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7/30/2019 Laporan Journal Reading Blok Indera
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Format Laporan Journal Reading
Judul Tulisan : The Roche European American Cataract Trial (REACT): A
randomized clinical trial to investigate the efficacy of an oral
antioxidant micronutrient mixture to slow progression of age-
related cataract.
Penulis : The REACT Group (Leo T. Chylack, Jr. ;M.D.,Nicholas P.
Brown, F.R.C.Ophth. ; Anthony Bron, F.R.C.Ophth. ; Mark
Hurst, O.D. ; Wolfgang Kpcke, Ph.D. ; UtaThien, Ph.D. ;
Wolfgang Schalch, Ph.D.)
Nama jurnal, volume, nomor dan tahun terbit : Ophthalmic Epidemiology,
Vol.9, No. I, 2002
Analisis PICOPatient : European and American with early cataract.
Intervention : oral antioxidant micronutrient mixture
Comparison : placebo
Outcome : Grup dengan oral antioxidant micronutrient menunjukkan
perlambatan pada progresi opacity lensa yang signifikan dibanding
dengan placebo.
Topik No Keterangan Ditemukan di halaman berapa,
jelaskan
Judul dan abstrak 1 1. Indicate the studys material (ex
plant) and subject (human or
animal)
2. Provide in the abstract an
informative and balanced summary
of what was done and what was
1. subjek penelitian terlihat pada
abstrak bagian patient.
Four-hundred-and-forty-five
patients were eligible; 297
were randomized; 231 (78%) were
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found
1. Menjelaskan subyek penelitian
2. Memberikan ringkasan yang
informatif dan seimbang atas apa
yang dilakukan dan apa yang
ditemukan (hasil) dalam abstrak
followed for two years; 158 (53%)
were followed for three years; 36
(12%) were followed for four years.
Twelve patients died during the trial
(9 on vitamins; 3 on placebo (p =
0.07)). There were no serious safety
issues.
2. untuk perlakuan partisipan terlihat
dalam bagian intervention
After a three-month placebo run-in,
patients were
randomized by clinical center to the
vitamin or placebo groups and
followed every four months.
Sementara hasilnya terlihat di bagian
resultdan conclusion
RESULT. There were no statistically
significant differences between
the treatment groups at baseline.
The characteristics of dropouts and
the mean follow-up times by
treatment group were the
same.After two
years of treatment, there was a
small positive treatment effect in
U.S.
patients (p = 0.0001); after three
years a positive effect was apparent
(p = 0.048) in both the U.S. and the
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U.K. groups. The positive effect
in the U.S. group was even greater
after three years: (IPO = 0.389
(vitamin) vs. IPO = 2.517 (placebo);
p = 0.0001). There was no statisti-
cally significant benefit of treatment
in the U.K. group. In spite of nearly
perfect randomization into
treatment groups, the U.S. and U.K.
cohorts
differed significantly
CONCLUSION.Daily use of the
afore-mentioned micronutrients for
three years produced a small
deceleration in progression of ARC.
Introduksi
Latarbelakang 2 Explain the scientific background
and rationale for the investigation
being reported
Menjelaskan latar belakang yang
ilmiah dan rasional mengapa
penelitian perlu dilakukan
Halaman kedua dan ketiga (50-51). Several studies in the past 10
years have suggested that
antioxidant vitamins (C and E) and
carotenoids reduce the risk of age-
related cataract (ARC). Many of
these publications stressed the
need for prospective, randomized,
double-masked clinical trials of the
efficacy of anti-oxidant vitamins
and micronutrients in slowing
progression
of ARC.
ARC is the leading cause
of blindness worldwide.
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In addition to reducing the
financial expenditures for cataract
surgery, uch treatment could offer
individuals with early cataract the
possibility of avoiding cataract
surgery altogether.
Tujuan 3 State specific objectives,
including any prespecified
hypotheses
Menentukan tujuan spesifik,
termasuk hipotesis yang diajukan.
