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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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