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



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'@

http://www.consort-statement.org/Statement/examples1.htm








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





http://www.consort-statement.org/Statement/examples3a.htm


http://www.consort-statement.org/Statement/examples3b.htm













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













!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





















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 %+.!













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.@



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






































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.
















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 '.@



;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'.


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



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.



Coentnterpretati

on

3 nterpretations o&

the result, taking

into account study

hypotheses, sources

o& potential bias orimprecision, and

outcomes.


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&



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



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.

Analisis Jurnal Blok Endokirn

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