Halamankedua (50).to determine if oral
supplementation with a mixture of
anti-oxidant micronutrients
[mg/day] b-carotene [18], vitamin C
[750], and vitamin. E [600] could
slow the progression of early age-
related cortical [C], nuclear [NO], or
posterior subcapsular [P] cataract
Bahan dan Cara
Bahan 4 Clearly defined how the material
were collected and prepared
Menjelaskan bagaimana data
dikumpulkan dan disiapkan.
Halaman ketiga (51) pada paragraf
pertama material and methode
patients
Patients were recruited
consecutively from outpatient oph-
thalmology clinics in the United
States (U.S.) and the United
Kingdom
(U.K.). The U.S. center was the
Brigham and Womens Hospital in
Boston; the U.K. centers were the
Nuffield Laboratory of Ophthal-
mology in Oxford and the
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University of Bradford. The tenets
of the
Declaration of Helsinki
23
were followed. Each centers
Human Studies
Committee approved the protocol.
Written informed consent was
obtained from all patients.Of 445
eligible patients, 315 entered into
the
placebo run-in phase of the trial.
The recruitment and randomization
took approximately 1.5 years
(Figures 1 & 2)
Participant Subyek
penelitian
5 Eligibility criteria for participant /
subject
Kriteria subyek penelitian
Halaman ketiga hingga kelima (51-
53). Pada sub-bagian inclusion
criteria dijabarkan kriteria per poinsecara rinci, dan didukung dengan
hasi linklusi/eksklus ipadaFig. 1. Flow
chart.
Inclusion/exclusion criteria to
determine
eligibility were applied during
recruitment. If they were violated,
the
subject was deemed ineligible for
the run-in phase. Each patient [a]
provided written informed consent,
[b] was able to attend for all visits,
and [c] was at least 40 years old.
[d] At least one eye met the follow-
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ing ocular criteria:
1. cataract extraction unlikely
within two years,
2. immature idiopathic senile
cataract present in one or both
eyes,
3. (U.S. patients) presence of
minimal cataract by Lens Opacities
Classification System [LOCS II]
14
criteria: NC, NO, and P grades:
>0, and 1; C grade: >0, and trace,
4. (U.K. patients) presence of
cataract of minimal Oxford grade:
cor-
tical and posterior subcapsular
grades: grade I; nuclear brunes-
cence: grade II; and white nuclearscatter: grade II.
5. If both eyes met the inclusion
criteria, and cataracts were of dif-
ferent types, the cataract type in
the eye with the worse visual
acuity determined the group for
randomization. If an eye had more
than one type of cataract, the
morphological type that in the
clini-
cians opinion was the more
destructive to visual acuity
determined
the group for randomization
6. logMAR acuity 0.5,
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Intervensi 6 Precise details of the intervention
intended for each group and how
and when they were actually
administered
Menjelaskan intervensi yang
dilakukan pada tiap kelompok
perlakuan dengan detail.
Termasuk bagaimana dan kapan
intervensi diberikan.
Halaman kelima (53). Study design,
bagian overview, dipaparkan waktu
dan proses berjalannya penelitian.
The REACT study began on
October 20, 1990 and was
concluded on July 20, 1995. It
began with Visit 1 at the beginning
of
a three-month placebo run-inperiod, after which the patient was
seen for Visit 2 and randomization
was carried out
Halamankeenam (54) bagian length
of trial, berisi rencana alokasi waktu
dan beberapakendala.
The original protocol specified the
length of the trial
as two years with patients
continuing on treatment until the
last ran-
domized patient completed two
years of follow-up. At the ninth
meeting of trial investigators a
formal amendment to the protocol
was
adopted: . . . that the trial be
continued until each subject has
com-
pleted at least 11 visits, which is
equivalent to a treatment duration
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nama metode yang digunakan.
The unit of randomization was the
individual. For
randomization patients were
stratified by clinical center
(Boston,Brad-
ford, Oxford). Each group was
further stratified for randomization
according to cataract class: C, NO,
and P. There was no stratification
according to age. If both eyes of a
patient had mixed cataracts (more
than one class of cataract in a
given lens), then the predominant
cataract type in the eye with the
worse visual acuity determined the
group for randomization. The
treatment allocation (vitamins orplacebo) was given at random in
each of the 9 groups (3 centers 3
classes of cataract).
