunkan kejadian
diabetes pada orang dengan risiko
tinggiThe $ell-%uilt clinical &uestion '
-erapi mana yang lebih baik antara perubahan gaya hidup dan met&ormin
untuk menurunkan angka kejadian DM type pada orang dengan risiko
tinggi)
T(!e o)
QuestionIdeal T(!e o) Stud(
-herapy -
Pre8ention - * ohort Study * ase ontrol
DiagnosisProspecti8e, blind controlled trial comparison to gold
standard
Prognosis
ohort Study * ase ontrol * ase Series"ase
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eport
9tiology":arm - * ohort Study * ase ontrol
ost analysis economic analysis
Note' *eta-anal(ses and s(steatic re#ie$s, $hen a#aila%le,o)ten !ro#ide the %est ans$ers to clinical &uestions.
Search Strate+( e#elo!ent
Priar( search ter S(non( S(non( .P ;ondiabetic namun resiko
tinggi DM tipe I Met&ormin
C #i&e style inter8ention
O Menurunkan angka kejadian DM
CONSORT C/0CK1IST
Section
and To!ic
Ite
No2
escri!tor Re!ort
ed on
Pa+e
No2
Content
Title and
A%stract
2 :ow participants
were allocated to
inter8entions %e.g.,
<random allocation<,
<randomi=ed<, or
<randomly
assigned<'.
!0! Dalam jurnal disebutkan
bahwa metode yang
digunakan adalah
dengan mengambil
pasien nondiabetik
secara acak.
>Methods ?e randol(
assi+ned !!
nondiabetic persons with
ele8ated &asting and
post1load plasma
glucose concentrations
to placebo, met&ormin
%5+3'@
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INTROU
CTION
Aackgroun
d
ScientiBc
background and
e(planation o&
rationale.
!0! Dalam jurnal djelaskan
bahwa diabetes tipe
adalah penyakit yang
mahal dan serius yangmenyerang kira1kira 5C
dari orang tua di
$merika.
>Diabetes mellitus,
&ormerly called non1
insulin1dependent
diabetes mellitus, is a
serious, costly disease
aecting appro(imately
5 percent o& adults in the
United States2@*0T/OS
Participant
s
! 9ligibility criteria &or
participants and the
settings and
locations where the
data were collected.
!0 Diambil dari 7 pusat
klinik. Kriteria yang
dimasukkan dalam
penelitian adalah orang
yang berusia lebih dari
+ tahun dengan M- atau lebih % atau lebih
untuk orang $sia' dan
konsentrasi glukosa
plasma puasa 0+12+
mg"d# % E 2+ mg"d#
pada orang $merika
ndian' dan 231200
mg"d# jam setelah
diberikan 7+ g glukosaoral.
>?e conducted a clinical
trial in8ol8ing persons at
.3 centers
who were at high risk &or
diabetes. 9ligibility
criteria included an
a+e o) at least .4
(ears, a %od(ass
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inde5 %the weight in
kilograms di8ided by the
sFuare o& the height in
meters' o& or higher
% or higher in $sians',and a !lasa +lucose
concentration o) 64 to
.4 + !er deciliter
%+.! to 6.0 mmol per
liter' in the &asting state
%G2+ mg per deciliter in
the $merican ndian
clinics' and 23 to 200
mg per deciliter %7.5 to
22.3 mmol per liter' two
hours a&ter a 7+1g oral
glucose load.
nter8entio
ns
Precise details o&
the inter8entions
intended &or each
group and how and
when they were
actuallyadministered.
!0 Di dalam jurnal
dijelaskan bahwa ada !
pelakuanH gaya hidup
standar ditambah
met&ormin %/lucophage'
dengan dosis ( 5+3mg, gaya hidup standar
ditambah plasebo (
sehari, atau program
intensi& modiBkasi gaya
hidup.
>Participants were
randomly assigned to
one o& threeinter8entionsH
standard li)est(le
recoendations
!lus et)orin
%/lucophage' at a dose
o& 5+3 mg twice daily,
standard li)est(le
recoendations
!lus !lace%o twicedaily, or an intensi8e
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!ro+ra o) li)est(le
odi7cation.@
4bjecti8es + SpeciBc objecti8es
and hypotheses.