Randomization was calculated by
Efrons biased
coin method.
Pada kedua bagian method, berisi
pelaksanaannya, siapa saja yang
berhubungan dengan penelitian ini
dan perannya.
Method of allocation concealment
and timing of the assignment The
intervention assignment and the
timing of the assignments were not
known to the participants, center
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administrators, or clinicians until
the
study and data sets were closed.
Method used to separate the
generator from the executor of the
assignment The generator of the
assignment (the individual who
gen-
erated, using a bias-free method,
the listing that identified the inter-
vention assignment for every
participant) was located in Munich,
Germany. The executor of the
assignment (the individual who,
having
determined a participants
eligibility, consulted the
assignment systemfor that participants intervention
designation) was also located in
Munich, Germany. The persons
who prepared the randomization
scheme were not involved in
determining eligibility,
administering
intervention, or assessing
outcomes.
Bagian masking, halaman ketujuh
(55), menjelaskan apa yang menjadi
intervensi yang akan diberikan pada
partisipan, dan sekilas tentang
bagaimana pemberiannya.
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Capsules for this trial were
provided by HLR
and contained 200mg all-rac
alpha-tocopherol acetate (Vitamin
E),
250mg ascorbic acid, and 6mg b-
carotene (in the form of beadlets).
The placebos were identical in
appearance and contained corn oil
as
the major constituent. At each
visit, active or placebo capsules
were
dispensed in one-week blister
packs, enough to cover the
capsule
requirement for the four-month
period between two consecutivevisits.
Three capsules per day were taken
with meals. See Figure 3 for evi-
dence that there was good
compliance with the intervention
schedule
and no apparent vitamin
supplementation by patients on
placebo
Untuk evaluation, halaman ketujuh
(55) berisikan rincian tentang apa
saja yang diukur dan meode atau
cara pengukurannya, hingga halaman
kesembilan (57), data hasil ada pada
tabel-tabel yang ada pada halaman
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62-65, 67, 69-70.
Outcome 7 Clearly defined primary and
secondary outcome measures
and, when applicable, any
methods used to enhance the
quality of measurements (e.g.,
multiple observations, training of
assessors).
Menjelaskan pengukuran
outcome, baik utama maupunsekunder,
Halaman kesembilan (57). Pada
Criteria for Response, bagian main
endpoints, dijelas kanapa yang
utamanya diukur pada penelitian ini,
yaitu progresi kataraknya, dengan
penjelasan. Dalam plasma analyses,
merupakan hal lain yang juga diukur
dalam penelitian ini, adalah
pengukuran semua kandunganplasma selama penelitian, data
lengkap terdapat padaTable 2 di
halaman keempat belas hingga
kelima belas (62-63) danTable 3(64-
65).
Besar sampel 8 Subject number used in the study
Jumlah subyek penelitian.
Terdapat di halaman 61
Table 3 contains baseline data
relevant to this trial for the158 patients who completed the
study (the completers).
Metode statistik 9 Statistical methods used to
compare groups for primary
outcome(s) and other outcome
Metode statistik yang digunakan
untuk membandingkan hasil
kelompok satu dengan yang
kelompok
Halaman kesepuluh hingga kedua
belas (58-60). Pada statistic, bagian
overview, dijelaskan secara ringkas
mengenai metode statistic yang
digunakan, dalam hal ini,yaitu, ITT
(intention-to-treat).Selain itu, juga
dijelaskan hal-hal lain yang
digunakan dalam memperoleh hasil
statistic, yaitu, macam analisis, dan
ketentuan-ketentuan, yang nantinya
akandijelaskan lebih lanjut di
hasil(result).
Hasil
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Alur penelitian 1
0
Defining the periods of study and
follow-up
Menjelaskan waktu penelitian dan
follow-up
Halaman kedua belas hingga ketiga
belas (60-61). Terdapat pada subbab
result, bagian patient population,
sebelumnya sudah digambarkan
pada Figure I, dan patients,
overview berisi pnjelasan ringkas
tentang perekrutan partisipan dan
proses follow-up. Paragraph
selanjutnya merincikan alasanya dan
partisipan yang tidak ikut serta pada
saat masih berjalannya penelitian dan
perbandingannya dengan partisipan
yang berpartisipasi hingga akhir.