Di dalam jurnal
dijelaskan bahwamereka menghipotesis
dengan memodiBkasi
gaya hidup atau dengan
pemberian met&ormin
akan mencegah atau
memperlambat
perkembangan diabetes.
>?e h(!othesi8ed that
odi)(in+ these
)actors $ith a
li)est(le-inter#ention
program or the
administration o&
met&ormin would
pre8ent or delay the
de8elopment o&
diabetes.@
4utcomes 6 learly deBnedprimary and
secondary outcome
measures and,
when applicable,
any methods used
to enhance the
Fuality o&
measurements
%e.g., multipleobser8ations,
training o&
assessors'.
!0 Dalam jurnal dijelaskanbahwa primary outcome
untuk diagnosis diabetes
dilakukan --/4 atau yang
secondary nya dengan
gula darah puasa menurut
kriteria $D$ tahun 2007.
>-he !riar( outcoe
was diabetes, diagnosed
on the basis o& an annual
oral glucose1tolerance
test or a semiannual
&asting plasma glucose
test, according to the
2007 criteria o& the
$merican Diabetes
$ssociationH a 8alue &or
plasma glucose o& 26
mg per deciliter %7.3mmol per liter' or higher
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in the &asting state or
33 mg per
deciliter %22.2 mmol per
liter' or higher two hours
a&ter a 7+1g oral glucoseload.
-he secondar(H n
addition to the
semiannual
measurements, &asting
plasma glucose was
measured i& symptoms
suggesti8e o& diabetes
de8eloped.
Sample
si=e
7 :ow sample si=e
was determined
and, when
applicable,
e(planation o& any
interim analyses
and stopping rules.
!0 Di dalam jurnal
dijelaskan bahwa yang
mengikuti peneliatian
adalah oarang yang
lebih dari + tahun yang
memenuhi kriteria. Iika
orang tersebut sedang
mengkonsumsi obat
yang dapat mengubahtoleransi glukosa atau
sedang sakit yang
harapan hidupnya
rendah maka orang
tersebut tidak masuk
kriteria
@ 9ligibility criteria
included an age o& atleast + years, a
bodymass nde( %the
weight in kilograms
di8ided by the sFuare o&
the height in meters' o&
or higher % or
higher in $sians', and a
plasma glucose
concentration o& 0+ to2+ mg per deciliter %+.!
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to 6.0 mmol per liter' in
the &asting state %G2+
mg per deciliter in the
$merican ndian clinics'
and23 to 200 mg perdeciliter %7.5 to 22.3
mmol per liter' two
hours a&ter a 7+1g oral
glucose load. -hese
concentrations are
ele8ated but are not
diagnostic o& diabetes
according to the 2007
criteria o& the $merican
Diabetes $ssociation.
Ae&ore Iune 2007, the
criterion &or plasma
glucose in the &asting
state was 233 to 2!0 mg
per deciliter %+.6 to 7.7
mmol per liter', or G2!0
mg per deciliter in the
$merican ndian clinics.
9ligible persons were
e(cluded i& they were
taking medicines known
to alter glucose
tolerance or i& they had
illnesses that could
seriously reduce their
li&e e(pectancy or their
ability to participate in
the trial. ecruitmentwas designed to enroll
appro(imately hal& the
participants &rom racial
or ethnic minority
groups. $ &our1step
screening and
recruitment process was
de8eloped to identi&y
eligible participants.@
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andomi=a
tion 11
SeFuence
generation
5 Method used to
generate the
random allocation
seFuence, including
details o& anyrestriction %egH
blocking,
stratiBcation'
Di dalam jurnal tidak
dijelaskan
andomi=a
tion 11
$llocation
concealme
nt
0 Method used to
implement the
random allocation
seFuence %e.g.,
numbered
containers or
central telephone',
clari&ying whether
the seFuence was
concealed until
inter8entions were
assigned.
1 Di dalam jurnal tidak
dijelaskan
andomi=a
tion 11
mplement
ation
23 ?ho generated the
allocation
seFuence, who
enrolledparticipants, and
who assigned
participants to their
groups.
!0!