Status pasien pada saat awal akan
diberikan intervensi (visitasikedua)
dan setelah selesai penelitian
dijelaskan pada bagian patient
characteristic, dandidukung dengandata padaTable 2danTable 3.
Bagaimana proses pemberian
inervensi dijelaskan pada bagian
treatment delivery, halaman 66.
Outcomedanestima
si
1
1
For each primary and secondary
outcome, a summary of results for
each group .
Untuk tiap outcome utama dan
sekunder, ringkasan atas hasil
bagi tiap kelompok.
Halaman kedelapan belas hingga
keduapuluh tiga (66 71). Pada bagian
outcome analyisis by treatment,
paragraph pertama memaparkan
hasil yang diperoleh, yaitu, terdapat
pengurangan bertambahnya opasitas
pada grup dengan intervens
ipemberian vitamin dibanding grup
dengan placebo.Paragraph
selanjutnya adalah menerang kanapa
yang telah terdata pada table 4 (main
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outcome), table 5 (measures of visual
function), dan table 6 (GEE-
generalized estimation equetion-
analyses). Diterangkan juga keadaan
yang membahayakan yang
ditemukan selama penelitian pada
bagian adverse events.
Diskusi
Interpretasi 1
2
Interpretation of the results, taking
into account study hypotheses,sources of potential bias or
imprecision and the dangers
associated with multiplicity of
analyses and outcomes.
Interpretasi hasil,
memperhitungkan hipotesis
penelitian, sumber bias atau
ketidaktepatan dan bahaya yangberhubungan dengan keragaman
analisis dan outcome.
Halaman kedua puluh tiga hingga
kedua puluh sembilan (71-77). Padaparagraph kedua, After two years of
treatment, there was a small
positive treatment effect in U.S.
patients (p = 0.0001).This positive
effect was even greater after three
years: (IPO = 0.389 (vitamin) vs. IPO
= 2.517 (placebo); p = 0.0001). After
three years of treatment thepositive effect was apparent (p =
0.048) in the entire cohort.
These results suggest that the
daily use of the afore-mentioned
micronutrients for three years
produced a small deceleration in
progression of ARC.
Pada paragraf akhir bagian bawah
halaman kedua puluhdelapan (76),
mengenai bias, We have considered
whether biases affected the REACT
trial and have concluded that they
did not.
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Generalizability 1
3
Generalizability (external validity)
of the trial findings.
Apakah hasil penelitian dapat
digeneralisasikan di masyarakat.
Halamankeduapulusdelapan (75).
The profile suggested that U.K.
subjects were less healthy and less
well-nourished than U.S. subjects.
That the beneficial effect appeared
earlier in the U.S. group than in the
U.K. group is most intriguing and
may be due to the differing healthand nutrition of the two groups.
.the greater benefit of vitamin
treatment was seen in the
population with the less severe
cataract.
The most striking differences
between U.K. patients and U.S.
patients in this trial were the lower
baseline levels of serum vitamins in
the U.K.
Bahwa pada masyarakat, perbedaan
regional atau tempa ttinggal dapat
mempengaruhi besar nilai yang
diperoleh dalam penelitian. Dalam hal
ini lebih terutama karena perbedaan
nutrisi. Selain itu, derajat katarak juga
mempengaruhi, makin ringan maka
nilai dari terapi vitamin lebihbesar.
Jenis katarak cortical (C)
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lebihmenunjukkan nilai efek lebih
besar daripada posterior subcapsular
(P), dannuclear cataract (NO).
Overall evidence 1
4
General interpretation of the
results in the context of current
evidence.
Interpretasi umum terhadap hasil
dalam konteks bukti terkini.
Halamankeduapuluhsembilan (77).
The deceleration may be greater
in C than in P and NO cataract.
The therapeutic effect was greater
in U.S. than U.K. patients and maybe due to the better nutritional
status in the former group.
.the efficacy of vitamin treatment
as a function of the maturity of the
cataract suggested that the
treatment was effective both in
early and moderately advanced
stages of cataract progression.
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