>-he ia%etes
Pre#ention Pro+ra
Research Grou! conducted a large,
randomi=ed clinical trial
in8ol8ing adults in the
Jnited States who were
at high risk &or the
de8elopment o& type
diabetes.@
Alinding%masking'
22 ?hether or notparticipants, those
administering the
inter8entions, and
those assessing the
outcomes were
blinded to group
assignment. & done,
how the success o&
blinding was
e8aluated.
!0 Di dalam jurnaldijelaskan bahwa antara
pemberian met&ormin
dan plasebo, keduanya
dibutakan.
>$ssignments to
met&ormin and placebo
were dou%le-%linded.@
>The %linded
treatent phase was
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terminated one year
early, in May 332, on
the ad8ice o& the data
monitoring board, on the
basis o& data obtainedthrough March !2, 332,
the closing date &or this
report.@Statistical
methods
2 Statistical methods
used to compare
groups &or primary
outcome%s'
Methods &or
additional analyses,
such as subgroup
analyses and
adjusted analyses.
!0 Dalam jurnal dijelaskan
bahwa pelakuan secara
acak diambil dari klinik
pusat. :arga nilai P %tak
berubah'
@ andom treatment
assignments were
stratiBed according to
the clinical center.
$ssignments to
met&ormin and placebo
were double1blinded.
-he study design and
analysis &ollowed the
intenion1to1treat
principle. ;ominal%unadjusted' P 8alues
and conBdence inter8als
are reported.@
ResultParticipant
Low
2! low o& participant
through each stage
%a diagram is
stronglyrecommended'.
SpeciBcally, &or
each group report
the number o&
participant
randomly assigned,
recei8ing intended
treatment,
completing the
study protocol, and
!0+ Dalam jurnal dijelaskan
pasrtisipan yang
mengikuti penelitian ini
dan tersaji dalan tabel 2.
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analy=ed &or the
primary outcome.
Discribe protocol
de8iations &rom
study planned,together with
reasons.
ecruitme
nt
2 Dates deBning the
periods o&
recruitment and&ollow up.
!0+ Dalam jurnal dijelaskan
bahwa pengumpulan
partisipan dilakukan daritahun 2006 sampai
2000.
>9ro 66: to 666,
we randomly assigned
!! study participants
to one o& the three
inter8entions %235 to
placebo, 237! tomet&ormin, and 2370 to
the intensi8e li&estyle
inter8ention'.@
>-he participants were
)ollo$ed )or an
a#era+e o) .2; (ears@Aaseline
data
2+ Aaseline
demographic and
clinical
characteristics o&
ech group.
!0+ Data diambil dari orang
mempunyai risiko tinggi
DM dan dimasukkan ke
dalam ! study group.
>Aase1line
characteristics, including
all measured risk &actors
&or diabetes, were
similar among the three
study groups %Ta%le '.@
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;umber
analy=ed
26 ;umber o&
participant
%denominator' in
eah group includedin each analysis and
whether the
analysis was by
>intention N to N
treat.@ State the
result in absolut
number as when
&easible %eg, 23"3,
not +3C'
!0+ Dalam jurnal disebutkan
bahwa yang mengikuti
penelitian ini ada !!
orang
>rom 2006 to 2000, we
randomly assigned !!
study participants to one
o& the three
inter8entions
%235 to placebo, 237!
to met&ormin, and 2370
to the intensi8e li&estyleinter8ention'.@
4utcomes
and
estimation
27 or each primary
and secondary
outcome, a
summary o& result
&or aech group, and
the estimated eect
and itOs precision
%eg, 0+C con8ident
inter8al'.
!07 Dalam jurnal dijelaskan
bahwa mereka
memperkirakan insidensi
DM dalam ! tahun
adalah 5,0C untuk
pemberian plasebo,
2,7C met&ormin, dan
2,C untuk modiBkasi
gaya hidup.
<-he estimated
cumulati8e
incidence o& diabetes at
three years was 5.0
percent, 2.7 percent,
and 2. percent in the
placebo, met&ormin, and
li&estyle1inter8ention
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groups, respecti8ely.
4n the basis o& these
rates, the estimated
number o& persons who
would need to be treated&or three
years to pre8ent one
case o& diabetes during
this period is 6.0 %0+
percent conBdence
inter8al, +. to 0.+' &or
the li&estyle inter8ention
and 2!.0 %0+ percent
conBdence inter8al, 5.7
to !!.0' &or met&ormin.@$ncillary
analyses
25 $dress multiplicity
by reporting any
other analyses
pe&ormed, including
sub group analyses
and adjusted
analyses, indicating
those prespecipied
and thosee(ploratory.
1 Di dalam jurnal tidak
dijelaskan
$d8erse
e8ent
20 $ll important
ad8erse e8ents or
side eects in each
inter8ention group.
!07
32
9&ek samping yang
ditimbulkan dari
penggunaan met&ormin
adalah gangguan
gastrointestinal berupa
diare, kentut, mual
muntah. Sedangkan dari
grup modiBkasi gayahidup adalah
muskuloskeletal
simptom berupa mialgia,
artriris, atau atralgia.
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Coentnterpretati
on
3 nterpretations o&
the result, taking
into account study
hypotheses, sources
o& potential bias orimprecision, and
outcomes.
!05 Dalam jurnal dijelaskan
bahwa hipotesis awal
sejalan dengan hasil dari
penelitian yaitu DM tipe
dapat dicegah ataudihambat
pertumbuhannya pada
seseorang dengan risiko
tinggi.
@ 4ur results support the
hypothesis that type
dibetes can be
pre8ented or delayed inpersons at high risk &or
the disease.@/enerali=ab
ility
2 /enerali=ability
%e(ternal 8alidity' o&
the trial Bndings.
!00 Di dalam jurnal
dijelaskan bahwa
penelitian sebelumnya
tidak menjelaskan
bahwa obat untuk
diabetes e&ekti& untuk
pencegahan, mungkin
karena sampel kecil dan
data kurang
>Pre8ious studies ha8e
not demonstrated that
drugs used to treat
diabetes are eecti8e &or
its pre8ention, perhaps
because o& small
samples and the lack o&
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data on adherence to
the prescribed regimens.
n contrast, met&ormin
was eecti8e in our
study, althoughless sothan the li&estyle
inter8ention.@48erall
e8idence
/eneral
interpretation o& the
result in the conte(t
o& current e8idence.
32 Dalam jurnal dijelaskan
pemberian met&ormin
dan modiBkasi gaya
hidup kali lebih e&ekti&
dalam menunda dan
pencegahan DM tipe .
>n summary, our study
showed that treatment
with met&ormin and
modiBcation o& li&estyle
were two highly eecti8e
means o& delaying or
pre8enting type
diabetes. -he li&estyle
inter8entions was
particularly eecti8e,with one case o&
diabetes pre8ented per
se8en persons treated
&or three years. -hus, it
should also be possible
to delay or pre8ent the
de8elopment o&
complications,
substantially reducingthe indi8idual and public
health burden o&
diabetes.@
T/0RAP" WORKS/00T
Is the research #alid<
2a. ?as the assignment o&
patients randomised)
% √ ' Qes
Coents
2a. Pasien diambil secara acak
dari 7 pusat klinik denganmengambil !! pasien
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2b. ?as the randomisation list
concealed)
2c. ?ere subjects and
clinicians blind R to whichtreatment was being
recei8ed)
% √ ' Qes
% √ ' Qes
nondiabetik namun risiko
tinggi DM.
2b. Pengacakan tidak
dilakukan secara sembunyi.
2c. $ntara subjek dan penelitidibutakan.
a. ?ere all subjects who
entered the trial accounted
&or at its conclution)
b. ?ere they analysed in the
groups to which they were
randomised)
% √ ' Qes
%√ ' Qes
a. Semua partisipan
diperhitungkan dalam hasil
yaitu berjumlah !! orang
dengan rincian plasebo 235,
met&ormin 237!, dan gaya
hidup 2370
b. Diambil dari 7 pusat
klinik secara acak sebanyak
!! orang dengan kriteria
yang memenuhi.
Sesuai dengan tabel 2
!a. $side &rom the
e(perimental treatment, were
the groups treated aFually)
!b. ?ere the groups similar at
the start o& the trial)
%√ ' ;o
% √ ' Qes
!a. Di dalam jurnal tidak
disebutkan
!b. Dari awal sampai akhir
penelitian berjumlah !!
orang dan sebanyak 00,6C
masih hidup.